NERVE CUFF DEPLOYMENT DEVICES

Abstract

Nerve cuff deployment apparatuses and methods of using them to deliver a nerve cuff electrode to a target nerve trunk.

Claims

1. A method of minimally invasively attaching a nerve cuff electrode to a patient's nerve root, the method comprising: inserting a cannula into the patient's tissue to a nerve root region; advancing a nerve cuff deployment tool distally through the cannula to the nerve root region, wherein the nerve cuff electrode is removably attached at a distal end of the nerve cuff deployment tool, wherein the nerve cuff electrode is self-curling or hinged to wrap around the patient's nerve root; and disengaging the nerve cuff electrode from the nerve cuff deployment tool and causing the nerve cuff electrode to wrap around the patient's nerve root.

2. The method of claim 1, wherein the nerve cuff deployment tool includes an elongated body having a column strength sufficient to resist buckling at compressive forces of at least 10 N.

3. The method of claim 1, wherein the nerve cuff electrode includes a self-curling sheet held in an inverted configuration within the nerve cuff deployment tool, wherein the nerve cuff electrode is biased to wrap itself around the patient's nerve root when released from the nerve cuff deployment tool.

4. The method of claim 1, wherein causing the nerve cuff electrode to wrap around the patient's nerve root includes manipulating the nerve cuff electrode to position the nerve cuff electrode around the patient's nerve root.

5. The method of claim 1, wherein the nerve cuff deployment tool is flexible and has a column strength sufficient to resist buckling at compressive forces of at least 10 N.

6. The method of claim 1, wherein the nerve cuff deployment tool includes a bifurcated end that engages with the nerve cuff electrode, wherein disengaging the nerve cuff electrode from the nerve cuff deployment tool includes pushing or pulling the nerve cuff electrode within the cannula.

7. The method of claim 1, wherein the nerve cuff deployment tool includes a hollow member that receives a lead connected to the nerve cuff electrode.

8. The method of claim 1, wherein the nerve cuff deployment tool includes a hinged distal end that is controllable to release the nerve cuff electrode.

9. The method of claim 1, further comprises securing the nerve cuff electrode using a suture.

10. The method of claim 1, wherein the nerve cuff electrode includes two halves joined by a hinge, wherein the method further comprises securing the two halves using a suture.

11. A nerve cuff deployment apparatus for minimally invasively attaching a nerve cuff electrode to a patient's nerve root, the apparatus comprising: an elongated body; and a nerve cuff engagement region at a distal end of elongated body, the nerve cuff engagement region configured to secure to the nerve cuff electrode having a self-curling sheet, wherein the nerve cuff engagement region is configured to release the nerve cuff electrode near the patient's nerve root and allow the self-curling sheet to wrap around the patient's nerve root.

12. The apparatus of claim 11, wherein the nerve cuff engagement region comprises a two-part capsule configured to at least partially enclose the nerve cuff electrode, the two-part capsule configured to separate or open for deployment of the nerve cuff electrode.

13. The apparatus of claim 11, wherein the nerve cuff engagement region is configured to hold the self-curling sheet in an inverted configuration, and to release the nerve cuff electrode such that the self-curling sheet wraps itself around the patient's nerve root.

14. The apparatus of claim 11, wherein the nerve cuff engagement region comprises a hook or fork configured to releasably engage with the nerve cuff electrode.

15. The apparatus of claim 11, wherein the nerve cuff engagement region comprises a rounded distal end configured to engage with the nerve cuff electrode.

16. The apparatus of claim 11, further comprising a pusher extending adjacent to the elongated body having a distal end configured to apply distal force to the nerve cuff electrode.

17. The apparatus of claim 11, further comprising a proximal control coupled to the elongated body and configured to disengage the nerve cuff engagement region from the nerve cuff electrode.

18. The apparatus of claim 11, wherein the elongated body is flexible and has a column strength sufficient to resist buckling at compressive forces of at least 10 N.

19. A nerve cuff electrode for attaching to a patient's nerve root, the nerve cuff electrode comprising: a nerve cuff body comprising: a first half and a second halve joined by a hinge, wherein the hinge is configured to transition the first and second halves between an open state and a closed state, wherein when in the closed state, the first and second halves are configured to encircle the patient's nerve root; a first lead coupled to and extending longitudinally from the first half of the nerve cuff body; and a second lead coupled to and extending longitudinally from the second half of the nerve cuff body.

20. The nerve cuff electrode of claim 19, wherein the first and second halves of the nerve cuff body each include suture holes configured to accept a suture for securing the first and second halves together in the closed state.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0036] FIG. 1 shows one example of a nerve cuff system (including nerve cuff, lead and implantable controller/waveform generator).

