Patent Publication Number: US-2022226641-A1

Title: Electrical stimulation cuff devices and systems with directional electrode configurations

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 63/139,240, filed Jan. 19, 2021, which is incorporated herein by reference. 
    
    
     FIELD 
     The present disclosure is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present disclosure is also directed to implantable electrical stimulation cuff devices, as well as methods of making and using the same. 
     BACKGROUND 
     Implantable electrical stimulation systems have proven therapeutic in 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 syndrome and incontinence, with a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities 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. 
     Stimulators have been developed to provide therapy for a variety of treatments. A stimulator 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 tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue. 
     BRIEF SUMMARY 
     One aspect is an electrical stimulation lead that includes a cuff having a cuff body having an exterior surface, an interior surface, and a circumference; longitudinal electrodes disposed on the interior surface of the cuff body, wherein each of the longitudinal electrodes has an aspect ratio of length/width of at least 20, wherein the longitudinal electrodes are divided into at least one set with each set including at least sixteen of the longitudinal electrodes spaced apart from each other in a circumferential arrangement round 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 a region outside of the cuff to within 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 with the conductors electrically coupled to the longitudinal electrodes. 
     In at least some aspects, the aspect ratio of each of the longitudinal electrodes is at least 50. In at least some aspects, each of the longitudinal electrodes has a width of no more than 100 μm. In at least some aspects, each of the longitudinal electrodes has a length of at least 1 mm. In at least some aspects, each of the at least one set includes at least 32 of the longitudinal electrodes spaced apart from each other in the circumferential arrangement around the circumference of the cuff body. 
     In at least some aspects, the cuff further includes at least one radial electrode extending around at least 75% of the circumference of the cuff body. In at least some aspects, the cuff further includes at least one set of radial electrodes, wherein each set of the radial electrodes includes at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body. 
     Another aspect is an electrical stimulation lead that includes a cuff having a cuff body having an exterior surface, an interior surface, and a circumference; longitudinal electrodes disposed on the interior surface of the cuff body, wherein each of the longitudinal electrodes has a width of no more than 100 μm, wherein the longitudinal electrodes are divided into at least one set with each set including at least sixteen of the longitudinal electrodes spaced apart from each other in a circumferential arrangement round 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 a region outside of the cuff to within 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 with the conductors electrically coupled to the longitudinal electrodes. 
     In at least some aspects, the aspect ratio of each of the longitudinal electrodes is at least 50. In at least some aspects, each of the longitudinal electrodes has a length of at least 1 mm. In at least some aspects, each of the at least one set includes at least 32 of the longitudinal electrodes spaced apart from each other in the circumferential arrangement round the circumference of the cuff body. 
     In at least some aspects, the cuff further includes at least one radial electrode extending around at least 75% of the circumference of the cuff body. In at least some aspects, the cuff further includes at least one set of radial electrodes, wherein each set of the radial electrodes includes at least two of the radial electrodes in a circumferential arrangement extending around at least 75% of the circumference of the cuff body. 
     A further aspect is an electrical stimulation lead that includes a cuff having a cuff body having an exterior surface, an interior surface, and a circumference; longitudinal electrodes disposed on the interior surface of the cuff body, wherein the longitudinal electrodes are divided into at least one set with each set including at least sixteen or thirty-two of the longitudinal electrodes spaced apart from each other in a circumferential arrangement round the circumference of the cuff body; one or more radial electrodes extending solely, or in a combination of two or more of the radial electrodes (for example, when there are two or more radial electrodes), 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 a region outside of the cuff to within 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 with conductors electrically coupled to the longitudinal and radial electrodes. 
     In at least some aspects, the aspect ratio of each of the longitudinal electrodes is at least 50. In at least some aspects, each of the longitudinal electrodes has a width of no more than 100 μm. In at least some aspects, each of the longitudinal electrodes has a length of at least 1 mm. In at least some aspects, each of the at least one set includes at least 32 of the longitudinal electrodes spaced apart from each other in the circumferential arrangement round the circumference of the cuff body. 
