Craniectomy cutting template

Abstract

Provided herein are cutting template devices and methods of use thereof for preparing a skull for implantation of a pulse generator (IPG) for deep brain stimulation. The cutting templates described herein may comprise a coarse texture and / or one or more protruding members to minimize movement of the cutting template when placed against an otherwise-slippery surface of the skull. The body of the cutting templates may be sized to correspond with a profile of an IPG and may include one or more curvatures corresponding with the anatomic curvature(s) of the skulk

Description

Attorney Docket No: 78895-20031.40 CRANIECTOMY CUTTING TEMPLATE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No.63 / 509,231, filed June 20, 2023, the contents of which are incorporated herein in its entirety. FIELD

[0002] This disclosure relates generally to craniectomy cutting templates, and more specifically to craniectomy cutting templates for deep brain stimulation (DBS) implantation procedures. BACKGROUND

[0003] Deep brain stimulation (DBS) is a neurostimulation therapy that can be used to treat neurodegenerative disorders such as epilepsy and Parkinson’s disease (PD). In DBS, an artificial electrical current is provided to specific parts of the brain to stimulate neurons, which in turn eases the symptoms experienced in different brain conditions. For example, in patients with PD, high-frequency stimulation is provided to regions of the basal ganglia (e.g., the subthalamic nucleus (STN) or internal globus pallidus (GPi)) to correct imbalances in excitation-inhibition in the basal ganglia circuit. DBS can ease motor symptoms experienced in PD and decrease the need for pharmacological treatment.

[0004] Deep brain stimulation systems commonly include one or more stimulation leads (e.g., comprising electrodes) implanted in the brain and a pulse generator (e.g., stimulator battery) implanted in the upper chest of the patient. One or more small incisions are made in the scalp of a patient, followed by one or more small openings in the skull that allow for lead implantation in the brain. In addition, a small incision is made in the upper chest to create a soft tissue pocket for the pulse generator. The stimulation leads are connected to the pulse generator, for example, using extension wires tunneled underneath the skin between the stimulation leads extending from the skull and the pulse generator in the upper chest. However, these extension leads can shift, causing pain and discomfort for the patient. Additionally, the extension leads may loosen, detach from the pulse generator, or break, each of which require subsequent surgical procedures to fix, reattach, or replace the leads. Additional surgical procedures can increase the risk of intraoperative and / or postoperative surgical complications, such as infection, bleeding,ny-2750746Attorney Docket No: 78895-20031.40 swelling, and in more severe cases, coma, sepsis, and stroke. Moreover, implanting the stimulation leads and the pulse generator requires preparation of at least two surgical sites (e.g., the upper chest and one or more sites on the skull), and each of the procedures are typically executed individually in separate visits, which is a source of inefficiency in the surgical suite that is also accommodated by increased risk of surgical complications (i.e., due to the number of procedures). SUMMARY

[0005] Described herein are cutting template devices and methods of using the cutting templates to cut a skull during, for example, a deep brain stimulation (DBS) implantation procedure. The cutting template may be designed such that it corresponds with features of a cranially mounted pulse generator (IPG), which facilitates the surgical process for implanting the cranially mounted IPG. For example, the size of the opening created using the cutting template may correspond with the size of the IPG such that only bone necessary to be removed to accommodate the IPG is resected. The cutting template may comprise a coarse texture and / or one or more protruding members on an inferior surface of the template configured to minimize movement of the cutting template on the slippery surface of the skull during use. In addition, the body of the cutting template may comprise one or more curvatures configured to correspond with the anatomic curvature of a skull, thus providing an accurate outline for a cranially mounted IPG.

[0006] In some embodiments, a cutting template is provided, comprising: a cutting template body comprising a superior surface and an inferior surface opposite from the superior surface, wherein at least a portion of the inferior surface comprises a coarse texture and / or one or more protruding members; and the inferior surface comprises a curvature configured to correspond with a curvature of a skull.

[0007] In some embodiments, a length of the one or more protruding members is at least 0.25 mm.

[0008] In some embodiments, the inferior surface of the cutting body template comprises one or more flexures.

