US20080103572A1 - Implantable medical lead with threaded fixation - Google Patents

Implantable medical lead with threaded fixation Download PDF

Info

Publication number
US20080103572A1
US20080103572A1 US11/591,171 US59117106A US2008103572A1 US 20080103572 A1 US20080103572 A1 US 20080103572A1 US 59117106 A US59117106 A US 59117106A US 2008103572 A1 US2008103572 A1 US 2008103572A1
Authority
US
United States
Prior art keywords
lead
threaded fixation
fixation structure
elongated member
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US11/591,171
Inventor
Martin T. Gerber
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Inc
Original Assignee
Medtronic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic Inc filed Critical Medtronic Inc
Priority to US11/591,171 priority Critical patent/US20080103572A1/en
Assigned to MEDTRONIC, INC. reassignment MEDTRONIC, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GERBER, MARTIN T.
Priority to EP07709826A priority patent/EP2089095B1/en
Priority to PCT/US2007/001962 priority patent/WO2008054445A1/en
Priority to EP11182040A priority patent/EP2422840A1/en
Publication of US20080103572A1 publication Critical patent/US20080103572A1/en
Priority to US16/528,089 priority patent/US10561835B2/en
Priority to US16/790,414 priority patent/US20200179677A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551Spinal or peripheral nerve electrodes
    • A61N1/0558Anchoring or fixation means therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0536Preventing neurodegenerative response or inflammatory reaction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system

