Patent Description:
Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder that is caused by the collapse of or increase in the resistance of the pharyngeal airway, often resulting from tongue obstruction. The obstruction of the upper airway is mainly caused by reduced genioglossus muscle activity during the deeper states of non-rapid eye movement (NREM) sleep. In some OSA patients, obstruction occurs predominantly during rapid eye movement (REM) sleep. This is known as REM OSA and has different cardiometabolic and neurocognitive risks. Obstruction of the upper airway causes breathing to pause during sleep. Cessation of breathing, in turn, causes a decrease in the blood oxygen saturation level, which is eventually corrected when the person wakes up and resumes breathing. The long-term effects of OSA include, but are not limited to, high blood pressure, heart failure, strokes, diabetes, headaches, and general daytime sleepiness and memory loss.

Some proposed methods of alleviating apneic events involve the use of neurostimulators to open the upper airway. Such therapy involves stimulating the nerve fascicles of the hypoglossal nerve (HGN) that innervate the intrinsic and extrinsic muscles of the tongue in a manner that prevents retraction of the tongue, which would otherwise close the upper airway during the inspiration portion of the respiratory cycle. In some instances, the trunk of the HGN is stimulated with a nerve cuff, including a cuff body and a plurality of electrically conductive contacts on the cuff body, that is positioned around the HGN trunk. The HGN trunk nerve cuff may be configured in such a manner that it can be used to selectively stimulate nerve fascicles which innervate muscles that extend the tongue, while avoiding other nerve fascicles, with what is predominantly radial vector stimulation. For example, the contacts may be axially aligned and circumferentially spaced around the perimeter of the HGN trunk. In other instances, a nerve cuff is placed on the branch of the HGN that is responsible for protruding the tongue (hereafter "HGN genioglossus muscle branch" or "HGN GM branch"). A smaller diameter cuff with two or three axially spaced contacts may be used at the HGN GM branch because the nerve fascicles within this branch generally innervate the specific tongue protrusor muscle, but not other muscles. Put another way, the entire HGN GM branch is stimulated with what is predominantly axial vector stimulation. Exemplary nerve cuffs are illustrated and described in <CIT>, <CIT>, <CIT> and <CIT>. <CIT> relates to nerve cuff electrodes fabricated using over-molded LCP. <CIT> relates to stimulator systems and methods for obstructive sleep apnea. <CIT> relates to an implantable cuff and method for functional electrical stimulation and monitoring.

The present inventors have determined that nerve cuffs are susceptible to improvement. In particular, at least some nerve cuffs include electrically conductive members that are laminated between two non-conductive layers, with one of the conductive layers including openings that expose the conductive members. The present inventors have determined that certain electrically conductive materials with otherwise desirable properties (e.g., platinum-iridium) do not bond well with the adhesive (e.g., silicone adhesive) that is used to bond non-conductive layers that are formed from materials that have desirable mechanical properties (e.g., silicone). The less than optimal bond may lead to delamination of the nerve cuff, and the present inventors have determined that it would be desirable to provide nerve cuffs that, among other things, employ materials and adhesives with desired properties in a manner that reduces the likelihood of delamination. The present inventors have further determine that it would be desirable to provide nerve cuffs with conductive member arrangements that improve the flexibility of the nerve cuffs.

An electrode lead in accordance with at least one of the present inventions includes an elongate lead body and a nerve cuff. The nerve cuff may include a cuff body affixed to the distal end of the lead body, first and second relatively wide electrically conductive members located between the first and second layers of the cuff body, spaced from one another in the length direction, and extending in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body is in the pre-set furled shape, the cuff body front layer including a plurality of openings that are spaced from one another in the width direction and are aligned with, and located inwardly of the perimeter of, the first relatively wide electrically conductive member and a plurality of openings that are spaced from one another in the width direction and are aligned with, and located inwardly of the perimeter of, the second relatively wide electrically conductive member, a plurality of relatively narrow electrically conductive members located between the first and second layers of the cuff body, the cuff body front layer including a plurality of openings that are spaced from one another in the width direction and are respectively aligned with the relatively narrow electrically conductive members, and a plurality of electrical conductors extending through the lead body from at least some of the electrically conductive contacts to the proximal end of the lead body.

An electrode lead in accordance with at least one of the present inventions includes an elongate lead body and a nerve cuff. The nerve cuff may include a cuff body affixed to the distal end of the lead body, a first row of electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction and are connected to one another in series by flexible conductors that extend in the length direction, a second row of electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction, the second row being spaced from the first row in the length direction, a third row of electrically conductive contacts carried by the cuff body that are spaced from one another in the width direction, the third row being located between the first and second rows, and a plurality of electrical conductors extending through the lead body from at least some of the electrically conductive contacts to the proximal end of the lead body.

An electrode lead in accordance with at least one of the present inventions includes an elongate lead body and a nerve cuff. The nerve cuff may include a first row of electrically conductive members carried by the cuff body, spaced from one another in the width direction, and defining first and second longitudinal ends and a length that is perpendicular to the width direction, at least some of the electrically conductive members in the first row being connected to one another in series by at least one conductor that is connected to one of the longitudinal ends of the connected electrically conductive members by a joint and that extends in the width direction, a second row of electrically conductive members carried by the cuff body, spaced from one another in the width direction, the second row being spaced from the first row in the length direction, a third row of electrically conductive members carried by the cuff body that are spaced from one another in the width direction, the third row being located between the first and second rows, and a plurality of electrical conductors extending through the lead body from at least some of the electrically conductive members to the proximal end of the lead body.

