Patent Description:
Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat chronic pain syndrome and incontinence, with a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients. Stimulation of the brain, such as deep brain stimulation, can be used to treat a variety of diseases or disorders.

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

<CIT> discloses a cuff electrode having a tubular body with controlled closing force.

The present invention relates to an electrical stimulation lead that includes a cuff having a cuff body having an exterior surface, an interior surface, and a circumference; a plurality of longitudinally elongated electrodes disposed on the interior surface of the cuff body and helically arranged with each of the longitudinally elongated electrodes longitudinally offset relative to any adjacent longitudinally elongated electrodes; and a longitudinal slit extending through the cuff body and further extending along an entire length of the cuff body, the longitudinal slit operable to receive a portion of a target nerve from a region outside of the cuff to within the cuff body. The lead also includes a lead body coupled to the cuff and a plurality of conductors extending through the lead body and the cuff with the conductors electrically coupled to the longitudinally elongated electrodes.

In at least some aspects, each of the longitudinally elongated electrodes has a width of no more than <NUM>. In at least some aspects, each of the longitudinally elongated electrodes has a length of at least <NUM>. In at least some aspects, the longitudinally elongated electrodes are arranged in at least one helical turn.

In at least some aspects, the longitudinally elongated electrodes are arranged in at least two helical turns. In at least some aspects, each of the helical turns includes at least eight of the longitudinally elongated electrodes. In at least some aspects, the longitudinally elongated electrodes of each of the helical turns are longitudinally aligned with corresponding ones of the longitudinally elongated electrodes of each of the other helical turns. In at least some aspects, the longitudinally elongated electrodes of at least one of the helical turns are circumferentially staggered relative to corresponding ones of the longitudinally elongated electrodes of at least one of the other helical turns.

In at least some aspects, the plurality of longitudinally elongated electrodes includes at least <NUM> of the longitudinally elongated electrodes. In at least some aspects, each of the longitudinally elongated electrodes is longitudinally offset from each adjacent one of the longitudinally elongated electrodes by at least <NUM>. In at least some aspects, each of the longitudinally elongated electrodes is longitudinally offset from each adjacent one of the longitudinally elongated electrodes by at least <NUM> percent of a length of the longitudinally elongated electrodes.

In at least some aspects, the cuff further includes at least one radial electrode extending around at least <NUM>% of the circumference of the cuff body. In at least some aspects, the at least one radial electrodes extends around at least <NUM>% of the circumference of the cuff body. In at least some aspects, at least one of the at least one radial electrodes is disposed on the cuff body is disposed at an end of the helical arrangement of the longitudinally elongated electrodes. In at least some aspects, the at least one radial electrodes includes two radial electrodes disposed at opposite ends of the helical arrangement of the longitudinally elongated electrodes. In at least some aspects, at least one of the at least one radial electrodes is disposed radially opposite of at least one of the longitudinally elongated electrodes.

In at least some aspects, the electrical stimulation lead further includes a cushioning layer disposed over the interior surface of the cuff body. In at least some aspects, the cuff body has a length of at least <NUM>. In at least some aspects, the electrical stimulation lead further includes a plurality of terminals disposed along the lead body and electrically coupled to the longitudinally elongated electrodes by the conductors.

A further aspect of the disclosure is an electrical stimulation lead that includes a cuff having a helical cuff body having an exterior surface and an interior surface and defining at least one helical turn, and electrodes disposed on the interior surface of the helical cuff body, wherein each of the at least one helical turn include at least eight of the electrodes. The electrical stimulation lead also includes a lead body coupled to the cuff and conductors extending through the lead body and the cuff with the conductors electrically coupled to the electrodes.

In at least some aspects, the helical cuff body defines at least two helical turns. In at least some aspects, each of the helical turns of the helical cuff body has a pitch of at least <NUM>. In at least some aspects, adjacent pairs of the electrodes are separated by at least <NUM>. In at least some aspects, each of the electrodes has a length or width of at least <NUM>.

Another aspect is an electrical stimulation system that includes any of the electrical stimulation described above and a control module configured to receive a portion of the lead body of the electrical stimulation lead and to electrically couple to the longitudinally elongated electrodes.

Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.

The present invention is directed to the area of implantable electrical stimulation systems.

Suitable implantable electrical stimulation systems include, but are not limited to, a least one lead with one or more electrodes disposed along a distal end of the lead. Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems with leads are found in, for example, <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT> and <CIT>.

