Patent Description:
Electrical stimulation, or stimming, of tissues may be used to aid in tissue repair. Electrical stimulation therapy, using an electrode apparatus, may be possible during a surgical procedure, by supplying electricity via the electrode apparatus to a tissue subject to treatment while a surgical site, or wound bed, remains open. In order to minimize the duration of a surgical procedure and reduce infection risk at a surgical site, however, the duration of such electrical stimulation therapy may be relatively short. And while it may be possible to continue supply of electrical stimulation therapy following closure of a surgical site by leaving a portion of the electrode apparatus inside a patient, upon expiration of the electrical stimulation therapy, the surgical site will require re-opening to remove the electrode apparatus. This requires that the patient either remain in an operation room or be returned to an operation room for an additional procedure. Further, the re-opening of the surgical site increases the overall duration of the surgical procedure as well as the infection risk. <CIT> describes a system with a lead including a distal electrode portion. The distal electrode portion may be configured to at least partially encircle a sympathetic chain in a lumbar region or thoracic region. The distal electrode portion may include at least one electrode oriented toward the sympathetic chain when the distal electrode portion at least partially encircles the sympathetic chain. The distal portion may include at least one anchoring site configured for use to mechanically secure the distal electrode portion to tissue proximate to the sympathetic chain. The lead may have a strain relief proximate to the distal electrode portion. <CIT> describes a treatment device for endoscope that is used for cutting body tissue while the treatment device is retractably projected from a catheter. The treatment device includes: a control wire inserted into the catheter; and a cutting electrode mounted at the distal end of the control wire with the cutting electrode being imparted a bent configuration in advance. The cutting electrode elastically deforms in a state where the cutting electrode is retracted into the catheter, thereby assuming such a shape as to resemble the configuration of the catheter. <CIT> describes a laparoscopic fixation, repair and ligation suture; and device has a central passageway with first and second parallel channels on opposite sides thereof. A suture extends through the central channel passageway and has a loop with a slip knot on the distal end and a pull on the proximal end. By pulling on the pull the loop can be drawn tightly about a tissue to be ligated. A nesting tube is provided in one channel to receive a suture needle attached to a loopless suture to easily suture to a body cavity wall. In another form, a tapered handle frictionally receives a suture needle attached to a looped and slip knotted suture to repair a tear or rupture in a body part by suturing through one or more laparoscopies without tying ligature knots inside the body cavity. In a third form, a curved carrying device in one channel and a ligation assist device in the other channel permits ligation of large vessels attached to a body part by fibrous tissue. <CIT> describes a surgical method and apparatus for positioning a diagnostic or therapeutic element within the body. The apparatus may be catheter-based or a probe including a relatively short shaft. <CIT> describes an endoscope that has an elongated flexible guide the distal end of which can be introduced into a selected chamber of a human or other animal heart or into the internal space of another body organ. The tube confines a major portion of an elongated flexible sheath the distal end of which carries an inflatable balloon for the distal end portions of elongated flexible optical conductors some of which serve to illuminate selected portions of a surface bounding an internal space. The remaining conductors serve to transmit images of the illuminated portions of the surface toward the proximal end of the tube. When inflated, the ballon shields the distal ends of the conductors from contact with the body fluid in the internal space. A three-dimensional frame is provided to maintain the inflated balloon in any one of a number of different positions in a body cavity. The frame as well as the inflated balloon are constructed, assembled and dimensioned in such a way that the balloon and the frame cannot interfere with pulsating, respiratory and/or other movements of the body organ while the endoscope is in actual use.

There is a need, therefore, for an electrode apparatus that allows surgeons to provide electrical stimulation therapy to a tissue during or immediately following a surgical procedure, to continue supply of electrical stimulation after closure of the surgical site, and to easily remove the electrode apparatus upon expiration of the electrical stimulation therapy without requiring re-opening of the surgical site.

The present invention is directed to overcoming one or more of these above-referenced challenges.

According to certain aspects of the disclosure, an electrode apparatus includes a handle, a cannula extending from a distal end of the handle, wherein the cannula includes at least one lumen therein, a ground wire extending through the cannula, and an electrode wire extending through the handle, and through the cannula, the electrode wire being extendable and retractable relative to a distal end of the cannula. The apparatus also includes a hook provided in the cannula, the hook being extendable and retractable relative to the cannula.

According to other aspects of the disclosure (not encompassed by the wording of the claims), a method of providing electrical stimulation therapy to a tissue using an electrode apparatus comprising a handle, a cannula extending from a distal end of the handle, an electrode wire extending from an electrical supply and through the cannula, the electrode wire being extendable and retractable relative to a distal end of the cannula, and a hook provided in the cannula, the hook being extendable and retractable relative to the distal end of the cannula, may include placing a distal portion of the cannula in a surgical site, adjacent to the tissue, wrapping a distal end of the electrode wire around a periphery of the tissue, engaging the distal end of the wrapped electrode wire with the hook, retracting the hook, with the electrode wire secured to the hook, into the distal end of the cannula, supplying electricity from the electrical supply to the electrode wire for a period of time, extending the hook, after stopping supply of electricity to the electrode wire, to extend out of the distal end of the cannula, thereby disengaging the distal end of the electrode wire from the slot of the hook, and retracting the cannula from the surgical site.

According to still other aspects of the disclosure (not encompassed by the wording of the claims), an electrode apparatus may include a handle having a first actuator, a cannula having a proximal end and a distal end, wherein a proximal end of the cannula extends from a distal portion of the handle, a ground wire extending to a distal end of the cannula, wherein the ground wire is configured to connect to an electrical ground, and an electrode wire extending through the cannula, and being extendable and retractable relative to the cannula in response to actuation of the first actuator.

According to yet other aspects (not encompassed by the wording of the claims), a method of providing electrical stimulation to a tissue using an electrode apparatus comprising a cannula having a proximal end and a distal end, a ground wire extending through the cannula, and an electrode wire extending through the cannula and being extendable and retractable relative to the cannula, may include placing the distal portion of the cannula in a surgical site, adjacent to the tissue, wrapping a distal end of the electrode wire around a periphery of the tissue, supplying electrical stimulation therapy to the tissue for a period of time to promote regeneration of the tissue, removing the electrode wire from the tissue, after stopping supply of electricity to the electrode wire, and retracting the cannula from the surgical site.

Additional objects and advantages of the disclosed embodiments will be set forth in part in the description that follows.

Various embodiments of the present disclosure relate generally to electrode apparatuses for use in electrical stimulation therapy, or stimming, during and/or following a surgical procedure.

The singular forms "a," "an," and "the" include plural reference unless the context dictates otherwise. The terms "approximately" and "about" refer to being nearly the same as a referenced number or value. As used herein, the terms "approximately" and "about" generally should be understood to encompass ± <NUM>% of a specified amount or value. The use of the term "or" in the claims and specification is used to mean "and/or" unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and "and/or. " As used herein "another" may mean at least a second or more. As used herein, the terms "comprises," "comprising," "including," "having," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. Additionally, the term "exemplary" is used herein in the sense of "example," rather than "ideal. " In addition, the term "between" used in describing ranges of values is intended to include the minimum and maximum values described herein. The term "proximal" is used to describe the end of a device that is located closest to an operator of the device when using a device on a subject, whereas the term "distal" is used to describe the end of a device that is located closest to a subject on whom the device is being used and farthest away from the operator.

The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the disclosure claimed.

Embodiments of the disclosure are generally drawn to electrode apparatuses including an electrode that can be placed in contact with a tissue-for example, wrapped around a portion of the tissue-during surgery and then removed from the tissue after closure of the surgical site. Example apparatuses may include an electrode portion for contacting the tissue at a distal end of the apparatus, a cannula into which the electrode may be retracted into when positioning the cannula in the patient and/or removing the electrode after surgery, and a handle operably coupled to the electrode and the cannula for controlling application and removal of the electrode during use.

Examples of tissue with which the electrode apparatuses may be used include nerve tissue, such as peripheral nerve tissue or central nervous system tissue. Other types of tissue suitable for the present disclosure include, but are not limited to epithelial tissue, conductive tissue, muscular tissue, capillary tissue, dermal tissue, smooth muscle tissue, and cardiac tissue. In other aspects, electrode apparatuses for applying electrical stimulation therapy may be used on tissue grafts, which may be synthetic or non-synthetic nerve grafts, or human or animal nerve grafts. For example, the tissue may be mammalian tissue, including human tissue and tissue of other primates, rodent tissue, equine tissue, canine tissue, rabbit tissue, porcine tissue, or ovine tissue. In addition, the tissue may be non-mammalian tissue, selected from piscine, amphibian, or insect tissue. The tissue may be allogeneic or xenogeneic to a subject into which the graft is implanted. The tissue may be a synthetic tissue, such as, but not limited to, laboratory-grown or 3D-printed tissue.

<FIG> shows an example of a handle portion <NUM> that is included in an exemplary electrode apparatus <NUM>. It is recognized that handle portion <NUM> as described herein may be modified with any combination of actuators (e.g., thumbwheels, levers, triggers, knobs, buttons, slides, or any other mechanisms) suitable for controlling insertion of the device, including extension of the distal electrode used to stimulate the tissue from the cannula, attachment of the electrode to the tissue, removal of the electrode from the tissue, and/or retraction of the electrode within the cannula. Though an example handle portion <NUM> is depicted with specific actuators, it is understood that handle portion <NUM> may be modified depending on the arrangement, method of attachment, and/or method of release of a distal electrode for applying stimulation. Specific examples of handles <NUM> suitable for use in conjunction with other embodiments of electrode apparatuses are described further below.

Handle portion <NUM> may be configured to control a distal end of electrode apparatus <NUM>, and may include an inlet <NUM> at a proximal end, an outlet <NUM> at a distal end, a trigger mechanism <NUM>, a slide mechanism <NUM>, a lock-out mechanism <NUM>, a strain relief mechanism <NUM>, and a spring-loaded clip mechanism <NUM>. In some aspects, the handle portion <NUM> may have an ergonomic shape and may be relatively lightweight, so as to comfortably fit within a hand of a user and to provide the user with adequate control of the electrode apparatus <NUM>.

An electrode wire <NUM> and a ground wire <NUM> extend through a lumen <NUM> to the inlet <NUM> of the handle portion <NUM>, and through a cannula <NUM> located within the handle portion <NUM> and extending distally from the outlet <NUM> of the handle portion <NUM>. A proximal end of the electrode wire <NUM> is shown electrically connected to an electrical stimulation platform, or electrical supply <NUM>, discussed in more detail below, and a proximal end of the ground wire <NUM> is shown electrically connected to an electrical ground <NUM>. The electrode wire <NUM> extends through cannula <NUM> and, in some embodiments, may form a loop <NUM> at a distal end thereof. In addition, in some embodiments, the distal end of the cannula <NUM> may have a hook <NUM> for selectively controlling the electrode wire <NUM>. For example, hook <NUM> may aid in attaching electrode wire <NUM> with the tissue, or removing or retracting the electrode wire <NUM> at the end of the treatment. Embodiments of the distal end of electrode apparatus <NUM> will be discussed in further detail below.

