Lead fixation devices and methods of use thereof

Abstract

Provided herein are lead fixation devices and methods of using the lead fixation devices to mount stimuiation leads to the skuil. The lead fixation devices may be used to mount stimulation leads for deep brain stimulation. The lead fixation devices may maintain a relative position of the stimulation lead while allowing for axial float of the lead. The lead fixation devices can comprise one or more flexures or bellows couplings to maintain the position of the stimulation lead while isolating forces acting on the lead.

Description

Attorney Docket No: 78895-20032.40 LEAD FIXATION DEVICES AND METHODS OF USE THEREOF CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No.63 / 509,233, filed June 20, 2023, the contents of which are incorporated herein in its entirety. FIELD

[0002] This disclosure relates generally to lead fixation devices, and more specifically to lead fixation devices for deep brain stimulation (DBS) systems that allow for axial float of the lead. BACKGROUND

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

[0004] Deep brain stimulation systems commonly include one or more stimulation leads implanted in the brain and a pulse generator implanted in the upper chest of the patient. One or more small incisions are made in the scalp of a patient, followed by one or more small openings in the skull that allow for lead implantation in the brain. The region in the brain in which stimulation leads can be implanted is dependent on the brain condition that is being treated. Thus, to uphold effectiveness of DBS, it is important that the stimulation lead(s) are not displaced in the brain tissue over time. To maintain this implanted location of the stimulation lead, the stimulation lead can be fixed to the skull of the patient after implantation in the brain. For example, the stimulation lead may be fixed using a lead clamp placed proximate to an opening in the skull. However, it is known that the brain can translate relative to the skull, which in contrast with the fixed lead, can cause stress on the lead, thereby weakening or even breaking the lead. The lead could also shift from the intended implantation site, thereby causing damage tony-2750753Attorney Docket No: 78895-20032.40 the brain tissue or decreasing the effectiveness of DBS. Each of the aforementioned consequences of the stimulation lead moving, weakening, and / or breaking can require subsequent surgical procedures to fix, reattach, or replace the leads. Additional surgical procedures can increase the risk of intraoperative and / or postoperative surgical complications, such as infection, bleeding, swelling, and in more severe cases, coma, sepsis, and stroke. SUMMARY

[0005] Described herein are lead fixation devices and methods of mounting stimulation leads on the skull with the lead fixation devices, the stimulation leads implanted for, e.g., deep brain stimulation. The lead fixation devices may be designed such that it allows for axial float of the stimulation lead relative to the skull. For example, the lead fixation devices may comprise one or more flexures and / or a bellows coupling that can be at least partially disposed in an opening in the skull and can flex to isolate forces acting on the lead. The lead fixation devices may comprise a mount that can be mounted to the skull to maintain a 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.

[0006] In some embodiments, a lead fixation apparatus is provided, comprising: a mount configured to mount the lead fixation apparatus to a surface of a skull; one or more flexures coupled to the mount and configured to be at least partially disposed in an opening in the skull; and a lead support coupled to the one or more flexures and configured to receive a first portion of a lead.

[0007] In some embodiments, the mount comprises a receiving portion configured to receive a second portion of the lead.

[0008] In some embodiments, the receiving portion of the mount is configured to secure the second portion of the lead to the surface of the skull.

[0009] In some embodiments, the surface of the skull to which the lead fixation apparatus is configured to be mounted is an outer surface of the skull.

[0010] In some embodiments, the one or more flexures are configured to flex to isolate a force acting on the lead.

[0011] In some embodiments, the one or more flexures are configured to maintain a relative position of the first portion of the lead and the lead support.ny-2750753Attorney Docket No: 78895-20032.40

[0012] In some embodiments, the lead support is configured to removably secure the first portion of the lead.

[0013] In some embodiments, the lead fixation apparatus comprises a burr hole cover configured to cover at least a portion of the opening in the skull.

[0014] In some embodiments, the burr hole cover is configured to be removably secured to the skull and / or to the mount.

[0015] In some embodiments, the opening is a burr hole.

[0016] In some embodiments, the one or more flexures are configured to allow between 3 mm and 7 mm of longitudinal movement of the lead support, a longitudinal axis extending between a distal end of the opening and a proximal end of the opening.

[0017] In some embodiments, one or more of the mount, the one or more flexures, and the lead support comprises a biocompatible material.

[0018] In some embodiments, the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

[0019] In some embodiments, a deep brain stimulation system is provided, comprising: the lead fixation apparatus; at least one lead configured to be received by the lead support of the lead fixation apparatus and implanted into a brain; and a pulse generator configured to be implanted in the skull and coupled to the at least one lead.

[0020] In some embodiments, a method of mounting a lead on a skull is provided, the method comprising: mounting a mount to a surface of the skull such that one or more flexures coupled to the mount is at least partially disposed in an opening in the skull; and inserting the lead into a lead support coupled to the one or more flexures such that a first portion of the lead is secured by the lead support.

[0021] In some embodiments, the method comprises generating the opening in the surface of the skull.

[0022] In some embodiments, the method comprises inserting a second portion of the lead into a receiving portion of the mount.

[0023] In some embodiments, inserting the second portion of the lead into the receiving portion of the mount comprises securing the second portion of the lead to the surface of the skull.ny-2750753Attorney Docket No: 78895-20032.40

[0024] In some embodiments, the surface of the skull to which the mount is mounted is the outer surface of the skull.

[0025] In some embodiments, the method comprises implanting the lead into a brain.

[0026] In some embodiments, the method comprises removably securing a burr hole cover to the skull and / or mount such that at least a portion of the opening is covered by the burr hole cover.

[0027] In some embodiments, the one or more flexures are configured to flex to isolate a force acting on the lead.

[0028] In some embodiments, the one or more flexures are configured to maintain a relative position of the first portion of the lead and the lead support.

[0029] In some embodiments, the one or more flexures are configured to allow between 3 mm and 7 mm of longitudinal displacement of the lead support, a longitudinal axis extending between a distal end of the opening and a proximal end of the opening.

[0030] In some embodiments, the opening is a burr hole.

