Skull resection cutting template

Abstract

A cutting template device and a method of using the same for preparing a skull for implantation of a pulse generator (IPG) for deep brain stimulation are provided herein. The cutting template described herein may include a rough texture and / or one or more protruding members to minimize the movement of the cutting template when placed against a typically slippery surface of the skull. The body of the cutting template may be sized to correspond to the shape of the IPG and may include one or more curves corresponding to the anatomical curves of the skull.

Description

Technical Field

[0001] The present disclosure generally relates to a craniectomy cutting template, and more specifically to a craniectomy cutting template for deep brain stimulation (DBS) implantation surgery.

[0002] (Cross - reference to related applications) This application claims the priority and benefit of U.S. Provisional Application No. 63 / 509,231, filed on June 20, 2023, the entire content of which is incorporated herein by reference.

Background Art

[0003] Deep brain stimulation (DBS) is a neurostimulation therapy that can be used to treat neurodegenerative diseases such as epilepsy and Parkinson's disease (PD). In DBS, an artificial current is supplied to specific parts of the brain to stimulate neurons, thereby alleviating the symptoms seen in various brain diseases. For example, in patients with PD, high - frequency stimulation is applied to regions of the basal ganglia (e.g., the subthalamic nucleus (STN) or the globus pallidus internus (GPi)) to correct the excitatory - inhibitory imbalance in the basal ganglia circuits. DBS can alleviate the motor symptoms seen in PD and reduce the need for drug treatment.

[0004] A deep brain stimulation (DVT) system typically includes one or more stimulation leads (e.g., electrodes) implanted in the brain and a pulse generator (e.g., stimulator battery) implanted in the patient's upper chest. One or more small incisions are made in the patient's scalp, followed by one or more small openings in the skull, allowing the leads to be implanted in the brain. Additionally, a small incision is made in the upper chest to form a soft tissue pocket for the pulse generator. The stimulation leads are connected to the pulse generator, for example, by using extension wires routed subcutaneously between the stimulation leads extending from the skull and the pulse generator in the upper chest. However, movement of these extension leads can cause pain and discomfort to the patient. Furthermore, the extension leads may loosen, detach from, or break, each of which may require subsequent surgical intervention for repair, reattachment, or replacement of the leads. Additional surgical intervention may increase the risk of intraoperative and / or postoperative surgical complications such as infection, bleeding, swelling, and, in more severe cases, coma, sepsis, or stroke. Furthermore, implanting stimulation leads and pulse generators requires preparation of at least two surgical sites (e.g., the upper chest and one or more sites on the skull), and each surgery is typically performed separately in different visits, which is not only a source of inefficiency in the operating room but also carries an increased risk of surgical complications (i.e., due to the number of surgeries). [Overview of the Initiative]

[0005] This specification describes a cutting template device and a method of using a cutting template for cutting the skull, for example, during deep brain stimulation (DBS) implantation surgery. The cutting template may be designed to correspond to the features of a skull-mounted pulse generator (IPG), thereby facilitating the surgical process for implanting the skull-mounted IPG. For example, the size of the opening formed using the cutting template may correspond to the size of the IPG, such that only the bone that needs to be removed to accommodate the IPG is excised. The cutting template may include a rough texture and / or one or more protruding members on the underside of the template, configured to minimize the movement of the cutting template on the slippery surface of the skull during use. Furthermore, the body of the cutting template may include one or more curves configured to correspond to the anatomical curvature of the skull, thus providing a precise contour of the skull-mounted IPG.

[0006] In some embodiments, a cutting template is provided, the cutting template body comprising an upper surface and a lower surface located opposite the upper surface, wherein at least a portion of the lower surface comprises a rough texture and / or one or more protruding members, and the lower surface comprises a curve configured to correspond to the curvature of the skull.

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

[0008] In some embodiments, the lower surface of the cutting template body includes one or more curved sections.

[0009] In some embodiments, one or more protruding members are arranged on one or more curved portions.

