Electrode Devices and Related Methods for Neuromodulation

Abstract

In embodiments, a neural interface comprising at least one C-ring portion can be used to apply pressure in the range of 1 mmHg to 30 mmHg to target tissue disposed within the C-ring portion, the neural interface comprising at least one electrode disposed on the at least one C-ring portion.

Description

[Technical field]

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

[0002] Electrical devices of various shapes and sizes, including one or more electrodes, have been used for neural stimulation / neuromodulation of target anatomical tissue. Summary of the Invention [Problem to be solved by the invention]

[0003] Conventional designs lack radial flexibility and self-sizing capabilities. If the target vessel is overly compressed by the device, nerve damage may occur due to reduced blood flow and pinching of nerve fibers. The effect of device positioning may cause temporary expansion of the target vessel, which may exacerbate such nerve damage. In contrast, a loosely pinched device may result in poor electrical contact, reducing treatment efficiency, and the device may further deteriorate over time as a result of ingrowth of connective tissue between the target vessel and the device. [Means for solving the problem]

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

[0005] The neural interface may further include a lead body comprising a conductor connectable to an implantable pulse generator, and the at least one electrode is electrically coupled to the conductor. The C-ring portion may apply radial pressure based on the stiffness of the insulating material comprising the body of the C-ring portion, the thickness of the insulating material comprising the body of the C-ring portion, the stiffness of the at least one electrode, the size and shape of the 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 the at least one electrode, the characteristics of the interconnections between different electrodes of the at least one electrode, the thickness of the C-ring material, and the diameter of the neural interface. The C-ring portion may have an inner diameter and a cross-sectional thickness, and the ratio of the inner diameter to the cross-sectional thickness is within the range of 5:1 to 6:1. The electrode may include an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to the C-ring portion and comprising a plurality of perforations. The electrode flange may be rectangular with rounded corners. The electrode flange may include a curved bottom edge. The plurality of perforations may include at least one perforation in a first side of the electrode flange and at least one perforation in a second opposite side of the electrode flange. The first side of the electrode flange and the second opposite side of the electrode flange may be longer than the third side and the fourth side of the electrode flange. The plurality of perforations may be square with rounded corners. The lead body may include at least one strain relief corrugated section.

[0006] The neural device may include a spine-like portion having a first end and a second end, the circumference of the first end of the spine-like portion tapering from a maximum circumference to a minimum circumference, and the lead body may be coupled to the first end of the spine-like portion and extend at least partially into the spine-like portion. The spine-like portion may have a substantially circular cross-section, and the second end of the spine-like 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 the plane defined by the inclined surface. The maximum circumference of the first end of the spine-like portion may be found in the vicinity of at least three C-ring portions, and the minimum circumference of the first end of the spine-like portion occurs where the spine-like portion terminates on the lead body. The distance between the maximum circumference and the minimum circumference may be in the range of 2 mm to 5 mm.

[0007] The neural interface may include at least two further C-ring portions, each C-ring portion having a first end and a second end, the first end of each C-ring portion being coupled to the spine-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 spine-like portion and the second end of the second C-ring portion disposed between the first and third C-ring portions is on a second opposite side of the spine-like portion. The first and third C-ring portions may be coupled to the spine-like portion for movement together relative to the second C-ring portion, the first and third C-ring portions extending from the spine-like portion in a direction opposite to that of the second C-ring portion. At least one of the C-ring portions may have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first and second ends, the third thickness being greater than the first and second thicknesses. A thickness of any of the C-ring portions can gradually increase between the first end and a point between the first end and the second end. At least one of the at least three C-ring portions can have a plurality of electrodes disposed thereon, with adjacent electrodes on the same C-ring portion being electrically coupled by an inter-electrode coil.

[0008] The neural interface may include at least one tethering tab coupled to the lead body. The tethering tab may include a covering mesh, optionally the mesh is covered by a material that fills the mesh. A C-ring portion may be provided at a first end of the lead body, a connector to an implantable pulse generator (IPG) may be provided at a second end of the lead body, and the tethering tab may be provided between the first end and the second end of the lead body. The tethering tab may be provided between the first end of the lead body and a central portion of the lead body located midway between the first end and the second end of the lead body, and a ratio of the distance between the first end of the lead body and the tethering tab to the distance between the second end of the lead body and the tethering tab is 1:1 to 1:50, optionally 1:2, 1:3, 1:4, or 1:5. The tethering tab may be movable along the lead body. The lead body may have more flexibility in a portion of the lead body 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, a system includes the neural interface described above and a deployment tool removably coupleable to the neural interface for introduction of the neural interface. The deployment tool can include a first section configured to be positioned near the neural interface and a connector anchored to the first section for releasably coupling the first section 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 section and a central section between the first section and the second section. The first section can be wider than the second section. A cut through the deployment tool can cut the connector and release the coupling between the deployment tool and the neural interface such that at least the first section moves away from the neural interface device. The deployment tool can further include at least one passageway extending from the first section to the second section through the central section, each passageway including a first opening in the first section and a second opening in the second section. The connector can be a suture anchored to the first section for passing through the at least one passage from the second opening to the first opening to hold the first section near the implantable device. The deployment tool can further include a cuttable portion extending across the at least one passage configured to release at least a portion of the connector in the at least one passage when the cuttable portion is cut, wherein release of the at least a portion of the suture allows the first section to move away from the implantable device.

[0010] The connector can include a first portion passing through at least one passage from the second opening to the first opening, the connector includes a second portion removably attached to the implantable device, and the connector includes a third portion passing through at least one passage from the first opening to the second opening, the first portion being connected to the second portion and the second portion being connected to the third portion. The system can include both a first passage and a second passage, the first portion passing through the first passage and the third portion passing through the second passage. The first and second regions can include rounded edges. The cuttable portion can be a recessed region in the central region that extends across at least the first and second passages. The recessed region in the central region can extend across only a portion of the width of the central region, such that when the recessed region 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 area, so that when the recessed area is cut to release the connector, the central area is cut into two pieces. The central area can include a series of alternating lateral ridges and valleys extending across the width of the central area to provide lateral stiffness when the deployment tool is unfolded while providing longitudinal flexibility to allow the deployment tool to be rolled up. The first area and the second area can include alternating lateral ridges and valleys extending across the width of the first area and the width of the second area. The passageway 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 anchored to the first area by molding to the first area. The connector can be anchored to the first area by gluing. The first area, the second area, and the central area can be molded from silicone. The second section can taper towards the second opening. The tapered second section can include a gripping point for manipulation, and the gripping point can include the 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 section and the central section can be tapered, a first portion of the plurality of longitudinal grooves can extend from the first section to the second section through the central section, and a second portion of the plurality of longitudinal grooves can extend from the first section to the central section. The second section can taper in thickness from an edge of the second section toward the central section. The thickness can increase from an edge of the second section toward the central section. The second section can include rounded edges.

[0011] The neural interface may be a cuff including a spine and at least two curved arms extending from the spine and carrying an electrode, each open end of the curved arms being removably coupled to a deployment tool. The neural interface may include a first arm moved in a first direction and one or more second arms moved in a second direction substantially opposite the first direction, and the second portion of the connector is removably attached to the one or more second arms. The second arms may include two arms positioned on either side of the first arm, one of the two arms aligned with the first opening of the first passageway and the other of the two arms aligned with the first opening of the second passageway. The second arm may include corresponding eyelets, and the second portion of the connector may be removably attached to the cuff by passing through the first and second eyelets to hold the first section close to the cuff, and then the second portion of the connector may be pulled away from the cuff when at least one of the first or third sections is cut at the cuttable portion. The thickness of the central section of the tab may be equal to or greater than the thickness of the neural interface. The second arm may have an arm height in a direction perpendicular to both the width and length of the tab, the central section having a height running substantially parallel to the arm height, the height of the central section being greater than the arm height. The width of the first section of the tab may be equal to or greater than the width of the neural interface. The cuff may have a width measured from the outside of one arm to the outside of the other arm, the width running substantially parallel to the width of the first section, the width of the first section being greater than the width of the cuff. The deployment tool may be configurable as a measurement tool for measuring the fit of the neural interface to a target. The fit measurement can be determined based on a distance between ridges or grooves or valleys of the deployment tool. The fit measurement can be determined based on a distance between a first portion of the deployment tool and a 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 a thickness of the C-ring portion of the neural interface.The width of the deployment tool may be greater than the width of the neural interface.

[0012] The deployment tool can be positioned within the C-ring portion of the neural interface. The deployment tool can be at least partially coiled within the neural interface, e.g., within the C-ring portion. Thus, the deployment tool can be configured to secure the electrodes within the C-ring portion until introduction of the neural interface.

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

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

[0015] In one embodiment, the system comprises a neural interface as disclosed herein, including those described in the previous paragraph, and a deployment tool removably coupleable to the neural interface for introduction of the neural interface.

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

[0017] The anchoring tabs can be as disclosed herein, including as described in any of the preceding paragraphs describing anchoring tabs. The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter. The figures and detailed description that follow more particularly exemplify various embodiments.

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

[0019] [Figure 1] FIG. 1 is a perspective view of a first side of one embodiment of a bipolar electrode device including a flexible hemispherical structure for holding the electrodes and positioning the device. [Figure 2A] FIG. 2 is an opposite perspective view of the embodiment of FIG. 1. [Figure 2B] FIG. 2B is a perspective view of one embodiment of a multipolar electrode device including a flexible hemispherical structure similar to FIGS. 1 and 2A. [Diagram 3] FIG. 1 is a perspective view of a first side of one embodiment of a tripolar electrode device including a flexible structure. [Figure 4A] FIG. 4 is an opposite perspective view of the embodiment of FIG. 3. [Figure 4B] FIG. 4B is a perspective view of one embodiment of a bipolar electrode device including a flexible structure similar to FIGS. 3 and 4A. [Diagram 5] FIG. 1 is a perspective view of one embodiment of an extravascular Venus FlyTrap electrode device. [Figure 6] FIG. 1 is a perspective view of one embodiment of an extravascular Venus flytrap electrode device. [Figure 7] FIG. 1 is a perspective view of one embodiment of an intravascular Venus flytrap electrode device. [Figure 8A] FIG. 4C is a perspective view of one embodiment of an extravascular bipolar electrode device including a flexible structure similar to FIG. 4B. [Figure 8B] FIG. 8B is a perspective view of components of the embodiment of FIG. 8A. [Figure 8C-1] FIG. 1 illustrates a perspective view of one embodiment of a deployment tool. [Figure 8C-2] FIG. 13 is a perspective view of another embodiment of a deployment tool. [Figure 8C-3] FIG. 13 is a perspective view of yet another embodiment of a deployment tool. [Figure 8C-4] FIG. 13 illustrates a perspective view of one embodiment of a deployment tool releasably attached to a neural interface device. [Figure 8D-1]FIG. 8D is another view of the deployment tool of FIG. 8C. [Figure 8D-2] FIG. 8D is another view of the deployment tool of FIG. 8C. [Figure 8D-3] FIG. 8D is another view of the deployment tool of FIG. 8C. [Figure 8E-1] FIG. 8D is another view of the deployment tool of FIG. 8C. [Figure 8E-2] FIG. 8D is another view of the deployment tool of FIG. 8C. [Figure 8E-3] FIG. 8D is another view of the deployment tool of FIG. 8C. [Figure 8E-4] 8D is another view of the deployment tool of FIG. 8C and a table of corresponding dimensions. [Figure 8F-1] FIG. 1 is a perspective view of one embodiment of a lead cap device. [Figure 8F-2] FIG. 8F-1 is a partial cross-sectional view of the lead cap device of FIG. [Figure 8F-3] FIG. 8F-1 is another perspective view of the lead cap device of FIG. [Figure 9A] FIG. 1 is a perspective view of one embodiment of an electrode device. [Figure 9B] 1 is a diagrammatic view of an electrode device and lead body according to one embodiment. [Figure 9C] 1 is a diagrammatic view of an electrode device and lead body according to another embodiment. [Figure 9D] FIG. 2 is a side view of an electrode device and lead body according to one embodiment. [Figure 9E] FIG. 13 is a photograph of a covered mesh structure for an anchoring tab according to one embodiment. [Figure 9F-1] FIG. 2 is a diagrammatic side view of a weld interface between a wire and an electrode according to one embodiment. [Figure 9F-2] 11 is a diagrammatic side view of a weld interface between a wire and an electrode according to another embodiment. [Figure 10A] FIG. 9B is an end view of the electrode device of FIG. 9A according to one embodiment. [Figure 10B] 9B is an end view of the electrode device of FIG. 9A according to another embodiment. [Figure 10C] 9B is an end view of the electrode device of FIG. 9A according to yet another embodiment. [Figure 11A] FIG. 9B is a partial perspective view of an electrode of the electrode device of FIG. 9A. [Figure 11B] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11C] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11D] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11E] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11F] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11G] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11H] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11I] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11J-1] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11J-2] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11K] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11L] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11M] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11N] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 11O] FIG. 2 is a partial perspective view of an electrode and a cuff portion of an electrode device according to one embodiment. [Figure 12A] FIG. 2 is an end view of an electrode device according to one embodiment. [Figure 12B]FIG. 13 is an end view of an electrode device according to another embodiment. [Figure 12C] 12C is an end view of an electrode of the embodiment of FIG. 12A and an electrode of the embodiment of FIG. 12B. [Figure 13A] FIG. 13 is a perspective view of a smaller cuff and electrode arrangement according to one embodiment. [Figure 13B] FIG. 13 is a perspective view of a medium sized cuff and electrode arrangement according to one embodiment. [Figure 13C] FIG. 13 is a perspective view of a larger cuff and electrode arrangement according to one embodiment. [Figure 14A] 11A-11D illustrate embodiments of providing power to the electrodes using different interconnection arrangements. [Figure 14B] 11A-11D illustrate embodiments of providing power to the electrodes using different interconnection arrangements. [Figure 14C] 11A-11D illustrate embodiments of providing power to the electrodes using different interconnection arrangements. [Figure 14D] 11A-11D illustrate embodiments of providing power to the electrodes using different interconnection arrangements. [Figure 14E] 11A-11D illustrate embodiments of providing power to the electrodes using different interconnection arrangements. [Figure 14F] 11A-11D illustrate embodiments of providing power to the electrodes using different interconnection arrangements. [Figure 15A] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15B] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15C] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15D] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15E] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15F] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15G] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15H] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 15I] FIG. 1 illustrates an exemplary embodiment in which a unitary electrode array is provided, with increased flexibility between the electrodes in the array. [Figure 16A] FIG. 1 illustrates a method of installing the devices described herein. [Figure 16B] FIG. 1 illustrates a method of installing the devices described herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0021] One embodiment of a bipolar extravascular neural interface according to the present disclosure is shown in Figures 1 and 2A. The neural interface 100 can include a hybrid cuff including a partially spirally formed support substrate 102 made from silicone or a similar flexible material, such as styrene isoprene butadiene (SIBS), polyamide, parylene, liquid crystal polymer (LCP), polytetrafluoroethylene (PTFE), polyethylene (PE), polypropylene (PP), fluorinated ethylene propylene (FEP), ethylene tetrafluoroethylene (ETFE), polyurethane, or another biocompatible polymer. Biocompatible silicone and other grades of silicone can be very flexible and pliable, thereby minimizing mechanical mismatch between the cuff and the target vessel and minimizing pinching of the target vessel. Polymeric materials can also be used, but they are stiffer and harder than silicone, which may require the use of thinner materials, which can be either an advantage or a disadvantage.

