US20090112327A1 - Burr hole plug designs - Google Patents
Burr hole plug designs Download PDFInfo
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- US20090112327A1 US20090112327A1 US12/258,382 US25838208A US2009112327A1 US 20090112327 A1 US20090112327 A1 US 20090112327A1 US 25838208 A US25838208 A US 25838208A US 2009112327 A1 US2009112327 A1 US 2009112327A1
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- burr hole
- plug base
- plug
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0539—Anchoring of brain electrode systems, e.g. within burr hole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
- A61B2090/103—Cranial plugs for access to brain
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0526—Head electrodes
- A61N1/0529—Electrodes for brain stimulation
- A61N1/0534—Electrodes for deep brain stimulation
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Abstract
A burr hole plug comprises a plug base including a flange configured for being mounted around a burr hole, an aperture through which an elongated medical device may pass, and tabs configured for extending within the cranial burr hole to center the plug base relative to the cranial burr hole. The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. A method may comprise locating the plug base within a burr hole, such that the tabs are disposed within the burr hole to center the plug base relative to the cranial burr hole, introducing the elongated medical device through the cranial burr hole and into the brain tissue of the patient, mounting the retainer within the aperture of the plug base, and actuating the retainer to secure the medical device.
Description
- The present application claims the benefit under 35 U.S.C. § 119 to U.S. Provisional Patent Application Ser. No. 60/983,099, filed Oct. 26, 2007. The foregoing application is hereby incorporated by reference into the present application in its entirety.
- The present inventions relate to apparatus for securing elongated medical devices, such as catheters or leads, within a cranial burr hole.
- Deep brain stimulation (DBS) and other related procedures involving implantation of electrical stimulation leads within the brain of a patient are increasingly used to treat disorders, such as Parkinson's disease, dystonia, essential tremor, seizure disorders, obesity, depression, restoration of motor control, and other debilitating diseases via electrical stimulation via stimulation of one or more target sites, including the ventrolateral thalamus, internal segment of globus pallidus, substantia nigra pars reticulate, subthalamic nucleus (STN), or external segment of globus pallidus. DBS has become a prominent treatment option for many disorders, because it is a safe, reversible alternative to lesioning. For example, DBS is the most frequently performed surgical procedure for the treatment of advanced Parkinson's Disease. There have been approximately 30,000 patients world-wide that have undergone DBS surgery. Consequently, there is a large population of patients who will benefit from advances in DBS treatment options.
- During DBS procedures, at least one burr hole is meticulously cut through the patient's cranium so as not to damage the brain tissue below, a large stereotactic targeting apparatus is mounted to the patient's cranium, and a cannula is scrupulously positioned towards the target site in the brain. A stimulation lead is then introduced through the cannula, through the burr hole, and into the parenchyma of the brain, such that one or more electrodes located on the lead are strategically placed at a target site in the brain of the patient. Once the lead is properly positioned, the portion of the lead exiting the burr hole is subcutaneously routed underneath the patient's scalp to an implantable pulse generator (IPG) implanted in the patient at a site remote from the burr hole (e.g., the patient's shoulder or chest region). Further details discussing the treatment of diseases using DBS are disclosed in U.S. Pat. Nos. 6,845,267, 6,845,267, and 6,950,707, which are expressly incorporated herein by reference.
- Significantly, it is crucial that proper location and maintenance of the lead position be accomplished in order to continuously achieve efficacious therapy. This is especially so with DBS applications, in which cases, the target site (or sites) that is intended for electrical stimulation is about the size of a pea and is located deep within the patient's brain. Thus, lead displacements of less than a millimeter may have a deleterious effect on the patient's therapy. Therefore, it is important that that the electrode(s) of the lead be accurately located at the target site and that such electrode(s) be securely maintained at the target site during and after implantation of the lead. In addition, it is important that the burr hole be sealed around the stimulation lead to prevent infection or leakage of cerebrospinal fluid.
- To address these issues, a cranial burr hole plug is installed within the burr hole during the implantation procedure to hold the stimulation lead in place, as well as to seal the burr hole. Typically, the burr hole plug is composed of a multitude of components, including a ring-shaped base, a retainer, and a cap, that are integrated together to form the burr hole plug.
- In particular, before the stimulation lead is introduced through the burr hole, the ring-shaped plug base is placed about the burr hole, and is then permanently mounted to the patient's cranium using conventional means, such as screws. The stimulation lead is then introduced through the plug base and into the parenchyma of the brain. Notably, any displacement of the portion of the lead exiting the burr hole will result in the translation of the electrodes positioned in the brain relative to the target site, thereby requiring the lead to be repositioned—a time-consuming process.
- Thus, once the lead is properly located at the tissue site, the retainer is installed within the plug base (typically in an interference arrangement, such as a snap-fit arrangement) to temporarily secure the lead, thereby preventing migration of the lead relative to the target site during subsequent manipulation of the proximal end of the lead and installation of the cap. In one exemplary embodiment, the retainer comprises a disk having a slot for receiving the lead and a clamping mechanism that can be rotated within the slot towards a mating surface on the disk to frictionally clamp the received lead therebetween. The clamping mechanism may have one or more locking mechanisms that can engage or disengage complementary locking mechanisms on the disk to prevent rotation of the clamping mechanism. The portion of the stimulation lead exiting the retainer can then be bent downward towards the plane of the disk into a recess formed in the plug base, and the cap can be installed onto the plug base over the retainer to permanently secure the lead within the recess, as well as to seal the burr hole. Further details regarding these types of burr hole plugs are disclosed in U.S. Patent Publication No. 2002/0156372.
- It can thus be appreciated from the foregoing that the burr hole plug serves as the platform for the entire DBS system, and therefore, it is important for this component to be robust, well-designed, and easy to use. Importantly, the burr hole plug should be designed such that lead migration is minimized during installation of the burr hole plug. While prior art burr hole plugs have proven to be useful in the DBS context, there are still improvements that can be made.
- As one example, prior art burr hole plugs are typically composed of biocompatible and non-corrosive material, such as a plastic (e.g., polypropylene or polycarbonate), which although less durable than other materials, is compatible with MRI, and unlike titanium, will not distort the MRI. To ensure that the burr hole plug is durable enough during its installation within the burr hole, the plug base typically has a closed architecture (closed ring). Because of this, as well as the location of the lead guidance equipment at the proximal end of the lead, the plug base must be mounted within or around the burr hole prior to delivery of the stimulation lead through the burr hole. While this, in itself, does not create a problem, if the lead is inadvertently delivered into the patient's brain before the plug base is located at the burr hole, the lead will need to be backed out of the burr hole and the lead delivery process initiated again. Also, because prior art plug bases are composed of a single piece, there is a risk that the plug base may fracture if the plug base is anchored to tightly to the cranium of the patient, especially if the bottom surface of the plug base does not match the curvature of the cranium.
- Because the retainer installed within the plug base is also composed of plastic material, the retainer will typically deform somewhat during its installation within the plug base and during manipulation of the clamping mechanism to stabilize the lead. In addition, because the clamping mechanism will deform somewhat along its length when clamped against the stimulation lead, an unequal force may be applied along the clamping mechanism, thereby weakening the retention force applied to the lead. Also, because of the relatively weak composition of the retainer, the clamping force between it and the mating surface of the disk is limited, thereby limiting the lead retention force of the clamping mechanism. Furthermore, because the application of a downward force is typically necessary to unlock and allow the clamping mechanism to rotate relative to the disk, such downward force may cause the clamping mechanism to be bent too far down, thereby permanently deforming or breaking it. In addition, since burr hole plugs are typically composed of biocompatible polymers that are extremely lubricious, particularly when wetted, the coefficient of friction of the retention surface of the clamping mechanism, as well as the mating surface of the disk, may be relatively low. As a result, the lead may migrate when only a moderate amount of tensile force is applied to it.
- As another example of a problem suffered from prior art burr hole plugs, the retainer may rotate within the plug base, potentially resulting in the inadvertent movement of the stimulation lead from the target site. Such rotation of the retainer mechanism may typically occur in response to the manipulation of the clamping mechanism, and in particular, a downward force applied to the clamping mechanism that causes partial disengagement between the retaining disk to which the clamping mechanism is mounted and the plug base, and a lateral force applied to the clamping mechanism that causes the disengaged disk to rotate within the plug base.
- As still another example, many DBS systems have evolved from a single lead (unilateral) system to double lead (bilateral) systems; for example, one lead is used to perform STN stimulation, while another lead is used to perform thalamus stimulation. Other DBS systems may use a recording lead to record brain signals that are then fed back to the IPG to control the stimulation applied to the target site by the stimulation lead(s). However, prior art burr hole plugs are not designed to stabilize more than one stimulation lead at time. This is because the slot within the disk can only secure leads that exit the burr hole along the diameter of the disk, although the leads may be offset from the diameter. Thus, despite the fact that the target sites stimulated and/or recorded by the leads may be adjacent to each other, multiple burr holes, each accommodating a stimulation lead and burr hole plug, are typically formed in the cranium of the patient when multiple stimulation leads are used. By creating multiple burr holes, the risk to the patient, time in the operating room (which also increases patient risk), the materials and staff needed in the operating room, and cost of the procedure are all increased, so a burr hole plug that can accommodate multiple leads through one burr hole is preferred.
- As yet another example, it is preferable that the portion of the stimulation lead exiting the burr hole be disposed at an angle perpendicular to the length of the slot of the retaining disk when bent down towards the plane of the disk, so that the lead does not move along the slot when tensed. However, because the recess of the plug base in which the lead is seated may be located obliquely (as opposed to perpendicular) to the slot, it may be difficult to bend the lead perpendicular to the slot towards the base recess if the lead support mechanism is not perfectly oriented relative to the plug base. In addition, rotation of the lead support mechanism relative to the base while the lead is seated within the base recess may cause the lead to be displaced from the target site.
- In yet another example, the plug base must be securely held in place while anchoring it to the cranium via screws. The retainer must also be mounted within the plug base, such that the retaining disk is properly seated within the plug base without disturbing the position of the lead, which is precariously held by the stereotactic targeting apparatus. However, due to the diminutive size of the burr hole plug components, they are difficult to position, manipulate, and handle. This, in combination with the limited working space between the targeting apparatus and the burr hole, makes it quite difficult to visualize and correctly install the plug within the burr hole and stabilize the lead. While the surgeon is installing the components of the burr hole plug, there is a risk of foreign objects (screws, tools, debris, etc.) falling into the exposed burr hole, as well as slippage of tools within the burr hole. Prior art tools, which stabilize plug bases while covering the burr hole and holding/aligning the screws used to anchor the plug bases, can be utilized. However, the screws often pop-out of these tools unintentionally and do not always screw into the cranium at the correct angle.
- Thus, installation of the burr hole plug without disturbing the lead position is nearly an impossible task without specialization of the tools and/or burr hole plug that can center the plug base while it is anchored to the patient's skull and securely hold and mount the retainer to the plug base. Typically, the surgeon may use a special tool that engages the retainer, such that it can be navigated and positioned within the plug base, and then pressed downward to snap-fit it into the plug base. However, this installation tool only engages the retaining disk at one location. Thus, it is possible that the disk may become skewed or tilted while attempting to install it within the plug base, or worse yet, given the spring force stored in the disk, it may be launched from the surgical site.
- In yet another example, prior art burr hole plugs are designed to be used with stimulation leads having one size. That is, the dimension between the retaining surface of the clamping device and the mating surface of the disk when the clamping device is in the locked position is designed to be slightly less than the diameter of the lead. If the diameter of the actual lead used with the burr hole plug is smaller than this intended, the retention force applied to the lead by the clamping mechanism will not be sufficient. If the diameter of the actual lead used with the burr hole plug is greater than this intended diameter, too much force will need to be applied to the lead in order to place the clamping mechanism within the locking position, thereby potentially damaging the retainer and/or the lead.
- As yet another example, once the plug base is mounted to the patient's cranium via screws, it is difficult to adjust the position of the plug base if it is desired. Also, due to the relatively large size of the stereotactic targeting apparatus, there is often little working space available between the targeting apparatus and the burr hole to anchor the plug base to the cranium of the patient.
- There, thus, remains a need for improved burr hole plug designs.
- In accordance with a first aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a plug base including a flange configured for being mounted around a cranial burr hole, an aperture through which an elongated medical device exiting the burr hole may pass, and a plurality of tabs (e.g., at least three tabs) configured for extending within the cranial burr hole to center the plug base relative to the cranial burr hole. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). In one embodiment, the plug base includes an open slot configured for laterally receiving the medical device. In another embodiment, the tabs are disposed on a bottom surface of the plug base flange and are coincident with the aperture. While the present inventions should not be so limited in their broadest aspects, the use of tabs to center the plug base relative to the cranial burr hole obviates the need to use a special tool to perform the centering function.
- The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. In one embodiment, the retainer is configured for being removably mounted within the aperture of the plug base. In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base. In still another embodiment, the retainer further includes a retainer support (e.g., a disk), a slot formed in the retainer support for receiving the medical device, and a clamping mechanism configured for applying a clamping force to the medical device received within the slot. The clamping mechanism may include a clamping bar configured for engaging the medical device, and a locking element configured for locking the clamping bar relative to the retainer support when the medical device is secured.
- The burr hole plug may comprise other components in addition to the plug base and retainer. For example, the burr hole plug may comprise fasteners configured for anchoring the plug base to a cranium of a patient, and a cap configured for being mounted to the plug base over the retainer. The plug base may have an exit groove configured for seating the medical device, in which case, the cap may be configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
- In accordance with a second aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises providing a plug base including a flange, an aperture, and a plurality of tabs. In one method, the tabs are equally spaced apart around the circumference of the cranial burr hole. In another method, the tabs are disposed on a bottom surface of the plug base flange. The method further comprises locating a plug base within a cranial burr hole, such that the flange is disposed about the cranial burr hole, and the tabs are disposed within the burr hole to center the plug base relative to the cranial burr hole.
- The method further comprises introducing an elongated medical device (e.g., an electrical lead) through the cranial burr hole and into the brain tissue of the patient, wherein the medical device exits the cranial burr hole through the aperture of the plug base. In one method, the plug base includes an open slot, in which case, the method may further comprising laterally introducing the medical device within the slot. In this case, the plug base may be mounted around the cranial burr hole after the medical device is introduced through the burr hole into the brain tissue of the patient. The method further comprises mounting a retainer within the aperture of the plug base, and actuating the retainer to secure the medical device. In one method, the plug base includes an open slot, in which case, the method may further comprise laterally introducing the medical device within the slot. In this case, the plug base may be mounted around the cranial burr hole after the medical device is introduced through the burr hole into the brain tissue of the patient. The method may also comprise mounting a cap to the plug base over the retainer.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- In accordance with a third aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a plug base including a flange configured for being mounted around a cranial burr hole, and an aperture through which an elongated medical device exiting the burr hole may pass. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). In one embodiment, the plug base includes an open slot configured for laterally receiving the medical device. In an optional embodiment, the plug base includes a plurality of tabs configured for extending within the cranial burr hole to center the plug base relative to the cranial burr hole. The tabs may, e.g., be disposed on a bottom surface of the plug base flange, and may be coincident with the plug base aperture.
- The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device, such that the retainer is at least partially recessed within the burr hole. In one embodiment, the flange has a bottom surface and the retainer is configured for extending below the bottom surface of the flange. While the present invention should not be so limited in their broadest aspects, the recession of the retainer into the burr hole allows the profile (i.e., height) of the burr hole plug to be reduced. In one embodiment, the retainer is configured for being removably mounted within the aperture of the plug base.
- In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base. In this case, the plug base may further include at least one annular flange extending from the inner annular ledge(s) below a bottom surface of the flange. The use of the annular flange(s) allows the retainer to be further recessed into the burr hole, thereby further decreasing the profile of the burr hole plug. In still another embodiment, the retainer further includes a retainer support (e.g., a disk), a slot formed in the retainer support for receiving the medical device, and a clamping mechanism configured for applying a clamping force to the medical device received within the slot. The clamping mechanism may include a clamping bar configured for engaging the medical device, and a locking element configured for locking the clamping bar relative to the retainer support when the medical device is secured.
