US20040215202A1 - High pressure applicator - Google Patents

High pressure applicator Download PDF

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US20040215202A1
US20040215202A1 US10/039,892 US3989201A US2004215202A1 US 20040215202 A1 US20040215202 A1 US 20040215202A1 US 3989201 A US3989201 A US 3989201A US 2004215202 A1 US2004215202 A1 US 2004215202A1
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column
high pressure
pressure applicator
wall
applicator
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US10/039,892
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Howard Preissman
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Arthrocare Corp
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Application filed by Individual filed Critical Individual
Priority to US10/039,892 priority Critical patent/US20040215202A1/en
Assigned to PARALLAX MEDICAL, INC. reassignment PARALLAX MEDICAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PREISSMAN, HOWARD E.
Priority to US10/301,454 priority patent/US7572263B2/en
Assigned to ARTHROCARE CORPORATION reassignment ARTHROCARE CORPORATION ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PARALLAX MEDICAL, INC.
Publication of US20040215202A1 publication Critical patent/US20040215202A1/en
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Assigned to ARTHROCARE CORPORATION reassignment ARTHROCARE CORPORATION RELEASE OF PATENT SECURITY AGREEMENT RECORDED AT REEL 017105 FRAME 0855 Assignors: BANK OF AMERICA, N.A.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8819Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8822Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8833Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4601Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4677Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor using a guide wire

