WO2020206208A1

WO2020206208A1 - Nerve holder device

Info

Publication number: WO2020206208A1
Application number: PCT/US2020/026516
Authority: WO
Inventors: Abhay K. VARMA; Christopher HAPSTACK; Joe RUSCITO; Mark Semler
Original assignee: Musc Foundation For Research Development
Priority date: 2019-04-03
Filing date: 2020-04-07
Publication date: 2020-10-08

Abstract

The present invention relates to nerve holder devices that are capable of holding and securing two nerve ends adjacent to each other during glue-based anastomosis procedure.

Description

TITLE

NERVE HOLDER DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62/828,588, filed April 3, 2019, and U.S. Provisional Patent Application No. 62/916,861, filed October 18, 2019, the contents of which are each incorporated by reference herein in their entirety.

BACKGROUND OF THE INVENTION

The peripheral nervous system provides pathways for motor and sensory signals throughout the body. Each year, millions of people around the world suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.

Many such peripheral nerve injuries require surgical intervention, especially when the nerve has become completely disconnected, or“transected.” Such injuries have historically been treated by either (1) suturing the ends of the transected nerve(s) together, or (2) in cases where there is a large gap between the two ends of the nerves, by bridging the gap using a nerve graft or synthetic device that connects the nerve ends and allows them to effectively grow back together. Even in the latter case, sutures are used to secure the graft or the synthetic materials to the nerve ends. Despite the fact that sutures have historically been considered the gold standard in such procedures, they are increasingly being viewed as a sub-optimal option, due to the potential for sutures to introduce additional trauma to the nerve, and due to the increasing availability - and efficaciousness - of suture-less options.

One such suture-less technique, which is quickly trending toward becoming the new gold-standard in peripheral nerve anastomosis, is the use of fibrin glue in the place of - or in some cases, in addition to - sutures. In numerous rodents, cadaver, and human studies, fibrin glue - relative to suture-only repair - has been shown to require less surgical experience to apply, to be quicker in application, and to be less likely to generate secondary damage. Despite its likely clinical advantages and its increasing adoption in the operating room, glue-based nerve anastomosis (i.e. reconnecting nerves that are disconnected) can still be tedious, time-consuming, and frustrating for surgeons, due primarily to limitations associated with currently-available application devices.

Thus, there is a need in the art for an improved application device that A) allows holding and securing of the nerve ends to each other, B) allows consistent application of a sufficient amount of the glue to the entire circumference of the gap, and C) allows surgeons to more quickly and effectively provide the most optimal treatment for peripheral nerve injuries to the patients.

SUMMARY OF THE INVENTION

In one aspect, the present invention relates to a nerve holder device comprising: a first and a second arm member, each arm having a proximal end nearest to a site of nerve injury and a distal end nearest to an operator of the device; a first and a second jaw member attached at the proximal end of the first and second arm member, respectively, the first and second jaw members each comprising an outer surface, an inner surface, and couple together such that the inner surfaces define a lumen; and at least one of the jaw member further comprising at least one port extending from an outer surface to an inner surface.

In one embodiment, the at least one port further comprising a sprue cutting ring. In one embodiment, the inner surface of the first and second jaw members further comprises a roughened texture. In one embodiment, the inner surface of the first and second jaw members further comprising at least one circumferential channel. In one embodiment, the inner surface of the first and second jaw members further comprising at least one channel. In one embodiment, the first and second jaw members are removable or detachable. In one embodiment, the inner surface of the first and second jaw members further comprising at least one supporting pad. In one embodiment, the inner surface of the first and second jaw members further comprising raised elements. In one

embodiment, the first and second jaw members are constructed from a biodegradable and absorbable material that may be removed or detached in part or entirely and left in a subject following a procedure. In one embodiment, the first and second jaw members further comprising interlocking lips. In one embodiment, further comprising at least one pivot point coupled to at least one arm member to actuate at least one jaw member. In one embodiment, the first and second arm members slide over each other to actuate the first and second jaw members. In one embodiment, the port is offset from center of the first jaw member. In one embodiment, the port further comprising a port lumen positioned laterally to first and second arm member. In one embodiment, further comprising a clip on at least one arm member capable of locking the first and second jaw members in the closed position.

In another aspect, the present invention relates to a method for repairing peripheral nerve injuries in a subject comprising: providing a nerve holder having a first and a second arm, an upper and lower jaw component attached to the first and second arm, respectively, the jaw components defining a lumen when coupled together, and at least one port fluidly connected to the lumen; placing and coupling the upper and lower jaw components around the two nerve ends such that the two nerve ends are held adjacent to each other within the lumen; inserting and utilizing an existing syringe filled with glue into the port such that the glue enters the lumen and surrounds the two nerve ends; and curing the glue.

In one embodiment, further comprising a step of uncoupling the jaw component and removing said components from the nerve ends. In one embodiment, the method at least one port comprises a sprue cutting ring, and further comprising a step of uncoupling the jaw components such that the sprue cutting ring detaches cured glue in the port from the nerve ends. In one embodiment, the inner surface of the first and second jaw members comprises a roughened texture. In one embodiment, the inner surface of the first and second jaw members comprises at least one circumferential channel. In one embodiment, the inner surface of the first and second jaw members comprises at least one axial channel. In one embodiment, the first and second jaw members are removable or detachable. In one embodiment, the first and second jaw members are constructed from a bioresorbable or degradable material. In one embodiment, the method further comprises a step of detaching the first and second jaw members in part or entirely from the nerve holder and leaving the detached first and second jaw members in a patient following a procedure. In one embodiment, the inner surface of the first and second jaw members comprises at least one supporting pad. In one embodiment, the inner surface of the first and second jaw members comprises raised elements. In one embodiment, the first and second jaw members comprise interlocking lips.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of embodiments of the invention will be better understood when read in conjunction with the appended drawings. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities of the embodiments shown in the drawings.

