Lead fixing device and method of use thereof

Abstract

This specification provides a lead fixing device and a method for using the lead fixing device to attach a stimulation lead to the skull. The lead fixing device may be used to attach a stimulation lead for deep brain stimulation. The lead fixing device may allow axial floating of the lead while maintaining the relative position of the stimulation lead. The lead fixing device may include one or more flexures or bellows couplings to isolate the forces acting on the lead while maintaining the position of the stimulation lead.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority and benefit to U.S. Provisional Patent Application No. 63 / 509,233, filed on June 20, 2023, the content of which is incorporated herein by reference in its entirety.

[0002] [Technical Field] The present disclosure generally relates to lead fixation devices, and more particularly to lead fixation devices for deep brain stimulation (DBS) systems that allow for axial float of the lead.

Background Art

[0003] Deep brain stimulation (DBS) is a neurostimulation therapy used to treat neurodegenerative diseases such as epilepsy and Parkinson's disease (PD). In DBS, an artificial current is supplied to specific regions of the brain to stimulate neurons, thereby alleviating the symptoms experienced in various brain diseases. For example, in Parkinson's disease patients, high - frequency stimulation is supplied to regions of the basal ganglia (e.g., the subthalamic nucleus (STN) or the globus pallidus interna (GPi)), correcting the imbalance between excitation and inhibition in the basal ganglia circuit. DBS can alleviate the motor symptoms experienced in Parkinson's disease and reduce the need for pharmacological treatment.

[0004] A deep brain stimulation (DBS) system typically includes 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, which allow for lead implantation into the brain. The area of ​​the brain into which the stimulation leads can be implanted depends on the condition of the brain being treated. Therefore, to maintain the effectiveness of DBS, it is crucial that the stimulation leads do not displace over time within the brain tissue. To maintain the implantation position of the stimulation leads, they can be fixed to the patient's skull after implantation into the brain. For example, the stimulation leads may be fixed using lead clamps placed near the openings in the skull. However, the brain is known to move relative to the skull, which, in contrast to fixed leads, can stress the leads, thereby weakening or even damaging them. Leads can also shift from their intended implantation site, potentially damaging brain tissue or reducing the effectiveness of DBS. Each of the aforementioned consequences, such as displacement, weakening, and / or breakage of the stimulation lead, may require subsequent surgical intervention to fix, reconnect, or replace the lead. Additional surgical intervention may increase the risk of intraoperative and / or postoperative surgical complications, such as infection, bleeding, swelling, and, in more severe cases, coma, sepsis, and stroke. [Overview of the Initiative]

[0005] This specification describes a lead fixation device and a method for using the lead fixation device to attach a stimulation lead, for example, implanted for deep brain stimulation, to the skull. The lead fixation device may be designed to allow axial floating of the stimulation lead relative to the skull. For example, the lead fixation device may be positioned at least partially in an opening in the skull and comprise one or more flexible flexures and / or bellows couplings to isolate forces acting on the lead. The lead fixation device may comprise a skull-mountable mount to allow the lead to move with the brain (for example, relative to the skull) while maintaining the relative position of the stimulation lead implanted in the brain. Thus, 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 device is provided, comprising: a mount configured to be attached to the surface of a skull; one or more flexures coupled to the mount and configured to be at least partially positioned 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 includes a receiving portion configured to receive the 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 fixing device is attached is the outer surface of the skull.

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

[0011] In some embodiments, the one or more flexures are configured to maintain the relative position between the first portion of the lead and the lead support.

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

[0013] In some embodiments, the lead fixing device includes a bur 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 fastened to the skull and / or the mount.

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

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

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

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

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

[0020] In some embodiments, a method is provided for attaching a lead to a skull, comprising: attaching a mount to the surface of the skull such that one or more flexures coupled to a mount are at least partially positioned in an opening in the skull; and inserting the lead into the lead support, which is 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 includes generating the opening on the surface of the skull.

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

[0023] In some embodiments, inserting the second portion of the lead into the receiving portion of the mount includes securing the second portion of the lead to the surface of the skull.

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

[0025] In some embodiments, the method includes implanting a lead in the brain.

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

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

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

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

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

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

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

[0033] In some embodiments, the 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 the relative position between the first portion of the lead and the lead support.

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

[0037] In some embodiments, the bellows coupling is configured to have a through-hole coaxial with the central axis of the bellows coupling and to receive a second portion of the lead.

[0038] In some embodiments, the lead fixing device includes a bur 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 fastened to the skull and / or the mount.

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

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

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

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

[0044] 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 embedded in the skull and configured to be coupled to the at least one lead.

[0045] In some embodiments, a method is provided for attaching a lead to a skull, comprising: attaching a mount to the surface of the skull such that a bellows coupling coupled to a mount is at least partially positioned in an opening in the skull; and inserting the lead into the 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 includes generating the opening on the surface of the skull.

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

[0048] In some embodiments, the method includes implanting a lead in the brain.

[0049] In some embodiments, the method includes removably fastening the bur hole cover to the skull and / or mount such that at least a portion of the opening is covered by the bur hole cover.

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

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

[0052] In some embodiments, the opening is a bar hole. [Brief explanation of the drawing]

[0053] Various aspects of the disclosed systems and methods are described in detail in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by referring to the detailed description of the exemplary embodiments and the appended drawings.