     In at least some aspects, the cuff further includes at least two sets of the radial electrodes, wherein each set of the radial electrodes includes at least one of the radial electrodes extending around at least 75% of the circumference of the cuff body. In at least some aspects, at least one of the sets of radial electrodes includes at least two of the radial electrodes extending, in combination, around at least 75% the circumference of the cuff body. In at least some aspects, the cuff further includes a cushioning layer disposed over the interior surface of the cuff body. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified. 
       For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein: 
         FIG. 1  is a schematic view of one embodiment of an electrical stimulation system that includes a lead electrically coupled to a control module; 
         FIG. 2A  is a schematic view of one embodiment of the control module of  FIG. 1  configured and arranged to electrically couple to an elongated device; 
         FIG. 2B  is a schematic view of one embodiment of a lead extension configured and arranged to electrically couple the elongated device of  FIG. 2A  to the control module of  FIG. 1 ; 
         FIG. 3  is a schematic perspective view of one embodiment of a cuff with two sets of sixteen longitudinal electrodes each and two radial electrodes; 
         FIG. 4  is a schematic perspective view of another embodiment of a cuff with four sets of sixteen longitudinal electrodes each and three radial electrodes; 
         FIG. 5  is a schematic perspective view of one embodiment of a cuff with four sets of sixteen longitudinal electrodes each and three sets of two radial electrodes each; 
         FIG. 6  is a schematic perspective view of one embodiment of a cuff with four sets of thirty-two longitudinal electrodes each and two radial electrodes; 
         FIG. 7  is a photograph of a cross-section of a portion of a vagus nerve; 
         FIG. 8  is a cross-sectional view of the cuff of  FIG. 6  disposed around a portion of the vagus nerve; and 
         FIG. 9  is a schematic overview of one embodiment of components of an electrical stimulation arrangement according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation cuff devices, as well as methods of making and using the same. 
     Suitable implantable electrical stimulation systems include, but are not limited to, a least one lead with 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 with leads are found in, for example, U.S. Pat. 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; 7,783,359; 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 Applications Publication Nos. 2007/0150036; 2009/0187222; 2009/0276021; 2010/0076535; 2010/0268298; 2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911; 2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615; and 2013/0105071; and U.S. patent application Ser. Nos. 12/177,823 and 13/750,725, all of which are incorporated by reference in their entireties. 
       FIG. 1  illustrates schematically 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  coupleable 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  FIG. 2A-2B ) disposed within the cuff  150  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 a control module  102 . Other embodiments may include two, three, four, or more leads  103  coupled to the control module  102 . In yet other embodiments, a 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  that are capable of handling 32 electrodes each. 
     The lead  103  can be coupled to the control module  102  in any suitable manner. In at least some embodiments, the lead  103  couples directly to the control module  102 . In at least some other embodiments, the lead  103  couples to the control module  102  via 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 ) can be disposed between the lead  103  and the control module  102  to extend the distance between the lead  103  and the control module  102 . Other intermediate devices may be used in addition to, or in lieu of, one or more lead extensions including, for example, a splitter, an adaptor, or the like or combinations thereof. It will be understood that, in the case where the electrical stimulation system  100  includes multiple elongated devices disposed between the lead  103  and the control module  102 , the intermediate devices may be configured into any suitable arrangement. 
     In  FIG. 1 , the electrical stimulation system  100  is shown having a splitter  107  configured and arranged for facilitating coupling of the lead  103  to the 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  109   a  and  109   b  configured and arranged to couple to the control module  102  (or another splitter, a lead extension, an adaptor, or the like). The splitter  107  and splitter connector  108  may be part of the lead  103  or may be a separate component that attaches to the lead. 
     The control module  102  typically includes a connector housing  112  and a sealed electronics housing  114 . Stimulation circuitry  110  and an 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 configured and arranged to make an electrical connection between the lead  103  and the stimulation circuitry  110  of the control module  102 . 
     The electrical stimulation system or components of the electrical stimulation system, including the lead body  106  and the control module  102 , are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like. 
     The lead body  106  can 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 in 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 . 
     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, adaptors, or the like) for electrical connection to corresponding connector contacts (e.g.,  214  and  240  in  FIG. 2B ). The connector contacts are disposed in connectors (e.g.,  144  in  FIGS. 1-2B ; and  222  in  FIG. 2B ) which, in turn, are disposed on, for example, the control module  102  (or a lead extension, a splitter, an adaptor, or the like). Electrically conductive wires  160 , 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 only connected to one electrode  134 . 