[0009] In some embodiments, the one or more protruding members are disposed on the one or more flexures.ny-2750746Attorney Docket No: 78895-20031.40

[0010] In some embodiments, the one or more flexures are configured to flex toward the superior surface when the inferior surface of the cutting template is pressed against the skull.

[0011] In some embodiments, the one or more flexures has a spring constant of at least 0.75 N / mm.

[0012] In some embodiments, the coarse texture of the inferior surface of the cutting template body covers the inferior surface.

[0013] In some embodiments, the coarse texture of the inferior surface has a surface roughness (Ra) of at least 3.2 μm.

[0014] In some embodiments, the curvature of the inferior surface of the cutting template extends latitudinally between a first end of the cutting template body and a second end of the cutting template body.

[0015] In some embodiments, a radius of the curvature of the inferior surface is between 80 mm and 140 mm.

[0016] In some embodiments, the inferior surface of the cutting template body comprises a second curvature configured to correspond with a second curvature of the skull.

[0017] In some embodiments, the second curvature of the inferior surface extends longitudinally between a first side of the cutting template body and a second side of the cutting template body.

[0018] In some embodiments, a radius of the second curvature is between 80 mm and 140 mm.

[0019] In some embodiments, at least a portion of the superior surface of the cutting template body is configured to correspond with one or more of the curvatures of the inferior surface of the cutting template body.

[0020] In some embodiments, the cutting template comprises a handle disposed on and extending outward from the superior surface of the cutting template body.

[0021] In some embodiments, the cutting template body comprises an elliptical or other oblong profile configured to correspond with a profile of an implantable pulse generator device.

[0022] In some embodiments, the cutting template body comprises a thickness between 1 mm and 5 mm.

[0023] In some embodiments, the inferior surface and / or the superior surface of the cutting template body comprises a biocompatible material.ny-2750746Attorney Docket No: 78895-20031.40

[0024] In some embodiments, the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

[0025] In some embodiments, the cutting template body is sterilizable, such that the cutting template is reusable for multiple craniectomy procedures.

[0026] In some embodiments, a deep brain stimulation system is provided, comprising: the cutting template provided herein; a pulse generator configured to be implanted in the skull, a profile of the pulse generator corresponding to a profile of the cutting template; and at least one electrode lead coupled to the pulse generator and configured to be implanted in a brain.

[0027] In some embodiments, a method for performing a craniectomy procedure is provided, comprising: placing a cutting template on a skull such that a surface of the cutting template is in contact with the skull, the surface comprising a coarse texture or one or more protruding members configured to maintain a position of the cutting template on the skull; tracing on the skull an outline of the cutting template while the cutting template is placed on the skull; and cutting the skull along the traced outline of the cutting template.

[0028] In some embodiments, the method comprises, prior to cutting the skull, removing the cutting template from being placed on the skull.

[0029] In some embodiments, tracing the outline of the cutting template on the skull comprises marking the outline of the cutting template on the skull using a surgical marker.

[0030] In some embodiments, the cutting template is placed on a lateral side of the skull.

[0031] In some embodiments, the method comprises inserting an implantable pulse generator (IPG) into the cut skull.

[0032] In some embodiments, the surface of the cutting template is an inferior surface comprising one or more flexures.

[0033] In some embodiments, the one or more protruding members are disposed on the one or more flexures.

[0034] In some embodiments, the one or more flexures are configured to flex toward a superior surface when the inferior surface of the cutting template is pressed against the skull.

[0035] In some embodiments, the surface of the cutting template comprises a first curvature configured to correspond with a first curvature of the skull, the first curvature of the surfaceny-2750746Attorney Docket No: 78895-20031.40 extending latitudinally between a first end of the cutting template and a second end of the cutting template.

[0036] In some embodiments, the surface of the cutting template comprises a second curvature configured to correspond with a second curvature of the skull, the second curvature extending longitudinally between a first side of the cutting template and a second side of the cutting template.

[0037] In some embodiments, the cutting template comprises a handle disposed on and extending outward from a second surface of the cutting template, the second surface disposed opposite from the surface of the cutting template.

