WO2017100522A1

WO2017100522A1 - Reversible compressive neuromodulator

Info

Publication number: WO2017100522A1
Application number: PCT/US2016/065746
Authority: WO
Inventors: William M. RIEDEL; Charles J. II RIEDEL; Charles J. RIEDEL
Original assignee: Riedel William M; Riedel Charles J Ii
Priority date: 2015-12-10
Filing date: 2016-12-09
Publication date: 2017-06-15

Abstract

A device and method are provided for altering neurologic function by applying reversible and variable compressive forces to neural tissue. The device can be implanted using a minimally invasive surgical technique. The device can be turned on and off and adjusted by telemetry, as needed for symptom control. The device contains an internal mechanism housed within an enclosure. The internal mechanism can be controlled through application of an external magnet, which enables control of pressure applied to a nerve or portion thereof. A bar constrained within a slot can be utilized to enable vertical movement and compress or decompress the targeted nerve. A specific dissector and applier are also described.

Description

REVERSIBLE COMPRESSIVE NEUROMODULATOR

FIELD OF THE INVENTION

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of prior U.S. Provisional Patent Application No. 62/265,531, filed December 10, 2015, which is incorporated in its entirety by reference herein.

[0002] The present invention relates to a compressive device and method that act on a nerve to alleviate or control excessive sweating, vascular tone and/or pain.

BACKGROUND OF THE INVENTION

[0003] Neuromodulation, in its broadest sense, encompasses a variety of technologies that are used to alter neurological function. The alterations produced may ameliorate symptoms from many human diseases and conditions. Modulatory technologies have targeted the central nervous system (brain and spinal cord), the peripheral nervous system, or the autonomic nervous system, particularly its sympathetic component.

[0004] Current neuromodulation techniques are dominated by devices employing electrical current to stimulate the nervous system for therapeutic alteration of function. Other devices infuse pharmacologic agents to modify neural function. The two main methods of neuromodulation widely used today are electrical stimulation and drug infusion devices. Electrical stimulation of the spinal cord is employed to treat chronic neck, back, and limb pain. Stimulation of deep brain nuclei, known as deep brain stimulation or DBS combats the symptoms of Parkinson's disease, essential tremor, dystonia, and obsessive-compulsive disorder (OCD). Peripheral nerve stimulation can be used to treat epilepsy when the vagal nerve is targeted and a variety of painful conditions such as headaches in which the occipital nerve may be stimulated.

[0005] Drug infusion devices attempt to give medication to specific target tissues and thus reduce systemic effects. An example of this is intrathecal therapy in which a drug is infused into the spinal fluid. Pain medications given in this manner at very low doses can treat severe pain, such as from cancer, with less overall side effects.

[0006] Compression is used as a surgical procedure by applying vascular clips to nerves. Unfortunately the effect of this operative technique cannot be turned on or off and is inconsistently reversible. Typically a second operation to remove the clips, usually within the first few weeks of the primary surgery, is required.

[0007] Accordingly, with electrical neuromodulation, electrical stimulation can be problematic due to malfunctioning issues that can occur, short circuiting, battery life if batteries are used, and the inability to immediately achieve neuromodulation. With chemical treatments such as drug infusion, besides the use of drugs which can typically have side effects on the patient, drug infusion also generally does not provide neuromodulation quickly and further, the ability to reverse neuromodulation with drugs is nearly impossible from a timing point of view. In other words, a drug infusion does not permit one to readily stop neuromodulation. Accordingly, there is a need in this medical field of neuromodulation to provide a device that can provide neuromodulation techniques or treatment that avoids the disadvantages that are present with electrical and chemical treatments.

SUMMARY OF THE INVENTION

[0008] A feature of the present invention is to provide a non-electrical and non-chemical device for neuromodulation. [0009] A further feature of the present invention is to provide a device and method that can be readily and easily used by a patient or other user to control neuromodulation.

[0010] An additional feature of the present invention is to provide a device and method that can be easily controlled with regard to the amount or degree of neuromodulation, especially in a rapid and controllable way.

[0011] An additional feature of the present invention is to provide a device that does not face the same operational complexities that an electrical neuromodulation device faces.

[0012] Additional features and advantages of the present invention will be set forth in part in the description that follows, and in part will be apparent from the description, or may be learned by practice of the present invention. The objectives and other advantages of the present invention will be realized and attained by means of the elements and combinations particularly pointed out in the description and appended claims.

[0013] To achieve these and other advantages, and in accordance with the purposes of the present invention, as embodied and broadly described herein, the present invention relates to a device and method that use compressive forces to enable reversible alteration of nervous system function, providing an alternative to the hazards of electrical stimulation such as cardiac arrhythmias and inconsistent responses. The device and method offer an alternative to the irreversibility of destructive surgical techniques such as excision or ablation of the sympathetic chain and resulting permanent side effects such as compensatory sweating. The device and method provide compression to alter neurologic function in a way that is reversible, adjustable, and can be turned on and off as warranted by symptoms and/or patient activity. Two endoscopic instruments, a right angle dissector, and an applier can optionally be used to permit proper placement.