An electrode lead in accordance with at least one of the present inventions includes an elongate lead body and a nerve cuff. The nerve cuff may include a cuff body affixed to the distal end of the lead body, a first row of electrically conductive members carried by the cuff body, spaced from one another in the width direction, and defining first and second lateral ends that are spaced apart from one another in the width direction and first and second longitudinal ends that are spaced apart from one another in the length direction, a first undulating conductor that connects the electrically conductive members in the first row to one another in series, that is connected to each of the conductive members at only one location by a joint that is located at one of the lateral ends of the conductive member, and that includes a plurality first regions that extend along the conductive members in the length direction and a plurality of second regions that extend from one first region to another first region in the width direction, a second row of electrically conductive members carried by the cuff body, spaced from one another in the width direction, a third row of electrically conductive members carried by the cuff body that are spaced from one another in the width direction, the third row being located between the first and second rows, and a plurality of electrical conductors extending through the lead body from at least some of the electrically conductive members to the proximal end of the lead body.

The present inventions also include systems with an implantable pulse generator or other implantable stimulation device in combination with such an electrode lead.

Detailed descriptions of exemplary embodiments will be made with reference to the accompanying drawings.

The following is a detailed description of the best presently known modes of carrying out the inventions. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the inventions.

Referring to <FIG>, a stimulation system <NUM> in accordance with one embodiment of a present invention includes an electrode lead <NUM> and an implantable stimulator such as the implantable pulse generator ("IPG") <NUM>. A clinician's programming unit <NUM>, a patient remote <NUM> and an IPG charger (not shown) may also be provided in some instances. The exemplary electrode lead <NUM> includes a nerve cuff <NUM> and a lead body <NUM> that couples the nerve cuff <NUM> to the IPG <NUM> by way of lead connector <NUM>, with a plurality contacts <NUM>, on the proximal end of the lead body <NUM> and a corresponding connector receptacle <NUM> on the IPG <NUM>. The nerve cuff <NUM> is configured in such a manner that it may be circumferentially disposed around either the HGN trunk or a HGN branch (e.g., the HGN GM branch) as is discussed below with reference to <FIG>. The lead body <NUM> may include one or more S-shaped sections in order to provide strain relief (as shown) or may be straight. The S-shaped sections accommodate body movement at the location within the neck where the lead body <NUM> is implanted, thereby reducing the likelihood that the HGN will be damaged due to unavoidable pulling of the electrode lead <NUM> that may result from neck movements. The accommodation provided by the S-shaped sections also reduces the likelihood of fatigue damage. Additionally, although the exemplary system <NUM> includes a single electrode lead <NUM>, other embodiments may include a pair of electrode leads <NUM> for bilateral HGN stimulation and an IPG (not shown) with two connector receptacles.

Turning to <FIG>, and as alluded to above, the nerve cuff <NUM> may be positioned around the trunk <NUM> of the HGN <NUM> and used to stimulate the muscles that anteriorly move the tongue <NUM> and, in particular, the fascicles of the HGN <NUM> that innervate the tongue protrusor muscles, such as the genioglossus <NUM> and/or the geniohyoid muscles <NUM>. The nerve cuff <NUM> is positioned on the HGN trunk <NUM> at a position <NUM> proximal to the HGN branches <NUM>. Although there are advantages to implanting the nerve cuff <NUM> at this proximal position <NUM>, i.e., reduced surgical time and effort as well as reduced risk and trauma to the patient, it introduces the problem of inadvertently stimulating other fascicles of the HGN trunk <NUM> that innervate muscles in opposition to the genioglossus <NUM> and/or the geniohyoid muscles <NUM>, i.e., the tongue retractor muscles, e.g., the hyoglossus <NUM> and styloglossus muscles <NUM>, as well as the intrinsic muscles of the tongue <NUM>. Accordingly, while some clinicians may desire to stimulate the HGN <NUM> at the HGN trunk <NUM>, others may desire to stimulate the HGN at the GM branch <NUM>. As illustrated in <FIG>, the same nerve cuff <NUM> is configured in such a manner that it may be positioned the HGN GM branch <NUM> instead of the trunk <NUM>.

The exemplary nerve cuff <NUM> is shown in a flattened, unfurled state in <FIG> and is shown in various furled states illustrated in <FIG> that the nerve cuff will be in when it wraps around an HGN trunk <NUM> or HGN GM branch <NUM>. In the illustrated implementation, the nerve cuff <NUM> is pre-set (or "pre-shaped") to the furled (or "curled") state illustrated in <FIG>, and an external force may be used to partially or completely unfurl the nerve cuff <NUM>. The nerve cuff <NUM> will return to the pre-shaped furled state when the force is removed and, as discussed below, may assume one of the furled states illustrated in <FIG> depending on the size of the HGN trunk or HGN branch that the nerve cuff <NUM> is placed around. Various examples of nerve cuffs that are capable of assuming different sizes are disclosed in aforementioned <CIT>.

Referring first to <FIG>, the nerve cuff <NUM> includes a cuff body <NUM> that defines a length L and a width W that is greater than the length, first and second relatively wide electrically conductive contacts (or "relatively wide contacts") <NUM> on the cuff body <NUM> that extend in the width direction and are spaced from one another in the length direction and a plurality of relatively narrow electrically conductive contacts (or "relatively narrow contacts") <NUM>. Such contacts may also be referred to as "electrodes. " Although the number may increase or decrease in the context of other nerve applications, at least five relatively narrow contacts <NUM> may be spaced from one another in the width direction are located between the first and second relatively wide contacts <NUM>, and there are five relatively narrow contacts <NUM> in the illustrated embodiment. As used herein, "relatively wide" structures are structures that are longer in the width direction than structures that are referred to as "relatively narrow" and "relatively narrow" structures are structures that are shorter in the width direction than structures that are referred to as "relatively wide. " In the implementation illustrated in <FIG>, the relatively narrow contacts <NUM> are centered relative to the relatively wide contacts <NUM> and are aligned with one another in the length direction. In other implementations, the relatively narrow contacts may be non-centered relative to the relatively wide contacts <NUM> and/or offset from one another in the length direction. With respect to shape, and although the present inventions are not so limited, the relatively wide contacts <NUM> are in the shape of rectangles with rounded corners, while the relatively narrow contacts <NUM> are squares with rounded corners. Other exemplary shapes for the relatively wide contacts <NUM> include, but are not limited to, rounded rectangles and ellipses, while other exemplary shapes for the relatively narrow contacts <NUM> include, but are not limited to, circles, ellipses, squares, and rectangles.

