Electrode devices and related methods for neuromodulation

Abstract

To provide an extravascular and intravascular device for nerve stimulation / neuromodulation of a target anatomy tissue having radial flexibility and own-size adjustment ability.SOLUTION: In an embodiment, by using a nerve interface including at least one C-ring portion, a pressure within a range of 1 mmHg to 30 mmHg can be applied to a target tissue arranged in the C-ring portion. The nerve interface includes at least one electrode arranged on the at least one C-ring portion.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure generally relates to neuromodulation, and more particularly to embodiments of extravascular and intravascular devices comprising electrodes for neuromodulation.

Background Art

[0002] Electrical devices of various shapes and sizes, including one or more electrodes, have been used for nerve stimulation / neuromodulation of target anatomical tissues.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Conventional designs lack radial flexibility and self-sizing capabilities. When the target blood vessel is overly compressed by the device, nerves may be damaged due to reduced blood flow and constriction of nerve fibers. Temporary dilation of the target blood vessel caused by the positioning of the device can exacerbate such nerve damage. In contrast, if the device is too loose, electrical contact may be insufficient, reducing treatment efficiency, and as a result of ingrowth of connective tissue between the target blood vessel and the device, the device may further deteriorate over time.

Means for Solving the Problems

[0004] In one embodiment, a nerve interface comprises at least one C-ring portion, the at least one C-ring portion applying a radial pressure within the range of 1 mmHg to 30 mmHg to target tissue disposed within the C-ring portion and comprising at least one electrode disposed on the at least one C-ring portion.

[0005] The neural interface may further include a lead body having a conductor connectable to an implantable pulse generator, with at least one electrode electrically coupled to the conductor. The C-ring portion can be subjected to radial pressure based on the rigidity of the insulating material constituting the body of the C-ring portion, the thickness of the insulating material constituting the body of the C-ring portion, the rigidity of at least one electrode, the size and shape of at least one electrode, the number of electrodes, the ratio of electrodes to the insulating material of the C-ring portion, the gap size between two electrodes of at least one electrode, the characteristics of the interconnection between different electrodes of at least one electrode, the thickness of the C-ring material, and the diameter of the neural interface. The C-ring portion may have an inner diameter and a cross-sectional thickness, with the ratio of inner diameter to cross-sectional thickness being in the range of 5:1 to 6:1. The electrode may include an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to the C-ring portion and having multiple perforations. The electrode flange may be rectangular with rounded corners. The electrode flange may include a curved bottom edge. The multiple perforations may include at least one perforation on the first side of the electrode flange and at least one perforation on the second opposite side of the electrode flange. The first side and the second opposite side of the electrode flange may be longer than the third and fourth sides of the electrode flange. The multiple perforations may be rectangular with rounded corners. The lead body may include at least one tension-relaxing wavy section.

[0006] The neural device may include a vertebral portion having a first end and a second end, the outer circumference of the first end of the vertebral portion tapering from a maximum to a minimum outer circumference, and a lead body may be coupled to the first end of the vertebral portion and extend at least partially into the vertebral portion. The vertebral portion may have a substantially circular cross-section, and the second end of the vertebral portion has an inclined surface, so that a plane parallel to this substantially circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with respect to the plane defined by the inclined surface. The maximum outer circumference of the first end of the vertebral portion may be found near at least three C-ring portions, and the minimum outer circumference of the first end of the vertebral portion occurs where the vertebral portion terminates on the lead body. The distance between the maximum and minimum outer circumferences may be in the range of 2 mm to 5 mm.

[0007] The neural interface may include at least two further C-ring portions, each having a first end and a second end, the first end of each C-ring portion being coupled to a vertebral portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first and third C-ring portions, is on the second opposite side of the vertebral portion. The first and third C-ring portions may be coupled to the vertebral portion so that they move together relative to the second C-ring portion, and the first and third C-ring portions extend from the vertebral portion in the opposite direction to the direction of the second C-ring portion. At least one of the C-ring portions may have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first and second ends, the third thickness being greater than the first and second thicknesses. The thickness of any of the C-ring portions can be gradually increased between the first end and the point between the first and second ends. Multiple electrodes can be placed in at least one of the at least three C-ring portions, and adjacent electrodes on the same C-ring portion are electrically coupled by an inter-electrode coil.

[0008] The neural interface may include at least one anchoring tab attached to the lead body. The anchoring tab may include a covering mesh, which may optionally be covered with a mesh-filling material. A C-ring portion may be provided at the first end of the lead body, a connector to an implantable pulse generator (IPG) may be provided at the second end of the lead body, and the anchoring tab may be provided between the first and second ends of the lead body. The anchoring tab may be provided between the first end of the lead body and the central portion of the lead body located midway between the first and second ends, and the ratio of the distance between the first end of the lead body and the anchoring tab to the distance between the second end of the lead body and the anchoring tab may be 1:1 to 1:50, optionally 1:2, 1:3, 1:4, or 1:5. The anchoring tab may be movable along the lead body. The lead body may have greater flexibility in the portion closer to the C-ring portion compared to the portion further away from the C-ring portion.

[0009] According to another embodiment, the system includes the neural interface described above and a deployment tool that is detachably coupled to the neural interface for the introduction of the neural interface. The deployment tool may include a first region configured to be positioned near the neural interface and a connector anchored to the first region for detachably coupling the first region to the neural interface. In embodiments, the deployment tool may have a planar or triangular shape. The deployment tool may also include a second region and a central region between the first and second regions. The first region may be wider than the second region. A cutting portion passing through the deployment tool can sever the connector and release the coupling between the deployment tool and the neural interface so that at least the first region moves away from the neural interface device. The deployment tool may further include at least one passage extending from the first region to the second region through the central region, each passage including a first opening in the first region and a second opening in the second region. The connector may be a suture anchored to the first area for holding the first area near the implantable device by passing through at least one passage from the second opening to the first opening. The deployment tool may further include a severable portion extending across at least one passage, which is configured to release at least a portion of the connector in at least one passage when the severable portion is cut, and the release of at least a portion of the suture allows the first area to move away from the implantable device.

[0010] The connector may include a first portion through which at least one passage passes from a second opening to a first opening, the connector may include a second portion that is removably attached to an implantable device, the connector may include a third portion through which at least one passage passes from a first opening to a second opening, the first portion being connected to the second portion, and the second portion being connected to the third portion. The system may include both the first and second passages, with the first portion passing through the first passage and the third portion passing through the second passage. The first and second areas may include rounded edges. The severable portion may be a recessed area within a central area extending across at least the first and second passages. The recessed area within the central area may extend across only a portion of the width of the central area, so that when the recessed area is cut to release the connector, at least a portion of the central area is not cut into two pieces. The recessed area can extend across the entire width of the central area, and therefore when the recessed area is cut to release the connector, the central area is cut into two sections. The central area may include a series of alternating lateral ridges and lateral valleys extending across the width of the central area to provide lateral rigidity when the deployment tool is unfolded, while providing longitudinal flexibility that allows the deployment tool to be wound up. The first and second areas may include alternating lateral ridges and lateral valleys extending across the widths of the first and second areas, respectively. The passages may be formed by tunnels through each lateral ridge and tubes across each lateral valley. The cuttable portion may be a lateral valley. The connector can be anchored to the first area by molding it into the first area. The connector can be anchored to the first area by adhesive. The first area, the second area, and the central area may be molded from silicone. The second area can taper towards the second opening. The tapered second area may include a gripping point for operation, and the gripping point may include an opening.The unfolding tool may include a first surface and a second surface opposite to the first surface, the first surface providing indication of the location of the cuttable portion, and the second surface including a plurality of longitudinal grooves along the length of the unfolding tool to reduce contact. The second and central areas may taper, the first portion of the plurality of longitudinal grooves may extend from the first area to the second area through the central area, and the second portion of the plurality of longitudinal grooves may extend from the first area to the central area. The second area may taper in thickness from the edge of the second area toward the central area. The thickness may increase from the edge of the second area toward the central area. The second area may include a rounded edge.

[0011] The neural interface may be a cuff comprising a spine and at least two curved arms extending from the spine and equipped with electrodes, the open end of each curved arm being detachably coupled to a deployment tool. The neural interface may include a first arm that moves in a first direction and one or more second arms that move in a second direction substantially opposite to the first direction, the second portion of the connector being detachably attached to one or more of the second arms. The second arms may include two arms positioned on either side of the first arm, one of which is aligned with a first opening in a first passage and the other of which is aligned with a first opening in a second passage. The second arm may include a corresponding hole, and the second portion of the connector may be detachably attached to the cuff by passing through the first and second holes so as to hold the first region close to the cuff, and then, when at least one of the first or third portions is cut at the severable portion, the second portion of the connector may be pulled away from the cuff. The thickness of the central region of the tab may be greater than or equal to the thickness of the neural interface. The second arm may have an arm height in a direction perpendicular to both the width and length of the tab, and the central region may have a height running substantially parallel to the arm height, and the height of the central region may be greater than the arm height. The width of the first region of the tab may be greater than or equal to the width of the neural interface. The cuff may have a width measured from the outside of one arm to the outside of the other arm, and this width may run substantially parallel to the width of the first region, and the width of the first region may be greater than the width of the cuff. The deployment tool may be configured as a measuring tool for measuring the fit of the neural interface to a target. The degree of engagement can be determined based on the distance between the ridge, groove, or valley of the deployment tool. The degree of engagement can also be determined based on the distance between the first part and the second part of the deployment tool. The deployment tool can be configured to function as a blunt cutting tool. The thickness of the deployment tool can be greater than the thickness of the C-ring portion of the nerve interface.The width of the deployment tool can be greater than the width of the neural interface.

[0012] The deployment tool can be positioned within the C-ring portion of the neural interface. The deployment tool can be at least partially wound up within the neural interface, for example, within the C-ring portion. Therefore, the deployment tool can be configured to protect the electrode within the C-ring portion until the neural interface is introduced.

[0013] The system described above may further include a lead cap device having a first end and a second end, the lead cap device comprising a body defining an internal cavity extending from the first end to the second end, and a suture loop coupled to the second end, the lead cap device being configured to removably receive a portion of the lead body within the internal cavity. The IPG connector portion of the lead body can be removably received within the internal cavity of the lead cap device, and further, the lead cap is configured to include a set screw block positioned within the body such that the set screw intersects the internal cavity, and to secure a portion of the lead body within the internal cavity by the set screw. In some embodiments, the system comprises the neural interface disclosed above and the lead cap device (i.e., without a deployment tool).

[0014] The systems described above can include different inner diameters of neural interface devices, but the total electrode area of ​​each neural interface device is substantially equal. Electrodes of neural interface devices with a larger inner diameter may have a smaller width and a longer length than electrodes of neural interface devices with a smaller inner diameter. Multiple electrodes can be electrically connected in parallel. A conductor may include a single continuous coil electrically coupled to multiple electrodes located in one of the C-ring portions. The single continuous coil may include a conductive bushing corresponding to each electrode. The conductive bushings can be crimped for mechanical and electrical connection to the single continuous coil, and each crimped bushing is further configured to be welded to the corresponding electrode so that the coil is electrically connected to the electrode. Electrodes may have an internal sleeve for housing the single continuous coil. The ratio of the gap between interconnected electrodes to the interconnector can be 1:2 to 1:3.

[0015] In one embodiment, the system comprises a neural interface disclosed herein, including those described in the preceding paragraph, and a deployment tool that can be detachably coupled to the neural interface for the introduction of the neural interface.

[0016] In one embodiment, the implantable system comprises a neural interface disclosed herein, including one described in any of the preceding paragraphs, and a tethering tab configured to be fixed to the right leg of a septum.

[0017] Mooring tabs may be disclosed herein, including those described in any of the preceding paragraphs describing mooring tabs. The above summary is not intended to describe each embodiment or all implementations of the subject matter shown. The following figures and detailed descriptions illustrate various embodiments in more detail.

[0018] The subject matter of this disclosure will be better understood by considering the following detailed descriptions of various embodiments in conjunction with the attached figures.

Brief Description of the Drawings

[0019] [Figure 1] It is a perspective view of the first side of an embodiment of a bipolar electrode device, including a flexible hemispherical structure for holding an electrode and positioning the device. [Figure 2A] It is a perspective view of the opposite side of the embodiment of FIG. 1. [Figure 2B] It is a perspective view of an embodiment of a multipolar electrode device, including a flexible hemispherical structure similar to that in FIGS. 1 and 2A. [Figure 3] It is a perspective view of the first side of an embodiment of a tripolar electrode device, including a flexible structure. [Figure 4A] It is a perspective view of the opposite side of the embodiment of FIG. 3. [Figure 4B] It is a perspective view of an embodiment of a bipolar electrode device, including a flexible structure similar to that in FIGS. 3 and 4A. [Figure 5] It is a perspective view of an embodiment of an extravascular Venus FlyTrap electrode device. [Figure 6] It is a perspective view of an embodiment of an extravascular Venus FlyTrap electrode device. [Figure 7] It is a perspective view of an embodiment of an intravascular Venus FlyTrap electrode device. [Figure 8A] It is a perspective view of an embodiment of an extravascular bipolar electrode device, including a flexible structure similar to that in FIG. 4B. [Figure 8B] It is a perspective view of the components of the embodiment of FIG. 8A. [Figure 8C-1] It is a perspective view of an embodiment of a deployment tool. [Figure 8C-2] It is a perspective view of another embodiment of a deployment tool. [Figure 8C-3] It is a perspective view of yet another embodiment of a deployment tool. [Figure 8C-4] It is a perspective view of an embodiment of a deployment tool releasably attached to a nerve interface device. [Figure 8D-1]Figure 8C is another diagram of the unfolding tool. [Figure 8D-2] Figure 8C is another diagram of the unfolding tool. [Figure 8D-3] Figure 8C is another diagram of the unfolding tool. [Figure 8E-1] Figure 8C is another diagram of the unfolding tool. [Figure 8E-2] Figure 8C is another diagram of the unfolding tool. [Figure 8E-3] Figure 8C is another diagram of the unfolding tool. [Figure 8E-4] Figure 8C shows another diagram of the unfolding tool and a table of corresponding dimensions. [Figure 8F-1] This is a perspective view of one embodiment of a lead cap device. [Figure 8F-2] Figure 8F-1 is a partial cross-sectional view of the lead cap device. [Figure 8F-3] Figure 8F-1 is another perspective view of the lead cap device. [Figure 9A] This is a perspective view of one embodiment of an electrode device. [Figure 9B] This is a diagram of an electrode device and lead body according to one embodiment. [Figure 9C] This is a diagram of an electrode device and lead body according to another embodiment. [Figure 9D] This is a side view of an electrode device and lead body according to one embodiment. [Figure 9E] This is a photographic diagram of the covering mesh structure of a mooring tab according to one embodiment. [Figure 9F-1] This is a side view of a welding interface between a wire and an electrode according to one embodiment. [Figure 9F-2] According to another embodiment, this is a side view of the welding interface between the wire and the electrode. [Figure 10A] This is an end view of the electrode device according to one embodiment, as shown in Figure 9A. [Figure 10B] This is an end view of the electrode device according to another embodiment, Figure 9A. [Figure 10C] Figure 9A is an end view of an electrode device according to yet another embodiment. [Figure 11A] Figure 9A is a partial perspective view of the electrode of the electrode device. [Figure 11B] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11C] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11D] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11E] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11F] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11G] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11H] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11I] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11J-1] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11J-2] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11K] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11L] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11M] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11N] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 11O] This is a partial perspective view of the electrode and electrode device cuff portion according to one embodiment. [Figure 12A] This is an end view of an electrode device according to one embodiment. [Figure 12B]This is an end view of an electrode device according to another embodiment. [Figure 12C] These are end view diagrams showing the electrodes of the embodiment in Figure 12A and the electrodes of the embodiment in Figure 12B. [Figure 13A] This is a perspective view of a smaller cuff and electrode arrangement according to one embodiment. [Figure 13B] This is a perspective view of the arrangement of a medium-sized cuff and electrodes according to one embodiment. [Figure 13C] This is a perspective view of a larger cuff and electrode arrangement according to one embodiment. [Figure 14A] This figure shows an embodiment of providing power to electrodes using different interconnection configurations. [Figure 14B] This figure shows an embodiment of providing power to electrodes using different interconnection configurations. [Figure 14C] This figure shows an embodiment of providing power to electrodes using different interconnection configurations. [Figure 14D] This figure shows an embodiment of providing power to electrodes using different interconnection configurations. [Figure 14E] This figure shows an embodiment of providing power to electrodes using different interconnection configurations. [Figure 14F] This figure shows an embodiment of providing power to electrodes using different interconnection configurations. [Figure 15A] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15B] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15C] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15D] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15E] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15F] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15G] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15H] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 15I] This figure shows an exemplary embodiment in which a single electrode array is provided, and the flexibility between electrodes within the array is increased. [Figure 16A] This figure shows how to install the device described in this specification. [Figure 16B] This figure shows how to install the device described in this specification. [Modes for carrying out the invention]

[0020] This disclosure relates to embodiments of extravascular and intravascular neural interface devices including electrodes for nerve stimulation / neuromodulation of target nerves or blood vessels. The devices can be housed within a flexible substrate, each substrate having a central portion through which conductors for electrodes are routed and housed. Multiple curved flaps or arms extend from the central portion, and the flaps or arms support the electrodes and position these electrodes inward, i.e., in an extravascular design, or outward, i.e., in an intravascular design. The extravascular neural interface device is configured to be positioned outside the target vessel, and the intravascular neural interface device is configured to be positioned at least partially inside the target vessel. The substrate flaps or arms may include one or more electrodes, and one or more of the electrodes may be configured to be positioned in a specific location relative to the target vessel.

