Electrode devices for neurostimulation and related methods

Abstract

To provide extravascular and intravascular devices comprising electrodes for neuromodulation.SOLUTION: A neural interface 100 comprises at least one C-ring portion 104, 106. The C-ring portion 104, 106 can apply a pressure in a range from 1 mmHg to 30 mmHg to a target tissue arranged within the C-ring portion and comprises at least one electrode 112, 114 arranged on the at least one C-ring portion 104, 106. The neural interface further comprises a lead body comprising a conductor 118 connectable to an implantable pulse generator. The at least one electrode 112, 114 is electrically coupled to the conductor 118.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 tissue.

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, the nerve may be damaged due to reduced blood flow and constriction of nerve fibers. If temporary dilation of the target blood vessel is caused by the influence of device positioning, such nerve damage may be exacerbated. In contrast, if the device is loosely clamped, 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 nerve interface can further include a lead body having a conductor connectable to an implantable pulse generator, and at least one electrode is electrically coupled to the conductor. The C-ring portion can apply a 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 the electrodes compared 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 nerve interface. The C-ring portion can have an inner diameter and a cross-sectional thickness, and the ratio of the inner diameter to the cross-sectional thickness is in the range of 5:1 to 6:1. The electrode can include an electrode contact on an electrode flange, and the electrode flange mechanically couples the electrode to the C-ring portion and has a plurality of perforations. The electrode flange can be square with rounded corners. The electrode flange can include a curved bottom edge. The plurality of perforations can 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 of the electrode flange and the second opposite side of the electrode flange can be longer than the third side and the fourth side of the electrode flange. The plurality of perforations can be square with rounded corners. The lead body can include at least one tension-relieving wavy section.

[0006] The nerve device can include a spinal-shaped portion having a first end and a second end. The outer periphery of the first end of the spinal-shaped portion tapers from a maximum outer periphery to a minimum outer periphery. The lead body can be coupled to the first end of the spinal-shaped portion and extends at least partially into the spinal-shaped portion. The spinal-shaped portion can have a substantially circular cross-section. The second end of the spinal-shaped portion has an inclined surface. Thus, the plane parallel to this substantially circular cross-section forms an angle greater than 0 degrees and less than 90 degrees with the plane defined by the inclined surface. The maximum outer periphery of the first end of the spinal-shaped portion can be found in the vicinity of at least three C-ring portions. The minimum outer periphery of the first end of the spinal-shaped portion occurs where the spinal-shaped portion terminates on the lead body. The distance between the maximum outer periphery and the minimum outer periphery can be in the range of 2 mm to 5 mm.

[0007] The nerve interface can include at least two additional C-ring portions. Each C-ring portion has a first end and a second end. The first end of each C-ring portion is coupled to the spinal-shaped portion. Thus, the second ends of the first C-ring portion and the third C-ring portion are on the first side of the spinal-shaped portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on the second opposite side of the spinal-shaped portion. The first C-ring portion and the third C-ring portion can be coupled to the spinal-shaped portion so as to move together with respect to the second C-ring portion. The first C-ring portion and the third C-ring portion extend from the spinal-shaped portion in a direction opposite to the direction of the second C-ring portion. At least one of the C-ring portions can 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 end and the second end. The third thickness is greater than the first thickness and the second thickness. The thickness of any of the C-ring portions can gradually increase between the first end and the point between the first end and the second end. A plurality of electrodes can be disposed on at least one of the at least three C-ring portions. Adjacent electrodes on the same C-ring portion are electrically coupled by an inter-electrode coil.

[0008] The nerve interface can include at least one anchoring tab coupled to the lead body. The anchoring tab can include a covering mesh, and optionally the mesh is covered by a material filling the mesh. The C-ring portion can be 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 further the anchoring tab is provided between the first end and the second end of the lead body. The anchoring tab can be provided between the first end of the lead body and the central portion of the lead body located intermediate 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 anchoring tab to the distance between the second end of the lead body and the anchoring tab is 1:1 to 1:50, optionally 1:2, 1:3, 1:4, or 1:5. The anchoring tab can be movable along the lead body. The lead body can have additional flexibility in a portion closer to the C-ring portion compared to a portion of the lead body further away from the C-ring portion.

[0009] According to another embodiment, the system includes the neural interface described above and a deployment tool removably attachable to the neural interface for introducing the neural interface. The deployment tool can include a first region configured to be positioned near the neural interface and a connector tethered to the first region for releasably coupling the first region to the neural interface. In an embodiment, the deployment tool can have a planar shape or a triangular shape. The deployment tool can also include a second region and a central region between the first region and the second region. The first region can be wider than the second region. A cut 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. The deployment tool can 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 can be a suture tethered to the first region for holding the first region near the implantable device by passing through at least one passage from the second opening to the first opening. The deployment tool can further include a cuttable portion extending across at least one passage, the cuttable portion being configured to release at least a portion of the connector within the at least one passage when the cuttable portion is severed, such that release of at least a portion of the suture allows the first region to move away from the implantable device.

[0010] The connector can include a first portion that passes through at least one passage from a second opening to a first opening. The connector can include a second portion removably attached to the embeddable device. The connector can include a third portion that passes through at least one passage from the first opening to the second opening. The first portion is connected to the second portion, and the second portion is connected to the third portion. The system can include both a first passage and a second passage. The first portion passes through the first passage, and the third portion passes through the second passage. The first region and the second region can include rounded edges. The cuttable portion can be a recessed area within a central region that extends across at least the first passage and the second passage. The recessed area within the central region can extend across only a portion of the width of the central region. Thus, when the recessed area is cut to release the connector, at least a portion of the central region is not cut into two pieces. The recessed area can extend across the entire width of the central region. Thus, when the recessed area is cut to release the connector, the central region is cut into two pieces. The central region can include a series of alternating lateral ridges and lateral valleys that extend across the width of the central region, providing longitudinal flexibility to allow the deployment tool to be wound up while providing lateral stiffness when the deployment tool is expanded. The first region and the second region can include alternating lateral ridges and lateral valleys that extend across the width of the first region and the width of the second region. The passage can be formed by a tunnel through each lateral ridge and a tube across each lateral valley. The cuttable portion can be a lateral valley. The connector can be tethered to the first region by molding to the first region. The connector can be tethered to the first region by adhesion. The first region, the second region, and the central region can be molded from silicone. The second region can taper towards the second opening. The tapered second region can include a gripping point for manipulation. The gripping point can include an opening.The deployment tool can include a first surface and a second surface opposite the first surface, the first surface providing an indication of the location of the cuttable portion, and the second surface including a plurality of longitudinal grooves along the length of the deployment tool to reduce contact. The second region and the central region can taper, and a first portion of the plurality of longitudinal grooves can extend from the first region to the second region through the central region, and a second portion of the plurality of longitudinal grooves can extend from the first region to the central region. The second region can taper from the edge of the second region towards the central region with respect to thickness. The thickness can increase from the edge of the second region towards the central region. The second region can include a rounded edge.

[0011] The nerve interface can be a cuff that includes a backbone and at least two curved arms extending from the backbone and having electrodes, and each open end of the curved arms is removably coupled to a deployment tool. The nerve interface can include a first arm that is moved in a first direction and one or more second arms that are moved in a second direction that is substantially opposite to the first direction, and a second portion of the connector is removably attached to the one or more second arms. The second arms can include two arms positioned on both sides of the first arm, one of the two arms being aligned with a first opening of a first passage, and the other of the two arms being aligned with a first opening of a second passage. The second arms can include corresponding small holes, and the second portion of the connector can be removably attached to the cuff by passing through the first small hole and the second small hole so as to hold a first region near the cuff, and then, when at least one of the first portion or the third portion is cut by a cuttable portion, the second portion of the connector can be pulled away from the cuff. The thickness of the central region of the tab can be greater than or equal to the thickness of the nerve interface. The second arms can have an arm height in a direction orthogonal to both the width and the length of the tab, the central region has a height running substantially parallel to the arm height, and the height of the central region is greater than the arm height. The width of the first region of the tab can be greater than or equal to the width of the nerve interface. The cuff can have a width measured from the outside of one arm to the outside of the other arm, this width runs substantially parallel to the width of the first region, and the width of the first region is greater than the width of the cuff. The deployment tool can be configured as a measuring tool for measuring the fit of the nerve interface to the target. The measurement of the fit can be determined based on the distance between the root, groove or valley of the deployment tool. The measurement of the fit can be determined based on the distance between the first portion and the second portion of the deployment tool. The deployment tool can be configured to function as a blunt dissection 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 made larger than the width of the nerve interface.

[0012] The deployment tool can be positioned within the C-ring portion of the nerve interface. The deployment tool can be at least partially wound within the nerve interface, for example, within the C-ring portion. Thus, the deployment tool can be configured to protect the electrodes within the C-ring portion until the introduction of the nerve interface.

[0013] The system described above can 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 towards 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. Further, the lead cap includes a set screw block disposed within the body such that the set screw intersects the internal cavity and is configured to fix a portion of the lead body within the internal cavity by the set screw. In some embodiments, the system comprises the nerve interface disclosed above and the lead cap device (i.e., without the deployment tool).

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

[0015] In one embodiment, the system includes a nerve interface disclosed herein that includes the foregoing, and a deployment tool removably attachable to the nerve interface for introduction of the nerve interface.

[0016] In one embodiment, the implantable system includes a nerve interface disclosed herein that includes any of the foregoing paragraphs, and a tether tab configured to be fixed to the right leg portion of the septum.

[0017] The tether tab can be any of those disclosed herein, including those described in any of the foregoing paragraphs describing the tether tab. The above summary is not intended to describe every embodiment or all implementations of the subject matter shown. The following figures and detailed description illustrate various embodiments in more detail.

[0018] The subject matter of the present disclosure will be more fully understood in view of the following detailed description of various embodiments in conjunction with the accompanying figures.

Brief Description of the Drawings

[0019]

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[0020] The present disclosure relates to embodiments of extravascular and intravascular nerve interface devices that include electrodes for nerve stimulation / neuromodulation of a target nerve or blood vessel. The device can be housed within a flexible substrate, each substrate having a central portion through which conductors for the electrodes are routed and housed. A plurality of curved flaps or arms extend from the central portion, the plurality of flaps or arms supporting the electrodes and positioning these electrodes either inwardly, i.e., an extravascular design, or outwardly, i.e., an intravascular design. The extravascular nerve interface device is configured to be positioned outside the target blood vessel, and the intravascular nerve interface device is configured to be positioned at least partially within the target blood vessel. The substrate flaps or arms can include one or more electrodes, and one or more of the electrodes can be configured to be disposed in a position specific to the target blood vessel.

[0021] One embodiment of a bipolar extracranial nerve interface according to the present disclosure is shown in FIGS. 1 and 2A. The nerve interface 100 can include a hybrid cuff that includes a support substrate 102 formed in a partially helical shape, and the support substrate 102 can be made of silicone or a similar flexible material such as styrene isoprene butadiene (SIBS), polyamide, parylene, liquid crystal polymer (LCP), polytetrafluoroethylene (PTFE), polyethylene (PE), polypropylene (PP), fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polyurethane, or another biocompatible polymer. Biocompatible silicone and other grades of silicone can have very high flexibility and softness, thereby minimizing mechanical mismatch between the cuff and the target blood vessel and minimizing constriction of the target blood vessel. Polymer materials can also be used, but those materials are more rigid and harder than silicone, and it may be necessary to use thinner materials, which can be both an advantage and a disadvantage.

[0022] The substrate 102 can include two C-ring portions 104 and 106, each C-ring portion being connected by a spinal-like portion to form a one-turn helix in opposite directions from a common central section 108 of the central portion 109 (when combined with the central portion 109 and one of the portions 104 or 106), terminating in a C-ring configuration, and the C-ring being substantially orthogonal to the target blood vessel when positioned. Within each C-ring end portion 104 and 106, a plurality of platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 112 and 114, can be disposed instead of the plurality of helical structures found in conventional systems. The electrode arrays 112 and 114 can be of a conventional type and can be wired to a controller via a conventional conductor 118, such as a stranded cable configuration (i.e., a 7×7 configuration (not shown)) or a multifilar coil configuration, within a 35N LT (registered trademark) DFT (Drawn Filled Tubing) having a 28% Ag core. The conductor is housed within a backbone or spinal-like portion 120 attached to a part of the end portion 106 and the central portion 109.

[0023] The configuration of the nerve interface 100 can significantly shorten the length of the nerve interface 100, thereby making it possible to reduce the portion of the target blood vessel or nerve that needs to be dissected during placement. Additionally, the opposite helical directions of the portions 104 and 106 and the low helical angle of each portion with respect to the spinal-like portion 120 enable the nerve interface 100 to be introduced and wrapped around the target blood vessel in a single pass rather than at least twice as in the case of conventional helical structures. The low helical angle or low pitch makes it possible to shorten the length of the nerve interface 100 (or its distal end), and as a result, less tissue dissection during positioning can be achieved.

[0024] The substrate 102 can include a plurality of features 110 disposed at different points on or within the substrate 102. The features can be configured such that a deployment tool (not shown) can grip, manipulate, and introduce the nerve interface 100. Thus, each feature can be referred to as an introduction feature. The features can be protrusions. One or more protrusions can include one or more openings or small holes for receiving a stylet (made of tungsten or a similar material) to, for example, straighten some portions of the substrate or to enable introduction of the nerve interface. The feature 110 can also be an opening, a small hole, or some other form of lumen that can be equally manipulated by the deployment tool.