[0037] FIG. 2A shows an example of the system of FIG. 1 implanted into a patient.

[0038] FIG. 2B schematically illustrates the attachment of and nerve cuff such as the one shown in FIGS. 1-2A onto a nerve trunk.

[0039] FIGS. 3A-3D illustrate application of a self-curling nerve cuff onto a model of a nerve trunk.

[0040] FIGS. 4A-4B illustrate one example of a method for minimally-invasively applying a self-rolling nerve cuff onto a nerve trunk as described herein. In FIG. 4A, access to the nerve trunk onto which the nerve cuff is to be applied is achieved using a trocar or cannula; a visualization tool (e.g., an endoscope for endoscopic visualization) is also shown allowing the physician to view the application directly. In FIG. 4B, a nerve cuff deployment device (tool) is used to support and protect the nerve cuff (e.g., self-rolling nerve cuff) so that it may be minimally invasively delivered to the nerve root and deployed for attachment over the nerve root.

[0041] FIGS. 5A-5G illustrate a method of minimally invasively applying a self-rolling nerve cuff onto a nerve trunk using one variation of a nerve trunk deployment tool, in greater detail.

[0042] FIGS. 6A and 6B illustrate the nerve cuff deployment tool shown in FIGS. 5A-5E. FIG. 6A shows the tool assembled to form a capsule that surrounds and protects the nerve cuff electrode. FIG. 6B shows an exploded view of the nerve cuff deployment tool of FIG. 6A, which may be assembled to fully enclose the nerve cuff electrode.

[0043] FIGS. 6C and 6D illustrate a nerve cuff deployment tool similar to that shown in FIG. 6A-6B. In FIG. 6C the nerve cuff deployment tool forms a capsule at the distal end to fully enclose the nerve cuff electrode; a pusher extends adjacent to and within the elongated body to apply distal force to the nerve cuff electrode. FIG. 6D shows an exploded view of the nerve cuff deployment tool of FIG. 6C.

[0044] FIGS. 7A1-7A2 show another example of a nerve cuff deployment tool that includes a flexible deployment tool having high column strength that may be releasably attached to the self-curling nerve cuff (as shown in FIG. 7A1) and used to push or pull the nerve cuff within a delivery cannula or trocar. FIG. 7A2 shows the tool unconnected to a nerve cuff.

[0045] FIG. 7B shows another example of a flexible deployment tool having a high column strength that may be used to push (or in some variations, pull) the self-curling nerve cuff distally through a delivery cannula or trocar for minimally invasive insertion, as described herein.

[0046] FIG. 7C shows another example of a flexible deployment tool having a high column strength that may be used to push (or in some variations, pull) the self-curling nerve cuff distally through a delivery cannula or trocar for minimally invasive insertion, as described herein.

[0047] FIGS. 7D1 and 7D2 show another example of a nerve cuff deployment tool that includes a flexible deployment tool having high column strength that may be releasably attached to the self-curling nerve cuff (as shown in FIG. 7) and used to push or pull the nerve cuff within a delivery cannula or trocar.

[0048] FIGS. 8A-8C illustrate alternative examples of nerve cuffs that may be used with any of the methods and apparatuses described herein. In FIG. 8A, the nerve cuff is hinged (e.g., two-part) nerve cuff. FIG. 8B shows the hinged nerve cuff of FIG. 8A wrapped around a nerve in an end view and FIG. 8C shows the hinged nerve cuff of FIG. 8A in an external perspective view on the nerve trunk.

DETAILED DESCRIPTION

[0049] In general, described herein are methods and apparatuses, including in particular tools such as nerve cuff deployment tools and methods of using them, for minimally invasively attaching a nerve cuff to a nerve trunk. In particular, described herein are methods and apparatuses for delivering nerve cuff electrode (particularly self-rolling nerve cuff electrodes) through an elongated cannula or other elongated, minimally invasive channel for deployment at, near or on a nerve root. In general, a nerve cuff deployment apparatus for minimally invasively attaching a nerve cuff electrode to a patient's nerve root may have a sufficient column strength (e.g., a column strength sufficient to resist buckling at compressive forces of at least 2 N, 5 N, 7 N, 8 N, 9 N, 10 N, 15 N, etc.) so that it may support and protect the generally flexible and loose nerve cuff electrode prior to placing it on the nerve root. The nerve cuff deployment device generally includes a nerve cuff engagement region at a distal end of elongated body that is configured to releasably secure to a nerve cuff electrode to be delivered.