[0021] One embodiment of a bipolar extravascular nerve interface according to this disclosure is shown in Figures 1 and 2A. The nerve interface 100 may comprise a hybrid cuff including a partially helically formed support substrate 102, the support substrate 102 being made from silicone or a similar flexible material, such as styrene-isoprene butadiene (SIBS), polyamide, parylene, liquid crystal polymer (LCP), polytetrafluoroethylene (PTFE), polyethylene (PE), polypropylene (PP), fluoroethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polyurethane, or another biocompatible polymer. Biocompatible silicones and other grades of silicone can have very high flexibility and pliability, thereby minimizing mechanical mismatch between the cuff and the target vessel and minimizing constriction of the target vessel. Polymer materials can also be used, but these materials are stiffer and harder than silicone, which may require the use of thinner materials, which can be both an advantage and a disadvantage.

[0022] The base material 102 may include two C-ring portions 104 and 106, each C-ring portion connected by a vertebral portion to form a helix of one turn in opposite directions from a common central section 108 of the central portion 109 (when the central portion 109 is combined with one of the portions 104 or 106), terminating in a C-ring configuration, the C-ring being substantially orthogonal to the target vessel when positioned. Within each C-ring termination portion 104 and 106, multiple platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 112 and 114, can be arranged, rather than multiple helical structures as seen in conventional systems. The electrode arrays 112 and 114 may be of conventional type and may be wired to a controller via conventional conductors 118, such as 35N LT® DFT (Drawn Filled Tubing) with a 28% Ag core, in a stranded cable configuration (i.e., a 7x7 configuration (not shown)) or a multifilament coil configuration. The conductor is housed within a spine or vertebral portion 120 attached to the terminal portion 106 and part of the central portion 109.

[0023] The configuration of the neural interface 100 allows for a significantly shorter length, thereby reducing the portion of the target vessel or nerve that needs to be separated during placement. In addition, the opposite spiral directions of portions 104 and 106, and the low spiral angle of each portion relative to the vertebral portion 120, allow for the introduction and wrapping of the neural interface 100 around the target vessel in a single pass, rather than at least two passes as in the case of conventional spiral structures. The low spiral angle or low pitch allows for a shorter length of the neural interface 100 (or its distal end), resulting in less tissue dissection during positioning.

[0024] The substrate 102 may include a plurality of features 110 positioned on or within the substrate 102. The features may be configured to allow a deployment tool (not shown) to grasp, manipulate, and introduce the neural interface 100. Thus, each feature may be called an introduction feature. The features may be projections. One or more projections may include one or more openings or holes for receiving a stylet (made of tungsten or a similar material) to allow, for example, straightening several parts of the substrate or introducing the neural interface. The features 110 may also be openings, holes, or any other form of lumen that can be equally manipulated by the deployment tool.

[0025] In one embodiment, the feature 110 can be positioned close enough to the open ends of the C-ring portions 104 and 106 and the end of the central portion 108 so that the deployment tool can grasp the feature and simultaneously open portions 104 and 108 and the central portion 108, and thus the neural interface can be positioned around a target vessel (not shown). Herein, “open end” refers to the end located on the outer circumference of a C-ring that is not attached to another feature (e.g., another C-ring or vertebral portion). In other words, each “open end” forms a gap side for the target vessel. Similarly, “closed end” refers to the end located on the outer circumference of a C-ring that is attached to another feature. In other words, each “closed end” does not form a gap for the target vessel. After the neural interface 100 is positioned around the target vessel, the deployment tool should carefully release the feature so that portions 104 and 108 and the central portion 108 can softly self-size to conform to the target vessel. “Self-sizing” means that the neural interface 100 naturally conforms to the shape of the target vessel.

[0026] A C-ring can exert radial pressure on a target blood vessel, nerve, or other structure. The amount of pressure applied can depend on several factors. The materials constituting the C-ring portion are, for example, insulating materials and conductive parts (such as electrodes, coils, foils, or welds, as described later) that pass through or are at least partially exposed to the C-ring portion (such as electrodes). The C-ring portion applies radial pressure depending on several characteristics, such as the stiffness of the insulating material constituting the body of the C-ring portion (e.g., 70-80 Shore). The thickness of the insulating material constituting the body of the C-ring portion also affects the radial pressure, as does the stiffness or hardness of one or more electrodes passing through the C-ring. As will be described in more detail with respect to Figures 14 and 15, the size and shape of at least one electrode can affect the flexibility of the electrode and therefore the applied radial pressure. The number of electrodes on any given C-ring can also affect the applied radial pressure. The surface of the C-ring facing the target can be formed from an active portion (also called the exposed electrode portion) and an inert portion (also called the insulating material portion), and the ratio of the active portion to the inert portion can affect the radial pressure. For example, the ratio of the active portion to the inert portion (i.e., active portion:inert portion) can be 1:0.5 to 1:10. In a preferred embodiment, this ratio can be 1:1.5 to 1:5, or 1:3. As will be described in more detail later, the gap size between any given pair of electrodes in the C-ring also affects the applied pressure. The characteristics of the interconnection between different electrodes can also affect the radial pressure.

[0027] In some embodiments, the thickness of the C-ring material is, for example, about 0.5 mm to 2 mm, for example, about 1 mm, about 1.2 mm, or about 1.4 mm. The thickness is defined, for example, along the radial direction from the central axis as shown in Figure 1. Referring again to Figure 1, in embodiments, the diameter of the cuff (i.e., the length of the C-ring material around the central axis) can be 1 mm to 25 mm, preferably about 3 mm to about 10 mm, for example, 4, 5, 6, 7, 8, or 9 mm, or any number in between, more preferably about 4 mm to 8 mm. However, this can also be selected based on the target size.

[0028] As shown in Figure 9A (and additional embodiments described later), each device has an inner diameter and an outer diameter. As used herein to describe such devices, the term “inner diameter” refers to the distance from the central axis of the device to the radially inward portion where the electrodes are located. In contrast, the “outer diameter” is the distance to the radially outward portion opposite those electrodes and defines the furthest radial range of the device. The outer diameter is the furthest radial range of the C-ring portion and is not defined by the radially outermost range of other protrusions, such as leads or other features attached to the radially outer surface of the C-ring portion. The C-ring portions of the neural interfaces described herein have an inner diameter and a cross-sectional thickness, and in some embodiments, the ratio of inner diameter to cross-sectional thickness is in the range of 4:1 to 9:1, or 5:1 to 7:1, or 5:1 to 6:1. In other embodiments, such as when a thin film is used, this ratio can be increased to 40:1, but to increase structural integrity, this ratio can be brought closer to 10:1. On the other hand, if a larger radial force is desired, this ratio can be reduced to 3:1. It will be understood by those skilled in the art that this ratio can also be selected in relation to the hardness of the material used. For example, the harder the material, the higher the Shore number, so using a higher ratio can achieve a radial force similar to that of a lower ratio, even with a less hard material.

[0029] Depending on the physical aspects discussed above and the resting radius of the C-ring relative to the nerve or blood vessel to which the force is applied (i.e., how much the C-ring expands), the radial pressure exerted by the C-ring can be determined as the average contact pressure. As used herein, the term “resting radius” refers to the inner radius of the device when no external force is applied. Since a target alone can maintain a larger radius compared to the resting radius and biases the device to a relatively more open position, the device can have different resting radii when positioned on a target. This average contact pressure can range from about 0 mmHg to about 30 mmHg. In some embodiments, the average contact pressure can be about 5 mmHg to about 25 mmHg, or about 5 mmHg to about 20 mmHg, or about 10 mmHg to about 20 mmHg, or about 10 mmHg to about 15 mmHg. In preferred embodiments, the C-ring exerts at least some radial pressure (e.g., at least 1 mmHg) but not pressure large enough to damage the underlying anatomical structure.

[0030] A change in radial size can directly correspond to the amount of force applied radially. As used herein, radial pressure corresponds to the applied pressure when the C-ring or cuff is open about 0% to 40% (i.e., the cuff diameter increases by 0% to 40% when introduced onto the target, compared to the original cuff diameter size). In other words, when the cuff diameter expansion is somewhere between 0% and 40%, the average radial pressure applied by the C-ring is about 0 mmHg to 30 mmHg. In some embodiments, when the cuff diameter expansion is somewhere between 0% and 35%, the average radial pressure applied by the C-ring is about 0 mmHg to 30 mmHg. In some embodiments, when the cuff diameter expansion is somewhere between 0% and 30%, the average radial pressure applied by the C-ring is about 0 mmHg to 30 mmHg. In some embodiments, when the cuff diameter expansion is somewhere between 0% and 25%, the average radial pressure applied by the C-ring is about 0 mmHg to 30 mmHg. In some embodiments, when the cuff diameter expansion is somewhere between 0% and 20%, the average radial pressure applied by the C-ring is approximately 0 mmHg to 30 mmHg. A preferred expansion, in some embodiments, can be between 10% and 30% for desirable electrical contact and average radial pressure. Expansion exceeding 40% typically occurs only during the introduction or removal of the C-ring from the target.

[0031] The separating or retaining force refers to the force required to remove the device from the target after it has been at least partially positioned around the target anatomical structure. In some embodiments, the separating force can be 0.05 N to 0.5 N. In preferred embodiments, the separating force can be 0.1 to 0.2 N. In preferred embodiments, it is sufficient to pull the device with a separating force of about 0.15 N perpendicular to the target axis to remove it from the target.

[0032] While an embodiment comprising three open-end arms is discussed and described as an example, various aspects of this disclosure can be applied to neural interfaces having different shapes or arrangements. For example, a neural interface may comprise only one open-end arm, two open-end arms, or four or more open-end arms. Furthermore, a neural interface may comprise arms having the same coupling and opening orientation, alternating coupling and opening orientations, or other patterns of arm coupling and arm orientation, arms of different relative sizes, arms of different or varying helical angles, and other variations, including those discussed herein in relation to other embodiments.

[0033] Another embodiment of the neural interface 200 is shown in Figure 2B, which is structurally similar to the embodiments shown in Figures 1 and 2A, namely having multiple C-rings and a common central section, forming two short helical rotations. The neural interface 200 can be multipolar rather than bipolar, as in the case of neural interface 100. In the neural interface 200, the base material 202 may include three C-ring portions 204, 206, and 208, each C-ring end portion 204 and 206 being connected by a helical rotation in the opposite direction to the common central section of the C-ring center portion 208, and terminating in a C-ring configuration that can be orthogonal to the target vessel when positioned on the target vessel. The C-ring center portion 208 can also be orthogonal to the target vessel. Within each C-ring portion 204, 206, and 208, multiple platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 212, 214, and 224, can be positioned, and such electrodes are fitted (arranged) such that the electrodes in one C-ring cover the gap in adjacent C-rings (along the length between the electrodes). Each electrode array is connected to a different conductor of the multiconductor 218 housed within the spinal portion 220, the spinal portion 220 being attached only to the central portion 208. The substrate 202 of the neural interface 200 does not have to contain any special material. By connecting individual electrodes or different electrode arrays to different conductors, and by individually controlling each connected device or individual electrode or individual electrode group, selective stimulation of target vessels can be enabled.

[0034] Figures 3 and 4A show one embodiment of a three-pole neural interface 300 according to the present disclosure. The neural interface 300 can be similar to the neural interface 100 in that it can be formed from a flexible substrate 302 of a similar material and can have two terminal portions 304 and 306 that form a C-ring configuration that can be attached to a spinal portion 308.

[0035] However, unlike the neural interface 100, the two terminal portions 304 and 306 do not have to be connected to the central section. Instead, a central portion 330 that forms a third C-ring can be utilized. The terminal portions 304 and 306 and the central portion 330 can have a very low spiral angle, or pitch, relative to the vertebral portion 308, thereby making the neural interface spiral while still being considerably shorter in length. The spiral angle can be approximately 15 to 30 degrees, but can also be less than 15 degrees.

[0036] Similar to the neural interface 100, each C-ring of the neural interface 300 may contain one or more electrodes or arrays of electrodes, such as 312, 314, and 316, with each electrode connected to a conductor 318 through a spinal portion 308. A single-electrode design can maximize the effective range of the electrode while minimizing the conductor interconnection process, such as laser welding or resistance welding. However, to minimize the rigidity of the electrode, i.e., to give it sufficient flexibility, the electrode may have to be very thin (typically 25 μm to 50 μm), which can make interconnecting the conductor to the electrode more difficult. Also, since surface features should reduce the flexibility of the electrode, it may not be possible to add surface features to the electrode in order to maintain the highest possible electrode flexibility. For this reason, a single electrode may be characterized as a concave electrode and have a silicone rim or silicone webbing that can serve to hold the electrode in place. However, making the electrode concave may potentially reduce the effectiveness of stimulation. On the other hand, the "split" electrode design can provide better mechanical compliance, introduce surface features, i.e., the possibility of protruding electrodes, and allow for individual control of each electrode (i.e., current steering). Trade-offs include limitations on the effective electrode range, increased interconnection processes, and reduced retention force. Split electrodes provide greater flexibility to the neural interface, thereby allowing the C-ring to be opened more broadly and for longer periods by the deployment tool compared to when a single electrode is used, without placing excessive stress on the electrode.

[0037] As shown in Figures 2A and 4A, the individual electrodes of the electrode arrays 112 and 114 of the neural interface 100 and the electrode arrays 312, 314, and 316 of the neural interface 300 can be uniformly spaced within the substrates 102 and 302, respectively. Uniformly spaced electrodes within the substrate allows for a more consistent distance between electrodes, providing a more uniform current density distribution and improved effectiveness of the neural interface. In some embodiments, the positions of the electrodes within the arrays can be staggered to achieve a better electrical effective range. With respect to the neural interface 300, specific characteristics of the neural interface 100 and / or 300, such as the spacing 350 between electrode arrays 312, 314, and 316, the size and shape of the electrodes, the size, shape and number of electrodes within the electrode arrays, the distance between electrodes within the electrode arrays, and the angle of the helix, can each be selected for specific applications of the neural interface. For example, the use of a neural interface for treating the splenic artery may require different characteristics than the use of a neural interface for treating different blood vessels. For example, when used to treat the splenic artery, an electrode width of approximately 1-4 mm is appropriate, with preferred widths being approximately 1-2 mm and 2-3 mm. When used to treat different blood vessels, different electrode widths may be desirable.

[0038] The neural interface 300 may also include at least one feature 310, which may be positioned on the outer surface of the substrate 302 near the open ends of the C-rings of portions 304, 306, and 330. As described above, the feature may include one or more openings or holes for receiving a stylet (made of tungsten or a similar material) to allow, for example, straightening several portions of the substrate and / or introducing the neural interface. The feature 310 may be configured to allow a deployment tool (not shown) to grasp, manipulate, and introduce the neural interface 300. In one embodiment, the feature 310 may be positioned sufficiently close to the open ends of the C-rings of portions 304, 306, and 330 so that a deployment tool can grasp the feature 310 and simultaneously open portions 304, 308, and 330, and thus the neural interface 300 can be positioned around a target vessel (not shown). After the neural interface 300 is positioned around the target vessel, the deployment tool should carefully release the material, so that parts 304, 308, and 330 can softly self-size to fit the target vessel. The configuration of neural interfaces 100 and 300 allows the neural interface to be positioned around the nerve / vascular vessel in a single pass, minimizing nerve / vascular manipulation and reducing tissue dissection around the area of ​​the nerve / vascular vessel where the interface is positioned.

[0039] The neural interface 400 in Figure 4B is similar to the neural interface 300. The neural interface 400 is formed from a flexible substrate 402 of a similar material and may have two terminal portions 404 and 406 that form a C-ring configuration including electrode arrays 412 and 414. A central portion 430 can be attached to the spinal portion 408 together with the terminal portions 404 and 406.

[0040] The central portion 430 does not necessarily have to include any electrodes and can only function to hold the positioned neural interface, although embodiments may include electrodes.