<FIG> illustrates schematically one embodiment of an electrical stimulation system <NUM>. The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator) <NUM> and a lead <NUM> coupleable to the control module <NUM>. The lead <NUM> includes a mount <NUM> and a cuff <NUM>. The lead <NUM> includes one or more lead bodies <NUM>, an array of electrodes <NUM>, such as electrode <NUM>, and an array of terminals (e.g., <NUM> in <FIG>) disposed within the cuff <NUM> attached to the one or more lead bodies <NUM>. In at least some embodiments, the lead is isodiametric along at least a portion of the longitudinal length of the lead body <NUM>. <FIG> illustrates one lead <NUM> coupled to a control module <NUM>. Other embodiments may include two, three, four, or more leads <NUM> coupled to the control module <NUM>. In yet other embodiments, a lead <NUM> may be coupled to multiple control modules <NUM>. For example, a lead with <NUM> electrodes may be coupled to two control modules <NUM> that are capable of handling <NUM> electrodes each.

The lead <NUM> can be coupled to the control module <NUM> in any suitable manner. In at least some embodiments, the lead <NUM> couples directly to the control module <NUM>. In at least some other embodiments, the lead <NUM> couples to the control module <NUM> via one or more intermediate devices (<NUM> in <FIG>). For example, in at least some embodiments one or more lead extensions <NUM> (see e.g., <FIG>) can be disposed between the lead <NUM> and the control module <NUM> to extend the distance between the lead <NUM> and the control module <NUM>. Other intermediate devices may be used in addition to, or in lieu of, one or more lead extensions including, for example, a splitter, an adaptor, or the like or combinations thereof. It will be understood that, in the case where the electrical stimulation system <NUM> includes multiple elongated devices disposed between the lead <NUM> and the control module <NUM>, the intermediate devices may be configured into any suitable arrangement.

In <FIG>, the electrical stimulation system <NUM> is shown having a splitter <NUM> configured and arranged for facilitating coupling of the lead <NUM> to the control module <NUM>. The splitter <NUM> includes a splitter connector <NUM> configured to couple to a proximal end of the lead <NUM>, and one or more proximal tails 109a and 109b configured and arranged to couple to the control module <NUM> (or another splitter, a lead extension, an adaptor, or the like). The splitter <NUM> and splitter connector <NUM> may be part of the lead <NUM> or may be a separate component that attaches to the lead.

The control module <NUM> typically includes a connector housing <NUM> and a sealed electronics housing <NUM>. Stimulation circuitry <NUM> and an optional power source <NUM> are disposed in the electronics housing <NUM>. A control module connector <NUM> is disposed in the connector housing <NUM>. The control module connector <NUM> is configured and arranged to make an electrical connection between the lead <NUM> and the stimulation circuitry <NUM> of the control module <NUM>.

The electrical stimulation system or components of the electrical stimulation system, including the lead body <NUM> and the control module <NUM>, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like.

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

Terminals (e.g., <NUM> in <FIG>) are typically disposed along the proximal end of the lead body <NUM> of the electrical stimulation system <NUM> (as well as any splitters, lead extensions, adaptors, or the like) for electrical connection to corresponding connector contacts (e.g., <NUM> and <NUM> in <FIG>). The connector contacts are disposed in connectors (e.g., <NUM> in <FIG>; and <NUM> in <FIG>) which, in turn, are disposed on, for example, the control module <NUM> (or a lead extension, a splitter, an adaptor, or the like). Electrically conductive wires <NUM>, cables, or the like (only one of which is shown in <FIG>) extend from the terminals to the electrodes <NUM>. Typically, one or more electrodes <NUM> are electrically coupled to each terminal. In at least some embodiments, each terminal is only connected to one electrode <NUM>.

The electrically conductive wires ("conductors") <NUM> (only one of which is illustrated in <FIG> for clarity) may be embedded in the non-conductive material of the lead body <NUM> or can be disposed in one or more lumens (not shown) extending along the lead body <NUM>. In some embodiments, there is an individual lumen for each conductor. In other embodiments, two or more conductors extend through a lumen. There may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead body <NUM>, for example, for inserting a stylet to facilitate placement of the lead body <NUM> within a body of a patient. Additionally, there may be one or more lumens (not shown) that open at, or near, the distal end of the lead body <NUM>, for example, for infusion of drugs or medication into the site of implantation of the lead body <NUM>. In at least one embodiment, the one or more lumens are flushed continually, or on a regular basis, with saline, epidural fluid, or the like. In at least some embodiments, the one or more lumens are permanently or removably sealable at the distal end.

