Neural Interface System

Abstract

The implantable neural interface system includes at least one electrode, a spine providing a passageway for electrical conductors connectable to a pulse generator and the at least one electrode, at least one arm extending from the spine, the at least one arm having an electrode positioned thereon, and a strain relief mechanism configured to reduce tension on relative movement of portions of the neural interface system and to accommodate axial curvature of the target, with the neural interface disposed on or within the target.

Description

[Technical Field]

[0001] The present invention relates generally to neural interface systems, also referred to as lead systems, for use with neuromodulation devices configured to neuromodulate a target, and more particularly to improving the alignment of neural interface systems. [Background technology]

[0002] A neural interface system or lead system implanted in a target, such as a nerve or neurovascular bundle, can provide electrical stimulation to the nerve through one or more electrodes when used in conjunction with a pulse generator. Neural interface systems and neural stimulation can vary widely based on the device's application and intended effect. Many neural interface systems benefit from accurate and safe placement of electrodes on the nerve bundle and proper adaptation of the neural interface system to the target for improved safety and effectiveness of the system.

[0003] An improperly attached or misaligned neural interface system, especially at the distal end of the neural interface system where the electrodes reside, can lead to several undesirable consequences. For example, a gap between the electrode and the target nerve can impact the neural interface system, leading to loss of therapy, the need to deliver significantly higher current to achieve the same therapeutic effect, or reduced efficiency. Misplacement can also constrict nearby vasculature, resulting in higher pressure areas that can potentially permanently alter it. Other effects can include increased inflammation at the implant site, increased fibrosis, increased stimulation requirements, and, in more severe cases, nerve death.

[0004] Current methods for addressing and maintaining proper neural interface system placement and providing strain relief include coiling the lead body during implantation, e.g., into a loop or S-shape. While coiling may be performed early in implantation, once fibrous tissue forms around the coil junction, the loops become locked in place and lose their effectiveness in providing strain relief. The fibrous tissue often forms several weeks after implantation. In other devices, the shape may be formed in a lead body made of polyurethane. The lead body may be located between the proximal end of the neural interface system (where the connection to the pulse generator may be located) and the distal end containing the electrodes. Thus, the lead body may contain electrical conductors for the electrodes. However, polyurethane materials are less biostable and axially less flexible than other materials, such as silicone. Summary of the Invention [Problem to be solved by the invention]

[0005] These types of designs are also typically ineffective for applications on pulsating structures. As discussed above, these strain relief designs are ineffective once fibrous tissue forms around the lead body, "locking" it in place. Additionally, the shape and coil formed on the lead body of a neural interface system are far from the distal end that includes the electrode and thus do not accommodate movement, e.g., vertical movement, of the distal end (which may include, e.g., a nerve cuff) when implanted on a pulsating structure. The minimal movement resulting from the pulsating artery can compromise the therapeutic performance and effectiveness of the neural interface. [Means for solving the problem]

[0006] A neural interface system, also referred to as a lead system, is provided for use with an implantable pulse generator for neuromodulation of a target, the system comprising at least one electrode and a strain relief mechanism for accommodating axial curvature of the target.

[0007] Also provided is a neural interface system comprising a plurality of electrodes, a spine providing a pathway for conductors to the plurality of electrodes, and two or more curved arms extending radially from the spine, where (i) the curved arms extend perpendicular to the spine and the plurality of electrodes are positioned on an inner circumference of the curved arms at an angle to the spine, or (ii) the curved arms are fixed at an angle to the spine and the plurality of electrodes are positioned perpendicularly along the inner circumference of the curved arms.

[0008] Various non-limiting embodiments are described below with reference to the accompanying drawings. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 depicts an example of a well-aligned cuff on a neurovascular bundle. [Figure 2] FIG. 1 depicts an example of a misaligned cuff on the neurovascular bundle. [Figure 3] 1A-1C depict nerve cuffs according to embodiments described herein. [Figure 4] FIG. 1 depicts a nerve cuff with hollow spines. [Figure 5] FIG. 1 depicts a nerve cuff having multiple strain relief notches. [Figure 6A] 10A-10C depict variations for strain relief notches according to embodiments described herein. [Figure 6B] 10A-10C depict variations for strain relief notches according to embodiments described herein. [Figure 7] FIG. 1 depicts the strain relief mechanism on the spine of the nerve cuff. [Figure 8] 10A-10C depict additional strain relief mechanisms according to embodiments described herein. [Figure 9A] FIG. 1 depicts a nerve cuff with angled arms. [Figure 9B]FIG. 1 depicts a nerve cuff with a tilted electrode array. [Figure 10A] FIG. 1 depicts a nerve cuff having arms that can pivot relative to the spine. [Figure 10B] FIG. 1 depicts a nerve cuff having arms that can pivot relative to the spine. [Figure 11] 10A-10C depict other designs in which the cuff arms may be modified to accommodate different angles and positions within the target anatomy. [Figure 12A] FIG. 1 is a diagrammatic view of an electrode device and lead body according to one embodiment. [Figure 12B] FIG. 10 is a diagrammatic view of an electrode device and lead body according to another embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0010] Various aspects of the present disclosure described herein generally relate to devices, systems, and methods and applications for improving the safety, effectiveness, and application of neural interface systems, also referred to as lead systems, to targets that may be nerves or neurovascular bundles. It should be understood that the examples provided are merely for clarity and understanding and are not intended to limit or restrict in any way the claimed subject matter or relevant portions of this disclosure. For example, in addition to the application of a nerve cuff, which has been described as an example of a distal end of a neural interface system with electrodes, other shapes or configurations of the distal end, such as a nerve patch, may also be used. Furthermore, such neural interface systems may be applied to any non-pulsatile target, such as neurovascular bundles as well as nerves.

