Patent Description:
Brain syndromes/diseases (e.g., Parkinsons, Alzheimers, etc.) may be treated with electrical leads (wires) that extend deep into a patient's brain and stimulate a selected portion of the brain with electricity. Traditionally, the electrical leads extend through one or more burr hole, which are holes made in a patient's skull. The industry has found that simply extending leads through a burr hole makes it difficult to maintain the leads' proper position over time. As such, burr hole coverings were developed to cover open portions of the skull and assist in maintaining the leads' positions.

An example of a conventional burr hole covering is a burr hole plate. Burr hole plates are often thin, circular immobile plates having one or more holes therein. After a burr hole is drilled, the plate is placed on the skull such that one of the holes within the plate lines up with the burr hole. The distal portion of the lead is placed into the proper position within the brain and the proximal portion of the lead exits the burr hole and is strung through the hole of the plate prior to the plate being mounted to the skull. Thereafter, the skull plate is mounted to the skull around the burr hole via screws, and it is expected that the plate will hold the lead in position.

While the burr hole plate may help maintain the lead's position, the inadaptable design has left much to be desired. The hole within the plate is fixed during manufacturing, but unfortunately, surgery is an inexact and sometimes unpredictable procedure. Only after a surgeon has removed necessary portions of the patience's scalp, drilled one or more holes into the patience's skull, analyzed and determined an optimal lead diameter, and positioned the lead deep within the patient's brain, will the doctor be able to precisely determine whether the hole within the burr hole plate is of the optimal diameter and in the optimal position within the plate. At times, the determined optimal lead diameter proved to be too large to be supported by the burr hole plate and the optimal burr hole's position did not line up with a hole within the burr hole plate.

The industry has attempted to reduce the inadaptability of the burr hole plate design by designing the plate with holes that are oversized, thereby ensuring that the hole of the plate is able to accommodate the lead a surgeon decides to use. However, some surgeons decide to use leads that are thinner than the oversized hole, and ill-fitting holes cause the leads to shift over time and lose their optimal positioning. Substantial lead shifting necessitates additional procedures to correct the shift, which increases risk to patients, decreases effectiveness of the procedure, and increases costs for all. Further, oversized holes cause portions of the skull to remain exposed and unprotected. This is certainly a drawback considering covering open portions of the skull is one of the functions of the burr hole covering.

The industry also attempted to reduce inadaptability of the burr hole plates' design by designing the plate with several holes of various sizes that are located at various locations within the burr hole plate. This attempt to fix the problems of burr hole plates has led to more frustration. Referring back to the surgical example above, after having determined the size and placement of a lead, the determination may be thwarted by the burr hole plate when the hole of proper size is located at the wrong location within the plate. Again, the surgeon resorts to selecting a hole that is the closest match to the patient's needs, but ill-fitting holes cause leads to shift over time and lose their optimal positioning. As explained above, ill-fitting holes may cause additional surgeries and/or leave portions of the skull unprotected.

Further, the immobility of burr hole plates cause the installation to be tedious. During installation, after having positioned the lead deep within the brain, the surgeon threads the lead through the hole within the plate and thereafter must hold everything steady while drilling the plate into the skull. Holding steady the position of a lead, a plate, a drill, and screws all at the same time has been proven to be quite difficult. Often the position of one or more components is lost during the installation process, thereby causing the process to be started over.

In response, some in the industry have moved to a two component design, for example, a two component burr hole clamp system. Typically, a burr hole clamp system includes a hard anchor (e.g., titanium clamp) that clamps a soft inner sleeve (e.g., silicon plug). The anchor has an open state and a closed state. Further, the anchor includes a hole through which a lead may pass. The hole is larger in the open state and smaller in the closed state. During installation, a surgeon may drill a burr hole. Then, the distal end of a lead may be positioned deep within the brain, and the proximal end of the lead may be threaded through the soft inner sleeve of the system. Thereafter, the anchor, in its open state, is positioned around the soft inner sleeve at the burr hole. The anchor is transitioned to its closed state, wherein the anchor clamps the soft inner sleeve through which the lead is threaded. The soft inner sleeve functions similar to an o-ring gasket seal, which holds the lead steady, prevents shifting, and provides skull coverage even when the hole of the anchor is larger than a surgeon selected lead. After the anchor clamps the soft inner sleeve, the anchor is mounted to the skull via screws.