The contacts <NUM> and <NUM> may be of any suitable construction. In the illustrated implementation, the cuff body <NUM> includes a front layer <NUM> that will face the HGN trunk or branch and a rear layer <NUM> that will face away from the HGN trunk or branch. With respect to the relatively wide contacts <NUM>, the exemplary nerve cuff <NUM> includes first and second relatively wide conductive members <NUM> are located between the front layer <NUM> and rear layer <NUM>. The relatively wide conductive members <NUM> are each exposed by way of respective pluralities of closely spaced openings <NUM> in the cuff body front layer <NUM>. The openings <NUM> are located inwardly of the outer perimeter of the conductive members <NUM>, which are shown in dashed lines in <FIG>. The openings <NUM> define a plurality of exposed regions <NUM> and a plurality of straps <NUM> (discussed below) therebetween. There are two sets of exposed regions <NUM>, the sets being separated by the relatively narrow contacts <NUM>, and the exposed regions <NUM> in each set together function as a single contact (i.e., one of the contacts <NUM>) because all of the exposed regions in each set are part of the same conductive member <NUM>. With respect to the relatively narrow contacts <NUM>, the exemplary nerve cuff <NUM> includes five relatively narrow conductive members <NUM> are located between the front layer <NUM> and rear layer <NUM>. Portions of the relatively narrow conductive members <NUM> are exposed by way of respective relatively narrow openings <NUM> in the cuff body front layer <NUM>, thereby defining the contacts <NUM>. The openings <NUM> and <NUM> extend from the outer surface of the front layer <NUM> to the associated conductive members <NUM> and <NUM>. The conductive members <NUM> and <NUM> may also include apertures <NUM> that, in conjunction with the material that forms the cuff body layers <NUM> and <NUM> and enters the apertures, anchor the conductive members in their intended locations.

There are a number of advantages associated with the exemplary straps <NUM> that are located between the openings <NUM>. For example, as compared to an otherwise identical nerve cuff where each of the relatively wide conductive members is exposed by way of a single relatively wide opening that extends through the front layer of the cuff body and covers a narrow portion of the conductive member at the perimeter of the conductive member, the plurality of straps <NUM> extend across the conductive members in the length direction and increase the amount of the front layer that covers, restrains and is bonded to the conductive members <NUM> and, accordingly, reduce the likelihood of delamination. Additional techniques, such as plasma, primer, and surface roughening, may also be employed to improve adhesion and further reduce the likelihood of delamination as the nerve cuff is manipulated.

The contacts <NUM> and <NUM> in the illustrated embodiment may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires <NUM> (<FIG>) that extend through the lead body <NUM>. Each wire <NUM> includes a conductor <NUM> and an insulator <NUM>. The conductors <NUM> may be connected to the rear side of the conductive members <NUM> and <NUM> by welding or other suitable processes. In other implementations, the contacts <NUM> may also be electrically connected to one another by a short wire. Here, only one of the contacts <NUM> will be connected to a contact <NUM> on the lead connector <NUM> by way of a wire <NUM>. It should also be noted that, in the exemplary nerve cuff <NUM> (as well as the nerve cuffs 102a-102e described below), the contacts <NUM> are not electrically connected in series to one another and are each connected to a respective one of the wires <NUM>. In other implementations, cables may be employed in place of the wires <NUM>.

The cuff body <NUM> in the exemplary implementation illustrated in <FIG> includes a stimulation region <NUM> and a compression region <NUM>. The contacts <NUM> and <NUM> are located within the stimulation region <NUM>. There are no contacts located within the compression region <NUM>. The compression region <NUM> wraps around at least a portion of the stimulation region <NUM> when the nerve cuff <NUM> is in the pre-shaped furled state and the slightly larger, expanded and less tightly furled states described below with reference to <FIG>, thereby resisting (but not preventing) expansion of the stimulation region and improving the electrical connection between the contacts <NUM> and <NUM> and the HGN.