[0038] In some embodiments, the cutting template comprises an elliptical or other oblong profile configured to correspond with a profile of an implantable pulse generator.

[0039] In some embodiments, the cutting template comprises a biocompatible material.

[0040] In some embodiments, the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

[0041] In some embodiments, the cutting template is sterilizable, such that the cutting template is reusable for multiple craniectomy procedures. BRIEF DESCRIPTION OF THE FIGURES

[0042] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative embodiments and the accompanying drawings.

[0043] FIG.1A illustrates a perspective view of a first exemplary cutting template, in accordance with some embodiments.

[0044] FIG.1B illustrates another perspective view of the first exemplary cutting template, in accordance with some embodiments.

[0045] FIG.1C illustrates a side view of the first exemplary cutting template, in accordance with some embodiments.ny-2750746Attorney Docket No: 78895-20031.40

[0046] FIG.2A illustrates a perspective view of a second exemplary cutting template, in accordance with some embodiments.

[0047] FIG.2B illustrates another perspective view of the second exemplary cutting template, in accordance with some embodiments.

[0048] FIG.2C illustrates a top view of the second exemplary cutting template, in accordance with some embodiments.

[0049] FIG.2D illustrates a side view of the second exemplary cutting template, in accordance with some embodiments.

[0050] FIG.3 illustrates a perspective view of an exemplary cutting template on a human head, in accordance with some embodiments. DETAILED DESCRIPTION

[0051] A cutting template device and method of using the cutting template to cut a skull is described herein. The cutting template may be used during a deep brain stimulation (DBS) implantation to prepare a skull for an implantable pulse generator (IPG). As discussed herein, the DBS system may include a cranially mounted IPG, as opposed to a system that includes an IPG implanted in the chest of the patient and connected to stimulation leads using one or more extension leads tunneled between the skull and chest. The cutting template as described herein may be sized such that it corresponds with the profile of the IPG. Thus, the size of the opening created using the cutting template may be approximately as large is as necessary to adequately accommodate the IPG. The cutting template provided herein may comprise a coarse texture and / or one or more protruding members on an inferior surface of the template configured to minimize movement of the cutting template on the slippery surface of the skull during use. In addition, the body of the cutting template may comprise one or more curvatures configured to correspond with the anatomic curvature of a skull, thus providing an accurate outline for a cranially mounted IPG.

[0052] Preparing the skull for an IPG may include performing a craniectomy. In traditional DBS implantation procedures, a craniectomy may be performed to create one or more small openings in the skull through which stimulation leads can be implanted in the brain. For example, one or more burr holes may be drilled into the skull to access the desired region of the brain. Thus, the size of the opening may be controlled and / or related to the size of the drillingny-2750746Attorney Docket No: 78895-20031.40 tool. In contrast, in preparation for a cranially mounted IPG, an opening sized to accommodate the IPG in the skull is necessary. However, the profile of the IPG may not be easily replicated using standard bone drilling tools. Attempting to estimate the necessary amount and shape of bone to drill may be challenging for the user and cause user frustration, increase surgical times, and / or cause an inaccurate amount of bone to be drilled.

[0053] FIGS.1A-1C illustrate a cutting template 100 comprising a cutting template body 102 including a superior surface 104 and an inferior surface 106 opposite from superior surface 104. Cutting template 100 may comprise one or more protruding members 108 and / or a coarse texture on at least a portion of the inferior surface 106. The inferior surface 106 of cutting template body 102 may comprise a curvature configured to correspond with a curvature of a skull.

[0054] As discussed herein, cutting template 100 may comprise one or more protruding members 108 (e.g., cleats, spikes, etc.) disposed on the inferior surface 106 of and extending outward from cutting template body 102. For example, cutting template 100 may comprise 1, 2, 3, 4, 5, 6, or more protruding members 108. FIGS. 1A-1C illustrate a cutting template 100 comprising a plurality of protruding members 108. A cross-section of one or more of protruding members 108 transverse to inferior surface 106 may comprise a circular, rectangular, triangular, elliptical, or other polygonal shape. For example, protruding members 108 may comprise a conical, cylindrical, or other three-dimensional (3-D) prismatic shape. The 3-D prism may extend from cutting template body 102 along a longitudinal axis. In some embodiments, the length of the one or more protruding members 108 extending along the longitudinal axis may be less than or equal to 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm, 0.40 mm, 0.45 mm, or 0.5 mm. In some embodiments, the length of the one or more protruding members 108 may be greater than or equal to 0.10 mm, 0.15 mm, 0.20 mm, 0.25 mm, 0.30 mm, 0.35 mm, 0.40 mm, 0.45 mm, or 0.5 mm.

