NZ730945B2 - Nerve cuff electrode for neuromodulation in large human nerve trunks - Google Patents

Abstract

nerve cuff electrode is disclosed. The nerve cuff electrode comprises a self-curling nerve cuff with a plurality of conductive nerve contact segments. The segments have an inner surface configured to contact a nerve trunk and an outer surface configured not to contact the nerve trunk. The nerve cuff electrodes comprise at least one wire of a conductive biocompatible material operatively connecting the plurality of conductive nerve contact segments thus forming a segmented strip. The wire is configured as helical portions separated by non-helical portions where the non-helical portions are secured to the surface of the conductive nerve contact segments configured not to contact the nerve trunk. The nerve cuff electrode comprises a conductive lead capable of operatively connecting a waveform generator to at least one of the plurality of nerve contact segments. The helical structure of the wire improves durability and flexibility of the cuff electrode. ff electrodes comprise at least one wire of a conductive biocompatible material operatively connecting the plurality of conductive nerve contact segments thus forming a segmented strip. The wire is configured as helical portions separated by non-helical portions where the non-helical portions are secured to the surface of the conductive nerve contact segments configured not to contact the nerve trunk. The nerve cuff electrode comprises a conductive lead capable of operatively connecting a waveform generator to at least one of the plurality of nerve contact segments. The helical structure of the wire improves durability and flexibility of the cuff electrode.

Description

NERVE CUFF ELECTRODE FOR NEUROMODULATION IN LARGE HUMAN NERVE TRUNKS This application is related to pending US. Patent ation Serial No. 14/276,200 filed May 13, 2014; which is a continuation of US. Patent Application Serial No. 13/474,926 filed May 18, 2012 now US. Patent No. 8,731,676; which claims priority to US. Patent Application Serial No. 61/487,877 filed May 19, 2011, each of which is expressly incorporated by reference herein in its entirety.

A nerve cuff ode with a ity of segmented platinum contacts connected by at least one wire made of durable and biocompatible tive material fashioned in a helical uration. In embodiments, two such wires fashioned in a helical configuration provided ancy. The helical configuration increased the durability of the interconnections relative to a lical wire or a straight wire. The inventive nerve cuff electrode provided enhanced durability, lasting on the order of 1,000,000 cycles of compression of up to 50% of diameter followed by uncompression to original diameter, compared to standard electrodes that disintegrated or broke after compression cycles on the order of 100,000 cycles. Durability is a particular problem, solved by the inventive apparatus and , when electrodes in use are used on relatively large nerve trunks in the lower extremities, generally defined as a nerve trunk having a er of 3 mm or greater. This is due to repeated ng, wrinkling, and/or breaking along their length, ng for example when the nerve trunk is repeatedly flattened and compressed during a patient’s daily activities.

The inventive nerve cuff electrode comprises a plurality of conductive nerve contact segments, with the segments having an inner surface contacting a nerve trunk and an outer surface not contacting the nerve trunk; at least a single wire of a conductive biocompatible material operatively connecting the plurality of tive nerve contact segments thus g a segmented strip, the wire configured as helical portions separated by non-helical portions where the non-helical portions are d to the surface of the conductive nerve t segments not contacting the nerve trunk; and a conductive lead capable of operatively connecting a waveform generator to at least one of the plurality of nerve contact segments. The wire helical portions are along the wire length between the conductive nerve contact segments, and the wire non-helical portions are secured to the tive nerve contact segments by a plurality of spot welds. The wire helical portions are embedded in a non-conductive material. The helical portions are separated by non-helical portions that connects the conductive nerve contact ts. A second wire may ively connect the plurality of nerve contact segments, with the second wire generally parallel with the first wire. In one embodiment, the conductive nerve contact segments are platinum, the wires are stainless steel, and the non-conductive al is silicone.

In one embodiment the nerve cuff electrode comprises a plurality of platinum nerve contact segments, each nerve contact segment comprising an inner surface contacting a nerve trunk and an outer surface not contacting the nerve trunk; at least two wires of a conductive biocompatible material operatively connecting the plurality of platinum nerve contact ts thus forming a segmented strip, the wires configured as helical portions ted by non-helical portions where the non-helical portions connect to the surface of the um nerve contact segments not contacting the nerve trunk by a plurality of spot welds, the wires embedded in a ne sheet such that only the inner surface of the platinum nerve contact segments contacts the nerve trunk; and a conductive lead e of operatively connecting a waveform generator to one of the ity of platinum nerve contact segments.

One embodiment is a method of increasing durability of a nerve cuff electrode by operatively ting a plurality of segmented conductive contacts of the electrode with at least a single wire thus forming a ted strip, the wire configured as helical portions separated by non-helical portions where the non-helical gap portions are secured to the surface of the conductive contacts. In this embodiment, the helical portions permit repeated electrode deformations, e.g., s, wrinkles, andlor breaks, without breaking. The segmented conductive contacts result in decreased stress on contacts.

