Wire fixation instrument and method of use thereof

Abstract

Provided herein are wire fixation instruments and methods of using wire fixation instruments to mount a stimulation wire to a skull. The lead fixation instrument may be used to mount a stimulation lead for deep brain stimulation. The wire fixation instrument may maintain the relative position of the stimulation wire while allowing the wire to axially float. The wire fixation instrument may include one or more flexure or bellows couplers to maintain the position of the stimulation wire while isolating forces acting on the wire.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 509,233, filed June 20, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to lead fixation devices, and more specifically, to lead fixation devices for deep brain stimulation (DBS) systems that allow the lead to float axially. Background Technology

[0004] Deep brain stimulation (DBS) is a neurostimulation therapy used to treat neurodegenerative diseases such as epilepsy and Parkinson's disease (PD). In DBS, artificial electrical currents are delivered to specific areas of the brain to stimulate neurons, thereby alleviating symptoms in various brain conditions. For example, in patients with PD, high-frequency stimulation is delivered to basal ganglia areas (e.g., the subthalamic nucleus (STN) or the globus pallidus (GPi)) to correct excitation-inhibition imbalances in the basal ganglia circuits. DBS can alleviate motor symptoms of PD and reduce the need for medication.

[0005] Deep brain stimulation (DBS) systems typically consist of one or more stimulation leads implanted in the brain and a pulse generator 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 to allow the leads to be implanted in the brain. The area in the brain where the stimulation leads can be implanted depends on the condition of the brain being treated. Therefore, to maintain the effectiveness of DBS, it is important that the stimulation leads (one or more) do not shift within the brain tissue over time. To maintain the implantation position of the stimulation leads, they can be secured to the patient's skull after implantation in the brain. For example, lead clips placed near openings in the skull can be used to secure the stimulation leads. However, it is known that the brain can translate relative to the skull, which, unlike a secured lead, can create stress on the lead, causing it to become loose or even break. The lead may also shift from the intended implantation site, resulting in brain tissue damage or reduced DBS effectiveness. Each of these consequences—movement, loosening, and / or breakage of the stimulation leads—requires subsequent surgical intervention to secure, reconnect, or replace the lead. Additional surgery increases the risk of intraoperative and / or postoperative complications, such as infection, bleeding, swelling, or, in more serious cases, coma, sepsis and stroke. Summary of the Invention

[0006] This article describes a lead fixation device and a method for implanting a stimulation lead onto the skull using the lead fixation device, the implanted stimulation lead being used for, for example, deep brain stimulation. The lead fixation device can be designed to allow the stimulation lead to float axially relative to the skull. For example, the lead fixation device may include one or more flexible elements and / or bellows couplers that may be at least partially disposed in an opening in the skull and be flexible to isolate forces acting on the lead. The lead fixation device may include a mount that can be mounted to the skull to maintain the relative position of the stimulation lead implanted in the brain while also allowing the lead to translate with the brain (e.g., relative to the skull). Therefore, damage to the lead and displacement of the lead from the implantation site in the brain can be minimized.

[0007] In some embodiments, a wire fixation device is provided, comprising: a mounting base configured to mount the wire fixation device to a surface of the skull; one or more flexible members coupled to the mounting base and configured to at least partially disposed in an opening in the skull; and a wire support coupled to the one or more flexible members and configured to receive a first portion of a wire.

[0008] In some embodiments, the mounting base includes a receiving section configured to receive a second portion of a wire.

[0009] In some embodiments, the receiving portion of the mounting base is configured to secure a second portion of the wire to the surface of the skull.

[0010] In some embodiments, the surface of the skull to which the wire fixing device is mounted is the outer surface of the skull.

[0011] In some embodiments, one or more flexible elements are configured to flex to isolate forces acting on the conductor.

[0012] In some embodiments, one or more flexible elements are configured to maintain the relative position of the first portion of the conductor and the conductor support.

[0013] In some embodiments, the wire support is configured to removably secure a first portion of the wire.

[0014] In some embodiments, the wire fixing device includes a skull drill cover configured to cover at least a portion of an opening in the skull.

[0015] In some embodiments, the skull drill cap is configured to be removably secured to the skull and / or mounting base.

[0016] In some embodiments, the opening is a drilled hole in the skull.

[0017] In some embodiments, one or more flexible elements are configured to allow longitudinal movement of the wire support between 3 mm and 7 mm, with the longitudinal axis extending between the distal end and the proximal end of the opening.

[0018] In some embodiments, one or more of the mounting base, one or more flexible elements, and wire support include a biocompatible material.

[0019] In some embodiments, the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer mixtures, or medical-grade metal mixtures.

[0020] In some embodiments, a deep brain stimulation system is provided, comprising: a lead fixation device; at least one lead configured to be received by a lead support of the lead fixation device and implanted in the brain; and a pulse generator configured to be implanted in the skull and connected to the at least one lead.

[0021] In some embodiments, a method of mounting a wire on a skull is provided, the method comprising: mounting a mounting base to a surface of the skull such that one or more flexible elements coupled to the mounting base are at least partially disposed in an opening in the skull; and inserting a wire into a wire holder coupled to the one or more flexible elements such that a first portion of the wire is secured by the wire holder.

[0022] In some embodiments, the method includes forming an opening in the surface of the skull.

[0023] In some embodiments, the method includes inserting a second portion of the wire into the receiving portion of the mounting base.

[0024] In some embodiments, inserting the second portion of the wire into the receiving portion of the mounting base includes securing the second portion of the wire to the surface of the skull.

[0025] In some embodiments, the surface of the skull on which the mounting base is mounted is the outer surface of the skull.

[0026] In some embodiments, the method includes implanting a wire into the brain.

[0027] In some embodiments, the method includes removably securing a skull drill cap to the skull and / or mounting base such that at least a portion of the opening is covered by the skull drill cap.

[0028] In some embodiments, one or more flexible elements are configured to flex to isolate forces acting on the conductor.

[0029] In some embodiments, one or more flexible elements are configured to maintain the relative position of the first portion of the conductor and the conductor support.

[0030] In some embodiments, one or more flexible elements are configured to allow longitudinal displacement of the wire support between 3 mm and 7 mm, with the longitudinal axis extending between the distal end and the proximal end of the opening.

[0031] In some embodiments, the opening is a drilled hole in the skull.

[0032] In some embodiments, a wire fixing device is provided, comprising: a mounting base configured to mount the wire fixing device to a surface of the skull; a bellows coupler coupled to the mounting base and configured to be at least partially disposed in an opening in the skull; and a wire support coupled to the bellows coupler and configured to receive a first portion of a wire.