[0011] In various embodiments described herein, the nerve cuff may include one or more arms attached to the spine to provide mechanical stability and a pathway for wiring to the electrode. The configuration of the nerve cuff, including the shape or number of the one or more arms, the spine, the positioning of the electrodes, and the materials for each aspect may vary depending on one or more factors and considerations, such as flexibility, durability, and positioning considerations.

[0012] An example target may be the splenic neurovascular bundle, a complex of autonomic nerves arranged around the splenic artery. The target implantation site may be a loop on the splenic artery that is sufficiently separated from the pancreas. However, the morphology of the splenic neurovascular bundle may vary in humans. The curvature of the loop may differ between patients and even within the same individual due to various factors, such as age and body mass index. Thus, maintaining proper alignment of the neural interface system may be challenging in some cases.

[0013] 1-2 depict an example of a neural interface system applied to the neurovascular bundle. The neural interface system shown in FIGS. 1-2 is a lead system including a neural cuff. While a neural interface system including a cuff portion is shown, those skilled in the art will recognize that the present disclosure applies to other neural interface systems including various other shapes and types of distal ends. For example, the neural interface system may be a paddle-type, wrap-type, or simply a lead system including primarily a neural interface portion such as a lead body and a cuff portion with exposed electrodes disposed at various distal end portions of the lead body. FIG. 1 depicts an example of a desirable, well-aligned lead system 233, while FIG. 2 shows two examples of poorly aligned lead systems 230 and 232.

[0014] One way to address variations in the neurovascular bundle and splenic loop is to fabricate multiple arterial cuffs and neural interfaces to accommodate the various curvatures. However, this approach may require multiple designs and subsequent additional effort to determine that the correct size cuff has been selected for the patient prior to implantation. Therefore, one challenge is to accommodate any changes in the morphology of the splenic artery within a patient, for example, changes with age.

[0015] Another challenge in designing a nerve cuff is minimizing pressure on the artery while allowing the cuff system to conform to a pulsating artery, which may have locally variable curvature and diameter. One way to address this challenge is to use an electrode small enough to attach to a single segment of the artery. While this method can minimize pressure on the artery, nerve coverage may be substandard and may activate only a small percentage of the neurovascular bundle. Small electrodes may also require additional anchoring mechanisms, such as adhesives or sutures, to remain in place. However, this type of fixation method introduces additional materials into the cuff system and implantation procedure, qualities that must be controlled and studied for biocompatibility and biologic stability, respectively. These methods may also make removal of the implanted tissue difficult and dangerous, particularly with regard to the sutures, which may be fragile, and / or may pose a risk of severe bleeding.

[0016] In addition to issues related to shape variations and potentially changing morphology of the splenic loop (or even if the nerve cuff is placed on a nerve or nerve bundle other than the splenic nerve), any chronically implanted nerve cuff is subject to a variety of forces across the patient due to different levels and modes of activity, anatomy variations, and routing strategies. During chronic implantation, a nerve cuff on a dynamically pulsating biological structure, such as the splenic neurovascular bundle, is subject to forces that can shift and misalign the neural interface system, particularly the distal end, on the neurovascular bundle over time. FIG. 3 shows an example of a neural interface system including a nerve cuff at its distal end. As described above with reference to FIGS. 1 and 2, the present disclosure applies not only to neural interface systems including nerve cuffs, but also to other neural interface systems including various other shapes and types of distal ends. For example, the neural interface system may be a paddle-type, a wrap-type, or simply a lead system including primarily a lead body and exposed electrodes at various distal end portions of the lead body. In some embodiments, the neural interface system may be wirelessly powered by including a receiver or coil in the neural interface system instead of a lead body providing a hardwired connection. In some embodiments, the implantable pulse generator referred to herein need not be implanted if the neural interface system can be powered by a wireless pulse generator, such as a device worn by the user. In some other embodiments, the neural interface system may include a miniature implantable pulse generator (IPG) with a wireless antenna for receiving power and communications from a transmitter. The IPG may receive power from an external source and / or include a battery that is charged from an external source, and the IPG is powered by the battery or an external source. Although the following figures refer to wired lead body-based embodiments, it should be understood that these embodiments may alternatively be wireless, and that the pulse generators described herein may be implanted, although they need not be or are not implantable.