While the two component burr hole clamp system assists with the lead shifting problems described above, the design has left much to be desired. For instance, installation of the burr hole clamp system is even more tedious than burr hole plates. As explained, after having positioned the lead deep within the brain, the surgeon threads the lead through the soft inner sleeve, positions the anchor around the sleeve, and positions the anchor on the skull at the burr hole. Thereafter, the surgeon must hold everything steady while drilling the anchor into the skull. Holding steady the position of the lead, the soft inner sleeve, the anchor plate, the drill, and the screws all at the same time has been proven to add difficulty to installation of simple burr hole plates. Often the position of one or more components is lost during the installation process, thereby causing the process to be started over.

In an effort to reduce the complexity of burr hole clamp systems' installation, some in the industry designed an anchor that partially mounts to the skull before positioning the lead and the soft inner sleeve. The thought being, if the anchor is at least partially drilled into place, then one less component must be held steady during the final installation of the lead and soft inner sleeve. To achieve this goal, the anchor includes a hinged portion that provides the open and closed states of the anchor. During installation, the anchor is mounted to the skull around the burr hole via screws. The hinged portion of the anchor is not yet mounted to the skull. Then, after having positioned the lead deep within the brain, the surgeon threads the lead through the soft inner sleeve, positions the soft inner sleeve within the anchor, closes the hinged portion of the anchor, and mounts the hinged portion of the anchor to the skull via screws. The partial installation of the anchor prior to positioning the lead and soft inner sleeve reduces some of the installation complexity, but still leaves much to be desired.

Due to the two component design, a surgeon is still tasked with steading multiple component pieces in position while installing the final screws. Often the position of one or more components is lost during the installation process, thereby causing the process to be started over. Further, the soft inner sleeve typically extends into and out from the anchor. Patients complain that the burr hole clamp system is uncomfortably thick, which makes them unpopular. In embodiments, after a burr hole system is mounted to the skull, skin is grown over the anchor and soft inner sleeve to provide protection from infection and minimize the appearance of the implant. In sub-dermal systems, the thickness of the implant is of great importance because the location of the sub-dermal implant appears to be a deformity. The two tiered design of two component systems cause the burr hole covering to be significantly thicker than burr hole plates. Due to this thickness, a patience's apparent deformity is a source of great embarrassment and causes some patients to avoid the procedure despite its neurological benefits. Further, while most burr hole coverings are abrasive to the dermis and subcutaneous tissues, the increased thickness and complexity of two component systems cause them to be increasingly abrasive. Moreover, the soft inner sleeve causes increased thickness making it harder for patients to comfortably lay down and/or rest in high back seats (e.g., airplane seats). Further still, in order to ensure the proper sealing effect, the soft inner sleeve typically extends into the burr hole. Thus, the two component system causes abrasiveness and irritation above and below the skull. In short, two component burr hole plugs cause physical and emotional discomfort to patients.

In an effort to solve the problems caused by burr hole plates and two component burr hole clamp systems, some in the industry have moved to burr hole plugs. Burr hole plugs are typically a two component device having a plug base that mounts to the skull, and a retainer that maintains the lead's position. When installed, the retainer mounts into the plug base, which holds the retainer in place. The plug base is mounted to the skull using screws and has an aperture in its center. When mounted, the aperture is positioned such that the aperture exposes a burr hole therethrough. After mounting the plug base to the skull, a lead may extend through the aperture, into the burr hole, and be positioned into the brain. The size of the burr plug's aperture is purposefully bigger than any expected burr hole, and instead, is sized to receive the second component, a retainer, therein. The retainer is then installed by clamping the lead and being fitted (e.g., snapped into) into the aperture of the plug base. The burr plug holds steady the retainer, which in turn holds the lead in place.