- In accordance with a fourth aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises mounting a plug base around the cranial burr hole, the plug base including a flange and an aperture, and introducing an elongated medical device (e.g., an electrical lead) through the cranial burr hole and into the brain tissue of the patient, wherein the medical device exits the cranial burr hole through the aperture of the plug base. In one method, the plug base includes an open slot, in which case, the method may further comprising laterally introducing the medical device within the slot. In this case, the plug base may be mounted around the cranial burr hole after the medical device is introduced through the burr hole into the brain tissue of the patient. The method further comprises mounting a retainer within the aperture of the plug base, such that the retainer is at least partially recessed within the burr hole, thereby providing the stated advantages above. The method further comprises actuating the retainer to secure the medical device.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- In accordance with a fifth aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a split plug base configured for being mounted around a cranial burr hole. The split plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). The plug base includes a plurality of base portions configured for being demated from each other to separate the plug base, and for being mated to each other to integrate the plug base. Although the present inventions should not be so limited in their broadest aspects, the use of the split plug base allows the plug base to be conveniently mounted around the burr hole after the stimulation lead has already been introduced through the burr hole.
- In one embodiment, plug base only includes two base portions that are both annular. The base portions may be configured for mating together in an interference arrangement. For example, one of the base portions may have a recess, and the other of the base portions may have a protuberance configured for being located within the recess to mate the base portions together. As one example, the recess may be disposed on an upper surface of the one base portion, and the protuberance may laterally extend from the other base portion, such that the other base portion can be dropped down on the one base portion to mate them together. In an optional embodiment, the plug base comprises at least one element (e.g., a pin) that firmly couples the base portions together. In this case, the element(s) can be configured for being shearing off after the base portions are demated from each other, so that the base portions can then be mated together without obstruction from the element(s).
- The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. In one embodiment, the retainer is configured for being removably mounted within the aperture of the plug base. In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base. In still another embodiment, the retainer further includes a retainer support (e.g., a disk), a slot formed in the retainer support for receiving the medical device, and a clamping mechanism configured for applying a clamping force to the medical device received within the slot. The clamping mechanism may include a clamping bar configured for engaging the medical device, and a locking element configured for locking the clamping bar relative to the retainer support when the medical device is secured.
- The burr hole plug may comprise other components in addition to the plug base and retainer. For example, the burr hole plug may comprise fasteners configured for anchoring the plug base to a cranium of a patient, and a cap configured for being mounted to the plug base over the retainer. The plug base may have an exit groove configured for seating the medical device, in which case, the cap may be configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
- In accordance with an sixth aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises introducing an elongated medical device (e.g., an electrical lead) through a cranial burr hole of the patient and into the brain tissue of the patient, such that an exposed portion of the medical device exits the cranial burr hole. The method further comprises locating a first plug base portion adjacent one side of the exposed portion of the medical device, locating a second plug base portion adjacent another side of the exposed portion of the medical device, and mating the first and second plug base portions together (e.g., in an interference arrangement) to form a plug base having an aperture through which the exposed portion of the medical device extends. The method further comprises anchoring the plug base around the cranial burr hole, mounting a retainer within the aperture of the plug base, and actuating the retainer to secure the medical device. The method may further comprise anchoring the plug base to the cranium of the patient. In one method, the first and second plug base portions are mated together while the first plug base portion is located on one side of the cranial burr hole. In another method, the first and second plug base portions are mated together by disposing the second plug base portion over the first plug base portion. In still another method, a cap is mounted to the plug base over the retainer.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- In accordance with a seventh aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a plug base configured for being mounted around a cranial burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). In one embodiment, the plug base includes an open slot configured for laterally receiving the medical device.
- The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base. In one embodiment, the retainer is configured for being removably mounted within the aperture of the plug base. In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base. The retainer includes a retainer support (e.g., a disk), a slot formed in the retainer support for receiving the medical device, and a clamping mechanism having a clamping bar and a slidable flange slidably engaged with the retainer support to laterally slide the clamping bar to secure the medical device received within the slot. In one embodiment, the retainer support has a fixed clamping bar on one side of the slot opposite the clamping bar, and the clamping bar is configured for clamping the medical lead against the fixed clamping bar. While the present invention inventions should not be so limited in their broadest aspects, the specific design of the retainer provides a robust clamping mechanism even if the retainer is composed of a relatively low durable and pliable material.
- The retainer may include a recess formed in the retainer support along which the slidable flange is slidably engaged. In this case, the retainer may further include a pair of C-channels disposed on opposite sides of the recess, wherein a pair of opposing edges of the slidable flange are respectively received within the C-channels. In another embodiment, the clamping bar has a clamping surface with relief features, e.g., to increase the retention force applied to the medical device. In still another embodiment, the slot is an open slot configured for laterally receiving the medical device. In yet another embodiment, the retainer support includes first and second portions, and the retainer further includes a hinge coupled to the first and second flange portions, whereby the first and second flange portions can be alternately hinged open to laterally receive the medical lead within the slot and hinged closed to encompass the medical lead within the slot.
- The clamping mechanism may include a locking element configured for locking the clamping bar relative to the retainer support when the medical device is secured. In this case, the retainer support may have a complementary locking element with which the locking element of the clamping mechanism is configured for engaging. In another embodiment, the retainer support may have a plurality of complementary locking mechanisms with which the locking element of the clamping mechanism is configured for selectively engaging, such that the clamping bar is configured for being locked relative to the retainer support at different positions.
- The clamping mechanism may also have a resilient arm on which the locking element is disposed, and the arm may be configured for being actively flexed to release the locking element from the complementary element. In one example, the locking element is a tab and the complementary locking mechanism is a stop, in which case, the clamping mechanism may be configured for being placed in a locked position by abutting the tab against the stop, and for being placed in an unlocked position by flexing the arm to disengage the tab from the stop. The tab and the stop may have abutment surfaces that are angled relative to a plane of the flange, e.g., to facilitate placing the clamping mechanism in the unlocked position. The clamping mechanism may have a recess configured for receiving the tip of a tool to flex the resilient arm. In this case, the recess may be angled relative to a plane of the retainer support, such that a portion of a downward force applied to the recess is transferred in a direction away from the slot along the plane of the retainer support. Thus, placement of the clamping mechanism in the unlocked position may be further facilitated. The recess may be located closer to a center of the retainer support than a circumference of the retainer support, so that, e.g., force applied to the circumference of the retainer support that may otherwise reduce the disengagement force between the retainer and the plug base may be minimized. The clamping mechanism may further comprise a stop affixed to the slidable flange for limiting the flexing of the resilient arm, thereby minimizing the chance that the resilient arm will be broken or otherwise damaged.
- The burr hole plug may comprise other components in addition to the plug base and retainer. For example, the burr hole plug may comprise fasteners configured for anchoring the plug base to a cranium of a patient, and a cap configured for being mounted to the plug base over the retainer. The plug base may have an exit groove configured for seating the medical device, in which case, the cap may be configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
- In accordance with an eighth aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises introducing an elongated medical device (e.g., an electrical lead) through a cranial burr hole of the patient and into the brain tissue of the patient. The method further comprises mounting a plug base around the cranial burr hole, such that the medical device extends through an aperture of the plug base, and mounting a retainer within the aperture of the plug base. The retainer includes a retainer support, a slot formed in the retainer support, and a clamping mechanism having a clamping bar and a slidable flange slidably engaged with the retainer support. The method further comprises receiving the medical device into the slot (e.g., laterally), and sliding the slidable flange relative to the retainer support to laterally slide the clamping bar, thereby securing the medical device received within the slot. The method may further comprise mounting a cap to the plug base over the retainer.
- In one method, the retainer support has a fixed clamping bar on one side of the slot opposite the clamping bar, such that the clamping bar clamps the medical lead against the fixed clamping bar. In another method, the clamping mechanism has a locking element, in which case, the method further comprises actuating the locking element to lock the clamping bar relative to the retainer support when the medical device is secured. The method may further comprise actuating the locking element to unlock the clamping bar relative to the retainer support when the medical device is secured. In this case, the clamping mechanism may have a resilient arm on which the locking element is disposed, and the method may comprise actively flexing the resilient arm to actuate the locking element to unlock the clamping bar relative to the retainer support when the medical device is secured. In another method, the locking element is actuated to lock the clamping bar at different positions.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- In accordance with an ninth aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a plug base configured for being mounted around a cranial burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). In one embodiment, the plug base includes an open slot configured for laterally receiving the medical device.
- The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base to secure the medical device. The retainer includes at least one exit groove (e.g., a plurality of grooves circumferentially distributed on the retainer) configured for seating the medical device, such that the medical device is radially directed towards the plug base. The exit groove(s) may, e.g., be configured for seating the medical device when it is bent at a ninety degree angle relative to an axis of the burr hole. Although the present inventions should not be so limited in their broadest aspects, the use of exit grooves on the retainer, itself, allows the medical device to exit the retainer at an angle that minimizes movement of the medical device within the retainer.
- In one embodiment, the retainer is configured for being removably mounted within the aperture of the plug base. In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base. In still another embodiment, the retainer further includes a retainer support (e.g., a disk), a slot formed in the retainer support for receiving the medical device, and a clamping mechanism configured for applying a clamping force to the medical device received within the slot. The clamping mechanism may include a clamping bar configured for engaging the medical device, and a locking element configured for locking the clamping bar relative to the retainer support when the medical device is secured.
- The burr hole plug may comprise other components in addition to the plug base and retainer. For example, the burr hole plug may comprise fasteners configured for anchoring the plug base to a cranium of a patient, and a cap configured for being mounted to the plug base over the retainer. The plug base may have an exit groove configured for seating the medical device, in which case, the cap may be configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
- In accordance with a tenth aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises introducing an elongated medical device (e.g., an electrical lead) through a cranial burr hole of the patient and into the brain tissue of the patient, mounting a plug base around a cranial burr hole, such that the medical device extends through an aperture of the plug base, and mounting a retainer within the aperture of the plug base. The method further comprises actuating the retainer to secure the medical device, and radially directing the medical device towards the plug base by seating the medical device within an exit groove of the retainer, thereby providing the stated advantages above.
- In one method, the medical device is bent at an angle relative to an axis of the burr hole (e.g., a ninety degree angle) prior to seating the medical device within the exit groove. In another method, one of a plurality of exit grooves of the retainer are selected, and the medical device is seated within the selected exit groove. The method further comprises mounting a cap to the plug base over the retainer, such that the medical device is secured between the plug base and the cap. In one method, the medical device is secured within the exit groove when the cap is mounted to the plug base over the retainer. In another method, the medical device is secured within a slot formed in the retainer, and the exit groove is radially oriented perpendicular to the slot.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- In accordance with a eleventh aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a plug base configured for being mounted around a cranial burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). In one embodiment, the plug base includes an open slot configured for laterally receiving the medical device.
- The burr hole plug further comprises a retainer configured for being mounted within the aperture of the plug base. In one embodiment, the retainer is configured for being removably mounted within the aperture of the plug base. In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base. The retainer further includes first and second slidable clamping mechanisms configured for securing the medical devices therebetween within the aperture of the plug base. While the present inventions should not be so limited in their broadest aspects, the use of two slidable clamping mechanisms conveniently facilitates the securing of more than one medical device within a single cranial burr hole. For example, the first and second slidable clamping mechanisms can be configured for securing the medical devices along any one of a plurality of chords of the aperture of the plug base.
- In one embodiment, the retainer further includes a retainer support (e.g., a disk) and a slot formed in the retainer support for receiving the medical devices. In one embodiment, the slot may be open slot configured for laterally receiving the medical device. In another embodiment, the retainer support includes first and second portions, and the retainer further includes a hinge coupled to the first and second flange portions, whereby the first and second flange portions can be alternately hinged open to laterally receive the medical lead within the slot and hinged closed to encompass the medical lead within the slot.
- The first and second clamping mechanisms may be slidably engaged with the retainer support to secure the medical devices received within the slot. In this case, each of the first and second clamping mechanisms may have a clamping bar and a slidable flange slidably engaged with the retainer support to laterally slide the clamping bar to secure the medical devices received within the slot. At least one of the clamping bars has a clamping surface with relief features, e.g., to increase the retention force applied to the medical device. The retainer may further include first and second recesses formed in the retainer support on opposite sides of the slot, and the slidable flanges of the first and second clamping mechanisms may be slidably engaged within the respective recesses. In this case, the retainer may include first and second pairs of C-channels, each pair disposed on opposite sides of the respective recess, such that a pair of opposing edges of each slidable flange are respectively received within the respective C-channels.
- The burr hole plug may comprise other components in addition to the plug base and retainer. For example, the burr hole plug may comprise fasteners configured for anchoring the plug base to a cranium of a patient, and a cap configured for being mounted to the plug base over the retainer. The plug base may have an exit groove configured for seating the medical device, in which case, the cap may be configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
- In accordance with a twelfth aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises introducing at least one elongated medical device (e.g., an electrical lead) through a cranial burr hole of the patient and into the brain tissue of the patient. The method further comprises mounting a plug base around a cranial burr hole, such that the medical device extends through an aperture of the plug base, and mounting a retainer within the aperture of the plug base. The retainer includes first and second clamping mechanisms. The method further comprises sliding the first and second clamping mechanisms secure the medical device(s) therebetween, thereby providing the same advantages described above. In one method, the first and second clamping mechanisms secure the medical devices along an off-center chord of the aperture of the plug base. In another method, the retainer further includes a retainer support and a slot formed in the retainer support for receiving the medical devices, in which case, the method may further comprise receiving the medical device(s) into the slot, wherein the first and second clamping mechanisms are slid relative to the retainer support to secure the at least one medical device received within the slot. The method may further comprise mounting a cap to the plug base over the retainer.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- In accordance with a thirteenth aspect of the present inventions, a cranial burr hole plug is provided. The burr hole plug comprises a plug base configured for being mounted around a cranial burr hole. The plug base includes an aperture through which an elongated medical device exiting the burr hole may pass. The plug base aperture has a suitable shape (e.g., circular) and a suitable dimension (e.g., equal to or less than 25 mm). In one embodiment, the plug base includes an open slot configured for laterally receiving the medical device.
- The burr hole plug further comprises a retainer including a retainer support (e.g., a semi-circular flange) configured for being mounted within the aperture of the plug base, and a clip configured for mating with the retainer support (e.g., in an interference arrangement) to secure the medical device between the clip and a clamping surface of the retainer support. In one embodiment, the retainer support is configured for being removably mounted within the aperture of the plug base. In another embodiment, the plug base includes at least one inner annular ledge configured for supporting the retainer support when mounted within the aperture of the plug base. In still another embodiment, the retainer support includes a pair of C-channels, and the clip includes a pair of resilient arms configured for slidably engaging the opposing C-channels. In this case, the clip may include a pair of tabs respectively disposed on ends of the arms, and the tabs may be configured for respectively engaging ends of the opposing C-channels to lock the clip relative to the retainer support. The arms may further be configured for being displaced toward each other away from the rails to disengage the tabs from the opposing C-channels.
- The burr hole plug may comprise other components in addition to the plug base and retainer. For example, the burr hole plug may comprise fasteners configured for anchoring the plug base to a cranium of a patient, and a cap configured for being mounted to the plug base over the retainer. The plug base may have an exit groove configured for seating the medical device, in which case, the cap may be configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
- In accordance with a fourteenth aspect of the present inventions, a method of performing a medical procedure on a patient is provided. The method comprises introducing an elongated medical device (e.g., an electrical lead) through a cranial burr hole of the patient and into the brain tissue of the patient. The method further comprises mounting a plug base around a cranial burr hole, such that the medical device extends through an aperture of the plug base, mounting a retainer support within the aperture of the plug base, and mating a clip to the retainer support (e.g., an interference arrangement) to secure the medical device between the clip and a clamping surface of the retainer support. In one method, the retainer support includes a pair of opposing C-channels, the clip includes a pair of resilient arms, and the clip is mated with the retainer support by sliding the arms within the C-channels. In this case, the clip may include a pair of tabs respectively disposed on ends of the arms, and the arms can be slid within the opposing C-channels until the tabs respectively engage ends of the opposing C-channels, thereby locking the clip relative to the retainer support. The arms may be displaced toward each other away from the C-channels to disengage the tabs from the opposing C-channels. One method further comprises mounting a cap to the plug base over the retainer.