[0022] The substrate 102 may include two C-ring sections 104 and 106, each connected by a spine to form a spiral in an opposing direction from a common central section 108 of a central section 109 (when combined with the central section 109 and one of sections 104 or 106) and terminating in a C-ring configuration, the C-ring being positioned substantially perpendicular to the target vessel. Within each C-ring end section 104 and 106, multiple platinum or platinum alloy electrodes (or electrode arrays) may be disposed, such as electrode arrays 112 and 114, rather than multiple spiral configurations as found in conventional systems. The electrode arrays 112 and 114 may be of a conventional type and may be wired to a controller via conventional conductors 118, such as 35N LT® DFT (Drawn Filled Tubing) with a 28% Ag core, in a stranded cable configuration (i.e., a 7×7 configuration (not shown)) or a multifilar coil configuration. The conductors are housed within a backbone or spine-like portion 120 that is attached to the end portions 106 and a portion of the central portion 109 .

[0023] The configuration of the neural interface 100 may allow for a significantly shorter length of the neural interface 100, thereby reducing the portion of the target vessel or nerve that needs to be separated during placement. Additionally, the opposing helical directions of portions 104 and 106, with each portion having a low helix angle relative to the spine portion 120, may allow for the neural interface 100 to be introduced and wrapped around the target vessel in a single pass, rather than at least two as with conventional helical configurations. A low helix angle or low pitch may allow for a shorter length of the neural interface 100 (or its distal end), resulting in less tissue dissection during positioning.

[0024] The substrate 102 may include a number of features 110 located at different points on or within the substrate 102. The features may be configured to allow a deployment tool (not shown) to grasp, manipulate, and introduce the neural interface 100. Thus, each feature may be referred to as an introduction feature. The features may be protrusions. One or more of the protrusions may include one or more openings or pores for receiving a stylet (made from tungsten or a similar material), for example, to straighten some portions of the substrate or to allow the introduction of the neural interface. The features 110 may also be openings, pores, or some other form of lumen that may equally be manipulated by a deployment tool.

[0025] In one embodiment, the feature 110 can be positioned close enough to the open ends of the C-ring portions 104 and 106 and the end of the central section 108 to allow a deployment tool to grasp the feature and simultaneously open the portions 104 and 108 and the central section 108, so that the neural interface can be positioned around a target vessel (not shown). As used herein, an "open end" refers to an end located at the periphery of the C-ring that is not attached to another feature (e.g., another C-ring or a spine-like portion). In other words, each of the "open ends" forms a gap side for the target vessel. Similarly, a "closed end" refers to an end located at the periphery of the C-ring that is attached to another feature. In other words, each of the "closed ends" does not form a gap for the target vessel. After the neural interface 100 is positioned around the target vessel, the deployment tool should carefully release the feature so that the portions 104 and 108 and the central section 108 can softly self-size to the target vessel. By "self-sizing" we mean that the neural interface 100 naturally conforms to the shape of the target vessel.

[0026] The C-ring can exert radial pressure on the target vessel, nerve, or other structure. The amount of pressure applied can depend on several factors. The material that comprises the C-ring portion, e.g., insulating material and conductive portions (such as electrodes, coils, foils, or welds, as described below) that pass through or are at least partially exposed (such as electrodes) in the C-ring portion. The C-ring portion exerts radial pressure depending on several characteristics, such as the stiffness (e.g., 70-80 Shore) of the insulating material that comprises the body of the C-ring portion. The thickness of the insulating material that comprises the body of the C-ring portion also affects the radial pressure, as does the stiffness or hardness of one or more electrodes that pass through the C-ring. As described in more detail below with respect to Figures 14 and 15, the size and shape of the at least one electrode can affect the flexibility of the electrode and therefore the radial pressure applied. The number of electrodes on any given C-ring can also affect the radial pressure applied. The target-facing surface of the C-ring can be formed of an active portion (also referred to as the exposed electrode portion) and an inactive portion (also referred to as 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 preferred embodiments, the ratio can be 1:1.5 to 1:5, or 1:3. As will be described in more detail below, the gap size between any given pair of electrodes in the C-ring also affects the applied pressure. The properties of the interconnection between the different electrodes can also affect the radial pressure.

[0027] In some embodiments, the thickness of the C-ring material is, for example, about 0.5 mm to 2 mm, for example, about 1 mm, about 1.2 mm, or about 1.4 mm. The thickness is defined, for example, along a radial direction from the central axis as shown in FIG. 1. Referring again to FIG. 1, in embodiments, the diameter of the cuff (i.e., the length of the C-ring material around the central axis) can be 1 mm to 25 mm, preferably about 3 mm to about 10 mm, for example, 4, 5, 6, 7, 8, or 9 mm, or any number therebetween, 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 (as well as in additional embodiments described below), each device has an inner diameter and an outer diameter. The term "inner diameter" as used herein to describe such devices refers to the distance from the central axis of the device to the radially inward portion where the electrodes are located. In contrast, the "outer diameter" is the distance to the radially outer portion opposite the electrodes, and defines the farthest radial extent of the device. The outer diameter is the farthest radial extent of the C-ring portion, and is not defined by the radially outermost extent of other projections, such as lead bodies or other features attached to the radially outer surface of the C-ring portion. The C-ring portion of the neural interfaces 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 a thin film is used, the ratio can be as high as 40:1, but for increased structural integrity, the ratio can be closer to 10:1. On the other hand, if a higher radial force is desired, the ratio can be as low as 3:1. One skilled in the art will appreciate that the ratio can also be selected relative to the hardness of the material used. For example, the harder the material, the higher the Shore number, so a higher ratio can be used to achieve a similar radial force as a less hard material but with a lower ratio.

[0029] Depending on the physical aspects discussed above and the rest radius of the C-ring relative to the nerve or vessel to which the force is applied (i.e., how much the C-ring expands), the radial pressure exerted by the C-ring can be determined as an 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 device can have a different rest radius when positioned on the target because the target alone can maintain an increased radius compared to the rest radius, biasing the device to a relatively more open position. 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 preferred embodiments, the C-ring exerts at least some radial pressure (e.g., at least 1 mmHg), but not so much pressure as to damage the underlying anatomical structures.

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

[0031] Separation or retention force refers to the force required to remove the device from the target after it has been at least partially positioned around the target anatomical structure. In some embodiments, the separation force can be between 0.05N and 0.5N. In preferred embodiments, the separation force can be between 0.1 and 0.2N. In preferred embodiments, a separation force of about 0.15N pulled orthogonally from the target axis is sufficient to remove the device from the target.

[0032] Although an embodiment with three open arms is discussed and depicted as an example, various aspects of the disclosure may be applied to neural interfaces having different shapes or configurations. For example, a neural interface may include only one open arm, two open arms, or four or more open arms. Additionally, a neural interface may include arms with 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 with different or varying helix angles, and other variations, including those discussed herein with respect to other embodiments.

[0033] Another embodiment of the neural interface 200 is shown in FIG. 2B, which is structurally similar to the embodiment shown in FIG. 1 and FIG. 2A, i.e., has multiple C-rings and a common central section, forming two short-length spiral turns. The neural interface 200 can be multipolar, rather than bipolar as in the case of the neural interface 100. In the neural interface 200, the substrate 202 can include three C-ring portions 204, 206, and 208, with each C-ring end portion 204 and 206 connected by a spiral of one turn in the opposite direction to the common central section of the C-ring central portion 208, terminating in a C-ring configuration that can be perpendicular to the target vessel when positioned over the target vessel. The C-ring central portion 208 can also be perpendicular to the target vessel. Within each C-ring portion 204, 206, and 208, multiple platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 212, 214, and 224, may be positioned such that the electrodes in one C-ring cover the gaps (along the length between the electrodes) in the adjacent C-ring. Each electrode array is connected to a different conductor of a multi-conductor 218 housed within a spine-like portion 220, which is attached only to the central portion 208. The substrate 202 of the neural interface 200 may be free of features. Connecting individual electrodes or different electrode arrays to different conductors may allow selective stimulation of target blood vessels by individually controlling each connected device or individual electrodes or groups of individual electrodes.

[0034] 3 and 4A show one embodiment of a tripolar neural interface 300 according to the present disclosure. The neural interface 300 may be similar to the neural interface 100 in that it may be formed from a flexible substrate 302 of a similar material and may have two end portions 304 and 306 forming a C-ring configuration that may be attached to a spine-like portion 308.

[0035] Unlike the neural interface 100, however, the two end portions 304 and 306 may not be connected to a central section. Instead, a central portion 330 may be utilized that forms a third C-ring. The end portions 304 and 306 as well as the central portion 330 may have a very low helix angle, or pitch, relative to the spine portion 308, allowing the neural interface to be helical and still have a significantly shorter length. The helix angle may be approximately 15-30 degrees, but may 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 an array of electrodes, such as 312, 314, and 316, with each electrode connected to a conductor 318 through the spine-like portion 308. A design including a single electrode can allow for minimizing the conductor interconnection process by laser welding, resistance welding, etc., while maximizing the effective range of the electrode. However, to minimize the stiffness of the electrode, i.e., to give the electrode sufficient flexibility, the electrode may have to be made very thin (typically 25 μm to 50 μm), which may make the interconnection of the conductor to the electrode more difficult. Also, to maintain the highest possible electrode flexibility, surface features may not be added to the electrode, since surface features would reduce the electrode's flexibility. For this reason, the single electrode can be characterized as being a concave electrode, with a silicone rim or silicone webbing that can serve to hold the electrode in place. However, making the electrode concave can potentially reduce the effectiveness of the stimulation. On the other hand, a "split" electrode design may provide better mechanical compliance, allow for surface features, i.e., protruding electrodes, and allow for individual control of each electrode (i.e., current steering). Trade-offs include limited electrode coverage, increased interconnection processes, and reduced retention force. Split electrodes provide additional flexibility to the neural interface, allowing the C-ring to be opened wider and for longer periods by the deployment tool than would be possible with a single electrode, without excessive stress on the electrode.

[0037] As shown in FIGS. 2A and 4A, the individual electrodes of the electrode arrays 112 and 114 of the neural interface 100 and the electrode arrays 312, 314, and 316 of the neural interface 300 can be uniformly spaced within the substrates 102 and 302, respectively. By uniformly spacing the electrodes within the substrate, the distance between the electrodes can be more consistent, providing a more uniform current density distribution and improved efficacy of the neural interface. In some embodiments, the location of the electrodes within the arrays can be staggered to achieve better electrical coverage. With respect to the neural interface 300, certain characteristics of the neural interface 100 and / or 300, such as the spacing 350 between the 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 helix angle, can each be selected for a particular application of the neural interface. For example, using a neural interface for treatment of a splenic artery may require different characteristics than using a neural interface for treatment of a different blood vessel. For example, when utilized to treat the splenic artery, an electrode width of about 1-4 mm is appropriate, with preferred width ranges of about 1-2 mm and about 2-3 mm. Different electrode widths may be desirable when utilized to treat different blood vessels.