[0054] [Figure 1A] A perspective view of a first lead fixing device with a partially removed burr hole cover, according to several embodiments, is shown.

[0055] [Figure 1B] Another perspective view of the first lead fixing device according to several embodiments is shown.

[0056] [Figure 1C] Another perspective view of a first lead fixing device with a burr hole cover, according to several embodiments, is shown.

[0057] [Figure 2] Cross-sectional views of a second lead fixing device according to several embodiments are shown.

[0058] [Figure 3] A cross-sectional view of a third lead fixing device according to several embodiments is shown. [Modes for carrying out the invention]

[0059] A lead fixation device and its use are described herein. This lead fixation device may be used to attach a stimulation lead implanted for deep brain stimulation (DBS) to the skull. This lead fixation device allows the stimulation lead to float axially relative to the skull, thereby allowing the lead to move with the brain (e.g., if the brain shifts relative to the skull). For example, the lead fixation device may include a bellows coupling and / or flexure that can be bent to isolate forces (e.g., stress) acting on the implanted stimulation lead. The lead fixation devices described herein can prevent the lead from loosening and / or moving away from its implantation site in the brain, and can also prevent excessive stress on the lead due to conflicting forces between the lead fixation device and the 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, 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 patient's skull. It will be understood by those skilled in the art that the lead fixation devices described herein are not limited to deep brain stimulation (DBS) systems with intracranially mounted pulse generators, but may be used in other DBS systems, and are not limited thereto. For example, the pulse generator in a DBS system may be implanted in a soft tissue pocket in the patient's upper chest, and one or more extension leads may be tunneled under the skin to connect the stimulation lead to the pulse generator.

[0061] Lead fixing devices and methods of use thereof can be described in relation to various embodiments, such as the first embodiment shown in Figures 1A-1C and the second embodiment shown in Figure 2. It should be understood that the lead fixing devices described herein are not exclusively limited to the features described in the drawings, and any combination of the features described herein can be embodied in exemplary lead fixing devices.

[0062] [Lead fixing device with flexure] Figures 1A-1C show a lead fixation device 100 according to an exemplary embodiment of the present disclosure. The lead fixation device 100 may comprise a mount 102, one or more flexures 104 coupled to the mount 102, and a lead support 106 coupled to the flexures 104. The mount 102 may be configured to attach the lead fixation device 100 to the surface of the skull. For example, the mount 102 may be attached to the skull near an opening 108 in the skull for implanting one or more stimulation leads 110. The flexures 104 may be configured to be at least partially positioned in the opening 108 of the skull. For example, the flexures 104 may extend outward from the side of the mount 102 and into the opening 108 of the skull. The lead support 106 may be configured to receive a portion of the stimulation lead 110 and maintain the relative position of the stimulation lead 110.

[0063] As shown in Figures 1A-1C, the mount 102 of the lead fixing device 100 may be attached to the outer surface of the skull. In some embodiments, the mount 102 may be attached to the inner surface of the skull instead or additionally. For example, Figure 3 shows a lead fixing device 300 in which the mount 302 is attached to the surface of the skull within a bur hole.

[0064] The mount 102 may include a receiving portion 112 configured to receive the stimulation lead 110. For example, the lead support 106 may be configured to receive a first portion of the lead 110, and the receiving portion 112 of the mount 102 may be configured to receive a second portion of the lead 110. The receiving portion 112 of the mount 102 may be configured to maintain the position of the second portion of the lead 110. For example, the receiving portion 112 of the mount 102 may restrict the lateral movement of the portion of the lead 110 positioned within the receiving portion 112 (e.g., movement along the Y-axis of the coordinate system shown in Figures 1A-1C). Alternatively or additionally, the receiving portion 112 of the mount 102 may 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 to allow the stimulation lead 110 to move axially (for example, along the longitudinal axis of the lead 110 or along the X-axis of the illustrated coordinate system) such that the interface between the receiving portion 112 of the mount 102 and the stimulation lead 110 constitutes a slip fit. In some embodiments, the receiving portion 112 of the mount 102 may restrict at least a portion of the movement of the lead 110 relative to the mount 102 such that the interface between the receiving portion 112 of the mount 102 and the stimulation lead 110 constitutes a press fit. Thus, in at least one direction, the receiving portion 112 of the mount 102 may be configured to secure a second portion of the stimulation lead 110 to the surface of the skull.

[0065] As shown, one or more bridges (i.e., protrusions relative to the outer surface of the skull) may function as the receiving portion 112 of the mount 102. One or more bridges may be isolated by notches and configured to receive the stimulation lead 110. The receiving portion 112 of the mount 102 may comprise two, three, four, or more bridges, with each set of bridges isolated by notches. In some embodiments, the receiving portion 112 of the mount 102 may comprise a single protrusion, i.e., a bridge, that can extend along any length of the mount 102 (for example, along a length defined by the X-axis of the illustrated coordinate system). For example, a single bridge may extend between a side of the mount 102 adjacent to the opening 108 of the skull and a side of the mount 102 distal to the opening 108. In other embodiments, a single bridge may extend along the length of the mount 102 between a first midpoint and a second midpoint, such that at least one of the ends of the bridge can be held in place by notches.

