Neural Interface System

Abstract

To provide an implantable neural interface system. [Solution] The implantable neural interface system comprises at least one electrode, a spine providing a passage for a pulse generator and a conductor connectable to at least one electrode, at least one arm extending from the spine on which the electrode is positioned, and a tension relief mechanism configured to reduce tension in the relative movement of the portion of the neural interface system and to adapt to the curvature of the axis of the target, wherein the neural interface is provided on or within the target.

Description

Technical Field

[0001] The present invention generally relates to a nerve interface system, also referred to as a lead system, for use with a nerve modulation device configured to modulate a target, and more particularly to improving the alignment of a nerve interface system.

Background Art

[0002] A nerve interface system or lead system implanted into a target such as a nerve or neurovascular bundle can provide electrical stimulation to the nerve through one or more electrodes when used with a pulse generator. The nerve interface system and nerve stimulation can vary widely based on the use of the device and the intended effect. Many nerve interface systems derive benefits for improved safety and efficacy of the system from the accurate and safe placement of electrodes over a nerve bundle and proper adaptation of the nerve interface system to the target.

[0003] Particularly at the distal end of a nerve interface system where electrodes are present, an improperly attached or misaligned nerve interface system can lead to several undesirable outcomes. For example, a gap between the electrode and the target nerve can affect the nerve interface system, lead to a loss of therapy, require delivering a significantly higher current to achieve the same therapeutic effect, or reduce efficiency. Incorrect placement can also constrict nearby vascular structures, resulting in potentially permanently altered higher pressure regions. Other effects can include high inflammation at the implant site, increased fibrosis, elevated stimulation requirements, and in more severe cases, nerve death.

[0004] Current methods for addressing and maintaining proper placement of neural interface systems and providing tension relief include coiling of the lead body during implantation, e.g., loops or S-shapes. Coiling may be performed in the early stages of implantation, but once fibrous tissue forms around the coil joint, loops become locked in place and lose their effectiveness in providing tension relief. Fibrous tissue often forms several weeks after implantation. In other devices, the shape may be formed on a lead body made of polyurethane. The lead body may be positioned between the proximal end of the neural interface system (which may be provided with a connection to a pulse generator) and the distal end equipped with electrodes. Thus, the lead body may be equipped with a conductor for the electrodes. However, polyurethane material is less biostable and less axially flexible than other materials such as silicone. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] This type of design is also typically inefficient for applications on pulsating structures. As mentioned above, once fibrous tissue forms around the lead body and "locks" the lead body in place, these tension-relieving designs are ineffective. In addition, the shape and coil formed on the lead body of the neural interface system are far from the distal end equipped with electrodes, and thus, when embedded on a pulsating structure, they do not accommodate the movement of the distal end (which may, for example, be equipped with a nerve cuff), such as vertical movement. Even minute movements arising from the pulsating artery can compromise the therapeutic performance and effectiveness of the neural interface. [Means for solving the problem]

[0006] The neural interface system, also known as a lead system, is provided for use with an implantable pulse generator for target neural modulation, and the system comprises at least one electrode and a tension-relaxing mechanism for adapting to the curvature of the target axis.

[0007] A neural interface system is also provided comprising a spine providing a path for conductors to a plurality of electrodes, and two or more curved arms extending radially from the spine, wherein (i) the curved arms extend perpendicularly 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.

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

[0009] [Figure 1] This diagram illustrates an example of cuffs that are well-aligned on a neurovascular bundle. [Figure 2] This diagram illustrates an example of a cuff poorly aligned on a neurovascular bundle. [Figure 3] This is a diagram illustrating a nerve cuff according to the embodiments described in the present specification. [Figure 4] This is a diagram illustrating a nerve cuff with a hollow spine. [Figure 5] This is a diagram illustrating a nerve cuff with multiple tension-relieving notches. [Figure 6A] This figure illustrates variations for tension-relieving notches according to embodiments described in the present specification. [Figure 6B] This figure illustrates variations for tension-relieving notches according to embodiments described in the present specification. [Figure 7] This diagram illustrates the tension-relaxation mechanism on the spine of a nerve cuff. [Figure 8] This figure illustrates an additional tension relief mechanism according to the embodiments described in this specification. [Figure 9A] This is a diagram depicting a nerve cuff with an inclined arm. [Figure 9B]This is a diagram illustrating a nerve cuff with an inclined electrode array. [Figure 10A] This diagram illustrates a nerve cuff with a pivotable arm relative to a spine. [Figure 10B] This diagram illustrates a nerve cuff with a pivotable arm relative to a spine. [Figure 11] This diagram depicts other designs in which the cuff arm may be modified to adapt to various angles and positions within the target biological structure. [Figure 12A] This is a diagram of an electrode device and a lead body according to one embodiment. [Figure 12B] This is a diagram of an electrode device and lead body according to another embodiment. [Modes for carrying out the invention]

[0010] The various aspects of the disclosure described herein relate, in general, to devices, systems, methods, and applications for improving the safety, effectiveness, and application of neural interface systems, also known as lead systems, to targets that may be nerves or neurovascular bundles. It should be understood that the examples provided are for clarity and understanding purposes only and are not intended in any way to limit or restrict the requested subject matter or relevant portions of this disclosure. For example, in addition to the application of a nerve cuff described as an example of the distal end of a neural interface system comprising electrodes, other shapes or arrangements of the distal end, such as a nerve patch, may be used. Furthermore, this type of neural interface system may be applied to neurovascular bundles and any non-pulsating targets such as nerves.

