Nerve cuff

An electrode cuff includes a first elongate portion and a second elongate portion. The first elongate portion is configured to removably contact a length of a nerve while the second elongate portion extends outwardly at an angle relative to a first side edge of the first elongate portion to at least partially wrap about the nerve. The electrode cuff includes a first series of electrodes that is spaced apart longitudinally along the first elongate portion. A width of the second elongate portion is sized to fit between adjacent branches extending from a nerve.

BACKGROUND

A forced contraction of a muscle can be caused via electrical stimulation of a nerve that innervates the muscle. Typically, a power source is coupled to the nerve via an electrical stimulation lead that is, in turn, coupled to the nerve. For example, a distal end of an electrical stimulation lead is formed as a cuff that can be secured about the nerve to orient an electrically conductive portion of the lead in direct contact with the nerve. However, in many instances, the location in which a particular nerve resides presents significant challenges in maneuvering the distal conductive portion of the electrical lead into a target position relative to the nerve and in securing the distal conductive portion in the target position.

DETAILED DESCRIPTION

Embodiments of the present disclosure are directed to nerve cuff assemblies adapted for ease of use and for secure implantation of a stimulation lead in a nerve stimulation system. In one embodiment, these nerve cuff assemblies are adapted for use in implantation relative to a hypoglossal nerve as part of a system and method of treating sleep disordered breathing, such as obstructive sleep apnea. In one aspect, these embodiments are configured to produce consistent, repeatable surgical implantation and robust coupling to a nerve. In another aspect, these embodiments are configured for implantation on a more distal portion of a hypoglossal nerve in which, in some instances, the nerve cuff will be located in proximity to one or more nerves branching off the main trunk of the hypoglossal nerve. In this regard, the particular features of the respective nerve cuff assemblies accommodate placement among such nerve branches.

These embodiments, and additional embodiments, are described and illustrated in detail in association withFIGS. 1A-20.

FIG. 1Ais a perspective view schematically illustrating an electrical lead20, including a lead body22and a distal cuff portion24, according to an embodiment of the present disclosure. In one embodiment, distal cuff portion24includes a spine portion26that extends from lead body22, and which supports a cuff body32defining a first elongate portion. The cuff body32includes a distal end28and a proximal end30and a series of electrodes34A,34B,34C extending therebetween to be spaced apart longitudinally along a length of the cuff body32. In some embodiments, distal cuff portion24additionally includes a flap40, defining a second elongate portion and having a distal end42(e.g. a tip) and a base44that extends from one side edge36of cuff body32. In one embodiment, flap40extends outwardly from the side edge36of cuff body32to form a generally acute angle (α) relative to side edge36of the cuff body32, as shown inFIG. 1B. In one embodiment, the angle (α) can fall within a range of about 10 to about 80 degrees, and in other embodiments, the angle (α) falls within a range of about 30 to about 60 degrees. In some embodiments, the angle (α) falls within a range of about 40 to about 50 degrees. In one embodiment, the angle (α) is about 45 degrees. In one aspect, the angle (α) is selected to orient the flap40to be interposed between two adjacent nerve branches and to wrap in contact about cuff body32, as will be further shown inFIGS. 4-5. In another aspect, base44of flap40is positioned at a proximal end30of cuff body32so that distal portion42is oriented toward distal end28of cuff body32.

It will be understood that in other embodiments, base44of flap40can be attached to distal end28of cuff body32so that flap40extends toward proximal end30of cuff body at an angle (α). In other words, the flap40would extend in direction opposite that shown inFIG. 1A.

FIG. 2is a side plan view further schematically illustrating the lead20ofFIG. 1. In one example, as shown inFIG. 2, two outer electrodes34A,34C are spaced apart from each other along a length of the cuff body32by a distance D1and each electrode (e.g. electrode34B) has a width (D2). In one example, the width W1of the flap40(FIG. 1A) is generally equal to or greater than the width (D2) of the central electrode34B but the width (W1) of flap40is less than the distance of separation (D1) between the two outer electrodes34A,34C. In this arrangement, flap40exhibits a narrow profile for fitting between adjacent nerve branches104,106, as depicted in at leastFIGS. 4-5.

In some examples, the width W1of flap40is twice the width (D2) of one of the respective electrodes (e.g. electrode34B). In other examples, the width W1of flap40is three times the width (D2) of one of the respective electrodes (e.g. electrode34B). In one aspect, by making flap40generally wider than a respective electrode (e.g. electrode34B) a sufficient overlap of the flap40relative to the electrode (e.g. electrode34B) is obtained.