Fig. 1 depicts a perspective view of an exemplary nerve holder device in an open position.

Fig. 2 depicts a perspective view of an exemplary nerve holder device in a closed position. The inset depicts an alternative handle arrangement with a spring force maintaining a closed position.

Fig. 3 depicts a magnified view of the working end of an exemplary nerve holder in a closed position.

Fig. 4 depicts a view of the inner surface of the upper and lower jaws of an exemplary nerve holder.

Fig. 5 depicts a view of the inside surface of the lower jaw of an exemplary nerve holder.

Fig. 6A through Fig. 6C depict an exemplary nerve holder device. Fig. 6A depicts a perspective view of an exemplary nerve holder in a closed position. Fig. 6B depicts a side view of an exemplary nerve holder in a closed position. Fig. 6C depicts a top view of the inside surface of the lower jaw.

Fig. 7A through Fig. 7D depict an exemplary nerve holder device. Fig. 7A depicts a top view of an exemplary nerve holder in an open position. Fig. 7B depicts a side view of an exemplary nerve holder in a closed position. Fig. 7C depicts a magnified view of the proximal end of an exemplary nerve holder in a closed position. Fig. 7D depicts a front view of an exemplary nerve holder in an open position. Fig. 8A through Fig. 8B depict an exemplary nerve holder device. Fig. 8A depicts a perspective view of an exemplary nerve holder in an open position. Fig. 8B depicts a side view of an exemplary nerve holder in an open position.

Fig. 9A through Fig. 9B depict an exemplary nerve holder device. Fig. 9A depicts a perspective view of an exemplary disassembled nerve holder. Fig. 9B depicts a side view of an exemplary disassembled nerve holder.

Fig. 10A through Fig. 10B depict a magnified view of the proximal end of an exemplary nerve holder in open position. Fig. 10A depicts a perspective view of the proximal end of an exemplary nerve holder in an open position. Fig. 10B depicts a side view of the proximal end of an exemplary nerve holder in an open position.

Fig. 11 A through Fig. 1 IB depict an exemplary nerve holder device. Fig.

11 A depicts a perspective view of an exemplary nerve holder in an open position. Fig.

1 IB depicts a partial cutaway perspective view of an exemplary nerve holder in an open position.

Fig. 12 depicts a partial cutaway perspective view of an exemplary nerve holder device.

Fig. 13 A through Fig. 13B depicts an exemplary nerve holder device. Fig. 13 A depicts a perspective view of an exemplary nerve holder in a closed position. Fig. 13B depicts a partial cutaway perspective view of an exemplary nerve holder in a closed position.

Fig. 14A through Fig. 14B depict a magnified view of the proximal end of an exemplary nerve holder device. Fig. 14A depicts a view of the inner surface of the upper jaw. Fig. 14B depicts a view of the inner surface of the lower jaw.

Fig. 15A through Fig. 15B depict an exemplary nerve holder device. Fig. 15A depicts a perspective view of an exemplary nerve holder device in a closed position. Fig. 15B depicts a perspective view of an exemplary nerve holder device in an open position.

Fig. 16 depicts a magnified view of the proximal end of an exemplary nerve holder device.

Fig. 17 depicts a perspective exploded view of the upper and lower arm of an exemplary nerve holder device. Fig. 18 depicts a perspective view of an exemplary nerve holder device in an open position.

Fig. 19 depicts a magnified view of the distal end of an exemplary nerve holder device.

Fig. 20 depicts a magnified view of the proximal end of an exemplary nerve holder device.

Fig. 21 depicts a perspective view of an exemplary nerve holder device in an open position.

Fig. 22 depicts a magnified view of the proximal end of an exemplary nerve holder device.

Fig. 23 is a flowchart depicting an exemplary method of repairing peripheral nerve injuries using the nerve holder device of the present invention.

DETAILED DESCRIPTION

It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in the field of surgical devices, including those indicated for the treatment of peripheral nerve anastomosis. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.

Definitions

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although any methods and materials similar or equivalent to those described herein can be used in the practice for testing of the present invention, exemplary materials and methods are described herein. In describing and claiming the present invention, the following terminology will be used.

It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

The articles“a” and“an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example,“an element” means one element or more than one element.

“About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value, as such variations are appropriate.

The terms“patient,”“subject,”“individual,” and the like are used interchangeably herein, and refer to any animal amenable to the systems, devices, and methods described herein. The patient, subject or individual may be a mammal, and in some instances, a human.

Ranges: throughout this disclosure, various aspects of the invention can be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5, 5.3, and 6. This applies regardless of the breadth of the range.

Nerve Holder for Glue-Based Anastomosis

The present invention relates in part to a nerve holder device that allows for holding and securing nerve ends adjacent to each other and quickly and constantly applying a sufficient amount of bio-adhesive to the entire circumference of a gap between the nerve ends. In one embodiment, the nerve holder device of this invention may be an implantable device that is able to hold both ends of a cut nerve adjacent to each other until the nerve is fully healed. In one embodiment, the nerve holder may be an

implantable and absorbable device.

Referring now to Fig. 1 and Fig. 2, an exemplary nerve holder 10 of the present invention is shown. Nerve holder 10 comprises two elongated arms 12 and 14, a proximal end 16 and a distal end 18. A working end 20 is connected to the proximal end 16 and comprises opposing jaw members 24 and 26, which are pivotably connected about a pivot pin 28 and are moveable relative to one another between an open position (Fig. 1) and a closed position (Fig. 2). In one embodiment, each jaw member 24 and 26 comprises a jaw component 32 and 34, respectively, that is releasably engaged thereon. Handle 30 is connected at the distal end 18 and comprises opposing handles 36 and 38. Each handle 36 and 38 comprises a finger hole 40 and 42 for receiving a finger of the user therethrough. As can be appreciated, finger holes 40 and 42 facilitate movement of arms 12 and 14 relative to one another, which in turn pivots jaw members 24 and 26 between the open position (Fig. 1) and the closed position (Fig. 2), wherein jaw component 32 and 34 cooperate to grasp a nerve therebetween. In one embodiment, opening arms 12 and 14 causes jaws members 24 and 26 to open, while closing arms 12 and 14 causes jaw members 24 and 26 to close. In one embodiment, opening arms 12 and 14 causes jaws members 24 and 26 to close, while closing arms 12 and 14 causes jaw members 24 and 26 to open; jaw members 24 and 26 can be maintained in a closed position by providing a spring force 13 between arms 12 and 14 (Fig. 2, inset).