[0041] The nerve interfaces 100, 200, 300, and 400 can be self-sizing, meaning these nerve interfaces can be formed from a flexible material, thereby allowing them to be manipulated for insertion, like a Nitinol cage, which can contract to fit into a catheter and return to its pre-contracted shape when released from the catheter, but return to its predetermined shape when released. This makes it possible to use the nerve interface to provide good electrical contact between the electrode array and the nerve / vascular surface while accommodating anatomical variations at the intervention site, thereby improving the efficiency of the interface. The flexible material of the interface can maintain compliance even when self-sizing to fit a nerve or blood vessel. This helps prevent the nerve interface from compressing the nerve or blood vessel, causing reduced blood flow and other constriction of nerve fibers. This also allows for better accommodation of radial expansion of nerves / vascular vessels resulting from edema or swelling after positioning, and can accommodate the pulsating behavior of the intervention site, such as arteries.

[0042] The naturally opening spiral structure of neural interfaces 100, 200, 300, and 400 reduces the extent around the nerve / vascular region, promoting more normal fluid and nutrient exchange with the intervention site and surrounding tissues. This also helps minimize connective tissue growth between the electrode neural / vascular interfaces. The open structure of each neural interface is configured such that, at any point along the length of the target vessel, the terminal or central portion does not form a closed circumscribing arc around the target vessel. In other words, this structure does not form a closed circle that covers 360 degrees of the orthogonal portion of the length of the target vessel. This open, unrestricted trench allows the target vessel to pulsate without constriction, and the initially bulging target vessel can return to its normal state over time, ensuring that the target vessel is not constricted when bulging and that contact between the electrode and the target vessel is not lost when the target vessel is in its normal state.

[0043] Figures 5 and 6 show additional embodiments of the self-sizing extravascular nerve interface 500. The nerve interface 500 can be shaped like a Venus Flytrap fastener, with a vertebral portion 502 connected to a conduit 504 containing a conductor for the nerve interface, and several sets of matching portions 510, 512, and 514 extending from the vertebral portion 502. The portions 510, 512, and 514 can be substantially orthogonal to the vertebral portion 502. Each of the terminal portions 510 and 512 and the central portion 514 may contain electrodes or electrode arrays 520, 522, and 524, respectively, which may be inwardly oriented to allow good electrical contact between the electrodes and the outer wall of the target vessel / nerve 530, and to allow the artery to pulsate more freely. As discussed earlier, this open trench can relieve pressure on nerves 532 within target vessel 530 sandwiched between the arterial wall and the nerve interface 500. The gaps or channels between sections 510, 512, and 514 can also provide space for the target vessel to pulsate and for fluids and nutrients to reach the target vessel.

[0044] The electrodes or electrode arrays 520, 522, and 524 can also be positioned at different locations in each of the portions 510, 512, and 514. The number of electrodes and their arrangement with the electrode arrays can vary. As shown in Figures 5 and 6, the electrode 520 in the terminal portion 510 is positioned near the tip of the terminal portion 510, the electrode 522 in the central portion 512 is positioned near the middle of the central portion 512, and the electrode 514 in the terminal portion 514 is positioned near the connection point between the terminal portion 514 and the spinal portion 502. Naturally, different positional configurations (i.e., all electrodes in the tip, middle, or spinal portion, or any other combination of positions) are also possible and can be specifically selected to provide different peripheral ranges for the type of nerve / vascular and the treatment being performed.

[0045] Similar to the neural interfaces 100 and 300 described above, the neural interface 500 is also self-sizing in that the shapes of portions 510, 512, and 514 are designed to fit substantially around most of the periphery of the target vessel, and the ribs are biased to a relaxed position and, once introduced, naturally wrap around most of the target vessel. In this specification, the word “substantially” does not exclude “completely,” and for example, a composition that “substantially does not contain” Y does not have to contain Y completely. The word “substantially” may be omitted from the definitions of this disclosure as needed. For example, substantially one turn of a helix may be one turn of a helix, substantially oppositely positioned features may be oppositely positioned, substantially spaced at a constant distance may be spaced at a constant distance, and electrodes that provide a substantially uniform current density may provide a uniform current density.

[0046] Parts 510, 512, and 514 can be perpendicular to the vertebral part 502, or have a low helical angle with respect to the vertebral part 502. Like nerve interfaces 100 and 300, the composition of the substrate for nerve interface 500 can be silicone or a similar material, and all such nerve interfaces can be further treated to prevent premature scarring (i.e., fibrous tissue). Such treatment can be performed only on selected surfaces, for example, on the side facing the nerve / artery wall. For example, silicone can be doped with a steroid drug such as dexamethasone. The outer surface of the substrate of the nerve interface can be further, or alternatively, coated with a hydrophilic polymer such as poly-2-hydroxyethyl methacrylate (pHEMA).

[0047] The tips of each section 510, 512, and 514 may be shaped to allow them to be grasped by a dispensing tool (not shown) for placement on or removal from their respective target vessels and / or nerves. Alternatively, features such as features 110 and 310 may be added to the outer surfaces of sections 510, 512, and 514 to allow them to be pulled and released from the nerve interface 500 for placement on or removal from target vessels.

[0048] Figure 7 shows one embodiment of a self-sizing intravascular nerve interface 700. Similar to the nerve interface 500, the nerve interface 700 can be shaped like a Venus Flytrap fastener, with a vertebral portion 702 connected to a conduit 704 containing a conductor for the nerve interface, and several sets of matching portions 710, 712, and 714 extending from the vertebral portion 702. However, in contrast to the nerve interface 500, each of portions 710, 712, and 714 may contain electrodes or electrode arrays 720, 722, and 724, respectively, which are outward-facing so that good electrical contact can exist between the electrodes and the inner wall of the target vessel / nerve 730, allowing the artery to pulsate more freely, thereby relieving the pressure on the nerve 732 in the target vessel 730 sandwiched between the internal arterial wall and the nerve interface 700. The gaps or channels (low-pressure trenches) between portions 710, 712, and 714 may also provide space for the target vessel to pulsate, and unlimited conduits for fluids and nutrients to reach the inner wall of the target vessel 730, while at the same time not completely enclosing the artery at any point in the cuff geometry. For example, with respect to each embodiment disclosed herein, no portion of the cuff geometry covers the outer periphery (a full 360-degree rotation) of the portion of the target vessel perpendicular to any point on the vertebral portion.

[0049] The electrodes or electrode arrays 720, 722, and 724 can also be positioned at different locations within each of the portions 710, 712, and 714. As shown in Figure 7, the electrode 720 in the terminal portion 710 is positioned near the connection point between the vertebral portion 702 and the terminal portion 710, the electrode 722 in the central portion 712 is positioned near the middle of the central portion 712, and the electrode 714 in the terminal portion 714 is also positioned near the vertebral portion 702. Naturally, different positional configurations (i.e., all in the terminal, intermediate, or vertebral positions, or any other combination) are possible and can be specifically selected for the periphery of the nerve / vascular region, the type of nerve / vascular region, and the treatment to be performed.

[0050] In contrast to the extravascular nerve interface embodiments described above, the nerve interface 700 can be positioned via a flexible / foldable catheter (not shown, but the nerve interface 700 folds within the catheter) rather than an external deployment tool. Depending on the location of the target vessel, the positioning procedure can be minimally invasive. For example, to position it within the splenic artery, the procedure can be performed by a total percutaneous access via a standard (e.g., femoral) arterial access. After the catheter is positioned for the introduction of the nerve interface 700, the catheter can be withdrawn, and the released nerve interface self-sizes to fit inside the target vessel 730, so that portions 710, 712, and 714 fold away from the spine 702 in a normal relaxed position and form to make good contact with the inner wall of the target vessel 730.

[0051] In the embodiment of Figure 8A, an extravascular bipolar electrode nerve interface 800 is shown. The interface 800 includes a flexible structure similar to the structure in Figure 4B. In Figure 8B, the nerve interface 800 of Figure 8A is also depicted, but the flexible substrate 802 and the cover for the vertebral portion 808 are not shown, which serve to further illustrate the internal components and deployment tools of the nerve interface 800. The nerve interface 800 is similar to the nerve interface 400 of Figure 4B. The flexible substrate 802 can be formed from a material similar to that disclosed with respect to the nerve interface 400. The nerve interface 800 may include two arms at both ends of the device, such as terminal portions 804 and 806, which may each have open ends 805 and 807. The terminal portions 804 and 806 may each be C-ring configurations and may include electrode arrays such as arrays 812 and 814 in Figure 8B. Similar to the closed ends of the terminal portions 804 and 806, the central arm portion 830 can be attached to the spinal portion 808. The central portion 830 does not have to include any electrodes and can only serve to hold the positioned neural interface, although embodiments may include electrodes.

[0052] As shown in Figure 8B, the four electrodes 815 of each array 812 and 814 are connected in series via three microcoil interconnects 817, the three microcoil interconnects 817 being connected in series to conductor 818 in the case of array 814 and to conductor 819 in the case of array 812. Conductors 818 and 819 can be covered with the same flexible substrate used to cover the terminal portions 804 and 806 and the central portion 830 over the length of the spinal portion 808, extending only a short distance from the neural interface 800. Conductors 818 and 819 are also covered with a silicon lead tube material 820 before emerging from the material of the spinal portion, forming a lead conductor 822.

[0053] As mentioned above, the features can be protrusions, but may also be openings or small holes. As shown in Figure 8A, the features may be openings 840 formed at the open ends 805 and 807 of the terminal portions 804 and 806. The deployment tool 841 may consist of connectors such as suture wires 842, grab tab tubing 844, connectors 846, and grab tube loops 848. The suture wires 842 can be passed through each opening 840 and the silicone tubing of the grab tabs 844. The suture wires 842 can then be joined with the connectors 846 to form the grab tube loops 848. During the introduction of the neural interface 800, the surgeon can position the central portion 830 around a target vessel (not shown in Figures 8A and 8B) while gently pulling the grab tube loops 848. Such pressure pulls the open ends 805 and 807 of the terminal portions 804 and 806 away from the vertebral portion 808, making it possible to position the neural interface 800.

[0054] When the nerve interface 800 is properly positioned, pressure can be released from the grab tube loop 848, and thus the open ends 805 and 807 can softly self-size around the target vessel. Although not shown in Figures 8A and 8B, the central portion 830 may also include an opening feature 840, which can open as well as the terminal portions 804 and 806 to self-size around the target vessel. After the nerve interface is properly positioned, the suture wire 842 can be cut and removed from the opening 840. The opening feature 840 may be a circular hole, an elliptical slot (not shown in Figures 8A and 8B), or other shapes, or a small hole (not shown in Figures 8A and 8B) extending tab-like from the terminal portions 805 and 807.

[0055] In another embodiment, the deployment tool 841 may include an additional suture wire portion, which may or may not include a silicone tubing 844 surrounding the additional suture wire portion, and the additional suture wire may extend between the double arms of the grab tab 844 to form a triangular shape in order to increase structural stability when introducing the neural interface device 812.

[0056] In another embodiment, referring to Figure 8C-1, the unfolding tool 841 comprises a tab-shaped body 850, rather than the double arm of the grab tab 844 depicted in the embodiments of Figures 8A and 8B. In the embodiment of Figure 8C, the first aperture 852 is similar to the grab tube loop 848, and the second aperture 854 and third aperture 856 provide portions to which a connector, such as a suture, can be anchored to the tab-shaped body 850. For example, anchoring can be provided by molding or by the use of an adhesive material. After anchoring by molding, apertures 854 and 856 are filled by molding and thus anchor the connector. Adhesive material can similarly fill apertures 854 and 856. In some embodiments, anchoring can be provided without providing any apertures 854 or 856. For example, the connector can be molded when forming the tab-shaped body 850. In other embodiments, an adhesive material can be used to anchor the connector to at least a portion of the tab-shaped body 850. The tab-shaped body 850 may also be provided with multiple sets of small holes 858 through which a connector can pass. The set of small holes forms first and second passages through which the connector can pass, as shown in Figure 8C-4. When the connector (e.g., a suture) passes through the first and second passages formed from the set of small holes, the connector forms a Y-shape similar to the deployment tool shown in Figures 8A and 8B. The tab-shaped body 850 provides further stability when deploying the neural interface because the tab keeps the arms of the neural interface parallel (along the edge of the tab to which the neural interface is releasably connected to the deployment tab). The planar shape of the deployment tab maintains a specific distance between the arms to prevent crossing or entanglement of the arms during deployment.

[0057] Other exemplary embodiments of the deployment tool 841 are shown in Figures 8C-2 and 8C-3. An example of one embodiment of the deployment tool 841 releasably mounted to the neural interface device 812 is also shown in Figure 8C-4.

[0058] The tab-shaped body 850 of the deployment tool 841 in Figure 8C offers advantages in addition to delivery, positioning, and deployment of the neural interface 800. The tab-shaped body 850 provides further structural stability when deploying the neural interface 800. For example, the two arms releasably attached to the neural interface 800 can be moved stably in a single direction.

[0059] For example, in some embodiments, the main body 850 can be used as a measuring tool. In one embodiment, referring to Figures 8D-1, 8D-2, and 8D-3, the gap between the end of the main body 850, which has a length L, and the vertebral portion 808 can be measured to determine the degree or amount of stretching of the nerve interface 800 around the target tissue. This also characterizes the radial length of the electrode arm opening. Understanding these characteristics can be useful for medical professional users in determining whether a nerve interface 841 of appropriate size has been selected for the target tissue. Figures 8D-1, 8D-2, and 8D-3 show radial gaps L1, L2, and L3, respectively, which can be evaluated by medical professional users during the delivery and deployment of the nerve interface 800.

[0060] In another use of the body 850 of the deployment tool 841, referring to Figures 8E-1, 8E-2, 8E-3, and 8E-4, in some embodiments, the rib-groove structure of the body 850 can be used as a “measuring tape” type measuring tool. The rib-groove structure of the body 850 can be flexible so as to be at least partially conformal around the target tissue, thereby providing another method by which a medical professional user can use the body 850 to evaluate the size and fit of the neural interface 800 to the target tissue. This can be achieved in several ways. In one embodiment, information can be provided to the medical professional user that translates the number of ribs (or grooves) into useful information. For example, separation of 3 to 5 ribs is acceptable, 2 or less means the cuff is too large, and 6 or more means the cuff is too small. Thus, as shown in Figures 8E-1, 8E-2, and 8E-3, simply counting the ribs (or grooves) can directly provide information about the fit. In another embodiment, a user, such as a medical professional, can first count the ribs (or grooves) as shown in Figures 8E-1, 8E-2, and 8E-3, and then evaluate the size and fit using known measurements between adjacent ribs (or grooves), as shown in Figure 8E-4. Similarly, known measurements can be converted into a table, which indicates the cuff opening in proportion to the circumference (outer length), advising the medical professional user on which is suitable. In the table in Figure 8E-4, values ​​3 through 7 are suitable for the target tissue, the first two indicate that the cuff is too large, and the last two indicate that the cuff is too small. Depending on the target and the specific embodiment of the neural interface used, a table containing different predetermined values ​​may be used.

[0061] As mentioned above, the tab-shaped body 850 also has multiple sets of small holes 858. When in use, a suture wire can be passed through each small hole 858 and then brought together at one aperture 852 to form a grab loop. During the introduction of the nerve interface 800, the surgeon can position the nerve interface 800 around the target vessel by gently pulling the grab loop. Such pressure pulls the open ends 805 and 807 of the terminal portions 804 and 806 of the nerve interface 800 away from the vertebral portion 808, allowing the nerve interface 800 to be positioned as desired.

[0062] When the neural interface 800 is properly positioned, pressure can be released from the grab loop, and thus the open ends 805 and 807 can gently self-size around the target vessel. After the neural interface is properly positioned, the suture wire can be cut and removed from the small hole 858 and the first aperture 852. The first aperture 852, the second aperture 854, and the third aperture 856, as well as the small hole 858, can be circular holes, elliptical or oblong slots, or other shapes, or feature tabs extending from the terminal portions 805 and 807 of the neural interface 800.

[0063] The deployment tool 841, having a tab-shaped body (also called a deployment tab), may have a thickness and / or width slightly greater than the thickness and / or width of the nerve cuff. The deployment tab may include a tethering suture, which is wrapped around the deployment tab and removably attached to the nerve cuff (for example, by a connector such as a suture on an introduction feature of the nerve cuff, such as an opening at the open end of the arm). The deployment tool can be completely removed from the nerve cuff by cutting at least a portion of the deployment tab. The deployment tab may include a series of transverse (or lateral) ridges and valleys on one side (along the width of the deployment tab), which can act as cutting guides and can allow the deployment tab to be rolled up to a smaller size for delivery. The deployment tab may include a series of longitudinal ridges and valleys on the opposite side, for example, the side shown in Figure 8D-1, as shown in Figures 8C-1 and 8C-2, and these ridges and valleys may serve to minimize the contact surface (including when the deployment tab is rolled up and during tissue introduction). The deployment tab may include a tapered proximal end and may be configured to act as an instrument (e.g., a go / no-go gauge) and a blunt cutting tool to ensure that the anatomical opening is large enough for the cuff. If the thickness and / or width of the deployment tab does not fit the anatomical area, a slightly smaller nerve cuff may also not fit. The anchoring suture is positioned within the deployment tab so that when at least a portion of the deployment tab is cut, the suture is also cut, thereby freeing the deployment tab from the pre-attached portion of the nerve cuff.