The trigger mechanism <NUM> may be used to extend and retract the hook <NUM>, and is therefore mechanically coupled to the hook <NUM> within the handle portion <NUM>, as described below with respect to <FIG>. The slide mechanism <NUM> may be used to loosen and tighten the electrode wire <NUM>, and is therefore mechanically coupled to the electrode wire <NUM>, as described below with respect to <FIG>. Although a slide mechanism is depicted in <FIG>, a thumbwheel or other appropriate actuation mechanism may be incorporated at location <NUM> of handle portion <NUM>. The strain relief <NUM> may be included to provide reinforcement and protection to a connection between the cannula <NUM> and the handle portion <NUM>. The lock-out mechanism <NUM> may inhibit movement of the slide mechanism <NUM>, as may be desired once the electrode wire <NUM> is tightened around a tissue, as will be described further below, to prevent overtightening of the electrode wire <NUM>, which could damage the tissue. The spring loaded clip <NUM> is optionally provided on an exterior surface of the handle portion <NUM>, and may allow a surgeon to clip the electrode apparatus to the patient, e.g., via clipping onto a gown worn by a patient or onto another suitable location, following placement of the apparatus <NUM>. The spring loaded clip <NUM> may promote portions of the apparatus <NUM> placed within the patient (described in more detail below) remaining in place within the patient until removal of the apparatus <NUM>.

<FIG> is a cutaway view of the handle portion <NUM> of the electrode apparatus <NUM> shown in <FIG>. In particular, <FIG> shows the trigger mechanism <NUM>, in which a trigger <NUM> is mechanically connected to the hook <NUM> via a pusher rod <NUM> to push and pull the electrode wire <NUM>. In this embodiment, when the trigger <NUM> is compressed or pulled, the pusher rod <NUM> extends distally to cause the hook <NUM> to protrude from the distal end of the cannula <NUM>, and when the trigger <NUM> is released, the pusher rod <NUM> withdraws in a proximal direction to retract the hook <NUM>. The slide mechanism <NUM> includes a slider <NUM> that is mechanically connected to the electrode wire <NUM> by actuators <NUM>, <NUM>, to provide slack or tension to the electrode wire <NUM>. The slider <NUM> is movable within a slot <NUM> provided in the handle portion <NUM>. The slider <NUM> is configured to move between an initial position, which may be approximately <NUM>/<NUM> back from a forward, or distal-most, position within the slot <NUM>, a cinching position, which may be approximately <NUM>/<NUM> back from the forward position, and the forward position, in which the slider <NUM> moves to a distal end of the slot <NUM>. When the slider <NUM> is in the initial position, the electrode wire <NUM> is relatively loose or slack, such that a distal end of the electrode wire <NUM> may be manipulated or bent and wound around a tissue. When the slider <NUM> is in the cinching position, the electrode wire <NUM> has a set amount of tension, such that the electrode wire <NUM> contacts all, substantially all, or some of a circumferential surface of the tissue. And when the slider <NUM> is in the forward position, the electrode wire <NUM> is loosened, potentially more so relative to the amount of slack of the electrode wire <NUM> in the initial position, so that the electrode wire <NUM> may be disengaged to unwrap from the tissue. The lock-out mechanism <NUM> locks the slider <NUM> in position, which may be the initial position, the cinching position, or the forward portion, to prevent over-tightening or inadvertent movement of the electrode wire <NUM>.

<FIG> shows elements suitable for the distal end of the electrode apparatus <NUM>, according to one or more embodiments. In particular, <FIG> shows the cannula <NUM>, which has a rounded, e.g., circular, cross-sectional shape. A length of the cannula <NUM> may be within a range of about <NUM> inches to about <NUM> feet (or about <NUM> to about <NUM>), and an outer diameter of the cannula <NUM> may be in a range of about <NUM> to about <NUM>. The cannula <NUM> may be formed of a biocompatible material, for example, polyurethane (PU), polytetrafluoroethylene (PTFE), polyolefins, crosslinked poly(vinyl acetate), and/or silicone. The cannula <NUM> may also be a single lumen cannula or a multi, e.g., dual, lumen cannula. Within a distal portion of the cannula <NUM>, an insert <NUM> may be provided, which may be PU, PTFE, polyolefins, crosslinked poly(vinyl acetate), and/or silicone. The insert <NUM> may have a protruding portion <NUM> to provide an interference fit between the insert <NUM> and the cannula <NUM> when the insert <NUM> is inserted into the distal portion of the cannula <NUM>. The insert <NUM> may also have a T-shaped divider <NUM> at a distal end thereof, through which different elements, e.g., the ground wire <NUM>, the electrode wire <NUM>, and the hook <NUM>, may be inserted. The divider <NUM> may have other shapes, as discussed in more detail below. The insert <NUM> may also have a circumferential slot <NUM>, proximal to the circumferential protruding portion <NUM>, into which a ground ring <NUM> may be inserted. The ground ring <NUM> is attached to a ground wire <NUM> that extends through a portion of the insert <NUM> and through the cannula <NUM> to an electrical ground <NUM> (<FIG> also shows an electrode wire <NUM>, wrapped around a tissue <NUM>. The ground ring <NUM> and the ground wire <NUM> provide electrical continuity through the electrode apparatus <NUM>, from an electrical stimulation platform <NUM> to an electrical ground <NUM> at a proximal end of the ground wire <NUM>.

The electrode wire <NUM> is shown in a looped configuration, meaning the electrode wire <NUM> extends from a distal end of cannula <NUM>, and upon extension beyond a distal end of the cannula <NUM>, turns or loops, and returns back toward the distal end, making a second pass through the cannula <NUM>. The loop <NUM> formed at the distal end of the electrode wire <NUM> may be secured using one of the mechanisms described herein (e.g., a hook, a ball, etc.). Although a looped embodiment of electrode wire <NUM> is shown in <FIG>, a non-looped embodiment, as described herein, may be included. For example, the electrode wire <NUM> may be a single or non-looped electrode wire that extends from a proximal end, connected to the electrical stimulation platform <NUM>, to a distal end that extends beyond the distal end of the cannula <NUM>. A length of the electrode wire <NUM> may be set depending on a size, and in particular, a diameter, of a tissue <NUM> around which the electrode wire <NUM> is to be wound, and depending on the particular configuration of the electrode wire <NUM> (e.g., looped vs. not looped). The length of the electrode wire <NUM> may be selected to ensure the electrode wire <NUM> is long enough to wrap around a tissue <NUM> having a diameter ranging, e.g., from about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM>-<NUM>, or about <NUM>-<NUM>.

The electrode wire <NUM> may be a stranded, flexible wire, as discussed relative to certain embodiments below. A relatively flexible electrode wire <NUM> may be easier to manipulate for wrapping around tissue <NUM> and for tensioning of the electrode wire <NUM> once it has been wrapped around the tissue <NUM>. The electrode wire <NUM> may be formed, for example, of a shape memory material, such as Nitinol®, or a non-shape memory material, such as copper, annealed copper, copper coated in gold, or copper with gold plating. The material may be "off-the-shelf," or the material may be customized, formed of common wire materials, but formed to particular specifications regarding materials, length, number of strands, and/or thickness of strands. One or more portions of electrode wire <NUM> may be insulated, including, for example, proximal portions not configured for contact with tissue <NUM>. A distal portion of electrode wire <NUM> may not include insulation, and, e.g., may be stripped of an insulation layer. In some embodiments, a portion, e.g., a distal tip, of the uninsulated distal portion of electrode wire <NUM> may be soldered using, for example, a biocompatible material, such as a material described in <NPL>).

In addition, while the electrode wire <NUM> may be shown or described in some embodiments as providing <NUM>° of conduction or connection to tissue <NUM> by virtue of the electrode wire <NUM> being wrapped <NUM>° around a circumferential surface of the tissue <NUM>, the electrode apparatus <NUM> described herein may provide sufficient electrical stimulation with only <NUM>% of conduction or connection to the tissue <NUM> (that is, even if the electrode wire <NUM> wraps only <NUM>° around the circumferential surface of the tissue <NUM>, the electrode apparatus <NUM> may still provide sufficient electrical stimulation). Further, as discussed in more detail below, depending on the particular embodiment, the electrode wire <NUM> may be secured to a tissue <NUM>, such as a nerve, that is intact or that is severed (for example, a nerve end). In addition, the electrode wire <NUM> may be secured to the tissue <NUM> before or after placement of a tissue graft. No internal securement to the tissue <NUM> may be required, rather the electrode wire <NUM> may only be externally secured to the tissue <NUM>.

The hook <NUM> may be integrally formed with the pusher rod <NUM>, and may have a rounded distal end to prevent damage to tissue <NUM>. In addition, the hook <NUM> may have a protrusion <NUM> on one surface for grasping a distal end or a loop <NUM> of the electrode wire <NUM>. One or more surfaces of the hook <NUM> may have a bevel. A stroke of the pusher rod <NUM> (<FIG>), representing a distance the hook <NUM> moves from an extended position to a retracted position, may be determined based, at least in part, on a size, e.g., a diameter, of the tissue <NUM> around which the electrode wire <NUM> is to be wrapped. For example, the pusher rod <NUM> may have a stroke of about <NUM> for a tissue <NUM> having a diameter of about <NUM> to about <NUM>, and a stroke of about <NUM> for a tissue <NUM> having a diameter of about <NUM>. Alternatively, the pusher rod <NUM> may have a stroke of about <NUM> for a tissue <NUM> having a diameter of about <NUM>, or about <NUM> for a tissue <NUM> having a diameter of about <NUM>.

In some embodiments, the insert <NUM> may be a cowling, having an opening for the electrode wire <NUM>, and having a closed distal face, which acts as a stop for the electrode wire <NUM>. In an embodiment in which the insert <NUM> is in the form of a cowling, a portion of the electrode wire <NUM> that extends beyond the distal end of the cannula <NUM> may have insulation in order to improve cinching. Insulation may alternatively be removed from the portion of the electrode wire <NUM> that extends beyond the distal end of the cannula <NUM>, to ensure interaction between conductive portions of the wire <NUM> and tissue <NUM>. Alternatively, the distal tip of the cannula <NUM> may not include a cowling, and the electrode wire <NUM> may have a welded tip without insulation. In such an embodiment, the electrode wire <NUM> extends beyond, or distal relative to, the hook <NUM>, and may be shaped to improve cinching. For example, the electrode wire <NUM> may have a small ball welded to a distal end thereof, which may act as a catch for the hook <NUM>.

The electrical stimulation platform <NUM> may have a voltage in a range of about <NUM> V to about <NUM> V, and more specifically, about <NUM> V to about <NUM> V, and a current in a range of about <NUM> mA to about <NUM> mA, and more specifically, about <NUM> mA to about <NUM> mA. The current may be supplied in square wave pulses at a pulse width in a range of about <NUM> to about <NUM>, and more specifically, about <NUM> to about <NUM>, and a frequency in a range of about <NUM> to about <NUM>. The duty cycle may be in a range of about <NUM>% to about <NUM>%, and, in particular, may be about <NUM>%. The duration of the electrical stimulation process may be in the range of about <NUM> minute to about <NUM> minutes, and may be monophasic. The power supply needed for the electrical stimulation platform may be a <NUM> volt direct current "wall wart" supply. An expected resistance load is in a range of about <NUM> kΩ ±<NUM> kΩ.

In addition, as shown in at least <FIG>, for example, the electrode apparatus <NUM> may be used with an adhesive skin tab <NUM>, which may hold the cannula <NUM> in place on skin <NUM> of a patient near the surgical site <NUM>, while the electrode wire <NUM> remains in place during electrical stimulation therapy. In addition or alternatively, one or more of sutures, bands, adhesives, or hook-and-loop fasteners (e.g., Velcro) may be used to secure and stabilize the cannula <NUM> on the skin <NUM> of the patient.