[0050] As already discussed above, FIGS. 1-2A illustrate current methods for positioning or placing a nerve cuff onto a nerve root. For example, in an above-the-knee amputee, a nerve cuff may be placed approximately 5 cm proximal to the neuroma on the sciatic nerve; prior to the inventions described herein, this required a long incision (e.g., 8-10 cm in length), e.g., between the biceps femoris and semimembranosus/semitendinosus region of the body. The nerve cuff (e.g., such as shown in FIG. 2B and 3A-3D) would then be positioned over and around the exposed nerve root. FIG. 3A-3D illustrates one example of this technique. For example, by exposing the nerve, e.g., by dissecting away material around the nerve, including in some cases cauterizing the tissue around the nerve, the nerve cuff electrode 303 may be pulled, e.g., by use of forceps 305 under and around the nerve. The cuff may be initially bathed in an antibiotic solution. Forceps (e.g., right angle forceps) may be used to gently pull the cuff underneath the nerve (FIG. 3B), and the cuff may be wrapped around the nerve, as shown in FIGS. 3C-3D. The electrode cable runs superiorly away from the cuff (e.g., distally).

[0051] Although any appropriate nerve cuff may be used, in particular, the nerve cuff may be a self-wrapping nerve cuff, such as illustrated in FIG. 2B. In this example, the nerve cuff 203 includes two proud regions 205 that each include suture holes through which a suture to secure the two regions together around the nerve may be positioned. The proud region extend up (e.g., 90 degrees) from the curved/curling plane of the arms forming the nerve cuff electrode. The first proud region is separated from the second proud region by less than the expected circumference of the nerve root onto which the nerve cuff is to be applied (e.g., +/−50% of the average expected circumference, or within 50% of the expected circumference), on one side of the wings, so that one “wing” may wrap against the nerve root and the other wing (with the two proud regions) may extend from the other wing and wrap over the first wing, as shown.

[0052] Described herein are methods of less invasively applying a nerve cuff electrode onto a nerve root, including methods of minimally invasively applying the nerve cuff electrode that do not require a large incision. For example, FIGS. 4A-4B illustrate a general method of less invasively applying a nerve cuff, including the use of a nerve cuff deployment tool as described herein. In FIG. 4A, a trocar 403 including a cannula) is first inserted into the body to the region of the nerve root region 407 onto which the nerve cuff electrode is to be positioned. In this example, the nerve root region is just proximal to a neuroma 411. Prior to inserting the trocar/cannula, a visualization tool such as an endoscope 409 may be inserted into the body to visualize the nerve root region. In this example, the endoscope is a rigid endoscope; any appropriate endoscope may be used. Once the trocar is used to position the cannula with a distal end opening into the nerve root region, the nerve cuff electrode may be inserted through the cannula and onto the nerve root. In general the nerve cuff electrode is loose, and overly flexible, so that it cannot be easily inserted through a cannula. Instead, as shown in FIG. 4B, a nerve cuff deployment device 415 may be used to deliver the nerve cuff electrode through the cannula and into position.

[0053] In FIG. 4B, the nerve cuff deployment device 415 includes a two-part elongated body that ends in a pair of halves that form a capsule 413 which may hold a nerve cuff electrode 417, a shown. In this example, the nerve cuff deployment device therefore include an elongated region that can be pushed to drive the capsule and therefore the nerve cuff electrode distally through the cannula.

[0054] FIGS. 5A-5G illustrate this method in additional detail. For example, in FIG. 5A, the nerve cuff electrode 517 is held within a nerve cuff engagement region forming a capsule 521; the lead coupled to the nerve cuff electrode is either also held within the capsule or extends proximally through the nerve cuff deployment device. In FIG. 5A, the nerve cuff deployment device is already loaded with the nerve cuff electrode; once the catheter 503 is positioned, the nerve cuff deployment device may be driven distally (e.g., by pushing on the proximal end 525) and extended out of the distal end of the catheter, as shown in FIGS. 5B-5C. Thereafter, the nerve cuff electrode may be disengaged from the nerve cuff deployment tool by separating the two halves 527, 527′ of the nerve cuff capsule; this may be done at the distal end of the nerve cuff deployment tool, as shown in FIG. 5D. These separated halves may then be withdrawn back into the catheter and/or fully removed, as shown in FIG. 5E. In some variations, an additional step of using a tool such as an endoscope manipulator 535 may be used to help wrap the nerve cuff electrode around the nerve root (“nerve”) as shown in FIG. 5G. In some variations the nerve cuff electrode may be held inverted within the capsule, so that the arms of the nerve cuff electrode are wrapped in the opposite direction. In this case, a self-wrapping nerve cuff may be biased to automatically wrap around the nerve root, or wrap around with assistance, e.g., from a minimally invasive manipulator.