[0025] In one embodiment, the feature 110 can be disposed sufficiently close to the open ends of the C-ring portions 104 and 106 and the ends of the central section 108 such that the deployment tool can grip the feature while simultaneously opening the portions 104 and 108 and the central section 108, and thus position the nerve interface around a target blood vessel (not shown). As used herein, an "open end" refers to an end located on the outer periphery of a C-ring that is not attached to another feature (e.g., another C-ring or a vertebral-shaped portion). In other words, each of the "open ends" forms a gap side for the target blood vessel. Similarly, a "closed end" refers to an end located on the outer periphery of a C-ring that is attached to another feature. In other words, each of the "closed ends" does not form a gap for the target blood vessel. After the nerve interface 100 is positioned around the target blood vessel, the deployment tool should carefully release the feature, and thus the portions 104 and 108 and the central section 108 can softly self-size to conform to the target blood vessel. "Self-sizing" means that the nerve interface 100 naturally conforms to the shape of the target blood vessel.

[0026] The C-ring can exert a radial pressure on a target blood vessel, nerve, or other structure. The amount of pressure applied can depend on a plurality of factors. The material constituting the C-ring portion can be, for example, an insulating material and a conductive portion (such as an electrode, coil, foil, or weld described later), which passes through the C-ring portion or is at least partially exposed (such as an electrode). The C-ring portion applies a radial pressure according to a plurality of characteristics such as the rigidity (for example, 70 to 80 Shore) of the insulating material constituting the main body of the C-ring portion. Similar to the rigidity or hardness of one or more electrodes passing through the C-ring, the thickness of the insulating material constituting the main body of the C-ring portion also affects the radial pressure. As will be described in more detail with respect to FIGS. 14 and 15, the size and shape of at least one electrode can affect the flexibility of the electrode and thus the radial pressure applied. The number of electrodes on any given C-ring can also affect the radial pressure applied. Among the C-rings, the surface facing the target can be formed from an active portion (also called the exposed electrode portion) and an inactive portion (also called the insulating material portion), and the ratio of the active portion to the inactive portion can affect the radial pressure. For example, the ratio of the active portion to the inactive portion (i.e., active portion: inactive 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 within the C-ring can also affect the pressure applied. 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, such as about 1 mm, about 1.2 mm, or about 1.4 mm. The thickness is defined, for example, radially along the central axis shown in FIG. 1. Referring back to FIG. 1, in an embodiment, 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, such as 4, 5, 6, 7, 8, or 9 mm, or any number in between, and more preferably about 4 mm to 8 mm. However, this can also be selected based on the target size.

[0028] As shown in FIG. 9A (and additional embodiments described below), each device has an inner diameter and an outer diameter. As used herein to describe such a device, the term "inner diameter" refers to the distance from the central axis of the device to the radially inward portion where the electrodes are disposed. In contrast, the "outer diameter" is the distance to the radially outer portion opposite those electrodes, defining the outermost radial extent of the device. The outer diameter is the outermost radial extent of the C-ring portion and is not defined by the outermost radial extent of other protrusions such as lead bodies or other features attached to the radially outer surface of the C-ring portion. The C-ring portion of the nerve interface described herein has an inner diameter and a cross-sectional thickness, and in some embodiments, the ratio of the inner diameter to the cross-sectional thickness is in the range of 4:1 to 9:1, or in the range of 5:1 to 7:1, or in the range of 5:1 to 6:1. In other embodiments, such as when thin films are used, this ratio can be increased up to 40:1, but in order 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 also be decreased down 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 materials used. For example, since the shore number increases with increasing hardness of the material, a higher ratio can be used to achieve a similar radial force with a material that is not as hard as in the case of a lower ratio.

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

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

[0031] The separation force or retention force refers to the force required to remove the device from the target after being at least partially disposed around the target anatomical structure. In some embodiments, the separation force can be 0.05 N to 0.5 N. In preferred embodiments, the separation force can be 0.1 to 0.2 N. In a preferred embodiment, it is sufficient to pull the device away from the target with a separation force of about 0.15 N in a direction orthogonal to the target axis to remove the device from the target.

[0032] An embodiment with three open-ended arms will be discussed and depicted as an example, but various aspects of the present disclosure can be applied to neural interfaces having different shapes or arrangements. For example, the neural interface can comprise only one open-ended arm, two open-ended arms, or four or more open-ended arms. Further, the neural interface can have the same coupling and aperture orientations, alternating coupling and aperture orientations, or other patterns of arm couplings and arm orientations, arms of different relative sizes, arms of different or varying helix angles, and other variations including those discussed herein with respect to other embodiments.

[0033] Another embodiment of the nerve interface 200 is shown in FIG. 2B. The nerve interface 200 is structurally similar to the embodiments shown in FIGS. 1 and 2A, i.e., it has a plurality of C-rings and a common central section, forming two helical turns of short length. The nerve interface 200 can be multipolar rather than bipolar as in the case of the nerve interface 100. In the nerve interface 200, the substrate 202 can include three C-ring portions 204, 206, and 208, and each C-ring end portion 204 and 206 is connected by a one-turn helix in a direction opposite to the common central section of the C-ring central portion 208 and ends in a C-ring configuration that can be orthogonal to the target blood vessel when positioned on the target blood vessel. The C-ring central portion 208 can also be orthogonal to the target blood vessel. A plurality of platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 212, 214, and 224, can be positioned within each C-ring portion 204, 206, and 208, and such electrodes are adapted (arranged) so that the electrodes within one C-ring cover the gaps within adjacent C-rings (along the length between the electrodes). Each electrode array is connected to a different conductor among the multi-conductors 218 housed within the vertebral portion 220, and the vertebral portion 220 is attached only to the central portion 208. The substrate 202 of the nerve interface 200 may not contain a characterizing substance. By connecting individual electrodes or different electrode arrays to different conductors, selective stimulation of the target blood vessel can be enabled by individually controlling each connected device or individual electrodes or groups of individual electrodes.

[0034] FIGS. 3 and 4A show an embodiment of a tripolar nerve interface 300 according to the present disclosure. The nerve interface 300 can be formed from a flexible substrate 302 of a similar material and can be similar to the nerve interface 100 in that it can have two end portions 304 and 306 that form a C-ring configuration that can be attached to the vertebral portion 308.

[0035] However, unlike the neural interface 100, the two terminal portions 304 and 306 may not be connected to the central section. Instead, the central portion 330 that forms the third C-ring can be utilized. The terminal portions 304 and 306 and the central portion 330 can have a very low helix angle, i.e., pitch, with respect to the spinal portion 308, thereby enabling the neural interface to be helical while still having a significantly shorter length. The helix angle can be about 15 to 30 degrees, but can also be less than 15 degrees.

[0036] Similar to the neural interface 100, each of the C - rings of the neural interface 300 can include one or more electrodes or arrays of electrodes such as 312, 314, and 316, and each electrode is connected to a conductor 318 through a spinal - like portion 308. A design with one electrode can enable maximizing the effective range of the electrode while minimizing the conductor - interconnect process such as laser welding, resistance welding, etc. However, in order to minimize the rigidity of the electrode, i.e., to give the electrode sufficient flexibility, the electrode may have to be made very thin (typically, 25μm - 50μm), which may make the interconnection of 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 flexibility of the electrode. For this reason, one electrode can be characterized as a concave electrode and has 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 the stimulation. On the other hand, the "split" - electrode design provides better mechanical compliance, allows for surface features, i.e., the possibility of protruding electrodes, and enables individual control of each electrode (i.e., current steering). The trade - offs include limitations in the electrode effective range, an increase in the interconnect process, and a decrease in the holding force. The split electrodes provide additional flexibility to the neural interface, thereby allowing the deployment tool to open the C - ring wider and for a longer period of time compared to what is possible with a single electrode without imposing excessive stress on the electrodes.

[0037] As shown in FIGS. 2A and 4A, the individual electrodes of electrode arrays 112 and 114 of nerve interface 100 and electrode arrays 312, 314, and 316 of nerve interface 300 can be uniformly spaced within substrates 102 and 302, respectively. By uniformly spacing the electrodes within the substrate, the distance between the electrodes becomes more constant, providing a more uniform current density distribution and an improvement in the effectiveness of the nerve interface. In some embodiments, the positions of the electrodes within the array can be staggered to achieve a better electrical effective range. For nerve interface 300, specific characteristics of nerve 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 and shape and number of electrodes within the electrode array, the distance between the electrodes within the electrode array, and the angle of the spiral angle, can each be selected for a particular application of the nerve interface. For example, the use of a nerve interface for the treatment of the splenic artery may require different characteristics than the use of a nerve interface for the treatment of different blood vessels. For example, when used for the treatment of the splenic artery, an electrode width of about 1 to 4 mm is suitable, and the preferred width ranges are about 1 to 2 mm and about 2 to 3 mm. Different electrode widths may be desirable when used for the treatment of different blood vessels.

[0038] The nerve interface 300 can also include at least one feature 310, and the at least one feature 310 can be positioned on the outer surface of the substrate 302 near the open ends of each C-ring of portions 304, 306, and 330. As described above, the feature can include one or more openings or small holes for receiving a stylet (made of tungsten or a similar material) to, for example, straighten some portions of the substrate and / or to enable introduction of the nerve interface. The feature 310 can be configured to enable a deployment tool (not shown) to grip, manipulate, and introduce the nerve interface 300. In one embodiment, the feature 310 can be disposed sufficiently close to the open ends of the C-rings of portions 304, 306, and 330 such that the deployment tool can grip the feature 310 and at the same time open portions 304, 308, and 330, and thus position the nerve interface 300 around a target blood vessel (not shown). After the nerve interface 300 is positioned around the target blood vessel, the deployment tool should carefully release the feature, and thus portions 304, 308, and 330 can flexibly self-size to conform to the target blood vessel. The configurations of the nerve interfaces 100 and 300 enable positioning of the nerve interface around the nerve / blood vessel in a single pass, minimizing manipulation of the nerve / blood vessel and reducing tissue dissection around the area of the nerve / blood vessel where the interface is positioned.

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

[0040] The central portion 430 may not include any electrodes and can only serve to hold the positioned nerve interface, although embodiments can also include electrodes.

[0041] The nerve interfaces 100, 200, 300, and 400 can be self-sizing, which means that these nerve interfaces can be formed from a flexible material, whereby they can be shrunk to fit within a catheter and return to their pre-shrunk shape when released from the catheter, similar to a nitinol cage that can be manipulated for introduction but returns to a predetermined shape when released. This allows the nerve interface to be used to provide good electrical contact between the electrode array and the nerve / vessel surface while still 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-sized to fit the nerve or vessel. This can help prevent the nerve interface from compressing the nerve or vessel, causing a reduction in blood flow and constriction of other nerve fibers. It can also better accommodate radial expansion of the nerve / vessel resulting from post-positioning edema or swelling and can accommodate the pulsatile behavior of the intervention site, such as an artery.

[0042] The naturally opening structure of the spirals of the nerve interfaces 100, 200, 300, and 400 can reduce the area around the nerve / vessel, promoting more normal fluid and nutrient exchange between the intervention site and the surrounding tissues. This can also help minimize the growth of connective tissue between the electrode nerve / vessel interfaces. The open structure of each nerve interface is configured such that at any point along the length of the target vessel, neither the terminal portion nor the central portion forms a closed circumscribing arc around the target vessel. In other words, with this structure, a closed circle that covers 360 degrees of the orthogonal portion of the length of the target vessel is not formed. This open and unrestricted trench enables the target vessel to pulsate without constriction, ensures that the initially expanded target vessel can return to its normal state over time, does not constrict the target vessel when it is expanded, and does not lose contact between the electrode and the target vessel when the target vessel is in its normal state.

[0043] Figures 5 and 6 show additional embodiments of the self-sizing extracorporeal nerve interface 500. The nerve interface 500 can be shaped like a venous flytrap fastener, with a spinal portion 502 connected to a conduit 504 that contains conductors for the nerve interface, and several sets of matching portions 510, 512, and 514 extending from the spinal bone 502. The portions 510, 512, and 514 can be substantially orthogonal to the spinal portion 502. Each of the terminal portions 510 and 512 and the central portion 514 can include an electrode or electrode array 520, 522, and 524, respectively, which are oriented inwardly so that good electrical contact can exist between the electrodes and the outer wall of the target vessel / nerve 530, allowing the artery to pulsate more freely. As discussed earlier, this open trench can relieve the pressure on the nerve 532 within the target vessel 530 sandwiched between the arterial wall and the nerve interface 500. The spacing or channels between the portions 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 respect to the electrode arrays can vary. As shown in FIGS. 5 and 6, the electrode 520 of the terminal portion 510 is positioned near the tip of the terminal portion 510, the electrode 522 of the central portion 512 is positioned near the middle of the central portion 512, and the electrode 514 of the terminal portion 514 is positioned near the connection point of the terminal portion 514 and the spinal portion 502. Of course, different positional configurations (i.e., all electrodes being at the tip, middle, or spinal portion, or any other combination of positions) are also possible and can be specifically selected to provide different outer perimeters for different nerve / vessel types and the treatments being performed.

[0045] Similar to the nerve interfaces 100 and 300 described above, the nerve interface 500 is also self-sizing in that the shapes of the portions 510, 512, and 514 are designed to substantially fit around most of the outer perimeter of the target vessel, the ribs are biased to a relaxed position, and when introduced, naturally wrap around most of the target vessel. As used herein, the word "substantially" does not exclude "completely"; for example, a composition that is "substantially free of" Y may not be completely free of Y. If desired, the word "substantially" can be omitted from the definitions of the present disclosure. For example, a substantially one-turn of a helix can be taken as one turn of the helix, features that are substantially oppositely positioned can be positioned oppositely, features that are substantially spaced apart by a certain distance can be spaced apart by a certain distance, and electrodes that provide a substantially uniform current density can provide a uniform current density.