[0011] In the various embodiments described herein, the nerve cuff may comprise one or more arms attached to the spine, providing mechanical stability and a passage for wiring to the electrodes. The arrangement 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 embodiment may vary depending on one or more factors and considerations, such as flexibility, durability, and positioning considerations.

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

[0013] Figures 1 and 2 illustrate examples of neural interface systems applied to neurovascular bundles. The neural interface systems shown in Figures 1 and 2 are lead systems with a neural cuff. While a neural interface system with a cuff portion is shown, it will be recognized by those skilled in the art that this disclosure applies to other neural interface systems with 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 primarily comprising a lead body and a neural interface portion such as a cuff portion having exposed electrodes provided on various distal end portions of the lead body. Figure 1 illustrates an example of a desirable, well-aligned lead system 233, while Figure 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 manufacture multiple arterial cuffs and nerve interfaces and adapt to various curvatures. However, this method may require multiple designs and may continue to require additional effort to determine that the correct size cuff has been selected for the patient prior to implantation. Thus, one challenge is to accommodate any changes in the morphology of the splenic artery within the patient, such as those due to age.

[0015] Another challenge in designing a nerve cuff is to minimize pressure on the artery while allowing the cuff system to conform to a pulsatile artery that can have local variable curvatures and diameters. One way to address this challenge is to use electrodes small enough to attach to a single portion of the artery. This method can minimize pressure on the artery, but the nerve coverage can be sub - optimal and can activate only a small percentage of the neurovascular bundle. Small electrodes may also require additional anchoring mechanisms, such as adhesives or sutures, to maintain them in place. However, this type of fixation method introduces additional materials into the cuff system and implantation procedure, which must be of a quality that is controlled and studied for biocompatibility and biomechanical stability, respectively. These methods can also make the removal of implanted tissue difficult and dangerous, particularly with respect to sutures, which are particularly vulnerable, and / or can have a risk of significant bleeding.

[0016] In addition to issues related to shape variations of the splenic loop and potentially changing morphologies (or even if the nerve cuff is provided to a nerve or nerve bundle other than the splenic nerve), any long - term implanted nerve cuff is subject to various forces across patients due to differences in levels and modes of activity, variations in biological structure, and routing strategies. In long - term implantation, a nerve cuff on a dynamically pulsating biological structure, such as the splenic neurovascular bundle, can shift the nerve interface system, particularly the distal alignment, on the neurovascular bundle over time and is subject to forces that can misalign the placement. FIG. 3 shows an example of a nerve interface system having a nerve cuff at its distal end. As described above with reference to FIGS. 1 and 2, the present disclosure is applicable not only to nerve interface systems having a nerve cuff, but also to other nerve interface systems having various other shapes and types of distal ends. For example, the nerve interface system may be a lead system mainly comprising a paddle type, a wrap type, or simply a lead body and exposed electrodes provided at various distal end portions of the lead body. In some embodiments, the nerve interface system may be powered wirelessly by including a receiver or coil in the nerve interface system instead of a lead body providing a wired connection. In some embodiments, when the nerve interface system can be powered by a wireless pulse generator such as a device worn by a user, the implantable pulse generator referred to in the present specification need not be implanted. In some other embodiments, the nerve interface system may comprise a miniature implantable pulse generator (IPG) having a wireless antenna for receiving power and communication from a transmitter. The IPG may receive power from an external source and / or may comprise a battery charged from an external source, and the IPG is powered by the battery or the external source. The following drawings refer to embodiments based on a wired lead body, but it should be understood that these embodiments may alternatively be wireless, and that the pulse generators described in the present specification need not be implanted or may not be implantable, but may be implanted.

[0017] According to some embodiments disclosed in this specification, it is formed through a two-shot molding process. The first shot 310 may have a stiffer durometer (e.g., at least Shore 70A) to prevent delamination of the electrode, and the second shot 320 may be significantly more flexible. In the second shot, the cuff bulk may have a significantly lower durometer than the first shot 310, providing lower bending stiffness and pressure applied over 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 having biocompatibility and biostable qualities, particularly for the intended positioning and application of the cuff. Similarly, the durometers of the first and second shots may be different.

[0018] In embodiments of the nerve cuff, one or more electrodes 330 may be assembled on a notched window on the arm 340 of the first shot. The electrodes 330 provide contact with the neurovascular bundle when assembled and are connected to the lead body conductor 350. In embodiments, after the electrodes are assembled on the first shot 310, the lead body conductor 350 may be welded to the electrodes. As will be apparent in the various embodiments and examples described herein, the positioning of the electrodes on the arm and the configuration and flexibility of the arm, spine and mounting point can vary considerably depending on sizing, intended positioning, tension relief requirements, and potential arterial dilation, movement, pulsation and shape.