[0014] The present invention further relates to a compressive neuromodulator that includes a housing that at least partially defines a nerve channel configured to accommodate at least a portion of a nerve;

an axle held by and within the housing;

a rotatable disc within the housing, mounted on the axle, and configured for rotation about the axle, the rotatable disc comprising an annular rim having a thickness in an axial direction relative to the rotatable disc, which continuously increases along an arc length of the rotatable disc;

a sliding bar within the housing and configured to be engaged by the annular rim such that rotation of the rotatable disc about the axle causes the sliding bar to move in a direction parallel to the axle, the sliding bar defining a surface of the nerve channel; and

a bracket within the housing and having a slot formed therein, the sliding bar being captured in the slot and configured for sliding movement within the slot, wherein rotation of the rotatable disc causes movement of the sliding bar within the slot and the movement of the sliding bar causes a cross-sectional area of the nerve channel to set a nerve channel size depending on the location of the rotatable disc. Thus, the nerve channel can increase or decrease in size depending on the directional rotation of the rotatable disc.

[0015] Also, the present invention relates to a compressive neuromodulator system that includes

a housing that at least partially defines a nerve channel configured to accommodate at least a portion of a nerve;

a magnetically controllable nerve compressor configured to move under the influence of an externally applied magnetic field and operably positioned within the housing to press against the portion of the nerve when the portion is disposed in the nerve channel; and a magnetic controller configured to apply an external magnetic field for controlling movement of the magnetically controllable nerve compressor.

[0016] Furthermore, the present invention relates to a system that includes the compressive neuromodulator and a remote telemetry controller.

[0017] Also, the present invention relates to a method of applying a compressive force to a nerve, that includes positioning a portion of a nerve in the nerve channel of the compressive neuromodulator and applying an external magnetic field to cause movement of the magnetically controllable nerve compressor such that magnetically controllable nerve compressor exerts a compressive force against the portion of the nerve.

[0018] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and intended to provide a further explanation of the present invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present invention will be more fully understood with reference to the appended drawings that are intended to illustrate, not limit, the present invention.

[0020] FIG. 1A is a front, right perspective view of a compressive neuromodulator according to one or more embodiments of the present invention.

[0021] FIG. IB is a right-side view of the compressive neuromodulator of FIG. 1 A.

[0022] FIG. 1C is a top view of the compressive neuromodulator of FIGS. 1 A and IB.

[0023] FIG. ID is a front view of the compressive neuromodulator shown in FIGS. 1 A-1C.

[0024] FIG. IE is a back view of the compressive neuromodulator shown in FIGS. 1 A-1D. [0025] FIG. 2A is a bottom, right perspective view of the compressive neuromodulator shown in FIGS. 1 A- IE, wherein the housing is shown transparently so that the internal mechanism can be seen.

[0026] FIG. 2B is a right-side view of the compressive neuromodulator with transparent housing, shown in FIG. 2A.

[0027] FIG. 2C is a top view of the compressive neuromodulator with transparent housing, shown in FIGS. 2A-2B.

[0028] FIG. 2D is a front view of the compressive neuromodulator with transparent housing, shown in FIGS. 2A-2C.

[0029] FIG. 2E is a left-side view of the compressive neuromodulator with transparent housing, shown in FIGS. 2A-2D.

[0030] FIGS. 3A-3D are a right-side view, left-side view, front view, and rear view, respectively, of the internal mechanism of the compressive neuromodulator shown in FIGS. 1A- 2E.

[0031] FIG. 3E is a rear, right-side, top perspective view of the internal mechanism shown in FIGS. 3A-3D.

[0032] FIG. 3F is a rear, left-side top perspective view of the internal mechanism shown in FIGS. 3A-3E.

[0033] FIG. 3G is a bottom, right-side perspective view of the internal mechanism shown in FIGS. 3A-3F.

[0034] FIGS. 4A-4D are a right-side view, left-side view, rear view, and front view, respectively, of the rotatable disc of the internal mechanism shown in FIGS. 3A-3G. [0035] FIGS. 4E and 4F are a bottom view and top view, respectively, of the rotatable disc shown in FIGS. 4A-4D.

[0036] FIG. 4G is a bottom, front perspective view of the rotatable disc shown in FIGS. 4A-4F.

[0037] FIG. 4H is a bottom, rear perspective view of the rotatable disc shown in FIGS. 4A-4G.

[0038] FIGS. 5A-5D are a right-side top perspective view, top view, front view, and right-side view, of a first bracket of the internal mechanism shown in FIGS. 3A-3G.

[0039] FIGS. 6A-6D are a right-side top perspective view, top view, front view, and right-side view, of a second bracket of the internal mechanism shown in FIGS. 3A-3G.

[0040] FIGS. 7A-7C are a right-side top perspective view, side view, and top view, respectively, of the axle of the internal mechanism shown in FIGS. 3A -3G.

[0041] FIGS. 8A-8C are a front top perspective view, side view, and top view, respectively, of the sliding bar of the internal mechanism shown in FIGS. 3A-3G.