Definitions

  • the invention relates to stimulation systems and, more particularly, to stimulation leads in stimulation systems.
  • Electrical stimulation systems may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, or gastroparesis.
  • An electrical stimulation system typically includes one or more stimulation leads coupled to an external or implantable electrical stimulator.
  • the stimulation lead may be percutaneously or surgically implanted in a patient on a temporary or permanent basis such that at least one stimulation electrode is positioned proximate to a target stimulation site.
  • the target stimulation site may be, for example, a spinal cord, pelvic nerve, pudendal nerve, stomach, muscle, or within a brain or other organ of a patient.
  • the electrodes located proximate to the target stimulation site may deliver stimulation therapy to the target stimulation site in the form of electrical signals.
  • Electrical stimulation of a sacral nerve may eliminate or reduce some pelvic floor disorders by influencing the behavior of the relevant structures, such as the bladder, sphincter and pelvic floor muscles.
  • Pelvic floor disorders include urinary incontinence, urinary urge/frequency, urinary retention, pelvic pain, bowel dysfunction, and male and female sexual dysfunction.
  • the organs involved in bladder, bowel, and sexual function receive much of their control via the second, third, and fourth sacral nerves, commonly referred to as S2, S3 and S4 respectively.
  • a stimulation lead is implanted proximate to the sacral nerve(s).
  • Occipital nerves such as a lesser occipital nerve, greater occipital nerve or third occipital nerve, exit the spinal cord at the cervical region, extend upward and towards the sides of the head, and pass through muscle and fascia to the scalp. Pain caused by an occipital nerve, e.g. occipital neuralgia, may be treated by implanting a lead proximate to the occipital nerve to deliver stimulation therapy.
  • a stimulation lead In many stimulation applications, including stimulation of a sacral nerve, it is desirable for a stimulation lead to resist migration following implantation. For example, it may be desirable for the electrodes disposed at a distal end of the implantable medical lead to remain proximate to a target stimulation site in order to provide adequate and reliable stimulation of the target stimulation site. In some applications, it may also be desirable for the electrodes to remain substantially fixed in order to maintain a minimum distance between the electrode and a nerve in order to help prevent inflammation to the nerve and in some cases, unintended nerve damage. Securing the stimulation lead at the target stimulation site may minimize lead migration.
  • the disclosure is directed toward securing electrodes of a medical lead adjacent to a target tissue site with a threaded fixation structure configured to engage tissue within a patient to resist migration of the medical lead.
  • the medical lead may be similar to a “screw” or “auger-like.”
  • the threaded fixation structure defines one or more threads disposed circumferentially about the outer surface of a lead body.
  • the threads of the threaded fixation structure may be arranged in a helical pattern.
  • a clinician may rotate the entire lead to “screw” the lead into the tissue of the patient until electrodes of the lead reside adjacent to a target tissue. In this manner, the threaded fixation structure secures the lead within the patient to resist lead migration.
  • the threaded fixation structure may allow a fine adjustment mechanism for the depth of the elongated member within the tissue.
  • the threaded fixation structure may be disposed on a portion of the lead proximal to or distal to the electrodes of the lead or over the portion of the lead that includes the electrodes. In some cases, the entire distal end of the lead may include the threaded fixation structure to engage a greater area of tissue. In other embodiments, the threaded fixation structure may be used with drug delivery catheters instead of electrical stimulation leads.
  • the disclosure is directed to a medical lead that includes an elongated member having a proximal end and a distal end, at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead, and at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
  • the disclosure is directed to method that includes inserting a medical lead into a patient, wherein the lead comprises at least one stimulation electrode and at least one threaded fixation structure extending around a portion of an outer surface of the lead, and rotating the lead to engage the threaded fixation structure with tissue of the patient to resist migration of the lead.
  • the disclosure is directed to a system that includes a medical lead having an elongated member having a proximal end and a distal end, at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead, and at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
  • the system also includes a stimulator that delivers electrical stimulation therapy to a patient via the medical lead within the patient.
  • the disclosure is directed to an apparatus that includes an elongated member having a proximal end and a distal end, a conduit disposed within the elongated member, an exit port disposed on an outer surface of the elongated member in fluidic communication with the conduit, and at least one threaded fixation structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
  • the disclosure may provide one or more advantages.
  • the threaded fixation structure may be engaged to the adjacent tissue of the patient and still allow the clinician to advance or retract the lead to finely adjust the lead position.
  • a sheath may also be used to cover the threaded fixation structure until the clinician desires to expose the threaded fixation structure to the adjacent tissue, and the sheath may collapse the threaded fixation structure to reduce the lead diameter until lead fixation is desired.
  • the clinician may remove the lead by rotating the lead and reducing tissue trauma.
  • FIG. 1A is a schematic perspective view of a therapy system including an electrical stimulator coupled to a stimulation lead that has been implanted in a body of a patient proximate to a target stimulation site.
  • FIG. 1B is an illustration of the implantation of a stimulation lead at a location proximate to an occipital nerve.
  • FIG. 2 is a block diagram illustrating various components of an electrical stimulator and an implantable lead.
  • FIGS. 3A and 3B are perspective drawings of a sheath that covers a lead prior to implantation and is removed after the lead is correctly positioned in a patient.
  • FIGS. 4A-4C are perspective drawings illustrating exemplary stimulation leads with varying configurations of threaded fixation mechanisms.
  • FIGS. 5A-5B are perspective drawings illustrating exemplary stimulation leads with varying threaded fixation mechanisms over electrodes of the lead.
  • FIG. 6 is a perspective drawing illustrating an exemplary stimulation lead with threads from the distal tip to a location proximal to electrodes.
  • FIG. 7 is a perspective drawing illustrating an exemplary stimulation lead with torsional reinforcement members within the elongated member.
  • FIGS. 8A and 8B are perspective drawings illustrating exemplary stimulation leads with foldable threads.
  • FIG. 9 is a flow diagram illustrating an exemplary process for securing a threaded lead to a tissue of a patient.
  • FIG. 10 is a flow diagram illustrating an exemplary process for removing a threaded lead from a tissue of a patient.
  • FIG. 11 is a flow diagram illustrating an exemplary process for securing a lead with folding threads to a tissue of a patient.
  • FIGS. 12A and 12B are perspective drawings illustrating exemplary medical catheters with a helical threaded structure.
  • FIGS. 13A and 13B are cross-sectional end views of a keyed stylet and reciprocally keyed medical lead.
  • the medical leads described herein include a threaded fixation mechanism that secures the medical lead within a tissue of a patient.
  • the threaded fixation mechanism prevents the electrodes of the lead from migrating away from the target stimulation tissue, which may lead to a reduction in therapy efficacy.
  • the threaded fixation mechanism includes a thread structure disposed around the outer surface of the elongated member, such that the lead resembles a “screw” or “auger” device that advances or retreats when rotated.
  • the threaded fixation mechanism may allow the clinician to finely adjust the elongated member location, in contrast to other medical lead fixation structures such as tines or adhesives.
  • the threads may be arranged in a helical pattern, but other types of thread patterns may also be used to secure the lead.
  • the threaded fixation mechanism may be referred to as a threaded fixation structure for purposes of illustration.
  • other non-helical thread patterns may be used in some embodiments.
  • the thread structure may be disposed distal to the electrodes, proximal to the electrodes, and/or at the same axial position of the electrodes.
  • the threaded fixation structure may be disposed on a tapered tip at the distal end of the elongated member to begin the engagement and tunneling of the lead through the tissue when the lead is rotated to secure the threaded fixation structure.
  • the thread structure may not engage the adjacent tissue until the user, e.g. a clinician, desires the structure to do so.
  • a sheath may be configured to cover the elongated member and thread structure for lead insertion and be removed to allow the threaded fixation structure to contact the adjacent tissue.
  • the thread structure may fold down against the elongated member outer surface when constricted by the sheath.
  • the threaded fixation structure extends away from the elongated member and returns to its original thread shape to secure the lead.
  • the thread structure may have elastic, super-elastic, or shape memory properties that cause it to assume an extended position when a sheath or other restraint mechanism is removed to expose the thread structure.
  • the medical lead may not include electrodes on the elongated member.
  • the medical lead may be a catheter that delivers a therapeutic agent through one or more lumens in the elongated member, while the threaded fixation structure secures the location of the catheter.
  • the lumen may end at one or more exit ports near the distal end of the elongated member, and the exit ports may be disposed in an axial or longitudinal outer surface of the elongated member.
  • FIG. 1A a schematic perspective view of therapy system 10 , which includes electrical stimulator 12 coupled to stimulation lead 14 , which has been implanted in body 16 of a patient proximate to target stimulation site 18 .
  • Electrical stimulator 12 provides a programmable stimulation signal (e.g., in the form of electrical pulses or substantially continuous-time signals) that is delivered to target stimulation site 18 by stimulation lead 14 , and more particularly, via one or more stimulation electrodes carried by lead 14 .
  • Electrical stimulator 12 may be either implantable or external.
  • electrical stimulator 12 may be subcutaneously implanted in the body of a patient 16 (e.g., in a chest cavity, lower back, lower abdomen, or buttocks of patient 16 ).
  • Electrical stimulator 12 may also be referred to as a pulse or signal generator, and in the embodiment shown in FIG. 1A , electrical stimulator 12 may also be referred to as a neurostimulator.
  • lead 14 may also carry one or more sense electrodes to permit stimulator 12 to sense electrical signals from target stimulation site 18 .
  • stimulator 12 may be coupled to two or more leads, e.g., for bilateral or multi-lateral stimulation.
  • Lead 14 further includes a lead body, or elongated member, and one or more threaded fixation structures (not shown in FIG. 1 ) which engage with tissue proximate to target stimulation site 18 to substantially fix a position of lead 14 proximate to target stimulation site 18 .
  • the threaded fixation structure is rotated during implantation to engage with tissue adjacent to target stimulation site 18 .
  • Proximal end 14 A of lead 14 may be both electrically and mechanically coupled to connector 13 of stimulator 12 either directly or via a lead extension.
  • lead 14 may include electrical contacts near proximal end 14 A to electrically connect conductors disposed within the elongated member to stimulation electrodes (and sense electrodes, if present) at a position adjacent to distal end 14 B of lead 14 to stimulator 12 .
  • Lead 14 may be connected directly or indirectly (e.g., via a lead extension) to stimulator 12 .
  • target stimulation site 18 is proximate to the S3 sacral nerve, and lead 14 has been introduced into the S3 sacral foramen 22 of sacrum 24 to access the S3 sacral nerve. Stimulation of the S3 sacral nerve may help treat pelvic floor disorders, urinary control disorders, fecal control disorders, interstitial cystitis, sexual dysfunction, and pelvic pain. Therapy system 10 , however, is useful in other stimulation applications.
  • target stimulation site 18 may be a location proximate to any of the other sacral nerves in body 16 or any other suitable nerve in body 16 , which may be selected based on, for example, a therapy program selected for a particular patient.
  • therapy system 10 may be used to deliver stimulation therapy to pudendal nerves, perineal nerves, or other areas of the nervous system, in which cases, lead 14 would be implanted and substantially fixed proximate to the respective nerve.
  • lead 14 may be positioned for temporary or chronic spinal cord stimulation for the treatment of pain, for peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve stimulation, intercostal nerve stimulation, gastric stimulation for the treatment of gastric mobility disorders and obesity, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles), for mitigation of other peripheral and localized pain (e.g., leg pain or back pain), or for deep brain stimulation to treat movement disorders and other neurological disorders.
  • FES functional electrical stimulation
  • a stimulation lead 14 in accordance with the invention may be adapted for application to a variety of electrical stimulation applications.
  • Migration of lead 14 following implantation may be undesirable, and may have detrimental effects on the quality of therapy delivered to a patient 16 .
  • migration of lead 10 may cause displacement of electrodes carried by lead 14 to a target stimulation site 18 .
  • the electrodes may not be properly positioned to deliver the therapy, possibly undermining therapeutic efficacy of the stimulation therapy from system 10 .
  • Substantially fixing lead 14 to surrounding tissue may help discourage lead 14 from migrating from target stimulation site 18 following implantation, which may ultimately help avoid harmful effects that may result from a migrating stimulation lead 14 .
  • the invention provides lead 14 with a thread structure (not shown in FIG. 1 ) disposed around the elongated member of lead 14 to provide fixation between lead 14 and tissue surrounding lead 14 , such as tissue within sacrum 16 in the example of FIG. 1A .
  • the thread structure may have a helical pattern that permits lead 14 to be, in effect, screwed into a tissue site.
  • using a threaded fixation structure to secure lead 14 in patient 16 may be beneficial in a minimally invasive surgery, which may allow for reduced pain and discomfort for patient 16 relative to invasive surgery, as well as a quicker recovery time.
  • the threaded fixation structure is disposed around the outer surface of the elongated body near the distal end of lead 14 and configured to engage with the adjacent tissue to prevent lead 14 movement.
  • Implanting lead 14 with the threaded fixation structure may be completed via a few methods.
  • the clinician may rotate lead 14 to advance lead 14 toward target stimulation sire 18 and utilize the threaded fixation structure to engage the adjacent tissue.
  • a sheath (not shown in FIG. 1A ) may be used initially to cover lead 14 and the included threaded fixation structure to allow the clinician to insert lead 14 into patient 16 until direct insertion is no longer possible.
  • the clinician may remove the sheath to expose the threaded fixation structure and then rotate lead 14 to advance lead 14 the rest of the distance towards target stimulation site 18 .
  • the rotation of lead 14 may be achieved directly by rotating the lead body, or by a stylet or other device that is inserted into an inner lumen of the lead to engage the lead.
  • the stylet may have a keyed structure, such as one or more longitudinal flanges, ribs, teeth or grooves that engage reciprocal structure in the inner lumen of the lead.
  • a keyed stylet may be inserted to engage the distal end of the lead and lock into interior grooves or teeth to facilitate the rotation of the lead.
  • reciprocal teeth or grooves, or the like may rotationally bear against each other such that rotation of the stylet causes rotation of the lead in the same direction.
  • the threaded fixation structure may be foldable against the elongated member of lead 14 when covered by the sheath.
  • the threaded fixation structure may stand up, or extend, away from the elongated member to its original shape.
  • the clinician may then rotate lead 14 to advance lead 14 to target stimulation site 18 . In either case, the thread tends to “bite” into the surrounding tissue to resist migration of the lead from the target stimulation site.
  • Patient programmer 28 may include a clinician programmer 26 and a patient programmer 28 .
  • Clinician programmer 26 may be a handheld computing device that permits a clinician to program stimulation therapy for patient 16 , e.g., using input keys and a display.
  • the clinician may specify stimulation parameters for use in delivery of stimulation therapy.
  • Clinician programmer 26 supports telemetry (e.g., radio frequency telemetry) with stimulator 12 to download stimulation parameters and, optionally, upload operational or physiological data stored by stimulator 12 . In this manner, the clinician may periodically interrogate stimulator 12 to evaluate efficacy and, if necessary, modifies the stimulation parameters.
  • telemetry e.g., radio frequency telemetry
  • patient programmer 28 may be a handheld computing device.
  • Patient programmer 28 may also include a display and input keys to allow patient 16 to interact with patient programmer 28 and implantable stimulator 12 .
  • patient programmer 28 provides patient 16 with an interface for control of stimulation therapy by stimulator 12 .
  • patient 16 may use patient programmer 28 to start, stop or adjust stimulation therapy.
  • patient programmer 28 may permit patient 16 to adjust stimulation parameters such as duration, amplitude, pulse width and pulse rate, within an adjustment range specified by the clinician via clinician programmer 28 , or select from a library of stored stimulation therapy programs.
  • Stimulator 12 , clinician programmer 26 , and patient programmer 28 may communicate via cables or a wireless communication, as shown in FIG. 2 .
  • Clinician programmer 26 and patient programmer 28 may, for example, communicate via wireless communication with stimulator 12 using radio frequency (RF) telemetry techniques known in the art.
  • Clinician programmer 26 and patient programmer 28 also may communicate with each other using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, or other standard or proprietary telemetry protocols.
  • FIG. 1B is a conceptual illustration of an alternative implantation site to the implantation of FIG. 1A .
  • Therapy system 10 may also be used to provide stimulation therapy to other nerves of a patient 16 .
  • lead 14 may be implanted and fixated with the two or more threaded fixation members proximate to an occipital region 29 of patient 30 for stimulation of one or more occipital nerves.
  • lead 14 may be implanted proximate to lesser occipital nerve 32 , greater occipital nerve 34 , and third occipital nerve 36 .
  • FIG. 1B is a conceptual illustration of an alternative implantation site to the implantation of FIG. 1A .
  • Therapy system 10 may also be used to provide stimulation therapy to other nerves of a patient 16 .
  • lead 14 may be implanted and fixated with the two or more threaded fixation members proximate to an occipital region 29 of patient 30 for stimulation of one or more occipital nerves.
  • lead 14 is aligned to be introduced into introducer needle 38 and implanted and anchored or fixated with fixation elements proximate to occipital region 29 of patient 30 for stimulation of one or more occipital nerves 32 , 34 , and/or 36 .
  • a stimulator e.g., stimulator 12 in FIG. 1A
  • lead 14 may be positioned proximate to one or more other peripheral nerves proximate to occipital nerves 32 , 34 , and 36 of patient 30 , such as nerves branching from occipital nerves 32 , 34 , and 36 , as well as stimulation of any other suitable nerve, organ, muscle, muscle group or other tissue site within patient 30 , such as, but not limited to, nerves within a brain, pelvis, stomach or spinal cord of patient 30 .
  • Implantation of lead 14 may involve the subcutaneous placement of lead 14 transversely across one or more occipital nerves 32 , 34 , and/or 36 that are causing patient 30 to experience pain.
  • a vertical skin incision 33 approximately two centimeters in length is made in the neck of patient 30 lateral to the midline of the spine at the level of the C1 vertebra. The length of vertical skin incision 33 may vary depending on the particular patient.
  • patient's skin and muscle are separated by a band of connective tissue referred to as fascia.
  • Introducer needle 38 is introduced into the subcutaneous tissue, superficial to the fascia and muscle layer but below the skin.
  • Occipital nerves 32 , 34 , and 36 are located within the cervical musculature and overlying fascia, and as a result, introducer needle 38 and, eventually, lead 14 are inserted superior to occipital nerves 32 , 34 , and 36 .
  • introducer needle 38 Once introducer needle 38 is fully inserted, lead 14 may be advanced through introducer needle 38 and positioned to allow stimulation of the lesser occipital nerve 32 , greater occipital nerve 34 , third occipital nerve 36 , and/or other peripheral nerves proximate to an occipital nerve. Upon placement of lead 14 , introducer needle 38 may be removed. In some embodiments, introducer needle 38 may be used to remove lead 14 after stimulation therapy is no longer needed.
  • lead 14 may employ the threaded fixation structure to secure lead 14 within patient 16 .
  • the threaded fixation structure may only extend from the elongated body of lead 14 a small distance to minimize patient detection of the threaded fixation structure at superficial implant locations.
  • the thread structure may be sized so as not to protrude excessively into the superficial tissues, thereby avoiding skin deformations and potential tissue erosion and damage.
  • lead 14 has been generally described as an electrical lead that includes electrodes
  • lead 14 may, in other embodiments, be a drug delivery catheter that delivers therapeutic agents to target stimulation site 18 ( FIG. 1A ) or occipital nerves 32 , 34 or 36 .
  • stimulator 12 is a drug pump that controls the delivery of therapeutic agent to patient 16 .
  • the drug delivery catheter embodiment of lead 14 may include an exit port for the therapeutic agent that is disposed on any surface of lead 14 , adjacent to or within the threaded fixation structure.
  • FIG. 2 is a block diagram illustrating various components of implantable stimulator 12 and an implantable lead 14 .
  • Stimulator 12 includes therapy delivery module 40 , processor 42 , memory 44 , telemetry module 46 , and power source 47 .
  • stimulator 12 may also include a sensing circuit (not shown in FIG. 2 ).
  • Implantable lead 14 includes elongated member 48 extending between proximal end 48 A and distal end 48 B. Elongated member 48 may also be described as an elongated member. Elongated member 48 may be a cylindrical or may be a paddle-shaped (i.e., a “paddle” lead).
  • Electrodes 50 A, 50 B, 50 C, and 50 D are disposed on elongated member 48 adjacent to distal end 48 B of elongated member 48 .
  • electrodes 50 are disposed on elongated member 48 adjacent to distal end 48 B of elongated member 48 .
  • threaded fixation structures are omitted from lead 14 for ease of illustration.
  • Stimulator 12 delivers stimulation therapy via electrodes 50 of lead 14 .
  • implantable signal generator within therapy delivery module 40 delivers electrical signals to patient 16 ( FIG. 1A ) via at least some of electrodes 50 under the control of a processor 42 .
  • the stimulation energy generated by therapy delivery module 40 may be formulated as stimulation energy, e.g., for treatment of any of a variety of neurological disorders, or disorders influenced by patient neurological response.
  • the signals may be delivered from therapy delivery module 40 to electrodes 50 via a switch matrix and conductors carried by lead 14 and coupled to respective electrodes 50 .
  • electrodes 50 may be ring electrodes. In other embodiments, electrodes 50 may be segmented or partial ring electrodes, each of which extends along an arc less than 360 degrees (e.g., 90-120 degrees) around the circumference of elongated member 48 . In embodiments in which lead 14 is a paddle lead, electrodes 50 may extend along a portion of the periphery defined by elongated member 48 . Electrodes 50 are electrically coupled to a therapy delivery module 40 of stimulator 12 via conductors within elongated member 48 .
  • Electrodes 50 extending around a portion of the circumference of lead body 48 or along one side of a paddle lead may be useful for providing an electrical stimulation field in a particular direction/targeting a particular therapy delivery site.
  • electrodes 50 may be disposed along lead body 48 such that the electrodes face toward occipital nerves 32 , 34 , and/or 36 , or otherwise away from the scalp of patient 30 . This may be an efficient use of stimulation because electrical stimulation of the scalp may provide minimally useful therapy, if any, to patient 30 .
  • segmented or partial ring electrodes 50 may also reduce the overall power delivered to electrodes 50 by stimulator 12 because of the efficient delivery of stimulation to occipital nerves 32 , 34 , and/or 36 (or other target stimulation site) by eliminating or minimizing the delivery of stimulation to unwanted or unnecessary regions within patient 30 .
  • the configuration, type, and number of electrodes 28 illustrated in FIG. 2 are merely exemplary.
  • lead 14 may include one or more orientation markers 45 proximate to proximal end 14 A that indicate the relative location of electrodes 50 .
  • Orientation marker 45 may be a printed marking on lead body 48 , an indentation in lead body 48 , a radiographic marker, or another type of marker that is visible or otherwise detectable (e.g., detectable by a radiographic device) by a clinician.
  • Orientation marker 45 may help a clinician properly orient lead 14 such that electrodes 50 face the desired direction (e.g., toward occipital nerves 32 , 34 , and/or 36 ) within patient 16 .
  • orientation marker 45 may also extend around the same portion of the circumference of lead body 48 or along the side of the paddle lead as electrodes 50 . In this way, orientation marker 45 faces the same direction as electrodes, thus indicating the orientation of electrodes 50 to the clinician. When the clinician implants lead 14 in patient 16 , orientation marker 45 may remain visible to the clinician.
  • Stimulator 12 delivers stimulation therapy via electrodes 50 of lead 14 .
  • an implantable signal generator or other stimulation circuitry within therapy delivery module 40 delivers electrical signals (e.g., pulses or substantially continuous-time signals, such as sinusoidal signals) to targets stimulation site 18 ( FIG. 1A ) via at least some of electrodes 50 under the control of a processor 42 .
  • the stimulation energy generated by therapy delivery module 40 may be formulated as stimulation energy, e.g., for treatment of any of a variety of neurological disorders, or disorders influenced by patient neurological response.
  • the signals may be delivered from therapy delivery module 40 to electrodes 50 via a switch matrix and conductors carried by lead 14 and electrically coupled to respective electrodes 50 .
  • the implantable signal generator may be coupled to power source 47 .
  • Power source 47 may take the form of a small, rechargeable or non-rechargeable battery, or an inductive power interface that transcutaneously receives inductively coupled energy. In the case of a rechargeable battery, power source 47 similarly may include an inductive power interface for transcutaneous transfer of recharge power.
  • Processor 42 may include a microprocessor, a controller, a DSP, an ASIC, an FPGA, discrete logic circuitry, or the like.
  • Processor 42 controls the implantable signal generator within therapy delivery module 40 to deliver stimulation therapy according to selected stimulation parameters.
  • processor 42 controls therapy delivery module 40 to deliver electrical signals with selected amplitudes, pulse widths (if applicable), and rates specified by the programs.
  • processor 42 may also control therapy delivery module 40 to deliver the stimulation signals via selected subsets of electrodes 50 with selected polarities.
  • electrodes 50 may be combined in various bipolar or multi-polar combinations to deliver stimulation energy to selected sites, such as nerve sites adjacent the spinal column, pelvic floor nerve sites, or cranial nerve sites.
  • processor 42 may control therapy delivery module 40 to deliver each signal according to a different program, thereby interleaving programs to simultaneously treat different symptoms or provide a combined therapeutic effect.
  • stimulator 12 may be configured to deliver stimulation therapy to treat other symptoms such as pain or incontinence.
  • Memory 44 of stimulator 12 may include any volatile or non-volatile media, such as a RAM, ROM, CD-ROM, NVRAM, EEPROM, flash memory, and the like.
  • memory 44 of stimulator 12 may store multiple sets of stimulation parameters that are available to be selected by patient 16 or a clinician for delivery of stimulation therapy.
  • memory 44 may store stimulation parameters transmitted by clinician programmer 26 ( FIG. 1A ).
  • Memory 44 also stores program instructions that, when executed by processor 42 , cause stimulator 12 to deliver stimulation therapy. Accordingly, computer-readable media storing instructions may be provided to cause processor 42 to provide functionality as described herein.
  • processor 42 controls telemetry module 170 to exchange information with an external programmer, such as clinician programmer 26 and/or patient programmer 28 ( FIG. 1A ), by wireless telemetry.
  • telemetry module 46 supports wireless communication with one or more wireless sensors that sense physiological signals and transmit the signals to stimulator 12 .
  • therapy delivery module 40 may include a fluid pump or other release mechanism to dispense a therapeutic agent through lead 14 and into patient 16 .
  • Therapy deliver module 40 may also, in this case, include a fluid reservoir which contains the therapeutic agent.
  • Possible therapeutic agents may include pharmaceutical agents, insulin, a pain relieving agent or a gene therapy agent. Refilling the fluid reservoir may be accomplished by inserting the needle of a syringe through the skin of patient 16 and into a refill port in the housing of stimulator 12 .
  • more than one lead may be coupled to therapy delivery module 40 .
  • FIGS. 3A and 3B are perspective drawings of a sheath that covers a lead prior to implantation and removed after the lead is correctly positioned in a patient, which includes a lead that includes a threaded fixation structure.
  • lead 52 is capable of delivering electrical stimulation to numerous tissue sites within patient 16 .
  • Lead 52 may be an embodiment of any lead described herein, including lead 14 .
  • elongated member 54 of lead 52 Prior to delivering stimulation, elongated member 54 of lead 52 is covered completely around the longitudinal outer surface with sheath 58 .
  • Sheath 58 may be constructed to protect electrodes 56 and threaded fixation structure 57 from implantation stresses or damage of adjacent tissues.
  • sheath 58 may be a restraint mechanism that keeps threaded fixation structure 57 from being deployed until the clinician removed the sheath.
  • Electrodes 56 are typically ring electrodes, but other types of electrodes may be used. For example, segmented electrodes, or multiple electrodes around the circumference of elongated member 54 may be employed.
  • lead 52 may be in a non-circular shape, such as a rectangular paddle lead.
  • lead 52 may also include one or more radio-opaque markers that allow the clinician to image the lead in real time to determine the exact position of the lead within patient after rotating the lead.
  • Sheath 58 may be constructed of a flexible polymer that provides a smooth interface between the sheath and elongated member 54 .
  • Sheath 58 may be dimensioned just larger than elongated member 54 , or the sheath may be shrunk to fit elongated member 54 snugly for implantation.
  • sheath 58 may constructed to assist the clinician in guiding lead 52 within patient 16 .
  • sheath 58 may be rigid or semi-rigid and similar to a lead introducer or a cannula introduction device.
  • FIG. 3B shows lead 52 with sheath 58 being removed from elongated member 54 in the direction of the arrow.
  • the clinician may begin removing lead 52 as shown.
  • threaded fixation structure 57 is exposed to the adjacent tissue to fix elongated member 54 in position.
  • the clinician may remove sheath 58 in sections as fixation elements need to be deployed or as necessary to ensure proper fixation within patient 16 .
  • threaded fixation structure 57 may have different dimensions, sizes, locations, and properties than shown in FIGS. 3A and 3B .
  • FIGS. 4A-4C are perspective drawings illustrating exemplary stimulation leads with varying configurations of threaded fixation mechanisms.
  • lead 60 includes elongated member 62 , electrodes 64 , tapered tip 68 , and threaded fixation structure 70 .
  • the distal end of lead 60 is shown.
  • Elongated member 62 is substantially cylindrical in shape, but the elongated member may also be configured into any other shape.
  • Electrodes 64 are ring electrodes disposed at the distal end of elongated member 62 .
  • tapered, conical tip 68 is attached to, or integrally formed with, elongated member 62 .
  • Threaded fixation structure 70 is disposed distal to electrodes 64 and around the outer surface of tapered tip 68 .
  • Tapered tip 68 is formed in the shape of a cone to facilitate the tunneling of lead 60 through tissue in order to reach the target tissue.
  • Threaded fixation structure 70 is disposed around the outer surface of tapered tip 68 from adjacent to the distal end of the tapered tip to the distal end of elongated member 62 . In this manner, threaded fixation structure 70 engages with the adjacent tissue of patient 16 as tapered tip 68 pierces through the tissue.
  • threaded fixation structure 70 advances the lead through the adjacent tissue and moves electrodes 64 increasingly closer to a target tissue with each turn of the lead.
  • threaded fixation structure 70 may only be disposed along a portion of tapered tip 68 .
  • Threaded fixation structure 70 may be constructed of a material similar to or different from elongated member 62 or tapered tip 68 .
  • the material of threaded fixation structure 70 may be substantially biologically inert, e.g., biocompatible, and may include any of metals, metal alloys, composites, or polymers. Some example materials may include stainless steel, titanium, nitinol, polypropylene, polyurethane, polycarbonate, polyethylene, nylon, silicone rubber, or expanded-polytetrafluoroethylene.
  • the material selection of threaded fixation structure 70 may be based upon whether the structure is desired to be rigid, semi-rigid, or flexible properties, which could affect the engagement of the structure to the adjacent material.
  • threaded fixation structure 70 may be a combination of different materials depending on the implantation site.
  • threaded fixation structure 70 may have a flexible distal portion that changes to a rigid portion for precise engagement with the adjacent tissue.
  • Threaded fixation structure 70 may be adhered to tapered tip 68 through a glue, an epoxy, welding, soldering, or any other attachment mechanism.
  • threaded fixation structure 70 may be an overmold that is fitted to a snug fit around elongated member 62 .
  • threaded fixation structure 70 may be formed with tapered tip 68 .
  • threaded fixation structure 70 may have a cross-sectional shape configured to assist the advancement of lead 60 through the adjacent tissue.
  • the cross-sectional shape of each thread may generally be a triangle, but other shapes are possible.
  • the cross-sectional shape of threaded fixation structure 70 may be a rounded triangle, a semi-circle, a square, a rectangle, a trapezoid, or any other shape desired by the clinician.
  • the cross-sectional shape may be angled in a direction non-perpendicular to the outer surface of tapered tip 68 .
  • threaded fixation structure 70 may be tilted toward the proximal end of lead 60 .
  • the angle between the outer surface of tapered tip 68 and the proximal side of threaded fixation structure 70 may be less than 90 degrees.
  • the angle between the outer surface of tapered tip 68 and the proximal side of threaded fixation structure 70 may be greater than 90 degrees.
  • Threaded fixation structure 70 may also be configured to advance through tissue at a predetermined rate or extend into the tissue a predetermined distance.
  • the pitch of threaded fixation structure 70 may be defined by the distance lead 60 is advanced with each full 360 degree rotation of the lead, i.e., the axial distance between two peaks of the threaded fixation structure.
  • Threaded fixation structure 70 may have a pitch between approximately 0.5 millimeters (mm) and 3 mm. The pitch may be less than approximately 0.5 mm or greater than 3 mm.
  • the height of threaded fixation structure 70 is the distance between the outer surface of tapered tip 68 and the top edge of the threaded fixation structure. Generally, the height is between approximately 0.1 mm and 3 mm.
  • threaded fixation structure 70 may include heights smaller than approximately 0.1 mm or greater than 3 mm. While threaded fixation structure 70 may have a constant height, the threaded fixation structure may increase in height as the threaded fixation structure moves away from the distal end of tapered tip 68 .
  • elongated member 62 may have an outside diameter between approximately 0.5 mm and 5 mm.
  • the wall thickness of elongated member 62 may be between approximately 0.1 mm and 2 mm.
  • the ratio of diameter to thread height may be between approximately 1 and 50, depending on the application of lead 60 .
  • FIG. 4B shows lead 72 , which is an embodiment of lead 60 ( FIG. 4A ).
  • Lead 72 includes elongated member 74 , electrodes 76 , tapered tip 80 , and threaded fixation structure 82 .
  • Lead 72 differs from lead 60 in the shape of tapered tip 80 . While tapered tip 68 is constructed as a cone shape, tapered tip 80 is a parabolic shape with an atraumatic, rounded distal end. Tapered tip 80 may be beneficial if the clinician does not want a tip that may damage adjacent tissue during extreme bends of elongated member 74 . In other embodiments, tapered tip 80 may be configured into a different shape.
  • tapered tip 80 may be curved in any parabolic shape different from that shape of the tapered tip shown in FIG. 4B .
  • tapered tip 80 may be asymmetrical or bent in a predetermined direction to facilitate creating a curved path for lead 72 .
  • FIG. 4C illustrates lead 84 with threaded fixation structure 90 disposed proximal to electrodes 88 .
  • Lead 84 includes elongated member 86 , electrodes 88 and threaded fixation structure 90 .
  • Threaded fixation structure 90 is disposed around the longitudinal outer surface of elongated member 86 , proximal to the location of electrodes 88 .
  • threaded fixation structure 90 may be disposed around the longitudinal outer surface of elongated member 86 at a location distal to electrodes 88 .
  • the distal position of threaded fixation structure 90 may be instead of or in addition to the proximal position of the threaded fixation structure.
  • Threaded fixation structure 90 may include any number of turns around elongated member 86 .
  • threaded fixation structure 90 may include 3 complete turns as shown in FIG. 4C .
  • threaded fixation structure 90 may include more than 3 or less than 3 turns, as desired by the clinician for a particular implantation site.
  • threaded fixation structure 90 may include partial turns, or even continuous structures with less than one complete turn.
  • multiple threaded fixation structures 90 may be disposed proximal to or distal to electrodes 88 .
  • lead 84 may include a tip that has a threaded fixation structure such as tapered tips 68 and 80 of leads 60 and 72 , respectively.
  • Threaded fixation structure 90 may be constructed of a material similar to or different from elongated member 86 .
  • the material of threaded fixation structure 90 may be substantially biologically inert, e.g., biocompatible, and may include any of metals, metal alloys, composites, or polymers. Some example materials may include stainless steel, titanium, nitinol, polypropylene, polyurethane, polycarbonate, polyethylene, nylon, silicone rubber, or expanded-polytetrafluoroethylene.
  • the material selection of threaded fixation structure 90 may be based upon whether the structure is desired to be rigid, semi-rigid, or flexible properties.
  • Threaded fixation structure 90 may be adhered to elongated member 86 through a glue, an epoxy, welding, soldering, or any other attachment mechanism. In other embodiments, threaded fixation structure 90 may be an overmold that is fitted to a snug fit around elongated member 86 . Alternatively, threaded fixation structure 90 may be integrally formed with elongated member 86 , e.g., by injection molding and/or insert molding.
  • threaded fixation structure 90 may have a cross-sectional shape configured to assist the advancement of lead 84 through the adjacent tissue.
  • the cross-sectional shape may generally be a triangle, but other shapes are possible.
  • the cross-sectional shape of threaded fixation structure 90 may be a rounded triangle, a semi-circle, a square, a rectangle, a trapezoid, or any other shape desired by the clinician.
  • the cross-sectional shape may be angled in a direction non-perpendicular to the outer surface of elongated member 86 .
  • threaded fixation structure 90 may be tilted toward the proximal end of lead 84 .
  • the angle between the outer surface of elongated member 86 and the proximal side of threaded fixation structure 90 may be less than 90 degrees.
  • the angle between the outer surface of elongated member 86 and the proximal side of threaded fixation structure 90 may be greater than 90 degrees.
  • Threaded fixation structure 90 may also be configured to advance through tissue at a predetermined rate or extend into the tissue a predetermined distance.
  • the pitch of threaded fixation structure 90 may be defined by the distance lead 84 is advanced with each full 360 degree rotation of the lead, i.e., the axial distance between two peaks of the threaded fixation structure.
  • Threaded fixation structure 90 may have a pitch between approximately 0.5 millimeters (mm) and 3 mm. In some embodiments, the pitch may be less than approximately 0.5 mm or greater than 3 mm.
  • the height of threaded fixation structure 90 is the distance between the outer surface of elongated member 86 and the top edge of the threaded fixation structure. Generally, the height is between approximately 0.1 mm and 3 mm.
  • threaded fixation structure 90 may include heights smaller than approximately 0.1 mm or greater than 3 mm. As threaded fixation structure 90 increases in height, the surface area of the threaded fixation structure increases as well. A larger surface area of threaded fixation structure 90 may increase the axial force lead 84 may be able to incur without allowing the lead to migrate in the direction of the axial force. In other words, a larger height of threaded fixation structure 90 may be desired in cases where lead 84 is subjected to greater movement. While threaded fixation structure 90 may have a constant height, the threaded fixation structure may increase in height as it moves towards the proximal end of the threaded fixation structure.
  • Elongated member 62 may have an outside diameter between approximately 0.5 mm and 5 mm.
  • the wall thickness of elongated member 62 may be between approximately 0.1 mm and 2 mm.
  • the ratio of diameter to thread height may be between approximately 1 and 50, depending on the application of lead 60 .
  • Implantation of all leads 60 , 72 , and 84 may vary depending on the target stimulation site within patient 16 or implant preferences of the clinician.
  • a sheath shown in FIGS. 3A and 3B
  • the clinician may remove the sheath and begin rotating the lead to engage to recently exposed threaded fixation structure.
  • the clinician may guide and rotate the lead through a substantial length of the insertion of the lead without the use of a sheath.
  • FIGS. 5A-5B are perspective drawings illustrating exemplary stimulation leads with varying threaded fixation mechanisms over electrodes of the lead.
  • lead 92 includes elongated member 94 , electrodes 96 , and threaded fixation structure 98 , a fixation structure.
  • Threaded fixation structure 98 is shown to be disposed around the same portion of elongated member 94 that includes electrodes 96 . In this manner, threaded fixation structure 98 is located over a portion of the surface of each electrode 96 as the threaded fixation structure rotates from the proximal end of the threaded fixation structure to the distal end of the threaded fixation structure.
  • Threaded fixation structure 98 may provide for reduced movement of electrodes 96 with respect to the target tissue, compared to threaded fixation structures located elsewhere along the longitudinal outer surface of lead 92 .
  • Threaded fixation structure 98 may be constructed similar to and have similar physical properties of threaded fixation structure 90 of FIG. 4C .
  • Threaded fixation structure 98 may attached to electrodes 96 with an adhesive or other bonding technique, while some embodiments may not have the threaded fixation structure attached to the electrodes.
  • threaded fixation structure 98 is shown to be substantially disposed around the entire portion of elongated member 94 that includes electrodes 96 , the threaded fixation structure may also be disposed further in the proximal or distal direction along the elongated member. In some embodiments, threaded fixation structure 98 may only be disposed on a portion of the surface including electrodes 96 . In other words, threaded fixation structure 98 may not be disposed around all electrodes 96 , e.g., the threaded fixation structure may only be disposed around the proximal two electrodes. In other embodiments, lead 92 may include threaded fixation structure 98 at locations along elongated body similar to leads 60 , 72 , or 84 of FIGS. 4A , 4 B, and 4 C, respectively.
  • FIG. 5B shows lead 100 that is substantially similar to lead 92 of FIG. 5A .
  • Lead 100 includes elongated member 102 , electrodes 104 , and threaded fixation structures 106 A, 106 B, 106 C, 106 D and 106 E (collectively “threaded fixation structures 106 ).
  • Threaded fixation structures 106 are disposed at the portion of elongated member 102 which also includes electrodes 104 . However, none of threaded fixation structures 106 are located over the surface of any of electrodes 104 . Instead, each of threaded fixation structures 106 are only attached to elongated member 102 and stop before covering any portion of electrodes 104 .
  • threaded fixation structures 106 may be substantially similar to threaded fixation structure 98 of FIG. 5B , but have any portion of the threaded fixation structure over electrodes 96 removed. In this manner, threaded fixation structures 106 are arranged in sections to avoid interference with the electrical field produced by electrodes 104 that provides therapy to the target tissue of patient 16 . Threaded fixation structures 106 may be constructed similar to and have physical properties similar to threaded fixation structure 90 of FIG. 4C . In some embodiments, one or more of threaded fixation structures 106 may be constructed of different materials to the other threaded fixation structures.
  • Threaded fixation structures 106 B-D are located between electrodes 104 , threaded fixation structure 106 A is disposed proximal to electrodes 104 and threaded fixation structure 106 E is disposed distal to the electrodes.
  • threaded fixation structure 106 A may include more turns and be disposed along a greater proximal portion of elongated member 102 .
  • threaded fixation structure 106 E may include more turns and be disposed along a greater distal portion of elongated member 102 .
  • one or more of threaded fixation structures 106 may not be included in lead 100 .
  • lead 100 may only include threaded fixation structures 106 A-C.
  • lead 100 may include threaded fixation structures at locations along elongated body similar to leads 60 , 72 , or 84 of FIGS. 4A , 4 B, and 4 C, respectively.
  • FIG. 6 is a perspective drawing illustrating lead 108 with threaded fixation structure extending from the distal end of the lead to a location proximate to electrodes 112 .
  • lead 108 includes elongate member 110 , electrodes 112 , tapered tip 114 , and threaded fixation structure 116 .
  • Threaded fixation structure begins at the distal tip of tapered tip 114 and continues to wrap around elongate member 110 past electrodes 112 to a location of the electrode member proximal to the electrodes.
  • Lead 108 may be a combination of threaded fixation structures described with respect to leads 60 , 72 , 84 , 92 , or 100 of FIGS. 4 and 5 .
  • threaded fixation structure 116 may have similar properties to any of threaded fixation structures 70 , 82 , 90 , 98 , or 106 .
  • threaded fixation structure 116 may be broken into two or more threaded fixation structures at any location along tapered tip 114 or elongated member 110 , including threaded fixation structures that do not cover the surface of electrodes 112 .
  • lead 108 may include threaded fixation structures at the proximal and/or intermediate locations of elongate member 110 instead of or in addition to threaded fixation structure 116 .
  • FIG. 7 is a perspective drawing illustrating lead 118 that includes a reinforcement member.
  • Lead 118 is substantially similar to lead 108 of FIG. 6 and includes elongate member 120 , electrodes 122 , tapered tip 124 , and threaded fixation structure 126 .
  • lead 118 includes helical reinforcement member 128 which resides within elongated member 120 .
  • Helical reinforcement member 128 is provided to add torsional rigidity to lead 118 which resists twisting of elongated member 120 when the clinician rotates the lead to engage threaded fixation structure 126 .
  • Helical reinforcement member 128 may be provided in a variety of methods. First, helical reinforcement member 128 may be a metal or polymer wire. Second, helical reinforcement member 128 may be a metal or polymer ribbon that creates a substantially contiguous cylinder. Other fibers, materials, or members may be used to construct helical reinforcement member 128 , in some embodiments. While helical reinforcement member 128 is shown as extending within elongate member 120 in a direction opposite threaded fixation structure 126 , some embodiments may employ the helical reinforcement member in the same direction as the threaded fixation structure.
  • helical reinforcement member 128 may include two helical reinforcement members in which one helical reinforcement member is arranged in one direction and the second helical reinforcement member is arranged in a second direction opposite the first direction.
  • Helical reinforcement member 128 may extend throughout the entire length of lead 118 or only a small portion of the lead.
  • FIGS. 8A and 8B are perspective drawings illustrating exemplary stimulation leads with foldable threads.
  • FIG. 8A illustrates lead 130 prior to the removal of sheath 138 .
  • Lead 130 includes elongated member 132 , electrodes 134 , threaded fixation structure 136 , and sheath 138 .
  • Lead 130 may be similar to any of leads 60 , 72 , 84 , 92 , 100 , 108 or 118 ; however, threaded fixation structure 136 is foldable, or compliant, such that sheath 138 prevents the threaded fixation structure from extending away from elongated member 132 . While threaded fixation structure 136 is shown to be disposed around the portion of elongated member 132 that includes electrodes 134 , the threaded fixation structure may be disposed at any portion of the elongated member as described herein.
  • Sheath 138 is provided to facilitate implantation of lead 130 . With sheath 138 covering elongated member 132 and collapsing threaded fixation structure 136 , the diameter of lead 130 is smaller to allow the clinician to push the lead through a lead introducer (not shown) or through tissue of patient 16 . Once the clinician inserts lead 130 to the desired position, sheath 138 is removed to expose threaded fixation structure 136 to the adjacent tissue. Threaded fixation structure 136 extends away from the outer surface of elongated member 132 to the originally formed threaded fixation structure dimensions. Rotating lead 130 may help threaded fixation structure 136 to extend away from the surface of elongated member 132 and engage the surrounding tissue.
  • the extended angle of threaded fixation structure 136 may be less than 90 degrees between the outer surface of elongated member 132 and the proximal surface of the threaded fixation structure. While threaded fixation structure 136 is foldable towards the proximal end of lead 130 , the threaded fixation structure may be foldable towards the distal end of the lead in other embodiments.
  • Threaded fixation structure 136 may be constructed of any bendable, pliable, elastic, or superelastic material that is biocompatible.
  • a polymer such as expanded-polytetrafluoroethylene or a shape memory metal alloy such as nitinol may be used to construct threaded fixation structure 136 .
  • Sheath 138 may be constructed of a thin polymer membrane that may slide over the surface of elongated member 132 and threaded fixation structure 136 while maintaining sufficient circumferential stiffness that retains the threaded fixation structure before deployment.
  • Sheath 138 may be initially configured to cover elongated member 132 and threaded fixation structure 136 by sliding the sheath from the distal end of lead 130 to the proximal end of the lead. Alternatively, sheath 138 may loosely cover lead 130 and be heated to shrink the circumference of the sheath and collapse threaded fixation structure 136 .
  • FIG. 8B shows lead 130 with sheath 138 being removed in the proximal direction of arrow 140 .
  • the distal portion of threaded fixation structure 136 has already extended away from elongated member 132 in the direction of arrow 142 .
  • the proximal portion of threaded fixation structure, indicated by arrow 144 is still restricted by sheath 138 that has not been fully removed.
  • the clinician may rotate the lead to engage threaded fixation structure 136 with the adjacent tissue.
  • the clinician may not be able to slide the sheath back over threaded fixation structure 136 .
  • sheath 138 may not be necessary for threaded fixation structure 136 to fold down against elongated member 132 .
  • Threaded fixation structure 136 may fold down from force from adjacent tissue when the clinician inserts lead 130 into patient 16 .
  • the clinician may pull back on the lead to cause threaded fixation structure 136 to engage with the adjacent tissue and extend the threaded fixation structure away from elongated member 132 .
  • the clinician can then begin to rotate lead 130 to screw the lead into the tissue and secure electrodes 134 to the desired location.
  • FIG. 9 is a flow diagram illustrating an exemplary process for securing a threaded lead to a tissue of a patient.
  • Any of leads 60 , 72 , 84 , 92 , 100 , 108 or 118 , or 130 may be implanted with this procedure, but lead 60 will be used as an example.
  • the clinician beings by inserting the lead introducer into the target stimulation site of patient 16 ( 146 ). Next, the clinician inserts lead 60 into the lead introducer until the lead is positioned correctly ( 148 ). The clinician then withdraws the sheath that covers lead 60 ( 150 ) and rotates the lead in the direction of threaded fixation structure 68 , e.g., clockwise, to secure the lead at the target tissue ( 152 ). If lead 60 is not correctly placed ( 154 ), the clinician continues to rotate the lead ( 152 ). If lead 60 is positioned correctly ( 154 ), the clinician may attach the proximal end of the lead to the stimulator and proceed with beginning therapy ( 156
  • the clinician may not need to remove a sheath to expose the threaded fixation structure.
  • the clinician may require a keyed stylet or other device that engages into the distal end of the lead and locks into interior grooves or teeth to facilitate the rotation of the lead and engagement of the threaded fixation structure.
  • the stylet may be inserted through a channel extending within lead 60 that attaches to grooves, slots, or teeth near the proximal end of the lead to facilitate lead rotation that engages the threaded fixation structure to the adjacent tissue.
  • FIG. 10 is a flow diagram illustrating an exemplary process for removing a threaded lead from a tissue of a patient.
  • Any of leads 60 , 72 , 84 , 92 , 100 , 108 or 118 , or 130 may be implanted with this procedure, but lead 60 will be used as an example.
  • the clinician may ready patient 16 for removal of the lead from stimulator 12 ( 158 ). If the threaded fixation structure is foldable ( 160 ), the clinician inserts a sheath down to the proximal end of the threaded fixation structure ( 162 ).
  • the clinician begins to rotate the lead in the opposite direction of the threaded fixation structure, e.g., counter-clockwise ( 164 ). If the threaded fixation structure is not released from tissue ( 166 ), the clinician continues to rotate lead 60 ( 164 ). If the threaded fixation structure has been released from tissue ( 166 ), the clinician may pull lead 60 from patient 16 ( 168 ).
  • Releasing the threaded fixation structure from the tissue may include either backing the threaded fixation structure into the sheath such that the structure folds under the sheath or rotating the lead enough that the threaded fixation structure is free from being engaged from any tissue of patient 16 .
  • some embodiments may require that the clinician use a keyed stylet or other device that engages into the distal end of the lead and locks into interior grooves or teeth to facilitate the rotation of the lead and disengagement of the threaded fixation structure.
  • the stylet may be inserted through a channel extending within lead 60 that attaches to grooves, slots, or teeth near the proximal end of the lead to facilitate lead rotation that disengages the threaded fixation structure from the adjacent tissue.
  • FIG. 11 is a method of implanting a lead in patient 12 with a different threaded fixation structure than the leads implanted in with the technique of FIG. 9 .
  • Any of leads 60 , 72 , 84 , 92 , 100 , 108 or 118 , or 130 with a foldable threaded fixation structure may be implanted with this procedure, but lead 130 will be used as an example.
  • the clinician beings by inserting the lead introducer into the target stimulation site of patient 16 ( 169 ), which causes threaded fixation structure 136 to fold down against the surface of lead 130 . Next, the clinician inserts lead 130 into the lead introducer until the lead is positioned correctly ( 171 ).
  • the clinician then removes the lead introducer that covers lead 130 ( 173 ) and pulls back on the lead to engage, or extend, the folded threaded fixation structure with the adjacent tissue ( 175 ).
  • the clinician then rotates the lead in the direction of threaded fixation structure 136 , e.g., clockwise, to secure the lead at the target tissue ( 177 ). If lead 130 is not correctly placed ( 179 ), the clinician continues to rotate the lead ( 177 ). If lead 130 is positioned correctly ( 179 ), the clinician may attach the proximal end of the lead to the stimulator and proceed with beginning therapy ( 181 ).
  • the clinician may be able to insert lead 130 directly into patient 16 without the use of a lead introducer.
  • foldable threaded fixation structure 136 folds down with the force of the adjacent tissue as lead 130 is inserted into patient 16 .
  • the clinician may require a keyed stylet or other device that engages into the distal end of the lead and locks into interior grooves or teeth to facilitate the rotation of the lead and engagement of the threaded fixation structure.
  • the stylet may be inserted through a channel extending within lead 130 that attaches to grooves, slots, or teeth near the proximal end of the lead to facilitate lead rotation that engages the threaded fixation structure to the adjacent tissue.
  • FIGS. 12A and 12B are perspective drawings illustrating exemplary medical catheters with a helical threaded structure.
  • Threaded fixation structures 174 and 184 may be similar to the threaded fixation structures of any of leads 60 , 72 , 84 , 92 , 100 , 108 or 118 , or 130 .
  • a conduit is used to deliver a therapeutic agent to the tissue instead of electrodes that deliver stimulation.
  • FIG. 12A shows lead 170 that includes elongated member 172 , threaded fixation structure 174 , conduit 176 , and exit port 178 .
  • Threaded fixation structure 174 is disposed about the outer surface of elongated member 172 at the distal end of the elongated body.
  • a drug pump may be attached to the proximal end of lead 170 for delivering a therapeutic agent through conduit 176 and out of exit port 178 into the adjacent target tissue.
  • Conduit 176 resides within elongated member 172 , and may or may not have a common central axis to the elongated member.
  • more than one threaded fixation structure 174 may be provided to secure the location of lead 170 and ensure that the therapeutic agent is delivered to the appropriate tissue of patient 16 .
  • FIG. 12B shows lead 180 which is similar to lead 170 of FIG. 12A .
  • Lead 180 includes elongated body 182 , threaded fixation structure 184 , conduit 186 , and exit port 188 .
  • Exit port 188 is disposed on a longitudinal outer surface of elongated member 182 , within threaded fixation structure 184 .
  • Conduit 186 resided within elongated member 182 , and may or may not have a common central axis with the elongated member. In other embodiments, exit port 188 may be located outside of threaded fixation structure 184 either distal to or proximal to the threaded fixation structure.
  • conduit 186 may be in fluidic communication with more than one exit port, where the multiple exit ports are located at various longitudinal or circumferential positions of elongated member 182 or in the axial surface of the elongated member.
  • lead 180 may include multiple conduits within elongated member 182 .
  • FIGS. 13A and 13B are cross-sectional end views of a keyed stylet 200 and a reciprocally keyed medical lead 202 .
  • rotational movement of a lead may be accomplished by simply rotating the lead body.
  • a stylet may provide added structural integrity relative to a flexible lead.
  • the stylet may be sized to frictionally engaged the inner wall of the inner lumen such that rotation of the stylet causes rotation of the lead body.
  • the stylet and the lead body may be formed with a reciprocal key structure, such as any combination of slots, grooves, teeth, ribs, rails, or the like.
  • stylet 200 includes a stylet body 203 with multiple teeth 204 A- 204 D.
  • the teeth may run longitudinally substantially the entire length of the stylet body 203 , or be provided only near a distal end of the stylet body, e.g., over the last 2 to 6 centimeters at the distal end of the stylet.
  • teeth 204 A- 204 D may be sized and shaped to engage reciprocal grooves 210 A- 210 D in a lead body 206 of lead 202 .
  • the grooves 210 A- 210 D may be formed by molding, extruding, scribing or other techniques. In any event, teeth 204 A- 204 D engage corresponding grooves 210 A- 210 D so that the teeth can bear against the grooves to transmit rotational force from stylet 200 to lead 202 .
  • FIG. 13B Also shown in FIG. 13B are representative portions 212 A, 212 B of a threaded fixation structure.
  • Any thread fixation structure, as described herein, may be combined with a lead 202 including slots, grooves, or the like.
  • the number of slots or grooves may be subject to wide variation.
  • lead 202 may include teeth while stylet 200 includes grooves. The exact combination, arrangement, size, and number of slots, grooves, teeth or the like is subject to variation provided the lead 202 and stylet 200 include reciprocal structure to impart rotational movement from the stylet to the lead.
  • a cannula device that is configured to fit around the outside of the lead may be used to rotate the lead and engage the threaded fixation structure.
  • the cannula device may be circumferentially locked to the lead via one or more slots, grooves, teeth, ribs, rails, or the like, disposed on the outside of the elongated member.
  • the cannula device may use a friction fit to lock to the lead. In either case, the cannula device may be slid down to the proximal end of the threaded fixation structure or some other location of the lead that still facilitates rotation of the lead.
  • a lead including threaded fixation may be useful for various electrical stimulation systems.
  • the lead may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, gastroparesis, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles) or obesity.
  • FES functional electrical stimulation
  • the helical fixation described herein may also be useful for fixing a catheter, such as a drug deliver catheter, proximate to a target drug delivery site.
  • the present invention further includes within its scope methods of making and using systems and leads for stimulation, as described herein.
  • the leads described herein may have a variety of stimulation applications, as well as possible applications in other electrical stimulation contexts, such as delivery of cardiac electrical stimulation, including paces, pulses, and shocks.