[0055] Cutting template 100 may comprise one or more flexures 110. For example, the one or more flexures 110 may be disposed on the inferior surface 106 of cutting template body 102 such that each of the protruding members 108 can be disposed on flexures 110, as shown. Thus, the number of flexures 110 may correspond with the number of protruding members 108. For example, cutting template body 102 may comprise 1, 2, 3, 4, 5, 6, or more flexures 110. In some embodiments, cutting template 100 may comprise an unequal number of flexures 110 and protruding members 108. In some embodiments, cutting template 100 may comprise one or moreny-2750746Attorney Docket No: 78895-20031.40 protruding members 108 and no flexures 110. Flexures 110 may comprise a profile corresponding to a cut-out in a portion of inferior surface 106 such that the one or more flexures can flex toward the superior surface 104 when a force is applied to the inferior surface 106 of the cutting template body 102. For example, flexures 110 may be configured to flex towards the superior surface 104 when inferior surface 106 is pressed against a skull during use of cutting template 100 (e.g., as shown in FIG.3). A spring constant of the one or more flexures 110 may be predefined and may correspond to the amount of flex allowed by the flexures 110. In some embodiments, the spring constant of the one or more flexures 110 may be greater than or equal to 0.50 N / mm, 0.75 N / mm, 1.0 N / mm, 1.25 N / mm, 1.5 N / mm, 1.75 N / mm, or 2.0 N / mm. In some embodiments, the spring constant of the one or more flexures 110 may be less than or equal to 0.50 N / mm, 0.75 N / mm, 1.0 N / mm, 1.25 N / mm, 1.5 N / mm, 1.75 N / mm, or 2.0 N / mm.

[0056] The profile of flexures 110 may comprise a pair of side walls connected on one end by a curve (e.g., an arc, line, etc.). In some embodiments, the profile side walls may be angled such that a flexure 110 tapers on an end of the profile of flexure 110 (e.g., on the end comprising the curve connecting the side walls, as shown). In some embodiments, the side walls may be parallel to one another. Each of the one or more flexures 110 may be angled on inferior surface 106 toward an outer edge of cutting template body 102. In some embodiments, a side wall of one or more of the flexures 110 may be parallel to an edge of the cutting template body 102.

[0057] In embodiments with a plurality of protruding members 108 and / or flexures 110, one or more protruding members 108 and / or flexures 110 may be disposed in a symmetrical array on the inferior surface 106 of cutting template body 102. For example, as shown at least in FIG.1A, a cutting template 100 may comprise 4 protruding members 108 and corresponding flexures 110, a pair of flexures 110 and protruding members 108 disposed on each end of the inferior surface 106 of cutting template body 102. Stated otherwise, a protruding member 108 and corresponding flexure 110 may be disposed in each quadrant of a cutting template body 102.

[0058] As discussed herein, the inferior surface 106 of cutting template body 102 may include a coarse texture instead of or in addition to one or more protruding members 108 (and / or flexures 110). FIGS.2A-2D illustrate an example cutting template 200 comprising a cutting template body 202. Cutting template body may comprise an inferior surface 206 without one or more protruding members 108 and / or flexures 110. Rather, inferior surface 206 may comprise a coarse texture that may cover the inferior surface 206. In some embodiments, the coarse textureny-2750746Attorney Docket No: 78895-20031.40 may cover less than the full inferior surface, such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99.9% of the inferior surface 206. The coarse texture may be defined by a surface roughness (or roughness average, Ra) on the inferior surface 206 that can provide traction for the cutting template 200 when pressed against a slippery and / or smooth surface, such as a skull during a cranial procedure. Surface roughness is described in greater detail in ASME B46.1. In some embodiments, the coarse texture may have a surface roughness (Ra) of less than or equal to 2.0 μm, 2.2 μm, 2.4 μm, 2.6 μm, 2.8 μm, 3.0 μm, 3.2 μm, 3.4 μm, 3.6 μm, 3.8 μm, or 4.0 μm. In some embodiments, the surface roughness (Ra) may be greater than or equal to 2.0 μm, 2.2 μm, 2.4 μm, 2.6 μm, 2.8 μm, 3.0 μm, 3.2 μm, 3.4 μm, 3.6 μm, 3.8 μm, or 4.0 μm.