<FIG> show an electrode apparatus <NUM> including an electrode wire <NUM> that has two branches configured to wrap around tissue <NUM>, according to an embodiment. Electrode apparatus <NUM> may include a cannula <NUM>, an electrode wire <NUM> extending beyond a distal end of the cannula <NUM>, an O-ring <NUM>, and a dissolvable suture <NUM> at a distal end thereof. The electrode apparatus <NUM> includes other features not shown in <FIG>, including, for example, a handle portion and a ground wire. <FIG> shows placement of the electrode apparatus <NUM> within a surgical site <NUM>. In particular, a distal end of the electrode wire <NUM> is split into two branches 410a and 410b, each having a ferrule <NUM> at a distal end thereof, with the dissolvable suture <NUM> being attached to the ferrules <NUM>, as shown in <FIG>. Ferrules <NUM> may provide a structural element to attach suture <NUM> to, and may be attached to or integrally formed with branches 410a, 410b. Here, the term "dissolvable" indicates that the material used to form the dissolvable suture <NUM> is absorbable into the human body. In an alternative embodiment, instead of a split electrode wire <NUM>, the electrode wire <NUM> and a ground wire may form two leads extending from a distal end of the cannula. In such an embodiment, distal tips of the electrode wire <NUM> and the ground wire may be insulated to promote the flow of electrical current across the tissue <NUM>, rather than down the wires.

During use, the cannula <NUM> is placed adjacent to a tissue end, and the branches 410a, 410b of the electrode wire <NUM> are placed around the tissue <NUM>. Although electrode wire <NUM> is shown in conjunction with a tissue graft <NUM> inserted between two portions of severed tissue <NUM>, electrode wire <NUM> may be used in conjunction with two ends of severed tissue <NUM> rejoined without the use of a graft <NUM>, or may be used with a tissue <NUM> that is not severed, since branches 410a, 410b may be wrapped around tissue <NUM> prior to application of dissolvable suture <NUM>. If used in conjunction with severed tissue <NUM>, branches 410a, 410b may be applied either before or after placement of a tissue graft <NUM>, or reconnection with an end of severed tissue <NUM>. <FIG> shows placement of the O-ring <NUM> around a portion of the branches 410a, 410b of the electrode wire <NUM>, and engagement of the dissolvable suture <NUM> at ends of the ferrules <NUM>, thereby securing the electrode wire <NUM> to the tissue <NUM>. In one embodiment, the dissolvable suture <NUM> may be pre-tied and the electrode wire <NUM> can be placed around the tissue <NUM> prior to placement of a tissue graft <NUM>. O-ring <NUM> may be cinched over branches 410a, 410b to fit branches 410a, 410b to the tissue <NUM> once in place.

Once the electrode wire <NUM> is secured to the tissue <NUM>, electrical stimulation therapy may begin. Then, the surgical site <NUM> may be closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining, shown in <FIG>, through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, and once the suture <NUM> has dissolved, the electrode wire <NUM> is disengaged from the tissue <NUM>, the electrode wire <NUM> may be retracted into cannula <NUM>, and the cannula <NUM> and the electrode wire <NUM> may be retracted or withdrawn through the small opening <NUM>. <FIG> show disengagement of the electrode wire <NUM> upon dissolution of the suture <NUM>, which allows the electrode wire <NUM> and the cannula <NUM> to be removed from the surgical site <NUM>.

The dissolvable suture <NUM> of the electrode apparatus <NUM> shown in <FIG> may be formed of an absorbable material, such as monomers, polymers, and copolymers, including, for example, materials derived from one or more of the following monomers: e-caprolactone, l-lactide, glycolide, p-dioxanone, and trimethylene carbonate. Other materials may include polymers, such as phenol polymers derived from tyrosol and/or other analogs, or diphenolic monomers derived from tyrosine and/or tyrosine analogs. Exemplary polymers are described, for example, in <CIT>, and <CIT>.

Still further, the material may include poly-vinyl alcohol, hyaluronic acid, or modified hyaluronic acids. Benefits of the embodiment shown in <FIG> include minimal to no new surgical techniques required for implantation of the electrode apparats <NUM> (e.g., only suture <NUM> may need to be applied, if not pre-set), no custom application or removal tools may be required, and the electrode apparatus <NUM> may be capable of providing nearly <NUM>° of conduction to the tissue <NUM>. This embodiment may allow a surgeon to establish an amount of compression on the tissue <NUM> based on a tightness with which the suture <NUM> is secured to the ferrules <NUM>. This embodiment may also provide for an electrode apparatus <NUM> that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> and <FIG> depict an electrode apparatus <NUM> according to another embodiment in which electrode wire <NUM> is applied to tissue <NUM> via a releasable knot <NUM>. <FIG> is a detail view of the electrode apparatus <NUM>, showing a cannula <NUM>, an electrode wire <NUM>, a ground wire <NUM>, and a releasable knot <NUM> formed from a filament <NUM>, including two cords, at a distal end of the electrode apparatus <NUM>. The electrode apparatus <NUM> includes other features not shown in <FIG> and <FIG>, including, for example, a handle portion. The releasable knot <NUM> may be, for example, a quick-release slip knot. The electrode apparatus <NUM> may be provided with a pre-tied releasable knot <NUM>, or releasable knot <NUM> may be tied during the procedure by a person applying electrode wire <NUM>, and the knot <NUM> may be released from outside of a surgical site <NUM>, via a proximal end <NUM> of the filament <NUM>, shown in <FIG>, to detach the electrode wire <NUM> from the tissue <NUM>.

<FIG> are schematic views of the electrode apparatus <NUM> shown in <FIG> in use. <FIG> shows placement of the electrode apparatus <NUM> within a surgical site <NUM>. The cannula <NUM> is placed adjacent to a tissue requiring treatment, and a loop <NUM> formed by the electrode wire <NUM> is placed around the tissue <NUM>, before placement of a tissue graft <NUM>, or prior to bringing ends of a transected tissue <NUM> together, in a case in which no tissue graft <NUM> is used. <FIG> shows securing of the looped electrode wire <NUM> using the releasable knot <NUM>. <FIG> also shows placement of an adhesive skin tab <NUM> on skin <NUM> of the patient, to secure the cannula <NUM> in position, thereby preventing movement of the cannula <NUM> during electrical stimulation therapy. During implantation, a proximal end <NUM> of filament <NUM> may be secured in place by, e.g., a tab <NUM> to inhibit accidental tightening or releasing of knot <NUM>. Once the tissue graft <NUM> is in place, the releasable knot <NUM> may be tightened by pulling on the proximal end <NUM> of one of the cords of the filament <NUM>, shown in <FIG>, which tightens the electrode wire <NUM> around the tissue <NUM> to promote contact between the electrode wire <NUM> and the tissue <NUM>. A tab <NUM> may be provided near the proximal end <NUM> of the filament <NUM>, to limit an amount by which the filament <NUM> may be pulled for tightening. This limit is to ensure the filament <NUM> is not pulled too far and does not damage the tissue <NUM>. Although electrode wire <NUM> is shown in conjunction with a tissue graft <NUM> inserted between two portions of severed tissue <NUM>, electrode wire <NUM> may be used in conjunction with two ends of severed tissue <NUM> rejoined, without the use of a graft <NUM>, or may be used with a tissue <NUM> that is not severed, since the electrode wire <NUM> may be wrapped around tissue <NUM> prior to tying of the releasable knot <NUM>. If used in conjunction with severed tissue <NUM>, the releasable knot <NUM> may be tied either before or after placement of a tissue graft <NUM>, or reconnection with an end of severed tissue <NUM>. In some aspects, releasable knot <NUM> may be pre-tied, so that a surgeon is able to simply slide the electrode wire <NUM> around a transected portion of tissue.

Once the electrode wire <NUM> is secured to the tissue <NUM>, electrical stimulation therapy may begin. Then, the surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, the electrode wire <NUM> is disengaged by pulling on the proximal end <NUM> of the other cord, of the two cords that form the filament <NUM>, thereby releasing the releasable knot <NUM>, while removing the tab <NUM>, to untie or release the knot <NUM>, as shown in <FIG>. Then, the cannula <NUM> and the electrode wire <NUM> are retracted or withdrawn through the small opening <NUM>.

The electrode apparatus <NUM> of the embodiment shown in <FIG> and <FIG> may provide positive feedback that the electrode wire <NUM> has been disengaged from the tissue <NUM> by virtue of the filament <NUM> being pulled, thereby releasing the knot <NUM>. Further, the electrode apparatus <NUM> of this embodiment may not require custom tools for application or removal of the apparatus <NUM>. The electrode apparatus <NUM> may also provide up to <NUM>° contact between the electrode wire <NUM> and the tissue <NUM>. This embodiment also provides for an electrode apparatus <NUM> that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> show an electrode apparatus <NUM> according to another embodiment that has a single electrode wire <NUM> that protrudes distally from cannula <NUM> and then reenters the distal end of cannula <NUM> to form a distal loop <NUM>. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM> that forms a loop <NUM> at a distal end of the apparatus <NUM>, a clasp <NUM> provided at a distal end of the cannula <NUM>, and a handle portion <NUM> having a slider mechanism <NUM> and a release mechanism <NUM>. The electrode apparatus <NUM> includes other features not shown in <FIG>, including, for example, a ground wire. <FIG> shows placement of the electrode apparatus <NUM> within a surgical site <NUM>. In particular, the electrode wire <NUM> forms the loop <NUM>, with the distal end of the electrode wire <NUM> being releasably held in the clasp <NUM>. A proximal end of the electrode wire <NUM> is operably attached to the slider mechanism <NUM> within the handle portion <NUM>. In some aspects, the connection between the electrode wire <NUM> and the slider mechanism <NUM> may be indicated through a slot <NUM> of the slider mechanism <NUM>.

During use, the cannula <NUM> is placed adjacent to a tissue end <NUM>, and the loop <NUM> formed by the electrode wire <NUM> is placed around the tissue end <NUM>. A slider <NUM> of the slider mechanism <NUM> is configured to provide slack or tension to the electrode wire <NUM>, allowing for tightening or loosening the loop <NUM>, respectively. In <FIG>, the slider <NUM> is in a forward or distal position, providing slack to the electrode wire <NUM>, as shown in <FIG>, to facilitate placement of the loop <NUM> around the tissue end <NUM>.

<FIG> shows tensioning of the electrode wire <NUM>, that is, tightening of the loop <NUM>, via moving of the slider <NUM> in a proximal direction, as shown in <FIG>. The electrode wire <NUM> may be tightened after placement of the loop on the tissue end, e.g., after placement of a tissue graft <NUM> in the surgical site <NUM>. The tensioning of the electrode wire <NUM> may be restricted, for example, to a pre-set limit based on the location of the connection between the electrode wire <NUM> and the slider mechanism <NUM>. Once the electrode wire <NUM> is tightened around the tissue <NUM>, electrical stimulation therapy may begin. The surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining, through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, the distal end of the electrode wire <NUM> may be disengaged from the clasp <NUM>, as shown in <FIG>. The distal end of the electrode wire <NUM> may be disengaged from the clasp <NUM>, e.g., by pressing a release button <NUM> of the release mechanism <NUM>. Release of the connection between the electrode wire <NUM> and the clasp <NUM> may be confirmed visually through the slot <NUM> of the slider mechanism <NUM>. For example, a portion of the electrode wire <NUM> may have indicia on a peripheral surface thereof, such that, when the electrode wire is retracted by a set amount, or length, after disengagement of the distal end from the clasp <NUM>, the indicia is visible in the slot <NUM>. The electrode wire <NUM> may then be retracted into the cannula <NUM> by moving slider mechanism <NUM> in the proximal direction, and the cannula <NUM> may be removed from the surgical site <NUM>. By virtue of this embodiment, the electrode apparatus <NUM> can be removed from the surgical site <NUM>, without damaging the tissue <NUM> or the tissue graft <NUM>. It will be recognized that although a slider mechanism and release button <NUM> are described in this embodiment, any suitable actuator, e.g., button, knob, lever, switch, thumbwheel, etc., may be incorporated in handle portion <NUM> in order to achieve the functions described above.