Abstract

The disclosure is directed to securing electrodes of a medical lead adjacent to a target tissue site. The medical lead may include one or more threaded fixation structures disposed circumferentially about the outer surface of the lead body, or elongated member, that resembles a “screw” or “auger.” During implantation, a clinician may rotate the entire lead to “screw” the lead into the tissue of the patient until electrodes of the lead reside adjacent to a target tissue. In this manner, the threaded fixation structure secures the lead within the patient to resist lead migration and improper therapy and provide a fine adjustment for depth of placement. The threaded fixation structure may be disposed on a portion of the lead proximal to or distal to the electrodes of the lead or over the portion of the lead that includes the electrodes.

Description

    TECHNICAL FIELD
  • The invention relates to stimulation systems and, more particularly, to stimulation leads in stimulation systems.
  • BACKGROUND
  • Electrical stimulation systems may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, or gastroparesis. An electrical stimulation system typically includes one or more stimulation leads coupled to an external or implantable electrical stimulator. The stimulation lead may be percutaneously or surgically implanted in a patient on a temporary or permanent basis such that at least one stimulation electrode is positioned proximate to a target stimulation site. The target stimulation site may be, for example, a spinal cord, pelvic nerve, pudendal nerve, stomach, muscle, or within a brain or other organ of a patient. The electrodes located proximate to the target stimulation site may deliver stimulation therapy to the target stimulation site in the form of electrical signals.
  • Electrical stimulation of a sacral nerve may eliminate or reduce some pelvic floor disorders by influencing the behavior of the relevant structures, such as the bladder, sphincter and pelvic floor muscles. Pelvic floor disorders include urinary incontinence, urinary urge/frequency, urinary retention, pelvic pain, bowel dysfunction, and male and female sexual dysfunction. The organs involved in bladder, bowel, and sexual function receive much of their control via the second, third, and fourth sacral nerves, commonly referred to as S2, S3 and S4 respectively. Thus, in order to deliver electrical stimulation to at least one of the S2, S3, or S4 sacral nerves, a stimulation lead is implanted proximate to the sacral nerve(s).
  • Electrical stimulation of a peripheral nerve, such as stimulation of an occipital nerve, may be used to induce paresthesia. Occipital nerves, such as a lesser occipital nerve, greater occipital nerve or third occipital nerve, exit the spinal cord at the cervical region, extend upward and towards the sides of the head, and pass through muscle and fascia to the scalp. Pain caused by an occipital nerve, e.g. occipital neuralgia, may be treated by implanting a lead proximate to the occipital nerve to deliver stimulation therapy.
  • In many stimulation applications, including stimulation of a sacral nerve, it is desirable for a stimulation lead to resist migration following implantation. For example, it may be desirable for the electrodes disposed at a distal end of the implantable medical lead to remain proximate to a target stimulation site in order to provide adequate and reliable stimulation of the target stimulation site. In some applications, it may also be desirable for the electrodes to remain substantially fixed in order to maintain a minimum distance between the electrode and a nerve in order to help prevent inflammation to the nerve and in some cases, unintended nerve damage. Securing the stimulation lead at the target stimulation site may minimize lead migration.
  • SUMMARY
  • In general, the disclosure is directed toward securing electrodes of a medical lead adjacent to a target tissue site with a threaded fixation structure configured to engage tissue within a patient to resist migration of the medical lead. The medical lead may be similar to a “screw” or “auger-like.” The threaded fixation structure defines one or more threads disposed circumferentially about the outer surface of a lead body. Specifically, the threads of the threaded fixation structure may be arranged in a helical pattern. During implantation, a clinician may rotate the entire lead to “screw” the lead into the tissue of the patient until electrodes of the lead reside adjacent to a target tissue. In this manner, the threaded fixation structure secures the lead within the patient to resist lead migration. In addition, the threaded fixation structure may allow a fine adjustment mechanism for the depth of the elongated member within the tissue. The threaded fixation structure may be disposed on a portion of the lead proximal to or distal to the electrodes of the lead or over the portion of the lead that includes the electrodes. In some cases, the entire distal end of the lead may include the threaded fixation structure to engage a greater area of tissue. In other embodiments, the threaded fixation structure may be used with drug delivery catheters instead of electrical stimulation leads.
  • In one embodiment, the disclosure is directed to a medical lead that includes an elongated member having a proximal end and a distal end, at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead, and at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
  • In another embodiment, the disclosure is directed to method that includes inserting a medical lead into a patient, wherein the lead comprises at least one stimulation electrode and at least one threaded fixation structure extending around a portion of an outer surface of the lead, and rotating the lead to engage the threaded fixation structure with tissue of the patient to resist migration of the lead.
  • In an additional embodiment, the disclosure is directed to a system that includes a medical lead having an elongated member having a proximal end and a distal end, at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead, and at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead. The system also includes a stimulator that delivers electrical stimulation therapy to a patient via the medical lead within the patient.
  • In another additional embodiment, the disclosure is directed to an apparatus that includes an elongated member having a proximal end and a distal end, a conduit disposed within the elongated member, an exit port disposed on an outer surface of the elongated member in fluidic communication with the conduit, and at least one threaded fixation structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
  • The disclosure may provide one or more advantages. The threaded fixation structure may be engaged to the adjacent tissue of the patient and still allow the clinician to advance or retract the lead to finely adjust the lead position. A sheath may also be used to cover the threaded fixation structure until the clinician desires to expose the threaded fixation structure to the adjacent tissue, and the sheath may collapse the threaded fixation structure to reduce the lead diameter until lead fixation is desired. In addition, the clinician may remove the lead by rotating the lead and reducing tissue trauma.
  • The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
  • BRIEF DESCRIPTION OF DRAWINGS
  • FIG. 1A is a schematic perspective view of a therapy system including an electrical stimulator coupled to a stimulation lead that has been implanted in a body of a patient proximate to a target stimulation site.
  • FIG. 1B is an illustration of the implantation of a stimulation lead at a location proximate to an occipital nerve.
  • FIG. 2 is a block diagram illustrating various components of an electrical stimulator and an implantable lead.
  • FIGS. 3A and 3B are perspective drawings of a sheath that covers a lead prior to implantation and is removed after the lead is correctly positioned in a patient.
  • FIGS. 4A-4C are perspective drawings illustrating exemplary stimulation leads with varying configurations of threaded fixation mechanisms.
  • FIGS. 5A-5B are perspective drawings illustrating exemplary stimulation leads with varying threaded fixation mechanisms over electrodes of the lead.
  • FIG. 6 is a perspective drawing illustrating an exemplary stimulation lead with threads from the distal tip to a location proximal to electrodes.
  • FIG. 7 is a perspective drawing illustrating an exemplary stimulation lead with torsional reinforcement members within the elongated member.
  • FIGS. 8A and 8B are perspective drawings illustrating exemplary stimulation leads with foldable threads.
  • FIG. 9 is a flow diagram illustrating an exemplary process for securing a threaded lead to a tissue of a patient.
  • FIG. 10 is a flow diagram illustrating an exemplary process for removing a threaded lead from a tissue of a patient.
  • FIG. 11 is a flow diagram illustrating an exemplary process for securing a lead with folding threads to a tissue of a patient.
  • FIGS. 12A and 12B are perspective drawings illustrating exemplary medical catheters with a helical threaded structure.
  • FIGS. 13A and 13B are cross-sectional end views of a keyed stylet and reciprocally keyed medical lead.
  • DETAILED DESCRIPTION
  • The medical leads described herein include a threaded fixation mechanism that secures the medical lead within a tissue of a patient. The threaded fixation mechanism prevents the electrodes of the lead from migrating away from the target stimulation tissue, which may lead to a reduction in therapy efficacy. Specifically, the threaded fixation mechanism includes a thread structure disposed around the outer surface of the elongated member, such that the lead resembles a “screw” or “auger” device that advances or retreats when rotated. The threaded fixation mechanism may allow the clinician to finely adjust the elongated member location, in contrast to other medical lead fixation structures such as tines or adhesives. Generally, the threads may be arranged in a helical pattern, but other types of thread patterns may also be used to secure the lead. Hence, the threaded fixation mechanism may be referred to as a threaded fixation structure for purposes of illustration. In addition, other non-helical thread patterns may be used in some embodiments. The thread structure may be disposed distal to the electrodes, proximal to the electrodes, and/or at the same axial position of the electrodes. In addition, in some embodiments, the threaded fixation structure may be disposed on a tapered tip at the distal end of the elongated member to begin the engagement and tunneling of the lead through the tissue when the lead is rotated to secure the threaded fixation structure.
  • In some embodiments, the thread structure may not engage the adjacent tissue until the user, e.g. a clinician, desires the structure to do so. For example, a sheath may be configured to cover the elongated member and thread structure for lead insertion and be removed to allow the threaded fixation structure to contact the adjacent tissue. In addition, the thread structure may fold down against the elongated member outer surface when constricted by the sheath. When the clinician removes the sheath, the threaded fixation structure extends away from the elongated member and returns to its original thread shape to secure the lead. In this case, the thread structure may have elastic, super-elastic, or shape memory properties that cause it to assume an extended position when a sheath or other restraint mechanism is removed to expose the thread structure.
  • Alternatively, the medical lead may not include electrodes on the elongated member. In this case, the medical lead may be a catheter that delivers a therapeutic agent through one or more lumens in the elongated member, while the threaded fixation structure secures the location of the catheter. The lumen may end at one or more exit ports near the distal end of the elongated member, and the exit ports may be disposed in an axial or longitudinal outer surface of the elongated member.
  • FIG. 1A a schematic perspective view of therapy system 10, which includes electrical stimulator 12 coupled to stimulation lead 14, which has been implanted in body 16 of a patient proximate to target stimulation site 18. Electrical stimulator 12 provides a programmable stimulation signal (e.g., in the form of electrical pulses or substantially continuous-time signals) that is delivered to target stimulation site 18 by stimulation lead 14, and more particularly, via one or more stimulation electrodes carried by lead 14. Electrical stimulator 12 may be either implantable or external. For example, electrical stimulator 12 may be subcutaneously implanted in the body of a patient 16 (e.g., in a chest cavity, lower back, lower abdomen, or buttocks of patient 16). Electrical stimulator 12 may also be referred to as a pulse or signal generator, and in the embodiment shown in FIG. 1A, electrical stimulator 12 may also be referred to as a neurostimulator. In some embodiments, lead 14 may also carry one or more sense electrodes to permit stimulator 12 to sense electrical signals from target stimulation site 18. Furthermore, in some embodiments, stimulator 12 may be coupled to two or more leads, e.g., for bilateral or multi-lateral stimulation.
  • Lead 14 further includes a lead body, or elongated member, and one or more threaded fixation structures (not shown in FIG. 1) which engage with tissue proximate to target stimulation site 18 to substantially fix a position of lead 14 proximate to target stimulation site 18. The threaded fixation structure is rotated during implantation to engage with tissue adjacent to target stimulation site 18. Proximal end 14A of lead 14 may be both electrically and mechanically coupled to connector 13 of stimulator 12 either directly or via a lead extension. In particular, lead 14 may include electrical contacts near proximal end 14A to electrically connect conductors disposed within the elongated member to stimulation electrodes (and sense electrodes, if present) at a position adjacent to distal end 14B of lead 14 to stimulator 12. Lead 14 may be connected directly or indirectly (e.g., via a lead extension) to stimulator 12.
  • In the example embodiment of therapy system 10 shown in FIG. 1A, target stimulation site 18 is proximate to the S3 sacral nerve, and lead 14 has been introduced into the S3 sacral foramen 22 of sacrum 24 to access the S3 sacral nerve. Stimulation of the S3 sacral nerve may help treat pelvic floor disorders, urinary control disorders, fecal control disorders, interstitial cystitis, sexual dysfunction, and pelvic pain. Therapy system 10, however, is useful in other stimulation applications. Thus, in alternate embodiments, target stimulation site 18 may be a location proximate to any of the other sacral nerves in body 16 or any other suitable nerve in body 16, which may be selected based on, for example, a therapy program selected for a particular patient. For example, in other embodiments, therapy system 10 may be used to deliver stimulation therapy to pudendal nerves, perineal nerves, or other areas of the nervous system, in which cases, lead 14 would be implanted and substantially fixed proximate to the respective nerve. As further alternatives, lead 14 may be positioned for temporary or chronic spinal cord stimulation for the treatment of pain, for peripheral neuropathy or post-operative pain mitigation, ilioinguinal nerve stimulation, intercostal nerve stimulation, gastric stimulation for the treatment of gastric mobility disorders and obesity, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles), for mitigation of other peripheral and localized pain (e.g., leg pain or back pain), or for deep brain stimulation to treat movement disorders and other neurological disorders. Accordingly, although sacral nerve stimulation will be described herein for purposes of illustration, a stimulation lead 14 in accordance with the invention may be adapted for application to a variety of electrical stimulation applications.
  • Migration of lead 14 following implantation may be undesirable, and may have detrimental effects on the quality of therapy delivered to a patient 16. For example, migration of lead 10 may cause displacement of electrodes carried by lead 14 to a target stimulation site 18. As a result, the electrodes may not be properly positioned to deliver the therapy, possibly undermining therapeutic efficacy of the stimulation therapy from system 10. Substantially fixing lead 14 to surrounding tissue may help discourage lead 14 from migrating from target stimulation site 18 following implantation, which may ultimately help avoid harmful effects that may result from a migrating stimulation lead 14.
  • To that end, the invention provides lead 14 with a thread structure (not shown in FIG. 1) disposed around the elongated member of lead 14 to provide fixation between lead 14 and tissue surrounding lead 14, such as tissue within sacrum 16 in the example of FIG. 1A. The thread structure may have a helical pattern that permits lead 14 to be, in effect, screwed into a tissue site. In comparison to some existing methods of fixing implanted medical leads, such as suturing lead 14 to surrounding tissue or applying a cuff electrode, using a threaded fixation structure to secure lead 14 in patient 16 may be beneficial in a minimally invasive surgery, which may allow for reduced pain and discomfort for patient 16 relative to invasive surgery, as well as a quicker recovery time. As described in further detail below, the threaded fixation structure is disposed around the outer surface of the elongated body near the distal end of lead 14 and configured to engage with the adjacent tissue to prevent lead 14 movement.
  • Implanting lead 14 with the threaded fixation structure may be completed via a few methods. First, the clinician may rotate lead 14 to advance lead 14 toward target stimulation sire 18 and utilize the threaded fixation structure to engage the adjacent tissue. Second, a sheath (not shown in FIG. 1A) may be used initially to cover lead 14 and the included threaded fixation structure to allow the clinician to insert lead 14 into patient 16 until direct insertion is no longer possible. At this point, the clinician may remove the sheath to expose the threaded fixation structure and then rotate lead 14 to advance lead 14 the rest of the distance towards target stimulation site 18.
  • The rotation of lead 14 may be achieved directly by rotating the lead body, or by a stylet or other device that is inserted into an inner lumen of the lead to engage the lead. In some embodiments, the stylet may have a keyed structure, such as one or more longitudinal flanges, ribs, teeth or grooves that engage reciprocal structure in the inner lumen of the lead. For example, a keyed stylet may be inserted to engage the distal end of the lead and lock into interior grooves or teeth to facilitate the rotation of the lead. In particular, reciprocal teeth or grooves, or the like, may rotationally bear against each other such that rotation of the stylet causes rotation of the lead in the same direction.
  • In addition, the threaded fixation structure may be foldable against the elongated member of lead 14 when covered by the sheath. When the sheath is removed, the threaded fixation structure may stand up, or extend, away from the elongated member to its original shape. The clinician may then rotate lead 14 to advance lead 14 to target stimulation site 18. In either case, the thread tends to “bite” into the surrounding tissue to resist migration of the lead from the target stimulation site.
  • Therapy system 10 also may include a clinician programmer 26 and a patient programmer 28. Clinician programmer 26 may be a handheld computing device that permits a clinician to program stimulation therapy for patient 16, e.g., using input keys and a display. For example, using clinician programmer 26, the clinician may specify stimulation parameters for use in delivery of stimulation therapy. Clinician programmer 26 supports telemetry (e.g., radio frequency telemetry) with stimulator 12 to download stimulation parameters and, optionally, upload operational or physiological data stored by stimulator 12. In this manner, the clinician may periodically interrogate stimulator 12 to evaluate efficacy and, if necessary, modifies the stimulation parameters.
  • Like clinician programmer 26, patient programmer 28 may be a handheld computing device. Patient programmer 28 may also include a display and input keys to allow patient 16 to interact with patient programmer 28 and implantable stimulator 12. In this manner, patient programmer 28 provides patient 16 with an interface for control of stimulation therapy by stimulator 12. For example, patient 16 may use patient programmer 28 to start, stop or adjust stimulation therapy. In particular, patient programmer 28 may permit patient 16 to adjust stimulation parameters such as duration, amplitude, pulse width and pulse rate, within an adjustment range specified by the clinician via clinician programmer 28, or select from a library of stored stimulation therapy programs.
  • Stimulator 12, clinician programmer 26, and patient programmer 28 may communicate via cables or a wireless communication, as shown in FIG. 2. Clinician programmer 26 and patient programmer 28 may, for example, communicate via wireless communication with stimulator 12 using radio frequency (RF) telemetry techniques known in the art. Clinician programmer 26 and patient programmer 28 also may communicate with each other using any of a variety of local wireless communication techniques, such as RF communication according to the 802.11 or Bluetooth specification sets, or other standard or proprietary telemetry protocols.
  • FIG. 1B is a conceptual illustration of an alternative implantation site to the implantation of FIG. 1A. Therapy system 10 may also be used to provide stimulation therapy to other nerves of a patient 16. For example, as shown in FIG. 1B, lead 14 may be implanted and fixated with the two or more threaded fixation members proximate to an occipital region 29 of patient 30 for stimulation of one or more occipital nerves. In particular, lead 14 may be implanted proximate to lesser occipital nerve 32, greater occipital nerve 34, and third occipital nerve 36. In FIG. 1B, lead 14 is aligned to be introduced into introducer needle 38 and implanted and anchored or fixated with fixation elements proximate to occipital region 29 of patient 30 for stimulation of one or more occipital nerves 32, 34, and/or 36. A stimulator (e.g., stimulator 12 in FIG. 1A) may deliver stimulation therapy to any one or more of occipital nerve 32, greater occipital nerve 34 or third occipital nerve 36 via electrodes disposed adjacent to distal end 14B of lead 14. In alternate embodiments, lead 14 may be positioned proximate to one or more other peripheral nerves proximate to occipital nerves 32, 34, and 36 of patient 30, such as nerves branching from occipital nerves 32, 34, and 36, as well as stimulation of any other suitable nerve, organ, muscle, muscle group or other tissue site within patient 30, such as, but not limited to, nerves within a brain, pelvis, stomach or spinal cord of patient 30.
  • Implantation of lead 14 may involve the subcutaneous placement of lead 14 transversely across one or more occipital nerves 32, 34, and/or 36 that are causing patient 30 to experience pain. In one example method of implanting lead 14 proximate to the occipital nerve, using local anesthesia, a vertical skin incision 33 approximately two centimeters in length is made in the neck of patient 30 lateral to the midline of the spine at the level of the C1 vertebra. The length of vertical skin incision 33 may vary depending on the particular patient. At this location, patient's skin and muscle are separated by a band of connective tissue referred to as fascia. Introducer needle 38 is introduced into the subcutaneous tissue, superficial to the fascia and muscle layer but below the skin. Occipital nerves 32, 34, and 36 are located within the cervical musculature and overlying fascia, and as a result, introducer needle 38 and, eventually, lead 14 are inserted superior to occipital nerves 32, 34, and 36.
  • Once introducer needle 38 is fully inserted, lead 14 may be advanced through introducer needle 38 and positioned to allow stimulation of the lesser occipital nerve 32, greater occipital nerve 34, third occipital nerve 36, and/or other peripheral nerves proximate to an occipital nerve. Upon placement of lead 14, introducer needle 38 may be removed. In some embodiments, introducer needle 38 may be used to remove lead 14 after stimulation therapy is no longer needed.
  • Accurate lead placement may affect the success of occipital nerve stimulation. If lead 14 is located too deep, i.e., anterior, in the subcutaneous tissue, patient 30 may experience muscle contractions, grabbing sensations, or burning. Such problems may additionally occur if lead 14 migrates after implantation. Furthermore, due to the location of implanted lead 14 on the back of patient's 30 neck, lead 14 may be subjected to pulling and stretching that may increase the chances of lead migration. For these reasons, lead 14 may employ the threaded fixation structure to secure lead 14 within patient 16. In locations near the skin of patient 16, the threaded fixation structure may only extend from the elongated body of lead 14 a small distance to minimize patient detection of the threaded fixation structure at superficial implant locations. In other words, the thread structure may be sized so as not to protrude excessively into the superficial tissues, thereby avoiding skin deformations and potential tissue erosion and damage.
  • Although lead 14 has been generally described as an electrical lead that includes electrodes, lead 14 may, in other embodiments, be a drug delivery catheter that delivers therapeutic agents to target stimulation site 18 (FIG. 1A) or occipital nerves 32, 34 or 36. In this case, stimulator 12 is a drug pump that controls the delivery of therapeutic agent to patient 16. The drug delivery catheter embodiment of lead 14 may include an exit port for the therapeutic agent that is disposed on any surface of lead 14, adjacent to or within the threaded fixation structure.
  • FIG. 2 is a block diagram illustrating various components of implantable stimulator 12 and an implantable lead 14. Stimulator 12 includes therapy delivery module 40, processor 42, memory 44, telemetry module 46, and power source 47. In some embodiments, stimulator 12 may also include a sensing circuit (not shown in FIG. 2). Implantable lead 14 includes elongated member 48 extending between proximal end 48A and distal end 48B. Elongated member 48 may also be described as an elongated member. Elongated member 48 may be a cylindrical or may be a paddle-shaped (i.e., a “paddle” lead). Electrodes 50A, 50B, 50C, and 50D (collectively “electrodes 50”) are disposed on elongated member 48 adjacent to distal end 48B of elongated member 48. In the example of FIG. 2, threaded fixation structures are omitted from lead 14 for ease of illustration.
  • Stimulator 12 delivers stimulation therapy via electrodes 50 of lead 14. In particular, implantable signal generator within therapy delivery module 40 delivers electrical signals to patient 16 (FIG. 1A) via at least some of electrodes 50 under the control of a processor 42. The stimulation energy generated by therapy delivery module 40 may be formulated as stimulation energy, e.g., for treatment of any of a variety of neurological disorders, or disorders influenced by patient neurological response. The signals may be delivered from therapy delivery module 40 to electrodes 50 via a switch matrix and conductors carried by lead 14 and coupled to respective electrodes 50.
  • In some embodiments, electrodes 50 may be ring electrodes. In other embodiments, electrodes 50 may be segmented or partial ring electrodes, each of which extends along an arc less than 360 degrees (e.g., 90-120 degrees) around the circumference of elongated member 48. In embodiments in which lead 14 is a paddle lead, electrodes 50 may extend along a portion of the periphery defined by elongated member 48. Electrodes 50 are electrically coupled to a therapy delivery module 40 of stimulator 12 via conductors within elongated member 48.
  • Electrodes 50 extending around a portion of the circumference of lead body 48 or along one side of a paddle lead may be useful for providing an electrical stimulation field in a particular direction/targeting a particular therapy delivery site. For example, in the electrical stimulation application shown in FIG. 1B, electrodes 50 may be disposed along lead body 48 such that the electrodes face toward occipital nerves 32, 34, and/or 36, or otherwise away from the scalp of patient 30. This may be an efficient use of stimulation because electrical stimulation of the scalp may provide minimally useful therapy, if any, to patient 30. In addition, the use of segmented or partial ring electrodes 50 may also reduce the overall power delivered to electrodes 50 by stimulator 12 because of the efficient delivery of stimulation to occipital nerves 32, 34, and/or 36 (or other target stimulation site) by eliminating or minimizing the delivery of stimulation to unwanted or unnecessary regions within patient 30. The configuration, type, and number of electrodes 28 illustrated in FIG. 2 are merely exemplary.
  • In embodiments in which electrodes 50 extend around a portion of the circumference of lead body 48 or along one side of a paddle lead, lead 14 may include one or more orientation markers 45 proximate to proximal end 14A that indicate the relative location of electrodes 50. Orientation marker 45 may be a printed marking on lead body 48, an indentation in lead body 48, a radiographic marker, or another type of marker that is visible or otherwise detectable (e.g., detectable by a radiographic device) by a clinician. Orientation marker 45 may help a clinician properly orient lead 14 such that electrodes 50 face the desired direction (e.g., toward occipital nerves 32, 34, and/or 36) within patient 16. For example, orientation marker 45 may also extend around the same portion of the circumference of lead body 48 or along the side of the paddle lead as electrodes 50. In this way, orientation marker 45 faces the same direction as electrodes, thus indicating the orientation of electrodes 50 to the clinician. When the clinician implants lead 14 in patient 16, orientation marker 45 may remain visible to the clinician.
  • Stimulator 12 delivers stimulation therapy via electrodes 50 of lead 14. In one embodiment, an implantable signal generator or other stimulation circuitry within therapy delivery module 40 delivers electrical signals (e.g., pulses or substantially continuous-time signals, such as sinusoidal signals) to targets stimulation site 18 (FIG. 1A) via at least some of electrodes 50 under the control of a processor 42. The stimulation energy generated by therapy delivery module 40 may be formulated as stimulation energy, e.g., for treatment of any of a variety of neurological disorders, or disorders influenced by patient neurological response. The signals may be delivered from therapy delivery module 40 to electrodes 50 via a switch matrix and conductors carried by lead 14 and electrically coupled to respective electrodes 50. The implantable signal generator may be coupled to power source 47. Power source 47 may take the form of a small, rechargeable or non-rechargeable battery, or an inductive power interface that transcutaneously receives inductively coupled energy. In the case of a rechargeable battery, power source 47 similarly may include an inductive power interface for transcutaneous transfer of recharge power.
  • Processor 42 may include a microprocessor, a controller, a DSP, an ASIC, an FPGA, discrete logic circuitry, or the like. Processor 42 controls the implantable signal generator within therapy delivery module 40 to deliver stimulation therapy according to selected stimulation parameters. Specifically, processor 42 controls therapy delivery module 40 to deliver electrical signals with selected amplitudes, pulse widths (if applicable), and rates specified by the programs. In addition, processor 42 may also control therapy delivery module 40 to deliver the stimulation signals via selected subsets of electrodes 50 with selected polarities. For example, electrodes 50 may be combined in various bipolar or multi-polar combinations to deliver stimulation energy to selected sites, such as nerve sites adjacent the spinal column, pelvic floor nerve sites, or cranial nerve sites.
  • In addition, processor 42 may control therapy delivery module 40 to deliver each signal according to a different program, thereby interleaving programs to simultaneously treat different symptoms or provide a combined therapeutic effect. For example, in addition to treatment of one symptom such as sexual dysfunction, stimulator 12 may be configured to deliver stimulation therapy to treat other symptoms such as pain or incontinence.
  • Memory 44 of stimulator 12 may include any volatile or non-volatile media, such as a RAM, ROM, CD-ROM, NVRAM, EEPROM, flash memory, and the like. In some embodiments, memory 44 of stimulator 12 may store multiple sets of stimulation parameters that are available to be selected by patient 16 or a clinician for delivery of stimulation therapy. For example, memory 44 may store stimulation parameters transmitted by clinician programmer 26 (FIG. 1A). Memory 44 also stores program instructions that, when executed by processor 42, cause stimulator 12 to deliver stimulation therapy. Accordingly, computer-readable media storing instructions may be provided to cause processor 42 to provide functionality as described herein.
  • In particular, processor 42 controls telemetry module 170 to exchange information with an external programmer, such as clinician programmer 26 and/or patient programmer 28 (FIG. 1A), by wireless telemetry. In addition, in some embodiments, telemetry module 46 supports wireless communication with one or more wireless sensors that sense physiological signals and transmit the signals to stimulator 12.
  • In some embodiments, where lead 14 is a drug delivery catheter, therapy delivery module 40 may include a fluid pump or other release mechanism to dispense a therapeutic agent through lead 14 and into patient 16. Therapy deliver module 40 may also, in this case, include a fluid reservoir which contains the therapeutic agent. Possible therapeutic agents may include pharmaceutical agents, insulin, a pain relieving agent or a gene therapy agent. Refilling the fluid reservoir may be accomplished by inserting the needle of a syringe through the skin of patient 16 and into a refill port in the housing of stimulator 12. In addition, more than one lead may be coupled to therapy delivery module 40.
  • FIGS. 3A and 3B are perspective drawings of a sheath that covers a lead prior to implantation and removed after the lead is correctly positioned in a patient, which includes a lead that includes a threaded fixation structure. As shown in FIG. 3A, lead 52 is capable of delivering electrical stimulation to numerous tissue sites within patient 16. Lead 52 may be an embodiment of any lead described herein, including lead 14. Prior to delivering stimulation, elongated member 54 of lead 52 is covered completely around the longitudinal outer surface with sheath 58. Sheath 58 may be constructed to protect electrodes 56 and threaded fixation structure 57 from implantation stresses or damage of adjacent tissues. In addition, sheath 58 may be a restraint mechanism that keeps threaded fixation structure 57 from being deployed until the clinician removed the sheath. Electrodes 56 are typically ring electrodes, but other types of electrodes may be used. For example, segmented electrodes, or multiple electrodes around the circumference of elongated member 54 may be employed. Alternatively, lead 52 may be in a non-circular shape, such as a rectangular paddle lead. In some embodiments, lead 52 may also include one or more radio-opaque markers that allow the clinician to image the lead in real time to determine the exact position of the lead within patient after rotating the lead.