[0010] In some embodiments, when the lower surface of the cutting template is pressed against the skull, one or more curved portions are configured to curve toward the upper surface.

[0011] In some embodiments, one or more curved sections have a spring constant of at least 0.75 N / mm.

[0012] In some embodiments, the rough texture on the underside of the cutting template body covers the underside.

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

[0014] In some embodiments, the curvature of the lower surface of the cutting template extends in the short direction between the first end and the second end of the cutting template body.

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

[0016] In some embodiments, the lower surface of the cutting template body includes a second curve configured to correspond to a second curvature of the skull.

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

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

[0019] In some embodiments, at least a portion of the upper surface of the cutting template body is configured to correspond to one or more of the curves on the lower surface of the cutting template body.

[0020] In some embodiments, the cutting template is positioned on the upper surface of the cutting template body and includes a handle extending outward from that upper surface.

[0021] In some embodiments, the cutting template body includes an elliptical or other elongated shape configured to correspond to the shape of the embedded pulse generator device.

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

[0023] In some embodiments, the lower and / or upper surfaces of the cutting template body include a biocompatible material.

[0024] In some embodiments, the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (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 so that the cutting template can be reused for multiple craniectomy surgeries.

[0026] In some embodiments, a deep brain stimulation system is provided, which includes a cutting template provided herein, a pulse generator configured to be implanted in the skull, a shape of the pulse generator corresponding to the shape of the cutting template, and at least one electrode lead wire connected to the pulse generator and configured to be implanted in the brain.

[0027] In some embodiments, a method of performing a craniotomy is provided, the method comprising placing a cutting template on the skull such that a surface of the cutting template contacts the skull, the surface including a rough texture or one or more protruding members configured to maintain the position of the cutting template on the skull; tracing the contour of the cutting template on the skull while the cutting template is disposed on the skull; and cutting the skull along the traced contour of the cutting template.

[0028] In some embodiments, the method includes removing the cutting template disposed on the skull before cutting the skull.

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

[0030] In some embodiments, the cutting template is disposed laterally to the skull.

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

[0032] In some embodiments, the surface of the cutting template is a lower surface including one or more curved portions.

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

[0034] In some embodiments, one or more curved portions are configured to curve towards an upper surface when the lower surface of the cutting template is pressed against the skull.

[0035] In some embodiments, the surface of the cutting template includes a first curvature configured to correspond to a first curvature of the skull, the first curvature of the surface extending in the short direction 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 includes a second curvature configured to correspond to 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 includes a handle positioned on a second surface of the cutting template and extending outward from there, the second surface being positioned on the opposite side of the surface of the cutting template.

[0038] In some embodiments, the cutting template includes an elliptical or other elongated shape configured to correspond to the shape of the embedded pulse generator.

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

[0040] In some embodiments, the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (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 so that it can be reused for multiple craniectomy surgeries. [Brief explanation of the drawing]

[0042] Various aspects of the disclosed systems and methods are described in detail in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods can be gained by referring to the detailed description of the exemplary embodiments and the appended drawings.

[0043] [Figure 1A] Figure 1A shows a perspective view of a first exemplary cutting template corresponding to several embodiments.

[0044] [Figure 1B] Figure 1B shows another perspective view of the first exemplary cutting template, corresponding to several embodiments.

[0045] [Figure 1C] Figure 1C shows a side view of a first exemplary cutting template corresponding to several embodiments.

[0046] [Figure 2A] Figure 2A shows a perspective view of a second exemplary cutting template corresponding to several embodiments.

[0047] [Figure 2B] Figure 2B shows another perspective view of a second exemplary cutting template corresponding to several embodiments.

[0048] [Figure 2C] Figure 2C shows a top view of a second exemplary cutting template corresponding to several embodiments.

[0049] [Figure 2D] Figure 2D shows a side view of a second exemplary cutting template corresponding to several embodiments.

