Patent Application
20220409888
The present disclosure relates generally to neuromodulation and more particularly to embodiments of extravascular and intravascular devices comprising electrodes for neuromodulation.
Electrical devices of various shapes and sizes including one or more electrodes have been used for neurostimulation/neuromodulation of target anatomy.
Conventional designs lack radial flexibility and self-sizing capabilities. If the target vessel is excessively compressed by the device, nerve damage may result from the decreased blood flow and constricted nerve fibers. Temporary swelling of the target vessel caused by the trauma of the positioning of the device can exacerbate such nerve damage. In contrast, loose fitting devices can result in poor electrical contact and low treatment efficiency, which can further degrade over times as a result of ingrowth of connective tissue between the target vessel and the device.
In an embodiment, a neural interface comprises at least one C-ring portion for applying a radial pressure in a range of 1 mmHg to 30 mmHg to a target tissue arranged within the C-ring portion and comprising at least one electrode arranged on the at least one C-ring portion.
The neural interface can further include a lead body comprising a conductor connectable to an implantable pulse generator, wherein the at least one electrode is electrically coupled to the conductor. The C-ring portion can apply a radial pressure based upon rigidity of an insulating material that makes up a body of the C-ring portion, thickness of an insulating material that makes up the body of the C-ring portion, rigidity of the at least one electrode, a size and shape of the at least one electrode, a quantity of electrodes, a proportion of electrode compared to the insulating material of the C-ring portion, a gap size between two electrodes of the at least one electrode, properties of the interconnect between different electrodes of the at least one electrode, thickness of the c-ring material, and a diameter of the neural interface. The C-ring portion(s) can have an inner diameter and a cross-sectional thickness, with a ratio of the inner diameter to the cross-sectional thickness being in a range of 5:1 to 6:1. The electrode can 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 can be rectangular with rounded corners. The electrode flange can include a curved under edge. The plurality of perforations can include at least one perforation on a first side of the electrode flange and at least one perforation on a second opposing side of the electrode flange. The first side of the electrode flange and the second opposing side of the electrode flange can be longer than a third side and a fourth side of the electrode flange. The plurality of perforations can be rectangular with rounded corners. The lead body can include at least one strain relieving undulating section.
The neural device can include a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference, and the lead body can be coupled to the first end of the spinal portion and extending at least partially into the spinal portion. The spinal portion can have a substantially circular cross-section, and the second end of the spinal portion has an angled surface such that a plane parallel to the substantially circular cross-section is at an angle of greater than 0 degrees and less than 90 degrees with respect to a plane defined by the angled surface. The maximum circumference of the first end of the spinal portion can be found proximate the at least three C-ring portions, and the minimum circumference of the first end of the spinal portion occurs where the spinal portion terminates on the lead body. The distance between the maximum circumference and the minimum circumference can be in a range of 2 mm to 5 mm.
The neural interface can 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 spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion. The first C-ring portion and the third C-ring portion can be coupled to the spinal portion to move together and relative to the second C-ring portion, and wherein the first C-ring portion and the third C-ring portion extend from the spinal portion in a direction opposing a direction of the second C-ring portion. At least one of the C-ring portions can have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first end and the second end, such that the third thickness is greater than the first thickness and the second thickness. A thickness of any of the C-ring portions can gradually increase between the first end and the point between the first end and the second end. A plurality of electrodes can be arranged 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.
The neural interface can include at least one anchoring tab coupled to the lead body. The anchoring tab can include a coated mesh, optionally wherein the mesh is coated with a material that fills the mesh. The C-ring portion can be provided at a first end of the lead body and a connector to an implantable pulse generator (IPG) is provided at a second of the lead body, further wherein the anchoring tab is provided between the first end and the second end of the lead body. The anchoring tab can be provided between the first end of the lead body and a middle section of the lead body situated half-way between the first end and the second end of the lead body, further wherein a ratio of a distance between the first end of the lead body and the anchoring tab and a distance between the second end of the lead body and the anchoring tab is between 1:1 and 1:50, optionally 1:2, 1:3, 1:4 or 1:5. The anchoring tab can be moveable along the lead body. The lead body can have increased flexibility in a portion closer to the C-ring portion compared to a portion of the lead body further away from the C-ring portion.
According to another embodiment, a system includes the neural interface as described above, as well as a deployment tool being removably coupleable to the neural interface for deployment of the neural interface. The deployment tool can include a first area configured to be positioned near the neural interface, and a connector for releasably coupling the first area to the neural interface, anchored to the first area. The deployment tool can have a planar shape or a triangular shape, in embodiments. The deployment tool can also include a second area and a central area between the first area and the second area. The first area can be wider than the second area. A cut through the deployment tool can cut through the connector and releases the coupling between the deployment tool and the neural interface for at least the first area to move away from the neural interface device. The deployment tool can further include at least one passage extending from the first area to the second area through the central area, each passage including a first opening in the first area and a second opening in the second area. The connector can be a suture thread for passing through the at least one passage from the second opening to the first opening and for holding the first area near the implantable device, and anchored to the first area. The deployment tool can further include a cuttable portion extending across the at least one passage and configured to release at least one portion of the connector within the at least one passage when the cuttable portion is cut through, wherein the release of the at least one portion of the suture thread enables the first area to move away from the implantable device.
The connector can include a first portion that passes through the at least one passage from the second opening to the first opening, wherein the connector includes a second portion that is removably attached to the implantable device, wherein the connector includes a third portion that passes through the at least one passage from the first opening to the second opening, and wherein the first portion is connected to the second portion and the second portion is connected to the third portion. Systems can include both a first passage and a second passage, wherein the first portion passes through the first passage, the third portion passes through the second passage. The first area and the second area can include rounded edges. The cuttable portion can be a depressed area in the central area that extends across at least the first passage and the second passage. The depressed area in the central area can extend only across a portion of width of the central area so that at least a portion of the central area is not cut into two pieces when the depressed area is cut through to release the connector. The depressed area can extend across a whole width of the central area so that the central area is cut into two pieces when the depressed area is cut through to release the connector. The central area can include a series of alternating lateral ridges and lateral valleys that extend across a width of the central area, for providing longitudinal flexibility that enables the deployment tool to be rolled up while providing lateral stiffness when the deployment tool is unrolled. The first area and the second area can include the alternating lateral ridges and lateral valleys that extend across a width of the first area and a width of the second area. The passage can be formed by a tunnel through each lateral ridge and a tube across each lateral valley. The cuttable portion can be a lateral valley. The connector can be anchored to the first area by being molded into the first area. The connector can be anchored to the first area by adhesive. The first area, second area, and central area can be molded from silicone. The second area can be tapered toward the second opening. The tapered second area can include a gripping point for manipulation, and the gripping point can include an opening. The deployment tool can include a first surface and a second surface opposite the first surface, the first surface providing an indication of the location of the cuttable portion, the second surface including a plurality of longitudinal grooves along a length of the deployment tool for reduced contact. The second area and the central area can be tapered, and a first portion of the plurality of longitudinal grooves can extend from the first area to the second area through the central area and a second portion of the plurality of longitudinal grooves extend from the first area to the central area. The second area can taper in thickness from an edge of the second area towards the central area. The thickness can increase from the edge of the second area towards the central area. The second area can include a rounded edge.
The neural interface can be a cuff that includes a spine and at least two curved arms extending from the spine and comprising electrodes, wherein each open end of the curved arm is removably coupled to the deployment tool. The neural interface can include a first arm for being moved in a first direction and one or more second arms for being moved in a second direction substantially opposite the first direction, and wherein the second portion of the connector is removably attached to the one or more second arms. The second arms can include two arms positioned on opposite sides of the first arm, one arm among the two arms aligned with the first opening of the first passage and the other arm among the two arms aligned with the first opening of the second passage. The second arms can include corresponding eyelets, and the second portion of the connector can be removably attached to the cuff by passing through the first eyelet and the second eyelet so as to hold the first area near the cuff until at least one of the first portion or the third portion is cut through at the cuttable portion so that the second portion of the connector can be pulled away from the cuff. The thickness of the central area of the tab can be equal or larger than a thickness of the neural interface. The second arms can have an arm height in a direction perpendicular to both a width and length of the tab, wherein the central area has a height that runs substantially parallel to the arm height, and wherein the height of the central area is greater than the arm height. The width of the first area of the tab can be equal or larger than a width of the neural interface. The cuff can have a width measured from an outer side of the one arm to an outer side of the other arm and that runs substantially parallel to the width of the first area, and wherein the width of the first area is greater than a width of the cuff. The deployment tool can be configurable as a measurement tool for measuring a fit of the neural interface to a target. A measurement of a fit can be determined based on a distance between the ridges or grooves or valleys of the deployment tool. The measurement of a fit 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. A thickness of the deployment tool can be larger than a thickness of a C-ring-portion of the neural interface. A width of the deployment tool can be larger than a width of the neural interface.
The deployment tool can be positioned within the C-ring portion of the neural interface. The deployment tool can be rolled at least partly in the neural interface, for example in the C-ring portion. The deployment tool can thus be configured to protect electrodes in the C-ring portion until deployment of the neural interface.