One embodiment is a method of using a segmented nerve cuff electrode to ameliorate sensory nerve pain in a t in need thereof. In this embodiment, a waveform generator is operatively connected to the inventive electrode in contact with a trunk of a sensory peripheral nerve having a diameter exceeding 3 mm and up to 12 mm, e.g., a sciatic nerve or a tibial nerve. In use, the method prevents action potential transmission in the nerve upon application of a waveform of at least 5 kHz up to 50 kHz at one of a voltage ranging from 4 Vpp to 20 Vpp, or a current g from 4 mApp to 26 mApp at a plurality of contact surfaces with the nerve trunk for an interval sufficient to effect substantially ate pain relief in the patient. The steps can be repeated as needed to rate nerve pain. The electrode contacting the nerve can be mono-, bi-, or tri-polar. The electrode cuff inner diameter may range from about 5 mm to about 12 mm. The method may also be applied to an ilioinguinal nerve to ameliorate post-surgical hernia pain, to an intercostal nerve to ameliorate pain from shingles, to a sciatic nerve to ameliorate neuropathic diabetes pain, and to an occipital nerve to ameliorate migraine pain.

One embodiment is a method of using a segmented nerve cuff electrode to effect a desired response in a patient using the above-described method. The desired response may rating spasticity of a muscle ted by the nerve, where the patient experiences spasticity amelioration substantially immediately upon application of the electrical waveform.

The desired response may be ameliorating an urge to void the bladder and the patient experiences urge ration substantially immediately upon ation of the electrical waveform, and the nerve contacted may be a pelvic nerve.

Successful s are disclosed from a method and apparatus that uses high frequency nerve block to acutely treat peripheral pain, either acute pain or chronic pain (more than 6 months in duration), in humans by blocking nerve conduction on an action potential.

Acute treatment is defined as on demand treatment with substantially immediate pain relief effect. In one embodiment, the method is used in peripheral nerves having a diameter up to about 12 mm, i.e., in relatively large nerves such as the sciatic nerve. In one embodiment, the method is used on a nerve to ameliorate a non-pain condition by therapy to a nerve, e.g., motor nerves resulting in spasticity, e.g., nerves providing an urge to void in overactive bladder.

Previous therapy for pain of eral origin, e.g., damaged nerves in a limb, consisted of one or a combination of the following methods.

One previous therapy was local injection of a pharmacologic anesthetic such as lidocaine. The therapeutic effect often lasts only a short time, e.g., a few hours. Repeated dosing is typically not feasible because of toxicity of the anesthetic and other reasons.

Another previous therapy was conventional ical stimulation by surface electrodes or ally implanted electrodes (e.g., TENS, Peripheral Nerve and Spinal Cord Stimulator). Electrical stimulation therapy is used to treat back pain and joint pain, but produces inconsistent effects. The inconsistencies are due to the indirect nature of the therapy; d of blocking pain signals from the origin of the pain, this type of electrical stimulation activates non-pain sensory nerves to generate other types of sensation (e.g., tingling) that mask the pain sensation. Such masking is by a complex, and often unreliable, ction of various parts of the nervous system.

A potential therapy involves reversibly blocking peripheral nerves by applying high frequency alternating current ly on a nerve trunk. Specifically, a current ranging from 5 kHz to 50 kHz was applied; this was denoted as high frequency, compared to a current of less than 1 kHz applied in the conventional electrical ation bed above. Efficacy of the high frequency alternating current y in acute non-human animal experiments (frog, cat) has been ed. US. Patent Nos. 7,389,145 and 8,060,208 describe in general this electrical stimulation technology. No data are described.

One embodiment of the invention discloses a method for reversibly blocking an action potential in a peripheral nerve having a diameter exceeding 3 mm and up to about 12 mm, e.g., a sciatic nerve, a tibial nerve, etc., in a patient in need thereof. The method comprises providing an electrical waveform for an interval of time sufficient to effect substantially immediate pain relief, defined generally as within about 10 min. One embodiment uses a waveform ranging from 5 kHz to 50 kHz. One embodiment uses a 10 kHz sinusoidal waveform at a current g from 4 mApp to 26 mApp. The electrode can be retained in a cuff encircling the desired peripheral nerve in which the action potential is to be blocked; the cuff inner diameter may range from about 5 mm to about 12 mm. The time interval may be about 10 minutes, but an interval may be ed by a magnitude sufficient to effect pain relief in the t. In one ment, the electrical waveform to effect pain relief ranges from a voltage from 4 Vpp to 20 Vpp, or a current ranging from 4 mApp to 26 mApp. The time of increasing magnitude can range from about 10 seconds to about 60 s with a steady ramp up of voltage or current. The waveform is provided by a waveform generator that is operatively connected to the electrode implanted in the patient; such methods are known in the art.