[0050] [Figure 3] Figure 3 shows a perspective view of an exemplary cutting template on a human head, corresponding to several embodiments. [Modes for carrying out the invention]

[0051] Cutting template devices and methods for using cutting templates to excise skull bone are described herein. Cutting templates may be used during deep brain stimulation (DBS) implantation surgery to prepare the skull for an implantable pulse generator (IPG). In contrast to systems including an IPG implanted in the patient's chest and connected to stimulation leads using one or more extension leads passed between the skull and chest, as discussed herein, DBS systems may include an IPG mounted in the skull. The cutting templates described herein can be sized to correspond to the shape of the IPG. Therefore, the size of the opening formed using the cutting template may be approximately the size necessary to adequately accommodate the IPG. The cutting templates provided herein may include a rough texture and / or one or more protruding members on the underside of the template, configured to minimize the movement of the cutting template on the slippery surface of the skull during use. Furthermore, the body of the cutting template may include one or more curves configured to correspond to the anatomical curvature of the skull, thus providing an accurate contour of the IPG mounted in the skull.

[0052] Skull preparation for IPG may involve performing a craniectomy. In conventional DBS implantation surgery, craniectomy may be performed to create one or more small openings in the skull so that stimulation leads can be implanted into the brain. For example, one or more burr holes may be drilled into the skull to access a desired area of ​​the brain. Thus, the size of the opening may be controlled and / or related to the size of the drilling tool. In contrast, in the preparation of an IPG to be implanted in the skull, an opening of a size sufficient to accommodate the IPG within the skull is required. However, the shape of the IPG may not be easily replicated using standard bone drilling tools. Attempting to estimate the required amount and shape of bone to drill is difficult for the user, causing user frustration, increasing surgical time, and / or potentially drilling an inaccurate amount of bone.

[0053] Figures 1A to 1C show a cutting template 100 including a cutting template body 102, which includes an upper surface 104 and a lower surface 106 opposite the upper surface 104. The cutting template 100 may include one or more protruding members 108 and / or a rough texture on at least a portion of the lower surface 106. The lower surface 106 of the cutting template body 102 may include a curve configured to correspond to the curvature of the skull.

[0054] As discussed herein, the cutting template 100 may include one or more protruding members 108 (e.g., anti-slip, spikes, etc.) positioned on the lower surface 106 of the cutting template body 102 and extending outward from the cutting template body 102. For example, the cutting template 100 may include one, two, three, four, five, six, or more protruding members 108. Figures 1A to 1C show a cutting template 100 including multiple protruding members 108. The cross-section of one or more protruding members 108 traversing the lower surface 106 may include circular, rectangular, triangular, elliptical, or other polygonal shapes. For example, the protruding members 108 may include conical, cylindrical, or other three-dimensional (3D) prism shapes. The 3D prism may extend along the longitudinal axis from the cutting template body 102. In some embodiments, the length of one or more protruding members 108 extending along the longitudinal axis may be 0.10 mm or less, 0.15 mm or less, 0.20 mm or less, 0.25 mm or less, 0.30 mm or less, 0.35 mm or less, 0.40 mm or less, 0.45 mm or less, or 0.5 mm or less. In some embodiments, the length of one or more protruding members 108 may be 0.10 mm or more, 0.15 mm or more, 0.20 mm or more, 0.25 mm or more, 0.30 mm or more, 0.35 mm or more, 0.40 mm or more, 0.45 mm or more, or 0.5 mm or more.