This two component design of the burr hole plug reduces installation complexity; however, the design leaves much to be desired. As with the clamp system, the two component design makes manufacturing and packaging more complicated and expensive. Because the retainer must perfectly seat into the plug base to be held securely, the fitting components of the retainer and the fitting components of the plug base have to be manufactured with extreme precision. Minimal manufacturing error is sufficient to cause the device to fail. Further, since the two different components are manufactured using two different machines, manufacturing facilities have to develop techniques to ensure the proper retaining component is properly packaged with the proper plug base. Improper packaging leads to malfunctioning burr hole plugs being delivered to a surgical room, which can be costly to the patient, surgeon, and surgical facility alike.

Further still, the two component burr hole plugs are uncomfortably thick, which makes them unpopular with patients. Due to this thickness, a patient's apparent deformity is a source of great embarrassment and causes some patients to avoid the procedure despite its neurological benefits. Further, while all burr coverings are abrasive to the dermis and subcutaneous tissues, the increased thickness and complexity of burr hole plugs cause them to be increasingly abrasive. Moreover, burr hole plugs' increased thickness makes it harder for patients to comfortably lay down and/or rest in high back seats (e.g., airplane seats). In short, burr hole plugs cause physical and emotional discomfort to patients.

Further still, a problem common to burr hole plates, two component burr hole clamp systems, and burr hole plugs is lead projection. When a lead exits a fully installed burr hole cover, the space of the burr hole covering causes the lead to project out away from the skull. Moreover, the thicker the burr hole cover, the larger the lead projection. The lead projection causes the implant system to be even thicker, which as explained above, causes patient embarrassment and discomfort. In embodiments wherein the lead projection is sub-dermal, the lead projection causes additional lumps, abrasiveness, and irritation. In embodiments wherein the lead projects out of the skin at the burr hole covering, the lead projection runs the risk of being caught in something (e.g., a hair brush) and shifting from its precise position deep within the brain. In short, traditional burr hole cover systems have yet to provide a satisfactory solution to lead projection problems.

In <CIT>, there are described examples of an instrument immobilizer and means for positioning the same. In one example, the instrument immobilizer grasps, secures, and immobilizes an electrode or other instrument that extends through a burr hole in a skull to a target location in a patient's brain.

In <CIT>, there is described an adjustable medical apparatus for anchoring a lead to a cranial burr hole. The apparatus comprises generally an anchoring plate mounted to and over a cranial burr hole, an anchoring arm pivotally mounted to the anchoring plate, and a resilient sleeve mounted between the anchoring plate and the anchoring arm.

Embodiments of the invention are defined by the dependent claims. The present application describes a lead stabilizer that may be surgically implanted sub-dermally on a patient's skull. The lead stabilizer may be a single component including at least a first portion and a second portion that are connected via a hinge. The first and second portions may transition, via the hinge, between an open and closed position. When installing the lead stabilizer, a user may install a lead deep within the brain, wherein the lead extends out of the skull. The user may open the lead stabilizer, position the lead stabilizer such that the lead is between the first and second portions, and close the lead stabilizer thereby clamping the lead therebetween. The lead stabilizer may also be affixed to the skull at the burr hole, wherein the lead stabilizer stabilizes the lead in place and prevents the lead from shifting.

The lead stabilizer may also include one or more surface channels that secures the lead therein. The surface channel may run along the surface of the lead stabilizer that is distal to the skull (e.g., the face of the lead stabilizer visible to the surgeon after implantation) and may be integral to the first portion and/or second portion of the lead stabilizer. A surface channel holds a lead flat against the distal surface of the lead stabilizer thereby reducing the lead's projection from the skull.

The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description that follows may be better understood. Additional features and advantages will be described hereinafter which form the subject of the claims. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present application. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the scope of the application as set forth in the appended claims. The novel features which are believed to be characteristic of embodiments described herein, both as to its organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the present embodiments.