[0031] In some embodiments, a lead fixation apparatus is provided, comprising: a mount configured to mount the lead fixation apparatus to a surface of a skull; a bellows coupling coupled to the mount and configured to be at least partially disposed in an opening in the skull; and a lead support coupled to the bellows coupling and configured to receive a first portion of a lead.

[0032] In some embodiments, a diameter of the bellows coupling is between 4 mm and 14 mm.

[0033] In some embodiments, a wall thickness of the bellows coupling is between 0.5 mm and 2 mm.

[0034] In some embodiments, the bellows coupling has a spring constant between 0.01 kg / mm and 1 kg / mm.

[0035] In some embodiments, the bellows coupling is configured to maintain a relative position of the first portion of the lead and the lead support.

[0036] In some embodiments, the lead support is configured to removably secure the first portion of the lead.

[0037] In some embodiments, the bellows coupling comprises a through-hole coaxial with the central axis of the bellows coupling and configured to receive a second portion of the lead.ny-2750753Attorney Docket No: 78895-20032.40

[0038] In some embodiments, the lead fixation apparatus comprises a burr hole cover configured to cover at least a portion of the opening in the skull.

[0039] In some embodiments, the burr hole cover is configured to be removably secured to the skull and / or to the mount.

[0040] In some embodiments, the opening is a burr hole.

[0041] In some embodiments, the bellows coupling is configured to allow between 3 mm and 7 mm of longitudinal displacement of the lead support, a longitudinal axis extending between a distal end of the opening and a proximal end of the opening.

[0042] In some embodiments, one or more of the mount, the bellows coupling, and the lead support comprises a biocompatible material.

[0043] In some embodiments, the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

[0044] In some embodiments, a deep brain stimulation system is provided, comprising: the lead fixation apparatus; at least one lead configured to be received by the lead support of the lead fixation apparatus; and a pulse generator configured to be implanted in the skull and coupled to the at least one lead.

[0045] In some embodiments, a method of mounting a lead on a skull is provided, the method comprising: mounting a mount to a surface of the skull such that a bellows coupling coupled to the mount is at least partially disposed in an opening in the skull; and inserting the lead into a lead support coupled to the bellows coupling such that a first portion of the lead is secured by the lead support.

[0046] In some embodiments, the method comprises generating the opening in the surface of the skull.

[0047] In some embodiments, the method comprises inserting a second portion of the lead into a through-hole of the bellows coupling coaxial with a central axis of the bellows coupling.

[0048] In some embodiments, the method comprises implanting the lead into a brain.

[0049] In some embodiments, the method comprises removably securing a burr hole cover to the skull and / or mount such that at least a portion of the opening is covered by the burr hole cover.ny-2750753Attorney Docket No: 78895-20032.40

[0050] In some embodiments, the bellows coupling is configured to maintain a relative position of the first portion of the lead and the lead support.

[0051] In some embodiments, the bellows coupling is configured to allow between 3 mm and 7 mm of longitudinal displacement of the lead support, a longitudinal axis extending between a distal end of the opening and a proximal end of the opening.

[0052] In some embodiments, the opening is a burr hole. BRIEF DESCRIPTION OF THE DRAWINGS

[0053] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative embodiments and the accompanying drawings.

[0054] FIG.1A illustrates a perspective view of the first lead fixation apparatus with a partially removed burr hole cover, in accordance with some embodiments.

[0055] FIG.1B illustrates another perspective view of the first lead fixation apparatus, in accordance with some embodiments.

[0056] FIG.1C illustrates another perspective view of the first lead fixation apparatus with a burr hole cover, in accordance with some embodiments.

[0057] FIG.2 illustrates a cross-sectional view of a second lead fixation apparatus, in accordance with some embodiments.

[0058] FIG.3 illustrates a cross-sectional view of a third lead fixation apparatus, in accordance with some embodiments. DETAILED DESCRIPTION

[0059] Lead fixation devices and methods of use thereof are described herein. The lead fixation devices may be used to mount stimulation leads implanted for deep brain stimulation (DBS) to the skull. The lead fixation devices may allow for axial float of the stimulation lead relative to the skull, such that the lead can translate with the brain (e.g., in the instance the brain shifts relative to the skull). For example, the lead fixation devices may include bellows couplings and / or flexures that can flex to isolate forces (e.g., stress) acting on the implanted stimulation lead. The lead fixation devices described herein may prevent the lead from loosening and / orny-2750753Attorney Docket No: 78895-20032.40 moving from the implantation site in the brain, and may also prevent excess stress on the lead due to conflicting forces between the lead fixation device and natural movement of the brain.

[0060] In some embodiments, the lead fixation devices described herein may be provided as components of a deep brain stimulation (DBS) system. For example, the DBS system may comprise a lead fixation apparatus comprising a lead support, at least one stimulation lead configured to be received by the lead support and implanted into 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 into the skull of the patient. It is to be understood by one of ordinary skill in the art that the lead fixation devices described herein are not limited to deep brain stimulation (DBS) systems with cranially mounted pulse generators and may be used in other systems, including but not limited to other DBS systems. For example, the pulse generator of the DBS system may be implanted into a soft tissue pocket in the upper chest of the patient, and one or more extension leads may be tunneled under the skin to connect the stimulation lead to the pulse generator.

[0061] The lead fixation devices and methods of use thereof may be described with respect to various embodiments, such as a first embodiment illustrated at least in FIGS.1A-1C and a second embodiment illustrated at least in FIG. 2. It is to be understood that lead fixation devices described herein are not limited exclusively to the features described with respect to the Figures, and any combination of features described herein may be embodied in an exemplary lead fixation device. Lead Fixation Apparatus Including Flexures

[0062] FIGS.1A-1C illustrate a lead fixation apparatus 100 in accordance with an exemplary embodiment of the present disclosure. Lead fixation apparatus 100 may comprise a mount 102, one or more flexures 104 coupled to mount 102, and a lead support 106 coupled to flexures 104. Mount 102 may be configured to mount lead fixation apparatus 100 to a surface of the skull. For example, mount 102 may be mounted to the skull proximate to an opening 108 in the skull for implanting one or more stimulation leads 110. Flexures 104 may be configured to be at least partially disposed in opening 108 of the skull. For example, flexures 104 may extend outward from a side of mount 102 and into opening 108 in the skull. Lead support 106 may be configuredny-2750753Attorney Docket No: 78895-20032.40 to receive a portion of a stimulation lead 110 and to maintain a relative position of stimulation lead 110.