[0066] As discussed herein, the length of the mount 102 may be defined as the length extending along the X-axis of the illustrated coordinate system between the edge of the opening 108 and the distal end of the mount 102. In some embodiments, the length of the mount 102 may be about 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, or 20 mm or less. In some embodiments, the length of the mount 102 may be about 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, or 20 mm or more.

[0067] The mount 102 may have one or more fixing portions 114. The fixing portions 114 may be configured to fix or fasten the mount 102 to the skull. The fixing portions 114 may have one or more through holes configured to receive fasteners, such as bone screws or other fasteners known to those skilled in the art for fastening implants to the body. For example, the fixing portion 114 may have 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 arranged to sandwich (e.g., surround laterally) the receiving portion 112 of the mount 102, as shown in Figures 1A-1C. For example, if the receiving portion 112 of the mount 102 has two raised bridges (as shown in Figures 1A-1C), the mount 102 may have a pair of fixing portions 114 (e.g., through holes), each through hole positioned laterally to a given bridge. Each fixing part 114 in a pair of fixing parts 114 may be positioned at a predetermined distance from each other. For example, the distance may be greater than or equal to the minimum distance required to position at least one stimulation lead 110 between the pair of fixing parts 114. In some embodiments, the distance between the first fixing part 114 on the first side of the receiving part 112 of the mount 102 and the second fixing part 114 on the second side of the receiving part 112 of the mount 102 (e.g., measured between the center points of the fixing parts) may be 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, or 11 mm or less. In some embodiments, the distance between the sets of the first and second fixing parts 114 may be 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5 mm, or 11 mm or more. If the fixing portion 114 has one or more through holes configured to receive fasteners, the diameter of one or more through holes may be 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 or less. In some embodiments, the diameter of one or more through holes may be 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 or more.

[0068] As discussed herein, the lead fixing device 100 may comprise one or more flexures 104 coupled to a mount 102. For example, the lead fixing device 100 may comprise one, two, three, four, or more flexures 104. The flexures 104 may be configured to be at least partially positioned in an opening 108 of the skull. For example, the opening 108 may be a burr hole, and the flexures 104 may be positioned within the burr hole and along its edge. If the mount 102 is attached to the outer surface of the skull, the flexures 104 may be positioned along the outer edge of the opening 108. On the other hand, if the mount 102 is attached to the inner surface of the skull, the flexures 104 may be positioned along the inner edge of the skull.

[0069] One or more flexures 104 may be configured to bend to isolate any forces that may act on the stimulating lead 110. For example, as discussed herein, the brain can move naturally relative to the skull. Therefore, if a portion of the stimulating lead 110 is embedded in the brain and another portion is fixed to the outer surface of the skull (for example, using a mount 102 as discussed herein), the stimulating lead 110 may feel tension that can cause shear stress in the lead 110, which, if not mitigated, could lead to displacement and / or weakening of the lead 110 over time, or in the worst case, breakage. To counteract these forces, the flexures 104 may be configured to bend (or flex) in accordance with the movement of the brain relative to the skull. Similarly, the stimulating lead 110 may feel tensile forces from the other end of the lead (for example, from the end of the lead 110 connected to a pulse generator, and / or from one or more extension leads connecting the stimulating lead 110 to a pulse generator). Therefore, the flexure 104 may be configured to isolate the stimulated lead 110 from various external forces acting on the lead.

[0070] The amount of bending allowed by one or more flexures 104 may be controlled based on one or more dimensions of the flexure 104. For example, the thickness of the flexure 104 may be proportional to the flexibility of the flexure 104. The thickness of the flexure 104 may be uniform throughout the body of the flexure 104. In some embodiments, different parts of the flexure 104 may have different thicknesses. The thickness of the flexure 104 may depend on the material and / or shape of the flexure 104. The thickness of the flexure 104 may be about 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm or less. In some embodiments, the thickness of the flexure 104 may be about 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm or more. This flexibility may be controlled additionally or instead based on the material of the flexure 104. For example, the material properties of the flexure 104 may affect the amount by which one or more flexures 104 can bend. In some embodiments, the mount 102, flexure 104, and / or lead support 106 of the lead fixing device 100 may be configured as a single rigid body having a uniform material composition. For example, the material may include one or more of the following: polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer mixtures, or medical-grade metal mixtures.

[0071] By resisting any tension and / or tensile force acting on the stimulating lead 110, the flexures 104 may maintain a lead support 106 coupled to one or more flexures 104, and consequently, the lead 110 positioned within the lead support 106. For example, the position of a first portion of the stimulating lead 110 (e.g., the portion of the lead 110 extending into the opening 108) in the plane defined by the XY axes in the coordinate axes shown in Figures 1A-1C may be restricted by the flexures 104.