The exemplary cuff body <NUM> may be formed from any suitable material. Such materials may be biologically compatible, electrically insulative, elastic and capable of functioning in the manner described herein. By way of example, but not limitation, suitable cuff body materials include silicone, polyurethane and styrene-isobutylene-styrene (SIBS) elastomers. Suitable materials for the contacts <NUM> and <NUM> include, but are not limited to, platinum-iridium and palladium. The cuff materials should be pliable enough to allow a clinician to unfurl the cuff body <NUM> (and nerve cuff <NUM>) and place the nerve cuff around the HGN trunk (or HGN GM branch). The exemplary materials should also be resilient enough to cause the nerve cuff return to the pre-shaped furled state illustrated in <FIG> when the force is removed, yet flexible enough to allow the cuff body <NUM> (and nerve cuff <NUM>) to instead assume the slightly larger, expanded and less tightly furled states illustrated in <FIG>. To that end, the furled cuff body <NUM> defines an inner lumen <NUM>, in which the nerve will be located after the nerve cuff <NUM> wraps around the nerve, as well as lateral ends <NUM> and <NUM>, which may be tapered in some implementations to reduce tissue irritation, that are respectively associated with the stimulation region <NUM> and the compression region <NUM>. Comparing the state illustrated in <FIG> to that state illustrated in <FIG>, the inner lumen <NUM> is slightly larger and the lateral and <NUM> is offset around the perimeter of the nerve cuff <NUM>. Similarly, comparing the state illustrated in <FIG> to that state illustrated in <FIG>, the inner lumen <NUM> is slightly larger and the lateral end <NUM> is offset around the perimeter of the nerve cuff <NUM>. For example, the inner lumen <NUM> in <FIG> is sized to accommodate an HGN structure that has a diameter of about <NUM> (e.g., the HGN GM branch <NUM>), the inner lumen <NUM> in <FIG> is sized to accommodate an HGN structure that has a diameter of about <NUM> (e.g., the HGN GM branch <NUM> in a swollen state), and the inner lumen <NUM> in <FIG> is sized to accommodate an HGN structure that has a diameter of about <NUM> (e.g., the HGN trunk <NUM>). The ability to assume slightly larger, expanded and less tightly furled states, in addition to the smaller fully furled state, allows the same nerve cuff <NUM> to accommodate either of the larger HGN trunk <NUM> or a smaller HGN branch <NUM>. The ability to assume slightly larger, expanded furled states also allows the nerve cuff to accommodate nerve swelling that may occur post-surgery and to self-adjust to a smaller state when the swelling subsides.

It should also be noted here that the relatively wide contacts <NUM> are sized such that they extend completely around the inner lumen <NUM>, i.e., <NUM>° or more around the longitudinal axis of the inner lumen, when the cuff body <NUM> is in the fully furled state illustrated in <FIG> that accommodates an HGN structure having a diameter of about <NUM>. Viewed as a group, the relatively narrow contacts <NUM> also extend completely around the inner lumen <NUM> when the when the cuff body <NUM> is in the fully furled state illustrated in <FIG>. The relatively wide contacts <NUM> also extend substantially around the inner lumen <NUM>, i.e., at least <NUM> in some examples and <NUM>° or more in other examples, around the longitudinal axis of the inner lumen, when the cuff body <NUM> is in the expanded and less tightly furled state illustrated in <FIG> that accommodates an HGN structure having a diameter of about <NUM>. Viewed as a group, the relatively narrow contacts <NUM> also extend substantially around the inner lumen <NUM> when the when the cuff body <NUM> is in the expanded and less tightly furled state illustrated in <FIG>.

The dimensions of the present nerve cuffs, including the various elements thereof, may by any dimensions that result in the nerve cuffs functioning as intended. With respect to the dimensions of the cuff body <NUM> of the exemplary nerve cuff <NUM>, referring to <FIG> and considering that <NUM> inch corresponds to <NUM>, the cuff body is about <NUM> inches wide and about <NUM> inches long. As used herein in the context of dimensions, the word "about" means ± <NUM>-<NUM>%. The width of the stimulation region <NUM> is about <NUM> inches, while the width of the compression region <NUM> is about <NUM> inches. The relatively wide contacts <NUM> are same size, and the relatively narrow contacts <NUM> are the same size, in the illustrated implementation. In other implementations, the relatively wide contacts <NUM> may be different sizes and/or the relatively narrow contacts <NUM> may be different sizes. Referring to <FIG>, the width W1 of the relatively wide contacts <NUM> is about <NUM> inches, the length L1 is about <NUM> inches, the distance D1 between the relatively wide contacts <NUM> is about <NUM> inches, and the width W3 of the straps <NUM> is about <NUM> inches. The width W2 of the relatively narrow contacts <NUM> is about <NUM> inches, the length L2 is about <NUM> inches and the distance D2 between the relatively narrow contacts <NUM> is about <NUM> inches. The distance D2 may also be increased or decreased as desired to accomplish various stimulation objectives. The distance D3 between the relatively narrow contacts <NUM> and the relatively wide contacts <NUM> is about <NUM> inches.

Turning to <FIG>, the exemplary IPG <NUM> includes the aforementioned receptacle <NUM>, a hermetically sealed outer case <NUM>, and various circuitry (e.g., stimulation circuitry <NUM>, control circuitry <NUM>, sensing circuitry <NUM>, memory <NUM>, and communication circuitry <NUM>) that is located within the outer case <NUM>. The outer case <NUM> may be formed from an electrically conductive, biocompatible material such as titanium. The stimulation circuitry <NUM>, which is coupled to the contacts <NUM> and <NUM> by way of the connector <NUM>, receptacle <NUM> and wires <NUM>, is configured to deliver stimulation energy to the HGN. The control circuitry <NUM> controls when and for how long the stimulation circuitry <NUM> applies stimulation, the intensity of the stimulation, the mode of stimulation (i.e., monopolar, bipolar or tripolar), and the particular contacts that are used in the stimulation. In the monopolar stimulation, at least a portion of the outer case <NUM> functions as a return electrode in the electrical circuit that also includes one or more of the contacts <NUM> and <NUM>. In bipolar stimulation, the outer case <NUM> is not part of the electrical circuit and current instead flows from one of the contacts <NUM> and <NUM> to one of the other contacts <NUM> and <NUM>. In tripolar stimulation, the outer case <NUM> is not part of the electrical circuit and current flows from one or more of the contacts <NUM> and <NUM> to more than one of the other contacts <NUM> and <NUM>. The contacts that the current flows to form part of the return path for the stimulation energy, as do the associated wires connected thereto. The stimulation may also be predominantly axial vector stimulation, predominantly radial vector stimulation, or a hybrid of axial vector and radial vector.