FIG. 3is a perspective view schematically illustrating a lead50having substantially the same features and attributes as lead20(FIG. 1), except with side edge35of cuff body32including a notched portion52, according to an embodiment of the present disclosure. In one embodiment, the notched portion52begins at the distal end28and, in some embodiments, extends a distance (X) that is about one-quarter to one-third of a length (L1) of the cuff body32, as shown inFIG. 3. The notched portion52is positioned and sized to permit a distal portion42of flap40to extend within notched portion52upon flap42being wrapped around a nerve (as shown inFIGS. 4-5) so that flap40retains a smaller profile when fully secured about nerve.

In other embodiments, notched portion52is located at a midportion of cuff body32or located at a proximal end30, such as the previously mentioned embodiment in which a flap40would extend from a distal end28of the cuff body toward the proximal end30.

In one embodiment, flap40is biased in a curled shape approximating the outer circumference of a nerve so that when flap40is released (from being held via forceps or other means), flap40automatically wraps about the nerve and distal portion42automatically falls within notch portion52of cuff body32. In another aspect, notched portion52is sized and positioned based on the angle (α) at which flap40extends (FIG. 1B) to ensure that distal portion42of flap40aligns with notched portion52.

FIG. 4is a diagram100schematically illustrating implantation of an electrode cuff124about a nerve102, according to an embodiment of the present disclosure. In one embodiment, electrode cuff124includes substantially the same features and attributes as electrode lead20(FIGS. 1-3) with similar reference numerals referring to similar elements. It will be understood that a lead body, such as lead body22, extending proximally from cuff124but is not shown for illustrative purposes.

As shown inFIG. 4, upon partial implantation, the cuff body132lies underneath nerve102and is positioned along a length of nerve102so that flap140, when wrapped about nerve102(as represented by directional arrow F), will pass through the gap G between branch nerves104,106. In one embodiment, flap140has width (W1inFIG. 1) less than a width of the gap (represented by length L2inFIG. 4) between the branch nerves104,106. In one embodiment, the width (W1) of flap140is substantially less than a length (L1inFIG. 4) of the cuff body132. In one embodiment, the electrodes134A,134B,134C provide a tripolar arrangement with a negative electrode (e.g. cathode) interposed between two positive electrodes (e.g. anodes), although it will be understood that other electrode configurations can be used. As shown inFIG. 4, the target zone for stimulation is generally represented by the marker “X” shown along nerve102. Accordingly, when the target zone for stimulation of the nerve falls within an area encroached by branch nerves104,106, the nerve cuff124is especially suited to being secured relative to nerve102despite the presence of the branch nerves104,106adjacent the target zone (represented by X). In particular, the relatively narrow width of flap40enables its positioning between branch nerves104,106while the angle (α) at which flap40extends from the proximal end130of the cuff body132further facilitates interposing the flap40between branch nerves104,160and the self-wrapping behavior of flap40about cuff body132and nerve102.

In one example, as shown inFIG. 4, two outer electrodes134A,134C are spaced apart from each other along a length of the cuff body132by a distance D1and each electrode (e.g. electrode134B) has a width (D2). In one example, the width W1of the flap140(such as W1of flap40inFIG. 1A) is generally equal to or greater than the width (D2) of the central electrode134B but width (W1) is less than the distance of separation (D1) between the two outer electrodes134A,134C. In this arrangement, flap140exhibits a narrow profile for fitting between adjacent nerve branches104,106.

In some examples, the width W1of flap140is twice the width (D2) of one of the respective electrodes (e.g. electrode134B). In other examples, the width W1of flap140is three times the width (D2) of one of the respective electrodes (e.g. electrode134B).

As shown inFIG. 5, upon guiding flap140through gap G and then permitting flap40to wrap itself about cuff body132, the cuff body132becomes releasably secured about nerve102. Moreover, because flap140straddles the gap G between the two branch nerves104,106, the cuff body132is further restrained from longitudinal movement along the length of nerve102.

As apparent fromFIG. 5, in one example flap140defines a first elongate portion having a length sufficient to extend from one side edge of the cuff body132, encircle the nerve, and overlap at least a portion of the opposite side edge of the cuff body132.