One embodiment is a device that reversibly blocks an action potential in a relatively large nerve, Le, a nerve with a diameter exceeding about 3 mm and up to 12 mm. The apparatus has a self-curling sheet of non-conductive material that includes a first layer, which is pre-tensioned, and a second layer, which is not pre-tensioned. The two layers are configured to form a cuff containing or holding strips of conducive material therebetween. ln embodiments, the device has one, two, three, four or more ted strips of a conductive al that are disposed adjacent, but not transverse, to one longitudinally extending edge of the self-curling sheet, each of these strips of conductive material is connected to an ically conductive lead. In one embodiment, the device contains one strip of a conductive material, termed a monopolar configuration. In one embodiment, the device contains at least two segmented strips, connected by an electrically conductive lead, of a tive material, termed a bipolar configuration. In one embodiment, the device contains at least three segmented strips, connected by an electrically conductive lead, of a conductive material, termed a tripolar configuration. In one ment, the device contains at least four segmented , connected by an electrically conductive lead, of a conductive material.

Multiple apertures, typically circular but not necessarily so limited in shape, are disposed at periodic intervals of the inner nerve-contacting surface along the curling length of one of the two non-conductive sheets or layers of the self-curling sheet / cuff. This provides contact to the nerve by exposing and providing continuous multiple conductive contact . The exposure may be at any interval that exposes as much of the conductive material as possible or desirable, and exceeds the contact surface area of conventional electrodes. Each of the first or top nductive sheet or layer and the second or bottom non-conductive sheet or layer still retains and contains the conductive material therebetween, i.e., sandwiched inside the sheets or layers, so that the conductive al is in fact retained and does not pop out or come out while providing efficient current ry. In one embodiment the non-conductive material is silicone, the electrically conductive lead is stainless steel, and the conductive material is platinum. Other materials for each of the non-conductive material, the electrically conductive lead or wire, and the conductive material are known in the art. In use, the device is operatively connected, e.g., by an external lead or wire, to a waveform generator that provides the regulated waveform.

One embodiment is a method for treating peripheral nerve pain in a t in need of this treatment. The described device encircled a particular segment of a targeted peripheral nerve, e.g., a sciatic nerve, a tibial nerve. Using a patient-implanted electrode connected to an electrical rm generator, an electrical waveform is applied for a time interval, e.g., 10 min, ient to effect substantially immediate patient pain , e.g., within min, and an extended period of pain relief up to l hours. The current in one embodiment ranges from 4 mApp to 26 mApp, and in one embodiment ranges from 4 mApp to 26 mApp.

Implementation of electrical nerve block or activation in patients for pain management or other ions often requires a direct interfacing device with peripheral nerves in the form of a cuff wrapping around a nerve trunk.

US. Patent No. 8,731,676 discloses a bipolar nerve cuff electrode with two continuous platinum strips ed in a silicone substrate used to wrap around a nerve trunk. However, ge of the platinum strips was found where a larger nerve trunk and/or certain anatomical characteristics (such as short stumps in above-knee amputees) were encountered. Inspections of explanted electrodes revealed that the platinum strips situated around the nerve trunk were wrinkledfcreased or broken along their length due to repeated bending when the nerve trunk was compressed and ned during daily activities.

Realizing platinum is of low mechanical strength despite its superior biocompatibility and electrical characteristics for charge delivery, a design was conceptualized with multiple segmented platinum contacts and each segment connected with wires made of a durable and biocompatible conductive material, e.g., stainless steel (88). The total surface area of all of the platinum contacts was equivalent to that ofa continuous strip by increasing the width to compensate for the gaps between the ts.

The configuration of the wire interconnection establishes the durability and flexibility of the cuff electrode. Specifically and in one embodiment, a 7-strand of 316LVM wire was wound into a helix. A gap was created along the helix er it overlaps with a platinum t. Conventional spot welding was used for connecting the wire to the platinum contact.

In embodiments, two wire helices lying in parallel were employed to provide redundancy. The helices were entirely embedded in the silicone sheeting and only the outer side of the platinum contacts was exposed to the surface of the nerve trunk.

Relative to prior electrodes, the ive segmented nerve cuff electrode had extended durability under repeated compression. Enhanced durability was demonstrated by subjecting electrodes to repetitive cycles of compressions of up to 50% of original diameter followed by ression to original er, and testing for continuity across segments.

Cuffs incorporating continuous platinum strips ent ssion cycles on the order 1,000,000 cycles and remained intact.

In the inventive method, data from a human study using high ncy electrical nerve block technology for pain management are provided. In one embodiment, the result was that amputation pain was d. Application of 10 kHz alternating current generated by a custom generator via a custom implanted nerve electrode icantly reduced pain in the majority of patients treated by the . The ed voltage / current level is reported. The duration for achieving reliable pain relief in specific human nerves is reported.