Definitions

  • the present invention relates to instruments for more accurately controlling the placement of implant material thereof, during surgical procedures for the repair of hard tissue by injection of hard tissue implant materials. Procedures for such repair include hip augmentation, mandible augmentation, and particularly vertebroplasty, among others.
  • PMMA Polymethylmethacrylate
  • Percutaneous vertebroplasty with methyl-methacrylate: technique, method, results [abstract].” Radiology 1990;117 (suppl):352, among others, have described the percutaneous injection of PMMA into vertebral compression fractures by the transpedicular or paravertebral approach under CT and/or fluoroscopic guidance. Percutaneous vertebroplasty is desirable from the standpoint that it is minimally invasive, compared to the alternative of surgically exposing the hard tissue site to be supplemented with PMMA or other filler.
  • the general procedure for performing percutaneous vertebroplasty involves the use of a standard 11 gauge Jamshidi needle.
  • the needle includes an 11 gauge cannula with an internal stylet.
  • the cannula and stylet are used in conjunction to pierce the cutaneous layers of a patient above the hard tissue to be supplemented, then to penetrate the hard cortical bone of the vertebra, and finally to traverse into the softer cancellous bone underlying the cortical bone.
  • a large force must be applied by the user, axially through the Jamshidi needle to drive the stylet through the cortical bone. Once penetration of the cortical bone is achieved, additional downward axial force, but at a reduced magnitude compared to that required to penetrate the cortical bone, is required to position the stylet/tip of the cannula into the required position within the cancellous bone. When positioned in the cancellous bone, the stylet is then removed leaving the cannula in the appropriate position for delivery of a hard tissue implant material to reinforce and solidify the damaged hard tissue.
  • a syringe is next loaded with polymethyl methacrylate (PMMA) and connected to the end of the cannula that is external of the patient's body. Pressure is applied to the plunger of the syringe to deliver the PMMA to the site of damaged bone at the distal end of the cannula. Because in general, 10 cc syringes are only capable of generating pressures of about 100-150 psi, this places a limitation on the viscosity of the PMMA that can be effectively “pushed through” the syringe and cannula and fully delivered to the implant site.
  • PMMA polymethyl methacrylate
  • a small barrel syringe e.g., a 1 cc syringe
  • pressures of 1000 psi and possibly as high as 1200-1500 psi may be generated using a 1 cc syringe.
  • a serious limitation with the use of a 1 cc syringe is that it will not hold a large enough volume to complete the procedure in one step or “load” and must be reloaded several times to complete the procedure, since, on average, about 3.5 cc of implant material per side of the vertebral body are required for an implantation procedure.
  • a viscous or paste-like consistency of PMMA is generally believed to be most advantageous for performing percutaneous vertebroplasty. Such a consistency insures that the implant material stays in place much better than a less viscous, more liquid material.
  • Leakage or seepage of PMMA from the vertebral implant site can cause a host of complications some of which can be very serious and even result in death.
  • Weil et al. reported cases of sciatica and difficulty in swallowing which were related to focal cement leakage, Radiology 1996;Vol 199, No. 1, 241-247.
  • a leak toward the distal veins poses an even more serious risk, since this can cause a pulmonary embolism which is often fatal.
  • the present invention includes a high pressure applicator for driving the delivery of a flowable tissue implant material.
  • a first column having an inner wall, an outer wall, a first open end and a second substantially closed end is provided with an orifice through the substantially closed end for passage implant materials therethrough under high pressure.
  • a second column is drivably engageable with the first column to generate fluid pressure within at least the first column.
  • a wall portion of the second column is drivably engageable with one of an inner and outer wall of the first column.
  • a handle is preferably fixedly attached or integral with the first column and may extend radially from the first column to provide a user a mechanical advantage upon grasping it.
  • At least one sealing element may be provided to interface with the inner wall of the first column, to enhance the generation of pressure in the first column.
  • a handle is also preferably integrally formed with or affixed to the second column and may extend radially therefrom to provide a user a mechanical advantage upon grasping it.
  • threading is provided on an outer wall of the first column.
  • the second column is substantially hollow, having an open first end, a closed second end and threading on an inner wall thereof.
  • the threading on the second column in this embodiment is engageable with the threading on the first column to provide a driving force for driving the second column with respect to the first column.
  • the second column may include an extension integrally formed with or affixed thereto and optionally having an end portion extending from the open end of the second column. The extension is adapted to be inserted through the open end of the first column and form a substantial pressure seal with the inner wall of the first column.
  • At least one sealing element may be provided at or near the end portion of the extension to form or enhance a pressure seal with the inner wall of the first column.
  • the sealing element(s) may be an O-ring(s), a grommet(s) or the like.
  • a plunger element which is adapted to be inserted within the first and second columns.
  • the plunger element has a first end portion and a second end portion, where the first end portion is adapted and configured to closely fit within the inner wall of the first column to form a pressure seal therewith.
  • At least one sealing element may be provided for the first end portion to form and/or enhance a pressure seal between the inner wall and the plunger element.
  • a handle may be integrally formed with or affixed to the second column, to optionally extend radially therefrom, to provide the user a mechanical advantage upon grasping it.
  • the plunger element may further be provided with at least one frictional element mounted to the second end portion and adapted to form a disengageable friction fit with the second column at or near the closed end of the second column.
  • a high pressure applicator may include threading on at least a portion of the inner wall of the first column, and the second column may have threading on at least a portion of an external wall thereof such that the threading of the external wall is engageable with the threading on at least a portion of the inner wall of the first column to provide a driving mechanism for driving the second column with respect to the first column.
  • the interengaging threads may be formed to closely fit to form a pressure seal therebetween upon their engagement.
  • At least one sealing element may be mounted to an end portion of the second column and adapted to form or enhance a pressure seal with the inner wall thereby forming or enhancing the pressure seal between the first and second columns.
  • the sealing element(s) may comprise an O-ring(s), a Teflon wrap(s), or the like.
  • a handle may be integrally formed with or affixed to the second column to extend radially therefrom, to provide a user a mechanical advantage upon grasping it.
  • Various portions of a pressure applicator may be sized to provide sufficient mechanical advantage to enable the application of pressures up to about 3000 or 4000 psi by hand.
  • the mechanical advantage of an applicator is determined in large part by handle size, the bore size of the first column, and the mechanical advantage of the engagement mechanism.
  • the engaging threads used as an engagement mechanism manufacturing and material considerations, and the diameter on which to place the threads will determine the thread pitch which may be used. This in turn determines the mechanical advantage of this engagement mechanism. Where a greater mechanical advantage is desired, a finer thread pitch will provide the same. To achieve this, the diameter of threaded sections of the first and second columns may be decreased.
  • a finer pitch thread may be used on a relatively larger diameter section by changing material or manufacturing procedure (such as cutting the threads into the respective members rather than molding the pieces as is presently preferred).
  • a pressure applicator produced according to the present invention is a balancing of various design goals relating to performance and cost.
  • the remainder of this wall of the second column is left relatively smooth.
  • only a portion of the inner wall of the first column has threads, and the remainder of the inner wall is left substantially smooth.
  • the relatively smooth end portion of the second column has a reduced diameter section having an outside diameter less than an inside diameter of the threads on said inner wall, to allow assembly or interfitting of the two columns.
  • An enlarged section extending from the reduced diameter portion closely fits with the substantially smooth inner wall to form a pressure seal therewith.
  • the first column in this arrangement additionally includes a hinged or removable section adapted to swing open or be removed therefrom to allow insertion of the second column.
  • At least one sealing element which may be an O-ring or the like, may be mounted to the end portion of the second column to form or enhance a pressure seal therewith.
  • the first column is substantially hollow and comprises an inside wall, an open first end and a closed second end, and a barrel portion of a syringe is received therein.
  • a plunger portion of the syringe is received within a second column.
  • the applicator may include threading on an outer wall of the first column and threading on an inner wall of the second column, where the threads are engageable with one another to provide a driving force for driving the plunger portion with respect to the barrel portion.
  • a handle may be integrally formed with or affixed to the second column and optionally extend radially therefrom and to provide the user a mechanical advantage upon grasping it.
  • An end of the barrel portion of the syringe may abut against the substantially closed end of the first column and an end of the plunger portion may abut against the closed end of said second column, such that driving of the second column with respect to the first column provides a driving force for advancing the plunger portion within the barrel portion.
  • the barrel portion may further include a wing or flanged portion adjacent an open end thereof.
  • the first column may have a first portion adjacent the open end, a second portion adjacent the substantially closed end and a transitional portion joining the first and second portions, where the first portion has an inside diameter larger than an inside diameter of the second portion.
  • the transitional portion may be adapted to abut against the wing or flanged portion, to provide additional or alternative support for the barrel portion as the plunger portion is being advanced with respect thereto.
  • a high pressure applicator may include a syringe having a barrel portion and a plunger portion, where the syringe barrel is received within the first column where threading is provided on at least a portion of the inner wall of the first column and on at least a portion of an external wall of the second column.
  • the second column includes an end adapted to abut an end of the plunger portion of the syringe and threading of the external wall is engageable with the threading on at least a portion of the inner wall to provide a driving force.
  • a method of preparing a high pressure applicator for driving the delivery of a flowable tissue implant material for use includes: providing an applicator having a first column having an inner wall, an outer wall, a first open end and a second substantially closed end having an orifice therethrough, and a second column drivably engageable with the first column to generate a pressure within the first column; loading the flowable tissue implant material into the first column; engaging the second column with the first column to enclose the tissue implant material; and advancing the second column toward the first column to generate a pressure for driving the flowable tissue material through the orifice.
  • the second column may include a plunger adapted to form a pressure seal with the inner wall of the first column, in which case the engagement of the second column with the first column includes introducing the plunger into the tissue implant material in such a way to avoid the introduction of air bubbles or other compliant matter together with the implant material to be delivered to a patient.
  • Advancement of the second column toward the first column generates a pressure for driving the flowable tissue material through the orifice, which may be at least 1000 psi.
  • a substantially non-compliant tube may be connected to the orifice prior to advancing the second column toward the first column to generate a pressure for driving the flowable tissue material through the orifice.
  • a substantially non-compliant tube may be connected to the orifice after advancing the second column toward the first column to generate a pressure for driving the flowable tissue material through the orifice, thereby purging the orifice prior to connecting the substantially noncompliant tube.
  • the substantially noncompliant tube may be, but is not necessarily prefilled (e.g., with saline or implant material) prior to connecting it to the orifice.
  • Loading of the first column with implant material may be done in such a way as to slightly overfill the first column to form a meniscus created by surface tension of the implant material.
  • the engagement of the first and second columns then may include introducing a plunger element into the implant material and then driving the plunger via the advancement of the second column.
  • a method of preparing a high pressure applicator for driving the delivery of a flowable tissue implant material for use includes: providing an applicator containing at least 5 cc of tissue implant material therein; and actuating the applicator to generate an internal pressure of at least 1000 psi which acts as a driving force to force a flow of the implant material from the applicator.
  • the pressure generated may be at least 1500 psi, at least 2000 psi, at least 2500 psi or up to about 3000 psi.
  • the applicator may be provided to contain at least 7.5 cc of tissue implant material, up to 10 cc of tissue implant material, or even up to about 15 cc of tissue implant material therein. A preferred embodiment currently holds about 9 cc of implant material.
  • FIG. 1 shows of an initial phase of insertion of a stylet into an implant site
  • FIG. 2 shows the stylet having penetrated the cortical bone and approaching cancellous bone
  • FIG. 3 shows the stylet having reached the desired site of implantation
  • FIG. 4 shows the positioning of a cannula by guiding it along the stylet
  • FIG. 5 shows the cannula in position at the desired site of implantation, with the stylet still in position
  • FIG. 6 shows a stage after the stylet has been removed and a high pressure applicator has been mounted to the cannula
  • FIG. 7 shows the high pressure applicator used in FIG. 6
  • FIG. 8 shows an alternative embodiment of a high pressure applicator according to the present invention
  • FIG. 9 shows another embodiment of a high pressure applicator according to the present invention.
  • FIG. 10 shows an embodiment of a pressure applicator according to the present invention in which a portion of the column 74 has been cut away to show the relationship between the column or shaft 76 and column 74 ;
  • FIG. 11 shows a variation of the pressure applicator in FIG. 10 in which a portion of the column 74 ′ has been cut away to show the relationship between the column or shaft 76 ′ and column 74 ′;
  • FIG. 12A shows the column 74 ′ in FIG. 11 with an opening formed by removal of a hinged or removable section
  • FIG. 12B shows the removable section 82 of column 74 ′
  • FIG. 12C shows the removable section taken along section line 12-12 in FIG. 12B;
  • FIG. 13 shows another embodiment of a pressure applicator according to the present invention.
  • FIG. 14 shows still another embodiment of a pressure applicator according to the present invention.
  • FIG. 15 shows a high pressure applicator after being loaded with a hard tissue implant material and assembled
  • FIG. 16 shows an alternative embodiment of the high pressure applicator in FIG. 6;
  • FIG. 17 shows the high pressure applicator used in FIG. 16
  • FIG. 18 shows an arrangement for high pressure, substantially non-compliant delivery of an implant material
  • FIG. 19 shows a cannula and two types of stylets useable with the present invention and indicates the manner in which they are assembled;
  • FIG. 20 shows a high pressure applicator having an enlarged introduction section, a substantially noncompliant tubing, a cannula and a stylet for use in performing a percutaneous implantation;
  • FIG. 21 shows the first column and a portion of the handle of the high pressure applicator in FIG. 20;
  • FIG. 22 shows alternate configurations of an end of the first column and an independent funnel useable with each
  • FIG. 23A shows a partially cut away view of a housing member, retainer member and plunger
  • FIG. 23B shows an end view of FIG. 23A
  • FIG. 23C is a sectional view of FIG. 23A showing the engagement of the plunger with the housing member.
  • the present invention substantially improves the delivery of hard tissue implant sites to the targeted zone of implantation, and is especially well suited for percutaneous deliveries.
  • the present invention substantially reduces several of the risk factors associated with the performance of percutaneous vertebroplasty. Additionally, the present invention enables an increase in an upper acceptable viscosity value of the implant to be delivered because of the increase in the amount of pressure available for controllably driving the delivery.
  • FIGS. 1-6 An example of a procedure for performing percutaneous vertebroplasty is illustrated in FIGS. 1-6. Beginning with FIG. 1, an example of the use of depth guided instruments will now be described. For a more detailed description of various depth-guided instruments that can be used for accessing the cortical bone, the reader is directed to copending application Ser. No. 08/950,382, filed on Oct. 14, 1997, entitled “Precision Depth Guided Instruments for Use in Vertebroplasty”; and copending application Ser. No. 08/949,839, filed on Oct. 14, 1997, entitled “Precision Depth Guided Instruments for Use in Vertebroplasty”. Both applications, numbered Ser. No. 08/950,832 and Ser. No.
  • 08/949,839 are hereby incorporated by reference in their entireties.
  • a currently preferred stylet 1 ′ and cannula 10 ′, and an optional direction guiding stylet 1 ′′ are shown in FIG. 19.
  • a detailed description of these devices and their uses are disclosed in a co-owned application filed concurrently herewith, entitled “Precision Instruments for Use in Vertebroplasty”, and bearing Attorney Docket No. 361722000420.
  • the aforementioned application bearing Attorney Docket No. 361722000420 is hereby incorporated by reference in its entirety.
  • a stylet 1 which has a length that is more than sufficient to span the distance from the epidermis of a patient to the cancellous bone tissue in the vertebra, in the preferred configuration.
  • the length of the stylet would be about three inches or greater, but lesser lengths may also be employed as well, depending on the size of the patient.
  • the length of the stylet can be readily modified without departing from the inventive features of the present invention.
  • the stylet 1 is preferably made of a surgical grade of stainless steel, but other known equivalent biocompatible metals and materials may be used for the same purpose. Ideally, the stylet, or at least a distal end thereof, will be radiopaque so that it can be monitored using fluoroscopy, CT or other imaging techniques during the procedure to help determine the depth and location of the penetration.
  • a first or distal end of the stylet 1 ends in a point 2 which is sharp and adapted to penetrate hard tissue when axially loaded. Extending from the tip 2 are self-tapping threads 4 .
  • the self-tapping threads 4 provide an advantage in that once the tip 2 has penetrated the cortical bone (e.g., see FIG. 2), the operator of the stylet can then proceed to advance the stylet by torquing the stylet, which engages the self-tapping threads 4 in the cortical bone 103 and begins to screw the stylet 1 into the cortical bone 103 .
  • Rotation of the stylet 1 is continued, to advance the stylet into the bone, while monitoring the advancement with some type of imaging technique, e.g., fluoroscopy or equivalent.
  • some type of imaging technique e.g., fluoroscopy or equivalent.
  • actual fluoroscopic views are generally from a perspective other than that shown in the Figures.
  • the Figures depict a transverse sectional view of the vertebra as the instruments enter the vertebral body.
  • Advancement is continued until the tip 2 reaches the site at which it is desired to deliver the implant material. Usually this site is in the cancellous bone as shown in FIG. 3, but could be anywhere within the bone where there is osteoporosis, or a fracture or other defect or trauma.
  • a cannula 10 is provided which includes an elongated tubular structure 111 to be positioned in the cancellous bone or other implantation site for delivery of PMMA or other bone implant material therein.
  • the tubular structure 11 of the cannula 10 is preferably made of a surgical grade of stainless steel, but may be made of known equivalent materials, similarly to the stylet 1 discussed above.
  • at least a distal end of the tubular structure is radiopaque.
  • the tubular structure 11 has an inside diameter which is only slightly larger than the outside diameter of the stylet 1 , so that the cannula may effortlessly pass axially over the stylet, while at the same time being supported and guided by the stylet.
  • a first or distal end 12 of the cannula is preferably (but not necessarily) beveled or tapered to ease the penetration of the cannula through the cutaneous and soft tissues, and especially through the hard tissues.
  • connector 18 Surrounding the second end of the tubular structure 11 (or 11 ′ in FIG. 19) is a connector 18 (FIGS. 6, 19) for linking the cannula 10 , 10 ′ with a pressure applicator according to the present invention, for supplying the PMMA or other implantable material that is to be injected via tubular structure 11 , 11 ′.
  • connector 18 is a Luer-lock type of connector, but other known connecting mechanisms may be successfully interchanged, e.g., a flat bottom threaded hole, a conventional threaded hole, a threads and locking nut arrangement, etc.
  • the cannula 10 is advanced over the stylet, until visualization of the process indicates that the end of the cannula 12 is substantially even with the tip of the stylet 2 , whereby it is confirmed that the cannula is properly positioned for delivery of the implant material.
  • the cannula 10 ′ and stylet 1 ′ are advanced together, which is currently the preferred method of insertion.
  • the stylet 1 is removed from the site, either by reverse rotation or by simply withdrawing it.
  • the cannula 10 is maintained in position to be readied for delivery of the implant material.
  • a pressure applicator 50 according to the present invention is next mounted to the connector 18 at the end of cannula 10 , as shown in FIG. 6.
  • the pressure applicator 50 is provided with a fitting 52 which is designed to form a pressure tight connection with the connector 18 .
  • the preferred type of connection is a Luer-lock type connection, but alternative, equivalent types of connectors may be employed.
  • the pressure applicator further includes a first column 54 for receiving and containing implant material.
  • the first column 54 is open at one end 54 a for receiving the material.
  • At the other end 54 b of the first column is a much smaller opening or orifice which ends with the connector or transfer fitting 52 or into which the connector or transfer fitting is mounted or placed (e.g., by threading, bonding, or the like).
  • a second column 56 is provided for overfitting first column 54 and providing a pressure seal therewith.
  • the second column 56 has interior threads 58 as shown in phantom in the exploded view of FIG. 7.
  • the interior threads 58 mate or engage with exterior threads 60 provided on the first column 54 .
  • other equivalent types of drivable engaging arrangements e.g., a ratchet and pawl arrangement, interior threading arrangement in the first column, or other equivalent arrangements could be used in place of the mating threads, so long as adequate force is able to be generated and maintained between the two columns for providing the driving pressure for the implant material.
  • Column 56 is open at end 56 a for receiving the first column 54 therein. At the opposite end 56 b , column 56 is closed to enable a generation of pressure within the two columns as they are moved toward one another and column 56 passes over column 54 .
  • at least one sealing element 57 e.g., a square, round or other type of O-ring, grommet, wrap of material or the like
  • the sealing element(s) 57 may also be provided integrally with the column 55 , e.g., by flaring out the column material to provide an interference fit, or the like. Since implant materials to be used in the invention (e.g. PMMA) are often very viscous, a high pressure capacity ensures that even thicker or more viscous mixes of implant material may be driven by the applicator 50 .
  • An advantageous implant material that may be used with the high pressure applicator of the present invention is a PMMA bone cement including contrast agents and/or tracer particles. Aspects of such a material are described in U.S. patent application Ser. No. 08/950,256, “Enhanced Visibility Materials For Implantation In Hard Tissue” (Attorney Docket 361722000200) by Preissman, filed Oct. 14, 1997. Contrast radiographic powder or particles of any typical material and of a size between 0.5 ⁇ to 1000 ⁇ may be included.
  • a separate “sealing” element need not necessarily be provided.
  • the O-ring or grommet optionally provided is preferred since it can move on the plunger rotationally and thus even if the plunger is turning with the handle, the seal can move independently.
  • a plunger element 55 is provided to be slidably driven by the first column 56 into the second column 54 .
  • At least one O-ring 57 or equivalent sealing mechanism is mounted near a first end 55 a of the plunger element 55 to provide a friction fit between the plunger element 55 and the interior wall of the first column 54 .
  • the plunger element 57 is “started” in the end 54 b of the column 54 , by inserting a small length of the plunger element 57 to an extent which is at least enough to seat the O-ring 57 with the inner wall of the column 54 .
  • the second column 56 is initially connected with the column 54 by mating the threads 58 and 60 .
  • a handle 62 is mounted on the column 56 to provide additional leverage for driving the column 56 with respect to column 54 .
  • the handle 62 is provided at the closed end 56 b to provide a greater mechanical advantage for torquing column 56 about its longitudinal axis.
  • the handle could be provided anywhere along the column 56 so long as it extends the effective radius for torquing about the longitudinal axis.
  • a handle 64 is fixedly attached, molded, or otherwise mounted to the first column 54 . The handle 64 may be grasped by the operator and provides leverage against rotation of the first column 54 during driving of the second column 56 .
  • the handle 64 is in the form of a lever as shown in FIG. 6, but alternative embodiments of the handle may include a circular handle, etc. so long as a sufficient mechanical advantage is provided to the user.
  • a lever might extend from the column in an embodiment using a ratchet and pawl type of driving mechanism.
  • the above described components of the pressure applicator 50 are all preferably formed of amorphous nylon or ABS plastic, with at least column 54 being formed of clear or translucent amorphous nylon.
  • any other materials which are durable, sterilizable, biofriendly and chemically compatible with the material to be implanted e.g., stainless steel
  • polycarbonate is not recommend for implanting PMMA, it may be fully acceptable for use in implanting other types of materials with which it has better chemical compatibility.
  • the plunger element 55 is shown as a separate component in the embodiment of FIG. 7, it is noted that this element may be integrally formed with the column 56 ′, as shown in the embodiment of FIG. 8, to form an extension 56 c ′ of the second column 56 ′.
  • the extension 56 c ′ is integrally formed or affixed to the closed end 56 b ′ of the column 56 ′ and extends the length thereof to emerge from the open end and extend therefrom to allow the sealing end and sealing element 57 to be inserted into the column 54 , prior to starting the interengagement of threads 58 and 60 .
  • threads 58 are not indicated in phantom, or at all, in FIG.
  • extension 56 c ′ does not have to take the form of the plunger 55 , but may have a much smaller cross section where it extends from the closed end.
  • the extension 56 c ′ may be formed as a much smaller rod with a first end having the same dimensions as that shown in FIG. 8, to provide a proper seal with the column 54 .
  • FIG. 9 shows another embodiment of a pressure applicator 50 ′′ according to the present application.
  • Pressure applicator 50 ′′ is provided with a plunger element 55 ′′ which includes sealing element 57 and frictional element 59 , both preferably O-rings, at opposite ends thereof.
  • the sealing and frictional arrangements are not limited to the placement of one O-ring or equivalent but may use two or another multiple of sealing elements.
  • Frictional element 59 is provided to form a friction fit inside the closed end 56 b ′′ of the column 56 ′′.
  • the plunger element 55 ′′ is inserted into the column 56 ′′ initially until the end 55 b ′′ bottoms out against the closed end 56 b ′′ and the frictional element 59 forms a friction fit with the inner wall of the column 56 ′′ adjacent the closed end 56 b ′′.
  • the friction fit is sufficient to maintain the plunger element 55 ′′ in position within the column 56 ′′ even when the column is held vertically, by the handle 62 , with the open end 56 a ′′ pointing downward.
  • the frictional forces between the sealing element 57 and the column 54 are greater than those between the sealing element 59 and the column 56 ′′ so that the sealing element 59 slips against the inner wall of the column 56 ′′ as the column 56 ′′ is torqued to advance both the column 56 ′′ and the plunger element 55 ′′ with respect to the column 54 .
  • the rotational movement of the closed end 56 b ′′ of the column 56 ′′ is converted to a solely translational force against driving the plunger element 55 ′′.
  • This feature is particularly important when the implant material comprises PMMA, as PMMA is somewhat abrasive.
  • the plunger element 55 ′′ and sealing element 57 are allowed to rotate or are driven to rotate with respect to the column 54 , this may allow some of the PMMA to work its way between a portion or all of the sealing element 57 and inner wall of the column 54 where it can act as an abrasive to prematurely degrade the sealing element 57 and/or the wall of the column 54 .
  • the end 55 b ′′ and sealing element 59 as shown have dimensions slightly larger than those of the end 55 a ′′ and sealing element 57 to account for the slightly larger inside diameter of the column 56 ′′ relative to the inside diameter of the column 54 . However, it is not necessary to use these dimensions, since a recess (not shown) having a smaller diameter can be formed (by boring, molding or otherwise) into the closed end 56 b ′′ so that a smaller end 55 b ′′ and sealing element 59 can be employed to form a friction fit therewith.
  • FIGS. 23A-23C Another variant of a frictional element useable to prevent rotation of the plunger or rod upon actuation of the applicator is pictured in FIGS. 23A-23C.
  • the enlarged base 55 b ′′′ of the piston/plunger rod 55 ′′′ includes and end 55 d having a spherical surface which is free to rotate with respect to the inner end surface 56 d of the second column 56 .
  • the enlarged base 55 b ′′′ is held in position by the placement of one or more (preferably two) internal retaining rings 59 which engage within a recess in second column 56 and abut the enlarged base 55 b ′′′ to substantially prevent translational movement thereof with respect to the second column 56 .
  • the rod 55 ′′′ will not fall out of the second column 56 when inverted or otherwise jostled, but the rod 55 ′′′ is still allowed to turn relative to the column 56 .
  • FIG. 10 is a partial sectional view of an embodiment of a pressure applicator 70 , according to the present invention, in which a portion of the column 74 has been cut away to show the relationship between the column or shaft 76 and column 74 .
  • column 74 is interiorly threaded with threads 71 which mate with threads 78 on the exterior of column 76 .
  • a sealing element 77 e.g., an O-ring, Teflon wrap (formed by wrapping with Teflon tape, for example) or other equivalent
  • a handle is also preferably mounted to the column 74 (e.g., similar to the handle 64 described above or to handles described below) to assist the user in developing the torque needed to generate high pressures.
  • a handle 72 is mounted to column 76 to further assist in generating torque.
  • FIG. 11 is a partial sectional view of a variation of an embodiment of a pressure applicator 70 ′, according to the present invention, in which a portion of the column 74 ′ has been cut away to show the relationship between the column or shaft 76 ′ and column 74 ′.
  • the threads 71 ′ are radially inset from the remainder of the inner wall 73 ′ of column 74 ′ which is left smooth.
  • Threads 78 ′ are exteriorly provided on column or shaft 76 ′ which mate with threads 71 ′.
  • the distal end of shaft 76 ′ is provided with an enlarged portion 79 which closely approximates or mates with the smooth inner wall 73 ′.
  • a sealing element 77 ′ (e.g., an O-ring, Teflon tape or other equivalent) may be mounted at or near the end of the enlarged portion 79 to enhance the pressure seal between the columns 76 ′ and 74 ′.
  • a handle 75 is also preferably mounted to the column 74 ′ to assist the user in developing the torque needed to generate high pressures. Although handle 75 is shown mounted to the proximal end of the column 74 ′, it is noted that the handle may also be mounted to the distal end, similar to that described with respect to handle 64 above, or at virtually any location along the length of the column that may be desirable, and still achieve the advantages of enhancing torque generation.
  • the handle 75 may be molded or otherwise formed integrally with the column 74 ′ or, alternatively, may be fixedly mounted to the column 74 ′ (e.g., by bonding, welding, splined or other mechanical arrangement) to provide torque to the column 74 ′ without slipping with respect thereto.
  • a handle 72 is mounted to column 76 ′ to further assist in generating torque.
  • Section 82 includes a hinge pin 84 which is insertable into a recess 86 in the wall of the remainder of the column 74 ′ for pivoting therewith, or allowing removal of the section altogether.
  • Other types of hinges or movable attachments may be readily substituted for the hinge pin 84 and recess 86 as would be apparent to those of ordinary skill in the art.
  • One or preferably both edges of the section 82 may be provided with flanges 88 or similar extensions to provide a snap or friction fit with the remainder of the column 74 ′ when the section 82 is installed. Further optionally, the inner wall of the remainder of the column may be provided with a recess or groove 87 to receive the flange or extension 88 to provide a more secure interlock. Additionally or alternatively, the column 74 ′ may be provided with a clamp or tying band (not shown) to surround the section 82 and column 74 ′ and compress the two pieces slightly to maintain them in a secure relationship.
  • Insertion of the column 76 ′ is performed by first removing or swinging open the section 82 away from the remainder of the column 74 ′.
  • the proximal portion 76 a ′ of the column 76 ′ has a smaller outside diameter than the threaded portion 78 ′ and is also sufficiently smaller than the inside diameter of the threads 71 ′, so that the enlarged portion 79 can be placed in the space 89 while the proximal portion 76 a ′ clears the threads 71 ′.
  • the section 82 is then replaced by snapping and/or clamping the same into position against the remainder of the column 74 ′, thereby surrounding the proximal portion 76 a ′ and enlarged portion 79 .
  • Threads 78 ′ can then be started with threads 71 ′ to ready the applicator 70 ′ for application of a pressurized driving force.
  • FIG. 13 is a plan view of another embodiment of a pressure applicator 90 according to the present invention.
  • Column 94 is configured and dimensioned to receive a disposable syringe 150 (shown in phantom lines) therein.
  • this embodiment can be used with a 10 cc syringe, thereby enabling much greater pressures to be generated than discussed above.
  • the column 94 can be formed as a two stage column, as shown, having a first inside diameter 94 c which is smaller than a second inside diameter 94 d . This design allows the barrel 152 of the syringe 150 to be received in the portion 94 c and abut against a tapered portion of the column 94 e .
  • a transition collar 94 f which interconnects the varying diameter portions 94 c and 94 d of the column 94 , provides a surface against which the flange or “wings” of the syringe barrel 152 abut.
  • An alternative arrangement could have a column having a single stage or inner diameter which could rely on the tapered region 94 e solely for abutment of the syringe barrel 152 .
  • the syringe plunger 154 is received in the larger diameter portion 94 d of the column 94 (which, in the alternative arrangement described would be the single stage or diameter).
  • a second column or shaft 96 is externally threaded and external threads 98 are designed to mate with internal threads (not shown) on the interior wall of the column portion 94 d .
  • the distal end 96 a of column 96 abuts against the end 158 of the syringe plunger 154 upon threading the column 96 into column 94 . Further torquing of the handle 92 with respect to the column 94 generates a driving force for translationally advancing the syringe plunger 154 to generate a high pressure driving force.
  • a sealing element (not shown) is preferably mounted at or near the distal end of the syringe plunger 154 , as is known in the art, to enhance the pressure generation.
  • a handle is also preferably mounted to the column 94 (e.g., similar to the handle 64 or 75 described above) to assist the user in developing the torque needed to generate high pressures.
  • FIG. 14 is a plan view of another embodiment of a pressure applicator 90 ′ according to the present invention.
  • Column 94 ′ is configured and dimensioned to receive a disposable syringe 150 (shown in phantom lines) therein.
  • the column 94 ′ can be formed as a two stage column, similar to that described above with regard to FIG. 13, but is formed as a single stage or single diameter column in FIG. 14. This design allows the barrel 152 of the syringe 150 to be received in the column 94 ′ and abut against a tapered portion of the column 94 e ′.
  • the syringe plunger 154 extends from the proximal opening 94 a ′ of the column 94 and is received in the column 96 ′.
  • Column 96 ′ is internally threaded (threads not shown) and the internal threads are designed to mate with external threads 93 on column 94 ′.
  • the closed proximal end 96 b ′ of column 96 ′ abuts against the end 158 of the syringe plunger 154 upon receiving the plunger 154 in column 96 ′ and beginning mating of the internal threads of the column 96 ′ with threads 93 .
  • a sealing element (not shown) is preferably mounted at or near the distal end of the syringe plunger 154 , as is known in the art, to enhance the pressure generation.
  • a handle is also preferably mounted to the column 94 ′ (e.g., similar to the handle 64 or 75 described above) to assist the user in developing the torque needed to generate high pressures.
  • a tissue implant material in this example, a hard tissue implant material 66 is loaded into the first column 54 and the second column 56 is connected with the first column 54 in preparation for implantation, see FIG. 15.
  • the pressure applicator 50 is shown in FIGS. 6, 15 and 18 , it is noted that the principles described with respect thereto are generally applicable to each of the embodiments described herein. Of course, minor variations in procedure may be necessary, e.g., loading the syringe 150 with implant material, rather than the pressure applicator column, when using the embodiments of FIGS. 13 and 14, etc., but the general principles described herein may be applied to any embodiment by those of ordinary skill in the art.
  • a tissue implant material 66 is loaded into the first column 54 and the second column 56 is connected with the first column 54 in preparation for implantation.
  • the introduction of air bubbles can be further substantially reduced or avoided by slightly overfilling the first column to form a meniscus created by surface tension of the implant material and then introducing the plunger element into the material and driving the plunger into the first column.
  • This optional technique may be used in all of the disclosed embodiments, but may be obviated by the features shown in the embodiments of FIGS. 20-22, as discussed below.
  • the first column is then rotated slightly with respect to the second column until a minimal amount of tissue implant material is expressed from the fitting 52 end, to ensure that no air has been entrapped in the applicator.
  • the cannula 10 is backfilled with saline, tissue implant material 66 , or other biocompatible fluid in order to displace the air therefrom.
  • the pressure applicator 50 is then mounted onto the cannula 10 as described above and shown in FIG. 6.
  • the operator next grasps the handle 62 in one hand and the handle 64 in the other and begins to torque the handle 62 while maintaining the handle 64 in its position.
  • the pressure applicator is capable of generating pressures of about 1000 to 3000 psi within the columns, which is a high driving force that is applied to the implantable material 66 .
  • Torquing of the handle 62 with respect to the handle 64 is continued until a sufficient amount of implant material 66 has been delivered to the implant site as verified by an appropriate imaging technique.
  • endpointing techniques are described in the application entitled “Precision Instruments for Use in Vertebroplasty”, and bearing Attorney Docket No. 36172-2000420, which was incorporated by reference above.
  • the pressure applicator 50 allows a first column 54 which is large enough in volume at least 5 cc, preferably at least 7.5 cc, and more preferably at least 10 cc and up to about 15 cc to contain sufficient implant material for an entire implantation process so that there is no need to refill the column 54 in the midst of a procedure.
  • the designs disclosed herein could be enlarged so as to have a capacity up to 25 cc and even upwards of 30 cc. It would further be apparent to those of ordinary skill in the art to modify the designs herein to have capacities even larger than that disclosed should an implantation procedure require larger volumes of material.
  • cannula 10 ′ includes a modified tubular structure design.
  • the first or distal portion 11 a of the tubular structure is of the same dimensions as the embodiment of FIGS. 1-6.
  • the second or proximal portion 11 b of the cannula 10 ′ has a substantially larger diameter than that of the first portion 11 a .
  • the diameter of second portion 11 b is about twice the diameter of the first portion 11 a , although any increase in the diameter of the second portion 11 b over that of the first portion 1 a will decrease the pressure requirement for effective delivery of the material to be implanted.
  • the first and second portions 11 a , 11 b have approximately equal lengths, but this is governed by the anatomy of the site to be accessed. In the “average” percutaneous vertebroplasty situation, the first portion 11 a is required to be about 1.5′′ long, as this is the length that is needed for traversing the cortical bone of the pedicle. Thus, the first portion should not be significantly enlarged due to the size constraints of the pedicle, the safety risks to the spinal column and aorta which are increased when the cannula size is increased intravertebrally, and by the desire to remove as little bone as possible when entering with the stylet and cannula, among other factors.
  • the portion of the cannula which will occupy the soft tissues can be significantly expanded without substantially adversely effecting the patient. Given the benefits of reducing the required injection pressure and ensuring a better delivery of the bone implant material, such a modification becomes a viable option.
  • the pressure applicator 50 ′′′ is essentially the same as that in the embodiment 50 , with modifications as follows.
  • the pressure applicator 50 ′′′ is provided with a fitting 52 ′′′ (FIG. 17) which is designed to form a pressure tight connection with the connector 18 ′ and is therefore of a significantly larger diameter than the connector 52 .
  • the first column 54 ′′′ is essentially open at both ends 54 a ′′′ and 54 b ′′′ as it does not taper or tapers much less than the previous embodiment at opening 54 b ′′′.
  • the preferred type of connection is a Luer-lock type connection, but alternative, equivalent types of connectors may be employed.
  • the components of the pressure applicator 50 ′′′ are all preferably formed of amorphous nylon.
  • the housing or second column or any portions which do not contact the implant material may be formed of ABS plastic. Additionally, any other materials which are durable, sterilizable, biofriendly and nonreactive with the particular implant materials to be contained therein, e.g., stainless steel, polypropylene, could be readily substituted.
  • a hard tissue implant material 66 is loaded into the first column 54 and the second column 56 is connected with the first column 54 in preparation for implantation.
  • the pressure applicator 50 ′ is then mounted onto the cannula 10 ′ as shown in FIG. 16.
  • the operator next grasps the handle 62 in one hand and the handle 64 in the other and begins to torque the handle 62 .
  • the pressure applicator is capable of generating controllable and sustainable pressures of up to about 3000 psi within the columns, which is a high driving force that is applied to the implantable material 66 .
  • a high pressure tubing 70 may be and preferably is interconnected between the pressure applicator 50 and the cannula 10 , as shown in FIG. 18.
  • the tubing be a substantially non-compliant tubing, to obviate problems of “oozing” and overfilling that occur when there is too much compliance in a high pressure implantation system.
  • high pressure, substantially non-compliant tubings include PEEK tubing, and other polymers such as Nylon, PTFE, and FEP which may be radially reinforced with a no-stretch coil such as a flat wire spring of stainless steel, aramid fibers such as Kevlar, etc.
  • a no-stretch coil such as a flat wire spring of stainless steel, aramid fibers such as Kevlar, etc.
  • the tubing 70 has male 72 and female 74 connectors for forming pressure tight seals with fitting 52 and connector 18 , respectively.
  • the tubing 70 enables both the applicator 50 , and thus the user's hands to be distanced from the radiographic field or other viewing field, which is advantageous both for safety purposes as well as improving the procedure.
  • This embodiment is particularly advantageous for the most frequent set-ups where bi-planar viewing is performed and two imaging devices are oriented at 90° to one another about the implantation site.
  • One of the advantages which is gained that improves the procedure is that the viewing instrumentation can be moved closer to the actual implantation site, thereby providing a more magnified view.
  • the tubing 70 is mounted to the pressure applicator prior to mounting on the cannula fitting 18 . After filling the pressure applicator with implant material as described above, the tubing 70 is mounted to fitting 52 . A small amount of pressure is next applied to the implant material to express the implant material until a minimal amount exits the open end of the tubing (i.e., the end where connector 74 is located). The tubing 70 is then connected to the connector 18 of the cannula 10 for implantation of the implant material into the desired location.
  • the foregoing is the desired order of connection so that the air space in the tubing can be prefilled with implant material, it is not the only possible progression for the procedure.
  • the tubing 70 can be connected to the fitting 18 of the cannula 10 and the tubing 70 and cannula 10 are then backfilled with saline, implant material, or other biocompatible fluid to displace any air residing in the structures.
  • the tubing can be connected to the fitting 52 and implantation of the implant material can be rapidly commenced thereafter.
  • FIG. 20 shows a high pressure applicator having an enlarged introduction section, a substantially noncompliant tubing, a cannula and a stylet for use in performing a percutaneous implantation.
  • High pressure applicator having the feature of an enlarged introduction section are further disclosed and claimed in a co-owned application filed concurrently herewith, entitled “High Pressure Delivery System” and bearing attorney docket number 361722000700.
  • the application filed concurrently herewith entitled “High Pressure Delivery System” and bearing attorney docket number 361722000700 is hereby incorporated by reference thereto in its entirety.
  • FIG. 21 is an enlarged detail showing of the first column 30 and a portion of the handle 40 of the high pressure applicator shown in FIG. 20.
  • the open end portion of the first column 30 is formed as an introduction section 24 which has a slightly larger cross-sectional area than that of the portion of the first column 30 adjacent to it. Providing a larger size or diameter introduction section 24 enables the introduction of the plunger 44 into the implant material without simultaneously forming a seal where compliant bubbles may be trapped.
  • the differential in sizes is provided so that when the smaller diameter portion of the first column 30 is fully filled and the introduction section 24 is at least partially filled, the end of the plunger 44 which might otherwise trap air bubbles resulting in system compliance will be dipped in the implant material thereby allowing for the exclusion of air bubbles prior to driving it into the smaller diameter portion.
  • the introduction section 24 may be relatively close in size to the adjoining smaller diameter portion to provide only a surrounding dam for a meniscus poured over the smaller diameter portion. Since the amount of material that needs to be provided in the introduction section need not be great to facilitate the venting or purging as described above, it is better to only introduce slightly more implant material than will fill the smaller diameter portion. Introduction of a larger amount of implant material is not only wasteful, but may result in material drainage out of the introduction section into other parts of the applicator—especially when the applicator is inverted or turned as will often be the case in preparing PMMA implant material for delivery.
  • a larger size of the introduction section 24 than strictly required for the venting feature discussed above may be used to act as a catch basin for excess material. This will provide a larger margin of error in pouring implant material into the applicator before overflowing the introduction section 24 will occur. Further, the walls of such an enlarged catch basin may help to prevent contamination of the applicator by virtue of adherence of the implant material to the surface area provided during inversion or agitation of the applicator.
  • the introduction section is provided with threads 32 which engage with threads (not shown) on the interior of the second column 36 , similar to the arrangements provided in the embodiments shown in FIGS. 6-9.
  • Handle 38 is provided for torquing the second column 36 with respect to the first column 30 .
  • the concept of the introduction section could be applied to any of those embodiments, and could also be adapted to the embodiments having threading internally of an introduction section with external threading on a second column.
  • the concept is also generally applicable to the embodiments shown in FIGS. 13 and 14, where an introduction section could be provided in the barrel 152 of the syringe.
  • FIG. 22 shows alternate configurations of an end of the first column 30 ′ and 30 ′′, and an independent funnel 54 useable with each.
  • the funnel or increased-size target region 54 may also be integrated into the introduction section 24 to aid in pouring implant material into the applicator.
  • Drive threads may be placed on the exterior funnel 54 .
  • a presently preferred thread size is 11 ⁇ 2-12 ACME 2.G 10° external.
  • a smaller introduction section 24 ′, 24 ′′ may be used to provide a greater mechanical advantage.
  • the drive threads placed exterior thereto may be of a finer pitch or higher thread count than those previously described to provide for greater mechanical advantage for generating higher driving pressures more easily.
  • a separate funnel element 54 may be provided to interface with the introduction section 24 .
  • the first column is advantageously about 0.50 inches in diameter and of a length of about 4 inches in order to provide sufficient volume for implant material for efficiency in performing vertebroplasty and yet have a small enough bore so that the mechanical advantage in applying pressure to the implant material is not overly affected as would be the case with a much larger bore.
  • the preferred size range for the first column is between about 0.375 to about 0.75 inches with a length of between about 1.5 and 4.5 inches.
  • the preferred capacitance of the first column is at least 5 cc, up to about 15 cc, as described above.