[0033] In some embodiments, the diameter of the bellows coupler is between 4 mm and 14 mm.

[0034] In some embodiments, the wall thickness of the bellows coupler is between 0.5 mm and 2 mm.

[0035] In some embodiments, the spring constant of the bellows coupler is between 0.01 kg / mm ​​and 1 kg / mm.

[0036] In some embodiments, the bellows coupler is configured to maintain the relative position of the first portion of the conductor and the conductor support.

[0037] In some embodiments, the wire support is configured to removably secure a first portion of the wire.

[0038] In some embodiments, the bellows coupler includes a through-hole coaxial with the central axis of the bellows coupler and configured to receive a second portion of a wire.

[0039] In some embodiments, the wire fixing device includes a skull drill cover configured to cover at least a portion of an opening in the skull.

[0040] In some embodiments, the skull drill cap is configured to be removably secured to the skull and / or mounting base.

[0041] In some embodiments, the opening is a drilled hole in the skull.

[0042] In some embodiments, the bellows coupler is configured to allow longitudinal displacement of the wire support between 3 mm and 7 mm, with the longitudinal axis extending between the distal end and proximal end of the opening.

[0043] In some embodiments, one or more of the mounting base, bellows coupler, and wire support include a biocompatible material.

[0044] In some embodiments, the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer mixtures, or medical-grade metal mixtures.

[0045] In some embodiments, a deep brain stimulation system is provided, comprising: a lead fixation device; at least one lead configured to be received by a lead support of the lead fixation device; and a pulse generator configured to be implanted in the skull and connected to the at least one lead.

[0046] In some embodiments, a method of mounting a wire on a skull is provided, the method comprising: mounting a mounting base to a surface of the skull such that a corrugated coupler coupled to the mounting base is at least partially disposed in an opening in the skull; and inserting a wire into a wire holder coupled to the corrugated coupler such that a first portion of the wire is secured by the wire holder.

[0047] In some embodiments, the method includes forming an opening in the surface of the skull.

[0048] In some embodiments, the method includes inserting a second portion of a wire into a through-hole of a bellows coupler, the through-hole being coaxial with the central axis of the bellows coupler.

[0049] In some embodiments, the method includes implanting a wire into the brain.

[0050] In some embodiments, the method includes removably securing a skull drill cap to the skull and / or mounting base such that at least a portion of the opening is covered by the skull drill cap.

[0051] In some embodiments, the bellows coupler is configured to maintain the relative position of the first portion of the conductor and the conductor support.

[0052] In some embodiments, the bellows coupler is configured to allow longitudinal displacement of the wire support between 3 mm and 7 mm, with the longitudinal axis extending between the distal end and proximal end of the opening.

[0053] In some embodiments, the opening is a drilled hole in the skull. Attached Figure Description

[0054] Various aspects of the disclosed systems and methods are set forth in detail in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by referring to the detailed description of the illustrative embodiments and the accompanying drawings.

[0055] Figure 1A A perspective view of a first wire fixation device for partially removing a skull drill hole cap according to some embodiments is shown.

[0056] Figure 1B Another perspective view of a first wire fixing device according to some embodiments is shown.

[0057] Figure 1C Another perspective view of a first wire fixing device with a skull drill hole cap according to some embodiments is shown.

[0058] Figure 2 A cross-sectional view of a second wire fixing device according to some embodiments is shown.

[0059] Figure 3 A cross-sectional view of a third conductor fixing device according to some embodiments is shown. Detailed Implementation

[0060] This document describes a lead fixation device and its method of use. The lead fixation device can be used to implant stimulation leads for deep brain stimulation (DBS) into the skull. The lead fixation device allows the stimulation lead to float axially relative to the skull, enabling the lead to translate with the brain (e.g., in cases where the brain is offset relative to the skull). For example, the lead fixation device may include a bellows coupler and / or a flexible element that can flex to isolate forces (e.g., stress) acting on the implanted stimulation lead. The lead fixation device described herein prevents the lead from loosening and / or moving from the implantation site in the brain, and also prevents excessive stress on the lead due to conflicting forces between the lead fixation device and the natural movement of the brain.

[0061] In some embodiments, the lead fixation device described herein can be provided as a component of a deep brain stimulation (DBS) system. For example, a DBS system may include a lead fixation device comprising: a lead support; at least one stimulation lead configured to be received by the lead support and implanted in the brain; and a pulse generator configured to be coupled to the stimulation lead. In some embodiments, the pulse generator may be configured to be implanted in the skull of a patient. Those skilled in the art will understand that the lead fixation device described herein is not limited to deep brain stimulation (DBS) systems with skull-implanted pulse generators, and can be used in other systems, including but not limited to other DBS systems. For example, the pulse generator of a DBS system may be implanted in a soft tissue pouch in the upper chest of a patient, and one or more extension leads may be inserted via a subcutaneous tunnel to connect the stimulation lead to the pulse generator.

[0062] The wire fixing device and its usage can be described with reference to various embodiments, such as at least in Figures 1A to 1C The first embodiment shown and at least in Figure 2 The second embodiment is shown. It should be understood that the wire fixation device described herein is not limited to the features described with reference to the accompanying drawings, and any combination of the features described herein can be implemented in the exemplary wire fixation device.

[0063] Including flexible conductor fixing device

[0064] Figures 1A to 1C A lead fixation device 100 according to an exemplary embodiment of the present disclosure is shown. The lead fixation device 100 may include a mounting base 102, one or more flexible elements 104 coupled to the mounting base 102, and a lead holder 106 coupled to the flexible elements 104. The mounting base 102 may be configured to mount the lead fixation device 100 to the surface of the skull. For example, the mounting base 102 may be mounted to the skull near an opening 108 in the skull for implanting one or more stimulation leads 110. The flexible elements 104 may be configured to be at least partially disposed in the opening 108 of the skull. For example, the flexible elements 104 may extend outward from one side of the mounting base 102 into the opening 108 of the skull. The lead holder 106 may be configured to receive a portion of the stimulation lead 110 and maintain the relative position of the stimulation lead 110.

[0065] like Figures 1A to 1C As shown, the mounting base 102 of the wire fixing device 100 can be mounted to the outer surface of the skull. In some embodiments, the mounting base 102 can be alternatively or additionally mounted to the inner surface of the skull. For example, Figure 3 A wire fixing device 300 is shown, wherein a mounting base 302 is mounted to the surface of the skull within a burr hole.