[0017] According to some of the embodiments disclosed herein, it is formed through a two-shot molding process. The first shot 310 may have a harder durometer (e.g., at least Shore 70A) to prevent delamination of the electrode, and the second shot 320 is significantly more flexible. In the second shot, the bulk of the cuff may have a significantly lower durometer than the first shot 310, providing low bending stiffness and pressure exerted on a target, such as an artery, when implanted. As a result, the nerve cuff has a two-layer design with differential durometers. In some examples, the cuff comprises silicone and / or one or more other materials with qualities of biocompatibility and biostability, particularly for the intended positioning and application of the cuff. Similarly, the durometers of the first and second shots may be different.

[0018] In nerve cuff embodiments, one or more electrodes 330 may be assembled onto cutout windows on the arms 340 of the first shot. The electrodes 330, when assembled, provide contact with the neurovascular bundle and are connected to lead body conductors 350. In embodiments, after the electrodes are assembled onto the first shot 310, the lead body conductors 350 may be welded to the electrodes. As is evident in the various embodiments and examples described herein, the positioning of the electrodes on the arms and the configuration and flexibility of the arms, spines, and attachment points can vary widely depending on sizing, intended positioning, strain relief requirements, and potential arterial dilation, movement, pulsation, and shape.

[0019] 4 depicts a nerve cuff with a hollow spine 410, which helps reduce spine stiffness and increase overall flexibility. In an embodiment, the spine is molded around a mandrel positioned through a main wiring coil 430 and removed after the mold has hardened to create a central opening 420. Molding may occur, for example, according to the two-shot molding process described above. In other embodiments, a hollow spine design may be achieved by forming a hole at the distal end after molding.

[0020] The hollow spine design results in several advantages over traditional spine designs. First, due to the low bending stiffness, the spine may conform to curved structures. This may improve the application and stability of the cuff to neurovascular bundles with varying shapes and sizes. Additionally, assuming the cuff can adapt to various curvatures, the flexibility of the spine may impose less pressure on the neurovascular bundle. This may reduce problems and potential damage that can arise from excessive pressure and the natural pulsation and movement of the arteries.

[0021] The hollow spine design can also provide manufacturing advantages. The mandrel can help prevent the wiring coil 430 from shifting during the molding process. The mandrel can help stabilize the coil, and the design can help prevent bias from causing misalignment during the molding process and prevent unwanted pressure buildup that can cause damage and reduce the effectiveness and lifespan of the nerve cuff. In some embodiments, at least a portion of the hollow spine can be filled (or backfilled). For example, the hollow spine can be filled with a material from which the spine or other portions of the cuff are formed, such as silicone or polyurethane. The hollow spine can be at least partially filled up to the point where the conductors are located. For example, referring to FIG. 4, the hollow central opening 420 can be partially filled from the right edge shown in the figure (which can be referred to as the distal end of the spine, where the proximal end of the spine is connectable to a lead body or extended spine section) to the start of the coil conductor 430.

[0022] Similar benefits may be achieved by adding one or more strain relief notches to the spine of the nerve cuff. FIG. 5 illustrates an example of a cuff embodiment with multiple strain relief notches 510, 520 on the spine 530. In various examples, depending on the desired spine flexibility and / or the contours of the neurovascular bundle, strain relief notches 510 may be added adjacent to or between one or more arms 540. This may provide additional flexibility for movement of the arms 540. In other aspects, notches 520 may be added to the lead body portion of the spine 530. These notches may help increase the range of movement 550 of the lead body relative to the head. Additionally, the additional flexibility and range of movement of the spine can accommodate the movement and various contours and curvatures of the neurovascular bundle, as well as reduce pressure on the contact points. It should be appreciated that the depth of the strain relief notches may be determined or limited depending on the size of the spine lumen and the size or type of conductors disposed within the spine lumen.

[0023] 6A and 6B illustrate design variations for strain relief notches. FIG. 6A illustrates two contour styles 610, 620 that partially or completely surround the circumference of the spine 650. The relief notches 610 may be located between each arm and may provide flexibility to the arm portion relative to the lead body portion of the spine. In particular, the notches 610 may be limited to the upper side 612 of the spine (i.e., opposite the arms) and the lower side 614 of the spine, which may provide vertical flexibility 616 for the spine to accommodate the curvature and contour of the artery to which it may be attached. Because the notches 610 only partially surround the circumference of the spine 650, the spine may still maintain rigidity in other directions, such as the horizontal direction. The strain relief notches 620 may have a different design with a circumferential notch with a curved contour. This may provide additional flexibility to the lead body, particularly the spine portion, compared to the notches 610. More specifically, the strain relief notch 620 may provide additional separation between the lead body and the cuff. Compared to a straight circumferential notch, the curved notch 620 may reduce stress on the spine during bending. The strain relief notch 620 also helps prevent additional pressure or stress on the wiring coil and allows the cuff system to adapt to various motions and contours of the attached artery and neurovascular body. The strain relief notch 620 can provide a smoother stiffness gradient between the lead body and the cuff, which can improve the bending fatigue performance of a neural interface system comprising a lead body and a cuff.