The required sequence and time to apply the electrical energy to minimize side effects is reported. The anticipated accompanying sensations and their time course is reported. The duration of pain relief after ation of the electrical current is reported. The cumulative effect of successive applications of the current on the extent of pain reduction is reported.

The apparatus was an implantable electrode operatively connected to an al or implanted waveform generator. The electrode was a spiral cuff electrode similar to that described in US. Patent No. 4,602,624, more fully described below. In use, the electrode was implanted in a human mammal on a desired peripheral nerve trunk proximal to the pain source (e.g., a neuroma), such that the cuff led the desired peripheral nerve in which the action potential was to be blocked. The cuff inner diameter ranged from about 5 mm to about 12 mm. The sciatic nerve is known to have a relatively large nerve trunk; the diameter of the proximal part of the sciatic nerve in a human adult is about 12 mm. In one embodiment, the apparatus and method was used on the sciatic nerve to treat limb pain in above knee amputees. In one embodiment, the tus and method was used on the tibial nerve to treat limb pain in below knee amputees.

BRIEF DESCRIPTION OF THE DRAWINGS is a ctive view of an external rm generator and interconnection cable. shows an in-use implanted waveform generator operably connected to a nerve cuff electrode encircling a patient’s nerve.

FIGS. 3A, 3B are a photograph on the implanted cuff and electrode, and a confirmatory fluoroscopy image of same, respectively. schematically shows the nerve cuff electrode and lead. graphs one patient’s pain relief comparing use of the invention versus drug treatment. graphs one patient’s pain intensity and pain relief using the invention. shows a general schematic of a tripolar electrode in an uncurled configuration; shows one embodiment of with specific dimensions. tabulates treatment es from five patients. shows a schematic of a lead and a nerve cuff electrode in an uncurled configuration incorporating a segmented contact strip and lead. shows a detailed tic view of a segmented contact strip.

FIGS. 11A and 11B show tic views of an apparatus to assess durability of a nerve cuff electrode.

In use, the external and ted waveform generator, shown in FIGS 1 and 2 respectively, delivered high frequency alternating current in any form (sinusoidal wave, rectangular, other shape) sufficient to block the nerve action potential. In use, the operator ively regulated the amount of t applied to the electrode, the duration, and any other desired parameters (e.g., continuous versus intermittent), etc. for therapy. In one ment, a sinusoidal rm frequency of 10 kHz effectively and repeatedly reduced pain. In one embodiment, a sinusoidal waveform frequency ranging from 20 kHz to 30 kHz effectively reduced pain, but required about two times higher voltage and higher current for a kHz sinusoidal waveform, and about three times higher voltage and higher current for a 30 kHz sinusoidal waveform, compared to that required for a 10 kHz sinusoidal waveform.

Using a idal waveform frequency of 10 kHz, ts reported a sensation threshold at a voltage ranging from 1 Vpp to 10 Vpp, and at a current ranging from 1 mApp to 16 mApp. The sensation threshold was the minimum stimulation at which a patient indicated that s/he feels a sensation due to the applied current, e.g., a patient may feel a tingling sensafion.

Indication of a sensation old does not indicate pain relief, which is defined broadly as any pain mitigation or amelioration including but not limited to complete pain relief.

Using a sinusoidal waveform of 10 kHz, the patient's relief from pain was achieved at a voltage ranging from 4 Vpp to 20 Vpp, and at a current ranging from 4 mApp to 26 mApp.

The interval between the two ters (the voltage 1 current required to be applied to achieve a sensation threshold, versus the voltage 1 current required to be applied to achieve pain relief) was optimally achieved by a conservative steady ramping up over a range from about 10 seconds to about 60 seconds. This minimized or prevented the patient from experiencing pain or other undesirable sensations at the outset of therapy.

In one embodiment, the electrode was implanted on the tibial nerve, as shown in FIG 3A. Proper tation was verified by fluoroscopy visualization, as shown in .

In one of five patients experiencing pain post lower-limb amputation, the extent of baseline pain intensity and relief of this pain by a self-administered narcotic pill were compared to the extent of each of ne pain intensity and relief of this pain using the disclosed nerve block apparatus and method was ssessed over a 21 consecutive day period. The patient ssessed pain ity using a 0-10 scale where 0 is no pain and 10 is as bad as it could be. The narcotic was hydrocodone/APAP formulated as a tablet at a dose of 10 mg / 325 mg. The patient dministered the tablet orally as needed.

When self-administering the electrical nerve block therapy, the parameters over which the patient did not have control were the amount of current applied, and the duration of each administration period. The parameters over which the patient did have control were the ) during the 24 hour period to dminister the therapy, and the time interval between the administrations. In one embodiment, each ent was for 10 minutes. In one embodiment, one dministered electrical treatment for 10 minutes was immediately followed by at least one additional self-administered electrical treatment for 10 minutes to result in cumulative pain reduction effect. The amount of current / voltage applied during each interval ranged from 4 mApp to 26 mApp / 4 Vpp to 20 Vpp, respectively.