- Other and further aspects and features of the invention will be evident from reading the following detailed description of the preferred embodiments, which are intended to illustrate, not limit, the invention.
- The drawings illustrate the design and utility of preferred embodiments of the present invention, in which similar elements are referred to by common reference numerals. In order to better appreciate how the above-recited and other advantages and objects of the present inventions are obtained, a more particular description of the present inventions briefly described above will be rendered by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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FIG. 1 is a plan view of a Deep Brain Stimulation (DBS) system constructed in accordance with one embodiment of the present inventions, wherein the DBS system is particularly shown implanted within a patient; -
FIG. 2 is an exploded perspective view of a first embodiment of a burr hole plug that can be used in the DBS system ofFIG. 1 ; -
FIG. 3 is top perspective view of the burr hole plug ofFIG. 2 ; -
FIG. 4 is a bottom perspective view of the burr hole plug ofFIG. 2 ; -
FIG. 5 is a top view of the burr hole plug ofFIG. 2 ; -
FIG. 6 is a side view of the burr hole plug ofFIG. 2 ; -
FIG. 7 is a cross-sectional view of the burr hole plug ofFIG. 2 ; -
FIG. 8 is a top perspective view of a plug base used in the burr hole plug ofFIG. 2 ; -
FIG. 9 is a bottom perspective view of the plug base ofFIG. 8 ; -
FIG. 10 is a bottom perspective view of a second embodiment of a burr hole plug that can be used in the DBS system ofFIG. 1 ; -
FIG. 11 is a side view of the burr hole plug ofFIG. 10 ; -
FIG. 12 is a top perspective view of an alternative plug base that can be used in the burr hole plug ofFIG. 10 ; -
FIG. 13 is a bottom perspective view of the plug base ofFIG. 12 ; -
FIG. 14 is a bottom close-up view of the plug base ofFIG. 8 ; -
FIG. 15 is a top close-up view of the burr hole plug ofFIG. 2 ; -
FIG. 16 is a top view of another alternative plug base that can be used in the burr hole plug ofFIG. 2 ; -
FIG. 17 is top integrated perspective view of still another alternative plug base that can be used in the burr hole plug ofFIG. 2 ; -
FIG. 18 is a top exploded perspective view of the plug base ofFIG. 17 -
FIGS. 18 a and 18 b are top perspective views of still other alternative plug bases that can be used in the burr hole plug ofFIG. 2 ; -
FIG. 19 is a top perspective view of still another alternative embodiment of a plug base that can be used in the burr hole plug ofFIG. 2 ; -
FIGS. 20 and 21 is a cross-sectional view of the plug base ofFIG. 19 , particularly showing one embodiment of a mechanism for mounting the plug base within a burr hole; -
FIGS. 22 and 23 is a cross-sectional view of the plug base ofFIG. 19 , particularly showing another embodiment of a mechanism for mounting the plug base within a burr hole; -
FIGS. 24 and 25 is a cross-sectional view of the plug base ofFIG. 19 , particularly showing still another embodiment of a mechanism for mounting the plug base within a burr hole; -
FIGS. 26 and 27 is a cross-sectional view of the plug base ofFIG. 19 , particularly showing yet another embodiment of a mechanism for mounting the plug base within a burr hole; -
FIG. 28 is a top perspective view of a retainer used in the burr hole plug ofFIG. 2 ; -
FIG. 29 is a bottom perspective view of the retainer ofFIG. 28 ; -
FIG. 30 is a top view of the retainer ofFIG. 28 , particularly showing the clamping mechanism is an open position; -
FIG. 31 is a bottom view of the retainer ofFIG. 28 , particularly showing the clamping mechanism in an open position; -
FIG. 32 is a top view of the retainer ofFIG. 28 , particularly showing the clamping mechanism is a closed position; -
FIG. 33 is a bottom view of the retainer ofFIG. 28 , particularly showing the clamping mechanism in a closed position; -
FIG. 34 is a bottom perspective view of a retainer support used in the retainer ofFIG. 28 ; -
FIG. 35 is a top perspective view of a clamping mechanism used in the retainer ofFIG. 28 ; -
FIG. 36 is a bottom perspective view of the clamping mechanism ofFIG. 35 ; -
FIG. 37 is a close-up top perspective view of the retainer ofFIG. 28 , particularly showing the clamping mechanism in a closed position; -
FIG. 38 is a close-up top perspective view of the retainer ofFIG. 28 , particularly showing the clamping mechanism in an open position; -
FIGS. 39A-39E are plan views showing the technique in which the clamping mechanism and retainer support of the retainer ofFIG. 28 interact to lock and unlock the clamping mechanism from the retainer support; -
FIG. 40 is a plan view showing an alternative technique in which the clamping mechanism and retainer support of the retainer ofFIG. 28 interact to lock and unlock the clamping mechanism from the retainer support; -
FIG. 41 is a plan view showing another alternative technique in which the clamping mechanism and retainer support of the retainer ofFIG. 28 interact to lock and unlock the clamping mechanism from the retainer support; -
FIGS. 42A-42N are perspective views showing different relief surfaces that can be used for the clamping mechanism ofFIG. 35 ; -
FIG. 43 is a plan view of an interlocking relief structure that can be used for the clamping mechanism ofFIG. 35 ; -
FIG. 44 is a top perspective view of an alternative embodiment of a retainer that can be used in the burr hole plug ofFIG. 2 ; -
FIG. 45 is a top perspective view of another alternative embodiment of a retainer that can be used in the burr hole plug ofFIG. 2 ; -
FIGS. 45 a-45 f are top views of still other alternative embodiments of a retainer that can be used in the burr hole plug ofFIG. 2 ; -
FIG. 46 is a diagram illustrating different chords along which stimulation leads may be clamped by the retainer ofFIG. 45 ; -
FIG. 47 is a diagram illustrating further chords along which stimulation leads may be clamped by the retainer ofFIG. 45 ; -
FIG. 48 is a top perspective view of still another alternative embodiment of a retainer that can be used in the burr hole plug ofFIG. 2 , particularly shown in an unclamped position; -
FIG. 49 is a top perspective view of the retainer ofFIG. 48 , particularly shown in a clamped position; -
FIG. 50 is a top perspective view of yet another alternative embodiment of a retainer that can be used in the burr hole plug ofFIG. 2 , particularly shown in an unclamped position; -
FIG. 51 is a top perspective view of the retainer ofFIG. 50 , particularly shown in a clamped position; -
FIG. 52 is a top perspective view of a cap used in the burr hole plug ofFIG. 2 ; -
FIG. 53 is a bottom perspective view of the cap ofFIG. 52 ; -
FIG. 54 is a top view of a plug base holding tool that can be used to mount the plug base ofFIG. 8 within a burr hole; -
FIG. 55 is a side view of the plug base holding tool ofFIG. 54 , particularly shown engaged with the plug base ofFIG. 8 ; -
FIG. 56 is a side view of the plug base holding tool ofFIG. 54 , particularly shown disengaged from the plug base ofFIG. 8 ; -
FIG. 57 is a top view of another plug base holding tool that can be used to mount the plug base ofFIG. 8 within a burr hole; -
FIG. 58 is a side view of the plug base holding tool ofFIG. 57 , particularly shown engaged with the plug base ofFIG. 8 ; -
FIG. 59 is a top perspective view of still another plug base holding tool that can be used to mount the plug base ofFIG. 8 within a burr hole, particularly showing the tool disengaged from the plug base; -
FIG. 60 is a top perspective view of the plug base holding tool ofFIG. 59 , particularly showing the tool engaged with the plug base; -
FIG. 61 is a cross-sectional view of the plug base holding tool and plug base ofFIG. 60 ; -
FIG. 62 is a top perspective view of a screw alignment mechanism of the plug base holding tool ofFIG. 59 ; -
FIG. 63 is a top perspective view of an insert used in the screw alignment mechanism ofFIG. 62 ; -
FIG. 64 is a top perspective view of a collar used in the screw alignment mechanism ofFIG. 62 ; -
FIG. 65 is top close-up perspective view of an alternative screw alignment mechanism that can be used with the plug base holding tool ofFIG. 59 ; -
FIG. 66 is a cross-sectional close-up view of the screw alignment mechanism ofFIG. 65 ; -
FIG. 67 is a cross-sectional view of another alternative screw alignment mechanism that can be used with the plug base holding tool ofFIG. 59 ; -
FIG. 68 is a top perspective view of the screw alignment mechanism ofFIG. 67 ; -
FIG. 69 is a top perspective view of the screw alignment mechanism ofFIG. 67 , particularly showing the screw mounted disposed within the collar; -
FIG. 70 is a top perspective view of one embodiment of a retainer holding tool engaged with a retainer; -
FIG. 71 is a side view of the retainer holding tool ofFIG. 70 ; -
FIG. 72 is a cross-sectional view of one leg of the retainer holding tool engaged with the retainer; -
FIG. 73 is a perspective view of another embodiment of a retainer holding tool; -
FIG. 74 is a perspective view of the retainer holding mechanism of the retainer holding tool ofFIG. 73 ; -
FIG. 75 is a close-up perspective view of the retainer holding tool ofFIG. 73 , particularly shown mounting the retainer ofFIG. 28 with the plug base ofFIG. 8 ; -
FIG. 76 is a perspective view of the retainer holding mechanism ofFIG. 74 , particularly showing the retainer holding mechanism in phantom; -
FIG. 77 is a close-up view of a blunt tip of the retainer holding tool ofFIG. 73 ; -
FIG. 78 is a perspective view of still another embodiment of a retainer holding tool; -
FIG. 79 is a close-up view of the retainer holding tool ofFIG. 78 ; -
FIG. 80 is a close-up view of showing a portion of the retainer holding tool ofFIG. 78 in phantom; -
FIG. 81 is a side view of the plug base ofFIG. 8 mounted within a burr hole; -
FIG. 82 is a side view of the plug base ofFIG. 12 mounted within a burr hole; -
FIG. 83 is a perspective view of the mounted plug base ofFIG. 81 , particularly showing a stimulation lead disposed through the aperture of the plug base; -
FIG. 84 is a perspective view of the plug base ofFIG. 16 prior to mounting within a burr hole, particularly showing a stimulation lead disposed through the aperture of the plug base; -
FIG. 85 is a perspective view of one portion of the plug base ofFIG. 17 mounted within a burr hole; -
FIG. 86 is a perspective view of the remaining portion of the plug base ofFIG. 17 mounted within the burr hole; -
FIG. 87 is a perspective view of the retainer ofFIG. 28 mounted within the plug base shown inFIG. 83 , particularly showing the clamping mechanism in an open position; -
FIG. 88 is a perspective view of the clamping mechanism ofFIG. 48 prior to mounting within the plug base shown inFIG. 83 , particularly showing the clamping mechanism in an unclamped position; -
FIG. 89 is a perspective view of the clamping mechanism ofFIG. 48 prior to mounting within the plug base shown inFIG. 83 , particularly showing the clamping mechanism in a clamped position; -
FIG. 90 is a perspective view of the retainer ofFIG. 28 mounted within the plug base shown inFIG. 83 , particularly showing the clamping mechanism in a closed position; -
FIG. 91 is a perspective view of the retaining disk of the retainer ofFIG. 58 mounted within the plug base shown inFIG. 83 ; -
FIG. 92 is a perspective view of the clip of the retainer ofFIG. 58 mounted to the retaining disk shown inFIG. 91 ; -
FIG. 93 is a perspective view of the retainer ofFIG. 45 mounted within the plug base shownFIG. 83 ; -
FIG. 94 is a perspective view of the retainer ofFIG. 28 mounted within the plug base shown inFIG. 83 , particularly showing the clamping mechanism in a closed position; and -
FIG. 95 is a perspective view of the cap ofFIG. 52 mounted to the plug base shown inFIG. 83 . - Turning first to
FIG. 1 , anexemplary DBS system 10 constructed in accordance with one embodiment of the present inventions is shown implanted within a patient for the treatment of a debilitating disease such as, Parkinson's disease, dystonia, essential tremor, seizure disorders, obesity, depression, etc. Thesystem 10 comprises astimulation lead 12 implanted within the parenchyma of thebrain 2 of apatient 1 in order to positionelectrodes 14 carried by the distal end of thestimulation lead 12 adjacent a target tissue region 3, such as a deep brain structure of the patient (e.g., the ventrolateral thalamus, internal segment of globus pallidus, substantia nigra pars reticulate, subthalamic nucleus, or external segment of globus pallidus). Thus, electrical stimulation energy can be conveyed from theelectrodes 14 to the target tissue region 3 to treat the disease. As can be seen, thestimulation lead 12 is introduced into thehead 4 of thepatient 1 via aburr hole 5 formed in thecranium 6 of thepatient 1. In alternative embodiments, multiple stimulation leads (not shown) may be used, all of which may be located within thehead 4 of thepatient 1 via thesame burr hole 5, as will be described in further detail below. - To secure the stimulation lead 12 (or leads) and to prevent infection and leakage of cerebral spinal fluid, the
system 10 further comprises aburr hole plug 16 mounted to thecranium 6 around theburr hole 5 of thepatient 1. Thestimulation lead 12 extends from theburr hole 5, through theburr hole plug 16, to a location external to thecranium 6. Details discussing the structure and function of various embodiments of theburr hole plug 16 will be discussed in further detail below. - The
DBS system 10 further comprises aneurostimulator 17, such as an implantable pulse generator (IPG), radio frequency (RF) receiver-stimulator, or any other device coupled to and capable of delivering electrical stimulation energy to thestimulation lead 12 in a controlled and therapeutic manner. Theneurostimulator 17 may be generally implanted in a surgically made pocket in the torso of the patient (e.g., the chest or shoulder region). Theneurostimulator 17 may, of course, also be implanted in other locations of the patient's body. TheDBS system 10 further comprises alead extension 19, which may be suitably connected to the proximal end of thestimulation lead 12 and subcutaneously advanced underneath thescalp 7 of thepatient 1 to the neurostimulator implantation site, thereby facilitating the location of theneurostimulator 17 away from the exit point of the stimulation lead 12 (i.e., the burr hole 5). In alternative embodiments, theneurostimulator 17 may be directly implanted on or within thecranium 6 of thepatient 1, as described in U.S. Pat. No. 6,920,359, which is expressly incorporated herein by reference. In this case, thelead extension 19 may not be needed. After implantation, theneurostimulator 17 is used to provide the therapeutic stimulation under control of thepatient 1. Thesystem 10 may include external components, such as a patient handheld programmer, a clinician programming station, and an external charger (all not shown), the details of which will not be described herein for purposes of brevity. - In should be understood that, while the invention lends itself well to applications in DBS, the invention, in its broadest aspects, may not be so limited. For example, the stimulation lead 12 (or leads) can be delivered within regions of the brain other than a deep brain structure, e.g., within or on the surface of the cerebral cortex. In addition, electrical leads, other than stimulation leads, may be delivered within the
head 4 of thepatient 1. For example, an electrical recording lead can be delivered into thehead 4 of thepatient 1 via theburr hole 5 to sense brain signals, either alone or in conjunction with a stimulation lead. Further, elongated medical devices other than electrical leads; for example, drug delivery catheters or needles, may be delivered into thehead 4 of thepatient 1 via theburr hole 5. Thus, it can be appreciated that the burr hole plugs described herein can be used with any elongated medical device intended to be delivered through aburr hole 5 within thecranium 6 of apatient 1 for any therapeutic and/or diagnostic purpose. - Referring now to
FIGS. 2-7 , one embodiment of aburr hole plug 16 will be described. Theburr hole plug 16 generally comprises a plug base (or shell) 18 configured for being fixably mounted about a burr hole, aretainer 20 configured for being mounted within theplug base 18 and for temporarily securing a stimulation lead extending through the burr hole, and acap 22 configured for being mounted to theplug base 18 over theretainer 20 in order to permanently secure the stimulation lead while sealing the burr hole. Theburr hole plug 16 further comprises a plurality of fasteners, and in this case, a pair ofscrews 14, for mounting theplug base 18 to thecranium 6 of thepatient 1. - Referring further to
FIGS. 8 and 9 , theplug base 18 includes a closed ring-shapedbody 24 and anaperture 26 through which the stimulation lead exiting from the burr hole may pass. The ring-shapedbody 24 is composed of a suitable hard biocompatible material, such as titanium, stainless steel, alloys, or hard polymers. The profile of the ring-shapedbody 24 is preferably minimized as much as possible, such that theplug base 18 does not noticeably protrude from the cranium underneath the scalp of the patient. As best shown inFIG. 6 , thetop surface 28 of the ring-shapedbody 24 may also be tapered to further reduce the visibility of theburr hole plug 16 below the patient's scalp. Thebottom surface 30 of the ring-shapedbody 24 may optionally be concave (not shown) in order to match the curvature of a typical cranium. Theplug base aperture 26 preferably matches the shape and size of the burr hole. For example, theaperture 26 may have a circular shape and its greatest dimension may be equal to or less than 25 mm. Thus, it can be appreciated that the ring-shapedbody 24 can be disposed about the burr hole, such that theaperture 26 is coincident with, and lies directly above, the burr hole. - To ensure that the ring-shaped