The systems described above may further include a lead cap device having a first end and a second end and comprising a body defining an internal cavity that extends 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 in the internal cavity. An IPG connector portion of the lead body can be removably received in the internal cavity of the lead cap device, further wherein the lead cap comprises a set screw block arranged in the body such that a setscrew intersects with the internal cavity and is configured to secure the portion of the lead body in the internal cavity by the setscrew. In some embodiments, the system comprises a neural interface as disclosed above and a lead cap device (i.e. without the deployment tool).
A system as described above can include inner diameters of the neural interface devices that differ whilst a total electrode area of each neural interface device is substantially equal. The electrode of a larger inner diameter neural interface device can have a smaller width and a larger length than an electrode of a smaller inner diameter neural interface device. A plurality of electrodes can be electrically connected in parallel. The conductor can include a single continuous coil electrically coupled to a plurality of electrodes on one of the C-ring portions. The single continuous coil can include a conductive bushing corresponding to each electrode. The conductive bushing can be crimped for mechanical and electrical connection with the single continuous coil, further wherein each crimped bushing is configured to be welded to each corresponding electrode such that the coil is electrically connected to the electrode. The electrode can have an inbuilt sleeve for accommodating the single continuous coil. A ratio of the gap between interconnecting electrodes to the interconnector can be between 1:2-1:3.
In an embodiment, a system comprises a neural interface as disclosed herein, including that of the preceding paragraph; and a deployment tool being removably coupleable to the neural interface for deployment of the neural interface.
In an embodiment, an implantable system comprises a neural interface as disclosed herein, including that of any preceding paragraph; and an anchoring tab configured to be secured to a right crus of the diaphragm.
The anchoring tab may be as disclosed herein, including that of any preceding paragraph describing the anchoring tab. The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments.
The subject matter of this disclosure may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:
The present disclosure is related to embodiments of extravascular and intravascular neural interface devices containing electrodes for neurostimulation/neuromodulation of a target nerve or vessel. The devices may be housed in flexible substrates, each substrate having a central portion through which conductors for the electrodes are routed and housed. Extending from the central portion are a plurality of curvilinear flaps or arms that support the electrodes and position the electrodes to either be inward facing, i.e., extravascular designs, or outward facing, i.e., intravascular designs. An extravascular neural interface device is configured to be positioned outside of the target vessel, while an intravascular neural interface device is configured to be positioned at least partially within the target vessel. The substrate flaps or arms may include one or more electrodes and be configured to place one or more of the electrodes at specific positions relative to the target vessel.
An embodiment of a bi-polar, extravascular neural interface in accordance with the present disclosure is illustrated in
The substrate 102 may include two C-ring portions 104 and 106, each connected by a spinal portion forming a helix of one turn (when combined with a center portion 109 and one of the portions 104 or 106) in the opposite direction from a common center section 108 of a central portion 109, and ending in an C-ring configuration where the C-ring is substantially orthogonal to the target vessel once positioned. Arranged within each C-ring end portion 104 and 106 may be multiple platinum or platinum alloy electrodes (or electrode arrays), such as electrode arrays 112 and 114, versus multiple helical structures as in conventional systems. The electrodes arrays 112 and 114 may be of a conventional type and wired to a controller through conventional conductors 118, such as 35N LT® DFT (Drawn Filled Tubing) with a 28% Ag core, in a stranded cable configuration (i.e., 7×7 configuration—not shown), or in a multi-filar coil configuration. The conductors are housed in a spine or spinal portion 120 that is affixed to end portion 106 and part of central portion 109.
The configuration of the neural interface 100 may make it possible to significantly shorten the length of the neural interface 100, thereby reducing the portion of target vessel or nerve that needs to be mobilized during placement. In addition, the opposing helical directions of the portions 104 and 106, which each have a low helix angle relative to the spinal portion 120 may allow the neural interface 100 to be deployed and wound around the target vessel in one pass instead of at least two, as with conventional helical structures. A low helix angle or low pitch may allow the length of the neural interface 100 (or its distal end) to be shorter, which may result in less dissection of tissue during positioning.
The substrate 102 may include a number of attributions 110 placed at different points on or in the substrate 102. The attribution may be configured to enable a deployment tool (not shown) to grip, manipulate and deploy the neural interface 100. Thus, each attribution may be referred to as a deployment feature. The attributions may be protrusions. One or more protrusions may include one or more openings or eyelets for receiving a stylet (made of tungsten or similar material), for instance, in order to enable portions of the substrate to be straightened or to deploy the neural interface. The attributions 110 may also be openings, eyelets or some other form of lumen that may be equally manipulated by a deployment tool.
In an embodiment, the attributions 110 may be placed sufficiently near the open ends of the C-rings of portions 104 and 106 and near the end of center section 108 to enable the deployment tool to grip the attributions and simultaneously open the portions 104 and 108 and the center section 108 so that the neural interface may be positioned around the target vessel (not shown). As referred to herein, “open ends” refer to the ends positioned around the circumference of the C-rings, which are not attached to another feature (e.g., another C-ring or a spinal portion). In other words, each one of the “open ends” forms a side of a gap for the target vessel. Similarly “closed ends” refer to ends positioned around the circumference of the C-rings which are attached to another feature. In other words, each one of the “closed ends” does not form a gap for the target vessel. Once the neural interface 100 has been positioned around the target vessel, the deployment tool would carefully release the attributions so that the portions 104 and 108 and the center section 108 may softly self-size to the target vessel. By “self-size” it is meant that the neural interface 100 conforms to the shape of the target vessel of its own accord.
The C-ring can exhibit a radial pressure on the target vessel, nerve, or other structure. The amount of pressure applied can depend on a number of factors. The material that makes up the C-ring portions is, for example, an insulative material and an electrically conductive portion (such as an electrode, a coil, foil, or weldments as described below) that passes therethrough or is exposed at least in part (such as an electrode). The C-ring portion applies a radial pressure that is a function of a number of features, such as the rigidity of an insulating material that makes up a body of the C-ring portion (for example 70-80 Shores). The thickness of an insulating material that makes up the body of the C-ring portion also affects the radial pressure, as does the rigidity or hardness of electrode or electrodes passing through the C-ring. As described in more detail below with respect to
Thickness of the C-ring material is, for example, between about 0.5mm-2 mm, such as about 1 mm, about 1.2 mm, or about 1.4 mm, in some embodiments. The thickness is defined along the radial direction from the central axis shown in
As shown in
Depending on the above discussed physical aspects, and depending upon the resting radius of the C-ring relative to the nerve or vessel that it is applied to (i.e., how much the C-ring is expanded), the radial pressure exerted by the C-ring can be determined as an average contact pressure. The term “resting radius” used herein refers to the inner radius of the device when no external force is applied to it. A device may have a different resting radius when positioned on a target, as the target can maintain an enlarged radius compared to the resting radius in isolation, biasing the device to a relatively more open position. This average contact pressure can be between about 0 mmHg and about 30 mmHg In some embodiments, the average contact pressure can be between about 5 mmHg and about 25 mmHg, or between about 5 mmHg and about 20 mmHg, or between about 10 mmHg and about 20 mmHg, or between about 10 mmHg and about 15 mmHg In preferred embodiments, the C-ring will exhibit at least some radial pressure (e.g., at least 1 mmHg) but will not exert so much pressure as to damage the underlying anatomical structure.
The change in radial size can correspond directly to the amount of radially applied force. Radial pressure, as referred to herein, corresponds to an applied pressure when the C-rings or the cuff are opened by about 0%-40% (i.e., 0-40% increase in the diameter of the cuff when deployed on a target compared to the original cuff diameter size). In other words, the average radial pressure exerted by the C-ring is between about OmmHg and 30mmHg when the cuff diameter expansion is anywhere between 0%-40%. In some embodiments, the average radial pressure exerted by the C-ring is between about OmmHg and 30mmHg when the cuff diameter expansion is anywhere between 0% and 35%. In some embodiments, the average radial pressure exerted by the C-ring is between about OmmHg and 30 mmHg when the cuff diameter expansion is anywhere between 0% and 30%. In some embodiments, the average radial pressure exerted by the C-ring is between about 0 mmHg and 30 mmHg when the cuff diameter expansion is anywhere between 0% and 25%. In some embodiments, the average radial pressure exerted by the C-ring is between about 0 mmHg and 30 mmHg when the cuff diameter expansion is anywhere between 0% and 20%. Preferred expansion may be between 10%-30% in some embodiments for desirable electrical contact and average radial pressure. Expansion beyond 40% typically occurs only during deployment or removal of the C-ring from the target.
Detachment force or retention force refer to the force required to remove the device from the target after it has been placed at least partially around the target anatomical structure. Detachment force can be between 0.05N-0.5N in some embodiments. In a preferred embodiment, detachment force can be between 0.1-0.2N. In a preferred embodiment, a detachment force of about 0.15N when pulled in perpendicular direction from the target axis is sufficient to remove the device from the target.
Whilst embodiments comprising three open ended arms are discussed as an example and depicted, various aspects of the present disclosure may be applied to neural interface with different shapes or arrangements. For example, the neural interface may comprise only one open ended arm, two open ended arms, or more than three open ended arms. Further, the neural interface may comprise arms with the same coupling and opening orientations, alternating coupling and opening orientations, or other patterns of arm coupling and arm orientations; arms of different relative sizes; arms of different or varying helical angles; and other variations, including as discussed herein with respect to other embodiments.