[0055] The cutting template 100 may include one or more curved portions 110. For example, one or more curved portions 110 may be positioned on the lower surface 106 of the cutting template body 102 such that each of the protruding members 108 can be positioned on the curved portion 110, as shown in the figure. Therefore, the number of curved portions 110 may correspond to the number of protruding members 108. For example, the cutting template body 102 may include one, two, three, four, five, six, or more curved portions 110. In some embodiments, the cutting template 100 may include an unequal number of curved portions 110 and protruding members 108. In some embodiments, the cutting template 100 may include one or more protruding members 108 and not include any curved portions 110. The curved portions 110 may include a shape corresponding to a notch in part of the lower surface 106 so that they can bend toward the upper surface 104 when a force is applied to the lower surface 106 of the curved portion cutting template body 102. For example, the curved portion 110 may be configured to curve toward the upper surface 104 when the lower surface 106 is pressed against the skull during use of the cutting template 100 (for example, as shown in Figure 3). The spring constants of one or more curved portions 110 may be predefined and may correspond to the amount of curvature enabled by the curved portion 110. In some embodiments, the spring constants of one or more curved portions 110 may be 0.5 N / mm or more, 0.75 N / mm or more, 1.0 N / mm or more, 1.25 N / mm or more, 1.5 N / mm or more, 1.75 N / mm or more, or 2.0 N / mm or more. In some embodiments, the spring constants of one or more curved portions 110 may be 0.50 N / mm or less, 0.75 N / mm or less, 1.0 N / mm or less, 1.25 N / mm or less, 1.5 N / mm or less, 1.75 N / mm or less, or 2.0 N / mm or less.

[0056] The shape of the curved portion 110 may include a pair of side walls connected at one end by a curve (e.g., an arc, a line, etc.). In some embodiments, the side wall shape may be angled such that the curved portion 110 tapers at the end of the shape of the curved portion 110 (e.g., the end including the curve connecting the side walls, as shown). In some embodiments, the side walls may be parallel to each other. Each of one or more curved portions 110 may be angled toward the outer edge of the cutting template body 102 on the lower surface 106. In some embodiments, one or more side walls of the curved portions 110 may be parallel to the edge of the cutting template body 102.

[0057] In embodiments having multiple protruding members 108 and / or curved portions 110, one or more protruding members 108 and / or curved portions 110 may be arranged symmetrically on the lower surface 106 of the cutting template body 102. For example, as shown in at least Figure 1A, the cutting template 100 may include four protruding members 108 and corresponding curved portions 110, or a pair of curved portions 110 and protruding members 108, each positioned at one end of the lower surface 106 of the cutting template body 102. In other words, the protruding members 108 and corresponding curved portions 110 may be positioned in each of the four regions into which the cutting template body 102 is divided.

[0058] As discussed herein, the lower surface 106 of the cutting template body 102 may include a rough texture instead of, or in addition to, one or more protruding members 108 (and / or curved portions 110). Figures 2A to 2D show an exemplary cutting template 200 including a cutting template body 202. The cutting template body may include a lower surface 206 without one or more protruding members 108 and / or curved portions 110. Instead, the lower surface 206 may include a rough texture that covers the lower surface 206. In some embodiments, the rough texture may cover less than the entire lower surface, such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99.9% of the lower surface 206. The rough texture may be defined by the surface roughness (or mean roughness Ra) on the underside 206, which can provide static friction to the cutting template 200 when pressed against a slippery and / or smooth surface such as a skull during skull surgery. Surface roughness is described in more detail in ASME B46.1. In some embodiments, the rough texture may have a surface roughness (Ra) of 2.0 μm or less, 2.2 μm or less, 2.4 μm or less, 2.6 μm or less, 2.8 μm or less, 3.0 μm or less, 3.2 μm or less, 3.4 μm or less, 3.6 μm or less, 3.8 μm or less, or 4.0 μm or less. In some embodiments, the surface roughness (Ra) may be 2.0 μm or more, 2.2 μm or more, 2.4 μm or more, 2.6 μm or more, 2.8 μm or more, 3.0 μm or more, 3.2 μm or more, 3.4 μm or more, 3.6 μm or more, 3.8 μm or more, or 4.0 μm or more.

[0059] The IPG cutting templates provided herein may be described primarily with reference to cutting template 100 and its corresponding features. However, it should be understood that the envisioned cutting templates may include any combination of the features of cutting template 100 and cutting template 200 discussed herein. In other words, cutting template 200 may include any one or more features of cutting template 100 described herein with respect to Figures 1A to 1C, and vice versa. Furthermore, the cutting template body 202 and the bottom surface 206 may each include any one or more features of cutting template body 102 and bottom surface 106 (and vice versa).

