ELECTRICAL STIMULATION CUFF DEVICE AND SYSTEM HAVING DIRECTIONAL ELECTRODE CONFIGURATION - Patent application

Abstract

The electrical stimulation lead includes a cuff having a cuff body having an outer surface, an inner surface, and a periphery, longitudinal electrodes disposed on the inner surface of the cuff body divided into at least one set with each set including at least sixteen longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body, and a longitudinal slit extending through the cuff body and further extending along the entire length of the cuff body. The electrical stimulation lead also includes a lead body coupled to the cuff, and conductors extending through the lead body and the cuff and electrically coupled to the electrodes.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 63 / 139,240, filed January 19, 2021, which is incorporated herein by reference.

[0002] The present disclosure relates to the field of implantable electrical stimulation systems and methods of making and using the systems. The present disclosure also relates to an implantable electrical stimulation cuff device, as well as methods of making and using the same. [Background technology]

[0003] Implantable electrical stimulation systems have demonstrated therapeutic benefits for a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat chronic pain syndromes and incontinence, along with several other applications under investigation. Functional electrical stimulation systems have been applied to restore some function to paralyzed limbs in spinal cord injury patients. Stimulation of the brain, such as deep brain stimulation, can be used to treat a variety of diseases or disorders.

[0004] Stimulators have been developed to provide therapy for a variety of treatments. Stimulators can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissues to be stimulated. A pulse generator in the control module generates electrical pulses that are delivered to the body tissue by the electrodes. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 6,181,969 [Patent Document 2] U.S. Patent No. 6,516,227 [Patent Document 3] U.S. Patent No. 6,609,029 [Patent Document 4] U.S. Patent No. 6,609,032 [Patent Document 5] U.S. Patent No. 6,741,892 [Patent Document 6] U.S. Patent No. 7,203,548 [Patent Document 7] U.S. Patent No. 7,244,150 [Patent Document 8] U.S. Patent No. 7,450,997 [Patent Document 9] U.S. Patent No. 7,596,414 [Patent Document 10] U.S. Patent No. 7,610,103 [Patent Document 11] U.S. Patent No. 7,672,734 [Patent Document 12] U.S. Pat. No. 7,761,165 [Patent Document 13] U.S. Pat. No. 7,783,359 [Patent Document 14] U.S. Patent No. 7,792,590 [Patent Document 15] U.S. Pat. No. 7,809,446 [Patent Document 16] U.S. Pat. No. 7,949,395 [Patent Document 17] U.S. Pat. No. 7,974,706 [Patent Document 18] U.S. Patent No. 6,175,710 [Patent Document 19] U.S. Patent No. 6,224,450 [Patent Document 20] U.S. Patent No. 6,271,094 [Patent Document 21] U.S. Patent No. 6,295,944 [Patent Document 22] U.S. Patent No. 6,364,278 [Patent Document 23] U.S. Patent No. 6,391,985 [Patent Document 24] US Patent Application Publication No. 2007 / 0150036 [Patent Document 25] US Patent Application Publication No. 2009 / 0187222 [Patent Document 26] US Patent Application Publication No. 2009 / 0276021 [Patent Document 27] US Patent Application Publication No. 2010 / 0076535 [Patent Document 28] US Patent Application Publication No. 2010 / 0268298 [Patent Document 29] US Patent Application Publication No. 2011 / 0004267 [Patent Document 30] US Patent Application Publication No. 2011 / 0078900 [Patent Document 31] US Patent Application Publication No. 2011 / 0130817 [Patent Document 32] US Patent Application Publication No. 2011 / 0130818 [Patent Document 33] US Patent Application Publication No. 2011 / 0238129 [Patent Document 34] US Patent Application Publication No. 2011 / 0313500 [Patent Document 35] US Patent Application Publication No. 2012 / 0016378 [Patent Document 36] US Patent Application Publication No. 2012 / 0046710 [Patent Document 37] US Patent Application Publication No. 2012 / 0071949 [Patent Document 38] US Patent Application Publication No. 2012 / 0165911 [Patent Document 39] US Patent Application Publication No. 2012 / 0197375 [Patent Document 40] US Patent Application Publication No. 2012 / 0203316 [Patent Document 41] US Patent Application Publication No. 2012 / 0203320 [Patent Document 42] US Patent Application Publication No. 2012 / 0203321 [Patent Document 43] US Patent Application Publication No. 2012 / 0316615 [Patent Document 44] US Patent Application Publication No. 2013 / 0105071 [Patent Document 45] U.S. Patent Application Serial No. 12 / 177,823 [Patent Document 46] U.S. Patent Application Serial No. 13 / 750,725 [Patent Document 47] U.S. Patent No. 7,596,414 [Patent Document 48] U.S. Pat. No. 7,974,706 [Patent Document 49] U.S. Pat. No. 8,423,157 [Patent Document 50] U.S. Pat. No. 10,485,969 [Patent Document 51] U.S. Pat. No. 10,493,269 [Patent Document 52] U.S. Pat. No. 10,709,888 [Patent Document 53] U.S. Pat. No. 10,814,127 [Patent Document 54] US Patent Application Publication No. 2017 / 0333692 [Patent Document 55] US Patent Application Publication No. 2018 / 0154156 [Patent Document 56] U.S. Patent No. 8,224,450 [Patent Document 57] U.S. Pat. No. 8,423,154 [Patent Document 58] U.S. Pat. No. 8,606,362 [Patent Document 59] U.S. Patent No. 8,620,436 [Patent Document 60] U.S. Pat. No. 9,308,383 [Patent Document 61] U.S. Patent No. 9,568,053 [Patent Document 62] U.S. Pat. No. 10,350,413 [Patent Document 63] U.S. Pat. No. 10,537,741 [Patent Document 64] US Patent Application Publication No. 2018 / 0071520 [Patent Document 65] US Patent Application Publication No. 2019 / 0083796 Summary of the Invention [Means for solving the problem]