[0024] FIG. 6B depicts additional examples of notch designs on a nerve cuff. Here, strain relief notch 630, located between arms 660, may comprise a vertical notch that surrounds the circumference of spine 650. This style may provide greater flexibility to the arm portion of the cuff system compared to notch 610 in FIG. 6A. Notch 640 on the lead body is similar to curved notch 620 in FIG. 6A but has a longer, flatter profile. The profile design may reduce stiffness in the lead body portion of the spine and allow additional flexibility for the arm portion. Additionally, while only one to three notches are depicted in each portion of spine 650 throughout FIGS. 6A-6B, any other number of notches may be implemented to achieve the desired flexibility and stiffness of the spine. For example, the notches may comprise a thread design, alone or in combination with any number of profile variations. As seen in FIG. 6A, the target is curved along the length of the neural interface system. In other words, there is a curvature in the axis of the target.

[0025] It should also be appreciated that strain relief notch designs may encompass any of a variety of styles, designs, and variations and are not limited to the examples depicted throughout the figures. The depicted designs are for illustrative purposes only, and various embodiments may include similar, different, or combinations of these and other designs, which are configured to provide strain relief to the spine, reduce spine stiffness, and increase spine flexibility in accordance with the embodiments described herein.

[0026] Referring to FIG. 7, an additional embodiment for providing strain relief to a nerve cuff lead is depicted. In this embodiment, the lead body comprises an internal thin-walled tube 710 that surrounds a wire coil 720 or conductor connected to an electrode 730. In an embodiment, the thin-walled tube 710 may comprise silicone and have a thickness of 0.25 mm. The tube 710 forms a layer of protection around the wire coil 720 (in this case, a four-filar common-radius conductor; in other embodiments, a two-filar common-radius conductor may be used for increased flexibility) and has a low spring constant for maximized or increased flexibility and stretchability. In this manner, the tube may be adaptable (or, in this case, separable) to the movements, pulsations, curvatures, and contours experienced by the cuff system. In an embodiment, the thin-walled tube 710 may be kept straight, improving ease of handling and delivery procedures. For example, a straight tube promotes a clean fibrous channel, which eliminates or reduces explantation problems that may be experienced with coiled and S-shaped tube designs.

[0027] Similarly, the wire coil 720 itself may comprise a common radius conductor with a low spring constant. Like the thin-walled tube 710, the wire coil also has maximized or increased stretchability and flexibility to accommodate the movements, contours, and changes experienced by the cuff system.

[0028] The wire coil 720 and thin-walled tube 710 may fit within an outer molding 740, which may include an elongated spine. As described in various embodiments herein, the spine may have one or more features for strain relief, such as one or more notches. The strain relief molding allows the lead body to rotate about and pivot away from one or more arms 750 and electrodes 730. The strain relief contours, in combination with the thin-walled tube 710, may also isolate the twisting motion experienced by the lead body from the attachment of the cuff on the neurovascular bundle. In this way, there may be reduced pressure on the contact area of ​​the neurovascular bundle and reduced forces within the cuff system on the wire coil 720 during movement.

[0029] FIG. 8 illustrates more of the strain relief mechanism and compares this type of feature to a conventional nerve cuff spine. In a conventional cuff spine 810, there is no strain relief mechanism. Typically, there is only a very short distance between the cuff and the lead body, which results in coupled forces between the lead body and the cuff. For example, twisting motion on the lead body is transmitted to the cuff. If the cuff is placed on an artery, this type of twisting motion can cause damage and / or excessive pressure in the artery. In some cases, the electrodes can become misaligned as a result of unexpected twisting or other motion, and therefore be less effective.

[0030] However, in the cuff and spine designs 820 disclosed herein, one or more strain relief mechanisms may function to extend the distance between the cuff and lead body junction 830. This greater distance, as well as the flexibility from the strain relief mechanism, may help to decouple forces between the cuff and lead body. Shaped pivot structures and S-shaped structures, as illustrated by strain relief mechanism 840, are some methods that may be used to reduce spine stiffness, increase flexibility, decouple forces between the cuff and lead body, and increase the longevity and effectiveness of the nerve cuff.

[0031] In addition to one or more notches and strain relief mechanisms that may be present in the implemented nerve cuff system, modifications to the cuff arms, including the positioning of the attached electrodes, can provide additional nerve coverage and stability, improving the overall effectiveness of the nerve cuff system.

[0032] 9A and 9B show two examples that may be used to promote proper placement of one or more electrodes and their stability in the proper position. This type of design may be particularly useful for neurovascular bundles that have curves and contours, as depicted in the figures. FIG. 9A shows a first embodiment in which arms 910 may be connected to a spine 940 at an angle. In a conventional cuff, one or more arms may be positioned perpendicular to the spine. Here, the arms may be positioned at an angle to maximize proper placement of the electrodes 920 on a curved target 950, such as an artery. In this example, the electrodes may be aligned perpendicular to the cuff arms 910. In this way, the placement of the electrodes 920 may follow the angle of the cuff arms 910 and circumferentially engage the artery 950 in an optimal position. In various embodiments, the cuff arms 910 may be molded into the angled position by a molding process, such as a two-shot process, or by any of a variety of methods.