Abstract

A pressure applicator for applying pressure to a flowable implant material, e.g., PMMA. A pressure applicator or driver includes a pair of columns which are engageable with one another, preferably by threads to generate a driving pressure. A handle is provided for the operator to grasp and steady the device as he turns the handle to apply pressure to the implantable material within the applicator. A luer-lock or other connecting device is provided for attaching the applicator to a cannula (or a connecting conduit that in turns connects with a cannula) that will deliver the implant material to the desired site. Pressures of about 1000-3000 psi may be generated by this device.

Description

    CROSS-REFERENCE TO RELATED APPLICATIONS
  • This application is a continuation-in-part of application Ser. No. 09/053,108, filed April 1, 1998, entitled “Pressure Applicator for Hard Tissue Implant Placement”, pending. Application Ser. No. 09/053,108 is hereby incorporated by reference in its entirety.[0001]
  • TECHNICAL FIELD
  • The present invention relates to instruments for more accurately controlling the placement of implant material thereof, during surgical procedures for the repair of hard tissue by injection of hard tissue implant materials. Procedures for such repair include hip augmentation, mandible augmentation, and particularly vertebroplasty, among others. [0002]
  • BACKGROUND ART
  • Polymethylmethacrylate (PMMA) has been used in anterior and posterior stabilization of the spine for metastatic disease, as described by Sundaresan et al., “Treatment of neoplastic epidural cord compression by vertebral body resection and stabilization.” [0003] J Neurosurg 1985;63:676-684; Harrington, “Anterior decompression and stabilization of the spine as a treatment for vertebral collapse and spinal cord compression from metastatic malignancy.” Clinical Orthodpaedics and Related Research 1988;233:177-197; and Cybulski, “Methods of surgical stabilization for metastatic disease of the spine.” Neurosurgery 1989;25:240-252.
  • Deramond et al., “Percutaneous vertebroplasty with methyl-methacrylate: technique, method, results [abstract].” [0004] Radiology 1990;117 (suppl):352, among others, have described the percutaneous injection of PMMA into vertebral compression fractures by the transpedicular or paravertebral approach under CT and/or fluoroscopic guidance. Percutaneous vertebroplasty is desirable from the standpoint that it is minimally invasive, compared to the alternative of surgically exposing the hard tissue site to be supplemented with PMMA or other filler.
  • The general procedure for performing percutaneous vertebroplasty involves the use of a standard 11 gauge Jamshidi needle. The needle includes an 11 gauge cannula with an internal stylet. The cannula and stylet are used in conjunction to pierce the cutaneous layers of a patient above the hard tissue to be supplemented, then to penetrate the hard cortical bone of the vertebra, and finally to traverse into the softer cancellous bone underlying the cortical bone. [0005]
  • A large force must be applied by the user, axially through the Jamshidi needle to drive the stylet through the cortical bone. Once penetration of the cortical bone is achieved, additional downward axial force, but at a reduced magnitude compared to that required to penetrate the cortical bone, is required to position the stylet/tip of the cannula into the required position within the cancellous bone. When positioned in the cancellous bone, the stylet is then removed leaving the cannula in the appropriate position for delivery of a hard tissue implant material to reinforce and solidify the damaged hard tissue. [0006]
  • A syringe is next loaded with polymethyl methacrylate (PMMA) and connected to the end of the cannula that is external of the patient's body. Pressure is applied to the plunger of the syringe to deliver the PMMA to the site of damaged bone at the distal end of the cannula. Because in general, 10 cc syringes are only capable of generating pressures of about 100-150 psi, this places a limitation on the viscosity of the PMMA that can be effectively “pushed through” the syringe and cannula and fully delivered to the implant site. Of course, the use of a small barrel syringe, e.g., a 1 cc syringe, enables the user to generate higher driving pressures. For example, pressures of 1000 psi and possibly as high as 1200-1500 psi (depending upon the strength of the user and the technique) may be generated using a 1 cc syringe. A serious limitation with the use of a 1 cc syringe, however, is that it will not hold a large enough volume to complete the procedure in one step or “load” and must be reloaded several times to complete the procedure, since, on average, about 3.5 cc of implant material per side of the vertebral body are required for an implantation procedure. This makes the procedure more complicated with more steps, and more risky in that the polymerization of the implant material causes it to become increasingly more viscous during the additional time required for reloading. Another problem with a 1 cc syringe is lack of control, as high pressures are generated in a “spike-like” response time and are not continuously controllable. [0007]
  • A viscous or paste-like consistency of PMMA is generally believed to be most advantageous for performing percutaneous vertebroplasty. Such a consistency insures that the implant material stays in place much better than a less viscous, more liquid material. Leakage or seepage of PMMA from the vertebral implant site can cause a host of complications some of which can be very serious and even result in death. For example, Weil et al. reported cases of sciatica and difficulty in swallowing which were related to focal cement leakage, [0008] Radiology 1996;Vol 199, No. 1, 241-247. A leak toward the distal veins poses an even more serious risk, since this can cause a pulmonary embolism which is often fatal.
  • In addition to the viscosity effects noted above that require greater pressure to deliver hard implant tissue material, when such material (like PMMA) is implanted percutaneously, the need to inject it through a relatively narrow needle or cannula also greatly increases the need for a high pressure driver. Still further, implantation of PMMA into a relatively closed implantation site (e.g., trabecular bone) further increases the resistance to flow of the PMMA, at the same time increasing the pressure requirements of the driver. Thus, there is a need for a high pressure applicator that has enough storage capacity to perform a complete implantation procedure without having to reload the device in the midst of the procedure, and which is consistently controllable, for an even, constant application of pressure during delivery of the entirety of the implant material. [0009]
  • Attempts have been made to increase the ability to apply pressure to drive PMMA to the vertebral implant site by providing a smaller barrel syringe, but this holds less volume and must be refilled once or several times to deliver enough volume of PMMA to the site. Since there is a limited amount of time to work with PMMA before it begins to polymerize or set up, this type of procedure is more difficult to successfully complete within the allotted time, and thus poses an additional risk to the success of the operation. [0010]
  • Accordingly, there exists a need for an improved apparatus and procedure for controllably applying higher pressures to a source of implant material, and particularly to hard tissue implant materials, to successfully implant the material at the desired location in a single batch, for the performance of vertebroplasty and particularly, percutaneous vertebroplasty. [0011]
  • DISCLOSURE OF THE INVENTION
  • The present invention includes a high pressure applicator for driving the delivery of a flowable tissue implant material. A first column having an inner wall, an outer wall, a first open end and a second substantially closed end is provided with an orifice through the substantially closed end for passage implant materials therethrough under high pressure. A second column is drivably engageable with the first column to generate fluid pressure within at least the first column. Preferably, a wall portion of the second column is drivably engageable with one of an inner and outer wall of the first column. A handle is preferably fixedly attached or integral with the first column and may extend radially from the first column to provide a user a mechanical advantage upon grasping it. [0012]
  • At least one sealing element may be provided to interface with the inner wall of the first column, to enhance the generation of pressure in the first column. A handle is also preferably integrally formed with or affixed to the second column and may extend radially therefrom to provide a user a mechanical advantage upon grasping it. [0013]
  • In one embodiment of the invention, threading is provided on an outer wall of the first column. The second column is substantially hollow, having an open first end, a closed second end and threading on an inner wall thereof. The threading on the second column in this embodiment is engageable with the threading on the first column to provide a driving force for driving the second column with respect to the first column. The second column may include an extension integrally formed with or affixed thereto and optionally having an end portion extending from the open end of the second column. The extension is adapted to be inserted through the open end of the first column and form a substantial pressure seal with the inner wall of the first column. [0014]
  • Additionally, at least one sealing element may be provided at or near the end portion of the extension to form or enhance a pressure seal with the inner wall of the first column. The sealing element(s) may be an O-ring(s), a grommet(s) or the like. [0015]
  • In another embodiment, a plunger element is provided which is adapted to be inserted within the first and second columns. The plunger element has a first end portion and a second end portion, where the first end portion is adapted and configured to closely fit within the inner wall of the first column to form a pressure seal therewith. At least one sealing element may be provided for the first end portion to form and/or enhance a pressure seal between the inner wall and the plunger element. A handle may be integrally formed with or affixed to the second column, to optionally extend radially therefrom, to provide the user a mechanical advantage upon grasping it. The plunger element may further be provided with at least one frictional element mounted to the second end portion and adapted to form a disengageable friction fit with the second column at or near the closed end of the second column. [0016]
  • A high pressure applicator according to the present invention may include threading on at least a portion of the inner wall of the first column, and the second column may have threading on at least a portion of an external wall thereof such that the threading of the external wall is engageable with the threading on at least a portion of the inner wall of the first column to provide a driving mechanism for driving the second column with respect to the first column. The interengaging threads may be formed to closely fit to form a pressure seal therebetween upon their engagement. At least one sealing element may be mounted to an end portion of the second column and adapted to form or enhance a pressure seal with the inner wall thereby forming or enhancing the pressure seal between the first and second columns. The sealing element(s) may comprise an O-ring(s), a Teflon wrap(s), or the like. A handle may be integrally formed with or affixed to the second column to extend radially therefrom, to provide a user a mechanical advantage upon grasping it. [0017]
  • Various portions of a pressure applicator may be sized to provide sufficient mechanical advantage to enable the application of pressures up to about 3000 or 4000 psi by hand. The mechanical advantage of an applicator is determined in large part by handle size, the bore size of the first column, and the mechanical advantage of the engagement mechanism. With regard to the engaging threads used as an engagement mechanism, manufacturing and material considerations, and the diameter on which to place the threads will determine the thread pitch which may be used. This in turn determines the mechanical advantage of this engagement mechanism. Where a greater mechanical advantage is desired, a finer thread pitch will provide the same. To achieve this, the diameter of threaded sections of the first and second columns may be decreased. Alternately, a finer pitch thread may be used on a relatively larger diameter section by changing material or manufacturing procedure (such as cutting the threads into the respective members rather than molding the pieces as is presently preferred). In all, a pressure applicator produced according to the present invention is a balancing of various design goals relating to performance and cost. [0018]
  • In an arrangement where the threads cover only a portion of the external wall, the remainder of this wall of the second column is left relatively smooth. In this arrangement, only a portion of the inner wall of the first column has threads, and the remainder of the inner wall is left substantially smooth. The relatively smooth end portion of the second column has a reduced diameter section having an outside diameter less than an inside diameter of the threads on said inner wall, to allow assembly or interfitting of the two columns. An enlarged section extending from the reduced diameter portion closely fits with the substantially smooth inner wall to form a pressure seal therewith. The first column in this arrangement additionally includes a hinged or removable section adapted to swing open or be removed therefrom to allow insertion of the second column. At least one sealing element, which may be an O-ring or the like, may be mounted to the end portion of the second column to form or enhance a pressure seal therewith. [0019]
  • In yet another embodiment, the first column is substantially hollow and comprises an inside wall, an open first end and a closed second end, and a barrel portion of a syringe is received therein. A plunger portion of the syringe is received within a second column. The applicator may include threading on an outer wall of the first column and threading on an inner wall of the second column, where the threads are engageable with one another to provide a driving force for driving the plunger portion with respect to the barrel portion. A handle may be integrally formed with or affixed to the second column and optionally extend radially therefrom and to provide the user a mechanical advantage upon grasping it. [0020]
  • An end of the barrel portion of the syringe may abut against the substantially closed end of the first column and an end of the plunger portion may abut against the closed end of said second column, such that driving of the second column with respect to the first column provides a driving force for advancing the plunger portion within the barrel portion. The barrel portion may further include a wing or flanged portion adjacent an open end thereof. The first column may have a first portion adjacent the open end, a second portion adjacent the substantially closed end and a transitional portion joining the first and second portions, where the first portion has an inside diameter larger than an inside diameter of the second portion. In this case, the transitional portion may be adapted to abut against the wing or flanged portion, to provide additional or alternative support for the barrel portion as the plunger portion is being advanced with respect thereto. [0021]
  • Alternatively, a high pressure applicator according to the present invention may include a syringe having a barrel portion and a plunger portion, where the syringe barrel is received within the first column where threading is provided on at least a portion of the inner wall of the first column and on at least a portion of an external wall of the second column. In this embodiment of the invention, the second column includes an end adapted to abut an end of the plunger portion of the syringe and threading of the external wall is engageable with the threading on at least a portion of the inner wall to provide a driving force. The operation and variations of this embodiment are substantially like those described directly above. [0022]
  • A method of preparing a high pressure applicator for driving the delivery of a flowable tissue implant material for use is disclosed to include: providing an applicator having a first column having an inner wall, an outer wall, a first open end and a second substantially closed end having an orifice therethrough, and a second column drivably engageable with the first column to generate a pressure within the first column; loading the flowable tissue implant material into the first column; engaging the second column with the first column to enclose the tissue implant material; and advancing the second column toward the first column to generate a pressure for driving the flowable tissue material through the orifice. [0023]
  • The second column may include a plunger adapted to form a pressure seal with the inner wall of the first column, in which case the engagement of the second column with the first column includes introducing the plunger into the tissue implant material in such a way to avoid the introduction of air bubbles or other compliant matter together with the implant material to be delivered to a patient. Advancement of the second column toward the first column generates a pressure for driving the flowable tissue material through the orifice, which may be at least 1000 psi. Optionally, a substantially non-compliant tube may be connected to the orifice prior to advancing the second column toward the first column to generate a pressure for driving the flowable tissue material through the orifice. [0024]
  • As another option, a substantially non-compliant tube may be connected to the orifice after advancing the second column toward the first column to generate a pressure for driving the flowable tissue material through the orifice, thereby purging the orifice prior to connecting the substantially noncompliant tube. In either case, the substantially noncompliant tube may be, but is not necessarily prefilled (e.g., with saline or implant material) prior to connecting it to the orifice. [0025]
  • Loading of the first column with implant material may be done in such a way as to slightly overfill the first column to form a meniscus created by surface tension of the implant material. In this case, the engagement of the first and second columns then may include introducing a plunger element into the implant material and then driving the plunger via the advancement of the second column. [0026]
  • A method of preparing a high pressure applicator for driving the delivery of a flowable tissue implant material for use is provided which includes: providing an applicator containing at least 5 cc of tissue implant material therein; and actuating the applicator to generate an internal pressure of at least 1000 psi which acts as a driving force to force a flow of the implant material from the applicator. The pressure generated may be at least 1500 psi, at least 2000 psi, at least 2500 psi or up to about 3000 psi. [0027]
  • Further, the method is described as torquing a first portion of the applicator with respect to a second portion of the applicator actuator to generate the driving force. The applicator may be provided to contain at least 7.5 cc of tissue implant material, up to 10 cc of tissue implant material, or even up to about 15 cc of tissue implant material therein. A preferred embodiment currently holds about 9 cc of implant material.[0028]
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • Each of the following figures diagrammatically illustrates aspects of the present invention. No aspect shown is intended to be limited to the expression pictured. [0029]
  • FIG. 1 shows of an initial phase of insertion of a stylet into an implant site; [0030]
  • FIG. 2 shows the stylet having penetrated the cortical bone and approaching cancellous bone; [0031]
  • FIG. 3 shows the stylet having reached the desired site of implantation; [0032]
  • FIG. 4 shows the positioning of a cannula by guiding it along the stylet; [0033]
  • FIG. 5 shows the cannula in position at the desired site of implantation, with the stylet still in position; [0034]
  • FIG. 6 shows a stage after the stylet has been removed and a high pressure applicator has been mounted to the cannula; [0035]
  • FIG. 7 shows the high pressure applicator used in FIG. 6; [0036]
  • FIG. 8 shows an alternative embodiment of a high pressure applicator according to the present invention; [0037]
  • FIG. 9 shows another embodiment of a high pressure applicator according to the present invention; [0038]
  • FIG. 10 shows an embodiment of a pressure applicator according to the present invention in which a portion of the [0039] column 74 has been cut away to show the relationship between the column or shaft 76 and column 74;
  • FIG. 11 shows a variation of the pressure applicator in FIG. 10 in which a portion of the [0040] column 74′ has been cut away to show the relationship between the column or shaft 76′ and column 74′;
  • FIG. 12A shows the [0041] column 74′ in FIG. 11 with an opening formed by removal of a hinged or removable section;
  • FIG. 12B shows the [0042] removable section 82 of column 74
  • FIG. 12C shows the removable section taken along section line 12-12 in FIG. 12B; [0043]
  • FIG. 13 shows another embodiment of a pressure applicator according to the present invention; [0044]
  • FIG. 14 shows still another embodiment of a pressure applicator according to the present invention; [0045]
  • FIG. 15 shows a high pressure applicator after being loaded with a hard tissue implant material and assembled; [0046]
  • FIG. 16 shows an alternative embodiment of the high pressure applicator in FIG. 6; [0047]
  • FIG. 17 shows the high pressure applicator used in FIG. 16; [0048]
  • FIG. 18 shows an arrangement for high pressure, substantially non-compliant delivery of an implant material; [0049]
  • FIG. 19 shows a cannula and two types of stylets useable with the present invention and indicates the manner in which they are assembled; [0050]
  • FIG. 20 shows a high pressure applicator having an enlarged introduction section, a substantially noncompliant tubing, a cannula and a stylet for use in performing a percutaneous implantation; [0051]
  • FIG. 21 shows the first column and a portion of the handle of the high pressure applicator in FIG. 20; [0052]
  • FIG. 22 shows alternate configurations of an end of the first column and an independent funnel useable with each; [0053]
  • FIG. 23A shows a partially cut away view of a housing member, retainer member and plunger; [0054]
  • FIG. 23B shows an end view of FIG. 23A; and [0055]
  • FIG. 23C is a sectional view of FIG. 23A showing the engagement of the plunger with the housing member.[0056]
  • BEST MODE FOR CARRYING OUT THE INVENTION
  • The present invention substantially improves the delivery of hard tissue implant sites to the targeted zone of implantation, and is especially well suited for percutaneous deliveries. The present invention substantially reduces several of the risk factors associated with the performance of percutaneous vertebroplasty. Additionally, the present invention enables an increase in an upper acceptable viscosity value of the implant to be delivered because of the increase in the amount of pressure available for controllably driving the delivery. [0057]
  • An example of a procedure for performing percutaneous vertebroplasty is illustrated in FIGS. 1-6. Beginning with FIG. 1, an example of the use of depth guided instruments will now be described. For a more detailed description of various depth-guided instruments that can be used for accessing the cortical bone, the reader is directed to copending application Ser. No. 08/950,382, filed on Oct. 14, 1997, entitled “Precision Depth Guided Instruments for Use in Vertebroplasty”; and copending application Ser. No. 08/949,839, filed on Oct. 14, 1997, entitled “Precision Depth Guided Instruments for Use in Vertebroplasty”. Both applications, numbered Ser. No. 08/950,832 and Ser. No. 08/949,839 are hereby incorporated by reference in their entireties. A currently preferred [0058] stylet 1′ and cannula 10′, and an optional direction guiding stylet 1″ are shown in FIG. 19. A detailed description of these devices and their uses are disclosed in a co-owned application filed concurrently herewith, entitled “Precision Instruments for Use in Vertebroplasty”, and bearing Attorney Docket No. 361722000420. The aforementioned application bearing Attorney Docket No. 361722000420 is hereby incorporated by reference in its entirety.
  • In the example shown in FIG. 1, a [0059] stylet 1 is provided which has a length that is more than sufficient to span the distance from the epidermis of a patient to the cancellous bone tissue in the vertebra, in the preferred configuration. Typically the length of the stylet would be about three inches or greater, but lesser lengths may also be employed as well, depending on the size of the patient. Of course, if other hard tissues are to be accessed, the length of the stylet can be readily modified without departing from the inventive features of the present invention.
  • The [0060] stylet 1 is preferably made of a surgical grade of stainless steel, but other known equivalent biocompatible metals and materials may be used for the same purpose. Ideally, the stylet, or at least a distal end thereof, will be radiopaque so that it can be monitored using fluoroscopy, CT or other imaging techniques during the procedure to help determine the depth and location of the penetration.
  • A first or distal end of the [0061] stylet 1 ends in a point 2 which is sharp and adapted to penetrate hard tissue when axially loaded. Extending from the tip 2 are self-tapping threads 4. The self-tapping threads 4 provide an advantage in that once the tip 2 has penetrated the cortical bone (e.g., see FIG. 2), the operator of the stylet can then proceed to advance the stylet by torquing the stylet, which engages the self-tapping threads 4 in the cortical bone 103 and begins to screw the stylet 1 into the cortical bone 103. Rotation of the stylet 1 is continued, to advance the stylet into the bone, while monitoring the advancement with some type of imaging technique, e.g., fluoroscopy or equivalent. It is noted that actual fluoroscopic views are generally from a perspective other than that shown in the Figures. However, for ease and clarity of illustration, the Figures depict a transverse sectional view of the vertebra as the instruments enter the vertebral body. Advancement is continued until the tip 2 reaches the site at which it is desired to deliver the implant material. Usually this site is in the cancellous bone as shown in FIG. 3, but could be anywhere within the bone where there is osteoporosis, or a fracture or other defect or trauma.
  • A [0062] cannula 10 is provided which includes an elongated tubular structure 111 to be positioned in the cancellous bone or other implantation site for delivery of PMMA or other bone implant material therein. The tubular structure 11 of the cannula 10 is preferably made of a surgical grade of stainless steel, but may be made of known equivalent materials, similarly to the stylet 1 discussed above. Preferably, at least a distal end of the tubular structure is radiopaque. The tubular structure 11 has an inside diameter which is only slightly larger than the outside diameter of the stylet 1, so that the cannula may effortlessly pass axially over the stylet, while at the same time being supported and guided by the stylet. A first or distal end 12 of the cannula is preferably (but not necessarily) beveled or tapered to ease the penetration of the cannula through the cutaneous and soft tissues, and especially through the hard tissues.
  • Surrounding the second end of the tubular structure [0063] 11 (or 11′ in FIG. 19) is a connector 18 (FIGS. 6, 19) for linking the cannula 10, 10′ with a pressure applicator according to the present invention, for supplying the PMMA or other implantable material that is to be injected via tubular structure 11, 11′. Preferably, connector 18 is a Luer-lock type of connector, but other known connecting mechanisms may be successfully interchanged, e.g., a flat bottom threaded hole, a conventional threaded hole, a threads and locking nut arrangement, etc.
  • As shown in FIGS. 4-5, the [0064] cannula 10 is advanced over the stylet, until visualization of the process indicates that the end of the cannula 12 is substantially even with the tip of the stylet 2, whereby it is confirmed that the cannula is properly positioned for delivery of the implant material. On the other hand, the cannula 10′ and stylet 1′ are advanced together, which is currently the preferred method of insertion. Next the stylet 1 is removed from the site, either by reverse rotation or by simply withdrawing it. At the same time the cannula 10 is maintained in position to be readied for delivery of the implant material.
  • A [0065] pressure applicator 50 according to the present invention is next mounted to the connector 18 at the end of cannula 10, as shown in FIG. 6. The pressure applicator 50 is provided with a fitting 52 which is designed to form a pressure tight connection with the connector 18. As mentioned above, the preferred type of connection is a Luer-lock type connection, but alternative, equivalent types of connectors may be employed. The pressure applicator further includes a first column 54 for receiving and containing implant material. The first column 54 is open at one end 54 a for receiving the material. At the other end 54 b of the first column is a much smaller opening or orifice which ends with the connector or transfer fitting 52 or into which the connector or transfer fitting is mounted or placed (e.g., by threading, bonding, or the like).
  • A [0066] second column 56 is provided for overfitting first column 54 and providing a pressure seal therewith. Preferably, the second column 56 has interior threads 58 as shown in phantom in the exploded view of FIG. 7. The interior threads 58 mate or engage with exterior threads 60 provided on the first column 54. However, other equivalent types of drivable engaging arrangements, e.g., a ratchet and pawl arrangement, interior threading arrangement in the first column, or other equivalent arrangements could be used in place of the mating threads, so long as adequate force is able to be generated and maintained between the two columns for providing the driving pressure for the implant material.
  • [0067] Column 56 is open at end 56 a for receiving the first column 54 therein. At the opposite end 56 b, column 56 is closed to enable a generation of pressure within the two columns as they are moved toward one another and column 56 passes over column 54. Preferably, at least one sealing element 57 (e.g., a square, round or other type of O-ring, grommet, wrap of material or the like) is provided to maintain a high pressure fitting between the columns 54 and 56 to better enable a high pressure driving force to be generated for driving implant material from within the device through the opening 54 b. The sealing element(s) 57 may also be provided integrally with the column 55, e.g., by flaring out the column material to provide an interference fit, or the like. Since implant materials to be used in the invention (e.g. PMMA) are often very viscous, a high pressure capacity ensures that even thicker or more viscous mixes of implant material may be driven by the applicator 50.
  • An advantageous implant material that may be used with the high pressure applicator of the present invention is a PMMA bone cement including contrast agents and/or tracer particles. Aspects of such a material are described in U.S. patent application Ser. No. 08/950,256, “Enhanced Visibility Materials For Implantation In Hard Tissue” (Attorney Docket 361722000200) by Preissman, filed Oct. 14, 1997. Contrast radiographic powder or particles of any typical material and of a size between 0.5μ to 1000μ may be included. [0068]
  • To form the requisite seal to drive the implant material, a separate “sealing” element need not necessarily be provided. However, especially where highly viscous materials are concerned, the O-ring or grommet optionally provided is preferred since it can move on the plunger rotationally and thus even if the plunger is turning with the handle, the seal can move independently. [0069]
  • Returning to the applicator in the embodiment of FIG. 7, however, a [0070] plunger element 55 is provided to be slidably driven by the first column 56 into the second column 54. At least one O-ring 57 or equivalent sealing mechanism is mounted near a first end 55 a of the plunger element 55 to provide a friction fit between the plunger element 55 and the interior wall of the first column 54. In use, the plunger element 57 is “started” in the end 54 b of the column 54, by inserting a small length of the plunger element 57 to an extent which is at least enough to seat the O-ring 57 with the inner wall of the column 54. Next the second column 56 is initially connected with the column 54 by mating the threads 58 and 60. Subsequent torquing of the handle 62 advances the closed end 56 b of the column 56 toward the second end 55 a of the plunger element 55 until it makes contact therewith. Continued torquing of the second column 56 with respect to the first column 54 advances the plunger element 55 against the implant material 66 (not shown in FIG. 7). Sealing element 57, in combination with the advancement of the plunger element 55, generates a pressurized driving force which results in expulsion of the implant material from end 54 b of the second column 54.