[0006] One aspect is an electrical stimulation lead that includes a cuff having a cuff body having an outer surface, an inner surface, and a perimeter, longitudinal electrodes disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a length / width aspect ratio of at least 20, the longitudinal electrodes being divided into at least one set including at least 16 longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body, and a longitudinal slit extending through the cuff body and further extending along the entire length of the cuff body and operable to receive a portion of the target nerve from a region outside the cuff into the cuff body. The electrical stimulation lead also includes a lead body coupled to the cuff and conductors extending through the lead body and the cuff, the conductors being electrically coupled to the longitudinal electrodes.

[0007] In at least some embodiments, the aspect ratio of each of the longitudinal electrodes is at least 50. In at least some embodiments, each of the longitudinal electrodes has a width not greater than 100 μm. In at least some embodiments, each of the longitudinal electrodes has a length of at least 1 mm. In at least some embodiments, each of the at least one set includes at least 32 longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body.

[0008] In at least some embodiments, the cuff further comprises at least one radial electrode extending around at least 75% of the circumference of the cuff body, hi at least some embodiments, the cuff further comprises at least one set of radial electrodes, each set of radial electrodes including at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body.

[0009] Another aspect is an electrical stimulation lead including a cuff having a cuff body having an outer surface, an inner surface, and a perimeter, longitudinal electrodes disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a width not greater than 100 μm, the longitudinal electrodes being divided into at least one set including at least 16 longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body, and a longitudinal slit extending through the cuff body and further extending along the entire length of the cuff body and operable to receive a portion of the target nerve from a region outside the cuff into the cuff body. The electrical stimulation lead also includes a lead body coupled to the cuff and conductors extending through the lead body and the cuff, the conductors being electrically coupled to the longitudinal electrodes.

[0010] In at least some embodiments, the aspect ratio of each of the longitudinal electrodes is at least 50. In at least some embodiments, each of the longitudinal electrodes has a length of at least 1 mm. In at least some embodiments, each of the at least one set includes at least 32 longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body.

[0011] In at least some embodiments, the cuff further comprises at least one radial electrode extending around at least 75% of the circumference of the cuff body, hi at least some embodiments, the cuff further comprises at least one set of radial electrodes, each set of radial electrodes including at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body.

[0012] Yet another aspect is an electrical stimulation lead including a cuff having a cuff body having an outer surface, an inner surface, and a perimeter, longitudinal electrodes disposed on the inner surface of the cuff body, the longitudinal electrodes being divided into at least one set, each set including at least 16 or 32 longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body, one or more radial electrodes extending around at least 75% of the circumference of the cuff body, either alone or in combination with two or more radial electrodes (e.g., when there are two or more radial electrodes), and a longitudinal slit extending through the cuff body and further along the entire length of the cuff body, operable to receive a portion of the target nerve from a region outside the cuff into the cuff body. The electrical stimulation lead also includes a lead body coupled to the cuff, and conductors extending through the lead body and the cuff, the conductors being electrically coupled to the longitudinal electrodes and the radial electrodes.

[0013] In at least some embodiments, the aspect ratio of each of the longitudinal electrodes is at least 50. In at least some embodiments, each of the longitudinal electrodes has a width not greater than 100 μm. In at least some embodiments, each of the longitudinal electrodes has a length of at least 1 mm. In at least some embodiments, each of the at least one set includes at least 32 longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body.

[0014] In at least some embodiments, the cuff further comprises at least two sets of radial electrodes, each set of radial electrodes including at least one of the radial electrodes extending around at least 75% of the circumference of the cuff body. In at least some embodiments, at least one of the sets of radial electrodes includes at least two of the radial electrodes that in combination extend around at least 75% of the circumference of the cuff body. In at least some embodiments, the cuff further comprises a cushioning layer disposed over an inner surface of the cuff body.

[0015] Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings, in which like reference numbers refer to like parts throughout the various views unless otherwise specified, in which:

[0016] For a better understanding of the present invention, reference should be made to the following detailed description, which is to be read in connection with the accompanying drawings. [Brief description of the drawings]

[0017] [Figure 1] FIG. 1 is a schematic diagram of one embodiment of an electrical stimulation system including a lead electrically coupled to a control module. [Figure 2A] 2 is a schematic diagram of one embodiment of the control module of FIG. 1 constructed and arranged to electrically couple to an elongate device. [Figure 2B] 2B is a schematic diagram of one embodiment of a lead extension constructed and arranged to electrically couple the elongate device of FIG. 2A to the control module of FIG. 1. [Diagram 3] FIG. 1 is a schematic perspective view of one embodiment of a cuff having two sets of 16 longitudinal electrodes each and two radial electrodes. [Figure 4] FIG. 13 is a schematic perspective view of another embodiment of a cuff having four sets of sixteen longitudinal electrodes each and three radial electrodes. [Diagram 5] FIG. 1 is a schematic perspective view of one embodiment of a cuff having four sets of sixteen longitudinal electrodes each and three sets of two radial electrodes each. [Figure 6] FIG. 1 is a schematic perspective view of one embodiment of a cuff having four sets of 32 longitudinal electrodes each and two radial electrodes. [Figure 7] This is a cross-sectional photograph of a portion of the vagus nerve. [Figure 8] 7 is a cross-sectional view of the cuff of FIG. 6 placed around a portion of the vagus nerve. [Figure 9] FIG. 1 is a schematic diagram of one embodiment of components of an electrical stimulation arrangement in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] The present invention relates to the field of implantable electrical stimulation systems and methods of making and using the systems. The present invention also relates to an implantable electrical stimulation cuff device, and methods of making and using the same.