     The electrically conductive wires (“conductors”)  160  (only one of which is illustrated in  FIG. 1  for clarity) may be embedded in the non-conductive material of the lead body  106  or can 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 a lumen. There may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body  106 , for example, for inserting a stylet to facilitate placement of the lead body  106  within a body of a patient. Additionally, there may be one or more lumens (not shown) that open at, or near, the distal end of the lead body  106 , for example, for infusion of drugs or medication into the site of implantation of the lead body  106 . In at least one embodiment, the one or more lumens are flushed continually, or on a regular basis, with saline, epidural fluid, or the like. In at least some embodiments, the one or more lumens are permanently or removably sealable at the distal end. 
       FIG. 1  also illustrates a mount  162 , part of the lead body  106 , coupled to cuff  150 . The conductors  160  (only one of which is illustrated in  FIG. 1  for clarity) from within the lead body  106  are received in the mount  162 , which in turn is attached to the cuff  150  such that each conductor passes through the mount  162  for a direct electrical connection with one of the electrodes  134  (e.g., one conductor is electrically connected with one electrode and so on). The mount  162  may be attached using a variety of means such as, but not limited to, molding or adhering 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 jumper, intermediate or transition wires from the lead body  106  to the electrodes  134 . 
     The mount  162  can be offset from the cuff  150 , as illustrated in  FIG. 1 , or in-line with the cuff or in any other suitable arrangement. Examples of cuff leads  103  can be found at U.S. Pat. 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 Publications Nos. 2017/0333692 and 2018/0154156, all of which are incorporated herein by reference in their entireties. 
       FIG. 2A  is a schematic side view of one embodiment of a proximal end of one or more elongated devices  200  configured and arranged for coupling to one embodiment of the control module connector  144 . The one or more elongated devices may include, for example, the lead body  106 , one or more intermediate devices (e.g., the lead extension  224  of  FIG. 2B , an adaptor, or the like or combinations thereof), or a combination thereof.  FIG. 2A  illustrates two elongated devices  200  coupled to the control module  102 . These two elongated devices  200  can be two tails as illustrated in  FIG. 1  or two different leads or any other combination of elongated devices. 
     The control module connector  144  defines at least one port into which a proximal end of the elongated device  200  can be inserted, as shown by directional arrow  212 . In  FIG. 2A  (and in other figures), the connector housing  112  is shown having two ports  204   a  and  204   b . The connector housing  112  can define any suitable number of ports including, for example, one, two, three, four, five, six, seven, eight, or more ports. 
     The control module connector  144  also includes a plurality of connector contacts, such as connector contact  214 , disposed within each port  204   a  and  204   b . When the elongated device  200  is inserted into the ports  204   a  and  204   b , the connector contacts  214  can be aligned with a plurality of terminals  210  disposed along the proximal end(s) of the elongated device(s)  200  to electrically couple the control module  102  to the electrodes ( 134  of  FIG. 1 ) disposed at a distal end of the lead  103 . Examples of connectors in control modules are found in, for example, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporated by reference in their entireties. 
       FIG. 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 elongated devices  200  (e.g., the lead body  106 , an adaptor, another lead extension, or the like or combinations 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 . Additionally, the lead extension  224  is shown configured and arranged to couple to a single elongated device  200 . In alternate embodiments, the lead extension  224  is configured and arranged to couple to multiple ports  204  defined in the control module connector  144 , or to receive multiple elongated devices  200 , or both. 
     A lead extension connector  222  is disposed on the lead extension  224 . In  FIG. 2B , the lead extension connector  222  is shown disposed at 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 terminals  210  of the elongated device  200  can be inserted, as shown by directional arrow  238 . The connector housing  228  also includes a plurality of connector contacts, such as connector contact  240 . When the elongated device  200  is inserted into the port  230 , the connector contacts  240  disposed in the connector housing  228  can be aligned with the terminals  210  of the elongated device  200  to electrically couple the lead extension  224  to the electrodes ( 134  of  FIG. 1 ) disposed along the lead ( 103  in  FIG. 1 ). 