FIG. 6is a diagram150including a side plan view schematically illustrating implantation of an electrode cuff154about a nerve102, according to an embodiment of the present disclosure. As shown inFIG. 6, flap170includes a base174mounted to or extending from a midportion161(intermediate between distal end158and proximal end160) of cuff body162. Accordingly, with cuff body162positioned along a length of nerve102to place electrodes164at a desired target portion of nerve102, flap170is sized with a width (W2) configured to be interposed between branch nerves104,106. However, unlike the angled flap40(FIG. 1-5), flap170extends generally perpendicular to the longitudinal axis of the cuff body162.FIG. 7schematically illustrates the arrangement upon flap170being wrapped about nerve102and the cuff body162to secure electrode cuff154about nerve102. Accordingly, the embodiment ofFIGS. 6-7includes substantially the same features and attributes as the embodiment ofFIGS. 1-5, except for flap170being mounted relative to a midportion161of cuff body162and for flap170being generally perpendicular to cuff body162.

In one example, as shown inFIG. 6, two outer electrodes164A,164C are spaced apart from each other along a length of the cuff body162by a distance D1and each electrode (e.g. electrode164B) has a width (D2). In one example, the width W2of the flap170is generally equal to or greater than the width (D2) of the central electrode164B but width (W2) is less than the distance of separation (D1) between the two outer electrodes164A,164C. In this arrangement, flap170exhibits a narrow profile for fitting between adjacent nerve branches104,106.

In some examples, the width W1of flap170is twice the width (D2) of one of the respective electrodes (e.g. electrode164B). In other examples, the width W1of flap170is three times the width (D2) of one of the respective electrodes (e.g. electrode164B). In one aspect, by making flap170generally wider than a respective electrode (e.g. electrode164B) a sufficient overlap of the flap170relative to the electrode (e.g. electrode164B) is obtained.

FIG. 8is a diagram schematically illustrating an electrode cuff184being implanted about nerve102using flap200, according to an embodiment of the present disclosure. Electrode cuff184includes substantially the same features and attributes as electrode cuff154as previously described in association withFIGS. 6-7, except with flap200having a tapered shape. As shown inFIG. 8, like flap170of electrode cuff154ofFIG. 6, flap200of electrode cuff184has a base204mounted at a midportion191of cuff body192. However, unlike the generally straight flap170, flap190includes a butterfly-type shape in which a waist portion203of flap200is substantially narrower than the base204and/or the distal portion202of flap200. In one aspect, waist portion203has a width (W3) substantially less than a width (W4) of the distal portion202or base204of flap190. In one embodiment, waist portion203is at an intermediate location between the distal portion202and base portion204. In one aspect, width (W3) of waist portion203is less than distance (gap G) between the branch nerves104,106. In one embodiment, distal portion202and base portion204have a width (W4) that is substantially less than a length (L1) of cuff body192.

In one aspect, by making the distal portion202and the base portion204substantially wider than the waist portion203, the flap200has a substantially greater surface area in contact with nerve102and with cuff body192as flap200wraps around those structures, which in turn, increases the holding strength the flap190relative to those structures. In addition, in another aspect, by providing generally wider portions202and204of flap200on opposite sides of the gap (G) between the branch nerves104,106, and sizing the waist portion203to fit between branch nerves104,106, the electrode cuff184becomes more securely anchored along the length of the nerve102(less likely to slide) and becomes more resistant to shifting/twisting.

In other embodiments, width (W4) of distal portion202and/or base portion204is generally equal to a length (L1) of cuff body132even while the waist portion193has width (W3) that remains sized to fit in the gap G between branch nerves104,106.

In one example, as shown inFIG. 8, two outer electrodes194A,194C are spaced apart from each other along a length of the cuff body192by a distance D1and each electrode (e.g. electrode194B) has a width (D2). In one example, the width W3of the narrower waist portion203of flap200is generally equal to or greater than the width (D2) of the central electrode194B but width (W3) is less than the distance of separation (D1) between the two outer electrodes194A,194C. In this arrangement, narrower waist portion203of flap200exhibits a narrow profile for fitting between adjacent nerve branches104,106.

In some examples, the width W3of waist portion203is twice the width (D2) of one of the respective electrodes (e.g. electrode194B). In other examples, the width W3of waist portion203is three times the width (D2) of one of the respective electrodes (e.g. electrode194B). In one aspect, by making flap200generally wider than a respective electrode (e.g. electrode194B) a sufficient overlap of the flap200relative to the electrode (e.g. electrode194B) is obtained.