Another embodiment of a neural interface 200, similar in structure to the embodiment illustrated in
However, unlike neural interface 100, the two end portions 304 and 306 may also not be connected to the center section. Instead, a center portion 330 forming a third C-ring may be utilized. The end portions 304 and 306 and the center portion 330 may have a very low helix angle, i.e., pitch, relative to the spinal portion 308, which enables the neural interface to be helical, but still have a significantly shorter length. The helix angle may be between approximately 15 and 30 degrees, but may also be less than 15 degrees.
As with neural interface 100, each of the C-rings of the neural interface 300 may include one or more electrodes or an array of electrodes, such as 312, 314 and 316, each connected to a conductor 318 through the spinal portion 308. A one-electrode design may make it possible to maximize electrode coverage while minimizing the conductor interconnection process, such as through laser welding, resistance welding, etc. However, to minimize the rigidity of the electrode, i.e., making it sufficiently flexible, the electrode may have to be very thin (typically between 25 μm and 50 μm), which may make the interconnection of the conductors to the electrodes more challenging. Also, to keep the electrode as flexible as possible, surface features may not be possible to add to the electrode as it would decrease the electrode flexibility. For this reason, a one electrode may feature recessed electrodes with silicone rims or silicone webbing that may serve to hold the electrode in place. However, recessing the electrode may potentially decrease the efficacy of the stimulation. On the other hand, “segmented” electrode designs may provide better mechanical compliance, create the possibility of surface features, i.e., protruding electrodes, and make it possible to control each electrode individually (i.e., current steering). The trade-offs include limited electrode coverage, increased interconnection processes, decreased retention force. Segmented electrodes provide increased flexibility to the neural interface, thereby making it possible open a C-ring with a deployment tool wider and for a longer period of time, without creating excessive stress on the electrodes, than might be possible with a single electrode.
As shown in
The neural interface 300 may also include at least one attribution 310 that may be positioned on the outer surface of the substrate 302 near the open ends of each C-ring of the portions 304, 306 and 330. As noted above, the attributions may include one or more openings or eyelets for receiving a stylet (made of tungsten or similar material), for instance, in order to enable portions of the substrate to be straightened and/or to deploy the neural interface. The attributions 310 may be configured to enable a deployment tool (not shown) to grip, manipulate and deploy the neural interface 300. In an embodiment, the attributions 310 may be placed sufficiently near the open ends of the C-rings of portions 304, 306 and 330 to enable the deployment tool to grip the attributions 310 and simultaneously open the portions 304, 308 and 330 so that the neural interface 300 may be positioned around the target vessel (not shown). Once the neural interface 300 has been positioned around the target vessel, the deployment tool would carefully release the attributions so that the portions 304, 308 and 330 may softly self-size to the target vessel. The configuration of the neural interfaces 100 and 300 may enable the neural interfaces to be positioned in a single pass around the nerve/vessel with minimal manipulation of the nerve/vessel and a reduction in tissue dissection around the area of the nerve/vessel where the interface is positioned.
The neural interface 400 in
The center portion 430 may not include any electrodes, serving just to retain the neural interface once positioned, but embodiments may include electrodes.
The neural interfaces 100, 200, 300 and 400 may be self-sizing; meaning that they may be formed of flexible materials that allow them to be manipulated for deployment, but when released return to a predetermined shape, much like a nitinol cage can be reduced down to fit in a catheter and return to its pre-reduced shape once released from the catheter. This may enable the neural interfaces to be used to accommodate anatomical variability of the intervention site, yet still provide good electrical contact between the electrode arrays and the surface of the nerve/vessel, thereby improving the efficient of the interface. The flexible material of the interface may remain compliant even when it has self-sized to a nerve or vessel. This may help to prevent the neural interface from compressing a nerve or vessel and causing reduced blood flow and otherwise constricting nerve fiber. This may also better accommodate radial expansion of the nerve/vessel as a result of post-positioning edema or swelling and may accommodate the pulsatile behavior of intervention sites such as arteries.
The naturally open structure of the helix of the neural interfaces 100, 200, 300 and 400 may reduce coverage of the nerve/vessel periphery to promote more normal fluid and nutrient exchange with the intervention site and surrounding tissue. This may also help to minimize growth of connective tissue between the electrode nerve/vessel interfaces. The open structure of each neural interface is configured such that no end portion or center portion forms a closed circumscribed circular arc around the target vessel at any point along a length of the target vessel. In other words, no closed circle covering 360 degrees of an orthogonal portion of the target vessel's length is formed by the structure. This open unrestricted trench may serve to ensure that the target vessel may pulsate without constriction and that an initially swollen target vessel can return to a normal state over time without constriction of the target vessel when it is swollen and without losing electrode to target vessel contact when the target vessel is in its normal state.
The electrode or electrode arrays 520, 522 and 524 may also be positioned at different locations within each of the portions 510, 512 and 514. The number of electrodes and their placement with the electrode arrays may vary. As shown in
As with the neural interface 100 and 300 described above, neural interface 500 is also self-sizing, in that the shapes of the portions 510, 512 and 514 are designed to substantially fit around most of the exterior circumference of the target vessel and the ribs are biased to a relaxed position that will cause them to wrap around most of the target vessel on their own accord once deployed. As used herein, the word “substantially” does not exclude “completely,” e.g., a composition which is “substantially free” from Y may be completely free from Y. Where necessary, the word “substantially” may be omitted from the definition of the disclosure. For example, a substantially full turn of a helix may be a full turn of a helix, features positioned substantially opposite may be placed opposite, features spaced a substantially constant distance apart may be spaced a constant distance apart, and electrodes providing a substantially uniform current density may provide a uniform current density.
The portions 510, 512 and 514 may be orthogonal to the spinal portion 502 or at a low helix angel relative the spinal portion 502. The composition of the substrate for the neural interface 500, like neural interfaces 100 and 300, can be silicon or a similar material, and all such neural interfaces can be further treated to prevent early scar formation (i.e., fibrous tissue). Such treatment may be done only on selected surfaces, e.g., the side facing the nerve/arterial wall. For example, silicon may be doped with a steroid drug, such as dexamethasone. The outer surface of the substrate of the neural interface may also, or alternatively, be coated with a hydrophilic polymer, such as poly-2-hydroeyethyl-methacrylate (pHEMA).
The tips of each portion 510, 512, and 514 may be shaped to enable the portions to be gripped by a deployment tool (not shown) for each placement on or removal from a target vessel and/or nerve. Alternatively, attributions, such as attributions 110 and 310 may be added to the exterior surface of the portions 510, 512 and 514 to enable the portions to be pulled back for placement on or removal from a target vessel and released when the neural interface 500.
The electrode or electrode arrays 720, 722 and 724 may also be positioned at different locations within each of the portions 710, 712 and 714. As shown in
In contrast to the extravascular neural interfaces embodiments described above, neural interface 700 may be positioned via a flexible/collapsible catheter (with the neural interface 700 collapsed inside the catheter, not shown) versus an external deployment tools. Depending on the location of the target vessel, the positioning procedure may be minimally invasive. For example, for positioning in a splenic artery, the procedure may be performed through a total percutaneous access via standard (e.g., femoral) artery access. Once the catheter is positioned for deployment of the neural interface 700, the catheter may be withdrawn and the released neural interface will self-size to the inside of the target vessel 730, which requires the portions 710, 712 and 714 to be formed so their normal relaxed position will cause them to fold away from the spine 702 so as to make good contact with the interior walls of the target vessel 730.
In the embodiment of
As shown in
As previously noted, attributions may be protrusions, but may also be openings or eyelets. As illustrated in
When the neural interface 800 is properly positioned, the pressure may be removed from the grab tube loop 848 so that the open ends 805 and 807 may softly self-size around the target vessel. Although not shown in
In another embodiment, the deployment tool 841 may comprise a further suture wire portion with or without a silicon tubing 844 surrounding the further suture wire portion, where the further suture wire extends between the dual arms of grab tab 844 to form a triangular shape for increased structural stability when deploying the neural interface device 812.
In another embodiment, and referring to
Other example embodiments of deployment tool 841 are depicted in
Tab-style body 850 of deployment tool 841 of
For example, in some embodiments body 850 can be used as a measuring tool. In one embodiment, and referring to
In another use of body 850 of deployment tool 841, and referring to
As previously noted, tab-style body 850 also comprises a plurality of sets of eyelets 858. In use, a suture wire may be looped through each eyelet 858 and then brought together at first aperture 852 to form a grab loop. During deployment of the neural interface 800, a surgeon may position neural interface 800 around a target vessel while pulling lightly on the grab loop. Such pressure will pull the open ends 805 and 807 of end portions 804 and 806 of neural interface 800 away from the spinal portion 808 and make it possible to position the neural interface 800 where desired.
When neural interface 800 is properly positioned, the pressure may be removed from the grab loop so that the open ends 805 and 807 may gently self-size around the target vessel. Once the neural interface has been properly positioned, the suture wire may be cut and removed from the eyelets 858 and first aperture 852. The first aperture 852, second and third apertures 854, 856 and eyelets 858 may be circular holes, oval-shaped or oblong slots, or other shapes, or features that extend on tabs from the end portions 805 and 807 of neural interface 800.