In accordance with aspects described in this application, an adaptable lead stabilizer is provided that stabilizes one or more leads of various sizes (e.g., unpredictable sizes) extending from one or more burr holes. Further, embodiments of lead stabilizers herein may comprise a single integral component, thereby reducing manufacturing and packaging costs, reducing the complexity of surgical installation, and reducing the thickness of the device. Further still, embodiments of lead stabilizers herein may include integral surface channels that secure leads extending from one or more burr holes, which reduces lead projection. As such, embodiments of lead stabilizers herein provide increased patient comfort and decreased embarrassment.

<FIG> is an example illustration of a lead stabilizer <NUM> as seen from outside a patient's skull <NUM>. Lead stabilizer <NUM> may include a first portion <NUM> and a second portion <NUM> that come together to form a plate. If desired, lead stabilizer <NUM> may include additional portions (e.g., third portion, nth portion), which come together to form the plate. Lead stabilizer <NUM> includes one or more hinge <NUM> connecting first portion <NUM> and second portion <NUM> (and/or any additional portions). Lead stabilizer <NUM> articulates between an open position (shown e.g., in <FIG> and <FIG>) and a closed position (shown e.g., in <FIG>, <FIG>, and <FIG>).

When in the closed position, the first portion <NUM> and second portion <NUM> come together to form a plate having one or more apertures <NUM>. A lead <NUM> may extend out from a patient's brain, through a burr hole in the patient's skull <NUM>, through aperture <NUM>, and extend away from lead stabilizer <NUM>. Lead <NUM> may be an electric lead, a coated wire having one or more electrodes at the proximal end (e.g., the end installed in the brain), an extension wire, a deep brain stimulator (DBS) lead, and/or the like. Lead <NUM> may be used to provide electrical pulses to a particular portion of the brain in order to treat brain syndromes and/or diseases (e.g., Parkinsons, Alzheimers, Dystonia, etc.).

The distal surface of lead stabilizer <NUM> may include one or more integral surface channels <NUM>. The distal surface of lead stabilizer <NUM> is the surface facing away from the skull in the z direction, the outer surface of the lead stabilizer as seen from the surgeon's perspective after installation of lead stabilizer <NUM> as shown in <FIG>, the outer surface of lead stimulator <NUM> that is approximately parallel to the outer surface of the skull. Surface channel <NUM> is an open faced channel (e.g., groove) that extends lengthwise on the surface of lead stabilizer <NUM>. Surface channel <NUM> has a proximal end <NUM> that terminates at an aperture <NUM> and a distal end <NUM> that terminates the perimeter <NUM> of lead stabilizer <NUM>.

In embodiments, first portion <NUM> may include one or more surface channel <NUM>; second portion <NUM> may include one or more surface channel <NUM>; and any additional portions (e.g., nth portion) may include one or more surface channel <NUM>. In the example illustrated in <FIG>, second portion <NUM> includes three surface channels <NUM> each having a proximal end terminating at three respective aperture <NUM>.

The depth of a surface channel <NUM> may vary as surface channel <NUM> extends lengthwise to the distal end <NUM> at the perimeter <NUM> of lead stabilizer <NUM>. As seen best in <FIG>, example surface channel <NUM> is deepest at the point of termination at aperture <NUM>. The proximal end <NUM> then slopes upward (e.g., the channel depth becomes more shallow) as surface channel <NUM> extends lengthwise towards the distal end <NUM>. In embodiments, the depth of surface channel <NUM> slopes upward from the proximal end <NUM> for a first length. Then the depth of surface channel <NUM> maintains a substantially constant depth for a second length terminating at the distal end <NUM>. Accordingly, the proximal end <NUM> of surface channel <NUM> may terminate at aperture <NUM> at a first angle, the distal end <NUM> of surface channel <NUM> may terminate at the perimeter <NUM> of second portion <NUM> at a second angle (e.g., <NUM> degrees), and the first angle is larger than the second angle.

The varying sloping depth of surface channel <NUM> allows lead <NUM>, which is traveling in the z direction up and out of the skull, to curve out of aperture <NUM> at an obtuse angle and seat into surface channel <NUM>. Such a transition from the burr hole, through aperture <NUM>, to surface channel <NUM> causes a lead directional change that is less abrupt than forcing lead <NUM> to make a <NUM> degree turn as lead <NUM> transitions from the burr hole, through aperture <NUM>, to surface channel <NUM>. By reducing the abruptness of the lead's <NUM> directional change, lead projection at aperture <NUM> is reduced and the lead is protected from excessive bending force which may damage the lead.