Specific selected data for each of two patients are shown in FIGS. 5 and 6 respectively. A summary of the results for all of the five patients is shown in The patients reported that they experienced pain mitigation within minutes of treatment onset. The patients reported that sensations such numbness, tingling, and pulling, subsided within minutes after treatment onset. The patients reported that, after a 10 min treatment cation of electrical blocking current), they experienced pain reduction that was sustained up to several hours after cessation of treatment.

A description of various ments of the electrode used for nerve conduction block is as follows. They differ from the use of the apparatus disclosed in Naples US. Patent No. 4,602,624. Naples' electrode is used to stimulate, i.e., excite, activate, generate, an action potential in a nerve having a diameter of about 1 mm to about 3 mm. In Naples, four sets of rectangular-shaped electrodes constitute the contact points that are ched between two layers of a non-conductive material such as silicone. The layers of non- conductive material were self-curling. The conductive contact points were disposed at uniform intervals therebetween at sites on the inner circumference of a first ently extensible layer. The conductive contact points are connected by conductive wires or leads, e.g., stainless steel wires. The layers have gs (windows) in the non-conductive material to expose the conductive contact points to the nerve upon selective regulation, in this case, tion to initiate an action potential. The distance between the openings (separation distance) and curling length of the layers is proportional to the nerve diameter.

In attempting to block an action potential in nerves having a diameter exceeding about 3 mm, the previously bed apparatus and method is inadequate. This is because a simple scale-up of the aforementioned design did not permit adequate current flow that is necessary to block tion of an action potential in a nerve that has a relatively larger diameter as compared to a typical nerve which has a diameter that does not exceed about 3 mm. For example, the sciatic nerve in an adult human has a diameter exceeding about 3 mm; it can be up to 12 mm diameter. The sciatic nerve is a frequent source of pathology and often requires therapy. The inventive method was used on nerves having a diameter exceeding about 3 mm for nerve conduction block.

In one embodiment the inventive method was used on nerves having a diameter between about 1 mm and about 8 mm. In one embodiment the inventive method was used on nerves having a diameter between about 3 mm and about 10 mm. In one ment the inventive method was used on nerves having a diameter between about 8 mm and about 12 mm. In one embodiment the inventive method was used on nerves having a diameter up to about 12 mm. The ive method blocked an action ial in a nerve, including the sciatic nerve, and thus rated andfor mitigated peripheral nerve pain. The inventive method was not used to generate an action potential in a nerve; rather, it was used to block conduction of an action ial. Blocking conduction of an action potential in a nerve, versus stimulating an action potential in a nerve, requires higher current, and hence lower resistance, at the interface n the nerve and the electrode. The inventive method used a generator that advantageously provided adequate voltage with lower power consumption.

The inventive method thus zed thermal damage to tissue from heat that was ted during its use, while providing improved efficiency.

In all embodiments, the electrode had a relatively larger contact surface with the nerve than conventional electrodes, such as ’ electrode. As only one illustrative example used in the inventive method, the apertures were spaced at an interval ranging from 0.5 mm up to 1.9 mm. In one embodiment, the apertures were spaced at 1.0 mm intervals, defined as a center-to-center dimension between oring apertures.

As shown in an external waveform generator 10 had an electrode connector operatively connected with cable 25, having connector 13, LED indicator 15, and on / off indicator 17. As shown in use in FIGS. 2, 3, and 4, nerve cuff electrode 50 had conductive material 51 contained in self-curling sheet 53 and lead 25 to connect to the waveform generator 10. As best shown in FIGS. 7A, 7B, the conductive al 51 was both contained and retained within an implantable expandable spiral cuff 52, shown in The cuff 52 provided the flexibility required for use to contact and regulate nerves having a diameter exceeding about 3 mm and up to about 12 mm, and provided a non-rigid t surface with the nerve in order to minimize tissue damage.