The deployment tool 841 with a tab-style body (also referred to as a deployment tab) may comprise a thickness and/or width slightly larger than the thickness and/or width of the neural cuff. The deployment tab may include an anchored suture that is wound through the deployment tab and removably attached to the neural cuff (for example by a connector such as a suture thread at a deployment attribute of the neural cuff such as an opening at an open end of the arm). A cut through at least a portion of the deployment tab may completely detach the deployment tool from the neural cuff. The deployment tab may include a series of transverse (or lateral, along a width of the deployment tab) ridges and valleys on one side, which may serve as a cut through guide and may enable the deployment tab to be rolled into a small size for delivery. The deployment tab may include a series of longitudinal ridges and valleys on the opposite side as shown in
Other tools and accessories may be provided to assist a surgeon in delivering, positioning, and deploying embodiments of neural interfaces discussed herein. For example,
In the embodiment of
In one embodiment, body 862 comprises a transparent or semi-transparent biocompatible material, such as silicone. Such a material enables visual feedback during use, as a surgeon can see into body 862 to determine how far an end of lead body 917 has gone into an internal cavity 870 of body 862. In some embodiments only a portion of body 862 may be transparent.
Internal cavity 870 includes a retention constriction 872, shown in the cross-sectional view of
In wired embodiments, lead body 917, more specifically an IPG connector part of the lead body 917, should be inserted sufficiently into lead cap device 860 that the portion of lead body 917 that engages with set screw 866 does not contain any sensitive components of lead body 917, such as contact portions of the lead conductors themselves. Damage to these contact portions during implantation could impair electrical isolation properties where the lead body 917 interfaces with a pulse generator, such as an implantable pulse generator (IPG). In other words, the end portions of lead body 917 configured to be coupled with other system components for use, such as the pulse generator, should be advanced past set screw 866 towards a second end 876 of lead cap device 860 and suture loop 868. When so positioned, retention constriction 872 also functions to retain lead body 917 therewithin and in some embodiments can do so even if setscrew 866 is not tightened (or is not sufficiently tightened).
The configuration and features of lead cap device 860 enable a surgeon to push and pull on lead body 917, in any orientation, in order to route it into position. Suture loop 868 can be grasped using a grasper tool or other device in order to pull lead cap device 860 (and thereby lead body 917). The portion of body 862 proximate second end 876 also can be grasped and pulled during routing. Similarly, the tapered configuration of first end 874 of body 862 can be pushed during routing.
Though discussed and described with respect to particular examples (such as neural interface 800), tab-style body 850, lead cap device 860, and other accessories and techniques described above also are applicable to and can be used with other embodiments of neural interfaces. Furthermore, not all embodiments necessarily include lead bodies. For example, the neural interface 900 of
For example,
Neural interface 900 comprises a spinal portion 902, a first C-ring portion 904, a second C-ring portion 906, and a third C-ring portion 908. Spinal 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 first C-ring portion 904. At least a portion of conductor 918 extends from lead body 917 and within spinal portion 902 from first end 901 towards second end 903, terminating in a connection to first C-ring portion 904. At an opposite end, lead body 917 and conductor 918 are connectable via a connector to an implantable pulse generator (not depicted).
Lead body 917 comprises conductor 918, which in one embodiment is a coradial bifilar conductor. The coradial bifilar design of conductor 918 provides increased flexibility and in some embodiments may make conductor 918 stretchable. In other embodiments, if the tube covering the coradial bifilar conductor 918 is not stretchable, the lead body has increased flexibility but not stretchable. These characteristics provide increased decoupling between lead body 917 and spinal portion 902. This means that even if lead body 917 is moved or flexed during application, spinal portion 902 (and C-ring portions 904, 906, 908) will not be moved on or off of the target tissue. Additionally, the coradial feature of conductor 908 makes conductor 908 more crush-resistant, which can be a benefit during laparoscopic delivery of neural interface 900 to target tissue while still maintaining flexibility to aid in delivery and placement.
In other embodiments, one or both of lead body 917 and conductor 918 can comprise structures or configurations to provide strain relief. Referring also to
Two examples of undulating sections 917b are depicted in
In some embodiments, undulating sections 917b can be located near neural interface 900, while in other embodiments undulating sections 917b can be located away from neural interface 900 or at various points along the length of lead body 917. Undulating sections 917b near neural interface 900 can help to block displacement forces from reaching neural interface 900 and affecting its stability and placement.
In still other embodiments, lead body 917 also can comprise at least one anchoring sleeve or tab 919. Though the configuration can vary, the term “anchoring tab” generally will be used herein even though in some embodiments the anchoring structure can comprise a sleeve or other device. Anchoring tabs 919 can be located at one or more points along lead body 917 and can be used to secure lead body 917 to tissue, such as by suturing anchoring tab 919 to tissue. For example, fixation of a lead anchor to a crus of the diaphragm can be accomplished with one or two permanent sutures. The right crus can be reached by retracting the lateral segment of the left lobe of the liver, such as with a Nathanson retractor, to allow visualization of the right crus of the diaphragm. The anchor of the lead can be placed in proximity to the right crus of the diaphragm and affixed to the right crus using one or two permanent sutures.
In one embodiment depicted in
Anchoring tabs 919 can be coupled to lead body 917 in a variety of ways. As mentioned above, in some embodiments anchoring tabs 919 comprise sleeves that extend around lead body 917 and may be slidable along at least a portion of lead body 917 (e.g., between adjacent undulating sections 917b). In other embodiments, these sliding anchoring tabs 919 may comprise a fastener, such that the sliding anchoring tab 919 can be placed in a desired location along the lead body 917 and then fixed by the fastener, which may include means to tighten around the lead body 917, or suture or silicone adhesive to be fixedly attached to the desired location along the lead body 917. In still other embodiments, anchoring tabs 919 are fixedly coupled to a particular point along lead body 917, such as by being adhered to lead body 917 by a silicone adhesive near first end 910 of neural spinal portion 902 of neural interface 900.
Anchoring tabs 919 can comprise many different biocompatible materials. In one embodiment depicted in
The coated mesh structure of anchoring tabs 919 can provide a variety of advantages. First, the mesh can maximize resistance to tearing. Coating the mesh structure can minimize tissue ingrowth by partially or completely filling the pores of the mesh, thereby reducing or preventing growth of tissue into the pores of the mesh over time, which aids in explantability of anchoring tabs 919 and neural interface 900 overall and reduces the likelihood of serious complications that can result from ingrowth of tissue. The coated mesh structure of anchoring tabs 919 also helps to minimize or reduce the rigidity of anchoring tabs 919, thereby improving reliability (as the smoother the stiffness gradient is at the transition from lead body 917 to anchoring structure 919, the more reliable the junction will be, generally speaking). Minimizing or reducing rigidity also aids surgical implantation, as the less rigid anchoring tab 919 is, the easier it is to suture in place. Additionally, the coated mesh structure helps to maximize or increase adhesion between anchoring structures 919 and lead body 917. In embodiments in which leady body 917 comprises silicone, the silicone adhesive and silicon coating of the mesh of anchoring structure 919 provide a strong bond to affix the anchor in the desired position, such as the right or left crus of the diaphragm, to hold the lead securely in place and avoid disruption of implant operation due to lead travel.
First end 901 of spinal portion 902 defines a tapered portion that tapers from a maximum circumference to a minimum circumference. In the embodiment of
Second end 903 presents an angled, blunted, or rounded-off surface, in that spinal portion 902 extends to an outer edge of first C-ring portion 904 at a bottom or lower side (with respect to the orientation of
Between first end 901 and second end 903, one end of each of first C-ring portion 904, second C-ring portion 906, and third C-ring portion 908 is coupled to spinal portion 902. In the embodiment depicted in
This relative arrangement of C-ring portions 904, 906 and 904 enables C-ring portions 904 and 908 to remain static (or move) together, while C-ring portion 906 moves (or remains static), during deployment of neural interface 900. As such, neural interface 900 provides a modest overall profile, enabling laparoscopic (i.e., minimally invasive) delivery while at the same time providing sufficient flexibility and relative movement of C-ring portions 904 and 908 with respect to C-ring portion 906 to enable neural interface to be “opened” for extravascular placement and deployment. This configuration of C-ring portions 904, 906 and 908 also increases the likelihood that neural interface 900 will not open unexpectedly after deployment and move to an undesired position.
In some embodiments, each C-ring portion 904, 906, 908 may have a very low helix angle, i.e., pitch, relative to the spinal portion 902, which enables neural interface 902 to be helical but still have a significantly shorter length. The helix angle may be between approximately 15 and 30 degrees but may also be less than 15 degrees.