[0072] As discussed herein, the flexures 104 may be configured such that they can be positioned at least partially within the opening 108 of the skull. For example, a first portion of the flexure 104 coupled to and extending from a mount 102 may be positioned along the surface of the skull. A second portion of the flexure 104 extends from the first portion of the flexure 104 in a direction transverse to the first portion of the flexure 104, and as a result, the second portion extends into the opening along the wall of the opening 108. For example, the second portion of the flexure 104 may extend into the opening 108 by about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more, from the distal end of the opening 108 (e.g., distal to the brain) to the proximal end of the opening 108. If the mount 102 is embedded in the inner surface of the skull, the second portion of the flexure 104 may extend from the proximal end of the opening 108 to the distal end of the opening 108. The third portion of the flexure 104 may extend from the second portion of the flexure 104 in a direction transverse to the second portion of the flexure 104. In other words, the third portion and the first portion of the flexure 104 may be substantially parallel. The third portion of the flexure 104 may extend from the wall of the opening 108 toward the central axis of the opening 108 (for example, the axis corresponding to the Z-axis in the coordinate system shown in Figure 1). For example, if the opening 108 has a circular bur hole, the lead support 106 coupled to one end of the flexure 104 (for example, the end of the flexure 104 opposite to the end coupled to the mount 102) may be approximately located within the central portion surrounding the central axis of the bur hole. Therefore, the flexure 104 may extend from the wall of the opening 108 toward the central portion within the opening 108 and terminate at a lead support 106 located in the central portion.

[0073] If the lead fixing device 100 includes a plurality of flexures 104 (for example, two or more flexures shown in Figures 1A-1C), the flexures 104 may be arranged at a predetermined distance from each other. For example, the distance between a first flexure and a second flexure may correspond to the distance between the first and second fixing parts of the fixing part 114, as discussed herein. The distance between the first and second flexures 104 may be uniform or variable along the length of the flexure 104. For example, one or more of the flexures 104 may be inclined inward from each other or inclined outward from each other. The flexures 104 may be inclined toward and away from each other in one or more parts of the flexure 104 as discussed herein (for example, a first part, a second part, and / or a third part). In some embodiments, the distance between the first flexure and the second flexure may be about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm or less.

[0074] As discussed herein, the lead fixing device 100 may comprise a lead support 106 coupled to one or more flexures 104. The lead support 106 may be configured to receive a portion of the stimulating lead 110. For example, the lead support 106 may be configured to receive a first portion of the lead 110, and the mount 102 (more specifically, the receiving portion 112 of the mount 102) may be configured to receive a second portion of the lead 110. The lead support 106 may comprise a cuff configured to surround at least a portion of the stimulating lead 110 when placed within the lead support 106. The cuff of the lead support 106 may extend longitudinally (for example, along the Z-axis in the coordinate system shown in Figures 1A-1C). The cuff of the lead support 106 may surround at least a portion of the stimulating lead 110 when detachably inserted into the lead support 106 so that the position of the stimulating lead 110 is maintained by the lead support 106. For example, the cuff of the lead support 106 may have a partially annular shape with a notch configured to allow the user to insert the stimulation lead 110 into the cuff of the lead support 106. In some embodiments, the cuff of the lead support 106 may extend to enclose at least about 50%, 60%, 70%, 80%, or 90% of the circumference of the cuff (depending on, for example, the diameter of the stimulation lead 110).

[0075] The lead support 106 may be configured to detachably retain the first portion of the stimulation lead 110. For example, the lead support 106 may restrict the lateral movement of the stimulation lead 110 (e.g., movement in a plane defined by the XY axes in the coordinate system shown in Figures 1A-1C). The inner diameter of the cuff of the lead support 106 may be approximately the same as the inner diameter of the stimulation lead 110. If the interface between the lead support 106 and the stimulation lead 110 is intended to be press-fit, the inner diameter of the cuff of the lead support 106 may be less than or equal to the inner diameter of the stimulation lead 110. On the other hand, if the interface between the lead support 106 and the stimulation lead 110 is intended to be slip-fit, the inner diameter of the cuff may be greater than or equal to the inner diameter of the stimulation lead 110. For example, the cuff may have 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.

[0076] The lead support 106 may be configured to move with the flexure 104, for example, when the flexure 104 bends to isolate the force acting on the lead 110. The flexure 104 may allow longitudinal movement of the lead support 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). This longitudinal axis may be defined by the Z-axis in the given coordinate system. In some embodiments, the flexure 104 may allow longitudinal displacement of the lead support 106 of 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm or less. In some embodiments, the flexure 104 may allow longitudinal displacement of the lead support 106 of 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm or more. As discussed herein, the movement of the lead 110 when placed within the lead support 106 may therefore be controlled by one or more flexures 104 coupled to the lead support 106. In other words, one or more flexures 104 may control the longitudinal movement of the stimulating lead 110 when placed within the lead support 106.

[0077] The lead fixing device 100 may include a bur hole cover 116 configured to cover at least a portion of the opening 108 in the skull. For example, Figure 1A shows a portion of a bur hole cover 116 configured to cover the opening 108, where, for illustrative purposes, a portion of the bur hole cover 116 has been removed to show at least the flexure 104 and lead support 106 located within the opening 108. Figure 1C shows the complete bur hole cover 116 covering at least a portion of the opening 108. The bur hole cover 116 may have a shape configured to correspond to the shape of the opening 108. For example, if the opening 108 is a circular bur hole, the profile of the bur hole cover 116 may be circular. In some embodiments, the profile of the bur hole cover 116 may be any shape, including but not limited to a square, rectangle, triangle, ellipse, or other polygon. In some embodiments, the bur hole cover 116 may have one or more portions (or parts) of the aforementioned profile shapes. For example, as shown in Figure 1C at least, the bar hole cover 116 may be configured to cover at least that portion of the opening 108 where components of the lead fixing device 100 are substantially absent. Thus, the area of ​​the opening 108 adjacent to the mount 102 and one or more flexures 104 does not have to be covered by the bar hole cover 116. In other words, the bar hole cover 116 does not have to extend to cover the mount 102. In some embodiments, the bar hole cover 116 may extend over the mount 102 to completely cover the opening 108.