DETAILED DESCRIPTION OF THE INVENTION

[0042] The sympathetic nervous system mediates a diverse spectrum of pathological conditions whose symptoms are potentially amenable to neuromodulatory techniques. Raynaud's phenomena, a vasoconstrictive condition affecting the fingers, complex regional pain syndromes, and hyperhidrosis or excessive sweating are all sympathetic mediated conditions that have been treated by disrupting the normal sympathetic pathways, both pharmacologically and surgically. The present invention provides a device and method for treating sympathetically mediated conditions, which method is intermittent and reversible, compressive rather than destructive or ablative, minimally invasive, and/or allows return of normal neurologic function, all under direct control of the patient if desired. The device and method are not limited to the sympathetic nervous system, but are also applicable to the central and peripheral nervous system. [0043] The reversible compressive neuromodulator of the present invention can have two major components. The first component is an internal, completely enclosed mechanism that is magnetically based, controllable by telemetry, and applies compressive forces to a sympathetic chain via a slot and bar mechanism. The bar slides in the slot and can be moved to apply adequate force to a nerve to temporarily preclude its function. The slot and bar mechanism is encased in a second component that comprises a housing. The housing can be a snap-closure housing with membrane opening. For instance, the housing can comprise a snap-closure housing and a membrane tunnel that surrounds a sympathetic chain and enables compression of the chain.

[0044] The internal mechanism can comprise or consist of five parts. A central rod axis can be included to which all other parts of the internal mechanism can be attached. Two pieces can be used to form the slot guide and the internal mechanism can also comprise a compressive bar and a magnetized disc that can rotate to apply variable and controlled pressure on the bar and, as a result, on the sympathetic chain. A pressure exceeding 120 mm Hg or 2 PSI can be applied which essentially blocks blood flow to the chain (e.g., a pressure from 0.01 PSI to 2.5 PSI (such as 0.1 PSI to 2 PSI, 0.5 PSI to 1.75 PSI, or 1 PSI to 2 PSI) or higher can be applied to a nerve).

[0045] The housing can be designed for easy, minimally invasive application and closure. It stabilizes the central axis and also contains a baseplate that allows for more uniform compression of the nerve. The housing can be completely enclosed to prevent fluid or scar tissue from contacting the internal mechanism, which could otherwise interfere with proper functioning.

[0046] In more detail, the reversible compressive neuromodulator can include two major components: a) an external enclosure or housing that maintains the nerve in proper position relative to the bar-in-slot compressor, preventing fluid and soft tissue from contacting the internal mechanism, and b) a magnetic compression mechanism. These components are described in more detail below, as are the dissector and applier for implantation.

[0047] The external enclosure can have a clamshell shape, hinged opposite the bar-in-slot portion of the mechanism. It also serves as the anchor points for the central axis of the internal mechanism. There is a baseplate that fits beneath the nerve and limits its downward displacement, insuring reproducible compressive forces. At the non-hinged end of the device, a tunnel can be provided to contain the nerve or portion thereof. The tunnel can be or include or be formed by a soft and flexible casing that will allow for adequate compression and decompression.

[0048] The compressive neuromodulator can comprise a housing, an axle, a rotatable disc mounted on the axle, a sliding bar, and a pair of slotted brackets. The housing at least partially defines a nerve channel that is configured to accommodate at least a portion of a nerve, for example, a length of a sympathetic nerve chain. The sliding bar defines a surface of the nerve channel, and, through movement of the sliding bar, the cross-sectional area of the nerve channel can be decreased to the point that the sliding bar exerts a compressive force on the nerve. The axle can be held within the housing, for example, clamped in the housing between top and bottom axle end recesses. The rotatable disc can be held completely within the housing and configured for rotation about the axle. The rotatable disc can comprise an annular rim having a thickness in an axial direction relative to the rotatable disc. The thickness of the annular rim can continuously increase along an arc length of the rotatable disc, until the thickness reaches a maximum. A plateau can be provided whereby the maximum thickness of the rim is constant along an arc length, for example, along an arc length of from about 5° to about 30° or from about 10° to about 20°. The thickness of the annular rim can increase stepwise, or continuously. A smoothly sloping ramped annular rim can be provided or a rim comprising a plurality of steps of increasing thickness can be provided.

[0049] The sliding bar can be slidingly captured within the slots of the slotted brackets such that the sliding bar can move up and down, within the housing, guided by the slots. The sliding bar can be configured to be engaged with the annular rim of the rotatable disc such that rotation of the disc about the axle causes the sliding bar to move in a direction parallel to the axle. Each of the first and second brackets of the pair of slotted brackets has a respective slot formed therein, and the two slots face each other, are parallel to one another, and can have the same dimensions as one another. The sliding bar can be cylindrical or substantially cylindrical in shape. The sliding bar can have a uniform diameter along an axial length thereof. The sliding bar can have two flanges or end caps at opposite ends of the sliding bar. The flanges or end caps can have diameters that are greater than the diameter of the sliding bar. The greater diameters of the flanges or end caps prevent the sliding bar from passing through the slots in the brackets.

[0050] The first and second brackets can comprise respective first ends, or top ends, that straddle the annular rim of the rotatable disc. The first ends of the brackets can be positioned such that rotation of the rotatable disc causes movement of the annular rim between the first ends of the brackets. For example, with respect to the radius of the rotatable disc, the first bracket can have a vertical portion that extends upwardly, outside the rotatable disc and outside the annular rim. The second bracket can have a vertical portion that extends upwardly inside the annular rim and up to the underside of the rotatable disc. The first bracket can also have a horizontal portion that intersects with its vertical portion at the top edge of the vertical position, for example, perpendicularly. The horizontal portion extends just above and parallel to a top surface of the rotatable disc, toward the center of the rotatable disc. Near its distal end, the horizontal portion of the first bracket is mounted onto a hex-nut near the top of the axle. The horizontal portion of the first bracket can have a hexagonal-shaped opening for receiving the top hex-nut of the axle, thus mounting the first bracket on the axle.