     In at least some embodiments, the proximal end of the lead extension  224  is similarly configured and arranged as a proximal end of the lead  103  (or other elongated device  200 ). The lead extension  224  may include a plurality of electrically conductive wires (not shown) that electrically couple the connector contacts  240  to a proximal end  248  of the lead extension  224  that is opposite to the distal end  226 . In at least some embodiments, the conductive wires disposed in the lead extension  224  can be electrically coupled to a plurality 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 in 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 . 
     Conventional cuff leads include a cuff that wraps around a portion of a nerve with one or more electrodes arranged on the cuff. In many conventional cuff leads, the individual electrodes also wrap around at least a portion of the circumference of a nerve in a radial wrap arrangement. The radial wrap arrangement of the electrodes typically results in stimulation of a circumferential region of the nerve. 
     However, a nerve is not a monolithic biological construct, but, instead, the nerve is made of many fibers (which can be arranged in groups) that extend longitudinally along the nerve.  FIG. 7  is a cross-section of a portion of the vagus nerve  280  illustrating the many fibers  282  within the nerve. In some instances, it may be desirable to stimulate only one fiber or a group of fibers. 
     Electrodes in a radial wrap arrangement generally cannot selectively stimulate fibers or groups of fibers, but, instead, such electrodes stimulate many fibers due to extending around the circumference of the nerve. In addition, such electrodes may produce unwanted side effects as multiple nerve fibers are stimulated. For example, a cuff lead with a cuff around the vagus nerve can have wide ranging effects when stimulating the vagus nerve because the different fibers connect to many parts of the body. 
     As described further herein, a cuff lead can include a cuff body that wraps around a nerve and includes longitudinal electrodes distributed around the circumference of the cuff body. In at least some embodiments, these longitudinal electrodes permit the targeting of selected longitudinal regions along the circumference of the cuff body. In at least some embodiments, there 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 a set around the circumference of the cuff body and there may be one, two, three, or more sets of longitudinal electrodes that are spaced apart longitudinally from each other along the cuff body. 
     In at least some embodiments, the cuff may also include one or more radial electrodes that can be used as a counter-electrode to one or more selected longitudinal electrodes. In at least some embodiments, one or more of the longitudinal electrodes can be used as a cathode(s) and one or more of the radial electrodes can be used as an anode(s). Any other suitable selection of cathode(s) or anode(s) from the longitudinal or radial electrodes can be used. 
     In at least some embodiments, the longitudinal electrodes can be used to selectively stimulate a nerve fiber or a set of nerve fibers. For example, a cuff lead with a cuff around the vagus nerve may be used to selectively stimulate immunomodulation fibers without stimulating (or with reduced or subthreshold stimulation of) cardiovascular fibers or somatotopic fibers in the nerve. For example, the immunomodulation fibers may be used to enhance, decrease, or halt signaling to or from the brain. In at least some embodiments, a cuff lead with longitudinal electrodes can be used to selectively provide fiber or fascicular stimulation. 
       FIG. 3  illustrates one embodiment of a cuff  350  of a cuff lead  103  ( FIG. 1 ). The cuff  350  includes a cuff body  352  with longitudinal electrodes  334  disposed on an interior surface  354  of the cuff body and arranged around the circumference of the cuff body in two sets  356   a ,  356   b . In the illustrated embodiment, each set  356   a ,  356   b  includes sixteen 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. A cuff lead can have one, two, three, four, or more sets of longitudinal electrodes  334 . The number of longitudinal electrodes  334  in a set can be the same for each set or can differ. In the illustrated embodiment, the longitudinal electrodes  334  of each set are aligned longitudinally with electrodes of the other set. In other embodiments, the longitudinal electrodes  334  of each set can be staggered or unaligned with the electrodes of the other set. 
     In addition, the cuff  350  includes two radial electrodes  358   a ,  358   b  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 extends the longitudinal length of the cuff body  352  so that the nerve can be loaded into the interior  362  of the cuff body by opening the slit to fit the cuff body over the nerve. The slit  360  is opened or initially sized to allow the target nerve (not shown) to be slipped, inserted, fed, or otherwise received into the cuff  350  such 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 the target nerve or relative to the target nerve whether rotationally or transitionally. 