[0046] Portions 510, 512, and 514 can be orthogonal to the vertebral portion 502 or can have a low helical angle with respect to the vertebral portion 502. For neural interfaces 100 and 300, the composition of the substrate for neural interface 500 can be silicon or a similar material, and all such neural interfaces can be further processed to prevent early scar formation (i.e., fibrous tissue). Such treatment can be performed only on a selected surface, for example, on the side facing the nerve / arterial wall. For example, silicon can be doped with a steroid drug such as dexamethasone. The outer surface of the substrate of the neural interface can further or alternatively be coated with a hydrophilic polymer such as poly-2-hydroxyethyl methacrylate (pHEMA).

[0047] The tips of each of the portions 510, 512, and 514 can be shaped to allow a deployment tool (not shown) to grip these portions for placement on or removal from each target blood vessel and / or nerve. Alternatively, features such as features 110 and 310 can be added to the outer surfaces of portions 510, 512, and 514 to allow these portions to be pulled and released from the neural interface 500 for placement on or removal from the target blood vessel.

[0048] FIG. 7 shows one embodiment of a self-sizing adjustable intravascular nerve interface 700. Similar to the nerve interface 500, the nerve interface 700 can be shaped like a venous flight trap retainer, with a vertebral portion 702 connected to a conduit 704 that includes conductors for the nerve interface, and several sets of mating portions 710, 712, and 714 extending from the vertebral portion 702. However, in contrast to the nerve interface 500, each of the portions 710, 712, and 714 can include an electrode or electrode array 720, 722, and 724, respectively, which are oriented outwardly so that good electrical contact can exist between the electrodes and the inner wall of the target blood vessel / nerve 730, allowing the artery to pulsate more freely, thereby relieving the pressure on the nerve 732 within the target blood vessel 730 sandwiched between the inner arterial wall and the nerve interface 700. The spacing or channels (low-pressure trenches) between the portions 710, 712, and 714 also provide space for the target blood vessel to pulsate and an unrestricted conduit for fluid and nutrients to reach the inner wall of the target blood vessel 730, while at the same time not completely surrounding the artery at any point in the cuff geometry. For example, for each embodiment disclosed herein, no portion of the cuff geometry covers the outer perimeter (a full 360-degree rotation) of the portion of the target blood vessel that is orthogonal 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 FIG. 7, the electrode 720 of the terminal portion 710 is positioned near the connection point between the vertebral portion 702 and the terminal portion 710, the electrode 722 of the central portion 712 is positioned near the middle of the central portion 712, and the electrode 714 of the terminal portion 714 is also positioned near the vertebral portion 702. Of course, different positional configurations (i.e., all at the tip, middle, or backbone, or any other combination of positions) are possible and can be specifically selected for the outer perimeter of the nerve / blood vessel, the type of nerve / blood vessel, and the treatment being performed.

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

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

[0052] As shown in FIG. 8B, the four electrodes 815 of each of the arrays 812 and 814 are connected in series via three microcoil interconnects 817, and the three microcoil interconnects 817 are connected in series to a conductor 818 in the case of array 814 and to a conductor 819 in the case of array 812. The 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 spine-like portion 808 and extend only a short distance from the nerve interface 800. The conductors 818 and 819 are also covered with a silicon lead body tube 820 before emerging from the material of the spine-like portion, forming lead body conductors 822.

[0053] As described above, the feature may be a protrusion, but may also be an opening or a small hole. As shown in FIG. 8A, the feature may be an opening 840 formed at the open ends 805 and 807 of the terminal portions 804 and 806. The deployment tool 841 can be composed of connectors such as a suture wire 842, a grab tab tubing 844, a connector 846, and a grab tube loop 848. The suture wire 842 can be passed through each opening 840 and the silicon tubing of the grab tab 844. Then, the suture wires 842 can be gathered with the connector 846 to form a grab tube loop 848. During the introduction of the nerve interface 800, the surgeon can position the central portion 830 around the target blood vessel (not shown in FIGS. 8A and 8B) while gently pulling the grab tube loop 848. Due to such pressure, the open ends 805 and 807 of the terminal portions 804 and 806 are pulled away from the spinal portion 808, making it possible to position the nerve interface 800.

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

[0055] In another embodiment, the deployment tool 841 can include additional suture wire portions, and there may or may not be a silicone tube member 844 surrounding the additional suture wire portions. The additional suture wire extends between the double arms of the grab tab 844 to form a triangular shape in order to increase the structural stability when introducing the nerve interface device 812.

[0056] In another embodiment, referring to FIG. 8C-1, the deployment tool 841 includes a tab-shaped body 850 instead of the double arms of the grab tab 844 depicted in the embodiments of FIGS. 8A and 8B. In the embodiment of FIG. 8C, a first aperture 852 is similar to the grab tube loop 848, and the second aperture 854 and the third aperture 856 provide portions where connectors such as suture threads can be moored to the tab-shaped body 850. For example, the mooring can be provided by the use of a molding or an adhesive material. After being moored by molding, the apertures 854 and 856 are filled by molding and thus moor the connector. Similarly, the adhesive material can also fill the apertures 854 and 856. In some embodiments, the mooring 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 moor the connector to at least a portion of the tab-shaped body 850. The tab-shaped body 850 can also include multiple sets of small holes 858 through which the connector can pass. A series of small holes form a first and a second passage through which the connector can pass, as shown in FIG. 8C-4. When a connector (e.g., a suture thread) passes through the first and second passages formed from the series of small holes, the connector forms a Y-shape similar to the deployment tool shown in FIGS. 8A and 8B. The tab-shaped body 850 provides additional stability when introducing the nerve interface in order to keep the tabs parallel to the arms of the nerve interface (along the edge of the tab to which the nerve interface is releasably connected to the deployment tab). The planar shape of the deployment tab maintains a specific distance between the arms to prevent the intersection or entanglement of the arms during introduction.

[0057] Other exemplary embodiments of the deployment tool 841 are depicted in FIGS. 8C-2 and 8C-3. An example of one embodiment of the deployment tool 841 releasably attached to the nerve interface device 812 is also shown in FIG. 8C-4.

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

[0059] For example, in some embodiments, the body 850 can be used as a measurement tool. In one embodiment, referring to FIGS. 8D-1, 8D-2, and 8D-3, the gap between the end of the body 850 having length L and the spinal portion 808 can be measured to determine the degree or amount of extension of the nerve interface 800 around the target tissue. This also characterizes the radial length of the electrode arm opening. Understanding these properties can be useful for a medical professional user to determine whether a properly sized nerve interface 841 has been selected for the target tissue. FIGS. 8D-1, 8D-2, and 8D-3 show radial gaps L1, L2, and L3, respectively, which can be evaluated by a medical professional user during the delivery and introduction of the nerve interface 800.

[0060] In another use of the body 850 of the deployment tool 841, referring to FIGS. 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" shaped measurement tool. The rib-groove structure of the body 850 can be flexible so as to be at least partially conformal around the target tissue, whereby it provides another way for a medical professional user to use the body 850 to evaluate the size and fit of the nerve interface 800 to the target tissue. This can be achieved in several ways. In one embodiment, information that converts the number of ribs (or grooves) into useful information can be provided to the medical professional user. For example, a separation of 3 to 5 ribs is acceptable, while 2 or less means the cuff is too large and 6 or more means the cuff is too small. Thus, as shown in FIGS. 8E-1, 8E-2, and 8E-3, simply counting the ribs (or grooves) can directly provide information regarding the fit. In another embodiment, a user such as a medical professional can first count the ribs (or grooves) as shown in FIGS. 8E-1, 8E-2, and 8E-3 and use known measurements between adjacent ribs (or grooves) as shown in FIG. 8E-4 to evaluate the size and fit. Similarly, the known measurements can be converted into a table that shows the cuff opening according to the percentage of the circumference (outer perimeter length) and advises the medical professional user as to which is suitable. In the table of FIG. 8E-4, for the target tissue, the 3rd to 7th values are suitable, 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 particular nerve interface embodiment being used, a table with different predetermined values can be used.

[0061] As described above, the tab-shaped body 850 also includes a plurality of sets of small holes 858. In use, suture wires can be passed through each of the small holes 858 and then gathered at the first 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 blood vessel while gently pulling on the grab loop. Such pressure causes the open ends 805 and 807 of the terminal portions 804 and 806 of the nerve interface 800 to be pulled away from the vertebral portion 808, allowing the nerve interface 800 to be positioned as desired.

[0062] When the nerve interface 800 is properly positioned, the pressure can be removed from the grab loop, and thus the open ends 805 and 807 can gently self-size around the target blood vessel. After the nerve interface is properly positioned, the suture wires can be cut and removed from the small holes 858 and the first aperture 852. The first aperture 852, the second aperture 854, and the third aperture 856, as well as the small holes 858, can be circular holes, elliptical or oblong slots, or other shapes, or features that extend from the terminal portions 805 and 807 of the nerve interface 800 onto the tab.

[0063] The deployment tool 841 having a tab-shaped body (also called a deployment tab) can include a thickness and / or width that is slightly larger than the thickness and / or width of the nerve cuff. The deployment tab can include a tethering suture that is wrapped around the deployment tab and removably attached to the nerve cuff (e.g., by a connector such as a suture at an introduction feature of the nerve cuff such as an opening at the open end of the arm). By cutting at least a portion of the deployment tab, the deployment tool can be completely removed from the nerve cuff. The deployment tab can include on one side a series of transverse (or lateral) ridges and valleys (along the width of the deployment tab) that can act as a cutting guide and enable the deployment tab to be wound to a small size for delivery. The deployment tab can include on the opposite side a series of longitudinal ridges and valleys, as shown in FIGS. 8C-1 and 8C-2, for example the side shown in FIG. 8D-1, and these ridges and valleys can serve to minimize the contact surface (including when the deployment tab is wound up and during introduction of the tissue). The deployment tab can include a tapered proximal end and can be configured to operate as a device (e.g., a go / no-go gauge) to confirm that the dissection opening is large enough for the cuff and as a blunt dissection tool. If the thickness and / or width of the deployment tab does not conform to the anatomy, a slightly smaller nerve cuff may also not conform. The tethering suture is positioned within the deployment tab such that when at least a portion of the deployment tab is cut, the suture is also cut, thereby releasing the deployment tab from the pre-attached portion of the nerve cuff.

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

[0065] In the embodiments of FIGS. 8F-1, 8F-2, and 8F-3, the lead cap device 860 includes a body 862, a set screw block 864 with a set screw 866, and a suture loop 868.

[0066] In one embodiment, the body 862 includes a transparent or translucent biocompatible material such as silicone. Such a material allows the surgeon to look through 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, enabling visual feedback during use. In some embodiments, only a portion of the body 862 can be made transparent.

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

[0068] In a wired embodiment, the lead body 917, and 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 the setscrew 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 can compromise 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 terminal 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 setscrew 866 and towards the second end 876 of the lead cap device 860 and the suture loop 868. When positioned in this way, the retaining constriction 872 also functions to hold the lead body 917 therein and, in some embodiments, can hold the lead body 917 even when the setscrew 866 is not tightened (or not fully tightened).

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

[0070] While discussing and describing specific examples (such as the nerve interface 800), the tabular body 850, lead cap device 860, and other accessories and techniques described above are also applicable to other embodiments of the nerve interface and can also be used with such other embodiments. Further, not all embodiments necessarily include a lead body. For example, more specifically, the nerve interface 900 of FIG. 9A, which is shown as being wired to an implantable pulse generator, may instead be wirelessly powered by including a receiver or coil in the nerve interface device 900 rather than a lead body 917 that provides a wired connection. It should be understood that in some embodiments, when the nerve interface device 900 can be powered by a wireless pulse generator such as a device worn by the user, it is not necessary for the implantable pulse generator referred to herein to be implanted. In some other embodiments, the nerve interface 900 can include a small implantable pulse generator (IPG) having a wireless antenna for receiving power and communication from a transmitter. The IPG can receive power from an external source and / or can include a battery for charging from an external source, and the IPG is powered by the battery or the external source. The following figures refer to embodiments based on a wired lead body, but these embodiments can alternatively be wireless and, unless otherwise specified, it should be understood that the pulse generators described herein do not need to be implanted or do not need to be implantable.

[0071] For example, FIG. 9A shows another embodiment of a nerve interface 900 according to the present disclosure. The nerve interface 900 can be similar to the nerve interfaces 100, 200, 300, 400 discussed above herein, unless otherwise described herein. For example, the nerve interface 900 can be formed from a flexible substrate of the same or similar material (i.e., silicone) and can share other features.

[0072] The nerve interface 900 includes a spinal portion 902, a first C-ring portion 904, a second C-ring portion 906, and a third C-ring portion 908. The spinal portion 902 includes a first end 901 coupled to a lead body 917 that includes 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, extends through the spinal portion 902 from the first end 901 toward the second end 903, and terminates at a connection to the first C-ring portion 904. At the opposite ends, 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 includes the conductor 918, and in one embodiment, the conductor 918 is a bifilar conductor of uniform diameter. The uniform-diameter bifilar design of the conductor 918 provides additional flexibility and, in some embodiments, enables the conductor 918 to be extensible. In other embodiments, if the tube covering the uniform-diameter bifilar conductor 918 is not extensible, the lead body has additional flexibility but is not extensible. These characteristics provide additional separation between the lead body 917 and the spinal portion 902. This means that, even if the lead body 917 is moved or bent during application, the spinal portion 902 (and the C-ring portions 904, 906, 908) is not moved on or away from the target tissue. Additionally, the uniform-diameter feature of the conductor 908 increases the compression resistance of the conductor 908 while maintaining the flexibility to assist delivery and placement, which can be beneficial during laparoscopic delivery of the nerve interface 900 to the target tissue.