[0051] The second bracket can also have a horizontal portion that extends from the second bracket vertical portion toward the center of the rotatable disc, but on the underside of the disc. The horizontal portion of the second bracket is mounted onto a lower hex-nut toward the bottom of the axle. The horizontal portion of the second bracket can have a hexagonal-shaped opening for receiving the bottom hex-nut of the axle, thus mounting the second bracket on the axle. As such, the rotatable disc is sandwiched between the horizontal portions of the first and second brackets and the annular rim is sandwiched between the vertical portions of the first and second brackets. Rotational movement of the rotatable disc is thus guided by the first and second brackets.

[0052] The vertical portions of the first and second brackets can also have second ends, or bottom ends, opposite the top ends. The second ends can partially define the nerve channel. For example, the bottom ends of the vertical portions of the first and second brackets can define a width of the nerve channel. The housing can comprise a base plate and the nerve channel can be defined by the base plate, the bottom ends of the vertical portions of the first and second brackets, and the sliding bar. Each of the first bracket and the second bracket can be mounted on the axle as described above. The hex-nuts on the axle can be threadedly engaged with the axle, for example, engaged after a center opening of the rotatable disc is mounted and centered on the axle.

[0053] The rotatable disc can comprise a magnetic material and rotation of the rotatable disc can be controllable by application of an external magnetic field in the vicinity of the compressive neuromodulator. Due to the increasing thickness of the annular rim of the rotatable disc, the thicker portion of the annular rim exhibits a greater magnetic attraction to an external magnet, compared to thinner portions of the annular rim. The rotatable disc can have an annular rim having a stepped profile, for example, a step-graded annular rim that provides variable degrees or steps of compression. Accordingly, if the compressive neuromodulator is implanted in a patient's back, moving an external magnetic-field-applying device from the left side of the patient to the right side of the patient, or vice versa, can be used to control rotation of the rotatable disc. Rotation of the rotatable disc translates into down and up movement of the sliding bar and compression and decompression of a nerve within the nerve channel.

[0054] A nerve tunnel can be provided through which the nerve can be positioned. The nerve tunnel can comprise or be a soft and/or plaint and/or resilient and/or elastomeric and/or elastically deformable material. The nerve tunnel can be made from or include a silicone material, a silicone elastomer, a medical grade silastic, or the like. Other suitable biocompatible materials for the nerve tunnel can be used or included. The nerve tunnel can surround at least the portion of the nerve that is disposed within the nerve channel. The nerve tunnel can protect the nerve and more evenly distribute the compressive force of the sliding bar as it acts to compress the nerve. Upon releasing the compressive force, for example, by reversing movement of the rotatable disc, the nature of the nerve tunnel material can provide a rebounding action such that the nerve tunnel forces the sliding bar up and away from the nerve. Other biasing devices, for example, springs or cushions, can instead be used to cause the rebounding action.

[0055] With the present invention, a method of applying a compressive force to a nerve is also provided. The method can involve positioning a portion of a nerve in the nerve channel of a compressive neuromodulator as described herein. The nerve can first be disposed within the nerve tunnel, or the nerve tunnel can fit around a portion of the nerve before the nerve portion is positioned in the nerve channel. The method can further include rotating the rotatable disc, for example, in a clockwise direction, such that the annular rim of the disc engages and pushes the sliding bar in a downward direction that decreases the cross-sectional area of the nerve channel and constricts (or applies pressure to) the nerve. The annular rim can thus rotate and press on the sliding bar and the sliding bar can, in-turn, press against the portion of the nerve in the nerve channel. The compression can cause a restriction in blood flow through the nerve and can control or reduce pain and/or can control or decrease sweating. The compression can affect, in a positive way, vascular tone and/or perfusion of an extremity. Movement of the sliding bar can be guided by the opposing slots in the first and second brackets. Rotation of the rotatable disc in an opposition direction, for example, in a counterclockwise direction, can release the compression on the sliding bar causing the sliding bar to move upwardly and decompressing the nerve. The nature of the nerve tunnel can optionally cause the biasing used to push back the sliding bar when the sliding bar is not pressed against the nerve tunnel and nerve portion by the annular rim.

[0056] The method can include moving an externally-applied magnetic field, for example, moving an external magnet, in the vicinity of the patient. Moving the position of the externally- applied magnetic field can effect rotation of the rotatable disc and thus effect movement of the sliding bar and compression or decompression of a nerve disposed in the nerve channel.

[0057] Control of the magnetic disc can be carried out initially by the implanting surgeon and subsequently by the patient via telemetry. When the patient wishes to alleviate symptoms, the patient can turn the device on, and rotate the disc to achieve the appropriate level of compression. When a patient is less symptomatic or in a state of activity requiring normal physiologic function, such as participating in a marathon or triathlon, the patient can rotate the disc to the off position, relieving compression and restoring normal function. In the case of hyperhidrosis, patients do not have excessive sweating while sleeping and the device can be placed in the off position at bedtime. The benefit to this ability is that the disc and thus the control of the nerve and thus pain relief can be immediate unlike chemical treatment, and reversal of the pressure can be immediate unlike chemical treatment, and the present invention avoids electrical malfunctions that can be an issue with other devices.