  • Sheath 58 may be constructed of a flexible polymer that provides a smooth interface between the sheath and elongated member 54. Sheath 58 may be dimensioned just larger than elongated member 54, or the sheath may be shrunk to fit elongated member 54 snugly for implantation. In some embodiments, sheath 58 may constructed to assist the clinician in guiding lead 52 within patient 16. In this case, sheath 58 may be rigid or semi-rigid and similar to a lead introducer or a cannula introduction device.
  • FIG. 3B shows lead 52 with sheath 58 being removed from elongated member 54 in the direction of the arrow. Once lead 52 is positioned such that electrodes 56 are adjacent to a target tissue for stimulation, the clinician may begin removing lead 52 as shown. As sheath 58 is removed, threaded fixation structure 57 is exposed to the adjacent tissue to fix elongated member 54 in position. In other embodiments, the clinician may remove sheath 58 in sections as fixation elements need to be deployed or as necessary to ensure proper fixation within patient 16. As will be described in detail below, threaded fixation structure 57 may have different dimensions, sizes, locations, and properties than shown in FIGS. 3A and 3B.
  • FIGS. 4A-4C are perspective drawings illustrating exemplary stimulation leads with varying configurations of threaded fixation mechanisms. As shown in FIG. 4A, lead 60 includes elongated member 62, electrodes 64, tapered tip 68, and threaded fixation structure 70. The distal end of lead 60 is shown. Elongated member 62 is substantially cylindrical in shape, but the elongated member may also be configured into any other shape. Electrodes 64 are ring electrodes disposed at the distal end of elongated member 62. At the distal tip of lead 60, tapered, conical tip 68 is attached to, or integrally formed with, elongated member 62. Threaded fixation structure 70 is disposed distal to electrodes 64 and around the outer surface of tapered tip 68.
  • Tapered tip 68 is formed in the shape of a cone to facilitate the tunneling of lead 60 through tissue in order to reach the target tissue. Threaded fixation structure 70 is disposed around the outer surface of tapered tip 68 from adjacent to the distal end of the tapered tip to the distal end of elongated member 62. In this manner, threaded fixation structure 70 engages with the adjacent tissue of patient 16 as tapered tip 68 pierces through the tissue. As a user, e.g., a clinician, rotates lead 60, threaded fixation structure 70 advances the lead through the adjacent tissue and moves electrodes 64 increasingly closer to a target tissue with each turn of the lead. In other embodiments threaded fixation structure 70 may only be disposed along a portion of tapered tip 68.
  • Threaded fixation structure 70 may be constructed of a material similar to or different from elongated member 62 or tapered tip 68. The material of threaded fixation structure 70 may be substantially biologically inert, e.g., biocompatible, and may include any of metals, metal alloys, composites, or polymers. Some example materials may include stainless steel, titanium, nitinol, polypropylene, polyurethane, polycarbonate, polyethylene, nylon, silicone rubber, or expanded-polytetrafluoroethylene. The material selection of threaded fixation structure 70 may be based upon whether the structure is desired to be rigid, semi-rigid, or flexible properties, which could affect the engagement of the structure to the adjacent material. In addition, threaded fixation structure 70 may be a combination of different materials depending on the implantation site. For example, threaded fixation structure 70 may have a flexible distal portion that changes to a rigid portion for precise engagement with the adjacent tissue. Threaded fixation structure 70 may be adhered to tapered tip 68 through a glue, an epoxy, welding, soldering, or any other attachment mechanism. In other embodiments, threaded fixation structure 70 may be an overmold that is fitted to a snug fit around elongated member 62. Alternatively, threaded fixation structure 70 may be formed with tapered tip 68.
  • In addition, threaded fixation structure 70 may have a cross-sectional shape configured to assist the advancement of lead 60 through the adjacent tissue. The cross-sectional shape of each thread may generally be a triangle, but other shapes are possible. For example, the cross-sectional shape of threaded fixation structure 70 may be a rounded triangle, a semi-circle, a square, a rectangle, a trapezoid, or any other shape desired by the clinician. In addition, the cross-sectional shape may be angled in a direction non-perpendicular to the outer surface of tapered tip 68. For example, threaded fixation structure 70 may be tilted toward the proximal end of lead 60. In other words, the angle between the outer surface of tapered tip 68 and the proximal side of threaded fixation structure 70 may be less than 90 degrees. Alternatively, the angle between the outer surface of tapered tip 68 and the proximal side of threaded fixation structure 70 may be greater than 90 degrees.
  • Threaded fixation structure 70 may also be configured to advance through tissue at a predetermined rate or extend into the tissue a predetermined distance. The pitch of threaded fixation structure 70 may be defined by the distance lead 60 is advanced with each full 360 degree rotation of the lead, i.e., the axial distance between two peaks of the threaded fixation structure. Threaded fixation structure 70 may have a pitch between approximately 0.5 millimeters (mm) and 3 mm. The pitch may be less than approximately 0.5 mm or greater than 3 mm. The height of threaded fixation structure 70 is the distance between the outer surface of tapered tip 68 and the top edge of the threaded fixation structure. Generally, the height is between approximately 0.1 mm and 3 mm. However, other embodiments of threaded fixation structure 70 may include heights smaller than approximately 0.1 mm or greater than 3 mm. While threaded fixation structure 70 may have a constant height, the threaded fixation structure may increase in height as the threaded fixation structure moves away from the distal end of tapered tip 68. Generally, elongated member 62 may have an outside diameter between approximately 0.5 mm and 5 mm. The wall thickness of elongated member 62 may be between approximately 0.1 mm and 2 mm. In addition, the ratio of diameter to thread height may be between approximately 1 and 50, depending on the application of lead 60.
  • FIG. 4B shows lead 72, which is an embodiment of lead 60 (FIG. 4A). Lead 72 includes elongated member 74, electrodes 76, tapered tip 80, and threaded fixation structure 82. Lead 72 differs from lead 60 in the shape of tapered tip 80. While tapered tip 68 is constructed as a cone shape, tapered tip 80 is a parabolic shape with an atraumatic, rounded distal end. Tapered tip 80 may be beneficial if the clinician does not want a tip that may damage adjacent tissue during extreme bends of elongated member 74. In other embodiments, tapered tip 80 may be configured into a different shape. For example, tapered tip 80 may be curved in any parabolic shape different from that shape of the tapered tip shown in FIG. 4B. In addition, tapered tip 80 may be asymmetrical or bent in a predetermined direction to facilitate creating a curved path for lead 72.
  • FIG. 4C illustrates lead 84 with threaded fixation structure 90 disposed proximal to electrodes 88. Lead 84 includes elongated member 86, electrodes 88 and threaded fixation structure 90. Threaded fixation structure 90 is disposed around the longitudinal outer surface of elongated member 86, proximal to the location of electrodes 88. In other embodiments, threaded fixation structure 90 may be disposed around the longitudinal outer surface of elongated member 86 at a location distal to electrodes 88. The distal position of threaded fixation structure 90 may be instead of or in addition to the proximal position of the threaded fixation structure.
  • Threaded fixation structure 90 may include any number of turns around elongated member 86. For example, threaded fixation structure 90 may include 3 complete turns as shown in FIG. 4C. However, threaded fixation structure 90 may include more than 3 or less than 3 turns, as desired by the clinician for a particular implantation site. In addition, threaded fixation structure 90 may include partial turns, or even continuous structures with less than one complete turn. In other embodiments, multiple threaded fixation structures 90 may be disposed proximal to or distal to electrodes 88. In alternative embodiments, lead 84 may include a tip that has a threaded fixation structure such as tapered tips 68 and 80 of leads 60 and 72, respectively.
  • Threaded fixation structure 90 may be constructed of a material similar to or different from elongated member 86. The material of threaded fixation structure 90 may be substantially biologically inert, e.g., biocompatible, and may include any of metals, metal alloys, composites, or polymers. Some example materials may include stainless steel, titanium, nitinol, polypropylene, polyurethane, polycarbonate, polyethylene, nylon, silicone rubber, or expanded-polytetrafluoroethylene. The material selection of threaded fixation structure 90 may be based upon whether the structure is desired to be rigid, semi-rigid, or flexible properties. Threaded fixation structure 90 may be adhered to elongated member 86 through a glue, an epoxy, welding, soldering, or any other attachment mechanism. In other embodiments, threaded fixation structure 90 may be an overmold that is fitted to a snug fit around elongated member 86. Alternatively, threaded fixation structure 90 may be integrally formed with elongated member 86, e.g., by injection molding and/or insert molding.
  • In addition, threaded fixation structure 90 may have a cross-sectional shape configured to assist the advancement of lead 84 through the adjacent tissue. The cross-sectional shape may generally be a triangle, but other shapes are possible. For example, the cross-sectional shape of threaded fixation structure 90 may be a rounded triangle, a semi-circle, a square, a rectangle, a trapezoid, or any other shape desired by the clinician. In addition, the cross-sectional shape may be angled in a direction non-perpendicular to the outer surface of elongated member 86. For example, threaded fixation structure 90 may be tilted toward the proximal end of lead 84. In other words, the angle between the outer surface of elongated member 86 and the proximal side of threaded fixation structure 90 may be less than 90 degrees. Alternatively, the angle between the outer surface of elongated member 86 and the proximal side of threaded fixation structure 90 may be greater than 90 degrees.
  • Threaded fixation structure 90 may also be configured to advance through tissue at a predetermined rate or extend into the tissue a predetermined distance. The pitch of threaded fixation structure 90 may be defined by the distance lead 84 is advanced with each full 360 degree rotation of the lead, i.e., the axial distance between two peaks of the threaded fixation structure. Threaded fixation structure 90 may have a pitch between approximately 0.5 millimeters (mm) and 3 mm. In some embodiments, the pitch may be less than approximately 0.5 mm or greater than 3 mm. The height of threaded fixation structure 90 is the distance between the outer surface of elongated member 86 and the top edge of the threaded fixation structure. Generally, the height is between approximately 0.1 mm and 3 mm. However, other embodiments of threaded fixation structure 90 may include heights smaller than approximately 0.1 mm or greater than 3 mm. As threaded fixation structure 90 increases in height, the surface area of the threaded fixation structure increases as well. A larger surface area of threaded fixation structure 90 may increase the axial force lead 84 may be able to incur without allowing the lead to migrate in the direction of the axial force. In other words, a larger height of threaded fixation structure 90 may be desired in cases where lead 84 is subjected to greater movement. While threaded fixation structure 90 may have a constant height, the threaded fixation structure may increase in height as it moves towards the proximal end of the threaded fixation structure. Elongated member 62 may have an outside diameter between approximately 0.5 mm and 5 mm. The wall thickness of elongated member 62 may be between approximately 0.1 mm and 2 mm. In addition, the ratio of diameter to thread height may be between approximately 1 and 50, depending on the application of lead 60.
  • Implantation of all leads 60, 72, and 84, may vary depending on the target stimulation site within patient 16 or implant preferences of the clinician. For example, a sheath (shown in FIGS. 3A and 3B) may be used to cover any threaded fixation structures to allow insertion of the lead without requiring rotation of the lead. Upon positioning the lead near the stimulation site, the clinician may remove the sheath and begin rotating the lead to engage to recently exposed threaded fixation structure. Alternatively, the clinician may guide and rotate the lead through a substantial length of the insertion of the lead without the use of a sheath.
  • FIGS. 5A-5B are perspective drawings illustrating exemplary stimulation leads with varying threaded fixation mechanisms over electrodes of the lead. As shown in FIG. 5A, lead 92 includes elongated member 94, electrodes 96, and threaded fixation structure 98, a fixation structure. Threaded fixation structure 98 is shown to be disposed around the same portion of elongated member 94 that includes electrodes 96. In this manner, threaded fixation structure 98 is located over a portion of the surface of each electrode 96 as the threaded fixation structure rotates from the proximal end of the threaded fixation structure to the distal end of the threaded fixation structure. Utilizing threaded fixation structure 98 over electrodes 96 may provide for reduced movement of electrodes 96 with respect to the target tissue, compared to threaded fixation structures located elsewhere along the longitudinal outer surface of lead 92. Threaded fixation structure 98 may be constructed similar to and have similar physical properties of threaded fixation structure 90 of FIG. 4C. Threaded fixation structure 98 may attached to electrodes 96 with an adhesive or other bonding technique, while some embodiments may not have the threaded fixation structure attached to the electrodes.
  • While threaded fixation structure 98 is shown to be substantially disposed around the entire portion of elongated member 94 that includes electrodes 96, the threaded fixation structure may also be disposed further in the proximal or distal direction along the elongated member. In some embodiments, threaded fixation structure 98 may only be disposed on a portion of the surface including electrodes 96. In other words, threaded fixation structure 98 may not be disposed around all electrodes 96, e.g., the threaded fixation structure may only be disposed around the proximal two electrodes. In other embodiments, lead 92 may include threaded fixation structure 98 at locations along elongated body similar to leads 60, 72, or 84 of FIGS. 4A, 4B, and 4C, respectively.
  • FIG. 5B shows lead 100 that is substantially similar to lead 92 of FIG. 5A. Lead 100 includes elongated member 102, electrodes 104, and threaded fixation structures 106A, 106B, 106C, 106D and 106E (collectively “threaded fixation structures 106). Threaded fixation structures 106 are disposed at the portion of elongated member 102 which also includes electrodes 104. However, none of threaded fixation structures 106 are located over the surface of any of electrodes 104. Instead, each of threaded fixation structures 106 are only attached to elongated member 102 and stop before covering any portion of electrodes 104. In other words, threaded fixation structures 106 may be substantially similar to threaded fixation structure 98 of FIG. 5B, but have any portion of the threaded fixation structure over electrodes 96 removed. In this manner, threaded fixation structures 106 are arranged in sections to avoid interference with the electrical field produced by electrodes 104 that provides therapy to the target tissue of patient 16. Threaded fixation structures 106 may be constructed similar to and have physical properties similar to threaded fixation structure 90 of FIG. 4C. In some embodiments, one or more of threaded fixation structures 106 may be constructed of different materials to the other threaded fixation structures.
  • Threaded fixation structures 106B-D are located between electrodes 104, threaded fixation structure 106A is disposed proximal to electrodes 104 and threaded fixation structure 106E is disposed distal to the electrodes. In some embodiments, threaded fixation structure 106A may include more turns and be disposed along a greater proximal portion of elongated member 102. Alternatively, threaded fixation structure 106E may include more turns and be disposed along a greater distal portion of elongated member 102. In other embodiments, one or more of threaded fixation structures 106 may not be included in lead 100. For example, lead 100 may only include threaded fixation structures 106A-C. In additional embodiments, lead 100 may include threaded fixation structures at locations along elongated body similar to leads 60, 72, or 84 of FIGS. 4A, 4B, and 4C, respectively.
  • FIG. 6 is a perspective drawing illustrating lead 108 with threaded fixation structure extending from the distal end of the lead to a location proximate to electrodes 112. As shown in FIG. 6, lead 108 includes elongate member 110, electrodes 112, tapered tip 114, and threaded fixation structure 116. Threaded fixation structure begins at the distal tip of tapered tip 114 and continues to wrap around elongate member 110 past electrodes 112 to a location of the electrode member proximal to the electrodes. Lead 108 may be a combination of threaded fixation structures described with respect to leads 60, 72, 84, 92, or 100 of FIGS. 4 and 5. In addition, threaded fixation structure 116 may have similar properties to any of threaded fixation structures 70, 82, 90, 98, or 106. In other embodiments threaded fixation structure 116 may be broken into two or more threaded fixation structures at any location along tapered tip 114 or elongated member 110, including threaded fixation structures that do not cover the surface of electrodes 112. In alternative embodiments, lead 108 may include threaded fixation structures at the proximal and/or intermediate locations of elongate member 110 instead of or in addition to threaded fixation structure 116.
  • FIG. 7 is a perspective drawing illustrating lead 118 that includes a reinforcement member. Lead 118 is substantially similar to lead 108 of FIG. 6 and includes elongate member 120, electrodes 122, tapered tip 124, and threaded fixation structure 126. In contrast to lead 108, lead 118 includes helical reinforcement member 128 which resides within elongated member 120. Helical reinforcement member 128 is provided to add torsional rigidity to lead 118 which resists twisting of elongated member 120 when the clinician rotates the lead to engage threaded fixation structure 126.
  • Helical reinforcement member 128 may be provided in a variety of methods. First, helical reinforcement member 128 may be a metal or polymer wire. Second, helical reinforcement member 128 may be a metal or polymer ribbon that creates a substantially contiguous cylinder. Other fibers, materials, or members may be used to construct helical reinforcement member 128, in some embodiments. While helical reinforcement member 128 is shown as extending within elongate member 120 in a direction opposite threaded fixation structure 126, some embodiments may employ the helical reinforcement member in the same direction as the threaded fixation structure. Alternatively, helical reinforcement member 128 may include two helical reinforcement members in which one helical reinforcement member is arranged in one direction and the second helical reinforcement member is arranged in a second direction opposite the first direction. Helical reinforcement member 128 may extend throughout the entire length of lead 118 or only a small portion of the lead.
  • FIGS. 8A and 8B are perspective drawings illustrating exemplary stimulation leads with foldable threads. FIG. 8A illustrates lead 130 prior to the removal of sheath 138. Lead 130 includes elongated member 132, electrodes 134, threaded fixation structure 136, and sheath 138. Lead 130 may be similar to any of leads 60, 72, 84, 92, 100, 108 or 118; however, threaded fixation structure 136 is foldable, or compliant, such that sheath 138 prevents the threaded fixation structure from extending away from elongated member 132. While threaded fixation structure 136 is shown to be disposed around the portion of elongated member 132 that includes electrodes 134, the threaded fixation structure may be disposed at any portion of the elongated member as described herein.
  • Sheath 138 is provided to facilitate implantation of lead 130. With sheath 138 covering elongated member 132 and collapsing threaded fixation structure 136, the diameter of lead 130 is smaller to allow the clinician to push the lead through a lead introducer (not shown) or through tissue of patient 16. Once the clinician inserts lead 130 to the desired position, sheath 138 is removed to expose threaded fixation structure 136 to the adjacent tissue. Threaded fixation structure 136 extends away from the outer surface of elongated member 132 to the originally formed threaded fixation structure dimensions. Rotating lead 130 may help threaded fixation structure 136 to extend away from the surface of elongated member 132 and engage the surrounding tissue. The extended angle of threaded fixation structure 136 may be less than 90 degrees between the outer surface of elongated member 132 and the proximal surface of the threaded fixation structure. While threaded fixation structure 136 is foldable towards the proximal end of lead 130, the threaded fixation structure may be foldable towards the distal end of the lead in other embodiments.
  • Threaded fixation structure 136 may be constructed of any bendable, pliable, elastic, or superelastic material that is biocompatible. For example, a polymer such as expanded-polytetrafluoroethylene or a shape memory metal alloy such as nitinol may be used to construct threaded fixation structure 136. Sheath 138 may be constructed of a thin polymer membrane that may slide over the surface of elongated member 132 and threaded fixation structure 136 while maintaining sufficient circumferential stiffness that retains the threaded fixation structure before deployment. Sheath 138 may be initially configured to cover elongated member 132 and threaded fixation structure 136 by sliding the sheath from the distal end of lead 130 to the proximal end of the lead. Alternatively, sheath 138 may loosely cover lead 130 and be heated to shrink the circumference of the sheath and collapse threaded fixation structure 136.
  • FIG. 8B shows lead 130 with sheath 138 being removed in the proximal direction of arrow 140. The distal portion of threaded fixation structure 136 has already extended away from elongated member 132 in the direction of arrow 142. The proximal portion of threaded fixation structure, indicated by arrow 144, is still restricted by sheath 138 that has not been fully removed. Once sheath 138 is fully removed from lead 130, the clinician may rotate the lead to engage threaded fixation structure 136 with the adjacent tissue. In addition, once sheath 138 is removed from lead 130, the clinician may not be able to slide the sheath back over threaded fixation structure 136.
  • In alternative embodiments, sheath 138 may not be necessary for threaded fixation structure 136 to fold down against elongated member 132. Threaded fixation structure 136 may fold down from force from adjacent tissue when the clinician inserts lead 130 into patient 16. When lead 130 is properly positioned, the clinician may pull back on the lead to cause threaded fixation structure 136 to engage with the adjacent tissue and extend the threaded fixation structure away from elongated member 132. The clinician can then begin to rotate lead 130 to screw the lead into the tissue and secure electrodes 134 to the desired location.
  • FIG. 9 is a flow diagram illustrating an exemplary process for securing a threaded lead to a tissue of a patient. Any of leads 60, 72, 84, 92, 100, 108 or 118, or 130 may be implanted with this procedure, but lead 60 will be used as an example. The clinician beings by inserting the lead introducer into the target stimulation site of patient 16 (146). Next, the clinician inserts lead 60 into the lead introducer until the lead is positioned correctly (148). The clinician then withdraws the sheath that covers lead 60 (150) and rotates the lead in the direction of threaded fixation structure 68, e.g., clockwise, to secure the lead at the target tissue (152). If lead 60 is not correctly placed (154), the clinician continues to rotate the lead (152). If lead 60 is positioned correctly (154), the clinician may attach the proximal end of the lead to the stimulator and proceed with beginning therapy (156).
  • In some embodiments, the clinician may not need to remove a sheath to expose the threaded fixation structure. In other embodiments, the clinician may require a keyed stylet or other device that engages into the distal end of the lead and locks into interior grooves or teeth to facilitate the rotation of the lead and engagement of the threaded fixation structure. Alternatively, the stylet may be inserted through a channel extending within lead 60 that attaches to grooves, slots, or teeth near the proximal end of the lead to facilitate lead rotation that engages the threaded fixation structure to the adjacent tissue.
  • FIG. 10 is a flow diagram illustrating an exemplary process for removing a threaded lead from a tissue of a patient. Any of leads 60, 72, 84, 92, 100, 108 or 118, or 130 may be implanted with this procedure, but lead 60 will be used as an example. After stimulation therapy has been completed or lead 60 needs to be removed for any other reason, the clinician may ready patient 16 for removal of the lead from stimulator 12 (158). If the threaded fixation structure is foldable (160), the clinician inserts a sheath down to the proximal end of the threaded fixation structure (162). If the threaded fixation structure of lead 60 is not foldable, or the sheath has been inserted to the foldable threads, the clinician begins to rotate the lead in the opposite direction of the threaded fixation structure, e.g., counter-clockwise (164). If the threaded fixation structure is not released from tissue (166), the clinician continues to rotate lead 60 (164). If the threaded fixation structure has been released from tissue (166), the clinician may pull lead 60 from patient 16 (168). Releasing the threaded fixation structure from the tissue may include either backing the threaded fixation structure into the sheath such that the structure folds under the sheath or rotating the lead enough that the threaded fixation structure is free from being engaged from any tissue of patient 16.
  • Similar to FIG. 9, some embodiments may require that the clinician use a keyed stylet or other device that engages into the distal end of the lead and locks into interior grooves or teeth to facilitate the rotation of the lead and disengagement of the threaded fixation structure. Alternatively, the stylet may be inserted through a channel extending within lead 60 that attaches to grooves, slots, or teeth near the proximal end of the lead to facilitate lead rotation that disengages the threaded fixation structure from the adjacent tissue.
  • FIG. 11 is a method of implanting a lead in patient 12 with a different threaded fixation structure than the leads implanted in with the technique of FIG. 9. Any of leads 60, 72, 84, 92, 100, 108 or 118, or 130 with a foldable threaded fixation structure may be implanted with this procedure, but lead 130 will be used as an example. The clinician beings by inserting the lead introducer into the target stimulation site of patient 16 (169), which causes threaded fixation structure 136 to fold down against the surface of lead 130. Next, the clinician inserts lead 130 into the lead introducer until the lead is positioned correctly (171). The clinician then removes the lead introducer that covers lead 130 (173) and pulls back on the lead to engage, or extend, the folded threaded fixation structure with the adjacent tissue (175). The clinician then rotates the lead in the direction of threaded fixation structure 136, e.g., clockwise, to secure the lead at the target tissue (177). If lead 130 is not correctly placed (179), the clinician continues to rotate the lead (177). If lead 130 is positioned correctly (179), the clinician may attach the proximal end of the lead to the stimulator and proceed with beginning therapy (181).
  • In some embodiments, the clinician may be able to insert lead 130 directly into patient 16 without the use of a lead introducer. In this case, foldable threaded fixation structure 136 folds down with the force of the adjacent tissue as lead 130 is inserted into patient 16. In other embodiments, the clinician may require a keyed stylet or other device that engages into the distal end of the lead and locks into interior grooves or teeth to facilitate the rotation of the lead and engagement of the threaded fixation structure. Alternatively, the stylet may be inserted through a channel extending within lead 130 that attaches to grooves, slots, or teeth near the proximal end of the lead to facilitate lead rotation that engages the threaded fixation structure to the adjacent tissue.
  • FIGS. 12A and 12B are perspective drawings illustrating exemplary medical catheters with a helical threaded structure. Threaded fixation structures 174 and 184 may be similar to the threaded fixation structures of any of leads 60, 72, 84, 92, 100, 108 or 118, or 130. However, a conduit is used to deliver a therapeutic agent to the tissue instead of electrodes that deliver stimulation. FIG. 12A shows lead 170 that includes elongated member 172, threaded fixation structure 174, conduit 176, and exit port 178. Threaded fixation structure 174 is disposed about the outer surface of elongated member 172 at the distal end of the elongated body. A drug pump may be attached to the proximal end of lead 170 for delivering a therapeutic agent through conduit 176 and out of exit port 178 into the adjacent target tissue. Conduit 176 resides within elongated member 172, and may or may not have a common central axis to the elongated member. In other embodiments, more than one threaded fixation structure 174 may be provided to secure the location of lead 170 and ensure that the therapeutic agent is delivered to the appropriate tissue of patient 16.
  • FIG. 12B shows lead 180 which is similar to lead 170 of FIG. 12A. Lead 180 includes elongated body 182, threaded fixation structure 184, conduit 186, and exit port 188. Exit port 188 is disposed on a longitudinal outer surface of elongated member 182, within threaded fixation structure 184. Conduit 186 resided within elongated member 182, and may or may not have a common central axis with the elongated member. In other embodiments, exit port 188 may be located outside of threaded fixation structure 184 either distal to or proximal to the threaded fixation structure. In alternative embodiments, conduit 186 may be in fluidic communication with more than one exit port, where the multiple exit ports are located at various longitudinal or circumferential positions of elongated member 182 or in the axial surface of the elongated member. In addition, lead 180 may include multiple conduits within elongated member 182.
  • FIGS. 13A and 13B are cross-sectional end views of a keyed stylet 200 and a reciprocally keyed medical lead 202. As discussed previously, rotational movement of a lead may be accomplished by simply rotating the lead body. In some embodiments, however, it may be desirable to rotate the lead body with the aid of a stylet inserted in an inner lumen of the lead body. For example, a stylet may provide added structural integrity relative to a flexible lead. The stylet may be sized to frictionally engaged the inner wall of the inner lumen such that rotation of the stylet causes rotation of the lead body. Alternatively, the stylet and the lead body may be formed with a reciprocal key structure, such as any combination of slots, grooves, teeth, ribs, rails, or the like.
  • In the example of FIGS. 13A and 13B, stylet 200 includes a stylet body 203 with multiple teeth 204A-204D. The teeth may run longitudinally substantially the entire length of the stylet body 203, or be provided only near a distal end of the stylet body, e.g., over the last 2 to 6 centimeters at the distal end of the stylet. In either case, teeth 204A-204D may be sized and shaped to engage reciprocal grooves 210A-210D in a lead body 206 of lead 202. The grooves 210A-210D may be formed by molding, extruding, scribing or other techniques. In any event, teeth 204A-204D engage corresponding grooves 210A-210D so that the teeth can bear against the grooves to transmit rotational force from stylet 200 to lead 202.
  • Also shown in FIG. 13B are representative portions 212A, 212B of a threaded fixation structure. Any thread fixation structure, as described herein, may be combined with a lead 202 including slots, grooves, or the like. Moreover, the number of slots or grooves may be subject to wide variation. Also, in some embodiments, lead 202 may include teeth while stylet 200 includes grooves. The exact combination, arrangement, size, and number of slots, grooves, teeth or the like is subject to variation provided the lead 202 and stylet 200 include reciprocal structure to impart rotational movement from the stylet to the lead.
  • Alternative to keyed stylet 200, a cannula device that is configured to fit around the outside of the lead may be used to rotate the lead and engage the threaded fixation structure. The cannula device may be circumferentially locked to the lead via one or more slots, grooves, teeth, ribs, rails, or the like, disposed on the outside of the elongated member. In some embodiments, the cannula device may use a friction fit to lock to the lead. In either case, the cannula device may be slid down to the proximal end of the threaded fixation structure or some other location of the lead that still facilitates rotation of the lead.
  • A lead including threaded fixation may be useful for various electrical stimulation systems. For example, the lead may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor disorders, gastroparesis, muscle stimulation (e.g., functional electrical stimulation (FES) of muscles) or obesity. In addition, the helical fixation described herein may also be useful for fixing a catheter, such as a drug deliver catheter, proximate to a target drug delivery site.
  • The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, therefore, that other expedients known to those skilled in the art or disclosed herein may be employed without departing from the invention or the scope of the claims. For example, the present invention further includes within its scope methods of making and using systems and leads for stimulation, as described herein. Also, the leads described herein may have a variety of stimulation applications, as well as possible applications in other electrical stimulation contexts, such as delivery of cardiac electrical stimulation, including paces, pulses, and shocks.
  • Many embodiments of the invention have been described. Various modifications may be made without departing from the scope of the claims. These and other embodiments are within the scope of the following claims.