[0074] In other embodiments, one or both of the lead body 917 and the conductor 918 can comprise a structure or configuration for providing tension relief. Referring again to FIGS. 9B and 9C, in some embodiments, the lead body 917 can comprise tension relief wavy sections 917b that are intermittently located between linear sections 917a. Any particular lead body 917 can comprise one wavy section 917b or multiple wavy sections 917b, and the specific configuration of the wavy sections 917b can vary. The wavy sections 917a serve to divide or block large or strong movements that affect the lead body 917 into smaller, individual, or local, weaker movements.

[0075] Two examples of the wavy sections 917b are depicted in FIGS. 9B and 9C, but these examples are not limiting with respect to all possible embodiments contemplated by the present disclosure. For example, the wave can be sinusoidal, square, rectangular, helical, coiled, regular, irregular, or other shapes or combinations of shapes. The number of waves can also vary, and some wavy sections 917b can have more or fewer waves as desired or preferred for regions that receive greater or lesser tension during use. However, generally, each turn of the wave pattern serves to prevent a pressure wave from traveling a longer distance along the length of the lead body 917.

[0076] In some embodiments, the wavy sections 917b can be located near the nerve interface 900, but in other embodiments, the wavy sections 917b can be located away from the nerve interface 900 or at various points along the length of the lead body 917. The wavy sections 917b near the nerve interface 900 can serve to prevent a displacement force from reaching the nerve interface 900 and affecting its stability and placement.

[0077] In yet other embodiments, the lead body 917 can also include at least one tethering sleeve or tab 919. This configuration can vary, and in some embodiments, the tethering structure can include a sleeve or other device, but herein the term "tethering tab" is used generally. The tethering tab 919 can be located at one or more points along the lead body 917 and can be used to secure the lead body 917 to tissue, such as by suturing the tethering tab 919 to the tissue. For example, fixation of a lead anchor to the leg of a septum can be achieved with one or two permanent sutures. Reaching the right leg of the septum can be enabled by retracting the lateral segment of the left lobe of the lever, such as with a Nathanson retractor, to allow visualization of the right leg of the septum. The lead anchor can be positioned near the right leg of the septum and attached to the right leg using one or two permanent sutures.

[0078] In one embodiment depicted in FIG. 9D, the tethering tab 919 is located near the first end 901 of the spinal portion 902. In this embodiment, the lead body 917 is approximately 650 mm in length and the tethering tab 919 is coupled to the lead body 917 at approximately 200 mm from the first end 901 of the spinal portion 902. The tethering tab 919 is approximately square, 10 mm on a side. These dimensions are merely exemplary of one embodiment and can vary proportionally or otherwise in other embodiments. In some embodiments, the tethering tab 919 is located near one or more undulating sections 917b, and in one particular embodiment, the tethering tab 919 is located on each side of the undulating section 917b.

[0079] The tether tab 919 can be coupled to the lead body 917 in a variety of ways. As described above, in some embodiments, the tether tab 919 comprises a sleeve that extends around the lead body 917 and can be slidable along at least a portion of the lead body 917 (e.g., between adjacent wavy sections 917b). In other embodiments, these slidable tether tabs 919 can comprise fasteners and thus the slidable tether tabs 919 can be positioned at a desired location along the lead body 917 and then secured by the fasteners, which can include means for cinching around the lead body 917 or suture or silicone adhesive for securing and attaching at a desired location along the lead body 917. In yet other embodiments, the tether tab 919 is fixedly coupled at a specific point along the lead body 917, such as by being adhered to the lead body 917 by a silicone adhesive near the first end 910 of the neurospinal portion 902 of the nerve interface 900.

[0080] The tether tab 919 can comprise many different biocompatible materials. In one embodiment depicted in FIG. 9D, the tether tab 919 comprises a mesh material such as a coated mesh material. For example, the tether tab 919 can comprise a mesh material of polyethylene terephthalate (commercially known as DACRON) and is coated with a room temperature vulcanizable silicone dispersion Nusil MED-6605. The mesh itself can comprise a warp-knit multifilament structure and has a thickness of 140 denier, from about 0.4 mm to about 0.6 mm (such as about 0.5 mm in one exemplary embodiment), and a pore size 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, oblong, or other shape and are of a size of about 1.0 mm×about 1.1 mm. 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 covering mesh structure of the tether tab 919 can provide various advantages. First, the mesh can maximize tear resistance. By covering the mesh structure, the pores of the mesh can be partially or completely filled, thereby minimizing in-growth of tissue, which can reduce or prevent the tissue from growing into the pores of the mesh over time, which aids in the explantability of the overall tether tab 919 and the nerve interface 900 and reduces the likelihood of serious complications that may result from in-growth of tissue. The covering mesh structure of the tether tab 919 also serves to minimize or reduce the stiffness of the tether tab 919, thereby helping to improve reliability (generally, the smoother the hardness gradient at the transition from the lead body 917 to the tether structure 919, the more secure the junction, because). Also, the lower the stiffness of the tether tab 919, the easier it is to suture in place, so minimizing or reducing the stiffness also aids in surgical implantation. In addition, the covering mesh structure serves to maximize or increase the adhesion between the tether structure 919 and the lead body 917. In embodiments where the lead body 917 includes silicone, the silicone adhesive and silicone coating of the mesh of the tether structure 919 attach an anchor at a desired location, such as the right or left leg of the septum, to fix the lead and hold it in place, providing a strong bond to avoid disruption of the implantation procedure due to movement of the lead.

[0082] The first end 901 of the spinal portion 902 defines a tapered portion that tapers from a maximum outer circumference to a minimum outer circumference. In the embodiment of FIG. 9A, the maximum outer circumference occurs at points near the C-ring portions 904, 906, 908, particularly where the spinal portion 902 is at least partially coupled to the third C-ring portion 908. The minimum outer circumference occurs where the spinal portion 902 terminates along the lead body 917. The length and dimensions of the tapered portion of the first end 901 provide the benefit of reducing the stiffness gradient when transitioning from the relatively stiff spinal portion 902 to the relatively flexible lead body 917. A large stiffness gradient can lead to inadequate flexure fatigue performance and potentially cause breakage of the conductor 918 at the transition. It is advantageous for embodiments of the nerve interface 900 to provide a smoother transition in stiffness / flexibility, thereby improving the structural stability at the junction of the spinal portion 902 and the lead body 917. At the same time, tapering the first end 901 enables the positioning, placement, and insertion of the nerve interface 900 as well as each of the first C-ring portion 904, the second C-ring portion 906, and the third C-ring portion 908, and serves to improve the flexibility of this portion of the nerve interface 900 by providing sufficient flexibility to maintain a satisfactory comfort level after insertion. 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 taper 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 taper 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 presents an inclined, blunt, or rounded surface, and the spinal portion 902 extends to the outer edge of the first C-ring portion 904 on the bottom or lower side (with respect to the orientation in FIG. 9A of the paper), but terminates further rearward on the top or upper side. In other words, the spinal portion 902 has a substantially circular cross-section, and the plane parallel to this circular cross-section forms 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 a substantially flat surface, a curved surface, or a surface including both a flat portion and a curved portion. For example, in the embodiment depicted in FIG. 9A, this surface is substantially flat from the top or upper end to the vicinity of the first C-ring portion 904, and in the vicinity of the first C-ring portion 904, the surface curves downward to the first C-ring portion 904. The angles, curvatures, relative compositions, and other characteristics of the flat portion and the curved portion of this end face can vary from the example depicted in FIG. 9A. However, generally, the second end 903 includes an end face that eliminates possible pressure points when the nerve interface 900 is introduced. Thereby, the comfort of the patient can be improved, and the operability and placement of the nerve interface 900 during the introduction process can also be increased.

[0084] Between the first end 901 and the second end 903, one end of each of the first C-ring portion 904, the second C-ring portion 906, and the third C-ring portion 908 is coupled to the spinal portion 902. In the embodiment depicted in FIG. 9A, the first C-ring portion 904 and the third C-ring portion 908 are coupled to the spinal portion 902 in the same orientation, and the openings within each C-ring portion 904, 908 are on the rear side or the left side of the nerve interface 900 with respect to its orientation in the paper. The C-ring portion 906 is coupled to the spinal portion 902 in the opposite orientation, and the opening within the C-ring portion 906 is on the front side or the right side of the nerve interface 900 with respect 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 spinal portion 902 in a direction opposite to the direction of the second C-ring portion 906.

[0085] Due to the C-ring portions 904, 906, and this relative arrangement of 904, during the introduction of the nerve interface 900, it is possible for both the C-ring portions 904 and 908 to remain stationary (or move), and for the C-ring portion 906 to move (or remain stationary). Thus, the nerve interface 900 provides a simple overall profile and enables laparoscopic (i.e., minimally invasive) delivery, while at the same time providing sufficient flexibility and relative movement of the C-ring portions 904 and 908 with respect to the C-ring portion 906 to allow the nerve interface to "open" for extravascular placement and introduction. This configuration of the C-ring portions 904, 906, and 908 also increases the likelihood that the nerve interface 900 will not unexpectedly open or move to an undesirable position after introduction.

[0086] In some embodiments, each of the C-ring portions 904, 906, 908 can have a very low helix angle, i.e., pitch, with respect to the spinal portion 902, which allows the nerve interface 902 to be helical while still having a significantly shorter length. The helix angle can be about 15 to 30 degrees, although it 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, with respect to the spinal portion 902, as shown, for example, in FIGS. 9A and 13A, 13B, and 13C. Additionally, each C-ring portion 904, 906, 908 may include rounded or smooth edges and ends, thereby facilitating delivery of the nerve interface 900, reducing damage to adjacent tissue, and increasing patient comfort. In other embodiments not specifically depicted, the nerve interface 900 may include more or fewer C-ring portions, the same orientation of the junctions and apertures, an alternating orientation of the junctions and apertures, or C-ring portions having other patterns of junction of the C-ring portions and orientation of the C-ring portions, C-rings of different relative sizes, C-ring portions of different or varying helical angles, as well as other variations, including those discussed herein with respect to other embodiments.

[0088] In the embodiment depicted in FIG. 9A, each C-ring portion 904, 906, 908 of the nerve interface 900 has a substantially regular or uniform thickness along its length. In other words, considering any thickness added by the electrodes on the C-ring portion, the thickness of each C-ring portion 904, 906, 908 from the first end coupled to the spinal-like 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 a ratio of the cuff inner diameter D (see FIG. 10A) to the thickness of the C-ring portion. For example, when the ratio of diameter to thickness is 6:1 and the diameter D of the C-ring portions 904, 906, 908 is 6 mm, the exemplary thickness of each C-ring portion 904, 906, 908 can be 1 mm. In another example, when the ratio is 5.4:1 and the diameter D of the C-ring portions 904, 906, 908 is 7 mm, the exemplary thickness of each C-ring portion 904, 906, 908 can be 1.3 mm. In yet another example, when the ratio is 5.6:1 and the diameter D of the C-ring portions 904, 906, 908 is 9 mm, the exemplary thickness of each C-ring portion 904, 906, 908 can be 1.6 mm. Thus, generally, the ratio of the cuff inner diameter to the thickness of the C-ring portion can be in the range of about 5:1 to about 7:1, such as 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 in various embodiments.

[0089] As can be seen from these examples, the thicknesses of the C-ring portions 904, 906, 908 increase as the diameter increases, thereby providing similar pressures regardless of the diameter of the cuff. It will be understood by those skilled in the art that without adjusting the thickness with respect to the diameter, the pressure should be expected to decrease as the diameter increases. Also, the thickness depends on the properties (e.g., hardness) of the material used to form the C-ring portions 904, 906, 908, which also means to those skilled in the art 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 portion, the aspect ratio of the electrodes on the C-ring portion, the number of electrodes on the C-ring portion, the material used for the electrodes, and other factors. In other words, embodiments of the nerve interface 900 can be configured to apply (or maintain) a pressure to the target tissue within the C-ring portion in the range of about 0 mmHg to about 30 mmHg, such as about 0 mmHg to about 25 mmHg, or about 0 mmHg to about 20 mmHg, or about 0 mmHg to about 15 mmHg, or about 0 mmHg to about 10 mmHg, or about 0 mmHg to about 5 mmHg, or about 0 mmHg to about 2 mmHg, or about 5 mmHg to about 20 mmHg, or about 5 mmHg to about 10 mmHg, such as about 20 mmHg, or such as about 10 mmHg, or such as about 5 mmHg. This pressure can be measured at various points along the inner diameter of the nerve interface 900 and can be the average value, mean value, or median value of a plurality of values obtained at a plurality of points, or a specific value at a specific point.

[0090] In other embodiments, the thickness can vary along the length of the C-ring portion, providing another way to provide uniform pressure along the length of each C-ring portion (i.e., at each electrode). For example, referring to FIGS. 10A-10C, an end view of a nerve interface 1000 is depicted. In FIG. 10A, the thickness of the C-ring portion 1010 varies from a first thickness T1 at the first end coupled to the spinal portion 1002 to a second thickness T2 at a point opposite the spinal portion 1002, and then to a third thickness T3 at the second end. In the depicted embodiment, the thicknesses T1 and T3 are similar or the same, and the thickness T2 is the maximum or greatest thickness of the C-ring portion 1010.