[0058] With the present invention, the compressive neuromodulator when operated such that a certain force is applied to the nerve, can be held at that force or compression level or position without any constant magnetic force being applied. In other words, the magnetic force or telemetry used to control the movement of the sliding bar that applies pressure on the nerve in the nerve channel of the device of the present invention requires no constant telemetry or magnetic force and remains in that selected place or state, once it is positioned at that particular location.

[0059] With the present invention, the telemetry or magnetic force applied to control the neuromodulator typically requires a magnetic device or field to be within two feet or one foot of the neuromodulator implanted in the patient. Generally, magnetic forces further away from the patient will have no effect on the operation of neuromodulator. Generally, the amount of magnetic field or force needed to control the device is from about 0.005 Teslas to about 0.3 Teslas, such as 0.01 Teslas to 0.2 Teslas, or from 0.02 Teslas to 0.1 Teslas. Alternatively, this magnetic field or force can be from about 50 Gauss to about 3,000 Gauss, or from 100 Gauss to 2,000 Gauss, or from 200 Gauss to 1,000 Gauss. [0060] The present invention also relates to a compressive neuromodulator system. The system includes a magnetically controllable compressive neuromodulator and a magnetic controller configured to magnetically control movement of a nerve compressor within the compressive neuromodulator. The compressive neuromodulator can, for example, be configured to be implanted in a patient. The compressive neuromodulator can be implanted along a nerve route and can be constructed, in-situ, for example, such that a nerve channel is formed by snapping two or more components of a housing together, around a sympathetic nerve chain. The housing can define the nerve channel and can comprise a hinged or clam shell configuration, or the like. The nerve compressor can comprise a magnetically controllable nerve compressor that is configured to move under the influence of an externally applied magnetic field. The magnetically controllable nerve compressor can be operably positioned within the housing, for example, in a tube portion of the housing or along a track defined in the housing, such that, the magnetically controllable nerve compressor can press against the portion of the nerve disposed in the nerve channel. Movement of the magnetically controllable nerve compressor within the housing can be guided by one or more slots, a track, a rail, a tunnel, a combination thereof, or the like, formed in, integral with, or provided in, the housing. The magnetically controllable nerve compressor can comprise, for example, a disc, a plunger, a magnetically rotatable disc, a combination thereof, or the like. The magnetic controller can be configured to apply an external magnetic field for controlling movement of the magnetically controllable nerve compressor within the housing. The magnetic controller can be or include a magnet(s). The magnetic controller can be or include an electromagnet that can be turned on and off. The magnetic controller can be or include an electromagnet that includes a magnetic field strength regulator. [0061] The magnetically controllable nerve compressor can frictionally engage one or more guide elements within the housing, such that, in the absence of an applied magnetic field, the magnetically controllable nerve compressor maintains its position within the housing and with respect to the nerve channel. The magnetic controller can be used to control the positioning of the magnetically controllable nerve compressor, and once an appropriate position is achieved, the magnetic controller can be turned off and the magnetically controllable nerve compressor can maintain its position, for example, during a full night of sleep. The frictional engagement can be achieved by the use of brushes, bushings, sleeves, patterned or embossed plastic components, screen-printed magnetic ink, a ratchet system, any combination thereof, or the like.

[0062] The internal mechanism can include five parts. The parts include a central axle, a rotatable magnetic disc, and a sliding bar. A pair of brackets are attached to the central axle, specifically, a first bracket and a second bracket, and they form a pair of slots that guides the sliding bar in its up and down motion. The attachment of the brackets to the central axle maintains the brackets in proper orientation with respect to each other and to the nerve. The first bracket is anchored to the axle above the magnetic disc and extends laterally to form the outer slot of the pair of slots. The second bracket attaches to the axle below the magnetic disc and forms the inner slot of the pair of slots. The-rotating magnetic disc is attached to the central axle between the two brackets. By its rotation, the magnetic disc displaces the sliding bar downwardly, compressing the nerve below and altering its function, or it rotates to allow the sliding bar to rise, releasing the nerve from compression and restoring nerve function.

[0063] Two instruments have been specifically designed to ease implantation using a thoracoscopic approach. The first is a curved right angle dissector that allows elevation and freeing of the nerve from the surrounding soft tissues. The applier holds the device in an open position while the nerve is properly positioned in the tunnel and then closes the snap-hinge mechanism.

[0064] The device can be in various sizes because of the variable ages, sizes and body habitus of patients.

[0065] With reference to the figures, FIGS. 1A-1E is one example, and show a housing 100 of a compressive neuromodulator. Housing 100 comprises a mid-body 108, a top cap 104, a housing bottom 110, and a bottom cap 112. A nerve channel 114 is defined by housing bottom 110 and bottom cap 112. As can be seen, a top channel half is formed in the bottom of housing bottom 110 and a bottom channel half is formed in the top of bottom cap 112. The shape of the nerve channel can be any geometrical shape, such as round, oval, triangular, rectangular, or other polygonal shapes. Other configurations can be used. Mid-body 108 includes a back mid-body portion 116 that is enclosed at its bottom by housing bottom 110. Top cap 104 includes a back portion 106 that encloses that top of the back mid-body portion 116. Back mid-body portion 1 16 defines a groove into which a first bracket 220 (FIGS. 3A-3G) is seated and secured. Housing 100 houses an internal mechanism 200 that is shown in detail in FIGS. 3A-3G and shown partially in phantom in FIGS. 2A-2E.