It should also be noted here that in most instances, contacts that are entirely separated from (and electrically disconnected from) the associated nerve by the cuff body will not be used by the IPG for current transmission and return. For example, when the exemplary nerve cuff <NUM> is in less lightly furled state illustrated in <FIG>, one of the contacts <NUM> is entirely separated from the GM branch <NUM> by the electrically non-conductive cuff body <NUM> and will not be used for current transmission or return. Such contacts may be identified by, for example, measuring the impedance at each contact.

The sensing circuitry <NUM> in the illustrated embodiment may be connected to one or more sensors (not shown) that are contained within the outer case <NUM>. Alternatively, or in addition, the sensors may be affixed to the exterior of the outer case <NUM> or positioned at a remote site within the body and coupled to the IPG <NUM> with a connecting lead. The sensing circuitry <NUM> can detect physiological artifacts that are caused by respiration (e.g., motion or ribcage movement), which are proxies for respiratory phases, such as inspiration and expiration or, if no movement occurs, to indicate when breathing stops. Suitable sensors include, but are not limited to, inertial sensors, bioimpedance sensors, pressure sensors, gyroscopes, ECG electrodes, temperature sensors, GPS sensors, and combinations thereof. The memory <NUM> stores data gathered by the sensing circuitry <NUM>, programming instructions and stimulation parameters. The control circuitry <NUM> analyzes the sensed data to determine when stimulation should be delivered. The communication circuitry <NUM> is configured to wirelessly communicates with the clinician's programming unit <NUM> and patient remote <NUM> using radio frequency signals.

The control circuitry <NUM> may apply stimulation energy to either the HGN truck or an HGN branch (e.g. the HGN GM branch) in various stimulation methodologies by way of the cuff <NUM> when the patient is in the inspiratory phase of respiration, and other conditions for stimulation are met, thereby causing anterior displacement of the tongue to keep the upper airway unobstructed. The control circuitry <NUM> causes the stimulation circuitry <NUM> to apply stimulation in the form of a train of stimulation pulses during these inspiratory phases of the respiratory cycle (or slightly before the inspiration and ending at the end of inspiration) and not the remainder of the respiration cycle. The train of stimulus pulses may be set to a constant time duration or may change dynamically based on a predictive algorithm that determines the duration of the inspiratory phase of the respiratory cycle.

Another exemplary nerve cuff is generally represented by reference numeral 102a in <FIG>. Nerve cuff 102a is substantially similar to nerve cuff <NUM> and similar elements are represented by similar reference numerals. For example, the nerve cuff 102a may form part of an electrode lead that may be connected to the IPG <NUM>, or other suitable device, and employed in stimulation methodologies such as those described above. The nerve cuff 102a includes a cuff body <NUM> with a front layer <NUM>, a rear layer <NUM>, two relatively wide contacts 112a, and a plurality of relatively narrow contacts <NUM> that are defined by portions of the relatively narrow conductive members <NUM> that are exposed by way of respective relatively narrow openings <NUM> in the cuff body front layer <NUM>. The cuff body <NUM> also has a stimulation region <NUM> and a compression region <NUM>. The contacts 112a and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. Here, however, each relatively wide contact 112a includes a plurality of spaced conductive members 120a that are electrically connected to one another in series and together function in a manner similar to a single, unitary conductive member (e.g., conductive member <NUM>). The conductive members 120a have portions 124a that are exposed by way of openings <NUM> in the cuff body front layer <NUM>. The straps <NUM> therebetween advantageously function in the manner described above.

Referring more specifically to <FIG>, the conductive members 120a in each contact 112a may be connected to one another by flexible conductors <NUM> such as, for example, conductive coils (as shown), wires, or braided cables. In the illustrated implementation, the flexible conductors <NUM> extend in the length direction L of the cuff body <NUM>. As used herein, a flexible conductor that extends in the length direction of the cuff body <NUM> is a flexible conductor that defines a diameter (or width) as well as a length that is greater than the diameter (or width) and the length of the flexible conductor is parallel to or at least substantially parallel to (i.e., ± <NUM>° from parallel to) the length direction L of the cuff body. The conductive members 120a include a main body <NUM> and a pair of crimp regions <NUM> that extend from the main body <NUM> in the width direction W of the cuff body <NUM>. A gap <NUM> is defined between the crimp regions <NUM>. The ends <NUM> of the flexible conductors <NUM> are crimped to the conductive members 120a at the crimp regions <NUM> and an uncrimped portion <NUM> of the flexible conductors is located within the gap <NUM> between the crimp regions. The uncrimped portion of the flexible conductors <NUM> accommodates the torsion force applied thereto as the nerve cuff moves in and out of its pre-set furled state. In at least some implementations, conductive coils or other flexible conductors 136a that extend to the lead connector <NUM> (<FIG>) may be employed in place of the above-described wires <NUM>.

The use of a plurality of spaced, electrically connected conductive members 120a increases the flexibility of the contacts 112a, as compared to otherwise similar contacts that include a single conductive member, thereby increasing the flexibility of the nerve cuff as it moves in and out of its pre-set furled state.

With respect to the crimping process, crimp tubes <NUM> (<FIG>) may be provided on the ends <NUM> of the flexible conductors <NUM> and the conductive members 120a may be provided with rolled portions <NUM> into which the conductor ends and crimp tubes are inserted prior to crimping and the formation of the crimp regions <NUM>. In other instances, and as described below with reference to <FIG>, portions of the conductive members may include a crimp tabs that are rolled or folded over the crimp tubes <NUM> and coil ends <NUM> prior to crimping and the formation of the crimp regions. The exemplary flexible conductors <NUM> may include a conductor and an insulator, or simply a conductor. In those instances where the conductive coils <NUM> include a conductor and an insulator, the portions of the insulators within the crimp regions may be removed prior to crimping or simply allowed to squeeze out of the resulting joint during the crimping process. Other exemplary methods of securing the flexible conductors <NUM> to conductive members 120a include, but are not limited to, forming joints by welding and combined welding/crimping processes.