[0033] FIG. 9B depicts a variation of FIG. 9A. In FIG. 9B, instead of the cuff arms being positioned at an angle relative to the cuff spine 940, the electrodes 935 may be positioned at an optimal angle for placement, while one or more arms 930 are positioned perpendicular to the cuff spine 940. In this embodiment, the design of the cuff system may be simpler due to the traditional design having cuff arms perpendicular to the spine. This design may also eliminate the precision required to determine the optimal arm angle, which may vary based on the morphology of the intended neurovascular bundle and may change over time.

[0034] In various embodiments, the electrodes 935 may be movable within the cuff arms 930, allowing for precise angular placement relative to the artery 950. In other embodiments, the electrodes may be attached to the cuff arms as described with respect to Figure 1. The electrodes 935 may be positioned at a predetermined angle, for example, to provide maximum contact and coverage relative to the artery, or may provide an optimal angle determined for a particular nerve cuff placement.

[0035] 10A and 10B show yet other variations in cuff system design in accordance with one or more embodiments herein. In these examples, one or more arms may pivot to provide additional flexibility 1070 to the spine 1040. In FIG. 10A, one or more notches 1050 (e.g., notches, necking, etc.) at or near the attachment point 1050 of the arm 1030 and spine 1040 allow the arm 1030 to pivot. In FIG. 10B, the arm pivot is achieved using one or more joints 1060, such as ball joints, applied between the arm 1030 and spine 1040. The joints may comprise any number of designs known in the art to allow for desired flexibility and movement between the spine and cuff arms.

[0036] The pivoting may allow the arms to move in one or more directions, which can help ensure proper placement and stability of the electrodes. For example, the pivotable arms allow the cuff system to accommodate neurovascular bundles and arteries with multiple shapes, curvatures, contours, and configurations. The pivotable arms can also help the cuff system maintain its position when unexpected motion, forces, or other biological changes are applied to the cuff system.

[0037] FIG. 11 depicts another design in which the cuff arms may be modified to accommodate various angles and positions within the target anatomy. Instead of the cuff arms being attached to the spine as in other embodiments, the arms are decoupled from the spine and lead body. The anode arm 1110a and cathode arm 1110b are not fixed relative to each other or even the spine. In this way, each arm 1110 can be precisely positioned and placed over the intended neurovascular bundle. This can provide significantly increased flexibility compared to conventional cuff designs and other designs described herein. This type of design can almost completely decouple the forces between the arms, significantly reducing any binding forces between the lead body and the arms. Thus, the decoupled arm design may easily adapt to the shape, curvature, contour, and position of various arterial anatomy, providing increased flexibility and adaptability for implantation.

[0038] In other embodiments, one or both of the lead body 650, 917 and the conductors 350, 918 can include a structure or configuration to provide strain relief. Referring also to FIGS. 12A and 12B, in some embodiments, the lead body 917 can include strain-relieving undulating portions 917b located intermittently between linear portions 917a. Any particular lead body 917 can include one undulating portion 917b or multiple undulating portions 917b, and the particular configuration of one or more undulating portions 917b can vary. The undulating portions 917b help to break up or disrupt large or forceful movements affecting the lead body 917 into smaller, discrete, or localized weaker movements.

[0039] Two examples of undulating portions 917b are depicted in Figures 12A and 12B, although these examples are not limiting with respect to all of the possible embodiments contemplated by this disclosure. For example, the undulating shapes can be sinusoidal, square, rectangular, spiral, helical, regular, irregular, other shapes, or combinations of these shapes. The number of undulating shapes can also be varied, with some undulating portions 917b having more or fewer undulating shapes, as may be desirable or preferred for areas that experience more or less tension during use. However, generally, each turn in the undulating pattern prevents pressure waves from traveling a greater distance along the length of the lead body 917.

[0040] In some embodiments, the undulating portion 917b can be located near the neural interface 900, while in other embodiments, the undulating portion 917b can be located away from the neural interface 900 or at various points along the length of the lead body 917. The undulating portion 917b near the neural interface 900 can help prevent displacement forces from reaching the neural interface 900 and affecting its stability and positioning.

[0041] The disclosed systems, methods, and devices may include a nerve cuff comprising a plurality of electrodes, a spine providing a passageway for electrical conductors, also referred to as conductors, to the plurality of electrodes, and at least two curved arms extending radially from a first portion of the spine, wherein the plurality of electrodes are positioned on an inner circumference of the curved arms. In embodiments, the spine may comprise a plurality of strain relief notches positioned in a first portion between the curved arms and in a second portion of the spine adjacent the first portion and proximate the curved arms, each of the plurality of notches partially or completely surrounding the circumference of the spine.

[0042] The strain relief notch may be positioned between the curved arms on the side of the spine opposite the attachment of the curved arms and may provide flexibility to the first portion of the spine. In other embodiments, the strain relief notch on the second portion of the spine generally surrounds the circumference of the spine, increasing flexibility between the first and second portions. Other variations of strain relief notches include at least two notches on the second portion of the spine and a notch generally surrounding the circumference of the spine, where the length of the notches on the second portion of the spine is longer than the length of the strain relief notch on the first portion.

[0043] In embodiments, the nerve cuff may further comprise a tube having a thickness of up to 0.25 mm, surrounding the conductor and positioned within the spine, hi other embodiments, the spine may be hollow and comprise silicone.