<FIG> also illustrates a mount <NUM>, part of the lead body <NUM>, coupled to cuff <NUM>. The conductors <NUM> (only one of which is illustrated in <FIG> for clarity) from within the lead body <NUM> are received in the mount <NUM>, which in turn is attached to the cuff <NUM> such that each conductor passes through the mount <NUM> for a direct electrical connection with one of the electrodes <NUM> (e.g., one conductor is electrically connected with one electrode and so on). The mount <NUM> may be attached using a variety of means such as, but not limited to, molding or adhering the mount <NUM> to the cuff <NUM>. In other embodiments, the conductors <NUM> from within the lead body <NUM> are electrically coupled to the electrodes <NUM> using jumper, intermediate or transition wires from the lead body <NUM> to the electrodes <NUM>.

The mount <NUM> can be offset from the cuff <NUM>, as illustrated in <FIG>, or in-line with the cuff or in any other suitable arrangement. Examples of cuff leads <NUM> can be found at <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT> and <CIT>.

<FIG> is a schematic side view of one embodiment of a proximal end of one or more elongated devices <NUM> configured and arranged for coupling to one embodiment of the control module connector <NUM>. The one or more elongated devices may include, for example, the lead body <NUM>, one or more intermediate devices (e.g., the lead extension <NUM> of <FIG>, an adaptor, or the like or combinations thereof), or a combination thereof. <FIG> illustrates two elongated devices <NUM> coupled to the control module <NUM>. These two elongated devices <NUM> can be two tails as illustrated in <FIG> or two different leads or any other combination of elongated devices.

The control module connector <NUM> defines at least one port into which a proximal end of the elongated device <NUM> can be inserted, as shown by directional arrow <NUM>. In <FIG> (and in other figures), the connector housing <NUM> is shown having two ports 204a and 204b. The connector housing <NUM> can define any suitable number of ports including, for example, one, two, three, four, five, six, seven, eight, or more ports.

The control module connector <NUM> also includes a plurality of connector contacts, such as connector contact <NUM>, disposed within each port 204a and 204b. When the elongated device <NUM> is inserted into the ports 204a and 204b, the connector contacts <NUM> can be aligned with a plurality of terminals <NUM> disposed along the proximal end(s) of the elongated device(s) <NUM> to electrically couple the control module <NUM> to the electrodes (<NUM> of <FIG>) disposed at a distal end of the lead <NUM>. Examples of connectors in control modules are found in, for example, <CIT> and <CIT>.

<FIG> is a schematic side view of another embodiment of the electrical stimulation system <NUM>. The electrical stimulation system <NUM> includes a lead extension <NUM> that is configured and arranged to couple one or more elongated devices <NUM> (e.g., the lead body <NUM>, an adaptor, another lead extension, or the like or combinations thereof) to the control module <NUM>. In <FIG>, the lead extension <NUM> is shown coupled to a single port <NUM> defined in the control module connector <NUM>. Additionally, the lead extension <NUM> is shown configured and arranged to couple to a single elongated device <NUM>. In alternate embodiments, the lead extension <NUM> is configured and arranged to couple to multiple ports <NUM> defined in the control module connector <NUM>, or to receive multiple elongated devices <NUM>, or both.

A lead extension connector <NUM> is disposed on the lead extension <NUM>. In <FIG>, the lead extension connector <NUM> is shown disposed at a distal end <NUM> of the lead extension <NUM>. The lead extension connector <NUM> includes a connector housing <NUM>. The connector housing <NUM> defines at least one port <NUM> into which terminals <NUM> of the elongated device <NUM> can be inserted, as shown by directional arrow <NUM>. The connector housing <NUM> also includes a plurality of connector contacts, such as connector contact <NUM>. When the elongated device <NUM> is inserted into the port <NUM>, the connector contacts <NUM> disposed in the connector housing <NUM> can be aligned with the terminals <NUM> of the elongated device <NUM> to electrically couple the lead extension <NUM> to the electrodes (<NUM> of <FIG>) disposed along the lead (<NUM> in <FIG>).