Claims (34)

1. A medical lead comprising:
an elongated member having a proximal end and a distal end;
at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead; and
at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
2. The medical lead of claim 1, wherein the portion of the outer surface is proximal to the at least one stimulation electrode.
3. The medical lead of claim 1, wherein the portion of the outer surface is distal to the at least one stimulation electrode.
4. The medical lead of claim 3, further comprising a tapered tip at the distal end of the elongated member, wherein the tapered tip includes the portion.
5. The medical lead of claim 1, wherein the portion of the outer surface includes the at least one stimulation electrode.
6. The medical lead of claim 1, wherein a plurality of threaded fixation structures are formed around the portion of the outer surface of the elongated member to simulate a continuous threaded fixation structure.
7. The medical lead of claim 1, wherein the threaded fixation structure is foldable in one direction to allow the thread structure to lay substantially flat against the elongated member when restrained by a sheath.
8. The medical lead of claim 1, further comprising a helical reinforcement member disposed within an inner surface of the elongated member to provide torsional rigidity to the elongated member.
9. The medical lead of claim 8, wherein the helical reinforcement member is disposed in a direction different than the direction of the threaded fixation structure.
10. The medical lead of claim 1, wherein the threaded fixation structure comprises a pitch between adjacent threads or approximately 0.5 millimeters (mm) to approximately 3 mm.
11. The medical lead of claim 1, wherein the threaded fixation structure comprises a thread height between approximately 0.1 millimeters (mm) and approximately 3 mm.
12. The medical lead of claim 1, wherein the threaded fixation structure comprises at least one of a biocompatible metal alloy and a biocompatible polymer.
13. A method comprising:
inserting a medical lead into a patient, wherein the lead comprises at least one stimulation electrode and at least one threaded fixation structure extending around a portion of an outer surface of the lead; and
rotating the lead to engage the threaded fixation structure with tissue of the patient to resist migration of the lead.
14. The method of claim 13, further comprising removing a sheath from the lead to expose the at least one threaded fixation structure after the lead is inserted into the patient.
15. The method of claim 14, wherein removing the sheath allows the at least one threaded fixation structure to unfold and extend from the lead.
16. The method of claim 13, further comprising generating electrical stimulation with a stimulator and delivering the electrical stimulation to the patient via the at least one stimulation electrode of the lead.
17. The method of claim 13, further comprising rotating the lead to disengage the threaded fixation structure from the tissue in the patient.
18. The method of claim 13, further comprising sliding a sheath over the lead to cover the at least one threaded fixation structure with the sheath.
19. The method of claim 18, further comprising removing the lead and sheath from the patient
20. The method of claim 13, wherein inserting a medical lead into a patient comprises forcing the at least one threaded fixation structure to fold down against the outer surface of the lead in a first direction.
21. The method of claim 20, further comprising pulling the lead in the first direction to extend the at least one threaded fixation structure into the tissue, and wherein rotating the lead causes the at least one threaded fixation structure to advance the lead in a second direction opposite the first direction.
22. The method of claim 13, further comprising positioning the at least one electrode adjacent to at least one of a sacral nerve, a pudendal nerve, a spinal cord, and an occipital nerve.
23. A system comprising:
a medical lead comprising:
an elongated member having a proximal end and a distal end;
at least one stimulation electrode disposed closer to the distal end of the lead than the proximal end of the lead; and
at least one threaded structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead; and
a stimulator that delivers electrical stimulation therapy to a patient via the medical lead within the patient.
24. An apparatus comprising:
an elongated member having a proximal end and a distal end;
a conduit disposed within the elongated member;
an exit port disposed on an outer surface of the elongated member in fluidic communication with the conduit; and
at least one threaded fixation structure extending around a portion of an outer surface of the elongated member and configured to engage tissue within a patient to resist migration of the medical lead.
25. The apparatus of claim 24, wherein the exit port is disposed on an axial outer surface of the distal end of the elongated member.
26. The apparatus of claim 24, wherein the exit port is disposed on a longitudinal outer surface of the elongated member.
27. The apparatus of claim 26, wherein the at least one threaded fixation structure is disposed at least one of proximal to the exit port and distal to the exit port.
28. The apparatus of claim 24, wherein the at least one threaded fixation structure is foldable in one direction to allow the thread structure to lay substantially flat against the elongated member when restrained by a sheath.
29. The apparatus of claim 24, further comprising a helical reinforcement member disposed within an inner surface of the elongated member to provide torsional rigidity to the elongated member.
30. The apparatus of claim 29, wherein the helical reinforcement member is disposed in a direction different than the direction of the at least one threaded fixation structure.
31. The apparatus of claim 24, wherein the threaded fixation structure comprises a pitch between approximately 0.5 millimeters (mm) and 3 mm.
32. The apparatus of claim 24, wherein the threaded fixation structure comprises a thread height between approximately 0.1 millimeters (mm) and 3 mm.
33. The apparatus of claim 24, wherein the threaded fixation structure comprises at least one of a biocompatible metal alloy and a biocompatible polymer.
34. The apparatus of claim 24, wherein the conduit delivers a therapeutic agent to the patient via the exit port.
US11/591,171 2006-10-31 2006-10-31 Implantable medical lead with threaded fixation Abandoned US20080103572A1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
US11/591,171 US20080103572A1 (en) 2006-10-31 2006-10-31 Implantable medical lead with threaded fixation
EP07709826A EP2089095B1 (en) 2006-10-31 2007-01-25 Implantable medical lead with threaded fixation
PCT/US2007/001962 WO2008054445A1 (en) 2006-10-31 2007-01-25 Implantable medical lead with threaded fixation
EP11182040A EP2422840A1 (en) 2006-10-31 2007-01-25 Implantable medical lead with threaded fixation
US16/528,089 US10561835B2 (en) 2006-10-31 2019-07-31 Implantable medical lead with threaded fixation
US16/790,414 US20200179677A1 (en) 2006-10-31 2020-02-13 Implantable medical lead with threaded fixation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11/591,171 US20080103572A1 (en) 2006-10-31 2006-10-31 Implantable medical lead with threaded fixation

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US12/632,503 Division US7810361B2 (en) 2005-03-15 2009-12-07 Washing apparatus
US16/528,089 Continuation US10561835B2 (en) 2006-10-31 2019-07-31 Implantable medical lead with threaded fixation

Publications (1)

Publication Number Publication Date
US20080103572A1 true US20080103572A1 (en) 2008-05-01

Family

ID=37966114

Family Applications (3)

Application Number Title Priority Date Filing Date
US11/591,171 Abandoned US20080103572A1 (en) 2006-10-31 2006-10-31 Implantable medical lead with threaded fixation
US16/528,089 Active US10561835B2 (en) 2006-10-31 2019-07-31 Implantable medical lead with threaded fixation
US16/790,414 Abandoned US20200179677A1 (en) 2006-10-31 2020-02-13 Implantable medical lead with threaded fixation

Family Applications After (2)

Application Number Title Priority Date Filing Date
US16/528,089 Active US10561835B2 (en) 2006-10-31 2019-07-31 Implantable medical lead with threaded fixation
US16/790,414 Abandoned US20200179677A1 (en) 2006-10-31 2020-02-13 Implantable medical lead with threaded fixation

Country Status (3)

Country Link
US (3) US20080103572A1 (en)
EP (2) EP2422840A1 (en)
WO (1) WO2008054445A1 (en)

Cited By (103)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060149336A1 (en) * 2005-01-05 2006-07-06 Advanced Bionics Corporation Devices and methods using an implantable pulse generator for brain stimulation
US20060149335A1 (en) * 2005-01-05 2006-07-06 Advanced Bionics Corporation Devices and methods for brain stimulation
US20080140153A1 (en) * 2006-12-06 2008-06-12 Spinal Modulation, Inc. Expandable stimulation leads and methods of use
US20080140169A1 (en) * 2006-12-06 2008-06-12 Spinal Modulation, Inc. Delivery devices, systems and methods for stimulating nerve tissue on multiple spinal levels
US20080147156A1 (en) * 2006-12-06 2008-06-19 Spinal Modulation, Inc. Grouped leads for spinal stimulation
US20080183257A1 (en) * 2007-01-29 2008-07-31 Spinal Modulation, Inc. Sutureless lead retention features
US20100137938A1 (en) * 2008-10-27 2010-06-03 Eyad Kishawi Selective stimulation systems and signal parameters for medical conditions
US20100179562A1 (en) * 2009-01-14 2010-07-15 Linker Fred I Stimulation leads, delivery systems and methods of use
US7837719B2 (en) 2002-05-09 2010-11-23 Daemen College Electrical stimulation unit and waterbath system
US20110130803A1 (en) * 2009-11-30 2011-06-02 Boston Scientific Neuromodulation Corporation Electrode array having concentric windowed cylinder electrodes and methods of making the same
US20110130816A1 (en) * 2009-11-30 2011-06-02 Boston Scientific Neuromodulation Corporation Electrode array with electrodes having cutout portions and methods of making the same
US20110190857A1 (en) * 2010-01-29 2011-08-04 Medtronic, Inc. Anchor assembly for use in occipital nerve stimulation
WO2011154937A1 (en) * 2010-06-08 2011-12-15 Rainbow Medical Ltd. Tibial nerve stimulation
US20120016377A1 (en) * 2010-07-15 2012-01-19 Greatbatch Ltd. Tunneling tool for implantable leads
WO2011143233A3 (en) * 2010-05-10 2012-03-15 Spinal Modulation, Inc. Methods, systems and devices for reducing migration
US8380318B2 (en) 2009-03-24 2013-02-19 Spinal Modulation, Inc. Pain management with stimulation subthreshold to paresthesia
US8518092B2 (en) 2006-12-06 2013-08-27 Spinal Modulation, Inc. Hard tissue anchors and delivery devices
US20140222018A1 (en) * 2009-09-24 2014-08-07 Chong Il Lee Device and means for adjusting the position of DBS brain and other neural and muscular implants
US8954165B2 (en) 2012-01-25 2015-02-10 Nevro Corporation Lead anchors and associated systems and methods
US9089693B2 (en) 2012-06-29 2015-07-28 Greatbatch Ltd. Lead positioning and finned fixation system
US9095700B2 (en) 2012-08-10 2015-08-04 Greatbach Ltd. Lead positioning and fixation system
US20150250998A1 (en) * 2009-04-07 2015-09-10 Boston Scientific Neuromodulation Corporation Anchoring units for implantable electrical stimulation systems and methods of making and using
US9186504B2 (en) 2010-11-15 2015-11-17 Rainbow Medical Ltd Sleep apnea treatment
US9205261B2 (en) 2004-09-08 2015-12-08 The Board Of Trustees Of The Leland Stanford Junior University Neurostimulation methods and systems
US9259569B2 (en) 2009-05-15 2016-02-16 Daniel M. Brounstein Methods, systems and devices for neuromodulating spinal anatomy
US9265935B2 (en) 2013-06-28 2016-02-23 Nevro Corporation Neurological stimulation lead anchors and associated systems and methods
US20160082247A1 (en) * 2014-09-22 2016-03-24 Boston Scientific Neuromodulation Corporation Systems and methods for making and using anchoring arrangements for leads of electrical stimulation systems
US9308022B2 (en) 2012-12-10 2016-04-12 Nevro Corporation Lead insertion devices and associated systems and methods
US9314618B2 (en) 2006-12-06 2016-04-19 Spinal Modulation, Inc. Implantable flexible circuit leads and methods of use
US9327110B2 (en) 2009-10-27 2016-05-03 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. (“SJM LUX SMI”) Devices, systems and methods for the targeted treatment of movement disorders
US20160157890A1 (en) * 2014-12-09 2016-06-09 Medtronic, Inc. Extravascular implant tools utilizing a bore-in mechanism and implant techniques using such tools
US9364658B2 (en) 2014-03-03 2016-06-14 Boston Scientific Neuromodulation Corporation Electrical stimulation leads with multiple anchoring units and methods of making and using
US9457186B2 (en) 2010-11-15 2016-10-04 Bluewind Medical Ltd. Bilateral feedback
US9486633B2 (en) 2004-09-08 2016-11-08 The Board Of Trustees Of The Leland Stanford Junior University Selective stimulation to modulate the sympathetic nervous system
US9533141B2 (en) 2014-07-07 2017-01-03 Boston Scientific Neuromodulation Corporation Electrical stimulation leads and systems with elongate anchoring elements
US9597521B2 (en) 2015-01-21 2017-03-21 Bluewind Medical Ltd. Transmitting coils for neurostimulation
WO2017049292A3 (en) * 2015-09-18 2017-04-27 Board Of Trustees Of The University Of Arkansas Electrode for peripheral nerve stimulation
US9649489B2 (en) 2014-06-02 2017-05-16 Boston Scientific Neuromodulation Corporation Electrical stimulation leads and systems with anchoring units having struts and methods of making and using
US9669210B2 (en) 2014-04-22 2017-06-06 Boston Scientific Neuromodulation Corporation Electrical stimulation leads and systems with folding anchoring units and methods of making and using
US9713707B2 (en) 2015-11-12 2017-07-25 Bluewind Medical Ltd. Inhibition of implant migration
US9724192B2 (en) 2011-11-08 2017-08-08 Valtech Cardio, Ltd. Controlled steering functionality for implant-delivery tool
US9764146B2 (en) 2015-01-21 2017-09-19 Bluewind Medical Ltd. Extracorporeal implant controllers
US9775709B2 (en) 2011-11-04 2017-10-03 Valtech Cardio, Ltd. Implant having multiple adjustable mechanisms
US9782589B2 (en) 2015-06-10 2017-10-10 Bluewind Medical Ltd. Implantable electrostimulator for improving blood flow
US9861812B2 (en) 2012-12-06 2018-01-09 Blue Wind Medical Ltd. Delivery of implantable neurostimulators
US9872769B2 (en) 2006-12-05 2018-01-23 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US9883943B2 (en) 2006-12-05 2018-02-06 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US9937042B2 (en) 2009-05-07 2018-04-10 Valtech Cardio, Ltd. Multiple anchor delivery tool
US9949828B2 (en) 2012-10-23 2018-04-24 Valtech Cardio, Ltd. Controlled steering functionality for implant-delivery tool
US9968452B2 (en) 2009-05-04 2018-05-15 Valtech Cardio, Ltd. Annuloplasty ring delivery cathethers
US9968454B2 (en) 2009-10-29 2018-05-15 Valtech Cardio, Ltd. Techniques for guide-wire based advancement of artificial chordae
US10004896B2 (en) 2015-01-21 2018-06-26 Bluewind Medical Ltd. Anchors and implant devices
US10098737B2 (en) 2009-10-29 2018-10-16 Valtech Cardio, Ltd. Tissue anchor for annuloplasty device
US10105540B2 (en) 2015-11-09 2018-10-23 Bluewind Medical Ltd. Optimization of application of current
US10124178B2 (en) 2016-11-23 2018-11-13 Bluewind Medical Ltd. Implant and delivery tool therefor
CN108992774A (en) * 2017-09-21 2018-12-14 美敦力公司 Imaging for stimulator lead marks
US10195030B2 (en) 2014-10-14 2019-02-05 Valtech Cardio, Ltd. Leaflet-restraining techniques
US10226342B2 (en) 2016-07-08 2019-03-12 Valtech Cardio, Ltd. Adjustable annuloplasty device with alternating peaks and troughs
US10299793B2 (en) 2013-10-23 2019-05-28 Valtech Cardio, Ltd. Anchor magazine
CN109957912A (en) * 2017-12-25 2019-07-02 青岛胶南海尔洗衣机有限公司 The processing method of clothes stains
US10349978B2 (en) 2014-12-18 2019-07-16 Medtronic, Inc. Open channel implant tool with additional lumen and implant techniques utilizing such tools
US10350068B2 (en) 2009-02-17 2019-07-16 Valtech Cardio, Ltd. Actively-engageable movement-restriction mechanism for use with an annuloplasty structure
US10376266B2 (en) 2012-10-23 2019-08-13 Valtech Cardio, Ltd. Percutaneous tissue anchor techniques
US10406353B2 (en) 2013-05-14 2019-09-10 Boston Scientific Neuromodulation Corporation Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using
US10470882B2 (en) 2008-12-22 2019-11-12 Valtech Cardio, Ltd. Closure element for use with annuloplasty structure
US10492909B2 (en) 2009-12-02 2019-12-03 Valtech Cardio, Ltd. Tool for actuating an adjusting mechanism
US10517719B2 (en) 2008-12-22 2019-12-31 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US10548729B2 (en) 2009-05-04 2020-02-04 Valtech Cardio, Ltd. Deployment techniques for annuloplasty ring and over-wire rotation tool
US10561835B2 (en) 2006-10-31 2020-02-18 Medtronic, Inc. Implantable medical lead with threaded fixation
US10561498B2 (en) 2005-03-17 2020-02-18 Valtech Cardio, Ltd. Mitral valve treatment techniques
US10610360B2 (en) 2012-12-06 2020-04-07 Valtech Cardio, Ltd. Techniques for guide-wire based advancement of a tool
US10653888B2 (en) 2012-01-26 2020-05-19 Bluewind Medical Ltd Wireless neurostimulators
US10682232B2 (en) 2013-03-15 2020-06-16 Edwards Lifesciences Corporation Translation catheters, systems, and methods of use thereof
US10695046B2 (en) 2005-07-05 2020-06-30 Edwards Lifesciences Corporation Tissue anchor and anchoring system
US10702274B2 (en) 2016-05-26 2020-07-07 Edwards Lifesciences Corporation Method and system for closing left atrial appendage
US10751182B2 (en) 2015-12-30 2020-08-25 Edwards Lifesciences Corporation System and method for reshaping right heart
US10765514B2 (en) 2015-04-30 2020-09-08 Valtech Cardio, Ltd. Annuloplasty technologies
US10792490B2 (en) 2013-11-12 2020-10-06 Medtronic, Inc. Open channel implant tools and implant techniques utilizing such tools
US10792152B2 (en) 2011-06-23 2020-10-06 Valtech Cardio, Ltd. Closed band for percutaneous annuloplasty
US10828160B2 (en) 2015-12-30 2020-11-10 Edwards Lifesciences Corporation System and method for reducing tricuspid regurgitation
US10835221B2 (en) 2017-11-02 2020-11-17 Valtech Cardio, Ltd. Implant-cinching devices and systems
US10856986B2 (en) 2008-12-22 2020-12-08 Valtech Cardio, Ltd. Adjustable annuloplasty devices and adjustment mechanisms therefor
US10918373B2 (en) 2013-08-31 2021-02-16 Edwards Lifesciences Corporation Devices and methods for locating and implanting tissue anchors at mitral valve commissure
US10918374B2 (en) 2013-02-26 2021-02-16 Edwards Lifesciences Corporation Devices and methods for percutaneous tricuspid valve repair
US10925610B2 (en) 2015-03-05 2021-02-23 Edwards Lifesciences Corporation Devices for treating paravalvular leakage and methods use thereof
US10973637B2 (en) 2013-12-26 2021-04-13 Valtech Cardio, Ltd. Implantation of flexible implant
US10980999B2 (en) 2017-03-09 2021-04-20 Nevro Corp. Paddle leads and delivery tools, and associated systems and methods
US11045627B2 (en) 2017-04-18 2021-06-29 Edwards Lifesciences Corporation Catheter system with linear actuation control mechanism
US11123191B2 (en) 2018-07-12 2021-09-21 Valtech Cardio Ltd. Annuloplasty systems and locking tools therefor
US11135062B2 (en) 2017-11-20 2021-10-05 Valtech Cardio Ltd. Cinching of dilated heart muscle
US11213685B2 (en) 2017-06-13 2022-01-04 Bluewind Medical Ltd. Antenna configuration
US11259924B2 (en) 2006-12-05 2022-03-01 Valtech Cardio Ltd. Implantation of repair devices in the heart
US11395648B2 (en) 2012-09-29 2022-07-26 Edwards Lifesciences Corporation Plication lock delivery system and method of use thereof
US11400299B1 (en) 2021-09-14 2022-08-02 Rainbow Medical Ltd. Flexible antenna for stimulator
US11420045B2 (en) 2018-03-29 2022-08-23 Nevro Corp. Leads having sidewall openings, and associated systems and methods
US11534583B2 (en) 2013-03-14 2022-12-27 Valtech Cardio Ltd. Guidewire feeder
CN115869534A (en) * 2021-09-29 2023-03-31 江苏畅医达医疗科技有限公司 Implanted electrode and peripheral nerve stimulation system thereof
US11660191B2 (en) 2008-03-10 2023-05-30 Edwards Lifesciences Corporation Method to reduce mitral regurgitation
US11660190B2 (en) 2007-03-13 2023-05-30 Edwards Lifesciences Corporation Tissue anchors, systems and methods, and devices
US11666442B2 (en) 2018-01-26 2023-06-06 Edwards Lifesciences Innovation (Israel) Ltd. Techniques for facilitating heart valve tethering and chord replacement
US11779217B2 (en) * 2018-05-31 2023-10-10 Inspire Medical Systems, Inc. System and method for collecting and displaying data acquired from an implantable therapy device using a consumer electronic device
US11779463B2 (en) 2018-01-24 2023-10-10 Edwards Lifesciences Innovation (Israel) Ltd. Contraction of an annuloplasty structure
US11819411B2 (en) 2019-10-29 2023-11-21 Edwards Lifesciences Innovation (Israel) Ltd. Annuloplasty and tissue anchor technologies