[0064] Other tools and accessories may also be provided to assist surgeons in delivering, positioning, and introducing embodiments of the neural interface discussed herein. For example, Figures 8F-1, 8F-2, and 8F-3 depict a lead cap device 860. The lead cap device 860 is positioned on the end of the lead body and protects the end of the lead body during the delivery and introduction of the neural interface. During the delivery and introduction of the neural interface, stresses are applied to the lead body, including the load of implantation and mechanical interactions when pushing or pulling surgical tools (such as capture devices) to move it into position, which may damage the lead body or conductor. The lead cap device 860 is sized and configured to fit onto a cannula or catheter. For example, in one embodiment, the lead cap device 860 is sized to fit onto a 5 mm cannula, but the lead cap device 860 can be provided in a range of sizes that can fit a range of catheter / cannula sizes.

[0065] In the embodiments shown in Figures 8F-1, 8F-2, and 8F-3, the lead cap device 860 comprises a main body 862, a set screw block 864 equipped with a set screw 866, and a suture loop 868.

[0066] In one embodiment, the body 862 comprises a transparent or translucent biocompatible material such as silicone. Such a material allows the surgeon to see inside the body 862 and determine how far the end of the lead body 917 has advanced into the internal cavity 870 of the body 862, thus providing visual feedback during use. In some embodiments, only a portion of the body 862 can be made transparent.

[0067] The internal cavity 870 includes a retaining constriction 872, as shown in the cross-sectional view of Figure 8F-2. The internal cavity 870 also passes through a set screw block 864. This configuration allows the lead body 917 (see Figure 8F-3) to be fed into the first end 874 of the lead cap device 860 and the internal cavity 870. After being fully inserted and positioned within the internal cavity 870 and the set screw block 864, the set screw 866 can be tightened to hold the lead body 917 therein. Tightening the set screw 866 in this manner can be achieved by a torque wrench (not shown). The torque wrench can provide an audible click when the maximum or desired torque is applied. The set screw block 864 is formed to engage with the body 862, and therefore rotation, movement, or misalignment of the set screw block 864 relative to the body 862 is prevented when the set screw 866 is tightened and the lead cap device 860 is operated during routing.

[0068] In wired embodiments, the lead body 917, more specifically the IPG connector portion of the lead body 917, should be fully inserted into the lead cap device 860 such that the portion of the lead body 917 that engages with the set screw 866 does not include any delicate components of the lead body 917, such as the contact portion of the lead conductor itself. Damage to these contact portions during implantation may impair the electrical isolation characteristics when the lead body 917 is connected to a pulse generator, such as an implantable pulse generator (IPG). In other words, the end portion of the lead body 917 configured to be coupled to other system components, such as a pulse generator, for use should be advanced beyond the set screw 866 toward the second end 876 and suture loop 868 of the lead cap device 860. When positioned in this manner, the retaining constriction 872 also functions to hold the lead body 917 within it, and in some embodiments, can hold the lead body 917 even if the set screw 866 is not tightened (or not tightened sufficiently).

[0069] The configuration and features of the lead cap device 860 allow the surgeon to push or pull the lead body 917 in any orientation to route the lead body 917 to a fixed position. To pull the lead cap device 860 (and thereby the lead body 917), the suture loop 868 can be captured using a capture tool or other device. The portion of the body 862 located near the second end 876 can also be captured and pulled during routing. Similarly, the tapered configuration of the first end 874 of the body 862 can also be pushed during routing.

[0070] While specific examples (such as the neural interface 800) have been discussed and explained, the tab-shaped body 850, lead cap device 860, and other accessories and techniques described above are also applicable to and can be used with other embodiments of the neural interface. Furthermore, not all embodiments necessarily include leads. For example, the neural interface 900 in Figure 9A, which will be discussed in more detail later, is shown as being wired to an implantable pulse generator, but it should be understood that the neural interface device 900 can also be powered wirelessly by including a receiver or coil in the neural interface device 900 instead of a lead 917 that provides a wired connection. In some embodiments, if the neural interface device 900 can be powered by a wireless pulse generator, such as a device worn by the user, then the implantable pulse generator referenced herein does not need to be implanted. In some other embodiments, the neural interface 900 may include a small implantable pulse generator (IPG) having a wireless antenna to receive power and communication from a transmitter. The IPG may receive power from an external source and / or may be equipped with a battery for charging from an external source, and the IPG may be powered by said battery or external source. The following figures refer to embodiments based on wired leads, but these embodiments may be wireless by alternative means, and it should be understood that, unless otherwise specified, the pulse generator described herein does not need to be embedded or able to be embedded.

[0071] For example, Figure 9A shows another embodiment of the neural interface 900 according to this disclosure. Unless otherwise specified herein, the neural interface 900 may be similar to the neural interfaces 100, 200, 300, and 400 discussed herein above. For example, the neural interface 900 may be formed from a flexible substrate of the same or similar material (i.e., silicone) and may share other features.

[0072] The neural interface 900 comprises a vertebral portion 902, a first C-ring portion 904, a second C-ring portion 906, and a third C-ring portion 908. The vertebral portion 902 comprises a first end 901 coupled to a lead body 917 having a conductor 918, and a second end 903 at least partially coupled to the first C-ring portion 904. At least a portion of the conductor 918 extends from the lead body 917, through the vertebral portion 902 from the first end 901 to the second end 903, and terminates at a connection to the first C-ring portion 904. At the opposite end, the lead body 917 and the conductor 918 are connectable via a connector to an implantable pulse generator (not shown).

[0073] The lead body 917 comprises a conductor 918, which in one embodiment is a bifilar conductor of the same diameter. The bifilar design of the bifilar conductor 918 provides further flexibility, and in some embodiments, the conductor 918 can be stretched. In other embodiments, if the tube covering the bifilar conductor 918 of the same diameter is not stretchable, the lead body has further flexibility but is not stretchable. These characteristics provide further separation between the lead body 917 and the vertebral portion 902. This means that even if the lead body 917 is moved or bent during application, the vertebral portion 902 (and C-ring portions 904, 906, 908) will not be moved on or separated from the target tissue. In addition, the bifilar characteristic of the conductor 908 provides greater compressive resistance to the conductor 908 while maintaining flexibility to aid in delivery and placement, which can be beneficial during laparoscopic delivery of the neural interface 900 to the target tissue.

[0074] In other embodiments, one or both of the lead body 917 and the conductor 918 may have a structure or configuration for providing tension relief. Referring again to Figures 9B and 9C, in some embodiments, the lead body 917 may have tension-relieving corrugated sections 917b intermittently located between linear sections 917a. Any particular lead body 917 may have one or more corrugated sections 917b, and the particular configuration of the corrugated sections 917b may vary. The corrugated sections 917a help to divide or interrupt large or strong motions affecting the lead body 917, resulting in smaller, individual, or localized, weaker motions.

[0075] Two examples of corrugated sections 917b are shown in Figures 9B and 9C, but these examples are not limited to all possible embodiments contemplated by this disclosure. For example, the corrugation can be sinusoidal, square, rectangular, helical, coiled, regular, irregular, or other shapes or combinations of shapes. The number of corrugations can also vary, with some corrugated sections 917b having more or fewer corrugations to be desirable or preferred for areas subjected to greater or lesser tension during use. However, generally, each turn of the corrugated pattern prevents the pressure wave from traveling a longer distance along the length of the lead body 917.

[0076] In some embodiments, the wavy section 917b may be located near the neural interface 900, while in other embodiments, the wavy section 917b may be located away from the neural interface 900 or at various points along the length of the lead body 917. A wavy section 917b located near the neural interface 900 may help prevent displacement forces from reaching the neural interface 900 and affecting its stability and position.

[0077] In yet another embodiment, the lead body 917 may also comprise at least one mooring sleeve or tab 919. This configuration can vary, and in some embodiments, the mooring structure may comprise a sleeve or other device, but the term “mooring tab” is used herein as a whole. The mooring tab 919 may be located at one or more points along the lead body 917, and therefor the lead body 917 may be secured to the tissue, for example, by suturing the mooring tab 919 to the tissue. For example, securing the lead anchor to the leg of a septum can be achieved by one or two permanent sutures. The right leg can be reached by retracting the lateral section of the left lobe of a lever, such as a Nathanson retractor, to allow visualization of the right leg of the septum. The lead anchor may be positioned near the right leg of the septum and can be attached to the right leg using one or two permanent sutures.

[0078] In one embodiment shown in Figure 9D, the mooring tab 919 is located near the first end 901 of the spine section 902. In this embodiment, the lead body 917 is approximately 650 mm long, and the mooring tab 919 is attached to the lead body 917 approximately 200 mm from the first end 901 of the spine section 902. The mooring tab 919 is approximately 10 mm square. These dimensions are merely examples of one embodiment and may vary proportionally or in other ways in other embodiments. In some embodiments, the mooring tab 919 is located near one or more corrugated sections 917b, but in one particular embodiment, the mooring tab 919 is located on each side of the corrugated section 917b.

[0079] The mooring tab 919 can be coupled to the lead body 917 in a variety of ways. As described above, in some embodiments, the mooring tab 919 comprises a sleeve extending around the lead body 917 and can be slidable along at least a portion of the lead body 917 (for example, between adjacent corrugated sections 917b). In other embodiments, these sliding mooring tabs 919 can be equipped with a fastener so that the sliding mooring tab 919 can be positioned at a desired location along the lead body 917 and then secured by the fastener, the fastener can include means for tightening around the lead body 917, or sutures or silicone adhesive for fixing and attaching to a desired location along the lead body 917. In yet another embodiment, the mooring tab 919 is fixed and coupled at a specific point along the lead body 917, for example, by being bonded to the lead body 917 with a silicone adhesive near the first end 910 of the neurovertebral portion 902 of the neural interface 900.

[0080] The mooring tab 919 can include many different biocompatible materials. In one embodiment depicted in Figure 9D, the mooring tab 919 includes a mesh material, such as a coated mesh material. For example, the mooring tab 919 may include a mesh material of polyethylene terephthalate (commercially known as DACRON) and be coated with a room-temperature vulcanizable silicone dispersion Nusil MED-6605. The mesh itself may include a warp-knitted multifilament structure, with a thickness of 140 denier, about 0.4 mm to about 0.6 mm (about 0.5 mm in one exemplary embodiment, for example), and pore diameters of about 0.9 mm, 1 mm, 1.1 mm, or more or less. In some embodiments, these pores are not circular but have an oval, oval, or other shape and are about 1.0 mm × about 1.1 mm in size. In other embodiments, these dimensions can vary by only ±5 percent, ±10 percent, ±15 percent, ±20 percent, ±25 percent, ±30 percent, ±35 percent, ±40 percent, ±45 percent, or ±50 percent, etc.

[0081] The mesh covering structure of the anchoring tab 919 can offer several advantages. Firstly, the mesh can maximize tear resistance. By covering the mesh structure, inward tissue growth can be minimized by partially or completely filling the mesh pores, thereby reducing or preventing tissue from growing into the mesh pores over time. This supports the overall explantability of the anchoring tab 919 and the neural interface 900 and reduces the possibility of serious complications that may result from inward tissue growth. The mesh covering structure of the anchoring tab 919 also helps to minimize or reduce the stiffness of the anchoring tab 919, thereby improving reliability (generally, the smoother the stiffness gradient at the transition from the lead body 917 to the anchoring structure 919, the more secure the bond will be). Furthermore, minimizing or reducing the stiffness of the anchoring tab 919 also aids in surgical implantation, as lower stiffness makes suturing to the correct position easier. In addition, the covering mesh structure helps to maximize or increase adhesion between the anchoring structure 919 and the lead body 917. In embodiments in which the lead body 917 contains silicone, the silicone adhesive and silicone covering of the mesh of the anchoring structure 919 provide a strong bond to secure and hold the lead in place by attaching anchors at desired locations such as the right or left leg of the septum, thereby avoiding disruption to the implantation surgery due to lead movement.

[0082] The first end 901 of the vertebral portion 902 defines a tapering portion that narrows from a maximum outer circumference to a minimum outer circumference. In the embodiment of Figure 9A, the maximum outer circumference occurs near the C-ring portions 904, 906, and 908, particularly where the vertebral portion 902 is at least partially joined to the third C-ring portion 908. The minimum outer circumference occurs where the vertebral portion 902 terminates along the lead body 917. The length and dimensions of the tapering portion of the first end 901 offer the benefit of reducing the stiffness gradient when transitioning from the relatively stiff vertebral portion 902 to the relatively flexible lead body 917. A large stiffness gradient can lead to insufficient bending fatigue performance and may cause fracture of the conductor 918 at the transition. Embodiments of the neural interface 900 are advantageous because they provide a smoother stiffness / flexibility transition, thereby improving structural stability at the junction of the vertebral portion 902 and the lead body 917. At the same time, tapering the first end 901 helps improve the flexibility of this portion of the neural interface 900 by enabling the positioning, placement, and introduction of the neural interface 900 and the first C-ring portion 904, the second C-ring portion 906, and the third C-ring portion 908, respectively, and by providing sufficient flexibility to maintain a satisfactory level of comfort after introduction. In various embodiments, the tapered portion is about 2 mm to about 5 mm in length, for example, about 2.1 mm in one exemplary embodiment. The outer circumference of the tapered portion can be tapered from about 3 mm to about 1.5 mm, for example, from about 2.5 mm to about 1.75 mm in one exemplary embodiment. The tapering angle can be in the range of about 5 degrees to about 15 degrees, for example, about 10 degrees in one exemplary embodiment.

[0083] The second end 903 has an inclined, blunt, or rounded surface, and the vertebral portion 902 extends to the outer edge of the first C-ring portion 904 on the bottom or bottom side (relative to the orientation of Figure 9A on the paper), but terminates further rearward on the top or top side. In other words, the vertebral portion 902 has a substantially circular cross-section, and a plane parallel to this circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with respect to the inclined surface of the second end. This surface can be substantially flat, curved, or a surface that includes both flat and curved portions. For example, in the embodiment shown in Figure 9A, this surface is substantially flat from the top or top end to the vicinity of the first C-ring portion 904, and near the first C-ring portion 904, the surface curves downward to the first C-ring portion 904. The angles, curvature, relative composition of the flat and curved portions, as well as other characteristics of this end face, can vary from the example shown in Figure 9A. However, generally, the second end 903 includes an end face that eliminates potential pressure points when the neural interface 900 is introduced. This can improve patient comfort and also increase the maneuverability and positioning of the neural interface 900 during the introduction process.

[0084] Between the first end 901 and the second end 903, one end each of the first C-ring portion 904, the second C-ring portion 906, and the third C-ring portion 908 is connected to the vertebral portion 902. In the embodiment shown in Figure 9A, the first C-ring portion 904 and the third C-ring portion 908 are connected to the vertebral portion 902 in the same orientation, and the openings in each C-ring portion 904, 908 are on the rear or left side of the neural interface 900 relative to its orientation in the paper. The C-ring portion 906 is connected to the vertebral portion 902 in the opposite orientation, and the opening in the C-ring portion 906 is on the front or right side of the neural interface 900 relative to its orientation in the paper. In other words, the first C-ring portion 904 and the third C-ring portion 908 extend from the vertebral portion 902 in the opposite direction to that of the second C-ring portion 906.

[0085] This relative arrangement of C-ring portions 904, 906, and 908 allows C-ring portions 904 and 908 to remain stationary (or move) together, while C-ring portion 906 moves (or remains stationary) during the introduction of the neural interface 900. Thus, the neural interface 900 provides a simple overall profile and enables laparoscopic (i.e., minimally invasive) delivery, while simultaneously providing sufficient flexibility and relative movement of C-ring portions 904 and 908 relative to C-ring portion 906, allowing the neural interface to be "opened" for extravascular placement and introduction. This configuration of C-ring portions 904, 906, and 908 also increases the likelihood that the neural interface 900 will not unexpectedly open or move to an undesirable position after introduction.

[0086] In some embodiments, each C-ring portion 904, 906, 908 can have a very low helical angle, or pitch, relative to the vertebral portion 902, thereby allowing the neural interface 902 to be helical while still being significantly shorter in length. The helical angle can be approximately 15 to 30 degrees, but can also be less than 15 degrees.

[0087] In other embodiments, each C-ring portion 904, 906, 908 may not be helical, or may not have a helical angle, i.e., pitch, relative to the vertebral portion 902, as shown, for example, in Figures 9A and 13A, 13B, and 13C. In addition, each C-ring portion 904, 906, 908 may include rounded or smooth edges and ends, thereby facilitating delivery of the neural interface 900, reducing damage to adjacent tissues, and increasing patient comfort. In other embodiments not specifically depicted, the neural interface 900 may comprise more or fewer C-ring portions, C-ring portions having the same connection and opening orientation, alternating connection and opening orientation, or other patterns of connection and orientation of the C-ring portions, C-rings of different relative sizes, C-ring portions with different or varying helical angles, and other modifications, including those discussed herein in relation to other embodiments.