Arms 12 and 14 lie on the same plane and are provided with locking tabs 44 and 46, respectively, which extend along the plane of arms 12 and 14 and extend toward each other. Locking tabs 44 and 46 are slightly offset so that locking tab 44 passes over locking tab 46 as arms 12 and 14 are squeezed more closely together by exerting force on handles 36 and 38 in the direction of locking tabs 44 and 46. Ribs 48, located on the inner surface of locking tab 44, and ribs 50, located on the inner surface of locking tab 46, extend from their respective tabs so that ribs 48 and 50 slide over each other as locking tabs 44 and 46 pass each other during closure of arms 12 and 14. Ribs 48 and 50 are releasably lockable at intervals to temporarily lock the position of arms 12 and 14.

As will be appreciated by those skilled in the art, locking tabs 44 and 46 and associated ribs 48 and 50 effectively define a ratchet of multiple locking positions, any of which may be selected by a user to accommodate various nerve thicknesses without damaging the nerves or otherwise further aggravating the trauma. With nerve holder 10 locked around a nerve, the user’s hand is then free to perform other necessary functions, which may include application of glue around the nerve ends to secure them in place. Disengagement of nerve holder 10 is facilitated by the pivotally connected arms 12 and 14. Opposing lateral movement of the handles 36 and 38 causes the ribs 48 and 50 to move apart to a point at which they no longer engage, permitting handles 36 and 38 to be repositioned to open jaw members 24 and 26. Furthermore, while locking tabs 44 and 46 and ribs 48 and 50 herein disclosed for purposes of the embodiment are similar in shape to a right triangle, thereby establishing a plurality of ramped teeth adapted for selective inter-engagement with each other, other forms of temporary locking mechanisms may also be employed.

In one embodiment, when closing, jaw components 32 and 34 intimately meet before ribs 48 and 50 come into contact so that nerve holder 10 may be used without necessarily engaging ribs 48 and 50 and locking nerve holder 10.

Arms 12 and 14, handles 36 and 38, and jaw members 24 and 26 may be constructed from any materials commonly used in the art, and particularly in forceps used in surgical procedures. For example, it may be constructed of suitable materials, including but not limited to steel, all grades of stainless steel, various other metals and alloys, plastics, ceramics, composites, as well as other materials known to be suitable to those skilled in the art. In one embodiment, arms 12 and 14 may be constructed in a variety of shapes and sizes dependent on a user’s preferences. In one embodiment, arms 12 and 14 can be straight.

In one embodiment, nerve holder 10 can be disposable. In one

embodiment, nerve holder 10 can be reusable.

Referring now to Fig. 3, an exemplary embodiment of working end 20 is shown. In one embodiment, working end 20 comprises jaw members 24 and 26, jaw components 32 and 34, pivot pin 28, an outer surface 53, an inner surface 55, a nerve holding channel 54, and a port 52. In one embodiment, in a closed position, jaw components 32 and 34 lock together via mechanical, magnetic, tensile or some other means and create nerve holding channel 54.

In one embodiment, nerve holding channel 54 has a diameter that can be between approximately 1 to 5 mm to be able to accommodate the majority of nerve sizes. In one embodiment, the nerve holding channel 54 has a diameter that can be between approximately 5 to 25 mm to be able to accommodate larger nerve sizes. In one embodiment, the nerve holding channel 54 has a diameter of 0.1 to 1 mm to be able to accommodate smaller nerve sizes. In one embodiment, nerve holder 10 can come be made in different sizes for the surgeon to choose from.

In one embodiment, working end 20 comprises port 52. Port 52 is used to introduce bio-adhesive (such as fibrin glue) into nerve holding channel 54. In one embodiment, port 52 is located on outer surface 53 of jaw component 32. In one embodiment, port 52 can be configured to receive any suitable injector nozzle, such as a syringe, in a generally fluid-tight form to facilitate injecting a bio-adhesive from an injector nozzle of a syringe through port 52 and into nerve holding channel 54.

Referring now to Fig. 4, jaw components 32 and 34 are described in detail. In one embodiment, inner surface 55 of jaw components 32 and 34 comprises three regions: right section 74, left section 70, and middle section 72. In one embodiment, each region can have the same length. In one embodiment, each region can have different lengths. In one embodiment, inner surface 55 of right section 74 and left section 70 of jaw components 32 and 34 is capable of securing nerve ends by being textured or roughened, such as with corrugation, ridges, grooves, and the like. In one embodiment, inner surface 55 securely holds opposing nerve ends, once jaw members 24 and 26 are in a closed position. In one embodiment, jaw component 34 further includes raised elements 68 (Fig. 5). In one embodiment, jaw component 32 further includes raised elements 68 (not pictured). In one embodiment, raised elements 68 are composed of at least one pillar 56. In one embodiment, pillars 56 are flexible. In one embodiment, pillars 56 are angled. In one embodiment, pillars 56 deflect inwards towards middle section 72 and pull nerve ends inwards together when jaw members 24 and 26 close around the nerve ends. In one embodiment, raised elements 68 are located on left section 70 and right section 74. In one embodiment, raised elements 68 are molded out of a material that is separate from and softer material than jaw component 34. In one embodiment, the material can be made of any biocompatible polymer including, but not limited to, Polyvinylchloride,

Polyethersulfone, Polytetrafluoroethylene, Polyethylene, Polyurethane, Polyetherimide, Polycarbonate, Polysulfone, Polyetheretherketone or Polypropylene.