[0019] Figure 4 depicts a nerve cuff having a hollow spine 410 that helps reduce the rigidity of the spine and increase the overall flexibility. In one embodiment, the spine is molded around a mandrel positioned through a main wiring coil 430 and removed after the molded part 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, the hollow spine design may be achieved by forming a hole at the distal end after molding.

[0020] The hollow spine design can produce several advantages over conventional spine designs. First, its low bending stiffness allows the spine to conform to curved structures. This can improve the application and stability of the cuff to neurovascular bundles with varying shapes and sizes. In addition, assuming the cuff can adapt to various curvatures, the flexibility of the spine can impart less pressure to the neurovascular bundle. This can reduce excessive pressure as well as problems and potential damage that may arise from the natural pulsation and movement of arteries.

[0021] The hollow spine design can also offer manufacturing advantages. A 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 misalignment during the molding process and prevent undesirable pressure rises that could cause damage and reduce the effectiveness and lifespan of the nerve cuff. In some embodiments, at least a portion of the hollow spine may be filled (or backfilled). For example, the hollow spine may be filled with a material that forms the spine or the rest of the cuff, such as silicone or polyurethane. The hollow spine may be filled at least partially up to the point where the conductor is provided. For example, referring to Figure 4, the hollow central opening 420 may be partially filled from the right edge shown in the figure (which can be called the distal end of the spine, where the proximal end of the spine can be connected to a lead body or an extended spine portion) to the start of the coil conductor 430.

[0022] Similar advantages may be achieved by adding one or more tension-relieving notches to the spine of the nerve cuff. Figure 5 shows an example of an embodiment of a cuff having multiple tension-relieving notches 510, 520 on the spine 530. In various examples, depending on the desired spine flexibility and / or the contour of the neurovascular bundle, the tension-relieving notches 510 may be added adjacent to or between one or more arms 540. This may provide additional flexibility for the movement of the arms 540. In other embodiments, notches 520 may be added to the portion of the lead body of the spine 530. These notches may help increase the range of motion 550 of the lead body relative to the head. In addition, the additional flexibility and range of motion of the spine can be adapted to the movement of the neurovascular bundle and various contours and curves, and can reduce pressure on the contact point. It should be noted that the depth of the tension-relieving notches may be determined or limited depending on the size of the spine lumen and the size or type of conductor provided within the spine lumen.

[0023] Figures 6A and 6B illustrate design variations of tension relief notches. Figure 6A shows two contour styles 610, 620 that partially or completely enclose the outer circumference of the spine 650. The relief notches 610 may be located between each arm and may provide flexibility to the arm portion of the spine relative to the lead body portion. 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 provides vertical flexibility 616 of the spine and can adapt to the curvature and contour of the artery to which it may be attached. Since the notches 610 only partially enclose the outer circumference of the spine 650, the spine can still maintain rigidity in other directions, such as horizontally. The tension relief notches 620 may have a different design with an outer circumference cutout having a curved contour. This may provide additional flexibility to the lead body, particularly the spine portion, compared to the notches 610. More specifically, the tension-relieving notch 620 may provide additional separation between the lead body and the cuff. Compared to a straight outer notch, the curved notch 620 can reduce stress on the spine during bending. The tension-relieving notch 620 also helps prevent additional pressure or stress on the wiring coil, and the cuff system can adapt to the various movements and contours of the attached arterial and neurovascular bodies. The tension-relieving notch 620 can provide a smoother stiffness gradient between the lead body and the cuff, which can improve the bending fatigue performance of the neural interface system comprising the lead body and cuff.

[0024] Figure 6B illustrates an example of an additional notch design on the neural cuff. Here, the tension-relieving notch 630 located between the arms 660 may have a vertical cutout that encircles the outer circumference of the spine 650. This style may provide greater flexibility to the arm portion of the cuff system compared to the notch 610 in Figure 6A. The notch 640 on the lead body is similar to the curved notch 620 in Figure 6A, but has a longer and flatter profile. The profile design may reduce the rigidity of the lead body portion of the spine and allow for additional flexibility to the arm portion. In addition, although only one to three notches are depicted on each portion of the spine 650 throughout Figures 6A and 6B, any other number of notches may be implemented to achieve the desired flexibility and rigidity of the spine. For example, the notches may have a threaded design, either alone or in combination with any number of profile variations. As seen in Figure 6A, the target is curved along the length of the neural interface system. In other words, there is a curve along the axis of the target.