[0019] Suitable implantable electrical stimulation systems include at least one lead having one or more electrodes disposed along a distal end of the lead. Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems having leads are described in, for example, U.S. Patent Nos. 6,181,969, 6,516,227, 6,609,029, 6,609,032, 6,741,892, 7,203,548, 7,244,150, 7,450,997, 7,596,414, 7,610,103, 7,672,734, 7,761,165, 7,771,175, 7,771,187, 7,771,190, 7,771,200, 7,771,300, 7,771,400, 7,771,500, 7,771,600, 7,771,700, 7,771,800, 7,771,900, 7,771,175, 7,771,190 ... ,783,359, 7,792,590, 7,809,446, 7,949,395, 7,974,706, 6,175,710, 6,224,450, 6,271,094, 6,295,944, 6,364,278, and 6,391,985, U.S. Patent Application Publication Nos. 2007 / 0150036 and 2009 / 0187222, Specification No. 2009 / 0276021, Specification No. 2010 / 0076535, Specification No. 2010 / 0268298, Specification No. 2011 / 0004267, Specification No. 2011 / 0078900, Specification No. 2011 / 0130817 Specification, Specification No. 2011 / 0130818, Specification No. 2011 / 0238129, Specification No. 2011 / 0313500, Specification No. 2012 / 0016378, Specification No. 2012 / 0046710, Specification No. 2012 / 00719 49, 2012 / 0165911, 2012 / 0197375, 2012 / 0203316, 2012 / 0203320, 2012 / 0203321, 2012 / 0316615, and 2013 / 0105071, and U.S. Patent Application Nos. 12 / 177,823 and 13 / 750,725, all of which are incorporated by reference in their entirety.

[0020] FIG. 1 illustrates a schematic of one embodiment of an electrical stimulation system 100. The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator) 102 and a lead 103 that can be coupled to the control module 102. The lead 103 includes a mount 162 and a cuff 150. The lead 103 includes one or more lead bodies 106, an array of electrodes 133, such as electrode 134, and an array of terminals (e.g., 210 in FIGS. 2A-2B) disposed within the cuff 150 that are attached to the one or more lead bodies 106. In at least some embodiments, the lead is isodiametric along at least a portion of the longitudinal length of the lead body 106. FIG. 1 illustrates one lead 103 coupled to the control module 102. Other embodiments may include two, three, four, or more leads 103 coupled to the control module 102. In still other embodiments, the lead 103 may be coupled to multiple control modules 102. For example, a lead with 64 electrodes may be coupled to two control modules 102, each capable of handling 32 electrodes.

[0021] The leads 103 may be coupled to the control module 102 in any suitable manner. In at least some embodiments, the leads 103 are directly coupled to the control module 102. In at least some other embodiments, the leads 103 are coupled to the control module 102 through one or more intermediate devices (200 in FIGS. 2A-2B). For example, in at least some embodiments, one or more lead extensions 224 (see, e.g., FIG. 2B) may be disposed between the leads 103 and the control module 102 to extend the distance between the leads 103 and the control module 102. Other intermediate devices, including, for example, splitters or adapters, or the like, or combinations thereof, may be used in addition to or instead of the one or more lead extensions. It will be appreciated that when the electrical stimulation system 100 includes multiple elongate devices disposed between the leads 103 and the control module 102, the intermediate devices may be configured in any suitable arrangement.

[0022] 1, an electrical stimulation system 100 is shown having a splitter 107 configured and arranged to facilitate coupling of a lead 103 to a control module 102. The splitter 107 includes a splitter connector 108 configured to couple to a proximal end of the lead 103 and one or more proximal tails 109a and 109b configured and arranged to couple to the control module 102 (or to another splitter, lead extension, adapter, etc.). The splitter 107 and splitter connector 108 may be part of the lead 103 or may be separate components attached to the lead.

[0023] The control module 102 typically includes a connector housing 112 and a sealed electronics housing 114. The stimulation circuitry 110 and optional power source 120 are disposed in the electronics housing 114. A control module connector 144 is disposed in the connector housing 112. The control module connector 144 is constructed and arranged to provide an electrical connection between the leads 103 and the stimulation circuitry 110 of the control module 102.

[0024] The electrical stimulation system or components, including the lead body 106 and the control module 102, are typically implanted within a patient. Electrical stimulation systems can be used for a variety of applications, including, but not limited to, brain stimulation, nerve stimulation, spinal cord stimulation, and muscle stimulation.

[0025] The lead body 106 may be made of, for example, a non-conductive biocompatible material such as, for example, silicone, polyurethane, polyetheretherketone ("PEEK"), epoxy, and the like, or combinations thereof. The lead body 106 may be formed into the desired shape by any process including, for example, molding (including injection molding), casting, and the like. The non-conductive material typically extends from the distal end of the lead body 106 to the proximal end of the lead body 106.