[0088] In the embodiment shown in Figure 9A, each C-ring portion 904, 906, 908 of the neural interface 900 has a substantially regular or uniform thickness along its length. In other words, disregarding any thickness added by electrodes on the C-ring portions, the thickness of each C-ring portion 904, 906, 908 from the first end connected to the spinal portion 902 to the second end is approximately the same. Alternatively, the thickness of each C-ring portion 904, 906, 908 can be expressed as the ratio of the cuff inner diameter D (see Figure 10A) to the thickness of the C-ring portion. For example, if the ratio of diameter to thickness is 6:1, and the diameter D of the C-ring portions 904, 906, 908 is 6 mm, then the exemplary thickness of each C-ring portion 904, 906, 908 can be 1 mm. In another example, if the ratio is 5.4:1 and the diameter D of the C-ring portions 904, 906, and 908 is 7 mm, the exemplary thickness of each C-ring portion 904, 906, and 908 can be 1.3 mm. In yet another example, if the ratio is 5.6:1 and the diameter D of the C-ring portions 904, 906, and 908 is 9 mm, the exemplary thickness of each C-ring portion 904, 906, and 908 can be 1.6 mm. Thus, generally speaking, the ratio of the cuff inner diameter to the thickness of the C-ring portion can range from about 5:1 to about 7:1 in various embodiments, for example, about 5.3:1 to about 6.5:1, or about 5.4:1 to about 6.2:1, or about 5.5:1 to about 6:1, or about 5.6:1 to about 6:1.

[0089] As can be seen from these examples, the thickness of the C-ring portions 904, 906, and 908 increases with increasing diameter, thereby providing similar pressure regardless of the cuff diameter. It will be understood by those skilled in the art that even without adjusting the thickness relative to the diameter, the pressure should be expected to decrease with increasing diameter. It will also be recognized by those skilled in the art that the thickness depends on the properties (e.g., hardness) of the material used to form the C-ring portions 904, 906, and 908, which means that in other embodiments, the above ratios (related to silicone) can vary according to the properties of the selected material. In addition, these ratios can depend on the aspect ratio of the C-ring portions, the aspect ratio of the electrodes on the C-ring portions, the number of electrodes on the C-ring portions, the material used for the electrodes, and other factors. In other words, embodiments of the neural interface 900 can be configured to apply (or maintain) pressure to the target tissue within the C-ring portion within a range of approximately 0 mmHg to approximately 30 mmHg, for example, approximately 0 mmHg to approximately 25 mmHg, or approximately 0 mmHg to approximately 20 mmHg, or approximately 0 mmHg to approximately 15 mmHg, or approximately 0 mmHg to approximately 10 mmHg, or approximately 0 mmHg to approximately 5 mmHg, or approximately 0 mmHg to approximately 2 mmHg, or approximately 5 mmHg to approximately 20 mmHg, or approximately 5 mmHg to approximately 10 mmHg, for example, approximately 20 mmHg, or for example, approximately 10 mmHg, or for example, approximately 5 mmHg. This pressure can be measured at various points along the inner diameter of the neural interface 900 and may be the average, mean, or median of multiple values ​​obtained at multiple points, or a specific value at a particular point.

[0090] In other embodiments, the thickness may vary along the length of the C-ring portion, providing another method for providing uniform pressure along the length of each C-ring portion (i.e., at each electrode). Referring, for example, to Figures 10A-10C, end views of the neural interface 1000 are depicted. In Figure 10A, the thickness of the C-ring portion 1010 varies from a first thickness T1 at the first end connected to the vertebral portion 1002 to a second thickness T2 at the point opposite the vertebral portion 1002, and then to a third thickness T3 at the second end. In the embodiments depicted, thicknesses T1 and T3 are similar or the same, and thickness T2 is the maximum or highest thickness of the C-ring portion 1010.

[0091] In one exemplary embodiment, the thickest part of the C-ring portion (e.g., T2 in Figure 10A) is approximately twice the thickness of the ends of the C-ring portion (e.g., T1 and T3 in Figure 10A). In addition, the thickness of the C-ring portion between electrodes may also be important. In one particular example, a 7 mm neural interface has gaps between adjacent electrodes at 31.5 and 94.5 degrees from the center of the "C", with gap thicknesses at these angles corresponding to 1.34 mm and 0.95 mm. As a result, the ratio is 1.4:1.

[0092] In other embodiments, the thickness can vary in other ways along the length of any C-ring portion. For example, Figures 10B and 10C depict two different examples of locally thinning the C-ring portion 1010. In other examples, the thickness of any individual C-ring portion of a particular neural interface, such as neural interface 1000, can vary relative to the thickness of other C-ring portions of the same neural interface 1000. For example, the thicknesses of the first and third C-ring portions can vary as shown in Figures 10A to 10C, while the thickness of an intermediate second C-ring portion can remain constant, especially if it does not include an electrode array (such as the C-ring portion 906 in neural interface 900 shown in Figure 9).

[0093] However, generally speaking, the objective is to reduce the contact pressure on the electrode 1012 closest to the vertebral portion 1002 and on the electrode 1012 at the far (open) end of the C-ring portion 1010. Within the C-ring portion, which has a constant thickness, these two electrodes bear the majority of the load. The tapered embodiment in Figure 10A can achieve this by reducing the beam thickness of the C-ring portion connecting the two "outer" electrodes to the intermediate electrode. Similar advantages for managing fluctuating thickness and pressure can be seen in a C-ring portion without an electrode array.

[0094] Referring again to Figure 9A, similar to neural interfaces 100, 200, 300, and 400, each C-ring portion 904, 906, and 908 of neural interface 900 may include one or more electrodes or arrays of electrodes 912. Each electrode array 912 is electrically coupled to a conductor 918 extending into the spinal portion 902. One electrode of each electrode array 912 is coupled to the conductor 918 through the spinal portion 902 via other electrodes.

[0095] The electrodes of each electrode array 912 coupled to the conductor 918 can be coupled to the conductor 918 in a variety of ways. In one embodiment, this coupling is achieved by welding, such as laser welding. Certain configurations of the laser weld provide tension relief and can reduce the possibility that the relative movement of the C-ring portions 904, 906, 908 relative to the conductor 918 will cause separation or breakage of the weld. In a conventional arrangement, the wires of the conductor 918 should be welded to the electrodes in substantially orthogonal directions, as shown in Figure 9F-1. In contrast, in embodiments of the present disclosure, the wires of the conductor 918 are welded to the electrodes in an oblique or tangential direction. This angle provides tension relief within the coupling of the electrodes to the conductor because the conductor does not need to bend or change direction abruptly at the welding point. This configuration also provides more space and surface area for the coupling of the weld because the tangential angle of the weld can increase the surface area for welding.

[0096] In the embodiment shown in Figure 9A, each electrode array 912 of the C-ring portions 904 and 908 comprises four electrodes. The first electrode is located at the end of each C-ring portion 904, 908 coupled to the spine portion 902 and is electrically coupled to the conductor 918 by a conductor wire 920. The second electrode is located adjacent to the first electrode and is electrically coupled to the first electrode (and thereby to the conductor 918) by an inter-electrode coil 922, which can be, for example, a microcoil made of platinum metal, a stranded cable, or a metal ribbon. An example of such a ribbon is shown in Figure 15I, for example, and will be described in more detail later. In other embodiments, for example, in the embodiments shown in Figures 15A to 15H, the electrodes can be formed from a single unit. The third electrode is located adjacent to the second electrode, on the opposite side of the first electrode from the second electrode, and is electrically coupled to the second electrode (and thereby to the conductor 918) by another inter-electrode coil 922. The fourth electrode is positioned between the third electrode and the open end of the C-ring portion and is electrically coupled to the third electrode (and thereby to the conductor 918) by another inter-electrode coil 922.

[0097] The individual electrodes of the electrode array 912 of the neural interface 900 can be uniformly spaced within the C-ring portions 904, 906, and 908. Uniformly spaced electrodes on the C-ring portions 904, 906, and 908 can provide a more consistent distance between electrodes, resulting in a more uniform current density distribution and improved effectiveness of the neural interface 900. In some embodiments, the positions of the electrodes within the electrode array 912 can be staggered to achieve a better or different electrical effective range. Specific characteristics of the neural interface 900 can be selected for specific applications of the neural interface 900, such as the spacing between adjacent C-ring portions 904, 906, and 908, the spacing between electrode arrays 912, the spacing between electrodes in the electrode array 912, the size and shape of the electrodes, the size, shape, and number of electrodes within the electrode array 912, the distance between electrodes within the electrode array 912, and the helical angle. For example, the use of the neural interface 900 for treatment by targeting a specific vessel, such as the splenic artery, may require different characteristics than the use of the neural interface 900 for treatment of different vessels. For example, when using splenic artery therapy (e.g., therapy provided by a nerve interface around the splenic artery), an electrode width of approximately 1 mm to 4 mm, such as approximately 1 mm to 2 mm or 2 mm to 3 mm, may be appropriate. When used for therapy via different blood vessels, different electrode widths may be desirable.

[0098] The electrode coil 922 can be configured to provide electrical coupling between adjacent electrodes of the electrode array 912 while also providing the desired flexibility itself, without simultaneously suppressing the flexibility or conformability of the C-ring portions 904 and 908. Since the coil provides flexibility due to spring properties not present in straight conductor wires, flexibility can be provided by the coiled arrangement of the electrode coil 922. For example, the electrode coil 922 can have improved bending fatigue performance compared to straight wires. During use, the neural interface 900 is located on a pulsating structure, and therefore the electrode coil 922 is subjected to numerous small bending loads. Coiled electrical coupling has better bending fatigue performance than straight wires. Similarly, the conformability of the C-ring portions 904 and 908 can be maintained or enhanced by adjusting the diameter and pitch of the electrode coil 922. In exemplary embodiments, the coil pitch of the electrode coil 922 may be in the range of 0.05 mm to 0.3 mm, for example, in the range of 0.10 mm to 0.25 mm, for example, 0.10 mm, 0.15 mm, or 0.23 mm. In various exemplary embodiments, the wire diameter of the electrode coil 922 may be in the range of 0.05 mm to 0.10 mm, for example, in the range of 0.07 mm to 0.09 mm, for example, 0.076 mm or 0.081 mm. The coil diameter of the electrode coil 922 may be in the range of 0.2 mm to 0.6 mm, for example, in the range of 0.3 mm to 0.5 mm, for example, 0.38 mm, 0.43 mm, or 0.46 mm. In various embodiments, these dimensions may be selected from the exemplary range according to the determined relationship between these dimensions or any other dimensions or characteristics of the electrode, C-ring portion, or overall neural interface.

[0099] In the embodiment shown in Figure 9A, no electrodes are placed on the second C-ring portion 906, and the same number and arrangement of electrodes are placed on the first C-ring portion 904 and the third C-ring portion 908 within the electrode array 912. In other embodiments, the number and arrangement of electrodes on any individual C-ring portions 904, 906, 908 or the electrode array 912 can vary, with more or fewer electrode arrays 912 being used as a whole, or more or fewer electrodes being placed on any particular C-ring portion 904, 906, 908. Electrodes can be placed on one C-ring, some but not all C-ring portions, or all C-ring portions 904, 906, 908.

[0100] In some embodiments, multiple electrodes or electrode arrays 912 on any one of the C-ring portions, such as those depicted on the C-ring portions 904 and 908 in Figure 9A, can be considered as a single electrode. In other words, in some contexts, the embodiment of the neural interface 900 depicted in Figure 9A comprises two electrodes, one located on the C-ring portion 904 and the other on the C-ring portion 908, and each electrode comprises multiple (four) electrode portions.

[0101] Electrodes can be made very thin (e.g., 25 μm to 50 μm), but not so thin that interconnection to the electrodes (which can be achieved by laser welding, for example) becomes difficult. In some embodiments, the electrodes can be recessed or embedded within their respective C-ring portions, and a silicone rim or silicone webbing is used to hold the electrodes in place. In other embodiments, the “split” electrode design can provide better mechanical compliance, introduce surface features, i.e., the possibility of protruding electrodes, and allow for individual control of each electrode (i.e., current steering). Split electrodes provide greater flexibility to the neural interface, thereby allowing the C-ring portions to be opened more widely and for longer periods by a deployment tool compared to when a single electrode is possible, without placing excessive stress on the electrode.

[0102] In further embodiments, the electrodes may be configured with features that improve flexibility, prevent the electrodes from detaching from the C-ring portion, and otherwise enhance the interoperability between the electrodes and the C-ring portion. For example, in embodiments where the electrodes are recessed or embedded within each C-ring portion, these electrodes may be provided with electrode pads that are recessed or embedded within the C-ring portion, or may be bonded to such electrode pads. The electrode pads may be made of the same material as the electrodes, or of different materials, such as materials having desired properties for bonding or joining the electrodes to the C-ring portion. In embodiments, the material of such electrode pads may vary and may be selected according to the material of the electrodes (e.g., platinum) and the C-ring portion (e.g., silicone).

[0103] Additionally or alternatively, the portion of the C-ring in which the electrode (or electrode pad) is embedded can be slightly larger than the electrode or electrode pad to allow for bending and movement of the electrode or electrode pad when the neural interface is introduced (i.e., when the C-ring is subjected to the most significant deformation), but to maintain the electrode and electrode pad in the desired position after introduction. For example, a gap can be provided within the C-ring at one or both ends of the electrode or electrode pad, the ends in Figure 9A being the two shorter sides of electrode 912. In other words, the length of the recess in which the electrode or electrode pad is positioned within the C-ring is longer than the length of the projection electrode or electrode pad itself, and acts as an exposed surface or contact surface (for contact with the target).

[0104] The characteristics of the recess can also be selected to accommodate the curvature and movement of the electrode or electrode pad within the recess. For example, the overall shape of the recess may be the same as or different from that of the electrode or electrode pad. In the embodiment of Figure 9A, the electrode is a rectangle with rounded corners, and the recess in the C-ring portion in which such an electrode is placed can also be a rectangle with rounded corners, or a rectangle with right-angled corners, or have some other shape different from that of the electrode (or electrode pad) itself. In these or other embodiments, the electrode or electrode pad may also comprise one or more flanges or anchors, which are configured to fit into or otherwise engage with the recess in the C-ring portion to hold the electrode or electrode pad within the recess.

[0105] In addition, or optionally, the electrodes may be made of a variety of different materials to achieve desired properties, such as flexibility or charge injection properties. For example, the electrodes may contain platinum, or be formed from an alloy of platinum and iridium, for example, an alloy made from 90% platinum and 10% iridium. Alternatively or additionally, the surface of the contact electrode may be coated with PEDOT, TiNi, IrOx, PtBlack, or treated using a laser roughening process.

[0106] In further embodiments, in addition to or instead of the other electrode and electrode pad features discussed herein, each electrode may be provided with a flange having one or more perforations. These perforations can improve the mechanical coupling between the electrode and the C-ring portion, prevent the electrode from detaching from the C-ring portion, increase the flexibility of both the electrode and the C-ring portion (particularly during the placement and introduction of the neural interface), and provide other benefits that will be understood by those skilled in the art.

[0107] For example, Figure 11A is a sub-view of Figure 9A and depicts an electrode 930 comprising an electrode contact 932 and an electrode flange 934. The electrode flange 934 comprises at least one perforation 936A. In the embodiment depicted, the electrode flange 934 comprises six perforations 936A, but in other embodiments, it may include more or fewer perforations. The perforations 936A are located on each long side of the electrode flange 934, with three perforations 936A on one side and three perforations 936A on the opposite side. Each perforation 936A is a rectangle with rounded corners or rounded short ends. In other embodiments, the perforations 936A may be located on the short sides, on both the short and long sides, or in some other configuration. The perforations 936A are equally sized and uniformly spaced, but in other embodiments, the size, shape, spacing, arrangement, orientation, or other characteristics of the perforations 936A may vary.

[0108] For example, in the embodiment of Figure 11B, the electrode flange 934 also has six perforations 938B, but the perforations 938B are round or circular, with three located on one short end of the electrode flange 934 and three located on the other short end of the electrode flange 934. The electrode flange 934 in Figure 11B also has a rounder circumference than the embodiment in Figure 11A.

[0109] The embodiment shown in Figure 11C is similar to that in Figure 11B, but in this embodiment there are two perforations 936C, both of which are roughly rectangular but have rounded short ends. One perforation 936C is located on each short end of the electrode flange 934.

[0110] The embodiment in Figure 11D is similar to the embodiment in Figure 11C, except that the electrode flange 934 is larger and wider than the electrode contact 932, and therefore its corners are rounded rather than its short end. In addition, the perforation 936D is also larger, with a length similar to that of the electrode contact 932, and a width greater than that of the perforation 936C in Figure 11C.

[0111] Figure 11E depicts an electrode 930 similar to that in Figure 11D, but with four perforations 936E. Each perforation 936E is a square with rounded corners and is located at each corner of the electrode flange 934.