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2014232252B2 (en) 2013-03-15 2018-01-18 Alfred E. Mann Foundation For Scientific Research Current sensing multiple output current stimulators with fast turn on time
CA3075310C (en) 2013-07-29 2022-04-05 Alfred E. Mann Foundation For Scientific Research Microprocessor controlled class e driver
WO2016025915A1 (en) 2014-08-15 2016-02-18 Axonics Modulation Technologies, Inc. Integrated electromyographic clinician programmer for use with an implantable neurostimulator
US9700731B2 (en) 2014-08-15 2017-07-11 Axonics Modulation Technologies, Inc. Antenna and methods of use for an implantable nerve stimulator
CA2982572C (en) 2014-08-15 2022-10-11 Axonics Modulation Technologies, Inc. Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indications
EP3180072B1 (en) 2014-08-15 2018-11-28 Axonics Modulation Technologies Inc. Electromyographic lead positioning and stimulation titration in a nerve stimulation system for treatment of overactive bladder
EP3180073B1 (en) 2014-08-15 2020-03-11 Axonics Modulation Technologies, Inc. System for neurostimulation electrode configurations based on neural localization
EP3180071B1 (en) 2014-08-15 2021-09-22 Axonics, Inc. External pulse generator device and associated system for trial nerve stimulation
CN107427675B (en) 2015-01-09 2021-10-26 艾克索尼克斯股份有限公司 Patient remote control and associated method for use with a neurostimulation system
EP3242721B1 (en) 2015-01-09 2019-09-18 Axonics Modulation Technologies, Inc. Attachment devices and associated methods of use with a nerve stimulation charging device
JP6946261B2 (en) 2015-07-10 2021-10-06 アクソニクス インコーポレイテッド Implantable nerve stimulators and methods with internal electronics without ASICs
CN108697886B (en) 2016-01-29 2022-11-08 艾克索尼克斯股份有限公司 Method and system for frequency adjustment to optimize charging of an implantable neurostimulator
US10376704B2 (en) 2016-02-12 2019-08-13 Axonics Modulation Technologies, Inc. External pulse generator device and associated methods for trial nerve stimulation
CN111741789A (en) 2018-02-22 2020-10-02 艾克索尼克斯调制技术股份有限公司 Neural stimulation leads for testing neural stimulation and methods of use
WO2020185902A1 (en) 2019-03-11 2020-09-17 Axonics Modulation Technologies, Inc. Charging device with off-center coil
US11439829B2 (en) 2019-05-24 2022-09-13 Axonics, Inc. Clinician programmer methods and systems for maintaining target operating temperatures
WO2020242900A1 (en) 2019-05-24 2020-12-03 Axonics Modulation Technologies, Inc. Trainer device for a neurostimulator programmer and associated methods of use with a neurostimulation system

Citations (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3857399A (en) * 1970-03-24 1974-12-31 F Zacouto Heart pacer
US4142530A (en) * 1978-03-06 1979-03-06 Vitatron Medical B. V. Epicardial lead
US4341226A (en) * 1980-09-22 1982-07-27 Medtronic, Inc. Temporary lead with insertion tool
US4379459A (en) * 1981-04-09 1983-04-12 Medtronic, Inc. Cardiac pacemaker sense amplifier
US4475560A (en) * 1982-04-29 1984-10-09 Cordis Corporation Temporary pacing lead assembly
US4476868A (en) * 1978-11-06 1984-10-16 Medtronic, Inc. Body stimulator output circuit
US4550737A (en) * 1983-10-12 1985-11-05 Peter Osypka Intravenously implantable electrode lead for use with cardiac pacemakers
US4556063A (en) * 1980-10-07 1985-12-03 Medtronic, Inc. Telemetry system for a medical device
US4716888A (en) * 1985-06-17 1988-01-05 Cordis Corporation Tined leads
US4821723A (en) * 1987-02-27 1989-04-18 Intermedics Inc. Biphasic waveforms for defibrillation
US4841971A (en) * 1987-05-26 1989-06-27 Cordis Leads, Inc. Endocardial lead with projections having saw tooth formation
US4997431A (en) * 1989-08-30 1991-03-05 Angeion Corporation Catheter
US5009229A (en) * 1989-12-06 1991-04-23 Medtronic, Inc. Steroid eluting intramuscular lead
US5071407A (en) * 1990-04-12 1991-12-10 Schneider (U.S.A.) Inc. Radially expandable fixation member
US5131388A (en) * 1991-03-14 1992-07-21 Ventritex, Inc. Implantable cardiac defibrillator with improved capacitors
US5144949A (en) * 1991-03-15 1992-09-08 Medtronic, Inc. Dual chamber rate responsive pacemaker with automatic mode switching
US5241957A (en) * 1991-11-18 1993-09-07 Medtronic, Inc. Bipolar temporary pacing lead and connector and permanent bipolar nerve wire
US5312453A (en) * 1992-05-11 1994-05-17 Medtronic, Inc. Rate responsive cardiac pacemaker and method for work-modulating pacing rate deceleration
US5314430A (en) * 1993-06-24 1994-05-24 Medtronic, Inc. Atrial defibrillator employing transvenous and subcutaneous electrodes and method of use
US5354316A (en) * 1993-01-29 1994-10-11 Medtronic, Inc. Method and apparatus for detection and treatment of tachycardia and fibrillation
US5374287A (en) * 1991-04-10 1994-12-20 British Technology Group Usa Inc. Defibrillator and demand pacer catheters and methods for using same
US5423884A (en) * 1992-08-28 1995-06-13 Siemens Elema Ab Medical electrode and electrode implantation device
US5456708A (en) * 1993-10-28 1995-10-10 Pacesetter, Inc. Rotatable pin, screw-in pacing and sensing lead having improved tip and fluidic seal
US5487758A (en) * 1992-09-28 1996-01-30 Siemens-Elema Ab Electrode system for pacemakers
US5496360A (en) * 1994-04-12 1996-03-05 Ventritex, Inc. Implantable cardiac electrode with rate controlled drug delivery
US5531781A (en) * 1993-11-02 1996-07-02 Alferness; Clifton A. Implantable lead having a steering distal guide tip
US5545186A (en) * 1995-03-30 1996-08-13 Medtronic, Inc. Prioritized rule based method and apparatus for diagnosis and treatment of arrhythmias
US5554139A (en) * 1993-12-24 1996-09-10 Terumo Kabushiki Kaisha Catheter
US5683446A (en) * 1995-05-25 1997-11-04 Medtronic, Inc. Medical electrical lead having an anchoring sleeve retaining device
US5728140A (en) * 1996-06-17 1998-03-17 Cardiac Pacemakers, Inc. Method for evoking capture of left ventricle using transeptal pacing lead
US5865842A (en) * 1996-08-29 1999-02-02 Medtronic, Inc. System and method for anchoring brain stimulation lead or catheter
US5948015A (en) * 1998-05-14 1999-09-07 Medtronic, Inc. Medical electrical lead
US6049736A (en) * 1997-09-03 2000-04-11 Medtronic, Inc. Implantable medical device with electrode lead having improved surface characteristics
US6078840A (en) * 1997-04-30 2000-06-20 Medtronic, Inc. Medical electrical lead having improved fixation
US6161047A (en) * 1998-04-30 2000-12-12 Medtronic Inc. Apparatus and method for expanding a stimulation lead body in situ
US6263250B1 (en) * 1999-07-13 2001-07-17 Cardiac Pacemakers, Inc. Ring electrode with porous member
US6405091B1 (en) * 1999-07-20 2002-06-11 Pacesetter, Inc. Lead assembly with masked microdisk tip electrode and monolithic controlled release device
US20020147485A1 (en) * 2000-11-15 2002-10-10 George Mamo Minimally invasive apparatus for implanting a sacral stimulation lead
US6607511B2 (en) * 2001-08-09 2003-08-19 Mdc Investment Holdings, Inc. Medical device with safety flexible needle
US20030199938A1 (en) * 2002-04-22 2003-10-23 Karel Smits Precise cardiac lead placement based on impedance measurements
US20030199962A1 (en) * 2002-04-22 2003-10-23 Chester Struble Anti-slip leads for placement within tissue
US20040054389A1 (en) * 2002-07-19 2004-03-18 Osypka Thomas P. Implantable cardiac lead having removable fluid delivery port
US20040059401A1 (en) * 2002-04-26 2004-03-25 Ela Medical S.A. Coronary probe including a sophisticated retention structure
US6792318B2 (en) * 2002-06-13 2004-09-14 Pacesetter, Inc. Technique for fixating a lead
US20040230282A1 (en) * 2003-04-11 2004-11-18 Cates Adam W. Acute and chronic fixation for subcutaneous electrodes
US20050010260A1 (en) * 2002-09-06 2005-01-13 Medtronic, Inc. Method, system and device for treating disorders of the pelvic floor by electrical stimulation of and drug delivery to the pudendal and sacral nerves
US20050102006A1 (en) * 2003-09-25 2005-05-12 Whitehurst Todd K. Skull-mounted electrical stimulation system
US6944507B2 (en) * 2000-02-18 2005-09-13 St. Jude Medical Ab Electrode for a medical implant
US20050215946A1 (en) * 2004-01-29 2005-09-29 Hansmann Douglas R Method and apparatus for detecting vascular conditions with a catheter
US20060032657A1 (en) * 2004-08-11 2006-02-16 Cardiac Pacemakers, Inc. Lead assembly with flexible portions and method therefor
US20060085042A1 (en) * 2004-10-20 2006-04-20 Hastings Roger N Leadless cardiac stimulation systems
US7081113B2 (en) * 2003-06-26 2006-07-25 Depuy Acromed, Inc. Helical probe