The electrode apparatus <NUM> of the embodiment shown in <FIG> may limit an amount of compression that may be applied to the tissue <NUM>, by, for example, setting a limit to the amount of slack or tension that may be provided to the electrode wire <NUM>. The electrode apparatus <NUM> of this embodiment may also provide positive feedback of disengagement of the electrode wire <NUM>, as a surgeon may confirm visually via the slot <NUM> of the slider mechanism <NUM>, that the distal end of the electrode wire <NUM> has been disconnected from the clasp <NUM>. This embodiment may also provide up to <NUM>° of connection or conduction to the tissue <NUM>. Further, minimal training may be required for installation and removal of the electrode apparatus <NUM>. This embodiment may also provide for an electrode apparatus <NUM> that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> show an electrode apparatus <NUM> having a coil-shaped electrode wire <NUM>, according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM> with a flexible spring coil <NUM> at a distal end thereof, and a handle portion <NUM> with a rotatable knob <NUM>. The electrode apparatus <NUM> includes other features not shown in <FIG>, including, for example, a ground wire. <FIG> shows the electrode wire <NUM> of the electrode apparatus <NUM>, with the flexible spring coil <NUM> being wrapped around the electrode wire <NUM>, formed from a semi-rigid core material, and the electrode wire <NUM> being wrapped around a tissue <NUM>. A surgeon may manually wrap a free end of the electrode wire <NUM> around the tissue <NUM> during placement of the apparatus <NUM>, as shown in <FIG>. Then, during removal of the apparatus <NUM>, the electrode wire <NUM> may be rotated to unwind the soft spring coil <NUM> from the tissue <NUM>, while retracting the electrode wire <NUM> into the cannula <NUM>.

<FIG> show placement, securing, and removal of the electrode apparatus <NUM> shown in <FIG>. In particular, <FIG> shows placement of the cannula <NUM> adjacent to an end of a transected tissue <NUM>, which may occur before or after installation of a tissue graft <NUM>. <FIG> shows a cross-sectional view of the cannula <NUM>, the electrode wire, and the tissue <NUM>, before the flexible spring coil <NUM> has been wrapped around the tissue <NUM>. <FIG> shows wrapping of the electrode wire <NUM> around the tissue <NUM> using a tool <NUM>, such as a forceps, and <FIG> shows a cross-sectional view of the cannula <NUM>, the electrode wire <NUM>, and the tissue <NUM>, with the flexible spring coil <NUM> being wound onto the tissue <NUM>. Although electrode wire <NUM> is shown in conjunction with a tissue graft <NUM> inserted between two portions of severed tissue <NUM>, electrode wire <NUM> may be used in conjunction with two ends of severed tissue <NUM> rejoined without the use of a graft <NUM>, or may be used with a tissue <NUM> that is not severed, since the flexible spring coil <NUM> may be wrapped around a peripheral surface of a tissue <NUM>. If used in conjunction with severed tissue <NUM>, the flexible spring coil <NUM> may be applied either before or after placement of a tissue graft <NUM>, or reconnection with an end of severed tissue <NUM>.

Once the spring coil <NUM> of the electrode wire <NUM> is secured around the tissue <NUM>, electrical stimulation therapy may begin. Then, the surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining, as shown in <FIG>, through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, the electrode wire <NUM> may be disengaged from the tissue <NUM> by rotating the electrode wire <NUM> so that the spring coil <NUM> unwinds from the tissue <NUM>, as shown in <FIG>. The electrode wire <NUM> may be rotated using the knob <NUM> on the handle portion <NUM>, as shown in <FIG>. Then, the cannula <NUM> and the electrode wire <NUM> may be retracted or withdrawn through the small opening <NUM>.

By virtue of the embodiment shown in <FIG>, an electrode apparatus <NUM> having a relatively simple installation procedure may be provided. The electrode apparatus <NUM> of this embodiment may provide up to <NUM>° connection between the electrode wire <NUM> and the tissue <NUM>. In addition, positive feedback of disengagement from the tissue <NUM> may be provided when the knob <NUM> stops rotating, indicating the coil <NUM> has been completely retracted into the cannula <NUM>. This embodiment provides for another electrode apparatus <NUM> that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> show an electrode apparatus <NUM> for use with a conductive ring <NUM>, according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM>, a ground wire <NUM>, a conductive ring <NUM>, a handle portion <NUM> (<FIG>), and a release button <NUM> (<FIG>) provided on the handle portion <NUM>. The electrode apparatus <NUM> may be used with a sleeve <NUM>. In particular, <FIG> shows a detail view of the sleeve <NUM> with the conductive ring <NUM> installed thereon. A cannula <NUM> is provided adjacent to the sleeve <NUM>, and the electrode wire <NUM> and the ground wire <NUM> extend through a distal end of the cannula <NUM> and are connected, for example, by a tab <NUM>, shown in <FIG>, to the conductive ring <NUM>. The conductive ring <NUM> may be formed of an electrically conductive material, which may also be a biologically compatible material, or an absorbable conductive compound. In particular, the conductive ring <NUM> may be formed from a bioresorbable conductive wire, such as a wire formed from an electron-beam evaporated magnesium layer on a surface of a polymer fiber, and insulated with an extrusion coated polymer sheath (e.g., a wire formed of a bioresorbable poly(desanino tyrosyl-tryosine ethyl ester carbonate) or poly(DTE carbonate) core fiber, coated with magnesium, and extrusion coated with bioresorbable poly(caprolactane) (PCL)) (as discussed in <NPL>, or such as those discussed in <NPL>.

<FIG> are schematic views of the electrode apparatus <NUM> and conductive ring <NUM> shown in <FIG> shows placement of the sleeve <NUM> including the conductive ring <NUM> on an end of a transected tissue <NUM> within a surgical site <NUM>. The sleeve <NUM> into which conductive <NUM> is incorporated may be a wrap or other suitable covering for a tissue. For example, sleeve <NUM> may be an Axogen Nerve Connector® or Axogen Nerve Protector®, and may be in the form of a sheet that is wrapped around tissue <NUM>, or pre-rolled and fit over a severed end of a tissue <NUM>. In such an embodiment, conductive ring <NUM> may be incorporated on a surface of, or may extend through or along a side of the Nerve Connector®, Nerve Protector®, or other wrap or covering, and tab <NUM> may also be included and configured to electrically connect the electrode wire <NUM> with the conductive ring <NUM>. <FIG> shows a cross-sectional view of a tissue <NUM> and the conductive ring <NUM>. <FIG> shows placement of the cannula <NUM> with the electrode wire <NUM> adjacent to the tissue <NUM> and the sleeve <NUM> with the conductive ring <NUM> around the tissue <NUM>. A tool <NUM> may be used to attach the electrode wire <NUM> and the ground wire <NUM> to the conductive ring <NUM>. <FIG> shows a cross-sectional view of the tissue <NUM> with the conductive ring <NUM> and the tab <NUM>, connecting the conductive ring <NUM> to the electrode wire <NUM> and the ground wire <NUM> at the distal end of the cannula <NUM>. Although electrode wire <NUM> is shown in conjunction with a tissue graft <NUM> inserted between two portions of severed tissue <NUM>, electrode wire <NUM> may be used in conjunction with two ends of severed tissue <NUM> rejoined without the use of a graft <NUM>, or may be used with a tissue <NUM> that is not severed, in a case in which a sleeve <NUM> with a conductive ring <NUM> is wrapped around a tissue <NUM>.

Once the wires are attached to the conductive ring <NUM>, electrical stimulation therapy may begin. Then, the surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, the electrode wire <NUM> and the ground wire <NUM> are detached from the conductive ring <NUM>. <FIG> shows the detachment of the wires from the conductive ring <NUM>. <FIG> shows pressing of the release button <NUM> on the handle portion <NUM>, for release of the electrode wire <NUM> and the ground wire <NUM> from the conductive ring <NUM>. In particular, pushing the release button <NUM> on the handle portion <NUM> may release the clasping force of <NUM> by extending the electrode wire <NUM> out of the cannula <NUM>, allowing the electrode wire <NUM> to separate. Pushing or pressing the release button <NUM> until a click or other audible or tactile indication is provided, may confirm that the release button <NUM> is fully depressed and may confirm that the electrode wire <NUM> is released from the conductive ring <NUM>. Once the wires are detached from the conductive ring <NUM>, the cannula <NUM> and the wires can be retracted from the surgical site <NUM>, and the small opening <NUM> can be closed.

By virtue of the embodiment shown in <FIG>, up to <NUM>° connection of the conductive ring <NUM> around the tissue <NUM> is ensured. In addition, no wires or connections would be expressed, or extended beyond the distal end of the cannula <NUM>, on the exterior of the electrode apparatus <NUM> prior to removal of the electrode apparatus <NUM>. This embodiment provides for another electrode apparatus <NUM> that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> show an electrode apparatus <NUM> having a dissolvable seam <NUM>, according to another embodiment. The electrode apparatus <NUM> includes a cannula <NUM>, an electrode wire <NUM>, a ground wire <NUM>, a conductive loop <NUM> attachable to the electrode wire <NUM> and the ground wire, and a dissolvable seam <NUM> attached to a sleeve <NUM>. As described above, the sleeve <NUM> into which conductive loop <NUM> and dissolvable seam <NUM> are incorporated may be an Axogen Nerve Connector® or Axogen Nerve Protector®, and may be in the form of a sheet that is wrapped around tissue <NUM>, or pre-rolled and fit over a severed end of a tissue <NUM>. The electrode wire <NUM> and the ground wire <NUM> may extend beyond a distal end of the cannula <NUM>, or may be extended beyond cannula <NUM>, and may be attached to the conductive loop <NUM>, as described in more detail with respect to <FIG> shows a cross-sectional view of the tissue <NUM>, the conductive loop <NUM>, and electrode wire <NUM>, the ground wire <NUM>, and the dissolvable seam <NUM>. The dissolvable seam <NUM> may be positioned at a location that is substantially opposite to a location at which the electrode wire <NUM> and the ground wire <NUM> are attached to the conductive loop <NUM>, as shown. The dissolvable seam <NUM> may, however, be provided at other locations on the conductive loop <NUM>. The dissolvable seam <NUM> may be formed of, for example, BioGlue® (available from Cryolife, Inc. ), chitosan, hyaluronic acid, modified hyaluronic acid, and/or polyvinyl alcohol. A material used to form the seam <NUM> may be chosen based on a rate of dissolution of the material, which may be matched to a duration of therapy needed as well as time needed for placement of the device within a surgical site, or other procedures. The seam <NUM> may dissolve, for example, after a period of time in a range of about <NUM> minute to about <NUM> minutes. In addition, an opening <NUM> is provided in a portion of the conductive loop <NUM>, as shown in <FIG>. As discussed in more detail below, the opening <NUM> is configured to receive a portion of the electrode wire <NUM> and a portion of the ground wire <NUM>.

<FIG> are detail schematic side views of a portion of the conductive loop <NUM>, including the opening <NUM>, the cannula <NUM>, the electrode wire <NUM>, and the ground wire <NUM>. In particular, <FIG> shows the electrode wire <NUM> and the ground wire <NUM> extending beyond a distal end of the cannula <NUM> towards the opening <NUM> of the conductive loop <NUM>, with the arrow indicating a direction of insertion of the wires into the opening <NUM> of the conductive loop <NUM>. <FIG> shows the ends of the electrode wire <NUM> and the ground wire <NUM> being snap fit onto the opening <NUM> of the conductive loop <NUM>. The distal tips of the electrode wire <NUM> and the ground wire <NUM> may be shaped so as to hook into the opening <NUM> of the conductive loop <NUM>. Other suitable connection mechanisms may be used instead of the snap-fit connection shown in <FIG>.