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

[0026] Referring to Figure 7, an additional embodiment for providing tension relief to the nerve cuff lead is depicted. In this embodiment, the lead body comprises an internal thin-walled tube 710 surrounding a wire coil 720 or conductor connected to an electrode 730. In this embodiment, the thin-walled tube 710 may contain silicone and may have a thickness of 0.25 mm. The tube 710 forms a protective layer around the wire coil 720 (in this case, a four-wound common-radius conductor; in other embodiments, a two-wound common-radius conductor may be used for increased flexibility) and has a low spring constant for maximization or increased flexibility and elasticity. Thus, the tube may be adaptable (or, in this case, separable) to the movement, pulsation, curvature and contour experienced by the cuff system. In this embodiment, the thin-walled tube 710 may be kept straight to improve ease of handling and explanation procedures. For example, a straight tube promotes a clean fibrous channel, which eliminates or reduces problems that can be experienced with coiled and S-shaped tube designs and problems with explantation.

[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 elasticity and flexibility to adapt to the motion, contour and changes experienced by the cuff system.

[0028] The wire coil 720 and the thin-walled tube 710 may be fitted within an outer molding 740 which may have an elongated spine. As described in various embodiments of this specification, the spine may have one or more features for tension relief, for example, one or more notches. The tension-relieving molding allows the lead body to rotate around one or more arms 750 and electrodes 730 and pivot away from one or more arms 750 and electrodes 730. The tension-relieving contour may also be combined with the thin-walled tube 710 to isolate the twisting motion experienced by the lead body from the attachment of the cuff on the neurovascular bundle. Thus, reduced pressure may be present on the contact area of ​​the neurovascular bundle, as well as reduced force within the cuff system on the wire coil 720 during movement.

[0029] Figure 8 shows more tension-relieving mechanisms and compares this type of feature with conventional nerve cuff spines. In conventional cuff spines 810, no tension-relieving mechanisms exist. Typically, only a very short distance exists between the cuff and the lead body, which results in a coupled force between the lead body and the cuff. For example, twisting motion on the lead body is transmitted to the cuff. If the cuff is incorporated over an artery, this type of twisting motion can cause damage and / or excessive pressure on the artery. In some cases, the electrodes may become misaligned as a result of unexpected twisting motion or other movements, and therefore their effectiveness may be weakened.

[0030] However, in the cuff and spine design 820 disclosed in this specification, one or more tension-relieving mechanisms may function to extend the distance between the cuff and the lead body joint 830. This greater distance and flexibility from the tension-relieving mechanisms may help to isolate forces between the cuff and the lead body. Molded pivot structures and S-shaped structures, as shown by the tension-relieving mechanism 840, are some methods that may be used to reduce spine stiffness, increase flexibility, isolate forces between the cuff and the lead body, and increase the lifespan and effectiveness of the nerve cuff.

[0031] In addition to one or more notches and tension-releasing mechanisms, which may be present in the implemented nerve cuff system, modifications to the cuff arm, including the positioning of the attached electrodes, can provide additional nerve range and stability, thereby improving the overall effectiveness of the nerve cuff system.

[0032] Figures 9A and 9B show two examples that may be used to facilitate the proper placement of one or more electrodes and their stability in the proper position. This type of design can be particularly useful for neurovascular bundles with curves and contours, as depicted in the drawings. Figure 9A shows a first embodiment in which the arm 910 may be connected to the spine 940 at a certain angle. In a conventional cuff, one or more arms may be positioned perpendicular to the spine. Here, the arms may be positioned at a certain angle to maximize the proper placement of the electrode 920 on a curved target 950, such as an artery. In this example, the electrodes may be aligned perpendicular to the cuff arm 910. Thus, the placement of the electrode 920 may also depend on the angle of the cuff arm 910, allowing it to engage with the artery 950 circumferentially at the optimal position. In various embodiments, the cuff arm 910 may be formed at an angle by a molding process, e.g., a two-shot process or any of the various methods.

[0033] Figure 9B depicts a variation of Figure 9A. In Figure 9B, instead of the cuff arms being positioned at a certain 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 can be simpler than that of conventional designs with cuff arms perpendicular to the spine. This design also eliminates the precision required to determine the optimal arm angle, which can vary based on the morphology of the intended neurovascular bundle and can change over time.

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

[0035] Figures 10A and 10B illustrate yet another variation of the cuff system design according to one or more embodiments of the present specification. In these examples, one or more arms may pivot and provide additional flexibility 1070 to the spine 1040. In Figure 10A, one or more notches 1050 (e.g., notches, neckings, etc.) at or near the mounting point 1050 of the arm 1030 and spine 1040 cause the arm 1030 to pivot. In Figure 10B, the arm pivot is achieved using one or more joints 1060, e.g., ball joints, applied between the arm 1030 and the spine 1040. The joints may comprise any number of designs well known in the prior art and may allow the desired flexibility and movement between the spine and the cuff arm.

[0036] The pivot allows the arm to move in one or more directions, which can help ensure proper placement and stability of the electrodes. For example, a pivotable arm allows the cuff system to be applied to neurovascular bundles and arteries with multiple shapes, curves, contours, and forms. Furthermore, when unexpected movement, force, or other biological changes are applied to the cuff system, the pivotable arm can help the cuff system maintain its position.