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

[0039] The neural interface 400 of Figure 4B is similar to the neural interface 300. The neural interface 400 is formed from a flexible substrate 402 of a similar material and can have two end portions 404 and 406 that form a C-ring configuration that contains the electrode arrays 412 and 414. Along with the end portions 404 and 406, a central portion 430 can be attached to a spine-like portion 408.

[0040] The central portion 430 may not include any electrodes and may only serve to hold the neural interface in position, although embodiments may include electrodes.

[0041] The neural interfaces 100, 200, 300, and 400 can be self-sizing, meaning that they can be formed from a flexible material, so that it is possible to manipulate the neural interface for introduction, such as a Nitinol cage that can shrink to fit within a catheter and return to its pre-shrink shape when released from the catheter, but returns to a predetermined shape when released. This can allow the neural interface to be used to accommodate anatomical variations at the intervention site while still providing good electrical contact between the electrode array and the nerve / vessel surface, thereby improving the efficiency of the interface. The flexible material of the interface can maintain compliance even when self-sizing to the nerve or vessel. This can help prevent the neural interface from compressing the nerve or vessel, causing reduced blood flow and otherwise pinching of the nerve fibers. This can also better accommodate radial expansion of the nerve / vessel as a result of edema or expansion after positioning, and accommodate the pulsatile behavior of the intervention site, such as an artery.

[0042] The naturally open structure of the helix of the neural interfaces 100, 200, 300, and 400 can reduce the extent of the nerve / vascular periphery to promote more normal fluid and nutrient exchange with the intervention site and surrounding tissue. This can also help minimize the growth of connective tissue between the electrode nerve / vascular interface. The open structure of each neural interface is configured such that at any point along the length of the target vessel, the terminal or central portions do not form a closed circumscribing arc around the target vessel. In other words, the structure does not form a closed circle that covers an orthogonal portion of the target vessel length 360 degrees. This open, unlimited trench can serve to ensure that the target vessel can pulsate without pinching, and that an initially expanded target vessel can return to a normal state over time, not pinching the target vessel when expanded, and not losing electrode-target vessel contact when the target vessel is in its normal state.

[0043] 5 and 6 show additional embodiments of a self-sizing extravascular neural interface 500. The neural interface 500 may be shaped like a Venus flytrap clasp, with a spine-like portion 502 connected to a conduit 504 containing conductors for the neural interface, and a set of matching portions 510, 512, and 514 extending from the spine 502. The portions 510, 512, and 514 may be substantially orthogonal to the spine-like portion 502. Each of the end portions 510 and 512 and the central portion 514 may include electrodes or electrode arrays 520, 522, and 524, respectively, that face inward so that there can be good electrical contact between the electrodes and the outer wall of the target vessel / nerve 530, allowing the artery to pulsate more freely. As discussed above, this open trench can relieve pressure on the nerve 532 in the target vessel 530 that is sandwiched between the arterial wall and the neural interface 500. The spaces 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 on each of the sections 510, 512, and 514. The number of electrodes and their arrangement with the electrode arrays can vary. As shown in Figures 5 and 6, the electrodes 520 on the terminal section 510 are positioned near the tip of the terminal section 510, the electrodes 522 on the central section 512 are positioned near the middle of the central section 512, and the electrodes 514 on the terminal section 514 are positioned near the connection point of the terminal section 514 with the spine-like section 502. Of course, different location configurations (i.e., all electrodes at the tip, middle, or spine-like sections, or any other combination of locations) are also possible and can be specifically selected to provide different circumferential coverage for the type of nerve / vessel and treatment being performed.

[0045] As with the neural interfaces 100 and 300 described above, the neural interface 500 is also self-sizing in that the shape of the portions 510, 512, and 514 are designed to substantially fit around a majority of the circumference of the target vessel, and the ribs are biased to a relaxed position and naturally wrap around a majority of the target vessel upon introduction. As used herein, the word "substantially" does not exclude "completely", e.g., a composition that is "substantially free" of Y may be completely free of Y. If desired, the word "substantially" may be omitted from the definition of the present disclosure. For example, substantially one turn of a helix may be one turn of a helix, substantially oppositely positioned features may be oppositely positioned, substantially spaced apart features may be spaced apart a fixed distance, and an electrode providing a substantially uniform current density may provide a uniform current density.

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

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

[0048] 7 illustrates an embodiment of a self-sizing endovascular neural interface 700. Similar to neural interface 500, neural interface 700 may be shaped like a Venus flytrap clasp, with a spine-like portion 702 connected to a conduit 704 containing the conductors for the neural interface, and a set of matching portions 710, 712, and 714 extending from the spine-like portion 702. However, in contrast to neural interface 500, each of portions 710, 712, and 714 may include electrodes or electrode arrays 720, 722, and 724, respectively, that face outward so that there can be good electrical contact between the electrodes and the inner wall of the target vessel / nerve 730, allowing the artery to pulsate more freely, thereby relieving pressure on a nerve 732 in the target vessel 730 that is sandwiched between the inner arterial wall and the neural interface 700. The spaces or channels (low pressure trenches) between portions 710, 712, and 714 may also not completely surround the artery at any point in the cuff geometry while at the same time providing space for the target vessel to pulsate and an unlimited conduit for fluids and nutrients to reach the inner wall of the target vessel 730. For example, for each of the embodiments disclosed herein, no portion of the cuff geometry covers the circumference (a complete 360 ​​degree turn) of the target vessel perpendicular to any point on the vertebral portion.

[0049] The electrodes or electrode arrays 720, 722, and 724 may also be positioned at different locations on each of the sections 710, 712, and 714. As shown in Figure 7, the electrodes 720 on the terminal section 710 are positioned near the connection point between the spine-like section 702 and the terminal section 710, the electrodes 722 on the central section 712 are positioned near the middle of the central section 712, and the electrodes 714 on the terminal section 714 are also positioned near the spine-like section 702. Of course, different location configurations (i.e., all at the tip, middle, or spine, or any other combination of locations) are possible and may be specifically selected for the circumferential extent of the nerves / vessels, the type of nerves / vessels, and the treatment being performed.

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

[0051] In the embodiment of FIG. 8A, an extravascular bipolar electrode neural interface 800 is shown. The interface 800 includes a flexible structure similar to that of FIG. 4B. In FIG. 8B, the neural interface 800 of FIG. 8A is also depicted, but without the flexible substrate 802 and the covering for the spine 808, which serves to further show the internal components of the neural interface 800 and the deployment tool. The neural interface 800 is similar to the neural interface 400 of FIG. 4B. The flexible substrate 802 can be formed from materials similar to those disclosed with respect to the neural interface 400. The neural interface 800 can include two arms at either end of the device, such as terminal portions 804 and 806, which can have open ends 805 and 807, respectively. The terminal portions 804 and 806 can each be in a C-ring configuration and can include an electrode array, such as arrays 812 and 814 of FIG. 8B. Similar to the closed ends of terminal portions 804 and 806, a central arm portion 830 can be attached to spine portion 808. Central portion 830 may not include any electrodes and may only serve to hold the neural interface in position, although embodiments may include electrodes.

[0052] As shown in Figure 8B, the four electrodes 815 of each array 812 and 814 are connected in series via three microcoil interconnects 817, which are connected in series to conductors 818 in the case of array 814 and to conductors 819 in the case of array 812. The conductors 818 and 819 may be covered over the length of the spine 808 with the same flexible substrate used to cover the end sections 804 and 806 and central section 830, and extend a short distance from the neural interface 800. The conductors 818 and 819 are also covered with silicone lead body tubing 820 before exiting the spine material, forming lead body conductors 822.

[0053] As previously mentioned, the features can be protrusions, but can also be apertures or holes. As shown in FIG. 8A, the features can be apertures 840 formed in the open ends 805 and 807 of the terminal sections 804 and 806. The deployment tool 841 can be comprised of a suture wire 842, grab tab tubing 844, connectors 846, and connectors such as grab tube loops 848. The suture wires 842 can be threaded through the silicone tubing of each aperture 840 and grab tabs 844. The suture wires 842 can then be brought together with connectors 846 to form grab tube loops 848. During introduction of the neural interface 800, the surgeon can position the central section 830 around the target vessel (not shown in FIGS. 8A and 8B) while gently pulling on the grab tube loops 848. Such pressure causes the open ends 805 and 807 of the terminal portions 804 and 806 to be pulled away from the spine-like portion 808, allowing the neural interface 800 to be positioned.

[0054] When the neural interface 800 is properly positioned, pressure can be removed from the grab tube loop 848 so that the open ends 805 and 807 can soften and self-size around the target vessel. Although not shown in FIGS. 8A and 8B, the central portion 830 can also include an opening feature 840 that can open in a similar manner to the end portions 804 and 806 to self-size around the target vessel. After the neural 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 oval slot (not shown in FIGS. 8A and 8B), or other shape or small hole (not shown in FIGS. 8A and 8B) that extends over a tab from the end portions 805 and 807.

[0055] In another embodiment, the deployment tool 841 can include an additional suture wire portion with or without silicone tubing 844 surrounding the additional suture wire portion, the additional suture wire extending between the double arms of the grab tab 844 to form a triangular shape to increase structural stability when introducing the neural interface device 812.

[0056] In another embodiment, referring to FIG. 8C-1, the deployment tool 841 includes a tab-shaped body 850 rather than the double arms of the grab tab 844 depicted in the embodiment of FIGS. 8A and 8B. In the embodiment of FIG. 8C, a first aperture 852 is similar to the grab tube loop 848, and a second aperture 854 and a third aperture 856 provide a portion where a connector, such as a suture, can be anchored to the tab-shaped body 850. For example, the anchoring can be provided by molding or by using an adhesive material. After anchoring by molding, the apertures 854 and 856 are filled by molding, thus anchoring the connector. An adhesive material can fill the apertures 854 and 856 as well. In some embodiments, the anchoring can be provided without any apertures 854 or 856. For example, the connector can be molded when forming the tab-shaped body 850. In other embodiments, an adhesive material can be used to anchor the connector to at least a portion of the tab-shaped body 850. The tab-shaped body 850 can also include a set of small holes 858 through which a connector can pass. The series of small holes form first and second passages through which the connector can pass, as shown in FIG. 8C-4. When the connector (e.g., a suture) 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 FIG. 8A and FIG. 8B. The tab-shaped body 850 provides additional stability when deploying the neural interface because the tabs keep the arms of the neural interface parallel (along the edges of the tabs where the neural interface is releasably connected to the deployment tabs). The planar shape of the deployment tabs maintains a specific distance between the arms to prevent crossing or entangling of the arms during deployment.

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

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

[0059] For example, in some embodiments, the body 850 can be used as a measuring tool. In one embodiment, referring to FIGS. 8D-1, 8D-2, and 8D-3, the gap between the end of the body 850 having the length L and the spine-like portion 808 can be measured to determine the degree or amount of stretch of the neural interface 800 around the target tissue. This also characterizes the radial length of the electrode arm opening. Understanding these characteristics can be useful to a medical professional user to determine whether an appropriate size neural interface 841 has been selected for the target tissue. In FIGS. 8D-1, 8D-2, and 8D-3, the radial gaps L1, L2, and L3, respectively, are shown, which can be evaluated by a medical professional user during delivery and introduction of the neural 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-and-groove structure of the body 850 can be used as a "measuring tape" type measuring tool. The rib-and-groove structure of the body 850 can be flexible to at least partially conform around the target tissue, providing another way that a medical professional user can use the body 850 to assess the size and fit of the neural interface 800 to the target tissue. This can be achieved in several ways. In one embodiment, information can be provided to a medical professional user that translates the number of ribs (or grooves) into useful information. For example, a separation of 3-5 ribs is acceptable, but 2 or less means the cuff is too big, and 6 or more means the cuff is too small. Thus, simply counting the ribs (or grooves) can directly provide information about the fit, as shown in Figs. 8E-1, 8E-2, and 8E-3. In another embodiment, a user, such as a medical professional, can first count the ribs (or grooves), as shown in Figures 8E-1, 8E-2, and 8E-3, and then use the known measurements between adjacent ribs (or grooves) to assess size and fit, as shown in Figure 8E-4. Similarly, the known measurements can be converted into a table that indicates the cuff opening as a percentage of the circumference, and advises the medical professional user as to which is suitable or not. In the table of Figure 8E-4, values ​​3-7 are suitable for the target tissue, with the first two indicating the cuff is too large and the last two indicating the cuff is too small. Tables with different predefined values ​​can be used depending on the target and the specific neural interface embodiment being used.

[0061] As mentioned above, the tab-shaped body 850 also includes a set of small holes 858. In use, a suture wire can be passed through each small hole 858 and then brought together at the first aperture 852 to form a grab loop. During introduction of the neural interface 800, the surgeon can position the neural interface 800 about the target 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 neural interface 800 to pull away from the spine-like portion 808, allowing the neural interface 800 to be positioned as desired.