[0091] In one exemplary embodiment, the thickest part of the C-ring portion (e.g., T2 in FIG. 10A) is about twice the thickness of the ends of the C-ring portion (e.g., T1 and T3 in FIG. 10A). Additionally, the thickness of the C-ring portion between electrodes can also be important. In one specific example, a 7 mm nerve interface has gaps between adjacent electrodes at 31.5 degrees and 94.5 degrees from the center of the "C", and the thicknesses of the gaps at these angles correspond 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, in FIGS. 10B and 10C, two different examples of locally thinning the C-ring portion 1010 are depicted. In other examples, the thickness of any individual C-ring portion of a particular nerve interface, such as the nerve interface 1000, can vary relative to the thickness of other C-ring portions of the same nerve interface 1000. For example, the thicknesses of the first and third C-ring portions can vary as depicted in FIGS. 10A-10C, and the thickness of the middle second C-ring portion can remain constant, particularly when not equipped with an electrode array (such as the C-ring portion 906 within the nerve interface 900 depicted in FIG. 9).

[0093] However, generally, this objective is to reduce the contact pressure on the electrode 1012 closest to the spinal portion 1002 and the electrode 1012 at the distal (open) end of the C-ring portion 1010. Within the C-ring portion having a certain thickness, these two electrodes bear most of the load. The tapered embodiment of FIG. 10A can achieve this by reducing the beam thickness of the C-ring portion that connects the two "outer" electrodes to the middle electrode. Similarly, in the C-ring portion without the electrode array, similar advantages for varying thickness and pressure management can be seen.

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

[0095] The electrodes of each electrode array 912 coupled to the conductor 918 can be coupled to the conductor 918 in various ways. In one embodiment, this coupling is achieved by welding such as laser welding. The specific configuration of the laser weld provides stress relaxation and can reduce the possibility that the relative movement of the C-ring portions 904, 906, 908 with respect to the conductor 918 causes separation or breakage of the weld. In the conventional arrangement, the wire of the conductor 918 should be welded to the electrode in a substantially orthogonal orientation as shown in FIG. 9F-1. In contrast, in the embodiments of the present disclosure, the wire of the conductor 918 is welded to the electrode in an oblique or tangential direction. This angle provides stress relaxation within the joint of the electrode to the conductor because the conductor does not need to bend or change direction suddenly at the weld point. This configuration also provides more space and surface area for the joint of the weld because the tangential angle of the weld can increase the surface area for welding.

[0096] In the embodiment of FIG. 9A, each of the electrode arrays 912 of the C-ring portion 904 and the C-ring portion 908 includes four electrodes. The first electrode is disposed at the end of each C-ring portion 904, 908 coupled to the spine-like portion 902 and is electrically coupled to the conductor 918 by the conductor wire 920. The second electrode is disposed adjacent to the first electrode and is electrically coupled to the first electrode (and thus the conductor 918) by the inter-electrode coil 922, and the inter-electrode coil 922 can be a microcoil, such as a platinum metal, a twisted cable, or a metal ribbon. An example of such a ribbon is shown in FIG. 15I, for example, as will be described in more detail later. In other embodiments, for example, in the embodiments shown in FIGS. 15A to 15H, the electrodes can be formed from a single unit. The third electrode is disposed adjacent to the second electrode on the opposite side of the second electrode with respect to the first electrode and is electrically coupled to the second electrode (and thus the conductor 918) by another inter-electrode coil 922. The fourth electrode is disposed between the third electrode and the opening of the C-ring portion and is electrically coupled to the third electrode (and thus the conductor 918) by another inter-electrode coil 922.

[0097] The individual electrodes of the electrode array 912 of the nerve interface 900 can be evenly spaced within the C-ring portions 904, 906, 908. By evenly spacing the electrodes on the C-ring portions 904, 906, 908, the distance between the electrodes becomes more uniform, providing a more uniform current density distribution and an improvement in the effectiveness of the nerve 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. Each of the specific characteristics of the nerve interface 900 can be selected for a specific application of the nerve interface 900, such as the spacing between adjacent C-ring portions 904, 906, 908, the spacing between electrode arrays 912, the spacing between the electrodes of the electrode array 912, the size and shape of the electrodes, the size, shape, and number of the electrodes within the electrode array 912, the distance between the electrodes within the electrode array 912, and the spiral angle. For example, the use of the nerve interface 900 for treatment by utilizing a target, such as the splenic artery, may require different characteristics than the use of the nerve interface 900 for the treatment of different blood vessels. For example, when utilizing splenic artery treatment (e.g., treatment provided by a nerve interface provided around the splenic artery), an electrode width in the range of about 1 mm to about 4 mm, such as a width range of about 1 mm to about 2 mm or about 2 mm to about 3 mm, may be appropriate. Different electrode widths may be desirable when utilized for treatment via different blood vessels.

[0098] The electrode coil 922 can be configured to provide electrical coupling between adjacent electrodes of the electrode array 912 while providing the desired flexibility itself and not suppressing the flexibility or conformability of the C-ring portions 904, 908. Since the coil provides flexibility due to spring characteristics that straight conductor wires do not have, the 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 a straight wire. In use, the nerve interface 900 is positioned on a pulsatile structure, and thus the electrode coil 922 is subject to a number of small bending loads. The coiled electrical coupling has better bending fatigue performance than a straight wire. 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 an exemplary embodiment, the coil pitch of the electrode coil 922 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 922 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 922 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 the exemplary ranges according to a determined relationship between these dimensions or any other dimensions or characteristics of the electrode, the C-ring portion, or the overall nerve interface.

[0099] In the embodiment depicted in FIG. 9A, no electrodes are disposed on the second C-ring portion 906, and the same number and arrangement of electrodes are disposed 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 in the electrode array 912 can vary, and more or fewer electrode arrays 912 can be used in total, or more or fewer electrodes can be disposed on any particular C-ring portions 904, 906, 908. Electrodes can be disposed 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 C-ring portion, such as those depicted on the C-ring portions 904 and 908 of FIG. 9A, can be considered a single electrode. In other words, in some contexts, the embodiment of the neural interface 900 depicted in FIG. 9A comprises two electrodes, one located on the C-ring portion 904 and one on the C-ring portion 908, and each electrode comprises a plurality (four) of electrode segments.

[0101] The electrodes can be made very thin (e.g., 25 μm to 50 μm), but cannot be made so thin that interconnecting the electrodes (which can be achieved, for example, by laser welding) 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, a “split” electrode design can provide better mechanical compliance, result in surface features, i.e., the possibility of protruding electrodes, and enable individual control of each electrode (i.e., current steering). Split electrodes provide additional flexibility to the neural interface, thereby allowing the C-ring portions to be opened wider and for a longer period of time by the deployment tool than would be possible with a single electrode without imposing excessive stress on the electrodes.

[0102] In still other embodiments, the electrodes can be configured by, or can comprise, features for improving flexibility, preventing peeling of the electrodes from the C-ring portion, and otherwise enhancing interoperability between the electrodes and the C-ring portion. For example, in embodiments where the electrodes are concave or embedded within their respective C-ring portions, these electrodes can comprise, or can be coupled to, electrode pads that are concave or embedded electrode pads within the C-ring portion. The electrode pads can comprise the same material as the electrodes, or different materials such as a material having desired properties for bonding or coupling the electrodes to the C-ring portion. In embodiments, the material of such electrode pads can vary and can be selected according to the material of the electrodes (such as platinum) and the C-ring portion (such as silicone).

[0103] Additionally or alternatively, the portion of the C-ring portion in which the electrodes (or electrode pads) are embedded can be made slightly larger than the electrodes or electrode pads so as to allow for curvature and movement of the electrodes or electrode pads when the nerve interface is introduced (i.e., when the C-ring portion undergoes its most significant deformation), but to maintain the electrodes and electrode pads in a desired position after introduction. For example, gaps can be provided within the C-ring portion at one or both ends of the electrodes or electrode pads, and the ends in FIG. 9A are the shorter two sides of the electrodes 912. In other words, the length of the recess within the C-ring portion in which the electrodes or electrode pads are disposed is longer than the length of the protruding electrodes or electrode pads themselves and serves as the exposed or contact surface (for contacting the target).

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

[0105] In addition or alternatively, the electrodes can comprise various different materials to achieve desired characteristics, such as flexibility or charge injection characteristics. For example, the electrodes can include platinum, or can be formed from an alloy of platinum and iridium, such as an alloy made from 90% platinum and 10% iridium. As an alternative or in addition, the surface of the contact electrodes can optionally be coated with PEDOT, TiNi, IrOx, PtBlack, or can be treated using a laser roughening process.

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

[0107] For example, FIG. 11A is a partial view of FIG. 9A and depicts an electrode 930 including an electrode contact 932 and an electrode flange 934. The electrode flange 934 includes at least one perforation 936A. In the depicted embodiment, the electrode flange 934 includes six perforations 936A, although in other embodiments, more or fewer perforations may be included. The perforations 936A are disposed 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 square with rounded corners or rounded short ends. In other embodiments, the perforations 936A may be disposed on short sides, on both short and long sides, or in some other configuration. The perforations 936A are equally sized and evenly spaced, although 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 FIG. 11B, the electrode flange 934 also includes six perforations 938B in this case, although the perforations 938B are round or circular, with three disposed on one short end of the electrode flange 934 and three disposed on the other short end of the electrode flange 934. The electrode flange 934 of FIG. 11B also has a rounder perimeter than the embodiment of FIG. 11A.

[0109] The embodiment depicted in FIG. 11C is similar to that of FIG. 11B, although in this embodiment, there are two perforations 936C, and both of the two perforations 936C are generally rectangular but have rounded short ends. One perforation 936C is disposed on each short end of the electrode flange 934.

[0110] The embodiment of FIG. 11D is similar to the embodiment of FIG. 11C, although the electrode flange 934 is larger and wider with respect to the electrode contact 932, and thus its corners rather than its short ends are rounded. In addition, the perforations 936D are also larger, with a length similar to that of the electrode contact 932 and a width larger than that of the perforations 936C of FIG. 11C.

[0111] FIG. 11E depicts an electrode 930 similar to that of FIG. 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] Yet another embodiment is depicted in FIG. 11F. In this embodiment, the perforation 936F comprises a cutout or aperture along the perimeter of the electrode flange 934. In other words, the perforation 936F forms notches along the long edges of the electrode flange 934.

[0113] In FIG. 11G, the electrode flange 934 extends along the central portion of each long edge of the electrode contact 932. The electrode flange 934 also includes a curved bottom edge portion 937 for additional mechanical connection between the electrode and the insulating portion or the insulating portion of the nerve interface. This curved bottom edge portion can also provide an area for an interconnect (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 of FIG. 11H is similar to the embodiment of FIG. 11G, but completely omits the perforations.

[0115] The embodiment of FIG. 11I is also similar to the embodiments of FIGS. 11G and 11H, but further includes portions of the electrode flange 934 that are located at each short end of the electrode contact 932 as compared to the embodiment of FIG. 11G, and these portions each include a round or circular perforation 936I. In addition to the round or circular perforations 936I, the curved bottom edge portion 937 also exists. In some embodiments, an interconnector for connecting the electrodes within the array can form a mechanical connection through the perforations 936I, or such an interconnector can be welded within the curved bottom edge portion 937.

[0116] In FIGS. 11J-1 and 11J-2, an embodiment of an electrode 930 with two anchors 938 is depicted, with one anchor extending from each short end of the electrode contact 932. The anchors 938 can be embedded or tethered into the silicone or other material of the C-ring portion. For example, the C-ring portion can comprise two channels, and each anchor 938 can slide within a channel. The channels and anchors 938 can be configured relative to each other such that the anchors 938 can slide within the channels while remaining engaged with the channels during positioning and bending of the C-ring portion. The embodiment of the electrode 930 shows a folded (or curved bottom) tethering perforation portion 938. For example, the insulating material of the C-ring provided around and / or through the anchors 938 and channels 936J provides improved mechanical coupling, embedding, or tethering of the electrode 930 to the insulating material of the C-ring portion.

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

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

[0119] The embodiment of FIG. 11M is similar to the embodiment of FIG. 11A, except that the perforation 936M is circular or round instead of oval or elliptical.

[0120] The embodiment of FIG. 11N is somewhat similar to the embodiment of FIG. 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 comprises a perforation 936N. The embodiment of FIG. 11N further includes a folded flange portion 934.

[0121] The embodiment of FIG. 11O has portions located at each short end of the electrode contact 932 among the electrode flanges 934, and these portions have similarities to the embodiment of FIG. 11I in that each of these portions includes a round or circular perforation 936O. However, in contrast to the embodiment of FIG. 11I, the portions located at each short end of the electrode contact 932 among the electrode flanges 934 are not continuous in the same plane from the electrode contact, but are substantially orthogonal to the electrode contact at each end.

[0122] An electrode and a lead conductor or a spring or microcoil (or any other interconnection) connecting between electrodes can be provided through the substantially round perforation 936O. In this way, since the connection part is already partially held in place by its arrangement with respect to the round perforation 936O, the stress applied to welding is reduced.

[0123] In other embodiments, still other configurations of the electrode contact 932, the electrode flange 934, and the electrode perforation 936 are also possible. For example, in various embodiments, some or all of the perforations 936 may not extend completely through the electrode flange 936. In other words, the perforation 936 can instead be regarded as a recess. In addition, in other embodiments, other shapes, sizes, positions, arrangements, features, dimensions, and other characteristics of any of the electrode contact 932, the electrode flange 934, and the electrode perforation 936 can be implemented and can be selected according to the desired application example of the specific nerve interface in which the electrode 930 is implemented.