[0037] Figure 11 depicts another design in which the cuff arms may be modified to adapt to various angles and positions within the target biostructure. Instead of cuff arms attached to the spine, as in other embodiments, the arms are separated from the spine and lead body. The anode arm 1110a and cathode arm 1110b are not fixed relative to each other or even to the spine. Thus, each arm 1110 can be precisely positioned and placed on the intended neurovascular bundle. This can provide significantly increased flexibility compared to conventional cuff designs and other designs described herein. This type of design allows for almost complete isolation of forces between the arms and significantly reduces any bonding forces between the lead body and the arms. Therefore, the isolated arm design can easily adapt to the morphology, curvature, contour and position of various arterial biostructures, providing increased flexibility and adaptability for implantation.

[0038] In other embodiments, one or both of the lead bodies 650, 917 and the conductors 350, 918 may have structures or configurations for providing tension relief. Referring also to Figures 12A and 12B, in some embodiments, the lead body 917 may have corrugated sections 917b that relieve tension intermittently located between the linear sections 917a. Any particular lead body 917 may have one or more corrugated sections 917b, and the specific configuration of one or more corrugated sections 917b may vary. The corrugated sections 917b help to distribute or interrupt large or strong movements affecting the lead body 917 into smaller, individual or localized weaker movements.

[0039] Two examples of the corrugated portions 917b are depicted in Figures 12A and 12B, but these examples are not limited to all possible embodiments considered by this disclosure. For example, the corrugated shape can be sinusoidal, square, rectangular, helical, spiral, regular, irregular, other shapes, or combinations thereof. The number of corrugated shapes can also be varied to suit the region where some corrugated portions 917b have more or fewer corrugated shapes, which is desirable or preferred for areas that experience some tension during use. However, generally speaking, each fold in the corrugated pattern prevents the pressure wave from traveling a longer distance along the length of the lead body 917.

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

[0041] The disclosed systems, methods, and devices may include a nerve cuff comprising a plurality of electrodes, a spine providing a passage for 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 the inner circumference of the curved arms. In embodiments, the spine may comprise a plurality of tension-relieving notches positioned in a first portion between the curved arms and in a second portion of the spine adjacent to the first portion and close to the curved arms, each of which partially or completely surrounds the outer circumference of the spine.

[0042] The tension-relieving notch may be positioned between the curved arms on the spine side opposite the mounting of the curved arms, and may provide flexibility to the first portion of the spine. In other embodiments, the tension-relieving notch on the second portion of the spine encloses the entire outer circumference of the spine, increasing flexibility between the first and second portions. Another variation of the tension-relieving notch includes at least two notches on the second portion of the spine and a notch that encloses the entire outer circumference of the spine, where the length of the notches on the second portion of the spine is longer than the length of the tension-relieving notch on the first portion.

[0043] In some 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. In other embodiments, the spine may be hollow or contain silicone.

[0044] In various embodiments, the curved arms may be pivotable relative to the spine. Each arm can be pivoted by using various pivot designs that include one or more notches at the mounting points between each of the curved arms and / or ball joints at the mounting points.

[0045] Additional cuff variations include (i) a curved arm extending perpendicularly to the spine and multiple electrodes positioned on the inner circumference of the arm curved 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 the steps of: providing a first shot comprising two or more curved arms; applying multiple electrodes to the inner circumferences of the two or more curved arms; connecting lead body conductors to the multiple electrodes; providing a second shot, which is an outer layer, to the two or more curved arms and lead bodies, wherein the second shot has a lower durometer than the first shot; and shaping the first shot into the second shot. Thus, a nerve interface system may be provided by a shot molding process. Nerve cuffs (or nerve interface systems) 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 in this specification. Various designs are provided in this specification to improve the attachment of nerve cuffs and to adapt to changes in morphology. In embodiments, the nerve cuff comprises a plurality of electrodes, a spine providing a passage for conductors to the electrodes, and two or more curved arms extending radially from the spine. The curved arms may be mounted perpendicular to the spine or at an angle to the spine. Similarly, electrodes mounted on the inner circumference of the curved arms may be aligned or at an angle to the curved arms. One or more tension-relieving notches may be applied to the spine to facilitate proper electrode placement and to provide flexibility to the spine. Various embodiments may be assembled using a shot-forming process.

[0048] Systems, methods, and devices for improving nerve cuffs applied to neurovascular bundles are disclosed in this specification. In one embodiment, the nerve cuff comprises a spine, a plurality of arms extending radially from the spine, and a plurality of electrodes positioned on the inner circumference of the curved arms. A plurality of tension-relieving notches positioned on the spine reduce spine stiffness and improve flexibility, thereby allowing the nerve cuff to adapt to various contours, movements, and morphologies of the neurovascular bundle. The tension-relieving notches may be positioned in a first portion of the spine between the curved arms and in a second portion of the spine adjacent to the first portion. The tension-relieving notches may encircle the entire or partial outer circumference of the spine and may help provide increased flexibility between one or more portions of the spine and between the curved arms. The implantable neural interface system comprises a spine having at least one electrode, a pulse generator and a conductor electrically connectable to at least one electrode, at least one arm extending from the spine on which the electrode is positioned, and a tension relief mechanism configured to reduce tension in the relative movement or displacement of the portion of the neural interface system.