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

[0063] The deployment tool 841, having a tab-shaped body (also referred to as a deployment tab), can include a thickness and / or width that is slightly greater than the thickness and / or width of the nerve cuff. The deployment tab can include an anchoring 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 entry feature of the nerve cuff, such as an opening at the open end of an arm). Cutting at least a portion of the deployment tab allows the deployment tool to be completely removed from the nerve cuff. The deployment tab can include a series of transverse (or lateral) ridges and valleys (along the width of the deployment tab) on one side that can act as cutting guides and allow the deployment tab to be rolled up to a smaller size for delivery. The deployment tab can include a series of longitudinal ridges and valleys on the opposing side, e.g., the side shown in FIG. 8D-1, as shown in FIG. 8C-1 and FIG. 8C-2, which can serve to minimize the contact surface (including when the deployment tab is rolled up and during tissue introduction). The deployment tab can include a tapered proximal end and can be configured to act as an instrument (e.g., a go / no-go gauge) to verify that the dissection opening is large enough for the cuff, as well as a blunt dissection tool. If the thickness and / or width of the deployment tab does not fit the dissection, a slightly smaller nerve cuff may not fit either. The anchoring 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 previously attached portion of the nerve cuff.

[0064] Other tools and accessories may be provided to assist the surgeon in delivering, positioning, and introducing the neural interface embodiments discussed herein. For example, Figures 8F-1, 8F-2, and 8F-3 depict a lead cap device 860. The lead cap device 860 is placed over the end of the lead body and protects the end of the lead body during delivery and introduction of the neural interface. During delivery and introduction of the neural interface, the lead body is subjected to stresses including implantation loads and mechanical interactions when pushing or pulling surgical tools (such as graspers) into position that may damage the lead body or conductor. The lead cap device 860 is sized and configured to fit into a cannula or catheter. For example, in one embodiment, the lead cap device 860 is sized to fit into a 5 mm cannula, although the lead cap device 860 may be provided in a range of sizes to accommodate a range of catheter / cannula sizes.

[0065] In the embodiment of FIGS. 8F-1, 8F-2, and 8F-3, the lead cap device 860 comprises 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 comprises a transparent or translucent biocompatible material, such as silicone. Such a material allows visual feedback during use, as the surgeon can see into the body 862 and determine how far the end of the lead body 917 has advanced into the interior cavity 870 of the body 862. In some embodiments, only a portion of the body 862 can be transparent.

[0067] The internal cavity 870 includes a retaining constriction 872, as shown in the cross-sectional view of FIG. 8F-2. The internal cavity 870 also passes through the set screw block 864. This configuration allows 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. Once fully inserted and positioned within the internal cavity 870 and set screw block 864, the set screw 866 can be tightened to retain the lead body 917 therein. Tightening the set screw 866 in this manner can be accomplished with a torque wrench (not shown). The torque wrench can provide an audible click when a maximum or desired torque is applied. The set screw block 864 is configured to engage the body 862, thus preventing rotation, movement, or misalignment of the set screw block 864 relative to the body 862 when the set screw 866 is tightened and the lead cap device 860 is manipulated during routing.

[0068] In wired embodiments, the lead body 917, and more specifically the IPG connector portion of the lead body 917, should be inserted sufficiently into the lead cap device 860 such that the portion of the lead body 917 that engages the set screw 866 does not include any sensitive components of the lead body 917, such as the contact portions of the lead conductor itself. Damage to these contact portions during implantation could compromise the electrical isolation properties when the lead body 917 connects to a pulse generator, such as an implantable pulse generator (IPG). In other words, the terminal portion of the lead body 917, which is configured for use to be coupled to other system components, such as a pulse generator, should be advanced past the set screw 866 toward the second end 876 and suture loop 868 of the lead cap device 860. When so positioned, the retention constriction 872 also functions to retain the lead body 917 therein, and in some embodiments can retain the lead body 917 even when the set screw 866 is not tightened (or is not sufficiently tightened).

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

[0070] Although discussed and illustrated with respect to a particular example (such as the neural interface 800), the tab-shaped body 850, lead cap device 860, and other accessories and techniques described above are also applicable to and can be used with other embodiments of the neural interface. Furthermore, not all embodiments necessarily include a lead body. For example, while the neural interface 900 in FIG. 9A, described in more detail below, is shown as being wired to an implantable pulse generator, it should be understood that the neural interface device 900 can instead be powered wirelessly by including a receiver or coil in the neural interface device 900 rather than the lead body 917 providing a wired connection. In some embodiments, the implantable pulse generator referred to herein need not be implanted if the neural interface device 900 can be powered by a wireless pulse generator, such as a device worn by the user. In some other embodiments, the neural interface 900 can include a miniature implantable pulse generator (IPG) having a wireless antenna to receive 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, the IPG being powered by said battery or external source. Although the following figures refer to embodiments based on wired lead bodies, it should be understood that these embodiments may alternatively be wireless, and that unless otherwise specified, the pulse generators described herein need not be implanted or implantable.

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

[0072] The neural interface 900 comprises a spine-like portion 902, a first C-ring portion 904, a second C-ring portion 906, and a third C-ring portion 908. The spine-like portion 902 comprises a first end 901 coupled to a lead body 917 comprising 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 and extends within the spine-like portion 902 from the first end 901 towards the second end 903, terminating in a connection to the first C-ring portion 904. At the opposite end, the lead body 917 and the conductor 918 are connectable to an implantable pulse generator (not shown) via a connector.

[0073] The lead body 917 includes conductors 918, which in one embodiment are uniform diameter bifilar conductors. The uniform diameter bifilar design of the conductors 918 provides additional flexibility and may allow the conductors 918 to be stretchable in some embodiments. In other embodiments, if the tube covering the uniform diameter bifilar conductors 918 is not stretchable, the lead body will have additional flexibility but not stretchable. These characteristics provide additional separation between the lead body 917 and the spine portion 902. This means that even if the lead body 917 is moved or bent during application, the spine portion 902 (and C-ring portions 904, 906, 908) will not move on or away from the target tissue. Additionally, the uniform diameter feature of the conductors 908 makes the conductors 908 more resistant to compression while still maintaining flexibility to aid in delivery and placement, which may be beneficial during laparoscopic delivery of the neural interface 900 to the target tissue.

[0074] In other embodiments, one or both of the lead body 917 and the conductor 918 can include a structure or configuration to provide strain relief. Referring again to Figures 9B and 9C, in some embodiments, the lead body 917 can include strain relief undulating sections 917b located intermittently between linear sections 917a. Any particular lead body 917 can include one undulating section 917b or multiple undulating sections 917b, and the particular configuration of the undulating sections 917b can vary. The undulating sections 917a serve to break up or block large or strong movements affecting the lead body 917 into smaller, discrete, or localized, weaker movements.

[0075] Two examples of undulating sections 917b are depicted in Figures 9B and 9C, although these examples are not limiting with respect to all of the possible embodiments contemplated by this disclosure. For example, the undulations can be sinusoidal, square, rectangular, spiral, coiled, regular, irregular, or other shapes or combinations of shapes. The number of undulations can also vary, with some undulating sections 917b having more or fewer undulations as desired or preferred for areas that experience more or less tension during use. In general, however, each turn of the undulating pattern prevents pressure waves from traveling a greater distance along the length of the lead body 917.

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

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

[0078] In one embodiment depicted in FIG. 9D, the anchoring tab 919 is located near the first end 901 of the spine 902. In this embodiment, the lead body 917 is about 650 mm long and the anchoring tab 919 is coupled to the lead body 917 about 200 mm from the first end 901 of the spine 902. The anchoring tab 919 is about 10 mm square. These dimensions are merely an example of one embodiment and may vary proportionally or otherwise in other embodiments. In some embodiments, the anchoring tab 919 is located near one or more undulating sections 917b, while in one particular embodiment, the anchoring tab 919 is located on each side of the undulating section 917b.

[0079] The tether tabs 919 can be coupled to the lead body 917 in a variety of ways. As discussed above, in some embodiments, the tether tabs 919 can comprise a sleeve that extends around the lead body 917 and be slidable along at least a portion of the lead body 917 (e.g., between adjacent undulating sections 917b). In other embodiments, these sliding tether tabs 919 can comprise fasteners, such that the sliding tether tabs 919 can be positioned at a desired location along the lead body 917 and then secured by a fastener, which can include a means for tightening around the lead body 917 or a suture or silicone adhesive for fixedly attaching to a desired location along the lead body 917. In still other embodiments, the tether tabs 919 are fixedly coupled at a specific point along the lead body 917, such as by being glued to the lead body 917 by a silicone adhesive near the first end 910 of the neural spine-like portion 902 of the neural interface 900.

[0080] The anchoring tab 919 can comprise many different biocompatible materials. In one embodiment depicted in FIG. 9D, the anchoring tab 919 comprises a mesh material, such as a coated mesh material. For example, the anchoring tab 919 can comprise a mesh material of polyethylene terephthalate (commercially known as DACRON) that is coated with a room temperature vulcanizable silicone dispersion, Nusil MED-6605. The mesh itself can comprise a warp knit, multifilament construction, having a denier of 140, a thickness of 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, the pores are not circular, but rather oval, elliptical, or other shape, and are about 1.0 mm by about 1.1 mm in size. In other embodiments, these dimensions can vary by ±5 percent, ±10 percent, ±15 percent, ±20 percent, ±25 percent, ±30 percent, ±35 percent, ±40 percent, ±45 percent, or ±50 percent, etc.

[0081] The coated mesh structure of the tether tab 919 can provide a variety of advantages. First, the mesh can maximize tear resistance. Coating the mesh structure can minimize tissue ingrowth by partially or completely filling the mesh pores, thereby reducing or preventing tissue from growing into the mesh pores over time, which aids in the overall tether tab 919 and neural interface 900 explantability and reduces the likelihood of serious complications that can result from tissue ingrowth. The coated mesh structure of the tether tab 919 also helps minimize or reduce the stiffness of the tether tab 919, thereby improving reliability (since generally the smoother the stiffness gradient at the transition from the lead body 917 to the tether structure 919, the more secure the bond). Minimizing or reducing stiffness also aids in surgical implantation, since the less stiff the tether tab 919 is, the easier it is to suture in place. Additionally, the coated mesh structure helps to maximize or increase the attachment between the tether structure 919 and the lead body 917. In embodiments in which the lead body 917 comprises silicone, the silicone adhesive and silicone coating of the mesh of the tether structure 919 provides a strong bond to attach the anchor to a desired location, such as the right or left leg of the septum, to secure and hold the lead in place and avoid disruption of the implantation procedure due to lead migration.

[0082] The first end 901 of the spine-like portion 902 defines a tapered portion that tapers from a maximum circumference to a minimum circumference. In the embodiment of FIG. 9A, the maximum circumference occurs at points near the C-ring portions 904, 906, 908, particularly where the spine-like portion 902 is at least partially attached to the third C-ring portion 908. The minimum circumference occurs where the spine-like 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 in the transition from the relatively stiff spine-like portion 902 to the relatively flexible lead body 917. A large stiffness gradient can lead to poor bending fatigue performance and cause breakage of the conductor 918 at the transition. Advantageously, embodiments of the neural interface 900 provide a smoother stiffness / flexibility transition, which can improve structural stability at the attachment points of the spine-like portion 902 and the lead body 917. At the same time, tapering the first end 901 helps improve the flexibility of this portion of the neural interface 900 by providing sufficient flexibility to allow for positioning, placement, and introduction of the neural interface 900 and each of the first C-ring portion 904, the second C-ring portion 906, and the third C-ring portion 908, and maintain a satisfactory comfort level once introduced. In various embodiments, the tapered portion is about 2 mm to about 5 mm in length, such as about 2.1 mm in one exemplary embodiment. The circumference of the tapered portion can taper from about 3 mm to about 1.5 mm, such as about 2.5 mm to about 1.75 mm in one exemplary embodiment. The taper angle can range from about 5 degrees to about 15 degrees, such as about 10 degrees in one exemplary embodiment.

[0083] The second end 903 presents a sloping, blunted or rounded surface, with the spine-like portion 902 extending to the outer edge of the first C-ring portion 904 at the bottom or lower side (relative to the orientation of FIG. 9A on the paper) but terminating further back at the top or upper side. In other words, the spine-like portion 902 has a substantially circular cross-section, with a plane parallel to the circular cross-section making an angle greater than 0 degrees and less than 90 degrees with the sloping surface of the second end. The surface can be substantially flat, curved or a surface that includes both flat and curved portions. For example, in the embodiment depicted in FIG. 9A, the surface is substantially flat from the top or upper end to the vicinity of the first C-ring portion 904, where the surface curves downwards to the first C-ring portion 904. The angles, curvatures, relative composition of the flat and curved portions, as well as other characteristics of this end surface can vary from the example depicted in Figure 9A. Generally, however, the second end 903 includes an end surface that eliminates possible pressure points as the neural interface 900 is introduced. This can improve patient comfort and can also increase maneuverability and positioning of the neural interface 900 during the introduction process.