[0078] The bur hole cover 116 may be configured to be removably fastened to the outer surface of the skull. For example, the bur hole cover 116 may have one or more fasteners 118 for fastening the cover to the skull. The fasteners 118 may have one or more features of the fasteners 114, as described herein with respect to at least the mount 102. For example, the fasteners 118 may have one or more through-holes, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more through-holes. These through-holes may be configured to receive one or more fasteners (e.g., fasteners), such as bone screws. One or more through-holes may be arranged along the circumference of the bur hole cover 116. If the opening 108 is a circular bur hole, one or more through-holes may instead or additionally be arranged along the circumference of the opening 108 (e.g., externally).

[0079] In some embodiments, the bar hole cover 116 may be configured to be removably fastened to the mount 102, either separately or additionally. For example, at least a portion of the fastener 118 may be aligned with the fastener 114 of the mount 102 so that a fastener is inserted into the fastener 114 and fastener 114 to fasten the bar hole cover 116 to the skull via the mount 102.

[0080] If at least a portion of the bar hole cover 116 is circular, the bar hole cover 116 may have a diameter. The diameter of the bar hole cover 116 may be about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm or less. In some embodiments, the diameter of the bar hole cover 116 may be about 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm or more. If the bar hole cover 116 has a shape other than a circle, the above diameter measurement may be interpreted as a length dimension extending from the first edge of the bar hole cover 116 to the second edge of the bar hole cover 116, captured in the plane defined by the XY axes of the coordinate system shown in Figures 1A-1C. For example, the first edge of the bar hole cover 116 may be located on the opposite side of the second edge of the bar hole cover 116 along the Y axis or X axis of the illustrated coordinate system.

[0081] The thickness of the 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 have a uniform or varying thickness throughout its body. For example, the thickness of the burr hole cover 116 may be about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm or less. In some embodiments, the thickness of the burr hole cover 116 may be about 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm or more.

[0082] As discussed herein, one or more components of the lead fixation device 100 (e.g., mount 102, flexure 104, lead support 106, burr hole cover 116) may include biocompatible materials. For example, the lead fixation device 100 may consist of a single, uniform material throughout, or one or more of the above components may consist of different materials. Biocompatible materials may include polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer mixtures, or medical-grade metal mixtures.

[0083] [Lead fixing device equipped with bellows coupling] Figure 2 shows a lead fixation device 200 according to another exemplary embodiment of the present disclosure. The lead fixation device 200 may comprise a mount 202, a bellows coupling 204 coupled to the mount 202, and a lead support 206 coupled to the bellows coupling 204. The mount 202 may be configured to attach the lead fixation device 200 to the surface of the skull. For example, the mount 202 may be attached to the skull near an opening 208 in the skull for implanting one or more stimulation leads 210. The bellows coupling 204 may be configured to be at least partially positioned in the opening 208 of the skull. For example, the bellows coupling 204 may extend from the mount 202 into the opening 208 of the skull. The lead support 206 may be configured to receive a portion of the stimulation lead 210 and maintain the relative position of the stimulation lead 210.

[0084] Mount 202 may have one or more features of the mount 102 described herein in relation to the lead fixing device 100 shown in Figures 1A-1C. For example, Mount 202 may be attached to the outer surface of the skull, as shown in Figure 2. In some embodiments, Mount 202 may be attached to the inner surface of the skull, either instead or additionally.

[0085] As discussed herein, the lead fixation device may include a bellows coupling 204 attached to a mount 202. For example, the bellows coupling 204 may be coupled to the surface of the mount 202 facing the opening 208. If the mount 202 is attached to the outer surface of the skull, the bellows coupling 204 may be coupled to the proximal surface of the mount 202 (e.g., relative to the brain) and extending from there. If the mount 202 is attached to the inner surface of the skull instead or additionally, the bellows coupling 204 may be coupled to the distal surface of the mount 202 and extending from there, additionally or instead.

[0086] As will be understood by those skilled in the art, a bellows coupling may be defined as a flexible coupling having one or more coupling ends (e.g., hubs) that sandwich a corrugated flexible tube (e.g., coupling body). A bellows coupling may be precisely designed 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] The lead fixing device 200 described herein is not intended to be limited to a bellows coupling and may instead include other flexible and annular components. For example, the lead fixing device 200 may include a standard or specially designed spring coupled to the mount 202 and the lead support 206. Exemplary springs include, but are not limited to, diaphragm springs and compression springs. Figure 3 shows an exemplary lead fixing device 300, which includes a spring component 304 connecting the mount 302 to the lead support 306. The spring component 304 may be configured to flex in order to isolate the stimulated lead 310 from external forces acting on the stimulated lead 310.

[0088] The mount 202 and the bellows coupling 204 may be configured as a single rigid body. In some embodiments, the mount 202 and the bellows coupling 204 may be detachably mounted. For example, a standard bellows coupling may be selected for use in the lead fixing device 200 and mounted on the mount 202. The bellows coupling 204 may be selected based, for example, on the size of the opening 208 (e.g., depth, diameter of the opening 208). In some embodiments, the opening 208 may have a bar hole.