[0044] In various embodiments, the curved arms may be pivotable relative to the spine by using various pivot designs including one or more notches at the attachment points between each of the curved arms and / or ball joints at the attachment points.

[0045] Additional cuff variations include (i) a curved arm extending perpendicular to the spine and multiple electrodes positioned on the inner circumference of the curved arm at an angle to the spine, and (ii) a curved arm fixed at an angle to the spine and multiple electrodes positioned perpendicularly along the inner circumference of the curved arm.

[0046] A method for assembling a nerve cuff includes providing a first shot having two or more curved arms, applying a plurality of electrodes to the inner circumference of the two or more curved arms, connecting lead body conductors to the plurality of electrodes, providing a second shot, an outer layer, on the two or more curved arms and the lead body, the second shot having a lower durometer than the first shot, and molding the first shot into the second shot. Thus, the neural interface system may be provided by a shot molding process. The nerve cuff (or neural interface system) can also be provided by various other methods, including, for example, 3D printing and extrusion.

[0047] Systems, methods, and devices for nerve cuffs applied to neurovascular bundles are disclosed herein. Various designs are provided herein to improve nerve cuff placement and accommodate morphological changes. In embodiments, the nerve cuff comprises multiple electrodes, a spine that provides a pathway for electrical conductors to the electrodes, and two or more curved arms that extend radially from the spine. The curved arms may be attached perpendicular to the spine or at an angle relative to the spine. Similarly, electrodes attached to the inner circumference of the curved arms may be aligned or angled relative to the curved arms. One or more strain relief notches may be applied to the spine to facilitate proper placement of the electrodes and provide flexibility to the spine. Various embodiments may be fabricated using a shot molding process.

[0048] Systems, methods, and devices for improving nerve cuffs applied to neurovascular bundles are disclosed herein. In one embodiment, the nerve cuff includes a spine, multiple arms extending radially from the spine, and multiple electrodes positioned on the inner circumference of the curved arms. Multiple strain relief notches positioned on the spine reduce spine stiffness and improve flexibility, allowing the nerve cuff to adapt to various contours, movements, and morphologies of the neurovascular bundle. The strain relief notches may be positioned on a first portion of the spine between the curved arms and on a second portion of the spine adjacent to the first portion. The strain relief notches may fully or partially surround the circumference of the spine and help provide increased flexibility between one or more portions of the spine and between the curved arms. The implantable neural interface system includes a spine including at least one electrode, electrical conductors electrically connectable to the pulse generator and the at least one electrode, at least one arm extending from the spine, the at least one arm having an electrode positioned thereon, and a strain relief mechanism configured to reduce tension upon relative movement or displacement of portions of the neural interface system.

[0049] The implantable neural interface system includes at least one electrode, a spine that provides a passageway for electrical conductors from the implantable pulse generator through the lead body to the at least one electrode, at least one arm extending from the spine, the at least one arm on which the electrode is positioned, and a strain relief mechanism configured to isolate movement between the lead body and the spine.

[0050] The implantable neural interface system includes at least one electrode, a spine that provides a passageway for electrical conductors from the implantable pulse generator through the lead body to the at least one electrode, at least one arm extending from the spine, the at least one arm on which the electrode is positioned, and a strain relief mechanism configured to isolate movement between the lead body and the arm.

[0051] The implantable neural interface system includes at least one electrode, a spine for electrical conductors for the at least one electrode, at least one arm extending from the spine, the at least one arm having an electrode positioned on it, and a strain relief mechanism.

[0052] The implantable neural interface system includes at least one electrode, a spine that provides a passageway for electrical conductors from the implantable pulse generator through the lead body to the at least one electrode, at least one arm extending from the spine, the at least one arm having an electrode positioned on it, and a strain relief mechanism.

[0053] The implantable neural interface system includes at least one electrode, a spine providing a pathway for electrical conductors from an implantable pulse generator to the at least one electrode, at least one arm extending from the spine, the at least one arm having an electrode positioned on the arm, and a strain relief mechanism configured to reduce tension upon one or more relative movements of the spine and the at least one arm and to accommodate axial curvature of the target, the spine and the at least one arm being disposed on or within the target.

[0054] The implantable neural interface system includes at least one electrode, a spine providing a pathway for electrical conductors from the implantable pulse generator to the at least one electrode, at least one arm extending from the spine, the at least one arm having an electrode positioned thereon, and a strain relief mechanism configured to reduce tension upon relative movement or displacement of portions of the neural interface system and to accommodate axial curvature of the target, with the neural interface disposed on or within the target.

[0055] The strain relief mechanism provides reduced tension compared to a section not provided with the strain relief mechanism.

[0056] The strain relief mechanisms may provide for axial curvature of the neural interface system, where the neural interface axis is the axis of the spine or is parallel to the axis of the spine. In other words, targets, which often have a generally tubular shape, may have a curved axis. These strain relief mechanisms may help accommodate this type of curvature of the target's curved axis.

[0057] The strain relief feature may comprise at least one of a notch, a joint, a ball-and-socket joint, a section with a more flexible material than the surrounding section, and a reduced cross-sectional area. Such reduced cross-sectional area may be achieved in a variety of ways, including providing a notch that completely surrounds the circumference of the spine or a notch that only partially surrounds the circumference of the spine. The reduced cross-sectional area may also be achieved by providing one or more sections within the spine that are at least partially hollow.