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 spinal portion 902, for example as illustrated in
In the embodiment depicted in
As can be seen from these examples, the thickness of the C-ring portions 904, 906, 908 increases as the diameter increases, which can provide a similar pressure regardless of the diameter of the cuff. Those skilled in the art will appreciate that without adjusting the thickness with diameter, the pressure would be expected to decrease as the diameter increases. Those skilled in the art also will recognize that the thickness will depend on properties (e.g., stiffness) of the material used to form C-ring portions 904, 906, 908, which means that the ratios above (associated with silicone) may vary according to the properties of selected materials in other embodiments. Additionally, the 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 materials used for the electrodes, and other factors. Expressed another way, embodiments of neural interface 900 can be configured to apply (or maintain) pressure to target tissue within the C-ring portions in a range of about 0 mmHg to about 30 mmHg, such as about 0 mmHg to about 25 mmHg, or about 0 mmHg to about 20 mmHg, or about 0 mmHg to about 15 mmHg, or about 0 mmHg to about 10 mmHg, or about 0 mmHg to about 5 mmHg, or about 0 mmHg to about 2 mmHg or about 5 mmHg to about 20 mmHg, or about 5 mmHg to about 10 mmHg, for example about 20 mmHg, or for example about 10 mmHg, or for example about 5 mmHg. This pressure can be measured at a variety of points along the inner diameter of neural interface 900 and can be an average value, a mean value, or a median value of a plurality of values taken at a plurality of points, or particular value at a particular point.
In other embodiments, thickness can vary along the length of the C-ring portion, providing another way for uniform pressure to be provided along the length of each C-ring portion (i.e., at each electrode). Referring, for example, to
In one example embodiment, the thickest part of a C-ring portion (e.g., at T2 in
In other embodiments, the thickness may vary in other ways along a length of any C-ring portion. For example, in
In general, however, the objective is to reduce the contact pressure for the electrode 1012 nearest spinal portion 1002 and the electrode 1012 at the far (open) end of the C-ring portion 1010. In C-ring portions with constant thickness, these two electrodes will bear most of the load. The tapered embodiment of
Referring again to
The electrode of each electrode array 912 that is coupled to conductor 918 can be coupled thereto in a variety of ways. In one embodiment, this coupling is accomplished by welding, such as by laser-welding. The particular configuration of the laser weld can provide strain relief, reducing the likelihood that relative movement of the C-ring portions 904, 906, 908 with respect to conductor 918 will cause separation or breakage of the weld. In conventional arrangements, the wire of conductor 918 would be welded to the electrode in a substantially perpendicular orientation, as shown in
In the embodiment of
The individual electrodes of electrode arrays 912 of neural interface 900 may be evenly spaced within C-ring portions 904, 906, 908. By evenly spacing the electrodes on C-ring portions 904, 906, 908, the inter-electrode distance is more constant, which may provide a more uniform current density distribution and enhancement of the effectiveness of neural interface 900. In some embodiments, the position of the electrodes in electrode arrays 912 may be staggered in order to achieve better, or different electrical coverage. Certain characteristics of neural interface 900 may each be chosen for a particular application of neural interface 900, such as: the spacing between adjacent C-ring portions 904, 906, 908; the spacing between electrode arrays 912; the spacing between electrodes of electrode arrays 912; the size and shape of the electrodes; the size, shape, and number of electrodes in electrode arrays 912; the inter-electrode distance within electrode arrays 912; and the helix angle. For example, utilization of neural interface 900 for treatment by utilizing a target, for example the splenic artery, may require different characteristics than utilization of neural interface 900 for treatment of a different vessel. For instance, when utilized for splenic artery treatment (e.g. treatment provided by the neural interface being provided around the splenic artery) an electrode width of approximately 1 mm to approximately 4 mm, such as width ranges between approximately 1 mm and approximately 2 mm or between approximately 2 mm and approximately 3 mm, may be appropriate. When utilized for treatment via different vessels, different electrode widths may be desirable.
Electrode coils 922 can be configured to provide electrical couplings between adjacent electrodes of electrode arrays 912 while also providing desired flexibility themselves and at the same time not inhibiting flexibility or conformity of C-ring portions 904, 908. Flexibility can be provided by the coiled arrangement of electrode coils 922, as coils provide flexibility with spring properties that straight conductor wires do not have. For example, electrode coils 922 can have improved flex fatigue performance as compared with straight wires. In use, neural interface 900 sits on a pulsatile structure such that electrode coils 922 will be subjected to multitudes of small flex loads. Coiled electrical couplings have better flex fatigue performance than straight wires. Similarly, conformity of C-ring portions 904 and 908 can be retained or enhanced by adjusting the diameter and pitch of electrode coils 922. In example embodiments, a coil pitch of electrode coils 922 can be in a range of 0.05 mm to 0.3 mm, such as in a range of 0.10 mm to 0.25 mm, for example 0.10 mm, 0.15 mm, or 0.23 mm. A wire diameter of electrode coils 922 can be in a range of 0.05 mm to 0.10 mm, such as a range of 0.07 mm to 0.09 mm, for example 0.076 mm or 0.081 mm, in various example embodiments. A coil diameter of electrode coils 922 can be in a range of 0.2 mm to 0.6 mm, such as in a range of 0.3 mm to 0.5 mm, for example 0.38 mm, 0.43 mm, or 0.46 mm. In various embodiments, these dimensions can be selected from example ranges according to a determined relationship between any of these dimensions or other dimensions or characteristics of the electrodes, the C-ring portion, or the overall neural interface.
In the embodiment depicted in
In some embodiments, multiple electrodes or an electrode array 912 on any one C-ring portion, such as are depicted on C-ring portions 904 and 908 in
The electrode may be very thin (for example between 25 μm and 50 μm) but not so thin so as to make interconnection (which may be accomplished by, e.g., laser welding) to the electrode difficult. In some embodiments the electrodes may be recessed or embedded into their respective
C-ring portions, with silicone rims or silicone webbing used to hold the electrodes in place. In other embodiments, “segmented” electrode designs may provide better mechanical compliance, create the possibility of surface features, i.e., protruding electrodes, and make it possible to control each electrode individually (i.e., current steering). Segmented electrodes provide increased flexibility to the neural interface, thereby making it possible open a C-ring portion with a deployment tool wider and for a longer period of time, without creating excessive stress on the electrodes, than might be possible with a single electrode.
In still other embodiments, the electrodes can be configured with or comprise features to improve flexibility, prevent delamination of the electrodes from the C-ring portions, and otherwise enhance interoperability between the electrodes and the C-ring portions. For example, in embodiments in which the electrodes are recessed or embedded into their respective C-ring portions, the electrodes can comprise or be coupled with an electrode pad such that it is the electrode pad that is recessed or embedded into the C-ring portions. The electrode pad can comprise the same material as the electrode or a different material, such as a material with desired properties for bonding or coupling the electrode to the C-ring portion. The material of such an electrode pad can vary in embodiments and may be selected according to the materials of the electrode (such as platinum) and C-ring portion (such as silicone).
Additionally or alternatively, the portion of the C-ring portion into which the electrode (or electrode pad is embedded can be slightly larger than the electrode or electrode pad to allow for curvature and movement of the electrode or electrode pad as the neural interface is deployed (i.e., when the C-ring portions experience the most significant deformation) while maintaining the electrodes and electrode pads in desired positions after deployment. For example, a gap can be provided in the C-ring portion on one or both ends of the electrode or electrode pad, where the ends in
Characteristics of the recess also can be selected to accommodate curvature and movement of the electrode or electrode pad therein. For example, the overall shape of the recess can be the same or different from the electrode or electrode pad. In the embodiment of
Additionally or optionally, the electrode may comprise various different materials in order to achieve a desired properties, for example flexibility or electrical charge injection properties. For example, the electrodes may comprise platinum, or be formed from an alloy of platinum and iridium, for example an alloy made from 90% platinum and 10% iridium. Alternatively or additionally, the surfaces of the contact electrodes may be coated possibly with PEDOT, TiNi, IrOx, PtBlack or treated using a process of laser roughening.
In still other embodiments, and in addition to or instead of other electrode and electrode pad features discussed herein, each electrode can comprise a flange having one or more perforations. These perforations can improve the mechanical coupling between the electrode and the C-ring portion, prevent delamination of the electrode from the C-ring portion, increase the flexibility of both the electrode and the C-ring portion (particularly during placement and deployment of the neural interface), and provide other benefits appreciated by those having skill in the art. For example,
For example, in the embodiment of
The embodiment depicted in
The embodiment of
Yet another embodiment is depicted in
In
The embodiment of
The embodiment of
In
The embodiment of
Similar to the embodiment of
The embodiment of
The embodiment of
The embodiment of
A spring or a micro-coil (or any other interconnection) connecting the electrode and the lead conductor or between electrodes could be provided through the substantially round perforation 9360. In this way, the stress on the welding is reduced as the connection is already partially held in place by its placement in relation to the round perforation 9360.
Still other configurations of electrode contact 932, electrode flange 934, and electrode perforations 936 are possible in other embodiments. For example, in various embodiments some or all of perforations 936 may not extend completely through electrode flange 936. In other words, perforations 936 instead may be considered to be recesses. Additionally, other shapes, sizes, positions, arrangements, features, dimensions and other characteristics of any of electrode contact 932, electrode flange 934, and electrode perforations 936 can be implemented in other embodiments and may be selected according to a desired application of a particular neural interface in which electrode 930 is implemented.