[0063] As shown in FIGS.1A-1C, mount 102 of lead fixation apparatus 100 may be mounted to an outer surface of the skull. In some embodiments, mount 102 may instead or additionally be mounted to an inner surface of the skull. For example, FIG. 3 illustrates a lead fixation apparatus 300 in which mount 302 is mounted to a surface of the skull within the burr hole.

[0064] Mount 102 may comprise a receiving portion 112 configured to receive stimulation lead 110. For example, lead support 106 may be configured to receive a first portion of lead 110 and receiving portion 112 of mount 102 may be configured to receive a second portion of lead 110. Receiving portion 112 of mount 102 may be configured to maintain a position of the second portion of lead 110. For example, receiving portion 112 of mount 102 may limit lateral movement (e.g., movement along a Y-axis of the illustrated coordinate system in FIGS.1A-1C) of the portion of lead 110 disposed within receiving portion 112. Receiving portion 112 of mount 102 may instead or additionally limit vertical movement (e.g., movement along a Z-axis of the coordinate system) of the second portion of stimulation lead 110. In some embodiments, receiving portion 112 of mount 102 may be configured such that stimulation lead 110 may translate axially (e.g., along a longitudinal axis of lead 110, or the X-axis of the illustrated coordinate system), such that the interface between receiving portion 112 of mount 102 and stimulation lead 110 comprises a slip-fit. In some embodiments, receiving portion 112 of mount 102 may limit at least some of the movement of lead 110 relative to mount 102, such that the interface between receiving portion 112 of mount 102 and stimulation lead 110 comprises a press fit. Thus, in at least one direction, receiving portion 112 of mount 102 may be configured to secure the second portion of stimulation lead 110 to the surface of the skull.

[0065] As shown, one or more bridges (i.e., raised portions relative to the outer surface of the skull) may act as receiving portion 112 of mount 102. The one or more bridges may be separated by a cut-out and configured to receive stimulation lead 110. Receiving portion 112 of mount 102 may comprise 2, 3, 4, or more bridges, each set of bridges separated by a cut-out. In some embodiments, receiving portion 112 of mount 102 may comprise a single raised portion, or bridge, which may extend along any length of mount 102 (e.g., along a length defined by an X- axis of the illustrated coordinate system). For example, a single bridge may extend between any-2750753Attorney Docket No: 78895-20032.40 side of mount 102 proximate to opening 108 in the skull and a side of mount 102 distal from opening 108. In other embodiments, a single bridge may extend between a first midpoint and a second midpoint along a length of mount 102, such that at least one of the ends of the bridge can be flanked by a cut-out.

[0066] As discussed herein, a length of mount 102 may be defined as extending along an X- axis of the illustrated coordinate system between an edge of opening 108 and a distal end of mount 102. In some embodiments, the length of mount 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 mount 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.

[0067] Mount 102 may comprise one or more fixation portions 114. Fixation portions 114 may be configured to fix, or secure, mount 102 to the skull. Fixation portions 114 may comprise one or more through-holes configured to receive a fastener, such as a bone screw or other fastener known to one of ordinary skill in the art used to secure implants in the body. For example, fixation portions 114 may comprise 1, 2, 3, 4, or more through-holes, each of which may be configured to receive a fastener. In some embodiments, fixation portions 114 may be disposed such that they flank (e.g., surround laterally) receiving portion 112 of mount 102, as shown in FIGS.1A-1C. For example, in the instance receiving portion 112 of mount 102 comprises two raised bridges (as illustrated in FIGS. 1A-1C), mount 102 may comprise a pair of fixation portions 114 (e.g., through-holes), each through-hole disposed lateral to a given bridge. Each fixation portion 114 in a pair of fixation portions 114 may be disposed a predetermined distance apart from one another. For example, the distance may be at least a minimum distance to dispose at least one stimulation lead 110 between the pairs of fixation portions 114. In some embodiments, the distance between a first fixation portion 114 on a first side of receiving portion 112 of mount 102 and a second fixation portion 114 on a second side of receiving portion 112 of mount 102 (e.g., measured between center points of the fixation 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 and second sets of fixation 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. In the instance fixation portions 114 comprises one or more through-holes configured to receive a fastener, the diameter of the one or more through-holes may be less than or equal to 9ny-2750753Attorney Docket No: 78895-20032.40 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.

[0068] As discussed herein, lead fixation apparatus 100 may comprise one or more flexures 104 coupled to mount 102. For example, lead fixation apparatus 100 may comprise 1, 2, 3, 4, or more flexures 104. Flexures 104 may be configured to be at least partially disposed in opening 108 in the skull. For example, opening 108 may be a burr hole, and flexures 104 may be configured such that they can be disposed within and reside along an edge of the burr hole. In the instance mount 102 is mounted to an outer surface of the skull, flexures 104 may reside along an outer edge of opening 108. On the other hand, in the instance mount 102 is mounted on an inner surface of the skull, flexures 104 may reside along an inner edge of the skull.

[0069] The one or more flexures 104 may be configured to flex to isolate forces that may act on stimulation lead 110. For example, as discussed herein, the brain can move naturally relative to the skull. Thus, when a portion of stimulation lead 110 is implanted into the brain and a portion of stimulation lead 110 is fixed to the outer surface of the skull (e.g., using mount 102, as discussed herein), stimulation lead 110 may experience tension forces that can cause shear stress on lead 110, which can contribute to lead 110 shifting and / or weakening over time, or worse, breaking, if not mitigated. To counteract these forces, flexures 104 may be configured to bend (or flex) to accommodate movement of the brain relative to the skull. In a similar nature, stimulation lead 110 may experience pulling forces from the other end of the lead (e.g., the end of lead 110 connected to a pulse generator and / or one or more extension leads connecting stimulation lead 110 to the pulse generator). Thus, flexures 104 can be configured to isolate stimulation lead 110 from the various external forces acting on the lead.