[0059] The IPG cutting template provided herein may be described primarily with reference to cutting template 100 and its corresponding features. However, it is to be understood that an envisaged cutting template may comprise any combination of features of cutting template 100 and cutting template 200 discussed herein. Stated otherwise, cutting template 200 may comprise any one or more features of cutting template 100 described herein with respect to FIGS.1A-1C, or vice versa. Moreover, cutting template body 202 and inferior surface 206 may comprise any one or more features of cutting template body 102 and inferior surface 106, respectively (and vice versa).

[0060] The inferior surface 106 (and therefore inferior surface 206) may comprise one or more curvatures configured to correspond with a curvature of the skull. In some embodiments, superior surface 104 may comprise substantially the same curvature as inferior surface 106, such that cutting template body 102 more generally comprises the curvature(s) described herein. A curvature (e.g., a first curvature) of inferior surface 106 may extend latitudinally between a first end and a second end of cutting template body 102. For example, in the instance the profile of cutting template body 102 comprises an elliptical shape, the first curvature may extend along the major radius of the ellipse. The curvature of inferior surface 106 may be based on standard data describing various dimensions (e.g., curvatures) of skulls. For example, the curvature of inferior surface 106 may correspond with (e.g., be substantially the same as) the curvature of one or more cranial fixation plates. The cranial fixation plates may be designed such that they can be used with a wide range of skulls comprising various anatomical dimensions. In some examples, surgeons and / or other professionals of skill in the art, in addition to cadaver studies, may inform the dimensions of cranial fixation plates, (which therefore extends to the dimensions of the 9ny-2750746Attorney Docket No: 78895-20031.40 curvature of inferior surface 106. In some embodiments, a radius of the curvature of the inferior surface 106 may be less than or equal to 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, or 160 mm. In some embodiments, the radius of the curvature may be greater than or equal to 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, or 160 mm.

[0061] In some embodiments, inferior surface 106 (and in some instances, superior surface 104) of cutting template body 102 may comprise a second curvature in addition to or in place of the first curvature described herein, the second curvature configured to correspond with a second curvature of a skull. The second curvature may extend longitudinally between a first side and a second side of the cutting template body 102. For example, in the instance the profile of cutting template body 102 comprises an elliptical shape, the second curvature may extend along the minor radius of the ellipse. As described with respect to the first curvature, the second curvature may be based on standard data describing various dimensions (e.g., curvatures) of skulls. For example, a radius of the second curvature of the inferior surface 106 may be less than or equal to 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, or 160 mm. In some embodiments, the radius of the second curvature may be greater than or equal to 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, or 160 mm.

[0062] In some embodiments, at least a portion of superior surface 104 of cutting template body 102 may comprise one or more curvatures configured to correspond with the one or more aforementioned curvatures of the inferior surface 106 of cutting template body 102. Thus, cutting template body 102 may comprise a uniform thickness, as discussed herein.