In this example, the electrode wire <NUM> and the ground wire <NUM> may each have a tapered, arrowhead-type distal tip that is configured to be snap fit into the opening <NUM> in the conductive loop <NUM>. Once the electrode wire <NUM> and the ground wire <NUM> are attached to the conductive loop <NUM>, electrical stimulation therapy may begin. The surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining, through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, and once the seam <NUM> has dissolved, the conductive loop <NUM> may be disengaged from the tissue <NUM>. Then, the cannula <NUM>, the electrode wire <NUM>, the ground wire <NUM>, and the conductive loop <NUM> are retracted or withdrawn through the small opening <NUM>.

<FIG> are schematic views of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM>, and a conductive ring <NUM>, similar to the conductive loop <NUM> shown in <FIG>, provided on a sleeve <NUM>. The conductive ring <NUM> has a conductive loop portion <NUM>, shown in <FIG>, for attachment of the electrode wire <NUM> upon placement of the cannula <NUM> at a surgical site <NUM>, and a dissolvable seam <NUM>. <FIG> shows placement of the conductive ring <NUM> and a sleeve <NUM>, which may be integrated with the conductive ring <NUM>, on a tissue <NUM>. <FIG> shows the dissolvable seam <NUM> on the conductive ring <NUM>, and an opening <NUM> in the conductive loop portion <NUM> of the conductive ring <NUM>. The seam <NUM> may be formed from a dissolvable material, such as BioGlue® (available from Cryolife, Inc. ), chitosan, hyaluronic acid, modified hyaluronic acid, and/or polyvinyl alcohol. A material used to form the seam <NUM> may be chosen based on a rate of dissolution of the material, which may be matched to a duration of therapy needed as well as time needed for placement of the device within a surgical site, or other procedures. The seam <NUM> may dissolve, for example, after a period of time in a range of about <NUM> minute to about <NUM> minutes. <FIG> shows placement of the electrode apparatus <NUM> into the surgical site <NUM>, with the cannula <NUM> being placed adjacent to the tissue <NUM>, and the electrode wire <NUM> extending through the cannula <NUM>, beyond a distal end, and being attached to the conductive loop portion <NUM> of the conductive ring <NUM>. <FIG> shows a detail side view of the electrode wire <NUM> attached to the conductive loop portion <NUM> of the conductive ring <NUM> through the opening <NUM>. In this example, the electrode wire <NUM> may have a tapered, arrowhead-type distal tip that is configured to be snap fit into the opening <NUM> in the conductive loop portion <NUM>. Once the electrode wire <NUM> is attached to the conductive ring <NUM>, electrical stimulation therapy may begin. Then, the surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining, through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, and once the seam <NUM> has dissolved, the conductive ring <NUM> may be disengaged from the tissue <NUM>, as shown in <FIG>. Then, the cannula <NUM>, the electrode wire <NUM>, and the conductive ring <NUM> are retracted or withdrawn through the small opening <NUM>. The seam may dissolve, for example, after a period of time in a range of about <NUM> minute to about <NUM> minutes.

By virtue of the embodiments shown in <FIG>, which incorporate use of a sleeve and a dissolvable seam, it is possible to eliminate an additional step of installing an electrode wire separately from a sleeve, rather the electrode wire and the ground wire can be attached to a conductive loop or a conductive ring when placing the electrode apparatus in a surgical site. In addition, the electrode apparatus <NUM> and the electrode apparatus <NUM> may be disengaged from a tissue upon dissolving of the seam, and therefore may not require action on the part of a surgeon to disengage the electrode wire from the tissue. These embodiments may also provide for up to <NUM>° of conduction to the tissue <NUM> by use of the conductive loop <NUM> and/or the conductive ring <NUM>. Further, minimal training may be required of surgeons for installation of the electrode apparatus of these embodiments. Further, these embodiments may provide for another electrode apparatus that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> show an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM>, a releasable cinch mechanism <NUM> that operates similar to a zip-tie, a handle portion <NUM>, and a release mechanism <NUM> provided on the handle portion <NUM>. The electrode apparatus <NUM> may include other features not shown in <FIG>, including, for example, a ground wire. The electrode wire <NUM> and the cinch mechanism <NUM> may be extendable beyond a distal end of the cannula <NUM>. In particular, <FIG> shows placement of the cannula <NUM> adjacent to a tissue <NUM>, and <FIG> shows a side detail view of the electrode wire <NUM> and the cinch mechanism <NUM> extending beyond the distal end of the cannula <NUM>. <FIG> shows wrapping of the electrode wire <NUM> around the tissue <NUM>, following placement of a tissue graft <NUM>. The electrode wire <NUM> may be wrapped using a tool <NUM>, such as a forceps. The electrode wire <NUM> may alternatively be wound around the tissue <NUM> prior to placement of a tissue graft <NUM>. And, although electrode wire <NUM> is shown in conjunction with a tissue graft <NUM> inserted between two portions of severed tissue <NUM>, electrode wire <NUM> may be used in conjunction with two ends of severed tissue <NUM> rejoined without the use of a graft <NUM>, or may be used with a tissue <NUM> that is not severed, since the electrode wire <NUM> may be wrapped around a peripheral surface of a tissue <NUM>. If used in conjunction with severed tissue <NUM>, the electrode wire <NUM> may be applied either before or after placement of a tissue graft <NUM>, or reconnection with an end of severed tissue <NUM>. In either case, a free end of the electrode wire <NUM> is wrapped around the tissue <NUM> and inserted into the cinch mechanism <NUM>. The electrode wire <NUM> can be pulled through the cinch mechanism <NUM> using tool <NUM> until a desired tightness of the wrapping of the electrode wire <NUM> around the tissue <NUM> is achieved. <FIG> shows the electrode wire <NUM> pulled through the cinch mechanism <NUM>.

Once the electrode wire <NUM> is securely wrapped around the tissue <NUM>, electrical stimulation therapy may begin. Then, the surgical site <NUM> may be substantially closed before, during, or after commencement of electrical stimulation therapy, with a small opening <NUM> remaining, through which the cannula <NUM> passes while electrical stimulation therapy continues. In other aspects, electrical stimulation therapy may begin once the surgical site <NUM> is closed. Upon completion of electrical stimulation therapy, the electrode wire <NUM> is disengaged from the tissue <NUM>. In particular, as shown in <FIG>, a pushrod <NUM>, which is mechanically connected to and actuated by the release mechanism <NUM>, pushes a release tab <NUM> of cinching mechanism <NUM>, which moves, e.g. rotates, to thereby release the free end of the electrode wire <NUM> from the cinch mechanism <NUM>. <FIG> shows the release of electrode wire <NUM>, and <FIG> shows pressing of the release mechanism <NUM> (here, a button) on the handle portion <NUM>. Although release mechanism <NUM> is depicted as a button, it is understood that any suitable mechanism, e.g., a lever, a switch, a slider, a thumbwheel, etc., may be incorporated in handle portion <NUM> to control release of electrode wire <NUM>. <FIG> shows a detail side view of the release electrode wire <NUM>. Then, the cannula <NUM> and the electrode wire <NUM> are retracted withdrawn through the small opening <NUM>, which can be closed following removal.

<FIG> are schematic detail views of the releasable cinch mechanism <NUM> at a distal end of the electrode apparatus <NUM> shown in <FIG>. In particular, <FIG> shows wing portions 1655a, 1655b of the cinch mechanism <NUM> in a cinching position. In this example, the wing portions 1655a, 1655b are configured to rotate about axes A and B, so that in the cinching position, ridges <NUM> provided on a surface of each wing portion 1655a and 1655b are positioned near each other. In this position, an electrode wire <NUM> inserted into the cinch mechanism <NUM> is gripped by the ridges <NUM> and retained between the wing portions 1655a, 1655b. When the release tab <NUM> is pushed in the direction of the arrow shown in <FIG>, the wing portions 1655a, 1655b rotate about axes A, B, respectively to an open position, shown in <FIG>, such that smooth surfaces <NUM> thereof are oriented towards the electrode wire <NUM>, and the electrode wire <NUM> inserted between the wing portions 1655a, 1655b is no longer gripped by the ridges <NUM>, and may be pulled out from the cinch mechanism <NUM>.

The electrode apparatus <NUM> of the embodiment shown in <FIG> provides for a secure mechanical connection between the electrode apparatus <NUM> and the tissue <NUM>, with minimal surgical techniques needed for installation. The electrode apparatus <NUM> of this embodiment may also be placed before or after placement of a tissue graft <NUM> at the surgical site <NUM>, if a tissue graft <NUM> is used. This embodiment also provides for up to <NUM>° of connection or conduction to the tissue <NUM>. This embodiment also provides for an electrode apparatus <NUM> that may be implanted during a surgical procedure, may remain in place after closure of a surgical site, e.g., while a patient is in recovery, to continue electrical stimulation therapy, and may be easily removed upon completion of the electrical stimulation therapy, without requiring additional surgical processes or resources.

<FIG> show an electrode apparatus <NUM> including a hook <NUM> and a wire loop <NUM>, according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM> having a loop <NUM> at a distal end thereof, and a hook <NUM> at a distal end of the cannula <NUM>. In particular, <FIG> shows the hook <NUM> and the looped electrode wire <NUM> in an extended or exposed position. In this embodiment, the extended or exposed position of the hook <NUM> and the looped electrode wire <NUM> is the starting position for a procedure in which the electrode wire <NUM> is to be placed around a nerve <NUM>, however, the electrode wire <NUM> and the hook <NUM> may be retracted within the cannula during placement of the electrode apparatus <NUM> in the surgical site <NUM>, and then may be extended distally to the starting position, once the apparatus <NUM> is in place. The electrode wire <NUM> extends distally of a distal end of the cannula <NUM>, and the looped end of the electrode wire <NUM> may be loose or slack. The hook <NUM> may also extend distally of the distal end of the cannula <NUM>.

<FIG> shows a handle portion <NUM> of the electrode apparatus <NUM> in the starting position. In this embodiment, the handle portion <NUM> of the electrode apparatus has an inlet <NUM>, a wire retraction spring <NUM> operatively connected to the electrode wire <NUM> and provided within the handle portion <NUM>, a trigger <NUM> for extending and retracting the hook <NUM>, a thumbwheel <NUM> for controlling slackening and tightening of the looped electrode wire <NUM>, an indicator window <NUM> used to indicate whether the electrode wire <NUM> is disconnected from the hook <NUM>, and an outlet <NUM> through which the cannula <NUM> extends distally to the handle portion <NUM>. The wire retraction spring <NUM> applies a spring load to retract the wire <NUM> in a proximal direction. The indicator window <NUM> has a flag <NUM> configured to be positioned within the indicator window <NUM> when the wire <NUM> is retracted, as shown in <FIG>, and that is positioned outside of the indicator window <NUM>, or hidden, when the wire <NUM> is extended, as shown in <FIG> (or vice versa). Although a flag <NUM> is described as being present or absent in order to indicate the position of wire <NUM>, any suitable indicator may be used. For example, different colors may be shown in the indicator window <NUM> to convey the position of wire <NUM> to a viewer. Inclusion of indicator window <NUM> may allow a user to confirm retraction of the electrode wire <NUM> prior to retraction of the electrode apparatus <NUM> from the surgical site <NUM>.