[0124] As with other embodiments of the nerve interface depicted and discussed herein, even if not explicitly depicted in the drawings, the nerve interface 900 can also include at least one feature positioned on the outer surface of the nerve interface 900, such as on the spinal portion 902. The feature can include one or more openings or apertures for receiving a connector, such as a stylet (made of tungsten or a similar material) or a suture for releasably connecting to a deployment tab, to enable, for example, manipulating the C-ring portion or introducing the nerve interface 900. The feature can be configured to enable a deployment tool to grip, manipulate, and introduce the nerve interface 900. In one embodiment, the feature can be positioned sufficiently close to an open end of at least one of the C-ring portions 904, 906, 908 such that the deployment tool can grip the feature and simultaneously open the C-ring portion 906 relative to the C-ring portions 904 and 908. This enables the nerve interface 900 to be positioned around the target blood vessel. After the nerve interface 900 is positioned around the target blood vessel, the deployment tool can (through the operation of the physician) carefully release the feature, and thus the C-ring portions 904, 906, 908 can softly self-size to fit the target blood vessel. The configuration of the nerve interface 900 can enable the nerve interface to be positioned around a nerve or blood vessel in a single pass, reducing the manipulation of the nerve or blood vessel and reducing the dissection of the tissue around the area of the nerve or blood 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. The C-ring portions 904, 906, 908 are particularly formed from a flexible material and are arranged such that the open ends are positioned alternately, providing easy manipulation for introduction and returning to a predetermined shape even without a strong elastic snap or spring force when released. Thereby, the neural interface 900 can 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 the target blood vessel, thereby improving the effectiveness of the neural interface 900. The flexible material of the C-ring portions 904, 906, 908 can maintain compliance even when self-sized to fit the nerve or blood vessel. This can help prevent the neural interface 900 from compressing the nerve or blood vessel, causing a reduction in blood flow and other nerve fiber constrictions. This also allows for better accommodation of the radial expansion of the nerve or blood vessel resulting from post-positioning edema or swelling and can accommodate the pulsatile behavior of the intervention site such as an artery.

[0126] The naturally opening structure of the C-ring portions 904, 906, 908 of the nerve interface 900 can reduce the extent around nerves or blood vessels, facilitating more normal fluid and nutrient exchange with the intervention site and surrounding tissues. It can also help reduce the growth of connective tissue into the nerve interface 900. The open structure of the nerve interface 900 is configured such that at any point along the length of the target blood vessel, neither the terminal portion nor the central portion forms a closed circumscribing arc around the target blood vessel. In other words, in this structure, a closed circle that covers 360 degrees of the orthogonal portion of the length of the target blood vessel is not formed. However, the tip of the arm can contact the backbone of the cuff. In other words, the complete extent of the target blood vessel can be provided without passing through a closed circle. This open and unrestricted trench allows the target blood vessel to pulsate without constriction, enabling the initially inflated target blood vessel to return to its normal state over time, not constricting the target blood vessel when inflated, and functioning to maintain contact between the electrodes and the target blood vessel when the target blood vessel is in its normal state.

[0127] As described above, electrodes (e.g., the electrodes of the electrode array 912 in FIG. 9A, or those depicted and discussed herein with respect to any of the figures) can be embedded within the material of the cuff of the nerve interface. Examples of embedded electrodes are depicted in FIGS. 12A and 12B. In FIG. 12A, each electrode 1212 is at least somewhat similar to the embodiments depicted in FIGS. 11A - 11N. In FIG. 12B, each electrode 1212 is at least somewhat similar to the embodiment depicted in FIG. 11O. The level or degree of embedding between the electrodes of FIG. 12A and those of FIG. 12B can be seen, in particular, in the partial cross-sectional view of the nerve interface of FIG. 12B.

[0128] In addition, different electrode embodiments can provide different extents of effective range for each cuff of the nerve interface. This can be seen in FIG. 12C, where the electrodes of FIG. 12A (shown on the left) each provide a larger range (i.e., proportion) of the inner cuff surface than the electrodes of FIG. 12B (shown on the right). In some applications or embodiments, one or the other may be advantageous or preferable.

[0129] For example, referring again to FIGS. 13A, 13B, and 13C, different electrode embodiments can be used within nerve interfaces (or cuffs of nerve interfaces) of different sizes. FIGS. 13A, 13B, and 13C depict a smaller cuff diameter, a medium cuff diameter, and a larger cuff diameter, respectively. In addition, consistent with the above discussion herein, as the cuff diameter increases, the thickness of the cuff arm also increases. Thus, the exemplary embodiments depicted are as follows.

[0130]

Table 1

[0131] Variations in the inner diameter, arm thickness, and number of electrodes can result from maintaining the desired contact and tension of the cuff arm and electrode contact area when the diameter (and thus length) of the cuff arm decreases or increases. Thus, the inner diameter of the nerve interface device may vary, but the total electrode area of each nerve interface device is substantially equal. In addition, the electrodes of a nerve interface device with a larger inner diameter can include a smaller width and a larger length than the electrodes of a nerve interface device with a smaller inner diameter.

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

[0133] In some embodiments, the interelectrode coil (such as coil 922 in FIG. 9A) can be replaced with a continuous coil or any other continuous interconnect. Embodiments of the continuous coil are advantageous in that they can reduce the mechanical load on the welding, make the welding more reliable, and reduce the impact of any single welding failure. For example, FIG. 14A shows another embodiment of a nerve interface 1400 according to the present disclosure. The nerve interface 1400 can be similar to the nerve interfaces 100, 200, 300, 400, 900 discussed above herein, unless otherwise described herein. For example, the nerve interface 1400 can be formed from a flexible substrate of the same or similar material (i.e., silicone) and can share other features.

[0134] The nerve interface 1400 includes a spinal portion 1402, a first C-ring portion 1404, a second C-ring portion 1406, and a third C-ring portion 1408. The spinal portion 1402 includes a first end 1401 coupled to a lead 1417 that includes 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 1417 and extends within the spinal portion 1402 from the first end 1401 toward the second end 1403 and terminates at a connection to the first C-ring portion 1404. At the opposite end, the lead 1417 and the conductor 1418 are connectable via a connector to an implantable pulse generator (not shown).

[0135] The first end 1401 of the spinal portion 1402 defines a tapered portion that tapers from a maximum outer circumference to a minimum outer circumference. In the embodiment of FIG. 14A, the maximum outer circumference occurs at a point near the C-ring portions 1404, 1406, 1408, particularly where the spinal portion 1402 is at least partially coupled to the third C-ring portion 1408. The minimum outer circumference occurs where the spinal portion 1402 terminates along the lead body 1417. The length and dimensions of the tapered portion of the first end 1401 provide the benefit of reducing the hardness gradient when transitioning from the relatively rigid spinal portion 1402 to the relatively flexible lead body 1417.

[0136] The second end 1403 presents an inclined, blunt, or rounded surface, and the spinal portion 1402 extends to the outer edge of the first C-ring portion 1404 on the bottom or lower side (with respect to the orientation of FIG. 14A on the paper), but terminates further rearward on the top or upper side. In other words, the spinal portion 1402 has a substantially circular cross-section, and a plane parallel to this circular cross-section forms 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 a substantially flat surface, a curved surface, or a surface including both a flat portion and a curved portion.

[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 coupled to the spinal portion 1402.

[0138] In some embodiments, each C-ring portion 1404, 1406, 1408 can have a very low helix angle, i.e., pitch, with respect to the spinal portion 1402. The helix angle can be about 15 - 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 has no helix angle, i.e., pitch, with respect to the spinal portion 1402, for example as shown in FIG. 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 further durability of the overall neural interface 1400 by reducing the number of interconnect points required within the electrode array 1412. Using a continuous interconnect such as the continuous coil 1422 reduces the interconnect points such as weld joints 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 exists in other embodiments. This larger contact can help to 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 depending on the welding orientation shown in FIG. 9F-2, for example.

[0141] FIG. 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 crimp bushing 1430, as discussed above, helps to achieve both mechanical and electrical connections through single or multiple weld points in the bushing, rather than directly welding the continuous coil 1422 to the electrode array 1412. FIG. 14B shows how connecting the coil to the array 1412 using the bushing 1430 strengthens the connection with multiple weld points 1434 and reduces the probability that any single welding failure will result in 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 so as to promote good conductivity and stable welding. The crimp bushing 1430 fits 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 an embodiment, the bushing 1430 can be curved to conform to the curvature of at least one electrode of the electrode array 1412, thus increasing the contact between the bushing and the array and providing a larger contact point that can be a good candidate for a weld 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 (ultimately between the coil and the electrode). Also, the curvature conformity between the bushing and the array can reduce the mechanical stress on the weld that connects the bushing and the array during use. In an embodiment, 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, but not limited to, soldering, with reference to welding, crimping, brazing, wiring, or other fastening to effect electrical and mechanical connection.

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

[0144] Other embodiments are also contemplated that can achieve the advantages of the example of the continuous coil of FIG. 14A. In FIG. 14C, the nerve interface 1440 uses a long jumper coil 1442 to provide improved stress relaxation and better separation force against the weld joint (e.g., compared to the smaller interelectrode coil 922 of FIG. 9A). As shown in the inset of FIG. 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 FIG. 14C, the jumper coil is welded to the edge of the electrode, but in different variations and embodiments, the position of the weld on the electrode can be varied. As shown in more detail in FIG. 14D, the position of the weld for crimping or mounting between coils that couple one electrode to another electrode may also vary between embodiments. In an embodiment, the weld / joint position can generally be within the central portion of the electrode. In a preferred embodiment, the ratio of the gap between the electrode and the interconnector (e.g., an interconnect microcoil or an interconnect coil) is about 1:3 (i.e., the interconnector is about three times as long compared to the gap between the electrodes), or it can also be about 1:1. In a further embodiment, the ratio of the length of the gap to the interconnector can be about 1:2.

[0145] In FIG. 14D, the nerve interface 1450 uses a continuous jumper coil 1452 that is different from the continuous coil 1422 of FIG. 14A by not connecting directly to the conductor 1408 (or α-helix 1432). The continuous jumper coil 1452 can be welded directly to the electrode array 1412 or attached by other means such as a crimping bushing 1454. In FIG. 14E, the nerve interface 1460 uses a continuous twisted cable 1462 to connect to the electrode array 1412. A bushing or sleeve 1464 (which can be crimped for an interference fit or connected by other means) can be used to connect the continuous cable 1462 to the individual electrodes within the electrode array 1412. Similar to the embodiments having the continuous jumper coils discussed above, the continuous twisted cable 1462 also provides a parallel connection between the electrodes.

[0146] In practice, the continuous jumper coils 1452 coupled to each of the electrodes in the array 1412 form parallel electrical connections. Connections to the conductor 1408 are provided to each of the electrode arrays 1412, so that even 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 the desired flexibility and high flex fatigue performance. The conformability 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 an exemplary embodiment, the coil pitch of the electrode coil 1422 can be in the range of 0.05 mm to 0.3 mm, such as in the range of 0.10 mm to 0.25 mm, such as 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, such as in the range of 0.07 mm to 0.09 mm, such as 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, such as in the range of 0.3 mm to 0.5 mm, such as 0.38 mm, 0.43 mm, or 0.46 mm. In various embodiments, these dimensions can be selected from the exemplary ranges according to the determined relationships between these dimensions or other dimensions or characteristics of the electrodes, C-ring portions, or the overall nerve interface.

[0148] The crimping bushing 1430 can be crimped to its 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, is designed to be tight enough (i.e., have a small enough cross-section) during crimping to promote 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 the degree of deformation) of the coil.

[0149] In FIG. 14E, another embodiment is shown that provides a parallel electrical connection of electrodes with reduced interconnects. In this embodiment, the electrodes comprise preformed or built-in sleeves (or crimps or tunnels) for accommodating continuous interconnects (e.g., wires, strips, or coils). These built-in sleeves (or crimps or tunnels) are provided on the back side of the electrodes (the electrodes can include a surface facing the target and a rear side). After an interconnect for connecting the electrodes in the array is passed through the built-in sleeve, mechanical and electrical coupling of the sleeve and the interconnect can be achieved by crimping, welding, or at least partial filling of the sleeve with a conductive material. The size of the sleeve can be determined by the thickness of the interconnect.

[0150] In the embodiment depicted in FIG. 14A, no electrodes are disposed on the second C-ring portion 1406, and the same number and arrangement of electrodes are disposed 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 portion 1404, 1406, 1408 or in the electrode array 1412 can vary, and more or fewer electrode arrays 1412 can be used in total, or more or fewer electrodes can be disposed on any particular C-ring portion 1404, 1406, 1408. Electrodes can be disposed on one C-ring, some but not all C-ring portions, or all C-ring portions 1404, 1406, 1408. Also, as previously described in connection with other embodiments, the cuff can be used in a wireless system or the cuff can comprise more or fewer C-ring portions.

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

[0152] Similar to neural interfaces 100, 200, 300, 400, and 900, neural interface 1400 can also be self-sizing. The C-ring portions 1404, 1406, 1408 are particularly formed from a flexible material and are arranged such that the open ends are positioned alternately, providing an easy operation for introduction and returning to a predetermined shape even without a strong elastic snap or spring force when released. Thereby, neural interface 1400 can 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 the target blood vessel. The flexible material of the C-ring portions 1404, 1406, 1408 can maintain compliance even when self-sized to fit the nerve or blood vessel. This can help prevent neural interface 1400 from compressing the nerve or blood vessel, causing a reduction in blood flow and constriction of other nerve fibers. It can also better accommodate radial expansion of the nerve or blood vessel resulting from post-positioning edema or swelling and can accommodate the pulsatile behavior of the intervention site such as an artery. Accordingly, disclosed herein is a spinal-shaped portion having a first end and a second end, wherein the outer periphery of the first end of the spinal-shaped portion tapers from a maximum outer periphery to a minimum outer periphery, a spinal-shaped portion, a lead body coupled to the first end of the spinal-shaped portion and having a conductor connectable to an implantable pulse generator and at least partially extending into the spinal-shaped 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-shaped portion, and thus 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-shaped portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on the second opposite side of the spinal-shaped portion, at least three C-ring portions, and at least one electrode disposed in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0153] The nerve interface can include a plurality of electrodes disposed in at least one of at least three C-ring portions, and adjacent electrodes on the same C-ring portion are electrically coupled by an inter-electrode coil.