[0112] Another embodiment is shown in Figure 11F. In this embodiment, the perforation 936F comprises a cutout or aperture along the periphery of the electrode flange 934. In other words, the perforation 936F forms a notch along the long edge of the electrode flange 934.

[0113] In Figure 11G, the electrode flange 934 extends along the center portion of each long edge of the electrode contact 932. The electrode flange 934 also includes a curved bottom edge portion 937 for further mechanical connection between the electrode and the insulating portion or the insulating portion of the neural interface. This curved bottom edge portion can also provide an area for interconnection (e.g., welding) to form a mechanical connection. Two perforations 936G are formed on each side along the length of the electrode flange 934.

[0114] The embodiment shown in Figure 11H is similar to the embodiment shown in Figure 11G, but the drilling is completely omitted.

[0115] The embodiment in Figure 11I is also similar to the embodiments in Figures 11G and 11H, but compared to the embodiment in Figure 11G, it further includes portions of the electrode flange 934 located at each short end of the electrode contact 932, each of which includes a round or circular perforation 936I. In addition to the round or circular perforation 936I, there is also a curved bottom edge portion 937. In some embodiments, an interconnector for connecting electrodes in the array can form a mechanical connection through the perforation 936I, or such an interconnector can be welded into the curved bottom edge portion 937.

[0116] Figures 11J-1 and 11J-2 depict one embodiment of an electrode 930 having two anchors 938, with one anchor extending from each short end of the electrode contact 932. The anchors 938 can be embedded or anchored within the silicone or other material of the C-ring portion. For example, the C-ring portion may have two channels, and each anchor 938 can slide within the channels. The channels and anchors 938 can be configured relative to each other so that the anchors 938 can slide within the channels while remaining engaged with the channels during positioning and bending of the C-ring portion. Embodiments of the electrode 930 show a folded (or curved bottom) anchoring perforated portion 938. For example, insulating material of the C-ring provided around and / or through the anchors 938 and channels 936J provides an improved mechanical coupling, embedding, or anchoring of the electrode 930 to the insulating material of the C-ring portion.

[0117] The embodiment in Figure 11K includes two perforations 936K, each of which extends along the long side of the electrode flange 934, curves around two corners, and partially extends along each short side of the electrode flange 934.

[0118] Similar to the embodiment in Figure 11K, the embodiment in Figure 11L includes two perforations 936L, each of which extends along the short side of the electrode flange 934, curves around two corners, and partially extends along each long side of the electrode flange 934.

[0119] The embodiment in Figure 11M is similar to the embodiment in Figure 11A, but the perforation 936M is circular or round, rather than oval or elliptical.

[0120] The embodiment in Figure 11N is somewhat similar to the embodiment in Figure 11I, in that it includes portions extending from each of the four sides of the electrode flange 934, and each portion of the electrode flange 934 also includes a perforation 936N. The embodiment in Figure 11N further includes a folded flange portion 934.

[0121] The embodiment in Figure 11O is similar to the embodiment in Figure 11I in that it includes portions of the electrode flange 934 located at each short end of the electrode contact 932, and each of these portions includes a round or circular perforation 936O. However, in contrast to the embodiment in Figure 11I, the portions of the electrode flange 934 located at each short end of the electrode contact 932 do not continue in the same plane as the electrode contact, but are substantially perpendicular to the electrode contact at each end.

[0122] An electrode and a lead conductor, or a spring or microcoil (or any other interconnect) connecting the electrodes, can be provided through the substantially round perforation 936O. In this way, the connection is already partially held in place by its position relative to the round perforation 936O, thus reducing the stress on welding.

[0123] In other embodiments, yet another configuration of the electrode contact 932, electrode flange 934, and electrode perforation 936 is also possible. For example, in various embodiments, some or all of the perforation 936 may not extend entirely through the electrode flange 936. In other words, the perforation 936 can instead be considered a recess. In addition, in other embodiments, any other shape, size, position, arrangement, features, dimensions, and other characteristics of any of the electrode contact 932, electrode flange 934, and electrode perforation 936 can be implemented and selected according to a desired application example of the particular neural interface in which the electrode 930 is implemented.

[0124] As with other embodiments of the neural interface described and discussed herein, even if not explicitly shown in the drawings, the neural interface 900 may also include at least one feature that can be positioned on the outer surface of the neural interface 900, such as on the vertebral portion 902. The feature may include one or more openings or holes for receiving connectors, such as sutures, for releasably connecting to a stylet (made of tungsten or a similar material) or deployment tab, for example, to allow manipulation of the C-ring portion or deployment of the neural interface 900. The feature may be configured to allow a deployment tool to grasp, manipulate, and deploy the neural interface 900. In one embodiment, the feature may be positioned sufficiently close to at least one open end of the C-ring portions 904, 906, and 908, so as to allow a deployment tool to grasp the feature and simultaneously open the C-ring portion 906 relative to the C-ring portions 904 and 908. This makes it possible to position the neural interface 900 around a target vessel. After the nerve interface 900 is positioned around the target vessel, the deployment tool can be carefully released (through the physician's operation), so that the C-ring portions 904, 906, and 908 can softly self-size to fit the target vessel. The configuration of the nerve interface 900 makes it possible to position the nerve interface around a nerve or vessel in a single pass, reducing the manipulation of the nerve or vessel and reducing the dissection of tissue around the area of ​​the nerve or vessel where the interface is positioned.

[0125] Similar to the neural interfaces 100, 200, 300, and 400, the neural interface 900 can also be self-sizing, and the C-ring portions 904, 906, and 908 are formed from a flexible material and arranged so that their open ends are alternately positioned, providing easy operation for insertion and returning to their predetermined shape without strong elastic snap or spring force when released. This allows the neural interface 900 to provide good electrical contact between the electrode array and the surface of the nerve or blood vessel while accommodating anatomical variations of the intervention site and target vessel, thereby improving the effectiveness of the neural interface 900. The flexible material of the C-ring portions 904, 906, and 908 can maintain compliance even when self-sizing to fit the nerve or blood vessel. This helps prevent the neural interface 900 from compressing the nerve or blood vessel, causing reduced blood flow and other constriction of nerve fibers. This also allows for better accommodation of radial expansion of the nerve or blood vessel resulting from edema or swelling after positioning, and can accommodate the pulsating behavior of the intervention site, such as arteries.

[0126] The naturally opening structure of the C-ring portions 904, 906, and 908 of the neural interface 900 can reduce the extent around the nerve or blood vessel, promoting more normal fluid and nutrient exchange with the intervention site and surrounding tissue. This can also help reduce the growth of connective tissue into the neural interface 900. The open structure of the neural interface 900 is configured such that, at any point along the length of the target vessel, the terminal or central portion does not form a closed circumscribing arc around the target vessel. In other words, this structure does not form a closed circle that covers 360 degrees of the orthogonal portion of the length of the target vessel. However, the tip of the arm can contact the spine of the cuff. In other words, it is possible to provide full extent of the target vessel without the need for a closed circle. This open, unrestricted trench allows the target vessel to pulsate without constriction, and the initially inflated target vessel can return to its normal state over time, working to avoid constricting the target vessel when inflated and to maintain contact between the electrode and the target vessel when the target vessel is in its normal state.

[0127] As previously mentioned, electrodes (for example, the electrodes of the electrode array 912 in Figure 9A, or those described and discussed herein with respect to any of the figures) can be embedded within the material of the neural interface cuff. Examples of embedded electrodes are shown in Figures 12A and 12B. In Figure 12A, each electrode 1212 is at least somewhat similar to the embodiments shown in Figures 11A to 11N. In Figure 12B, each electrode 1212 is at least somewhat similar to the embodiment shown in Figure 11O. The level or extent of embedding between the electrodes in Figure 12A and Figure 12B can be seen in particular in the partial translucent view of the neural interface in Figure 12B.

[0128] In addition, different electrode embodiments can provide different degrees of effective range for each cuff of the neural interface. This can be seen in Figure 12C, where each electrode in Figure 12A (shown on the left) provides a larger area (i.e., a larger proportion) of internal cuff surface than the electrode in Figure 12B (shown on the right). In some applications or embodiments, one or the other may be advantageous or preferred.

[0129] For example, referring again to Figures 13A, 13B, and 13C, different electrode embodiments can be used within different sized neural interfaces (or cuffs of neural interfaces). Figures 13A, 13B, and 13C depict smaller, medium, and larger cuff diameters, respectively. In addition, consistent with the above discussion in this specification, the thickness of the cuff arm increases as the cuff diameter increases. Thus, the exemplary embodiments depicted are as follows:

[0130] [Table 1]

[0131] Variations in the inner diameter, arm thickness, and number of electrodes may result from maintaining the desired contact and tension of the cuff arm and electrode contact area when the diameter (and therefore length) of the cuff arm decreases or increases. Thus, although the inner diameters of neural interface devices may differ, the total electrode area of ​​each neural interface device is substantially equal. In addition, electrodes of a neural interface device with a larger inner diameter may have a smaller width and a greater length than electrodes of a neural interface device with a smaller inner diameter.

[0132] The size of the neural interface is considered in order to define different sizes and shapes of electrodes. That is, the shape and size of the electrodes can be determined by the diameter of the relevant neural interface. In other embodiments or applications, different factors may be considered when sizing the cuff and determining the number of electrodes. In some embodiments, each arm of the cuff may be the same as the other arms, while in other embodiments, there may be differences in size, number of electrodes, or configuration between the arms of the same cuff.

[0133] In some embodiments, the inter-electrode coil (such as coil 922 in Figure 9A) can be replaced with a continuous coil or any other continuous interconnection. The continuous coil embodiment is advantageous because it reduces the mechanical load on the welding, making welding more reliable and mitigating the impact of any single welding failure. For example, Figure 14A shows another embodiment of the neural interface 1400 according to this disclosure. Unless otherwise specified herein, the neural interface 1400 may be similar to the neural interfaces 100, 200, 300, 400, and 900 discussed above. For example, the neural interface 1400 may be formed from a flexible substrate of the same or similar material (i.e., silicone) and may share other features.

[0134] The neural interface 1400 comprises a vertebral portion 1402, a first C-ring portion 1404, a second C-ring portion 1406, and a third C-ring portion 1408. The vertebral portion 1402 comprises a first end 1401 coupled to a lead body 1417 having a conductor 1418, and a second end 1403 at least partially coupled to the first C-ring portion 1404. At least a portion of the conductor 1418 extends from the lead body 1417, through the vertebral portion 1402 from the first end 1401 to the second end 1403, and terminates at a connection to the first C-ring portion 1404. At the opposite end, the lead body 1417 and the conductor 1418 are connectable via a connector to an implantable pulse generator (not shown).

[0135] The first end 1401 of the vertebral portion 1402 defines a tapering portion that narrows from the maximum outer circumference to the minimum outer circumference. In the embodiment of Figure 14A, the maximum outer circumference occurs near the C-ring portions 1404, 1406, and 1408, particularly where the vertebral portion 1402 is at least partially joined to the third C-ring portion 1408. The minimum outer circumference occurs where the vertebral portion 1402 terminates along the lead body 1417. The length and dimensions of the tapering portion of the first end 1401 offer the benefit of reducing the stiffness gradient when transitioning from the relatively stiff vertebral portion 1402 to the relatively flexible lead body 1417.

[0136] The second end 1403 has an inclined, blunt, or rounded surface, and the vertebral portion 1402 extends to the outer edge of the first C-ring portion 1404 on the bottom or bottom side (relative to the orientation in Figure 14A of the paper), but terminates further aft on the top or top side. In other words, the vertebral portion 1402 has a substantially circular cross-section, and a plane parallel to this circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with respect to the inclined surface of the second end. This surface can be substantially flat, curved, or a surface that includes both flat and curved portions.

[0137] Between the first end 1401 and the second end 1403, one end of each of the first C-ring portion 1404, the second C-ring portion 1406, and the third C-ring portion 1408 is connected to the vertebral portion 1402.

[0138] In some embodiments, each C-ring portion 1404, 1406, 1408 may have a very low helical angle, or pitch, relative to the vertebral portion 1402. The helical angle can be about 15 to 30 degrees, but can also be less than 15 degrees. In addition, each C-ring portion 1404, 1406, 1408 includes rounded or smooth edges and ends. In other embodiments, each C-ring portion 1404, 1406, 1408 is not helical, or does not have a helical angle, or pitch, relative to the vertebral portion 1402, as shown, for example, in Figure 14.

[0139] The electrode array 1412 can be connected by a continuous coil 1422. The use of the continuous coil 1422 can contribute to the overall durability of the neural interface 1400 by reducing the number of interconnection points required within the electrode array 1412. By using a continuous interconnector such as the continuous coil 1422, the number of interconnection points, such as welded joints, is reduced compared to some of the embodiments described above.

[0140] In some embodiments, the continuous coil 1422 can provide a larger potential contact area between the coil 1422 and the electrode array 1412 than is present in other embodiments. This larger contact can help achieve a stronger electrical and mechanical connection between the coil 1422 and the electrode array 1412. For example, since the continuous coil 1422 extends along the entire length of the electrode array 1412, the continuous coil 1422 can be welded to the electrode array 1412 at multiple points. Multiple individual turns of the continuous coil 1422 can be welded to the electrode array, such as by the welding orientation shown in Figure 9F-2.

[0141] Figure 14A depicts a continuous coil 1422 attached to an electrode array 1412 via a bushing or sleeve, such as a crimp bushing 1430. The use of a bushing, such as a crimp bushing 1430, helps to achieve both mechanical and electrical connections via one or more weld points in the bushing, rather than welding the continuous coil 1422 directly to the electrode array 1412, as discussed above. Figure 14B shows how connecting the coil to the array 1412 using a bushing 1430 allows multiple weld points 1434 to strengthen the connection, reducing the probability that any single welding failure will result in a loss of connection between the coil and the array. The material of the bushing can generally be a conductive material such as platinum. The material of the bushing can be selected according to the material selection for the continuous coil, electrode array, and C-ring to promote good conductivity and stable welding. The crimp bushing 1430 is fitted around the continuous coil by interference fit, thereby providing an electrical and mechanical coupling between the continuous coil 1422 and at least one electrode of the electrode array 1412.

[0142] In embodiments, the bushing 1430 can be curved to match the curvature of at least one electrode of the electrode array 1412, thereby increasing contact between the bushing and the array and providing a larger contact point that can be a good candidate for a welding point between the bushing and the array. Thus, more desirable contact points can be selected for welding, or the number of welds can be increased as needed, thereby strengthening the connection between the bushing and the array (and ultimately between the coil and the electrode). The matching of the curvature between the bushing and the array can also reduce the mechanical stress on the weld connecting the bushing and the array during use. In embodiments, the bushing can be crimped to close the tunnel gap and hold the wire by interference fit. Note that other forms of connection can be used between the bushing and the array, including soldering, crimping, brazing, wiring, or other fastenings to produce an electrical and mechanical connection, although welding is referred to, but is not limited thereto.

[0143] By connecting the electrode array 1412 using the continuous coil 1422, it becomes possible to electrically connect one of the electrodes in the electrode array 1412 in parallel. Therefore, even if the connection to an electrode located "upstream" of the remaining connected electrodes (closer to the α connection 1432 between conductor 1418 and the continuous coil 1422, or simply closer to conductor 1418) is lost, the loss of connection between coil 1422 and any one electrode will not interrupt the power supply to the other electrodes. For example, if bushing 1430a loses its connection to electrode 1412a, electrode 1412a may become unconnected to any power supply means for providing stimulation or blocking a target. However, since the continuous coil 1422 carries power from the conductor 1418 to electrodes 1412b-1412d independently of the connection between the coil 1422 and the first electrode 1412a, each of the electrode arrays 1412a-1412d remains operational independently of the connection state of any electrode and continuous coil within the same C-ring 1404. In this particular embodiment, the continuous coil 1422 is connected to the conductor 1418 via an α-helix 1432. In other embodiments, the continuous coil 1422 can be directly connected to the conductor 1418. For example, the tip of the continuous coil can form an α-helix 1432.

[0144] Other embodiments are also conceivable that can realize the advantages of the continuous coil example in Figure 14A. In Figure 14C, the neural interface 1440 uses a long jumper coil 1442 to provide improved tension relief and better isolation force to the welded joint (compared, for example, to the smaller inter-electrode coil 922 in Figure 9A). As shown in the inset of Figure 14C, the α-helix 1432 includes an α-welded outer shell portion coupled to the jumper coil, which is laser-welded to the electrode. In Figure 14C, the jumper coil is welded to the edge of the electrode, but in different modifications and embodiments, the location of the weld on the electrode can be varied. As shown in more detail in Figure 14D, the location of the weld for the crimp or inter-coil attachment that connects one electrode to another may also vary between embodiments. In embodiments, the weld / join location can generally be within the central portion of the electrode. In a preferred embodiment, the ratio of the gap between the electrodes and the interconnector (e.g., interconnector microcoil or interconnector coil) is about 1:3 (i.e., the interconnector is about 3 times longer than the gap between the electrodes), or it can be about 1:1. In a further embodiment, the ratio of the gap length to the interconnector can be about 1:2.