[0066] FIGS. 2A-2E show housing 100 comprised of transparent materials and internal mechanism 200 can be seen housed therein. Internal mechanism 200 comprises an axle 204 that is mounted or otherwise fixed in housing 100. Top cap 104 comprises an axle recess 206 formed in the inside surface thereof and mid-body 108 comprises of a bottom wall 120 having a second axle recess 208 formed therein. After a bottom end 272 (FIGS. 7A-7C) of axle 204 is placed inside second axle recess 208, top cap 104 can be positioned over and snapped onto mid-body 108 seating a top end 270 (FIGS. 7A-7C) of axle 204 in top axle recess 206. With axle 204 secured in place, a magnetically rotatable disc 202 can rotate freely about axle 204. Reference numerals shown in FIGS. 2A-2E that are the same as those shown in FIGS. 1A-1E denote the same features.

[0067] FIGS. 3 A-3G show that internal mechanism 200 comprises axle 204, rotatable disc 202, a first bracket 220, a second bracket 230, and a sliding bar 240. Sliding bar 240 is captured within a slot 222 formed in first bracket 220 and captured in a slot 232 formed in second bracket 230. End caps 242 and 244 or other flanges are fixed to opposite ends of sliding bar 240 so that sliding bar 240 will not slip out of slots 222 and 232. One end of sliding bar 240 can comprise an integrally molded flange and the other end of the sliding bar 240 can be capped-off with a flanged end cap after an uncapped end of sliding bar 240 is slid through slots 222 and 232. Rotatable disc 202 includes an annular rim 250 having an arc length and terminating at a maximum thickness plateau 252.

[0068] FIGS. 4A-4H shows details of rotatable disc 202. Annular rim 250 has a radial width that can be equal to about 50 percent of the radius, for example, from about 40% to about 60% of the radius. Annular rim 250 has a thickness in the axial direction that can vary, and, as shown, comprises a gradually sloped ramp 256 and a plateau 252 having a maximum axial thickness 254. Ramp 256 can have an arc length of about 180°, for example, from about 160° to about 200°. Plateau 252 can have an arc length of about 45°, for example, from about 35° to about 55°. Rotatable disc 200 has a central opening 258 into which axle 204 (shown in FIGS. 3A-3G) is positioned for rotation of rotatable disc 202 about axle 204.

[0069] FIGS. 5A-5D show first bracket 220 and slot 222 formed therein. First bracket 220 comprises a vertical portion 224 and a horizontal portion 226 that intersect at an edge 227. Horizontal portion 226 defines a hexagonal-shaped opening 228 into which an upper hex-nut 274 (FIGS. 7A-7C) of axle 204 can be seated.

[0070] FIGS. 6A-6D show second bracket 230 and slot 232 formed therein. Second bracket 230 comprises a vertical portion 234 and a horizontal portion 236 that intersect with one another. Horizontal portion 236 defines a hexagonal-shaped opening 238 into which a bottom hex-nut 276 (FIGS. 7A-7C) of axle 204 is seated.

[0071] FIGS. 7A-7C show axle 204 and hex-nuts 274 and 276 secured thereon. Either or both of hex-nuts 274 and 276 can be mounted on axle 204 during manufacture or assembly. Hex-nuts 274 and 276 can be threadedly engaged with axle 204, snapped into grooves, or otherwise mounted on axle 204. FIGS. 7A-7C also depict a top end 270 of axle 204, which is received in axle recess 206 of housing cap 104 as shown in FIGS. 2A-2E. Bottom end 272 of axle 204 is received in bottom axle recess 208 of mid-body 108 as shown in FIGS. 2A-2E.

[0072] FIGS. 8A-8C show sliding bar 240 and end flanges 242 and 244. One or both of end flanges 242 and 244 can be in the form of end caps that snap into or onto sliding bar 240 during manufacture. As can be seen, the diameter of flanges 242 and 244 is greater than the diameter of sliding bar 240 and greater than the widths of slots 222 and 232 (as shown in FIGS. 3A-3G).

[0073] The specific dimensions of the various components can vary. Just as an example, the rotatable disc can have a diameter of from about 7 millimeters (mm) to about 14 mm, for example, from about 8 mm to about 10 mm. The rotatable disc can have an axial thickness of from about 2 mm to about 5 mm or from about 3 mm to about 4 mm. The first bracket can have a height and a length, each of from about 6 mm to about 10 mm, for example, from about 6 mm to about 8 mm. The first bracket can have a width of from about 3 mm to about 6 mm or from about 3.5 mm to about 5 mm. The second bracket can have a top length of from about 4 mm to about 7 mm or from about 4 mm to about 6 mm. The second bracket can have a height from about 4 mm to about 8 mm or from about 4 mm to about 6 mm. The second bracket can have a width from about 3 mm to about 6 mm or from about 3.5 mm to about 5 mm. The axle can have a diameter of from about 0.5 mm to about 2 mm, for example, from about 0.75 mm to about 1.5 mm. The axle can have a height of from about 4 mm to about 8 mm or from about 5 mm to about 7 mm. The sliding bar can have a diameter of from about 1 mm to about 4 mm or from about 1.5 mm to about 3 mm. The sliding bar can have a length from about 3 mm to about 7 mm or from about 3.5 mm to about 6 mm. The housing can have a diameter of from about 8 mm to about 16 mm or from about 10 mm to about 14 mm, a length of from about 10 mm to about 18 mm or from about 12 mm to about 16 mm, a mid-body and top combined height of from about 6 mm to about 10 mm or from about 6 mm to about 8 mm, and a total height of from about 9 mm to about 14 mm or from about 9 mm to about 11 mm. The nerve channel can have a cross-section (e.g., circular cross-section) having a diameter from about 3 mm to about 7 mm or from about 3.75 mm to about 6 mm, and a length from about 4 mm to about 8 mm or from about 4 mm to about 6 mm. The circumferential surface area of the nerve channel can be from about 7 mm to about 38.5 mm 2 , for example, from about 11 mm 2 to about 28 mm 2.