[0154] Each of the electrodes can include an electrode contact on an electrode flange, and the electrode flange mechanically couples the electrode to the C-ring portion and includes a plurality of perforations.

[0155] The spinal portion can have a substantially circular cross-section, and the second end of the spinal portion can have an inclined surface, and thus a plane parallel to this substantially circular cross-section forms an angle greater than 0 degrees and less than 90 degrees with the plane defined by the inclined surface.

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

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

[0158] The first C-ring portion and the third C-ring portion can be coupled to the spinal 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 spinal portion in a direction opposite to the direction of the second C-ring portion.

[0159] At least one of the at least three C-ring portions of the nerve interface can 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 end and the second end, and the third thickness is greater than the first thickness and the second thickness.

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

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

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

[0163] The plurality of perforations in the electrode flange of the nerve interface can 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.

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

[0165] Each of the plurality of perforations in the electrode flange of the nerve interface can be square with rounded corners.

[0166] The nerve interface can include at least one anchoring tab coupled to the lead body.

[0167] The at least one anchoring tab can include a coating mesh.

[0168] The lead body can include at least one wavy section.

[0169] The nerve interface is to provide a spinal - shaped portion having a first end and a second end, wherein the outer periphery of the first end of the spinal - shaped portion tapers from a maximum outer periphery to a minimum outer periphery; to couple a lead body to the first end of the spinal - shaped portion, wherein a conductor of the lead body connectable to an implantable pulse generator extends at least partially into the spinal - shaped portion; to couple at least three C - ring portions to the spinal - shaped 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 coupled to the spinal - shaped portion, and thus 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 - shaped portion, and the second end of the second C - ring portion disposed between the first C - ring portion and the third C - ring portion is on the second opposite side of the spinal - shaped portion; and to form by disposing at least one electrode on each of the at least three C - ring portions and electrically coupling the at least one electrode to the conductor.

[0170] The nerve interface can further comprise a plurality of electrodes on 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.

[0171] Each of the electrodes can comprise an electrode contact on an electrode flange, and the electrode flange mechanically couples the electrode to the C - ring portion and has a plurality of perforations.

[0172] The method can further include forming the spinal - shaped portion to have a substantially circular cross - section and forming the second end of the spinal - shaped portion to have an inclined surface, and thus a plane parallel to this substantially circular cross - section forms an angle greater than 0 degrees and less than 90 degrees with respect to a plane defined by the inclined surface.

[0173] Forming the nerve interface can also include forming at least one of at least three C-ring portions such that it has a first thickness at a first end, a second thickness at a second end, and a third thickness at a point between the first end and the second end, the third thickness being greater than the first thickness and the second thickness.

[0174] In another embodiment, the nerve interface comprises a spinal-like portion having a first end and a second end, a conductor coupled to the first end of the spinal-like portion and connectable to an implantable pulse generator, a lead extending at least partially into the spinal-like portion from the first end towards the second end, 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 spinal-like portion, such that the second end of the first C-ring portion and the second end of the third C-ring portion are on a first side of the spinal-like portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on a second opposite side of the spinal-like portion, each C-ring portion having an inner diameter and a thickness, the ratio of the inner diameter to the thickness being in the range of 5:1 to 6:1, at least three C-ring portions, and at least one electrode disposed in at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0175] In yet another embodiment, the nerve interface comprises a spinal-like portion having a first end and a second end, a conductor coupled to the first end of the spinal-like portion and connectable to an implantable pulse generator, a lead extending at least partially into the spinal-like portion from the first end towards 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-like portion, such 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-like portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on the second opposite side of the spinal-like portion, each C-ring portion being configured such that a pressure in the range of about 0 mmHg to about 30 mmHg is applied to a target tissue disposed within the C-ring portion during use, and at least one electrode disposed within at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0176] FIG. 15A shows an example of an electrode assembly of the C-ring portion 1510 according to one embodiment. In the simplest embodiment, the C-ring portion 1510 can include a metal foil strip or ribbon 1512, and electrodes (not shown) are formed on the metal foil strip 1512. To provide flexibility within a single electrode array 1512, in some embodiments, the foil strip 1512 can be cut or formed such that a mesh connector is cut out within the foil strip 1512 to form a flexible foil 1514. The apertures cut out within the foil 1514 reduce the cross-sectional area of the foil in regions other than the welding or crimping sites, so the flexible foil 1514 has higher flexibility than the metal foil strip 1512. As a result of these reduced cross-sectional areas, increased flexibility for introduction is provided, and a single (or integral) electrode array is provided with no additional connections between the electrodes. In other words, a non-welded interconnect (i.e., no welding is used to provide a connection between two electrodes within the array) electrode array is provided. For further stress relief, a longer (along the strip) section having a reduced surface area can be provided. Although there is no welding between the electrodes, in some embodiments, welding may be required for connection to the leads.

[0177] As shown in the lower row of FIG. 15A, a specific portion 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 (e.g., as shown in FIG. 15D or FIG. 15H). The active electrode surface 1542 can also be roughened with a laser to provide electrodes 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 the C - ring portion formed in the same manner as the C - ring portion 1510 shown in Figure 15A. In an embodiment, a radial punching or other forming method can also provide additional curvature in the z - axis within a section of reduced width in order to provide additional stress relaxation (for example, similar to the interconnection of ribbons). The regions of reduced width in exemplary embodiments 1520, 1530 can increase flexibility and reduce the required material.

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

[0180] Figures 15E - 15H depict various ways of an embodiment 1550 of the serpentine portion, similar to those discussed above in relation to the exemplary C - rings 1520, 1530 of Figures 15A - 15C. The serpentine portion between the electrodes provides another electrode array without additional welding, and the serpentine portion is another form that realizes a reduction in the cross - sectional surface area for additional flexibility within the portion between the electrodes. In an embodiment, the serpentine 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 - 15H provide interconnection means that do not require the use of welding or other non - integral joining means between the electrodes. In other words, this is a single - piece embodiment.

[0182] FIG. 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 spot welds 1564 across each gap between the electrodes to effect spring formation by the ribbon. Welding of platinum to platinum can provide additional weld strength compared to welding of mixed materials. The curvature within the ribbon 1562 can provide flexibility that acts as a stress relief when the cuff is “opened” for implantation or removal. A completely flat or straight ribbon can induce a larger stress or load at a single point, whereas the curvature absorbs some of the stress or load that would otherwise be applied to the weld. In addition, a straight interconnection can cause plastic deformation, such as permanent “wrinkles” in the material, which can lead to easier breakage. The embodiment shown in FIG. 15I can provide a simplified weld configuration compared to some of the surface-rich coil-based embodiments for welding, such as multiple welding or edge welding, depending on the material composition.

[0183] Furthermore, as disclosed herein, the system includes a nerve interface as described in any of the embodiments disclosed above herein, and a lead cap device having a first end and a second end, the lead cap device including a body defining an internal cavity extending from the first end toward the second end, a set screw block disposed within the body such that the set screw intersects the internal cavity, and a suture loop coupled to the second end, the lead cap device configured to removably receive a portion of a lead body within the internal cavity and to fix the portion of the lead body within the internal cavity by the set screw, and 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, the tab-shaped body further including a series of root portions and grooves, the deployment tool configured to be removably coupled to the nerve interface by a suture thread that can be passed through at least one of the first aperture and the plurality of sets of small holes by the second aperture and the third aperture.

[0184] The nerve interface can include 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 configured to apply or maintain a pressure within a range of 0 mmHg to 30 mmHg to a target tissue disposed within the C-ring portion and including at least one electrode disposed within the at least one C-ring portion and electrically coupled to the conductor. In the nerve interface, the at least one C-ring portion has an inner diameter and a cross-sectional thickness, and the ratio of the inner diameter to the cross-sectional thickness is within a range of 5:1 to 6:1. In an embodiment, this ratio can vary widely. For example, in a thin film embodiment, 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 can comprise an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to a C-ring portion and comprising a plurality of perforations. The electrode flange can be square-shaped with rounded corners. The electrode flange can comprise a curved bottom edge. The plurality of perforations can 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 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. Each of the plurality of perforations can be square-shaped with rounded corners. The lead body can comprise at least one strain-relieving corrugated section.

[0186] In an embodiment, the nerve interface can further comprise a spinal-shaped portion having a first end and a second end, the outer perimeter of the first end of the spinal-shaped portion tapering from a maximum outer perimeter to a minimum outer perimeter, the lead body being coupled to the first end of the spinal-shaped portion and extending at least partially within the spinal-shaped portion. The spinal-shaped portion can have a substantially circular cross-section, the second end of the spinal-shaped portion can have an inclined surface, and thus a plane parallel to this substantially circular cross-section forms an angle greater than 0 degrees and less than 90 degrees with respect to a plane defined by the inclined surface. The maximum outer perimeter of the first end of the spinal-shaped portion can be located in the vicinity of at least three C-ring portions, and the minimum outer perimeter of the first end of the spinal-shaped portion can occur where the spinal-shaped portion terminates on the lead body. The distance between the maximum outer perimeter and the minimum outer perimeter is in the range of 2 mm to 5 mm.

[0187] In an embodiment, the nerve interface can further include 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 the spinal-like portion, and thus the second end of the first C-ring portion and the second end of the third C-ring portion being on the first side of the spinal-like portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion being on the second opposite side of the spinal-like portion. The first C-ring portion and the third C-ring portion can be coupled to the spinal-like portion so as to move together relative to the second C-ring portion, and the first C-ring portion and the third C-ring portion can extend from the spinal-like 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 has a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first end and the second end, and the third thickness can be greater than the first thickness and the second thickness. The thickness of at least one of the at least three C-ring portions gradually increases between the first end and a point between the first end and the second end. The thickness of at least one of the at least three C-ring portions gradually increases between the second end and a point between the first end and the second end.

[0188] The nerve interface can further include a plurality of electrodes disposed on 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.

[0189] The nerve interface can further include at least one tether tab coupled to the lead body. The at least one tether tab can include 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 further the tether tab can be provided between the first end and the second end 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 intermediate between the first and second ends of the lead body. 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 can be 1:1 to 1:50, optionally 1:2, 1:3, 1:4, or 1:5. The mooring tab can be movable along the lead body.

[0192] The lead body can include further flexibility in a portion closer to the C-ring portion as compared to a portion of the lead body further away from the C-ring portion.

[0193] In one embodiment, the system comprises a neural interface according to any of the embodiments, configurations, or combinations described hereinabove, and a deployment tool removably attachable to the neural interface for introduction of the neural interface. The deployment tool can comprise a first region configured to be positioned near the neural interface, and a connector for releasably coupling the first region to the neural interface, moored to the first region. The deployment tool can have a planar shape or a triangular shape.

[0194] In an embodiment, the deployment tool can further comprise a second region and a central region between the first and second regions. The first region can be wider than the second region.

[0195] A cut 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 can further comprise 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.

[0197] The connector can be a suture tethered to a first region for holding near an implantable device by passing at least one passage from a second opening to a first opening.

[0198] The deployment tool can further comprise a cuttable portion extending across at least one passage, the cuttable portion being configured to release at least a portion of the connector within the at least one passage when the cuttable portion is cut, and release of at least a portion of the suture enables the first region to move away from the implantable device.

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

[0200] The at least one passage can include a first passage and a second passage, the first portion passes through the first passage, and the third portion passes through the second passage.

[0201] At least the first region and the second region can include rounded edges.

[0202] The severable portion can be a recessed area within a central region extending across at least the first passage and the second passage. The recessed area within the central region can extend across only a portion of the width of the central region, such that when the recessed area is severed to release the connector, at least a portion of the central region is not severed into two pieces. The recessed area can extend across the entire width of the central region, such that when the recessed area is severed to release the connector, the central region is severed into two pieces. At least the central region can include a series of alternating lateral ridges and lateral valleys extending across the width of the central region to provide longitudinal flexibility to allow the deployment tool to be wound up while providing lateral stiffness when the deployment tool is expanded. The first region and the second region include alternating lateral ridges and lateral valleys extending across the width of the first region and the width of the second region. At least one passage can be formed by a tunnel through each lateral ridge and a tube across each lateral valley. The severable portion can be a lateral valley. The connector can be anchored to the first region by being molded into the first region. The connector can be anchored to the first region by adhesion. The first region, the second region, and the central region can be molded from silicone. At least the second region can taper towards the second opening. The tapered second region can include a gripping point for manipulation. The gripping point includes an opening.

[0203] The deployment tool can include a first surface and a second surface opposite the first surface, the first surface providing an indication of the location of the severable portion and the second surface including a plurality of longitudinal grooves along the length of the deployment tool to reduce contact.

[0204] At least the second region and the central region can taper, the first portions of the plurality of longitudinal grooves can extend from the first region to the second region through the central region, and the second portions of the plurality of longitudinal grooves can extend from the first region to the central region. The second region can taper towards the central region from the edge of the second region with respect to its thickness. The thickness can increase from the edge of the second region towards the central region. The second region can have a rounded edge.