In one embodiment, middle section 72 comprises circumferential channels 58, axial channels 60, sprue cutter 62, support pads 64 and interlocking lips 66. In one embodiment, axial channels 60 and circumferential channels 58 are orthogonal to each other and are spaced equally apart within middle section 72. In one embodiment, circumferential channels 58 and axial channels 60 direct the flow of bio-adhesive around the circumference of a nerve. In one embodiment, there is at least one circumferential channel 58 in middle section 72. In one embodiment, there are at least three

circumferential channels 58 in middle section 72. In one embodiment, there is at least one axial channel 60 in middle section 72. In one embodiment, there are at least four axial channels 60 in middle section 72. Support pads 64 extend from inner surface 55 of jaw components 32 and 34 to define a lumen and occupy the space between circumferential channels 58 and axial channels 60. In one embodiment, support pads 64 prevent nerve ends from dipping during an anastomosis procedure. In one embodiment, there is at least one support pad 64 in the middle section 72. In one embodiment, there are at least eight support pads 64 in the middle section. The lumen formed by support pads 64 can be sized to be slightly larger than nerve holding channel 54 to allow bio-adhesive to flow entirely around the circumference of nerve ends held within jaw component 32 and 34. In one embodiment, the diameter of the lumen formed by support pads 64 is between approximately 1 to 5 mm. In one embodiment, the diameter of the lumen formed by support pads 64 is between approximately 5 to 50 mm. In one embodiment, the diameter of the lumen formed by support pads 64 is between approximately 0.1 to 1 mm.

In one embodiment, jaw component 34 further comprises sprue cutter 62. Sprue cutter 62 is located adjacent to port 52 and is composed of two interlocking halves from port 52 through which bio-adhesive flows. In one embodiment, sprue cutter 62 includes a small ring on jaw member 34 that slices a cured channel of bio-adhesive formed within port 52 after delivery of a fluid from a syringe to a nerve.

In one embodiment, jaw components 32 and 34 comprise interlocking lips 66. In one embodiment, interlocking lips 66 are configured to keep jaw components 32 and 34 connected and to prevent bio-adhesive from seeping out. In one embodiment Jaw components 32 and 34 have mated L-shape edges to allow them to lock and stay closed when jaw component 32 is placed above the jaw component 34.

In one embodiment Jaw components 32 and 34 are made from a translucent material to allow a user to easily see the position of the gap between two nerve ends held between jaw components 32 and 34.

In one embodiment Jaw components 32 and 34 are detachable. In one embodiment, the jaw components 32 and 34 are detachable at the junction with jaw members 24 and 26. In one embodiment, the jaw components 32 and 34 are detachable at a breaking point 57. Breaking point 57 can be constructed from a perforated material or scored material that can be cleanly broken off from the portion of jaw components 32 and 34 encompassing nerve holding channel 54 and directly surrounds a nerve. In one embodiment, jaw components 32 and 34 are implantable. In one embodiment, jaw components 32 and 34 may be detached from handle 30 after securing two adjacent nerve ends to each other and left within a subject. In one embodiment, jaw components 32 and 34, may be composed of any material including any suitable bioabsorbable or resorbable material. The terms bioabsorbable and resorbable are used herein to mean dissolving inside the human body after a period of time. In some examples, the bioabsorbable material may be chosen based on a time duration at which the material dissolves. For example, the bioabsorbable material may have the property that it does not substantially dissolve within seven days after installation along the tissue but dissolves any time after one week while maintaining structural integrity before then. For example, the

bioabsorbable material may comprise a biocompatible, bioabsorbable polymer such as Poly-L-Lactic Acid/Poly glycolic acid (PLLA/PGA), Polycapralactone, or some combination thereof. By using a bioabsorbable material, no permanent foreign body is left in the tissue following surgery.

Referring now to Fig. 6A through Fig. 6C, another exemplary nerve holder 200 is shown. In one embodiment, nerve holder 200 comprises a pair of forceps having an upper and lower jaw member 202 and 204 at the forceps tips, elongated arms 206 and 208 and a ratchet lock 210 between arms 206 and 208. Jaw members 202 and 204 define a lumen in a closed position (Fig. 7A, Fig. 7B). In one embodiment, upper jaw member 202 comprises a channel 212 fluidly connected to the lumen. In one embodiment, channel 212 can be configured to receive any suitable injector nozzle, such as from a syringe, in a generally fluid tight form. In one embodiment, channel 212 is used to introduce bio adhesive into the lumen.

Referring now to Fig. 7A through Fig. 7D, another exemplary nerve holder 300 is shown. Nerve holder 300 comprises two elongated upper arms 302 and 304, a proximal end 306 and two elongated lower arms 308 and 310. Upper concave plate 312 and 314 are connected to the proximal end 306 of elongated upper arms 302 and 304, respectively, and lower concave plates 316 and 318 are connected to the proximal end 306 of elongated lower arms 308 and 310, respectively. Upper concave plates 312 and 314 curve inwardly toward lower concave plates 316 and 318 such that they couple to form a lumen capable of receiving nerve ends (Fig. 7B). In one embodiment, arms 302 and 308 can move toward each other in direction 320 to allow upper and lower concave plate 312 and 316 to couple and form a portion of the lumen. In one embodiment, arms 304 and 310 can move toward each other in direction 320 to allow upper and lower concave plate 314 and 318 to couple and form a portion of the lumen. The concave surfaces of the plates conform to the shape of nerve ends to enhance grip and to reduce trauma. In one embodiment, upper concave plates 312 and 314 are smaller in diameter compared to lower concave plates 316 and 318. In one embodiment, upper and lower concave plate 312 and 316, when coupled together, are able to secure a nerve end in place. In one embodiment, upper and lower concave plate 314 and 318, when coupled together, are able to secure an opposing nerve end in place. In order to connect the two nerve ends together, arms 302 and 308 can move in direction 322 towards arms 304 and 310. In one embodiment, after coupling of the two nerve ends by lateral movement of the multiple arms toward each other, glue can be applied through the empty space 324 to secure the nerve ends together. In one embodiment, nerve holder 300 comprises a ratchet lock 326 between arms 302 and 308. In one embodiment, nerve holder 300 comprises a ratchet lock 326 between arms 304 and 310. In one embodiment, nerve holder 300 comprises a ratchet lock 326 between arms 302 and 304. In one embodiment nerve holder 300 comprises a ratchet lock 326 between arms 308 and 310.