[0063] As illustrated at least in FIGS.1A-1C, cutting template 100 may include a handle 110 disposed on and extending outward from the superior surface 102 of cutting template body 102. The handle 110 may be configured such that a user (e.g., a surgeon, etc.) can easily grasp the cutting template 100 and stabilize the device against a skull. For example, handle 110 may be designed to be grasped by a user using, for example, 2, 3, 4, or 5 fingers. Handle 110 may comprise one or more ergonomic features (e.g., indentations, textures, etc.) intended to improve grip on handle 110. In some embodiments, handle 110 may extend about 16-24 mm outward from the superior surface 104 of cutting template body 102. For example, the height of handle 110 may be about 16 mm, 18 mm, 20 mm, 22 mm, or 24 mm. Handle 110 may comprise a cross-sectional shape, such as a circular, rectangular, triangular, elliptical, or other polygonal shape. In some embodiments, handle 110 may comprise a thickness extending from a first sideny-2750746Attorney Docket No: 78895-20031.40 of handle 110 to a second side of handle 110 of about 1-5 mm. For example, the thickness of handle 110 may be about 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm. In some embodiments, handle 110 may comprise a length extending from a first end of handle 110 to a second end of handle 110 of about 15-25 mm. For example, the length of handle 110 may be about 15 mm, 17 mm, 19 mm, 21 mm, 23 mm, or 25 mm.

[0064] As discussed herein, the profile of cutting template body 102 may comprise an elliptical, rectangular, circular, or other oblong shape. The shape of the profile of cutting template body 102 may be configured to correspond with the profile of a pulse generator (IPG) configured to be implanted in the skull of the patient. Thus, outlining cutting template body 102 during use of the cutting template 100 may generate an accurate outline corresponding to the size and shape necessary to implant the IPG in the skull, with minimal excess bone removed.

[0065] The thickness of cutting template body 102 may be uniform or variable throughout the area of the body. For example, in the instance each of superior surface 104 and inferior surface 106 comprise substantially the same curvature(s), the thickness of cutting template body 102 may be substantially uniform throughout. In the instance inferior surface 106 comprises one or more curvatures and superior surface 104 does not comprise curvatures (or does not comprise substantially the same curvatures), the thickness of cutting template body 102 may not be uniform throughout the area of cutting template body 102. The thickness may be less than or equal to 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm. The thickness may be greater than or equal to 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, or 5 mm.

[0066] One or more components of cutting template 102 may be manufactured from biocompatible materials. For example, at least the inferior surface 106 and / or superior surface 104 of cutting template body 102 may comprise biocompatible materials. In some embodiments, the biocompatible materials may comprise one or more of polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals. At least the cutting template body 102 may be sterilizable such that cutting template 100 is reusable for multiple procedures, such as multiple craniectomy procedures. For example, cutting template 102 may be sterilizable using moist heat (steam), dryny-2750746Attorney Docket No: 78895-20031.40 heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and / or other sterilization methods (e.g., chlorine dioxide gas, vaporized peracetic acid, nitrogen dioxide, etc.).

[0067] In some embodiments, cutting template 100 as described herein may be provided in a kit, or system, such that the device may be used to prepare a skull for a pulse generator of a deep brain stimulation system, the pulse generator configured to be implanted in the skull of the patient. For example, the system may comprise at least cutting template 100, a pulse generator comprising a profile corresponding to the profile of cutting template 100, and at least one electrode lead coupled to the pulse generator and configured to be implanted in a brain.

[0068] FIG.3 illustrates a perspective view of the cutting template 300 on a human head, in accordance with some embodiments. Cutting template 300 may comprise any one or more features of cutting template 100 and / or cutting template 200 as described herein with respect to FIGS.1A-1C and FIGS.2A-2D, respectively. As shown, the inferior surface (e.g., inferior surface 106 of cutting template 100) may be configured to contact an outer surface of the skull of a patient. A handle (e.g., handle 110) extending outward from the superior surface may therefore also extend outward from the skull of the patient.

[0069] A method for performing a craniectomy procedure with a cutting template (e.g., cutting template 100) may comprise placing cutting template 100 on the skull such that a surface (e.g., inferior surface 106) of the cutting template body 102 contacts the skull. The cutting template 100 may in some embodiments be placed on a lateral side of the skull, such that the position of the cutting template 100 corresponds with a region of the brain configured to have one or more electrodes implanted for deep brain stimulation. As discussed herein, the surface may comprise a coarse texture and / or one or more protruding members (e.g., spikes, cleats, etc.) 108 configured to maintain the position of cutting template 100 on the skull. In some embodiments, the inferior surface 106 of the cutting guide 100 may comprise one or more flexures 110, the position of the one or more flexures 110 configured to correspond with that of the one or more protruding members 108 on the inferior surface of cutting template body 102. The flexures 110 may be configured to flex toward a superior surface 104 of the cutting template body 102 when the inferior surface 106 is pressed against a skull.