[0145] In Figure 14D, the neural interface 1450 uses a continuous jumper coil 1452, which differs from the continuous coil 1422 in Figure 14A by not directly connecting to the conductor 1408 (or α-helix 1432). The continuous jumper coil 1452 can be directly welded to the electrode array 1412 or attached by other means, such as a crimp bushing 1454. In Figure 14E, the neural interface 1460 connects to the electrode array 1412 using a continuous stranded cable 1462. The continuous cable 1462 can be connected to individual electrodes in the electrode array 1412 using a bushing or sleeve 1464 (which can be crimped for interference fitting or connected by other means). Similar to the embodiments with continuous jumper coils discussed above, the continuous stranded cable 1462 also provides parallel connections between electrodes.

[0146] In practice, the continuous jumper coils 1452 coupled to each electrode in the array 1412 form a parallel electrical connection. Connections to the conductor 1408 are provided to each of the electrode array 1412, so that if any one of these connections is lost, the other electrodes 1412 remain powered.

[0147] The electrode coil 1422 can be configured to provide electrical coupling between adjacent electrodes of the electrode array 1412 while also providing desired flexibility and high bending fatigue performance. The conformality or flexibility of the C-ring portions 1404 and 1408 can be maintained or enhanced by adjusting the diameter and pitch of the electrode coil 1422. In exemplary embodiments, the coil pitch of the electrode coil 1422 can be in the range of 0.05 mm to 0.3 mm, for example, in the range of 0.10 mm to 0.25 mm, for example, 0.10 mm, 0.15 mm, or 0.23 mm. In various exemplary embodiments, the wire diameter of the electrode coil 1422 can be in the range of 0.05 mm to 0.10 mm, for example, in the range of 0.07 mm to 0.09 mm, for example, 0.076 mm or 0.081 mm. The coil diameter of the electrode coil 1422 can be in the range of 0.2 mm to 0.6 mm, for example, in the range of 0.3 mm to 0.5 mm, for example, 0.38 mm, 0.43 mm, or 0.46 mm. In various embodiments, these dimensions can be selected from an exemplary range according to the determined relationship between these dimensions or any other dimensions or characteristics of the electrode, C-ring portion, or the overall neural interface.

[0148] The crimp bushing 1430 can be crimped to a final size according to the size or final force of the continuous coil 1422. The crimp can increase the electrical contact between the coil and the bushing, and in embodiments, it is designed to become sufficiently tight when crimped (i.e., the cross section becomes sufficiently small) to facilitate electrical and mechanical contact between the coil and the bushing. In embodiments, the compressive force of the crimp or the minimum final size can be limited to prevent deformation (or degree of deformation) of the coil.

[0149] Figure 14E shows another embodiment that provides parallel electrical connection of electrodes by reduced interconnection. In this embodiment, the electrodes include a pre-formed or built-in sleeve (or crimp or tunnel) for housing a continuous interconnector (e.g., wire, strip, or coil). These built-in sleeves (or crimp or tunnels) are provided on the rear surface of the electrodes (the electrodes may include a target-facing surface and a rear surface). After the interconnectors for connecting the electrodes in the array are passed through the built-in sleeves, mechanical and electrical coupling of the sleeves and interconnectors can be achieved by crimping, welding, or at least partial filling of the sleeves with conductive material. The size of the sleeve can be determined by the thickness of the interconnector.

[0150] In the embodiment shown in Figure 14A, no electrodes are placed on the second C-ring portion 1406, and the same number and arrangement of electrodes are placed on the first C-ring portion 1404 and the third C-ring portion 1408 within the electrode array 1412. In other embodiments, the number and arrangement of electrodes on any individual C-ring portions 1404, 1406, 1408 or the electrode array 1412 can vary, with more or fewer electrode arrays 1412 used as a whole, or more or fewer electrodes placed on any particular C-ring portions 1404, 1406, 1408. Electrodes can be placed on one C-ring, some but not all C-ring portions, or all C-ring portions 1404, 1406, 1408. Also, as previously mentioned in relation to other embodiments, the cuff can be used in a wireless system, or the cuff can have fewer or more C-ring portions.

[0151] In some embodiments, multiple electrodes or electrode arrays 1412 on any one of the C-ring portions, such as those depicted on C-ring portions 1404 and 1408 in Figure 14A, can be considered as a single electrode. In other words, in some contexts, the embodiment of the neural interface 1400 depicted in Figure 14A comprises two electrodes, one located on C-ring portion 1404 and the other on C-ring portion 1408, and each electrode comprises multiple (four) electrode portions.

[0152] Similar to the neural interfaces 100, 200, 300, 400, and 900, the neural interface 1400 can also be self-sizing, and the C-ring portions 1404, 1406, and 1408 are formed from a flexible material and arranged with alternating open ends, providing easy operation for insertion and returning to their predetermined shape without strong elastic snap or spring force when released. This allows the neural interface 1400 to provide good electrical contact between the electrode array and the surface of the nerve or blood vessel while accommodating anatomical variations of the intervention site and target vessel. The flexible material of the C-ring portions 1404, 1406, and 1408 can maintain compliance even when self-sizing to fit the nerve or blood vessel. This helps prevent the neural interface 1400 from compressing the nerve or blood vessel, causing reduced blood flow and other constriction of nerve fibers. This also allows for better accommodation of radial expansion of the nerve or blood vessel resulting from edema or swelling after positioning, and can accommodate the pulsating behavior of the intervention site, such as arteries. Accordingly, the specification discloses a neural interface comprising: a vertebral portion having a first end and a second end, wherein the outer circumference of the first end of the vertebral portion tapers from the maximum outer circumference to the minimum outer circumference; a lead body coupled to the first end of the vertebral portion and comprising a conductor connectable to an implantable pulse generator, and extending at least partially into the vertebral portion; at least three C-ring portions, each having a first end and a second end, wherein the first end of each C-ring portion is coupled to the vertebral portion, and therefore the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first C-ring portion and the third C-ring portion, is on the second opposite side of the vertebral portion; and at least one electrode positioned in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0153] The neural interface may comprise multiple electrodes positioned on at least one of at least three C-ring portions, with adjacent electrodes on the same C-ring portion being electrically coupled by an inter-electrode coil.

[0154] Each electrode may have an electrode contact on an electrode flange, the electrode flange mechanically connecting the electrode to a C-ring portion and having multiple perforations.

[0155] The vertebral portion may have a substantially circular cross-section, and the second end of the vertebral portion may have an inclined surface, so that the plane parallel to this substantially circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with respect to the plane defined by the inclined surface.

[0156] The maximum outer circumference of the first end of the vertebral portion can be located near at least three C-ring portions, and the minimum outer circumference of the first end of the vertebral portion can occur where the vertebral portion terminates on the lead body.

[0157] The distance between the maximum and minimum outer circumference can be within the range of 2 mm to 5 mm.

[0158] The first C-ring portion and the third C-ring portion can be connected to the vertebral portion so as to move together with respect to the second C-ring portion, and the first C-ring portion and the third C-ring portion can extend from the vertebral portion in a direction opposite to the direction of the second C-ring portion.

[0159] At least one of the three C-ring portions of the neural interface may have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first and second ends, wherein the third thickness is greater than the first and second thicknesses.

[0160] The thickness of at least one of the three C-ring portions of the neural interface can be gradually increased between the first end and the point between the first end and the second end.

[0161] The thickness of at least one of the three C-ring portions of the neural interface can be gradually increased between the second end and the point between the first end and the second end.

[0162] The electrode flange of the neural interface can be a square shape with rounded corners.

[0163] Multiple perforations within the electrode flange of the neural interface may include at least one perforation on a first side of the electrode flange and at least one perforation on a second opposite side of the electrode flange.

[0164] The first side of the electrode flange and the second opposite side of the electrode flange can be longer than the third and fourth sides of the electrode flange.

[0165] Each of the multiple perforations within the electrode flange of the neural interface can be a square with rounded corners.

[0166] The neural interface may include at least one anchoring tab attached to the lead body.

[0167] At least one mooring tab may be equipped with a covering mesh.

[0168] The lead body may have at least one corrugated section.

[0169] The neural interface can be formed by providing a vertebral portion having a first end and a second end, wherein the outer circumference of the first end of the vertebral portion tapers from the maximum outer circumference to the minimum outer circumference; connecting a lead to the first end of the vertebral portion, wherein the conductor of the lead, connectable to an implantable pulse generator, extends at least partially into the vertebral portion; connecting at least three C-ring portions to the vertebral portion, wherein each of the at least three C-ring portions has a first end and a second end, the first end of each C-ring portion is connected to the vertebral portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first C-ring portion and the third C-ring portion, is on the second opposite side of the vertebral portion; and placing at least one electrode on each of the at least three C-ring portions, with at least one electrode electrically coupled to a conductor.

[0170] The neural interface may further include multiple electrodes in at least one of the three C-ring portions, and adjacent electrodes on the same C-ring portion are electrically coupled by an inter-electrode coil.

[0171] Each electrode may have an electrode contact on an electrode flange, the electrode flange mechanically connecting the electrode to a C-ring portion and having multiple perforations.

[0172] This method may further include forming a vertebral portion having a substantially circular cross-section, and forming a second end of the vertebral portion having an inclined surface, such that the plane parallel to this substantially circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with respect to the plane defined by the inclined surface.

[0173] Forming a neural interface may also involve forming at least one of at least three C-ring portions such that it has a first thickness at the first end, a second thickness at the second end, and a third thickness at the point between the first and second ends, wherein the third thickness is greater than the first and second thicknesses.

[0174] In another embodiment, the neural interface may comprise: a spinal portion having a first end and a second end; a lead body coupled to the first end of the spinal portion and having a conductor connectable to an implantable pulse generator, extending at least partially into the spinal portion from the first end toward the second end; at least three C-ring portions, each having a first end and a second end, wherein the first end of each C-ring portion is coupled to the spinal portion, and therefore the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the spinal portion, and the second end of the second C-ring portion, positioned between the first C-ring portion and the third C-ring portion, is on the second opposite side of the spinal portion, and each C-ring portion has an inner diameter and a thickness, with the ratio of the inner diameter to the thickness being in the range of 5:1 to 6:1; and at least one electrode positioned in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0175] In yet another embodiment, the neural interface may comprise: a vertebral portion having a first end and a second end; a lead body coupled to the first end of the vertebral portion and comprising a conductor connectable to an implantable pulse generator, extending at least partially into the vertebral portion from the first end to the second end; at least three C-ring portions, each having a first end and a second end, wherein the first end of each C-ring portion is coupled to the vertebral portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first and third C-ring portions, is on the second opposite side of the vertebral portion, and each C-ring portion is configured to apply a pressure in the range of about 0 mmHg to about 30 mmHg to target tissue positioned within the C-ring portion during use; and at least one electrode positioned in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0176] Figure 15A shows an example of an electrode assembly of a C-ring portion 1510 according to one embodiment. In the simplest embodiment, the C-ring portion 1510 may include a metal foil strip or ribbon 1512 on which electrodes (not shown) are formed. To provide flexibility within a single electrode array 1512, in some embodiments, the foil strip 1512 may be cut or formed to form a flexible foil 1514 such that a mesh connector is cut into the foil strip 1512. The aperture cut into the foil 1514 reduces the cross-sectional area of ​​the foil in areas other than the welded or crimped areas, so the flexible foil 1514 has greater flexibility than the metal foil strip 1512. As a result of these reduced cross-sectional areas, flexibility for introduction is increased, and a single (or integrated) electrode array is provided with no additional connections between electrodes. In other words, a weld-free interconnected electrode array is provided (i.e., no welding is used to provide a connection between two electrodes in the array). For further tension relief, a longer section (along the strip) with a reduced surface area can be provided. There is no welding between electrodes, although in some embodiments welding may be required for connection to the lead body.

[0177] As shown in the lower row of Figure 15A, specific portions of the surface of the strip 1514 can be punched out to provide an active electrode surface 1542 for the insulating material of the C-ring portion 1510 to protrude (for example, as shown in Figure 15D or Figure 15H). The active electrode surface 1542 can also be laser-roughened to provide an electrode with further performance. Radial punching can be used to form the foil into the final desired C-ring shape or to provide other desired shapes.

[0178] Figures 15B-15C show other exemplary embodiments 1520, 1530 of a C-ring portion formed similarly to the C-ring portion 1510 shown in Figure 15A. In the embodiments, radial punching or other forming methods can also provide additional curvature along the z axis within the narrowed section to provide additional tension relief (for example, similar to the interconnection of ribbons). The narrowed sections of the exemplary embodiments 1520, 1530 can increase flexibility and reduce the amount of material required.

[0179] Figure 15D is an exemplary embodiment 1540 showing an exemplary cross-sectional view of the embodiments shown in Figures 15A to 15C. As described above with respect to Figures 15A to 15C, reducing the cross-sectional area of ​​the foil makes the final structure more flexible. As shown in Figure 15D, a region of the conductive wire (also called foil or strip) 1542 is exposed on the radial inner edge of embodiment 1540, while other regions are inside the device, and therefore only a few portions of the conductive wire 1542 corresponding to the electrode region are exposed to the target.

[0180] Figures 15E to 15H illustrate various methods of the meandering portion embodiment 1550, similar to those discussed above in relation to the exemplary C-rings 1520 and 1530 in Figures 15A to 15C, where the meandering portion between electrodes provides another weldless electrode array, and the meandering portion is another embodiment that achieves a reduction in cross-sectional surface area for further flexibility within the portion between electrodes. In embodiments, the meandering joint 1552 of the exemplary embodiment 1550 can be formed as a leaf spring to provide greater flexibility.

[0181] The embodiments illustrated in Figures 15A to 15H provide interconnection means that do not require welding between electrodes or other non-integral joining means. In other words, this is a standalone embodiment.

[0182] Figure 15I depicts an exemplary embodiment 1560 in which a platinum ribbon 1562 provides interconnection between electrodes. For example, the platinum ribbon 1562 is welded using point welds 1564 across each gap between electrodes to achieve spring formation by the ribbon. Platinum-to-platinum welding can provide greater weld strength compared to welding of mixed materials. Curvature within the ribbon 1562 can provide flexibility that acts as tension relief when the cuff is "opened" for embedding or removal. Curvature absorbs some of the stress or load that would normally be applied to the weld, whereas a perfectly flat or straight ribbon may induce greater stress or load at a single point. In addition, straight interconnections can develop plastic deformation due to permanent "wrinkles" in the material, which can lead to more easily broken. The embodiment shown in Figure 15I can provide a simplified weld configuration compared to some embodiments based on coils with many surfaces for welding, such as multi-layer welding or edge welding, depending on the material composition.

[0183] Furthermore, as disclosed herein, the system comprises a neural interface as described in any of the embodiments disclosed herein above, and a lead cap device having a first end and a second end, comprising a body defining an internal cavity extending from the first end to the second end, a set screw block positioned within the body such that a set screw intersects the internal cavity, and a suture loop coupled to the second end, and configured to removably receive a portion of a lead body into the internal cavity and to secure a portion of the lead body into the internal cavity by a set screw, and the first An unfolding tool comprising a tab-shaped body having an end and a second end, a first aperture formed in the first end, a second aperture and a third aperture formed in the second end, and a plurality of sets of small holes formed in the tab-shaped body between the first end and the second end, wherein the tab-shaped body further comprises a series of ridges and grooves, and the unfolding tool is removablely connectable to a neural interface by the second and third apertures via sutures that can pass through the first aperture and at least one of the plurality of sets of small holes.

[0184] The neural interface may comprise a lead body having a conductor connectable to an implantable pulse generator, and at least one C-ring portion, the at least one C-ring portion applying or maintaining a pressure in the range of 0 mmHg to 30 mmHg to target tissue placed within the C-ring portion, and comprising at least one electrode located in the at least one C-ring portion and electrically coupled to the conductor. In the neural interface, the at least one C-ring portion has an inner diameter and a cross-sectional thickness, the ratio of the inner diameter to the cross-sectional thickness being in the range of 5:1 to 6:1. In embodiments, this ratio can vary considerably. For example, in thin-film embodiments, a ratio of 40:1 can be achieved, but generally, a ratio of 10:1 to 3:1 is sufficient.

[0185] At least one electrode may have an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to a C-ring portion and having a plurality of perforations. The electrode flange may be rectangular with rounded corners. The electrode flange may have a curved bottom edge. The plurality of perforations may include at least one perforation on a first side of the electrode flange and at least one perforation on a second opposite side of the electrode flange. The first side and the second opposite side of the electrode flange may be longer than the third and fourth sides of the electrode flange. Each of the plurality of perforations may be rectangular with rounded corners. The lead body may have at least one tension-relaxing wavy section.