body 24 is centered relative to the burr hole, theplug base 18 further comprises a plurality of self-centeringtabs 32 configured for extending within the burr hole. In the illustrated embodiment, thetabs 32 are disposed on thebottom surface 30 of the ring-shapedbody 24, so that thetabs 32 do not obstruct the passage of the stimulation lead through theplug base aperture 26. Notably, because thetabs 32, as opposed to a continuous cylindrical flange, are independently flexible, theplug base 18 can be centered within burr holes that are slightly smaller than the circumference defined by thetabs 32. Thus, theplug base 18 can be used with differently sized burr holes. - The
plug base 18 preferably includes at least threetabs 32 equidistantly spaced around theaperture 26 in order to maximize the centering function. Thetabs 32 are preferably arranged in a manner such that they fit tightly against the inner surface of the circumference of the burr hole so as to avoid any movement of theplug base 18 relative to the burr hole. In this case, thetabs 32 will be coincident with the plug base aperture 26 (assuming that theaperture 26 is of the same size and shape as the burr hole). Thetabs 32 are designed to be permanently disposed on the ring-shapedbody 24, such that thetabs 32 will remain located within the burr hole after implantation. Thetabs 32 may be suitably disposed onto the ring-shapedbody 24, for example, by molding thetabs 32 andbody 24 as a unibody design. Significantly, the self-centeringtabs 32 conveniently and quickly allow theplug base 18 to be centered relative to the burr hole without the aid of a special centering tool. - In the illustrated embodiment, the
plug base 18 is permanently anchored to the cranium of the patient. To this end, theplug base 18 includes twofastening holes 34 formed within the ring-shapedbody 24 for respectively receiving anchoring fasteners, such as, e.g., screws, pins, spikes, tabs, or buttons. Alternatively, other means of anchoring theplug base 18 to the cranium of the patient, such as, e.g., adhesion, can be used. Relief structures (not shown) may be added to thebottom surface 30 of the ring-shapedbody 24 and the outer surfaces of thetabs 32 to prevent rotational movement between theplug base 18 and the burr hole prior to permanent anchoring to the cranium. Such relief structures may include, e.g., a rough sandpaper-like surface, notches, bumps, horizontal or vertical ribs or threads, etc. - The
plug base 18 further comprises a plurality of lead exit grooves 36 (in this case, four equally spaced grooves) configured for seating the stimulation lead. In particular, the portion of the stimulation lead exiting the burr hole through theaperture 26 of the plug base 18 (i.e., the proximal end of the stimulation lead) can be bent down at a perpendicular angle and seated within one of thelead exit grooves 36 of theplug base 18, such that the proximal end of the stimulation lead lies generally parallel to the exterior surface of the cranium. As will be described in further detail below, the stimulation lead will be firmly secured within the selectedexit groove 36 when thecap 22 is mounted to theplug base 18. - The
plug base 18 further comprises a cap pop-out recess 38 located at aninner edge 40 of the ring-shapedbody 24 adjacent theaperture 26, and a plurality of cap locking recesses 42 (in this case, a pair of oppositely disposed locking recesses). As will be described in further detail below, a tool can be inserted into the cap pop-out recess 38 to remove the previously mountedcap 22 from theplug base 18, and the cap locking recesses 42 can receive corresponding cap locking tabs (described below) for facilitating mounting of thecap 22 to theplug base 18. Theplug base 18 also comprises at least one inner annular ledge 44 (in this case, three equally spaced annular ledges) configured for supporting theretainer 20 when mounted within theplug base aperture 26. To this end, theannular ledges 44 are disposed on an inner surface 46 (best shown inFIG. 14 ) of the ring-shapedbody 24 surrounding theaperture 26, thereby preventing theretainer 20 from descending too far into the burr hole when mounted within theaperture 26. In an alternative embodiment illustrated inFIGS. 10-13 , aplug base 57 is similar to theplug base 18, with the exception that it comprises at least one annular flange 45 (in this case, one) extending from the respectiveannular ledges 44 below thebottom surface 30 of the ring-shapedbody 24. Thus, it can be appreciated that theannular flanges 45 allow the top surface of theannular ledges 44 to be flush with thebottom surface 30 of theplug base body 24, so that theretainer 20 can be recessed further down into the burr hole (compare retainer placement inFIG. 11 withFIG. 6 ). - Referring back to
FIGS. 8 and 9 , and further toFIGS. 14 and 15 , theplug base 18 further comprises a plurality of mechanisms that lock theretainer 20 in place while preventing, or at least hindering, the rotation of theretainer 20 within theplug base aperture 26. In particular, theplug base 18 includes a plurality of ramps 48 (only one shown inFIG. 15 ) disposed around theinner surface 46 of the ring-shapedbody 24 just above theannular ledges 44. Theramps 48 taper inward from top to bottom, such that as theretainer 20 is forced downward intoaperture 26, the edges of theretainer 20 slidably engage theramps 48 and then move past theramps 48 until theretainer 20 is seated between theannular ledges 44 and bearing surfaces 50 (the bottom surfaces) (best shown inFIG. 14 ) of theramps 48, thereby providing an interference fit that locks theretainer 20 within theplug base aperture 26. Preferably, the vertical distance between the bearing surfaces 50 of theramps 48 and theannular ledges 44 are approximately equal to the thickness of theretainer 20, such that theretainer 20 cannot move up or down within theaperture 26 once it is locked in place. Once theretainer 20 is located between the bearing surfaces 50 of theramps 48 and theannular ledges 44, theramps 48 also engage corresponding sun-dial ticks (described below) located on the upper surface of theretainer 20 when theretainer 20 is rotated within theaperture 26, thereby limiting the rotation of theretainer 20, and thus, any inadvertent movement of the stimulation lead, as will be described in further detail below. - In the embodiment illustrated in
FIGS. 8 and 9 , the ring-shapedbody 24 is closed, which maximizes the durability of theplug base 18. Alternatively, a slottedplug base 58 may include an open ring-shapedbody 64, as illustrated inFIG. 16 . In particular, the open ring-shapedbody 64 is similar to the closed ring-shapedbody 24, with the exception that it comprises anopen slot 66 configured for laterally receiving the stimulation lead. This permits theplug base 58 to be mounted to the cranium around the burr hole after the stimulation lead has been inserted through the burr hole and into the brain tissue by simply sliding the stimulation lead through theslot 66 as theplug base 58 is moved into place. Notably, because the open architecture of the ring-shapedbody 64 inherently weakens its structure, the ring-shapedbody 64 is preferably composed of an extremely durable material, such as, e.g., titanium, thereby overcoming any issues inherently within the open ring-shaped body, such as excessive bending. In one particularly advantageous embodiment, the ring-shapedbody 64 is composed of polyethertheterketone (PEEK), which is not only extremely durable and biocompatible, but is also MRI-compatible, and, importantly, will not distort the MRI. Alternatively, the ring-shapedbody 64 may be composed of nylon, silicone, Utlem®, Elasthane™, Tecothane®, and/or Bionate®. - In an alternative embodiment, a
split plug base 78 illustrated inFIGS. 17 and 18 may be used. Theplug base 78 is similar to theplug base 18 illustrated inFIGS. 8 and 9 , with the exception that theplug base 78 comprises a plurality of annular body portions, and in particular, a firstannular body portion 80 and a secondannular body portion 82, that are configured for being demated from each other to separate the plug base 78 (FIG. 18 ) and for being mated to each other to integrate the plug base 78 (FIG. 17 ). Theplug base 78 also differs from theplug base 18 in that it comprises a continuous annular flange 79 (instead of self-centering tabs 32) that fits within the cranial burr hole. Theplug base 78 is also not shown with a cap pop-out recess 38, cap locking recesses 42, or ramps 48. - In the illustrated embodiment, opposing ends 84, 86 of the first
annular body portion 80 respectively include afemale coupling element 92 and amale coupling element 94, and opposing ends 88, 90 of the secondannular body portion 82 respectively include amale coupling element 96 and afemale coupling element 98. The male and female elements 92-98 match each other, such that the ends 84, 88 of theannular body portions male coupling element 96 of the secondannular body portion 82 into thefemale coupling element 92 of the firstannular body portion 80, and theends annular body portions male coupling element 94 of the firstannular body portion 80 into thefemale coupling element 98 of the secondannular body portion 82. Alternatively, bothmale coupling elements annular body portion 80, and bothfemale coupling elements annular body portion 82, or vice versa, with similar results. - In the embodiment illustrated in
FIGS. 17 and 18 , the male and female coupling elements 92-98 are configured in a manner, such that theannular body portions annular body portion 82 down on top of the firstannular body portion 80. In particular, the female andmale coupling elements annular body portion 80 respectively take the form of a rectangular recess and a rectangular boss located on the upper surface of the firstannular body portion 80, and the male andfemale coupling elements annular body portion 82 respectively take the form of a rectangular protuberance and a C-channel that laterally extend from the upper region of the secondannular body portion 82. Thus, when the secondannular body portion 82 is lowered onto the firstannular body portion 80, the laterally extendingprotuberance 96 of the secondannular body portion 82 will be received by therecess 92 of the firstannular body portion 80, and the boss of the firstannular body portion 94 will be received by the C-channel 98 of the secondannular body portion 82. - Thus, it can be appreciated that the
annular body portions plug base 18, which can then be anchored to the cranium of the patient. It should also be appreciated that, since theplug base 18 is composed of several independent components that can move relative to each other, there is less of a chance of fracturing theplug base 78 when it is anchored to the cranium of the patient. - Even though the
plug base 78 is designed to be separated into two pieces, it may still be desirable to alternatively maintain theplug base 78 as a single piece (i.e., as a prior art plug base), for example, when theplug base 18 is to be mounted to the cranium of the patient prior to introducing the stimulation lead through the burr hole. To this end, theplug base 78 comprises additional coupling elements that firmly couple theannular body portions complementary pins 100 and recesses (not shown) that firmly engage each other, such that the mated first and secondannular body portions annular body portions pins 100 can be broken off or otherwise removed, so that the secondannular body portion 82 can be lowered down on to the firstannular body portions 80 when they are mated together without any hindrance from thepins 100. Alternatively, the coupling elements can simply take the form of bonding material or other connection that can be easily fractured to demate theannular body portions - In alternative embodiments, the
complementary body portions FIG. 18 a, thecomplementary body portions rod 104, which allows thebody portions body portions rod 104, so that therod 104 can be removed from thebody portions FIG. 18 b, thecomplementary body portions member 106, such as a screw, that is rotated in order to gradually force thebody portions - Referring to
FIGS. 19-21 , another alternative embodiment of aplug base 108 will now be described. Instead of being permanently anchored to the cranium of the patient, theplug base 108 may be reversibly anchored to a burr hole (i.e., it can be anchored without leaving holes other than the burr hole in the cranium), while still providing the benefits of a permanently anchoredplug base 18. In particular, theplug base 108 generally comprises an upper ring-shapedplug body 110, a lower ring-shapedplug body 112, and a ring-shaped seal 114 (and in this case, an O-ring) disposed between theplug bodies seal 114 may be composed of a biocompatible and flexible material, such as, e.g., silicone. The upper ring-shapedplug body 110 has alower surface 116 with an outerannular recess 120 in which theseal 114 is disposed, and the lower ring-shapedplug body 112 has anupper surface 118 with an outerannular boss 122 on which theseal 114 is disposed. Theplug base 108 may have features (not shown) on the upper ring-shapedplug body 110; for example, an annular ledge to support theretainer 20, locking mechanisms to prevent rotation of theretainer 20, or lead exit grooves for seating the stimulation lead. - The outer diameters of the
plug bodies plug base 108 can be disposed entirely within the burr hole. The outer diameter of theseal 114, when uncompressed (FIG. 20 ), is substantially equal to the diameter of the burr hole. When theseal 114 is compressed (FIG. 21 ) in a vertical direction, which can be accomplished by displacing theplug bodies seal 114 increases, thereby firmly engaging the surface of the burr hole, such that the burr hole is sealed. To this end, theplug base 108 comprises fasteners, and inparticular screws 124, which are disposed within threaded holes 126 formed through theplug bodies - Thus, it can be appreciated that rotation of the
screws 124 in one direction using a tool, such as a screwdriver, will cause theplug bodies annular boss 122 of thelower plug body 112 to move into theannular recess 120 of theupper plug body 110 to compress theseal 114 in the vertical direction, thereby expanding theseal 114 in the horizontal direction to sealingly mount theplug base 108 within the burr hole. Rotation of thescrews 124 in the opposite direction will cause theplug bodies annular boss 122 of thelower plug body 112 to move out of theannular recess 120 of theupper plug body 110 to allow theseal 114 to expand in the vertical direction, thereby allowing theseal 114 to compress in the horizontal direction to release theplug base 18 from within the burr hole. Although only twoscrews 124 are shown, more than two screws (e.g., four), can be used to ensure substantially uniform compression of theseal 114 around its circumference. - In an alternative embodiment, a
plug base 128 illustrated inFIGS. 22 and 23 is similar to theprevious plug base 108, with the exception that it comprises upper and lower ring-shapedplug bodies plug bodies upper surfaces seal 114 disposed.Screws 138 are disposed within threaded holes 140 formed through theplug bodies seal 114. Thus, it can be appreciated that rotation of thescrews 138 in one direction using a tool, such as a screwdriver, will cause theplug bodies upper surfaces seal 114 in the vertical direction, thereby expanding theseal 114 in the horizontal direction to sealingly mount theplug base 128 within the burr hole. Rotation of thescrews 138 in the opposite direction will cause theplug bodies seal 114 to expand in the vertical direction, thereby allowing theseal 114 to compress in the horizontal direction to demount theplug base 128 from within the burr hole. - While the fasteners that displace the upper and lower plug bodies to compress the seal have been described as screws, other types of fasteners can be used, such as complementary coupling elements that are fit together in an interference arrangement. For example, as illustrated in
FIGS. 24 and 25 , flaredpins 142 can be disposed on thelower surface 134 of theupper plug body 130, and matching flared recesses 144 can be disposed on theupper surface 136 of thelower plug body 132. Thus, the flared pins 142 can be respectively introduced through holes 146 in theseal 114 and snap-fit into the flared recesses 144, thereby causing the lower andupper surfaces FIG. 25 ) in the vertical direction, thereby expanding theseal 114 in the horizontal direction to sealingly mount theplug base 128 within the burr hole. A tool (not shown) can be used to hold thelower plug body 132 in place while the flared pins 142 are snap-fit into the flared recesses 144. Theupper plug body 130 can be displaced from thelower plug body 132 to remove the flared pins 142 from the flared recesses 144 to allow theseal 114 to expand (FIG. 24 ) in the vertical direction, thereby allowing theseal 114 to compress in the horizontal direction to release theplug base 128 from the burr hole. - In another alternative embodiment illustrated in
FIGS. 26 and 27 , anotherplug base 148 that can be non-invasively mounted within a burr hole will be described. Theplug base 148 is similar to theplug base 108, with the exception that it includes a threadedcollar 150 mounted to anupper surface 160 of thelower plug body 132 viastandoffs 152 that extend throughholes 154 in theseal 114. In this case, theupper plug body 130 includes a threadedouter surface 156 that engages the threadedcollar 150 to displace theupper plug body 130 relative to thelower plug body 132. Thus, it can be appreciated that rotation of theupper plug body 130 in one direction will cause theplug bodies upper surfaces FIG. 27 ) in the vertical direction, thereby expanding theseal 114 in the horizontal direction to sealingly mount theplug base 148 within the burr hole. Rotation of theupper plug body 130 in the opposite direction will cause theplug bodies seal 114 to expand (FIG. 26 ) in the vertical direction, thereby allowing theseal 114 to compress in the horizontal direction to release theplug base 148 from within the burr hole. - Referring to