[0074] The present invention includes the following numbered aspects, embodiments, and features, in any order and/or in any combination:

1. A compressive neuromodulator comprising:

an axle held by and within the housing; a rotatable disc within the housing, mounted on the axle, and configured for rotation about the axle, the rotatable disc comprising an annular rim having a thickness in an axial direction relative to the rotatable disc, which continuously increases along an arc length of the rotatable disc;

a bracket within the housing and having a slot formed therein, the sliding bar being captured in the slot and configured for sliding movement within the slot, wherein rotation of the rotatable disc causes movement of the sliding bar within the slot and the movement of the sliding bar causes a cross-sectional area of the nerve channel to increase or decrease in size depending on the direction of rotation of the rotatable disc. The movement of the sliding bar causes a cross- sectional area of the nerve channel to set a nerve channel size depending on the location of the rotatable disc.

2. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the increase or decrease in the cross-sectional area of the nerve channel causes an increase or decrease, respectively, of a compressive force applied to a portion of the nerve when the portion is disposed in the nerve channel.

3. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, further comprising a second bracket within the housing and having a second slot formed therein, wherein the sliding bar is also captured within the second slot and is configured for sliding movement within the second slot. 4. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the bracket and the second bracket comprise respective first ends that straddle the annular rim and are positioned such that rotation of the rotatable disc causes movement of the annular rim between the first ends.

5. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the bracket and the second bracket comprise respective second ends that partially define the nerve channel.

6. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the housing comprises a baseplate and the nerve channel is defined by the baseplate, the second ends, and the sliding bar.

7. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the bracket and the second bracket are each mounted on the axle and together form a groove within which the annular rim moves upon rotation of the rotatable disc.

8. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the rotatable disc comprises a magnetic material and rotation of the rotatable disc is controllable by application of an external magnetic field in the vicinity of the compressive neuromodulator.

9. A system comprising the compressive neuromodulator of any preceding or following embodiment/feature/aspect and a remote telemetry controller, wherein the remote telemetry controller is configured to generate a magnetic field for controlling rotation and a direction of rotation of the rotatable disc.

10. The system of any preceding or following embodiment/feature/aspect, wherein the remote telemetry controller is configured to be turned on and off such that, when the remote telemetry controller is turned on, it is configured to enable movement of the rotatable disc to a desired position, and when the remote telemetry controller is turned off, it is configured to enable the rotatable disc to be maintained in the desired position.

11. The system of any preceding or following embodiment/feature/aspect, wherein the remote telemetry controller is configured to incrementally adjust the position of the rotatable disc.

12. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, further comprising a nerve tunnel within the nerve channel and configured to surround at least a portion of the nerve when the portion is disposed in the nerve channel.

13. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, implanted in a patient, and further comprising at least a portion of a nerve surrounded by the nerve tunnel.

14. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the nerve tunnel comprises an elastically deformable silicone material.

15. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the slot comprises an elongated slot, the sliding bar comprises at least one flange on an end thereof, the elongated slot comprises a slot width, and the at least one flange has a diameter that is larger than the slot width.

16. A method of applying compressive force to a nerve of any preceding or following embodiment/feature/aspect, comprising:

positioning a portion of a nerve in the nerve channel of a compressive neuromodulator of any preceding or following embodiment/feature/aspect; and rotating the rotatable disc such that the annular rim engages and pushes the sliding bar in a direction that decreases a cross-sectional area of the nerve channel and presses the sliding bar against the portion of the nerve.

17. The method of any preceding or following embodiment/feature/aspect, wherein the rotatable disc comprises a magnetic material and the rotating comprises applying an external magnetic field from a remote telemetry controller, to rotate the rotatable disc.

18. A compressive neuromodulator system of any preceding or following embodiment/ feature/aspect comprising:

a magnetically controllable nerve compressor configured to move under the influence of an externally applied magnetic field and operably positioned within the housing to press against the portion of the nerve when the portion is disposed in the nerve channel; and

a magnetic controller configured to apply an external magnetic field for controlling movement of the magnetically controllable nerve compressor.

19. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the magnetically controllable nerve compressor comprises a disc.

20. The compressive neuromodulator of any preceding or following embodiment/feature/ aspect, wherein the magnetically controllable nerve compressor comprises a plunger.

21. A method of applying a compressive force to a nerve, of any preceding or following embodiment/feature/aspect, comprising:

positioning a portion of a nerve in the nerve channel of a compressive neuromodulator of any preceding or following embodiment/feature/aspect; and applying an external magnetic field to cause movement of the magnetically controllable nerve compressor such that magnetically controllable nerve compressor exerts a compressive force against the portion of the nerve.

22. The method of any preceding or following embodiment/feature/aspect, further comprising wrapping the portion of the nerve in an elastically deformable nerve tunnel prior to positioning the portion of the nerve in the nerve channel, wherein the magnetically controllable nerve compressor presses against the nerve tunnel and the nerve tunnel presses against the portion of the nerve.