Another exemplary nerve cuff is generally represented by reference numeral 102b in <FIG>. Nerve cuff 102b is substantially similar to nerve cuff <NUM> and similar elements are represented by similar reference numerals. For example, the nerve cuff 102b may form part of an electrode lead that may be connected to the IPG <NUM>, or other suitable device, and employed in stimulation methodologies such as those described above. The nerve cuff 102b includes a cuff body <NUM> with a front layer <NUM>, a rear layer <NUM>, two relatively wide contacts 112b, and a plurality of relatively narrow contacts <NUM> that are defined by portions of the relatively narrow conductive members <NUM> that are exposed by way of respective relatively narrow openings <NUM> in the cuff body front layer <NUM>. The cuff body <NUM> also has a stimulation region <NUM> and a compression region <NUM>. The contacts 112b and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. Here, however, each relatively wide contact 112b includes a plurality of spaced conductive members 120b that are electrically connected to one another in series and together function in a manner similar to a single, unitary conductive member (e.g., conductive member <NUM>). The conductive members 120b have portions 124b that are exposed by way of openings <NUM> in the cuff body front layer <NUM>. The straps <NUM> therebetween advantageously function in the manner described above.

Referring more specifically to <FIG>, the conductive members 120b in each contact 112b may be connected to one another in series by, for example, a conductive braided cable 152b (as shown), a coil, or a wire. In the illustrated implementation, the conductive cable 152b extends in the width direction W of the cuff body <NUM>. As used herein, a conductive cable that extends in the width direction of the cuff body <NUM> is a conductive cable that defines a diameter (or width) as well as a length that is greater than the diameter (or width) and the length of the conductive cable is parallel to or at least substantially parallel to (i.e., ± <NUM>° from parallel to) the width direction W of the cuff body. The conductive members 120b include a main body 154b, defining a length in the length direction L of the cuff body <NUM> and a width in the width direction W, and a single crimp region 156b at one of the longitudinal ends of the main body. In the exemplary nerve cuff 102b, the crimp regions 156b are all at the same longitudinal end. Portions 160b of the conductive cable 152b are crimped to the conductive members 120b at the crimp regions 156b.

The use of a plurality of spaced, electrically connected conductive members 120b increases the flexibility of the contacts 112b, as compared to otherwise similar contacts that include a single conductive member, thereby increasing the flexibility of the nerve cuff as it moves in and out of its pre-set furled state.

With respect to the crimping process, crimp tubes <NUM> (<FIG>) may be provided at spaced locations along the conductors 156b and the conductive members 120b may be provided with rolled portions <NUM> through which the conductive cable 152b is passed prior to crimping and the formation of the crimp regions 156b. It should be noted here that positioning a rolled portion <NUM> at the longitudinal end of the conductive member 120b reduces the complexity of the manufacturing process, as compared to a process where the structure that receives the cable is located in the middle region of the conductive member. A first cable 152b connects each of the conductive members 120b in one of the contacts 112b to one another in series, while a second cable 152b connects each of the conductive members 120b in the other contact 112b to one another in series. In other instances, and as described below with reference to <FIG>, the conductive members may each include a crimp tab that is rolled or folded over the crimp tubes <NUM> and cable portions 160b prior to crimping and the formation of the crimp regions. The exemplary conductive cables 152b may include a conductor and an insulator, or simply a conductor. In those instances where the conductive cables 152b include a conductor and an insulator, portions of the insulators within the crimp regions may be removed prior to crimping or simply squeeze out of the resulting joint during the crimping process. Other exemplary methods of securing the flexible conductors 152b to conductive members 120b include, but are not limited to, forming joints by welding and combined welding/crimping processes.

The contacts 112b and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. In at least some implementations, coiled wires may be employed.

Another exemplary nerve cuff is generally represented by reference numeral 102c in <FIG>. Nerve cuff 102c is substantially similar to nerve cuff <NUM> and similar elements are represented by similar reference numerals. For example, the nerve cuff 102c may form part of an electrode lead that may be connected to the IPG <NUM>, or other suitable device, and employed in stimulation methodologies such as those described above. The nerve cuff 102c includes a cuff body <NUM> with a front layer <NUM>, a rear layer <NUM>, two relatively wide contacts 112c, and a plurality of relatively narrow contacts <NUM> that are defined by portions of the relatively narrow conductive members <NUM> that are exposed by way of respective relatively narrow openings <NUM> in the cuff body front layer <NUM>. The cuff body <NUM> also has a stimulation region <NUM> and a compression region <NUM>. The contacts 112c and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. Here, however, each relatively wide contact 112c includes a plurality of spaced conductive members 120c that are connected to one another in the manner described below with reference to <FIG> and that together function in a manner similar to a single, unitary conductive member (e.g., conductive member <NUM>). The conductive members 120c have portions 124c that are exposed by way of openings <NUM> in the cuff body front layer <NUM>. The straps <NUM> therebetween advantageously function in the manner described above.

Referring to <FIG>, each contact 112c in the illustrated embodiment includes two sets of conductive members 120c arranged such that adjacent conductive members are in different sets. The conductive members 120c in each set are connected to one another in series by, for example, a conductive braided cable 152c (as shown), a coil, or a wire. As such, each contact 112c includes two conductive braided cables 152c-<NUM> and 152c-<NUM> that extend in the width direction and are respectively connected to different subsets of the conductive members 120c. Adjacent conductive members 120c are also oriented differently than one other, with the crimp regions 156c of adjacent conductive members being on opposite longitudinal ends of the main body 154c, to accommodate the two cables 152c-<NUM> and 152c-<NUM>. Portions 160c of the conductive cables 152c-<NUM> and 152c-<NUM> are crimped to the conductive members 120c at the crimp regions 156c. Portions 161c of the conductive cables 152c-<NUM> and 152c-<NUM>, which are located between the crimped portions 160c, pass over the conductive members 120c and are not crimped or otherwise secured to the conductive members.