[0060] The lower surface 106 (and by extension, the lower surface 206) may include one or more curves configured to correspond to the curvature of the skull. In some embodiments, the upper surface 104 may include substantially the same curvature as the lower surface 106, such that the cutting template body 102 includes the curvature described herein, more generally. The curvature of the lower surface 106 (e.g., a first curvature) may extend in the short direction between the first and second ends of the cutting template body 102. For example, if the shape of the cutting template body 102 includes an ellipse, the first curvature may extend along the major axis of the ellipse. The curvature of the lower surface 106 may be based on standard data indicating various dimensions (e.g., curvature) of the skull. For example, the curvature of the lower surface 106 may correspond to (e.g., substantially the same as) the curvature of one or more skull fixation plates. The skull fixation plates may be designed to be used with a wide range of skulls, including various anatomical dimensions. In some cases, surgeons and / or other persons skilled in the art may, in addition to cadaver studies, provide the dimensions of the skull fixation plate (and thus extend to the dimensions of the curvature of the lower surface 106). In some embodiments, the radius of the curvature of the lower surface 106 may be 60 mm or less, 80 mm or less, 100 mm or less, 120 mm or less, 140 mm or less, or 160 mm or less. In some embodiments, the radius of the curvature may be 60 mm or more, 80 mm or more, 100 mm or more, 120 mm or more, 140 mm or more, or 160 mm or more.

[0061] In some embodiments, the lower surface 106 (and in some examples, the upper surface 104) of the cutting template body 102 may include a second curve in addition to, or instead of, the first curve described herein, the second curve being configured to correspond to a second curve of the skull. The second curve may extend longitudinally between the first and second sides of the cutting template body 102. For example, if the shape of the cutting template body 102 includes an ellipse, the second curve may extend along the minor radius of the ellipse. As described with respect to the first curve, the second curve may be based on standard data indicating various dimensions (e.g., curvature) of the skull. For example, the radius of the second curve of the lower surface 106 may be 60 mm or less, 80 mm or less, 100 mm or less, 120 mm or less, 140 mm or less, or 160 mm or less. In some embodiments, the radius of the second curvature may be 60 mm or more, 80 mm or more, 100 mm or more, 120 mm or more, 140 mm or more, or 160 mm or more.

[0062] In some embodiments, at least a portion of the upper surface 104 of the cutting template body 102 may include one or more curves configured to correspond to one or more of the aforementioned curves of the lower surface 106 of the cutting template body 102. Thus, the cutting template body 102 may include a uniform thickness, as discussed herein.

[0063] As shown at least in Figures 1A to 1C, the cutting template 100 may include a handle 112 positioned on the upper surface 102 of the cutting template body 102 and extending outward from there. The handle 112 may be configured to allow a user (e.g., a surgeon) to easily grasp the cutting template 100 and stabilize the device against the skull. For example, the handle 112 may be designed to be grasped by the user using, for example, two, three, four, or five fingers. The handle 112 may include one or more ergonomic features (e.g., indentations, textures, etc.) intended to improve the grip of the handle 112. In some embodiments, the handle 112 may extend outward about 16 to 24 mm from the upper surface 104 of the cutting template body 102. For example, the height of the handle 112 may be about 16 mm, 18 mm, 20 mm, 22 mm, or 24 mm. The handle 112 may include a cross-sectional shape such as a circle, rectangle, triangle, ellipse, or other polygon. In some embodiments, the handle 112 may include a thickness of about 1 to 5 mm extending from a first side of the handle 112 to a second side of the handle 112. For example, the thickness of the handle 112 may be about 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm. In some embodiments, the handle 112 may include a length of about 15 to 25 mm extending from a first end of the handle 112 to a second end of the handle 112. For example, the length of the handle 112 may be about 15 mm, 17 mm, 19 mm, 21 mm, 23 mm, or 25 mm.