[0058] The strain relief mechanism may increase flexibility for relative movement of portions of the neural interface system and / or may allow relative movement of portions of the neural interface system, optionally in a direction perpendicular to the axis of the target, and optionally resulting in bending of the neural interface such that there is curvature in the length of the neural interface parallel to the axis of the target.

[0059] A strain relief mechanism may be provided at an attachment region between the curved at least one arm and the spine, allowing the at least one arm to pivot at an angle relative to the axis of the spine.

[0060] The neural interface system may comprise a plurality of arms, the spine comprising a strain relief mechanism positioned between a curved arm and a portion of the spine adjacent to the curved arm, each of the strain relief mechanisms partially or completely surrounding the circumference of the spine.

[0061] The neural interface system may further comprise a silicone tube surrounding the electrical conductor positioned within the spine.

[0062] The neural interface system may also include an extended spine portion between the spine portion from which the arms extend and the lead body, which includes the portion of the conductor between the spine and the implantable pulse generator, and a strain relief mechanism is provided on the extended spine portion. For example, an extended spine portion of this type is shown in FIG. 6A, which includes a strain relief mechanism 620 on the extended spine portion.

[0063] At least two curved arms may extend at least partially radially from a first portion of the spine, and the spine may include a strain relief mechanism positioned in the first portion between the curved arms and in a second portion of the spine adjacent the first portion and proximate the curved arms, the second portion also being referred to as an extended spine section.

[0064] A strain relief mechanism may be provided between the arms furthest from the lead body.

[0065] The neural interface system may include a tube that surrounds the conductor and is positioned inside the spine.

[0066] The tube may have a thickness of up to 0.25 mm.

[0067] The spine may be at least partially hollow.

[0068] The spine may comprise silicone or polyurethane.

[0069] A strain relief mechanism between the curved arms may be positioned on the side of the spine opposite the attachment of the curved arms and may provide flexibility to a first portion of the spine.

[0070] The strain relief feature on the second portion of the spine may completely surround the circumference of the spine and may increase flexibility between the first and second portions.

[0071] There may be at least two strain relief features on the second portion of the spine.

[0072] The strain relief may comprise a notch that generally surrounds the circumference of the spine.

[0073] In the neural interface system described above, the length of the strain relief feature on the second portion of the spine is greater than the length of the strain relief feature on the first portion.

[0074] A two-shot molding process may be used to radially attach the arms to the spine.

[0075] The method includes the steps of connecting conductors passing through the body of the spine to a plurality of electrodes; radially attaching two or more curved arms to a first portion of the spine, the plurality of electrodes being positioned on the inner circumference of the curved arms; and providing a plurality of strain relief mechanisms on the first portion of the spine between the curved arms and on a second portion of the spine adjacent the first portion, each of the strain relief mechanisms partially or completely surrounding the outer circumference of the spine.

[0076] A two-shot molding process may be used to radially attach the curved arms to the spine.

[0077] The neural interface system may comprise a plurality of electrodes, a spine providing a pathway for conductors to the plurality of electrodes, and two or more curved arms extending radially from the spine, where (i) the curved arms extend perpendicular to the spine and the plurality of electrodes are positioned on the inner circumference of the curved arms at an angle to the spine, or (ii) the curved arms are fixed at an angle to the spine and the plurality of electrodes are positioned perpendicularly along the inner circumference of the curved arms.

[0078] The spine may include a plurality of strain relief mechanisms positioned between the curved arms and portions of the spine adjacent to the curved arms, and each of the strain relief mechanisms may partially or completely surround the circumference of the spine.

[0079] The arm may be formed by a first shot, and the outer layer of the arm and the lead body are formed by a second shot that overmolds the arm.

[0080] The second shot may have a lower hardness than the first shot.

[0081] In other embodiments, the second shot may have a higher hardness than the first shot in some embodiments. The second shot may be formed from conductive silicone. The electrodes may be formed from conductive silicone.

[0082] The first shot may have a durometer of at least Shore 70A.

[0083] The second shot may include silicone.

[0084] Different materials may be used for the first and second shots.

[0085] A method of manufacturing a nerve cuff may include providing a first shot having two or more curved arms, applying a plurality of electrodes to an inner circumference of the two or more curved arms, connecting lead body conductors to the plurality of electrodes, providing a second shot, which is an outer layer, to the two or more curved arms and the lead body, the second shot having a lower durometer than the first shot, and molding the first shot into the second shot.

[0086] Two or more curved arms may be positioned at an angle relative to the second shot.

[0087] Multiple electrodes may be positioned on each curved arm at an angle.

[0088] Each of the curved arms may be in a fixed position relative to the spine when provided at an angle, or when the electrode is positioned at an angle.

[0089] The neural interface system may include a proximal end (lead connector), a lead body including conductors (e.g., coils and cables) and insulators (e.g., silicone tubing, PU tubing), and a distal end including a substrate (e.g., cuff portion) and an electrode (or array of electrodes).