Referring now to Fig. 8 A through Fig. 10B, another exemplary nerve holder 500 is shown. In one embodiment, nerve holder 500 comprises a pair of forceps having a proximal end 501, a distal end 503, working end 505, elongated arms 506 and 508, arm extension 512, first hinge 514, and second hinge 516.

In one embodiment, working end 505 comprises jaw member 502 and 504, jaw components 528 and 529, and a nerve holding chamber (Fig. 10A and Fig. 10B). Jaw component 528 further comprises a top surface 530 (Fig. 10B), raised elements and a port 532. In one embodiment, raised elements are composed of at least one pillar. In one embodiment, pillars are flexible. In one embodiment, pillars are angled. In one embodiment, jaw component 529 further comprises a sprue cutter. In one embodiment, in a closed position, jaw components 528 and 529 lock together via mechanical, magnetic, tensile, or some other means and create nerve holding channel. Working end 505 further comprises a pair of jaw guides 534. Jaw guides 534 allow jaw members 502 and 504 to align. Working end 505 works in the similar manner as working end 20 described elsewhere herein.

Arm 506 comprises a thumb plate 518. Arm 506 is connected to arm extension 512 at proximal end 501, through first hinge 514. Arm extension 512 is further connected to top surface 530, through second hinge 516, such that arm extension 512 is located between first and second hinge 514 and 516. First hinge 514 is rotatable along arm 506, whereas second hinge 516 is rotatable along jaw member 502. In various embodiments, first and second hinge 514 and 516 can be living hinges, barrel hinges, or any other suitable hinge. In one embodiment, arm 506 is connected to thumb plate 518 at distal end 503 for receiving a finger of a user.

Arm 508 comprises a finger hole 520 and a third hinge 526. Arm 508 is connected to jaw member 504 at proximal end 501. Jaw member 504 is stationary and continuous to arm 508. Arm 508 further comprises a finger hole 520 at distal end 503 for receiving a finger of a user therethrough. As can be appreciated finger hole 520 and thumb plate 518 facilitate movement of arms 506 and 508 relative to one another. Arm 508 is hingedly connected to jaw member 502 at proximal end 501 through third hinge 526. In one embodiment, third hinge 526 can be living hinges, barrel hinges, or any other suitable hinge. Jaw member 502 is rotatable in relation to the stationary jaw member 504. Arm extension 512 is hingedly connected to jaw member 502 at second hinge 516 and hingedly connected to arm 506 at first hinge 514, such that arm extension 512 translates movement from arm 506 into movement in jaw member 502 to open and close jaw member 502 relative to jaw member 504.

Arms 506 and 508 each have oppositely aligned spring guides 524 and 522 respectively, each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 506 and 508 in an open position. Arm 506 is constructed to have an interior diameter that is slightly larger than arm 508 to allow arm 508 to slide up and down over arm 506. Arm 506 can slide down on arm 508 while depressing both spring guides 524 and 522 and put nerve holder 500 into a closed position. As the pressure is lifted from finger plate 518, the compression spring pushes arm 506 and 508 into the expanded steady state position (open position).

Referring now to Fig. 11 A through Fig. 14B, another exemplary nerve holder 600 is shown. In one embodiment, nerve holder 600 comprises a pair of forceps having a proximal end 601, a distal end 603, working end 605, elongated arms 606 and 608, arm extension 612, first hinge 614, and second hinge 616.

Referring to Fig. 14A and Fig. 14B, an exemplary working end 605 is depicted. In one embodiment, working end 605 comprises jaw member 602 and 604 and jaw components 628 and 629, and nerve holding chamber. Jaw component 628 further comprises a top surface 630, raised elements and a port 632. In one embodiment, raised elements are composed of at least one pillar. In one embodiment, pillars are flexible. In one embodiment, pillars are angled. In one embodiment, jaw component 629 further comprises a sprue cutter. In one embodiment, in a closed position, jaw components 628 and 629 lock together via mechanical, magnetic, tensile or some other means and create nerve holding channel. Working end 605 works in the similar manner as working end 20 described elsewhere herein.

Arm 606 comprises a thumb plate 618. Arm 606 is connected to arm extension 612 at proximal end 601, through first hinge 614. Second hinge 616 is connected to top surface 630. Arm extension 612 is located between first and second hinge 614 and 616. First hinge 614 is rotatable along arm 606, whereas second hinge 616 is rotatable along jaw member 602. First and second hinge 614 and 616 can be living hinges, barrel hinges, or any other suitable hinge. In one embodiment, arm 606 is connected to thumb plate 618 at distal end 603 for receiving a finger of the user.

Arm 608 may be constructed from two essentially mirror halves and comprises a middle section 613, a finger hole 620 and a third hinge 626. Arm 608 is connected to jaw member 604 at proximal end 601. Jaw member 604 is stationary and continuous to arm 608. Arm 608 further comprises a finger hole 620 at distal end 603 for receiving a finger of the user therethrough. As can be appreciated finger hole 620 and thumb plate 618 facilitate movement of arms 606 and 608 relative to one another. Arm 608 is hingedly connected to jaw member 602 at proximal end 601 through third hinge 626. In one embodiment, third hinge 626 can be living hinges, barrel hinges, or any other suitable hinge. Jaw member 602 is rotatable in relation to the stationary jaw member 604. Arm extension 612 is hingedly connected to jaw member 602 at second hinge 616 and hingedly connected to arm 606 at first hinge 614, such that arm extension 612 translates movement from arm 606 into movement in jaw member 602 to open and close jaw member 602 relative to jaw member 604.