The use of a plurality of spaced, electrically connected conductive members 120c increases the flexibility of the contacts 112c, as compared to otherwise similar contacts that include a single conductive member, thereby increasing the flexibility of the nerve cuff as it moves in and out of its pre-set furled state. Moreover, the alternating manner by which the contact members 120c are connected, and the corresponding increase in the distance between adjacent crimp regions, further increases the flexibility of the contacts 112c and resistance to fatigue failure.

With respect to the crimping process, crimp tubes <NUM> (<FIG>) may be provided at spaced locations along the conductors 152c and the conductive members 120c may be provided with a rolled portion (e.g., rolled portion 155b in <FIG>) through which a conductive cable 152c is passed prior to crimping and the formation of the crimp regions 156c. A first pair of cables 152c-<NUM> and 152c-<NUM> respectively connect alternating and oppositely oriented conductive members 120c to one another in one of the contacts 112c, while a second pair of cables 152c-<NUM> and 152c-<NUM> respectively connect alternating and oppositely oriented conductive members 120c to one another in the other contact 112c. In other instances, and as described below with reference to <FIG>, the conductive members may include a crimp tab that is rolled or folded over the crimp tubes <NUM> (<FIG>) and cable portions 160c prior to crimping and the formation of the crimp regions. The exemplary conductive cables 152c may include a conductor and an insulator and portions of the insulators within the crimp regions 156c may be removed prior to crimping or simply squeeze out of the resulting joint during the crimping process. Other exemplary methods of securing the flexible conductors 152c to conductive members 120c include, but are not limited to, joints that are formed by welding and combined welding/crimping processes.

The contacts <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. With respect to the contacts 112c, the wires <NUM> that are connected to the contacts 112c may be connected to two adjacent conductive members 120b in each contact welding or other suitable processes, as shown in <FIG>.

Another exemplary nerve cuff is generally represented by reference numeral 102d in <FIG>. Nerve cuff 102d is substantially similar to nerve cuff <NUM> and similar elements are represented by similar reference numerals. For example, the nerve cuff 102d may form part of an electrode lead that may be connected to the IPG <NUM>, or other suitable device, and employed in stimulation methodologies such as those described above. The nerve cuff 102d includes a cuff body <NUM> with a front layer <NUM>, a rear layer <NUM>, two relatively wide contacts 112d and a plurality of relatively narrow contacts <NUM> that are defined by portions of the relatively narrow conductive members <NUM> that are exposed by way of respective relatively narrow openings <NUM> in the cuff body front layer <NUM>. The cuff body <NUM> also has a stimulation region <NUM> and a compression region <NUM>. The contacts 112d and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. Here, however, each relatively wide contact 112d includes a plurality of spaced conductive members 120d that are electrically connected to one another in series. The conductive members 120d have portions 124d that are exposed by way of openings <NUM> in the cuff body front layer <NUM>. The straps <NUM> therebetween advantageously function in the manner described above.

Referring to <FIG>, the conductive members 120d of each contact 112d may be connected to one another by, for example, a conductive wire 152d (as shown), a coil, or a braided cable. In the illustrated implementation, the conductive members 120d include a main body 154d, with longitudinal ends in the length direction L and lateral ends in the width direction W, and a crimp region 156d. The conductive wire 152d extends from conductive member to conductive member in an undulating manner and includes regions 162d that extend in the length direction and regions 164d that extend in the width direction. Portions 160d of the conductive wire regions 162d that extend in the length direction are crimped to the conductive members 120d at the crimp regions 156d. In particular, the conductive wire 152d is crimped to each conductive member 120d at only a single location (i.e., crimp region 156d) that is adjacent to only one of the lateral ends of the conductive member. The length of the crimp regions 156d is less than the length of the conductive members 120d. The regions 164d that extend in the width direction are located adjacent to alternating longitudinal ends (i.e., alternating ends in the length direction) of the conductive members 120d.

The use of a plurality of spaced, electrically connected conductive members 120d increases the flexibility of the contacts 112d, as compared to otherwise similar contacts that include a single conductive member, thereby increasing the flexibility of the nerve cuff as it moves in and out of its pre-set furled state. The undulating shape of the wire 152d further increases the flexibility of the nerve cuff and reduces the likelihood of fatigue failure of the wire.

With respect to the crimping process, crimp tubes 153d (<FIG>) may be provided at spaced locations along the wires 152d and the conductive members 120d may be provided with a rolled portion 155d (<FIG>) through which the wire 152d passes. The conductive members 120d may be provided with a tab 155d' (<FIG>) that is rolled or folded over the wire 152d, thereby forming the rolled portions 155d or similar folded portions, prior to crimping and the formation of the crimp regions 156d. The exemplary wires 152d may include a conductor and an insulator, or simply a conductor. In those instances where the wires 152d include a conductor and an insulator, portions of the insulators within the crimp regions may be removed prior to crimping or simply squeeze out of the resulting joint during the crimping process. Other exemplary methods of securing the flexible conductors 152d to conductive members 120d include, but are not limited to, joints that are formed by welding and combined welding/crimping processes.

The contacts 112d and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. In at least some implementations, coiled wires may be employed.

