Patent Grant
12194291
The present disclosure is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present disclosure is also directed to implantable electrical stimulation cuff devices, as well as methods of making and using the same.
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.
One aspect is an electrical stimulation lead that includes a cuff having a cuff body having an exterior surface, an interior surface, and a circumference; 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 100 μm. In at least some aspects, each of the longitudinally elongated electrodes has a length of at least 0.5 mm. 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 20 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 0.2 mm. 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 10 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 10% of the circumference of the cuff body. In at least some aspects, the at least one radial electrodes extends around at least 75% 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 10 mm. 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 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 1 mm. In at least some aspects, adjacent pairs of the electrodes are separated by at least 0.02 mm. In at least some aspects, each of the electrodes has a length or width of at least 0.1 mm.
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.
For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein:
The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation cuff devices, as well as methods of making and using the same.
Suitable implantable electrical stimulation systems include, but are not limited to, a least one lead with one or more electrodes disposed along a distal end of the lead.
Leads include, for example, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,203,548; 7,244,150; 7,450,997; 7,596,414; 7,610,103; 7,672,734; 7,761,165; 7,783,359; 7,792,590; 7,809,446; 7,949,395; 7,974,706; 6,175,710; 6,224,450; 6,271,094; 6,295,944; 6,364,278; and 6,391,985; U.S. Patent Applications Publication Nos. 2007/0150036; 2009/0187222; 2009/0276021; 2010/0076535; 2010/0268298; 2011/0004267; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710; 2012/0071949; 2012/0165911; 2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321; 2012/0316615; and 2013/0105071; and U.S. patent application Ser. Nos. 12/177,823 and 13/750,725, all of which are incorporated by reference in their entireties.
The lead 103 can be coupled to the control module 102 in any suitable manner. In at least some embodiments, the lead 103 couples directly to the control module 102. In at least some other embodiments, the lead 103 couples to the control module 102 via one or more intermediate devices (200 in
In
The control module 102 typically includes a connector housing 112 and a sealed electronics housing 114. Stimulation circuitry 110 and an optional power source 120 are disposed in the electronics housing 114. A control module connector 144 is disposed in the connector housing 112. The control module connector 144 is configured and arranged to make an electrical connection between the lead 103 and the stimulation circuitry 110 of the control module 102.
The electrical stimulation system or components of the electrical stimulation system, including the lead body 106 and the control module 102, are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, and the like.
The lead body 106 can be made of, for example, a non-conductive, biocompatible material such as, for example, silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, and the like or combinations thereof. The lead body 106 may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. The non-conductive material typically extends from the distal end of the lead body 106 to the proximal end of the lead body 106.
Terminals (e.g., 210 in
The electrically conductive wires (“conductors”) 160 (only one of which is illustrated in
The mount 162 can be offset from the cuff 150, as illustrated in
The control module connector 144 defines at least one port into which a proximal end of the elongated device 200 can be inserted, as shown by directional arrow 212. In
The control module connector 144 also includes a plurality of connector contacts, such as connector contact 214, disposed within each port 204a and 204b. When the elongated device 200 is inserted into the ports 204a and 204b, the connector contacts 214 can be aligned with a plurality of terminals 210 disposed along the proximal end(s) of the elongated device(s) 200 to electrically couple the control module 102 to the electrodes (134 of
A lead extension connector 222 is disposed on the lead extension 224. In
In at least some embodiments, the proximal end of the lead extension 224 is similarly configured and arranged as a proximal end of the lead 103 (or other elongated device 200). The lead extension 224 may include a plurality of electrically conductive wires (not shown) that electrically couple the connector contacts 240 to a proximal end 248 of the lead extension 224 that is opposite to the distal end 226. In at least some embodiments, the conductive wires disposed in the lead extension 224 can be electrically coupled to a plurality of terminals (not shown) disposed along the proximal end 248 of the lead extension 224. In at least some embodiments, the proximal end 248 of the lead extension 224 is configured and arranged for insertion into a connector disposed in another lead extension (or another intermediate device). In other embodiments (and as shown in
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 cardio-vascular 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, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, or more helical turns. In at least some embodiments, there are at least 8, 9, 10, 11, 12, 16, 20, 25, 28, 32, 36, 40, 48, 50, 64, 80, 99, 100, 120, 128, 150, 200, 250, 256, 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 10, 20, 25, 30, 33, 40, 50, 60, 75, 80, 90, or 95 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.
For arrangements with more than one helical turn, corresponding elongated electrodes 334 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 350) 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 350).