In at least some embodiments, the proximal end of the lead extension <NUM> is similarly configured and arranged as a proximal end of the lead <NUM> (or other elongated device <NUM>). The lead extension <NUM> may include a plurality of electrically conductive wires (not shown) that electrically couple the connector contacts <NUM> to a proximal end <NUM> of the lead extension <NUM> that is opposite to the distal end <NUM>. In at least some embodiments, the conductive wires disposed in the lead extension <NUM> can be electrically coupled to a plurality of terminals (not shown) disposed along the proximal end <NUM> of the lead extension <NUM>. In at least some embodiments, the proximal end <NUM> of the lead extension <NUM> is configured and arranged for insertion into a connector disposed in another lead extension (or another intermediate device). In other embodiments (and as shown in <FIG>), the proximal end <NUM> of the lead extension <NUM> is configured and arranged for insertion into the control module connector <NUM>.

Conventional cuff leads include a cuff that wraps around a portion of a nerve with one or more electrodes arranged on the cuff. In many conventional cuff leads, the individual electrodes also wrap around at least a portion of the circumference of a nerve in a radial wrap arrangement. The radial wrap arrangement of the electrodes typically results in stimulation of a circumferential region of the nerve.

In contrast to conventional cuff leads with radial electrodes, cuff leads can include longitudinally elongated electrodes in a helical arrangement for stimulation of nerves. In at least some embodiments, the cuffs can be useful to provide differential internal organ stimulation or control by stimulating nerves leading to those organs. Differential organ control can be useful for providing therapy for disorders of, for example, the cardiovascular system, the pulmonary system, the gastrointestinal system, the urinary system, and other internal organ systems.

In at least some embodiments, a nerve cuff with a helical arrangement of elongated electrodes can produce diameter-selective stimulation of the vagus or other nerves. In at least some instances, diameter-selective vagus nerve stimulation can be used for differential control of specific internal organs. In at least some embodiments, positioning the elongated electrodes in a helical arrangement can facilitate sensing of nerve impulses. In at least some embodiments, as compared to conventional stimulation cuffs, positioning the electrodes in a helical arrangement can provide a larger surface area from an electrical diagonal slice of the nerve between two selected electrodes for stimulation. In at least some embodiments, the cuff lead can be used to block nerve impulses to or from an organ or other body structure.

A cuff lead can include a cuff body that wraps around a nerve and further include longitudinally elongated electrodes in a helical arrangement on the interior surface of the cuff body. The helical arrangement can include any suitable number of full or partial helical turns helical turns including, but not limited to, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more helical turns. In at least some embodiments, there are at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more elongated electrodes in each helical turn with partial helical turns including a corresponding fraction of the number of elongated electrodes.

In at least some embodiments, the cuff may also include one or more radial electrodes that can be used as a counter-electrode to one or more selected elongated electrodes. In at least some embodiments, a radial electrode extends around at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent of a circumference of the cuff body. In at least some embodiments, a radial electrode can be disposed at one or both ends of the helical arrangement of elongated electrodes. In at least some embodiments, one or more radial electrodes can be positioned radially opposite one or more of the elongated electrodes. In at least some embodiments, one or more of the elongated electrodes can be used as a cathode(s) and one or more of the radial electrodes can be used as an anode(s). Any other suitable selection of cathode(s) or anode(s) from the elongated or radial electrodes can be used.

<FIG> illustrates one embodiment of a cuff <NUM> of a cuff lead <NUM> (<FIG>). The cuff <NUM> includes a cuff body <NUM> with longitudinally elongated electrodes <NUM> disposed on an interior surface <NUM> of the cuff body and arranged around the circumference of the cuff body in a helical arrangement. In the illustrated embodiment, the helical arrangement includes <NUM> elongated electrodes <NUM> arranged in two helical turns. Any other suitable number of electrodes can be used including, but not limited to, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more elongated electrodes in each helical turn. The number of elongated electrodes <NUM> can be the same for each helical turn or can differ between helical turns. In at least some embodiments, the elongated electrodes <NUM> can be arranged in a double or triple helix.

For arrangements with more than one helical turn, corresponding elongated electrodes <NUM> of each helical turn (e.g., the first elongated electrodes of helical turn) can be longitudinally aligned (e.g., aligned along a single longitudinal line parallel to the longitudinal axis of the cuff <NUM>) with each other or can be circumferentially staggered with respect to each other (e.g., not aligned along a single longitudinal line parallel to the longitudinal axis of the cuff <NUM>).