Two mirror halves of case 608 are attached together by a friction fit, a snap fit, threaded fitting, or any another means of attachment. Arm 606 is fitted between the two mirrored halves of case 608 with enough space to allow arm 606 to slide up and down.

Arms 606 and 608, each have oppositely aligned spring guides

respectively located in middle section 613, parallel to arm 606 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 606 and 608 in an open position. Further, arms 606 and 608, each have oppositely aligned spring guides respectively located in between first hinge 614 and third hinge 626, having smaller diameter than arm 608 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 606 and 608 in an open position. Arm 606 is constructed to have an exterior diameter that is slightly smaller than arm 608 to allow arm 606 to slide up and down within arm 608. Arm 606 can slide down on arm 608 while depressing both spring guides and put nerve holder 600 into a closed position. As the pressure is lifted from finger plate 618, compression spring pushes arm 606 and 608 back to its steady state position (open position).

Referring now to Figs. 15 A, 15B, 16 and 17, another exemplary nerve holder 700 is shown. In one embodiment, nerve holder 700 comprises a pair of forceps having a proximal end 701, a distal end 703, a working end 705, elongated arms 706 and 708, arm extension 712, first hinge 714 and second hinge 716.

Referring to Fig. 16, an exemplary working end 705 is depicted. In one embodiment, working end 705 comprises jaw members 702 and 704 and jaw components 728 and 729 and a nerve holding chamber. Jaw component 728 further comprises a top surface 730, raised elements and a port 732. In one embodiment, raised elements are composed of at least one pillar. In one embodiment, pillars are flexible. In one embodiment, pillars are angled. In one embodiment, jaw component 729 further comprises a sprue cutter. In one embodiment, in a closed position, jaw components 728 and 729 lock together via mechanical, magnetic, tensile or some other means and create nerve holding channel. Working end 705 works in the similar manner as working end 20 described elsewhere herein.

Arm 706 comprises a thumb plate 718. Arm 706 is connected to arm extension 712 at proximal end 701, through first hinge 714. Second hinge 716 is connected to top surface 730. Arm extension 712 is located between first and second hinge 714 and 716. First hinge 714 is rotatable along arm 706, whereas second hinge 716 is rotatable along jaw member 702. In one embodiment, first and second hinge 714 and 716 can be living hinges, barrel hinges, or any other suitable hinge. In one embodiment, arm 706 is connected to thumb plate 718 at distal end 703 for receiving a finger of the user.

Arm 708 comprises a middle section 713, a finger hole 720, plurality of rails 736 and a third hinge 726. Arm 708 is connected to jaw member 704 at proximal end 701. Jaw member 704 is stationary and continuous to arm 708. Arm 708 further comprises a finger hole 720 at distal end 703 for receiving a finger of the user therethrough. As can be appreciated finger hole 720 and thumb plate 718 facilitate movement of arms 706 and 708 relative to one another. Arm 708 is hingedly connected to jaw member 702 at proximal end 701 through third hinge 726. In one embodiment, third hinge 726 can be living hinges, barrel hinges, or any other suitable hinge. Jaw member 702 is rotatable in relation to the stationary jaw member 704. Arm extension 712 is hingedly connected to jaw member 702 at second hinge 716 and hingedly connected to arm 706 at first hinge 714, such that arm extension 712 translates movement from arm 706 into movement in jaw member 702 to open and close jaw member 702 relative to jaw member 704.

In one embodiment, arms 706 and 708 each have oppositely aligned spring guides respectively located in middle section 713, parallel to arm 706 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 706 and 708 in an open position. Arm 706 further comprises plurality of clips 734 throughout the length of the arm. In one embodiment, arm 706 is attached to arm 708 by engaging clips 734 to rails 736. In one embodiment, plurality of clips 734 can be spaced apart by any suitable distance. In one embodiment, arm 706 can slide down on arm 708 while depressing spring guides and put nerve holder 700 into a closed position. As the pressure is lifted from finger plate 718, compression spring pushes arm 706 and 708 back to its steady state position (open position). In one embodiment, the sliding range of motion, is the amount of travel of clip 734 within rail 736.

Referring now to Figs. 18, 19 and 20, another exemplary nerve holder 800 is shown. In one embodiment, nerve holder 800 comprises a pair of forceps having a proximal end 801, a distal end 803, a working end 805, elongated arms 806 and 808, arm extension 812, first hinge 814 and second hinge 816.

Arm 806 comprises a thumb plate 818 and an actuated snap clip 819 (visible in Fig. 19). Arm 806 is connected to arm extension 812 at proximal end 801, through first hinge 814. Second hinge 816 is connected to top surface 830 (as labeled in Fig. 20). Arm extension 812 is located between first and second hinge 814 and 816. First hinge 814 is rotatable along arm 806, whereas second hinge 816 is rotatable along jaw member 802. First and second hinge 814 and 816 can be living hinges, barrel hinges, or any other suitable hinge. In one embodiment, arm 806 is connected to thumb plate 818 at distal end 803 for receiving a finger of the user.

Arm 808 may be constructed from two essentially mirror halves and comprises a middle section 813, a finger hole 820 and a third hinge 826. Arm 808 is connected to jaw member 804 at proximal end 801. Jaw member 804 is stationary and continuous to arm 808. Arm 808 further comprises a finger hole 820 at distal end 803 for receiving a finger of the user therethrough. As can be appreciated finger hole 820 and thumb plate 818 facilitate movement of arms 806 and 808 relative to one another. Arm 808 is hingedly connected to jaw member 802 at proximal end 801 through third hinge 826. In one embodiment, third hinge 826 can be living hinges, barrel hinges, or any other suitable hinge. Jaw member 802 is rotatable in relation to the stationary jaw member 804. Arm extension 812 is hingedly connected to jaw member 802 at second hinge 816 and hingedly connected to arm 806 at first hinge 814, such that arm extension 812 translates movement from arm 806 into movement in jaw member 802 to open and close jaw member 802 relative to jaw member 804.