FIGS. 28-37 , the details of theretainer 20 will now be described. Theretainer 20 generally comprises a retainingsupport 160 configured for being mounted within theplug base aperture 26, and aclamping mechanism 162 mounted to the retainingsupport 160 and configured for applying a clamping force to the stimulation lead. The clamping force applied to the stimulation lead secures the stimulation lead before and while thecap 22 is being mounted to theplug base 18 to more firmly secure the stimulation lead. The components of theretainer 20 may be composed of the same material as theplug base 18 described above; namely, a suitable hard biocompatible material, such as titanium, stainless steel, alloys, or hard polymers. Alternatively, the components of theretainer 20 may be composed of PEEK to provide certain structural advantages, as will be described in further detail below. - In the illustrated embodiment, the retaining
support 160 comprises adisk 164 and anopen lead slot 166 formed in thedisk 164 for laterally receiving the stimulation lead, thereby allowing theretainer 20 to be mounted within theplug base aperture 26 after the stimulation lead has been introduced through the burr hole. As best shown inFIGS. 7 and 15 , theretainer 20, and in particular, thedisk 164, can be interference fit between theramps 48 and theannular ledges 44 located on theinner surface 46 of the ring-shapedbody 24. In the illustrated embodiment, thedisk 164 has anannular lip 168 disposed around its circumference that is interference fit between theramps 48 and theannular ledges 44 of the ring-shapedbody 24, and athicker center portion 170 that extends below theannular ledges 44 in order to accommodate theclamping mechanism 162 in a robust manner. - The
annular ledges 44 are displaced from the top surface of the plug base 18 a dimension that causes at least a portion of theretainer 20, and in particular thedisk 164, below thebottom surface 30 of the ring-shapedplug body 24. As a result, at least a portion of thedisk 164 will be recessed within the burr hole when mounted within theplug base 18, thereby lowering the profile of the portion of the burr plug 16 above the burr hole. In the case whereannular flanges 45 are provided, as illustrated inFIGS. 10-13 , thedisk 164 will be further recessed within the burr hole. Theretainer 20 is configured for being removably mounted within theplug base aperture 26. To this end, theretainer support 160 further comprises a retainer pop-out notch 172 located on the circumference of thedisk 164. The pop-out notch 172 can receive a tool that can be manipulated to pop theretainer 20 out of the plug base 18 (i.e., by overcoming the interference fit between theramps 48 andannular ledges 44 of the plug base 18). Alternatively, there can simply be a hole a, hook, or an eyelet in or on the disk for receiving a tool to pop theretainer 20 out of theplug base 18. - As discussed above, the
retainer 20, and in particular theretainer support 160 comprises a plurality of sun-dial ticks 174 that engage theramps 48, thereby limiting rotation of theretainer 20 within theplug base aperture 26. In this case, the sun-dial ticks 174 take the form of radially extending ribs that are distributed about the circumference on thetop surface 171 of thedisk 164. Notably, as the circumferential distance between the sun-dial ticks 174 decreases, the rotational movement of theretainer 20 within theaperture 26 of theplug body 24 will be incrementally decreased to the same extent. In this illustrated embodiment, the circumferential spacing between the sun-dial ticks 174 is approximately 24 degrees, and therefore, the rotation of theretainer 20 will be limited to 24 degrees. - The
retainer support 160 comprises a fixedclamping bar 176 disposed on an inner edge of thedisk 164 adjacent one side of thelead slot 166. Theclamping mechanism 162 operates in conjunction with the fixedclamping bar 176 to secure the stimulation lead therebetween, as will be described in further detail below. As best shown inFIG. 34 ,retainer support 160 further comprises arecess 178 formed in thedisk 164 and a pair of C-channels 180 on opposite sides of therecess 178 to accommodate theclamping mechanism 162, and a recessedstop 182 within therecess 178 for accommodating a locking element of theclamping mechanism 162, as will be described below. Thedisk 164 may optionally have a “living hinge” that allows it to be bent along thelead slot 166, thereby facilitating insertion of theclamping mechanism 162 into thedisk 164 during assembly. - The
clamping mechanism 162 comprises amovable clamping bar 184 and aflange 186 slidably engaged with thedisk 164 to laterally slide themovable clamping bar 184 relative to thedisk 164 and selectively secure the stimulation lead received within thelead slot 166 or release the stimulation lead received within thelead slot 166. Themovable clamping bar 184 extends parallel to thelead slot 166 opposite to the fixedclamping bar 176 on thedisk 164, such that aclamping surface 188 of themovable clamping bar 184 is configured for clamping the stimulation lead against a clampingsurface 190 of the clampingbar 176. In the illustrated embodiment, the clamping surfaces 188, 190 of therespective clamping bar 184 and clampingbar 176 are ribbed in order to provide localized gripping of the stimulation lead, thereby increasing the lead retention force. Theclamping mechanism 162 further comprises anangled flange 192 located at the end of themovable clamping bar 184, thereby preventing the stimulation lead from being located past themovable clamping bar 184 at the end of theslot 166 where it could potentially be wedged between theclamping mechanism 162 and the end of theslot 166. - In the illustrated embodiment, the
flange 186 is U-shaped and includes a pair oflegs 194 extending perpendicularly from themovable clamping bar 184 away from thelead slot 166 and across bar 196 that extends between thelegs 194 in a direction generally parallel to thelead slot 166. TheU-shaped flange 186 further comprisesrails 198 that extend along the outer surface of thelegs 194. The sliding arrangement between theflange 186 of theclamping mechanism 162 and thedisk 164 of theretainer support 160 is provided between thelegs 194 of theU-shaped flange 186 and the C-channels 180 of theretainer support 160. In particular, theU-shaped flange 186 is received within therecess 178, with therails 198 of theflange 186 slidably received within the C-channels 180 in a closely toleranced relationship, so that theflange 186, and thus themovable clamping bar 184, can be smoothly moved back and forth in a lateral direction (i.e., perpendicular to the lead slot 166). - The
clamping mechanism 162 is configured for being placed between an unlocked (or open) position (FIGS. 30-31 and 38) wherein theclamping mechanism 162 can be freely slid relative to thedisk 164, and a locked (or closed) position (FIGS. 32-33 and 37) wherein theclamping mechanism 162 cannot be freely slid relative to theretainer support 160 without additional manipulation of theclamping mechanism 162. To this end, theclamping mechanism 162 further comprises aresilient arm 200 extending perpendicularly from themovable clamping bar 184 between thelegs 194 of theU-shaped flange 186, and a locking element, and in particular, atab 202 located at the end of theresilient arm 200. Thelocking tab 202 is configured for engaging a complementary locking element, and in particular, the recessedstop 182 on thedisk 164 to lock themovable clamping bar 184 relative to thedisk 164 when the stimulation lead is secured. In particular, as best shown inFIGS. 34-38 , thelocking tab 202 includes abearing surface 204 configured for sliding along a bearingsurface 206 of the recessedstop 182 when theclamping mechanism 162 is in the unlocked position, and anabutment surface 208 that abuts anabutment surface 210 of the recessedstop 182 when theclamping mechanism 162 in the locked position. The resiliency of thearm 200 on which thelocking tab 202 is disposed will naturally cause thelocking tab 202 to transition from the bearingsurface 204 of the recessedstop 182 to theabutment surface 208 of the recessedstop 182 when thelocking tab 202 reaches the end of the recessedstop 182. - Thus, the
clamping mechanism 162 can be placed from the unlocked position (or open position) (FIG. 39A ) to the locked position (FIG. 39C ) by sliding theU-shaped flange 186, and thus, themovable clamping bar 184, relative to thedisk 164 towards the fixedclamping bar 176 as the bearingsurface 204 of thelocking tab 202 slides along the bearingsurface 206 of the recessedstop 182 until thelocking tab 202 reaches the end of the recessed stop 182 (FIG. 39B ), after which the resiliency of thearm 200 will cause theabutment surface 208 of thelocking tab 202 to abut theabutment surface 210 of the recessed stop 182 (FIG. 39C ). - The
clamping mechanism 162 can be placed from the locked position (FIG. 39C ) to the unlocked position by applying a downward force on theresilient arm 200 to disengage the abutment surfaces 208, 210 of therespective locking tab 202 and recessed stop 182 from each other (FIG. 39D ), and sliding theU-shaped flange 186, and thus, themovable clamping bar 184, relative to thedisk 164 away from the fixedclamping bar 176 until the bearingsurface 204 of thelocking tab 202 slides along the bearingsurface 206 of the recessed stop 182 (FIG. 39E ). - Significantly, the relative dimensions between the
resilient arm 200, lockingtab 202, and recess stop 182 are selected, such that theabutment surface 208 of thelocking tab 202 becomes coincident with theabutment surface 210 of the recessedstop 182 as the stimulation lead becomes secured between the clampingsurface 188 of themovable clamping bar 184 and the clampingsurface 190 of the fixedclamping bar 176. In the manner, firm clamping of the stimulation lead is ensured without damaging the stimulation lead. - To facilitate manipulation of the
clamping mechanism 162 relative to thedisk 164, theclamping mechanism 162 comprises arecess 212 formed on thebearing surface 204 of thelocking tab 202 for receiving a tool that can be used to flex theresilient arm 200 in order to transition theclamping mechanism 162 from the locked position into the unlocked position. The tool can also be received within therecess 212 to slide themovable clamping bar 184 towards or away from the fixedclamping bar 176 to secure or release the stimulation lead. It should be noted that therecess 212 is closer to the center of thedisk 164 than the circumference of thedisk 164. Thus, when a downward force applied to therecess 212, any force applied to the circumference of thedisk 164, which may otherwise disengage, or weaken the engagement between, the sun-dial ticks 174 on thetop surface 171 of thedisk 164 from theramps 48 on theinner surface 46 of the ring-shapedplug body 24, will be minimized or decreased. - To further facilitate placing the
clamping mechanism 162 from the locked position into the unlocked position, the bearingsurface 204 of thelocking tab 202, and thus, therecess 212, may be angled (as best shown inFIG. 35 ) relative to the plane of thedisk 164, such that a portion of the downward force applied to therecess 212 by the tool is transferred in a direction away from theslot 166 along the plane of thedisk 164. In this manner, as theflexible arm 200 is flexed, the bearingsurface 204 of thelocking tab 202 will naturally slide along the bearingsurface 206 of the recessedstop 182 once the abutment surfaces 208, 210 of therespective locking tab 202 and recessedstop 182 are disengaged from each other. In the embodiment illustrated inFIGS. 39A-39E , the abutment surfaces 208, 210 of thelocking tab 202 and recessedstop 182 are perpendicular relative to the plane of thedisk 164, thereby maximizing locking engagement of theclamping mechanism 162. However, in an alternative embodiment illustrated inFIG. 40 , the abutment surfaces 208, 210 of thelocking tab 202 and recessedstop 182 are tapered (i.e., obliquely angled) relative to the plane of thedisk 164, thereby facilitating the placement of theclamping mechanism 162 from the locked position into the unlocked position. - To prevent the
resilient arm 200 from fatiguing or breaking, theclamping mechanism 162 further comprises astop 214 that is affixed to theU-shaped flange 186 to prevent theresilient arm 200 from bending past a certain point, as best shown inFIGS. 35 and 36 . In the illustrated embodiment, thestop 214 is located at the center of theU-shaped flange 186 between thelegs 194, so that thebottom surface 216 of theresilient arm 200 bears against anupper surface 218 of thestop 214 when the downward force is applied to thelocking tab 202. - In an alternative embodiment, the
retainer support 160 has a plurality of complementary locking mechanisms with which a locking element of theclamping mechanism 162 is configured for selectively engaging, such that themovable clamping bar 184 is configured for being located relative to thedisk 164 at different positions. For example, as illustrated inFIG. 41 , theretainer support 160 may be provided with aratchet 220 havingteeth 222, any of which thelocking tab 202 of theresilient arm 200 may engage. Thus, theU-shaped flange 186 may be slid towards thelead slot 166, such that theabutment surface 208 of thelocking tab 202 slides along theratchet 214. When movement of theU-shaped flange 186 ceases, the end of theresilient arm 200 will engage one of theteeth 222 on theratchet 220. In this manner, different sized leads may be used with theburr hole plug 16. - Notably, the
retainer support 160 and theclamping mechanism 162 may have additional features that maximize the clamping force applied to the stimulation lead. For example, theretainer 20, including theretainer support 160 and theclamping mechanism 162, can be composed of PEEK, thereby substantially increasing the durability of theretainer 20, even in view of the open architecture of theretainer support 160. Since deformation of themovable clamping bar 184 will be substantially decreased by the PEEK composition, the clamping force will be more uniformly distributed along themovable clamping bar 184, thereby securing the stimulation lead in a more reliable manner. The reduced deformation of theU-shaped flange 186 anddisk 164 will also allow theclamping mechanism 162 to slide relative to theretainer support 160 in a more reliable and robust manner. - In addition, the clamping surfaces 188, 190 of the
movable clamping bar 184 and/or fixedclamping bar 176 may be provided with any one of a variety of relief features. For example, the relief features may include horizontal ridges or bars (FIG. 42A ), dimples or bumps (FIG. 42B ), horizontal serrations (FIG. 42C ), vertical corrugations (FIG. 42D ), tread plates (FIG. 42E ), knurl pattern (FIG. 42F ), spring (FIG. 42G), barbs (FIG. 42H ), grit finish (blasted, plated, mold finish) (FIG. 42I ), non-skid surface (FIG. 42J ), spikes or tines (FIG. 42K ), horizontal channel (FIG. 42L ), flex barb (FIG. 42M ), any combination of the above, e.g., horizontal ridges and dimples or bumps (FIG. 42N ). - The above relief features will increase the retention force of the
movable clamping bar 184 and/or fixedclamping bar 176 by altering the coefficient of friction, increasing compression, “biting” into the lead, creating edges to catch the lead, increasing surface area, locally increasing clamping force, deformation of the lead into surface recesses, etc. Combinations of relief features in multiple directions on themovable clamping bar 184 and/or fixedclamping bar 176 can prevent the lead from moving in multiple directions (e.g., along the lead axis and along the face of themovable clamping bar 184 and/or fixedclamping bar 176 perpendicular to the lead axis). Relief structures can be provided on the clamping surfaces 188, 190 of both themovable clamping bar 184 and the fixedclamping bar 176 to operate in combination with each other to neck or otherwise provide a tortuous path for the lead. For example, the relief structures on the clamping surfaces 188, 190 may be staggered or interlocking (FIG. 43 ) to neck or create a tortuous path for the stimulation lead. - While the
burr hole plug 16 illustrated inFIGS. 2-7 providelead exit grooves 36 on theplug base 18, lead exit grooves can be advantageously provided on the retainer instead. For example, referring toFIG. 44 , anotherretainer 230 that can be mounted within theaperture 26 of theplug base 18 will now be described. Theretainer 230 is similar to theretainer 20 illustrated inFIGS. 28-33 , with the exception that it comprises a plurality of lead exit grooves 232 (in this case, two) configured for seating the stimulation lead when it is bent at a ninety degree angle relative to the axis of the burr hole, such that the stimulation lead is radially directed towards theplug base 18. In this case, theplug base 18 need not include lead exit grooves. In the illustrated embodiment, theexit grooves 232 are located on opposite sides of each other and are circumferentially oriented perpendicular to thelead slot 166, and thus, themovable clamping bar 184. That is, an imaginary line drawn from eachexit groove 232 to the center of thedisk 164 will be perpendicular to themovable clamping bar 184. In this manner, it is assured that when the stimulation lead is bent down and received into one of theexit grooves 232, any tensile force applied to the stimulation lead will be directed at an angle perpendicular to the orientation of thelead slot 166, and thus, counteracted by the retention force between the top edges of themovable clamping bar 184 and fixedclamping bar 176 and the stimulation lead. - Because there are two
exit grooves 232, the direction in which the stimulation lead exits theretainer 230 may be selected. In an alternative embodiment, a plurality of fastening exit grooves (not shown) can be provided on each side of theclamping slot 166, such that the stimulation lead may be placed and perpendicularly bent downward at multiple locations along theclamping slot 166. In another alternative embodiment, eachfastening exit groove 232 may be slid back and forth in a direction parallel to theclamping slot 166, such that the stimulation lead may be placed and perpendicularly bent downward at multiple locations along theclamping slot 166. - While the