[0084] Between the first end 901 and the second end 903, one end 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 spine-like 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 spine-like portion 902 in the same orientation, with the opening in each C-ring portion 904, 908 being on the rear or left side of the neural interface 900 relative to its orientation in the plane of the page. The C-ring portion 906 is coupled to the spine-like portion 902 in the opposite orientation, with the opening in the C-ring portion 906 being on the front or right side of the neural interface 900 relative to its orientation in the plane of the page. In other words, the first C-ring portion 904 and the third C-ring portion 908 extend from the spine-like portion 902 in a direction opposite to that of the second C-ring portion 906.

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

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

[0087] In other embodiments, each C-ring portion 904, 906, 908 may not be helical or have a helix angle, i.e., pitch, relative to the vertebral portion 902, as shown, for example, in Figures 9A and 13A, 13B, and 13C. Additionally, each C-ring portion 904, 906, 908 may include rounded or smooth edges and ends, which may facilitate delivery of the neural interface 900, reduce adjacent tissue damage, and increase patient comfort. In other embodiments not specifically depicted, the neural interface 900 may include more or fewer C-ring portions, C-ring portions having the same bond and aperture orientations, alternating bond and aperture orientations, or other patterns of bond and C-ring portion orientations, C-rings of different relative sizes, C-ring portions with different or varying helix angles, and 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 neural interface 900 has a substantially regular or uniform thickness along its length. In other words, the thickness of each C-ring portion 904, 906, 908 from the first end coupled to the spine-like portion 902 to the second end is approximately the same, not considering any thickness added by the electrodes on the C-ring portion. 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, if the diameter to thickness ratio is 6:1, and the diameter D of the C-ring portions 904, 906, 908 is 6 mm, an exemplary thickness of each C-ring portion 904, 906, 908 can be 1 mm. In another example, if the ratio is 5.4:1 and the diameter D of the C-ring portions 904, 906, 908 is 7 mm, an exemplary thickness of each C-ring portion 904, 906, 908 can be 1.3 mm. In yet another example, if the ratio is 5.6:1 and the diameter D of the C-ring portions 904, 906, 908 is 9 mm, an 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 portions can range from about 5:1 to about 7:1 in various embodiments, such as from about 5.3:1 to about 6.5:1, or from about 5.4:1 to about 6.2:1, or from about 5.5:1 to about 6:1, or from about 5.6:1 to about 6:1.

[0089] As can be seen from these examples, the thickness of the C-ring portions 904, 906, 908 increases as the diameter increases, thereby providing a similar pressure regardless of the diameter of the cuff. Those skilled in the art will appreciate that even without adjusting the thickness for the diameter, the pressure would be expected to decrease as the diameter increases. Those skilled in the art will also recognize that the thickness depends on the properties (e.g., hardness) of the material used to form the C-ring portions 904, 906, 908, which means that in other embodiments, the above ratios (relating to silicone) can vary according to the properties of the material selected. Additionally, these ratios can depend on the aspect ratio of the C-ring portions, the aspect ratio of the electrodes on the C-ring portions, the number of electrodes on the C-ring portions, the material used for the electrodes, and other factors. Stated another way, embodiments of the neural interface 900 can be configured to apply (or maintain) a pressure to the target tissue within the C-ring portion at a range of about 0 mmHg to about 30 mmHg, e.g., 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, e.g., about 20 mmHg, or e.g., about 10 mmHg, or e.g., about 5 mmHg. This pressure can be measured at various points along the inner diameter of the neural interface 900 and can be an average, mean, or median of multiple values ​​obtained at multiple points, or a particular value at a particular point.

[0090] In other embodiments, the thickness can vary along the length of the C-ring portion, providing another way of providing 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 neural interface 1000 is depicted. In FIG. 10A, the thickness of the C-ring portion 1010 varies from a first thickness T1 at a first end coupled to the spine portion 1002, to a second thickness T2 at a point opposite the spine portion 1002, and then to a third thickness T3 at the second end. In the depicted embodiment, thicknesses T1 and T3 are similar or the same, and thickness T2 is the maximum or highest thickness of the C-ring portion 1010.

[0091] In one exemplary embodiment, the thickest part of the C-ring portion (e.g., T2 in FIG. 10A) is approximately twice the thickness of the ends of the C-ring portion (e.g., T1 and T3 in FIG. 10A). In addition, the thickness of the C-ring portion between the electrodes can also be important. In one particular example, a 7 mm neural interface has gaps between adjacent electrodes at 31.5 degrees and 94.5 degrees from the center of the "C", which correspond to gap thicknesses of 1.34 mm and 0.95 mm at these angles. This results in a ratio of 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 Figures 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 neural interface, such as neural interface 1000, can vary relative to the thickness of other C-ring portions of the same neural interface 1000. For example, the thickness of the first and third C-ring portions can vary as depicted in Figures 10A-10C, while the thickness of the intermediate second C-ring portion can remain constant, particularly if it does not include an electrode array (such as C-ring portion 906 in neural interface 900 depicted in Figure 9).

[0093] In general, however, the objective is to reduce the contact pressure on the electrode 1012 closest to the spine 1002 and the electrode 1012 at the distal (open) end of the C-ring portion 1010. In a C-ring portion with constant thickness, these two electrodes carry 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. Similar benefits to variable thickness and pressure management can be seen in C-ring portions without electrode arrays as well.

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

[0095] The electrodes of each electrode array 912 that are coupled to the conductor 918 can be coupled to the conductor 918 in a variety of ways. In one embodiment, the coupling is accomplished by welding, such as laser welding. The particular configuration of the laser welds can provide strain relief and reduce the likelihood that relative movement of the C-ring portions 904, 906, 908 with respect to the conductor 918 will cause the welds to separate or break. In a conventional arrangement, the wires of the conductor 918 would be welded to the electrode in a substantially orthogonal orientation, as shown in FIG. 9F-1. In contrast, in an embodiment of the present disclosure, the wires of the conductor 918 are welded to the electrode in an oblique or tangential direction. This angle provides strain relief in the coupling of the electrode to the conductor, as the conductor does not have to make a sharp bend or change direction at the weld point. This configuration also provides more space and surface area for the weld coupling, as the tangential angle of the weld can increase the surface area for welding.

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

[0097] The individual electrodes of the electrode array 912 of the neural interface 900 can be uniformly spaced within the C-ring portions 904, 906, 908. By uniformly spacing the electrodes on the C-ring portions 904, 906, 908, the distance between the electrodes can be more consistent, providing a more uniform current density distribution and improved effectiveness of the neural interface 900. In some embodiments, the locations of the electrodes within the electrode array 912 can be staggered to achieve better or different electrical coverage. Each particular characteristic of the neural interface 900 can be selected for a particular application of the neural interface 900, such as the spacing between adjacent C-ring portions 904, 906, 908, the spacing between the electrode array 912, the spacing between the electrodes of the electrode array 912, the size and shape of the electrodes, the size, shape, and number of electrodes within the electrode array 912, the distance between the electrodes within the electrode array 912, and the helix angle. For example, the use of the neural interface 900 for treatment by utilizing a target, such as the splenic artery, may require different characteristics than the use of the neural interface 900 for treatment of a different blood vessel. For example, when utilizing splenic artery therapy (e.g., therapy provided by a neural interface placed around the splenic artery), an electrode width 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 therapy 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 also providing the desired flexibility itself and at the same time not inhibiting the flexibility or conformality of the C-ring portions 904, 908. Flexibility can be provided by the coiled arrangement of the electrode coil 922 since the coil provides flexibility due to spring properties that straight conductor wires do not have. For example, the electrode coil 922 can have improved bending fatigue performance compared to straight wires. In use, the neural interface 900 is located on a pulsating structure and therefore the electrode coil 922 is subjected to multiple small bending loads. The coiled electrical coupling has better bending fatigue performance than straight wires. Similarly, the conformality 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, 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 922 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 922 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 a determined relationship between any of these dimensions or other dimensions or characteristics of the electrode, the C-ring portion, or the overall neural interface.

[0099] 9A, there are no electrodes 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 in the electrode array 912. In other embodiments, the number and arrangement of electrodes or electrode arrays 912 on any individual C-ring portion 904, 906, 908 can be varied, with more or fewer electrode arrays 912 being used overall, or more or fewer electrodes being disposed on any particular C-ring portion 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 C-ring portions 904 and 908 in Figure 9A, can be considered to be a single electrode. In other words, in some contexts, the embodiment of the neural interface 900 depicted in Figure 9A comprises two electrodes, one located on C-ring portion 904 and one on C-ring portion 908, each electrode comprising multiple (four) electrode portions.

[0101] The electrodes can be very thin (e.g., 25-50 μm), but not so thin that interconnects to the electrodes (which can be achieved, for example, by laser welding) are difficult. In some embodiments, the electrodes can be recessed or recessed into their respective C-ring portions, with silicone rims or silicone webbing used to hold the electrodes in place. In other embodiments, a "split" electrode design can provide better mechanical compliance, provide the potential for surface features, i.e., protruding electrodes, and allow for individual control of each electrode (i.e., current steering). Split electrodes provide additional flexibility to the neural interface, allowing the C-ring portions to be opened wider and for longer periods by a deployment tool than would be possible with a single electrode, without causing undue stress on the electrode.

[0102] In yet other embodiments, the electrodes can be configured with or include features to improve flexibility, prevent detachment of the electrodes from the C-ring portion, and otherwise improve interoperability between the electrodes and the C-ring portion. For example, in embodiments where the electrodes are recessed or embedded into the respective C-ring portion, the electrodes can include or be coupled to electrode pads that are recessed or embedded into the C-ring portion. The electrode pads can include the same material as the electrodes, or a different material, such as a material that has desired properties for bonding or bonding 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 (e.g., platinum) and the C-ring portion (e.g., silicone).

[0103] Additionally or alternatively, the portion of the C-ring portion in which the electrode (or electrode pad) is embedded can be slightly larger than the electrode or electrode pad to allow bending and movement of the electrode or electrode pad when the neural interface is introduced (i.e., when the C-ring portion undergoes the most significant deformation), but maintain the electrode and electrode pad in a desired position after introduction. For example, one or both ends of the electrode or electrode pad can be provided with a gap in the C-ring portion, the ends in FIG. 9A being the two shorter sides of the electrode 912. In other words, the length of the recess in which the electrode or electrode pad is located in the C-ring portion is longer than the length of the protruding electrode or electrode pad itself, and acts as an 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 electrode or electrode pad within the recess. For example, the overall shape of the recess can be the same as or different from the electrode or electrode pad. In the embodiment of FIG. 9A, the electrode is rectangular with rounded corners, and the recess in the C-ring portion in which such electrode is placed can also be rectangular with rounded corners, or rectangular with square corners, or have some other shape different from that of the electrode (or electrode pad) itself. In these or other embodiments, the electrode or electrode pad can also include one or more flanges or anchors that are configured to fit or otherwise engage the recess in the C-ring portion to hold the electrode or electrode pad within the recess.

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

[0106] In yet other embodiments, in addition to or in lieu of other electrode and electrode pad features discussed herein, each electrode can include a flange having one or more perforations that can improve the mechanical bond between the electrode and the C-ring portion, prevent detachment of the electrode from the C-ring portion, increase the flexibility of both the electrode and the C-ring portion (particularly during placement and introduction of the neural interface), and provide other benefits that will be appreciated by those skilled in the art.

[0107] For example, FIG. 11A is a partial view of FIG. 9A and depicts an electrode 930 comprising an electrode contact 932 and an electrode flange 934. The electrode flange 934 comprises at least one perforation 936A. In the depicted embodiment, the electrode flange 934 comprises six perforations 936A, although other embodiments may include more or fewer perforations. The perforations 936A are disposed on each long side of the electrode flange 934, with three perforations 936A disposed on one side and three perforations 936A disposed opposite the other. Each perforation 936A is rectangular with rounded corners or rounded short ends. In other embodiments, the perforations 936A may be disposed on the short side, on both the short and long sides, or in some other configuration. The perforations 936A are equally sized and uniformly spaced apart, 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 Figure 11B, the electrode flange 934 again includes six perforations 938B, but the perforations 938B are round or circular, with three located on one short end of the electrode flange 934 and three located on the other short end of the electrode flange 934. The electrode flange 934 of Figure 11B also has a more rounded perimeter than the embodiment of Figure 11A.

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

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

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

[0112] Yet another embodiment is depicted in Figure 11F. In this embodiment, the perforations 936F comprise cutouts or apertures along the periphery of the electrode flange 934. In other words, the perforations 936F form notches along the long edge of the electrode flange 934.

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

[0114] The embodiment of FIG. 11H is similar to that of FIG. 11G, but omits the perforations entirely.

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

[0116] 11J-1 and 11J-2, an embodiment of the electrode 930 is depicted with two anchors 938, one extending from each short end of the electrode contact 932. The anchors 938 can be embedded or anchored into the silicone or other material of the C-ring portion. For example, the C-ring portion can include two channels, and each anchor 938 can slide into the 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 therewith during positioning and bending of the C-ring portion. The embodiment of the electrode 930 shows a folded (or curved bottom) anchoring perforated portion 938. For example, insulating material of the C-ring provided around and / or through the anchors 938 and the channel 936J provides improved mechanical coupling, embedding, or anchoring of the electrode 930 to the insulating material of the C-ring portion.