[0064] As discussed herein, the shape of the cutting template body 102 may include an elliptical, rectangular, circular, or other elongated shape. The contour shape of the cutting template body 102 may be configured to correspond to the shape of a pulse generator (IPG) configured to be implanted in the patient's skull. Thus, by tracing the contour of the cutting template body 102 while using the cutting template 100, a precise contour corresponding to the size and shape required to implant the IPG in the skull may be formed while minimizing excessive bone removal.

[0065] The thickness of the cutting template body 102 may be uniform throughout the entire area of ​​the body, or it may vary. For example, if the upper surface 104 and the lower surface 106 each contain substantially the same curvature, the thickness of the cutting template body 102 may be substantially uniform throughout. If the lower surface 106 contains one or more curvatures and the upper surface 104 does not contain any curvatures (or does not contain substantially the same curvatures), the thickness of the cutting template body 102 does not have to be uniform throughout the entire area of ​​the cutting template body 102. The thickness may be 1 mm or less, 1.5 mm or less, 2 mm or less, 2.5 mm or less, 3 mm or less, 3.5 mm or less, 4 mm or less, 4.5 mm or less, or 5 mm or less. The thickness may be 1 mm or more, 1.5 mm or more, 2 mm or more, 2.5 mm or more, 3 mm or more, 3.5 mm or more, 4 mm or more, 4.5 mm or more, or 5 mm or more.

[0066] One or more components of the cutting template body 102 may be made from a biocompatible material. For example, at least the lower surface 106 and / or upper surface 104 of the cutting template body 102 may contain a biocompatible material. In some embodiments, the biocompatible material may include one or more of the following: polypropylene, polyethylene, polyetheretherketone (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 so that the cutting template 100 can be reused for multiple surgeries, such as multiple craniectomy surgeries. For example, the cutting template body 102 may be sterilizable using wet heating (steam), dry heating, 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, as described herein, the cutting template 100 may be provided in a kit or system such that the device is used to prepare the skull for the pulse generator of a deep brain stimulation system, and the pulse generator is configured to be implanted in the patient's skull. For example, the system may include at least the cutting template 100, a pulse generator having a shape corresponding to the shape of the cutting template 100, and at least one electrode lead wire connected to the pulse generator and configured to be implanted in the brain.

[0068] Figure 3 shows a perspective view of a cutting template 300 on a human head, corresponding to several embodiments. The cutting template 300 may include any one or more features of the cutting templates 100 and / or 200 described herein with respect to Figures 1A-1C and 2A-2D, respectively. As shown, the lower surface (e.g., the lower surface 106 of the cutting template 100) may be configured to contact the outer surface of the patient's skull. Therefore, a handle extending outward from the upper surface (e.g., a handle 112) may also extend outward from the patient's skull.

[0069] A method for performing a craniotomy using a cutting template (e.g., cutting template 100) may include positioning the cutting template 100 on the skull such that the surface (e.g., the lower surface 106) of the cutting template body 102 is in contact with the skull. In some embodiments, the cutting template 100 may be positioned laterally on the skull such that the position of the cutting template 100 corresponds to a region of the brain configured to have one or more electrodes implanted for deep brain stimulation. As discussed herein, the surface may include a rough texture and / or one or more protruding members 108 (e.g., spikes, anti-slip, etc.) configured to maintain the position of the cutting template 100 on the skull. In some embodiments, the lower surface 106 of the cutting guide 100 may include one or more curved portions 110, the positions of which are configured to correspond to the positions of one or more protruding members 108 on the lower surface of the cutting template body 102. The curved portion 110 may be configured to curve toward the upper surface 104 of the cutting template body 102 when its lower surface 106 is pressed against the skull.

[0070] Following the placement of the cutting guide 100, the method may include tracing the contour of the shape of the cutting template body 102 on the skull while the cutting template 100 is positioned on the skull. Tracing may include marking the contour of the cutting template body 102 using a surgical instrument (e.g., a surgical pen, marker, etc.). As discussed herein, the cutting template 100 may include a handle 112 positioned on a second surface (e.g., top surface 104) opposite to the surface of the cutting template body 102 and extending outward from there. The user may engage with (or hold) the handle 112 while tracing the contour of the cutting template body 102. Optionally, the cutting template 100 may be removed from the skull after tracing the contour shape of the skull.