Two mirror halves of case 808 are attached together by a friction fit, a snap fit, threaded fitting, or any another means of attachment. Arm 806 is fitted between the two mirrored halves of case 808 with enough space to allow arm 806 to slide up and down.

Arms 806 and 808, each have oppositely aligned spring guides

respectively located in middle section 813, parallel to arm 806 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 806 and 808 in an open position. Further, arms 806 and 808, each have oppositely aligned spring guides respectively located in between first hinge 814 and third hinge 826, having smaller diameter than arm 808 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 806 and 808 in an open position. Arm 806 is constructed to have an exterior diameter that is slightly smaller than arm 808 to allow arm 806 to slide up and down within arm 808. Arm 806 can slide down on arm 808 while depressing both spring guides and put nerve holder 800 into a closed position In one embodiment, snap clip 819 locks jaw members 802 and 804 in the closed position as the pressure is lifted from thumb plate 818. In one embodiment, from the closed position, pushing snap clip 819 past thumb plate 818 unlocks jaw members 802 and 804 and compression spring pushes arm 806 and 808 back to its steady state position (open position).

Referring now to Fig. 20, an exemplary working end 805 comprises jaw members 802 and 804, jaw components 828 and 829, a nerve holding chamber, and a port 832. In one embodiment, port 832 positioned laterally and partly attached to elongated arm 808 and comprises a lumen that extends from port 832 to jaw member 804. In one embodiment, this design is to help direct the glue injection so that glue flows along the nerve and does not apply a perpendicular force directly at the point of contact between two nerve ends. In one embodiment, this design improves the visibility at proximal end 801 of nerve holder 800 when applying the glue. Jaw component 828 further comprises a top surface 830 and raised elements 856. In one embodiment, raised elements are composed of at least one pillar. In one embodiment, the pillars are flexible. In one embodiment, the pillars are angled. In one embodiment, jaw component 829 further optionally comprises a sprue cutter. In one embodiment, in a closed position, jaw components 828 and 829 lock together via mechanical, magnetic, tensile or some other means and create a nerve holding channel. Working end 805 works in the similar manner as working end 20 described elsewhere herein.

Referring now to Figs. 21 and Fig. 22, another exemplary nerve holder 900 is shown. In one embodiment, nerve holder 900 comprises a pair of forceps having a proximal end 901, a distal end 903, a working end 905, elongated arms 906 and 908, arm extension 912, first hinge 914 and second hinge 916.

Arm 906 comprises a thumb plate 918 and an actuated snap clip 919. Arm 906 is connected to arm extension 912 at proximal end 901, through first hinge 914. Second hinge 916 is connected to top surface 930. Arm extension 912 is located between first and second hinge 914 and 916. First hinge 914 is rotatable along arm 906, whereas second hinge 916 is rotatable along jaw member 902. First and second hinge 914 and 916 can be living hinges, barrel hinges, or any other suitable hinge. In one embodiment, arm 906 is connected to thumb plate 918 at distal end 903 for receiving a finger of the user.

Arm 908 may be constructed from two essentially mirror halves and comprises a middle section 913, a finger hole 920 and a third hinge 926. Arm 908 is connected to jaw member 904 at proximal end 901. Jaw member 904 is stationary and continuous to arm 908. Arm 908 further comprises a finger hole 920 at distal end 903 for receiving a finger of the user therethrough. As can be appreciated finger hole 920 and thumb plate 918 facilitate movement of arms 906 and 908 relative to one another. Arm 908 is hingedly connected to jaw member 902 at proximal end 901 through third hinge 926. In one embodiment, third hinge 926 can be living hinges, barrel hinges, or any other suitable hinge. Jaw member 902 is rotatable in relation to the stationary jaw member 904. Arm extension 912 is hingedly connected to jaw member 902 at second hinge 916 and hingedly connected to arm 906 at first hinge 914, such that arm extension 912 translates movement from arm 906 into movement in jaw member 902 to open and close jaw member 902 relative to jaw member 904.

Two mirror halves of case 908 are attached together by a friction fit, a snap fit, threaded fitting, or any another means of attachment. Arm 908 is fitted between the two mirrored halves of case 908 with enough space to allow arm 906 to slide up and down.

Arms 906 and 908, each have oppositely aligned spring guides respectively located in middle section 913, parallel to arm 906 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 906 and 908 in an open position. Further, arms 906 and 908, each have oppositely aligned spring guides respectively located in between first hinge 914 and third hinge 926, having smaller diameter than arm 908 and each sized to receive opposing ends of a compression spring (not pictured) to provide a spring force between arms 906 and 908 in an open position. Arm 906 is constructed to have an exterior diameter that is slightly smaller than arm 908 to allow arm 906 to slide up and down within arm 908. Arm 906 can slide down on arm 908 while depressing both spring guides and put nerve holder 900 into a closed position. In one embodiment, snap clip 919 locks jaw members 902 and 904 in the closed position as the pressure is lifted from thumb plate 918. In one embodiment, from the closed position, pushing snap clip 919 past thumb plate 918 unlocks jaw members 902 and 904 and compression spring pushes arm 906 and 908 back to its steady state position (open position).