[0070] The amount of flex allowed by the one or more flexures 104 may be controlled based on one or more dimensions of flexures 104. For example, the thickness of flexures 104 may be proportional to the flexibility of flexures 104. The thickness of flexures 104 may be uniform throughout the body of flexures 104. In some embodiments, different portions of flexures 104 may comprise different thicknesses. The thickness of flexures 104 may be dependent on material and / or geometry of the flexures 104. The thickness of flexures 104 may 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 flexures 104 may be greater than or equal to about 0.5 mm, 0.75 mm, 1 mm, 1.25ny-2750753Attorney Docket No: 78895-20032.40 mm, 1.5 mm, 1.75 mm, or 2 mm. The flexibility may additionally or instead be controlled based on the material of flexures 104. For example, material properties of flexures 104 may influence the amount that the one or more flexures 104 can bend. In some embodiments, mount 102, flexures 104, and / or lead support 106 of lead fixation apparatus 100 may comprise a single rigid body comprising a uniform material composition. For example, the material may comprise one or more of polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

[0071] By counteracting any tension and / or pulling forces experienced by stimulation lead 110, flexures 104 may maintain a lead support 106 coupled to the one or more flexures 104 and therefore lead 110 disposed within lead support 106. For example, the position of a first portion of stimulation lead 110 (e.g., the portion of lead 110 extending into opening 108) within a plane defined by the X-Y axes in the illustrated coordinate axis in FIGS.1A-1C may be limited by flexures 104.

[0072] As discussed herein, flexures 104 may be configured such that they can be at least partially disposed in opening 108 in the skull. For example, a first portion of flexures 104 coupled to and extending from mount 102 may reside along a surface of the skull. A second portion of flexures 104 may extend from the first portion of flexures 104 and in a direction transverse to the first portion of flexures 104, such that the second portion extends along a wall of opening 108 into the opening. For example, the second portion of flexures 104 may extend from a distal end of opening 108 (e.g., distal relative to the brain) to a proximal end of opening 108, such as about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more into opening 108. In the instance mount 102 is implanted on an inner surface of the skull, the second portion of flexures 104 may extend from the proximal end of opening 108 to the distal end of opening 108. A third portion of flexures 104 may extend from the second portion of flexures 104 and in a direction transverse to the second portion of flexures 104. Stated otherwise, the third portion and first portion of flexures 104 may be substantially parallel. The third portion of flexures 104 may extend from a wall of opening 108 toward a central axis of opening 108 (e.g., an axis corresponding to the Z-axis in the coordinate system illustrated in FIG.1). For example, in the instance opening 108 comprises a circular burr hole, lead support 106 coupled to an end of flexures 104 (e.g., the end of flexures 104 opposite from the end coupled to mount 102) may beny-2750753Attorney Docket No: 78895-20032.40 approximately disposed within a central portion surrounding the central axis of the burr hole. Thus, flexures 104 may extend from the wall of opening 108 toward the central portion within opening 108, terminating with lead support 106 disposed in the central portion.

[0073] In the instance lead fixation apparatus 100 comprises a plurality of flexures 104 (e.g., two or more flexures as illustrated in FIGS.1A-1C), flexures 104 may be disposed a predetermined distance apart from one another. For example, the distance between a first flexure and second flexure may correspond to a distance between a first fixation portion and second fixation portion of fixation portions 114, as discussed herein. The distance between the first and second flexure 104 may be uniform or variable along a length of the flexures 104. For example, one or more of the flexures 104 may be angled inwards towards one another or outwards away from one another. The flexures 104 may be angled toward and / or away from one another at one or more portions of the flexures 104 discussed herein (e.g., the first portion, second portion, and / or third portion). In some embodiments, the distance between the first flexure and second flexure 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 flexure and second flexure 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.

[0074] As discussed herein, lead fixation apparatus 100 may comprise a lead support 106 coupled to one or more flexures 104. Lead support 106 may be configured to receive a portion of stimulation lead 110. For example, lead support 106 may be configured to receive a first portion of lead 110, and mount 102 (and more specifically, receiving portion 112 of mount 102) may be configured to receive a second portion of lead 110. Lead support 106 may comprise a cuff configured to surround at least a portion of the stimulation lead 110 when disposed in lead support 106. The cuff of lead support 106 may extend in a longitudinal direction (e.g., along the Z-axis in the coordinate system illustrated in FIGS. 1A-1C). The cuff of lead support 106 may surround at least a portion of the stimulation lead 110 when removably inserted into lead support 106, such that a position of the stimulation lead 110 can be maintained by lead support 106. For example, the cuff of lead support 106 may comprise a partially annular shape with a cut-out configured to allow a user to insert stimulation lead 110 into the cuff of lead support 106 via the cut-out. In some embodiments, the cuff of lead support 106 may extend around at least aboutny-2750753Attorney Docket No: 78895-20032.40 50%, 60%, 70%, 80%, or 90% of the circumference of the cuff (e.g., dependent on the diameter of stimulation lead 110).

[0075] Lead support 106 may be configured to removably secure the first portion of stimulation lead 110. For example, lead support 106 may limit lateral movement (e.g., movement within a plane defined by the X-Y axes in the illustrated coordinate system in FIGS.1A-1C) of stimulation lead 110. The inner diameter of the cuff of lead support 106 may be about the same as that of stimulation lead 110. In the instance the interface between lead support 106 and stimulation lead 110 is intended to be a press-fit, the inner diameter of the cuff of lead support 106 may be less than or equal to that of stimulation lead 110. On the other hand, in the instance the interface between lead support 106 and stimulation lead 110 is intended to be a slip-fit, the inner diameter of the cuff may be greater than or equal to that of stimulation lead 110. For example, the cuff may comprise an inner diameter of about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2.0 mm.