As in other embodiments of neural interfaces depicted and discussed herein, and even if not explicitly depicted in the drawings, neural interface 900 may also include at least one attribution that may be positioned on an outer surface of neural interface 900, such as on spinal portion 902. The attributions may include one or more openings or eyelets for receiving a stylet (made of tungsten or similar material) or a connector such as a suture thread to releasably connect to the deployment tab, for instance, in order to enable the C-ring portions to be manipulated or to deploy neural interface 900. The attributions may be configured to enable a deployment tool to grip, manipulate and deploy neural interface 900. In one embodiment, the attributions may be placed sufficiently near the open ends of at least one of the C-ring portions 904, 906, 908 to enable the deployment tool to grip the attributions and simultaneously open C-ring portion 906 relative to C-ring portions 904 and 908. This enables positioning of neural interface 900 around a target vessel. Once neural interface 900 has been positioned around the target vessel, the deployment tool (via physician manipulation) can carefully release the attributions so that C-ring portions 904, 906, 908 can softly self-size to the target vessel. The configuration of neural interface 900 may enable the neural interface to be positioned in a single pass around a nerve or vessel with reduced manipulation of the nerve or vessel and a reduction in tissue dissection around the area of the nerve or vessel where the interface is positioned.
Like neural interfaces 100, 200, 300 and 400, neural interface 900 also can be self-sizing, in that C-ring portions 904, 906, 908 in particular are formed of flexible materials and arranged with alternating open ends to provide for easy manipulation for deployment and, when released, return to a predetermined shape without a strong elastic snap or spring force. This enables neural interface 900 to accommodate anatomical variability of the intervention site and target vessel while still providing good electrical contact between the electrode arrays and the surface of the nerve or vessel, thereby improving the efficacy of neural interface 900. The flexible material of C-ring portions 904, 906, 908 may remain compliant even when self-sized to a nerve or vessel. This may help to prevent neural interface 900 from compressing a nerve or vessel and causing reduced blood flow and otherwise constricting nerve fiber. This also may better accommodate radial expansion of the nerve or vessel as a result of post-positioning edema or swelling and may accommodate the pulsatile behavior of intervention sites such as arteries.
The naturally open structure of C-rings 904, 906, 908 portion of neural interface 900 may reduce coverage of the nerve or vessel periphery in a way that promotes more normal fluid and nutrient exchange with the intervention site and surrounding tissue. This may also help to reduce growth of connective tissue into neural interface 900. The open structure of neural interface 900 is configured such that no end portion or center portion forms a closed circumscribed circular arc around the target vessel at any point along a length of the target vessel. In other words, no closed circle covering 360 degrees of an orthogonal portion of the target vessel's length is formed by the structure. However, a tip of the arm may be in contact with the spine of the cuff. In other words, whilst a full coverage of the target vessel may be provided but not via a closed circle. This open unrestricted trench may serve so that the target vessel may pulsate without constriction and that an initially swollen target vessel can return to a normal state over time without constriction when or if it is swollen and without losing electrode-to-target vessel contact when the target vessel is in its normal state.
As previously mentioned, the electrodes (e.g., of electrode array 912 in
Additionally, different electrode embodiments can provide different degrees of coverage with each cuff of the neural interface. This can be seen in
For example, and referring also to
The variations in internal diameter, arm thickness and number of electrodes can be attributed to maintaining desired contact and tension of the cuff arms and electrode contact area as the diameter (and therefore the length) of the cuff arm decreases or increases. Thus, inner diameters of the neural interface devices can differ while a total electrode area of each neural interface device is substantially equal. Additionally, an electrode of a larger inner diameter neural interface device can comprise a smaller width and a larger length than an electrode of a smaller inner diameter neural interface device.
In order to define the different size and shape of the electrode, the neural interface size is considered. That is, the electrode shape and size can be determined by the relevant neural interface diameter. In other embodiments or applications, different factors may be considered when sizing the cuff and determining a number of electrodes. In some embodiments, each arm of the cuff can be the same as the others, while in other embodiments there may be differences in size or electrode number or configuration between arms of the same cuff.
In some aspects, the inter-electrode coils (such as coils 922 in
Neural interface 1400 comprises a spinal portion 1402, a first C-ring portion 1404, a second C-ring portion 1406, and a third C-ring portion 1408. Spinal 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 first C-ring portion 1404. At least a portion of conductor 1418 extends from lead body 1417 and within spinal portion 1402 from first end 1401 towards second end 1403, terminating in a connection to first C-ring portion 1404. At an opposite end, lead body 1417 and conductor 1418 are connectable via a connector to an implantable pulse generator (not depicted).
First end 1401 of spinal portion 1402 defines a tapered portion that tapers from a maximum circumference to a minimum circumference. In the embodiment of
Second end 1403 presents an angled, blunted, or rounded-off surface, in that spinal portion 1402 extends to an outer edge of first C-ring portion 1404 at a bottom or lower side (with respect to the orientation of
Between first end 1401 and second end 1403, one end of each of first C-ring portion 1404, second C-ring portion 1406, and third C-ring portion 1408 is coupled to spinal portion 1402.
In some embodiments, each C-ring portion 1404, 1406, 1408 may have a very low helix angle, i.e., pitch, relative to the spinal portion 1402. The helix angle may be between approximately 15 and 30 degrees, but may also be less than 15 degrees. Additionally, each C-ring portion 1404, 1406, 1408 comprises rounded or smooth edges and ends. In other embodiments, each C-ring portion 1404, 1406, 1408 are not helical or have a helix angle, i.e., pitch, relative to the spinal portion 1402, for example as illustrated in
Electrode arrays 1412 may be connected by a continuous coil 1422. 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 arrays 1412. Using a continuous interconnector, such as continuous coil 1422 reduces interconnection points such as the weld joints compared to some of the embodiments described above.
In some embodiments, continuous coil 1422 can provide greater potential contact area between coil 1422 and electrode arrays 1412 than would be present in other embodiments. This greater contact can help achieve stronger electrical and mechanical connections between coil 1422 and electrode arrays 1412. For instance, since continuous coil 1422 extends along the full length of electrode array 1412, continuous coil 1422 may be welded to electrode array 1412 at multiple points. Multiple individual turns of continuous coil 1422 may be welded to the electrode array, such as with the weld orientation shown in
In embodiments, bushing 1430 may 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 for a greater points of contact that can be good candidates for welding points between the bushing and the array. Thus, more desirable contact points may be chosen for welding or the number of weld may be increased as required, which may strength the connection between the bushing and the array (and ultimately between the coil and the electrode). A match in curvature between bushing and array can also reduce the mechanical stress placed on the welds connecting the bushing and the array during use. In embodiments, the bushing may be crimped to close the tunnel gaps and hold the wire by interference fit. It is noted that whilst welding is referred to, other forms of connection may be used between the bushing and the array, including but not limited to soldering, crimping, brazing, wiring, or otherwise fastening to create electrical and mechanical connection.
Use of continuous coil 1422 to connect electrode arrays 1412 enables the electrodes in one of the electrode arrays 1412 to be electrically connected in parallel. Thus, loss of a connection between the coil 1422 and any one electrode will not interrupt the supply of power to any other electrodes, even if the connection is lost to an electrode which is “upstream” (closer to alpha connection 1432 between the conductor 1418 and the continuous coil 1422, or simply closer to the conductor 1418) of the remaining connected electrodes. For instance, if bushing 1430a lost its connection to electrode 1412a, electrode 1412a may not be connected to any powering means to provide stimulate or block the target. However, since continuous coil 1422 carries power from the conductor 1418 to electrodes 1412b-d independent of the connection between the coil 1422 and first electrode 1412a, each of electrode array 1412a-d remains operable independent of the condition of any electrode and continuous coil connection in the same C-ring 1404. In this particular embodiment the continuous coil 1422 is connected to the conductor 1418 via alpha helix 1432. In other embodiments, the continuous coil 1422 may be connected directly to the conductor 1418. For example, a tip of the continuous coil may form the alpha helix 1432.
Other embodiments are envisioned which may also achieve the advantages of the continuous coil example in
The position of the welds for attachments between crimps or coils coupling one electrode to another can also differ between embodiments, as shown in more detail in
In
In effect, the continuous jumper coil 1452 coupled to each of the electrodes in an array 1412 makes a parallel electrical connection. The connection to the conductor 1408 is provided to each of the electrode arrays 1412 such that even if any one of the connections is lost, the other electrodes 1412 remain powered.
Electrode coils 1422 can be configured to provide electrical couplings between adjacent electrodes of electrode arrays 1412 while also providing desired flexibility and high flex fatigue performance. Conformity or flexibility of C-ring portions 1404 and 1408 can be retained or enhanced by adjusting the diameter and pitch of electrode coils 1422. In example embodiments, a coil pitch of electrode coils 1422 can be in a range of 0.05 mm to 0.3 mm, such as in a range of 0.10 mm to 0.25 mm, for example 0.10 mm, 0.15 mm, or 0.23 mm. A wire diameter of electrode coils 1422 can be in a range of 0.05 mm to 0.10 mm, such as a range of 0.07 mm to 0.09 mm, for example 0.076 mm or 0.081 mm, in various example embodiments. A coil diameter of electrode coils 1422 can be in a range of 0.2 mm to 0.6 mm, such as in a range of 0.3 mm to 0.5 mm, for example 0.38 mm, 0.43 mm, or 0.46 mm. In various embodiments, these dimensions can be selected from example ranges according to a determined relationship between any of these dimensions or other dimensions or characteristics of the electrodes, the C-ring portion, or the overall neural interface.