In the illustrated embodiment, the elongated electrodes 334 of each helical turn are uniformly spaced around the circumference 351 of the cuff body. In other embodiments, the elongated electrodes 334 of each helical turn can be non-uniformly spaced around the circumference 351 of the cuff body.
In at least some embodiments, the pitch of the helical turns is no more then 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 mm. For arrangements with more than one helical turn, the helical turns can have the same or different pitches.
In addition, the cuff 350 includes a radial electrodes 358 that wraps around at least 20, 25, 30, 33, 40, 50, 60, 75, 80, 90, or 95 percent of the circumference of the cuff body 352. In the illustrated embodiment, a radial electrode 358 is disposed at both ends of the helical arrangement of elongated electrodes 334.
The cuff 350 also defines a slit 360 that extends the longitudinal length of the cuff body 352 so that the nerve can be loaded into the interior 362 of the cuff body by opening the slit to fit the cuff body over the nerve. The slit 360 is opened or initially sized to allow the target nerve (not shown) to be slipped, inserted, fed, or otherwise received into the cuff 350 such that the cuff 350 wraps around the target nerve. In at least some embodiments, the slit 360 allows the cuff 350 to be easily moved over and around the target nerve or relative to the target nerve whether rotationally or transitionally. In at least some embodiments, the slit 360 is self-sealing when the cuff 350 is positioned around the nerve.
The electrodes 334, 358 can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. In at least some embodiments, one or more of the electrodes 334 are formed from one or more of: platinum, platinum alloys such as platinum iridium, palladium alloys such as palladium rhodium, titanium, titanium alloys, nickel alloys, cobalt alloys, nickel/cobalt alloys, stainless steels, tantalum, conductive carbon, conductive plastics, epoxy, or other adhesive filled with metallic powder, Nitinol™, or the like or any combination thereof. The electrodes 334, 358 can be formed by any suitable process including, but not limited to, machining, molding (for example, powdered metal molding), photolithography, additive techniques, stamping, or the like or any combination thereof.
In at least some embodiments, the electrodes 334, 358 have a contact surface that is flush or slightly protruding (for example, no more than 200, 100, or 50 μm) from the cuff body 352 which, at least in some circumstances, may reduce or eliminate physical pressure on the nerve. It will be recognized that the electrodes can be used to provide electrical stimulation or to sense electrical signals from tissue or any combination thereof.
In at least some embodiments, the elongated electrodes 334 have a width of no more than 250, 200, 150, 100, 75, 50, 40, 30, or 25 micrometers (μm) and a length of at least 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, or more millimeters (mm). The width of the elongated electrodes corresponds to a distance in the circumferential direction 351 around the cuff body. In at least some embodiments, the length of the elongated electrodes 334 is no more than 10 mm. The length of the elongated electrodes corresponds to a distance along the longitudinal direction 353 of the cuff body. In at least some embodiments, the elongated electrodes 334 have an aspect ratio (length/width) or at least 5, 10, 20, 40, 50, 80, 100, 150, 200, or more. In at least some embodiments, each of the elongated electrodes 334 has the same width, length, and aspect ratio. In other embodiments, the elongated electrodes 334 can have different widths, lengths, or aspect ratios.
In the illustrated embodiment, each of the elongated electrodes 334 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 350. In at least some embodiments, the longitudinal offset between immediately adjacent elongated electrodes 334 is at least 0.2, 0.25, 0.3, 0.5, 0.75, 1, or 1.5 mm or more or is at least 10, 20, 25, 30, 33, 40, or 50 percent or more of the length of the elongated electrodes. In at least some embodiments, the longitudinal offset between immediately adjacent elongated electrodes 334 is no more than 3, 2.5, 2, 1.5, 1, or 0.5 mm or less or no more than 90, 80, 75, 66, 50, 40, 33, 30, 25, 20, or 10 percent or less of the length of the elongated electrodes.
In at least some embodiments, the elongated electrodes 334 and radial electrodes 358 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 334 or radial electrode 358. 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 334. One or more of the radial electrode 358 (or one or more of the elongated electrodes 334) can be selected as the counter-electrode.
The cuff body 352 can be formed of any suitable biocompatible and biostable non-conductive material including, but not limited to, polymer materials such as silicone, polyurethane, polyetheretherketone (“PEEK”), epoxy, or the like or any combination thereof. In at least some embodiments, the cuff body 352 can have a circular, oval, or any other suitable cross-sectional shape and, at least in some embodiments, may be sufficiently flexible to alter the cross-sectional shape to accommodate the nerve. In at least some embodiments, the electrodes 334, 358 can be molded with the cuff body 352 or formed by techniques such as etching or ablation of conductive layers, films, or the like. In at least some embodiments, the cuff body 352 has an inner diameter (which can correspond to the largest diameter of a non-circular cuff body) in a range of 0.5 to 5.5 mm or in a range of 1 to 3 mm. In at least some embodiments, the cuff body 352 has a length of at least 5, 10, 20, 30, 40, or 50 mm or more. In at least some embodiments, the cuff 350 is configured to fit around a portion of the vagus, splanchnic, hapatic, hypogastric, or other nerves.