Family Cites Families (216)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3646940A (en) 1969-07-15 1972-03-07 Univ Minnesota Implantable electronic stimulator electrode and method
US4019518A (en) 1975-08-11 1977-04-26 Medtronic, Inc. Electrical stimulation system
US4044774A (en) 1976-02-23 1977-08-30 Medtronic, Inc. Percutaneously inserted spinal cord stimulation lead
US4340062A (en) 1978-11-06 1982-07-20 Medtronic, Inc. Body stimulator having selectable stimulation energy levels
US4366493A (en) 1980-06-20 1982-12-28 International Business Machines Corporation Semiconductor ballistic transport device
US4558702A (en) 1983-01-21 1985-12-17 Cordis Corporation Cardiac pacer having input/output circuit programmable for use with unipolar and bipolar pacer leads
US4744371A (en) 1987-04-27 1988-05-17 Cordis Leads, Inc. Multi-conductor lead assembly for temporary use
US4998975A (en) 1989-10-30 1991-03-12 Siemens-Pacesetter, Inc. Travenously placed defibrillation leads
US5165403A (en) 1991-02-26 1992-11-24 Medtronic, Inc. Difibrillation lead system and method of use
GB9211085D0 (en) 1992-05-23 1992-07-08 Tippey Keith E Electrical stimulation
US6249703B1 (en) 1994-07-08 2001-06-19 Medtronic, Inc. Handheld patient programmer for implantable human tissue stimulator
US6035237A (en) 1995-05-23 2000-03-07 Alfred E. Mann Foundation Implantable stimulator that prevents DC current flow without the use of discrete output coupling capacitors
US5690693A (en) 1995-06-07 1997-11-25 Sulzer Intermedics Inc. Transcutaneous energy transmission circuit for implantable medical device
US5702431A (en) 1995-06-07 1997-12-30 Sulzer Intermedics Inc. Enhanced transcutaneous recharging system for battery powered implantable medical device
DE19623788A1 (en) 1996-06-04 1997-12-11 Biotronik Mess & Therapieg Implantable stimulation device
US6609031B1 (en) 1996-06-07 2003-08-19 Advanced Neuromodulation Systems, Inc. Multiprogrammable tissue stimulator and method
SE9604143D0 (en) 1996-11-13 1996-11-13 Pacesetter Ab Implantable electrode cable
US5741316A (en) 1996-12-02 1998-04-21 Light Sciences Limited Partnership Electromagnetic coil configurations for power transmission through tissue
US5735887A (en) 1996-12-10 1998-04-07 Exonix Corporation Closed-loop, RF-coupled implanted medical device
JP3954177B2 (en) 1997-01-29 2007-08-08 日本碍子株式会社 Bonding structure between metal member and ceramic member and method for manufacturing the same
US8555894B2 (en) 1997-02-26 2013-10-15 Alfred E. Mann Foundation For Scientific Research System for monitoring temperature
US7460911B2 (en) 1997-02-26 2008-12-02 Alfred E. Mann Foundation For Scientific Research System and method suitable for treatment of a patient with a neurological deficit by sequentially stimulating neural pathways using a system of discrete implantable medical devices
US6208894B1 (en) 1997-02-26 2001-03-27 Alfred E. Mann Foundation For Scientific Research And Advanced Bionics System of implantable devices for monitoring and/or affecting body parameters
US8684009B2 (en) 1997-02-26 2014-04-01 Alfred E. Mann Foundation For Scientific Research System for determining relative distance(s) and/or angle(s) between at least two points
US5871513A (en) 1997-04-30 1999-02-16 Medtronic Inc. Centerless ground feedthrough pin for an electrical power source in an implantable medical device
US6191365B1 (en) 1997-05-02 2001-02-20 General Science And Technology Corp Medical devices incorporating at least one element made from a plurality of twisted and drawn wires
CA2297022A1 (en) 1997-08-01 1999-02-11 Alfred E. Mann Foundation For Scientific Research Implantable device with improved battery recharging and powering configuration
EP0977297B1 (en) 1997-11-20 2005-08-17 Seiko Epson Corporation Electronic device
US6306100B1 (en) 1997-12-16 2001-10-23 Richard L. Prass Intraoperative neurophysiological monitoring system
US6221513B1 (en) 1998-05-12 2001-04-24 Pacific Coast Technologies, Inc. Methods for hermetically sealing ceramic to metallic surfaces and assemblies incorporating such seals
US6941171B2 (en) 1998-07-06 2005-09-06 Advanced Bionics Corporation Implantable stimulator methods for treatment of incontinence and pain
US6735474B1 (en) 1998-07-06 2004-05-11 Advanced Bionics Corporation Implantable stimulator system and method for treatment of incontinence and pain
US6027456A (en) 1998-07-10 2000-02-22 Advanced Neuromodulation Systems, Inc. Apparatus and method for positioning spinal cord stimulation leads
US6178353B1 (en) 1998-07-27 2001-01-23 Advanced Bionics Corporation Laminated magnet keeper for implant device
US7231254B2 (en) 1998-08-05 2007-06-12 Bioneuronics Corporation Closed-loop feedback-driven neuromodulation
US6212431B1 (en) 1998-09-08 2001-04-03 Advanced Bionics Corporation Power transfer circuit for implanted devices
US7142925B1 (en) 1998-09-16 2006-11-28 Axon Engineering, Inc. Combined stimulation of ventral and dorsal sacral roots for control of bladder function
IL127481A (en) 1998-10-06 2004-05-12 Bio Control Medical Ltd Incontinence treatment device
DE69931797T2 (en) 1998-10-06 2007-05-24 Bio Control Medical, Ltd. CHECKING DRY INCONTINENCE
AU6465399A (en) 1998-10-30 2000-05-22 Aalborg Universitet A method to control an overactive bladder
EP1128869B1 (en) 1998-11-09 2008-07-09 Medtronic, Inc. Extractable implantable medical lead
US6052624A (en) 1999-01-07 2000-04-18 Advanced Bionics Corporation Directional programming for implantable electrode arrays
US7555346B1 (en) 1999-01-07 2009-06-30 Boston Scientific Neuromodulation Corporation Implantable pulse generator having current steering means
US6393325B1 (en) 1999-01-07 2002-05-21 Advanced Bionics Corporation Directional programming for implantable electrode arrays
AU772100B2 (en) 1999-02-08 2004-04-08 Cochlear Limited Offset coils for radio frequency transcutaneous links
US6172556B1 (en) 1999-03-04 2001-01-09 Intersil Corporation, Inc. Feedback-controlled low voltage current sink/source
WO2000056677A1 (en) 1999-03-24 2000-09-28 Alfred E. Mann Foundation Method and apparatus of a strong metal-ceramic braze bond
JP5021119B2 (en) 1999-03-24 2012-09-05 セカンド サイト メディカル プロダクツ インコーポレイテッド Retina artificial color prosthesis for color vision recovery
US6055456A (en) 1999-04-29 2000-04-25 Medtronic, Inc. Single and multi-polar implantable lead for sacral nerve electrical stimulation
US6505075B1 (en) 1999-05-29 2003-01-07 Richard L. Weiner Peripheral nerve stimulation method
US6516227B1 (en) 1999-07-27 2003-02-04 Advanced Bionics Corporation Rechargeable spinal cord stimulator system
US7177690B2 (en) 1999-07-27 2007-02-13 Advanced Bionics Corporation Implantable system having rechargeable battery indicator
US7047082B1 (en) 1999-09-16 2006-05-16 Micronet Medical, Inc. Neurostimulating lead
US6654642B2 (en) 1999-09-29 2003-11-25 Medtronic, Inc. Patient interactive neurostimulation system and method
US6442434B1 (en) 1999-10-19 2002-08-27 Abiomed, Inc. Methods and apparatus for providing a sufficiently stable power to a load in an energy transfer system
US6466817B1 (en) 1999-11-24 2002-10-15 Nuvasive, Inc. Nerve proximity and status detection system and method
AU779567B2 (en) 1999-11-24 2005-01-27 Nuvasive, Inc. Electromyography system
US6438423B1 (en) 2000-01-20 2002-08-20 Electrocore Technique, Llc Method of treating complex regional pain syndromes by electrical stimulation of the sympathetic nerve chain
US6662051B1 (en) 2000-03-31 2003-12-09 Stephen A. Eraker Programmable pain reduction device
WO2001080795A1 (en) 2000-04-20 2001-11-01 Cochlear Limited Transcutaneous power optimization circuit for cochlear implant
US7305268B2 (en) 2000-07-13 2007-12-04 Northstar Neurscience, Inc. Systems and methods for automatically optimizing stimulus parameters and electrode configurations for neuro-stimulators
IT1316598B1 (en) 2000-08-07 2003-04-24 Caen Microelettronica E Sistem TEXTILE MANUFACTURE WITH ILLUMINATED FIBERS, ITEM OF CLOTHING OBTAINED AND PRODUCTION METHOD OF THE MANUFACTURE.
US7054689B1 (en) 2000-08-18 2006-05-30 Advanced Bionics Corporation Fully implantable neurostimulator for autonomic nerve fiber stimulation as a therapy for urinary and bowel dysfunction
US6745077B1 (en) 2000-10-11 2004-06-01 Advanced Bionics Corporation Electronic impedance transformer for inductively-coupled load stabilization
US6971393B1 (en) 2000-11-15 2005-12-06 George Mamo Minimally invasive method for implanting a sacral stimulation lead
US6600954B2 (en) 2001-01-25 2003-07-29 Biocontrol Medical Bcm Ltd. Method and apparatus for selective control of nerve fibers
US6975906B2 (en) 2001-02-08 2005-12-13 Wilson Greatbatch Ltd. One piece header assembly over molded to an implantable medical device
US6901287B2 (en) 2001-02-09 2005-05-31 Medtronic, Inc. Implantable therapy delivery element adjustable anchor
US6708065B2 (en) 2001-03-02 2004-03-16 Cardiac Pacemakers, Inc. Antenna for an implantable medical device
US6584355B2 (en) 2001-04-10 2003-06-24 Cardiac Pacemakers, Inc. System and method for measuring battery current
US8145324B1 (en) 2001-04-13 2012-03-27 Greatbatch Ltd. Implantable lead bandstop filter employing an inductive coil with parasitic capacitance to enhance MRI compatibility of active medical devices
US8989870B2 (en) 2001-04-13 2015-03-24 Greatbatch Ltd. Tuned energy balanced system for minimizing heating and/or to provide EMI protection of implanted leads in a high power electromagnetic field environment
US6892098B2 (en) 2001-04-26 2005-05-10 Biocontrol Medical Ltd. Nerve stimulation for treating spasticity, tremor, muscle weakness, and other motor disorders
US6792314B2 (en) 2001-06-18 2004-09-14 Alfred E. Mann Foundation For Scientific Research Miniature implantable array and stimulation system suitable for eyelid stimulation
EP1417000B1 (en) 2001-07-11 2018-07-11 Nuvasive, Inc. System for determining nerve proximity during surgery
US20030028231A1 (en) 2001-08-01 2003-02-06 Cardiac Pacemakers, Inc. Radiopaque drug collar for implantable endocardial leads
US6456256B1 (en) 2001-08-03 2002-09-24 Cardiac Pacemakers, Inc. Circumferential antenna for an implantable medical device
US7151914B2 (en) 2001-08-21 2006-12-19 Medtronic, Inc. Transmitter system for wireless communication with implanted devices
US7734355B2 (en) 2001-08-31 2010-06-08 Bio Control Medical (B.C.M.) Ltd. Treatment of disorders by unidirectional nerve stimulation
US6999819B2 (en) 2001-08-31 2006-02-14 Medtronic, Inc. Implantable medical electrical stimulation lead fixation method and apparatus
EP2481338A3 (en) 2001-09-25 2012-09-05 Nuvasive, Inc. System for performing surgical procedures and assessments
US7187978B2 (en) 2001-11-01 2007-03-06 Medtronic, Inc. Method and apparatus for programming an implantable medical device
US6721603B2 (en) 2002-01-25 2004-04-13 Cyberonics, Inc. Nerve stimulation as a treatment for pain
US7317948B1 (en) 2002-02-12 2008-01-08 Boston Scientific Scimed, Inc. Neural stimulation system providing auto adjustment of stimulus output as a function of sensed impedance
US20030199961A1 (en) 2002-04-03 2003-10-23 Bjorklund Vicki L. Method and apparatus for fixating a pacing lead of an implantable medical device
US7582058B1 (en) 2002-06-26 2009-09-01 Nuvasive, Inc. Surgical access system and related methods
EP2462983A1 (en) 2002-06-28 2012-06-13 Boston Scientific Neuromodulation Corporation Microstimulator having self-contained power source and bi-directional telemetry system
US8386048B2 (en) 2002-06-28 2013-02-26 Boston Scientific Neuromodulation Corporation Systems and methods for communicating with or providing power to an implantable stimulator
US7351247B2 (en) 2002-09-04 2008-04-01 Bioconnect Systems, Inc. Devices and methods for interconnecting body conduits
US7328068B2 (en) 2003-03-31 2008-02-05 Medtronic, Inc. Method, system and device for treating disorders of the pelvic floor by means of electrical stimulation of the pudendal and associated nerves, and the optional delivery of drugs in association therewith
US7369894B2 (en) 2002-09-06 2008-05-06 Medtronic, Inc. Method, system and device for treating disorders of the pelvic floor by electrical stimulation of the sacral and/or pudendal nerves
US7082335B2 (en) * 2002-09-30 2006-07-25 Medtronic, Inc. Multipolar pacing method and apparatus
AU2002951734A0 (en) 2002-09-30 2002-10-17 Cochlear Limited Feedthrough with conductive pathways of varing configurations
US7127298B1 (en) 2002-10-18 2006-10-24 Advanced Bionics Corporation Switched-matrix output for multi-channel implantable stimulator
EP1572292B1 (en) 2002-10-31 2010-09-29 Medtronic, Inc. Method and device for applying filter information to identify combinations of electrodes
US7181286B2 (en) 2002-10-31 2007-02-20 Medtronic, Inc. Distributed system for neurostimulation therapy programming
US7933655B2 (en) 2002-10-31 2011-04-26 Medtronic, Inc. Neurostimulation therapy manipulation
JP2004283550A (en) 2002-11-05 2004-10-14 Wilson Greatbatch Technologies Inc Integrated type header assembly for implanted type medical device
US6990376B2 (en) 2002-12-06 2006-01-24 The Regents Of The University Of California Methods and systems for selective control of bladder function
US7952349B2 (en) 2002-12-09 2011-05-31 Ferro Solutions, Inc. Apparatus and method utilizing magnetic field
EP1578485A4 (en) 2002-12-16 2006-04-05 Meagan Medical Inc Coupling percutaneous devices to a patient
US7742821B1 (en) 2003-06-11 2010-06-22 Boston Scientific Neutomodulation Corporation Remote control for implantable medical device
US7463928B2 (en) 2003-04-25 2008-12-09 Medtronic, Inc. Identifying combinations of electrodes for neurostimulation therapy
US7617002B2 (en) 2003-09-15 2009-11-10 Medtronic, Inc. Selection of neurostimulator parameter configurations using decision trees
US7225032B2 (en) 2003-10-02 2007-05-29 Medtronic Inc. External power source, charger and system for an implantable medical device having thermal characteristics and method therefore
US7286880B2 (en) 2003-10-02 2007-10-23 Medtronic, Inc. System and method for transcutaneous energy transfer achieving high efficiency
US20050075696A1 (en) 2003-10-02 2005-04-07 Medtronic, Inc. Inductively rechargeable external energy source, charger, system and method for a transcutaneous inductive charger for an implantable medical device
US8140168B2 (en) 2003-10-02 2012-03-20 Medtronic, Inc. External power source for an implantable medical device having an adjustable carrier frequency and system and method related therefore
US7515967B2 (en) 2003-10-02 2009-04-07 Medtronic, Inc. Ambulatory energy transfer system for an implantable medical device and method therefore
US6989200B2 (en) 2003-10-30 2006-01-24 Alfred E. Mann Foundation For Scientific Research Ceramic to noble metal braze and method of manufacture
US8260436B2 (en) * 2003-10-31 2012-09-04 Medtronic, Inc. Implantable stimulation lead with fixation mechanism
US20080161874A1 (en) 2004-02-12 2008-07-03 Ndi Medical, Inc. Systems and methods for a trial stage and/or long-term treatment of disorders of the body using neurostimulation
WO2005082453A1 (en) 2004-02-25 2005-09-09 Advanced Neuromodulation Systems, Inc. System and method for neurological stimulation of peripheral nerves to treat low back pain
US7738963B2 (en) 2004-03-04 2010-06-15 Advanced Neuromodulation Systems, Inc. System and method for programming an implantable pulse generator
US7212110B1 (en) 2004-04-19 2007-05-01 Advanced Neuromodulation Systems, Inc. Implantable device and system and method for wireless communication
US7532936B2 (en) 2004-04-20 2009-05-12 Advanced Neuromodulation Systems, Inc. Programmable switching device for implantable device
US7245972B2 (en) 2004-04-29 2007-07-17 Alfred E. Mann Foundation For Scientific Research Electrical treatment to treat shoulder subluxation
US7359751B1 (en) 2004-05-05 2008-04-15 Advanced Neuromodulation Systems, Inc. Clinician programmer for use with trial stimulator
US7450991B2 (en) 2004-05-28 2008-11-11 Advanced Neuromodulation Systems, Inc. Systems and methods used to reserve a constant battery capacity
US7539538B2 (en) 2004-05-28 2009-05-26 Boston Science Neuromodulation Corporation Low power loss current digital-to-analog converter used in an implantable pulse generator
WO2006022993A2 (en) 2004-06-10 2006-03-02 Ndi Medical, Llc Implantable generator for muscle and nerve stimulation
WO2008153726A2 (en) 2007-05-22 2008-12-18 Ndi Medical, Inc. Systems and methods for the treatment of bladder dysfunctions using neuromodulation stimulation
US7336104B2 (en) 2004-06-28 2008-02-26 Technion Research & Development Foundation Ltd. Multiple-output transistor logic circuit
US20060041295A1 (en) 2004-08-17 2006-02-23 Osypka Thomas P Positive fixation percutaneous epidural neurostimulation lead
US7458971B2 (en) 2004-09-24 2008-12-02 Boston Scientific Scimed, Inc. RF ablation probe with unibody electrode element
US7771838B1 (en) 2004-10-12 2010-08-10 Boston Scientific Neuromodulation Corporation Hermetically bonding ceramic and titanium with a Ti-Pd braze interface
US7578819B2 (en) 2005-05-16 2009-08-25 Baxano, Inc. Spinal access and neural localization
US8489189B2 (en) 2004-10-29 2013-07-16 Medtronic, Inc. Expandable fixation mechanism
US7515965B2 (en) 2005-02-23 2009-04-07 Medtronic, Inc. Implantable medical device providing adaptive neurostimulation therapy for incontinence
US8774912B2 (en) 2005-02-23 2014-07-08 Medtronic, Inc. Implantable neurostimulator supporting trial and chronic modes
US8768452B2 (en) 2005-02-23 2014-07-01 Medtronic, Inc. Implantable neurostimulator supporting trial and chronic modes
US7330765B2 (en) 2005-04-25 2008-02-12 Cardiac Pacemakers, Inc. Cardiac lead having self-expanding fixation features
US7979119B2 (en) 2005-04-26 2011-07-12 Boston Scientific Neuromodulation Corporation Display graphics for use in stimulation therapies
US7406351B2 (en) 2005-04-28 2008-07-29 Medtronic, Inc. Activity sensing for stimulator control
US7774069B2 (en) 2005-04-29 2010-08-10 Medtronic, Inc. Alignment indication for transcutaneous energy transfer
US7676275B1 (en) 2005-05-02 2010-03-09 Pacesetter, Inc. Endovascular lead for chronic nerve stimulation
US7890166B2 (en) 2005-06-09 2011-02-15 Medtronic, Inc. Regional therapies for treatment of pain
KR100792311B1 (en) 2005-07-30 2008-01-07 엘에스전선 주식회사 Rechargeable power supply, rechargeable device, battery device, contactless recharger system and method for charging rechargeable battery cell
AU2006279641A1 (en) 2005-08-15 2007-02-22 Synecor, Llc Lead fixation and extraction
US8175717B2 (en) 2005-09-06 2012-05-08 Boston Scientific Neuromodulation Corporation Ultracapacitor powered implantable pulse generator with dedicated power supply
US7640059B2 (en) 2005-09-08 2009-12-29 Medtronic, Inc. External presentation of electrical stimulation parameters
US7551960B2 (en) 2005-09-08 2009-06-23 Medtronic, Inc. External presentation of electrical stimulation parameters
US7444181B2 (en) 2005-12-14 2008-10-28 Boston Scientific Neuromodulation Corporation Techniques for sensing and adjusting a compliance voltage in an implantable stimulator device
US7720547B2 (en) 2006-01-04 2010-05-18 Kenergy, Inc. Extracorporeal power supply with a wireless feedback system for an implanted medical device
US7809443B2 (en) 2006-01-31 2010-10-05 Medtronic, Inc. Electrical stimulation to alleviate chronic pelvic pain
US8019423B2 (en) 2006-02-17 2011-09-13 Marc Possover Laparoscopic implantation of neurostimulators
US7747330B2 (en) 2006-03-09 2010-06-29 Medtronic, Inc. Global parameter adjustment for multiple stimulation programs
US8447402B1 (en) 2006-03-31 2013-05-21 Alfred E. Mann Foundation For Scientific Research Zirconia to platinum assembly using a titanium connector
US8204569B2 (en) 2006-04-27 2012-06-19 Medtronic, Inc. Implantable medical electrical stimulation lead fixation method and apparatus
US8219202B2 (en) 2006-04-28 2012-07-10 Medtronic, Inc. Electrical stimulation of ilioinguinal nerve to alleviate chronic pelvic pain
US7761166B2 (en) 2006-04-28 2010-07-20 Medtronic, Inc. Electrical stimulation of iliohypogastric nerve to alleviate chronic pelvic pain
US8892214B2 (en) 2006-04-28 2014-11-18 Medtronic, Inc. Multi-electrode peripheral nerve evaluation lead and related system and method of use
US7881783B2 (en) 2006-04-28 2011-02-01 Medtronics, Inc. Implantable medical electrical stimulation lead, such as a PNE lead, and method of use
US20070255368A1 (en) 2006-04-28 2007-11-01 Bonde Eric H Implantable medical electrical stimulation lead with distal fixation and method
US7738965B2 (en) 2006-04-28 2010-06-15 Medtronic, Inc. Holster for charging pectorally implanted medical devices
US7715920B2 (en) 2006-04-28 2010-05-11 Medtronic, Inc. Tree-based electrical stimulator programming
US20070265675A1 (en) 2006-05-09 2007-11-15 Ams Research Corporation Testing Efficacy of Therapeutic Mechanical or Electrical Nerve or Muscle Stimulation
AU2007258756B2 (en) 2006-06-05 2012-03-01 Ams Research Corporation Electrical muscle stimulation to treat fecal incontinence and/or pelvic prolapse
US20070282376A1 (en) 2006-06-06 2007-12-06 Shuros Allan C Method and apparatus for neural stimulation via the lymphatic system
US8116862B2 (en) 2006-06-08 2012-02-14 Greatbatch Ltd. Tank filters placed in series with the lead wires or circuits of active medical devices to enhance MRI compatibility
EP2422841B1 (en) 2006-08-18 2013-10-09 Second Sight Medical Products, Inc. Package for an implantable neural stimulation device
US7979126B2 (en) 2006-10-18 2011-07-12 Boston Scientific Neuromodulation Corporation Orientation-independent implantable pulse generator
US20100076534A1 (en) 2006-10-25 2010-03-25 William Alan Mock Malleable needle having a plurality of electrodes for facilitating implantation of stimulation lead and method of implanting an electrical stimulation lead
US9713706B2 (en) 2006-10-31 2017-07-25 Medtronic, Inc. Implantable medical elongated member including intermediate fixation
US20080103572A1 (en) 2006-10-31 2008-05-01 Medtronic, Inc. Implantable medical lead with threaded fixation
US8549015B2 (en) 2007-05-01 2013-10-01 Giancarlo Barolat Method and system for distinguishing nociceptive pain from neuropathic pain
US7932696B2 (en) 2007-05-14 2011-04-26 Boston Scientific Neuromodulation Corporation Charger alignment indicator with adjustable threshold
US9427573B2 (en) 2007-07-10 2016-08-30 Astora Women's Health, Llc Deployable electrode lead anchor
US20100049289A1 (en) 2007-07-10 2010-02-25 Ams Research Corporation Tissue anchor
CA2733081C (en) 2007-08-06 2015-12-15 Great Lakes Biosciences, Llc Methods and apparatus for electrical stimulation of tissues using signals that minimize the effects of tissue impedance
WO2009035711A2 (en) 2007-09-13 2009-03-19 Medtronic, Inc. Medical electrical lead with jacketed conductive elements
US8362742B2 (en) 2007-10-26 2013-01-29 Medtronic, Inc. Method and apparatus for dynamic adjustment of recharge parameters
US8019440B2 (en) 2008-02-12 2011-09-13 Intelect Medical, Inc. Directional lead assembly
US8332040B1 (en) 2008-03-10 2012-12-11 Advanced Neuromodulation Systems, Inc. External charging device for charging an implantable medical device and methods of regulating duty of cycle of an external charging device
US8019443B2 (en) 2008-04-01 2011-09-13 Boston Scientific Neuromodulation Corporation Anchoring units for leads of implantable electric stimulation systems and methods of making and using
EP2262442B1 (en) 2008-04-11 2015-03-25 BAL Seal Engineering Connector cartridge stack for electrical transmission
WO2009135075A1 (en) 2008-04-30 2009-11-05 Medtronic, Inc. Techniques for placing medical leads for electrical stimulation of nerve tissue
US8314594B2 (en) 2008-04-30 2012-11-20 Medtronic, Inc. Capacity fade adjusted charge level or recharge interval of a rechargeable power source of an implantable medical device, system and method
US8103360B2 (en) 2008-05-09 2012-01-24 Foster Arthur J Medical lead coil conductor with spacer element
US7957818B2 (en) 2008-06-26 2011-06-07 Greatbatch Ltd. Stimulation lead design and method of manufacture
US8055337B2 (en) 2008-07-24 2011-11-08 Boston Scientific Neuromodulation Corporation System and method for maintaining a distribution of currents in an electrode array using independent voltage sources
US8219196B2 (en) 2008-10-31 2012-07-10 Medtronic, Inc. Determination of stimulation output capabilities throughout power source voltage range
US8255057B2 (en) 2009-01-29 2012-08-28 Nevro Corporation Systems and methods for producing asynchronous neural responses to treat pain and/or other patient conditions
US8538530B1 (en) 2008-11-19 2013-09-17 Advanced Bionics Hermetically sealed feedthrough case
US20100256696A1 (en) 2009-04-07 2010-10-07 Boston Scientific Neuromodulation Corporation Anchoring Units For Implantable Electrical Stimulation Systems And Methods Of Making And Using
US8214042B2 (en) 2009-05-26 2012-07-03 Boston Scientific Neuromodulation Corporation Techniques for controlling charging of batteries in an external charger and an implantable medical device
US8571677B2 (en) 2009-10-21 2013-10-29 Medtronic, Inc. Programming techniques for stimulation with utilization of case electrode
US8577474B2 (en) 2009-11-11 2013-11-05 Boston Scientific Neuromodulation Corporation Minimizing interference between charging and telemetry coils in an implantable medical device
US8457756B2 (en) 2009-11-11 2013-06-04 Boston Scientific Neuromodulation Corporation Using the case of an implantable medical device to broaden communication bandwidth
US8478431B2 (en) 2010-04-13 2013-07-02 Medtronic, Inc. Slidable fixation device for securing a medical implant
JP5774683B2 (en) 2010-05-11 2015-09-09 カーディアック ペースメイカーズ, インコーポレイテッド Implantable medical device with means to automatically recover from interrupted therapy
US8989861B2 (en) 2010-06-07 2015-03-24 Medtronic, Inc. Stimulation therapy for bladder dysfunction
US8948882B2 (en) 2010-08-25 2015-02-03 Medtronic, Inc. Fixation components for implantable medical devices and associated device construction
US8942829B2 (en) 2011-01-20 2015-01-27 Medtronic, Inc. Trans-septal lead anchoring
EP3498333B1 (en) 2011-02-08 2020-05-13 Boston Scientific Neuromodulation Corporation Leads with spirally arranged segmented electrodes and methods of making and using the leads
US8543223B2 (en) 2011-03-11 2013-09-24 Greatbach Ltd. Implantable lead with braided conductors
US8738141B2 (en) 2011-04-07 2014-05-27 Greatbatch, Ltd. Contact assembly for implantable pulse generator and method of use
US9259582B2 (en) 2011-04-29 2016-02-16 Cyberonics, Inc. Slot antenna for an implantable device
US9265958B2 (en) 2011-04-29 2016-02-23 Cyberonics, Inc. Implantable medical device antenna
US8515545B2 (en) 2011-04-29 2013-08-20 Greatbatch Ltd. Current steering neurostimulator device with unidirectional current sources
US9240630B2 (en) 2011-04-29 2016-01-19 Cyberonics, Inc. Antenna shield for an implantable medical device
US8954148B2 (en) 2011-06-28 2015-02-10 Greatbatch, Ltd. Key fob controller for an implantable neurostimulator
US20130006330A1 (en) 2011-06-28 2013-01-03 Greatbatch, Ltd. Dual patient controllers
US8571667B2 (en) 2011-07-01 2013-10-29 Greatbatch Ltd. Active current control using the enclosure of an implanted pulse generator
EP2545958B1 (en) 2011-07-12 2014-05-14 Sorin CRM SAS Probe for implantable cardiac prosthesis, comprising a means for protection against the thermal effects of MRI fields
US8700175B2 (en) 2011-07-19 2014-04-15 Greatbatch Ltd. Devices and methods for visually indicating the alignment of a transcutaneous energy transfer device over an implanted medical device
CN103889502B (en) 2011-08-02 2016-02-24 梅恩斯塔伊医疗公司 For the equipment of the electrode guiding piece that grappling uses together with implantable neuromuscular electric stimulation therapy device
EP2773419B1 (en) 2011-11-04 2019-02-27 Shanghai MicroPort Medical (Group) Co., Ltd. Implantable passive medical lead
US10206710B2 (en) 2011-11-10 2019-02-19 Medtronic, Inc. Introduction and anchoring tool for an implantable medical device element
JP2013123484A (en) 2011-12-13 2013-06-24 Olympus Corp Nerve stimulating device and nerve stimulating system
US8571654B2 (en) 2012-01-17 2013-10-29 Cyberonics, Inc. Vagus nerve neurostimulator with multiple patient-selectable modes for treating chronic cardiac dysfunction
US9981137B2 (en) 2012-01-27 2018-05-29 Nuvectra Corporation Heat dispersion for implantable medical devices
WO2013156038A1 (en) 2012-04-20 2013-10-24 Neurodan A/S Implantable medical device
US8761897B2 (en) 2012-08-31 2014-06-24 Greatbatch Ltd. Method and system of graphical representation of lead connector block and implantable pulse generators on a clinician programmer
US9502754B2 (en) 2014-01-24 2016-11-22 Medtronic, Inc. Implantable medical devices having cofire ceramic modules and methods of fabricating the same
CA2982572C (en) 2014-08-15 2022-10-11 Axonics Modulation Technologies, Inc. Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indications

Patent Citations (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3857399A (en) * 1970-03-24 1974-12-31 F Zacouto Heart pacer
US4142530A (en) * 1978-03-06 1979-03-06 Vitatron Medical B. V. Epicardial lead
US4476868A (en) * 1978-11-06 1984-10-16 Medtronic, Inc. Body stimulator output circuit
US4341226A (en) * 1980-09-22 1982-07-27 Medtronic, Inc. Temporary lead with insertion tool
US4556063A (en) * 1980-10-07 1985-12-03 Medtronic, Inc. Telemetry system for a medical device
US4379459A (en) * 1981-04-09 1983-04-12 Medtronic, Inc. Cardiac pacemaker sense amplifier
US4475560A (en) * 1982-04-29 1984-10-09 Cordis Corporation Temporary pacing lead assembly
US4550737A (en) * 1983-10-12 1985-11-05 Peter Osypka Intravenously implantable electrode lead for use with cardiac pacemakers
US4716888A (en) * 1985-06-17 1988-01-05 Cordis Corporation Tined leads
US4821723A (en) * 1987-02-27 1989-04-18 Intermedics Inc. Biphasic waveforms for defibrillation
US4841971A (en) * 1987-05-26 1989-06-27 Cordis Leads, Inc. Endocardial lead with projections having saw tooth formation
US4997431A (en) * 1989-08-30 1991-03-05 Angeion Corporation Catheter
US5009229A (en) * 1989-12-06 1991-04-23 Medtronic, Inc. Steroid eluting intramuscular lead
US5071407A (en) * 1990-04-12 1991-12-10 Schneider (U.S.A.) Inc. Radially expandable fixation member
US5131388A (en) * 1991-03-14 1992-07-21 Ventritex, Inc. Implantable cardiac defibrillator with improved capacitors
US5144949A (en) * 1991-03-15 1992-09-08 Medtronic, Inc. Dual chamber rate responsive pacemaker with automatic mode switching
US5374287A (en) * 1991-04-10 1994-12-20 British Technology Group Usa Inc. Defibrillator and demand pacer catheters and methods for using same
US5241957A (en) * 1991-11-18 1993-09-07 Medtronic, Inc. Bipolar temporary pacing lead and connector and permanent bipolar nerve wire
US5312453A (en) * 1992-05-11 1994-05-17 Medtronic, Inc. Rate responsive cardiac pacemaker and method for work-modulating pacing rate deceleration
US5423884A (en) * 1992-08-28 1995-06-13 Siemens Elema Ab Medical electrode and electrode implantation device
US5487758A (en) * 1992-09-28 1996-01-30 Siemens-Elema Ab Electrode system for pacemakers
US5354316A (en) * 1993-01-29 1994-10-11 Medtronic, Inc. Method and apparatus for detection and treatment of tachycardia and fibrillation
US5314430A (en) * 1993-06-24 1994-05-24 Medtronic, Inc. Atrial defibrillator employing transvenous and subcutaneous electrodes and method of use
US5456708A (en) * 1993-10-28 1995-10-10 Pacesetter, Inc. Rotatable pin, screw-in pacing and sensing lead having improved tip and fluidic seal
US5531781A (en) * 1993-11-02 1996-07-02 Alferness; Clifton A. Implantable lead having a steering distal guide tip
US5554139A (en) * 1993-12-24 1996-09-10 Terumo Kabushiki Kaisha Catheter
US5496360A (en) * 1994-04-12 1996-03-05 Ventritex, Inc. Implantable cardiac electrode with rate controlled drug delivery
US5545186A (en) * 1995-03-30 1996-08-13 Medtronic, Inc. Prioritized rule based method and apparatus for diagnosis and treatment of arrhythmias
US5683446A (en) * 1995-05-25 1997-11-04 Medtronic, Inc. Medical electrical lead having an anchoring sleeve retaining device
US5728140A (en) * 1996-06-17 1998-03-17 Cardiac Pacemakers, Inc. Method for evoking capture of left ventricle using transeptal pacing lead
US5865842A (en) * 1996-08-29 1999-02-02 Medtronic, Inc. System and method for anchoring brain stimulation lead or catheter
US6078840A (en) * 1997-04-30 2000-06-20 Medtronic, Inc. Medical electrical lead having improved fixation
US6049736A (en) * 1997-09-03 2000-04-11 Medtronic, Inc. Implantable medical device with electrode lead having improved surface characteristics
US6161047A (en) * 1998-04-30 2000-12-12 Medtronic Inc. Apparatus and method for expanding a stimulation lead body in situ
US5948015A (en) * 1998-05-14 1999-09-07 Medtronic, Inc. Medical electrical lead
US6263250B1 (en) * 1999-07-13 2001-07-17 Cardiac Pacemakers, Inc. Ring electrode with porous member
US6405091B1 (en) * 1999-07-20 2002-06-11 Pacesetter, Inc. Lead assembly with masked microdisk tip electrode and monolithic controlled release device
US6944507B2 (en) * 2000-02-18 2005-09-13 St. Jude Medical Ab Electrode for a medical implant
US20020147485A1 (en) * 2000-11-15 2002-10-10 George Mamo Minimally invasive apparatus for implanting a sacral stimulation lead
US6607511B2 (en) * 2001-08-09 2003-08-19 Mdc Investment Holdings, Inc. Medical device with safety flexible needle
US20030199962A1 (en) * 2002-04-22 2003-10-23 Chester Struble Anti-slip leads for placement within tissue
US20030199938A1 (en) * 2002-04-22 2003-10-23 Karel Smits Precise cardiac lead placement based on impedance measurements
US20040059401A1 (en) * 2002-04-26 2004-03-25 Ela Medical S.A. Coronary probe including a sophisticated retention structure
US6792318B2 (en) * 2002-06-13 2004-09-14 Pacesetter, Inc. Technique for fixating a lead
US20040054389A1 (en) * 2002-07-19 2004-03-18 Osypka Thomas P. Implantable cardiac lead having removable fluid delivery port
US20050010260A1 (en) * 2002-09-06 2005-01-13 Medtronic, Inc. Method, system and device for treating disorders of the pelvic floor by electrical stimulation of and drug delivery to the pudendal and sacral nerves
US20040230282A1 (en) * 2003-04-11 2004-11-18 Cates Adam W. Acute and chronic fixation for subcutaneous electrodes
US7081113B2 (en) * 2003-06-26 2006-07-25 Depuy Acromed, Inc. Helical probe
US20050102006A1 (en) * 2003-09-25 2005-05-12 Whitehurst Todd K. Skull-mounted electrical stimulation system
US20050215946A1 (en) * 2004-01-29 2005-09-29 Hansmann Douglas R Method and apparatus for detecting vascular conditions with a catheter
US20060032657A1 (en) * 2004-08-11 2006-02-16 Cardiac Pacemakers, Inc. Lead assembly with flexible portions and method therefor
US20060085042A1 (en) * 2004-10-20 2006-04-20 Hastings Roger N Leadless cardiac stimulation systems