[0076] Lead support 106 may be configured to move with flexures 104, for example, when flexures 104 flex to isolate forces acting on the lead 110. Flexures 104 may allow between 3 mm and 7 mm of longitudinal movement of lead support 106, a longitudinal axis extending at least between a distal end and a proximal end of opening 108 (e.g., relative to the brain). The longitudinal axis may otherwise be defined by the Z-axis in the illustrated coordinate system. In some embodiments, flexures 104 may allow less than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm of longitudinal displacement of lead support 106. In some embodiments, flexures 104 may allow greater than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm of longitudinal displacement of lead support 106. As discussed herein, the movement of lead 110 when disposed in lead support 106 may therefore be controlled by one or more flexures 104 coupled to lead support 106. Thus, stated otherwise, the one or more flexures 104 may control longitudinal movement of stimulation lead 110 when disposed in lead support 106.

[0077] Lead fixation apparatus 100 may comprise a burr hole cover 116 configured to cover at least a portion of opening 108 in the skull. For example, FIG.1A illustrates a portion of a burr hole cover 116 configured to cover opening 108, wherein for illustrative purposes a portion of burr hole cover 116 is removed to depict at least flexures 104 and lead support 106 disposed in opening 108. FIG.1C illustrates a full burr hole cover 116 covering at least a portion of opening 108. Burr hole cover 116 may comprise a shape configured to correspond with the shape ofny-2750753Attorney Docket No: 78895-20032.40 opening 108. For example, in the instance opening 108 is a circular burr hole, the profile of burr hole cover 116 may be a circle. In some embodiments, the profile of burr hole cover 116 may be any shape including but not limited to a square, rectangle, triangle, ellipse, or other polygonal shape. In some embodiments, burr hole cover 116 may comprise a portion (or fraction) of one or more of the aforementioned profile shapes. For example, as shown at least in FIG. 1C, burr hole cover 116 may be configured to cover at least the portion of opening 108 substantially free from components of lead fixation apparatus 100. Thus, the area of opening 108 proximate to mount 102 and the one or more flexures 104 may not be covered by burr hole cover 116. Stated otherwise, burr hole cover 116 may not extend to cover mount 102. In some embodiments, burr hole cover 116 may extend over mount 102 to fully cover opening 108.

[0078] Burr hole cover 116 may be configured to be removably secured to the outer surface of the skull. For example, burr hole cover 116 may comprise one or more fixation portions 118 to secure the cover to the skull. Fixation portions 118 may comprise any one or more features of fixation portions 114 as described herein at least with respect to mount 102. For example, fixation portions 118 may comprise one or more through-holes, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more through-holes. The through-holes may be configured to receive one or more fixation devices (e.g., fasteners), such as bone screws. The one or more through-holes may be disposed along a circumference of burr hole cover 116. In the instance opening 108 is a circular burr hole, the one or more through-holes may instead or additionally be disposed along (e.g., external to) a circumference of opening 108.

[0079] In some embodiments, burr hole cover 116 may be configured to instead or additionally be removably secured to mount 102. For example, at least a portion of fixation portions 118 may align with fixation portions 114 of mount 102 such that a fasteners can be inserted into aligned fixation portions 114 and fixation portions 114 to secure burr hole cover 116 to the skull via mount 102.

[0080] In the instance at least a portion of burr hole cover 116 comprises a circular shape, the burr hole cover 116 may comprise a diameter. The diameter of burr hole 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 burr hole 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. In the instance burr hole cover 116 comprises a shape other than a circle, the aforementioned diameterny-2750753Attorney Docket No: 78895-20032.40 measurements may otherwise be interpreted as a lengthwise dimension extending from a first edge of burr hole cover 116 to a second edge of burr hole cover 116, the lengthwise dimension captured within a plane defined by the X-Y axes of the coordinate system illustrated in FIGS. 1A-1C. For example, the first edge of burr hole cover 116 may be disposed opposite from the second edge of burr hole cover 116 along a Y-axis or X-axis of the illustrated coordinate system.

[0081] A thickness of burr hole cover 116 may be configured such that the cover does not substantially protrude from the outer surface of the skull. The burr hole cover 116 may comprise a uniform or varying thickness throughout the body of burr hole cover 116. For example, the thickness of burr hole 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 burr hole 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.

[0082] As discussed herein, one or more components of lead fixation apparatus 100 (e.g., mount 102, flexures 104, lead support 106, burr hole cover 116) may comprise biocompatible materials. For example, lead fixation apparatus 100 may comprise a single uniform material throughout, or one or more of the aforementioned components may comprise a different material. The biocompatible materials may comprise polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals. Lead Fixation Apparatus Including a Bellows Coupling

[0083] FIG.2 illustrates a lead fixation apparatus 200 in accordance with another exemplary embodiment of the present disclosure. Lead fixation apparatus 200 may comprise a mount 202, a bellows coupling 204 coupled to mount 202, and a lead support 206 coupled to bellows coupling 204. Mount 202 may be configured to mount lead fixation apparatus 200 to a surface of a skull. For example, mount 202 may be mounted to the skull proximate to an opening 208 in the skull for implanting one or more stimulation leads 210. Bellows coupling 204 may be configured to be at least partially disposed in opening 208 of the skull. For example, bellows coupling 204 may extend from mount 202 and into opening 208 in the skull. Lead support 206 may beny-2750753Attorney Docket No: 78895-20032.40 configured to receive a portion of stimulation lead 210 and to maintain a relative position of stimulation lead 210.

[0084] Mount 202 may comprise any one or more features of mount 102 described herein with respect to lead fixation apparatus 100 illustrated in FIGS.1A-1C. For example, mount 202 may be mounted to an outer surface of the skull, as shown in FIG.2. In some embodiments, mount 202 may instead or additionally be mounted to an inner surface of the skull.

[0085] As discussed herein, lead fixation apparatus may comprise a bellows coupling 204 mounted to mount 202. For example, bellows coupling 204 may be coupled to a surface of mount 202 that is directed toward opening 208. In the instance mount 202 is mounted to an outer surface of the skull, bellows coupling 204 may be coupled to and extend from a proximal surface of mount 202 (e.g., relative to the brain). In the instance mount 202 is instead or additionally mounted to an inner surface of the skull, bellows coupling 204 may additionally or instead be coupled to and extend from a distal surface of mount 202.