[0049] The implantable neural interface system comprises at least one electrode, a spine providing a passage for a conductor from an implantable pulse generator to at least one electrode via a lead body, at least one arm extending from the spine on which the electrode is positioned, and a tension-relaxing mechanism configured to isolate motion between the lead body and the spine.

[0050] The implantable neural interface system comprises at least one electrode, a spine providing a passage for a conductor from an implantable pulse generator to at least one electrode via a lead body, at least one arm extending from the spine on which the electrode is positioned, and a tension-relaxing mechanism configured to isolate the motion between the lead body and the arm.

[0051] The implantable neural interface system comprises at least one electrode, a spine for a conductor for at least one electrode, at least one arm extending from the spine on which the electrode is positioned, and a tension relief mechanism.

[0052] The implantable neural interface system comprises at least one electrode, a spine providing a passage for a conductor from an implantable pulse generator to at least one electrode via a lead body, at least one arm extending from the spine on which the electrode is positioned, and a tension relief mechanism.

[0053] The implantable neural interface system comprises at least one electrode; a spine providing a passage for a conductor from an implantable pulse generator to at least one electrode; at least one arm extending from the spine, on which an electrode is positioned; and a tension relief mechanism configured to reduce tension in one or more relative movements of the spine and at least one arm and to adapt to the curvature of the target axis, wherein the spine and at least one arm are located on or within a target.

[0054] The implantable neural interface system comprises at least one electrode, a spine providing a passage for a conductor from an implantable pulse generator to at least one electrode, at least one arm extending from the spine on which an electrode is positioned, and a tension relief mechanism configured to reduce tension in relative motion or displacement of a portion of the neural interface system and to adapt to the curvature of the target axis, wherein the neural interface is provided on or within a target.

[0055] The tension relief mechanism provides reduced tension compared to the section where the tension relief mechanism is not provided.

[0056] The tension-relieving mechanism may provide curvature of the axis of the neural interface system, where the axis of the neural interface is either the axis of the spine or parallel to the axis of the spine. In other words, targets, which often have an overall tubular shape, may have a curved axis. These tension-relieving mechanisms may help adapt to this type of curvature of the target's curved axis.

[0057] The tension relief mechanism may include at least one of a notch, a joint, a ball joint, a portion having a higher flexibility material than the surrounding portion, and a reduced cross-sectional area. This type of reduced cross-sectional area may be achieved in various ways, including providing a notch that completely encloses the outer circumference of the spine, or a notch that partially encloses the outer circumference of the spine. The reduced cross-sectional area may also be achieved by providing one or more portions of the spine that are at least partially void.

[0058] The tension-relaxing mechanism may increase the flexibility for relative movement of parts of the neural interface system, and / or enable relative movement of parts of the neural interface system, optionally the movement being perpendicular to the axis of the target, and optionally the movement resulting in bending of the neural interface such that there is a curvature along the length of the neural interface parallel to the axis of the target.

[0059] The tension relief mechanism may be provided in the mounting region between at least one curved arm and the spine, thereby allowing at least one arm to pivot at an angle with respect to the axis of the spine.

[0060] The neural interface system may have multiple arms, and the spine may have tension-relieving mechanisms positioned between a curved arm and a portion of the spine adjacent to the curved arm, each of which partially or completely surrounds the outer circumference of the spine.

[0061] The neural interface system may further include a silicone tube that surrounds a conductor positioned inside the spine.

[0062] The neural interface system may include an extended spine, which lies between a spine to which an arm extends and a lead body having a conductive portion between the spine and an implantable pulse generator, and the tension relief mechanism is provided in the extended spine. For example, this type of extended spine is shown in Figure 6A, and the tension relief mechanism 620 is provided in this extended spine.

[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 tension-relieving mechanism positioned in the first portion between the curved arms and in the second portion of the spine adjacent to the first portion and close to the curved arms. The second portion may also be referred to as the extended spine portion.

[0064] The tension 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 contain silicone or polyurethane.

[0069] The tension-relieving mechanism between the curved arms may be positioned on the spine side opposite the mounting of the curved arms, and may provide flexibility to the first portion of the spine.

[0070] The tension-relaxing mechanism on the second portion of the spine may enclose the entire outer circumference of the spine, or it may increase the flexibility between the first and second portions.

[0071] At least two tension-relaxing mechanisms may be present on the second portion of the spine.

[0072] The tension relief mechanism may include a notch that completely surrounds the outer circumference of the spine.

[0073] In the neural interface system described above, the length of the tension-relaxing mechanism on the second portion of the spine is longer than the length of the tension-relaxing mechanism on the first portion.

[0074] The arms may be attached radially to the spine using a two-shot molding process.