previous retainers FIG. 45 , anotherretainer 240 that can be mounted within theaperture 26 of theplug base 18 will now be described. Like theprevious retainer 20, theretainer 240 comprises a retainingsupport 242 that includes adisk 244 and anopen slot 246 formed in thedisk 244 for laterally receiving the stimulation lead, thereby allowing theretainer 240 to be mounted within theplug base aperture 26 after the stimulation lead has been introduced through the burr hole. Theretainer 240 may include other features, such as a pop-out notch, sun-dial ticks, and lead exit grooves (not shown) located on thedisk 244. - The
retainer 240 differs from theretainer 20 in that it comprises twoslidable clamping mechanisms 252, each including amovable clamping bar 254 and aflange 256 slidably engaged with thedisk 244 to laterally slide themovable clamping bar 254 relative to thedisk 244 and selectively secure the stimulation lead received within thelead slot 246 or release the stimulation lead received within thelead slot 246. The movable clamping bars 254 extend parallel to thelead slot 246 opposite each other, such that clamping surfaces 258 (only one shown) of the respective clamping bars 254 are configured for clamping the stimulation lead against each other. Like the clamping surfaces 188, 190 of therespective clamping bar 184 and clampingbar 176 discussed above with respect to theretainer 20, the clamping surfaces 258 of the clamping bars 254 may be ribbed or comprise other relief features (not shown), thereby increasing the lead retention force. In addition, eachclamping mechanism 252 may alternatively include a U-shaped flange, resilient arm, locking tab, and an arm stop (all not shown) similar to theU-shaped flange 186,resilient arm 200, lockingtab 202, and arm stop 220 described above with respect to theretainer 20. - The
retainer 240 may include features formed into thedisk 244 for accommodating theslidable clamping mechanisms 252. For example, theretainer support 242 may include recesses with opposing C-channels (not shown) similar to therecess 178 and opposing C-channels 180 described above with respect to theretainer 20. Theretainer support 242 may also include recessed stops (not shown) similar to the recessedstop 182 described above with respect to theretainer 20 for respectively accommodating locking elements of theclamping mechanism 252. Preferably, the clamping bars 254 of the clampingmechanisms 252 can be variably locked in different positions, e.g., by utilizingratchets 220, as illustrated inFIG. 41 . - Thus, it can be appreciated that instead of securing the stimulation lead between a slidable clamping bar and a fixed clamping bar, the
slidable clamping mechanisms 252 may both be slid relative to thedisk 244 in order to secure a stimulation lead between the movable clamping bars 254. Significantly, because both clampingmechanisms 252 are slidable relative to thedisk 244, a plurality of stimulation leads can be secured along any one of a plurality of different chords C1-C4 of theplug base aperture 26, as illustrated inFIG. 46 . Notably, because theretainer 240 may be mounted within theplug base aperture 26 in any rotational orientation, the chords C1-C4 along which the stimulation leads are secured by the clampingmechanisms 252 may also be in different rotational orientations, as illustrated inFIG. 47 . Thus, given any number of stimulation leads arranged along a single chord (for example, any pair of leads), theretainer 240 is capable of simultaneously securing the stimulation leads, thereby obviating the need to have separate burr holes, decreasing patient risk, decreasing procedure time, decreasing cost to the patient, etc. - Although the
retainer 240 includes two slidable clamping mechanisms, retainers constructed in accordance with the present inventions may include more than two slidable clamping mechanisms. For example, referring toFIGS. 45 a and 45 b, anotherretainer 241 that can be mounted within theaperture 26 of theplug base 18 will now be described. Like theprevious retainer 240, theretainer 241 comprises a retainingsupport 243 that includes adisk 245 and anopen slot 247 formed in thedisk 245 for laterally receiving the stimulation lead, thereby allowing theretainer 241 to be mounted within theplug base aperture 26 after the stimulation lead has been introduced through the burr hole. Theretainer 240 may include other features, such as a pop-out notch, sun-dial ticks, and lead exit grooves (not shown) located on thedisk 245. Theretainer 241 differs from theretainer 240 in that it comprises threeslidable clamping mechanisms 249, each including aflange 251 with aconcave tip 253. In another embodiment illustrated inFIGS. 45 c and 45 d, theretainer 241 may include fourslidable clamping mechanisms 249. - In either embodiment, each
flange 251 is slidably engaged with thedisk 245 to laterally slide theconcave tip 253 radially inward relative to thedisk 245 and selectively secure the stimulation lead received within the lead slot 247 (FIGS. 45 b and 45 d) or laterally slide theconcave tip 253 radially outward relative to thedisk 245 and release the stimulation lead received within the lead slot 247 (FIGS. 45 a and 45 c). Theconcave tips 253 are opposite to each other to clamp the stimulation lead therebetween. Eachclamping mechanism 253 may alternatively include a U-shaped flange, resilient arm, locking tab, and an arm stop (all not shown) similar to theU-shaped flange 186,resilient arm 200, lockingtab 202, and arm stop 220 described above with respect to theretainer 20. - In an alternative embodiment illustrated in
FIGS. 50 and 51 , multiple opposing sets ofslidable clamping mechanisms 255 can be independently slid relative to each other to selectively secure multiple stimulation leads received within the lead slot (FIG. 45 f) or release the stimulation leads received within the lead slot (FIG. 45 e). - While the
previous retainers FIGS. 48 and 49 , a hingedretainer 260 will now be described. Theretainer 260 is similar to theretainer 240 illustrated inFIG. 45 , with the exception that it comprises a retainingsupport 262 that includes a pair ofsemi-spherical disk portions 264, a pair ofslidable clamping mechanisms 266, and ahinge 268 coupled to thedisk portions 264, such that thedisk portions 264 can be alternately hinged open (FIG. 48 ) to open alead slot 270 for laterally receiving the stimulation lead and hinged close (FIG. 49 ) to close thelead slot 270 around the stimulation lead. In this manner, theretainer 260 may still be mounted within theplug base aperture 26 after the stimulation lead has been introduced through the burr hole without sacrificing the structural integrity typically associated with a disk that is completely closed around its circumference. Theretainer 240 further comprises a locking mechanism 272 (best shown inFIG. 48 ) in the form of a protuberance the end of one of thedisk portions 264 and a corresponding recess (not shown) on the end of theother disk portion 264, such that thelead slot 270 remains closed when manipulating the clampingmechanisms 266. The clampingmechanisms 266 function in the same manner as the clampingmechanisms 252 described above to selectively secure the stimulation lead received within thelead slot 268 or release the stimulation lead received within thelead slot 268. - Other types of lead retainers are also contemplated by the present inventions. For example, referring to
FIGS. 50 and 51 , anotherlead retainer 280 comprises a retainingsupport 282 configured for being mounted within the aperture of theplug base 18, and aclip 284 configured for mating with the retainingsupport 282. In the illustrated embodiment, the retainingsupport 282 comprises asemi-circular flange 286, a fixedclamping bar 288 located on the diameter of thesemi-circular flange 286, and a pair of opposing annular C-channels 290 extending along the circumference of thesemi-circular flange 286. Theretainer 280 may include other features, such as a pop-out notch, sun-dial ticks, and lead exit grooves (not shown) located on thesemi-circular flange 286. - The
clip 284 comprises atransverse member 292 and a clampingbar 294 disposed on thetransverse member 292. Thus, when theclip 294 is mated with the retainingsupport 292, the stimulation lead will be secured between a clampingsurface 296 of the retaining support 282 (and in particular the fixed clamping bar 288) and aclamping surface 298 of the clip 284 (and in particular the movable clamping bar 294). Theclip 284 is configured for mating with the retainingsupport 282 in an interference arrangement. To this end, theclip 284 has a pair of opposingresilient arms 300 extending from thetransverse member 292. Thearms 300 are configured for slidably engaging the respective C-channels 290 located on thesemi-circular flange 286. Thus, theclip 284 can be mated with the retainingsupport 282 by inserting therespective arms 300 of theclip 284 into the C-channels 290. Notably, the resiliency of thearms 300 allows them to flex outward as they are inserted into the C-channels 290, and once fully inserted, they flex back to the normal shape to grasp the C-channels 290. - The
clip 284 further comprises a pair of locking elements, and in particular, a pair oftabs 302 respectively disposed on the ends of thearms 300, such that when thearms 300 are fully inserted into the C-channels 290, thetabs 302 engage the ends of the opposing C-channels 290 to lock theclip 284 relative to the retainingsupport 282. Thearms 300 may be displaced toward each other away from the C-channels 290 to disengage the lockingtabs 302 from the opposing C-channels 290, thereby allowing theclip 284 to be removed from the retainingsupport 282. Theclip 284 further comprises a pair ofstops 304 located between thetransverse member 292 and the respectiveresilient arms 300 that abut the fixedclamping bar 288 and the front of the C-channels 290 when theclip 284 is mated with the retainingsupport 282. In this manner, the clampingbar 294 of theclip 284 is prevented from moving past a certain point, thereby preventing damage to the stimulation lead. - Referring to
FIGS. 52 and 53 , the details of thecap 22 will now be described. Thecap 22 is configured for mounting to theplug base 18 over theretainer 20, thereby securing the stimulation lead, as well as closing the burr hole. Thecap 22 may be composed of a suitable hard or soft biocompatible material, such as titanium, a hard polymer, a soft polymer, silastic, elastomer, or any other combination thereof. Thecap 22 may be composed of PEEK, although the durability of thecap 22 may not be as important as the other components of theburr hole plug 16. - The
cap 22 comprises a circular lid-type body 310 having arim 312 sized and shaped to be disposed within theplug base aperture 26 and resting on theretaining disk 164. To accommodate the locking ramps 48 located on theinner surface 46 of theplug base body 24, thecap 22 includes a plurality ofrecesses 314 located on the exterior surface of therim 312. The number of circumferential spacing of therecesses 314 matches the number and spacing of the locking ramps 48, such that eachramp 48 is received into acorresponding recess 314 when thecap 22 is mounted to theplug base 18. - The
cap 22 further comprises a plurality of winged tabs 316 (in this case, two) configured for being received into the corresponding locking recesses 42 located on the plug base body 24 (shown inFIG. 8 ) in an interference arrangement, and in particular, a snap-fit arrangement, thereby preventing rotation of thecap 22, as well as also ensuring that thecap 22 is securely mounted to theplug base 18. Alternatively, other locking mechanisms, such as snaps, hooks, grips, ledges, etc, or any other mechanical structure can be used to lock thecap 22 in place. Thecap 22 also comprises a plurality of pop-out notches 318 (in this case, two) formed in therim 312 of thecap body 310, such that when thecap 22 is mounted and secured to theplug base 18, one of the pop-outnotches 318 corresponds with the pop-out recess 38 located at theinner edge 40 of the ring-shaped plug body 24 (shown inFIG. 8 ). Thus, thecap 22 can be conveniently removed from theplug base 18 by inserting a tool within the pop-out recess 38 and into the corresponding pop-out notch 318 in thecap 22. - The
cap 22 further comprises a plurality of lead clamp grooves 320 (in this case, four) located on the bottom surface of thecap 22 and extending through therim 312. The number and circumferential spacing of thelead clamp grooves 320 matches the number of spacing of thelead exit grooves 36 located on the plug base 18 (shown inFIG. 8 ), such thatlead clamp grooves 320 will circumferentially align with, and be immediately radially adjacent to, thelead exit grooves 36. In this manner, when thecap 22 is mounted to theplug base 18, the stimulation lead will be firmly seated within the selectedlead clamp groove 320. Thus, the selectedlead clamp groove 320 will apply downward pressure to the stimulation lead causing the correspondinglead exit groove 36 to counter with an upward pressure to the stimulation lead, thereby providing a secure frictional fit between the stimulation lead and the lead exit andlead clamp grooves - Having described the
burr hole plug 16, various tools that can be used to install a burr hole plug into a burr hole will now be described. Referring toFIGS. 54-56 , one embodiment of a plugbase holding tool 330 configured for holding theplug base 18 to aid in its mounting to the cranium of the patient will be described. The plugbase holding tool 330 generally comprises aburr hole cover 332, ahandle 334 mounted to theburr hole cover 332, and a pair ofscrew holder arms 336 extending in opposite directions from thehandle 334. Thetool 330 may be composed of a suitable rigid and robust material, such as stainless steel or a durable plastic, such as polypropylene, polycarbonate, or even if PEEK if very little deformation is desired. Thetool 330, or at least the structural portion of the tool, may be a unibody design, thereby increasing the strength and robustness of thetool 330. - The
burr hole cover 332 has a lid-shape having an aperture geometrically similar to theaperture 26 of the plug base 16 (in this case, circular) and is sized to fit into and completely cover theplug base aperture 26. The lip of theburr hole cover 332 may rest on annular ledges of theplug base 16 in the same manner as the retainer rests on the annular ledges described above. In this manner, any potential for debris, such as screws, falling through theplug base aperture 26 and into the burr hole, or accidental slippage of tools, such as a screwdriver, into the burr hole, is minimized. In an optional embodiment, theburr hole cover 332 includes features, such as snaps, keyways, set screws, adhesive, suction ports, threads, etc., that engage theplug base 16 in a manner that secures theburr hole cover 332 within theaperture 26 and also allows theburr hole cover 332 to be removed from theplug base 16 after theplug base 16 is anchored to the cranium of the patient. Alternatively, thetool 330 can be shaped in a manner that positions its center of gravity, such that thetool 330 remains on a flat surface without fastening it to the plug base 16 (i.e., it does not fall over). In the case where theplug base 16 does not include self-centering tabs, thetool 330 may include centering tabs (not shown) that extend downward from thecover 332, through theaperture 26 in theplug base 16, and into the burr hole, in order to center both theplug base 16 relative to the burr hole. - The
handle 334 laterally extends away from theburr hole cover 332, and thus the burr hole, as to not interfere with the placement, visualization, alignment, and anchoring of theplug base 16 to the burr hole. Thehandle 334 is shaped to more ergonomically allow the physician to grasp the handle. For example, the profile of thehandle 334 flares out as thehandle 334 laterally extends from theburr hole cover 332 to allow thehandle 334 to be more easily gripped. In addition, thehandle 334 includes relief features (in this case, grooves in a criss-cross pattern) to facilitate gripping of thehandle 334, which may be important in a slippery environment (such as a physician wearing wet gloves). In an alternative embodiment illustrated inFIGS. 57 and 58 , two opposinghandles 334 laterally extend from theburr hole cover 332 in opposite directions, thereby allowing the physician the option of holding thetool 330 from two different sides (e.g., in case the physician does not have access to one side of the burr hole). Additional handles (not shown) can be provided (e.g., two opposing handles clocked ninety degrees from the handles 334) to provide additional gripping options for the physician. - In the illustrated embodiment, the
burr hole cover 304 includes a pair ofrecesses 338 formed in its upper surface to accommodate the laterally extendingscrew holder arms 336. Thescrew holder arms 336 includecollars 340 that are spaced from each other, such that they respectively align with the screw holes 34 located on theplug base 18 when theburr hole cover 332 is mounted within theplug base aperture 26. Thus, thescrews 15 may be accurately inserted through thecollars 340 and aligned with the screw holes 34 (shown inFIG. 8 ) in theplug base 18, such that thescrews 15 can be conveniently screwed into the cranium of the patient. Preferably, the apertures within thecollars 340 are slightly larger than the diameter of the screw heads, such that the screw heads can be recessed into thecollars 340, thereby allowing thescrews 15 to be fully screwed into the cranium without removing the tool. In addition to aligning thescrews 15 with the screw holes 34 of theplug base 18, thecollars 340 also limit slippage of the screw driver should it occur. - Referring to