[0055] FIGS. 6A and 6B illustrate the nerve cuff deployment tool variations shown in FIGS. 5A-5G, which includes a capsule region that encloses and protects (and may constrain) a nerve cuff electrode. In FIG. 6A the nerve cuff deployment tool is pre-loaded to include the nerve cuff electrode. FIG. 6B shows an exploded view in which a left half 603 and a right half 603′ of the nerve cuff engagement region forming the enclosed capsule is shown. In FIG. 6B, the two halves may be closed over the nerve cuff electrode and either coupled together or held together within the cannula. The nerve cuff electrode 617 includes a highly flexible lead 618 that may also be held within the capsule, or it may be within the elongated body of the nerve cuff deployment tool. FIGS. 6C and 6D illustrate a similar variation of the nerve cuff deployment tool that also includes an inner pusher 621. The pusher may be coupled to the nerve cuff electrode (in FIG. 6C-6D, the pusher is shown to include a forked distal end 623 to engage with the rolled nerve cuff electrode within the capsule. In this example, the pusher is a high-column strength member than can either hold the nerve cuff electrode in position when disengaging from the nerve cuff deployment tool or may drive the nerve cuff electrode distally (e.g., towards the nerve root) when deploying.

[0056] FIGS. 7A1-7D2 illustrate other variations of nerve cuff deployment tools that may be used with any of the methods descried herein. Elements from any of the nerve cuff deployment tools shown in any of the variations and embodiments described may be used with any of other variation or embodiment of a nerve cuff deployment tool. For example, a pusher such as the one shown in FIG. 6C-6D may be used with any of the nerve cuff deployment tools shown in FIG. 7A1-7D2.

[0057] FIG. 7A1 shows a nerve cuff deployment tool 715 releasably coupled to a nerve cuff electrode 717. In this example, the nerve cuff deployment tool has a bifurcated end 716 (e.g., forked or split) that may couple and engage with the nerve cuff electrode, and particularly the wrapping arms of the nerve cuff electrode. In some variations one or both arms may be hinged so as to close (e.g., clamp) onto each other to releasably secure the nerve cuff assembly between them; a control (e.g., handle, etc. on the distal end of the nerve cuff deployment tool may be operated to release the arms of the nerve cuff deployment tool. FIG. 7A2 shows a perspective view of the nerve cuff deployment tool not coupled to the nerve cuff.

[0058] FIG. 7B shows another variation of a nerve cuff deployment tool 719 having a distal end that is rounded 720 to apply force to a portion of the nerve cuff electrode 717 without damaging it. In this example the nerve cuff deployment tool is a hollow member that receives the lead connected to the nerve cuff assembly and provide structural support to drive the nerve cuff electrode distally. The lead may be held within the nerve cuff deployment tool in tension, so that the nerve cuff assembly is secured to the distal end of the nerve cuff deployment tool.

[0059] FIG. 7C shows another example of a nerve cuff deployment tool 723 that includes a partial capsule that is distally open. The distal-facing end region may hold (and constrain expansion of) the nerve cuff electrode 717 until it is deployed; for example by withdrawing the nerve cuff deployment tool elongated body 733 proximally while holding a pusher (not shown) in place relative to the patient's body, or advancing it slightly distally.

[0060] FIGS. 7D1 and 7D2 show another example of a nerve cuff deployment tool 725 in which the nerve cuff engagement region 736 at the distal end of the nerve cuff deployment tool is configured to releasably couple with the nerve cuff electrode 717. This variation is similar to that shown in FIGS. 7A1-7A2, but may extend over the distal side of the nerve cuff electrode, allowing it to be both pulled and pushed robustly. This variations may also include a release, e.g., at the proximal end, and the distal end region may be hinged in one or more positions to remove the connection to the nerve cuff electrode. Alternatively, in some variations a pusher such as that shown in FIG. 6C-6D may be used to disengage the nerve cuff electrode from the nerve cuff deployment tool.

[0061] Although in general, the nerve cuff electrodes described herein are similar to those shown in FIGS. 2B-3D, any appropriate nerve cuff electrode may be used. FIGS. 8A-8C illustrate another variation of a nerve cuff electrode in which two halve or sides of the nerve cuff electrode are hinged together and may be coupled over and around a nerve root. For example, in FIG. 8A, the nerve cuff electrode shows a left side 803 and a right side 803′ that are joined initially by hinge region 805. The electrodes within the nerve cuff electrode may be similar to those described above, and each half may be connected to a lead 807, 807′. FIG. 8B shows the nerve cuff electrode of FIG. 8A extended over a nerve, and secured on the opposite side by, e.g., a suture. FIG. 8C shows the nerve cuff electrode of FIG. 8A in a perspective view over a nerve.

[0062] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.

[0063] When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[0064] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.

[0065] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0066] Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0067] Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0068] In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.

[0069] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0070] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0071] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.