Surface channel <NUM> retains lead <NUM> therein. In embodiments, surface channel <NUM> may be more narrow than a diameter of lead <NUM> thereby causing surface channel <NUM> to hold lead <NUM> snuggly therein. Additionally and/or alternatively, surface channel <NUM> may include one or more flanges <NUM> (e.g., edges, ridges, lips, snaps, clips, projections, rims, fasteners, claps, and/or the like) that snaps lead <NUM> within surface channel <NUM>. Holding lead <NUM> tight to surface channel <NUM> reduces lead projection as lead <NUM> travels away from aperture <NUM> and assists in preventing lead shifts. Please note that while <FIG> does not show a surface channel, a surface channel may be included in any embodiment as is desired.

As illustrated, lead stabilizer <NUM> further includes one or more fixation aperture <NUM>, which assists in fixing lead stabilizer <NUM> to the skull <NUM>. Fixator hole <NUM> receives fixator <NUM> (e.g., a screw, nail, fastener, cement, and/or the like), therein, and fixator <NUM> couples lead stabilizer <NUM> to skull <NUM>. Fixator aperture <NUM> may traverse one or more hinge <NUM>, wherein fixator <NUM> immobilizes hinge <NUM> in a particular position when fixator <NUM> is installed into the skull <NUM>. For example, a surgeon may use screw <NUM> to traverse hinge <NUM> and mount lead stabilizer <NUM> onto skull <NUM>, wherein upon one or more screw <NUM> being tightened, hinge <NUM> can no longer open and close.

As explained, lead stabilizer <NUM> is used by a surgeon to stabilize one or more lead <NUM>, which may be installed deep within a patient's brain. During the implantation procedure, a surgeon may prepare the site by removing and/or cutting back portions of the scalp covering the implantation site. Then, the surgeon may drill one or more burr holes in the patient's skull. Further, the surgeon may partially mount lead stabilizer <NUM> to skull <NUM>. Lead stabilizer <NUM> may be transitioned into an open position at hinge <NUM> as shown in <FIG>. In the open state, a portion of lead stabilizer <NUM> may be mounted to skull <NUM>. For example, first portion <NUM> may be partially attached to skull <NUM> via one or more fixator <NUM>, which traverses one or more fixator aperture <NUM>. Fixator <NUM> may be tightened sufficiently to hold first portion <NUM> in position, but remain loose enough to allow one or more hinge <NUM> to pivot.

First portion <NUM> may be attached to skull <NUM> in a location such that a portion of a burr hole is surrounded by cutout <NUM> of first portion <NUM>. As will be explained further below, cutout <NUM> will later meet together with a corresponding cutout <NUM> of second portion <NUM>, thereby forming aperture <NUM>. At some point (before or after first portion <NUM> is partially attached to skull <NUM>), one or more leads <NUM> are selected for implantation within the brain. The length, thickness, and/or other characteristics of selected lead <NUM> may be selected based on the patient's needs at that time. After lead <NUM> is properly positioned within the brain and exiting the burr hole, hinge <NUM> is transitioned from an open position to a closed position thereby causing second portion <NUM> to clamp lead <NUM> in place.

Second portion <NUM> includes at least one cutout <NUM> at second portion's <NUM> inner edge <NUM>. First portion <NUM> likewise includes at least one cutout <NUM> at first portion's <NUM> inner edge <NUM>. While in the open position, cutout <NUM> and its corresponding cutout <NUM> move away from each other creating space therebetween. As such, even if a portion of lead stabilizer <NUM> is already partially attached to skull <NUM>, this created space gives a surgeon room to perform other steps of the installation process (e.g., installing lead <NUM> within the brain, positioning its exit, drilling additional burr holes, and/or the like). Further, because a portion of lead stabilizer <NUM> is at least partially attached to skull <NUM>, the procedure's complexity is reduced because lead stabilizer <NUM> is being held in place hands free. When the surgeon is ready, second portion <NUM> is transitioned to meet with first portion <NUM>, such that cutout <NUM> and a corresponding cutout <NUM> form aperture <NUM> through which lead <NUM> extends. Many apertures <NUM> may be formed by a plurality of cutouts <NUM>, 110b-110n meeting with a plurality of respective corresponding cutouts <NUM>, 114b-114n.