[0075] The present invention can include any combination of these various features or embodiments above and/or below as set-forth in sentences and/or paragraphs. Any combination of disclosed features herein is considered part of the present invention and no limitation is intended with respect to combinable features.

[0076] The entire contents of all references cited in this disclosure are incorporated herein in their entireties, by reference. Further, when an amount, dimension, or other value or parameter is given as either a range, preferred range, or a list of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether such ranges are separately disclosed. Where a range of numerical values is recited herein, unless otherwise stated, the range is intended to include the endpoints thereof, and all integers and fractions within the range. It is not intended that the scope of the invention be limited to the specific values recited when defining a range.

[0077] Other embodiments of the present invention will be apparent to those skilled in the art from consideration of the present specification and practice of the present invention disclosed herein. It is intended that the present specification and examples be considered as exemplary only with a true scope and spirit of the invention being indicated by the following claims and equivalents thereof.

Claims

WHAT IS CLAIMED IS:

1. A compressive neuromodulator comprising:

an axle held by and within the housing;

a bracket within the housing and having a slot formed therein, the sliding bar being captured in the slot and configured for sliding movement within the slot, wherein rotation of the rotatable disc causes movement of the sliding bar within the slot and the movement of the sliding bar causes a cross-sectional area of the nerve channel to increase or decrease in size depending on the direction of rotation of the rotatable disc.

2. The compressive neuromodulator of claim 1, wherein the increase or decrease in the cross- sectional area of the nerve channel causes an increase or decrease, respectively, of a compressive force applied to a portion of the nerve when the portion is disposed in the nerve channel.

3. The compressive neuromodulator of claim 1, further comprising a second bracket within the housing and having a second slot formed therein, wherein the sliding bar is also captured within the second slot and is configured for sliding movement within the second slot.

4. The compressive neuromodulator of claim 3, wherein the bracket and the second bracket comprise respective first ends that straddle the annular rim and are positioned such that rotation of the rotatable disc causes movement of the annular rim between the first ends.

5. The compressive neuromodulator of claim 4, wherein the bracket and the second bracket comprise respective second ends that partially define the nerve channel.

6. The compressive neuromodulator of claim 5, wherein the housing comprises a baseplate and the nerve channel is defined by the baseplate, the second ends, and the sliding bar.

7. The compressive neuromodulator of claim 4, wherein the bracket and the second bracket are each mounted on the axle and together form a groove within which the annular rim moves upon rotation of the rotatable disc.

8. The compressive neuromodulator of claim 1, wherein the rotatable disc comprises a magnetic material and rotation of the rotatable disc is controllable by application of an external magnetic field in the vicinity of the compressive neuromodulator.

9. A system comprising the compressive neuromodulator of claim 8 and a remote telemetry controller, wherein the remote telemetry controller is configured to generate a magnetic field for controlling rotation and a direction of rotation of the rotatable disc.

10. The system of claim 9, wherein the remote telemetry controller is configured to be turned on and off such that, when the remote telemetry controller is turned on, it is configured to enable movement of the rotatable disc to a desired position, and when the remote telemetry controller is turned off, it is configured to enable the rotatable disc to be maintained in the desired position.

11. The system of claim 10, wherein the remote telemetry controller is configured to incrementally adjust the position of the rotatable disc.

12. The compressive neuromodulator of claim 1, further comprising a nerve tunnel within the nerve channel and configured to surround at least a portion of the nerve when the portion is disposed in the nerve channel.

13. The compressive neuromodulator of claim 12, implanted in a patient, and further comprising at least a portion of a nerve surrounded by the nerve tunnel.

14. The compressive neuromodulator of claim 12, wherein the nerve tunnel comprises an elastically deformable silicone material.

15. The compressive neuromodulator of claim 1, wherein the slot comprises an elongated slot, the sliding bar comprises at least one flange on an end thereof, the elongated slot comprises a slot width, and the at least one flange has a diameter that is larger than the slot width.

16. A method of applying compressive force to a nerve, comprising:

positioning a portion of a nerve in the nerve channel of the compressive neuromodulator of claim 1 ; and

rotating the rotatable disc such that the annular rim engages and pushes the sliding bar in a direction that decreases a cross-sectional area of the nerve channel and presses the sliding bar against the portion of the nerve.

17. The method of claim 16, wherein the rotatable disc comprises a magnetic material and the rotating comprises applying an external magnetic field from a remote telemetry controller, to rotate the rotatable disc.

18. A compressive neuromodulator system comprising:

19. The compressive neuromodulator of claim 18, wherein the magnetically controllable nerve compressor comprises a disc.

20. The compressive neuromodulator of claim 18, wherein the magnetically controllable nerve compressor comprises a plunger.

21. A method of applying a compressive force to a nerve, comprising:

positioning a portion of a nerve in the nerve channel of the compressive neuromodulator of claim 18; and

applying an external magnetic field to cause movement of the magnetically controllable nerve compressor such that magnetically controllable nerve compressor exerts a compressive force against the portion of the nerve.

22. The method of claim 21, further comprising wrapping the portion of the nerve in an elastically deformable nerve tunnel prior to positioning the portion of the nerve in the nerve channel, wherein the magnetically controllable nerve compressor presses against the nerve tunnel and the nerve tunnel presses against the portion of the nerve.