FIGS. 59-61 , another embodiment of a plugbase holding tool 350 configured for being attached to theplug base 18 to aid in its mounting to the cranium of the patient will be described. The plugbase holding tool 350 generally comprises aburr hole cover 352, ahandle 354 mounted to theburr hole cover 352, and a pair ofscrew holder mechanisms 356 extending in opposite directions from theburr hole cover 352. Thetool 350 may be composed of a suitable rigid and robust material, such as stainless steel or a durable plastic, such as polypropylene, polycarbonate, or even if PEEK if very little deformation is desired. Thetool 350, or at least the structural portion of the tool, may be a unibody design, thereby increasing the strength and robustness of thetool 350. - The
burr hole cover 352 has a cylindrical shape having a diameter substantially the same as the diameter of theaperture 26 of the plug base 18 (in this case, circular) and is sized to cover theplug base aperture 26. In this manner, any potential for debris, such as screws, falling through theplug base aperture 26 and into the burr hole, or accidental slippage of tools, such as a screwdriver, into the burr hole, is minimized. Thetool 350 includes a plurality of centeringtabs 358 extending downward from theburr hole cover 352, such that the centeringtabs 358 rest against theinner surface 46 of theplug base 18 when theburr hole cover 352 is mounted within theplug base aperture 26. In the illustrated embodiment, two pairs of centering tabs 358 (only one pair shown) are circumferentially disposed opposite each other. - The
tool 350 further includes various features that engage theplug base 18 in a manner that secures theburr hole cover 352 within theaperture 26 and also allows theburr hole cover 352 to be removed from theplug base 18 after theplug base 18 is anchored to the cranium of the patient. In particular, thetool 350 comprises uppergrasping tabs 360 and lowergrasping tabs 362 arranged in manner, such that when thetool 350 is disposed within theaperture 26 of theplug base 18, the thickness of theplug base 18 is disposed between thegrasping tabs plug base 18 is grasped from above and below; that is the uppergrasping tabs 360 have lower surfaces that frictionally grasp thetop surface 28 theplug base 18, and the lowergrasping tabs 362 have upper surfaces that frictionally grasp thebottom surface 30 of theplug base 18. The upper surfaces of the lowergrasping tabs 362 may be slightly convex, so that they mate perfectly with the slightlyconcave bottom surface 30 of theplug base 18. - In the illustrated embodiment, there are two upper grasping tabs 360 (only one shown) radially extending from, and circumferentially disposed on opposite sides of, the outer surface of the
burr hole cover 352, and two pairs of lower grasping tabs 362 (only one pair shown) extending radially extending from, and circumferentially disposed on opposite sides of, the respective pairs of centeringtabs 358. Each pair of lowergrasping tabs 362 circumferentially straddles the respectiveupper grasping tab 360 to firmly engage a circumferential portion of theplug base 18 therebetween. Thus, it can be appreciated that the graspingtabs tool 350 to grasp and pick up theplug base 18, as well as to prevent thetool 350 from being separating from theplug base 18 when anchoring theplug base 18 to the cranium of the patient. - The
tool 350 also comprises a plurality ofrotational alignment tabs 364 radially extending from the outer surface of theburr hole cover 352 in order to rotationally align thescrew holder mechanisms 356 with the fastening holes 34 in theplug base 18, as well as to prevent thetool 350 from rotating or spinning in theaperture 26 of theplug base 18. In the illustrated embodiment, tworotational alignment tabs 364 are circumferentially disposed opposite each other, and are sized and shaped for being firmly disposed within the cap locking recesses 42 in theplug base 18. Alternatively, thetool 350 may include rotational alignment tabs (not shown) that are sized and shaped for being firmly disposed within thelead exit grooves 36 of theplug base 18. - The
handle 354 is shaped such that the physician may ergonomically grasp it to prevent thetool 350 and theplug base 18 from moving when theplug base 18 is being anchored to the cranium of the patient. Thehandle 354 may have any one of a variety of shapes. In the embodiment illustrated inFIGS. 59-61 , thehandle 354 has a butterfly shape, thereby providing a broader base for the physician to apply a downward force on theplug base 18. The symmetry of thehandle 354 allows the downward force to be applied equally to each side of theplug base 18, thereby preventing thetool 350 and theplug base 18 from rocking back and forth. The butterfly shape of thehandle 354 also prevents the physician's hand from creating an obstruction for the fastening holes 34 of theplug base 18, thescrew alignment mechanisms 356, or the screwdriver. - Referring further to
FIGS. 62-64 , thescrew alignment mechanisms 356 respectively include twoarms 366 andcollars 368 disposed at the ends of thearms 368. Thecollars 368 are spaced from each other, such that they respectively align with the fastening holes 34 located on theplug base 18 when theburr hole cover 352 is mounted within theplug base aperture 26. Thus, thescrews 15 may be accurately inserted through thecollars 368 and aligned with the fastening holes 34 in theplug base 18, such that thescrews 15 can be conveniently screwed into the cranium of the patient. Eachcollar 368 has an upperlarge diameter bore 370 and a lower small diameter bore 372 in communication with theupper bore 370. The diameter of thelower bore 372 is equal to the outer diameter of the head of thescrew 15, such that thescrew 15 remains constantly centered with therespective fastening hole 34 in theplug base 18 as the head of thescrew 15 passes through thebore 372. - Each
screw alignment mechanism 356 includes aninsert 374 disposed within theupper bore 370 of thecollar 368. Theinsert 374 is composed of a flexible and pliable material, e.g., silicone. Theinsert 374 takes the form of a ring- or gasket-like structure that firmly holds and centers therespective screw 15 within thecollar 368. In particular, as best shown inFIGS. 61 and 63 , theinsert 374 includes anouter ring 376 and aninner ring 378 concentrically disposed within theouter ring 376. Thus, theinsert 374 effectively reduces the diameter of theupper bore 370, thereby facilitating the centering of therespective screw 15 before the head of thescrew 15 passed into thelower bore 372. The pliability ofinsert 374 allows the head of thescrew 15, which has a larger diameter than the inner diameter of theinner ring 378, to pass through theinner ring 378. Theinsert 374 also centers the screwdriver (not shown), both when it is introduced into thelower bore 372, and when it is removed and reentered into thelower bore 372. In the latter case, this makes it easier to align the screwdriver with the head of thescrew 15. Optionally, there may be a metal insert (not shown) within thecollar 368 to prevent plastic from being scraped off. - As best shown in
FIGS. 63 and 64 , eachcollar 368 has aledge 380 between the upper andlower bores slots 382 formed through theledge 380, and therespective insert 374 includes a pair of circumferentially opposing retainingtabs 384 extending from the bottom of theouter ring 376. Eachtab 384 extends downward from the bottom of theouter ring 376 and then radially outward. Thus, when theinsert 374 is mounted within theupper bore 370, thetabs 384 of theinsert 374 are respectively disposed through theslots 382 in theledge 380 of thecollar 368, thereby firmly retaining theinsert 374 with theupper bore 370. - In an alternative embodiment illustrated in
FIGS. 65 and 66 , thetool 350 comprises ascrew alignment mechanism 386 that includes acollar 388 having abore 390 with a uniform diameter extending therethrough. Thescrew alignment mechanism 386 also comprises aninsert 392 that, like the previously describedinsert 374, is composed of a flexible and pliable material, e.g., silicone. Theinsert 392 has an upperannular flange 394, a lowerannular flange 396, and a smaller diametercylindrical portion 398 extending between the upper and lowerannular flanges insert 392 is configured for being mounted within thecollar 388, such that thecylindrical portion 398 is disposed within thebore 390 of thecollar 368, and the upper and lowerannular flanges collar 368 to firmly retain thecylindrical portion 398 within thebore 390. - As best shown in
FIG. 66 , theinsert 392 includes a plurality of inner rings 400 (in this case, two) concentrically disposed along the length of thecylindrical portion 398. Thus, the inner diameters of theinner rings 400 are equal to the outer diameter of thescrew 15, thereby facilitating the centering of therespective screw 15 within thebore 390 of thecollar 388. The pliability of theinsert 392 allows the head of thescrew 15, which has a larger diameter than the inner diameter of theinner rings 400, to pass through the inner rings 400. Theinsert 392 also centers the screwdriver (not shown), both when it is introduced into thebore 390, and when it is removed and reentered into thebore 390. In the latter case, this makes it easier to align the screwdriver with the head of thescrew 15. - In another alternative embodiment illustrated in
FIGS. 67 and 68 , thetool 350 comprises ascrew alignment mechanism 406 includes the previously describedcollar 388 and a plurality of tabs orflanges 408 radially extending inward around the inner circumference of thecollar 388 into thebore 390. Theradial tabs 408 may be formed as a unibody structure with thecollar 388, and are thin enough, such that they will bend without breaking as thescrew 15 passes through thebore 390 of thecollar 388. Alternatively, theradial tabs 408 may be composed of a material that is more flexible or pliable than the material from which thecollar 368 is composed. As can be appreciated, theradial tabs 408 effectively reduce the diameter of thebore 390 of thecollar 368, thereby facilitating the centering of therespective screw 15 within thebore 390. The pliability ofradial tabs 408 allows the head of thescrew 15 to pass through thebore 390. Theradial tabs 408 may also center the screwdriver (not shown) in the same manner as theinner rings 400 of theinsert 392 described above. In the illustrated embodiment, theradial tabs 408 are arranged in several layers (in this case two layers of four tabs each) extending inward along the length ofcollar 368 within thebore 390. - Referring next to
FIGS. 70 and 71 , one embodiment of aretainer holding tool 430 configured for mounting theretainer 20 within theaperture 26 of the plug base 18 (shown inFIG. 8 ) will now be described. Theretainer holding tool 430 generally comprises ahandle 432 and a plurality offingers 434 extending from thehandle 432 and configured for engaging connection points 436 on thetop surface 171 of theretaining disk 164. Thetool 430 may be composed of a suitable rigid and robust material, such as stainless steel or a durable plastic, such as polypropylene, polycarbonate, or even if PEEK if very little deformation is desired. Thehandle 432 is angled relative to thefingers 434 in order to facilitate the manipulation, navigation, and placement of theretainer 20 in tight spaces; for example, due to its angle relative to the plane of theretainer 20 that it supports, the movement of thehandle 432 may not be obstructed by equipment immediately above the burr hole. - The distal ends of the
fingers 434, and thus the contact points 436 on thetop surface 171 of theretaining disk 164, are spaced from each other in a manner that substantially distributes any downward force applied by thetool 430 across the plane of theretaining disk 164 when mounted within theplug base aperture 26. In the embodiment illustrated inFIGS. 70 and 71 , the distal ends of threefingers 434 are engaged withcontact points 436, and in particular, small recesses or possibly holes, formed in thetop surface 171 of theretaining disk 164. Thefingers 434 of thetool 430 are configured to engage therecesses 436 in an interference arrangement, e.g., a snap-fit arrangement. As will be described in further detail below, the retention force between thefingers 434 of thetool 430 and theretainer 20 should be less than the retention force between theretainer 20 and theplug base 18, so that thetool 430 can be easily removed from theretainer 20 when mounted within theplug base 18. - Preferably, this interference arrangement is sufficient enough to provide a firm engagement between the
tool 430 and theretainer 20, but should be capable of being overcome after theretainer 20 is mounted within theplug base 18, so that thetool 430 can be easily removed from theretainer 20, while leaving theretainer 20 firmly mounted within theplug base 18. For example, as illustrated inFIG. 72 , therecesses 436 may be formed entirely through the thickness of theretaining disk 164, and the distal ends of thefingers 434 may havebarbs 438 that extend through therecesses 436 and engage the bottom surface of theretaining disk 164. The size of thebarbs 438 should be designed, such that they remain within therecesses 436 during normal manipulation, navigation, and placement of theretainer 20, but should be capable of being displaced through therecesses 436 when thetool 430 is removed fromretainer 20; that is, the upward force required to pull thebarbs 438 through therecesses 436 should be less than the upward force required to remove the firmly mountedretainer 20 from theplug base 18. The portions offingers 434 above therecesses 436 may be flared or increased to provide a more stable base that more uniformly distributed the downward force across thetop surface 171 of theretaining disk 164. - In one preferred embodiment, the
fingers 434 are resiliently flexible, so that they store a spring force when engaged with therecesses 436 on theretaining disk 164. In this case, the spacing between the distal ends of thefingers 434, in the absence of any lateral force, is slightly less than the spacing between therecesses 436 on theretaining disk 164. In this manner, thefingers 434 will act as biased springs when engaged with therecesses 436, thereby providing an additional grasping force that strengthens the engagement with theretainer 20. That is, thefingers 434 will slightly spread out when located within therecesses 436, thereby creating a spring force that laterally urges or biases thefingers 434 inward within therecesses 436 to create a frictional force that facilitates engagement between thefingers 434 and therecesses 436. Thefingers 434, as well as thehandle 432, may be composed of a suitable resilient material, such as, polypropylene, polycarbonate, etc. Alternatively, thetool 430 may be provided with a separate spring-like mechanism 440 engaged between thefingers 434, as illustrated inFIG. 71 . In alternative embodiments, the proximal end of thetool 430 may be designed to perform another function, such as moving theclamping mechanism 162 or popping out theretainer 20 from theplug base 18. - Referring to
FIGS. 73-75 , anotherretainer holding tool 450 configured for mounting theretainer 20 within theaperture 26 of aplug base 18 will now be described. The holdingtool 450 is specifically designed as to not interfere with the stimulation lead when theretainer 20 is mounted within theplug base aperture 26. In particular, the holdingtool 450 generally comprises ahandle 452, a C-shapedflange 454, and pegs 456 extending downward from the C-shapedflange 454. Thetool 450 may be composed of a suitable rigid and robust material, such as stainless steel or a durable plastic, such as polypropylene, polycarbonate, or even if PEEK if very little deformation is desired. - In the illustrated embodiment, two
pegs 456 are provided on the C-shapedflange 454, one located on one end of the C-shapedflange 454 and the other one located near the center of the C-shapedflange 454. Optionally, a third peg (not shown) can be provided on the other end of the C-shapedflange 454. Thepegs 456 are spaced from each other, such that they engage with contact points, and in particular, corresponding recesses or holes 458 (only one show inFIG. 75 ) formed in thetop surface 171 of theretaining disk 164. Thepegs 456 of thetool 430 are configured to engage therecesses 458 in an interference arrangement, e.g., a frictional fit. The retention force between thepegs 456 of thetool 430 and theretainer 20 should be less than the retention force between theretainer 20 and theplug base 18, so that thetool 450 can be easily removed from theretainer 20 when mounted within theplug base 18. As with the previously describedfingers 434, the spacing between thepegs 456 may be slightly less than the spacing between therecesses 458 to increase the frictional force between thepegs 456 and therecesses 458; that is, a spring force is stored in thepegs 456 to urge them inward when engaged with therecesses 458. Optionally, to strengthen the interference fit, thepegs 456 may have barbs (not shown) and therecesses 458 may be formed all the way through the thickness of thedisk 164 in the same manner described above with respect to thetool 430. - As can be appreciated from
FIG. 75 , the C-shapedflange 454 accommodates the stimulation lead exiting the burr hole. That is, the C-shapedflange 454 is sized and shaped, such that it extends around or near the outer periphery of thedisk 164 without obstructing theclamping slot 166, and the correspondingrecesses 458 are similarly disposed on or near the outer periphery of thedisk 164. Thetool 450 further comprises asupport tab 460 located on the end of the C-shapedflange 454 opposite thepeg 456, thereby facilitating the application of uniform pressure on thedisk 164 when mounted within theplug base aperture 26 by thetool 450. In an optional embodiment, theU-shaped flange 454 is configured for rotating about the axis of the handle 452 (shown by the arrow inFIG. 74 ). - To this end, and as best shown in