[0071] After tracing the contour of the cutting template body 102, the method may include cutting the skull along the traced contour. For example, the skull may be cut using a skull drill, a craniotomy tool, a drilling drill, an acorn bit, and / or other tools known to those skilled in the art that are configured to cut bone. For example, the method may first create a burr hole (e.g., using a drilling drill and / or an acorn bit) to access the full depth of the skull, and then use a craniotomy tool to cut along the contour of the cutting template body 102. Once a portion of the cut bone has been removed from the skull, the method may include inserting an implantable pulse generator (IPG) into the cut skull. In some embodiments, before inserting the IPG into the cut skull, any sharp edges resulting from the bone removal may be removed using a curette, a Kerrison Rongeur tool, or other tools known to those skilled in the art to reduce the sharp edges on the skull.

[0072] It should be understood by those skilled in the art that the cutting templates described herein may be used and / or adapted for use in other surgeries, including but not limited to other craniectomy, craniotomy, and / or other temporary or permanent bone removal surgeries. For example, a cutting template (and its variations) may be used to prepare for the resection of a portion of the skull for the implantation of stimulating leads in a DBS system. More generally, a cutting template (and its variations) described herein may be applied to more accurately determine the location and / or size of a resection on bone, such as the skull.

[0073] Unless otherwise defined, all technical terms, notations, and other technical terms, as well as scientific terms or terms, used herein are intended to have the same meaning as that generally understood by those skilled in the art in which the claiming body belongs. In some cases, terms that have a generally understood meaning are defined herein for clarity and / or for easy reference, and the inclusion of such definitions herein should not necessarily be interpreted as representing a substantial difference from that which is generally understood in the art.

[0074] Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms unless the context explicitly indicates otherwise. Where used herein, the terms “and / or” should be understood to mean any and all possible combinations of one or more of the enumerated items relating to the subject, and to encompass them. Where used herein, the terms “includes,” “including,” “comprises,” and / or “comprising” identify the presence of a described feature, integer, process, operation, element, component, and / or unit, but do not exclude the presence or addition of one or more other features, integers, processes, operations, elements, components, units, and / or groups thereof.

[0075] Since this disclosure can be implemented across the entire disclosed numerical range, no strict range limitation is made verbatim herein; however, the disclosed numerical range essentially supports any range or value within the disclosed numerical range, including its endpoints.

[0076] The foregoing description is illustrated by reference to specific embodiments for illustrative purposes. However, the above exemplary considerations are not intended to be exhaustive or to limit the invention to the exact form disclosed. Many modifications and variations are possible in light of the above description. The embodiments have been selected and described to best illustrate the principles of the art and their practical applications. Therefore, those skilled in the art will be able to best utilize the art and various embodiments with various modifications to suit their particular intended use.

[0077] While this disclosure and examples are adequately described with reference to the accompanying drawings, it should be noted that various changes and modifications will be apparent to those skilled in the art. Such changes and modifications should be understood to be within the scope of this disclosure and examples as defined by the claims.

Claims

1. The cutting template body includes an upper surface and a lower surface located opposite to the upper surface, At least a portion of the lower surface includes a rough texture and / or one or more protruding members, The lower surface includes a curve configured to correspond to the curvature of the skull, Cutting template.

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

3. The cutting template according to claim 1 or 2, wherein the lower surface of the cutting template body includes one or more curved portions.

4. The cutting template according to claim 3, wherein one or more protruding members are arranged on one or more curved portions.

5. The cutting template according to claim 3 or 4, wherein one or more of the curved portions are configured to curve toward the upper surface when the lower surface of the cutting template is pressed against the skull.

6. The cutting template according to claim 4 or 5, wherein one or more of the curved portions have a spring constant of at least 0.75 N / mm.

7. The cutting template according to any one of claims 1 to 6, wherein the rough texture on the lower surface of the cutting template body covers the lower surface.