[0086] As is understood by one of ordinary skill in the art, a bellows coupling can be defined as a flexible coupling with one or more coupling ends (e.g., hubs) that flank a corrugated, flexible tube (e.g., coupling body). The bellows coupling can be precision-engineered to control motion (e.g., angular position and torque). For example, different bellows couplings may provide different combinations of stiffness, radial compensation, and axial motion.

[0087] Lead fixation apparatus 200 as described herein is not intended to be limited to bellows couplings and may instead include other flexible and annular components. For example, lead fixation apparatus 200 may include standard or specially designed springs coupled to mount 202 and lead support 206. Example springs may include but are not limited to diaphragm springs, compression springs, etc. FIG.3 illustrates an exemplary lead fixation apparatus 300 comprising spring components 304 connecting mount 302 to lead support 306. The spring components 304 may be configured to flex to isolate stimulation lead 310 from external forces acting on the lead.

[0088] Mount 202 and bellows coupling 204 may comprise a single rigid body. In some embodiments, mount 202 and bellows coupling 204 may be removably attached. For example, a standard bellows coupling may be selected for use in lead fixation apparatus 200 and may be attached to mount 202. Bellows coupling 204 may be selected, for example, based on the size ofny-2750753Attorney Docket No: 78895-20032.40 opening 208 (e.g., the depth, diameter, etc. of opening 208). In some embodiments, opening 208 may comprise a burr hole.

[0089] At least a portion of bellows coupling 204 (e.g., the coupling body, as discussed herein) may comprise an annular shape. Bellows coupling 204 may comprise at least one through-hole coaxial with the central axis of bellows coupling 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 stimulation lead 210 may be received by a lead support 206 coupled to bellows coupling 204, and a second portion of stimulation lead 210 may be received by bellows coupling 204 (e.g., within the through-hole of bellows coupling 204).

[0090] The length and diameter of bellows coupling 204 may be variable dependent on the state of bellows coupling 204 (e.g., fully expanded, fully contracted, or partially expanded and contracted). An diameter (e.g., an inner and / or outer diameter) of bellows coupling 204 may be between 4 mm and 14 mm. For example, the diameter may 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 may 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.

[0091] The length of bellows coupling 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 bellows coupling 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. Bellows coupling 204 may be configured to contract and expand along the length of opening 208. For example, bellows coupling 204 may contract and expand between 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 99%, of the length of opening 208.

[0092] The wall thickness of bellows coupling 204 may be defined as the difference between an outer diameter and an inner diameter of bellows coupling 204. In the instance bellows coupling 204 is replaced by a spring component in lead fixation apparatus 200, the wall thickness may be the diameter of the coil of the spring. For example, the wall thickness may be between about 0.5 mm and 2 mm. In some embodiments, the wall thickness of bellows coupling 204 may 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 bellows coupling 204 may 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.ny-2750753Attorney Docket No: 78895-20032.40

[0093] Bellows coupling 204 may be configured to bend away from a central axis (e.g., in a direction along the X-axis illustrated in FIG.2 and / or a Y-axis not explicitly illustrated in FIG.2, at least because FIG.2 illustrates a cross-sectional view of lead fixation apparatus 200 in an X-Z plane intersecting the Y-axis). For example, bellows coupling 204 may be configured to bend about 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm.

[0094] Bellows coupling 204 may have a spring constant between 0.01 kg / mm and 1 kg / mm. For example, the spring constant of bellows coupling 204 may 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 bellows coupling 204 may 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.

[0095] As discussed herein, lead fixation apparatus 200 may comprise a lead support 206 coupled to bellows coupling 204. In some embodiments, lead support 206 may be a part of bellows coupling 204. For example, bellows coupling 204 may comprise one or more coupling ends, and a given coupling end disposed within opening 208 may be the lead support 206. In some embodiments, lead support 206 may instead be an individual component and thus may be removably attached to bellows coupling 204.

[0096] Lead support 206 may comprise a through-hole configured to receive a first portion of stimulation lead 110. In some embodiments, lead support 206 may comprise 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 lead support 206.

[0097] Lead support 206 may be configured to removably secure the first portion of stimulation lead 210. For example, lead support 206 may limit lateral movement of stimulation lead 210. The diameter of the through-hole of lead support 106 may be about the same as that of the cuff of stimulation lead 210. In the instance the interface between lead support 206 and stimulation lead 210 is intended to be a press-fit, the diameter of the through-hole of lead support 206 may be less than or equal to that of stimulation lead 210. For example, the diameter of the through-hole may be about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2.0mm.

[0098] Lead support 206 may be configured to move with bellows coupling 204, for example, when bellows coupling 204 moves (e.g., bends, rotates, etc.) to isolate forces acting on stimulation lead 210. Bellows coupling 204 may allow between 3 mm and 7 mm of longitudinalny-2750753Attorney Docket No: 78895-20032.40 displacement of lead support 206, a longitudinal axis extending between at least a distal end and a proximal end of opening 208 (e.g., relative to the brain). As discussed herein, the longitudinal axis may otherwise be defined by the Z-axis in the coordinate system illustrated in FIG.2. In some embodiments, bellows coupling 204 may allow less than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm of longitudinal displacement of lead support 206. In some embodiments, bellows coupling 204 may allow greater than or equal to 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm of longitudinal displacement of lead support 206. The movement of lead 210 when disposed in lead support 206 may therefore be controlled by bellows coupling 204 coupled to lead support 206. Thus, stated otherwise, the bellows coupling 204 may control longitudinal movement of stimulation lead 210 when disposed in lead support 206.

[0099] Although not explicitly illustrated in FIG. 2, it is to be understood that lead fixation apparatus 200 may comprise a cover configured to cover at least a portion of opening 208 and / or a distal opening in bellows coupling 204. The cover may comprise any one or more features of burr hole cover 116 described herein with respect to lead fixation apparatus 100 illustrated in FIGS.1A-1C. For example, the cover of lead fixation apparatus 200 may be configured to be removably secured to the skull and / or to mount 202.