FIG. 9is diagram including a side plan view schematically illustrating the flap200of cuff184ofFIG. 8when completely wrapped about the cuff body192and nerve102.

FIG. 10is a perspective view schematically illustrating an electrode lead220, according to an embodiment of the present disclosure. As shown inFIG. 10, electrode lead220includes a lead body222and an electrode cuff224. The cuff224includes cuff body225having a short flap portion226on a first side228and a long flap portion230on a second opposite side232of the cuff body225. In one aspect, the long flap portion230is substantially longer (in a direction generally perpendicular to a longitudinal axis of the lead body202) than the short flap portion226. In addition, an elongate strap240extends from a side edge245of the long flap portion230. The elongate strap240is sized and positioned to help guide the long flap portion230behind a nerve during surgery. In one embodiment, elongate strap240has a width (W5) that is substantially less than a length of long flap portion230and of the cuff body225in general.

FIG. 11is a diagram300schematically illustrating a stimulation system300, according to an embodiment of the present disclosure. As shown inFIG. 11, system300includes an implantable cuff module310and an external support module312. The implantable cuff module310includes a cuff320, an antenna322, and an integrated circuit324. In one embodiment, cuff320includes any one of the cuff designs described within the present disclosure as well as other cuff designs. In one embodiment, the antenna322comprises a radiofrequency (RF) antenna for performing wireless communication with a reciprocating antenna or circuitry.

The external support module312includes an external antenna330(external to the body in which cuff module310is implanted), microcontroller332, memory and programming element334, sensor array336, and power unit338.

The external antenna330is equipped to perform wireless communication via RF waves or using other wireless communication protocols. Microcontroller332directs operation of the cuff module310and various components of the support module312. Memory and programming element334stores a therapy regimen and stimulation control profiles for electrode cuff322. Sensor array336includes one or more sensors placed and configured to detect physiologic parameters relating to respiration and general indicators of health in order to detect obstructed breathing patterns and/or whether or not an efficacious response has occurred as a result of therapy applied via system300. In some embodiments, the sensors336sense information regarding acoustic parameters, position/posture of a patient, heart rate, bioimpedance, blood oxygenation, respiratory rate, inspiratory and expiratory phases, etc.

In one embodiment, as represented by dashed lines344, the components and elements of external support module312are housed in one or more containing elements. In some embodiments, the containing elements include one or more of a garment360, pillow362, bed364, and headband366. In one aspect, the garment360includes one or more of a shirt, pants, necklace, wristband, and/or sleeve or other article that can be worn on the body and is constructed to house one or more of the elements of the external support module312in relatively close proximity to the implanted cuff module310to enable wireless communication between the cuff module310and the external support module312. In one aspect, by housing power unit338in garment360, the patient avoids having a power unit implanted in their body. The garment360is sized and shaped so that when the patient is sleeping while wearing garment360, the power unit338becomes positioned in sufficiently close proximity to the implanted cuff module310to ensure proper communication and transmission of power to the cuff module310.

FIG. 12is perspective view schematically illustrating a lead system380, according to an embodiment of the present disclosure, in which lead body380includes an anchor portion382secured to a nearby tendon or body structure, such as the digastric tendon386. In one embodiment, anchor portion382forms a coiled or pigtail shape configured to automatically wrap itself about the tendon386. In this way, cuff390becomes more securely attached in the vicinity of its implantation about a nerve386. In one embodiment, the anchor portion382is implemented on a freestanding cuff module, such as cuff390inFIG. 12or cuff module310inFIG. 11. In other embodiments, the anchor portion382is deployed on a full length lead that extends from a cuff module to an implanted pulse generator or controller.

FIG. 13is a diagram450including a top plan view schematically illustrating an electrode cuff460aligned for deployment on a nerve462, according to an embodiment of the present disclosure. The electrode cuff460includes a first end470, a second end472with an array480of electrodes481aligned along a portion of cuff460. As shown inFIG. 13, in one embodiment, the array480of electrodes481includes a first anode484, a cathode486, and second anode488with cathode486interposed between the respective anodes484,488.

In general terms, the electrode cuff460is configured for mounting on nerve102so that a longitudinal axis of the electrode array480is aligned generally perpendicular to a longitudinal axis of nerve102in the vicinity at which cuff460is deployed. In other words, instead of aligning a series of electrodes to extend along a length of nerve102, the cuff460is sized and configured so that the series of electrodes extend circumferentially about a nerve and generally perpendicular to a longitudinal axis of the nerve102.