[0089] At least a portion of the bellows coupling 204 (for example, the coupling body discussed herein) may have an annular shape. The bellows coupling 204 may have at least one through-hole coaxial with the central axis of the bellows coupling 204. The through-hole may be configured to receive a portion of the stimulating lead 210. For example, as discussed herein, a first portion of the stimulating lead 210 may be received by a lead support 206 coupled to the bellows coupling 204, and a second portion of the stimulating lead 210 may be received by the bellows coupling 204 (for example, within the through-hole of the bellows coupling 204).

[0090] The length and diameter of the bellows coupling 204 may be variable depending on the state of the bellows coupling 204 (e.g., fully expanded, fully contracted, or partially expanded and contracted). The diameter of the bellows coupling 204 (e.g., inner and / or outer diameter) may be between 4 mm and 14 mm. For example, the diameter may be 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm or less. In some embodiments, the inner and / or outer diameter may be 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, or 14 mm or more.

[0091] The length of the bellows coupling 204 may be approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm or less. In some embodiments, the length of the bellows coupling 204 may be approximately 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm or more. The bellows coupling 204 may be configured to contract and expand along the length of the opening 208. For example, the bellows coupling 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.

[0092] The wall thickness of the bellows coupling 204 may be defined as the difference between the outer diameter and the inner diameter of the bellows coupling 204. If the bellows coupling 204 is replaced by a spring component in the lead fixing device 200, the wall thickness may be the diameter of the spring coil. For example, the wall thickness may be between approximately 0.5 mm and 2 mm. In some embodiments, the wall thickness of the bellows coupling 204 may be approximately 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm or less. In some embodiments, the wall thickness of the bellows coupling 204 may be approximately 0.5 mm, 0.75 mm, 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm or more.

[0093] The bellows coupling 204 may be configured to bend away from the central axis (for example, in the direction along the X axis shown in Figure 2, and / or in the direction along the Y axis not explicitly shown in Figure 2, at least so that Figure 2 shows a cross-sectional view of the lead fixing device 200 in the XZ plane intersecting the Y axis). For example, the bellows coupling 204 may be configured to bend by about 1 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2 mm.

[0094] The bellows coupling 204 may have a spring constant between 0.01 kg / mm ​​and 1 kg / mm. For example, the spring constant of the bellows coupling 204 may be 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 ​​or less. In some embodiments, the spring constant of the bellows coupling 204 may be 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 ​​or more.

[0095] As discussed herein, the lead fixing device 200 may include a lead support 206 coupled to a bellows coupling 204. In some embodiments, the lead support 206 may be part of the bellows coupling 204. For example, the bellows coupling 204 may have one or more coupling ends, and a particular coupling end located within the opening 208 may be the lead support 206. In some embodiments, the lead support 206 may instead be a separate component and therefore may be detachably attached to the bellows coupling 204.

[0096] The lead support 206 may have a through-hole configured to receive a first portion of the stimulating lead 110. In some embodiments, the lead support 206 may have 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 support 206.

[0097] The lead support 206 may be configured to detachably secure the first portion of the stimulation lead 210. For example, the lead support 206 may restrict the lateral movement of the stimulation lead 210. The diameter of the through-hole in the lead support 106 may be approximately the same as the diameter of the cuff of the stimulation lead 210. If the interface between the lead support 206 and the stimulation lead 210 is intended to be press-fit, the diameter of the through-hole in the lead support 206 may be less than or equal to the diameter of the stimulation lead 210. For example, the diameter of the through-hole may be approximately 0.5 mm, 0.75 mm, 1.0 mm, 1.25 mm, 1.5 mm, 1.75 mm, or 2.0 mm.

[0098] The lead support 206 may be configured to move with the bellows coupling 204 to isolate the forces acting on the stimulating lead 210 when the bellows coupling 204 moves (e.g., bends, rotates, etc.). The bellows coupling 204 may allow a longitudinal displacement of 3 mm to 7 mm of the lead support 206 along a longitudinal axis (e.g., relative to the brain) extending between at least the distal and proximal ends of the opening 208. As discussed herein, the longitudinal axis may be defined in other ways by the Z-axis of the coordinate system shown in Figure 2. In some embodiments, the bellows coupling 204 may allow a longitudinal displacement of 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm or less of the lead support 206. In some embodiments, the bellows coupling 204 may allow a longitudinal displacement of 3 mm, 4 mm, 5 mm, 6 mm, or 7 mm or more of the lead support 206. Thus, the movement of the lead 210 positioned within the lead support 206 may be controlled by the bellows coupling 204 coupled to the lead support 206. Therefore, in other words, the bellows coupling 204 may control the longitudinal movement of the stimulating lead 210 when it is positioned within the lead support 206.

[0099] Although not explicitly shown in Figure 2, the lead fixation device 200 is interpreted to include a cover configured to cover at least a portion of the opening 208 and / or the distal opening of the bellows coupling 204. This cover may have one or more features of the burhall cover 116 described herein with respect to the lead fixation device 100 shown in Figures 1A-1C. For example, the cover of the lead fixation device 200 may be configured to be removably fastened to the skull and / or mount 202.