[0205] The nerve interface can be a cuff comprising a backbone and at least two curved arms extending from the backbone and having electrodes, and each open end of the curved arms is removably coupled to a deployment tool.

[0206] The nerve interface can comprise a first arm moved in a first direction and one or more second arms moved in a second direction substantially opposite to the first direction, and the second portion of the connector can be removably attached to the one or more second arms. The one or more second arms can include two arms positioned on both sides of the first arm, one of the two arms being aligned with the first opening of the first passage and the other of the two arms being aligned with the first opening of the second passage. The one or more second arms can include a first small hole, the other arm can include a second small hole, and the second portion of the connector can be removably attached to the cuff by passing through the first small hole and the second small hole so as to hold the first region near the cuff, and then, when at least one of the first portion or the third portion is cut by a cuttable portion, the second portion of the connector can be pulled away from the cuff. The thickness of the central region of the tab can be equal to or greater than the thickness of the nerve interface. The one or more second arms can have an arm height in a direction orthogonal to both the width and the length of the tab, the central region has a height running substantially parallel to the arm height, and the height of the central region is greater than the arm height. The width of the first region of the tab is equal to or greater than the width of the nerve interface.

[0207] The cuff can have a width measured from the outside of one arm to the outside of the other arm, this width running substantially parallel to the width of the first region, the width of the first region being greater than the width of the cuff.

[0208] The deployment tool can be configured as a measurement tool for measuring the fit of the nerve interface to the target. The measurement of the fit can be determined based on the distance between the root or groove or valley of the deployment tool. The measurement of the fit can be determined based on the distance between the first part and the second part of the deployment tool.

[0209] The system can further comprise a lead cap device having a first end and a second end, a body defining an internal cavity extending from the first end towards the second end, a set screw block disposed within the body such that the set screw intersects the internal cavity, 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 and fix a 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 can comprise a set comprising a plurality of nerve interface devices according to any of the embodiments discussed or disclosed herein, the inner diameters of the nerve interface devices being different, but the total electrode area of each nerve interface device being substantially equal. The electrodes of the nerve interface device with a larger inner diameter can include a smaller width and a larger length than the electrodes of the nerve interface device with a smaller inner diameter.

[0211] In some embodiments, a neural interface includes a spinal-like portion, a conductor at least partially disposed within the spinal-like portion, and 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-like portion, such that the second end of the first C-ring portion and the second end of the third C-ring portion are on a first side of the spinal-like portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on a second opposite side of the spinal-like portion, at least three C-ring portions, 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 within 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, a neural interface includes a spinal-like portion having a first end and a second end, wherein an outer periphery of the first end of the spinal-like portion tapers from a maximum outer periphery to a minimum outer periphery, a conductor coupled to the first end of the spinal-like portion and comprising a lead body connectable to an implantable pulse generator and extending at least partially into the spinal-like portion, and 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-like portion, such that the second end of the first C-ring portion and the second end of the third C-ring portion are on a first side of the spinal-like portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on a second opposite side of the spinal-like portion, at least three C-ring portions, and at least one electrode disposed in at least one of the at least three C-ring portions and electrically coupled to the conductor.

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

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

[0215] In yet another embodiment, a nerve interface includes a spinal-like portion having a first end and a second end, a conductor coupled to the first end of the spinal-like portion and connectable to an implantable pulse generator, a lead extending at least partially into the spinal-like 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-like portion, such that the second end of the first C-ring portion and the second end of the third C-ring portion are on a first side of the spinal-like portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on a second, opposite side of the spinal-like portion, each C-ring portion being configured such that a pressure in the range of about 0 mmHg to about 30 mmHg during use is applied to a target tissue disposed within the C-ring portion, and at least one electrode disposed within at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0216] In a further embodiment, a system can include a nerve interface of any of the embodiments disclosed herein, a lead cap device having a first end and a second end, the body defining an internal cavity extending from the first end toward the second end, a set screw block disposed within the body such that a set screw intersects the internal cavity, and a suture loop coupled to the second end, the lead cap device configured to removably receive a portion of a lead within the internal cavity and to secure the portion of the lead within the internal cavity with the set screw, a deployment tool having 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, the tab-shaped body further comprising a series of tails and grooves, the deployment tool being removably coupleable to the nerve interface by a suture thread that can pass through at least one of the first aperture and the plurality of sets of small holes.

[0217] In addition to, or alternatively to, the above, examples consistent with the present teachings are described in the sections numbered below.

[0218] The features and components of the different embodiments discussed herein can be combined in other embodiments. Additionally, the 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, lead features designed to reduce strain can be used in various other types of devices where lead strain can be a problem. In another example, the configuration of components for laser welding can be applicable in other types of devices and structures. How the further other features and components discussed herein can be used with other devices and systems in other applications and methods will be understood by those skilled in the art. In this way, specific effects can be designed and realized to meet particular desires or needs in the art. The 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 plus or minus 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. Further, it should be understood that the various features of the described embodiments can be combined in various ways to create numerous additional embodiments. Additionally, although various materials, dimensions, shapes, configurations, and locations, etc. have been described for use with the disclosed embodiments, other than those disclosed can also be utilized without exceeding the scope of the claimed invention.

[0220] It will be understood by those skilled in the art that the subject matter of the present invention can include fewer features than those shown in any of the individual embodiments described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter of the present invention can be combined. Thus, as will be understood by those skilled in the art, these embodiments are not combinations of mutually exclusive features, and the various embodiments can include combinations of different individual features selected from different individual embodiments. Further, unless otherwise stated, elements described with respect to one embodiment can be practiced in other embodiments even when not described in such embodiments.

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

[0222] The applicant incorporates by reference the content of the previously filed PCT application published as WO2019 / 020986. In particular, the electrodes described herein can be replaced with the coil electrodes described in that application. Any incorporation by reference of the above documents is limited so that no subject matter conflicting with the explicit disclosure herein is incorporated. Any incorporation by reference of the above documents is further limited so that the claims contained in these documents are not incorporated herein by reference. Any incorporation by reference of the above documents is further limited so that any definitions provided in these documents are not incorporated herein by reference unless explicitly included herein.

[0223] For the purpose of describing the claims, it is expressly intended that the provisions of 35 U.S.C. 112(f) shall not be triggered unless the specific terms "means for" or "step for" are recited in the claims.

Claims

1. Comprising at least one C-ring portion, wherein the at least one C-ring portion applies a radial pressure within the range of 1 mmHg to 30 mmHg to a target tissue disposed within the C-ring portion, and comprising at least one electrode disposed on the at least one C-ring portion. A nerve interface.

2. Further comprising a lead body having a conductor connectable to an implantable pulse generator, wherein the at least one electrode is electrically coupled to the conductor. The nerve interface according to claim 1.

3. The C-ring portion is 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 the at least one electrode, The size and shape of the at least one electrode, The number of the electrodes, The ratio of the electrodes compared to the insulating material of the C-ring portion, The gap size between two electrodes among the at least one electrode, The characteristics of the interconnection between different electrodes among the at least one electrode, The thickness of the c-ring material, and Applying a radial pressure based on one or more of the group including the diameter of the nerve interface. The nerve interface according to claim 1.

4. The at least one C-ring portion has an inner diameter and a cross-sectional thickness, and the ratio of the inner diameter to the cross-sectional thickness is within the range of 5:1 to б:

1. The nerve interface according to claim 1.

5. The at least one electrode comprises an electrode contact on an electrode flange, and the electrode flange mechanically couples the electrode to the C-ring portion and comprises a plurality of perforations. The nerve interface according to any one of claims 1 to б.

6. The electrode flange is square with rounded corners. The nerve interface according to any one of claims 1 to 5.

7. The electrode flange comprises a curved bottom edge. The nerve interface according to any one of claims 1 to 6.

8. The plurality of perforations includes 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 nerve interface according to any one of claims 1 to 7.

9. The nerve interface according to any one of claims 1 to 8, wherein the first side portion of the electrode flange and the second opposite side portion of the electrode flange are longer than the third side portion and the fourth side portion of the electrode flange.

10. The nerve interface according to any one of claims 1 to 9, wherein each of the plurality of perforations is square with rounded corners.

11. The nerve interface according to claim 2, wherein the lead body includes at least one tension-relieving wavy section.

12. Further comprising a spinal-shaped portion having a first end and a second end, wherein the outer periphery of the first end of the spinal-shaped portion tapers from a maximum outer periphery to a minimum outer periphery, the lead body is coupled to the first end of the spinal-shaped portion and extends at least partially into the spinal-shaped portion, The nerve interface according to claim 2 or 11.

13. The nerve interface according to any one of claims 1 to 12, wherein the spinal-shaped portion has a substantially circular cross-section, and the second end of the spinal-shaped portion has an inclined surface, such that a plane parallel to the substantially circular cross-section forms an angle greater than 0 degrees and less than 90 degrees with respect to the plane defined by the inclined surface.

14. The nerve interface according to claim 12 or 13, wherein the maximum outer periphery of the first end of the spinal-shaped portion is in the vicinity of the at least three C-ring portions, and the minimum outer periphery of the first end of the spinal-shaped portion occurs at the location where the spinal-shaped portion terminates on the lead body.

15. The nerve interface according to any one of claims 12 to 14, wherein the distance between the maximum outer periphery and the minimum outer periphery is in the range of 2 mm to 5 mm.

16. Further comprising at least two additional C-ring portions, each C-ring portion having a first end and a second end, and the first end of each C-ring portion being coupled to the spinal-shaped portion, such 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-shaped portion, and the second end of the second C-ring portion disposed between the first C-ring portion and the third C-ring portion is on the second opposite side of the spinal-shaped portion, The nerve interface according to any one of claims 12 to 15.

17. The first C-ring portion and the third C-ring portion are coupled to the spinal-like portion such that both move relative to the second C-ring portion, and the first C-ring portion and the third C-ring portion extend from the spinal-like portion in a direction opposite to the direction of the second C-ring portion, the nerve interface according to claim 16.

18. At least one of the at least three C-ring portions has a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first end and the second end, the third thickness being greater than the first thickness and the second thickness, the nerve interface according to claim 16 or 17.

19. The thickness of at least one of the at least three C-ring portions gradually increases between the first end and the point between the first end and the second end, the nerve interface according to any one of claims 16 to 18.

20. The thickness of at least one of the at least three C-ring portions gradually increases between the second end and the point between the first end and the second end, the nerve interface according to any one of claims 16 to 19.

21. The nerve interface according to any one of claims 16 to 20, further comprising a plurality of electrodes disposed in at least one of the at least three C-ring portions, adjacent electrodes on the same C-ring portion being electrically coupled by an interelectrode coil.

22. The nerve interface according to any one of claims 1 to 21, further comprising at least one anchoring tab coupled to the lead body.

23. The nerve interface according to claim 22, wherein the at least one anchoring tab comprises a covering mesh, and optionally the mesh is coated with a material filling the mesh.

24. 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 further the anchoring tab is provided between the first end and the second end of the lead body, the nerve interface according to claim 22 or 23.

25. The tether tab is provided between the first end of the lead body and the central portion of the lead body located intermediate between the first end and the second end of the lead body, and further, a ratio of a distance between the first end of the lead body and the tether tab to a distance between the second end of the lead body and the tether tab is between 1:1 and 1:50, optionally 1:2, 1:3, 1:4, or 1:

5. The nerve interface according to claim 24.

26. The tether tab is movable along the lead body. The nerve interface according to any one of claims 22 to 25.

27. The lead body has higher flexibility in a portion closer to the C-ring portion than in a portion farther from the C-ring portion of the lead body. The nerve interface according to any one of claims 1 to 26.

28. A plurality of electrodes are electrically connected in parallel. The nerve interface according to any one of claims 1 to 27.

29. The conductor includes a single continuous coil electrically coupled to a plurality of electrodes located in one of the C-ring portions. The nerve interface according to any one of claims 1 to 28.

30. The single continuous coil includes conductive bushings corresponding to each electrode. The nerve interface according to claim 29.

31. The conductive bushings are crimped for mechanical and electrical connection with the single continuous coil, and each crimped bushing is configured to be welded to a corresponding electrode so that the coil is electrically connected to the electrode. The nerve interface according to claim 30.

32. The electrode includes a built-in sleeve for accommodating the single continuous coil. The nerve interface according to claim 28 or 29.

33. A nerve interface according to any one of claims 1 to 32, a deployment tool removably attachable to the nerve interface for introduction of the nerve interface, and a system comprising the same.

34. The deployment tool is configurable as a measurement tool for measuring a fit of the nerve interface to a target. The system according to claim 33.

35. The deployment tool is configured to function as a blunt dissection tool. The system according to claim 33 or 34.

36. The system according to any one of claims 33 to 35, wherein the thickness of the deployment tool is greater than the thickness of the C-ring portion of the nerve interface.

37. The system according to any one of claims 33 to 35, wherein the width of the deployment tool is greater than the width of the nerve interface.

38. The system according to any one of claims 33 to 37, further comprising 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 towards 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.

39. The system according to claim 38, 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 disposed within the body such that a set screw intersects the internal cavity, the set screw being configured to fix the portion of the lead body within the internal cavity.

40. A system comprising a set of a plurality of nerve interface devices according to any one of claims 1 to 27, wherein the inner diameters of the nerve interface devices are different, but the total electrode area of each nerve interface device is substantially equal.

41. The system according to claim 41, wherein the electrodes of the nerve interface device with a larger inner diameter include a smaller width and a larger length than the electrodes of the nerve interface device with a smaller inner diameter.

42. The system according to any one of claims 33 to 41, wherein the deployment tool is positioned within the C-ring portion of the nerve interface.

43. The system according to claim 42, wherein the deployment tool is at least partially wound within the nerve interface.

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