In one embodiment, the electrode cuff460has a width (W6) and a length (L2) with length (L2) being substantially greater than width (W6). In one aspect, width (W6) is at least one-half the length (L2) with the width (W6) sized to fit between branch nerves (such as branch nerves104,106inFIG. 4). Accordingly, electrode cuff460is suited for deployment in more distal regions of nerve and/or in regions in which tight spacing exists between adjacent branches from a nerve.

In one example, as shown inFIG. 13, electrodes481have a width (D2) and the width W6of the cuff460is generally equal to or greater than the width (D2) of the electrodes481. In some examples, the width W6of cuff460is about twice the width (D2) of the electrodes481. In other examples, the width W6of cuff460is about three times the width (D2) of each electrode481. In these arrangements, cuff460exhibits a narrow profile for fitting between adjacent nerve branches (such as nerve branches104,106shown inFIGS. 4-5).

FIG. 14is a sectional view of an elongate electrode cuff (such as cuff460inFIG. 13) deployed about a nerve501, according to an embodiment of the disclosure. As shown inFIG. 14, with the array480of electrodes positioned about the circumference of the nerve102and upon applying an electrical stimulation signal to the nerve501via cuff460, an energy field (represented by E within the boundaries504and506) exerted upon nerve501, which thereby causes firing of various fascicles within nerve501(as represented by region502).

FIG. 15is sectional view an elongate electrode cuff (such as cuff460inFIG. 13) deployed about a nerve501, according to an embodiment of the disclosure. However, in this embodiment, a portion511of the electrode cuff460extends generally outward from the rest of the cuff460to orient additional electrodes at a spaced distance from the nerve and the other electrodes (488,486) that are in contact with the nerve. In this arrangement, a controller is used to select whether electrode484,512,514is activated and depending upon which electrode484,512,514is activated, a different shape and size energy field will act on the nerve. In general terms, because the electrodes512,514are spaced apart from the nerve501, the energy field is expanded and stretched upon activation of one of those remotely located electrodes. As shown inFIG. 15, upon activation of electrode484along with electrodes (488,486), the energy field takes the shape and size represented by region502as shown inFIGS. 14 and 15. However, if electrode512is activated instead of electrode484, then one boundary of the energy field moves from dashed line A to B, and the resulting energy field takes on the size and shape depicted as the sum of regions502and503inFIG. 16. Similarly, if electrode514were activated instead of electrodes484or512, then the energy field would be further expanded in size toward the “right” side of the nerve with the new boundary defined by dashed line C, shown inFIG. 15.

In one embodiment, cuff410is deployed so that the extended portion511extends toward a surface of the body.

In one aspect, the electrode cuff460is particularly adapted for mounting transversely to longitudinal axis of the nerve at the target stimulation location to fit between adjacent branch nerves. In addition, when additional electrodes such as electrodes512and514are incorporated into the cuff410, an operator can selectively modify a shape and size of the energy field applied to a cross-section of the nerve to achieve the targeted stimulation.

FIG. 17is a diagram520schematically illustrating an electrode lead521being mounted relative to a nerve, according to an embodiment of the present disclosure. As shown inFIG. 17, electrode lead521includes an electrode portion522, a transverse portion523, and a body portion524. A longitudinal axis of the electrode portion522extends generally parallel to a longitudinal axis of the body portion524. Meanwhile, the transverse portion523is interposed between, extends generally perpendicular to, the respective electrode and body portions522,524.

The electrode portion522includes an array of electrodes530aligned in series. The transverse portion523has length (L3) sufficient to extend about at least one-third to one-half of a circumference of the nerve and has a width (W8) sized to fit between adjacent branch nerves527,529(see also104,106inFIG. 3). In one aspect, branch nerves527,529are spaced apart by a distance D3.

In one aspect, the transverse portion523is biased to self wrap partially about the circumference of the nerve which in turn aligns the electrode portion522generally parallel to a longitudinal axis of the nerve and for contact with the nerve in that alignment. Similarly, the transverse alignment of the transverse portion523also aligns body portion to extend alongside the nerve and to be further secured thereto.