In the illustrated embodiment, the elongated electrodes <NUM> of each helical turn are uniformly spaced around the circumference <NUM> of the cuff body. In other embodiments, the elongated electrodes <NUM> of each helical turn can be non-uniformly spaced around the circumference <NUM> of the cuff body.

In at least some embodiments, the pitch of the helical turns is no more then <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. For arrangements with more than one helical turn, the helical turns can have the same or different pitches.

In addition, the cuff <NUM> includes a radial electrodes <NUM> that wraps around at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent of the circumference of the cuff body <NUM>. In the illustrated embodiment, a radial electrode <NUM> is disposed at both ends of the helical arrangement of elongated electrodes <NUM>.

The cuff <NUM> also defines a slit <NUM> that extends the longitudinal length of the cuff body <NUM> so that the nerve can be loaded into the interior <NUM> of the cuff body by opening the slit to fit the cuff body over the nerve. The slit <NUM> is opened or initially sized to allow the target nerve (not shown) to be slipped, inserted, fed, or otherwise received into the cuff <NUM> such that the cuff <NUM> wraps around the target nerve. In at least some embodiments, the slit <NUM> allows the cuff <NUM> to be easily moved over and around the target nerve or relative to the target nerve whether rotationally or transitionally. In at least some embodiments, the slit <NUM> is self-sealing when the cuff <NUM> is positioned around the nerve.

The electrodes <NUM>, <NUM> can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. In at least some embodiments, one or more of the electrodes <NUM> are formed from one or more of: platinum, platinum alloys such as platinum iridium, palladium alloys such as palladium rhodium, titanium, titanium alloys, nickel alloys, cobalt alloys, nickel/cobalt alloys, stainless steels, tantalum, conductive carbon, conductive plastics, epoxy, or other adhesive filled with metallic powder, Nitinol™, or the like or any combination thereof. The electrodes <NUM>, <NUM> can be formed by any suitable process including, but not limited to, machining, molding (for example, powdered metal molding), photolithography, additive techniques, stamping, or the like or any combination thereof.

In at least some embodiments, the electrodes <NUM>, <NUM> have a contact surface that is flush or slightly protruding (for example, no more than <NUM>, <NUM>, or <NUM>) from the cuff body <NUM> which, at least in some circumstances, may reduce or eliminate physical pressure on the nerve. It will be recognized that the electrodes can be used to provide electrical stimulation or to sense electrical signals from tissue or any combination thereof.

In at least some embodiments, the elongated electrodes <NUM> have a width of no more than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> micrometers (µm) and a length of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more millimeters (mm). The width of the elongated electrodes corresponds to a distance in the circumferential direction <NUM> around the cuff body. In at least some embodiments, the length of the elongated electrodes <NUM> is no more than <NUM>. The length of the elongated electrodes corresponds to a distance along the longitudinal direction <NUM> of the cuff body. In at least some embodiments, the elongated electrodes <NUM> have an aspect ratio (length/width) or at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more. In at least some embodiments, each of the elongated electrodes <NUM> has the same width, length, and aspect ratio. In other embodiments, the elongated electrodes <NUM> can have different widths, lengths, or aspect ratios.

In the illustrated embodiment, each of the elongated electrodes <NUM> is longitudinally offset from the immediately adjacent elongated electrodes by a uniform amount. In other embodiments, the longitudinal offset between immediately adjacent elongated electrodes can be vary along the cuff <NUM>. In at least some embodiments, the longitudinal offset between immediately adjacent elongated electrodes <NUM> is at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> or more or is at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent or more of the length of the elongated electrodes. In at least some embodiments, the longitudinal offset between immediately adjacent elongated electrodes <NUM> is no more than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> or less or no more than <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent or less of the length of the elongated electrodes.

In at least some embodiments, the elongated electrodes <NUM> and radial electrodes <NUM> are rectangular or rectangular with rounded corners. Any other suitable shape can be used for the elongated electrodes including, but not limited to, oblong, oval, modified rectangular with one or more sides (or portions of sides) that are curved, or the like or any combination thereof. The length and width measurements described above correspond to the longest or widest portion of the elongated electrode <NUM> or radial electrode <NUM>. For example, for an oval electrode, the length along the major axis of the oval corresponds to the length measurement and the length along the minor axis corresponds to the width measurement.

Stimulation can be performed using one or more of the elongated electrodes <NUM>. One or more of the radial electrode <NUM> (or one or more of the elongated electrodes <NUM>) can be selected as the counter-electrode.