[0026] Terminals (e.g., 210 in FIGS. 2A-2B ) are typically disposed along the proximal end of the lead body 106 of the electrical stimulation system 100 (as well as any splitters, lead extensions, or adapters, etc.) for electrical connection to corresponding connector contacts (e.g., 214 and 240 in FIG. 2B ). The connector contacts are disposed on a connector (e.g., 144 in FIGS. 1-2B and 222 in FIG. 2B ), which is in turn disposed, for example, on the control module 102 (or lead extensions, splitters, or adapters, etc.). Conductive wires 160 or cables or the like (only one of which is shown in FIG. 1 ) extend from the terminals to the electrodes 134. Typically, one or more electrodes 134 are electrically coupled to each terminal. In at least some embodiments, each terminal is connected to only one electrode 134.

[0027] The electrically conductive wires ("conductors") 160 (only one is shown in FIG. 1 for clarity) may be embedded in the non-conductive material of the lead body 106 or may be disposed in one or more lumens (not shown) extending along the lead body 106. In some embodiments, there is an individual lumen for each conductor. In other embodiments, two or more conductors extend through the lumens. There may also be one or more lumens (not shown) opening at or near the proximal end of the lead body 106, for example, to insert a stylet to facilitate placement of the lead body 106 within the patient's body. In addition, there may be one or more lumens (not shown) opening at or near the distal end of the lead body 106, for example, for injection of drugs or agents into the site of implantation of the lead body 106. In at least one embodiment, the one or more lumens are continuously or periodically flushed, such as with saline or epidural fluid. In at least some embodiments, the one or more lumens are permanently or removably sealable at the distal end.

[0028] 1 also illustrates a mount 162 that is part of the lead body 106 coupled to the cuff 150. Conductors 160 from within the lead body 106 (only one of which is shown in FIG. 1 for clarity) are received in the mount 162, which is then attached to the cuff 150 such that each conductor passes through the mount 162 for direct electrical connection with one of the electrodes 134 (e.g., one conductor electrically connects with one electrode, etc.). The mount 162 may be attached using a variety of means, such as, but not limited to, molding or gluing the mount 162 to the cuff 150. In other embodiments, the conductors 160 from within the lead body 106 are electrically coupled to the electrodes 134 using jumpers, intermediate wires, or transition wires from the lead body 106 to the electrodes 134.

[0029] The mount 162 may be offset from the cuff 150, aligned with the cuff, as shown in Figure 1, or in any other suitable arrangement. Examples of cuff leads 103 can be found in U.S. Patent Nos. 7,596,414, 7,974,706, 8,423,157, 10,485,969, 10,493,269, 10,709,888, and 10,814,127, and U.S. Patent Application Publication Nos. 2017 / 0333692 and 2018 / 0154156, all of which are incorporated by reference herein in their entireties.

[0030] 2A is a schematic side view of an embodiment of a proximal end of one or more elongate devices 200 configured and arranged to couple to an embodiment of the control module connector 144. The one or more elongate devices may include, for example, the lead body 106, one or more intermediate devices (e.g., the lead extension 224 of FIG. 2B, or an adapter, or the like, or a combination thereof), or a combination thereof. FIG 2A illustrates two elongate devices 200 coupled to the control module 102. These two elongate devices 200 may be two tails as shown in FIG 1, or two different leads, or any other combination of elongate devices.

[0031] The control module connector 144 defines at least one port into which the proximal end of the elongate device 200 can be inserted, as indicated by directional arrow 212. In FIG. 2A (and in other figures), the connector housing 112 is shown having two ports 204a and 204b. The connector housing 112 may define any suitable number of ports, including, for example, 1, 2, 3, 4, 5, 6, 7, 8, or more ports.

[0032] The control module connector 144 also includes a number of connector contacts, such as connector contacts 214 disposed within each of the ports 204a and 204b. When the elongate device 200 is inserted into the ports 204a and 204b, the connector contacts 214 may align with a number of terminals 210 disposed along the proximal end of the elongate device 200 to electrically couple the control module 102 to electrodes (134 in FIG. 1 ) disposed at the distal ends of the leads 103. Examples of connectors within control modules can be found, for example, in U.S. Patent Nos. 7,244,150 and 8,224,450, which are incorporated by reference in their entireties.

[0033] 2B is a schematic side view of another embodiment of the electrical stimulation system 100. The electrical stimulation system 100 includes a lead extension 224 that is configured and arranged to couple one or more elongate devices 200 (e.g., a lead body 106, an adapter, or another lead extension, or the like, or a combination thereof) to the control module 102. In FIG. 2B, the lead extension 224 is shown coupled to a single port 204 defined in the control module connector 144. In addition, the lead extension 224 is shown configured and arranged to couple to a single elongate device 200. In alternative embodiments, the lead extension 224 is configured and arranged to couple to multiple ports 204 defined in the control module connector 144, to receive multiple elongate devices 200, or both.

[0034] The lead extension 224 is disposed on the lead extension connector 222. In FIG. 2B, the lead extension connector 222 is shown disposed on a distal end 226 of the lead extension 224. The lead extension connector 222 includes a connector housing 228. The connector housing 228 defines at least one port 230 into which the terminal 210 of the elongate device 200 can be inserted, as indicated by directional arrow 238. The connector housing 228 also includes a number of connector contacts, such as connector contacts 240. When the elongate device 200 is inserted into the port 230, the connector contacts 240 disposed on the connector housing 228 can be aligned with the terminal 210 of the elongate device 200 to electrically couple the lead extension 224 to an electrode (134, FIG. 1) disposed along the lead (103, FIG. 1).