FIG. 18is a top plan view of an electrode cuff550, according to an embodiment of the present disclosure. As shown inFIG. 18, electrode cuff550includes an electrode portion552and a body portion554from which the electrode portion552extends. The electrode portion552has a first electrode portion557and a second electrode portion558. The first electrode portion557supports an array560including electrodes562,564, and566while the second electrode portion558supports a second electrode array570including electrodes572,574, and electrode566. Accordingly, electrode566serves in both electrode arrays560,570depending upon which electrode array560,570is activated (or if both electrode arrays560,570are activated). In another aspect, first electrode portion557(and its electrode array560) extends generally perpendicular to second electrode portion558(and its electrode array570). The first electrode portion557is sized and positioned for alignment generally parallel to a longitudinal axis of a nerve while the second electrode portion is sized and position for alignment transverse to the longitudinal axis of the nerve. In one embodiment, either the first end portion559A or the second end portion559B of the second electrode portion558is aligned to extend at least partially circumferentially about the nerve, such as between two adjacent branch nerves (such as branch nerves527,529inFIG. 17). In another aspect, the second end portion559B of second electrode portion558extends between the first electrode portion557and the body portion554.

In one embodiment, second electrode portion558is sized and biased to self-wrap at least partially about a circumference of the nerve, which in turn aligns first electrode portion557to be generally parallel to a longitudinal axis of the nerve and for contact with the nerve in that alignment.

In one example, second electrode portion558has a width (W10) sized to fit between adjacent branch nerves527,529(FIG. 17). Accordingly, the width W10is less than the distance D3between the adjacent nerve branches527,529. In one example, the width W10is at least twice the width (or diameter) D4of each electrode566,572,574and less than the distance D3. In another example, the width W10is at least three times the width (or diameter) D4of each electrode566,572,574and less than the distance D3.

FIG. 19is a top plan view of an electrode cuff600, according to an embodiment of the present disclosure. As shown inFIG. 18, electrode cuff600includes an electrode portion610and a body portion614from which the electrode portion612extends. The electrode portion612has a first electrode portion617and a second electrode portion618. The first electrode portion617supports an array620including electrodes622,624, and626while the second electrode portion618supports a second electrode array630including electrodes632,634,636and electrode626. Accordingly, electrode626serves in both electrode arrays depending upon which electrode array620,630is activated (or if both electrode arrays620,630are activated). In another aspect, first electrode portion617(and its electrode array620) extends generally perpendicular to second electrode portion618(and its electrode array630) with the respective first and second electrode portions617,618forming a cross shape with electrode626in the center of the cross. The first electrode portion617is sized and positioned for alignment generally parallel to a longitudinal axis of a nerve while the second electrode portion618is sized and position for alignment transverse to the longitudinal axis of the nerve. In one embodiment, either the first end portion619A or the second end portion619B of the second electrode portion618is aligned to extend at least partially circumferentially about the nerve, such as between two adjacent branch nerves (such as branch nerves527,529inFIG. 17).

In this arrangement, the second electrode portion618is sized and shaped to be interposed between a pair of adjacent branch nerves (such as nerves104,106inFIGS. 4-5) and/or to fit between or among other structures surrounding the nerve, thereby ensuring quick and robust implantation of nerve cuff610about the nerve.

Moreover, second electrode portion618is biased to self-wrap at least partially about a circumference of the nerve, which in turn aligns second electrode portion617to be generally parallel to a longitudinal axis of the nerve and for contact with the nerve in that alignment. At the same time, the self-wrapping properties of second electrode portion618places the electrodes of array630in contact with the nerve.

In one embodiment, second electrode portion618has length (L4) sufficient to extend about at least one-third to one-half of a circumference of the nerve and in some embodiments, second electrode portion618has a length (L4) to extend substantially completely about an entire circumference of the nerve.

FIG. 20is a diagram650that schematically illustrates a sectional view (a) and a side view of a nerve (b) when electrode cuff610is deployed on a nerve, according to an embodiment of the present disclosure. As shown inFIG. 20, electrodes632,634,626,636generally encircle and contact the nerve601while electrodes622,626,624extend along the length of and contact the nerve601. In this way, the electrode cuff610is positioned to apply a stimulation signal using the second electrode array630(electrodes632,634,626,636) or the first electrode array620(electrodes622,626,624) or some combination of some of the electrodes of the two different arrays620,630. In this latter arrangement, during an implantation and testing phase, a controller is used to determine which combination of electrodes produces the most efficacious stimulation signal and going forward, that combination of electrodes is used to apply the therapeutic treatment. Of course, it will be understood that via the controller, additional adjustments regarding the selection of active electrodes can be made after implantation and after some period of treatment.