In at least some embodiments, the cuff body 352 can be formed using any suitable technique including, but not limited to, molding, casting, formed in a sheet and then shaped using adhesive as a binder, formed flat and shaped using heat, formed flat and attached to a cuff-shaped scaffold, pressed, or extruded into the cuff shape, assembled by adhering sheets together, or the like or any combination thereof. In at least some embodiments, the elongated and radial electrodes 334, 358 can be attached to the cuff body 352 using any suitable technique including, but not limited to, attaching with adhesive, molding (for example, insert molding) into the cuff body, using heat to adhere the electrodes to the cuff body, heating and pressing the electrodes into the cuff body, depositing electrode material on the cuff body, and using photolithography and etching, or the like or any combination thereof.
In at least some embodiments, once the cuff 350 has been placed in a desired position relative to the target nerve, the edges of the cuff body 352 defining the slit 360 can be sutured to capture the target nerve without undesirably compressing the target nerve. In at least some embodiments, suture holes (not shown) are optionally incorporated into the edges of the cuff 350 to allow for closing or partially closing the cuff 350 around the target nerve.
In other embodiments, radial electrodes 358 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 25%, 30%, 33%, 40%, 45%, or 48% 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 352 or can extend by different amounts around the circumference of the cuff body. Each set can be identical, or the sets can have a different arrangement of radial electrodes. In at least some embodiments, the radial electrodes of a set, in combination, extend around at least 75%, 80%, 90%, or 95% of the circumference of the cuff body 352.
The electrodes 334 are arranged around the helical cuff body 352 on the interior surface 354 of the helical cuff body. Any other suitable number of electrodes can be used including, but not limited to, 8, 9, 10, 11, 12, 16, 20, 25, 28, 32, 36, 40, 48, 50, 64, 80, 99, 100, 120, 128, 150, 200, 250, 256, or more elongated electrodes in each helical turn of the helical cuff body 352. The number of electrodes 334 can be the same for each helical turn or can differ between helical turns.
In the illustrated embodiment, the electrodes 334 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 334 can have a width or length of at least 0.1, 0.2, 0.5, 0.6, 0.7, or 1 mm. In at least some embodiments, the electrodes 334 can have a width or length of no more than 2, 1.5, 1.25, 1, or 0.5 mm. In at least some embodiments, adjacent electrodes 334 along the helical cuff body 352 are separated by a distance of at least 0.02, 0.05, 0.07, or 0.1 mm.
The cuff lead 103 (
If the power source 708 is a rechargeable battery or chargeable capacitor, the power source may be recharged/charged using the antenna 710, if desired. Power can be provided for recharging/charging by inductively coupling the power source 708 through the antenna 710 to a recharging unit 736 external to the user. Examples of such arrangements can be found in the references identified above.
In at least some embodiments, electrical current is emitted by the electrodes (such as electrodes 134 in
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 738 that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor 734 is coupled to a receiver 732 which, in turn, is coupled to the antenna 710. This allows the processor 734 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 710 is capable of receiving signals (e.g., RF signals) from an external telemetry unit 740 that is programmed by the programming unit 738. The programming unit 738 can be external to, or part of, the telemetry unit 740. The telemetry unit 740 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 740 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 738 can be any unit that can provide information to the telemetry unit 740 for transmission to the electrical stimulation system 700. The programming unit 738 can be part of the telemetry unit 740 or can provide signals or information to the telemetry unit 740 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 740.
The signals sent to the processor 734 via the antenna 710 and the receiver 732 can be used to modify or otherwise direct the operation of the electrical stimulation system 700. 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 700 to cease operation, to start operation, to start charging the battery, or to stop charging the battery.
Optionally, the electrical stimulation system 700 may include a transmitter (not shown) coupled to the processor 734 and the antenna 710 for transmitting signals back to the telemetry unit 740 or another unit capable of receiving the signals. For example, the electrical stimulation system 700 may transmit signals indicating whether the electrical stimulation system 700 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 734 may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics.
The above specification provides a description of the structure, manufacture, and use of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Ser. No. 63/191,449, filed May 21, 2021, which is incorporated herein by reference.
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