<FIG> shows the looped electrode wire <NUM> being wrapped around a tissue <NUM>, and being looped onto the hook <NUM>, using a tool <NUM>, such as a forceps. That is, a surgeon may use the tool <NUM> to manipulate the distal portion of the electrode wire <NUM>, or the loop <NUM>, so that the loop <NUM> wraps around the tissue <NUM> and catches onto the hook <NUM>. <FIG> shows the hook <NUM> and the loop <NUM> in a retracted position, after the loop <NUM> has been wrapped around the tissue <NUM>. The arrow in <FIG> indicates the direction in which the hook <NUM> retracts into the cannula <NUM>, bringing a portion of the looped electrode wire <NUM> into the cannula <NUM> as well. <FIG> shows a direction of rotation of a thumbwheel <NUM> when retracting the electrode wire <NUM> and thereby tightening the loop <NUM> around the tissue <NUM>. The thumbwheel <NUM> may operate through use of a friction wheel (not shown), which contacts the electrode wire <NUM> within the handle portion <NUM>, such that when the thumbwheel <NUM> rotates, the electrode wire <NUM> translates in a direction so as to extend the electrode wire <NUM> in a distal direction (which loosens the loop <NUM>), or to retract the electrode wire <NUM> in a proximal direction (to tighten the loop <NUM> or, when the loop <NUM> is disengaged from the hook <NUM>, to retract the electrode wire <NUM>). When the hook <NUM> and the electrode wire <NUM> are in the positions shown in <FIG>, electrical stimulation therapy may be performed while the electrode wire <NUM> is wrapped around the tissue <NUM>. Then, when electrical stimulation therapy is complete, the hook <NUM> may be exposed or extended out of the distal end of the cannula <NUM>, and the looped electrode wire <NUM> may be loosened, as shown in <FIG>. The arrow in <FIG> shows a direction in which the hook <NUM> extends, to allow for release of the loop <NUM>. That is, as the hook <NUM> rotates or extends out of the distal end of the cannula <NUM>, an end of the hook <NUM> extends outward and the loop <NUM> of the electrode wire <NUM> slides off the hook <NUM>.

<FIG> shows a rotation direction of the thumbwheel <NUM> and compression of the trigger <NUM> to extend the hook <NUM> and the loop <NUM> to the positions shown in <FIG>. More specifically, by pressing the trigger <NUM> in the direction of the arrow shown in <FIG>, the hook <NUM> extends and/or rotates out of the distal end of the cannula <NUM>. And, by rotating the thumbwheel <NUM> in the direction of the arrow shown in <FIG>, the distal end of the electrode wire <NUM> becomes relatively slack or loose, allowing the loop <NUM> of the electrode wire <NUM> to slip off the extended hook <NUM>. Finally, <FIG> shows retraction of the electrode wire <NUM> into the cannula <NUM>. The arrow shown in <FIG> indicates a direction in which the electrode wire <NUM> retracts into the cannula <NUM>, upon turning of the thumbwheel <NUM> in a direction shown by the arrow in <FIG>. According to this embodiment, one or both of the looped electrode wire <NUM> or hook <NUM> may be retracted into the cannula <NUM> before removal of the cannula <NUM> from a surgical site, or, one or both of the looped electrode wire <NUM> or hook <NUM> may remain extended distal to the end of cannula <NUM> during removal of the cannula <NUM> from the surgical site.

<FIG> are schematic views of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM> having a loop <NUM>, and a hook <NUM> extendable and retractable into a distal end of the cannula <NUM>. The electrode apparatus <NUM> also has a handle portion <NUM>, an inlet <NUM>, a trigger <NUM> for extending and retracting the hook <NUM>, a thumbwheel <NUM> for controlling slackening and tightening of the electrode wire <NUM>, including the loop <NUM>, an indicator window <NUM> in which a flag <NUM> displays depending on whether or not the electrode wire <NUM> is disconnected from the hook <NUM>, and an outlet <NUM> through which the cannula <NUM> extends distally from the handle portion <NUM>.

In particular, <FIG> shows the electrode wire <NUM> and the hook <NUM> in a retracted position. In this embodiment, the retracted position of the hook <NUM> and the electrode wire <NUM> is the starting position for a start of a surgical procedure. <FIG> shows elements of a handle portion <NUM> of the electrode apparatus <NUM> including the inlet <NUM>, the trigger <NUM> for extending and retracting the hook <NUM>, the thumbwheel <NUM> for controlling slackening and tightening of the electrode wire <NUM>, the indicator window <NUM>, and the outlet <NUM> through which the cannula <NUM> extends distally relative to the handle portion <NUM>. The flag <NUM> is displayed in the indicator window <NUM> when the wire <NUM> is retracted, as shown in <FIG>, and is positioned outside of the indicator window <NUM> (that is, not displayed in the indicator window <NUM>) when the wire <NUM> is extended, as shown in <FIG>. As described above, although a flag <NUM> is described as being present or absent in indicator window <NUM> in order to indicate the position of wire <NUM>, any suitable indicator may be used. For example, different colors may be shown in the indicator window <NUM> to convey the position of wire <NUM> to a viewer. Inclusion of indicator window <NUM> may allow a user to confirm the position of the electrode wire <NUM> during a procedure.

<FIG> shows the electrode wire <NUM> and the hook <NUM> in an extended position, with the loop <NUM> of the electrode wire <NUM> being wrapped around a tissue <NUM> and onto the hook <NUM>, using a tool <NUM>, such as a forceps. That is, a surgeon may use the tool <NUM> to manipulate the distal region of the electrode wire <NUM>, or the loop <NUM>, so that the loop <NUM> wraps around the tissue <NUM> and catches onto the hook <NUM>. <FIG> shows a rotation direction of the thumbwheel <NUM> for extending or loosening the electrode wire <NUM>, and a pulling or compression of the trigger <NUM> to extend the hook <NUM> so as to extend out of the distal end of the cannula <NUM>. <FIG> shows the hook <NUM> in a retracted state, after the electrode wire <NUM> has been wrapped around the tissue <NUM> and the hook <NUM>. <FIG> shows a rotation direction of the thumbwheel <NUM> and a release direction of the trigger <NUM>. Rotating the thumbwheel <NUM> tightens the loop <NUM> formed by the electrode wire <NUM>, and release of the trigger <NUM> retracts the hook <NUM> into the distal end of the cannula <NUM>.

Once the hook <NUM> and the electrode wire <NUM> are in the state shown in <FIG>, electrical stimulation therapy may be performed. Then, upon completion of the electrical stimulation therapy, the hook <NUM> may be extended by compressing the trigger <NUM>, as shown in <FIG>, for release of the wire <NUM>. To ensure the loop <NUM> of the electrode wire <NUM> is released from the hook <NUM>, the thumbwheel <NUM> may be rotated in the direction shown in <FIG> shows the electrode wire <NUM> having been released from the hook <NUM> and unwrapped from the tissue <NUM>, and ready for retraction and removal from the surgical site <NUM>. According to this embodiment, the electrode wire <NUM> and the hook <NUM> remain extended during removal of the cannula <NUM>. In other aspects, however, one or both of electrode wire <NUM> and the hook <NUM> may be retracted into cannula <NUM> during removal.

<FIG> are schematic views of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM>, and a hook <NUM> at a distal end of the cannula <NUM>. The electrode apparatus <NUM> also has a handle portion <NUM>, an inlet <NUM>, a trigger <NUM> for extending and retracting the hook <NUM>, a thumbwheel <NUM> for controlling slackening and tightening of the looped electrode wire <NUM>, an indicator window <NUM> in which a flag <NUM> displays depending on whether or not the electrode wire <NUM> is disconnected from the hook <NUM>, and an outlet <NUM> through which the cannula <NUM> extends distally from the handle portion <NUM>. In particular, <FIG> shows a direction in which hook <NUM> extends outward from a distal end of the cannula <NUM>, upon squeezing of the trigger <NUM> in a direction of the arrow shown in <FIG> shows wrapping of the electrode wire <NUM> around a tissue <NUM> and around the extended hook <NUM>, which may be performed by a surgeon using a tool <NUM>, such as a forceps. Once the electrode wire <NUM> is wrapped around the tissue <NUM> and the hook <NUM>, the hook <NUM> may be retracted and the electrode wire <NUM> may be tightened, as shown in <FIG>. That is, the hook <NUM> may be retracted into the distal end of the cannula <NUM> in the direction of the arrow shown in <FIG> shows a rotation direction of the thumbwheel <NUM> to retract the electrode wire <NUM>, and release of the trigger <NUM> to retract the hook <NUM>. Once the electrode wire <NUM> and the hook <NUM> are in the wrapped and retracted positions shown in <FIG>, electrical stimulation therapy may be performed. Then, upon completion of electrical stimulation therapy, the hook <NUM> may be extended outward from the distal end of the cannula <NUM> by compressing the trigger <NUM>, and the electrode wire <NUM> may be loosened, as shown in <FIG> shows a compression direction of the trigger <NUM> to extend the hook <NUM>, and the direction of rotation of the thumbwheel <NUM> to loosen the electrode wire <NUM>.

In this embodiment, if a user tries to rotate the thumbwheel <NUM> and retract the wire <NUM> without releasing the trigger <NUM> (i.e., retracting hook <NUM> back into cannula <NUM>), rotation of the thumbwheel <NUM> would not retract the electrode wire <NUM>. This may prevent tightening of the electrode wire <NUM> around the tissue <NUM>, and ensures that the electrode wire <NUM> may only be retracted upon release of the trigger <NUM>, and thus removal of electrode wire <NUM> from around tissue <NUM>. <FIG> shows retraction of the released electrode wire <NUM> into the distal end of the cannula <NUM> as shown with the arrow. <FIG> shows a rotation direction of the thumbwheel <NUM> to retract the electrode wire <NUM> in the direction shown by the arrow in <FIG> also shows a pulling or compression direction of the trigger <NUM> to maintain the hook <NUM> in the extended state while the electrode wire <NUM> is retracted into the cannula <NUM>. Once the electrode wire <NUM> is retracted into the cannula <NUM>, the trigger <NUM> may be released so that the hook <NUM> may be retracted into the cannula <NUM>, as shown by the arrow in <FIG> shows release of the trigger <NUM>, as well as the flag <NUM> displayed in the indicator window <NUM> on the handle portion <NUM>, to confirm that the electrode wire <NUM> is retracted. According to this embodiment, a single electrode wire <NUM> (that is, a wire that is not looped) may be cinched or held in place by a hook <NUM>, both the hook <NUM> and the electrode wire <NUM> may retracted into the cannula <NUM> before removal of the cannula <NUM>, and the likelihood of a protruding tail of the electrode wire <NUM> may be reduced.

<FIG> are schematic end views of a cannula <NUM> with a looped electrode wire <NUM> and a ground wire <NUM> arranged therein, with each figure depicting a variation of an arrangement of a hook <NUM>, <NUM>, and <NUM>. In each embodiment, the hook <NUM>, <NUM>, <NUM> has slots <NUM> for receiving a free end of the electrode wire <NUM> (or the looped end of the electrode wire <NUM>), to facilitate retention of the electrode wire <NUM>. <FIG> shows a loop inner arrangement of the hook <NUM>, in which the slots <NUM> are on an inner side relative to a T-divider <NUM> of an insert <NUM>, so that the hook <NUM> retains the looped electrode wire <NUM> on an inner side thereof. <FIG> shows a loop outer arrangement of the hook <NUM>, in which the slots <NUM> of the hook <NUM> are on an outer side relative to the T-divider <NUM> of the insert <NUM>, so that the hook <NUM> retains the looped electrode wire <NUM> on an outer side thereof. And <FIG> shows an angled loop arrangement of the hook <NUM>, in which the slots <NUM> of the hook <NUM> are arranged at an angle relative to the T-divider <NUM>, so that the hook <NUM> retains the electrode wire <NUM> at an angle. The embodiments shown in <FIG> allow for varying degrees of contact with the electrode wire <NUM> and the desired tissue <NUM> and may improve stimulation delivery over a range of tissue diameters. The variations shown in <FIG> also provide for differences in tightness of the loop around the specified tissue <NUM>, providing optimal conditions based on user expectations. The various hook embodiments of <FIG> may be used interchangeably with any of the embodiments described above in which a hook may be included in the electrode apparatus. For example, the embodiments of <FIG> may be used in conjunction with the embodiments of <FIG>, <FIG>, or <FIG>.