     The electrodes  334 ,  358   a ,  358   b  can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, 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 adhesive filled with metallic powder, Nitinol, or the like or any combination thereof. The electrodes  334 ,  358   a ,  358   b  can be formed by any suitable process including, but not limited to, machining, molding (for example, powdered metal molding), photolithography, additive techniques, stamping, or the like or any combination thereof. 
     In at least some embodiments, the electrodes  334 ,  358   a ,  358   b  have a contact surface that is flush or slightly protruding (for example, no more than 200, 100, or 50 μm from the cuff body  352  which, at least in some circumstances, may reduce or eliminate physical pressure on the nerve. It will be recognized that the electrodes can be used to provide electrical stimulation or to sense electrical signals from tissue or any combination thereof. 
     In at least some embodiments, the longitudinal electrodes  334  have a width of no more 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 the circumferential direction  351  around the cuff body. In at least some embodiments, the length of the longitudinal electrodes  334  is no more than 10 mm. The length of the longitudinal electrodes corresponds to a distance along the longitudinal direction  353  of the cuff body. In at least some embodiments, the longitudinal electrodes  334  have an aspect ratio (length/width) or 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 electrodes of a set have the same or different widths, lengths, or aspect ratios within the set or between sets. 
     In at least some embodiments, the longitudinal electrodes  334  are rectangular or rectangular with rounded corners. Any other suitable shape can be used for the longitudinal electrodes including, but not limited to, oblong, oval, modified rectangular 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 preceding paragraph correspond to the longest or widest portion of the electrode  334 . For example, for an oval electrode, the length along the major axis of the oval corresponds to the length measurement and the length along the minor axis corresponds to the width measurement. 
     The narrow width of the longitudinal electrodes  334  can facilitate the ability to select particular fibers or groups of fibers in the nerve and steer the stimulation to the selected fiber or group of fibers. The number of longitudinal electrodes  334  in each set can further enhance the fiber selectivity with increasing numbers of longitudinal electrodes  334  providing more selectivity. Stimulation can be performed using one or more of the longitudinal electrodes  334 . The selection of an appropriate radial electrode  358   a ,  358   b  (or one or more of the longitudinal electrodes  334 ) as the counter-electrode can further enhance steering of the stimulation to the selected fiber or group of fibers. 
     The cuff body  352  can be formed of any suitable biocompatible and biostable non-conductive material including, but not limited to, polymer materials such as silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, or the like or any combination thereof. In at least some embodiments, the cuff body  352  can have a circular, oval, or any other suitable cross-sectional shape and, at least in some embodiments, may be sufficiently flexible to alter the cross-sectional shape to accommodate the nerve. In at least some embodiments, the electrodes  334 ,  358   a ,  358   b  can be molded with the cuff body  352  or formed by techniques such as etching or ablation of conductive layers, films, or the like. In at least some embodiments, the cuff body  352  has an inner diameter (which can correspond to the largest diameter of a non-circular cuff body) in a range of 0.5 to 5 mm or in a 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. 
     In at least some embodiments, the cuff body  352  can be formed using any suitable technique including, but not limited to, molding, casting, formed in a sheet and then shaped using adhesive as a binder, formed flat and shaped using heat, formed flat and attached to a cuff-shaped scaffold, pressed or extruded into the cuff shape, or the like 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 adhesive, molding (for example, insert molding) into the cuff body, using heat to adhere the electrodes to the cuff body, heating and pressing the electrodes into the cuff body, depositing electrode material on the cuff body and using photolithography and etching, or the like or any combination thereof. 
     In at least some embodiments, the interior surface  354  of the cuff body  352  can be coated with a cushioning layer  364  ( FIG. 8 ) to act as a cushion to reduce damage to the nerve. Examples of materials for the cushioning layer  364  include, but are not limited to, paraffin, a combination of isotonic saline and artificial cerebrospinal fluid, or the like or any combination thereof. The cushioning layer  364  is made of a material that permits flow of current from the electrodes  334  to the nerve through the cushioning layer. 
     In at least some embodiments, once the cuff  350  has been placed in a desired position relative to the target nerve, the edges of the cuff body  352  defining the slit  360  can be sutured to capture the target nerve without undesirably compressing 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. 