The cuff body <NUM> can be formed of any suitable biocompatible and biostable non-conductive material including, but not limited to, polymer materials such as silicone, polyurethane, polyetheretherketone ("PEEK"), epoxy, or the like or any combination thereof. In at least some embodiments, the cuff body <NUM> can have a circular, oval, or any other suitable cross-sectional shape and, at least in some embodiments, may be sufficiently flexible to alter the cross-sectional shape to accommodate the nerve. In at least some embodiments, the electrodes <NUM>, <NUM> can be molded with the cuff body <NUM> or formed by techniques such as etching or ablation of conductive layers, films, or the like. In at least some embodiments, the cuff body <NUM> has an inner diameter (which can correspond to the largest diameter of a non-circular cuff body) in a range of <NUM> to <NUM> or in a range of <NUM> to <NUM>. In at least some embodiments, the cuff body <NUM> has a length of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> or more. In at least some embodiments, the cuff <NUM> is configured to fit around a portion of the vagus, splanchnic, hapatic, hypogastric, or other nerves.

In at least some embodiments, the cuff body <NUM> can be formed using any suitable technique including, but not limited to, molding, casting, formed in a sheet and then shaped using adhesive as a binder, formed flat and shaped using heat, formed flat and attached to a cuff-shaped scaffold, pressed, or extruded into the cuff shape, assembled by adhering sheets together, or the like or any combination thereof. In at least some embodiments, the elongated and radial electrodes <NUM>, <NUM> can be attached to the cuff body <NUM> using any suitable technique including, but not limited to, attaching with adhesive, molding (for example, insert molding) into the cuff body, using heat to adhere the electrodes to the cuff body, heating and pressing the electrodes into the cuff body, depositing electrode material on the cuff body, and using photolithography and etching, or the like or any combination thereof.

In at least some embodiments, once the cuff <NUM> has been placed in a desired position relative to the target nerve, the edges of the cuff body <NUM> defining the slit <NUM> can be sutured to capture the target nerve without undesirably compressing the target nerve. In at least some embodiments, suture holes (not shown) are optionally incorporated into the edges of the cuff <NUM> to allow for closing or partially closing the cuff <NUM> around the target nerve.

<FIG> illustrates another embodiment of a cuff <NUM> with a cuff body <NUM> and <NUM> longitudinally elongated electrodes <NUM> arranged in a single helical turn. The cuff <NUM> includes two radial electrodes 358a, 358b that are circumferentially offset (and, in the illustrated embodiment, circumferentially opposite) from one or more of the elongated electrodes <NUM>.

<FIG> illustrates another embodiment of a cuff <NUM> with a cuff body <NUM> and <NUM> longitudinally elongated electrodes <NUM> arranged in a single helical turn. The cuff <NUM> includes one radial electrode <NUM> at one end of the helical arrangement.

In other embodiments, radial electrodes <NUM> can be arranged in a set of two or more radial electrodes disposed around the circumference of the cuff body with each of the radial electrodes extending around less than half the circumference of the cuff body (for example, at least <NUM>%, <NUM>%, <NUM>%, <NUM>%, <NUM>%, or <NUM>% of the circumference of the cuff body). It will be understood that each set can include, for example, two, three, four, six or more radial electrodes (or any other number of radial electrodes). The radial electrodes of a set can extend a same amount around the circumference of the cuff body <NUM> or can extend by different amounts around the circumference of the cuff body. Each set can be identical, or the sets can have a different arrangement of radial electrodes. In at least some embodiments, the radial electrodes of a set, in combination, extend around at least <NUM>%, <NUM>%, <NUM>%, or <NUM>% of the circumference of the cuff body <NUM>.

<FIG> illustrates yet another embodiment of a cuff <NUM> with a helical cuff body <NUM> in the form of a helix. A lead body <NUM> (<FIG>) can be attached to an end of the helical cuff body <NUM> or the exterior surface <NUM> of the helical cuff body. In at least some embodiments, the helical cuff body <NUM> has a width <NUM> of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In at least some embodiments, the helical cuff body <NUM> has a width <NUM> of no greater than <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. The helical cuff body <NUM> can include any suitable number of full or partial helical turns helical turns including, but not limited to, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more helical turns. In at least some embodiments, the pitch of the helical turns of the helical cuff body <NUM> is no more then <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. For arrangements with more than one helical turn, the helical turns can have the same or different pitches.