[0066] Mounting base 102 may include a receiving portion 112 configured to receive a stimulation lead 110. For example, lead holder 106 may be configured to receive a first portion of the lead 110, and the receiving portion 112 of mounting base 102 may be configured to receive a second portion of the lead 110. The receiving portion 112 of mounting base 102 may be configured to hold the position of the second portion of the lead 110. For example, the receiving portion 112 of mounting base 102 may restrict lateral movement (e.g., along) of the portion of the lead 110 disposed within the receiving portion 112. Figures 1A to 1C(Movement along the Y-axis of the coordinate system shown). The receiving portion 112 of the mount 102 may alternatively or additionally restrict the vertical movement of the second portion of the stimulation lead 110 (e.g., movement along the Z-axis of the coordinate system). In some embodiments, the receiving portion 112 of the mount 102 may be configured such that the stimulation lead 110 can be axially translated (e.g., along the longitudinal axis of the lead 110, or the X-axis of the coordinate system shown), such that the engagement between the receiving portion 112 of the mount 102 and the stimulation lead 110 comprises a sliding fit. In some embodiments, the receiving portion 112 of the mount 102 may restrict at least some movement of the lead 110 relative to the mount 102, such that the engagement between the receiving portion 112 of the mount 102 and the stimulation lead 110 comprises a press fit. Thus, in at least one direction, the receiving portion 112 of the mount 102 may be configured to secure the second portion of the stimulation lead 110 to the surface of the skull.

[0067] As shown, one or more bridge portions (i.e., protrusions relative to the outer surface of the skull) can serve as receiving portions 112 of the mount 102. The one or more bridge portions may be separated by slits and configured to receive stimulation leads 110. The receiving portion 112 of the mount 102 may include two, three, four, or more bridge portions, each group of bridge portions separated by slits. In some embodiments, the receiving portion 112 of the mount 102 may include a single protrusion or bridge portion that may extend along any length of the mount 102 (e.g., along a length defined by the X-axis of the coordinate system shown). For example, a single bridge portion may extend between a side of the mount 102 near the opening 108 in the skull and a side of the mount 102 away from the opening 108. In other embodiments, a single bridge portion may extend along the length of the mount 102 between a first midpoint and a second midpoint, such that at least one end of the bridge portion has a slit on one side.

[0068] As discussed herein, the length of the mounting base 102 can be defined as extending along the X-axis of the illustrated coordinate system between the edge of the opening 108 and the distal end of the mounting base 102. In some embodiments, the length of the mounting base 102 may be less than or equal to about 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, or 20 mm. In some embodiments, the length of the mounting base 102 may be greater than or equal to about 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, or 20 mm.

[0069] Mounting base 102 may include one or more fixing portions 114. The fixing portions 114 may be configured to secure or fasten the mounting base 102 to the skull. The fixing portions 114 may include one or more through-holes configured to receive fasteners, such as bone screws or other fasteners known to those skilled in the art for securing implants in the body. For example, the fixing portions 114 may include one, two, three, four, or more through-holes, each of which may be configured to receive a fastener. In some embodiments, the fixing portions 114 may be configured such that they are located on the sides of the receiving portion 112 of the mounting base 102 (e.g., laterally surrounding the receiving portion 112 of the mounting base 102), such as... Figures 1A to 1C As shown. For example, in the case where the receiving portion 112 of the mounting base 102 includes two protruding bridge portions (such as... Figures 1A to 1C As shown, the mounting base 102 may include a pair of fixing portions 114 (e.g., through holes), each through hole being disposed laterally on a designated bridge portion. Each fixing portion 114 in the pair of fixing portions 114 may be spaced apart from each other by a predetermined distance. For example, this distance may be at least the minimum distance between the pair of fixing portions 114 for at least one stimulation lead 110 to be disposed. In some embodiments, the distance between the first fixing portion 114 on the first side of the receiving portion 112 of the mounting base 102 and the second fixing portion 114 on the second side of the receiving portion 112 of the mounting base 102 (e.g., measured between the center points of the fixing portions) may be less than or equal to 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, or 11 mm. In some embodiments, the distance between the first set of fixing portions 114 and the second set of fixing portions 114 may be greater than or equal to 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, or 11 mm. When the fixing part 114 includes one or more through holes configured to receive fasteners, the diameter of the one or more through holes may be less than or equal to about 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2.0 mm, 2.25 mm, 2.5 mm, 2.75 mm, or 3 mm. In some embodiments, the diameter of the one or more through holes may be greater than or equal to about 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, 2.0 mm, 2.25 mm, 2.5 mm, 2.75 mm, or 3 mm.

[0070] As discussed herein, the wire fixation device 100 may include one or more flexible elements 104 coupled to the mounting base 102. For example, the wire fixation device 100 may include one, two, three, four, or more flexible elements 104. The flexible elements 104 may be configured to be at least partially disposed in an opening 108 in the skull. For example, the opening 108 may be a skull borehole, and the flexible elements 104 may be configured such that they can be disposed within the skull borehole and positioned along the edge of the skull borehole. When the mounting base 102 is mounted to the outer surface of the skull, the flexible elements 104 may be positioned along the outer edge of the opening 108. Alternatively, when the mounting base 102 is mounted to the inner surface of the skull, the flexible elements 104 may be positioned along the inner edge of the skull.

[0071] One or more flexible elements 104 may be configured to flex to isolate forces that may act on the stimulation lead 110. For example, as discussed herein, the brain can move naturally relative to the skull. Therefore, when a portion of the stimulation lead 110 is implanted in the brain and a portion of the stimulation lead 110 is secured to the outer surface of the skull (e.g., using the mount 102, as discussed herein), the stimulation lead 110 may be subjected to tension that can induce shear stress on the lead 110, which can cause the lead 110 to shift and / or become weak over time, or worse, break if not relieved. To counteract these forces, the flexible element 104 may be configured to bend (or flex) to accommodate the movement of the brain relative to the skull. Similarly, the stimulation lead 110 may be subjected to tensile forces from the other end of the lead (e.g., the end of the lead 110 connected to the pulse generator and / or one or more extension leads connecting the stimulation lead 110 to the pulse generator). Therefore, the flexible element 104 can be configured to isolate the stimulation wire 110 from various external forces acting on the wire.