       FIG. 4  illustrates another embodiment of a cuff  350  with a cuff body  352  and longitudinal electrodes  334  arranged in four groups  356   a ,  356   b ,  356   c ,  356   d  with sixteen electrodes in each group. The cuff  350  includes three radial electrodes  358   a ,  358   b ,  358   c.    
       FIG. 5  illustrates another embodiment of a cuff  350  with a cuff body  352  and longitudinal electrodes  334  arranged in four groups  356   a ,  356   b ,  356   c ,  356   d  with sixteen electrodes in each group. The cuff  350  includes six radial electrodes  358   a ,  358   b ,  358   c ,  358   d ,  358   e ,  358   f  that each extend around less than half the circumference of the cuff body  352  (for example, at least 25%, 30%, 33%, 40%, 45%, or 48% of the circumference of the cuff body) with two of these radial electrodes disposed in each of three sets. It will be understood that other arrangement 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 a same amount around the circumference of the cuff body  352  or can extend by different amounts around the circumference of the cuff body. Each set can be identical, or the sets can have a different arrangement 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 . 
       FIG. 6  illustrates yet another embodiment of a cuff  350  with a cuff body  352  and longitudinal electrodes  334  arranged in four groups  356   a ,  356   b ,  356   c ,  356   d  with 32 electrodes in each group. The cuff  350  includes two radial electrodes  358   a ,  358   b.    
       FIG. 8  illustrates a cross-section of the cuff  350  of  FIG. 6  disposed around the vagus nerve  280  with the longitudinal electrodes  334  arranged around the circumference of the cuff and vagus nerve. Optionally, the cushioning layer  364  is disposed between the cuff  350 /electrodes  334  and the nerve  280 . 
     The cuff lead  103  ( FIG. 1 ) can be coupled to one or more control modules  102  ( FIG. 1 ). When the 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 can be used to provide stimulation to selected longitudinal electrodes  334 . Multiplexing arrangements may be part of the control module  102 , cuff lead  103 , or a separate module or the like or any combination thereof. Examples of multiplexing and of 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 Publications Nos. 2018/0071520 and 2019/0083796, all of which are incorporated herein by reference in their entireties. 
       FIG. 9  is a schematic overview of one embodiment of components of an electrical stimulation arrangement  904  that includes an electrical stimulation system  900  with a lead  902 , stimulation circuitry  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 configurations disclosed in the stimulator references cited herein. 
     If the power source  908  is a rechargeable battery or chargeable capacitor, the power source may be recharged/charged using the antenna  910 , if desired. Power can be provided for recharging/charging by inductively coupling the power source  908  through the antenna  910  to a recharging unit  936  external to the user. Examples of such arrangements can be found in the references identified above. 
     In at least some embodiments, electrical current is emitted by the 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  can include, among other components, a processor  934  and a receiver  932 . The processor  934  is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor  934  can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor  934  can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor  934  selects which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor  934  is used to identify which electrodes provide the most useful stimulation of the desired tissue. 
     Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an external programming unit  938  that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor  934  is coupled to a receiver  932  which, in turn, is coupled to the antenna  910 . This allows the processor  934  to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired. 
     In at least some embodiments, the antenna  910  is capable of receiving signals (e.g., RF signals) from an external telemetry unit  940  that is programmed by the 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 is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired. As another alternative, the telemetry unit  940  may not be worn or carried by the user but may only be available at a home station or at a clinician&#39;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  via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit  940 . 
     The signals sent to the processor  934  via the antenna  910  and the receiver  932  can be used to modify or otherwise direct the 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 pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct the electrical stimulation system  900  to cease operation, to start operation, to start charging the battery, or to stop charging the battery. 
     Optionally, the electrical stimulation system  900  may include a transmitter (not shown) coupled to the processor  934  and the antenna  910  for transmitting signals back to the telemetry unit  940  or another unit capable of receiving the signals. For example, the electrical stimulation system  900  may transmit signals indicating whether the electrical stimulation system  900  is operating properly or not or indicating 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 about the pulse characteristics so that a user or clinician can determine or verify the characteristics. 
     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 also resides in the claims hereinafter appended.