[0100] The lead fixing device 200 (e.g., one or more of the mount 202, bellows coupling 204, and / or lead support 206) may include one or more biocompatible materials. For example, the lead fixing device 200 may comprise one or more biocompatible materials discussed herein with respect to the lead fixing device 100. For example, the biocompatible materials of the mount 202, bellows coupling 204, and / or lead support 206 may include one or more of polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, polymer mixtures, or medical-grade metal mixtures.

[0101] [Method for attaching leads using a lead fixing device] Methods for attaching a stimulation lead 110 to a skull using a lead fixing device 100 may be described herein according to several embodiments. Unless otherwise stated, the methods described herein may be used to attach a stimulation lead 210 to a skull using a lead fixing device 200.

[0102] This method may include creating an opening 108 on the surface of the skull (e.g., by drilling). For example, the opening 108 may consist of a burr hole created using a cranial drill (e.g., a craniotomy tool).

[0103] In some embodiments, the method may include implanting the stimulating lead 110 into the brain through the opening 108 before implanting the lead fixation device 100.

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

[0105] If the method discussed herein is used to implant the lead fixation device 200, the method may include attaching the mount 202 to the surface of the skull such that the bellows coupling 204 coupled to the mount is at least partially positioned in the opening 208 of the skull.

[0106] When the method discussed herein is used to implant the lead fixation device 300, the method may include attaching the mount 302 to the inner surface of the skull (e.g., the surface of the burr hole) so that the spring component 304 and the lead support 306 can be positioned within the burr hole.

[0107] This method may include inserting the stimulating lead 110 into a lead support 106 coupled to one or more flexures 104 such that a first portion of the lead 110 is secured by the lead support 106. For example, a through-hole in the lead support 106 may be configured to receive the stimulating lead 110, and a cuff of the lead support 106 that at least partially surrounds the through-hole may therefore at least partially surround the stimulating lead 110, thereby maintaining the position of the lead 110 after it has been inserted into the lead support 106.

[0108] This method may include inserting a second portion of the stimulation lead 110 into the receiving portion 112 of the mount 102. Once the lead is inserted into the receiving portion 112 of the mount 102, the second portion of the lead 110 may be secured to the surface of the skull. For example, one or more bridges of the receiving portion 112 may be configured to restrict the displacement of the stimulation lead 110 in one or more directions (e.g., at least the Y and Z directions in the coordinate system shown in Figures 1A-1C).

[0109] If the method discussed herein is used to embed the lead fixing device 200, the method may include inserting a second portion of the lead (e.g., a stimulating lead 210) into a through-hole of the bellows coupling 204 that is coaxial with the central axis of the bellows coupling 204.

[0110] A method for attaching the stimulation lead 110 to the skull may include removably fastening the bur hole cover 116 to the skull and / or mount 102 such that at least a portion of the opening 108 can be covered by the bur hole cover 116. As discussed herein, the bur hole cover 116 may have one or more fastening portions 118, which in some embodiments may be through holes. Thus, fastening the bur hole cover 116 to the mount 102 and / or skull may include inserting and fastening one or more fasteners into the skull through the receiving portions 118 (for example, optionally via the mount 102).

[0111] In some embodiments, this 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 before implantation.

[0112] Modifications to the order of the steps and / or the manner in which one or more of the aforementioned steps are performed will be understandable to those skilled in the art and will be construed as being within the scope of the disclosures provided herein. For example, attaching the mount 102 to the surface of the skull may be performed before or after the insertion of the stimulating lead 110 into the receiving portion 112 and / or lead support 106 of the mount 102. In another example, the mount 102 may be fixed to the surface of the skull using a method and / or a different tool than those described herein.

[0113] Unless otherwise defined, all technical terms, notations, and other technical and scientific or specialized terms used herein are intended to have the same meaning as those generally understood by those skilled in the art in which the claimed subject matter belongs. In some cases, terms that have a generally understood meaning are defined herein for clarity and / or reference, and the inclusion of such definitions herein should not necessarily be construed as representing a substantial difference from the generally understood meaning in the art.

[0114] Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context explicitly indicates otherwise. Where used herein, the terms “and / or” should be interpreted as referring to and encompassing any possible combination of one or more of the listed items relating to them. Furthermore, where used herein, the terms “include,” “contains,” “equip,” and / or “equip,” should be understood to specify the presence of the described features, integers, steps, actions, elements, components, units, and / or units, but not to exclude the presence or addition of one or more other features, integers, steps, actions, elements, components, units, and / or groups thereof.

[0115] The disclosed numerical range essentially supports any range or value (including the endpoint) within the disclosed numerical range, even if the exact range limitation is not stated verbatim in the specification, because the disclosure may be implemented across the entire disclosed numerical range.

[0116] The foregoing description is written with reference to specific embodiments for illustrative purposes. However, the above exemplary discussion is not intended to be exhaustive or to limit the invention to the exact form disclosed. In view of the above teachings, many modifications and variations are possible. The embodiments have been selected and described to best illustrate the principles of the art and their practical applications. Thus, those skilled in the art can best utilize the art and its various embodiments by making various modifications suitable for specific intended uses.

[0117] While the present disclosure and examples have been adequately described with reference to the accompanying drawings, it should be noted that various changes and modifications will be apparent to those skilled in the art. Such changes and modifications should be understood to be included within the scope of the disclosure and examples as defined by the claims.