Another exemplary nerve cuff is generally represented by reference numeral 102e in <FIG>. Nerve cuff 102e is substantially similar to nerve cuff <NUM> and similar elements are represented by similar reference numerals. For example, the nerve cuff 102e may form part of an electrode lead that may be connected to the IPG <NUM>, or other suitable device, and employed in stimulation methodologies such as those described above. The nerve cuff 102e includes a cuff body <NUM> with a front layer <NUM>, a rear layer <NUM>, two relatively wide contacts 112e and a plurality of relatively narrow contacts <NUM> that are defined by portions of the relatively narrow conductive members <NUM> that are exposed by way of respective relatively narrow openings <NUM> in the cuff body front layer <NUM>. The cuff body <NUM> also has a stimulation region <NUM> and a compression region <NUM>. The contacts 112e and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. Here, however, each relatively wide contact 112e includes a plurality of spaced conductive members 120e that are electrically connected to one another in series. The conductive members 120e have portions 124e that are exposed by way of openings <NUM> in the cuff body front layer <NUM>. The straps <NUM> therebetween advantageously function in the manner described above.

Referring to <FIG>, the conductive members 120e of each contact 112e may be connected to one another by, for example, a conductive wire 152e (as shown), a coil, or a braided cable. In the illustrated implementation, the conductive members 120e include a main body 154e, with longitudinal ends in the length direction L and lateral ends in the width direction W, and a crimp region 156e. The conductive wire 152e extends from conductive member to conductive member in an undulating manner and includes regions 162e that extend in the length direction and regions 164e that extend in the width direction. Portions 160e of the conductive wire regions 162e that extend in the length direction are crimped to the conductive members 120e at the crimp regions 156e. In particular, the conductive wire 152e is crimped to each conductive member 120e at only a single location (i.e., crimp region 156e) that is adjacent to only one of the lateral ends of the conductive member. The length of the crimp regions 156e is substantially equal to the length of the conductive members 120e. The regions 162e that extend in the length direction include a portion of the wire 152e with a <NUM>° bend and, accordingly, the regions 164e that extend in the width direction are located adjacent to the same longitudinal ends (i.e., the same ends in the length direction) of the conductive members 120e.

The use of a plurality of spaced, electrically connected conductive members 120e increases the flexibility of the contacts 112e, as compared to otherwise similar contacts that include a single conductive member, thereby increasing the flexibility of the nerve cuff as it moves in and out of its pre-set furled state. The undulating shape of the wire 152e, and associated increase in wire length, further increases the flexibility of the nerve cuff and reduces the likelihood of fatigue failure of the wire, while placement of the regions 164e that extend in the width direction at the same longitudinal end of the conductive members 120e reduces the length of the contacts 112e, thereby facilitating a reduction in length of the nerve cuff.

With respect to the crimping process, crimp tubes 153e (<FIG>) may be provided at spaced locations along the wires 152e and the conductive members 120e may be provided with a rolled portion 155e (<FIG>) in which the crimp tubes 153e and associated portions of the wire 152e are located. The conductive members 120d may be provided with a tab 155e' (<FIG>) that is rolled or folded over the wire 152e and crimp tubes 153e, thereby forming the rolled portions 155e or similar folded portions, prior to crimping and the formation of the crimp regions 156e. The exemplary wires 152e may include a conductor and an insulator, or simply a conductor. In those instances where the wires 152e include a conductor and an insulator, portions of the insulators within the crimp regions may be removed prior to crimping or simply squeeze out of the resulting joint during the crimping process. Other exemplary methods of securing the flexible conductors 152e to conductive members 120e include, but are not limited to, joints that are formed by welding and combined welding/crimping processes.

The contacts 112e and <NUM> may be individually electrically connected to the plurality contacts <NUM> on the lead connector <NUM> (<FIG>) by wires that extend through the lead body <NUM> in the manner described above with reference to <FIG>. In at least some implementations, coiled wires may be employed.

Although the inventions disclosed herein have been described in terms of the preferred embodiments above, numerous modifications and/or additions to the above-described preferred embodiments would be readily apparent to one skilled in the art.

Claim 1:
An electrode lead, comprising:
an elongate lead body (<NUM>) having a proximal end and a distal end; and
a nerve cuff (<NUM>) including;
a biologically compatible, elastic, electrically insulative cuff body (<NUM>) affixed to the distal end of the lead body (<NUM>), the cuff body (<NUM>) being configured to be circumferentially disposed around a nerve, having a pre-set furled state that defines an inner lumen, being movable to an unfurled state, including front and rear layers (<NUM>, <NUM>), and defining a length (L), a length direction, a width (W) in the unfurled state that is greater than the length, and a width direction,
first and second relatively wide electrically conductive members (<NUM>) located between the front and rear layers (<NUM>, <NUM>) of the cuff body (<NUM>), spaced from one another in the length direction, and extending in the width direction to such an extent that they extend completely around the cuff body inner lumen when the cuff body (<NUM>) is in the pre-set furled shape,
the cuff body front layer (<NUM>) including a plurality of openings (<NUM>) that are spaced from one another in the width direction and are aligned with, and located inwardly of the perimeter of, the first relatively wide electrically conductive member (<NUM>) and a plurality of openings (<NUM>) that are spaced from one another in the width direction and are aligned with, and located inwardly of the perimeter of, the second relatively wide electrically conductive member (<NUM>),
a plurality of relatively narrow electrically conductive members (<NUM>) located between the front and rear layers (<NUM>, <NUM>) of the cuff body (<NUM>), spaced from one another in the width direction, and located between the first and second relatively wide electrically conductive members (<NUM>),
the cuff body front layer (<NUM>) including a plurality of openings (<NUM>) that are spaced from one another in the width direction and are respectively aligned with the relatively narrow electrically conductive members (<NUM>), and
a plurality of electrical conductors (<NUM>) extending through the lead body (<NUM>) from at least some of the electrically conductive members (<NUM>, <NUM>) to the proximal end of the lead body (<NUM>).