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

[0118] Like the embodiment of FIG. 11K, the embodiment of FIG. 11L includes two perforations 936L that each extend along a short side of the electrode flange 934, curve around two corners, and extend 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 perforations 936M are circular or round rather than oval or elliptical.

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

[0121] The embodiment of Figure 11O has similarities to the embodiment of Figure 11I in that it includes a portion of the electrode flange 934 located at each short end of the electrode contact 932, each of which includes a round or circular perforation 936O. However, in contrast to the embodiment of Figure 11I, the portion of the electrode flange 934 located at each short end of the electrode contact 932 is approximately perpendicular to the electrode contact at each end, rather than continuing in the same plane from the electrode contact.

[0122] A spring or microcoil (or any other interconnect) connecting the electrode and the lead conductor or between the electrodes can be provided through the substantially round bore 936O. In this way, stress on the weld is reduced since the connection is already partially held in place by its placement against the round bore 936O.

[0123] In other embodiments, still other configurations of the electrode contacts 932, electrode flange 934, and electrode perforations 936 are 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 perforations 936 may instead be considered to be recesses. Additionally, in other embodiments, other shapes, sizes, positions, arrangements, features, dimensions, and other characteristics of any of the electrode contacts 932, electrode flange 934, and electrode perforations 936 may be implemented and selected according to the desired application of the particular neural interface in which the electrode 930 is implemented.

[0124] As with other embodiments of the neural interface depicted and discussed herein, even if not explicitly depicted in the drawings, the neural interface 900 may also include at least one feature that may be positioned on an exterior surface of the neural interface 900, such as on the spine portion 902. The feature may include one or more openings or apertures for receiving connectors, such as a stylet (made from tungsten or a similar material) or a suture for releasably connecting to a deployment tab, for example, to allow manipulation of the C-ring portion or introduction of the neural interface 900. The feature may be configured to allow a deployment tool to grasp, manipulate, and introduce the neural interface 900. In one embodiment, the feature may be positioned sufficiently close to an open end of at least one of the C-ring portions 904, 906, 908 to allow a deployment tool to grasp the feature and simultaneously open the C-ring portion 906 relative to the C-ring portions 904 and 908. This allows the neural interface 900 to be positioned around a target vessel. After the neural interface 900 is positioned about the target vessel, the deployment tool (through manipulation by the physician) can carefully release the features so that the C-ring portions 904, 906, 908 can softly self-size to the target vessel. The configuration of the neural interface 900 can allow the neural interface to be positioned about a nerve or vessel in a single pass, reducing manipulation of the nerve or vessel and reducing dissection of tissue around the area of ​​the nerve or vessel where the interface is positioned.

[0125] Similar to the neural interfaces 100, 200, 300, and 400, the neural interface 900 can also be self-sizing, with the C-ring portions 904, 906, 908 being particularly formed from a flexible material and arranged with alternating open ends to provide easy manipulation for introduction and return to a predetermined shape upon release without strong elastic snap or spring force. This allows the neural interface 900 to accommodate anatomical variations of the intervention site and the target vessel while still providing good electrical contact between the electrode array and the surface of the nerve or vessel, thereby improving the efficacy of the neural interface 900. The flexible material of the C-ring portions 904, 906, 908 can maintain compliance even when self-sizing to the nerve or vessel. This can help prevent the neural interface 900 from compressing the nerve or vessel, causing reduced blood flow and otherwise pinching of the nerve fibers. This can also better accommodate radial expansion of the nerve or vessel resulting from edema or expansion after positioning, and accommodate the pulsatile behavior of the intervention site, such as an artery.

[0126] The naturally open structure of the C-ring portions 904, 906, 908 of the neural interface 900 can reduce the coverage around the nerve or blood vessel to facilitate more normal fluid and nutrient exchange with the intervention site and surrounding tissue. This can also help reduce the growth of connective tissue into the neural interface 900. The open structure of the neural interface 900 is configured such that at any point along the length of the target vessel, the end or central portions do not form a closed circumscribing arc around the target vessel. In other words, the structure does not form a closed circle that covers an orthogonal portion of the length of the target vessel 360 degrees. However, the tips of the arms can contact the spine of the cuff. In other words, complete coverage of the target vessel can be provided without going through a closed circle. This open, unlimited trench can act to allow the target vessel to pulsate without constriction and allow the initially inflated target vessel to return to a normal state over time, not constricting the target vessel when inflated, and not losing electrode-target vessel contact when the target vessel is in its normal state.

[0127] As mentioned above, electrodes (e.g., electrodes of electrode array 912 of FIG. 9A or those depicted and discussed with respect to any of the figures herein) may be embedded within the material of the cuff of the neural 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 embodiment 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 FIG. 12B can be seen particularly in the partial see-through view of the neural interface in FIG. 12B.

[0128] In addition, different electrode embodiments may provide different degrees of coverage for each cuff of the neural interface. This can be seen in Figure 12C, where the electrodes in Figure 12A (shown on the left) each provide a greater extent of inner cuff surface coverage (i.e., percentage) than the electrodes in Figure 12B (shown on the right). In some applications or embodiments, one or the other may be advantageous or preferred.

[0129] For example, referring again to Figures 13A, 13B, and 13C, different electrode embodiments can be used in different sized neural interfaces (or cuffs of the neural interface). Figures 13A, 13B, and 13C depict smaller, medium, and larger cuff diameters, respectively. Additionally, consistent with the discussion herein above, 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 inner diameter, arm thickness, and number of electrodes can result from maintaining desired contact and tension of the cuff arms and electrode contact areas as the diameter (and therefore length) of the cuff arms decreases or increases. Thus, the inner diameters of the neural interface devices may vary, but the total electrode area of ​​each neural interface device is substantially equal. Additionally, electrodes of a neural interface device with a larger inner diameter can include a smaller width and a larger length than electrodes of a neural interface device with a smaller inner diameter.

[0132] To define different sizes and shapes of electrodes, the size of the neural interface is taken into consideration. That is, the shape and size of the electrodes can be determined by the diameter of the associated neural interface. In other embodiments or applications, different factors can be considered when sizing the cuff and determining 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 or configuration of electrodes between arms of the same cuff.

[0133] In some aspects, the inter-electrode coil (such as coil 922 in FIG. 9A) can be replaced with a continuous coil or any other continuous interconnection. Continuous coil embodiments can advantageously reduce the mechanical load on the weld, making the weld more secure and reducing the impact of any one weld failure. For example, FIG. 14A illustrates another embodiment of a neural interface 1400 according to the present disclosure. The neural interface 1400 can be similar to the neural interfaces 100, 200, 300, 400, 900 discussed herein above, unless otherwise stated herein. For example, the neural interface 1400 can be formed from a flexible substrate of the same or similar material (i.e., silicone) and can share other characteristics.

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

[0135] The first end 1401 of the spine 1402 defines a tapered portion that tapers from a maximum circumference to a minimum circumference. In the embodiment of FIG. 14A, the maximum circumference occurs at points near the C-ring portions 1404, 1406, 1408, particularly where the spine 1402 is at least partially attached to the third C-ring portion 1408. The minimum circumference occurs where the spine 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 stiffness gradient when transitioning from the relatively stiff spine 1402 to the relatively flexible lead body 1417.

[0136] The second end 1403 presents a beveled, blunted or rounded surface, with the spine-like portion 1402 extending to the outer edge of the first C-ring portion 1404 on the bottom or lower side (relative to the orientation of FIG. 14A on the paper) but terminating further back on the top or upper side. In other words, the spine-like portion 1402 has a substantially circular cross-section, and a plane parallel to this circular cross-section makes an angle greater than 0 degrees and less than 90 degrees with the beveled surface of the second end. This surface can be substantially flat, curved or includes both flat and curved portions.

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

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

[0139] The electrode array 1412 may be connected by a continuous coil 1422. The use of a continuous coil 1422 may contribute to greater durability of the overall neural interface 1400 by reducing the number of interconnection points required within the electrode array 1412. The use of a continuous interconnect such as the continuous coil 1422 reduces interconnection points such as welded joints as compared to some of the embodiments described above.

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

[0141] FIG. 14A depicts a continuous coil 1422 attached to an electrode array 1412 via a bushing or sleeve, such as a crimped bushing 1430. The use of a bushing, such as a crimped bushing 1430, helps achieve both mechanical and electrical connection via single or multiple weld points in the bushing, rather than directly welding the continuous coil 1422 to the electrode array 1412, as discussed above. FIG. 14B illustrates how using a bushing 1430 to connect the coil to the array 1412 allows multiple weld points 1434 to strengthen the connection and reduce the probability that any single weld 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 selection of materials for the continuous coil, the electrode array, and the C-ring to promote good electrical conductivity and stable welding. A crimp bushing 1430 fits around the continuous coil with an 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 match the curvature of at least one electrode of the electrode array 1412, thus increasing the contact between the bushing and the array, and thus providing larger contact points that may be good candidates for welds 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, which can provide a stronger connection between the bushing and the array (and ultimately between the coil and the electrode). Matching the curvature between the bushing and the array can also reduce mechanical stress on the welds connecting the bushing and the array during use. In an embodiment, the bushing can be crimped to close the tunnel gap and hold the wires by an interference fit. Although reference is made to welding, it is noted that other forms of connection can be used between the bushing and the array, including but not limited to soldering, crimping, brazing, wiring, or other fasteners to create an electrical and mechanical connection.

[0143] Using the continuous coil 1422 to connect the electrode arrays 1412 allows the electrodes in one of the electrode arrays 1412 to be electrically connected in parallel. Thus, if a connection is lost to an electrode that is "upstream" of the remaining connected electrodes (closer to the alpha connection 1432 between the conductor 1418 and the continuous coil 1422, or simply closer to the conductor 1418), the loss of the connection between the coil 1422 and any one electrode will not interrupt the supply of power to the other electrodes. For example, if the bushing 1430a loses its connection to the electrode 1412a, the electrode 1412a may no longer be connected to any power supply means to provide stimulation or block the target. However, because the continuous coil 1422 carries power from the conductor 1418 to the electrodes 1412b-1412d independent of the connection between the coil 1422 and the first electrode 1412a, each of the electrode arrays 1412a-1412d remains operable independent of the state of any electrode and continuous coil connections within the same C-ring 1404. In this particular embodiment, the continuous coil 1422 is connected to the conductor 1418 via an alpha 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 alpha helix 1432.

[0144] Other embodiments are also contemplated that may realize the advantages of the continuous coil example of FIG. 14A. In FIG. 14C, the neural interface 1440 uses a long jumper coil 1442 to provide improved strain relief and better separation force for the weld joint (e.g., compared to the smaller inter-electrode coil 922 of FIG. 9A). As shown in the inset of FIG. 14C, the alpha helix 1432 includes an alpha weld 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 location of the weld on the electrode may vary. As shown in more detail in FIG. 14D, the location of the weld for the crimp or coil-to-coil attachment that couples one electrode to another may also vary between embodiments. In an embodiment, the weld / joint location may be generally within the center portion of the electrode. In a preferred embodiment, the ratio of the gap between the electrodes and the interconnector (e.g., interconnected microcoil or interconnected coil) is about 1:3 (i.e., the interconnector is about three times longer than 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 neural interface 1450 uses a continuous jumper coil 1452 that differs from the continuous coil 1422 of FIG. 14A by not directly connecting to the conductor 1408 (or the alpha helix 1432). The continuous jumper coil 1452 can be directly welded to the electrode array 1412 or can be attached in other ways, such as with a crimped bushing 1454. In FIG. 14E, the neural interface 1460 uses a continuous stranded cable 1462 to connect to the electrode array 1412. The continuous cable 1462 can be connected to the individual electrodes in the electrode array 1412 using bushings or sleeves 1464 (which can be crimped for an interference fit or connected by other means). Similar to the embodiment with a continuous jumper coil discussed above, the continuous stranded cable 1462 also provides a parallel connection between electrodes.

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

[0147] The electrode coil 1422 can be configured to provide electrical coupling between adjacent electrodes of the electrode array 1412 while also providing desired flexibility and high bending fatigue performance. The conformality or flexibility of the C-ring portions 1404 and 1408 can be maintained or enhanced by adjusting the diameter and pitch of the electrode coil 1422. In exemplary embodiments, the coil pitch of the electrode coil 1422 can be in the range of 0.05 mm to 0.3 mm, 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 determined relationships between any of these or other dimensions or characteristics of the electrode, the C-ring portion, or the overall neural interface.

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

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

[0150] In the embodiment depicted in FIG. 14A, there are no electrodes 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 in the electrode array 1412. In other embodiments, the number and arrangement of electrodes or electrode arrays 1412 on any individual C-ring portion 1404, 1406, 1408 can be varied, with more or fewer electrode arrays 1412 being used overall, or more or fewer electrodes being 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 discussed above in connection with other embodiments, a cuff can be used with a wireless system, or a cuff can have fewer or more C-ring portions.