[0075] The method includes the steps of connecting a conductor passing through the body of a spine to a plurality of electrodes, and mounting two or more curved arms radially to a first portion of the spine, wherein the plurality of electrodes are positioned on the inner circumference of the curved arms, and providing a plurality of tension-relieving mechanisms to a first portion of the spine between the curved arms and a second portion of the spine adjacent to the first portion, each of which tension-relieving mechanisms partially or completely surrounds the outer circumference of the spine.

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

[0077] The neural interface system may comprise a spine providing pathways for conductors to a plurality of electrodes, and two or more curved arms extending radially from the spine, wherein (i) the curved arms extend perpendicularly 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 tension-relieving mechanisms positioned between the curved arm and the portion of the spine adjacent to the curved arm, each of which may partially or completely surround the outer circumference of the spine.

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

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

[0085] A method for manufacturing a nerve cuff may include the steps of: providing a first shot comprising 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, which is an outer layer, to the two or more curved arms and lead bodies, wherein the second shot has a lower durometer than the first shot; and shaping the first shot into the second shot.

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

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

[0088] Each of the curved arms may be in a fixed position relative to the spine when it is positioned at a certain angle, or when the electrodes are positioned at a certain angle.

[0089] The neural interface system may include a lead body comprising a proximal end (lead connector), a conductor (e.g., coil and cable), and an insulator (e.g., silicone tube, PU tube), and a distal end comprising a substrate (e.g., cuff portion) and electrodes (or an array of electrodes).

[0090] The reed body may have increased flexibility in the parts closer to the cuff compared to the parts of the reed body farther away from the cuff.

[0091] Systems and devices for nerve cuffs applied to neurovascular bundles are disclosed in this specification. Various designs are provided in this specification to improve the attachment of nerve cuffs and to adapt to changes in morphology. In embodiments, the nerve cuff comprises a plurality of electrodes, a spine providing a passage for leads to the electrodes, and two or more curved arms extending radially from the spine. The curved arms may be mounted perpendicular to the spine or at an angle to the spine. Similarly, electrodes mounted on the inner circumference of the curved arms may be aligned or at an angle to the curved arms. One or more tension-relieving notches may be applied to the spine to facilitate proper electrode placement and provide flexibility to the spine. Various embodiments may be assembled using a shot-forming process.

[0092] Systems, methods, and devices for improving nerve cuffs applied to neurovascular bundles are disclosed in this specification. In embodiments, the nerve cuff comprises a spine, a plurality of arms extending radially from the spine, and a plurality of electrodes positioned on the inner circumference of the curved arms. A plurality of tension-relieving notches positioned on the spine may reduce spine stiffness and improve flexibility, thereby allowing the nerve cuff to adapt to various contours, movements, and morphologies of the neurovascular bundle. The tension-relieving notches may be positioned in a first portion of the spine between the curved arms and in a second portion of the spine adjacent to the first portion. The tension-relieving notches may encircle the entire or partial outer circumference of the spine and may help provide increased flexibility between one or more portions of the spine and between the curved arms.

[0093] It should be noted that the various features and processes described above may be used independently of each other or combined in various ways. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure.

[0094] The conditional language used in this specification, particularly “can,” “may,” “might,” “may,” and “for example,” is generally intended to convey that a particular embodiment includes certain features, elements, and / or steps, and other embodiments do not, unless other meanings are explicitly stated or understood to mean other meanings within the context in which they are used. Therefore, this type of conditional language is generally not intended to mean that features, elements, and / or steps are required in any form for one or more embodiments, or that one or more embodiments necessarily include logic for determining whether these features, elements, and / or steps should be included or performed in any particular embodiment, with or without input or instructions from the author. The terms “equip,” “include,” and “have” are synonymous and are used inclusively in an open-ended manner, not excluding additional elements, features, actions, or behaviors. Furthermore, the term “or” is used in its inclusive (and exclusive) sense, so for example, when used to connect a list of elements, “or” means one, some, or all of the elements in the list.

[0095] While specific exemplary embodiments are described, these embodiments are presented merely as examples and are not intended to limit the scope of the invention disclosed herein. Therefore, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is essential or indispensable. In fact, the novel methods and systems described herein may be implemented in various other forms, and furthermore, various omissions, substitutions, and modifications of the forms of the methods and systems described herein may be made, provided that they do not depart from the spirit of the invention disclosed herein. The appended claims and their equivalents are intended to cover forms or modifications that fall within the specific scope and spirit of the invention disclosed herein.

Claims

1. An implantable neural interface system, At least one electrode, A spine, optionally configured to provide a passage for a conductor from an implantable pulse generator to at least one electrode, At least one arm extending from the spine, wherein the electrode is positioned on the arm, A tension-relieving mechanism configured to reduce tension in one or more relative movements of the spine and the at least one arm and to adapt to the curvature of the target axis, wherein the spine and the at least one arm are located on or within the target, An implantable neural interface system.

2. An implantable neural interface system, At least one electrode, A spine, optionally configured to provide a passage for a conductor from an implantable pulse generator to at least one electrode, At least one arm extending from the spine, wherein the electrode is positioned on the arm, A tension-relaxing mechanism configured to reduce tension in the relative motion or displacement of multiple parts of a neural interface system and to adapt to the curvature of the target axis, wherein the neural interface is provided on or within the target. An implantable neural interface system.