[0035] In at least some embodiments, the proximal end of the lead extension 224 is configured and arranged similarly to the proximal end of the lead 103 (or other elongate device 200). The lead extension 224 may include a number of conductive wires (not shown) electrically coupling the connector contacts 240 to a proximal end 248 of the lead extension 224 opposite the distal end 226. In at least some embodiments, the conductive wires disposed on the lead extension 224 may be electrically coupled to a number of terminals (not shown) disposed along the proximal end 248 of the lead extension 224. In at least some embodiments, the proximal end 248 of the lead extension 224 is configured and arranged for insertion into a connector disposed on another lead extension (or another intermediate device). In other embodiments (and as shown in FIG. 2B ), the proximal end 248 of the lead extension 224 is configured and arranged for insertion into the control module connector 144.

[0036] A conventional cuff includes a cuff that wraps around a portion of the circumference of a nerve with one or more electrodes disposed on the cuff. In many conventional cuffs, the individual electrodes also wrap around at least a portion of the circumference of the nerve in a radial wrap arrangement. The radial wrap arrangement of the electrodes typically results in stimulation of a circumferential region of the nerve.

[0037] However, nerves are not monolithic biological constructs; rather, instead, nerves are made up of many fibers (which may be arranged in groups) that run longitudinally along the nerve. Figure 7 is a cross-section of a portion of the vagus nerve 280 illustrating the many fibers 282 within the nerve. In some cases, it may be desirable to stimulate only one fiber or group of fibers.

[0038] Electrodes in a radial wrap configuration generally cannot selectively stimulate a fiber or group of fibers, but instead stimulate many fibers due to extending around the circumference of the nerve. In addition, such electrodes may produce undesirable side effects because multiple nerve fibers are stimulated. For example, a cuffed electrode around the vagus nerve may have a broad effect when stimulating the vagus nerve, since different fibers connect to many parts of the body.

[0039] As further described herein, the cuff lead can include a cuff body that wraps around the circumference of the nerve and includes longitudinal electrodes distributed around the circumference of the cuff body. In at least some embodiments, these longitudinal electrodes allow for targeting of selected longitudinal regions along the circumference of the cuff body. In at least some embodiments, these are at least 16, 20, 25, 28, 32, 36, 40, 48, 50, 64, 80, 100, 120, 128, 150, 200, 250, 256, or more longitudinal electrodes arranged in sets around the circumference of the cuff body, and there may be 1, 2, 3, or more sets of longitudinal electrodes spaced apart longitudinally from one another along the cuff body.

[0040] In at least some embodiments, the cuff may also include one or more radial electrodes that can be used as counter electrodes to one or more selected longitudinal electrodes. In at least some embodiments, one or more of the longitudinal electrodes can be used as cathodes and one or more of the radial electrodes can be used as anodes. Any other suitable selection of cathodes or anodes from the longitudinal or radial electrodes can be used.

[0041] In at least some embodiments, longitudinal electrodes can be used to selectively stimulate nerve fibers or sets of nerve fibers. For example, a cuff with a cuff around the vagus nerve may be used to selectively stimulate immunomodulatory fibers without stimulating (or reducing or below threshold stimulating) cardiovascular or somatotopic fibers within the nerve. For example, immunomodulatory fibers may be used to enhance, reduce, or stop signals to or from the brain. In at least some embodiments, a cuff with longitudinal electrodes can be used to selectively provide fiber or myofascial stimulation.

[0042] FIG. 3 illustrates one embodiment of a cuff 350 of the cuff lead 103 (FIG. 1). The cuff 350 includes a cuff body 352 having longitudinal electrodes 334 disposed on an inner surface 354 of the cuff body and arranged around the circumference of the cuff body in two sets 356a, 356b. In the illustrated embodiment, each set 356a, 356b includes 16 longitudinal electrodes 334. Any other suitable number of electrodes can be used, including, but not limited to, 16, 20, 25, 28, 32, 36, 40, 48, 50, 64, 80, 100, 120, 128, 150, 200, 250, 256, or more longitudinal electrodes. The cuff lead can have 1, 2, 3, 4, or more sets of longitudinal electrodes 334. The number of longitudinal electrodes 334 in a set can be the same or different for each set. In the illustrated embodiment, the longitudinal electrodes 334 of each set are longitudinally aligned with the electrodes of the other set, in other embodiments, the longitudinal electrodes 334 of each set may be interleaved or misaligned with the electrodes of the other set.

[0043] In addition, the cuff 350 includes two radial electrodes 358a, 358b that wrap around at least 75%, 80%, 90%, or 95% of the circumference of the cuff body 352. The cuff 350 also defines a slit 360 that runs the longitudinal length of the cuff body 352 so that a nerve can be loaded into the interior 362 of the cuff body by opening the slit and fitting the cuff body over the nerve. The slit 360 is opened or initially sized to allow a target nerve (not shown) to be slid, inserted, fed, or otherwise received into the cuff 350 so that the cuff 350 wraps around the target nerve. In at least some embodiments, the slit 360 allows the cuff 350 to be easily moved over and around or relative to the target nerve, whether rotationally or translationally.