<FIG> are schematic cross-sectional views of a distal end of the cannula <NUM> shown in <FIG>, with varying positions of the T-divider <NUM>, and the elements contained therein, including the hook <NUM>, the looped electrode wire <NUM>, and the ground wire <NUM>, relative to a tissue <NUM>. In particular, <FIG> shows the T-divider <NUM> in a side position, with the electrode wire <NUM> extending through the insert <NUM> and outward from the distal end of the cannula <NUM>, and the hook <NUM> being near or adjacent to the tissue <NUM>, and the ground wire <NUM> being relatively far from the tissue <NUM>. <FIG> shows the T-divider <NUM> in a bottom position, with the electrode wire <NUM> extending through the insert <NUM> and outward from the distal end of the cannula <NUM>, and the ground wire <NUM> extending through the insert <NUM> to the distal end of the cannula <NUM>, with both wires being near or adjacent to the tissue <NUM>, and the hook <NUM> being far from the tissue <NUM>. And <FIG> shows the T-divider <NUM> in an upper position, with the electrode wire <NUM> extending through the insert <NUM> and outward from the distal end of the cannula <NUM>, and the ground wire <NUM> extending through the insert <NUM> to the distal end of the cannula <NUM>, being relatively far from the tissue <NUM>, and the hook <NUM> being near or adjacent to the tissue <NUM>. Using <FIG> as the starting point, cannula <NUM> may be rotated either clockwise to the position shown in <FIG>, or counterclockwise to the position shown in <FIG>. The embodiments shown in <FIG> allow for varying degrees of contact with the electrode wire <NUM> and the desired tissue <NUM> and may improve stimulation delivery over a range of tissue diameters. The variations shown in <FIG> also provide for differences in tightness of the loop around the specified tissue <NUM>, providing optimal conditions based on user expectations.

<FIG> are schematic views of a cannula <NUM> with a single (or non-looped) electrode wire <NUM> and a hook <NUM>, <NUM>, <NUM> arranged therein. <FIG> depict different sample arrangements of the hook and slot that may be used to securely-but releasably-keep electrode wire <NUM> hooked in place when wrapped around tissue <NUM> during electrical stimulation therapy. <FIG> shows a perspective view of a hook <NUM> with an angled slot <NUM>, and <FIG> shows a cross-sectional view of the hook <NUM> with the angled slot <NUM>. In this embodiment, once electrode wire <NUM> is wrapped around tissue <NUM>, a free end of the electrode wire <NUM> is retained within the slot <NUM> provided on the hook <NUM>. The slot <NUM> is angled relative to a radial axis C of the hook <NUM>, for example, at an angle θ, as shown in <FIG>. The angle θ may be, for example, in a range of about <NUM>° to about <NUM>°.

<FIG> shows a perspective view of a hook <NUM> with a straight slot <NUM>, and <FIG> shows a cross-sectional view of the hook <NUM> with the straight slot <NUM>. In this embodiment, once electrode wire <NUM> is wrapped around tissue <NUM>, a free end of the electrode wire <NUM> is retained within the slot <NUM> provided on the hook <NUM>, and the slot <NUM> is collinear with a radial axis D of the hook <NUM>. <FIG> shows a perspective view of a hook <NUM> with a recessed slot <NUM>. In this embodiment, the hook <NUM> may be relatively shorter than the hooks <NUM>, <NUM> of the embodiments shown in <FIG>, and the insert <NUM> has a "+'-shaped divider <NUM>, dividing the distal end of the cannula <NUM> into quadrants, with the hook <NUM> extending through one quadrant. The hook <NUM> may retract into the insert <NUM>, within the cannula <NUM>, so that it is recessed within the cannula <NUM>. The hooks <NUM> and <NUM> of the embodiments shown in <FIG> may also be recessed, or shrouded, within the cannula <NUM>. Alternatively, the hooks <NUM>, <NUM>, and <NUM> of the embodiments shown in <FIG> may not be partially recessed, or shrouded, and may extend distally of the distal end of cannula <NUM>. In each of the embodiments, the arrangement of the slot <NUM>, <NUM>, <NUM> on the hook <NUM>, <NUM>, <NUM>, respectively, serves to securely retain the electrode wire <NUM>, while preventing the electrode wire <NUM> from protruding into tissue <NUM> (e.g., a nerve).

The various hook embodiments of <FIG> may be used interchangeably with any of the embodiments described above in which a hook may be included in the electrode apparatus. For example, the embodiments of <FIG> may be used in conjunction with the embodiments of <FIG>, <FIG>, or <FIG>.

In each of the embodiments shown in <FIG>, the cannula of the electrode apparatus may have an indicia, such as a marker, label, or engraving to indicate to a user the type of hook and cannula design. For example, the indicia may include descriptions including such as "SINGLE SHORT," indicating a short hook embodiment with a single electrode wire, "SINGLE TALL ANGLED," indicating a tall angled hook embodiment with a single electrode wire, "SINGLE TALL STRAIGHT," indicating a tall straight hook embodiment with a single electrode wire, "LOOP OUTER," indicating a looped electrode wire with a slot of the hook being on an outer side thereof, "LOOP INNER," indicating a looped electrode wire with a slot of the hook being on an inner side thereof, and "LOOP ANGLED," indicating a looped electrode wire with a slot of the hook being angled. Any other suitable indicia may be used, including shapes, symbols, colors, and/or numbers, for example.

In each of the embodiments in which the hook has a slot, a surgeon may wrap a free end of the electrode wire around tissue, and insert or nest the free end of the electrode wire into the slot, and then the hook may be retracted at least partially into the cannula to secure the electrode wire in the slot. This may provide a secure connection between the electrode wire and the hook, and a secure connection between the electrode wire and the tissue. Then, by extending the hook distally, the electrode wire may be released from the slot and retracted by pulling the electrode wire in a proximal direction.

<FIG> are schematic views of a distal end of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM>, and a hook <NUM> having a projection <NUM> extending radially out from a longitudinal axis of hook <NUM>. The electrode apparatus <NUM> may include other features not shown in <FIG>, including, for example, a ground wire, a handle portion, etc. In this embodiment, the hook <NUM> extends through a distal end of the cannula <NUM> when in an extended state, and retracts into the distal end of the cannula <NUM> when in a retracted state. The extension and retraction of the hook <NUM> may be controlled, for example, by the pusher rod <NUM> described above with respect to the embodiment shown in <FIG> and a handle portion with a trigger as described in embodiments above. The electrode wire <NUM> extends through a lumen of the cannula <NUM>, and extends through the distal end of the cannula <NUM>, as shown in <FIG>. The electrode wire <NUM> is in a looped configuration, so that the electrode wire <NUM> may be looped onto the hook <NUM>, as shown in <FIG>.

The looped electrode wire <NUM> may extend from a distal end of cannula <NUM>, be wrapped around a tissue <NUM>, and then placed onto the hook <NUM> (e.g., using a tool such as a forceps) and may catch on the projection portion of the hook <NUM>. The hook <NUM> may then be retracted into the cannula <NUM>, as shown in <FIG>. When the hook <NUM> retracts into the cannula <NUM>, the electrode wire <NUM> may be securely retained by the hook <NUM>. In addition, once retained by the hook <NUM>, the electrode wire <NUM> may be tightened or tensioned to ensure sufficient contact between the electrode wire <NUM> and the tissue <NUM>. The electrode wire <NUM> may be tensioned using, for example, the slide mechanism described above with respect to the embodiment shown in <FIG>, or a thumbwheel, as described in <FIG>, <FIG>, and <FIG>, or any other suitable actuator. To release the wire <NUM>, the hook <NUM> may be extended outward from the distal end of the cannula <NUM>, and the electrode wire <NUM> may be removed from the hook <NUM> by, for example, loosening of the electrode wire <NUM> via the slide mechanism or thumbwheel. Once the electrode wire <NUM> is released, the hook <NUM> and the electrode wire <NUM> may be retracted into the cannula <NUM> for removal of cannula <NUM> from a surgical site. In other embodiments, one or both of hook <NUM> and electrode wire <NUM> may remain in an extended state during removal. By virtue of the embodiment shown in <FIG>, the electrode wire <NUM> may be easily released when the hook <NUM> is in an extended state. In addition, the use of a stranded wire in this embodiment may prevent excessive force on the tissue <NUM>. In particular, a stranded wire may be more flexible and may have more "give" in it. A stranded wire may be more likely to release due to pressure placed on it by the tissue <NUM>, whereas a solid wire may be more likely to retain its shape.

<FIG> are schematic views of a distal end of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> includes a cannula <NUM>, and an electrode wire <NUM> with a ball or ferrule <NUM> at an end thereof. <FIG> shows the cannula <NUM> with the electrode wire <NUM> extending distally from a distal end, wrapping around a tissue <NUM>, and reentering the cannula <NUM> via an opening <NUM>. <FIG> shows a cut-away schematic view of the distal end of the electrode apparatus <NUM>, showing the ball <NUM> of the electrode wire <NUM> located within a cavity <NUM> of the cannula <NUM>. The cavity <NUM> may be correspondingly shaped like the ball <NUM> or may have any other suitable shape. The opening <NUM> may be narrower than the cavity <NUM> and slightly narrower than a diameter of the ball <NUM>, in order to retain the ball <NUM> of the electrode wire <NUM> within the cavity <NUM> of the cannula <NUM>. The material that forms the cannula <NUM> may have some flexibility to allow for deflection of the relatively narrower opening <NUM> and insertion of the ball <NUM> into the cavity <NUM>, while also having sufficient strength to retain the ball <NUM> within the cavity <NUM>. A release mechanism <NUM> may also be provided in the cannula <NUM>, and includes a rod <NUM> extending through the cannula <NUM> to the cavity <NUM>, as shown in <FIG>. Upon actuation of the release mechanism <NUM>, the rod <NUM> moves in a distal direction and pushes the ball <NUM> outward from the cavity <NUM>, for release of the electrode wire <NUM>. Then, the electrode wire <NUM> unwraps from the tissue <NUM>, and may be retracted into the cannula <NUM> and removed from a surgical site.

One benefit of the embodiment shown in <FIG> is that the apparatus <NUM> may be simple to assemble and thus may reduce manufacturing costs. In addition, feedback confirming removal of the ball <NUM> from the cannula <NUM> may be received due to the force of the detent of the ball <NUM> being pushed out of the cannula <NUM> by the rod <NUM>. Further, release of the ball <NUM> may be confirmed by a depth to which the rod <NUM> of the release mechanism <NUM> extends to push the ball <NUM> in a distal direction.

<FIG> are schematic views of a distal end of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> has a cannula <NUM>, an electrode wire <NUM>, and a spool mechanism <NUM>. In particular, <FIG> shows the electrode apparatus <NUM> with a coiled wire <NUM> extending from the spool mechanism <NUM> at the distal end of the cannula <NUM>. <FIG> shows a cut-away schematic view of the electrode apparatus <NUM>, showing a spool portion <NUM> of the spool mechanism <NUM>. The electrode wire <NUM> is wound around the spool portion <NUM>, such that rotation of the spool mechanism <NUM> causes rotation and translation, relative to a longitudinal axis of the cannula <NUM>, of the electrode wire <NUM>. By this configuration, rotating the spool portion <NUM>, e.g., in a direction of the arrow E, rotates the coiled electrode wire <NUM> and causes the coiled electrode wire <NUM> to translate in a distal direction, and rotating the spool portion <NUM> in an opposite direction rotates the coiled electrode wire <NUM> and causes the coiled electrode wire <NUM> to translate in a proximal direction. Thus, the coiled electrode wire <NUM> can be rotated to extend distally of the distal end of the cannula <NUM> during a surgical procedure, to thereby be wrapped around a tissue <NUM>, and can be rotated in an opposite direction to withdraw or retract proximally into the cannula <NUM>, for removal of the electrode apparatus <NUM> from a surgical site. Rotation of the spool portion <NUM> may be controlled, for example, by a knob located within the handle portion, such as the knob <NUM> of the embodiment shown in <FIG>, or with a thumbwheel or slide mechanism as described above, or another suitable actuator. The actuator may be mechanically coupled to the spool portion <NUM>. By virtue of this embodiment, an electrode apparatus <NUM> is provided in which an electrode wire <NUM> may not press into a tissue <NUM> during implantation or extraction of the electrode apparatus <NUM>.