[0072] The allowable amount of deflection of one or more flexible elements 104 can be controlled based on one or more dimensions of the flexible element 104. For example, the thickness of the flexible element 104 can be proportional to the flexibility of the flexible element 104. The thickness of the flexible element 104 can be uniform across the entire body of the flexible element 104. In some embodiments, different portions of the flexible element 104 may include different thicknesses. The thickness of the flexible element 104 can depend on the material and / or geometry of the flexible element 104. The thickness of the flexible element 104 can be less than or equal to about 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm. In some embodiments, the thickness of the flexible element 104 can be greater than or equal to about 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm. The flexibility can be additionally or alternatively controlled based on the material of the flexible element 104. For example, the material properties of the flexible element 104 can affect the amount of bending of one or more flexible elements 104. In some embodiments, the mounting base 102, flexible element 104, and / or wire support 106 of the wire fixing device 100 may include a single rigid body comprising a uniform material composition. For example, the material may include one or more of polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer blends, or medical-grade metal blends.

[0073] By counteracting any tension and / or pulling force experienced by the stimulation lead 110, the flexible member 104 can retain the lead support 106 connected to one or more flexible members 104 and thus retain the lead 110 disposed within the lead support 106. For example, a first portion of the stimulation lead 110 (e.g., the portion of the lead 110 extending into the opening 108) is held in place by... Figures 1A to 1C The position within the plane defined by the XY axes in the coordinate system shown can be restricted by the flexible element 104.

[0074] As discussed herein, the flexible elements 104 can be configured such that they can be at least partially disposed within the opening 108 of the skull. For example, a first portion of the flexible element 104, coupled to and extending from the mount 102, can be positioned along the surface of the skull. A second portion of the flexible element 104 can extend from the first portion of the flexible element 104 in a direction transverse to the first portion of the flexible element 104, such that the second portion extends along the wall of the opening 108 into the opening. For example, the second portion of the flexible element 104 can extend from the distal end of the opening 108 (e.g., relative to the distal end of the brain) to the proximal end of the opening 108, for example, about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or more into the opening 108. In the case where the mount 102 is implanted on the inner surface of the skull, the second portion of the flexible element 104 can extend from the proximal end of the opening 108 to the distal end of the opening 108. A third portion of the flexible member 104 can extend from the second portion of the flexible member 104 in a direction transverse to the second portion of the flexible member 104. In other words, the third portion of the flexible member 104 and the first portion can be substantially parallel. The third portion of the flexible member 104 can extend from the wall of the opening 108 toward the central axis of the opening 108 (e.g., the axis corresponding to the Z-axis in the coordinate system shown in FIG. 1). For example, in the case where the opening 108 includes a circular skull borehole, the wire support 106 connected to the end of the flexible member 104 (e.g., the end of the flexible member 104 opposite to the end connected to the mounting base 102) can be disposed approximately within the central portion surrounding the central axis of the skull borehole. Thus, the flexible member 104 can extend from the wall of the opening 108 toward the central portion within the opening 108, terminating at the wire support 106 disposed in the central portion.

[0075] When the wire fixing device 100 includes a plurality of flexible members 104 (e.g., such as...) Figures 1A to 1C(As shown, there are two or more flexible members), and the flexible members 104 may be spaced apart from each other by a predetermined distance. For example, the distance between the first flexible member and the second flexible member may correspond to the distance between the first fixing portion and the second fixing portion of the fixing portion 114, as discussed herein. The distance between the first flexible member 104 and the second flexible member 104 may be uniform or variable along the length of the flexible member 104. For example, one or more flexible members 104 may be angled toward each other inward or outward away from each other. The flexible members 104 may be angled toward each other and / or away from each other at one or more portions of the flexible member 104 discussed herein (e.g., the first portion, the second portion, and / or the third portion). In some embodiments, the distance between the first flexible member and the second flexible member may be less than or equal to about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. In some embodiments, the distance between the first flexible member and the second flexible member may be less than or equal to about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm or 10 mm.

[0076] As discussed herein, the lead securing device 100 may include a lead holder 106 coupled to one or more flexible members 104. The lead holder 106 may be configured to receive a portion of the stimulation lead 110. For example, the lead holder 106 may be configured to receive a first portion of the lead 110, and the mounting base 102 (more specifically, the receiving portion 112 of the mounting base 102) may be configured to receive a second portion of the lead 110. The lead holder 106 may include a clamp configured to surround at least a portion of the stimulation lead 110 when the stimulation lead 110 is positioned in the lead holder 106. The clamp of the lead holder 106 may extend in a longitudinal direction (e.g., along...). Figures 1A to 1C (Z-axis in the coordinate system shown). When the stimulation lead 110 is removably inserted into the lead holder 106, the clamp of the lead holder 106 may surround at least a portion of the stimulation lead 110, such that the position of the stimulation lead 110 may be held by the lead holder 106. For example, the clamp of the lead holder 106 may include a partially annular shape with a cutout configured to allow a user to insert the stimulation lead 110 into the clamp of the lead holder 106 via the cutout. In some embodiments, the clamp of the lead holder 106 may extend around at least about 50%, 60%, 70%, 80%, or 90% of the circumference of the clamp (e.g., depending on the diameter of the stimulation lead 110).

[0077] The lead support 106 can be configured to removably secure a first portion of the stimulation lead 110. For example, the lead support 106 can restrict lateral movement of the stimulation lead 110 (e.g., in the case of...). Figures 1A to 1C(Motion within the plane defined by the XY axes in the coordinate system shown). The inner diameter of the clamp of the lead frame 106 can be approximately the same as the inner diameter of the stimulation lead 110. When the engagement between the lead frame 106 and the stimulation lead 110 is intended to be a press fit, the inner diameter of the clamp of the lead frame 106 can be less than or equal to the inner diameter of the stimulation lead 110. On the other hand, when the engagement between the lead frame 106 and the stimulation lead 110 is intended to be a sliding fit, the inner diameter of the clamp can be greater than or equal to the inner diameter of the stimulation lead 110. For example, the clamp may include an inner diameter of approximately 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2.0 mm.

[0078] The lead frame 106 can be configured to move together with the flexible element 104, for example, when the flexible element 104 flexes to isolate forces acting on the lead 110. The flexible element 104 can allow longitudinal movement of the lead frame 106 between 3 mm and 7 mm, with the longitudinal axis extending at least between the distal and proximal ends of the opening 108 (e.g., relative to the brain). The longitudinal axis can also be defined by the Z-axis in the coordinate system shown. In some embodiments, the flexible element 104 can allow longitudinal displacement of the lead frame 106 less than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm. In some embodiments, the flexible element 104 can allow longitudinal displacement of the lead frame 106 greater than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm. As discussed herein, when the lead 110 is disposed in the lead frame 106, movement of the lead 110 can therefore be controlled by one or more flexible elements 104 coupled to the lead frame 106. Therefore, in other words, when the stimulation lead 110 is disposed in the lead support 106, one or more flexible elements 104 can control the longitudinal movement of the stimulation lead 110.