  • A [0071] handle 62 is mounted on the column 56 to provide additional leverage for driving the column 56 with respect to column 54. In the example shown in FIGS. 6 and 7, the handle 62 is provided at the closed end 56 b to provide a greater mechanical advantage for torquing column 56 about its longitudinal axis. Of course, the handle could be provided anywhere along the column 56 so long as it extends the effective radius for torquing about the longitudinal axis. A handle 64 is fixedly attached, molded, or otherwise mounted to the first column 54. The handle 64 may be grasped by the operator and provides leverage against rotation of the first column 54 during driving of the second column 56. Preferably, the handle 64 is in the form of a lever as shown in FIG. 6, but alternative embodiments of the handle may include a circular handle, etc. so long as a sufficient mechanical advantage is provided to the user.
  • For other types of driving mechanisms, other types of handles might be employed. For example, a lever might extend from the column in an embodiment using a ratchet and pawl type of driving mechanism. [0072]
  • The above described components of the [0073] pressure applicator 50 are all preferably formed of amorphous nylon or ABS plastic, with at least column 54 being formed of clear or translucent amorphous nylon. However, any other materials which are durable, sterilizable, biofriendly and chemically compatible with the material to be implanted (e.g., stainless steel) could be readily substituted. As a further example, although polycarbonate is not recommend for implanting PMMA, it may be fully acceptable for use in implanting other types of materials with which it has better chemical compatibility.
  • Although the [0074] plunger element 55 is shown as a separate component in the embodiment of FIG. 7, it is noted that this element may be integrally formed with the column 56′, as shown in the embodiment of FIG. 8, to form an extension 56 c′ of the second column 56′. As shown by the phantom lines, the extension 56 c′ is integrally formed or affixed to the closed end 56 b′ of the column 56′ and extends the length thereof to emerge from the open end and extend therefrom to allow the sealing end and sealing element 57 to be inserted into the column 54, prior to starting the interengagement of threads 58 and 60. Note that threads 58 are not indicated in phantom, or at all, in FIG. 8 for purposes of simplification of the Figure and to allow the phantom lines depicting the extension 56 c′ more clearly. It is further noted that the extension 56 c′ does not have to take the form of the plunger 55, but may have a much smaller cross section where it extends from the closed end. For example, the extension 56 c′ may be formed as a much smaller rod with a first end having the same dimensions as that shown in FIG. 8, to provide a proper seal with the column 54.
  • FIG. 9 shows another embodiment of a [0075] pressure applicator 50″ according to the present application. Pressure applicator 50″ is provided with a plunger element 55″ which includes sealing element 57 and frictional element 59, both preferably O-rings, at opposite ends thereof. The sealing and frictional arrangements are not limited to the placement of one O-ring or equivalent but may use two or another multiple of sealing elements. Frictional element 59 is provided to form a friction fit inside the closed end 56 b″ of the column 56″. Thus, the plunger element 55″ is inserted into the column 56″ initially until the end 55 b″ bottoms out against the closed end 56 b″ and the frictional element 59 forms a friction fit with the inner wall of the column 56″ adjacent the closed end 56 b″. The friction fit is sufficient to maintain the plunger element 55″ in position within the column 56″ even when the column is held vertically, by the handle 62, with the open end 56 a″ pointing downward.
  • Additionally, after implant material is loaded into the [0076] column 54, and the end 55 a″ and sealing element 57 are started into the column 54 to seat the sealing element 57 against the inner wall of the column 54, the friction fit between sealing element 57 and column 54, in combination with the friction fit between the sealing element 59 and column 56″ act to prevent rotation of the plunger element with respect to the column 54 as the plunger element is advanced into the column by the driving force of the column 56″. Specifically, the frictional forces between the sealing element 57 and the column 54 are greater than those between the sealing element 59 and the column 56″ so that the sealing element 59 slips against the inner wall of the column 56″ as the column 56″ is torqued to advance both the column 56″ and the plunger element 55″ with respect to the column 54. By this action, the rotational movement of the closed end 56 b″ of the column 56″ is converted to a solely translational force against driving the plunger element 55″. This feature is particularly important when the implant material comprises PMMA, as PMMA is somewhat abrasive. If the plunger element 55″ and sealing element 57 are allowed to rotate or are driven to rotate with respect to the column 54, this may allow some of the PMMA to work its way between a portion or all of the sealing element 57 and inner wall of the column 54 where it can act as an abrasive to prematurely degrade the sealing element 57 and/or the wall of the column 54. By eliminating rotation of the sealing element 57 with respect to the inner wall of the column 54 so purely translational or sliding movement occurs upon actuation of the applicator, migration of PMMA between the sealing element 57 and column 54 wall are minimized or eliminated.
  • The [0077] end 55 b″ and sealing element 59 as shown have dimensions slightly larger than those of the end 55 a″ and sealing element 57 to account for the slightly larger inside diameter of the column 56″ relative to the inside diameter of the column 54. However, it is not necessary to use these dimensions, since a recess (not shown) having a smaller diameter can be formed (by boring, molding or otherwise) into the closed end 56 b″ so that a smaller end 55 b″ and sealing element 59 can be employed to form a friction fit therewith.
  • Another variant of a frictional element useable to prevent rotation of the plunger or rod upon actuation of the applicator is pictured in FIGS. 23A-23C. The [0078] enlarged base 55 b′″ of the piston/plunger rod 55′″ includes and end 55 d having a spherical surface which is free to rotate with respect to the inner end surface 56 d of the second column 56. The enlarged base 55 b′″ is held in position by the placement of one or more (preferably two) internal retaining rings 59 which engage within a recess in second column 56 and abut the enlarged base 55 b′″ to substantially prevent translational movement thereof with respect to the second column 56. Thus the rod 55′″ will not fall out of the second column 56 when inverted or otherwise jostled, but the rod 55′″ is still allowed to turn relative to the column 56.
  • FIG. 10 is a partial sectional view of an embodiment of a [0079] pressure applicator 70, according to the present invention, in which a portion of the column 74 has been cut away to show the relationship between the column or shaft 76 and column 74. In this embodiment, column 74 is interiorly threaded with threads 71 which mate with threads 78 on the exterior of column 76. A sealing element 77 (e.g., an O-ring, Teflon wrap (formed by wrapping with Teflon tape, for example) or other equivalent) may be mounted at or near the end of the column 76 to enhance the pressure seal between the columns 76 and 74, although close tolerance threads may be employed to generate sufficient pressure without the use of a sealing element. Although not shown, a handle is also preferably mounted to the column 74 (e.g., similar to the handle 64 described above or to handles described below) to assist the user in developing the torque needed to generate high pressures. A handle 72 is mounted to column 76 to further assist in generating torque.
  • FIG. 11 is a partial sectional view of a variation of an embodiment of a [0080] pressure applicator 70′, according to the present invention, in which a portion of the column 74′ has been cut away to show the relationship between the column or shaft 76′ and column 74′. In this embodiment, the threads 71′ are radially inset from the remainder of the inner wall 73′ of column 74′ which is left smooth. Threads 78′ are exteriorly provided on column or shaft 76′ which mate with threads 71′. The distal end of shaft 76′ is provided with an enlarged portion 79 which closely approximates or mates with the smooth inner wall 73′. A sealing element 77′ (e.g., an O-ring, Teflon tape or other equivalent) may be mounted at or near the end of the enlarged portion 79 to enhance the pressure seal between the columns 76′ and 74′. A handle 75 is also preferably mounted to the column 74′ to assist the user in developing the torque needed to generate high pressures. Although handle 75 is shown mounted to the proximal end of the column 74′, it is noted that the handle may also be mounted to the distal end, similar to that described with respect to handle 64 above, or at virtually any location along the length of the column that may be desirable, and still achieve the advantages of enhancing torque generation. Also, the handle 75 may be molded or otherwise formed integrally with the column 74′ or, alternatively, may be fixedly mounted to the column 74′ (e.g., by bonding, welding, splined or other mechanical arrangement) to provide torque to the column 74′ without slipping with respect thereto. A handle 72 is mounted to column 76′ to further assist in generating torque.
  • [0081] Column 74′ must be provided with an access as shown in FIG. 12A, to allow insertion of the shaft 76′, since the outside diameter of the enlarged portion 79′ is greater than the diameter of the distal opening 74 a′ of the column 74′. One example of providing such an access, is to provide a hinged or removable section 82 which may be swung open or removed from the remainder of the column 74′ during the insertion of the column 76′. In the example shown in FIGS. 11-12C, section 82 includes a hinge pin 84 which is insertable into a recess 86 in the wall of the remainder of the column 74′ for pivoting therewith, or allowing removal of the section altogether. Other types of hinges or movable attachments may be readily substituted for the hinge pin 84 and recess 86 as would be apparent to those of ordinary skill in the art.
  • One or preferably both edges of the [0082] section 82 may be provided with flanges 88 or similar extensions to provide a snap or friction fit with the remainder of the column 74′ when the section 82 is installed. Further optionally, the inner wall of the remainder of the column may be provided with a recess or groove 87 to receive the flange or extension 88 to provide a more secure interlock. Additionally or alternatively, the column 74′ may be provided with a clamp or tying band (not shown) to surround the section 82 and column 74′ and compress the two pieces slightly to maintain them in a secure relationship.
  • Insertion of the [0083] column 76′ is performed by first removing or swinging open the section 82 away from the remainder of the column 74′. The proximal portion 76 a′ of the column 76′ has a smaller outside diameter than the threaded portion 78′ and is also sufficiently smaller than the inside diameter of the threads 71′, so that the enlarged portion 79 can be placed in the space 89 while the proximal portion 76 a′ clears the threads 71′. The section 82 is then replaced by snapping and/or clamping the same into position against the remainder of the column 74′, thereby surrounding the proximal portion 76 a′ and enlarged portion 79. Threads 78′ can then be started with threads 71′ to ready the applicator 70′ for application of a pressurized driving force.
  • FIG. 13 is a plan view of another embodiment of a [0084] pressure applicator 90 according to the present invention. Column 94 is configured and dimensioned to receive a disposable syringe 150 (shown in phantom lines) therein. For example, this embodiment can be used with a 10 cc syringe, thereby enabling much greater pressures to be generated than discussed above. The column 94 can be formed as a two stage column, as shown, having a first inside diameter 94 c which is smaller than a second inside diameter 94 d. This design allows the barrel 152 of the syringe 150 to be received in the portion 94 c and abut against a tapered portion of the column 94 e. Additionally, or alternatively, a transition collar 94 f which interconnects the varying diameter portions 94 c and 94 d of the column 94, provides a surface against which the flange or “wings” of the syringe barrel 152 abut. An alternative arrangement could have a column having a single stage or inner diameter which could rely on the tapered region 94 e solely for abutment of the syringe barrel 152.
  • The [0085] syringe plunger 154 is received in the larger diameter portion 94 d of the column 94 (which, in the alternative arrangement described would be the single stage or diameter). A second column or shaft 96 is externally threaded and external threads 98 are designed to mate with internal threads (not shown) on the interior wall of the column portion 94 d. The distal end 96 a of column 96 abuts against the end 158 of the syringe plunger 154 upon threading the column 96 into column 94. Further torquing of the handle 92 with respect to the column 94 generates a driving force for translationally advancing the syringe plunger 154 to generate a high pressure driving force. A sealing element (not shown) is preferably mounted at or near the distal end of the syringe plunger 154, as is known in the art, to enhance the pressure generation. Although not shown, a handle is also preferably mounted to the column 94 (e.g., similar to the handle 64 or 75 described above) to assist the user in developing the torque needed to generate high pressures.
  • FIG. 14 is a plan view of another embodiment of a [0086] pressure applicator 90′ according to the present invention. Column 94′ is configured and dimensioned to receive a disposable syringe 150 (shown in phantom lines) therein. The column 94′ can be formed as a two stage column, similar to that described above with regard to FIG. 13, but is formed as a single stage or single diameter column in FIG. 14. This design allows the barrel 152 of the syringe 150 to be received in the column 94′ and abut against a tapered portion of the column 94 e′. The syringe plunger 154 extends from the proximal opening 94 a′ of the column 94 and is received in the column 96′. Column 96′ is internally threaded (threads not shown) and the internal threads are designed to mate with external threads 93 on column 94′. The closed proximal end 96 b′ of column 96′ abuts against the end 158 of the syringe plunger 154 upon receiving the plunger 154 in column 96′ and beginning mating of the internal threads of the column 96′ with threads 93. Further torquing of the handle 92′ with respect to the column 94′ generates a driving force for translationally advancing the syringe plunger 154 to generate a high pressure driving force. A sealing element (not shown) is preferably mounted at or near the distal end of the syringe plunger 154, as is known in the art, to enhance the pressure generation. Although not shown, a handle is also preferably mounted to the column 94′ (e.g., similar to the handle 64 or 75 described above) to assist the user in developing the torque needed to generate high pressures.
  • In using the pressure applicator according to the present invention to drive a tissue implant material, a tissue implant material, in this example, a hard [0087] tissue implant material 66 is loaded into the first column 54 and the second column 56 is connected with the first column 54 in preparation for implantation, see FIG. 15. Although the pressure applicator 50 is shown in FIGS. 6, 15 and 18, it is noted that the principles described with respect thereto are generally applicable to each of the embodiments described herein. Of course, minor variations in procedure may be necessary, e.g., loading the syringe 150 with implant material, rather than the pressure applicator column, when using the embodiments of FIGS. 13 and 14, etc., but the general principles described herein may be applied to any embodiment by those of ordinary skill in the art. Prior to mounting the pressure applicator 50 on the cannula 10, a tissue implant material 66 is loaded into the first column 54 and the second column 56 is connected with the first column 54 in preparation for implantation. Optionally, the introduction of air bubbles can be further substantially reduced or avoided by slightly overfilling the first column to form a meniscus created by surface tension of the implant material and then introducing the plunger element into the material and driving the plunger into the first column. This optional technique may be used in all of the disclosed embodiments, but may be obviated by the features shown in the embodiments of FIGS. 20-22, as discussed below. The first column is then rotated slightly with respect to the second column until a minimal amount of tissue implant material is expressed from the fitting 52 end, to ensure that no air has been entrapped in the applicator. The cannula 10 is backfilled with saline, tissue implant material 66, or other biocompatible fluid in order to displace the air therefrom. The pressure applicator 50 is then mounted onto the cannula 10 as described above and shown in FIG. 6. The operator next grasps the handle 62 in one hand and the handle 64 in the other and begins to torque the handle 62 while maintaining the handle 64 in its position. When operated as described, the pressure applicator is capable of generating pressures of about 1000 to 3000 psi within the columns, which is a high driving force that is applied to the implantable material 66.
  • Torquing of the [0088] handle 62 with respect to the handle 64 is continued until a sufficient amount of implant material 66 has been delivered to the implant site as verified by an appropriate imaging technique. A variety of endpointing techniques are described in the application entitled “Precision Instruments for Use in Vertebroplasty”, and bearing Attorney Docket No. 36172-2000420, which was incorporated by reference above. Advantageously, the pressure applicator 50 allows a first column 54 which is large enough in volume at least 5 cc, preferably at least 7.5 cc, and more preferably at least 10 cc and up to about 15 cc to contain sufficient implant material for an entire implantation process so that there is no need to refill the column 54 in the midst of a procedure. For uses that require the delivery of larger volumes of implant material, the designs disclosed herein could be enlarged so as to have a capacity up to 25 cc and even upwards of 30 cc. It would further be apparent to those of ordinary skill in the art to modify the designs herein to have capacities even larger than that disclosed should an implantation procedure require larger volumes of material.
  • A modification of the apparatus described above is shown in FIG. 16. In this embodiment, [0089] cannula 10′ includes a modified tubular structure design. The first or distal portion 11 a of the tubular structure is of the same dimensions as the embodiment of FIGS. 1-6. The second or proximal portion 11 b of the cannula 10′, however, has a substantially larger diameter than that of the first portion 11 a. Preferably, the diameter of second portion 11 b is about twice the diameter of the first portion 11 a, although any increase in the diameter of the second portion 11 b over that of the first portion 1 a will decrease the pressure requirement for effective delivery of the material to be implanted.
  • The first and [0090] second portions 11 a, 11 b have approximately equal lengths, but this is governed by the anatomy of the site to be accessed. In the “average” percutaneous vertebroplasty situation, the first portion 11 a is required to be about 1.5″ long, as this is the length that is needed for traversing the cortical bone of the pedicle. Thus, the first portion should not be significantly enlarged due to the size constraints of the pedicle, the safety risks to the spinal column and aorta which are increased when the cannula size is increased intravertebrally, and by the desire to remove as little bone as possible when entering with the stylet and cannula, among other factors.
  • However, the portion of the cannula which will occupy the soft tissues can be significantly expanded without substantially adversely effecting the patient. Given the benefits of reducing the required injection pressure and ensuring a better delivery of the bone implant material, such a modification becomes a viable option. [0091]
  • The [0092] pressure applicator 50′″ is essentially the same as that in the embodiment 50, with modifications as follows. The pressure applicator 50′″ is provided with a fitting 52′″ (FIG. 17) which is designed to form a pressure tight connection with the connector 18′ and is therefore of a significantly larger diameter than the connector 52. Additionally, the first column 54′″ is essentially open at both ends 54 a′″ and 54 b′″ as it does not taper or tapers much less than the previous embodiment at opening 54 b′″. As mentioned above, the preferred type of connection is a Luer-lock type connection, but alternative, equivalent types of connectors may be employed.
  • Like [0093] pressure applicator 50, the components of the pressure applicator 50′″ are all preferably formed of amorphous nylon. The housing or second column or any portions which do not contact the implant material, may be formed of ABS plastic. Additionally, any other materials which are durable, sterilizable, biofriendly and nonreactive with the particular implant materials to be contained therein, e.g., stainless steel, polypropylene, could be readily substituted.
  • Although the above modifications with regard to FIG. 16 have been described and shown as applied to the [0094] applicator 50, it is noted that similar modifications can be effected with regard to applicators 50′, 50″, 70, and 70′. It is further recognized that even embodiments 90 and 90′ could be so modified, although this would also likely require modification of the disposable syringes which might not then be as readily accessible commercially.
  • Prior to mounting the [0095] pressure applicator 50′ on the cannula 10′, a hard tissue implant material 66 is loaded into the first column 54 and the second column 56 is connected with the first column 54 in preparation for implantation. The pressure applicator 50′ is then mounted onto the cannula 10′ as shown in FIG. 16. The operator next grasps the handle 62 in one hand and the handle 64 in the other and begins to torque the handle 62. When operated as described, the pressure applicator is capable of generating controllable and sustainable pressures of up to about 3000 psi within the columns, which is a high driving force that is applied to the implantable material 66.
  • Alternative to the direct connection of the [0096] pressure applicator 50 to the connector 18 via fitting 52, as shown in FIG. 6, a high pressure tubing 70 may be and preferably is interconnected between the pressure applicator 50 and the cannula 10, as shown in FIG. 18. In addition to a high pressure rating, it is preferable that the tubing be a substantially non-compliant tubing, to obviate problems of “oozing” and overfilling that occur when there is too much compliance in a high pressure implantation system. Preferred examples of high pressure, substantially non-compliant tubings include PEEK tubing, and other polymers such as Nylon, PTFE, and FEP which may be radially reinforced with a no-stretch coil such as a flat wire spring of stainless steel, aramid fibers such as Kevlar, etc. A more detailed description of high pressure, substantially non-compliant tubings which are suitable for tubing 70 is given in copending application Ser. No. 09/276,062, filed Mar. 25, 1999 and entitled “Non-Compliant System for Delivery of Implant Material”. Application Ser. No. 09/276,062 is hereby incorporated herein its entirety, by reference thereto.
  • Similar to previous modifications, this modification applies to all other embodiments, in addition to the [0097] applicator 50 which is specifically referred to. The tubing 70 has male 72 and female 74 connectors for forming pressure tight seals with fitting 52 and connector 18, respectively. The tubing 70 enables both the applicator 50, and thus the user's hands to be distanced from the radiographic field or other viewing field, which is advantageous both for safety purposes as well as improving the procedure. This embodiment is particularly advantageous for the most frequent set-ups where bi-planar viewing is performed and two imaging devices are oriented at 90° to one another about the implantation site. One of the advantages which is gained that improves the procedure, is that the viewing instrumentation can be moved closer to the actual implantation site, thereby providing a more magnified view.
  • It is preferred that the [0098] tubing 70 is mounted to the pressure applicator prior to mounting on the cannula fitting 18. After filling the pressure applicator with implant material as described above, the tubing 70 is mounted to fitting 52. A small amount of pressure is next applied to the implant material to express the implant material until a minimal amount exits the open end of the tubing (i.e., the end where connector 74 is located). The tubing 70 is then connected to the connector 18 of the cannula 10 for implantation of the implant material into the desired location. Although the foregoing is the desired order of connection so that the air space in the tubing can be prefilled with implant material, it is not the only possible progression for the procedure. Alternatively, the tubing 70 can be connected to the fitting 18 of the cannula 10 and the tubing 70 and cannula 10 are then backfilled with saline, implant material, or other biocompatible fluid to displace any air residing in the structures. After filling of the pressure applicator 50 with implant material, the tubing can be connected to the fitting 52 and implantation of the implant material can be rapidly commenced thereafter.
  • FIG. 20 shows a high pressure applicator having an enlarged introduction section, a substantially noncompliant tubing, a cannula and a stylet for use in performing a percutaneous implantation. High pressure applicator having the feature of an enlarged introduction section are further disclosed and claimed in a co-owned application filed concurrently herewith, entitled “High Pressure Delivery System” and bearing attorney docket number 361722000700. The application filed concurrently herewith entitled “High Pressure Delivery System” and bearing attorney docket number 361722000700 is hereby incorporated by reference thereto in its entirety. [0099]
  • FIG. 21 is an enlarged detail showing of the [0100] first column 30 and a portion of the handle 40 of the high pressure applicator shown in FIG. 20. The open end portion of the first column 30 is formed as an introduction section 24 which has a slightly larger cross-sectional area than that of the portion of the first column 30 adjacent to it. Providing a larger size or diameter introduction section 24 enables the introduction of the plunger 44 into the implant material without simultaneously forming a seal where compliant bubbles may be trapped. Put another way, the differential in sizes is provided so that when the smaller diameter portion of the first column 30 is fully filled and the introduction section 24 is at least partially filled, the end of the plunger 44 which might otherwise trap air bubbles resulting in system compliance will be dipped in the implant material thereby allowing for the exclusion of air bubbles prior to driving it into the smaller diameter portion.
  • The [0101] introduction section 24 may be relatively close in size to the adjoining smaller diameter portion to provide only a surrounding dam for a meniscus poured over the smaller diameter portion. Since the amount of material that needs to be provided in the introduction section need not be great to facilitate the venting or purging as described above, it is better to only introduce slightly more implant material than will fill the smaller diameter portion. Introduction of a larger amount of implant material is not only wasteful, but may result in material drainage out of the introduction section into other parts of the applicator—especially when the applicator is inverted or turned as will often be the case in preparing PMMA implant material for delivery.
  • To help account for the possibility of excess implant material and associated potential of fouling of the applicator with such an excess, a larger size of the [0102] introduction section 24 than strictly required for the venting feature discussed above may be used to act as a catch basin for excess material. This will provide a larger margin of error in pouring implant material into the applicator before overflowing the introduction section 24 will occur. Further, the walls of such an enlarged catch basin may help to prevent contamination of the applicator by virtue of adherence of the implant material to the surface area provided during inversion or agitation of the applicator.
  • In the example shown in FIGS. 20 and 21, the introduction section is provided with [0103] threads 32 which engage with threads (not shown) on the interior of the second column 36, similar to the arrangements provided in the embodiments shown in FIGS. 6-9. Handle 38 is provided for torquing the second column 36 with respect to the first column 30. Accordingly, the concept of the introduction section could be applied to any of those embodiments, and could also be adapted to the embodiments having threading internally of an introduction section with external threading on a second column. The concept is also generally applicable to the embodiments shown in FIGS. 13 and 14, where an introduction section could be provided in the barrel 152 of the syringe.
  • FIG. 22 shows alternate configurations of an end of the [0104] first column 30′ and 30″, and an independent funnel 54 useable with each. The funnel or increased-size target region 54 may also be integrated into the introduction section 24 to aid in pouring implant material into the applicator. Drive threads may be placed on the exterior funnel 54. A presently preferred thread size is 1½-12 ACME 2.G 10° external. However, when no integral funnel is provided, a smaller introduction section 24′,24″ may be used to provide a greater mechanical advantage. Additionally on the smaller introduction section, or alternatively on the larger introduction section, the drive threads placed exterior thereto may be of a finer pitch or higher thread count than those previously described to provide for greater mechanical advantage for generating higher driving pressures more easily. To help in loading material into the applicator when no integral funnel is used, a separate funnel element 54 may be provided to interface with the introduction section 24.
  • In the embodiments shown, the first column is advantageously about 0.50 inches in diameter and of a length of about 4 inches in order to provide sufficient volume for implant material for efficiency in performing vertebroplasty and yet have a small enough bore so that the mechanical advantage in applying pressure to the implant material is not overly affected as would be the case with a much larger bore. The preferred size range for the first column is between about 0.375 to about 0.75 inches with a length of between about 1.5 and 4.5 inches. The preferred capacitance of the first column is at least 5 cc, up to about 15 cc, as described above. [0105]
  • Further details as to the use or other aspects of the high-pressure implant system may be noted in the above referenced applications already referred to in describing the present invention which are herein incorporated by reference in their entirety. It is noted that this invention has been described and specific examples of the invention have been portrayed which may be advantageous. The use of those specific examples is, however, not intended to limit the invention in any way. Additionally, to the extent that there are variations of the invention which are within the spirit of the disclosure and yet are equivalent to the inventions found in the claims, it is the intent that the claims cover those variations as well. All equivalents are considered to be within the scope of the claimed invention, even those which may have not been set forth herein merely for the sake of brevity. Also, the various aspects of the invention described herein may be modified and/or used in combination with such other aspects also described to be part of the invention or references discussed to form other advantageous variations considered to be part of the invention covered. [0106]