[0186] In embodiments, the neural interface may further comprise a vertebral portion having a first end and a second end, the outer circumference of the first end of the vertebral portion tapering from a maximum to a minimum outer circumference, and the lead body is coupled to the first end of the vertebral portion and extends at least partially into the vertebral portion. The vertebral portion may have a substantially circular cross-section, and the second end of the vertebral portion may have an inclined surface, so that a plane parallel to this substantially circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with respect to the plane defined by the inclined surface. The maximum outer circumference of the first end of the vertebral portion may be located near at least three C-ring portions, and the minimum outer circumference of the first end of the vertebral portion may occur where the vertebral portion terminates on the lead body. The distance between the maximum and minimum outer circumferences is in the range of 2 mm to 5 mm.

[0187] In embodiments, the neural interface may further comprise at least two additional C-ring portions, each C-ring portion having a first end and a second end, the first end of each C-ring portion being coupled to a vertebral portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first and third C-ring portions, is on the second opposite side of the vertebral portion. The first and third C-ring portions may be coupled to the vertebral portion so as to move together with respect to the second C-ring portion, and the first and third C-ring portions may extend from the vertebral portion in a direction opposite to the direction of the second C-ring portion. At least one of the at least three C-ring portions may have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first and second ends, the third thickness may be greater than the first and second thicknesses. The thickness of at least one of the three C-ring portions gradually increases between the first end and the point between the first and second ends. The thickness of at least one of the three C-ring portions gradually increases between the second end and the point between the first and second ends.

[0188] The neural interface may further comprise multiple electrodes positioned on at least one of at least three C-ring portions, with adjacent electrodes on the same C-ring portion being electrically coupled by an inter-electrode coil.

[0189] The neural interface may further comprise at least one anchoring tab attached to the lead body. The at least one anchoring tab may comprise a covering mesh.

[0190] The C-ring portion can be provided at the first end of the lead body, the IPG connector can be provided at the second end of the lead body, and the mooring tab can be provided between the first and second ends of the lead body.

[0191] The mooring tab can be provided between the first end of the lead body and the central portion of the lead body located midway between the first and second ends. Furthermore, the ratio of the distance between the first end of the lead body and the mooring tab to the distance between the second end of the lead body and the mooring tab can be 1:1 to 1:50, or optionally 1:2, 1:3, 1:4, or 1:5. The mooring tab can be made movable along the lead body.

[0192] The lead body can have more flexibility in the part closer to the C-ring compared to the part further away from the C-ring.

[0193] In one embodiment, the system comprises a neural interface in any embodiment, configuration, or combination described herein, and a deployment tool that is detachably coupled to the neural interface for introducing the neural interface. The deployment tool may comprise a first area configured to be positioned near the neural interface, and a connector anchored to the first area for detachably coupling the first area to the neural interface. The deployment tool may have a planar or triangular shape.

[0194] In the embodiment, the deployment tool may further include a second area and a central area between the first and second areas. The first area may be larger than the second area.

[0195] The cutting portion passing through the deployment tool can sever the connector and release the connection between the deployment tool and the neural interface, so that at least the first region moves away from the neural interface device.

[0196] The deployment tool may further comprise at least one passage extending from a first area to a second area through a central area, each passage including a first opening in the first area and a second opening in the second area.

[0197] The connector may be a suture anchored to the first area for holding the first area near an implantable device by passing through at least one passage from the second opening to the first opening.

[0198] The deployment tool may further comprise a severable portion extending across at least one passage, the severable portion being configured to release at least a portion of the connector in at least one passage when the severable portion is cut, the release of at least a portion of the suture allowing the first area to move away from the implantable device.

[0199] The connector may include a first portion passing through at least one passage from a second opening to a first opening, the connector may include a second portion removably attached to an implantable device, and the connector may include a third portion passing through at least one passage from a first opening to a second opening, the first portion connected to the second portion, and the second portion connected to the third portion.

[0200] At least one passage may include a first passage and a second passage, the first portion passing through the first passage and the third portion passing through the second passage.

[0201] At least the first and second areas may include rounded edges.

[0202] The severable portion may be a recessed area within the central area extending across at least the first and second passages. The recessed area within the central area may extend across only a portion of the width of the central area, and therefore when the recessed area is cut to release the connector, at least a portion of the central area is not cut into two pieces. The recessed area may extend across the entire width of the central area, and therefore when the recessed area is cut to release the connector, the central area is cut into two pieces. At least the central area may include a series of alternating lateral ridges and lateral valleys extending across the width of the central area to provide lateral rigidity when the deployment tool is extended, while providing longitudinal flexibility that allows the deployment tool to be rolled up. The first and second areas include alternating lateral ridges and lateral valleys extending across the widths of the first and second areas, respectively. At least one passage can be formed by a tunnel through each lateral ridge and a tube crossing each lateral valley. The severable portion can be a lateral valley. The connector can be anchored to the first area by molding it into the first area. The connector can be anchored to the first area by adhesive. The first area, the second area, and the central area can be molded from silicone. At least the second area can be tapered toward a second opening. The tapered second area may include a gripping point for operation. The gripping point includes an opening.

[0203] The unfolding tool may include a first surface and a second surface opposite to the first surface, the first surface providing indication of the location of the cuttable portion, and the second surface including multiple longitudinal grooves along the length of the unfolding tool to reduce contact.

[0204] At least the second and central areas can be tapered, and the first portion of the plurality of longitudinal grooves can extend from the first area to the second area through the central area, and the second portion of the plurality of longitudinal grooves can extend from the first area to the central area. The second area can be tapered in terms of its thickness from its edge toward the central area. The thickness can increase from its edge toward the central area. The second area can have a rounded edge.

[0205] The neural interface may be a cuff comprising a spine and at least two curved arms extending from the spine and equipped with electrodes, the open end of each curved arm being detachably coupled to a deployment tool.

[0206] The neural interface may comprise a first arm that moves in a first direction and one or more second arms that move in a second direction substantially opposite to the first direction, and the second portion of the connector may be detachably attached to one or more of the second arms. The one or more second arms may include two arms positioned on either side of the first arm, one of which is aligned with a first opening in a first passage, and the other of which is aligned with a first opening in a second passage. One or more of the second arms may include a first hole, and the other arm may include a second hole, and the second portion of the connector may be detachably attached to the cuff by passing through the first and second holes so as to hold a first area close to the cuff, and thereafter, when at least one of the first or third portion is cut at the severable portion, the second portion of the connector may be pulled away from the cuff. The thickness of the central area of ​​the tab may be greater than or equal to the thickness of the neural interface. One or more second arms may have arm heights perpendicular to both the width and length of the tab, and the central region has a height running substantially parallel to the arm height, with the height of the central region being greater than the arm height. The width of the first region of the tab is greater than or equal to the width of the neural interface.

[0207] The cuff may have a width measured from the outside of one arm to the outside of the other arm, and this width runs substantially parallel to the width of the first area, the width of the first area being greater than the width of the cuff.

[0208] The deployment tool can be configured as a measuring tool for measuring the fit of a neural interface to a target. The fit can be determined based on the distance between the ridges, grooves, or valleys of the deployment tool. The fit can also be determined based on the distance between a first part of the deployment tool and a second part of the deployment tool.

[0209] The system may further comprise a lead cap device having a first end and a second end, comprising a body defining an internal cavity extending from the first end to the second end, a set screw block positioned within the body such that the set screw intersects the internal cavity, and a suture loop coupled to the second end, wherein the lead cap device is configured to removably receive a portion of a lead body within the internal cavity and to secure the portion of the lead body within the internal cavity by the set screw. The IPG connector portion of the lead body can be removably received within the internal cavity of the lead cap device.

[0210] The system may comprise a set of multiple neural interface devices according to any embodiment discussed or disclosed herein, wherein the neural interface devices have different inner diameters, but the total electrode area of ​​each neural interface device is substantially equal. Electrodes of neural interface devices with a larger inner diameter may have a smaller width and a larger length than electrodes of neural interface devices with a smaller inner diameter.

[0211] In some embodiments, the neural interface includes a vertebral portion, a conductor at least partially disposed within the vertebral portion, at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the vertebral portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion disposed between the first and third C-ring portions is on the second opposite side of the vertebral portion, and at least one electrode array disposed in at least one of the at least three C-ring portions and electrically coupled to the conductor, each of the at least one electrode array comprising one or more electrodes, adjacent electrodes in each electrode array being electrically coupled by an inter-electrode coil, each electrode comprising an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to the C-ring portion and comprising a plurality of perforations.

[0212] In one embodiment, the neural interface comprises: a spinal portion having a first end and a second end, wherein the outer circumference of the first end of the spinal portion tapers from the maximum outer circumference to the minimum outer circumference; a lead body coupled to the first end of the spinal portion and having a conductor connectable to an implantable pulse generator, extending at least partially into the spinal portion; at least three C-ring portions, each having a first end and a second end, wherein the first end of each C-ring portion is coupled to the spinal portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the spinal portion, and the second end of the second C-ring portion, positioned between the first C-ring portion and the third C-ring portion, is on the second opposite side of the spinal portion; and at least one electrode positioned in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0213] In one embodiment, a method for forming a neural interface includes providing a vertebral portion having a first end and a second end, wherein the outer circumference of the first end of the vertebral portion tapers from the maximum outer circumference to the minimum outer circumference; coupling a lead body to the first end of the vertebral portion, wherein the conductor of the lead body, connectable to an implantable pulse generator, extends at least partially into the vertebral portion; coupling at least three C-ring portions to the vertebral portion, wherein each of the at least three C-ring portions has a first end and a second end, and the first end of each C-ring portion is coupled to the vertebral portion, so that the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first C-ring portion and the third C-ring portion, is on the second opposite side of the vertebral portion; and placing at least one electrode on each of the at least three C-ring portions, and electrically coupling at least one electrode to a conductor.

[0214] In another embodiment, the neural interface may comprise: a spinal portion having a first end and a second end; a lead body coupled to the first end of the spinal portion and having a conductor connectable to an implantable pulse generator, extending at least partially into the spinal portion from the first end toward the second end; at least three C-ring portions, each having a first end and a second end, wherein the first end of each C-ring portion is coupled to the spinal portion, and therefore the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the spinal portion, and the second end of the second C-ring portion, positioned between the first C-ring portion and the third C-ring portion, is on the second opposite side of the spinal portion, and each C-ring portion has an inner diameter and a thickness, with the ratio of the inner diameter to the thickness being in the range of 5:1 to 6:1; and at least one electrode positioned in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0215] In yet another embodiment, the neural interface may comprise: a vertebral portion having a first end and a second end; a lead body coupled to the first end of the vertebral portion and comprising a conductor connectable to an implantable pulse generator, extending at least partially into the vertebral portion from the first end toward the second end; at least three C-ring portions, each having a first end and a second end, wherein the first end of each C-ring portion is coupled to the vertebral portion, and therefore the second end of the first C-ring portion and the second end of the third C-ring portion are on the first side of the vertebral portion, and the second end of the second C-ring portion, positioned between the first and third C-ring portions, is on the second opposite side of the vertebral portion, and each C-ring portion is configured to apply a pressure in the range of about 0 mmHg to about 30 mmHg to target tissue located within the C-ring portion during use; and at least one electrode located in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0216] In further embodiments, the system may comprise a neural interface of any embodiment disclosed herein, a lead cap device having a first end and a second end, comprising a body defining an internal cavity extending from the first end to the second end, a set screw block positioned within the body such that a set screw intersects the internal cavity, and a suture loop coupled to the second end, configured to removably receive a portion of a lead body into the internal cavity and to secure a portion of the lead body within the internal cavity by a set screw, and a deployment tool comprising a tab-shaped body having a first end and a second end, a first aperture formed within the first end, a second aperture and a third aperture formed within the second end, and a plurality of sets of small holes formed within the tab-shaped body between the first end and the second end, wherein the tab-shaped body further comprises a series of ridges and grooves, and the deployment tool is removably coupled to the neural interface by a suture that can pass through the first aperture and at least one of the plurality of sets of small holes.

[0217] In addition to or as an alternative to the above, examples consistent with this instruction are provided in the following numbered sections.

[0218] Features and components of different embodiments discussed herein can be combined in other embodiments. In addition, features and components discussed herein with respect to a particular embodiment or type of neural interface or device can be used with other devices, including other types of electrodes and leads. For example, a lead feature designed to reduce strain can be used in various other types of devices where lead strain may be a problem. In another example, the configuration of components for laser welding can also be applicable to other types of devices and structures. Those skilled in the art will understand how yet more features and components discussed herein can be used with other devices and systems in other applications and methods. In this way, specific effects can be designed and achieved to meet specific demands or needs in the industry. Dimensions given in the description or drawings are examples and may vary independently or in combination in other embodiments. Ranges or dimensions disclosed as values ​​with "about" or "approximately" may vary within ±5 percent of the value.

[0219] Various embodiments of systems, devices, and methods have been described herein. These embodiments are provided for illustrative purposes only and are not intended to limit the scope of the claimed invention. Furthermore, it should be understood that various features of the described embodiments can be combined in various ways to create numerous additional embodiments. In addition, various materials, dimensions, shapes, configurations, and locations have been described for use with the disclosed embodiments, but other materials may also be used without exceeding the scope of the claimed invention.

[0220] Those skilled in the art will understand that the subject matter of the present invention may include fewer features than those shown in any of the individual embodiments described above. The embodiments described herein are not intended to be an exhaustive presentation of how various features of the subject matter of the present invention can be combined. Therefore, as those skilled in the art will understand, these embodiments are not mutually exclusive combinations of features, and various embodiments may include different combinations of individual features selected from different individual embodiments. Furthermore, unless otherwise stated, elements described in relation to one embodiment may be implemented in other embodiments even if they are not described in that embodiment.

[0221] In the claims, a dependent claim may refer to a specific combination of one or more other claims, but other embodiments may also include a combination of that dependent claim and the subject matter of another dependent claim, or a combination of one or more features and another dependent or independent claim. Such combinations are proposed herein unless otherwise stated that a specific combination is not intended.

[0222] The applicant incorporates by reference the contents of a previously filed PCT application, published as WO2019 / 020986. In particular, the electrodes described herein may be replaced with the coil electrodes described in that application. Any incorporation by reference to the above documents is limited so as not to incorporate any subject matter that contradicts the express disclosure herein. Any incorporation by reference to the above documents is further limited so as not to incorporate by reference any claims contained in those documents. Any incorporation by reference to the above documents is further limited so as not to incorporate by reference any definitions provided in those documents unless expressly included herein.

[0223] It is explicitly intended that unless the specific terms “means for” or “step for” are used in the claims for the purpose of describing the claims, Section 112(f) of the U.S. Patent Act will not be invoked.

Claims

1. It comprises at least one C-ring portion, the at least one C-ring portion applies a radial pressure in the range of 1 mmHg to 30 mmHg to a target tissue placed within the C-ring portion, and comprises at least one electrode placed on the at least one C-ring portion. It comprises at least one mooring tab connected to a lead body, the at least one mooring tab comprising a covering mesh, the covering mesh including a mesh, and the mesh being covered with a material filling the mesh. Neural interface.

2. The neural interface according to claim 1, wherein the C-ring portion is provided at the first end of the lead body, a connector to an implantable pulse generator (IPG) is provided at the second end of the lead body, and the anchoring tab is provided between the first end and the second end of the lead body.

3. The neural interface according to claim 2, wherein the mooring tab is provided between the first end of the lead body and the central portion of the lead body located midway between the first end and the second end of the lead body, and further, the ratio of the distance between the first end of the lead body and the mooring tab to the distance between the second end of the lead body and the mooring tab is arbitrarily between 1:1 and 1:50, and is 1:2, 1:3, 1:4, or 1:

5.

4. The neural interface according to any one of claims 1 to 3, wherein the mooring tab is movable along the lead body.

5. The neural interface according to any one of claims 1 to 4, wherein the lead body has higher flexibility in the portion of the lead body closer to the C-ring portion compared to the portion of the lead body further away from the C-ring portion.

6. A neural interface according to any one of claims 1 to 5, wherein multiple electrodes are electrically connected in parallel.

7. A neural interface according to any one of claims 1 to 6, A deployment tool that can be detachably coupled to the neural interface for the introduction of the neural interface, A system equipped with these features.

8. The system according to claim 7, wherein the deployment tool can be configured as a measuring tool for measuring the degree to which the neural interface fits into a target.

9. The system according to claim 7 or 8, wherein the deployment tool is configured to function as a blunt cutting tool.

10. The system according to any one of claims 7 to 9, wherein the thickness of the deployment tool is greater than the thickness of the C-ring portion of the neural interface.

11. The system according to any one of claims 7 to 9, wherein the width of the deployment tool is greater than the width of the neural interface.

12. The system according to any one of claims 7 to 11, further comprising a lead cap device having a first end and a second end, wherein the lead cap device comprises a body defining an internal cavity extending from the first end to the second end and a suture loop coupled to the second end, and the lead cap device is configured to removably receive a portion of the lead body into the internal cavity.

13. The system according to claim 12, wherein the IPG connector portion of the lead body is removably received within the internal cavity of the lead cap device, and the lead cap device further comprises a set screw block positioned within the main body such that the set screw intersects with the internal cavity, and the portion of the lead body is fixed within the internal cavity by the set screw.

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