[0079] The wire securing device 100 may include a skull drill hole cap 116 configured to cover at least a portion of an opening 108 in the skull. For example, Figure 1A A portion of a skull drill cover 116 configured to cover an opening 108 is shown, wherein for illustrative purposes, a portion of the skull drill cover 116 is removed to depict at least the flexible element 104 and the wire support 106 disposed in the opening 108. Figure 1CA complete cranial borehole cover 116 covering at least a portion of opening 108 is shown. The cranial borehole cover 116 may include a shape configured to correspond to the shape of opening 108. For example, in the case where opening 108 is a circular cranial borehole, the outline of the cranial borehole cover 116 may be circular. In some embodiments, the outline of the cranial borehole cover 116 may be any shape, including but not limited to square, rectangle, triangle, ellipse, or other polygons. In some embodiments, the cranial borehole cover 116 may include a portion (or segment) of one or more of the aforementioned outline shapes. For example, at least as... Figure 1C As shown, the skull drill cover 116 can be configured to cover the portion of the opening 108 that is at least substantially free of the wire securing device 100. Therefore, the area of ​​the opening 108 near the mounting base 102 and one or more flexible members 104 may not be covered by the skull drill cover 116. In other words, the skull drill cover 116 may not extend to cover the mounting base 102. In some embodiments, the skull drill cover 116 may extend over the mounting base 102 to completely cover the opening 108.

[0080] The skull drill cover 116 can be configured to be removably secured to the outer surface of the skull. For example, the skull drill cover 116 may include one or more retention portions 118 for securing the cover to the skull. Retention portions 118 may include any one or more features of retention portions 114 as described herein with at least reference to mounting base 102. For example, retention portions 118 may include one or more through holes, such as one, two, three, four, five, six, seven, eight, nine, ten, or more through holes. The through holes may be configured to receive one or more fixation devices (e.g., fasteners), such as bone screws. One or more through holes may be provided along the circumference of the skull drill cover 116. In the case where the opening 108 is a circular skull drill hole, one or more through holes may alternatively or additionally be provided along the circumference of the opening 108 (e.g., on its exterior).

[0081] In some embodiments, the skull drill cover 116 may be configured to be removably secured to the mounting base 102, either alternatively or additionally. For example, at least a portion of the retaining portion 118 may be aligned with the retaining portion 114 of the mounting base 102, such that fasteners may be inserted into the aligned retaining portions 114 to secure the skull drill cover 116 to the skull via the mounting base 102.

[0082] Where at least a portion of the skull drill cover 116 comprises a circular shape, the skull drill cover 116 may have a diameter. The diameter of the skull drill cover 116 may be less than or equal to about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm. In some embodiments, the diameter of the skull drill cover 116 may be greater than or equal to about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm. Where the skull drill cover 116 comprises a shape other than circular, the aforementioned diameter measurement may be further interpreted as the longitudinal dimension extending from the first edge of the skull drill cover 116 to the second edge of the skull drill cover 116, which longitudinal dimension is determined by… Figures 1A to 1C The coordinate system shown is obtained in the plane defined by the X and Y axes. For example, the first edge of the skull drill cover 116 can be positioned opposite the second edge of the skull drill cover 116 along the Y or X axis of the coordinate system shown.

[0083] The thickness of the skull drill cover 116 can be configured such that the cover does not substantially protrude from the outer surface of the skull. The skull drill cover 116 may include a uniform or varying thickness throughout its entire body. For example, the thickness of the skull drill cover 116 may be less than or equal to about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm. In some embodiments, the thickness of the skull drill cover 116 may be greater than or equal to about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm.

[0084] As discussed herein, one or more components of the lead fixation device 100 (e.g., mounting base 102, flexible element 104, lead support 106, skull drill cap 116) may comprise biocompatible materials. For example, the lead fixation device 100 may comprise a single homogeneous material throughout, or one or more of the aforementioned components may comprise different materials. Biocompatible materials may include polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer blends, or medical-grade metal blends.

[0085] Including the wire fixing device for the bellows coupler

[0086] Figure 2A lead fixation device 200 according to another exemplary embodiment of the present disclosure is shown. The lead fixation device 200 may include a mounting base 202, a bellows coupler 204 coupled to the mounting base 202, and a lead holder 206 coupled to the bellows coupler 204. The mounting base 202 may be configured to mount the lead fixation device 200 to the surface of the skull. For example, the mounting base 202 may be mounted to the skull near an opening 208 in the skull for implanting one or more stimulation leads 210. The bellows coupler 204 may be configured to be at least partially disposed in the opening 208 of the skull. For example, the bellows coupler 204 may extend from the mounting base 202 and into the opening 208 in the skull. The lead holder 206 may be configured to receive a portion of the stimulation lead 210 and maintain the relative position of the stimulation lead 210.

[0087] Mounting base 202 may include, as described herein, referenced. Figures 1A to 1C The wire fixing device 100 shown describes any one or more features of the mounting base 102. For example, the mounting base 202 can be mounted to the outer surface of the skull, such as... Figure 2 As shown. In some embodiments, the mounting base 202 may be alternatively or additionally mounted to the inner surface of the skull.

[0088] As discussed herein, the wire fixing device may include a bellows coupler 204 mounted to the mounting base 202. For example, the bellows coupler 204 may be coupled to a surface of the mounting base 202 facing the opening 208. When the mounting base 202 is mounted to an outer surface of the skull, the bellows coupler 204 may be coupled to and extend from a proximal surface of the mounting base 202 (e.g., relative to the brain). When the mounting base 202 is alternatively or additionally mounted to an inner surface of the skull, the bellows coupler 204 may be additionally or alternatively coupled to and extend from a distal surface of the mounting base 202.

[0089] As known to those skilled in the art, a bellows coupler can be defined as a flexible coupler in which one or more coupler ends (e.g., connectors) are located on the side of a bellows flexible tube (e.g., coupler body). Bellows couplers can be precisely designed to control motion (e.g., angular position and torque). For example, different bellows couplers can provide different combinations of stiffness, radial compensation, and axial motion.