[0090] The lead body may have increased flexibility in portions closer to the cuff portion compared to portions of the lead body further away from the cuff portion.

[0091] Systems and devices for nerve cuffs applied to neurovascular bundles are disclosed herein. Various designs are provided herein to improve nerve cuff placement and accommodate morphological changes. In embodiments, the nerve cuff comprises a spine that provides a passageway for multiple electrodes and leads to the electrodes, and two or more curved arms extending radially from the spine. The curved arms may be attached perpendicular to the spine or at an angle relative to the spine. Similarly, electrodes attached to the inner circumference of the curved arms may be aligned or angled relative to the curved arms. One or more strain relief notches may be applied to the spine to facilitate proper placement of the electrodes and provide flexibility to the spine. Various embodiments may be fabricated using a shot molding process.

[0092] Systems, methods, and devices for improving nerve cuffs applied to neurovascular bundles are disclosed herein. In embodiments, the nerve cuff includes a spine, multiple arms extending radially from the spine, and multiple electrodes positioned on the inner circumference of the curved arms. Multiple strain relief notches positioned on the spine may reduce spine stiffness and improve flexibility, allowing the nerve cuff to adapt to various contours, movements, and morphologies of the neurovascular bundle. The strain relief notches may be positioned on a first portion of the spine between the curved arms and on a second portion of the spine adjacent to the first portion. The strain relief notches may fully or partially surround the circumference of the spine and help provide increased flexibility between one or more portions of the spine and between the curved arms.

[0093] It should be appreciated that the various features and processes described above may be used independently of one another or may be combined in various ways, and all possible combinations and subcombinations are intended to fall within the scope of this disclosure.

[0094] Conditional language used herein, particularly terms such as "can," "could," "might," "may," "for example," and the like, is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, and that other embodiments do not, unless otherwise expressly stated or understood within the context in which it is used. Thus, such conditional language is generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps should be included in or performed in any particular embodiment, with or without author input or direction. The terms "comprise," "include," "have," and the like are synonymous and used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Additionally, the term "or" is used in its inclusive sense (as well as its exclusive sense), so that, for example, when used to connect a list of elements, the term "or" may mean one, some, or all of the elements of the list.

[0095] While specific example embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the invention(s) disclosed herein. Accordingly, nothing in the above description is intended to imply that any particular feature, characteristic, step, module, or block is essential or essential. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms, and various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the invention(s) disclosed herein. The accompanying claims and their equivalents are intended to cover such forms or modifications as fall within the scope and spirit of the particular invention(s) disclosed herein.

Claims

1. 1. An implantable neural interface system, comprising: at least one electrode; a spine configured to provide a pathway for electrical conductors from an implantable pulse generator to the at least one electrode; at least one arm extending from the spine, the electrode being positioned on the arm; a strain relief mechanism configured to reduce tension in relative movement or displacement of portions of the neural interface system; the strain relief feature is provided as at least one of a notch, a joint, a ball joint, a section with a more flexible material than the surrounding section, and a reduced cross-sectional area, to reduce tension in the relative movement of one or more of the spine and the at least one arm compared to when the strain relief feature is not provided; the at least one arm includes a first shot layer having the at least one electrode formed on an inner surface thereof, and a second shot layer covering an outer surface of the first shot layer, the second shot layer having a lower hardness than the first shot layer; Implantable neural interface system.

2. the strain relief mechanism is located at an attachment region between the at least one arm and the spine such that the at least one arm can pivot at an angle relative to the axis of the spine.

10. The neural interface system of claim 1.

3. the at least one arm comprises a curved arm; the strain relief mechanism is positioned between the curved arm and the portion of the spine closest to the curved arm; 3. A neural interface system according to claim 1 or 2.

4. the at least one arm comprises at least two curved arms; the at least two curved arms extend at least partially radially from the first portion of the spine; the spine including the strain relief mechanism positioned at the first portion between the curved arms and the strain relief mechanism positioned at a second portion of the spine adjacent to the first portion. A neural interface system according to any one of claims 1 to 3.

5. Further provided with a lead body, the strain relief mechanism is located between the arms furthest from the lead body; A neural interface system according to any one of claims 1 to 4.

6. Further provided with a lead body, the lead body includes a conductor and a tube surrounding the conductor and positioned within the spine; the tube has a thickness of up to 0.25 mm; the tubing is a silicone tubing; A neural interface system according to any one of claims 1 to 5.

7. The spine is hollow and made of silicone or polyurethane.

7. A neural interface system according to any one of claims 1 to 6.

8. the strain relief mechanism between the curved arms is positioned on a side of the spine opposite the attachment of the curved arms to provide flexibility to the first portion of the spine. The neural interface system of claim 4.

9. there are at least two of the strain relief features on the second portion of the spine; The neural interface system of claim 4.

10. a length of the strain relief feature on the second portion of the spine that is greater than a length of the strain relief feature on the first portion of the spine; 10. The neural interface system of claim 4 or 9.

11. the first shot layer has a durometer of at least Shore 70A; the second shot layer is made of silicone, Different materials are used for the first shot layer and the second shot layer; A neural interface system according to any one of claims 1 to 10.

Images