Crimped bushing 1430 may be crimped to a final size, according to the size of continuous coil 1422, or a final force. Crimping may increase the electrical contact between the coil and the bushing and in embodiments are designed to be tight enough upon crimping (i.e., small enough in cross-section) to promote electrical and mechanical contact between the coil and the bushing. The compressive force or minimum final size of the crimp may be limited, in embodiments, in order to prevent deformation (or extent of deformation) of the coil.
In
In the embodiment depicted in
In some embodiments, multiple electrodes or an electrode array 1412 on any one C-ring portion, such as are depicted on C-ring portions 1404 and 1408 in
Like neural interfaces 100, 200, 300, 400 and 900, neural interface 1400 also may be self-sizing, in that C-ring portions 1404, 1406, 1408 in particular are formed of flexible materials and arranged with alternating open ends to provide for easy manipulation for deployment and, when released, return to a predetermined shape without a strong elastic snap or spring force. This enables neural interface 1400 to accommodate anatomical variability of the intervention site and target vessel while still providing good electrical contact between the electrode arrays and the surface of the nerve or vessel. The flexible material of C-ring portions 1404, 1406, 1408 may remain compliant even when self-sized to a nerve or vessel. This may help to prevent neural interface 1400 from compressing a nerve or vessel and causing reduced blood flow and otherwise constricting nerve fiber. This also may better accommodate radial expansion of the nerve or vessel as a result of post-positioning edema or swelling and may accommodate the pulsatile behavior of intervention sites such as arteries. Therefore, disclosed herein is a neural interface comprising a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference; a lead body coupled to the first end of the spinal portion and comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spinal portion; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion; and at least one electrode arranged on at least one of the at least three C-ring portions and electrically coupled to the conductor.
The neural interface can comprise a plurality of electrodes arranged 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.
Each of the electrodes can comprise 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 spinal portion can have a substantially circular cross-section, and the second end of the spinal portion can have an angled surface such that a plane parallel to the substantially circular cross-section is at an angle of greater than 0 degrees and less than 90 degrees with respect to a plane defined by the angled surface.
The maximum circumference of the first end of the spinal portion can be proximate the at least three C-ring portions, and the minimum circumference of the first end of the spinal portion can occur where the spinal portion terminates on the lead body.
A distance between the maximum circumference to the minimum circumference can be in a range of 2 mm to 5 mm.
The first C-ring portion and the third C-ring portion can be coupled to the spinal portion to move together and relative to the second C-ring portion, and the first C-ring portion and the third C-ring portion can extend from the spinal portion in a direction opposing a direction of the second C-ring portion
At least one of the at least three C-ring portions of the neural interface can have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first end and the second end, wherein the third thickness is greater than the first thickness and the second thickness.
A thickness of the at least one of the at least three C-ring portions of the neural interface can gradually increase between the first end and the point between the first end and the second end.
A thickness of the at least one of the at least three C-ring portions of the neural interface can gradually increase between the second end and the point between the first end and the second end.
The electrode flange of the neural interface can be rectangular with rounded corners.
The plurality of perforations in the electrode flange of the neural interface can comprise 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.
The first side of the electrode flange and the second opposing side of the electrode flange can be longer than a third side and a fourth side of the electrode flange.
Each of the plurality of perforations in the electrode flange of the neural interface can be rectangular with rounded corners.
The neural interface can comprise at least one anchoring tab coupled to the lead body.
The at least one anchoring tab can comprise a coated mesh.
The lead body can comprise at least one undulating section.
A neural interface can be formed by providing a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference; coupling a lead body to the first end of the spinal portion such that a conductor of the lead body, connectable to an implantable pulse generator, extends at least partially into the spinal portion; coupling at least three C-ring portions to the spinal portion, each of the at least three C-ring portions having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion; and arranging 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.
The neural interface can 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.
Each of the electrodes can comprise 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 method can further include forming the spinal portion to have a substantially circular cross-section and the second end of the spinal portion to have an angled surface such that a plane parallel to the substantially circular cross-section is at an angle of greater than 0 degrees and less than 90 degrees with respect to a plane defined by the angled surface.
Forming the neural interface also can include forming at least one of the at least three C-ring portions to have a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first end and the second end, wherein the third thickness is greater than the first thickness and the second thickness.
In another embodiment, a neural interface can comprise a spinal portion having a first end and a second end; a lead body coupled to the first end of the spinal portion and comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spinal portion from the first end toward the second end; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion, each C-ring portion having an inner diameter and a thickness, with a ratio of the inner diameter to the thickness being in a range of 5:1 to 6:1; and at least one electrode arranged on at least one of the at least three C-ring portions and electrically coupled to the conductor.
In yet another embodiment, a neural interface can comprise a spinal portion having a first end and a second end; a lead body coupled to the first end of the spinal portion and comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spinal portion from the first end toward the second end; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion, each C-ring portion being configured such that in use a pressure in a range of about 0 mmHg to about 30 mmHg is applied to a target tissue arranged within the C-ring portions; and at least one electrode arranged on at least one of the at least three C-ring portions and electrically coupled to the conductor.
As shown in the bottom row of
The embodiments exemplified in
Further as disclosed herein, a system can comprise a neural interface of any of the embodiments disclosed herein above; a lead cap device having a first end and a second end and comprising a body defining an internal cavity that extends from the first end toward the second end, a set screw block arranged in the body such that a setscrew intersects with 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 in the internal cavity and secure the portion of the lead body in the internal cavity by the setscrew; and a deployment tool comprising a tab-style 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 eyelets formed in the tab-style body between the first end and the second end, the tab-style body further comprising a series of ridges and grooves, and the deployment tool being removably coupleable to the neural interface by the second aperture and the third aperture and by a suture that can be threaded through the first aperture and at least one of the plurality of sets of eyelets.
A neural interface can comprise a lead body comprising a conductor connectable to an implantable pulse generator; and at least one C-ring portion for applying or maintaining a pressure in a range of 0 mmHg to 30 mmHg to a target tissue arranged within the C-ring portion and comprising at least one electrode arranged on 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, with a ratio of the inner diameter to the cross-sectional thickness being in a range of 5:1 to 6:1. In embodiments, this ratio can vary substantially. For example, in thin film embodiments a ratio of 40:1 can be achieved, though generally ratios between 10:1 and 3:1 may suffice.
The at least one electrode can comprise 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 can be rectangular with rounded corners. The electrode flange can comprise a curved under edge. The plurality of perforations can comprise 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. The first side of the electrode flange and the second opposing side of the electrode flange can be longer than a third side and a fourth side of the electrode flange. Each of the plurality of perforations can be rectangular with rounded corners. The lead body can comprise at least one strain relieving undulating section.
In embodiments, the neural interface can further comprise a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference, with the lead body being coupled to the first end of the spinal portion and extending at least partially into the spinal portion. The spinal portion can be a substantially circular cross-section, and the second end of the spinal portion can have an angled surface such that a plane parallel to the substantially circular cross-section is at an angle of greater than 0 degrees and less than 90 degrees with respect to a plane defined by the angled surface. The maximum circumference of the first end of the spinal portion can be proximate the at least three C-ring portions, and the minimum circumference of the first end of the spinal portion can occur where the spinal portion terminates on the lead body. A distance between the maximum circumference and the minimum circumference is in a range of 2 mm to 5 mm.
In embodiments, the neural interface can further comprise 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 spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion. The first C-ring portion and the third C-ring portion can be coupled to the spinal portion to move together and relative to the second C-ring portion, and the first C-ring portion and the third C-ring portion can extend from the spinal portion in a direction opposing a direction of the second C-ring portion. At least one of the at least three C-ring portions has a first thickness at the first end, a second thickness at the second end, and a third thickness at a point between the first end and the second end, and the third thickness can be greater than the first thickness and the second thickness. 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. A thickness of the at least one of the at least three C-ring portions gradually increases between the second end and the point between the first end and the second end.
The neural interface can further comprise a plurality of electrodes arranged 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.
The neural interface can further comprise at least one anchoring tab coupled to the lead body. The at least one anchoring tab can comprise a coated mesh.
The C-ring portion can be provided at a first end of the lead body and an IPG connector can be provided at a second of the lead body, further wherein the anchoring tab can be provided between the first end and the second end of the lead body.
The anchoring tab can be provided between the first end of the lead body and a middle section of the lead body situated half-way between the first end and the second end of the lead body, further wherein a ratio of a distance between the first end of the lead body and the anchoring tab and a distance between the second end of the lead body and the anchoring tab can be between 1:1 and 1:50, optionally 1:2, 1:3, 1:4 or 1:5. The anchoring tab can be moveable along the lead body.
The lead body can comprise increased flexibility in a portion closer to the C-ring portion compared to a portion of the lead body further away from the C-ring portion.