[0070] Following placement of cutting guide 100, the method may include tracing on the skull an outline of the profile of cutting template body 102 while the cutting template 100 is placed on the skull. Tracing may comprise marking the outline of the cutting template body 102ny-2750746Attorney Docket No: 78895-20031.40 using a surgical utensil (e.g., a surgical pen, marker, etc.). As discussed herein, cutting template 100 may comprise a handle 110 disposed on and extending outward from a second surface (e.g., superior surface 104) opposite from the surface of the cutting template body 102. The user may engage with (or hold) handle 110 while tracing the outline of cutting template body 102. Optionally after tracing the profile outline on the skull, the cutting template 100 may be removed from the skull.

[0071] After tracing the outline of cutting template body 102, the method may include cutting through the skull along the traced outline. For example, the skull may be cut through using a cranial drill, craniotome, perforator drill, acorn bit, and / or other tool know to one of ordinary skill in the art that is configured to cut bone. For example, the method may include first creating a burr hole (e.g., using a perforator drill and / or acorn bit) to access the full depth of the skull, followed by using a craniotome to cut along the outline for the cutting template body 102. Once the portion of cut bone is resected from the skull, the method may include inserting an implantable pulse generator (IPG) into the cut skull. In some embodiments, prior to inserting the IPG into the cut skull, any sharp edges from the bone resection may be removed using a curette, Kerrison Rongeur tool, or other tool known to one of ordinary skill in the art to lessen sharp edges on the skull.

[0072] It is to be understood by one of ordinary skill in the art that the cutting template described herein may be used and / or adapted for use in other procedures, including but not limited to other craniectomy procedures, craniotomy procedures, and / or other temporary or permanent bone removal procedures. In one example, the cutting template (and variations thereof) may be used to prepare for the resection of a portion of the skull for the implantation of stimulation leads in DBS systems. More generally, the cutting template described herein (and variations thereof) may be applied to more accurately determine the location and / or size of a resection on a bone, such as the skull.

[0073] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.ny-2750746Attorney Docket No: 78895-20031.40

[0074] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understood that the term “and / or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms “includes, “including,” “comprises,” and / or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or units but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0075] The numerical ranges disclosed inherently support any range or value within the disclosed numerical ranges, including the endpoints, even though a precise range limitation is not stated verbatim in the specification because this disclosure can be practiced throughout the disclosed numerical ranges.

[0076] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated.

[0077] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.ny-2750746

Claims

Attorney Docket No: 78895-20031.40 CLAIMS What is claimed is:

1. A cutting template, comprising: a cutting template body comprising a superior surface and an inferior surface opposite from the superior surface, wherein at least a portion of the inferior surface comprises a coarse texture and / or one or more protruding members; and the inferior surface comprises a curvature configured to correspond with a curvature of a skull.

2. The cutting template of claim 1, wherein a length of the one or more protruding members is at least 0.25 mm.

3. The cutting template of claim 1 or 2, wherein the inferior surface of the cutting body template comprises one or more flexures.

4. The cutting template of claim 3, wherein the one or more protruding members are disposed on the one or more flexures.

5. The cutting template of claim 3 or 4, wherein the one or more flexures are configured to flex toward the superior surface when the inferior surface of the cutting template is pressed against the skull.

6. The cutting template of claim 4 or 5, wherein the one or more flexures has a spring constant of at least 0.75 N / mm.

7. The cutting template of any one of claims 1-6, wherein the coarse texture of the inferior surface of the cutting template body covers the inferior surface.ny-2750746Attorney Docket No: 78895-20031.40 8. The cutting template of any one of claims 1-7, wherein the coarse texture of the inferior surface has a surface roughness (Ra) of at least 3.2 μm.

9. The cutting template of any one of claims 1-8, wherein the curvature of the inferior surface of the cutting template extends latitudinally between a first end of the cutting template body and a second end of the cutting template body.