FIG. 76 , thetool 450 further comprises acollar 462 mounted perpendicularly to the C-shaped flange 454 (both shown in phantom), and thehandle 452 includes a reduceddiameter boss 464 received within thecollar 462, so that thecollar 462, and thus, the C-shapedflange 454, may rotate about thehandle 452. The reduceddiameter boss 464 of thehandle 452 is configured for being interference fit within thecollar 462, such that thecollar 462 and the C-shapedflange 454 does not separate when detaching thepegs 456 from the correspondingrecesses 458 in thedisk 164. To this end, thetool 450 further comprises amovable pin 466 disposed within the side wall of the collar, and the reduceddiameter boss 464 has anannular recess 468 that receives thepin 466. Thepin 466 may be composed of a suitable material, e.g., stainless steel. It can be appreciated that thepin 466 can slide with theannular recess 468, thereby allowing thecollar 462, and thus, the C-shapedflange 454, to rotate about the axis of thehandle 452. Because thepin 466 is firmly seated within theannular recess 468, however, the C-shapedflange 454 cannot be removed from thehandle 452 without using a significant amount of axial force. Notably, thepin 466 frictionally engages theannular recess 468, such that the C-shapedflange 454 does not freely spin; that is, the C-shapedflange 454 will not rotate relative to thehandle 452 without applying a deliberate force to the C-shaped flange, e.g., by being rotated by hand. - Notably, the
handle 452 is angled relative to the C-flange 454 in order to facilitate the manipulation, navigation, and placement of theretainer 20 in tight spaces. That is, due to its angle relative to the plane of theretainer 20 that it supports, the movement of thehandle 452 may not be obstructed by equipment immediately above the burr hole. To this end, the distal end of thehandle 452 to which thecollar 462 is mounted has a bend (e.g., a 45 degree or a 60 degree angle between thecollar 462 and the handle 452) to effect the angling of thehandle 452 relative to the C-flange 454. The distal end of thehandle 452 may optionally be made malleable to allow the physician to create the optimum angle for insertion of theretainer 20 into theplug base aperture 26. The proximal end of thetool 450 may be designed to perform another function, such as locking or unlocking theclamping mechanism 162 or popping theretainer 20 out from theplug base 18. For example, as illustrated inFIG. 77 , a taperedblunt tip 470 can be formed on the proximal end of thehandle 452. - Referring to
FIGS. 78-80 , still anotherretainer holding tool 480 configured for mounting theretainer 20 within theaperture 26 of a plug base 18 (shown inFIG. 75 ) will now be described. Like thetool 450 previously described above, thetool 480 may be composed of a suitable rigid and robust material, such as stainless steel or a durable plastic, such as polypropylene, polycarbonate, or even if PEEK if very little deformation is desired. Thetool 480 comprises ahandle 482 that is of a similar construction as thehandle 452, and a radially compressible/resilient tip 484 that can be inserted into any one of therecesses 458 formed in thetop surface 171 of theretaining disk 164 illustrated inFIG. 75 . The outer radius of thetip 484 is slightly larger than the radius of eachrecess 458, such that, when thetip 484 is inserted into therecess 458, thetip 484 radially compresses. The resiliency of thetip 484 applies a radially outward force against the inner wall of therecess 458, thereby creating a frictional interference fit that holds theretainer 20 on thetool 480. - In the illustrated embodiment, the
tip 484 takes the form of a spring mechanism, and in particular a spring clip, that includes a pair ofparallel arms 486 that move toward each other from a relaxed position to a compressed position in response to a compressive force, and move away from each other from the compressed position to the relaxed position in the absence of the compressive force. Thetool 480 comprises acollar 488 formed at the distal end of thehandle 482 for retaining thetip 484. In particular, thecollar 488 includes areceptacle 490 that receives thearms 486 of thetip 484 in an interference arrangement. Specifically, thecollar 488 is split or forked to form a pair of opposingannular flanges 492 that respectively receive thearms 486 of thetip 484 therein. Thetip 484 can be arranged as an insert that can be passed through adistal aperture 494 of thereceptacle 490. Once inserted within thereceptacle 494, the resiliency of thetip 484 will cause thearms 486 to be urged radially outward away from each other into firm contact with the respectiveannular flanges 492, thereby mounting thetip 484 to thehandle 482. In this state, thetip 484 will be partially radially compressed. When thetip 484 is inserted into therecess 486 of theretaining disk 164, thetip 484 will be further radially compressed within therecess 486 to create the aforementioned frictional fit. To prevent thetip 484 from axially moving out of thereceptacle 490 during such compression, thetip 484 further comprises a pair of radiallyoutward tabs 496 respectively formed on the ends of thearms 484. The distal end of thehandle 482 further includes correspondingrecesses 498 for receiving and holding thetabs 496 therein. - Having described the structure and function of the
burr hole plug 16 and tools used with burr hole plugs into a burr hole, a method of mounting theburr hole plug 16 into a burr hole will now be described. Referring first toFIG. 81 , theplug base 18 is placed on top of thecranium 6 of the patient. Notably, the centeringtabs 32 located on theplug base 18 can be disposed within theburr hole 5, thereby centering theplug base 18 about theburr hole 5. If the recessedplug base 57 illustrated inFIGS. 10-13 is used, theannular flange 45 will also be recessed into theburr hole 5, as illustrated inFIG. 82 , to allow theretainer 20 to be recessed further down into the burr hole. Referring back toFIG. 81 , theplug base 18 is then anchored to thecranium 6 using thescrews 15 introduced through the screw holes 34 in theplug base 18. Any of the plug base anchoring tools 300 (FIGS. 54-58 ), 350 (FIGS. 59-68 ), or 410 (FIG. 69 ) can be used to align thescrews 15 with the screw holes 34 while covering theaperture 26 in theplug base 18, and if self-centering tabs are not provided on theplug base 18, can aid in centering theplug base 18 relative to theburr hole 5. - Next, as illustrated in
FIG. 83 , thestimulation lead 12 is introduced through theplug base aperture 26, through theburr hole 5, and into the brain tissue, such that the electrodes (not shown) of thestimulation lead 12 are adjacent the target site. In the case where the slottedplug base 58 illustrated inFIG. 16 is used, thestimulation lead 12 may first be introduced through theburr hole 5, thestimulation lead 12 can be laterally introduced within theslot 66 of theplug base 58, as illustrated inFIG. 84 , and then theplug base 58 can be disposed over and anchored to thecranium 6 in the same manner described above with respect toFIG. 81 . In the case where thesplit plug base 78 illustrated inFIGS. 17 and 18 is used, thestimulation lead 12 may first be introduced through theburr hole 5 and the firstplug base portion 80 can be located adjacent to one side of thestimulation lead 12, the secondplug base portion 82 can be located adjacent to the other side of thestimulation lead 12, and then the first and secondplug base portions plug base 78. This can be accomplished by locating the firstplug base portion 80 onto thecranium 6 adjacent the one side of thestimulation lead 12, as illustrated inFIG. 85 , and then placing the secondplug base portion 82 onto the firstplug base portion 80 adjacent the other side of thestimulation lead 12, as illustrated inFIG. 86 . If the first and secondplug base portions complementary pins 100 and recesses 102, thepins 100 can be sheared off prior to mating thebase portions base portions integrated plug base 78 can then be anchored to thecranium 6 in the same manner described above with respect toFIG. 81 . Of course, the slottedplug base 58 or thesplit plug base 78 can be anchored to thecranium 6 before thestimulation lead 12 is introduced through theburr hole 5 in the same manner described above with respect to theplug base 18. - After the
plug base 18 has been anchored to thecranium 6 and thestimulation lead 12 introduced through theburr hole 5 and properly located adjacent the target site, theretainer 20 is mounted within theplug base aperture 26, as illustrated inFIG. 87 . Thestimulation lead 12 can be laterally introduced within theslot 166 formed in theretaining disk 164 as theretainer 20 is mounted to theplug base 18. In the case, where the hingedretainer 260 illustrated inFIGS. 48 and 49 is used, the first andsecond disk portions 264 can be hinged open to laterally receive thestimulation lead 12, as illustrated inFIG. 88 , and then hinged closed to encompass thestimulation lead 12, as illustrated inFIG. 89 . Any of the retainer placement tools 430 (FIGS. 70-72 ), 450 (FIGS. 73-77 ), or 480 (FIGS. 78-80 ) can be used to place and mount the retainer 20 (or retainer 260) within theplug base aperture 26. - Once the retainer 20 (or retainer 230) is firmly mounted within the
plug base aperture 26, theretainer 20 is actuated to secure thestimulation lead 12 within theplug base aperture 26, as illustrated inFIG. 90 . In particular, theclamping mechanism 162 is slid relative to thedisk 164 to laterally slide themovable clamping bar 184 towards the fixedclamping bar 176 of thedisk 164, thereby securing thestimulation lead 12 received within theslot 166, and specifically, clamping thestimulation lead 12 between themovable clamping bar 184 and the fixedclamping bar 176 of thedisk 164. Once thestimulation lead 12 is secured, the locking element of theclamping mechanism 162 can be actuated to lock themovable clamping bar 184 relative to thedisk 164. In particular, themovable clamping bar 184 can be slid towards the fixedclamping bar 176 until thelocking tab 202 abuts the recessedstop 182. Theclamping mechanism 162 can be actuated to unlock themovable clamping bar 184 relative to thedisk 164, e.g., by flexing theresilient arm 200 by applying a downward force on therecess 212 of thelocking tab 202 via a tool. - Notably, if the
retainer 280 illustrated inFIGS. 50 and 51 is used, the retainingsupport 282 can be mounted within theaperture 26 of theplug base 18, as illustrated inFIG. 91 , and then thearms 300 of theclip 284 can be slid into the C-channels 290 located on thesemi-circular flange 286 until the lockingtabs 302 engage the ends of the C-channels 290 to secure thestimulation lead 12 between the clampingbars FIG. 92 . If a plurality of stimulation leads 12 are to be secured, theretainer 240 illustrated inFIG. 45 can be mounted within theplug base aperture 26 in a similar manner as theretainer 20 described above. The clampingmechanisms 252 can then be slid to secure the stimulation leads 12 between the clampingbars 254, as illustrated inFIG. 93 . As shown, the stimulation leads 12 are secured along an off-center chord of theplug base aperture 26. - After the stimulation lead 12 (or leads) is secured within the
plug base aperture 26, thestimulation lead 12 is radially directed towards theplug base 18 by bending thestimulation lead 12 at an angle (e.g. perpendicular) relative to an axis of theburr hole 5 and seating thestimulation lead 12 within one of thelead exit grooves 36 located on theplug base 18, as illustrated inFIG. 94 . If theretainer 230 illustrated inFIG. 44 is used, thestimulation lead 12 may be seated within one of thelead exit grooves 232. Next, thecap 22 is mounted to theplug base 18 over theretainer 20, such that thestimulation lead 12 is secured between theplug base 18 and thecap 22, as illustrated inFIG. 95 . Notably, thelead clamp groove 320 of thecap 22 will capture and apply downward pressure to thestimulation lead 12 to frictionally secure thestimulation lead 12 within theexit groove 36 of theplug base 18. - Although particular embodiments of the present inventions have been shown and described, it will be understood that it is not intended to limit the present inventions to the preferred embodiments, and it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present inventions. Thus, the present inventions are intended to cover alternatives, modifications, and equivalents, which may be included within the spirit and scope of the present inventions as defined by the claims.
Claims (24)
1. A cranial burr hole plug, comprising:
a plug base including a flange configured for being mounted around a cranial burr hole, an aperture through which an elongated medical device exiting the burr hole may pass, and a plurality of tabs configured for extending within the cranial burr hole to center the plug base relative to the cranial burr hole; and
a retainer configured for being mounted within the aperture of the plug base to secure the medical device.
2. The burr hole plug of claim 1 , wherein the aperture of the plug base is circular.
3. The burr hole plug of claim 1 , wherein the greatest dimension of the aperture in equal to or less than 25 mm.
4. The burr hole plug of claim 1 , wherein the plug base includes an open slot configured for laterally receiving the medical device.
5. The burr hole plug of claim 1 , wherein the plurality of tabs comprises at least three tabs.
6. The burr hole plug of claim 1 , wherein the tabs are disposed on a bottom surface of the plug base flange.
7. The burr hole plug of claim 2 , wherein the tabs are coincident with the aperture.
8. The burr hole plug of claim 2 , wherein the retainer is configured for being removably mounted within the aperture of the plug base.
9. The burr hole plug of claim 2 , wherein the plug base includes at least one inner annular ledge configured for supporting the retainer when mounted within the aperture of the plug base.
10. The burr hole plug of claim 2 , wherein the retainer further includes a retainer support and a slot formed in the retainer support for receiving the medical device.
11. The burr hole plug of claim 10 , wherein the retainer includes a clamping mechanism configured for applying a clamping force to the medical device received within the slot.
12. The burr hole plug of claim 11 , wherein the clamping mechanism includes a clamping bar configured for engaging the medical device, and a locking element configured for locking the clamping bar relative to the retainer support when the medical device is secured.
13. The burr hole plug of claim 11 , wherein the retainer support is a disk.
14. The burr hole plug of claim 1 , further comprising fasteners configured for anchoring the plug base to a cranium of a patient.
15. The burr hole plug of claim 1 , further comprising a cap configured for being mounted to the plug base over the retainer.
16. The burr hole plug of claim 14 , wherein the plug base has an exit groove configured for seating the medical device, and wherein the cap is configured for firmly securing the medical device within the exit groove when the cap is mounted to the plug base.
17. A method of performing a medical procedure on a patient, comprising:
providing a plug base including a flange, an aperture, and a plurality of tabs;
locating a plug base within a cranial burr hole, such that the flange is disposed about the cranial burr hole, and the tabs are disposed within the burr hole to center the plug base relative to the cranial burr hole;
anchoring the plug base relative to the cranial burr hole;
introducing an elongated medical device through the cranial burr hole and into the brain tissue of the patient, wherein the medical device exits the cranial burr hole through the aperture of the plug base;
mounting a retainer within the aperture of the plug base; and
actuating the retainer to secure the medical device.
18. The method of claim 17 , wherein the tabs are equally spaced apart around the circumference of the cranial burr hole.
19. The method of claim 17 , wherein the tabs are disposed on a bottom surface of the plug base flange.
20. The method of claim 17 , wherein the medical device is an electrical lead.
21. The method of claim 17 , wherein the plug base includes an open slot form in the plug base flange, the method further comprising laterally introducing the medical device within the slot.
22. The method of claim 21 , wherein the plug base is mounted around the cranial burr hole after the medical device is introduced through the burr hole into the brain tissue of the patient.
23. The method of claim 17 , further comprising mounting a cap to the plug base over the retainer.
24.-171. (canceled)
Priority Applications (3)
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US12/258,382 US20090112327A1 (en) | 2007-10-26 | 2008-10-24 | Burr hole plug designs |
US12/630,761 US8731686B2 (en) | 2007-10-26 | 2009-12-03 | Burr hole plug having dual slidable clamping mechanisms |
US14/266,649 US9043000B2 (en) | 2007-10-26 | 2014-04-30 | Burr hole plug having sidable clamping mechanism |
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US14/266,649 Active US9043000B2 (en) | 2007-10-26 | 2014-04-30 | Burr hole plug having sidable clamping mechanism |
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US14/266,649 Active US9043000B2 (en) | 2007-10-26 | 2014-04-30 | Burr hole plug having sidable clamping mechanism |
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US11826561B2 (en) * | 2020-11-02 | 2023-11-28 | Medtronic, Inc. | Burr hole device insertion tool |
US20220280786A1 (en) * | 2021-03-05 | 2022-09-08 | QV Bioelectronics Ltd. | Cranial prosthetic |
US11717680B2 (en) * | 2021-03-05 | 2023-08-08 | QV Bioelectronics Ltd. | Cranial prosthetic |
Also Published As
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EP2200529A2 (en) | 2010-06-30 |
AU2008316640A1 (en) | 2009-04-30 |
JP2014087655A (en) | 2014-05-15 |
EP2540248A1 (en) | 2013-01-02 |
CA2696791A1 (en) | 2009-04-30 |
US9043000B2 (en) | 2015-05-26 |
ES2394045T3 (en) | 2013-01-16 |
US20140243945A1 (en) | 2014-08-28 |
JP2011500291A (en) | 2011-01-06 |
WO2009055746A3 (en) | 2009-08-20 |
EP2200529B1 (en) | 2012-09-05 |
US20100145357A1 (en) | 2010-06-10 |
WO2009055746A2 (en) | 2009-04-30 |
EP2540248B1 (en) | 2015-11-25 |
JP5980190B2 (en) | 2016-08-31 |
US8731686B2 (en) | 2014-05-20 |
AU2008316640B2 (en) | 2014-03-06 |
ES2562618T3 (en) | 2016-03-07 |
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