[0044] The electrodes 334, 358a, 358b can be formed using any conductive and biocompatible material. Examples of suitable materials include metals, metal alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. In at least some embodiments, one or more of the electrodes 334 are formed from one or more of platinum, platinum alloys such as platinum-iridium, palladium alloys such as palladium-rhodium, titanium, titanium alloys, nickel alloys, cobalt alloys, nickel / cobalt alloys, stainless steel, tantalum, conductive carbon, conductive plastics, epoxy or other adhesives filled with metal powder, Nitinol®, and the like, or any combination thereof. The electrodes 334, 358a, 358b can be formed by any suitable process, including, but not limited to, machining, molding (e.g., powdered metal molding), photolithography, additive techniques, stamping, and the like, or any combination thereof.

[0045] In at least some embodiments, the electrodes 334, 358a, 358b have a contact surface that is flush with or protrudes slightly from the cuff body 352 (e.g., no more than 200, 100, or 50 μm), which may, at least in some circumstances, reduce or eliminate physical pressure on the nerve. It will be appreciated that the electrodes can be used to provide electrical stimulation or to sense electrical signals from tissue, or any combination thereof.

[0046] In at least some embodiments, the longitudinal electrodes 334 have a width not greater than 100, 75, 50, 40, 30, or 25 micrometers (μm) and a length of at least 1, 2, 3, 4, 5, 7, or more millimeters (mm). The width of the longitudinal electrodes corresponds to a distance in a circumferential direction 351 around the cuff body. In at least some embodiments, the length of the longitudinal electrodes 334 is not greater than 10 mm. The length of the longitudinal electrodes corresponds to a distance along a longitudinal direction 353 of the cuff body. In at least some embodiments, the longitudinal electrodes 334 have an aspect ratio (length / width) of at least 20, 40, 50, 80, 100, 150, 200, or more. In at least some embodiments, each of the electrodes 334 has the same width, length, and aspect ratio. In other embodiments, the electrodes 334 can have different widths, lengths, or aspect ratios, with the electrodes of a set having the same or different widths, lengths, or aspect ratios within or between the sets.

[0047] In at least some embodiments, the longitudinal electrodes 334 are rectangular or rectangular with rounded corners. Any other suitable shapes can be used for the longitudinal electrodes, including, but not limited to, ovals, ellipses, modified rectangles with one or more sides (or portions of sides) that are curved, or the like, or any combination thereof. The length and width measurements described in the immediately preceding paragraph correspond to the longest or widest portions of the electrodes 334. For example, for an elliptical electrode, the length along the major axis of the ellipse corresponds to the length measurement, and the length along the minor axis corresponds to the width measurement.

[0048] The narrow width of the longitudinal electrodes 334 can facilitate the ability to select specific fibers or groups of fibers within the nerve and steer stimulation to the selected fibers or groups of fibers. The number of longitudinal electrodes 334 in each set can further enhance fiber selectivity by providing more selectivity with an increasing number of longitudinal electrodes 334. Stimulation can be performed using one or more of the longitudinal electrodes 334. Selection of an appropriate radial electrode 358a, 358b (or one or more of the longitudinal electrodes 334) as a counter electrode can further enhance steering of stimulation to selected fibers or groups of fibers.

[0049] The cuff body 352 may be formed of any suitable biocompatible and biostable non-conductive material, including, but not limited to, polymeric materials such as silicone, polyurethane, polyetheretherketone ("PEEK"), epoxy, and the like, or any combination thereof. In at least some embodiments, the cuff body 352 may have a circular, elliptical, or any other suitable cross-sectional shape, and in at least some embodiments, may be sufficiently flexible to change cross-sectional shape to accommodate a nerve. In at least some embodiments, the electrodes 334, 358a, 358b may be molded with the cuff body 352 or formed by techniques such as etching or ablation of a conductive layer or film, and the like. In at least some embodiments, the cuff body 352 has an inner diameter (which may correspond to the maximum diameter of a non-circular cuff body) in the range of 0.5 to 5 mm, or in the range of 1 to 3 mm. In at least some embodiments, the cuff body 352 has a length of at least 5, 10, or 20 mm.

[0050] In at least some embodiments, the cuff body 352 can be formed using any suitable technique including, but not limited to, molding, casting, formed into a sheet and then formed using an adhesive as a binder, formed flat and formed using heat, formed flat and attached to a cuff-like scaffold, or pressed or extruded into a cuff shape, or any combination thereof. In at least some embodiments, the electrodes 334 can be attached to the cuff body 352 using any suitable technique including, but not limited to, attaching with an adhesive, molding into the cuff body (e.g., insert molding), using heat to bond the electrodes to the cuff body, heating the electrodes and forcing them into the cuff body, depositing electrode material on the cuff body and using photolithography and etching, or any combination thereof.

[0051] In at least some embodiments, the inner surface 354 of the cuff body 352 can be coated with a buffer layer 364 (FIG. 8) that acts as a cushion to reduce damage to the nerve. Examples of materials for the buffer layer 364 include, but are not limited to, paraffin or a combination of isotonic saline and artificial cerebrospinal fluid, and the like, or any combination thereof. The buffer layer 364 is made of a material that allows the flow of electrical current from the electrode 334 through the buffer layer to the nerve.