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

[0152] Similar to the neural interfaces 100, 200, 300, 400, and 900, the neural interface 1400 can also be self-sizing, with the C-ring portions 1404, 1406, 1408 being particularly made of a flexible material and arranged with alternating open ends to provide easy manipulation for introduction and return to a predetermined shape upon release without a strong elastic snap or spring force. This allows the neural interface 1400 to accommodate anatomical variations of the intervention site and the target vessel, while still providing good electrical contact between the electrode array and the surface of the nerve or vessel. The flexible material of the C-ring portions 1404, 1406, 1408 can maintain compliance even when self-sizing to the nerve or vessel. This can help prevent the neural interface 1400 from compressing the nerve or vessel, causing reduced blood flow and otherwise pinching of nerve fibers. This can also better accommodate radial expansion of the nerve or vessel resulting from edema or expansion after positioning, and accommodate the pulsatile behavior of the intervention site, such as an artery. Accordingly, disclosed herein is a neural interface comprising: a vertebrae-like portion having a first end and a second end, where an outer circumference of the first end of the vertebrae-like portion tapers from a maximum outer circumference to a minimum outer circumference; a lead body coupled to the first end of the vertebrae-like portion, the lead body comprising a conductor connectable to an implantable pulse generator and extending at least partially into the vertebrae-like portion; at least three C-ring portions, each having a first end and a second end, where the first end of each C-ring portion is coupled to the vertebrae-like portion such that a second end of the first C-ring portion and a second end of a third C-ring portion are on a first side of the vertebrae-like portion and a second end of a second C-ring portion disposed between the first C-ring portion and the third C-ring portion are on a second opposite side of the vertebrae-like portion; and at least one electrode disposed on at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0153] The neural interface may comprise a plurality of electrodes disposed on at least one of the at least three C-ring segments, with adjacent electrodes on the same C-ring segment being electrically coupled by an inter-electrode coil.

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

[0155] The vertebral portion can have a substantially circular cross-section and the second end of the vertebral portion can have 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 the plane defined by the inclined surface.

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

[0157] The distance between the maximum and minimum circumferences may 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 spine-like portion for movement together relative to the second C-ring portion, and the first C-ring portion and the third C-ring portion can extend from the spine-like portion in a direction opposite to that of the second C-ring portion.

[0159] At least one of the at least three C-ring portions of the neural interface can have 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.

[0160] At least one of the at least three C-ring portions of the neural interface may have a gradually increasing thickness between the first end and a point between the first end and the second end.

[0161] At least one of the at least three C-ring portions of the neural interface may have a gradually increasing thickness between the second end and a point between the first end and the second end.

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

[0163] The plurality of perforations in the electrode flange of the neural interface may include at least one perforation on a first side of the electrode flange and at least one perforation on a second, opposing side of the electrode flange.

[0164] The first side of the electrode flange and the second opposing side of the electrode flange may 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 neural interface may be square with rounded corners.

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

[0167] At least one of the anchoring tabs may comprise a coated mesh.

[0168] The lead body may include at least one undulating section.

[0169] The neural interface can be formed by providing a vertebrae-like portion having a first end and a second end, where an outer circumference of the first end of the vertebrae-like portion tapers from a maximum outer circumference to a minimum outer circumference; coupling a lead body to the first end of the vertebrae-like portion, where a conductor of the lead body connectable to an implantable pulse generator extends at least partially into the vertebrae-like portion; coupling at least three C-ring portions to the vertebrae-like portion, where each of the at least three C-ring portions has a first end and a second end, where the first end of each C-ring portion is coupled to the vertebrae-like portion such that a second end of the first C-ring portion and a second end of the third C-ring portion are on a first side of the vertebrae-like portion and a second end of a 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 vertebrae-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.

[0170] The neural interface may further comprise a plurality of electrodes on at least one of the at least three C-ring portions, with adjacent electrodes on the same C-ring portion being electrically coupled by an inter-electrode coil.

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

[0172] The method may further include forming the vertebrae to have a substantially circular cross-section and forming a second end of the vertebrae to have 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 a plane defined by the inclined surface.

[0173] Forming the neural interface can also include forming at least one of the at least three C-ring portions to have 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, a neural interface can comprise: a spine-like portion having a first end and a second end; a lead body coupled to the first end of the spine-like portion, the lead body comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spine-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 spine-like portion such that a second end of the first C-ring portion and a second end of a third C-ring portion are on a first side of the spine-like portion and a second end of a 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 spine-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; and at least one electrode disposed on at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0175] In yet another embodiment, a neural interface can comprise: a vertebrae-like portion having a first end and a second end; a lead body coupled to the first end of the vertebrae-like portion, the lead body comprising a conductor connectable to an implantable pulse generator and extending at least partially into the vertebrae-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 coupled to the vertebrae-like portion such that a second end of the first C-ring portion and a second end of a third C-ring portion are on a first side of the vertebrae-like portion and a second end of a second C-ring portion disposed between the first C-ring portion and the third C-ring portion are on a second opposite side of the vertebrae-like portion, each C-ring portion configured such that, during use, 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; and at least one electrode disposed on 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 a 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 on which electrodes (not shown) are formed. To provide flexibility in the unitary electrode array 1512, in some embodiments, the foil strip 1512 can be cut or formed to form a flexible foil 1514 such that mesh connectors are cut into the foil strip 1512. The flexible foil 1514 has a higher flexibility than the metal foil strip 1512 because the apertures cut into the foil 1514 reduce the cross-sectional area of ​​the foil in areas other than the weld or crimp sites. These reduced cross-sectional areas result in increased flexibility for introduction and provide a unitary (or monolithic) electrode array without any additional connections between the electrodes. In other words, an electrode array without weld-free interconnections (i.e., no welding is used to provide a connection between two electrodes in the array) is provided. For additional strain relief, longer sections (along the strip) with reduced surface area can be provided. There are no welds between the electrodes, although in some embodiments a weld may be required for connection to the lead body.

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

[0178] 15B-15C show other exemplary embodiments 1520, 1530 of C-ring portions formed similarly to C-ring portion 1510 shown in FIG. 15A. In an embodiment, radial punching or other forming methods can also provide additional curvature in the z-axis (e.g., similar to ribbon interconnects) within the reduced width sections to provide additional strain relief. The reduced width areas of the exemplary embodiments 1520, 1530 can increase flexibility and reduce material required.

[0179] FIG 15D is an exemplary embodiment 1540 showing an exemplary cross-sectional view of the embodiment shown in FIG 15A-15C. As discussed above with respect to FIG 15A-15C, reducing the cross-sectional area of ​​the foil makes the final structure easier to bend. As shown in FIG 15D, areas of the conductive wire (also called foil or strip) 1542 are exposed at the radially inner edge of the embodiment 1540, and other areas are inside the device, so that only some portions of the conductive wire 1542 corresponding to the electrode areas are exposed to the target.

[0180] 15E-15H depict various methods of serpentine embodiment 1550 similar to those discussed above in connection with the exemplary C-rings 1520, 1530 of Figures 15A-15C, where the serpentine section between the electrodes provides another weld-free electrode array, where the serpentine section is another form that provides reduced cross-sectional surface area for more flexibility within the section between the electrodes. In an embodiment, the serpentine joints 1552 of the exemplary embodiment 1550 can be formed as leaf springs to provide greater flexibility.

[0181] The embodiment illustrated in Figures 15A-15H provides a means of interconnection that does not require the use of welding or other non-integral joining means between the electrodes - in other words, it is a unitary embodiment.

[0182] FIG. 15I depicts an exemplary embodiment 1560 in which a platinum ribbon 1562 provides the interconnection between the electrodes. For example, the platinum ribbon 1562 is welded using point-to-point welds 1564 across each gap between the electrodes to achieve a spring formation with the ribbon. Platinum-to-platinum welds can provide additional weld strength compared to mixed material welds. The curvature in the ribbon 1562 can provide flexibility to act as a strain relief when "opening" the cuff for implantation or removal. A perfectly 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. Additionally, straight interconnects can cause plastic deformation, such as by permanent "wrinkles" in the material, which can lead to easier breakage. Depending on the material configuration, the embodiment shown in FIG. 15I can provide a simplified welding configuration compared to some of the coil-based embodiments that have more surface area for welding, such as multiple welds or edge welds.

[0183] Further as disclosed herein, a system may include a neural interface according to any of the embodiments disclosed herein above; 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 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 secure the portion of the lead body within the internal cavity by the set screw; and and a deployment tool comprising a tab-shaped body having an end and a second end, a first aperture formed in the first end, a second aperture and a third aperture formed in the second end, and a plurality of sets of small holes formed in the tab-shaped body between the first and second ends, the tab-shaped body further comprising a series of ridges and grooves, the deployment tool being releasably coupleable to the neural interface by a suture that can be threaded through at least one of the first aperture and the plurality of sets of small holes by way of the second and third apertures.

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

[0185] The at least one electrode may include an electrode contact on an electrode flange, the electrode flange mechanically coupling the electrode to the C-ring portion and including a plurality of perforations. The electrode flange may be square with rounded corners. The electrode flange may include a curved bottom edge. The plurality of perforations may include at least one perforation on a first side of the electrode flange and at least one perforation on a second, opposite side of the electrode flange. The first side of the electrode flange and the second, opposite side of the electrode flange may be longer than the third side and the fourth side of the electrode flange. Each of the plurality of perforations may be square with rounded corners. The lead body may include at least one strain relief corrugated section.

[0186] In an embodiment, the neural interface may further comprise a spine-like portion having a first end and a second end, the circumference of the first end of the spine-like portion tapering from a maximum circumference to a minimum circumference, and the lead body being coupled to the first end of the spine-like portion and extending at least partially into the spine-like portion. The spine-like portion may be of substantially circular cross-section, and the second end of the spine-like portion may have a beveled 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 the plane defined by the beveled surface. The maximum circumference of the first end of the spine-like portion may be located near at least three C-ring portions, and the minimum circumference of the first end of the spine-like portion may occur where the spine-like portion terminates on the lead body. The distance between the maximum circumference and the minimum circumference is in the range of 2 mm to 5 mm.

[0187] In an embodiment, the neural interface may further comprise at least two additional C-ring portions, each C-ring portion having a first end and a second end, the first end of each C-ring portion being coupled to the spine-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 spine-like portion and the second end of the second C-ring portion disposed between the first and third C-ring portions is on a second opposite side of the spine-like portion. The first and third C-ring portions may be coupled to the spine-like portion for movement together relative to the second C-ring portion, and the first and third C-ring portions may extend from the spine-like portion in a direction opposite to that of the second C-ring portion. At least one of the at least three C-ring portions may have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first and second ends, the third thickness being greater than the first and second thicknesses. At least one of the at least three C-ring segments has a thickness that gradually increases between the first end and a point between the first end and the second end.At least one of the at least three C-ring segments has a thickness that gradually increases between the second end and a point between the first end and the second end.

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

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

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

[0191] The tether tab may be disposed between the first end of the lead body and a central portion of the lead body midway between the first and second ends of the lead body, and the ratio of the distance between the first end of the lead body and the tether tab to the distance between the second end of the lead body and the tether tab may be between 1:1 and 1:50, optionally 1:2, 1:3, 1:4, or 1:5. The tether tab may be movable along the lead body.

[0192] The lead body may include more flexibility in a portion of the lead body 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, a system comprises a neural interface according to any embodiment, configuration, or combination described herein above, and a deployment tool removably coupleable to the neural interface for introduction of the neural interface. The deployment tool may comprise a first section configured to be positioned proximate to the neural interface, and a connector tethered to the first section for releasably coupling the first section to the neural interface. The deployment tool may comprise a planar shape or a triangular shape.

[0194] In embodiments, the deployment tool can further comprise a second section and a central section between the first section and the second section. The first section can be wider than the second section.

[0195] A cut through the deployment tool can sever the connector and release the coupling between the deployment tool and the neural interface such that at least the first section moves away from the neural interface device.

[0196] The deployment tool can further include at least one passageway extending through the central region from the first region to the second region, each passageway including a first opening in the first region and a second opening in the second region.

[0197] The connector can be a suture anchored to the first section for passing through at least one passage from the second opening to the first opening to hold the first section close to the implantable device.

[0198] The deployment tool can further include a cuttable portion extending across the at least one passageway, the cuttable portion configured to release at least a portion of the connector in the at least one passageway when the cuttable portion is cut, wherein releasing at least a portion of the suture enables the first section to move away from the implantable device.

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

[0200] The at least one passageway may include a first passageway and a second passageway, the first portion passing through the first passageway and the third portion passing through the second passageway.

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

[0202] The cuttable portion can be a recessed area in the central region that extends across at least the first and second passages. The recessed area in the central region can extend across only a portion of the width of the central region, such that 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, such that when the recessed area is cut to release the connector, the central region is cut into two pieces. At least the central region can include a series of alternating lateral ridges and valleys that extend across the width of the central region to provide lateral stiffness when the deployment tool is unfolded while providing longitudinal flexibility to allow the deployment tool to be rolled up. The first and second regions include alternating lateral ridges and valleys that extend across the width of the first region and the width of the second region. The at least one passageway may be formed by a tunnel through each lateral ridge and a tube across each lateral valley. The cuttable portion may be a lateral valley. The connector may be anchored to the first section by molding into the first section. The connector may be anchored to the first section by gluing. The first section, second section, and central section may be molded from silicone. At least the second section may taper toward a second opening. The tapered second section may 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, where the first surface provides an indication of the location of the cuttable portion and the second surface includes a plurality of longitudinal grooves along a length of the deployment tool to reduce contact.