[0090] The wire securing device 200 described herein is not limited to bellows couplers, but may include other flexible and annular components. For example, the wire securing device 200 may include a standard or specially designed spring coupled to the mounting base 202 and the wire support 206. Exemplary springs may include, but are not limited to, diaphragm springs, compression springs, etc. Figure 3An exemplary lead securing device 300 is shown, which includes a spring member 304 connecting a mounting base 302 to a lead holder 306. The spring member 304 can be configured to flex to isolate the stimulation lead 310 from external forces acting on the lead.

[0091] Mounting base 202 and bellows coupler 204 may comprise a single rigid body. In some embodiments, mounting base 202 and bellows coupler 204 may be removably attached. For example, a standard bellows coupler may be selected for the wire securing device 200 and may be attached to mounting base 202. Bellows coupler 204 may be selected, for example, based on the size of opening 208 (e.g., depth, diameter, etc. of opening 208). In some embodiments, opening 208 may comprise a skull borehole.

[0092] At least a portion of the bellows coupler 204 (such as the coupler body discussed herein) may include an annular shape. The bellows coupler 204 may include at least one through-hole coaxial with the central axis of the bellows coupler 204. The through-hole may be configured to receive a portion of the stimulation lead 210. For example, as discussed herein, a first portion of the stimulation lead 210 may be received by a lead support 206 coupled to the bellows coupler 204, and a second portion of the stimulation lead 210 may be received by the bellows coupler 204 (e.g., received within the through-hole of the bellows coupler 204).

[0093] The length and diameter of the bellows coupler 204 can vary depending on the state of the bellows coupler 204 (e.g., fully deployed, fully retracted, or partially deployed and retracted). The diameter (e.g., inner and / or outer diameter) of the bellows coupler 204 can be between 4 mm and 14 mm. For example, the diameter can be less than or equal to 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm. In some embodiments, the inner and / or outer diameter can be greater than or equal to 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm.

[0094] The length of the bellows coupler 204 may be less than or equal to about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. In some embodiments, the length of the bellows coupler 204 may be greater than or equal to about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm. The bellows coupler 204 may be configured to contract and expand along the length of the opening 208. For example, the bellows coupler 204 may contract and expand between 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99% of the length of the opening 208.

[0095] The wall thickness of the bellows coupler 204 can be defined as the difference between the outer diameter and the inner diameter of the bellows coupler 204. When the bellows coupler 204 in the wire fixing device 200 is replaced by a spring component, the wall thickness can be the diameter of the spring coil. For example, the wall thickness can be between about 0.5 mm and 2 mm. In some embodiments, the wall thickness of the bellows coupler 204 can be less than or equal to about 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm. In some embodiments, the wall thickness of the bellows coupler 204 can be greater than or equal to about 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm.

[0096] The bellows coupler 204 can be configured to bend away from the central axis (e.g., along the central axis). Figure 2 The X-axis direction and / or shown Figure 2 In the Y-axis direction not explicitly shown in the text, at least because Figure 2 (This shows a cross-sectional view of the wire fixing device 200 in the XZ plane intersecting the Y-axis). For example, the bellows coupler 204 can be configured to bend by approximately 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm.

[0097] The spring constant of the bellows coupler 204 can be between 0.01 kg / mm ​​and 1 kg / mm. For example, the spring constant of the bellows coupler 204 can be less than or equal to 0.01 kg / mm, 0.05 kg / mm, 0.1 kg / mm, 0.25 kg / mm, 0.5 kg / mm, 0.75 kg / mm, or 1 kg / mm. In some embodiments, the spring constant of the bellows coupler 204 can be greater than or equal to 0.01 kg / mm, 0.05 kg / mm, 0.1 kg / mm, 0.25 kg / mm, 0.5 kg / mm, 0.75 kg / mm, or 1 kg / mm.

[0098] As discussed herein, the wire securing device 200 may include a wire holder 206 coupled to the bellows coupler 204. In some embodiments, the wire holder 206 may be a component of the bellows coupler 204. For example, the bellows coupler 204 may include one or more coupler ends, and a designated coupler end disposed within the opening 208 may be the wire holder 206. In some embodiments, the wire holder 206 may alternatively be a separate component and thus may be removably attached to the bellows coupler 204.

[0099] The lead holder 206 may include a through-hole configured to receive a first portion of the stimulation lead 110. In some embodiments, the lead holder 206 may include an annular body surrounding at least a portion of the through-hole. For example, at least 50%, 60%, 70%, 80%, or 90% of the circumference of the through-hole may be surrounded by the body of the lead holder 206.

[0100] The lead holder 206 can be configured to removably secure a first portion of the stimulation lead 210. For example, the lead holder 206 can restrict lateral movement of the stimulation lead 210. The diameter of the through-hole in the lead holder 206 can be approximately the same as the diameter of the clamp on the stimulation lead 210. When the engagement between the lead holder 206 and the stimulation lead 210 is intended to be a press fit, the diameter of the through-hole in the lead holder 206 can be less than or equal to the diameter of the stimulation lead 210. For example, the diameter of the through-hole can be approximately 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2.0 mm.

[0101] The lead frame 206 can be configured to move together with the bellows coupler 204, for example, when the bellows coupler 204 moves (e.g., bends, rotates, etc.) to isolate forces acting on the stimulation lead 210. The bellows coupler 204 allows longitudinal displacement of the lead frame 206 between 3 mm and 7 mm, with the longitudinal axis extending at least between the distal and proximal ends (e.g., relative to the brain) of the opening 208. As discussed herein, the longitudinal axis can be... Figure 2 The Z-axis is defined in the coordinate system shown. In some embodiments, the bellows coupler 204 allows the lead frame 206 to have a longitudinal displacement of less than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm. In some embodiments, the bellows coupler 204 allows the lead frame 206 to have a longitudinal displacement of greater than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm. Therefore, the movement of the lead 210 when it is positioned in the lead frame 206 can be controlled by the bellows coupler 204 connected to the lead frame 206. In other words, the bellows coupler 204 can control the longitudinal movement of the stimulation lead 210 when it is positioned in the lead frame 206.

[0102] although Figure 2 Not explicitly shown herein, but it should be understood that the wire securing device 200 may include a cover configured to cover at least a portion of the opening 208 and / or the distal opening of the bellows coupler 204. This cover may include elements referenced herein. Figures 1A to 1C The illustrated wire fixation device 100 describes any one or more features of the skull drill cover 116. For example, the cover of the wire fixation device 200 may be configured to be removably secured to the skull and / or the mounting base 202.

[0103] The lead fixation device 200 (e.g., one or more of the mounting base 202, the corrugated coupler 204, and / or the lead holder 206) may include one or more biocompatible materials. For example, the lead fixation device 200 may include one or more biocompatible materials discussed herein with reference to the lead fixation device 100. For example, the biocompatible materials of the mounting base 202, the corrugated coupler 204, and / or the lead holder 206 may include one or more of polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer blends, or medical-grade metal blends.