In one embodiment, shown in general and in one specific embodiment shown in , the electrode contained continuous strips of conductive material 51, ically platinum in , in a sandwich configuration, with two opposing surfaces or sheets of a non-conductive material 53, specifically silicone in , along the entire length of the non- conductive material 51. The non-conductive material 53 was self-curling. To provide points of contact of tive material 51 with the nerve, around which the cuff 52 was implanted, openings or apertures 57 were d in one surface of the non-conductive material 53 at periodic intervals 59. The spacing of the intervals 59 is such that the conductive material 51 was contained and retained within the non-conductive material 53 during use, i.e., the non- conductive material does not pop out or come out, and provides sufficient exposure of the conductive material 51 for electrical contact with the nerve. In one ment, the openings 57 were created at 1 mm intervals. In one ment, the openings 57 were created at intervals ranging between about 1 mm to about less than 2 mm. The openings 57 were created in the non-conductive al 53; it was at these openings 57 that the nerve was exposed to the conductive material 51 in order to block tion of an action potential. In a bi- or lar embodiments, the ce or spacing between strips is 1 : 1 depending upon the nerve size to be treated; larger sized nerves can accommodate larger space between the strips. In , for each electrode, the strip length with conductive material contacts 70 is shown for each of leads or wires A, B, and C. This electrode design achieved efficient current delivery to effect this blockage of the action potential. This electrode design contained and retained the conductive material 51 within the two layers of non-conductive material 53.

In one ment, shown in general in FIGS. 9 and 10, the lead 25 was ively connected to a urling nerve cuff 54 with a segmented strip 56 of conductive material 51, such as platinum. Each segmented strip 56 was formed ofa plurality of contact segments 58 operatively connected by wire 60, made of a durable and conductive biocompatible material such as stainless steel (SS), to form a lly linear string of the contact segments 58. The total surface area of all of the t segments 58 may be equivalent to that of a continuous contact strip by sing the width of the segments 58 to compensate for the spaces 59 therebetween.

Such wire 60 was wound into a helix 62, with gaps 64 therein to accommodate attachment to the contact segments 58 by conventional spot welds 66. In one embodiment, the stainless steel wire is 7-strand 316LVM wire. The helical structure of the wire 60 es durability and ility of the cuff ode by enhancing the ability of segmented strip 56 to curl about the nerve trunk in cooperation with the nerve cuff 54 by allowing the segmented strip 56 to wrap about the nerve trunk by the wire 60 without significantly bending, wrinkling, or creasing the contact segments 58 themselves. The helical structure of the wire 60 is well-suited to absorb stresses introduced by conformational changes of the nerve trunk as the patient conducts daily ties, e the helixes 62 of the wire 60 can bend and axially expand or compress in response to such environmental s without impacting the t segments 58 themselves.

In one embodiment, two el wires 60 were used to connect the contact segments 58 to provide redundancy in case one wire failed. The helixes 62 are entirely embedded in non-conductive al 53, such as silicone sheeting, such that only the side of the contact segments 58 opposite the helixes 62 is exposed to the surface of the nerve trunk.

In the embodiments shown in FIGS. 9 and 10, the nerve cuff 54 includes two segmented strips 56 of conductive material 51 disposed adjacent, but not transverse, to one longitudinally extending edge of the self-curling sheet, where each of these strips 56 is ted to the electrically conductive lead 25 (a bipolar configuration). However, the nerve cuff 54 may alternately n only one segmented strip 56 (monopolar), or three (tripolar), four, or more segmented strips 56 as suitable for the particular application.

Although the disclosed segmented strips are bed in the context of reversibly blocking an action potential in large human nerve trunks, the utility of the disclosed segmented strips 56 is broadly applicable to other nerve stimulation and/or blocking contexts, as well as to a variety of other applications where it is desirable to wrap an electric contact surface about an outer e of a target substrate, e.g., for contact with a large nerve trunk for restoring motor or sensory function. The dimensions of the segmented strips 56, wire(s) 60, and other components are scalable. lity for one embodiment of the inventive electrode with segmented strips 56 was assessed compared to durability of an electrode with continuous strips. The electrode with segmented strips 56 included a conductive band of segmented platinum contacts connected by a stainless steel helix. The electrode with continuous strips included a conductive band of a continuous platinum strip. In each case, the respective cuff 72 was wrapped around a length of le rubber tubing 74 of 3 mm to 12 mm diameter, g as a ate nerve trunk to form a cuff-tube assembly 76 (FIGS. 11A-B). The cuff-tube assembly 76 was mounted n two parallel plates 78, 80 configured to move relative to each other to compress and decompress the assembly 76.

For each assessment, the cuff-tube assembly 76 was repeatedly compressed and decompressed between the plates 78, 80 between an uncompressed state (A), where assembly 76 has er D, and a compressed state (B), where assembly 76 has ssed diameter D'). The cuff-tube assembly 76 was compressed by 30%-50%, i.e., at % compression, D' = 0.7 x D, and at 50% compression, D' = 0.5 x D. Compressions were performed at 200 cycles per minute. During these assessments, the cuff-tube assembly 76 was mounted at different orientations about the longitudinal axis of the assembly 76 to test the durability of the cuff 72 under stress from various directions. The electrical continuity of the conducting band within the cuff 72 was continuously monitored by a data acquisition system.

The cuff with continuous strips failed, i.e. electrical continuity was disrupted, after an e of 143,667 cycles at 30% compression, and after 16,000 cycles at 50% compression.