[0100] Lead fixation apparatus 200 (e.g., one or more of mount 202, bellows coupling 204, and / or lead support 206) may comprise one or more biocompatible materials. For example, lead fixation apparatus 200 may comprise one or more biocompatible materials discussed herein with respect to lead fixation apparatus 100. For example, biocompatible materials of mount 202, bellows coupling 204, and / or lead support 206 may comprise one or more of polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals. Method of Mounting a Lead Using a Lead Fixation Apparatus

[0101] A method of mounting a stimulation lead 110 on a skull using lead fixation apparatus 100 may be described herein in accordance with some embodiments. Unless stated otherwise, it is to be understood that the method described herein may be used to mount stimulation lead 210 on a skull using lead fixation apparatus 200.ny-2750753Attorney Docket No: 78895-20032.40

[0102] The method may include generating (e.g., drilling) opening 108 in the surface of the skull. For example, opening 108 may comprise a burr hole generated using a cranial drill (e.g., craniotome).

[0103] In some embodiments, prior to implanting lead fixation apparatus 100, the method may include implanting stimulation lead 110 into the brain via opening 108.

[0104] The method may include mounting mount 102 to the surface of the skull such that one or more flexures 104 coupled to mount 102 are at least partially disposed in opening 108 in the skull. Mount 102 may be mounted to the outer surface of the skull. In some embodiments, mount 102 may instead or additionally be mounted to the inner surface of the skull. As discussed herein, mount 102 may comprise one or more fixation portions 114, each fixation portion 114 configured to receive a corresponding fastener (e.g., bone screw). Thus, mounting mount 102 to the skull may include inserting and fastening one or more fasteners to fixation portions 114 of mount 102.

[0105] In the instance the method discussed herein is used to implant lead fixation apparatus 200, the method may include mounting mount 202 to the surface of the skull such that bellows coupling 204 coupled to the mount is at least partially disposed in opening 208 in the skull.

[0106] In the instance the method discussed herein is used to implant lead fixation apparatus 300, the method may include mounting mount 302 to an inner surface of the skull (e.g., a burr hole surface) such that spring components 304 and lead support 306 can be disposed within the burr hole.

[0107] The method may include inserting stimulation lead 110 into lead support 106 coupled to the one or more flexures 104 such that a first portion of lead 110 is secured by lead support 106. For example, a through-hole of lead support 106 may be configured to receive stimulation lead 110, and a cuff of lead support 106 at least partially surrounding the through-hole may therefore at least partially surround stimulation lead 110, such that the position of lead 110 once inserted into lead support 106 can be maintained.

[0108] The method may include inserting a second portion of stimulation lead 110 into a receiving portion 112 of mount 102. The second portion of lead 110 may be secured to the surface of the skull upon inserting the lead into the receiving portion 112 of mount 102. For example, one or more bridges of receiving portion 112 may be configured to limit theny-2750753Attorney Docket No: 78895-20032.40 displacement of stimulation lead 110 in one or more directions (e.g., at least in a Y-direction and Z-direction in the coordinate system illustrated in FIGS.1A-1C).

[0109] In the instance the method discussed herein is used to implant lead fixation apparatus 200, the method may include inserting the second portion of the lead (e.g., stimulation lead 210) into a through-hole of bellows coupling 204, the through-hole coaxial with a central axis of bellows coupling 204.

[0110] The method for mounting stimulation lead 110 on the skull may include removably securing a burr hole cover 116 to the skull and / or to mount 102 such that at least a portion of opening 108 can be covered by burr hole cover 116. As discussed herein, burr hole cover 116 may comprise one or more fixation portions 118 which may in some embodiments be through- holes. Thus, securing burr hole cover 116 to mount 102 and / or to the skull may comprise inserting and securing one or more fasteners through receiving portions 118 and into the skull (e.g., optionally via mount 102).

[0111] In some embodiments, the method may comprise connecting stimulation lead 110 to an implantable pulse generator (IPG). For example, the IPG may be implanted in the skull, and prior to implantation, stimulation lead 110 may be connected to the IPG.

[0112] Variations in the order of steps and / or the manner in which one or more of the aforementioned steps are executed will be known to one of ordinary skill in the art and are understood to be covered within the scope of the disclosure provided herein. For example, mounting mount 102 to the surface of the skull may be executed before or after insertion of stimulation lead 110 into receiving portion 112 of mount 102 and / or lead support 106. In another example, mount 102 may be fixed to the surface of the skull in a different manner and / or using different tools than that which is described herein.

[0113] Unless defined otherwise, all terms of art, notations and other technical and scientific terms or terminology used herein are intended to have the same meaning as is commonly understood by one of ordinary skill in the art to which the claimed subject matter pertains. In some cases, terms with commonly understood meanings are defined herein for clarity and / or for ready reference, and the inclusion of such definitions herein should not necessarily be construed to represent a substantial difference over what is generally understood in the art.

[0114] As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understoodny-2750753Attorney Docket No: 78895-20032.40 that the term “and / or” as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms “includes, “including,” “comprises,” and / or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or units but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.

[0115] The numerical ranges disclosed inherently support any range or value within the disclosed numerical ranges, including the endpoints, even though a precise range limitation is not stated verbatim in the specification because this disclosure can be practiced throughout the disclosed numerical ranges.

[0116] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated.

[0117] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.ny-2750753

Claims

Attorney Docket No: 78895-20032.40 CLAIMS What is claimed is:

1. A lead fixation apparatus, comprising: a mount configured to mount the lead fixation apparatus to a surface of a skull; one or more flexures coupled to the mount and configured to be at least partially disposed in an opening in the skull; and a lead support coupled to the one or more flexures and configured to receive a first portion of a lead.

2. The lead fixation apparatus of claim 1, wherein the mount comprises a receiving portion configured to receive a second portion of the lead.

3. The lead fixation apparatus of claim 2, wherein the receiving portion of the mount is configured to secure the second portion of the lead to the surface of the skull.

4. The lead fixation apparatus of any one of claims 1-3, wherein the surface of the skull to which the lead fixation apparatus is configured to be mounted is an outer surface of the skull.

5. The lead fixation apparatus of any one of claims 1-4, wherein the one or more flexures are configured to flex to isolate a force acting on the lead.