Once all leads <NUM> are implanted and lead stabilizer <NUM> is ready to be fully mounted, the surgeon may ensure that lead stabilizer <NUM> is in the desired position (e.g., closed position and/or a position between the opened and closed position) and then fully mount lead stabilizer <NUM> via additional fixators <NUM> through additional fixator apertures <NUM>. <FIG>, <FIG>, and <FIG> show examples wherein lead stabilizers <NUM> have two fixator apertures <NUM>. <FIG> shows an example lead stabilizer <NUM> having four fixator holes <NUM>. Of course any number of fixator apertures <NUM> are contemplated.

<FIG>, <FIG> illustrate a variety of hinges <NUM> that lead stabilizer <NUM> may include. <FIG> shows a slotted arm 108a, which allows second portion <NUM> to move laterally down away from first portion <NUM>. In embodiments, slotted arm <NUM> of <FIG> may also allow second portion <NUM> to pivot away from first portion <NUM> at any point along the slotted arm. <FIG> shows an example of a lead stabilizer <NUM> having a plurality of hinges <NUM>. Hinge <NUM> may be a break-away hinge <NUM> that functions as a hinge while joined with hinge counterparts (e.g., hinge 108b) but is also capable of breaking away from its hinge counterparts (e.g., 108c) when desired. In <FIG>, lead stabilizer <NUM> may open from hinge 108b and/or hinge 108c, which makes lead stabilizer <NUM> more adaptable. From time to time, a surgeon may open hinge 108b, hinge 108c, and/or both hinges depending on circumstances encountered during a procedure. <FIG> shows an example hinge 108d, which is not traversed by a fixation hole <NUM>.

Embodiments of lead stabilizers <NUM> may include one or more hinge <NUM> of one or more variety. Hinges <NUM> may also be immobilized in a variety of ways. In embodiments, hinge <NUM> may be immobilized by tightening a fixator <NUM>, which penetrates fixation hole <NUM>. For example, a surgeon may secure a screw <NUM> through hole <NUM> and into skull <NUM>, which mounts lead stabilizer <NUM> to skull <NUM> while also immobilizing hinge <NUM>. Various embodiments of hinges <NUM> may be immobilized by a pin, snap, cement, etc. Further, as shown in <FIG>, hinge <NUM> is immobilized when first portion <NUM> and second portion <NUM> are mounted via fixators <NUM> traversing fixator apertures <NUM> into skull <NUM>.

<FIG> is an example illustration of a deep brain stimulator (DBS) surgical kit <NUM>. DBS surgical kit <NUM> may be manufactured, sterilized, and packaged at a manufacturing facility. Thereafter, the sterilized package may be delivered to a surgical facility and brought into a surgical room thereby reducing the preparation work of employees at the surgical facility. Further, prepackaging at the manufacturing plant reduces the likelihood of contamination of any individual components of the kit at least because less people handle the components at less facilities. Further still, prepacking the surgical kit may save the surgical facility money and time because equipment sterilizing devices and procedures may be avoided. Yet further, because the surgical kit comes prepackaged with the components used during the procedure, the surgical kit reduces the likelihood of an employee of the surgical facility forgetting to include one or more components on a surgical tray, which results in more efficient surgeries.

Example DBS surgical kit <NUM> includes one or more leads <NUM>. Leads <NUM> may be of various thickness, length, impedance, coating material, electrode number, electrical conduit, texture, and/or other characteristics. Further, two or more leads <NUM> may have the same characteristics. Any number of leads <NUM> may be included in a surgical kit <NUM>.