The electrodes <NUM> are arranged around the helical cuff body <NUM> on the interior surface <NUM> of the helical cuff body. Any other suitable number of electrodes can be used including, but not limited to, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or more elongated electrodes in each helical turn of the helical cuff body <NUM>. The number of electrodes <NUM> can be the same for each helical turn or can differ between helical turns.

In the illustrated embodiment, the electrodes <NUM> have a square or rectangular shape, but any other suitable shape can be used including, but not limited to, circular, oval, triangular, rhomboid, hexagonal, octagonal, irregular, or the like. In at least some embodiments, the electrodes <NUM> can have a width or length of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In at least some embodiments, the electrodes <NUM> can have a width or length of no more than <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In at least some embodiments, adjacent electrodes <NUM> along the helical cuff body <NUM> are separated by a distance of at least <NUM>, <NUM>, <NUM>, or <NUM>.

<FIG> illustrates a cross-section of a cuff <NUM> disposed around a nerve <NUM> with the elongated electrodes <NUM> arranged around the circumference of the cuff and vagus nerve. In at least some embodiments, the interior surface <NUM> of the cuff body <NUM> can be coated with a cushioning layer <NUM> to act as a cushion to reduce damage to the nerve. Examples of materials for the cushioning layer <NUM> include, but are not limited to, paraffin, a combination of isotonic saline and artificial cerebrospinal fluid, polyethylene glycol, or the like or any combination thereof. The cushioning layer <NUM> is made of a material that permits flow of current from the electrodes <NUM> to the nerve through the cushioning layer.

The cuff lead <NUM> (<FIG>) can be coupled to one or more control modules <NUM> (<FIG>). When the cuff lead <NUM> has many elongated electrodes <NUM>, multiple control modules <NUM> may be used to independently control the elongated electrodes <NUM>. Additionally or alternatively, multiplexing techniques and arrangements can be used to provide stimulation to selected elongated electrodes <NUM>. Multiplexing arrangements may be part of the control module <NUM>, cuff lead <NUM>, or a separate module or the like or any combination thereof. Examples of multiplexing and of independent control and delivery of stimulation through selected electrodes can be found in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; and <CIT> and <CIT>.

<FIG> is a schematic overview of one embodiment of components of an electrical stimulation arrangement <NUM> that includes an electrical stimulation system <NUM> with a lead <NUM>, stimulation circuitry <NUM>, a power source <NUM>, and an antenna <NUM>. The electrical stimulation system can be, for example, any of the electrical stimulation systems described above. It will be understood that the electrical stimulation arrangement can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein.

If the power source <NUM> is a rechargeable battery or chargeable capacitor, the power source may be recharged/charged using the antenna <NUM>, if desired. Power can be provided for recharging/charging by inductively coupling the power source <NUM> through the antenna <NUM> to a recharging unit <NUM> external to the user. Examples of such arrangements can be found in the references identified above.

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

Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an external programming unit <NUM> that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor <NUM> is coupled to a receiver <NUM> which, in turn, is coupled to the antenna <NUM>. This allows the processor <NUM> to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired.

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

The signals sent to the processor <NUM> via the antenna <NUM> and the receiver <NUM> can be used to modify or otherwise direct the operation of the electrical stimulation system <NUM>. For example, the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct the electrical stimulation system <NUM> to cease operation, to start operation, to start charging the battery, or to stop charging the battery.

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

Claim 1:
An electrical stimulation lead (<NUM>) comprising:
a cuff (<NUM>) comprising
a cuff body (<NUM>) having an exterior surface, an interior surface, and a circumference,
a plurality of longitudinally elongated electrodes (<NUM>) disposed on the interior surface of the cuff body (<NUM>) and helically arranged with each of the longitudinally elongated electrodes (<NUM>) longitudinally offset relative to any adjacent longitudinally elongated electrodes, and
a longitudinal slit (<NUM>) extending through the cuff body (<NUM>) and further extending along an entire length of the cuff body, the longitudinal slit (<NUM>) operable to receive a portion of a target nerve from a region outside of the cuff to within the cuff body;
a lead body (<NUM>) coupled to the cuff (<NUM>); and
a plurality of conductors (<NUM>) extending through the lead body (<NUM>) and the cuff (<NUM>) with the conductors (<NUM>) electrically coupled to the longitudinally elongated electrodes (<NUM>).