Claims (51)

1. A high pressure applicator for driving the delivery of a flowable tissue implant material, comprising:
a first column having an inner wall, an outer wall, a first end and a second end having an orifice for delivering implant material therethrough;
a second column, said second column being drivable with respect to said first column to generate a pressure within said first column; and
a handle attached to said first column and radially extending therefrom to provide a user a mechanical advantage upon grasping said handle.
2. The high pressure applicator of claim 1, further comprising at least one sealing element interfacing with said inner wall of said first column, said at least one sealing element providing for or enhancing generation of said pressure.
3. The high pressure applicator of claim 1, wherein said second column comprises a wall which is drivably engageable with one of said inner and outer walls.
4. The high pressure applicator of claim 1, further comprising a handle integrally formed with or affixed to and extending radially from said second column to provide the user a mechanical advantage upon grasping said handle.
5. The high pressure applicator of claim 1, further comprising threading on said outer wall of said first column, wherein said second column is substantially hollow and comprises an open first end, a closed second end and threading on an inner wall thereof, said threading on said second column being engageable with said threading on said first column.
6. The high pressure applicator of claim 5, wherein said second column further comprises an extension integrally formed with or affixed to said second column and having an end portion extending from said open end of said second column, said extension adapted to be inserted through said open end of said first column and form a substantial pressure seal with said inner wall.
7. The high pressure applicator of claim 6, further comprising at least one sealing element mounted to said end portion of said extension and adapted to form a pressure seal with said inner wall thereby forming a pressure seal between said first and second columns.
8. The high pressure applicator of claim 7, wherein said at least one sealing element comprises an O-ring.
9. The high pressure applicator of claim 5, further comprising a plunger element adapted to be inserted within said first and second columns, said plunger element having a first end portion and a second end portion.
10. The high pressure applicator of claim 9, wherein said first end portion is adapted and configured to closely fit within said inner wall of said first column to form a pressure seal therewith.
11. The high pressure applicator of claim 9, further comprising at least one sealing element mounted to said first end portion and adapted to form a pressure seal between said inner wall and said plunger element.
12. The high pressure applicator of claim 9, further comprising a handle integrally formed with or affixed to and extending radially from said second column to provide the user a mechanical advantage upon grasping said handle.
13. The high pressure applicator of claim 11, wherein said at least one sealing element comprises an O-ring.
14. The high pressure applicator of claim 11, further comprising at least one frictional element mounted to said second end portion and adapted to form a friction fit with said second column at or near said second closed end.
15. The high pressure applicator of claim 3, further comprising threading for at least a portion of said inner wall of said first column, and wherein said wall of said second column is an external wall comprising threading along at least a portion thereof, said threading of said external wall being engageable with said threading on at least a portion of said inner wall.
16. The high pressure applicator of claim 15, wherein said threading on said external wall engages with said threading on said inner wall to form a pressure seal therebetween.
17. The high pressure applicator of claim 15, further comprising at least one sealing element mounted to an end portion of said second column and adapted to form or enhance a pressure seal with said inner wall.
18. The high pressure applicator of claim 17, wherein said at least one sealing element comprises an O-ring.
19. The high pressure applicator of claim 17, wherein said at least one sealing element comprises a Teflon wrap.
20. The high pressure applicator of claim 1, wherein said handle is integrally formed with or affixed said first column.
21. The high pressure applicator of claim 15, wherein said threads cover only a portion of said second column external wall, an end portion of said second column being relatively smooth.
22. The high pressure applicator of claim 21, wherein only a portion of said inner wall comprises threads, the remainder of said inner wall being substantially smooth.
23. The high pressure applicator of claim 22, wherein said relatively smooth end portion comprises a reduced diameter section having an outside diameter less than an inside diameter of said threads on said inner wall, and an enlarged section which closely fits with said substantially smooth inner wall to form a pressure seal therewith.
24. The high pressure applicator of claim 1, wherein said first column comprises a hinged or removable section adapted to swing open or be removed from said first column for drivably engaging said first and second columns.
25. The high pressure applicator of claim 22, wherein said end portion of said external wall closely fits with said remainder of said inner wall to form a pressure seal therewith.
26. The high pressure applicator of claim 25, further comprising at least one sealing element mounted to said end portion of said second column and adapted to enhance said pressure seal.
27. The high pressure applicator of claim 25, wherein said at least one sealing element comprises an O-ring.
28. The high pressure applicator of claim 1, further comprising a syringe including a barrel portion and a plunger portion, wherein said second column is substantially hollow and comprises an inside wall, an open first end and a closed second end, and wherein said barrel portion is received within said first column and said plunger portion is received within said second column.
29. The high pressure applicator of claim 28, further comprising threading on said outer wall of said first column and threading on said inner wall of said second column, said threading on said second column being engageable with said threading on said first column.
30. The high pressure applicator of claim 28, further comprising a handle integrally formed with or affixed to and extending radially from said second column to provide the user a mechanical advantage upon grasping said handle.
31. The high pressure applicator of claim 28, wherein an end of said barrel portion abuts against said substantially closed end of said first column and an end of said plunger portion abuts against said closed end of said second column, wherein driving of said second column with respect to said first column provides a driving force for advancing said plunger portion within said barrel portion.
32. The high pressure applicator of claim 29, wherein said barrel portion further comprises a wing or flanged portion adjacent an open end thereof; and
said first column comprises a first portion adjacent said open end and a second portion adjacent said substantially closed end and a transitional portion joining said first and second portions, wherein said first portion has an inside diameter larger than an inside diameter of said second portion, and wherein said transitional portion is adapted to abut against said wing or flanged portion.
33. The high pressure applicator of claim 1, further comprising a syringe including a barrel portion and a plunger portion, wherein said syringe is received within said first column.
34. The high pressure applicator of claim 33, further comprising a handle integrally formed with or affixed to and extending radially from said second column to provide the user a mechanical advantage upon grasping said handle.
35. The high pressure applicator of claim 33, further comprising threading on at least a portion of said inner wall of said first column, and wherein said second column comprises an end adapted to abut an end of said plunger portion and an external wall including threading along at least a portion thereof, said threading of said external wall being engageable with said threading on at least a portion of said inner wall.
36. The high pressure applicator of claim 35, wherein an end of said barrel portion abuts against said substantially closed end of said first column, wherein driving of said second column with respect to said first column provides a driving force for advancing said plunger portion within said barrel portion.
37. The high pressure applicator of claim 35, wherein said barrel portion further comprises a wing or flanged portion adjacent an open end thereof, and
said first column comprises a first portion adjacent said open end and a second portion adjacent said substantially closed end and a transitional portion joining said first and second portions, wherein said first portion has an inside diameter larger than an inside diameter of said second portion, and wherein said transitional portion is adapted to abut against said wing or flanged portion.
38. The high pressure applicator of claim 1, wherein said applicator is capable of generating pressures of at least about 1000 psi.
39. The high pressure applicator of claim 1, wherein said applicator is capable of generating pressures of at least 1500 psi.
40. The high pressure applicator of claim 1, wherein said applicator is capable of generating pressures up to about 2000 psi.
41. The high pressure applicator of claim 1, wherein said applicator is capable of generating pressures up to about 2500 psi.
42. The high pressure applicator of claim 1, wherein said applicator is capable of generating pressures up to about 3000 psi.
43. A high pressure applicator for driving the delivery of a flowable tissue implant material, comprising:
a first column having an inner wall, an outer wall, a first open end and a second substantially closed end having an orifice therethrough;
a second column adapted to overfit at least a portion of said first column, said second column having an inner wall, an outer wall, an open end and a closed end; and
a plunger element having a first end portion adapted to be inserted within said first column and a second end portion adapted to abut said closed end of said second column.
44. The high pressure applicator of claim 43, further comprising threads on at least a portion of said outer wall of said first column and threads on at least a portion of said inner wall of said second column, said threads on said second column being engageable with said threads on said first column.
45. The high pressure applicator of claim 43, wherein said first end portion is adapted and configured to closely fit within said inner wall of said first column to form a pressure seal therewith.
46. The high pressure applicator of claim 43, further comprising at least one sealing element mounted to said first end portion and adapted to form a pressure seal between said inner wall of said first column and said plunger element.
47. The high pressure applicator of claim 46, wherein said at least one sealing element comprises an O-ring.
48. The high pressure applicator of claim 43, further comprising at least one frictional element mounted to said second end portion and adapted to form a friction fit with said second column at or near said closed end.
49. The high pressure applicator of claim 48, wherein said at least one frictional element comprises an O-ring.
50. The high pressure applicator of claim 43, wherein said second end portion of said plunger element comprises a spherical surface.
51. The high pressure applicator of claim 43, further comprising a handle fixedly attached to said first column and radially extending therefrom to provide a user a mechanical advantage upon grasping said handle.
US10/039,892 1998-04-01 2001-10-26 High pressure applicator Abandoned US20040215202A1 (en)

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US09/409,934 US6383190B1 (en) 1998-04-01 1999-09-30 High pressure applicator
US10/039,892 US20040215202A1 (en) 1998-04-01 2001-10-26 High pressure applicator

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Cited By (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040249347A1 (en) * 1999-09-30 2004-12-09 Miller Scott H. High pressure delivery system
US20070118142A1 (en) * 2005-11-18 2007-05-24 Krueger John A Device, system and method for delivering a curable material into bone
US20070142842A1 (en) * 2005-11-18 2007-06-21 Krueger John A Device, system and method for delivering a curable material into bone
US20070173938A1 (en) * 2006-01-26 2007-07-26 Spinal Generations, Llc Interbody cage system
US20070191858A1 (en) * 2005-09-01 2007-08-16 Csaba Truckai Systems for delivering bone fill material
US20070197971A1 (en) * 2006-02-22 2007-08-23 Krueger John A Curable material delivery device with a rotatable supply section
US20080109008A1 (en) * 2006-11-02 2008-05-08 Stryker Trauma Gmbh Implantation device and method for applying the same
US20080269901A1 (en) * 2007-04-27 2008-10-30 Baynham Bret O Spinal implant
US20080275506A1 (en) * 2007-04-27 2008-11-06 Baynham Bret O Spinal implant
US20090057168A1 (en) * 2007-08-31 2009-03-05 Smit Karen L Medical cement monomer ampoule cartridge for storing the ampoule, opening the ampoule and selectively discharging the monomer from the ampoule
US20090257306A1 (en) * 2006-10-06 2009-10-15 Coffeen Jared P Bone cement mixing and delivery system with automated bone cement transfer between mixer and delivery device and method of mixing and automated transfer of bone cement between mixer and delivery device and method of mixing and automated transfer of bone cement between mixer and delivery device
US20110015640A1 (en) * 2006-01-30 2011-01-20 Stryker Leibinger Gmbh & Co. Kg Syringe
US8066713B2 (en) 2003-03-31 2011-11-29 Depuy Spine, Inc. Remotely-activated vertebroplasty injection device
US8109933B2 (en) 2007-04-03 2012-02-07 Dfine, Inc. Bone treatment systems and methods
US8277506B2 (en) 2008-06-24 2012-10-02 Carefusion 2200, Inc. Method and structure for stabilizing a vertebral body
USD669168S1 (en) 2005-11-18 2012-10-16 Carefusion 2200, Inc. Vertebral augmentation needle
US8361078B2 (en) 2003-06-17 2013-01-29 Depuy Spine, Inc. Methods, materials and apparatus for treating bone and other tissue
US8360629B2 (en) 2005-11-22 2013-01-29 Depuy Spine, Inc. Mixing apparatus having central and planetary mixing elements
US8415407B2 (en) 2004-03-21 2013-04-09 Depuy Spine, Inc. Methods, materials, and apparatus for treating bone and other tissue
US8579908B2 (en) 2003-09-26 2013-11-12 DePuy Synthes Products, LLC. Device for delivering viscous material
US8690884B2 (en) 2005-11-18 2014-04-08 Carefusion 2200, Inc. Multistate-curvature device and method for delivering a curable material into bone
US8950929B2 (en) 2006-10-19 2015-02-10 DePuy Synthes Products, LLC Fluid delivery system
US8992541B2 (en) 2003-03-14 2015-03-31 DePuy Synthes Products, LLC Hydraulic device for the injection of bone cement in percutaneous vertebroplasty
US9044284B2 (en) 2010-09-29 2015-06-02 Spinal Generations, Llc Intervertebral insert system
US9168078B2 (en) 2009-11-10 2015-10-27 Carefusion 2200, Inc. Apparatus and method for stylet-guided vertebral augmentation
US9381024B2 (en) 2005-07-31 2016-07-05 DePuy Synthes Products, Inc. Marked tools
US9642932B2 (en) 2006-09-14 2017-05-09 DePuy Synthes Products, Inc. Bone cement and methods of use thereof
US9918767B2 (en) 2005-08-01 2018-03-20 DePuy Synthes Products, Inc. Temperature control system
US20180207356A1 (en) * 2015-09-22 2018-07-26 Thomas Jefferson University Continuous subcutaneous insulin infusion catheter
US10136934B2 (en) 2005-08-22 2018-11-27 Dfine, Inc. Bone treatment systems and methods
CN110573091A (en) * 2017-03-15 2019-12-13 史密夫和内修有限公司 Graft preparation and delivery apparatus and methods
US11026734B2 (en) 2004-12-06 2021-06-08 Dfine, Inc. Bone treatment systems and methods