3. The neural interface system according to claim 1 or 2, wherein the tension relief mechanism comprises at least one of a notch, a joint, a ball joint, a portion having a higher flexibility material than the surrounding portion, and a reduced cross-sectional area.

4. The tension-relaxing mechanism increases flexibility for relative movement of a plurality of parts of the neural interface system and / or enables relative movement of a plurality of parts of the neural interface system, optionally the movement being perpendicular to the axis of the target, and optionally the movement resulting in bending of the neural interface such that there is a curvature in the length of the neural interface parallel to the axis of the target, according to any one of claims 1 to 3.

5. The neural interface system according to any one of claims 1 to 4, wherein the tension relief mechanism is provided in a mounting region between the curved at least one arm and the spine, so that the at least one arm is pivotable at an angle with respect to the axis of the spine.

6. The neural interface system according to any one of claims 1 to 5, comprising a plurality of arms, the spine comprising a tension relief mechanism positioned between a curved arm and a portion of the spine adjacent to the curved arm, each of the tension relief mechanisms partially or completely surrounding the outer circumference of the spine.

7. The neural interface system according to any one of claims 1 to 6, further comprising a silicone tube surrounding the conductor positioned inside the spine.

8. The neural interface system according to any one of claims 1 to 7, comprising an extended spine portion, the extended spine portion being located between the spine portion to which the arm extends and a lead body comprising a portion of the conductor between the spine and an implantable pulse generator, and the tension relief mechanism being provided in the extended spine portion.

9. A neural interface system according to any one of claims 1 to 8, wherein at least two curved arms extend at least partially radially from a first portion of the spine, and the spine comprises the tension relief mechanism positioned in the first portion between the curved arms and in the second portion of the spine adjacent to the first portion and close to the curved arms.

10. The neural interface system according to any one of claims 1 to 9, wherein the tension relief mechanism is provided between the arms furthest from the lead body.

11. The neural interface system according to any one of claims 1 to 10, further comprising a tube that surrounds the conductor and is positioned inside the spine.

12. The neural interface system according to claim 11, wherein the tube has a thickness of up to 0.25 mm.

13. The neural interface system according to any one of claims 1 to 12, wherein the spine is hollow.

14. The neural interface system according to any one of claims 1 to 13, wherein the spine comprises silicone or polyurethane.

15. The neural interface system according to any one of claims 1 to 14, wherein the tension relief mechanism between the curved arms is positioned on the side of the spine opposite to the mounting of the curved arms, providing flexibility to the first portion of the spine.

16. The neural interface system according to any one of claims 1 to 15, wherein the tension relief mechanism on the second portion of the spine completely surrounds the outer circumference of the spine and increases flexibility between the first portion and the second portion.

17. The neural interface system according to any one of claims 1 to 16, wherein at least two tension-relaxing mechanisms are present on the second portion of the spine.

18. The neural interface system according to any one of claims 1 to 17, wherein the tension relief mechanism comprises a notch that completely surrounds the outer circumference of the spine.

19. The neural interface system according to any one of claims 1 to 18, wherein the length of the tension relief mechanism on the second portion of the spine is longer than the length of the tension relief mechanism on the first portion.

20. The neural interface system according to any one of claims 1 to 19, wherein a two-shot molding process is used to attach the arms radially to the spine.

21. A neural interface system, Multiple electrodes, A spine that provides a passage for conductors to the aforementioned plurality of electrodes, It comprises two or more curved arms extending radially from the spine, (i) The curved arm extends perpendicularly to the spine, and the plurality of electrodes are positioned on the inner circumference of the curved arm at an angle to the spine, or (ii) The curved arm is fixed at an angle to the spine, and the plurality of electrodes are positioned perpendicularly along the inner circumference of the curved arm. Neural interface system.

22. The neural interface system according to claim 21, wherein the spine comprises a plurality of tension-relieving mechanisms positioned between a curved arm and a portion of the spine adjacent to the curved arm, each of which tension-relieving mechanisms partially or completely surrounds the outer circumference of the spine.

23. The neural interface system according to claim 21 or 22, further comprising a tube that surrounds the conductor and is positioned inside the spine.

24. The neural interface system according to any one of claims 21 to 23, wherein the spine comprises silicone.

25. The neural interface system according to any one of claims 1 to 24, wherein the system is formed by a shot molding process, optionally the arm is formed by a first shot, the outer layer of the arm and the lead body are formed by a second shot, and optionally the second shot is an overmolding.

26. The neural interface system according to claim 25, wherein the second shot has a lower hardness than the first shot.

27. The neural interface system according to claim 25 or 26, wherein the first shot has a durometer of at least Shore 70A.

28. The second shot comprises silicone, the neural interface system according to any one of claims 25 to 27.

29. A neural interface system according to any one of claims 25 to 28, wherein different materials are used for the first and second shots.

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