Claims

1. Lead fixing device, A mount configured to attach the lead fixing device to the surface of the skull, One or more flexures, which are coupled to the mount and configured to be at least partially positioned in the opening of the skull, A lead support configured to receive a first portion of a lead, which is coupled to one or more flexures. A lead fixing device equipped with the following features.

2. The lead fixing device according to claim 1, wherein the mount comprises a receiving portion configured to receive a second portion of the lead.

3. The lead fixing device according to 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 fixing device according to any one of claims 1 to 3, wherein the surface of the skull to which the lead fixing device is attached is the outer surface of the skull.

5. The lead fixing device according to any one of claims 1 to 4, wherein one or more flexures are configured to bend to isolate the force acting on the lead.

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

7. The lead fixing device according to any one of claims 1 to 6, wherein the lead support is configured to detachably secure the first portion of the lead.

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

9. The lead fixing device according to claim 8, wherein the bur hole cover is configured to be removably fastened to the skull and / or the mount.

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

11. The lead fixing device according to any one of claims 1 to 10, wherein one or more flexures are configured to allow longitudinal movement of the lead support in the range of 3 mm to 7 mm, and the longitudinal axis extends between the distal end of the opening and the proximal end of the opening.

12. The lead fixing device according to any one of claims 1 to 11, wherein one or more of the mount, the one or more flexures, and the lead support are made of a biocompatible material.

13. The lead fixing device according to claim 12, wherein the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

14. It is a deep brain stimulation system, The lead fixing device according to claim 1, At least one lead is configured to be received by the lead support of the lead fixing device and to be implanted in the brain, A pulse generator, which is embedded in the skull and configured to be coupled to at least one lead, A deep brain stimulation system equipped with these features.

15. A method of attaching the lead to the skull, The mount is attached to the surface of the skull such that one or more flexures coupled to the mount are at least partially positioned in the opening of the skull, Inserting the lead into the lead support connected to one or more flexures, such that the first portion of the lead is secured by the lead support, Methods that include...

16. The method according to claim 15, comprising generating the opening on the surface of the skull.

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

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

19. The lead fixing device according to any one of claims 15 to 18, wherein the surface of the skull to which the mount is attached is the outer surface of the skull.

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

21. The method according to any one of claims 15 to 20, comprising removably fastening the 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 according to any one of claims 15 to 21, wherein one or more flexures are configured to bend to isolate the force acting on the lead.

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

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

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

26. Lead fixing device, A mount configured to attach the lead fixing device to the surface of the skull, A bellows coupling, which is coupled to the mount and configured to be at least partially positioned in the opening of the skull, A lead support configured to receive a first portion of a lead, which is coupled to the bellows coupling, A lead fixing device equipped with the following features.

27. The lead fixing device according to claim 26, wherein the diameter of the bellows coupling is between 4 mm and 14 mm.

28. The lead fixing device according to claim 26 or 27, wherein the wall thickness of the bellows coupling is between 0.5 mm and 2 mm.

29. The lead fixing device according to any one of claims 26 to 28, wherein the bellows coupling has a spring constant between 0.01 kg / mm ​​and 1 kg / mm.

30. The lead fixing device according to any one of claims 26 to 29, wherein the bellows coupling is configured to maintain the relative position between the first portion of the lead and the lead support.

31. The lead fixing device according to any one of claims 26 to 30, wherein the lead support is configured to detachably secure the first portion of the lead.

32. The lead fixing device according to any one of claims 26 to 31, wherein the bellows coupling has a through hole coaxial with the central axis of the bellows coupling and is configured to receive a second portion of the lead.

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

34. The lead fixing device according to claim 33, wherein the bur hole cover is configured to be removably fastened to the skull and / or the mount.

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

36. The lead fixing device according to any one of claims 26 to 35, wherein the bellows coupling is configured to allow longitudinal displacement of the lead support in the range of 3 mm to 7 mm, and the longitudinal axis extends between the distal end of the opening and the proximal end of the opening.

37. The lead fixing device according to any one of claims 26 to 36, wherein one or more of the mount, the bellows coupling, and the lead support are made of a biocompatible material.

38. The lead fixing device according to claim 37, wherein the biocompatible material includes polypropylene, polyethylene, polyetheretherketone (PEEK), polycarbonate (PC), polyphenylsulfone (PPSU), polyethylene terephthalate (PET), medical-grade stainless steel, titanium, a mixture of polymers, or a mixture of medical-grade metals.

39. It is a deep brain stimulation system, The lead fixing device according to claim 26, At least one lead configured to be received by the lead support of the lead fixing device, A pulse generator, which is embedded in the skull and configured to be coupled to at least one lead, A deep brain stimulation system equipped with these features.

40. A method of attaching the lead to the skull, The mount is attached to the surface of the skull such that the bellows coupling coupled to the mount is at least partially positioned in the opening of the skull, Inserting the lead into the lead support coupled to the bellows coupling such that the first portion of the lead is secured by the lead support, Methods that include...

41. The method according to claim 40, comprising generating the opening on the surface of the skull.

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

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

44. The method according to any one of claims 40 to 43, comprising removably fastening the 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 according to any one of claims 40 to 44, wherein the bellows coupling is configured to maintain the relative position between the first portion of the lead and the lead support.

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

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

Images