[0104] Method of installing wires using wire fixing devices

[0105] According to some embodiments, this document describes a method for mounting a stimulation lead 110 onto the skull using a lead fixation device 100. Unless otherwise stated, it should be understood that the method described herein can also be used to mount a stimulation lead 210 onto the skull using a lead fixation device 200.

[0106] The method may include forming (e.g., drilling) an opening 108 on the surface of the skull. For example, the opening 108 may include a skull drill hole formed using a skull drill (e.g., a craniotomy drill).

[0107] In some embodiments, prior to implanting the lead fixation device 100, the method may include implanting the stimulation lead 110 into the brain via the opening 108.

[0108] The method may include mounting a mounting base 102 to a surface of the skull such that one or more flexible elements 104 coupled to the mounting base 102 are at least partially disposed in an opening 108 of the skull. The mounting base 102 may be mounted to an outer surface of the skull. In some embodiments, the mounting base 102 may alternatively or additionally be mounted to an inner surface of the skull. As discussed herein, the mounting base 102 may include one or more fixing portions 114, each configured to receive a corresponding fastener (e.g., a bone screw). Thus, mounting the mounting base 102 to the skull may include inserting and securing one or more fasteners to the fixing portions 114 of the mounting base 102.

[0109] In the case of the method discussed herein being used for implanting the lead fixation device 200, the method may include mounting the mounting base 202 to the surface of the skull such that the bellows coupler 204 coupled to the mounting base is at least partially disposed in the opening 208 of the skull.

[0110] In the case of the method discussed herein being used to implant the lead fixation device 300, the method may include mounting the mounting base 302 to the inner surface of the skull (e.g., the surface of a skull borehole) such that the spring member 304 and the lead support 306 can be disposed within the skull borehole.

[0111] The method may include inserting a stimulation lead 110 into a lead holder 106 connected to one or more flexible members 104, such that a first portion of the lead 110 is secured by the lead holder 106. For example, a through-hole in the lead holder 106 may be configured to receive the stimulation lead 110, and a clamp of the lead holder 106 at least partially surrounding the through-hole may therefore at least partially surround the stimulation lead 110, such that the lead 110 retains its position once inserted into the lead holder 106.

[0112] The method may include inserting a second portion of a stimulation lead 110 into a receiver 112 of a mounting base 102. After inserting the lead into the receiver 112 of the mounting base 102, the second portion of the lead 110 may be secured to the surface of the skull. For example, one or more bridge portions of the receiver 112 may be configured to limit displacement of the stimulation lead 110 in one or more directions (e.g., at least in...). Figures 1A to 1C (In the coordinate system shown, in the Y and Z directions).

[0113] In the case of the method discussed herein being used for implanting a lead fixation device 200, the method may include inserting a second portion of a lead (e.g., a stimulation lead 210) into a through-hole of a bellows coupler 204, the through-hole being coaxial with the central axis of the bellows coupler 204.

[0114] Methods of mounting the stimulation lead 110 on the skull may include removably securing a skull drill cap 116 to the skull and / or mounting base 102 such that at least a portion of the opening 108 is covered by the skull drill cap 116. As discussed herein, the skull drill cap 116 may include one or more retaining portions 118, which in some embodiments may be through-holes. Therefore, securing the skull drill cap 116 to the mounting base 102 and / or the skull may include inserting one or more fasteners through the receiving portion 118 and securing them into the skull (e.g., optionally via the mounting base 102).

[0115] In some embodiments, the method may include connecting the stimulation lead 110 to an implantable pulse generator (IPG). For example, the IPG may be implanted in the skull, and the stimulation lead 110 may be connected to the IPG prior to implantation.

[0116] Those skilled in the art will understand that variations in the sequence of steps and / or the manner in which one or more of the above steps are performed are possible and should be understood to be covered within the scope of the disclosure provided herein. For example, mounting the mount 102 to the surface of the skull may be performed before or after inserting the stimulation lead 110 into the receiver 112 and / or lead holder 106 of the mount 102. In another example, the mount 102 may be secured to the surface of the skull in a manner different from that described herein and / or using different tools.

[0117] Unless otherwise defined, all technical terms, symbols, and other scientific and technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some instances, terms with commonly understood meanings are defined herein for clarity and / or ease of reference, and the inclusion of such definitions herein should not be construed as representing a material difference from the commonly understood meaning in the art.

[0118] As used herein, unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well. It should also be understood that the term “and / or” as used herein refers to and covers any and all possible combinations of one or more associated listed items. It should also be understood that the terms “includes,” “including,” “comprises,” and / or “comprising,” when used herein, specify the presence of the 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 combinations thereof.

[0119] The disclosed numerical ranges inherently support any range or value within the disclosed numerical ranges, including endpoints, even if the precise range limits are not stated verbatim in the specification, because this disclosure can be practiced throughout the disclosed numerical ranges.

[0120] For illustrative purposes, the foregoing description has been made with reference to specific embodiments. However, the illustrative discussion above is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the foregoing teachings. These embodiments were chosen and described in order to best explain the principles of these techniques and their practical application. Therefore, those skilled in the art will be able to best utilize these techniques and various embodiments with various modifications suited to specific intended uses.

[0121] Although the disclosure and examples have been fully 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 included within the scope of the disclosure and examples as defined in the claims.

Claims

1. A wire fixing device, comprising: Mounting base, which is configured to mount the wire fixing device to the surface of the skull; One or more flexible elements are coupled to the mounting base and configured to be at least partially disposed in the opening of the skull; as well as A conductor support, which is connected to the one or more flexible members and configured to receive a first portion of the conductor.

2. The wire fixing device according to claim 1, wherein the mounting base includes a receiving portion configured to receive a second portion of the wire.

3. The wire fixing device according to claim 2, wherein the receiving portion of the mounting base is configured to fix the second portion of the wire to the surface of the skull.

4. The wire fixing device according to any one of claims 1 to 3, wherein the surface of the skull to which the wire fixing device is configured to be mounted is the outer surface of the skull.

5. The conductor fixing device according to any one of claims 1 to 4, wherein the one or more flexible members are configured to flex to isolate forces acting on the conductor.

6. The wire fixing device according to any one of claims 1 to 5, wherein the one or more flexible members are configured to maintain the relative position of the first portion of the wire and the wire support.