Families Citing this family (221)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6716216B1 (en) 1998-08-14 2004-04-06 Kyphon Inc. Systems and methods for treating vertebral bodies
US6241734B1 (en) * 1998-08-14 2001-06-05 Kyphon, Inc. Systems and methods for placing materials into bone
US20070282443A1 (en) * 1997-03-07 2007-12-06 Disc-O-Tech Medical Technologies Ltd. Expandable element
IL128261A0 (en) * 1999-01-27 1999-11-30 Disc O Tech Medical Tech Ltd Expandable element
US7572263B2 (en) * 1998-04-01 2009-08-11 Arthrocare Corporation High pressure applicator
WO1999049819A1 (en) 1998-04-01 1999-10-07 Parallax Medical, Inc. Pressure applicator for hard tissue implant placement
US20050228397A1 (en) * 1998-08-14 2005-10-13 Malandain Hugues F Cavity filling device
EP1112095B1 (en) * 1998-09-11 2002-11-20 Gerhard Dr. Schmidmaier Biologically active implants
US7621950B1 (en) 1999-01-27 2009-11-24 Kyphon Sarl Expandable intervertebral spacer
WO2000056254A1 (en) * 1999-03-24 2000-09-28 Parallax Medical, Inc. Non-compliant system for delivery of implant material
US7641657B2 (en) 2003-06-10 2010-01-05 Trans1, Inc. Method and apparatus for providing posterior or anterior trans-sacral access to spinal vertebrae
US6899716B2 (en) * 2000-02-16 2005-05-31 Trans1, Inc. Method and apparatus for spinal augmentation
US7744599B2 (en) 2000-02-16 2010-06-29 Trans1 Inc. Articulating spinal implant
US6558390B2 (en) * 2000-02-16 2003-05-06 Axiamed, Inc. Methods and apparatus for performing therapeutic procedures in the spine
US6575979B1 (en) * 2000-02-16 2003-06-10 Axiamed, Inc. Method and apparatus for providing posterior or anterior trans-sacral access to spinal vertebrae
US6740090B1 (en) 2000-02-16 2004-05-25 Trans1 Inc. Methods and apparatus for forming shaped axial bores through spinal vertebrae
EP1578315B2 (en) 2000-02-16 2011-12-07 TRANS1, Inc. Apparatus for spinal distraction and fusion
US6740093B2 (en) * 2000-02-28 2004-05-25 Stephen Hochschuler Method and apparatus for treating a vertebral body
EP1272131B1 (en) * 2000-04-05 2006-03-01 Kyphon Inc. Devices for treating fractured and/or diseased bone
DE10064202A1 (en) 2000-05-25 2001-11-29 Pajunk Gmbh Device for applying bone cement and cannula for such a device
WO2001093787A2 (en) * 2000-06-08 2001-12-13 Cook Incorporated High pressure injection syringe
WO2001093768A1 (en) * 2000-06-09 2001-12-13 Synthes Ag Chur Osteosynthesis implant from a plastic material
US6749595B1 (en) 2000-06-15 2004-06-15 Kieran P. J. Murphy Cement delivery needle
JP2004500963A (en) * 2000-06-27 2004-01-15 カイフォン インコーポレイテッド System and method for injecting flowable material into bone
JP4611607B2 (en) 2000-06-30 2011-01-12 ジンテーズ ゲゼルシャフト ミト ベシュレンクテル ハフツング Bone cement injection equipment
WO2002017801A2 (en) 2000-07-14 2002-03-07 Kyphon Inc. Systems and methods for treating vertebral bodies
US20080086133A1 (en) * 2003-05-16 2008-04-10 Spineology Expandable porous mesh bag device and methods of use for reduction, filling, fixation and supporting of bone
DE60141653D1 (en) * 2000-07-21 2010-05-06 Spineology Group Llc A STRONG, POROUS NET BAG DEVICE AND ITS USE IN BONE SURGERY
MY133943A (en) 2000-08-22 2007-11-30 Synthes Gmbh Bone replacement material
AU2008207386B2 (en) * 2001-02-12 2010-12-16 Modmed Therapeutics, Inc. Multi-use surgical cement dispenser apparatus
AU2005204244B2 (en) * 2001-02-12 2008-05-22 Modmed Therapeutics, Inc Multi-use surgical cement dispenser apparatus
US7371241B2 (en) * 2001-02-12 2008-05-13 Modmed Therapeutics, Inc. Multi-use surgical cement dispenser apparatus and kit for same
US7008433B2 (en) 2001-02-15 2006-03-07 Depuy Acromed, Inc. Vertebroplasty injection device
CN1835720B (en) * 2001-07-25 2011-09-28 Disc整形外科技术股份有限公司 Deformable tools and implants
US6793660B2 (en) 2001-08-20 2004-09-21 Synthes (U.S.A.) Threaded syringe for delivery of a bone substitute material
US6582438B2 (en) * 2001-09-28 2003-06-24 Imp, Inc. Bone graft inserter device
JP3993855B2 (en) * 2001-11-01 2007-10-17 スパイン・ウェイブ・インコーポレーテッド Device for spinal disc recovery
US6780191B2 (en) 2001-12-28 2004-08-24 Yacmur Llc Cannula system
TW200400062A (en) * 2002-04-03 2004-01-01 Mathys Medizinaltechnik Ag Kneadable, pliable bone replacement material
ITVI20020140A1 (en) 2002-06-26 2003-12-29 Tecres Spa DEVICE FOR THE MANUAL DOSING OF A MEDICAL FLUID, PARTICULARLY BONE CEMENT
JP4495589B2 (en) * 2002-08-27 2010-07-07 ウォーソー・オーソペディック・インコーポレーテッド System for intravertebral reduction
US8808284B2 (en) 2008-09-26 2014-08-19 Relievant Medsystems, Inc. Systems for navigating an instrument through bone
US6907884B2 (en) 2002-09-30 2005-06-21 Depay Acromed, Inc. Method of straddling an intraosseous nerve
US8361067B2 (en) 2002-09-30 2013-01-29 Relievant Medsystems, Inc. Methods of therapeutically heating a vertebral body to treat back pain
US7258690B2 (en) 2003-03-28 2007-08-21 Relievant Medsystems, Inc. Windowed thermal ablation probe
US7488337B2 (en) * 2002-09-30 2009-02-10 Saab Mark A Apparatus and methods for bone, tissue and duct dilatation
US9782572B2 (en) 2002-09-30 2017-10-10 Nordson Corporation Apparatus and methods for treating bone structures, tissues and ducts using a narrow gauge cannula system
US8613744B2 (en) 2002-09-30 2013-12-24 Relievant Medsystems, Inc. Systems and methods for navigating an instrument through bone
WO2004041075A2 (en) * 2002-11-05 2004-05-21 Spineology, Inc. A semi-biological intervertebral disc replacement system
US6951562B2 (en) * 2002-11-13 2005-10-04 Ralph Fritz Zwirnmann Adjustable length tap and method for drilling and tapping a bore in bone
US7776042B2 (en) * 2002-12-03 2010-08-17 Trans1 Inc. Methods and apparatus for provision of therapy to adjacent motion segments
IL166017A0 (en) * 2004-12-28 2006-01-15 Disc O Tech Medical Tech Ltd Materials devices and methods for treating bones
AU2003249828B2 (en) * 2003-08-08 2007-06-14 Synthes Gmbh Method for impregnating a porous bone substitute material
AU2004273794A1 (en) * 2003-09-05 2005-03-31 Norian Corporation Bone cement compositions having fiber-reinforcement and/or increased flowability
AU2004283727A1 (en) * 2003-10-23 2005-05-06 Trans1 Inc. Tools and tool kits for performing minimally invasive procedures on the spine
WO2005041793A2 (en) * 2003-10-23 2005-05-12 Trans1, Inc. Spinal mobility preservation apparatus and method
EP1596736B1 (en) * 2003-11-18 2006-08-30 SOMATEX Medical Technologies GmbH Injection pump
US20050113843A1 (en) * 2003-11-25 2005-05-26 Arramon Yves P. Remotely actuated system for bone cement delivery
US7608092B1 (en) 2004-02-20 2009-10-27 Biomet Sports Medicince, LLC Method and apparatus for performing meniscus repair
WO2005084684A1 (en) * 2004-03-05 2005-09-15 Synthes Ag Chur Use of a mixture for the production of an agent for treating defective or degenerated cartilage in the production of natural cartilage replacement in vitro
US20050222538A1 (en) * 2004-03-30 2005-10-06 Sdgi Holdings, Inc. Surgical system for delivery of viscous fluids
US20060062825A1 (en) * 2004-04-19 2006-03-23 Maria Maccecchini Method of implanting a sterile, active agent-coated material and composition made according to same
WO2005105121A1 (en) * 2004-05-05 2005-11-10 Synthes Gmbh Use of platelets or platelet rich plasma (prp)
WO2005110506A1 (en) * 2004-05-13 2005-11-24 Synthes Gmbh Resorbable polymeric medical goods with improved mechanical properties and method for producing same
US8142462B2 (en) 2004-05-28 2012-03-27 Cavitech, Llc Instruments and methods for reducing and stabilizing bone fractures
JP4414461B2 (en) * 2004-06-03 2010-02-10 ジンテーズ ゲゼルシャフト ミト ベシュレンクテル ハフツング Device for impregnation of porous bone substitute material
US20050278023A1 (en) 2004-06-10 2005-12-15 Zwirkoski Paul A Method and apparatus for filling a cavity
TWI374036B (en) 2004-06-10 2012-10-11 Sean Kerr Flexible bone composite
JP2008504913A (en) * 2004-07-06 2008-02-21 ジンテーズ ゲゼルシャフト ミト ベシュレンクテル ハフツング Colored coatings that generate interference for surgical implants and devices
EP1771490B1 (en) 2004-07-26 2019-01-02 Synthes GmbH Biocompatible, biodegradable polyurethane materials with controlled hydrophobic to hydrophilic ratio
US8038682B2 (en) 2004-08-17 2011-10-18 Boston Scientific Scimed, Inc. Apparatus and methods for delivering compounds into vertebrae for vertebroplasty
US20060058788A1 (en) * 2004-08-27 2006-03-16 Hammer Michael A Multi-axial connection system
US8951290B2 (en) * 2004-08-27 2015-02-10 Blackstone Medical, Inc. Multi-axial connection system
US8597360B2 (en) 2004-11-03 2013-12-03 Neuropro Technologies, Inc. Bone fusion device
US8303604B2 (en) 2004-11-05 2012-11-06 Biomet Sports Medicine, Llc Soft tissue repair device and method
US7857830B2 (en) 2006-02-03 2010-12-28 Biomet Sports Medicine, Llc Soft tissue repair and conduit device
US8137382B2 (en) 2004-11-05 2012-03-20 Biomet Sports Medicine, Llc Method and apparatus for coupling anatomical features
US9017381B2 (en) 2007-04-10 2015-04-28 Biomet Sports Medicine, Llc Adjustable knotless loops
US20060189993A1 (en) 2004-11-09 2006-08-24 Arthrotek, Inc. Soft tissue conduit device
US7909851B2 (en) 2006-02-03 2011-03-22 Biomet Sports Medicine, Llc Soft tissue repair device and associated methods
US8088130B2 (en) 2006-02-03 2012-01-03 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to a bone
US7905903B2 (en) 2006-02-03 2011-03-15 Biomet Sports Medicine, Llc Method for tissue fixation
US8298262B2 (en) 2006-02-03 2012-10-30 Biomet Sports Medicine, Llc Method for tissue fixation
US8128658B2 (en) 2004-11-05 2012-03-06 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to bone
US9801708B2 (en) 2004-11-05 2017-10-31 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to a bone
US7905904B2 (en) 2006-02-03 2011-03-15 Biomet Sports Medicine, Llc Soft tissue repair device and associated methods
US8118836B2 (en) 2004-11-05 2012-02-21 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to a bone
US7749250B2 (en) 2006-02-03 2010-07-06 Biomet Sports Medicine, Llc Soft tissue repair assembly and associated method
US8361113B2 (en) 2006-02-03 2013-01-29 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to a bone
US7658751B2 (en) 2006-09-29 2010-02-09 Biomet Sports Medicine, Llc Method for implanting soft tissue
US8840645B2 (en) 2004-11-05 2014-09-23 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to a bone
US8998949B2 (en) 2004-11-09 2015-04-07 Biomet Sports Medicine, Llc Soft tissue conduit device
US20060133193A1 (en) * 2004-12-17 2006-06-22 Arthrocare Corporation High pressure injection system for delivering therapeutic agents having fluid tight connector
US20060164913A1 (en) * 2005-01-21 2006-07-27 Arthrocare Corporation Multi-chamber integrated mixing and delivery system
EP2319440B1 (en) 2005-02-22 2015-12-16 Depuy Spine Inc. Materials for treating bone
ES2561493T3 (en) 2005-02-22 2016-02-26 Depuy Spine, Inc. Bone treatment materials
US20060265077A1 (en) * 2005-02-23 2006-11-23 Zwirkoski Paul A Spinal repair
CA2602201C (en) * 2005-03-24 2013-03-12 Synthes Gmbh Device for the cement augmentation of bone implants
WO2006118884A2 (en) * 2005-04-29 2006-11-09 Wyeth Drug delivery devices and related components, systems and methods
US7578823B2 (en) * 2005-04-29 2009-08-25 Warsaw Orthopedic, Inc. Delivery tool and method for delivering bone growth material
US7914810B2 (en) * 2005-05-06 2011-03-29 Synthes Usa, Llc Methods for the in situ treatment of bone cancer
CN101193834B (en) * 2005-06-09 2012-08-08 罗伯特·马泰斯·斯蒂夫腾 Formed article
IL174347A0 (en) 2005-07-31 2006-08-20 Disc O Tech Medical Tech Ltd Bone cement and methods of use thereof
CN101237834B (en) * 2005-08-10 2012-12-26 斯恩蒂斯有限公司 Porous implant
EP1933936B1 (en) 2005-10-13 2019-03-20 Synthes GmbH Drug-impregnated encasement
US8641667B2 (en) * 2005-10-20 2014-02-04 DePuy Synthes Products, LLC Perfusion device and method
US9468433B2 (en) 2006-02-03 2016-10-18 Biomet Sports Medicine, Llc Method and apparatus for forming a self-locking adjustable loop
US8771352B2 (en) 2011-05-17 2014-07-08 Biomet Sports Medicine, Llc Method and apparatus for tibial fixation of an ACL graft
US8574235B2 (en) 2006-02-03 2013-11-05 Biomet Sports Medicine, Llc Method for trochanteric reattachment
US8506597B2 (en) 2011-10-25 2013-08-13 Biomet Sports Medicine, Llc Method and apparatus for interosseous membrane reconstruction
US11311287B2 (en) 2006-02-03 2022-04-26 Biomet Sports Medicine, Llc Method for tissue fixation
US10517587B2 (en) 2006-02-03 2019-12-31 Biomet Sports Medicine, Llc Method and apparatus for forming a self-locking adjustable loop
US8652172B2 (en) 2006-02-03 2014-02-18 Biomet Sports Medicine, Llc Flexible anchors for tissue fixation
US8968364B2 (en) 2006-02-03 2015-03-03 Biomet Sports Medicine, Llc Method and apparatus for fixation of an ACL graft
US7959650B2 (en) 2006-09-29 2011-06-14 Biomet Sports Medicine, Llc Adjustable knotless loops
US9078644B2 (en) 2006-09-29 2015-07-14 Biomet Sports Medicine, Llc Fracture fixation device
US8562645B2 (en) 2006-09-29 2013-10-22 Biomet Sports Medicine, Llc Method and apparatus for forming a self-locking adjustable loop
US8652171B2 (en) 2006-02-03 2014-02-18 Biomet Sports Medicine, Llc Method and apparatus for soft tissue fixation
US11259792B2 (en) 2006-02-03 2022-03-01 Biomet Sports Medicine, Llc Method and apparatus for coupling anatomical features
US9538998B2 (en) 2006-02-03 2017-01-10 Biomet Sports Medicine, Llc Method and apparatus for fracture fixation
US9271713B2 (en) 2006-02-03 2016-03-01 Biomet Sports Medicine, Llc Method and apparatus for tensioning a suture
US8597327B2 (en) 2006-02-03 2013-12-03 Biomet Manufacturing, Llc Method and apparatus for sternal closure
US8251998B2 (en) 2006-08-16 2012-08-28 Biomet Sports Medicine, Llc Chondral defect repair
US9149267B2 (en) 2006-02-03 2015-10-06 Biomet Sports Medicine, Llc Method and apparatus for coupling soft tissue to a bone
US8562647B2 (en) 2006-09-29 2013-10-22 Biomet Sports Medicine, Llc Method and apparatus for securing soft tissue to bone
US8801783B2 (en) 2006-09-29 2014-08-12 Biomet Sports Medicine, Llc Prosthetic ligament system for knee joint
US20070191788A1 (en) * 2006-02-16 2007-08-16 Volskay Timothy K Pre-primed IV tubing
US7922690B2 (en) * 2006-02-22 2011-04-12 Michael Plishka Curable material delivery device
US8128632B2 (en) 2006-05-22 2012-03-06 Orthovita, Inc. Delivery of multicomponent compositions
US20080058673A1 (en) * 2006-08-29 2008-03-06 Lex Jansen Tissue extraction device and method of using the same
US20080058674A1 (en) * 2006-08-29 2008-03-06 Lex Jansen Tissue extraction device and method of using the same
US20080065088A1 (en) * 2006-09-07 2008-03-13 Wyeth Bone Cement Mixing Systems and Related Methods
WO2008033501A2 (en) * 2006-09-14 2008-03-20 Spineology, Inc. Absorbent fabric implant
US8672969B2 (en) 2006-09-29 2014-03-18 Biomet Sports Medicine, Llc Fracture fixation device
US11259794B2 (en) 2006-09-29 2022-03-01 Biomet Sports Medicine, Llc Method for implanting soft tissue
US9918826B2 (en) 2006-09-29 2018-03-20 Biomet Sports Medicine, Llc Scaffold for spring ligament repair
US8500818B2 (en) 2006-09-29 2013-08-06 Biomet Manufacturing, Llc Knee prosthesis assembly with ligament link
US20080114364A1 (en) * 2006-11-15 2008-05-15 Aoi Medical, Inc. Tissue cavitation device and method
US8197491B2 (en) 2006-12-19 2012-06-12 Synthes Usa, Llc Injectable fastener system and method
US7947065B2 (en) 2008-11-14 2011-05-24 Ortho Innovations, Llc Locking polyaxial ball and socket fastener
US8197518B2 (en) 2007-05-16 2012-06-12 Ortho Innovations, Llc Thread-thru polyaxial pedicle screw system
US7942910B2 (en) * 2007-05-16 2011-05-17 Ortho Innovations, Llc Polyaxial bone screw
US7942909B2 (en) 2009-08-13 2011-05-17 Ortho Innovations, Llc Thread-thru polyaxial pedicle screw system
US7951173B2 (en) 2007-05-16 2011-05-31 Ortho Innovations, Llc Pedicle screw implant system
US7942911B2 (en) 2007-05-16 2011-05-17 Ortho Innovations, Llc Polyaxial bone screw
CA2692002A1 (en) * 2007-05-21 2008-11-27 Aoi Medical Inc. Articulating cavitation device
US20090054934A1 (en) * 2007-07-25 2009-02-26 Depuy Spine, Inc. Expandable fillers for bone cement
US8556949B2 (en) 2007-11-14 2013-10-15 DePuy Synthes Products, LLC Hybrid bone fixation element and methods of using the same
US9510885B2 (en) 2007-11-16 2016-12-06 Osseon Llc Steerable and curvable cavity creation system
US20090131867A1 (en) 2007-11-16 2009-05-21 Liu Y King Steerable vertebroplasty system with cavity creation element
CA2719490A1 (en) * 2008-03-28 2009-10-01 Spineology Inc. Method and device for interspinous process fusion
ITVR20080067A1 (en) * 2008-06-11 2009-12-12 Tecres Spa DEVICE FOR SURGICAL USE
KR20100030153A (en) * 2008-09-09 2010-03-18 삼성전자주식회사 Fuel cell system and method to supply fuel the same
US10028753B2 (en) 2008-09-26 2018-07-24 Relievant Medsystems, Inc. Spine treatment kits
CA2957010C (en) 2008-09-26 2017-07-04 Relievant Medsystems, Inc. Systems and methods for navigating an instrument through bone
EP2361568A1 (en) * 2008-10-17 2011-08-31 St. Marianna University School of Medicine Bone cement injection needle
JP5804325B2 (en) * 2008-10-30 2015-11-04 デピュイ・シンセス・プロダクツ・インコーポレイテッド System and method for delivering bone cement to a bone anchor
US7805920B2 (en) * 2008-11-13 2010-10-05 The Toro Company Lawn mower having steeply inclined exit tunnel and battery access through rear face of mower cutting deck
US8075603B2 (en) 2008-11-14 2011-12-13 Ortho Innovations, Llc Locking polyaxial ball and socket fastener
US20100160921A1 (en) * 2008-12-19 2010-06-24 Arthrocare Corporation Cancellous bone displacement system and methods of use
WO2010094032A2 (en) 2009-02-16 2010-08-19 Aoi Medical Inc. Trauma nail accumulator
EP2413992B1 (en) 2009-04-03 2019-07-03 Zimmer Biomet Spine, Inc. Apparatus for delivering bone cement
US20100298832A1 (en) 2009-05-20 2010-11-25 Osseon Therapeutics, Inc. Steerable curvable vertebroplasty drill
US8343227B2 (en) 2009-05-28 2013-01-01 Biomet Manufacturing Corp. Knee prosthesis assembly with ligament link
US8747472B2 (en) * 2009-08-14 2014-06-10 Baxano Surgical, Inc. Spinal therapy device with fixated distraction distance
US9220554B2 (en) 2010-02-18 2015-12-29 Globus Medical, Inc. Methods and apparatus for treating vertebral fractures
WO2011137377A1 (en) 2010-04-29 2011-11-03 Dfine, Inc. System for use in treatment of vertebral fractures
CN103108660A (en) 2010-07-26 2013-05-15 华沙整形外科股份有限公司 Calcium particle-embedded, snap-to-dough, high-viscosity bone cement
EP2611373B1 (en) 2010-08-30 2015-11-04 Zimmer Spine, Inc. Polyaxial pedicle screw
US20120064481A1 (en) * 2010-09-13 2012-03-15 Wade Cannon Composite delivery system
EP2688631B1 (en) 2011-03-25 2021-12-01 Nordson Corporation Apparatus and methods for accessing and dilating bone structures using a narrow gauge cannula
US8603096B2 (en) 2011-06-10 2013-12-10 Globus Medical, Inc. Biomaterial dispensing device
DE102011107374A1 (en) 2011-06-29 2013-01-03 Heraeus Medical Gmbh Apparatus for application of bone cement in bone cavities, has lever arm which is connected with another lever arm over joint, where one of both lever arms has sleeve for receiving syringe
US9119639B2 (en) 2011-08-09 2015-09-01 DePuy Synthes Products, Inc. Articulated cavity creator
WO2013023096A1 (en) 2011-08-09 2013-02-14 Neuropro Technologies, Inc. Bone fusion device, system and method
US9358123B2 (en) 2011-08-09 2016-06-07 Neuropro Spinal Jaxx, Inc. Bone fusion device, apparatus and method
US9155580B2 (en) 2011-08-25 2015-10-13 Medos International Sarl Multi-threaded cannulated bone anchors
US9357991B2 (en) 2011-11-03 2016-06-07 Biomet Sports Medicine, Llc Method and apparatus for stitching tendons
US9314241B2 (en) 2011-11-10 2016-04-19 Biomet Sports Medicine, Llc Apparatus for coupling soft tissue to a bone
US9370350B2 (en) 2011-11-10 2016-06-21 Biomet Sports Medicine, Llc Apparatus for coupling soft tissue to a bone
US9381013B2 (en) 2011-11-10 2016-07-05 Biomet Sports Medicine, Llc Method for coupling soft tissue to a bone
TWI590843B (en) 2011-12-28 2017-07-11 信迪思有限公司 Films and methods of manufacture
WO2013101772A1 (en) 2011-12-30 2013-07-04 Relievant Medsystems, Inc. Systems and methods for treating back pain
US9259217B2 (en) 2012-01-03 2016-02-16 Biomet Manufacturing, Llc Suture Button
US9155578B2 (en) 2012-02-28 2015-10-13 DePuy Synthes Products, Inc. Expandable fastener
US9532883B2 (en) 2012-04-13 2017-01-03 Neuropro Technologies, Inc. Bone fusion device
EP3593740B1 (en) 2012-06-20 2021-10-06 Stryker Corporation System for off-axis tissue manipulation
US10588691B2 (en) 2012-09-12 2020-03-17 Relievant Medsystems, Inc. Radiofrequency ablation of tissue within a vertebral body
CA2889478C (en) 2012-11-05 2020-11-24 Relievant Medsystems, Inc. Systems and methods for creating curved paths through bone and modulating nerves within the bone
EP2740429A1 (en) 2012-12-06 2014-06-11 Heraeus Medical GmbH Device for the application of bone cement
US9241729B2 (en) 2012-12-14 2016-01-26 DePuy Synthes Products, Inc. Device to aid in the deployment of a shape memory instrument
US10285818B2 (en) * 2012-12-26 2019-05-14 Symbiomedik, Llc Apparatus, kit, and method for percutaneous intervertebral disc restoration
US9439693B2 (en) 2013-02-01 2016-09-13 DePuy Synthes Products, Inc. Steerable needle assembly for use in vertebral body augmentation
US9757119B2 (en) 2013-03-08 2017-09-12 Biomet Sports Medicine, Llc Visual aid for identifying suture limbs arthroscopically
US9918827B2 (en) 2013-03-14 2018-03-20 Biomet Sports Medicine, Llc Scaffold for spring ligament repair
WO2014159225A2 (en) 2013-03-14 2014-10-02 Baxano Surgical, Inc. Spinal implants and implantation system
US10098757B2 (en) 2013-03-15 2018-10-16 Neuropro Technologies Inc. Bodiless bone fusion device, apparatus and method
WO2014176141A2 (en) * 2013-04-24 2014-10-30 Medovex Corp. Minimally invasive methods for spinal facet therapy to alleviate pain and associated surgical tools, kits and instructional media
US9453526B2 (en) 2013-04-30 2016-09-27 Degen Medical, Inc. Bottom-loading anchor assembly
KR102249720B1 (en) 2013-06-21 2021-05-11 디퍼이 신테스 프로덕츠, 인코포레이티드 Films and methods of manufacture
US9724151B2 (en) 2013-08-08 2017-08-08 Relievant Medsystems, Inc. Modulating nerves within bone using bone fasteners
US10136886B2 (en) 2013-12-20 2018-11-27 Biomet Sports Medicine, Llc Knotless soft tissue devices and techniques
US9707314B2 (en) * 2014-03-26 2017-07-18 DePuy Synthes Products, Inc. Acrylic bone cement having a delayed release polymerization inhibitor such as an anti-oxidant for increased working time
US9615822B2 (en) 2014-05-30 2017-04-11 Biomet Sports Medicine, Llc Insertion tools and method for soft anchor
US9700291B2 (en) 2014-06-03 2017-07-11 Biomet Sports Medicine, Llc Capsule retractor
US10357257B2 (en) * 2014-07-14 2019-07-23 KB Medical SA Anti-skid surgical instrument for use in preparing holes in bone tissue
US10398494B2 (en) 2014-07-30 2019-09-03 Medovex Corp. Surgical tools for spinal facet therapy to alleviate pain and related methods
US10039543B2 (en) 2014-08-22 2018-08-07 Biomet Sports Medicine, Llc Non-sliding soft anchor
US9955980B2 (en) 2015-02-24 2018-05-01 Biomet Sports Medicine, Llc Anatomic soft tissue repair
US9974534B2 (en) 2015-03-31 2018-05-22 Biomet Sports Medicine, Llc Suture anchor with soft anchor of electrospun fibers
CN109862834B (en) 2016-10-27 2022-05-24 Dfine有限公司 Bendable osteotome with cement delivery channel
US11116570B2 (en) 2016-11-28 2021-09-14 Dfine, Inc. Tumor ablation devices and related methods
US10463380B2 (en) 2016-12-09 2019-11-05 Dfine, Inc. Medical devices for treating hard tissues and related methods
EP3565486B1 (en) 2017-01-06 2021-11-10 Dfine, Inc. Osteotome with a distal portion for simultaneous advancement and articulation
US10729560B2 (en) 2017-01-18 2020-08-04 Neuropro Technologies, Inc. Bone fusion system, device and method including an insertion instrument
US10213321B2 (en) * 2017-01-18 2019-02-26 Neuropro Technologies, Inc. Bone fusion system, device and method including delivery apparatus
US10973657B2 (en) 2017-01-18 2021-04-13 Neuropro Technologies, Inc. Bone fusion surgical system and method
US10111760B2 (en) 2017-01-18 2018-10-30 Neuropro Technologies, Inc. Bone fusion system, device and method including a measuring mechanism
US11419733B2 (en) 2018-01-12 2022-08-23 Percheron Spine, Llc Spinal disc implant and device and method for percutaneous delivery of the spinal disc implant
US11510723B2 (en) 2018-11-08 2022-11-29 Dfine, Inc. Tumor ablation device and related systems and methods
EP4027912A4 (en) 2019-09-12 2023-08-16 Relievant Medsystems, Inc. Systems and methods for tissue modulation