6. The lead fixation apparatus of any one of claims 1-5, wherein the one or more flexures are configured to maintain a relative position of the first portion of the lead and the lead support.

7. The lead fixation apparatus of any one of claims 1-6, wherein the lead support is configured to removably secure the first portion of the lead.

8. The lead fixation apparatus of any one of claims 1-7, comprising a burr hole cover configured to cover at least a portion of the opening in the skull.ny-2750753Attorney Docket No: 78895-20032.40 9. The lead fixation apparatus of claim 8, wherein the burr hole cover is configured to be removably secured to the skull and / or to the mount.

10. The lead fixation apparatus of any one of claims 1-9, wherein the opening is a burr hole.

11. The lead fixation apparatus of any one of claims 1-10, wherein the one or more flexures are configured to allow between 3 mm and 7 mm of longitudinal movement of the lead support, a longitudinal axis extending between a distal end of the opening and a proximal end of the opening.

12. The lead fixation apparatus of any one of claims 1-11, wherein one or more of the mount, the one or more flexures, and the lead support comprises a biocompatible material.

13. The lead fixation apparatus of claim 12, wherein the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

14. A deep brain stimulation system, comprising: the lead fixation apparatus of claim 1; at least one lead configured to be received by the lead support of the lead fixation apparatus and implanted into a brain; and a pulse generator configured to be implanted in the skull and coupled to the at least one lead.

15. A method of mounting a lead on a skull, the method comprising: mounting a mount to a surface of the skull such that one or more flexures coupled to the mount is at least partially disposed in an opening in the skull; and inserting the lead into a lead support coupled to the one or more flexures such that a first portion of the lead is secured by the lead support.ny-2750753Attorney Docket No: 78895-20032.40 16. The method of claim 15, comprising generating the opening in the surface of the skull.

17. The method of claim 15 or 16, comprising inserting a second portion of the lead into a receiving portion of the mount.

18. The method of claim 17, wherein inserting the second portion of the lead into the receiving portion of the mount comprises securing the second portion of the lead to the surface of the skull.

19. The lead fixation apparatus of any one of claims 15-18, wherein the surface of the skull to which the mount is mounted is the outer surface of the skull.

20. The method of any one of claims 15-19, comprising implanting the lead into a brain.

21. The method of any one of claims 15-20, comprising removably securing a burr hole cover to the skull and / or mount such that at least a portion of the opening is covered by the burr hole cover.

22. The method of any one of claims 15-21, wherein the one or more flexures are configured to flex to isolate a force acting on the lead.

23. The method of any one of claims 15-22, wherein the one or more flexures are configured to maintain a relative position of the first portion of the lead and the lead support.

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

25. The method of any one of claims 15-24, wherein the opening is a burr hole.ny-2750753Attorney Docket No: 78895-20032.40 26. A lead fixation apparatus, comprising: a mount configured to mount the lead fixation apparatus to a surface of a skull; a bellows coupling coupled to the mount and configured to be at least partially disposed in an opening in the skull; and a lead support coupled to the bellows coupling and configured to receive a first portion of a lead.

27. The lead fixation apparatus of claim 26, wherein a diameter of the bellows coupling is between 4 mm and 14 mm.

28. The lead fixation apparatus of claim 26 or claim 27, wherein a wall thickness of the bellows coupling is between 0.5 mm and 2 mm.

29. The lead fixation apparatus of any one of claims 26-28, wherein the bellows coupling has a spring constant between 0.01 kg / mm and 1 kg / mm.

30. The lead fixation apparatus of any one of claims 26-29, wherein the bellows coupling is configured to maintain a relative position of the first portion of the lead and the lead support.

31. The lead fixation apparatus of any one of claims 26-30, wherein the lead support is configured to removably secure the first portion of the lead.

32. The lead fixation apparatus of any one of claims 26-31, wherein the bellows coupling comprises a through-hole coaxial with the central axis of the bellows coupling and configured to receive a second portion of the lead.

33. The lead fixation apparatus of any one of claims 26-32, comprising a burr hole cover configured to cover at least a portion of the opening in the skull.

34. The lead fixation apparatus of claim 33, wherein the burr hole cover is configured to be removably secured to the skull and / or to the mount.ny-2750753Attorney Docket No: 78895-20032.40 35. The lead fixation apparatus of any one of claims 26-34, wherein the opening is a burr hole.

36. The lead fixation apparatus of any one of claims 26-35, wherein the bellows coupling is configured to allow between 3 mm and 7 mm of longitudinal displacement of the lead support, a longitudinal axis extending between a distal end of the opening and a proximal end of the opening.

37. The lead fixation apparatus of any one of claims 26-36, wherein one or more of the mount, the bellows coupling, and the lead support comprises a biocompatible material.

38. The lead fixation apparatus of claim 37, wherein the biocompatible material comprises polypropylene, polyethylene, polyether ether ketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), Polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

39. A deep brain stimulation system, comprising: the lead fixation apparatus of claim 26; at least one lead configured to be received by the lead support of the lead fixation apparatus; and a pulse generator configured to be implanted in the skull and coupled to the at least one lead.

40. A method of mounting a lead on a skull, the method comprising: mounting a mount to a surface of the skull such that a bellows coupling coupled to the mount is at least partially disposed in an opening in the skull; and inserting the lead into a lead support coupled to the bellows coupling such that a first portion of the lead is secured by the lead support.

41. The method of claim 40, comprising generating the opening in the surface of the skull. 27ny-2750753Attorney Docket No: 78895-20032.40 42. The method of claim 40 or claim 41, comprising inserting a second portion of the lead into a through-hole of the bellows coupling coaxial with a central axis of the bellows coupling.

43. The method of any one of claims 40-42, comprising implanting the lead into a brain.

44. The method of any one of claims 40-43, comprising removably securing a burr hole cover to the skull and / or mount such that at least a portion of the opening is covered by the burr hole cover.

45. The method of any one of claims 40-44, wherein the bellows coupling is configured to maintain a relative position of the first portion of the lead and the lead support.

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

47. The method of any one of claims 40-46, wherein the opening is a burr hole.ny-2750753

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