[0052] In at least some embodiments, with the cuff 350 in a desired position relative to the target nerve, the edges of the cuff body 352 that define the slits 360 can be sutured to capture the target nerve without undue compression of the target nerve. In at least some embodiments, suture holes (not shown) are optionally incorporated into the edges of the cuff 350 to allow for closing or partially closing the cuff 350 around the target nerve.

[0053] 4 illustrates another embodiment of a cuff 350 having a cuff body 352 and longitudinal electrodes 334 arranged in four groups 356a, 356b, 356c, 356d with 16 electrodes in each group. The cuff 350 includes three radial electrodes 358a, 358b, 358c.

[0054] 5 illustrates another embodiment of a cuff 350 having a cuff body 352 and longitudinal electrodes 334 arranged in four groups 356a, 356b, 356c, 356d with 16 electrodes in each group. The cuff 350 includes six radial electrodes 358a, 358b, 358c, 358d, 358e, 358f, each extending around less than half the circumference of the cuff body 352 (e.g., at least 25%, 30%, 33%, 40%, 45%, or 48% of the circumference of the cuff body), with two of these radial electrodes arranged in each of three sets. It will be appreciated that other arrangements can include, for example, three, four, six, or more radial electrodes (or any other number of radial electrodes) per set. The radial electrodes of a set can extend the same amount around the circumference of the cuff body 352 or can extend different amounts around the circumference of the cuff body. Each set can be identical, or the sets can have different arrangements of radial electrodes. In at least some embodiments, the radial electrodes of a set, in combination, extend around at least 75%, 80%, 90%, or 95% of the circumference of the cuff body 352.

[0055] 6 illustrates yet another embodiment of a cuff 350 having a cuff body 352 and longitudinal electrodes 334 arranged in four groups 356a, 356b, 356c, 356d with 32 electrodes in each group. The cuff 350 includes two radial electrodes 358a, 358b.

[0056] 8 illustrates a cross-section of the cuff 350 of FIG. 6 placed around the vagus nerve 280, with longitudinal electrodes 334 arranged around the circumference of the cuff and vagus nerve. Optionally, a cushioning layer 364 is placed between the cuff 350 / electrodes 334 and the nerve 280.

[0057] A cuff lead 103 (FIG. 1) may be coupled to one or more control modules 102 (FIG. 1). Where a cuff lead 103 has many longitudinal electrodes 334, multiple control modules 102 may be used to independently control the longitudinal electrodes 334. Additionally or alternatively, multiplexing techniques and arrangements may be used to provide stimulation to selected longitudinal electrodes 334. The multiplexing arrangement may be part of the control module 102, the cuff lead 103, or a separate module, or any combination thereof. Examples of multiplexing and independent control and delivery of stimulation through selected electrodes can be found in U.S. Pat. Nos. 8,423,154, 8,606,362, 8,620,436, 9,308,383, 9,568,053, 10,350,413, and 10,537,741, and U.S. Patent Application Publication Nos. 2018 / 0071520 and 2019 / 0083796, all of which are incorporated by reference in their entireties.

[0058] 9 is a schematic diagram of one embodiment of components of an electrical stimulation arrangement 904 including an electrical stimulation system 900 having a lead 902, a stimulation circuit 906, a power source 908, and an antenna 910. The electrical stimulation system can be, for example, any of the electrical stimulation systems described above. It will be understood that the electrical stimulation arrangement can include more, fewer, or different components and can have a variety of different configurations, including those disclosed in the stimulator references listed herein.

[0059] Where the power source 908 is a rechargeable battery or a rechargeable capacitor, the power source may be recharged / charged, if desired, using the antenna 910. Power for recharging / charging may be provided by inductively coupling the power source 908 through the antenna 910 to a recharging unit 936 external to the user. Examples of such arrangements may be found in the documents identified above.

[0060] In at least some embodiments, electrical current is emitted by electrodes (such as electrodes 134 in FIG. 1) on the lead 902 to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system. The stimulation circuitry 906 may include a processor 934 and a receiver 932, among other components. The processor 934 is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor 934 may control one or more of the timing, frequency, intensity, duration, and waveform of the pulses, if desired. In addition, the processor 934 may select which electrodes may be used to provide stimulation, if desired. In some embodiments, the processor 934 selects which electrodes are cathodes and which electrodes are anodes. In some embodiments, the processor 934 is used to identify which electrodes provide the most useful stimulation of the desired tissue.

[0061] Any processor can be used, and can be as simple as, for example, an electronic device that generates pulses at regular intervals, or the processor can have the capability to receive and interpret instructions from an external programming unit 938, for example, allowing modification of the pulse characteristics. In the illustrated embodiment, the processor 934 is coupled to a receiver 932, which is in turn coupled to the antenna 910. This allows the processor 934 to receive instructions from an external source that, for example, dictates the pulse characteristics and electrode selection, if desired.

[0062] In at least some embodiments, the antenna 910 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 940 that are programmed by a programming unit 938. The programming unit 938 can be external to or part of the telemetry unit 940. The telemetry unit 940 can be a device that can be worn on the skin of the user or carried by the user, and can have a form similar to a pager, cell phone, or remote control, if desired. As another alternative, the telemetry unit 940 may not be worn or carried by the user, but rather may only be available at a home station or clinician's office. The programming unit 938 can be any unit that can provide information to the telemetry unit 940 for transmission to the electrical stimulation system 900. The programming unit 938 can be part of the telemetry unit 940 or can provide signals or information to the telemetry unit 940 through a wireless or wired connection. One example of a suitable programming unit is a computer operated by a user or clinician to send signals to the telemetry unit 940.