7. The wire fixing device according to any one of claims 1 to 6, wherein the wire support is configured to removably fix the first portion of the wire.

8. The wire fixing device according to any one of claims 1 to 7, comprising a skull drill hole cover configured to cover at least a portion of the opening in the skull.

9. The wire fixing device of claim 8, wherein the skull drill cap is configured to be removably fixed to the skull and / or the mounting base.

10. The wire fixing device according to any one of claims 1 to 9, wherein the opening is a skull drill hole.

11. The wire fixing device according to any one of claims 1 to 10, wherein the one or more flexible elements are configured to allow longitudinal movement of the wire support between 3 mm and 7 mm, the longitudinal axis extending between the distal end and the proximal end of the opening.

12. The wire fixing device according to any one of claims 1 to 11, wherein one or more of the mounting base, the one or more flexible elements, and the wire support comprises a biocompatible material.

13. The wire fixation device according to claim 12, wherein the biocompatible material comprises polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical grade stainless steel, titanium, polymer mixtures, or medical grade metal mixtures.

14. A deep brain stimulation system, comprising: The wire fixing device according to claim 1; At least one wire, configured to be received by the wire holder of the wire fixation device and implanted into the brain; as well as A pulse generator is configured to be implanted in the skull and connected to the at least one wire.

15. A method for mounting a wire on the skull, the method comprising: The mounting base is mounted to the surface of the skull such that one or more flexible elements connected to the mounting base are at least partially disposed in an opening in the skull; as well as The wire is inserted into a wire holder connected to one or more flexible elements, such that a first portion of the wire is secured by the wire holder.

16. The method of claim 15, further comprising forming the opening in the surface of the skull.

17. The method according to claim 15 or 16, further comprising inserting a second portion of the wire into the receiving portion of the mounting base.

18. The method of claim 17, wherein inserting the second portion of the wire into the receiving portion of the mounting base includes securing the second portion of the wire to the surface of the skull.

19. The wire fixing device according to any one of claims 15 to 18, wherein the surface of the skull on which the mounting base is mounted is the outer surface of the skull.

20. The method according to any one of claims 15 to 19, comprising implanting the wire into the brain.

21. The method according to any one of claims 15 to 20, comprising removably securing a skull drill cap to the skull and / or the mounting base such that at least a portion of the opening is covered by the skull drill cap.

22. The method according to any one of claims 15 to 21, wherein the one or more flexible elements are configured to flex to isolate forces acting on the conductor.

23. The method according to any one of claims 15 to 22, wherein the one or more flexible elements are configured to maintain the relative position of the first portion of the conductor and the conductor support.

24. The method according to any one of claims 15 to 23, wherein the one or more flexible elements are configured to allow longitudinal displacement of the conductor support between 3 mm and 7 mm, the longitudinal axis extending between the distal end and the proximal end of the opening.

25. The method according to any one of claims 15 to 24, wherein the opening is a skull drill hole.

26. A wire fixing device, comprising: Mounting base, which is configured to mount the wire fixing device to the surface of the skull; A bellows coupler, which is connected to the mounting base and configured to be at least partially disposed in the opening of the skull; as well as A wire support, which is connected to the bellows coupler and configured to receive a first portion of the wire.

27. The wire fixing device according to claim 26, wherein the diameter of the corrugated coupler is between 4 mm and 14 mm.

28. The wire fixing device according to claim 26 or claim 27, wherein the wall thickness of the corrugated coupler is between 0.5 mm and 2 mm.

29. The wire fixing device according to any one of claims 26 to 28, wherein the spring constant of the bellows coupler is between 0.01 kg / mm ​​and 1 kg / mm.

30. The wire fixing device according to any one of claims 26 to 29, wherein the corrugated coupler is configured to maintain the relative position of the first portion of the wire and the wire support.

31. The wire fixing device according to any one of claims 26 to 30, wherein the wire support is configured to removably fix the first portion of the wire.

32. The wire fixing device according to any one of claims 26 to 31, wherein the corrugated coupler includes a through hole coaxial with the central axis of the corrugated coupler and configured to receive a second portion of the wire.

33. The wire fixing device according to any one of claims 26 to 32, comprising a skull drill cover configured to cover at least a portion of the opening in the skull.

34. The wire fixing device of claim 33, wherein the skull drill cap is configured to be removably fixed to the skull and / or the mounting base.

35. The wire fixing device according to any one of claims 26 to 34, wherein the opening is a skull drill hole.

36. The wire fixing device according to any one of claims 26 to 35, wherein the corrugated coupler is configured to allow longitudinal displacement of the wire support between 3 mm and 7 mm, the longitudinal axis extending between the distal end and the proximal end of the opening.

37. The wire fixing device according to any one of claims 26 to 36, wherein one or more of the mounting base, the corrugated coupler, and the wire support comprises a biocompatible material.

38. The wire fixation device according to claim 37, wherein the biocompatible material comprises polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylene sulfone (PPSU), polyethylene terephthalate (PET), medical grade stainless steel, titanium, polymer mixtures, or medical grade metal mixtures.

39. A deep brain stimulation system, comprising: The wire fixing device according to claim 26; At least one wire is configured to be received by the wire support of the wire fixing device; as well as A pulse generator is configured to be implanted in the skull and connected to the at least one wire.

40. A method for mounting a wire on the skull, the method comprising: The mounting base is installed onto the surface of the skull such that the bellows coupler connected to the mounting base is at least partially disposed in an opening in the skull; as well as The wire is inserted into the wire bracket connected to the corrugated pipe coupler, such that the first part of the wire is fixed by the wire bracket.

41. The method of claim 40, further comprising forming the opening in the surface of the skull.

42. The method according to claim 40 or claim 41, further comprising inserting a second portion of the conductor into a through-hole of the bellows coupler, the through-hole being coaxial with the central axis of the bellows coupler.

43. The method according to any one of claims 40 to 42, comprising implanting the wire into the brain.

44. The method according to any one of claims 40 to 43, comprising removably securing a skull drill cap to the skull and / or the mounting base such that at least a portion of the opening is covered by the skull drill cap.

45. The method according to any one of claims 40 to 44, wherein the bellows coupler is configured to maintain the relative position of the first portion of the conductor with respect to the conductor support.

46. ​​The method according to any one of claims 40 to 45, wherein the bellows coupler is configured to allow longitudinal displacement of the wire support between 3 mm and 7 mm, the longitudinal axis extending between the distal end and the proximal end of the opening.

47. The method according to any one of claims 40 to 46, wherein the opening is a skull drill hole.

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