10. The cutting template of any one of claims 1-9, wherein a radius of the curvature of the inferior surface is between 80 mm and 140 mm.

11. The cutting template of any one of claims 1-10, wherein the inferior surface of the cutting template body comprises a second curvature configured to correspond with a second curvature of the skull.

12. The cutting template of claim 11, wherein the second curvature of the inferior surface extends longitudinally between a first side of the cutting template body and a second side of the cutting template body.

13. The cutting template of claim 11 or 12, wherein a radius of the second curvature is between 80 mm and 140 mm.

14. The cutting template of any one of claims 11-13, wherein at least a portion of the superior surface of the cutting template body is configured to correspond with one or more of the curvatures of the inferior surface of the cutting template body.

15. The cutting template of any one of claims 1-14, comprising a handle disposed on and extending outward from the superior surface of the cutting template body.

16. The cutting template of any one of claims 1-15, wherein the cutting template body comprises an elliptical or other oblong profile configured to correspond with a profile of an implantable pulse generator device.ny-2750746Attorney Docket No: 78895-20031.40 17. The cutting template of any one of claims 1-16, wherein the cutting template body comprises a thickness between 1 mm and 5 mm.

18. The cutting template of any one of claims 1-17, wherein the inferior surface and / or the superior surface of the cutting template body comprises a biocompatible material.

19. The cutting template of claim 18, wherein the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

20. The cutting template of claim 18 or 19, wherein the cutting template body is sterilizable, such that the cutting template is reusable for multiple craniectomy procedures.

21. A deep brain stimulation system, comprising: the cutting template of any one of claims 1-20; a pulse generator configured to be implanted in the skull, a profile of the pulse generator corresponding to a profile of the cutting template; and at least one electrode lead coupled to the pulse generator and configured to be implanted in a brain.

22. A method for performing a craniectomy procedure, comprising: placing a cutting template on a skull such that a surface of the cutting template is in contact with the skull, the surface comprising a coarse texture or one or more protruding members configured to maintain a position of the cutting template on the skull; tracing on the skull an outline of the cutting template while the cutting template is placed on the skull; and cutting the skull along the traced outline of the cutting template.ny-2750746Attorney Docket No: 78895-20031.40 23. The method of claim 22, comprising, prior to cutting the skull, removing the cutting template from being placed on the skull.

24. The method of claim 22 or 23, wherein tracing the outline of the cutting template on the skull comprises marking the outline of the cutting template on the skull using a surgical marker.

25. The method of any one of claims 22-24, wherein the cutting template is placed on a lateral side of the skull.

26. The method of any one of claims 22-25, comprising inserting an implantable pulse generator (IPG) into the cut skull.

27. The method of any one of claims 22-26, wherein the surface of the cutting template is an inferior surface comprising one or more flexures.

28. The method of claim 27, wherein the one or more protruding members are disposed on the one or more flexures.

29. The method of claim 28, wherein the one or more flexures are configured to flex toward a superior surface when the inferior surface of the cutting template is pressed against the skull.

30. The method of any one of claims 22-29, wherein the surface of the cutting template comprises a first curvature configured to correspond with a first curvature of the skull, the first curvature of the surface extending latitudinally between a first end of the cutting template and a second end of the cutting template.

31. The method of claim 30, wherein the surface of the cutting template comprises a second curvature configured to correspond with a second curvature of the skull, the second curvature extending longitudinally between a first side of the cutting template and a second side of the cutting template.ny-2750746Attorney Docket No: 78895-20031.40 32. The method of any one of claims 22-31, wherein the cutting template comprises a handle disposed on and extending outward from a second surface of the cutting template, the second surface disposed opposite from the surface of the cutting template.

33. The method of any one of claims 22-32, wherein the cutting template comprises an elliptical or other oblong profile configured to correspond with a profile of an implantable pulse generator.

34. The method of any one of claims 22-33, wherein the cutting template comprises a biocompatible material.

35. The method of claim 34, wherein the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

36. The method of claim 34 or 35, wherein the cutting template is sterilizable, such that the cutting template is reusable for multiple craniectomy procedures.ny-2750746

Images