In contrast, the cuff with segmented strips , in two cases, after 000 and 3,590,000 cycles at 50% ssion, and in another case after ~4,600,000 cycles including 1.40 million cycles at 30% compression and 3.18 n cycles at 50% compression. In other cases, testing terminated without failure after several million cycles at 50% ssion.

Consider Table 1, below: Continuous 16,000 Segmented 30% for 1.40M 000 Segmented 30% for 1.19M >5,100,000* Segmented >4,030,000* Segmented >4,030,000* * Test terminated before failure These testing data demonstrated that the cuff with segmented strips is at least -five times more durable than the cuff with continuous strips. Cuffs with continuous strips, currently used in clinical practice, typically show breakage in clinical applications as early as six months after implantation. Patients thus must regularly seek further professional care to replace damaged cuffs. Thus, the disclosed cuff with ted strips significantly increases the useful life of devices into which it is incorporated, thereby decreasing the procedures, cost, and inconvenience to patients having such implanted devices.

In one embodiment, the curled configuration of the apparatus had a er of 10 mm with a 1.5 wrap, g that one half of the circumference contained a single sandwiched sheet (i.e., 2 layers) of non-conductive material 53, and the other 1.5 wrap of the circumference contained two sandwiched sheets (i.e., 4 layers) of non-conductive al 53.

Any wrap resulting in a compliant, flexible cuff that does not damage the nerve may be used.

The interpolar distance was about 0.75 times to 1.5 times the inner cuff diameter. The contact surface area was relatively larger than the contact surface area of conventional electrodes, such as the electrode Naples sed for nerve stimulation and activation, safely delivered the required higher amount of charge to block the nerve action potential, even in nerves up to 12 mm in er.

In one embodiment, the electrode was bipolar. In another embodiment, the electrode used three contact groups, i.e., tripolar. In this embodiment, the electrode contained three continuous strips of conductive material, connected by electrically conductive leads (A, B, C in FIGS. 7A, 78), that was provided between the two opposing non-conductive surfaces in the same manner as described above for two continuous strips of conductive material. The tion, i.e., distance, between the two, three, or more conductor bands is a function of the diameter of the cuff. The ratio of separation : diameter ranged between 0.75 : 1.5.

The above-described electrode blocked us nerve fascicles and/or nerve fibers. The ge was reversible; the cuff was implantable along any length of nerve at any site, and electrical parameters (current, voltage, duration, etc.) were selected by the operator. In one embodiment, the recipient of the implantable apparatus is the operator. In one embodiment, a health care professional is the operator. Use of the electrode results in lower resistance at the interface between the nerve and the electrode. Such multiple points of contact, and vely large openings, s the electrode to block at least one portion of the nerve trunk. In the ment with a tripolar configuration, the electrode can be used to first block at least one portion of the nerve trunk, and then stimulate the other portion to verify blockage.

The inventive method has use in a variety of pain and non-pain applications. One embodiment uses the method and electrode to block eral nerve pain. Besides use to ameliorate amputation pain, the uses and description of which was previously described, other examples of ameliorating pain e, but are not limited to, ameliorating neuropathic pain, nociceptive pain, c neurogenic pain, migraine pain, post-herpetic neuralgia, pelvic pain, chronic post-surgical pain, urgical pain, and neuralgia. As known in the art, pain is defined as an unpleasant sensation caused by noxious stimulation of the sensory nerve endings. Amputation pain is pain ing from the surgical removal of a part of the body or a limb or a part of a limb to treat for therapy resulting from, 9.9., pathology, trauma, etc.

Neuropathic pain is pain that results from the direct inputs of nervous tissue of the peripheral or central nervous system, lly felt as burning or tingling and often occurring in an area of sensory loss. Nociceptive pain is pain that results from stimulation of the neural ors for painful stimuli, i.e., inputs of nociceptors. Chronic neurogenic pain is pain that originates in the nervous system and persists overtime (i.e., not acute but chronic). Migraine pain result in headaches and is related to dilation of extracranial blood vessels, the origin of which may be defined (e.g., consumption of certain foods, external i) or may be unknown. Post- herpetic neuralgia is a form of neuralgia with intractable pain that develops at the site of a previous eruption of herpes zoster. Pelvic pain is pain that is centered in the pelvis region i.e. lower part of the trunk of the body. Chronic post-surgical pain is pain persisting for a long period of time beginning after treatment of disease or trauma by lative and operative methods. Post-surgical pain is pain beginning after treatment of disease or trauma by manipulative and ive methods. Neuralgia is pain, often severe and characterized as "stabbing", resulting from any number of nervous system pathologies or disorders.