Citations (96)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US29083A (en) * 1860-07-10 Benjamin irving
US115794A (en) * 1871-06-06 Improvement in stop-valves
US1142210A (en) * 1912-02-29 1915-06-08 Rayvio Water Company Liquid-dispensing device.
US2002610A (en) * 1931-09-18 1935-05-28 Elmer L Nall Fluid dispensing device
US2676475A (en) * 1951-10-12 1954-04-27 Ronson Art Metal Works Inc Cigar lighter structure
US2919692A (en) * 1956-02-23 1960-01-05 Ackermann Wolfgang Vertebral trephine biopsy instruments
US2973758A (en) * 1956-12-27 1961-03-07 Invenex Pharmaceuticals Apparatus for manufacturing parenteral solutions
US3581399A (en) * 1969-08-08 1971-06-01 Centrix Inc Composite resin filling syringe and technique
US3701771A (en) * 1969-06-27 1972-10-31 Nyegaard & Co As N-(2,4,6-triiodobenzoyl)-sugar amines
US3750667A (en) * 1972-01-31 1973-08-07 N Pshenichny Device for intraosseous injection of liquid substances
US3835890A (en) * 1973-03-29 1974-09-17 Uniroyal Inc Buoyant liquid-conveying hose
US3882858A (en) * 1973-04-21 1975-05-13 Merck Patent Gmbh Surgical synthetic-resin material and method of treating osteomyelitis
US3900954A (en) * 1974-07-10 1975-08-26 William B Dragan Dental filling gun and nozzle tip therefor
US3919773A (en) * 1973-12-20 1975-11-18 Sybron Corp Direct moldable implant material
US4011685A (en) * 1974-06-24 1977-03-15 Boyd William A Plant injection method and apparatus
US4032118A (en) * 1975-10-21 1977-06-28 Phillips Edwin D Sealing means for stirring apparatus
US4155969A (en) * 1975-09-02 1979-05-22 Ex-Cell-O Corporation Method for injection foam molding
US4184490A (en) * 1978-08-23 1980-01-22 John Jacklich Precision endodontic syringe
US4189065A (en) * 1976-02-04 1980-02-19 Espe Fabrik Pharmazeutischer Praeparate Gmbh Metering dispenser for high-viscosity compositions
US4274163A (en) * 1979-07-16 1981-06-23 The Regents Of The University Of California Prosthetic fixation technique
US4288355A (en) * 1978-05-22 1981-09-08 Minnesota Mining And Manufacturing Company Surgical cement composition
US4312343A (en) * 1979-07-30 1982-01-26 Leveen Harry H Syringe
US4341691A (en) * 1980-02-20 1982-07-27 Zimmer, Inc. Low viscosity bone cement
US4373217A (en) * 1979-02-16 1983-02-15 Merck Patent Gesellschaft Mit Beschrankter Haftung Implantation materials and a process for the production thereof
US4374093A (en) * 1981-02-20 1983-02-15 Mobil Oil Corporation Continuous-stream upflow zeolite crystallization apparatus
US4404327A (en) * 1979-10-31 1983-09-13 Crugnola Aldo M Orthopaedic cement from acrylate polymers
US4448188A (en) * 1982-02-18 1984-05-15 Laserscope, Inc. Method for providing an oxygen bearing liquid to a blood vessel for the performance of a medical procedure
US4469109A (en) * 1981-12-24 1984-09-04 Creative Research And Manufacturing Inc. Bone marrow aspiration needle
US4610692A (en) * 1981-02-20 1986-09-09 Mundipharma Gmbh Implant for filling bone cavities and fixing bone fragments in a living body, method of producing the same, and bone implant system
US4614437A (en) * 1984-11-02 1986-09-30 Dougherty Brothers Company Mixing container and adapter
US4637931A (en) * 1984-10-09 1987-01-20 The United States Of America As Represented By The Secretary Of The Army Polyactic-polyglycolic acid copolymer combined with decalcified freeze-dried bone for use as a bone repair material
US4653489A (en) * 1984-04-02 1987-03-31 Tronzo Raymond G Fenestrated hip screw and method of augmented fixation
US4670008A (en) * 1985-07-01 1987-06-02 Albertini Beat High flux threaded needle
US4671263A (en) * 1984-07-11 1987-06-09 Klaus Draenert Device and process for mixing and applying bone cement
US4728570A (en) * 1985-10-29 1988-03-01 United States Surgical Corporation Calcium-hydroxide-treated polymeric implant matrial
US4795444A (en) * 1986-05-02 1989-01-03 Sunstar Kabushiki Kaisha Syringe
US4798596A (en) * 1985-10-07 1989-01-17 Muehlbauer Ernst Applicator syringe for a dental compound
US4815454A (en) * 1987-11-16 1989-03-28 Dozier Jr John K Apparatus and method for injecting bone cement
US4837279A (en) * 1988-02-22 1989-06-06 Pfizer Hospital Products Corp, Inc. Bone cement
US4838282A (en) * 1987-02-26 1989-06-13 Manan Manufacturing Co., Inc. Bone biopsy needle assembly
US4863072A (en) * 1987-08-18 1989-09-05 Robert Perler Single hand operable dental composite package
US4900546A (en) * 1987-07-30 1990-02-13 Pfizer Hospital Products Group, Inc. Bone cement for sustained release of substances
US4921479A (en) * 1987-10-02 1990-05-01 Joseph Grayzel Catheter sheath with longitudinal seam
US4929238A (en) * 1988-11-23 1990-05-29 Coeur Laboratories, Inc. Multi-pressure injector device
US4966601A (en) * 1986-03-21 1990-10-30 Klaus Draenert Evacuatable bone cement syringe
US4986814A (en) * 1988-06-13 1991-01-22 Indianapolis Center For Advanced Research One-punch catheter
US5014717A (en) * 1989-02-10 1991-05-14 Lohrmann Guenter Punch-biopsy apparatus with cannula-aiming device
US5108404A (en) * 1989-02-09 1992-04-28 Arie Scholten Surgical protocol for fixation of bone using inflatable device
US5112354A (en) * 1989-11-16 1992-05-12 Northwestern University Bone allograft material and method
US5195525A (en) * 1990-11-26 1993-03-23 Pelc Norbert J Noninvasive myocardial motion analysis using phase contrast mri maps of myocardial velocity
US5282861A (en) * 1992-03-11 1994-02-01 Ultramet Open cell tantalum structures for cancellous bone implants and cell and tissue receptors
US5290260A (en) * 1991-05-31 1994-03-01 Vance Products Incorporated Rotational pressure drive for a medical syringe
US5304586A (en) * 1989-01-30 1994-04-19 Dentsply Research & Development Corp. Radiopaque fluoride releasing VLC dental composites and the use of specific fillers therein
US5336699A (en) * 1992-02-20 1994-08-09 Orthopaedic Research Institute Bone cement having chemically joined reinforcing fillers
US5336263A (en) * 1992-04-06 1994-08-09 Robert A. Ersek Treatment of urological and gastric fluid reflux disorders by injection of mmicro particles
US5341816A (en) * 1989-11-06 1994-08-30 Allen William C Biopsy device
US5344232A (en) * 1991-09-30 1994-09-06 Stryker Corporation Bone cement mixing and loading apparatus
US5346495A (en) * 1994-02-28 1994-09-13 Vargas Iii Joseph H Biomedical cement applicator
US5431654A (en) * 1991-09-30 1995-07-11 Stryker Corporation Bone cement injector
US5451406A (en) * 1994-07-14 1995-09-19 Advanced Uroscience, Inc. Tissue injectable composition and method of use
US5456267A (en) * 1994-03-18 1995-10-10 Stark; John G. Bone marrow harvesting systems and methods and bone biopsy systems and methods
US5507813A (en) * 1993-12-09 1996-04-16 Osteotech, Inc. Shaped materials derived from elongate bone particles
US5514137A (en) * 1993-12-06 1996-05-07 Coutts; Richard D. Fixation of orthopedic devices
US5527298A (en) * 1990-06-11 1996-06-18 Schneider (Usa) Inc. Tracking guidewire
US5558136A (en) * 1994-01-31 1996-09-24 Stryker Corporation Bone cement cartridge with secondary piston
US5591171A (en) * 1991-06-14 1997-01-07 Brown; Byron L. Adapter and method for measuring pressures of fluid materials
US5599305A (en) * 1994-10-24 1997-02-04 Cardiovascular Concepts, Inc. Large-diameter introducer sheath having hemostasis valve and removable steering mechanism
US5599315A (en) * 1995-12-01 1997-02-04 Charles J. McPhee Syringe actuation device
US5603701A (en) * 1995-03-27 1997-02-18 Ultradent Products, Inc. Syringe apparatus with threaded plunger for delivering tooth composites and other solid yet pliable materials
US5647856A (en) * 1993-09-23 1997-07-15 Heraeus Kulzer Gmbh Syringe for the controlled discharge of viscous materials
US5650108A (en) * 1994-10-06 1997-07-22 Merck Patent Gesellschaft Mit Beschrankter Haftung Porous bone replacement materials
US5653730A (en) * 1993-09-28 1997-08-05 Hemodynamics, Inc. Surface opening adhesive sealer
US5658332A (en) * 1994-06-30 1997-08-19 Orthovita, Inc. Bioactive granules for bone tissue formation
US5660186A (en) * 1995-06-07 1997-08-26 Marshfield Clinic Spiral biopsy stylet
US5676146A (en) * 1996-09-13 1997-10-14 Osteotech, Inc. Surgical implant containing a resorbable radiopaque marker and method of locating such within a body
US5681872A (en) * 1995-12-07 1997-10-28 Orthovita, Inc. Bioactive load bearing bone graft compositions
US5788702A (en) * 1992-06-15 1998-08-04 Draenert; Klaus Applicator system
US5792478A (en) * 1996-07-08 1998-08-11 Advanced Uro Science Tissue injectable composition and method of use
US5795922A (en) * 1995-06-06 1998-08-18 Clemson University Bone cement composistion containing microencapsulated radiopacifier and method of making same
US5797679A (en) * 1996-02-09 1998-08-25 Stryker Corporation Surgical cement mixer apparatus
US5800405A (en) * 1995-12-01 1998-09-01 I-Flow Corporation Syringe actuation device
US5873855A (en) * 1992-01-07 1999-02-23 Arthrocare Corporation Systems and methods for electrosurgical myocardial revascularization
US5885238A (en) * 1991-07-16 1999-03-23 Heartport, Inc. System for cardiac procedures
US6019765A (en) * 1998-05-06 2000-02-01 Johnson & Johnson Professional, Inc. Morsellized bone allograft applicator device
US6019747A (en) * 1997-10-21 2000-02-01 I-Flow Corporation Spring-actuated infusion syringe
US6033105A (en) * 1996-11-15 2000-03-07 Barker; Donald Integrated bone cement mixing and dispensing system
US6042262A (en) * 1997-07-29 2000-03-28 Stryker Technologies Corportion Apparatus for storing, mixing, and dispensing two-component bone cement
US6080801A (en) * 1990-09-13 2000-06-27 Klaus Draenert Multi-component material and process for its preparation
US6277112B1 (en) * 1996-07-16 2001-08-21 Arthrocare Corporation Methods for electrosurgical spine surgery
US6383190B1 (en) * 1998-04-01 2002-05-07 Parallax Medical, Inc. High pressure applicator
US6468279B1 (en) * 1998-01-27 2002-10-22 Kyphon Inc. Slip-fit handle for hand-held instruments that access interior body regions
US6554803B1 (en) * 1997-04-02 2003-04-29 Arthur Ashman Combination syringe and aspirator for bone regeneration material and method for using the syringe
US6602248B1 (en) * 1995-06-07 2003-08-05 Arthro Care Corp. Methods for repairing damaged intervertebral discs
US6712794B2 (en) * 2001-08-21 2004-03-30 Spinal Specialties, Inc. Apparatus for delivering a viscous liquid to a surgical site
US6875219B2 (en) * 2003-02-14 2005-04-05 Yves P. Arramon Bone access system
US20050119650A1 (en) * 2003-10-20 2005-06-02 Arthrocare Corporation Electrosurgical method and apparatus for removing tissue within a bone body

Family Cites Families (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3835860A (en) 1973-06-21 1974-09-17 H Garretson Surgical bone punch
DE2909439A1 (en) 1979-03-08 1980-09-18 Schering Ag NEW NON-ionic x-ray contrast agents
US4338925A (en) 1979-12-20 1982-07-13 Jo Miller Pressure injection of bone cement apparatus and method
US4595006A (en) * 1982-08-16 1986-06-17 Burke Dennis W Apparatus for cemented implantation of prostheses
CH657980A5 (en) 1982-10-21 1986-10-15 Sulzer Ag DISPOSABLE BONE CEMENT SYRINGE.
US4585035A (en) 1983-12-19 1986-04-29 The Goodyear Tire & Rubber Company Reinforced hose
US4554686A (en) 1984-02-29 1985-11-26 Technical Research Associates, Inc. Polymethylmethacrylate bone cements and methods for preparing such bone cements
DE3443167C2 (en) * 1984-11-27 1986-12-18 orthoplant Endoprothetik GmbH, 2800 Bremen Surgical cement syringe
US4699178A (en) 1985-01-25 1987-10-13 Parker Hannifin Corporation Low volumetric expansion hose
GB8524152D0 (en) 1985-10-01 1985-11-06 Cole Polymers Ltd Bone cement
US4653487A (en) 1986-01-29 1987-03-31 Maale Gerhard E Intramedullary rod assembly for cement injection system
US4793363A (en) * 1986-09-11 1988-12-27 Sherwood Medical Company Biopsy needle
US4776704A (en) * 1986-12-15 1988-10-11 Dentsply Research & Development Corp. Mixing and dispensing syringe
US4813871A (en) * 1987-09-25 1989-03-21 Friedman Stephen J Dental viscous material dispenser
US5195526A (en) 1988-03-11 1993-03-23 Michelson Gary K Spinal marker needle
US5258028A (en) 1988-12-12 1993-11-02 Ersek Robert A Textured micro implants
ATE241395T1 (en) 1990-09-13 2003-06-15 Klaus Draenert MULTI-COMPONENT MATERIAL AND METHOD FOR PRODUCING IT
DE4033343A1 (en) 1990-10-19 1992-04-23 Draenert Klaus MATERIAL AS THE STARTING MATERIAL FOR THE PRODUCTION OF BONE CEMENT AND METHOD FOR THE PRODUCTION THEREOF
US5367002A (en) 1992-02-06 1994-11-22 Dentsply Research & Development Corp. Dental composition and method
US5660210A (en) 1992-03-05 1997-08-26 Toyoda Gosei Co., Ltd. Layered rubber hose with reinforcing
US5361806A (en) 1992-07-07 1994-11-08 Titeflex Corporation Kevlar reinforced high pressure hose assembly with grip and environmental barrier
US5702446A (en) * 1992-11-09 1997-12-30 Board Of Regents, The University Of Texas System Bone prosthesis
US5372583A (en) * 1992-11-25 1994-12-13 Cardiopulmonary Specialities, Inc. Bone marrow infuser and method of use
US5398483A (en) * 1993-01-29 1995-03-21 Polymers Reconstructive A/S Method and apparatus for packaging, mixing and delivering bone cement
ES2232711T3 (en) 1995-07-27 2005-06-01 Micro Therapeutics, Inc. EMBOLIZATION COMPOSITIONS.
JP2001505281A (en) 1995-09-28 2001-04-17 ファイバースパー スプーラブル プロダクツ,インク. Composite tube that can be wound
US5928468A (en) 1995-10-18 1999-07-27 Tolson; John Thomas High pressure glue injection device
US5681317A (en) * 1996-06-12 1997-10-28 Johnson & Johnson Professional, Inc. Cement delivery system and method
US6039084A (en) 1997-06-13 2000-03-21 Teleflex, Inc. Expanded fluoropolymer tubular structure, hose assembly and method for making same
WO1999002214A1 (en) 1997-07-09 1999-01-21 Tegementa, L.L.C. Interbody device and method for treatment of osteoporotic vertebral collapse
US5951160A (en) * 1997-11-20 1999-09-14 Biomet, Inc. Method and apparatus for packaging, mixing and delivering bone cement
US6086569A (en) * 1999-05-04 2000-07-11 Schweizer; Kenneth M. Hypodermic syringe