Cited By (191)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7837719B2 (en) 2002-05-09 2010-11-23 Daemen College Electrical stimulation unit and waterbath system
US10232180B2 (en) 2004-09-08 2019-03-19 The Board Of Trustees Of The Leland Stanford Junior University Selective stimulation to modulate the sympathetic nervous system
US9486633B2 (en) 2004-09-08 2016-11-08 The Board Of Trustees Of The Leland Stanford Junior University Selective stimulation to modulate the sympathetic nervous system
US9205261B2 (en) 2004-09-08 2015-12-08 The Board Of Trustees Of The Leland Stanford Junior University Neurostimulation methods and systems
US8938308B2 (en) 2005-01-05 2015-01-20 Boston Scientific Neuromodulation Corporation Devices and methods for brain stimulation
US7783359B2 (en) * 2005-01-05 2010-08-24 Boston Scientific Neuromodulation Corporation Devices and methods using an implantable pulse generator for brain stimulation
US7809446B2 (en) 2005-01-05 2010-10-05 Boston Scientific Neuromodulation Corporation Devices and methods for brain stimulation
US20060149336A1 (en) * 2005-01-05 2006-07-06 Advanced Bionics Corporation Devices and methods using an implantable pulse generator for brain stimulation
US20110004267A1 (en) * 2005-01-05 2011-01-06 Boston Scientific Neuromodulation Corporation Devices and methods for brain stimulation
US20060149335A1 (en) * 2005-01-05 2006-07-06 Advanced Bionics Corporation Devices and methods for brain stimulation
US8755905B2 (en) 2005-01-05 2014-06-17 Boston Scientific Neuromodulation Corporation Devices and methods for brain stimulation
US8498718B2 (en) 2005-01-05 2013-07-30 Boston Scientific Neuromodulation Corporation Devices and methods for brain stimulation
US10561498B2 (en) 2005-03-17 2020-02-18 Valtech Cardio, Ltd. Mitral valve treatment techniques
US11497605B2 (en) 2005-03-17 2022-11-15 Valtech Cardio Ltd. Mitral valve treatment techniques
US10695046B2 (en) 2005-07-05 2020-06-30 Edwards Lifesciences Corporation Tissue anchor and anchoring system
US10561835B2 (en) 2006-10-31 2020-02-18 Medtronic, Inc. Implantable medical lead with threaded fixation
US9974653B2 (en) 2006-12-05 2018-05-22 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US9883943B2 (en) 2006-12-05 2018-02-06 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US10357366B2 (en) 2006-12-05 2019-07-23 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US10363137B2 (en) 2006-12-05 2019-07-30 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US11344414B2 (en) 2006-12-05 2022-05-31 Valtech Cardio Ltd. Implantation of repair devices in the heart
US11259924B2 (en) 2006-12-05 2022-03-01 Valtech Cardio Ltd. Implantation of repair devices in the heart
US9872769B2 (en) 2006-12-05 2018-01-23 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US8983624B2 (en) 2006-12-06 2015-03-17 Spinal Modulation, Inc. Delivery devices, systems and methods for stimulating nerve tissue on multiple spinal levels
US8518092B2 (en) 2006-12-06 2013-08-27 Spinal Modulation, Inc. Hard tissue anchors and delivery devices
US9623233B2 (en) 2006-12-06 2017-04-18 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. (“SJM LUX SMI”) Delivery devices, systems and methods for stimulating nerve tissue on multiple spinal levels
US9427570B2 (en) 2006-12-06 2016-08-30 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. (“SJM LUX SMI”) Expandable stimulation leads and methods of use
US20080140169A1 (en) * 2006-12-06 2008-06-12 Spinal Modulation, Inc. Delivery devices, systems and methods for stimulating nerve tissue on multiple spinal levels
US20080140153A1 (en) * 2006-12-06 2008-06-12 Spinal Modulation, Inc. Expandable stimulation leads and methods of use
US9314618B2 (en) 2006-12-06 2016-04-19 Spinal Modulation, Inc. Implantable flexible circuit leads and methods of use
US20080147156A1 (en) * 2006-12-06 2008-06-19 Spinal Modulation, Inc. Grouped leads for spinal stimulation
US9044592B2 (en) 2007-01-29 2015-06-02 Spinal Modulation, Inc. Sutureless lead retention features
US20080183257A1 (en) * 2007-01-29 2008-07-31 Spinal Modulation, Inc. Sutureless lead retention features
US11660190B2 (en) 2007-03-13 2023-05-30 Edwards Lifesciences Corporation Tissue anchors, systems and methods, and devices
US11660191B2 (en) 2008-03-10 2023-05-30 Edwards Lifesciences Corporation Method to reduce mitral regurgitation
US11890472B2 (en) 2008-10-27 2024-02-06 Tc1 Llc Selective stimulation systems and signal parameters for medical conditions
US9056197B2 (en) 2008-10-27 2015-06-16 Spinal Modulation, Inc. Selective stimulation systems and signal parameters for medical conditions
US9409021B2 (en) 2008-10-27 2016-08-09 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. Selective stimulation systems and signal parameters for medical conditions
US20100137938A1 (en) * 2008-10-27 2010-06-03 Eyad Kishawi Selective stimulation systems and signal parameters for medical conditions
US10856986B2 (en) 2008-12-22 2020-12-08 Valtech Cardio, Ltd. Adjustable annuloplasty devices and adjustment mechanisms therefor
US10517719B2 (en) 2008-12-22 2019-12-31 Valtech Cardio, Ltd. Implantation of repair devices in the heart
US10470882B2 (en) 2008-12-22 2019-11-12 Valtech Cardio, Ltd. Closure element for use with annuloplasty structure
US11116634B2 (en) 2008-12-22 2021-09-14 Valtech Cardio Ltd. Annuloplasty implants
US20100179562A1 (en) * 2009-01-14 2010-07-15 Linker Fred I Stimulation leads, delivery systems and methods of use
US11202709B2 (en) 2009-02-17 2021-12-21 Valtech Cardio Ltd. Actively-engageable movement-restriction mechanism for use with an annuloplasty structure
US10350068B2 (en) 2009-02-17 2019-07-16 Valtech Cardio, Ltd. Actively-engageable movement-restriction mechanism for use with an annuloplasty structure
US9468762B2 (en) 2009-03-24 2016-10-18 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. (“SJM LUX SMI”) Pain management with stimulation subthreshold to paresthesia
US8380318B2 (en) 2009-03-24 2013-02-19 Spinal Modulation, Inc. Pain management with stimulation subthreshold to paresthesia
US20150250998A1 (en) * 2009-04-07 2015-09-10 Boston Scientific Neuromodulation Corporation Anchoring units for implantable electrical stimulation systems and methods of making and using
US20170151428A1 (en) * 2009-04-07 2017-06-01 Boston Scientific Neuromodulation Corporation Anchoring units for implantable electrical stimulation systems and methods of making and using
US9610435B2 (en) * 2009-04-07 2017-04-04 Boston Scientific Neuromodulation Corporation Anchoring units for implantable electrical stimulation systems and methods of making and using
US11766327B2 (en) 2009-05-04 2023-09-26 Edwards Lifesciences Innovation (Israel) Ltd. Implantation of repair chords in the heart
US10548729B2 (en) 2009-05-04 2020-02-04 Valtech Cardio, Ltd. Deployment techniques for annuloplasty ring and over-wire rotation tool
US9968452B2 (en) 2009-05-04 2018-05-15 Valtech Cardio, Ltd. Annuloplasty ring delivery cathethers
US11076958B2 (en) 2009-05-04 2021-08-03 Valtech Cardio, Ltd. Annuloplasty ring delivery catheters
US11185412B2 (en) 2009-05-04 2021-11-30 Valtech Cardio Ltd. Deployment techniques for annuloplasty implants
US11844665B2 (en) 2009-05-04 2023-12-19 Edwards Lifesciences Innovation (Israel) Ltd. Deployment techniques for annuloplasty structure
US10856987B2 (en) 2009-05-07 2020-12-08 Valtech Cardio, Ltd. Multiple anchor delivery tool
US9937042B2 (en) 2009-05-07 2018-04-10 Valtech Cardio, Ltd. Multiple anchor delivery tool
US11723774B2 (en) 2009-05-07 2023-08-15 Edwards Lifesciences Innovation (Israel) Ltd. Multiple anchor delivery tool
US9259569B2 (en) 2009-05-15 2016-02-16 Daniel M. Brounstein Methods, systems and devices for neuromodulating spinal anatomy
US9089687B2 (en) * 2009-09-24 2015-07-28 Chong Il Lee Device and means for adjusting the position of DBS brain and other neural and muscular implants
US20140222018A1 (en) * 2009-09-24 2014-08-07 Chong Il Lee Device and means for adjusting the position of DBS brain and other neural and muscular implants
US9327110B2 (en) 2009-10-27 2016-05-03 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. (“SJM LUX SMI”) Devices, systems and methods for the targeted treatment of movement disorders
US11141271B2 (en) 2009-10-29 2021-10-12 Valtech Cardio Ltd. Tissue anchor for annuloplasty device
US10098737B2 (en) 2009-10-29 2018-10-16 Valtech Cardio, Ltd. Tissue anchor for annuloplasty device
US9968454B2 (en) 2009-10-29 2018-05-15 Valtech Cardio, Ltd. Techniques for guide-wire based advancement of artificial chordae
US11617652B2 (en) 2009-10-29 2023-04-04 Edwards Lifesciences Innovation (Israel) Ltd. Apparatus and method for guide-wire based advancement of an adjustable implant
US10751184B2 (en) 2009-10-29 2020-08-25 Valtech Cardio, Ltd. Apparatus and method for guide-wire based advancement of an adjustable implant
US20110130816A1 (en) * 2009-11-30 2011-06-02 Boston Scientific Neuromodulation Corporation Electrode array with electrodes having cutout portions and methods of making the same
US8391985B2 (en) 2009-11-30 2013-03-05 Boston Scientific Neuromodulation Corporation Electrode array having concentric windowed cylinder electrodes and methods of making the same
US8295944B2 (en) 2009-11-30 2012-10-23 Boston Scientific Neuromodulation Corporation Electrode array with electrodes having cutout portions and methods of making the same
US8560074B2 (en) 2009-11-30 2013-10-15 Boston Scientific Neuromodulation Corporation Electrode array having concentric windowed cylinder electrodes and methods of making the same
US8442654B2 (en) 2009-11-30 2013-05-14 Boston Scientific Neuromodulation Corporation Electrode array with electrodes having cutout portions and methods of making the same
US20110130803A1 (en) * 2009-11-30 2011-06-02 Boston Scientific Neuromodulation Corporation Electrode array having concentric windowed cylinder electrodes and methods of making the same
US8666509B2 (en) 2009-11-30 2014-03-04 Boston Scientific Neuromodulation Corporation Electrode array with electrodes having cutout portions and methods of making the same
US11602434B2 (en) 2009-12-02 2023-03-14 Edwards Lifesciences Innovation (Israel) Ltd. Systems and methods for tissue adjustment
US10492909B2 (en) 2009-12-02 2019-12-03 Valtech Cardio, Ltd. Tool for actuating an adjusting mechanism
US20110190857A1 (en) * 2010-01-29 2011-08-04 Medtronic, Inc. Anchor assembly for use in occipital nerve stimulation
US8554339B2 (en) * 2010-01-29 2013-10-08 Medtronic, Inc. Anchor assembly for use in occipital nerve stimulation
CN103079489A (en) * 2010-05-10 2013-05-01 脊髓调制公司 Methods, systems and devices for reducing migration
US11413451B2 (en) 2010-05-10 2022-08-16 St. Jude Medical Luxembourg Holdings SMI S.A.R.L. (“SJM LUX SMI”) Methods, systems and devices for reducing migration
WO2011143233A3 (en) * 2010-05-10 2012-03-15 Spinal Modulation, Inc. Methods, systems and devices for reducing migration
WO2011154937A1 (en) * 2010-06-08 2011-12-15 Rainbow Medical Ltd. Tibial nerve stimulation
US8755893B2 (en) 2010-06-08 2014-06-17 Bluewind Medical Ltd. Tibial nerve stimulation
US20120016377A1 (en) * 2010-07-15 2012-01-19 Greatbatch Ltd. Tunneling tool for implantable leads
US9381030B2 (en) * 2010-07-15 2016-07-05 Nuvectra Corporation Tunneling tool for implantable leads
US9457186B2 (en) 2010-11-15 2016-10-04 Bluewind Medical Ltd. Bilateral feedback
US9186504B2 (en) 2010-11-15 2015-11-17 Rainbow Medical Ltd Sleep apnea treatment
US10792152B2 (en) 2011-06-23 2020-10-06 Valtech Cardio, Ltd. Closed band for percutaneous annuloplasty
US10363136B2 (en) 2011-11-04 2019-07-30 Valtech Cardio, Ltd. Implant having multiple adjustment mechanisms
US9775709B2 (en) 2011-11-04 2017-10-03 Valtech Cardio, Ltd. Implant having multiple adjustable mechanisms
US11197759B2 (en) 2011-11-04 2021-12-14 Valtech Cardio Ltd. Implant having multiple adjusting mechanisms
US9724192B2 (en) 2011-11-08 2017-08-08 Valtech Cardio, Ltd. Controlled steering functionality for implant-delivery tool
US10568738B2 (en) 2011-11-08 2020-02-25 Valtech Cardio, Ltd. Controlled steering functionality for implant-delivery tool
US11857415B2 (en) 2011-11-08 2024-01-02 Edwards Lifesciences Innovation (Israel) Ltd. Controlled steering functionality for implant-delivery tool
US8954165B2 (en) 2012-01-25 2015-02-10 Nevro Corporation Lead anchors and associated systems and methods
US10653888B2 (en) 2012-01-26 2020-05-19 Bluewind Medical Ltd Wireless neurostimulators
US11648410B2 (en) 2012-01-26 2023-05-16 Bluewind Medical Ltd. Wireless neurostimulators
US11013911B2 (en) 2012-06-29 2021-05-25 Cirtec Medical Corp. Lead positioning and finned fixation system
US9089693B2 (en) 2012-06-29 2015-07-28 Greatbatch Ltd. Lead positioning and finned fixation system
US9717900B2 (en) 2012-06-29 2017-08-01 Nuvectra Corporation Lead positioning and finned fixation system
US9095700B2 (en) 2012-08-10 2015-08-04 Greatbach Ltd. Lead positioning and fixation system
US11395648B2 (en) 2012-09-29 2022-07-26 Edwards Lifesciences Corporation Plication lock delivery system and method of use thereof
US11344310B2 (en) 2012-10-23 2022-05-31 Valtech Cardio Ltd. Percutaneous tissue anchor techniques
US9949828B2 (en) 2012-10-23 2018-04-24 Valtech Cardio, Ltd. Controlled steering functionality for implant-delivery tool
US10893939B2 (en) 2012-10-23 2021-01-19 Valtech Cardio, Ltd. Controlled steering functionality for implant delivery tool
US10376266B2 (en) 2012-10-23 2019-08-13 Valtech Cardio, Ltd. Percutaneous tissue anchor techniques
US11890190B2 (en) 2012-10-23 2024-02-06 Edwards Lifesciences Innovation (Israel) Ltd. Location indication system for implant-delivery tool
US9861812B2 (en) 2012-12-06 2018-01-09 Blue Wind Medical Ltd. Delivery of implantable neurostimulators
US10238863B2 (en) 2012-12-06 2019-03-26 Bluewind Medical Ltd. Delivery of implantable neurostimulators
US11583400B2 (en) 2012-12-06 2023-02-21 Edwards Lifesciences Innovation (Israel) Ltd. Techniques for guided advancement of a tool
US10610360B2 (en) 2012-12-06 2020-04-07 Valtech Cardio, Ltd. Techniques for guide-wire based advancement of a tool
US11464966B2 (en) 2012-12-06 2022-10-11 Bluewind Medical Ltd. Delivery of implantable neurostimulators
US11278719B2 (en) 2012-12-06 2022-03-22 Bluewind Medical Ltd. Delivery of implantable neurostimulators
US10213229B2 (en) 2012-12-10 2019-02-26 Nevro Corp. Lead insertion devices and associated systems and methods
US9308022B2 (en) 2012-12-10 2016-04-12 Nevro Corporation Lead insertion devices and associated systems and methods
US11103280B2 (en) 2012-12-10 2021-08-31 Nevro Corp. Lead insertion devices and associated systems and methods
US10918374B2 (en) 2013-02-26 2021-02-16 Edwards Lifesciences Corporation Devices and methods for percutaneous tricuspid valve repair
US11793505B2 (en) 2013-02-26 2023-10-24 Edwards Lifesciences Corporation Devices and methods for percutaneous tricuspid valve repair
US11534583B2 (en) 2013-03-14 2022-12-27 Valtech Cardio Ltd. Guidewire feeder
US11890194B2 (en) 2013-03-15 2024-02-06 Edwards Lifesciences Corporation Translation catheters, systems, and methods of use thereof
US10682232B2 (en) 2013-03-15 2020-06-16 Edwards Lifesciences Corporation Translation catheters, systems, and methods of use thereof
US10406353B2 (en) 2013-05-14 2019-09-10 Boston Scientific Neuromodulation Corporation Electrical stimulation leads with anchoring unit and electrode arrangement and methods of making and using
US9687649B2 (en) 2013-06-28 2017-06-27 Nevro Corp. Neurological stimulation lead anchors and associated systems and methods
US9265935B2 (en) 2013-06-28 2016-02-23 Nevro Corporation Neurological stimulation lead anchors and associated systems and methods
US10918373B2 (en) 2013-08-31 2021-02-16 Edwards Lifesciences Corporation Devices and methods for locating and implanting tissue anchors at mitral valve commissure
US11744573B2 (en) 2013-08-31 2023-09-05 Edwards Lifesciences Corporation Devices and methods for locating and implanting tissue anchors at mitral valve commissure
US11065001B2 (en) 2013-10-23 2021-07-20 Valtech Cardio, Ltd. Anchor magazine
US11766263B2 (en) 2013-10-23 2023-09-26 Edwards Lifesciences Innovation (Israel) Ltd. Anchor magazine
US10299793B2 (en) 2013-10-23 2019-05-28 Valtech Cardio, Ltd. Anchor magazine
US10792490B2 (en) 2013-11-12 2020-10-06 Medtronic, Inc. Open channel implant tools and implant techniques utilizing such tools
US10973637B2 (en) 2013-12-26 2021-04-13 Valtech Cardio, Ltd. Implantation of flexible implant
US9364658B2 (en) 2014-03-03 2016-06-14 Boston Scientific Neuromodulation Corporation Electrical stimulation leads with multiple anchoring units and methods of making and using
US9669210B2 (en) 2014-04-22 2017-06-06 Boston Scientific Neuromodulation Corporation Electrical stimulation leads and systems with folding anchoring units and methods of making and using
US9649489B2 (en) 2014-06-02 2017-05-16 Boston Scientific Neuromodulation Corporation Electrical stimulation leads and systems with anchoring units having struts and methods of making and using
US9533141B2 (en) 2014-07-07 2017-01-03 Boston Scientific Neuromodulation Corporation Electrical stimulation leads and systems with elongate anchoring elements
WO2016049050A1 (en) * 2014-09-22 2016-03-31 Boston Scientific Neuromodulation Corporation Systems and methods for making and using anchoring arrangements for leads of electrical stimulation systems
US20160082247A1 (en) * 2014-09-22 2016-03-24 Boston Scientific Neuromodulation Corporation Systems and methods for making and using anchoring arrangements for leads of electrical stimulation systems
US11071628B2 (en) 2014-10-14 2021-07-27 Valtech Cardio, Ltd. Leaflet-restraining techniques
US10195030B2 (en) 2014-10-14 2019-02-05 Valtech Cardio, Ltd. Leaflet-restraining techniques
US11083491B2 (en) * 2014-12-09 2021-08-10 Medtronic, Inc. Extravascular implant tools utilizing a bore-in mechanism and implant techniques using such tools
US20220061886A1 (en) * 2014-12-09 2022-03-03 Medtronic, Inc. Extravascular implant tools utilizing a bore-in mechanism and implant techniques using such tools
US20160157890A1 (en) * 2014-12-09 2016-06-09 Medtronic, Inc. Extravascular implant tools utilizing a bore-in mechanism and implant techniques using such tools
US10349978B2 (en) 2014-12-18 2019-07-16 Medtronic, Inc. Open channel implant tool with additional lumen and implant techniques utilizing such tools
US9764146B2 (en) 2015-01-21 2017-09-19 Bluewind Medical Ltd. Extracorporeal implant controllers
US10004896B2 (en) 2015-01-21 2018-06-26 Bluewind Medical Ltd. Anchors and implant devices
US9597521B2 (en) 2015-01-21 2017-03-21 Bluewind Medical Ltd. Transmitting coils for neurostimulation
US10925610B2 (en) 2015-03-05 2021-02-23 Edwards Lifesciences Corporation Devices for treating paravalvular leakage and methods use thereof
US11020227B2 (en) 2015-04-30 2021-06-01 Valtech Cardio, Ltd. Annuloplasty technologies
US10765514B2 (en) 2015-04-30 2020-09-08 Valtech Cardio, Ltd. Annuloplasty technologies
US10369366B2 (en) 2015-06-10 2019-08-06 Bluewind Medical Ltd. Implantable electrostimulator for improving blood flow
US9782589B2 (en) 2015-06-10 2017-10-10 Bluewind Medical Ltd. Implantable electrostimulator for improving blood flow
US10688299B2 (en) 2015-09-18 2020-06-23 Bioventures, Llc Electrode for peripheral nerve stimulation
WO2017049292A3 (en) * 2015-09-18 2017-04-27 Board Of Trustees Of The University Of Arkansas Electrode for peripheral nerve stimulation
US10105540B2 (en) 2015-11-09 2018-10-23 Bluewind Medical Ltd. Optimization of application of current
US11116975B2 (en) 2015-11-09 2021-09-14 Bluewind Medical Ltd. Optimization of application of current
US11612747B2 (en) 2015-11-09 2023-03-28 Bluewind Medical Ltd. Optimization of application of current
US9713707B2 (en) 2015-11-12 2017-07-25 Bluewind Medical Ltd. Inhibition of implant migration
US10449374B2 (en) 2015-11-12 2019-10-22 Bluewind Medical Ltd. Inhibition of implant migration
US11890193B2 (en) 2015-12-30 2024-02-06 Edwards Lifesciences Corporation System and method for reducing tricuspid regurgitation
US10828160B2 (en) 2015-12-30 2020-11-10 Edwards Lifesciences Corporation System and method for reducing tricuspid regurgitation
US10751182B2 (en) 2015-12-30 2020-08-25 Edwards Lifesciences Corporation System and method for reshaping right heart
US11660192B2 (en) 2015-12-30 2023-05-30 Edwards Lifesciences Corporation System and method for reshaping heart
US10702274B2 (en) 2016-05-26 2020-07-07 Edwards Lifesciences Corporation Method and system for closing left atrial appendage
US11540835B2 (en) 2016-05-26 2023-01-03 Edwards Lifesciences Corporation Method and system for closing left atrial appendage
US10226342B2 (en) 2016-07-08 2019-03-12 Valtech Cardio, Ltd. Adjustable annuloplasty device with alternating peaks and troughs
US10959845B2 (en) 2016-07-08 2021-03-30 Valtech Cardio, Ltd. Adjustable annuloplasty device with alternating peaks and troughs
US11439833B2 (en) 2016-11-23 2022-09-13 Bluewind Medical Ltd. Implant-delivery tool
US10744331B2 (en) 2016-11-23 2020-08-18 Bluewind Medical Ltd. Implant and delivery tool therefor
US10124178B2 (en) 2016-11-23 2018-11-13 Bluewind Medical Ltd. Implant and delivery tool therefor
US10980999B2 (en) 2017-03-09 2021-04-20 Nevro Corp. Paddle leads and delivery tools, and associated systems and methods
US11759631B2 (en) 2017-03-09 2023-09-19 Nevro Corp. Paddle leads and delivery tools, and associated systems and methods
US11045627B2 (en) 2017-04-18 2021-06-29 Edwards Lifesciences Corporation Catheter system with linear actuation control mechanism
US11883611B2 (en) 2017-04-18 2024-01-30 Edwards Lifesciences Corporation Catheter system with linear actuation control mechanism
US11213685B2 (en) 2017-06-13 2022-01-04 Bluewind Medical Ltd. Antenna configuration
US11318297B2 (en) 2017-09-21 2022-05-03 Medtronic, Inc. Imaging markers for stimulator leads
CN108992774A (en) * 2017-09-21 2018-12-14 美敦力公司 Imaging for stimulator lead marks
US10835221B2 (en) 2017-11-02 2020-11-17 Valtech Cardio, Ltd. Implant-cinching devices and systems
US11832784B2 (en) 2017-11-02 2023-12-05 Edwards Lifesciences Innovation (Israel) Ltd. Implant-cinching devices and systems
US11135062B2 (en) 2017-11-20 2021-10-05 Valtech Cardio Ltd. Cinching of dilated heart muscle
CN109957912A (en) * 2017-12-25 2019-07-02 青岛胶南海尔洗衣机有限公司 The processing method of clothes stains
US11779463B2 (en) 2018-01-24 2023-10-10 Edwards Lifesciences Innovation (Israel) Ltd. Contraction of an annuloplasty structure
US11666442B2 (en) 2018-01-26 2023-06-06 Edwards Lifesciences Innovation (Israel) Ltd. Techniques for facilitating heart valve tethering and chord replacement
US11420045B2 (en) 2018-03-29 2022-08-23 Nevro Corp. Leads having sidewall openings, and associated systems and methods
US11779217B2 (en) * 2018-05-31 2023-10-10 Inspire Medical Systems, Inc. System and method for collecting and displaying data acquired from an implantable therapy device using a consumer electronic device
US11123191B2 (en) 2018-07-12 2021-09-21 Valtech Cardio Ltd. Annuloplasty systems and locking tools therefor
US11890191B2 (en) 2018-07-12 2024-02-06 Edwards Lifesciences Innovation (Israel) Ltd. Fastener and techniques therefor
US11819411B2 (en) 2019-10-29 2023-11-21 Edwards Lifesciences Innovation (Israel) Ltd. Annuloplasty and tissue anchor technologies
US11400299B1 (en) 2021-09-14 2022-08-02 Rainbow Medical Ltd. Flexible antenna for stimulator
CN115869534A (en) * 2021-09-29 2023-03-31 江苏畅医达医疗科技有限公司 Implanted electrode and peripheral nerve stimulation system thereof

Also Published As

Publication number Publication date
WO2008054445A1 (en) 2008-05-08
EP2089095B1 (en) 2013-03-06
US20200179677A1 (en) 2020-06-11
EP2422840A1 (en) 2012-02-29
US10561835B2 (en) 2020-02-18
US20190351218A1 (en) 2019-11-21
EP2089095A1 (en) 2009-08-19

Similar Documents

Publication Publication Date Title
US10561835B2 (en) Implantable medical lead with threaded fixation
US10556104B2 (en) Implantable medical elongated member with adhesive elements
US8688238B2 (en) Implantable medical elongated member including fixation elements along an interior surface
US10856904B2 (en) Flexible introducer
CA2957962C (en) Implantable lead affixation structure for nerve stimulation to alleviate bladder dysfunction and other indications
EP2086630B1 (en) Implantable medical elongated member including expandable fixation members
US7774072B2 (en) Attached implantable medical elongated members
US9713706B2 (en) Implantable medical elongated member including intermediate fixation
US7684873B2 (en) Implantable medical lead including a directional electrode and fixation elements along an interior surface
US20080103573A1 (en) Implantable medical elongated member including wire-like fixation elements
AU2022203792A1 (en) Methods, systems and devices for reducing migration
US20080103578A1 (en) Implantable medical elongated member with in situ formed fixation element
US20080103580A1 (en) Implantable medical elongated member with dual purpose conduit
US20080132982A1 (en) Method of implanting a medical device including a fixation element
US9993639B2 (en) Implantable medical elongated member including a tissue receiving fixation cavity

Legal Events

Date Code Title Description
AS Assignment

Owner name: MEDTRONIC, INC., MINNESOTA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:GERBER, MARTIN T.;REEL/FRAME:018808/0010

Effective date: 20070110

STCV Information on status: appeal procedure

Free format text: ON APPEAL -- AWAITING DECISION BY THE BOARD OF APPEALS

STCV Information on status: appeal procedure

Free format text: BOARD OF APPEALS DECISION RENDERED

STPP Information on status: patent application and granting procedure in general

Free format text: NOTICE OF ALLOWANCE MAILED -- APPLICATION RECEIVED IN OFFICE OF PUBLICATIONS

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STCB Information on status: application discontinuation

Free format text: EXPRESSLY ABANDONED -- DURING EXAMINATION