8. The cutting template according to any one of claims 1 to 7, wherein the rough texture on the lower surface has a surface roughness (Ra) of at least 3.2 μm.

9. The cutting template according to any one of claims 1 to 8, wherein the curvature of the lower surface of the cutting template extends in the short direction between the first end of the cutting template body and the second end of the cutting template body.

10. The cutting template according to any one of claims 1 to 9, wherein the radius of the curvature of the lower surface is between 80 mm and 140 mm.

11. The cutting template according to any one of claims 1 to 10, wherein the lower surface of the cutting template body includes a second curvature configured to correspond to the second curvature of the skull.

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

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

14. The cutting template according to any one of claims 11 to 13, wherein at least a portion of the upper surface of the cutting template body is configured to correspond to one or more of the curves of the lower surface of the cutting template body.

15. A cutting template according to any one of claims 1 to 14, comprising a handle disposed on the upper surface of the cutting template body and extending outward from the upper surface.

16. The cutting template according to any one of claims 1 to 15, wherein the cutting template body includes an elliptical or other elongated shape configured to correspond to the shape of an embedded pulse generator device.

17. The cutting template according to any one of claims 1 to 16, wherein the cutting template body includes a thickness between 1 mm and 5 mm.

18. The cutting template according to any one of claims 1 to 17, wherein the lower surface and / or upper surface of the cutting template body include a biocompatible material.

19. The cutting template according to claim 18, wherein the biocompatible material comprises polypropylene, polyethylene, polyetheretherketone (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 according to claim 18 or 19, wherein the cutting template body is sterilizable so that the cutting template can be reused for multiple craniectomy surgeries.

21. A cutting template according to any one of claims 1 to 20, A pulse generator configured to be embedded in the skull, wherein the shape of the pulse generator corresponds to the shape of the cutting template, Includes at least one electrode lead wire connected to a pulse generator and configured to be implanted in the brain. Deep brain stimulation system.

22. A method for performing a skull resection surgery, Placing a cutting template on a skull, wherein the surface of the cutting template is positioned in contact with the skull, and the surface includes a rough texture or one or more protruding members configured to maintain the position of the cutting template on the skull. While the cutting template is on the skull, the contour of the cutting template is traced on the skull. This includes cutting the skull along the traced contour of the cutting template, method.

23. The method according to claim 22, comprising removing the cutting template placed on the skull before cutting the skull.

24. The method according to claim 22 or 23, wherein tracing the contour of the cutting template on the skull includes marking the contour of the cutting template on the skull using a surgical marker.

25. The method according to any one of claims 22 to 24, wherein the cutting template is positioned on the side of the skull.

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

27. The method according to any one of claims 22 to 26, wherein the surface of the cutting template is a lower surface including one or more curved portions.

28. The method according to claim 27, wherein one or more protruding members are arranged on one or more curved portions.

29. The method according to claim 28, wherein one or more of the curved portions are configured to curve toward the upper surface when the lower surface of the cutting template is pressed against the skull.

30. The method according to any one of claims 22 to 29, wherein the surface of the cutting template includes a first curvature configured to correspond to a first curvature of the skull, and the first curvature of the surface extends in the short direction between a first end of the cutting template and a second end of the cutting template.

31. The method according to claim 30, wherein the surface of the cutting template includes a second curvature configured to correspond to a second curvature of the skull, the second curvature extending longitudinally between a first side surface of the cutting template and a second side surface of the cutting template.

32. The method according to any one of claims 22 to 31, wherein the cutting template includes a handle positioned on a second surface of the cutting template and extending outward from the second surface of the cutting template, the second surface being positioned on the opposite side of the surface of the cutting template.

33. The method according to any one of claims 22 to 32, wherein the cutting template includes an elliptical or other elongated shape configured to correspond to the shape of an embedded pulse generator.

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

35. The method according to claim 34, wherein the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (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 according to claim 34 or 35, wherein the cutting template is sterilizable so that it can be reused for multiple craniectomy surgeries.

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