<FIG> are schematic views of a distal end of an electrode apparatus <NUM> according to another embodiment. The electrode apparatus <NUM> includes a cannula <NUM>, an electrode wire <NUM>, and an electrode wire sleeve <NUM>, with a free end of the electrode wire <NUM> being coiled and extending from the distal end of the sleeve <NUM>. In particular, <FIG> shows a distal end of the cannula <NUM>, alongside a tissue <NUM>, with the electrode wire <NUM> extending beyond the distal end of the cannula <NUM> and wrapped around the tissue <NUM>. The electrode wire <NUM> extends through the sleeve <NUM>, and a distal end of the electrode wire <NUM> is coiled. <FIG> shows a schematic view of the electrode apparatus <NUM>, with the cannula <NUM> and the sleeve <NUM> shown in hidden lines. The electrode wire <NUM> extends from a proximal end of the cannula <NUM>, through a channel within the sleeve <NUM>, and extends distally outward from the distal end of the sleeve <NUM>. In this embodiment, only a distal-most portion of the electrode wire <NUM> is in a coiled configuration, which may be done by a surgeon wrapping the electrode wire <NUM> around a tissue <NUM> during a surgical procedure. The electrode wire <NUM> may be pulled into the channel of the sleeve <NUM> for removal of the electrode apparatus <NUM>. The electrode wire <NUM> may be relatively flexible so that, as the electrode wire <NUM> is pulled into the channel, the electrode wire <NUM> uncoils and straightens. By virtue of this embodiment, an electrode apparatus <NUM> is provided in which the electrode wire <NUM> may unravel relative to the tissue <NUM>, without pressing into the tissue <NUM>, to be easily and safely removed following electrical stimulation therapy.

<FIG> is a schematic view of a pre-coiled electrode wire <NUM> of an electrode apparatus according to one of the embodiments described above. The pre-coiled electrode wire <NUM> of this embodiment may be used, for example, in an electrode apparatus according to the embodiment shown in <FIG> or any other suitable embodiment. In particular, a portion of the electrode wire <NUM> that extends beyond a distal end of a cannula <NUM> may be wound into a coil shape, prior to placement around an end of a tissue <NUM>, rather than being wound around a tissue <NUM> during a surgical procedure. This embodiment allows for an electrode wire <NUM> formed of a material having a relatively high tensile strength. Further, the higher strength of pre-coiled electrode wire <NUM> may make it less susceptible to spring back, which may occur when the electrode wire <NUM> is bent into a particular configuration using a tool or a user's hand and, upon release of the pre-coiled electrode wire <NUM>, the wire may revert slightly from the configuration (e.g., when the electrode wire <NUM> is coiled and, upon release, the coil formed by the electrode wire <NUM> expands or loosens). Another potential benefit of this embodiment may be that a kit comprising an electrode apparatus may also include multiple pre-coiled electrode wires <NUM> having a range of coil diameters, allowing the electrode apparatus to be used on a tissues of varying sizes. In other aspects, pre-coiled electrode wires <NUM> may be sold separately.

<FIG> is a schematic view of an x-looped wire <NUM> which may be used in conjunction with any of the embodiments described above. The x-looped electrode wire <NUM> of this embodiment may be used, for example, in an electrode apparatus according to the embodiment shown in <FIG>, <FIG>, and <FIG>. As shown, the looped electrode wire <NUM> extends from a distal end of a cannula <NUM>, winds around a tissue <NUM>, and reenters the cannula <NUM> after crossing, or forming an X with, the portion of the electrode wire <NUM> just distal to the distal end of the cannula <NUM>. By virtue of this embodiment, contact between the electrode wire <NUM> and majority of the periphery or an entire periphery of the tissue <NUM> may be achieved.

In each of the embodiments of an electrode apparatus described herein, the electrode wire, as well as any other end effectors, is retractable within the cannula, and may be retracted during insertion of the cannula in a surgical site and/or removal of the cannula from a surgical site. In addition, although directions of rotation of a thumbwheel, sliding of a slider, and compression or release of a trigger are specified in the embodiments described above, the directions may vary from those described and shown. In particular, the directions of rotation of the thumbwheel, sliding of the slider, and compression or release of the trigger may be opposite to those described and shown above, in order to extend and retract the respective elements (i.e., a hook or an electrode wire). For example, a trigger mechanism, provided on the handle and operably coupled to the hook, may be configured to move the hook in one of a distal direction and a proximal direction, upon compression of a trigger of the trigger mechanism, and to move the hook in the other one of the distal direction and the proximal direction, upon release of the trigger. As another example, a slide mechanism, provided on the handle and operably coupled to the electrode wire, may be configured to move the electrode wire in one of a distal direction and a proximal direction, upon translation of a slide to a distal position within a slot, and to move the electrode wire in the other one of the distal direction and the proximal direction, upon translation of the slide to a proximal position within the slot. As still another example, a thumbwheel, provided on the handle and operably coupled to the electrode wire, may be configured to move the electrode wire in one of a distal direction and a proximal direction, upon rotation of the thumbwheel in a distal direction, and to move the electrode wire in the other one of the distal direction and the proximal direction, upon rotation of the thumbwheel in a proximal direction.

As noted above with respect to the various embodiments of the electrode apparatus, the surgical site may be closed with a small opening remaining through which the cannula passes while electrical stimulation therapy continues. Upon completion of electrical stimulation therapy, the electrode wire may be disengaged from the tissue, and the electrode wire the cannula and the electrode wire may be retracted or withdrawn through the small opening. The small opening may then be closed without requiring further surgical procedures, without requiring use of an operation room, and without requiring further involvement of a surgeon, thus reducing the overall cost and complexity of procedures including electrical stimulation therapy.

The electrode apparatus of the embodiments described herein may be disposable or reusable. In this regard, exemplary electrode apparatuses may include relatively simple mechanical connections and components, to reduce the cost of manufacturing the apparatuses.

<FIG> shows a flowchart of a method <NUM> (not encompassed by the wording of the claims) of providing electrical stimulation to a tissue using an electrode apparatus according to one or more embodiments. For example, the method <NUM> shown in <FIG> may use an electrode apparatus according to the embodiment shown in one of <FIG> and <NUM>. The method <NUM> includes a step <NUM> of placing a distal portion of a cannula in a surgical site, adjacent to the tissue. The distal portion of the cannula may be placed by a surgeon, for example. In some aspects, once the cannula is placed at the surgical site, a more proximal portion of the cannula may be secured to the patient, as described above and shown, e.g., in <FIG>.

Once placed at the surgical site, one or both of an electrode wire or a hook may be extended from the distal end of the cannula. The electrode wire may be a looped wire or a single wire. The method <NUM> further includes a step <NUM> of wrapping a distal end of the electrode wire around a periphery of the tissue. The distal end of the electrode wire may be wrapped using a tool, such as a forceps. The method <NUM> also includes a step <NUM> of engaging the distal end of the wrapped electrode wire with a hook of the electrode apparatus extending from a distal end of the cannula. This step may also be performed by a surgeon using a tool. Then, the method <NUM> includes a step <NUM> of retracting the hook, with the distal end of the electrode wire secured by the hook, into the distal end of the cannula. This step allows that the distal end of the electrode wire to be securely held in place by the hook within the cannula to promote contact with the tissue.

Next, a step <NUM> may be performed, in which electricity is supplied from an electrical supply, such as an electrical stimulation platform as described herein. This step is performed for a predetermined period of time. For example, the period of time may be in a range of about <NUM> minute to about <NUM> month, and, in particular applications, about <NUM> minute to about <NUM> minutes, or in other applications, about <NUM> hour to about <NUM> weeks, for example. During this period of time, the surgical site may be substantially closed, for example, using sutures, while a small opening in the skin of the patient remains through which the cannula remains inserted in the patient. Then, when the period of time has elapsed and supply of electricity has stopped, in a step <NUM>, the hook is extended out of the distal end of the cannula, allowing the distal end of the electrode wire to disengage from the hook. Finally, the method <NUM> includes a step <NUM> of removing the electrode wire from the tissue, and retracting the cannula from the surgical site. In some aspects, one or both of the electrode wire or the hook may be retracted into the cannula prior to retracting the cannula from the surgical site. Steps <NUM>-<NUM> may be performed by a surgeon or another medical professional, such as a nurse, after the patient has been moved out of an operating room. The small opening may then be closed.

Although the method <NUM> is described as including steps <NUM> to <NUM>, the method may include a subset of these step or additional steps.

<FIG> shows a flowchart of another method <NUM> (not encompassed by the wording of the claims) of providing electrical stimulation to a tissue using an electrode apparatus according to any of the embodiments described above. For example, the method <NUM> shown in <FIG> may use an electrode apparatus according to the embodiment shown in one of <FIG> and <FIG>. The method <NUM> includes a step <NUM> of placing a distal portion of a cannula in a surgical site, adjacent to the tissue. The distal portion of the cannula may be placed by a surgeon. In some aspects, once the cannula is placed at the surgical site, a more proximal portion of the cannula may be secured to the patient, as described above and shown, e.g., in <FIG>.

Once placed at the surgical site, one or both of an electrode wire or a hook may be extended from the distal end of the cannula. The electrode wire may be a looped or a single wire. The method <NUM> further includes a step <NUM> of wrapping a distal end of the electrode wire around a periphery of the tissue. The distal end of the electrode wire may be wrapped using a tool, such as a forceps. In an alternative embodiment, a distal portion of the electrode wire may be pre-formed in a coil, or pre-coiled, and this step may include rotating the electrode apparatus and/or the electrode wire so that the coiled portion of the electrode wire wraps around a periphery of the tissue. The method <NUM> also includes a step <NUM> of supplying electricity from an electrical supply, such as an electrical stimulation platform as described herein. This step is performed for a predetermined period of time. For example, the period of time may be in a range of about <NUM> minute to about <NUM> minutes, for example. During this period of time, the surgical site may be substantially closed, for example, using sutures, while a small opening in the skin of the patient remains through which the cannula remains inserted in the patient. Then, when the period of time has elapsed and supply of electricity has stopped, in a step <NUM>, the electrode wire is detached from the tissue and retracted into the distal end of the cannula, and the cannula is retracted from the surgical site out of the small opening in the skin. Steps <NUM> and <NUM> may be performed by a surgeon or another medical professional, such as a nurse, after the patient has been moved out of an operating room. The small opening may then be closed.

Claim 1:
An electrode apparatus (<NUM>), comprising:
a handle (<NUM>);
a cannula (<NUM>) extending from a distal end of the handle, wherein the cannula includes at least one lumen (<NUM>) therein;
a ground wire (<NUM>) extending through the cannula;
an electrode wire (<NUM>) extending through the handle, and through the cannula, the electrode wire being extendable and retractable relative to a distal end of the cannula; and
a hook (<NUM>) provided in the cannula, the hook being extendable and retractable relative to the cannula.