Patent Citations (100)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US29083A (en) * 1860-07-10 Benjamin irving
US115794A (en) * 1871-06-06 Improvement in stop-valves
US1142210A (en) * 1912-02-29 1915-06-08 Rayvio Water Company Liquid-dispensing device.
US2002610A (en) * 1931-09-18 1935-05-28 Elmer L Nall Fluid dispensing device
US2676475A (en) * 1951-10-12 1954-04-27 Ronson Art Metal Works Inc Cigar lighter structure
US2919692A (en) * 1956-02-23 1960-01-05 Ackermann Wolfgang Vertebral trephine biopsy instruments
US2973758A (en) * 1956-12-27 1961-03-07 Invenex Pharmaceuticals Apparatus for manufacturing parenteral solutions
US3701771A (en) * 1969-06-27 1972-10-31 Nyegaard & Co As N-(2,4,6-triiodobenzoyl)-sugar amines
US3581399A (en) * 1969-08-08 1971-06-01 Centrix Inc Composite resin filling syringe and technique
US3750667A (en) * 1972-01-31 1973-08-07 N Pshenichny Device for intraosseous injection of liquid substances
US3835890A (en) * 1973-03-29 1974-09-17 Uniroyal Inc Buoyant liquid-conveying hose
US3882858A (en) * 1973-04-21 1975-05-13 Merck Patent Gmbh Surgical synthetic-resin material and method of treating osteomyelitis
US3919773A (en) * 1973-12-20 1975-11-18 Sybron Corp Direct moldable implant material
US4011685A (en) * 1974-06-24 1977-03-15 Boyd William A Plant injection method and apparatus
US3900954A (en) * 1974-07-10 1975-08-26 William B Dragan Dental filling gun and nozzle tip therefor
US4155969A (en) * 1975-09-02 1979-05-22 Ex-Cell-O Corporation Method for injection foam molding
US4032118A (en) * 1975-10-21 1977-06-28 Phillips Edwin D Sealing means for stirring apparatus
US4189065A (en) * 1976-02-04 1980-02-19 Espe Fabrik Pharmazeutischer Praeparate Gmbh Metering dispenser for high-viscosity compositions
US4288355A (en) * 1978-05-22 1981-09-08 Minnesota Mining And Manufacturing Company Surgical cement composition
US4184490A (en) * 1978-08-23 1980-01-22 John Jacklich Precision endodontic syringe
US4373217A (en) * 1979-02-16 1983-02-15 Merck Patent Gesellschaft Mit Beschrankter Haftung Implantation materials and a process for the production thereof
US4274163A (en) * 1979-07-16 1981-06-23 The Regents Of The University Of California Prosthetic fixation technique
US4312343A (en) * 1979-07-30 1982-01-26 Leveen Harry H Syringe
US4404327A (en) * 1979-10-31 1983-09-13 Crugnola Aldo M Orthopaedic cement from acrylate polymers
US4341691A (en) * 1980-02-20 1982-07-27 Zimmer, Inc. Low viscosity bone cement
US4374093A (en) * 1981-02-20 1983-02-15 Mobil Oil Corporation Continuous-stream upflow zeolite crystallization apparatus
US4610692A (en) * 1981-02-20 1986-09-09 Mundipharma Gmbh Implant for filling bone cavities and fixing bone fragments in a living body, method of producing the same, and bone implant system
US4469109A (en) * 1981-12-24 1984-09-04 Creative Research And Manufacturing Inc. Bone marrow aspiration needle
US4448188A (en) * 1982-02-18 1984-05-15 Laserscope, Inc. Method for providing an oxygen bearing liquid to a blood vessel for the performance of a medical procedure
US4653489A (en) * 1984-04-02 1987-03-31 Tronzo Raymond G Fenestrated hip screw and method of augmented fixation
US4671263A (en) * 1984-07-11 1987-06-09 Klaus Draenert Device and process for mixing and applying bone cement
US4637931A (en) * 1984-10-09 1987-01-20 The United States Of America As Represented By The Secretary Of The Army Polyactic-polyglycolic acid copolymer combined with decalcified freeze-dried bone for use as a bone repair material
US4614437A (en) * 1984-11-02 1986-09-30 Dougherty Brothers Company Mixing container and adapter
US4670008A (en) * 1985-07-01 1987-06-02 Albertini Beat High flux threaded needle
US4798596A (en) * 1985-10-07 1989-01-17 Muehlbauer Ernst Applicator syringe for a dental compound
US4728570A (en) * 1985-10-29 1988-03-01 United States Surgical Corporation Calcium-hydroxide-treated polymeric implant matrial
US5015101A (en) * 1986-03-21 1991-05-14 Klaus Draenert Apparatus and process for mixing and filling
US4966601A (en) * 1986-03-21 1990-10-30 Klaus Draenert Evacuatable bone cement syringe
US4795444A (en) * 1986-05-02 1989-01-03 Sunstar Kabushiki Kaisha Syringe
US4838282A (en) * 1987-02-26 1989-06-13 Manan Manufacturing Co., Inc. Bone biopsy needle assembly
US4900546A (en) * 1987-07-30 1990-02-13 Pfizer Hospital Products Group, Inc. Bone cement for sustained release of substances
US4863072A (en) * 1987-08-18 1989-09-05 Robert Perler Single hand operable dental composite package
US4921479A (en) * 1987-10-02 1990-05-01 Joseph Grayzel Catheter sheath with longitudinal seam
US4815454A (en) * 1987-11-16 1989-03-28 Dozier Jr John K Apparatus and method for injecting bone cement
US4837279A (en) * 1988-02-22 1989-06-06 Pfizer Hospital Products Corp, Inc. Bone cement
US4986814A (en) * 1988-06-13 1991-01-22 Indianapolis Center For Advanced Research One-punch catheter
US4929238A (en) * 1988-11-23 1990-05-29 Coeur Laboratories, Inc. Multi-pressure injector device
US5304586A (en) * 1989-01-30 1994-04-19 Dentsply Research & Development Corp. Radiopaque fluoride releasing VLC dental composites and the use of specific fillers therein
US5108404A (en) * 1989-02-09 1992-04-28 Arie Scholten Surgical protocol for fixation of bone using inflatable device
US5014717A (en) * 1989-02-10 1991-05-14 Lohrmann Guenter Punch-biopsy apparatus with cannula-aiming device
US5341816A (en) * 1989-11-06 1994-08-30 Allen William C Biopsy device
US5112354A (en) * 1989-11-16 1992-05-12 Northwestern University Bone allograft material and method
US5527298A (en) * 1990-06-11 1996-06-18 Schneider (Usa) Inc. Tracking guidewire
US6080801A (en) * 1990-09-13 2000-06-27 Klaus Draenert Multi-component material and process for its preparation
US5195525A (en) * 1990-11-26 1993-03-23 Pelc Norbert J Noninvasive myocardial motion analysis using phase contrast mri maps of myocardial velocity
US5290260A (en) * 1991-05-31 1994-03-01 Vance Products Incorporated Rotational pressure drive for a medical syringe
US5591171A (en) * 1991-06-14 1997-01-07 Brown; Byron L. Adapter and method for measuring pressures of fluid materials
US5885238A (en) * 1991-07-16 1999-03-23 Heartport, Inc. System for cardiac procedures
US5344232A (en) * 1991-09-30 1994-09-06 Stryker Corporation Bone cement mixing and loading apparatus
US5415474A (en) * 1991-09-30 1995-05-16 Stryker Corporation Bone cement mixing and loading apparatus
US5431654A (en) * 1991-09-30 1995-07-11 Stryker Corporation Bone cement injector
US5873855A (en) * 1992-01-07 1999-02-23 Arthrocare Corporation Systems and methods for electrosurgical myocardial revascularization
US5336699A (en) * 1992-02-20 1994-08-09 Orthopaedic Research Institute Bone cement having chemically joined reinforcing fillers
US5282861A (en) * 1992-03-11 1994-02-01 Ultramet Open cell tantalum structures for cancellous bone implants and cell and tissue receptors
US5336263A (en) * 1992-04-06 1994-08-09 Robert A. Ersek Treatment of urological and gastric fluid reflux disorders by injection of mmicro particles
US5788702A (en) * 1992-06-15 1998-08-04 Draenert; Klaus Applicator system
US5647856A (en) * 1993-09-23 1997-07-15 Heraeus Kulzer Gmbh Syringe for the controlled discharge of viscous materials
US5653730A (en) * 1993-09-28 1997-08-05 Hemodynamics, Inc. Surface opening adhesive sealer
US5514137A (en) * 1993-12-06 1996-05-07 Coutts; Richard D. Fixation of orthopedic devices
US5507813A (en) * 1993-12-09 1996-04-16 Osteotech, Inc. Shaped materials derived from elongate bone particles
US5558136A (en) * 1994-01-31 1996-09-24 Stryker Corporation Bone cement cartridge with secondary piston
US5346495A (en) * 1994-02-28 1994-09-13 Vargas Iii Joseph H Biomedical cement applicator
US5456267A (en) * 1994-03-18 1995-10-10 Stark; John G. Bone marrow harvesting systems and methods and bone biopsy systems and methods
US5658332A (en) * 1994-06-30 1997-08-19 Orthovita, Inc. Bioactive granules for bone tissue formation
US5451406A (en) * 1994-07-14 1995-09-19 Advanced Uroscience, Inc. Tissue injectable composition and method of use
US5650108A (en) * 1994-10-06 1997-07-22 Merck Patent Gesellschaft Mit Beschrankter Haftung Porous bone replacement materials
US5599305A (en) * 1994-10-24 1997-02-04 Cardiovascular Concepts, Inc. Large-diameter introducer sheath having hemostasis valve and removable steering mechanism
US5603701A (en) * 1995-03-27 1997-02-18 Ultradent Products, Inc. Syringe apparatus with threaded plunger for delivering tooth composites and other solid yet pliable materials
US5795922A (en) * 1995-06-06 1998-08-18 Clemson University Bone cement composistion containing microencapsulated radiopacifier and method of making same
US6602248B1 (en) * 1995-06-07 2003-08-05 Arthro Care Corp. Methods for repairing damaged intervertebral discs
US5660186A (en) * 1995-06-07 1997-08-26 Marshfield Clinic Spiral biopsy stylet
US5599315A (en) * 1995-12-01 1997-02-04 Charles J. McPhee Syringe actuation device
US5800405A (en) * 1995-12-01 1998-09-01 I-Flow Corporation Syringe actuation device
US5681872A (en) * 1995-12-07 1997-10-28 Orthovita, Inc. Bioactive load bearing bone graft compositions
US5797679A (en) * 1996-02-09 1998-08-25 Stryker Corporation Surgical cement mixer apparatus
US5792478A (en) * 1996-07-08 1998-08-11 Advanced Uro Science Tissue injectable composition and method of use
US6277112B1 (en) * 1996-07-16 2001-08-21 Arthrocare Corporation Methods for electrosurgical spine surgery
US5676146A (en) * 1996-09-13 1997-10-14 Osteotech, Inc. Surgical implant containing a resorbable radiopaque marker and method of locating such within a body
US5676146B1 (en) * 1996-09-13 2000-04-18 Osteotech Inc Surgical implant containing a resorbable radiopaque marker and method of locating such within a body
US6033105A (en) * 1996-11-15 2000-03-07 Barker; Donald Integrated bone cement mixing and dispensing system
US6554803B1 (en) * 1997-04-02 2003-04-29 Arthur Ashman Combination syringe and aspirator for bone regeneration material and method for using the syringe
US6042262A (en) * 1997-07-29 2000-03-28 Stryker Technologies Corportion Apparatus for storing, mixing, and dispensing two-component bone cement
US6176607B1 (en) * 1997-07-29 2001-01-23 Stryker Technologies Corporation Apparatus for dispensing a liquid component of a two-component bone cement and for storing, mixing, and dispensing the cement
US6019747A (en) * 1997-10-21 2000-02-01 I-Flow Corporation Spring-actuated infusion syringe
US6468279B1 (en) * 1998-01-27 2002-10-22 Kyphon Inc. Slip-fit handle for hand-held instruments that access interior body regions
US6383190B1 (en) * 1998-04-01 2002-05-07 Parallax Medical, Inc. High pressure applicator
US6019765A (en) * 1998-05-06 2000-02-01 Johnson & Johnson Professional, Inc. Morsellized bone allograft applicator device
US6712794B2 (en) * 2001-08-21 2004-03-30 Spinal Specialties, Inc. Apparatus for delivering a viscous liquid to a surgical site
US6875219B2 (en) * 2003-02-14 2005-04-05 Yves P. Arramon Bone access system
US20050119650A1 (en) * 2003-10-20 2005-06-02 Arthrocare Corporation Electrosurgical method and apparatus for removing tissue within a bone body

Cited By (84)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040249347A1 (en) * 1999-09-30 2004-12-09 Miller Scott H. High pressure delivery system
US7048743B2 (en) * 1999-09-30 2006-05-23 Arthrocare Corporation Methods for delivering tissue implant material with a high pressure applicator
US8123756B2 (en) 1999-09-30 2012-02-28 Neurotherm, Inc. High pressure delivery system
US8992541B2 (en) 2003-03-14 2015-03-31 DePuy Synthes Products, LLC Hydraulic device for the injection of bone cement in percutaneous vertebroplasty
US10799278B2 (en) 2003-03-14 2020-10-13 DePuy Synthes Products, Inc. Hydraulic device for the injection of bone cement in percutaneous vertebroplasty
US9186194B2 (en) 2003-03-14 2015-11-17 DePuy Synthes Products, Inc. Hydraulic device for the injection of bone cement in percutaneous vertebroplasty
US10485597B2 (en) 2003-03-31 2019-11-26 DePuy Synthes Products, Inc. Remotely-activated vertebroplasty injection device
US9839460B2 (en) 2003-03-31 2017-12-12 DePuy Synthes Products, Inc. Remotely-activated vertebroplasty injection device
US8066713B2 (en) 2003-03-31 2011-11-29 Depuy Spine, Inc. Remotely-activated vertebroplasty injection device
US8333773B2 (en) 2003-03-31 2012-12-18 Depuy Spine, Inc. Remotely-activated vertebroplasty injection device
US8361078B2 (en) 2003-06-17 2013-01-29 Depuy Spine, Inc. Methods, materials and apparatus for treating bone and other tissue
US10039585B2 (en) 2003-06-17 2018-08-07 DePuy Synthes Products, Inc. Methods, materials and apparatus for treating bone and other tissue
US9504508B2 (en) 2003-06-17 2016-11-29 DePuy Synthes Products, Inc. Methods, materials and apparatus for treating bone and other tissue
US8540722B2 (en) 2003-06-17 2013-09-24 DePuy Synthes Products, LLC Methods, materials and apparatus for treating bone and other tissue
US8956368B2 (en) 2003-06-17 2015-02-17 DePuy Synthes Products, LLC Methods, materials and apparatus for treating bone and other tissue
US8579908B2 (en) 2003-09-26 2013-11-12 DePuy Synthes Products, LLC. Device for delivering viscous material
US10111697B2 (en) 2003-09-26 2018-10-30 DePuy Synthes Products, Inc. Device for delivering viscous material
US9750840B2 (en) 2004-03-21 2017-09-05 DePuy Synthes Products, Inc. Methods, materials and apparatus for treating bone and other tissue
US8415407B2 (en) 2004-03-21 2013-04-09 Depuy Spine, Inc. Methods, materials, and apparatus for treating bone and other tissue
US8809418B2 (en) 2004-03-21 2014-08-19 DePuy Synthes Products, LLC Methods, materials and apparatus for treating bone and other tissue
US11026734B2 (en) 2004-12-06 2021-06-08 Dfine, Inc. Bone treatment systems and methods
US9381024B2 (en) 2005-07-31 2016-07-05 DePuy Synthes Products, Inc. Marked tools
US9918767B2 (en) 2005-08-01 2018-03-20 DePuy Synthes Products, Inc. Temperature control system
US10136934B2 (en) 2005-08-22 2018-11-27 Dfine, Inc. Bone treatment systems and methods
US11672579B2 (en) 2005-08-22 2023-06-13 Dfine Inc. Bone treatment systems and methods
US8066712B2 (en) 2005-09-01 2011-11-29 Dfine, Inc. Systems for delivering bone fill material
US20070191858A1 (en) * 2005-09-01 2007-08-16 Csaba Truckai Systems for delivering bone fill material
US9795429B2 (en) 2005-11-18 2017-10-24 Stryker Corporation Device and method for removing bodily material
US7713273B2 (en) 2005-11-18 2010-05-11 Carefusion 2200, Inc. Device, system and method for delivering a curable material into bone
US20070118142A1 (en) * 2005-11-18 2007-05-24 Krueger John A Device, system and method for delivering a curable material into bone
US20070142842A1 (en) * 2005-11-18 2007-06-21 Krueger John A Device, system and method for delivering a curable material into bone
US8690884B2 (en) 2005-11-18 2014-04-08 Carefusion 2200, Inc. Multistate-curvature device and method for delivering a curable material into bone
US8529576B2 (en) 2005-11-18 2013-09-10 Carefusion 2200, Inc. Device, system and method for delivering a curable material into bone
USD669168S1 (en) 2005-11-18 2012-10-16 Carefusion 2200, Inc. Vertebral augmentation needle
US20100121336A1 (en) * 2005-11-18 2010-05-13 Linderman Evan D Device, system, and method for forming a cavity in and delivering a curable material into bone
US8128633B2 (en) 2005-11-18 2012-03-06 Carefusion 2200, Inc. Device, system, and method for forming a cavity in and delivering a curable material into bone
US7799035B2 (en) 2005-11-18 2010-09-21 Carefusion 2200, Inc. Device, system and method for delivering a curable material into bone
US20100087828A1 (en) * 2005-11-18 2010-04-08 Krueger John A Device, system and method for delivering a curable material into bone
US9358059B2 (en) 2005-11-18 2016-06-07 Carefusion 2200, Inc. Device and method for delivering a curable material into bone
US10314633B2 (en) 2005-11-18 2019-06-11 Stryker Corporation Shape memory device with temperature-dependent deflectable segment and methods of positioning a shape memory device within a bone structure
US9259696B2 (en) 2005-11-22 2016-02-16 DePuy Synthes Products, Inc. Mixing apparatus having central and planetary mixing elements
US8360629B2 (en) 2005-11-22 2013-01-29 Depuy Spine, Inc. Mixing apparatus having central and planetary mixing elements
US10631906B2 (en) 2005-11-22 2020-04-28 DePuy Synthes Products, Inc. Apparatus for transferring a viscous material
US8419795B2 (en) 2006-01-26 2013-04-16 Spinal Generations, Llc Interbody cage system
US7588599B2 (en) * 2006-01-26 2009-09-15 Spinal Generations, Llc Interbody cage system
US20070173938A1 (en) * 2006-01-26 2007-07-26 Spinal Generations, Llc Interbody cage system
US20110015640A1 (en) * 2006-01-30 2011-01-20 Stryker Leibinger Gmbh & Co. Kg Syringe
US8303599B2 (en) 2006-01-30 2012-11-06 Stryker Leibinger Gmbh & Co. Kg Syringe
US8361032B2 (en) * 2006-02-22 2013-01-29 Carefusion 2200 Inc. Curable material delivery device with a rotatable supply section
US20070197971A1 (en) * 2006-02-22 2007-08-23 Krueger John A Curable material delivery device with a rotatable supply section
US9642932B2 (en) 2006-09-14 2017-05-09 DePuy Synthes Products, Inc. Bone cement and methods of use thereof
US10272174B2 (en) 2006-09-14 2019-04-30 DePuy Synthes Products, Inc. Bone cement and methods of use thereof
US20110194371A1 (en) * 2006-10-06 2011-08-11 Coffeen Jared P Motorized bone cement mixing and delivery system that allows a user to detach the delivery device from the mixer for delivery
US8172456B2 (en) * 2006-10-06 2012-05-08 Stryker Corporation Motorized bone cement mixing and delivery system that allows a user to detach the delivery device from the mixer for delivery
US20100110820A1 (en) * 2006-10-06 2010-05-06 Coffeen Jared P Motorized bone cement mixing and delivery system that automatically transfers bone cement between the mixer and the delivery device and that automatically terminates the mixing and delivery processes
US7854543B2 (en) * 2006-10-06 2010-12-21 Stryker Corporation Motorized bone cement mixing and delivery system that automatically transfers bone cement between the mixer and the delivery device and that automatically terminates the mixing and transfer processes
US20120218851A1 (en) * 2006-10-06 2012-08-30 Coffeen Jared P Motorized bone cement mixing and delivery system with a flexible delivery extension tube and enlarged connector for delivering cement into living tissue
US9597138B2 (en) 2006-10-06 2017-03-21 Stryker Corporation Motorized bone cement mixing and delivery system with an enlarged connector for connecting to the cannula through which the cement is injected into the patient
US10499971B2 (en) 2006-10-06 2019-12-10 Stryker Corporation Mechanised bone cement delivery system with a valve that closes to stop the flow of pressurized cement
US7658537B2 (en) 2006-10-06 2010-02-09 Stryker Corporation Bone cement mixing and delivery system with automated bone cement transfer between mixer and delivery device
US20090257306A1 (en) * 2006-10-06 2009-10-15 Coffeen Jared P Bone cement mixing and delivery system with automated bone cement transfer between mixer and delivery device and method of mixing and automated transfer of bone cement between mixer and delivery device and method of mixing and automated transfer of bone cement between mixer and delivery device
US8950929B2 (en) 2006-10-19 2015-02-10 DePuy Synthes Products, LLC Fluid delivery system
US10494158B2 (en) 2006-10-19 2019-12-03 DePuy Synthes Products, Inc. Fluid delivery system
US20080109008A1 (en) * 2006-11-02 2008-05-08 Stryker Trauma Gmbh Implantation device and method for applying the same
US8109933B2 (en) 2007-04-03 2012-02-07 Dfine, Inc. Bone treatment systems and methods
US8523871B2 (en) 2007-04-03 2013-09-03 Dfine, Inc. Bone treatment systems and methods
US8556910B2 (en) 2007-04-03 2013-10-15 Dfine, Inc. Bone treatment systems and methods
US8083799B2 (en) 2007-04-27 2011-12-27 Atlas Spine, Inc. Spinal implant
US20080275506A1 (en) * 2007-04-27 2008-11-06 Baynham Bret O Spinal implant
US20080269901A1 (en) * 2007-04-27 2008-10-30 Baynham Bret O Spinal implant
US8172905B2 (en) 2007-04-27 2012-05-08 Atlas Spine, Inc. Spinal implant
US20090057168A1 (en) * 2007-08-31 2009-03-05 Smit Karen L Medical cement monomer ampoule cartridge for storing the ampoule, opening the ampoule and selectively discharging the monomer from the ampoule
US8132959B2 (en) 2007-08-31 2012-03-13 Stryker Corporation Medical cement monomer ampoule cartridge for storing the ampoule, opening the ampoule and selectively discharging the monomer from the ampoule into a mixer
US8277506B2 (en) 2008-06-24 2012-10-02 Carefusion 2200, Inc. Method and structure for stabilizing a vertebral body
US10022173B2 (en) 2009-11-10 2018-07-17 Stryker Corporation Systems and methods for vertebral or other bone structure height restoration and stabilization
US9168078B2 (en) 2009-11-10 2015-10-27 Carefusion 2200, Inc. Apparatus and method for stylet-guided vertebral augmentation
US9907595B2 (en) 2009-11-10 2018-03-06 Stryker Corporation Systems and methods for vertebral or other bone structure height restoration and stabilization
US9526551B2 (en) 2009-11-10 2016-12-27 Stryker Corporation Apparatus and method for stylet-guided vertebral augmentation
US10905487B2 (en) 2009-11-10 2021-02-02 Stryker Corporation Systems and methods for vertebral or other bone structure height restoration and stabilization
US11666366B2 (en) 2009-11-10 2023-06-06 Stryker Corporation Systems and methods for vertebral or other bone structure height restoration and stabilization
US9808355B2 (en) 2010-09-29 2017-11-07 Spinal Generations, Llc Insertion tool for intervertebral insert
US9044284B2 (en) 2010-09-29 2015-06-02 Spinal Generations, Llc Intervertebral insert system
US20180207356A1 (en) * 2015-09-22 2018-07-26 Thomas Jefferson University Continuous subcutaneous insulin infusion catheter
CN110573091A (en) * 2017-03-15 2019-12-13 史密夫和内修有限公司 Graft preparation and delivery apparatus and methods

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