[0204] At least the second region and the central region can be tapered, 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 in thickness from an edge of the second region toward the central region. The thickness can increase from an edge of the second region toward the central region. The second region can include rounded edges.

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

[0206] The neural interface may comprise a first arm that is moved in a first direction and one or more second arms that are moved in a second direction substantially opposite to the first direction, and the second portion of the connector may be removably attached to the one or more second arms. The one or more second arms may include two arms positioned on either side of the first arm, one of the two arms being aligned with the first opening of the first passageway and the other of the two arms being aligned with the first opening of the second passageway. The one or more second arms may include a first small hole and the other arm includes a second small hole, and the second portion of the connector may be removably attached to the cuff by passing through the first small hole and the second small hole to hold the first section close to the cuff, and then the second portion of the connector may be pulled away from the cuff when at least one of the first section or the third section is cut at the cuttable section. The thickness of the central section of the tab may be equal to or greater than the thickness of the neural interface. The one or more second arms can have an arm height in a direction perpendicular to both the width and length of the tab, and the central section has a height running substantially parallel to the arm height, the height of the central section being greater than the arm height. The width of the first section of the tab is greater than or equal to the width of the neural interface.

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

[0208] The deployment tool can be configurable as a measurement tool to measure the fit of the neural interface relative to the target. The fit measurement can be determined based on a distance between ridges or grooves or valleys of the deployment tool. The fit measurement can be determined based on a distance between a first portion of the deployment tool and a second portion of the deployment tool.

[0209] The system may further include a lead cap device comprising a body having a first end and a second end and 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 the lead body within the internal cavity and secure the portion of the lead body within the internal cavity with the set screw. An IPG connector portion of the lead body may be removably received within the internal cavity of the lead cap device.

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

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

[0212] In one embodiment, a neural interface comprises: a vertebrae-like portion having a first end and a second end, where an outer circumference of the first end of the vertebrae-like portion tapers from a maximum outer circumference to a minimum outer circumference; a lead body coupled to the first end of the vertebrae-like portion, the lead body comprising a conductor connectable to an implantable pulse generator and extending at least partially into the vertebrae-like portion; at least three C-ring portions, each having a first end and a second end, where the first end of each C-ring portion is coupled to the vertebrae-like portion such that a second end of the first C-ring portion and a second end of a third C-ring portion are on a first side of the vertebrae-like portion and a second end of a second C-ring portion disposed between the first C-ring portion and the third C-ring portion are on a second opposite side of the vertebrae-like portion; and at least one electrode disposed on 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 neural interface includes providing a vertebrae-like portion having a first end and a second end, where an outer circumference of the first end of the vertebrae-like portion tapers from a maximum outer circumference to a minimum outer circumference; coupling a lead body to the first end of the vertebrae-like portion, where a conductor of the lead body connectable to an implantable pulse generator extends at least partially into the vertebrae-like portion; coupling at least three C-ring portions to the vertebrae-like portion, where each of the at least three C-ring portions has a first end and a second end, where the first end of each C-ring portion is coupled to the vertebrae-like portion such that a second end of the first C-ring portion and a second end of the third C-ring portion are on a first side of the vertebrae-like portion and a second end of a 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 vertebrae-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 neural interface can comprise: a spine-like portion having a first end and a second end; a lead body coupled to the first end of the spine-like portion, the lead body comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spine-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 spine-like portion such that a second end of the first C-ring portion and a second end of a third C-ring portion are on a first side of the spine-like portion and a second end of a 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 spine-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; 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 neural interface can comprise: a vertebrae-like portion having a first end and a second end; a lead body coupled to the first end of the vertebrae-like portion, the lead body comprising a conductor connectable to an implantable pulse generator and extending at least partially into the vertebrae-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 coupled to the vertebrae-like portion such that a second end of the first C-ring portion and a second end of a third C-ring portion are on a first side of the vertebrae-like portion and a second end of a second C-ring portion disposed between the first C-ring portion and the third C-ring portion are on a second opposite side of the vertebrae-like portion, each C-ring portion configured such that, during use, 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; and at least one electrode disposed on at least one of the at least three C-ring portions and electrically coupled to the conductor.

[0216] In a further embodiment, a system may comprise a neural interface of any of the embodiments disclosed herein; 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 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 releasably receive a portion of a lead body within the internal cavity and secure the portion of the lead body within the internal cavity by the set screw; and a deployment tool comprising a tab-shaped body having a first end and a second end, a first aperture formed in the first end, a second aperture and a third aperture formed in the second end, and a plurality of sets of small holes formed in the tab-shaped body between the first end and the second end, the tab-shaped body further comprising a series of ridges and grooves, the deployment tool being releasably coupleable to the neural interface by a suture that may be passed through at least one of the first aperture and the plurality of sets of small holes.

[0217] Additionally or alternatively, examples consistent with the present teachings are set forth in the following numbered sections:

[0218] The features and components of different embodiments discussed herein can be combined in other embodiments. In addition, 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 distortion can be used in various other types of devices where lead distortion may be an issue. In another example, the configuration of components for laser welding can have applicability in other types of devices and structures. Those skilled in the art will understand how still other features and components discussed herein can be used in other applications and methods with other devices and systems. In this manner, specific effects can be designed and achieved to meet specific wants or needs in the industry. Dimensions provided in the description or drawings are examples and may vary independently or in combination in other embodiments. Ranges or dimensions disclosed as values ​​with "about" or "approximately" may vary within ±5 percent of the value.

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

[0220] Those skilled in the art will understand that the inventive subject matter may 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 listing of ways in which various features of the inventive subject matter may be combined. Thus, those skilled in the art will understand that the embodiments are not mutually exclusive combinations of features, and that various embodiments may include combinations of different individual features selected from different individual embodiments. Furthermore, unless otherwise stated, elements described with respect to one embodiment may be implemented in other embodiments even when not described in such embodiment.

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

[0222] Applicant hereby incorporates by reference the contents of its previously filed PCT application, published as WO2019 / 020986. In particular, the electrodes described herein can be replaced with the coil electrodes described therein. Any incorporation by reference of the above documents is limited such that no subject matter is incorporated that is inconsistent with the express disclosure herein. Any incorporation by reference of the above documents is further limited such that the claims contained therein are not incorporated by reference herein. Any incorporation by reference of the above documents is further limited such that any definitions provided in these documents are not incorporated by reference herein unless expressly included herein.

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

Claims

1. at least one C-ring portion, the at least one C-ring portion applying a radial pressure in the range of 1 mmHg to 30 mmHg to a target tissue disposed within the at least one C-ring portion, and at least one electrode disposed on the at least one C-ring portion; at least one tether tab connected to the lead body, the at least one tether tab comprising a covering mesh; Neural interface.

2. The neural interface of claim 1 , further comprising a lead body comprising a conductor connectable to an implantable pulse generator, the at least one electrode being electrically coupled to the conductor.

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; a stiffness of said at least one electrode; the size and shape of the at least one electrode; The number of electrodes; the ratio of electrodes compared to the insulating material in the C-ring portion; a gap size between two of the at least one electrode; a characteristic of the interconnections between different ones of the at least one electrode; the thickness of the insulating material; and The neural interface of claim 1 , wherein radial pressure is applied based on one or more of the group including a diameter of the neural interface.

4. 2. The neural interface of claim 1, wherein the at least one C-ring portion has an inner diameter and a cross-sectional thickness, the ratio of the inner diameter to the cross-sectional thickness being within a range of 5:1 to 6:

1.

5. 5. The neural interface of claim 1, wherein the at least one electrode comprises 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.

6. The neural interface of claim 5, wherein the electrode flange is square with rounded corners.

7. 7. The neural interface of claim 5 or 6, wherein the electrode flange comprises a curved bottom edge.

8. 8. The neural interface of claim 5, wherein 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.

9. 9. The neural interface of claim 8, wherein the first side of the electrode flange and the second opposing side of the electrode flange are longer than a third side and a fourth side of the electrode flange.

10. The neural interface of any one of claims 5 to 9, wherein each of the plurality of perforations is square with rounded corners.

11. The neural interface of claim 2 , wherein the lead body comprises at least one tension relief corrugated section.

12. a spine having a first end and a second end, the first end of the spine tapering in circumference from a maximum circumference to a minimum circumference; the lead body is coupled to the first end of the vertebral portion and extends at least partially into the vertebral portion; A neural interface according to claim 2 or 11.

13. 13. The neural interface of claim 12, wherein the vertebrae have a substantially circular cross-section and the second end of the vertebrae has an inclined surface such that a plane parallel to the substantially circular cross-section forms an angle with a plane defined by the inclined surface that is greater than 0 degrees and less than 90 degrees.

14. 14. The neural interface of claim 12 or 13, wherein the maximum circumference of the first end of the spine is near the at least three C-ring portions and the minimum circumference of the first end of the spine occurs where the spine terminates on the lead body.

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

16. 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 spine-like portion such that the second end of a first C-ring portion and the second end of a third C-ring portion are on a first side of the spine-like portion, and the second end of a 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 spine-like portion. A neural interface according to any one of claims 12 to 15.

17. 17. The neural interface of claim 16, wherein the first C-ring portion and the third C-ring portion are coupled to the spine-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 extend from the spine-like portion in a direction opposite to that of the second C-ring portion.

18. 18. The neural interface of claim 16 or 17, wherein 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.

19. 20. The neural interface of claim 18, wherein a thickness of the 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.

20. 20. The neural interface of claim 18 or 19, wherein 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.

21. 21. The neural interface of any one of claims 16 to 20, further comprising a plurality of electrodes disposed on at least one of the at least three C-ring portions, wherein adjacent electrodes on the same C-ring portion are electrically coupled by an inter-electrode coil.

22. The neural interface of claim 1 , wherein the at least one anchoring tab comprises a coated mesh.

23. 23. The neural interface of claim 21 or 22, wherein the C-ring portion is provided at a first end of the lead body, a connector to an implantable pulse generator (IPG) is provided at a second end of the lead body, and the anchoring tab is provided between the first and second ends of the lead body.

24. 24. The neural interface of claim 23, wherein the tether tab is disposed between the first end of the lead body and a central portion of the lead body midway between the first end and the second end of the lead body, and wherein 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.

25. 25. The neural interface of any one of claims 1 to 24, wherein the tethering tab is movable along the lead body.

26. 26. The neural interface of any one of claims 1 to 25, wherein the lead body has a higher flexibility in a portion of the lead body closer to the C-ring portion compared to a portion of the lead body further from the C-ring portion.

27. 27. The neural interface of any one of claims 1 to 26, wherein multiple electrodes are electrically connected in parallel.

28. 22. The neural interface of any one of claims 2 or 11-21, wherein the conductor comprises a single continuous coil electrically coupled to multiple electrodes located in one of the C-ring portions.

29. 30. The neural interface of claim 28, wherein the single continuous coil includes a conductive bushing corresponding to each electrode.

30. 30. The neural interface of claim 29, wherein the conductive bushings are crimped for mechanical and electrical connection with the single continuous coil, and each crimped bushing is further configured to be welded to a corresponding respective electrode such that the single continuous coil is electrically connected to the electrode.

31. 31. The neural interface of claim 29 or 30, wherein the electrode comprises an internal sleeve for housing the single continuous coil.

32. A neural interface according to any one of claims 1 to 31, a deployment tool removably coupleable to the neural interface for deployment of the neural interface; A system comprising:

33. 33. The system of claim 32, wherein the deployment tool is configurable as a measurement tool for measuring the fit of the neural interface relative to a target.

34. 34. The system of claim 32 or 33, wherein the deployment tool is configured to function as a blunt dissection tool.

35. 35. The system of any one of claims 32 to 34, wherein a thickness of the deployment tool is greater than a thickness of a C-ring portion of the neural interface.

36. 35. The system of any one of claims 32 to 34, wherein a width of the deployment tool is greater than a width of the neural interface.

37. 37. The system of any one of claims 32 to 36, 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 toward the second end and a suture loop coupled to the second end, the lead cap device configured to removably receive a portion of the lead body within the internal cavity.

38. 38. The system of claim 37, wherein an IPG connector portion of the lead body is removably received within the internal cavity of the lead cap device, the lead cap device further comprising a set screw block disposed within the body such that a set screw intersects with the internal cavity and configured to secure the portion of the lead body within the internal cavity with the set screw.

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

40. 40. The system of claim 39, wherein the electrodes of the larger inner diameter neural interface device comprise a smaller width and a greater length than the electrodes of the smaller inner diameter neural interface device.

41. 41. The system of any one of claims 32 to 40, wherein the deployment tool is positioned within the C-ring portion of the neural interface.

42. 42. The system of claim 41, wherein the deployment tool is at least partially retracted within the neural interface.

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