In an embodiment, a system comprises the neural interface according to any embodiment, configuration, or combination herein above; and a deployment tool removably coupleable to the neural interface for deployment of the neural interface. The deployment tool can comprise a first area configured to be positioned near the neural interface; and a connector, for releasably coupling the first area to the neural interface, anchored to the first area. The deployment tool can comprise a planar shape or a triangular shape.
In embodiments, the deployment tool can further comprise a second area; and a central area between the first area and the second area. The first area can be wider than the second area.
A cut through the deployment tool can cut through the connector and release the coupling between the deployment tool and the neural interface for at least the first area to move away from the neural interface device.
The deployment tool can further comprise at least one passage extending from the first area to the second area through the central area, each passage including a first opening in the first area and a second opening in the second area.
The connector can be a suture thread for passing through the at least one passage from the second opening to the first opening and for holding the first area near the implantable device, and anchored to the first area.
The deployment tool can further comprise a cuttable portion extending across the at least one passage and configured to release at least one portion of the connector within the at least one passage when the cuttable portion is cut through, wherein the release of the at least one portion of the suture thread enables the first area to move away from the implantable device.
The connector can include a first portion that passes through the at least one passage from the second opening to the first opening, wherein the connector includes a second portion that is removably attached to the implantable device, wherein the connector includes a third portion that passes through the at least one passage from the first opening to the second opening, and wherein the first portion is connected to the second portion and the second portion is connected to the third portion.
The at least one passage can include a first passage and a second passage, wherein the first portion passes through the first passage, the third portion passes through the second passage.
At least the first area and the second area can include rounded edges.
The cuttable portion can be a depressed area in the central area that extends across at least the first passage and the second passage. The depressed area in the central area can extend only across a portion of width of the central area so that at least a portion of the central area is not cut into two pieces when the depressed area is cut through to release the connector. The depressed area can extend across a whole width of the central area so that the central area is cut into two pieces when the depressed area is cut through to release the connector. At least the central area can include a series of alternating lateral ridges and lateral valleys that extend across a width of the central area, for providing longitudinal flexibility that enables the deployment tool to be rolled up while providing lateral stiffness when the deployment tool is unrolled. The first area and the second area include the alternating lateral ridges and lateral valleys that extend across a width of the first area and a width of the second area. The at least one passage can be formed by a tunnel through each lateral ridge and a tube across each lateral valley. The cuttable portion can be a lateral valley. The connector can be anchored to the first area by being molded into the first area. The connector can be anchored to the first area by adhesive. The first area, the second area and the central area can be molded from silicone. At least the second area can be tapered toward the second opening. The tapered second area can include a gripping point for manipulation. The gripping point includes an opening.
The deployment tool can include a first surface and a second surface opposite the first surface, the first surface providing an indication of the location of the cuttable portion, the second surface including a plurality of longitudinal grooves along a length of the deployment tool for reduced contact.
At least the second area and the central area can be tapered, wherein a first portion of the plurality of longitudinal grooves can extend from the first area to the second area through the central area and a second portion of the plurality of longitudinal grooves can extend from the first area to the central area. The second area can taper in its thickness from an edge of the second area towards the central area. The thickness can increase from the edge of the second area towards the central area. The second area can comprise a rounded edge.
The neural interface can be a cuff comprising a spine and at least two curved arms extending from the spine and comprising electrodes, wherein each open end of the curved arm is removably coupled to the deployment tool.
The neural interface can comprise a first arm for being moved in a first direction and one or more second arms for being moved in a second direction substantially opposite the first direction, and the second portion of the connector can be removably attached to the one or more second arms. The one or more second arms can include two arms positioned on opposite sides of the first arm, one arm among the two arms aligned with the first opening of the first passage and the other arm among the two arms aligned with the first opening of the second passage. The one or more second arms can include a first eyelet and the other arm includes a second eyelet, and the second portion of the connector can be removably attached to the cuff by passing through the first eyelet and the second eyelet so as to hold the first area near the cuff until at least one of the first portion or the third portion is cut through at the cuttable portion so that the second portion of the connector can be pulled away from the cuff. A thickness of the central area of the tab can be equal or larger than a thickness of the neural interface. The one or more second arms can have an arm height in a direction perpendicular to both a width and length of the tab, wherein the central area has a height that runs substantially parallel to the arm height, and wherein the height of the central area is greater than the arm height. A width of the first area of the tab is equal or larger than a width of the neural interface.
The cuff can have a width measured from an outer side of the one arm to an outer side of the other arm and that runs substantially parallel to the width of the first area, and wherein the width of the first area is greater than a width of the cuff.
The deployment tool can be configurable as a measurement tool for measuring a fit of the neural interface to a target. A measurement of a fit can be determined based on a distance between the ridges or grooves or valleys of the deployment tool. A measurement of a fit can be determined based on a distance between a first portion of the deployment tool and a second portion of the deployment tool.
The system can further comprise a lead cap device having a first end and a second end and comprising a body defining an internal cavity that extends from the first end toward the second end, a set screw block arranged in the body such that a setscrew intersects with 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 in the internal cavity and secure the portion of the lead body in the internal cavity by the setscrew. An IPG connector portion of the lead body can be removably received in the internal cavity of the lead cap device.
A system can comprise a set comprising a plurality of neural interface devices according to any embodiment discussed or disclosed herein, wherein inner diameters of the neural interface devices differ whilst a total electrode area of each neural interface device is substantially equal. An electrode of a larger inner diameter neural interface device can comprise a smaller width and a larger length than an electrode of a smaller inner diameter neural interface device.
In some embodiments, neural interface includes a spinal portion; a conductor at least partially arranged in the spinal portion; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion; and at least one electrode array arranged 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 with adjacent electrodes in a respective 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.
In an embodiment, a neural interface comprises a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference; a lead body coupled to the first end of the spinal portion and comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spinal portion; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion; and at least one electrode arranged on at least one of the at least three C-ring portions and electrically coupled to the conductor.
In an embodiment, a method of forming a neural interface comprises providing a spinal portion having a first end and a second end, a circumference of the first end of the spinal portion tapering from a maximum circumference to a minimum circumference; coupling a lead body to the first end of the spinal portion such that a conductor of the lead body, connectable to an implantable pulse generator, extends at least partially into the spinal portion; coupling at least three C-ring portions to the spinal portion, each of the at least three C-ring portions having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion; and arranging 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.
In another embodiment, a neural interface can comprise a spinal portion having a first end and a second end; a lead body coupled to the first end of the spinal portion and comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spinal portion from the first end toward the second end; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion, each C-ring portion having an inner diameter and a thickness, with a ratio of the inner diameter to the thickness being in a range of 5:1 to 6:1; and at least one electrode arranged on at least one of the at least three C-ring portions and electrically coupled to the conductor.
In yet another embodiment, a neural interface can comprise a spinal portion having a first end and a second end; a lead body coupled to the first end of the spinal portion and comprising a conductor connectable to an implantable pulse generator and extending at least partially into the spinal portion from the first end toward the second end; at least three C-ring portions each having a first end and a second end, the first end of each C-ring portion being coupled to the spinal portion such that the second ends of a first C-ring portion and a third C-ring portion are on a first side of the spinal portion and the second end of a second C-ring portion, arranged between the first C-ring portion and the third C-ring portion, is on a second opposing side of the spinal portion, each C-ring portion being configured such that in use a pressure in a range of about 0 mmHg to about 30 mmHg is applied to a target tissue arranged within the C-ring portions; and at least one electrode arranged on at least one of the at least three C-ring portions and electrically coupled to the conductor.
In a further embodiment, a system can comprise a neural interface of any of the embodiments disclosed herein; a lead cap device having a first end and a second end and comprising a body defining an internal cavity that extends from the first end toward the second end, a set screw block arranged in the body such that a setscrew intersects with 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 in the internal cavity and secure the portion of the lead body in the internal cavity by the setscrew; and a deployment tool comprising a tab-style 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 eyelets formed in the tab-style body between the first end and the second end, the tab-style body further comprising a series of ridges and grooves, and the deployment tool being removably coupleable to the neural interface by a suture that can be threaded through the first aperture and at least one of the plurality of sets of eyelets.
In addition to or as an alternative to the above, examples consistent with the present teachings are set out in the following numbered clauses.
Features and components of different embodiments discussed herein can be combined in other embodiments. Additionally, features and components discussed herein with respect to particular embodiments or types of neural interfaces or devices can be used with other devices, including other types of electrodes and leads. For example, lead features designed to reduce strain can be used in a variety of other types of devices in which lead strain may be an issue. In another example, component configurations for laser-welding can have applicability in other types of devices and structures. Those skilled in the art will recognize how still other features and components discussed herein may be used with other devices and systems as well as in other applications and methods. In this way particular effects can be designed and achieved in order to meet particular desires or needs in the industry. Dimensions given in the description or drawings are examples and can vary, independently or in combination, in other embodiments. Ranges or dimensions disclosed as being “about” or “approximately” a value can vary by plus/minus 5 percent of the value.
Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.
Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.
Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.
Applicant incorporates by reference the contents of the previously-filed PCT application published as WO 2019/020986. In particular, the electrode described herein may be replaced with the coil electrode described in this application. Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.
For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/070824 | 11/27/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62941311 | Nov 2019 | US |