[0063] The signals sent through the antenna 910 and receiver 932 to the processor 934 can be used to modify or otherwise direct operation of the electrical stimulation system 900. For example, the signals may be used to modify the pulses of the electrical stimulation system, such as modifying one or more of the pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also instruct the electrical stimulation system 900 to stop operation, start operation, start charging a battery, or stop charging a battery.

[0064] Optionally, the electrical stimulation system 900 may include a transmitter (not shown) coupled to the processor 934 and the antenna 910 for transmitting a signal back to the telemetry unit 940 or another unit capable of receiving the signal. For example, the electrical stimulation system 900 may transmit a signal indicating whether the electrical stimulation system 900 is operating properly, or when the battery needs to be charged, or the level of charge remaining in the battery. The processor 934 may also be capable of transmitting information regarding pulse characteristics so that a user or clinician can determine or verify the characteristics.

[0065] The above specification provides a description of the structure, manufacture, and use of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention resides in the claims hereinafter appended. [Explanation of symbols]

[0066] 334 Longitudinal Electrode 352 Cuff body 354 Inner surface of cuff body 358a, 358b radial electrodes 360 Slit

Claims

1. A cuff, a cuff body having an outer surface, an inner surface, and a perimeter; a plurality of longitudinal electrodes disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a width not greater than 100 μm and a length / width aspect ratio of at least 20, the plurality of longitudinal electrodes being arranged in at least one set, each set comprising at least 16 of the longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body; and a longitudinal slit extending through the cuff body and further extending along an entire length of the cuff body, the longitudinal slit operable to receive a portion of a target nerve from an area outside the cuff into the cuff body; The cuff comprising: a lead body coupled to the cuff; a plurality of conductors extending through the lead body and the cuff and electrically coupled to the longitudinal electrode; 1. An electrical stimulation lead comprising:

2. The electrical stimulation lead of claim 1 , wherein each of the longitudinal electrodes has a width not greater than 50 μm.

3. The electrical stimulation lead of claim 1 or 2, wherein the cuff further comprises at least one radial electrode extending around at least 75% of the circumference of the cuff body.

4. the cuff further comprises at least one set of radial electrodes; 4. The electrical stimulation lead of claim 1, wherein each set of radial electrodes comprises at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body.

5. A cuff, a cuff body having an outer surface, an inner surface, and a perimeter; a plurality of longitudinal electrodes disposed on the inner surface of the cuff body, each of the longitudinal electrodes having a width not greater than 100 μm and a length of at least 1 mm, the plurality of longitudinal electrodes being arranged in at least one set, each set comprising at least 16 of the longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body; and a longitudinal slit extending through the cuff body and further extending along an entire length of the cuff body, the longitudinal slit operable to receive a portion of a target nerve from an area outside the cuff into the cuff body; The cuff comprising: a lead body coupled to the cuff; a plurality of conductors extending through the lead body and the cuff and electrically coupled to the longitudinal electrode; 1. An electrical stimulation lead comprising:

6. The electrical stimulation lead of claim 5 , wherein the cuff further comprises at least one radial electrode extending around at least 75% of the circumference of the cuff body.

7. the cuff further comprises at least one set of radial electrodes; 7. The electrical stimulation lead of claim 5 or 6, wherein each set of radial electrodes comprises at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body.

8. A cuff, a cuff body having an outer surface, an inner surface, and a perimeter; a plurality of longitudinal electrodes disposed on the inner surface of the cuff body, the plurality of longitudinal electrodes being arranged in at least one set, each set comprising at least 32 of the longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body; one or more radial electrodes, either alone or in combination of two or more of the radial electrodes, extending around at least 75% of the circumference of the cuff body; and a longitudinal slit extending through the cuff body and further extending along an entire length of the cuff body, the longitudinal slit operable to receive a portion of a target nerve from an area outside the cuff into the cuff body; A cuff comprising: a lead body coupled to the cuff; a buffer layer disposed across the inner surface of the cuff body and the inner surface of the longitudinal electrode, the buffer layer allowing current to flow from the longitudinal electrode through the buffer layer; a plurality of conductors extending through the lead body and the cuff and electrically coupled to the longitudinal and radial electrodes; 1. An electrical stimulation lead comprising:

9. The electrical stimulation lead of claim 8 , wherein each of the longitudinal electrodes has a width not greater than 100 μm.

10. The cuff further comprises at least two sets of radial electrodes; 10. The electrical stimulation lead of claim 8 or 9, wherein each set of radial electrodes comprises at least one of the radial electrodes extending around at least 75% of the circumference of the cuff body.

11. The electrical stimulation lead of claim 10 , wherein at least one of the sets of radial electrodes comprises at least two of the radial electrodes that extend in combination around at least 75% of the circumference of the cuff body.

12. The electrical stimulation lead of any one of claims 1 to 11, wherein each of the elongate electrodes has an aspect ratio of at least 50.

13. The electrical stimulation lead of claim 1 , further comprising a cushioning layer disposed over the inner surface of the cuff body.

14. The electrical stimulation lead of any preceding claim, wherein each of the longitudinal electrodes has a length of at least 2 mm.

15. 15. The electrical stimulation lead of claim 1, wherein each of the at least one set comprises at least 32 of the longitudinal electrodes spaced apart from one another in a circumferential arrangement around the circumference of the cuff body.

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