DBS surgical kit <NUM> may also include one or more lead stabilizer <NUM>. Also included may be one or more fixators <NUM>. Surgical kit <NUM> includes more screws <NUM> than will likely be used in the installation process. Providing extra screws is helpful just in case a screw is dropped during the procedure. A DBS surgical kit <NUM> may also include tools used during the implantation process. Example surgical kit <NUM> includes drill <NUM>, which may be electrical or manual, and/or one or more drill bits <NUM> of the same or varying sizes. A surgeon may use drill <NUM> to make burr holes. Further, the drill may be used to make holes which will receive fixators <NUM>. In embodiments, one or more drill bit may be sized to correspond to thicknesses of leads <NUM> included in the kit; one or more drill bit may be sized to correspond to diameters of apertures <NUM> included in the kit; and one or more drill bit may be sized to correspond to diameters of fixators <NUM> included in the kit. Further, leads <NUM> of the kit may be sized to correspond to diameters of apertures <NUM> of the kit, which would improve lead stabilizer's grip of a lead. Further, fixators' diameters may be sized to correspond to apertures' diameters, which may reduce an amount of hardware included in the kit because drill bits for fixators would couple as drill bits for apertures.

DBS surgical kit <NUM> may also include one or more driving bit <NUM>, which drive a fixator <NUM> into a skull <NUM>. Examples of driving bits are phillips head bits, flathead bits, allen wrench bits, star head bits, and/or any other shape. A surgical kit may also include one or more sizing and guide instruments. Surgical kit <NUM> shows an example sizing wheel <NUM>, which may be used to select one or more fixator and/or drill bit as well as be used as a stencil while drilling holes in skull <NUM>. Any number and/or type of sizing instruments may be included which may assist a surgeon with cuts, holes, placement, etc. during the procedure.

In embodiments, some or all components of the kit are embedded in a well formed in tray <NUM>. A well helps hold a component in place on the tray while the procedure is being performed. Tray <NUM> may be covered by cover <NUM>, which may be transparent, translucent, and/or opaque. A transparent cover <NUM> may be helpful to see the components included within the kit. During assembly of surgical kit <NUM>, each component included in a respective kit <NUM> may be sterilized. Then, tray <NUM> and the components held thereon are sealed with sterilized cover <NUM>. Tray <NUM> and cover <NUM> create a sterile environment therein. As a result, sealed DBS surgical kit <NUM> may be transported and will maintain its sterility.

In embodiments, cover <NUM> may be sealed such that each individual component and/or some individual components are held in separate environments. For example, cover <NUM> may be a plastic cover that is sealed around each well. As such, a surgeon can unseal one well without unsealing another well. Thus, if a surgeon uses one lead <NUM>, any unused leads <NUM> will remained sealed in their sterile environment and may be used at a later time.

It should be noted that DBS surgical kit <NUM> may be packaged at any facility including a surgical facility if desired.

While this specification contains many implementation details, these should not be construed as limitations on the scope of the invention or of what may be claimed, but rather as descriptions of features specific to particular implementations of the invention.

In certain circumstances, multitasking may be advantageous.

Claim 1:
A lead stabilizer (<NUM>) configured to be that surgically implanted on a skull, the lead stabilizer comprises:
a first portion (<NUM>);
a second portion (<NUM>);
a hinge (<NUM>) coupled to the first portion and the second portion, wherein the hinge transitions the lead stabilizer between an open position and a closed position;
a first cutout on an inner edge of the first portion;
a second cutout on an inner edge of the second portion, wherein when the lead stabilizer is in the closed position, the first cutout and the second cutout frame an aperture (<NUM>) through which a lead extends out from a burr hole;
a surface channel (<NUM>) that secures a portion of the lead extending out from the burr hole along an upper surface of the second portion, the surface channel comprising:
a proximal end (<NUM>) that begins at the aperture corresponding to the first and second cutouts, and
a distal end (<NUM>) that terminates at a perimeter (<NUM>) of the second portion,
wherein the surface channel has a depth that extends from the proximal end to the distal end,
characterized in that the hinge comprises one or more fixation apertures configured to receive a fixation device to affix the lead stabilizer to the skull and immobilize the hinge in a selected position.