Referring now to Fig. 22, an exemplary working end 905 comprises jaw members 902 and 904, jaw components 928 and 929, and a nerve holding chamber. Jaw component 929 further comprises a top surface 930, raised elements 956 and a port 932. In one embodiment, port 932 is located off center on outer surface 930 of jaw component 929. This design is to help direct the glue injection so that glue flows along the nerve and does not apply a perpendicular force directly at the point of contact between two nerve ends. In one embodiment, the raised elements are composed of at least one pillar. In one embodiment, the pillars are flexible. In one embodiment, the pillars are angled. In one embodiment Jaw component 929 further optionally comprises a sprue cutter. In one embodiment, in a closed position, jaw components 928 and 929 lock together via mechanical, magnetic, tensile or some other means and create a nerve holding channel. Working end 905 works in the similar manner as working end 20 described elsewhere herein.

Method of Use

The present invention also relates to methods for performing nerve anastomosis. In some embodiments, the methods include steps of providing a nerve holder of the present invention, holding and securing opposing nerve ends of a subject adjacent to each other using the nerve holder, and quickly and consistently applying a sufficient amount of bio-adhesive to the entire circumference of the gap between the nerve ends. In one embodiment, the methods include steps of providing an implantable nerve holder, holding and securing opposing nerve ends of a subject adjacent to each other using the implantable nerve holder, applying a sufficient amount of bio-adhesive to the entire circumference of the gap between the nerve ends, and leaving the implantable component inside the subject. In one embodiment, the method further comprises a step of removing the implantable nerve holder from a repaired nerve. In one embodiment, the implantable nerve holder is absorbable and is not removed from a repaired nerve.

Referring now to Fig. 23, an exemplary method 400 of using a nerve holder for glue-based anastomosis is depicted. Method 400 begins with step 402, wherein a nerve holder is provided, the nerve holder having a handle comprising a first and a second arm, an upper and lower jaw component attached to the first and second arm, respectively, the jaw components defining a lumen when coupled together, and at least one port fluidly connected to the lumen. In step 404, the upper and lower jaw components are placed and coupled around two nerve ends such that the two nerve ends are held adjacent to each other within the lumen. In step 406, an existing syringe filled with glue is inserted into the port and utilized such that the glue enters the lumen and surrounds the two nerve ends. In step 408, the glue is cured. In step 410, the jaw components are optionally uncoupled, wherein the at least one port optionally comprises a sprue cutter that detaches cured glue in the port from the nerve ends or leaving the bioresorbable or degradable jaw components in the patient to be bio-resorbed or degrade.

The disclosures of each and every patent, patent application, and publication cited herein are hereby each incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.

Claims

CLAIMS What is claimed is:

1. A nerve holder device comprising:

a first and a second arm member, each arm having a proximal end nearest to a site of nerve injury and a distal end nearest to an operator of the device; a first and a second jaw member attached at the proximal end of the first and second arm member, respectively, the first and second jaw members each comprising an outer surface, an inner surface, and couple together such that the inner surfaces define a lumen; and at least one of the jaw member further comprising at least one port extending from an outer surface to an inner surface.

2. The nerve holder device of claim 1, the at least one port further comprising a sprue cutting ring.

3. The nerve holder device of claim 1, the inner surface of the first and second jaw members further comprises a roughened texture.

4. The nerve holder device of claim 1, the inner surface of the first and second jaw members further comprising at least one circumferential channel.

5. The nerve holder device of claim 1, the inner surface of the first and second jaw members further comprising at least one channel.

6. The nerve holder device of claim 1, the first and second jaw members are removable or detachable.

7. The nerve holder device of claim 1, the inner surface of the first and second jaw members further comprising at least one supporting pad.

8. The nerve holder device of claim 1, the inner surface of the first and second jaw members further comprising raised elements.

9. The nerve holder device of claim 1, the first and second jaw members are constructed from a biodegradable and absorbable material that may be removed or detached in part or entirely and left in a subject following a procedure.

10. The nerve holder device of claim 1, the first and second jaw members further comprising interlocking lips.

11. The nerve holder device of claim 1, further comprising at least one pivot point coupled to at least one arm member to actuate at least one jaw member.

12. The nerve holder device of claim 1, the first and second arm members slide over each other to actuate at least one jaw member.

13. The nerve holder device of claim 1, the port is offset from center of the first jaw member.

14. The nerve holder device of claim 1, the port further comprising a port lumen positioned laterally to first and second arm member.

15. The nerve holder device of claim 1, further comprising a clip on at least one arm member capable of locking the first and second jaw members in the closed position.

16. A method for repairing peripheral nerve injuries in a subject comprising: providing a nerve holder having a first and a second arm, an upper and lower jaw component attached to the first and second arm, respectively, the jaw components defining a lumen when coupled together, and at least one port fluidly connected to the lumen;

placing and coupling the upper and lower jaw components around the two nerve ends such that the two nerve ends are held adjacent to each other within the lumen;

inserting and utilizing an existing syringe filled with glue into the port such that the glue enters the lumen and surrounds the two nerve ends; and

curing the glue.

17. The method of claim 16, further comprising a step of uncoupling the jaw component and removing said components from the nerve ends.

18. The method of claim 16, at least one port comprises a sprue cutting ring, and further comprising a step of uncoupling the jaw components such that the sprue cutting ring detaches cured glue in the port from the nerve ends.

19. The method of claim 16, wherein the inner surface of the first and second jaw members comprises a roughened texture.

20. The method of claim 16, wherein the inner surface of the first and second jaw members comprises at least one circumferential channel.

21. The method of claim 16, wherein the inner surface of the first and second jaw members comprises at least one axial channel.

22. The method of claim 16, wherein the first and second jaw members are removable or detachable.

23. The method of claim 22, wherein the first and second jaw members are constructed from a bioresorbable or degradable material.

24. The method of claim 23, further comprising a step of detaching the first and second jaw members in part or entirely from the nerve holder and leaving the detached first and second jaw members in a patient following a procedure.

25. The method of claim 16, wherein the inner surface of the first and second jaw members comprises at least one supporting pad.

26. The method of claim 16, wherein the inner surface of the first and second jaw members comprises raised elements.

27. The method of claim 16, wherein the first and second jaw members comprise interlocking lips.