In other ments, the inventive method is used in in applications where blocking the action potential of a nerve provides the desired ration outcome. One example of such a non-pain use is in ameliorating obesity. As known in the art, obesity is an abnormal increase in the proportion of fat cells, mainly in the viscera and subcutaneous tissues. The inventive method may be used on the vagus nerve in this embodiment. Another example of such a non-pain use in ameliorating overactive bladder, which is a colloquial term for bladder storage function disorders or ogies. The method and electrode can be used on the pelvic nerve to ameliorate the sudden urge to void that may be difficult to suppress and may lead to incontinence. Another example of such a non-pain use is in ameliorating spasticity of any motor nerve; spasticity results in excessive muscle contraction and can be due to any of several nervous system disorders. The following hypothetical examples illustrate these embodiments.

A patient with advanced type 2 es is experiencing neuropathic pain in his feet as a result of loss of blood flow to his legs. Normal doses of pain-killing narcotics are either ineffective or cause undesirable side effects. After implantation of the electrode and placement of the cuff on the right sciatic nerve trunk at the popliteal fossa, the patient self- treats pain for 10 minutes at 10 mApp, experiencing ate pain relief. The patient repeats the procedure on demand, as needed.

A migraine patient experiences severe headaches unresponsive to conventional treatment. After implantation of the electrode and placement of the cuff on the greater occipital nerve trunk, the patient self-treats pain for 10 minutes at 10 mApp, experiencing immediate pain relief. The patient repeats the procedure on demand, as needed.

A t with shingles experiences postherpetic neuralgia, unresponsive to conventional treatment. After implantation of the electrode and placement of the cuff on the ostal nerves, the t self-treats pain for 10 minutes at 10 mApp, experiencing immediate pain relief. The patient repeats the ure on , as needed.

A post-operative inguinal hernia repair patient experiences chronic pain. After implantation of the electrode and placement of the cuff on the ilioinguinal nerve, the patient self-treats pain for 10 s at 10 mApp, experiencing immediate pain relief. The patient repeats the procedure on demand, as .

A patient with overactive bladder syndrome undergoes a procedure for implantation of the electrode and placement of the cuff on the pelvic nerve. The patient self-treats at 10 mApp upon an urge to urinate, experiencing urge cessation.

A patient with muscle spasticity undergoes a procedure for implantation of the electrode and placement of the cuff on a motor nerve. The patient self-treats at 10 mApp when needed, ameliorating spasticity of the muscle to which the nerve ates The embodiments shown and described are specific embodiments of inventors who are skilled in the art and are not limiting in any way. Therefore, various s, modifications, or alterations to those embodiments may be made without departing from the spirit of the ion in the scope of the ing claims. The nces cited are expressly incorporated by reference herein in their entirety.

Claims (11)

What is claimed is:

1. A nerve cuff electrode comprising a urling nerve cuff with a plurality of conductive nerve contact segments, the segments having an inner surface configured to contact a nerve trunk and an outer surface configured not to contact the nerve trunk; at least one wire of a conductive biocompatible material operatively connecting the plurality of conductive nerve contact segments thus forming a segmented strip, the wire configured as helical portions separated by non-helical portions where the lical portions are secured to the surface of the conductive nerve contact segments configured not to contact the nerve trunk; and a conductive lead capable of operatively connecting a waveform generator to at least one of the plurality of nerve contact segments.

2. The ode of claim 1 where the wire helical portions are along the wire length between the tive nerve contact segments.

3. The electrode of claim 1 where the wire non-helical portions are secured to the conductive nerve contact segments by a plurality of spot welds.

4. The electrode of claim 1 where the wire helical portions are embedded in a nonconductive material.

5. The electrode of claim 1 where the wire lical portion connects the tive nerve t segments.

6. The electrode of claim 1 further comprising a second wire operatively connecting the plurality of nerve contact segments, the second wire generally el with the first wire.

7. The electrode of claim 1 where the conductive nerve contact segments are platinum.

8. The electrode of claim 1 where the wires are stainless steel.

9. The electrode of claim 4 where the non-conductive material is silicone.

10. The electrode of claim 1 comprising at least two wires of a conductive biocompatible material operatively connecting the plurality of platinum nerve contact segments thus forming a ted strip, the wires configured as helical portions separated by non-helical portions where the non-helical portions connect to the surface of the um nerve contact segments configured not to t the nerve trunk by a plurality of resistive welds, the wires embedded in a silicone sheet such that only the inner surface of the platinum nerve contact ts are configured to contact the nerve trunk; and a conductive lead capable of operatively ting a rm generator to one of the plurality of platinum nerve contact segments.

11. A method of increasing durability of a nerve cuff electrode, the method comprising operatively connecting, on a self-curling nerve cuff, a plurality of segmented conductive contacts of the electrode with at least one wire thus forming a ted strip, the wire configured as helical portions separated by non- helical portions where the non-helical gap portions are secured to the surface of the conductive contacts. Neuros Medical, Inc By the Attorneys for the Applicant SPRUSON & FERGUSON Per: