Tissue clamp and implantation method

Abstract

To provide surgical tissue clamps, methods of using them, and transplantation techniques.SOLUTION: A surgical clamp 14 for aligning the margins of incised or wounded tissue has jaws 16, 20 with parallel clamping faces, and a handle 24 for manipulating the clamp to align the margins of the tissue. The jaws are in a normally closed position; however, they can be opened by compressing the handle to open the jaws. Prongs project from the inferior surface of the jaws. The clamp is positioned in a desired position over the margins of a wound to be closed, the prongs engage the margins of the wound to be aligned, and the jaws are closed by releasing compressive force on the handle. As the jaws close, the prongs help move the tissue into alignment. Suture guide slots 54 through the jaws assist in the placement of precisely placed sutures across the incision.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] This invention was made with Government support under Project No. Z01#:EY000533-03 awarded by the National Institutes of Health, National Eye Institute. The Government has certain rights in this invention.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 62 / 419,804, filed November 9, 2016, which is incorporated herein by reference in its entirety.

[0003] Field The present invention relates to surgical tissue clamps and their methods of use and implantation techniques. [Background technology]

[0004] background Minimally invasive surgery reduces surgical tissue damage by allowing procedures to be performed with miniature instruments introduced through smaller incisions. However, minimally invasive procedures often require multiple small incisions through which different instruments are introduced into the body. For example, minimally invasive surgery may require the introduction of scalpels, cannulas, and illuminated laser probes into the body through various incisions.

[0005] During vitreoretinal surgery, multiple instruments are introduced through a scleral opening (sclerotomy) in the eye wall, through which vitreous and other fluids can leak. Loss of intraocular fluid can lead to surgical complications such as eye collapse, retinal hemorrhage, and retinal detachment. Some intraocular procedures, such as retinal transplantation or implantation with in vitro retinal tissue, can require creating a significant incision, in that the eye must be repeatedly opened and closed while minimizing disruption of intraocular pressure equilibrium. A fluid-tight scleral incision, which mandates constant infusion of replacement fluid into the eye, would avoid excessive or continuous fluid loss.

[0006] Many other surgical or traumatic wounds require selective closure with coaptation of the wound's conformal edges. Examples of such wounds include incisions in large blood vessels, the skin, or hollow internal organs (such as the intestines). Battlefield or other traumatic injuries may produce wounds, such as lacerations, that require rapid closure to achieve life-saving hemostasis, or penetrating injuries that may require temporary closure that aborts the entire surgical repair.

[0007] Currently available medical clamps do not easily reversibly join opposing edges of a surgical incision in a safe and efficient manner and maintain the structural integrity of variable size incisions. The incision can be manually sutured to close the wound, and the sutures can then be removed to open it, but this approach is time consuming and can damage the tissue. U.S. Patent No. 6,217,594 discloses an expandable malleable metal clamp that is pressed against the surface of the eye to create a scleral fold and close the incision. U.S. Patent Application Publication No. 2005 / 0251204 describes a wound clamp with hinged identical halves that are biased together with a spring or elastic band to clamp the underlying tissue. Each half of the wound clamp has a cutout portion associated with the other half of the clamp that, when closed, leaves a central opening in the clamp. U.S. Patent Application Publication No. 2013 / 0204294 shows a clamshell clamp having complementary opposing arms with a distal end that can be locked into place with a ratchet for rapid closure of surgical and traumatic wounds.

[0008] Surgical clips are commonly used to ligate, clamp, or otherwise occlude blood vessels within a surgical site to keep the surgical site relatively blood-free and minimize blood loss. Clips are often in the form of thin, narrow, metallic or polymeric U- or V-shaped members that are placed across a vessel or tissue and then urged into a closed position using a clip applicator. Clips are typically constructed from metal and may be first opened and then permanently transformed into a closed or clamping configuration around a desired blood vessel or other tissue structure using an appropriate clip applicator. Examples of such clips are described in U.S. Patent Nos. 5,201,746, 4,976,722, 4,844,066, 4,799,481, 4,449,530, and 4,146,130.

[0009] Clips are also known that have clamping members configured in a normally closed position. A normally closed clip typically has its clamping members biased together using the resilience of the material from which it is constructed. Generally, to apply a clip configured in a normally closed position, the clamping members must be pushed open by a suitable clip applicator and then released to its closed position in place over the desired structure to be clamped. Normally closed clips may be formed from a continuous wire with a torsion spring or tension coil, as described, for example, in U.S. Pat. No. 5,593,414, or may be of various other configurations, such as those described, for example, in U.S. Pat. Nos. 5,695,505, 5,601,574, 5,366,458, and 4,957,500.

[0010] There is a need for a convenient tissue clamp that can be easily manually manipulated and rapidly closed to selectively open and close surgical incisions and traumatic wounds, such as penetrating injuries, which must achieve hemostasis and protect the wound until the surgical repair can be completed. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Patent No. 6,217,594 [Patent Document 2] US Patent Application Publication No. 2005 / 0251204 [Patent Document 3] US Patent Application Publication No. 2013 / 0204294 [Patent Document 4] U.S. Pat. No. 5,201,746 [Patent Document 5] U.S. Pat. No. 4,976,722 [Patent Document 6] U.S. Pat. No. 4,844,066 [Patent Document 7] U.S. Pat. No. 4,799,481 [Patent Document 8] U.S. Pat. No. 4,449,530 [Patent Document 9] U.S. Pat. No. 4,146,130 [Patent Document 10] U.S. Patent No. 5,695,505 [Patent Document 11] U.S. Pat. No. 5,601,574 [Patent Document 12] U.S. Pat. No. 5,366,458 [Patent Document 13] U.S. Patent No. 4,957,500 Summary of the Invention [Means for solving the problem]

[0012] Abstract The aforementioned needs are addressed by the disclosed surgical instrument for clamping a target structure, such as the margins of a surgical incision or other wound. The instrument has a clamp with a first jaw forming a first clamping surface and a second jaw forming a second clamping surface opposite the first clamping surface. A handle connects to the first and second jaws, the handle having a resilient biasing force that urges the first and second clamping surfaces relative to one another into a substantially closed relationship for clamping the target structure. The handle functions like a normally closed clip that is movable to overcome the resilient biasing force and open the clamp by moving the first and / or second jaws to an open position while maintaining the first and second clamping surfaces in an orientation that is substantially parallel to one another.

[0013] In some examples, the handle is a clip-like structure made of a single continuous length of resiliently biased material configured to open the jaws in response to a compressive force applied to the handle. The handle may be a continuous metal or alloy wire connector having an arm portion and a leg portion that may be flush with one another. The arm portion has first and second substantially parallel arms that are connected to the first and second jaws, respectively, while the legs are non-parallel and join at a common apex of the leg portion with a resilient biasing force that closes the jaws. Compression of the non-parallel legs of the handle moves the first and second arms against the resilient biasing force and opens the jaws. In some embodiments, at the middle portion of the handle (between the arm portion and the leg portion), the handle crosses over itself, for example, forming a stabilizing channel. Compression of the leg portion moves the first and second arms and the attached jaws away from one another without twisting the jaws out of a pre-determined (e.g., parallel) relationship. Compression of the handle of the instrument allows the jaws to be dexterously opened by the surgeon or assistant during the procedure. This ease of use allows the wound to be repeatedly closed and reopened during the course of the procedure, if desired, allowing the instrument to be introduced into and removed from the body while selectively securing and closing the wound when, for example, open access is not required. In some embodiments, the jaws of the clamp do not form an opening through which a surgical instrument other than a needle may be placed. Alternatively, a small opening may be provided through the closed jaws to form a surgical port channel for accessing the ocular cavity without opening the clamp. Some surgical instruments, such as vitreoretinal instruments (e.g., 25 or 27 gauge retinal forceps or vitrectomy), may be introduced into the eye through the opening of the closed jaws.

[0014] In some embodiments, the handle is compressible to open the clamp while maintaining the first and second biting surfaces in a substantially parallel relationship to each other. The alignment guide maintains the first and second biting surfaces in a substantially parallel relationship to each other and resists torque as the jaws open and close. For example, the alignment guide may be interdigitated alignment members carried by each of the first and second jaws, respectively. In the illustrated embodiment, the alignment members include a pair of parallel guide bars extending from the first jaw toward the second jaw and an alignment bar extending from the second jaw toward the first jaw. The alignment bar slides between the parallel guide bars to maintain the movement of the jaws in a plane defined by the parallel guide bars. In other embodiments, the alignment guide is a channel on the handle, formed, for example, by bending a wire frame of the handle into an alignment channel through which one of the arms of the instrument projects and guides the movement of that arm in a plane defined by the plane of the guide channel.

[0015] In some embodiments, the suture guide slot extends through the first and second jaws and defines a needle trajectory for placing the suture across the incision closed by the clamp. For example, the suture guide slot extends laterally between the first and second jaws for a predetermined distance corresponding to the entry and exit points of the suture placed across the incision. The guide slot may have a bevel at its end (opposite the slot) to guide the needle along the needle trajectory. The guide slot helps control the width and depth of the suture, which may be advantageous, especially when operating on relatively thin structures such as the eyewall.

[0016] In yet another embodiment, the clamp has a lower surface cooperatively formed by the first and second jaws for resting on the tissue to be clamped, and a counter-upper surface cooperatively formed by the first and second jaws, and the clamp thickness tapers toward the bite surface and the suture guide slot to minimize the clamp thickness along the path of the suture guide. One or both of the upper and lower surfaces may be arcuate. The arcuate upper surface may, for example, reduce the thickness of the jaw toward the bite surface and the suture guide slot. In another example, the upper surface is arcuate and tapers symmetrically to the opposing bite surface, and the suture guide slot extends substantially perpendicular to the opposing bite surface. In another example, the lower surface of the jaw is curved to conform to the shape of the anatomical structure to be clamped, e.g., the target structure, such as an intestinal wall, a blood vessel, or an eye wall. In yet another embodiment, the jaw is a thin curved member having top and bottom surfaces that are curved with a predetermined radius of curvature to conform to the shape of the underlying surface to be clamped. For example, when the clamp is to be used on a curved surface such as the eye, the radius of curvature may be about 10-14 mm, for example 12 mm.

[0017] In other embodiments, compression protrusions extend downwardly from the underside of each jaw toward one another and toward the incision to be closed. The protrusions may be substantially straight barbs or curved barbs, although straight barbs may provide improved hemostasis at the wound margins.

[0018] Methods are also disclosed for closing wounds using clamps. The clamps may be opened by moving the handles, for example by compressing the handles to overcome the normal closing bias of the jaws. The clamps are placed on the wound with the wound edges between the biting surfaces of the jaws, and the clamps are closed with the wound edges retained between the biting surfaces. The wound may be sutured with the clamps in place on the wound, for example by introducing a needle and suture into the guide slot along a trajectory defined by a slot in the jaws. In those embodiments having barbs on the jaws, the barbs grasp tissue on opposing edges of the wound. While wounds may be the result of traumatic injuries, clamps are particularly adapted for use in surgical procedures to selectively open and close surgical incisions. In certain examples, the clamps are used for intraocular surgical procedures, such as vitreoretinal procedures, to selectively open and close incisions to help maintain intraocular fluid balance and avoid undesirable complications such as eye collapse, bleeding, and retinal detachment.

[0019] Emerging potential cell-based therapies in the eye designed to treat age-related macular degeneration (AMD), geographic atrophy (GA), retinal pigment epithelial tears, choroidal neovascularization, and retinitis pigmentosa (RP) require the delivery of newly grown cell layers such as retinal pigment epithelium (RPE), retinal cells, choroidal cells, microvessels, or combinations thereof. Retinal prosthesis electrode tips, such as the Argus® II retinal prosthesis, may also be used. Many of these procedures are performed through large sclerotomies to deliver tissue to the inside of the eye, which results in increased risk of eye collapse, retinal detachment, and bleeding due to loss of intraocular pressure (IOP). These risks can be minimized by the use of the clamps of the present disclosure, which can be kept closed when not in use, allowing repeated re-entry through the wound. For example, the clamps can be used in procedures to deliver iPS cell-derived RPE cell layers grown on a biodegradable scaffold into the subretinal space. In other disclosed embodiments, the clamp is useful for rapid closure of penetrating traumatic injuries to the eye, or for surgical procedures on any anatomical structure, such as a body cavity, blood vessel, or hollow viscera.

[0020] When used on the eye, the clamp can close large eye wounds and maintain and / or stabilize intraocular pressure. In eye or any other type of surgery, the clamp can also help establish hemostasis. The clamp can provide precise tissue alignment and in some embodiments even allow precise suture placement at controlled depth and distance from the tissue edge. This allows for passage of surgical instruments into the eye and can be scaled and modified to apply to a variety of surgical procedures. The disclosed clamp allows opposing edges of the wound to be precisely and selectively aligned, easily reopened, allowing re-entry through the sclerotomy, and subsequently aligned for good permanent closure with sutures. The present invention provides, for example, the following: (Item 1) 1. A surgical instrument for gripping a target structure, comprising: a clamp having a first jaw defining a first biting surface and a second jaw defining a second biting surface opposite the first biting surface; a handle connecting to the first and second jaws, the handle having a resilient biasing force resiliently biasing the first and second gripping surfaces relative to one another into a substantially closed relationship for gripping the target structure; Equipped with The handle is movable to overcome the resilient biasing force and open the clamp by moving the first jaw and / or the second jaw to an open position while maintaining the first and second biting surfaces in a substantially aligned orientation relative to one another. (Item 2) 2. The surgical instrument of claim 1, wherein the handle is a single continuous length of resiliently biased material configured to open the jaws in response to a compressive force applied to the handle. (Item 3) 3. The surgical instrument of claim 2, wherein the handle comprises a continuous metal or alloy wire connector forming an arm portion and a leg portion of the handle, the arm portion comprising first and second substantially parallel arms connected to the first and second jaws, respectively, the leg portions comprising first and second legs that are non-parallel and join at a common apex of the leg portions with a resilient biasing force that closes the jaws, and compression of the non-parallel first and second legs of the handle towards one another moves the first and second arms against the resilient biasing force to open the jaws. (Item 4) 4. The surgical instrument of claim 3, wherein the handle includes an intermediate portion between the arm portion and the leg portion, the intermediate portion crossing over itself such that compression of the leg portions to move the first and second legs toward one another overcomes the resilient biasing force and moves the first and second arms away from one another, thereby moving the first and second jaws of the clamp away from one another. (Item 5) 5. The surgical instrument of any one of claims 1-4, wherein the handle is compressible to open the clamp while maintaining the first and second biting surfaces in a substantially parallel relationship relative to one another. (Item 6) 6. The surgical instrument of any one of claims 1-5, further comprising an alignment guide that maintains the first and second bite surfaces in a substantial aligned relationship relative to one another and resists torque that would twist the first and second bite surfaces out of the aligned relationship. (Item 7) 7. The surgical instrument of claim 6, wherein the alignment guide comprises interdigitated alignment members carried by each of the first and second jaws, respectively. (Item 8) 8. The surgical instrument of claim 7, wherein the alignment member comprises a pair of parallel guide bars extending from the first jaw toward the second jaw and an alignment bar extending from the second jaw toward the first jaw, the alignment bar sliding between the parallel guide bars to maintain movement of the jaws in a plane defined by the parallel guide bars. (Item 9) 8. The surgical instrument of claim 6 or 7, wherein the alignment guide is formed by a bent portion of an intermediate portion of the wire connector. (Item 10) 10. The surgical instrument of claim 9, wherein the bent portion comprises a bend in a first leg of the wire connector forming an elongated alignment channel through which the second leg extends and which maintains an aligned orientation of the first and second bite surfaces. (Item 11) 11. The surgical instrument of any one of claims 1-10, wherein the first and second biting surfaces are arcuate. (Item 12) 12. The surgical instrument of any one of items 1-11, further comprising a suture guide slot extending through the first and second jaws and defining a needle trajectory for placing a suture across an incision closed by the clamp. (Item 13) Item 13. The surgical instrument of item 12, wherein the suture guide slot extends laterally between the first and second jaws a predetermined distance corresponding to entry and exit points of a suture placed across the incision. (Item 14) 14. The surgical instrument of claim 12 or 13, wherein the guide slot includes a bevel at an end thereof to guide the needle along the needle trajectory. (Item 15) 15. The surgical instrument of any one of items 12-14, wherein the biting surface comprises an underside of the clamp formed by the first and second jaws in cooperation for placement on tissue to be bitten, the clamp further comprising a counter-upside surface formed by the first and second jaws in cooperation that is arcuate, and the clamp thickness tapers toward the biting surface and the suture guide slot to minimize clamp thickness along the path of the suture guide. (Item 16) Item 16. The surgical instrument of item 15, wherein the upper surface is arcuate and symmetrically tapered relative to the opposing biting surface, and the suture guide slot extends substantially perpendicular to the opposing biting surface. (Item 17) Item 17. The surgical instrument of any one of items 1-16, wherein the clamp has a lower surface for placement on tissue to be clamped and an opposing surface facing upwardly away from the tissue, the clamp further comprising a compression protrusion extending downwardly from the underside of each jaw toward the incision to be closed. (Item 18) Item 18. The surgical instrument of item 17, wherein the prongs are barbed. (Item 19) Item 18. The surgical instrument of item 17, wherein the prongs are substantially straight needles. (Item 20) 20. The surgical instrument of any one of claims 1-19, wherein the clamp has a lower surface for placement on tissue to be clamped and an opposing surface, the lower surface being curved to conform to the shape of the anatomical structure to be clamped. (Item 21) 21. The surgical instrument of any one of claims 1-20, wherein the arms and legs of the handle are substantially coplanar. (Item 22) 1. A surgical instrument for gripping a wound or surgical incision, comprising: a clamp having a first jaw forming a first gripping surface and a second jaw forming a second gripping surface, each of the jaws having a lower surface for placement against tissue to be gripped and an upper surface facing upwardly and away from the tissue; a compression projection extending downwardly from the underside of each jaw, said projections being angled in a closing direction; a handle connected to said first and second jaws, said handle being a one-piece continuous length resiliently biased metal or alloy wire connector that resiliently biases said first and second bite surfaces relative to one another into a substantially closed relationship for biting said target structure, said handle being compressible to open said jaws in response to a compressive force applied to said handle, said handle comprising an arm portion and a leg portion, said arm portion comprising first and second substantially parallel arms connected to said first and second jaws, respectively, said leg portions comprising first and second non-parallel legs joining at a common apex of said leg portions with a resilient biasing force that closes said jaws, but compression of the first and second non-parallel legs of the handle moves the first and second arms against the resilient biasing force to open said jaws while holding said first and second bite surfaces in a substantially aligned relationship relative to one another; an alignment guide for maintaining the first and second bite surfaces in a substantially parallel relationship relative to one another, the alignment guide comprising interdigitated first and second alignment members carried by the first and second jaws, respectively; a suture guide slot extending through the first and second jaws and defining a needle trajectory for placing a suture across an incision closed by the clamp, the guide slot extending substantially transversely to the first and second bite surfaces; a compression barb extending downwardly from an underside of the first jaw and the second jaw, the barb on the underside of the first jaw being angled toward a barb on the underside of the second jaw to compress the incision to be closed; A surgical instrument comprising: (Item 23) 23. The surgical instrument of claim 22, wherein the guide slot includes a bevel at opposing ends thereof to guide the needle along the needle trajectory, and a lower and / or upper surface of the clamp is curved. (Item 24) 24. A method of closing a wound using a device according to any one of items 1-23, comprising: moving the handle to overcome the resilient biasing force and open the clamp; placing the clamp on the wound with the wound edge between the gripping surfaces of the first and second jaws; closing the jaws of the clamp with the wound edges retained between the bite surfaces; A method comprising: (Item 25) Item 25. The method of item 24, wherein the handle is a single continuous length of resiliently biased material configured to open the jaws in response to a compressive force applied to the handle, and wherein moving the handle to overcome the resilient biasing force and open the clamp includes compressing the handle. (Item 26) 26. The method of any one of claims 24 or 25, wherein the instrument includes a guide slot extending laterally through the first and second jaws and defining the needle trajectory, the method further comprising the steps of introducing a curved needle into the needle trajectory and placing a suture along the needle trajectory across a margin of the wound. (Item 27) 27. The method of any one of claims 24-26, wherein the instrument comprises a barb on an underside of the jaw, the method further comprising inserting the barb into the skin as the jaws of the clamp close with the wound edges retained between the bite surfaces. (Item 28) 28. The method according to any one of items 24-27, wherein the wound is a surgical incision. (Item 29) 30. The method of claim 28, wherein the surgical incision is opened and closed multiple times during the surgical procedure by removing and reapplying the clamp to the incision. (Item 30) 30. The method of any one of items 24-29, wherein the surgical incision is a sclerotomy in the eye, and the choroid underlying the sclerotomy incision is pre-treated with a laser to cauterize blood vessels in the choroid underlying the sclerotomy incision prior to making the surgical incision. (Item 31) 31. The method of any one of items 24-30, wherein the surgical incision is a sclerotomy incision in the eye, and retinal tissue or a retinal prosthesis is implanted into the retina of the eye, and further wherein the tissue recipient is immunosuppressed after the procedure to minimize rejection of the implanted tissue.

[0021] The foregoing and other objects, features, and advantages of the present invention will become more apparent from the following detailed description of the invention, considered in conjunction with the accompanying drawings. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a top perspective view of a first embodiment of a surgical clamp in a closed configuration in which opposing inner surfaces fit together to close an incision or other wound. [Diagram 2] FIG. 2 is a top perspective view of the clamp shown in FIG. 1, but with the spring clip handle compressed, opening the jaws of the clamp body. [Figure 3A] 3A is an end elevational view of the surgical clamp of FIG. 1 illustrating a first embodiment of a wound compression projection on the underside of the arm. [Figure 3B] FIG. 3B is an end elevational view similar to FIG. 3A, but showing an alternative embodiment of the wound compression projection. [Figure 4] FIG. 4 is an enlarged perspective view of the clamp jaws and the distal end of the clip handle. [Diagram 5] 5 is an isolated perspective view, partially in section, of a portion of the clamp taken along line 5-5 in FIG. 4 through the needle guide of the clamp jaws. [Figure 6]FIG. 6 is a schematic diagram of a surgical clamp in use to close a sclerotomy incision in a patient's eye during a vitreoretinal surgical procedure. [Figure 7] FIG. 7 is a perspective view of another embodiment of a surgical clamp applied to the wall of a curved structure, such as a hollow organ or blood vessel, to temporarily close an incision or wound. [Figure 8] FIG. 8 is a perspective view of another embodiment of a surgical clamp for application to a substantially flat surface area, such as skin. [Figure 9] FIG. 9 is a bottom view of the embodiment shown in FIG. 3B illustrating the orientation of the closed needle on the underside of the jaw. [Figure 10] FIG. 10 is an end perspective view of the distal end of the clamp showing a first embodiment of a clamp alignment structure for maintaining the clamp substantially flat with its arms aligned, and needle-shaped compression protrusions on the underside of the clamp jaws. [Figure 11A] FIG. 11A is a schematic cross-section of an eye showing a clamp closing a sclerotomy incision and a compression protrusion compressing tissue into a tight fit on either side of the surgical incision through the eye wall below the closed clamp. [Figure 11B] FIG. 11B is an enlarged view of the surgical clamp shown in FIG. 11A illustrating tissue margin alignment and hemostasis achieved by the compression needles of the closed clamp. [Figure 12A]12A-12D illustrate another embodiment of a surgical clamp, where the jaws are curved to achieve a tighter seal of the wound, and the middle portion of the wire clip is bent to form a guide channel to maintain the jaws in a desired alignment as the clamp is opened and closed. The narrow width of the clamp jaws also minimizes obstruction of the surgical field and the microscope field. Placing the guide channel in the handle (instead of the jaws) minimizes inadvertent trauma to the underlying tissue while allowing the arms of the handle to move apart in the plane of the channel and maintain a predetermined alignment of the jaws as they move away from and towards each other. For example, the opposing faces of the jaws are maintained substantially parallel to each other as the jaws move. Small openings through the jaws allow smaller bore instruments to be placed directly through the jaws. Larger instruments are introduced into the eye by opening the jaws of the clamp. [Figure 12B] 12A-12D illustrate another embodiment of a surgical clamp, where the jaws are curved to achieve a tighter seal of the wound, and the middle portion of the wire clip is bent to form a guide channel to maintain the jaws in a desired alignment as the clamp is opened and closed. The narrow width of the clamp jaws also minimizes obstruction of the surgical field and the microscope field. Placing the guide channel in the handle (instead of the jaws) minimizes inadvertent trauma to the underlying tissue while allowing the arms of the handle to move apart in the plane of the channel and maintain a predetermined alignment of the jaws as they move away from and towards each other. For example, the opposing faces of the jaws are maintained substantially parallel to each other as the jaws move. Small openings through the jaws allow smaller bore instruments to be placed directly through the jaws. Larger instruments are introduced into the eye by opening the jaws of the clamp. [Figure 12C]12A-12D illustrate another embodiment of a surgical clamp, where the jaws are curved to achieve a tighter seal of the wound, and the middle portion of the wire clip is bent to form a guide channel to maintain the jaws in a desired alignment as the clamp is opened and closed. The narrow width of the clamp jaws also minimizes obstruction of the surgical field and the microscope field. Placing the guide channel in the handle (instead of the jaws) minimizes inadvertent trauma to the underlying tissue while allowing the arms of the handle to move apart in the plane of the channel and maintain a predetermined alignment of the jaws as they move away from and towards each other. For example, the opposing faces of the jaws are maintained substantially parallel to each other as the jaws move. Small openings through the jaws allow smaller bore instruments to be placed directly through the jaws. Larger instruments are introduced into the eye by opening the jaws of the clamp. [Figure 12D] 12A-12D illustrate another embodiment of a surgical clamp, where the jaws are curved to achieve a tighter seal of the wound, and the middle portion of the wire clip is bent to form a guide channel to maintain the jaws in a desired alignment as the clamp is opened and closed. The narrow width of the clamp jaws also minimizes obstruction of the surgical field and the microscope field. Placing the guide channel in the handle (instead of the jaws) minimizes inadvertent trauma to the underlying tissue while allowing the arms of the handle to move apart in the plane of the channel and maintain a predetermined alignment of the jaws as they move away from and towards each other. For example, the opposing faces of the jaws are maintained substantially parallel to each other as the jaws move. Small openings through the jaws allow smaller bore instruments to be placed directly through the jaws. Larger instruments are introduced into the eye by opening the jaws of the clamp. [Figure 13A]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13B]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13C]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13D]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13E]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13F]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13G]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 13H]13A-13H diagrammatically illustrate a surgical procedure for delivering a subretinal implant into an eye through a sclerotomy that can be selectively opened and closed with a surgical clamp. The eye is prepared for surgery using a standard three or four port vitrectomy procedure. FIG. 13A shows the retina being separated from the retinal pigment epithelium by subretinal injection of saline solution. FIG. 13B shows an implant entry port created by creating an incision in the retina in the area of ​​the retinotomy. In FIG. 13C, an incision is made through the sclera and one of the disclosed surgical clamps is applied to the sclerotomy site to maintain intraocular pressure during the procedure. In FIG. 13D, the clamp is temporarily opened or removed and a tissue implantation tool is inserted into the subretinal space through the previously created retinal incision. In FIG. 13E, the implant is deposited into the subretinal space, and in FIG. 13F, the embedding tool is retracted and the clamp is reapplied to the sclerotomy. In some embodiments, the clamp includes a suture guide to facilitate placement of sutures at the proper depth and / or distance from each other to securely close the incision. [Figure 14A] Figures 14A-14D are digital images illustrating the use of the instrument of Figure 12. Figures 14A and 14B show a tubular implantation device for introducing transplanted cells into the eye (such as into the retina). The jaws of the clamp are slightly opened to accommodate the diameter of the implantation device (which exceeds the diameter of the opening). Figures 14C and 14D show a smaller diameter vitrectomy device that is small enough to be placed into the eye through a small opening in the jaws directly during a surgical procedure on the eye. [Figure 14B] Figures 14A-14D are digital images illustrating the use of the instrument of Figure 12. Figures 14A and 14B show a tubular implantation device for introducing transplanted cells into the eye (such as into the retina). The jaws of the clamp are slightly opened to accommodate the diameter of the implantation device (which exceeds the diameter of the opening). Figures 14C and 14D show a smaller diameter vitrectomy device that is small enough to be placed into the eye through a small opening in the jaws directly during a surgical procedure on the eye. [Figure 14C]Figures 14A-14D are digital images illustrating the use of the instrument of Figure 12. Figures 14A and 14B show a tubular implantation device for introducing transplanted cells into the eye (such as into the retina). The jaws of the clamp are slightly opened to accommodate the diameter of the implantation device (which exceeds the diameter of the opening). Figures 14C and 14D show a smaller diameter vitrectomy device that is small enough to be placed into the eye through a small opening in the jaws directly during a surgical procedure on the eye. [Figure 14D] Figures 14A-14D are digital images illustrating the use of the instrument of Figure 12. Figures 14A and 14B show a tubular implantation device for introducing transplanted cells into the eye (such as into the retina). The jaws of the clamp are slightly opened to accommodate the diameter of the implantation device (which exceeds the diameter of the opening). Figures 14C and 14D show a smaller diameter vitrectomy device that is small enough to be placed into the eye through a small opening in the jaws directly during a surgical procedure on the eye. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Detailed Description As used herein, the singular forms "a," "an," and "the" include the plural unless the context clearly indicates otherwise. As used herein, the term "or" is understood to be inclusive unless specifically stated or apparent from the context. The term "including" is used herein to mean, and is used interchangeably with, the phrase "including, but not limited to." The terms "comprising," "comprising," "containing," "having," and equivalents may have the meanings set forth in U.S. Patent Law and may mean "including," "comprises," and equivalents. "Consisting essentially of" or "consisting essentially of" may likewise have the meanings set forth in U.S. Patent Law and is open-ended, allowing for the presence of more than what is recited, but excluding prior art embodiments, so long as the basic or novel characteristics of the recited items are not altered by the presence of more than what is recited.

[0024] "Distal" and "proximal" are used with reference to the user of the instrument. Thus, a "proximal" portion of the instrument is closer to the operator in use and a "distal" portion is further from the operator in use. For example, the handle of the disclosed instruments is proximal and the jaws are more distal to the person using the instrument to bite down on an incision.

[0025] "Retinal transplantation" refers to the delivery of a retinal tissue graft through a sclerotomy. The retinal tissue graft may be actual retinal tissue, artificial retinal tissue, a component part of the retina, or a scaffold onto which retinal cells may grow.

[0026] The term "subject" or "patient" refers to an animal that is the object of treatment, observation, or experiment. By way of example only, a subject includes, but is not limited to, a mammal, including a human or a non-human mammal such as, but not limited to, a non-human primate, marine animal, cow, horse, dog, bovine, or cat.

[0027] A "sclerotomy" is a surgical incision made through the wall of the eye to expose, for example, the anterior or posterior chamber of the eye.

[0028] "Vitrectomy" refers to procedures performed on the vitreous and / or retina of the eye. "Vitrectomy" is a controlled surgical approach typically performed with an operating microscope and a vitrectomy machine, which is a handheld cutting and suction instrument connected to a console that can be selectively activated by the operator. The intraocular cutting / suction tip has a hollow, movable inner shaft through which variable negative pressure can be applied. At the distal end of the shaft is a small port, and the hollow inner shaft moves the outer port to open and close, drawing the vitreous tissue as negative pressure is applied. The vitrectomy system further includes a light source and an infusion line through which infusion solution is introduced and maintained at a normal pressure-volume relationship during surgery.

[0029] 1-6 illustrate a first embodiment of a surgical instrument 10 for clamping a target structure 12, e.g., an anatomical target structure such as an eye (FIG. 6). The clamp 14 includes a first jaw 16 forming a first narrow, flat clamping surface 18 and a second jaw 20 forming a second narrow, flat clamping surface 22 (FIG. 2). The illustrated clamping surfaces 18, 22 are narrow, flat mirror images of the jaws 16, 20 that are maintained substantially parallel to one another by the instrument. A handle 24 connects the first and second jaws 16, 20 and has a resilient biasing force that biases the first and second clamping surfaces 18, 22 in a substantially closed relationship relative to one another for clamping a target structure (such as opposing edges of a surgical incision) between the clamping surfaces 18, 22. The handle 24 is movable to overcome the resilient biasing force and open the clamp by moving the jaws 16, 20 to an open position while maintaining the biting surfaces 18, 22 in an orientation that is substantially parallel to one another. The clamp illustrated in Figures 1-5 has rectangular shaped mirror image jaws of substantially the same width, but the jaws can also be of different widths and not mirror images of one another. The jaws can be symmetrical with respect to one another, for example, when the first and second jaws are substantially the same dimensions and mirror images of one another, butting along the centerline CL of the instrument.

[0030] The handle 24 provides a means for a user to grasp and manipulate the instrument 10 with one hand and open and close the clamp 14 by manipulating the handle with the same hand that holds it. For example, in Figures 1 and 2, the handle is a single continuous length of resiliently biased wire frame material configured to open the jaws 16, 20 in response to a compressive force applied to the handle. The material is a single continuous non-slip bendable wire that is shaped or bent to form an arm portion that connects to the jaws 16, 20 and a leg portion that would be more proximal to the user. The ends of the wire form first and second substantially parallel arms 28, 30 that connect to the first and second jaws 16, 20, respectively. The leg portions are continuous loops formed by non-parallel legs 32, 34 that are joined at a common distal apex 36 of the leg portions and have a resilient bias to close the jaws. For purposes of illustration, the centerline CL of the instrument is shown symmetrically bisecting the handle 24.

[0031] In the illustrated embodiment of a normally closure device shown in Figure 1, the middle portion 38 of the handle crosses over itself at the centerline of the device and the leg portions abut the arm portions such that the movement of the legs 32, 34 towards each other in response to the bias of the legs increases the distance between the arms 28, 30. In Figure 1, the biased handle is not compressed and the legs 32, 34 extend away from each other at an angle from the common apex 36 such that the distance between the legs 32, 34 (and from the centerline CL) increases as they move from the apex towards the middle portion 38. However, the end sections 40, 42 of the legs 32, 34, respectively, are angled towards the centerline CL and cross each other at the middle portion 38 and the centerline CL. After crossing, the end sections 40, 42, respectively, then bend back towards parallel alignment again to form the arms 30, 28, respectively, that are substantially parallel.

[0032] Thus, the continuous handle in the unbiased state shown in FIG. 1 includes a first arm 28 that extends parallel to the centerline CL and then bends toward the centerline CL (e.g., at an angle of about 45 degrees) to an end section 42 that extends across the centerline CL at an intermediate portion 38. The continuous wire of the handle then bends back toward the centerline CL at an angle greater than the angle at which the arm 28 is bent, but in such a way that it slopes toward an apex 36 where the leg 34 abuts the leg 32. The leg 32 then continues from the apex 36 away from the centerline CL until its end section 40 bends toward the centerline CL and crosses under the end section 42 before again bending in parallel relationship with the centerline CL to form the arm 30. The illustrated handle 24 is thus compressible to open the jaws of the clamp while maintaining the first and second bite surfaces 18, 22 substantially parallel to one another.

[0033] The parallel alignment of the biting surfaces 18, 22 is aided by an alignment guide 46, which resists torque within the instrument as the handles are compressed. The alignment guide can take many forms that allow the mating portions of the first and second jaws 16, 20 to be interdigitated and maintained in alignment during all or part of the movement of the jaws 16, 20, resisting torque that would otherwise interfere with the ability of the clamp to securely close the biting surfaces 18, 22 in a locking abutment. An example of an alignment guide is illustrated in Figures 1-4 and includes interdigitated alignment members carried at their distal ends by each of the first and second jaws 16, 20, respectively. A pair of parallel guide bars 48, 50 extend toward an alignment bar 52, which is carried at its distal end by the first jaw 16 and projects along the distal edge of the second jaw 20 toward the guide bar 48, 50. An alignment bar 52 slides between the guide bars 48, 50 as the jaws 16, 20 move toward and away from one another, stabilizing the jaws relative to one another and maintaining them in a common plane as the clamp 14 is opened and closed.

[0034] During use of the clamp 14, once the edges of an incision or other wound have been temporarily brought into approximation by closing the clamp, the wound may be more securely or permanently closed by placing a suture across the edges of the incision. Precise suture placement of the proper depth and width is facilitated by a suture guide slot that extends through the first and second jaws 16, 20 and defines a needle trajectory for placing the suture 56 across the wound. The guide slot 54 extends laterally across the first and second jaws 16, 20 for a predetermined distance that corresponds to the distance between the entry point 58 and exit point 60 (FIG. 5) of the suture 56 placed across the incision. In the illustrated embodiment, the guide slot 54 has bevels 62, 64 at its ends to support a curved suture needle in its trajectory, in and out of the slot through the tissue beneath the clamp.

[0035] The jaws 16, 20 depicted in Figures 1-2 are generally rectangular members elongated longitudinally along a centerline CL of the clamp 14 with the jaws 16, 20 extending longitudinally away from the arms 28, 30 to which they are connected. The clamp thus has two outer longitudinal edges that are substantially parallel to the clamping surfaces 18, 22 and two lateral edges that are substantially perpendicular to the longitudinal edges. The jaws each have a lower surface that cooperates to form the lower surface of the clamp 14 for resting on the tissue of the target structure 12 to be clamped (Figures 5 and 6). The jaws 16, 20 also each have an opposed upper surface that cooperates to form the upper surface of the clamp.

[0036] As illustrated in Figures 1-2 and 4-5, the thickness of the clamp 14 tapers toward the biting surfaces 18, 22 and the lateral guide slots 54 to facilitate placement of the suture through the guide slots. The thickness of the clamp 14 is therefore at its minimum (thinnest) at the center of the clamp at the intersection of the biting surfaces 18, 22 and the guide slots 54. Bevels 62, 64 (Figure 5) at each end of the guide slots 54 have a curved upper surface that slopes at an angle from the lower surface to the upper surface of the clamp 14 at a radius of curvature that complements the trajectory of a curved needle used to place the suture 56 into the clamped tissue 12. In the illustrated embodiment, the upper surface of the clamp 14 is arcuate and tapers symmetrically relative to the biting surfaces 18, 22 and the guide slots 54 such that the clamp 14 is thickest along its outer edges, e.g., at its opposing longitudinal edges and along its opposing lateral edges. Arms 28,30 connect to the jaws 16,20 along a first lateral edge of the clamp 14, and an alignment guide 46 is secured to a second lateral edge of the clamp 14 and extends substantially perpendicular to the bite surfaces 18,22.

[0037] As shown in Figures 3A and 3B, some embodiments of the clamp 14 also have compression members or protrusions, such as bite needles or barbs, extending from the underside of the clamp. A plurality of bite needles or barbs can be arrayed in a row longitudinally along the underside of each jaw 16, 20 with the barbs extending away from the underside of the jaw toward the target tissue to be clamped. The row of needles or barbs is preferably aligned parallel to and substantially equidistant from the bite surface of each jaw. The barbs or bite needles have a base that is attached to the underside of the jaw but taper to a sharp or sharp tip to pierce tissue outside the edges of the wound or incision for clamping between the bite surfaces 18, 22 and aid in moving the underlying tissue together with the wound edges in apposition. The barbs or needles at their base generally extend at an included angle of 15 to 30 degrees relative to the underside of the clamp toward the midline of the instrument or the edges of the wound to be closed. The barbs or needles extend parallel to one another and they are all inclined to the underside of the clamp at substantially the same included angle. The barbs or needles on each jaw are substantially mirror images of one another and their sharp tips point toward but do not completely abut when the jaws are closed.

[0038] The embodiment shown in Figure 3A shows two opposing barbs 68, 70 on the underside of the opposing jaws that are curved from base to tip so that as they approach the sharp tips they are substantially parallel to the underside of the clamp 14. In the embodiment shown in Figure 3B, straight compression needles 72, 74 extend from the underside of each jaw with their sharp tips pointing in a direction that will help pierce underlying tissue and seal the edges of an incision or other wound as the jaws close.

[0039] The arrangement of the rows of needles is illustrated in Figures 9 and 10, which show the lower flat surfaces of the jaws 16, 20 with a row of compression members arrayed along the lower surface of each jaw. In the illustrated embodiment, the compression members are straight needle-type fixed at their bases to the lower surface of the jaw. The bases of the needles 72 are affixed to the lower surface of the jaw 16, with the needles 72 extending substantially parallel to one another toward a plane along which the biting surfaces 18, 22 abut. A symmetrical mirror image set of needles 74 is affixed to the lower surface of the jaw 20, with the needles in each set each extending substantially parallel to one another toward a plane along which the biting surfaces 18, 22 abut. The tips of the opposing needles generally point toward a common point in space, although the opposing needles need not abut at that common point.

[0040] The needles or other protrusions project far enough from the underside of the jaws to enable them to grasp only the underlying superficial tissue that will be mobilized to align and approximate opposing edges of an incision or other wound without penetrating the wall of the anatomical structure being grasped. For example, the needles are of sufficient length and oriented at a suitable angle to engage the conjunctiva and sclera of opposing wound edges and move them toward each other as the jaws close, without introducing a perforation that would penetrate the eye wall and create a transmural wound that would itself require repair to maintain intraocular pressure within the eye.

[0041] In use, for example, during a surgical procedure on the eye, an incision 78 (FIGS. 11A, 11B) is made through the eye wall 80 to gain access to the posterior chamber 82 of the eye to perform, for example, a vitreoretinal procedure, such as epiretinal surgery or implantation of a retinal implant. After the incision is made, the surgeon or other user grasps the instrument 10 by the handle 24 and positions the closed clamp 14 (FIG. 1) over the incision with the bite surfaces 18, 22 positioned across and aligned with the incision 78. The legs 32, 34 of the handle 24 are then manually compressed toward one another, allowing the sections 40, 42 to slide freely over one another and moving the legs 32, 34 closer together against the biasing force of the handle 24. This action moves the arms 28, 30 away from one another a distance generally proportional to the degree of compression of the handle 24 (FIG. 2). During this movement, the alignment guides 46 maintain the jaws 16, 20 in a relatively fixed position relative to one another, with the clamping surfaces 18, 22 being substantially parallel to one another as the jaws slide away from one another in a common plane.

[0042] Once the jaws 16, 20 are opened, the undersides of the jaws 16, 20 are seated firmly on the surface of the eye with the barbs 68, 70 or needles 72, 74 engaging the tissue beneath the jaws. As illustrated in Figure 11A, the compression needles enter the eye wall adjacent opposite edges of the incision, and the needles penetrate progressively deeper into the eye wall 80 without perforating it as compression of the handle 24 is released in a controlled manner, the legs 32, 34 move apart due to their biasing force, and the arms 28, 30 move toward each other, closing the jaws 16, 20 with the clamping surfaces 18, 22 in close contact (Figures 1, 5, and 6). During these movements, the compression needles 72, 74 mobilize the underlying tissue and draw the edges 76, 77 of the incision 78 toward one another, maintaining a substantially fluid-tight closure that avoids disruption of pressure balance within the eye that may result from loss of vitreous and other intraocular fluids through the sclerotomy. As illustrated in FIG. 11B, when the clamp is closed across the incision, the tips of the needles 72, 74 abut one another. The needles compress the scleral tissue between the needles and the underside of the clamp that rests on the eye, compressing the tissue between the opposing needles and helping to achieve hemostasis by reducing tissue perfusion. The areas of reduced perfusion (and improved hemostasis) are indicated by the shaded areas 84, 86 in FIG. 11B.

[0043] In some vitreoretinal and other procedures, it is desirable to repeatedly open and close the incision to introduce and remove instruments through the incision. To release the clamp from the closed position shown in Figure 1, the handle 24 is compressed as described above, moving the legs 32, 34 toward each other and the arms 28, 30 and jaws 16, 20 apart. The clamp may then be closed by again releasing the compressive force on the handle.

[0044] The illustrated embodiment of the clamp shown in FIGS. 1-6 is made from a surgical metal, such as surgical stainless steel, and is 4-5 mm wide, 4-5 mm long, and 1-2 mm thick. For example, a specific embodiment would be about 4.5 mm wide, 4 mm long, and 1 mm thick. Modifications can be made to the dimensions of the clamp design in clamp size, clamp body curvature, spring clip handle orientation and design, and suture guide placement and number. The clamp can be adapted for a variety of surgical procedures, e.g., other types of wounds or incisions in blood vessels, intestines, and skin wounds. The jaws of the clamp can be configured to approximately or substantially conform to the anatomical structure to be clamped. For example, the underside of the jaws to clamp the anatomical structure may be curved to substantially conform to a curved anatomical structure, such as a blood vessel or intestinal wall, or the underside of the jaws may be flat to fit against a more planar surface, such as a spread of skin, approximating a plane. The spring clip handle can also be compressed into two or more clamping positions, such as an unset and a set position. The clamp can also be a sterilized clamp for use in a surgical procedure, and can be cleaned, resterilized, and reused as desired.

[0045] To illustrate some of these variations, an alternative embodiment of a clamp is shown in Fig. 7, with a clamp 90 having two elongated curved jaws 92, 94 that abut at a clamping junction that longitudinally bisects the clamp 90, and a handle 96 for opening and closing this embodiment of the clamp. The handle includes a first arm 100 secured to jaw 92, a second substantially parallel arm 102 secured to jaw 94, a leg 104 for arm 102, and a leg 106 for arm 100. The legs 104, 106 abut at an apex 108. This embodiment of the spring clip handle 96 differs from the previously depicted embodiment by having a torsion coil 110 incorporated into the handle 96 to increase the spring biasing force that closes the jaws 92, 94 of the clamp 14. For example, the handle 96 may be a single continuous wire member that is bent into the cross configuration shown in FIG.

[0046] This embodiment of the clamp includes multiple suture guide slots. In FIG. 7, a pair of suture guide slots 112, 114 extend laterally through the clamp across the bite meeting point between the clamp and the elongated jaws 92, 94. Each of the guide slots 112, 114 has a portion of the slot in each of the elongated jaws 92, 94 such that the guide slot is cooperatively defined by the slot portions in each jaw. In this case, the length of each slot is divided equally between each jaw. FIG. 7 illustrates a suture 116 placed in guide slot 112 and another suture 118 placed in guide slot 114 by a curved needle that enters each guide slot at one end of the slot in jaw 94 and exits the same guide slot at its opposite end in jaw 92.

[0047] The clamp 90 in FIG. 7 is illustrated as being used on the wall of a curved structure 120, such as the wall of an intestine or blood vessel. The jaws 92, 94 are of substantially the same thickness and each have a lower curved surface that rests on the curved structure 120 and an opposing upper curved surface through which sutures 116, 118 are introduced to close the incision or other wound just below the bite point. Both the upper and lower surfaces of the jaws are curved and have similar radii of curvature about a common center point. The particular curvature of the surfaces of the jaws 92, 94 is selected to conform to the curved anatomical structure to which the clamp 90 will be applied to clamp the wound. The clamp 90 is then closed across the incision in the manner described above using the biasing force of the spring-loaded handle 96 by releasing the compressive force on the legs 104, 106 of the handle 96.

[0048] 8 illustrates yet another embodiment in which a clamp 130 includes a pair of elongated cubical or rectangular block shaped jaws 132, 134 that abut along a bite junction 135 located across an incision 136 having edges 136a, 136b that are brought into close contact by the clamp 130. A pair of suture guide slots 138, 140 extend laterally across the jaws 132, 134 and through the bite junction 135. A curved suture needle 142 is shown entering a first end of the guide slot 138 carrying a suture 144 for placement across edges 136a, 136b and exiting the second end. A second curved suture needle 150 carrying an attached suture 152 is shown entering a second end of the guide slot 140 and exiting the first end. The handle 154 is operable to open the jaws 132, 134 against the biasing force of the handle 154 by compressing the legs of the handle, as previously described, and then close the jaws 132, 134 by removing the compression.

[0049] 12A-12D illustrate yet another embodiment of a surgical instrument. A clamp 230 includes a pair of narrow, elongated curved or arcuate jaws 218, 220 aligned to form mirror image flat parallel surfaces that meet along a bite junction 235. The jaws each have the same radius of curvature, e.g., about 12 mm, and each jaw is narrow in width (e.g., 1.5 mm). The curve of the jaws causes their free ends to be higher than the handle, elevating the tips of the jaws above the plane of the handle deformed by the wire frame. For example, the tips of the jaws are elevated about 30 degrees relative to the plane of the wire frame handle.

[0050] Each jaw face of the jaws 218, 220 contains a mirror image recess that cooperates to form a central circular opening or aperture 237 for placement of several surgical instruments therethrough (forming a port for accessing the ocular cavity without releasing the clamp). The handle of the instrument includes arms 228, 230 and legs 232, 234 that abut at an apex 254 that resiliently biases the legs 232, 234 away from one another in a non-parallel relationship and biases the arms 228, 230 and jaws 218, 220 toward one another in a parallel relationship. An intermediate portion of the instrument between the legs and arms forms an alignment guide that maintains the opposing mirror image faces of the jaws in a substantially aligned orientation relative to one another, e.g., substantially parallel to one another, and resists torque forces that would twist the first and second biting surfaces out of alignment. The alignment guides are formed by bending the wire frame of the instrument, such as legs 232, 234 and / or arms 228, 230. In the illustrated embodiment, the alignment guides are formed by bent sections of wire that form the middle portion 238 of the surgical instrument. The wire frame of each of the legs 232, 234 is bent into a loop 256, 258 that forms opposing finger grips 256, 258 against which an operator's fingertips may press to open the clamp.

[0051] 12C, the intermediate portion 238 may be formed from the wire of the leg 234 by bending the wire through an arc at approximately a 90 degree angle from the leg 234 toward the midline of the instrument, slightly over the arm 228 to form a first straight section 238a, and then bending back on itself through an arc around the arm 228 at approximately a 180 degree angle to form a second straight section 238b slightly spaced from and substantially parallel to section 238a, forming a guide channel 240 therebetween. The wire is then bent through an arc again and back on itself again to form a third straight section 238c adjacent to and parallel to the first section 238a. The third section 238c extends beyond the arm 228 toward the midline of the instrument, at which point it bends through an arc at an angle of approximately 90 degrees to orient the arm 230 substantially parallel to the arm 228 when the opposing mirror image surfaces of the jaws abut. With the arms 228, 230 parallel to one another, the jaws 218, 220 are held in a fixed, predetermined orientation relative to one another when the jaws 218, 220 are closed, with their opposing surfaces substantially parallel along the bite junction 235.

[0052] In use, the clamp 230 is released by compressing the legs 232, 234 toward one another against the biasing force of the apex 254 as the arm 228 slides away from the arm 230 within the channel 240 while maintaining a predetermined desired alignment (e.g., substantially parallel relationship) of the opposing mirror image surfaces of the jaws 218, 220. After placing the instrument in a clamping position relative to the incision, the compression of the legs 232, 234 ceases to allow the legs to move away from one another to their normally biased position as the arm 228 slides toward the arm 230 within the guide channel 240. The jaws 232, 234 have barbs 272 on their curved undersides which engage underlying tissue and assist in moving the edges of the incision to be clamped by the jaws toward one another.

[0053] In use, the clamp is applied to a wound, such as a surgical incision, to close the wound. In certain embodiments, the wound is a surgical incision in the eye, e.g., the sclera, and the curvature of the jaws is selected to conform that curvature of the jaws to the curvature of the underlying eye. Barbed clamp surfaces are placed on the edges of the incision and, in response to the biasing force of spring 254, draw the edges toward each other as the jaws are moved toward each other. Once the jaws are closed, the incision is sealed except for a circular opening 237, which provides an access port through which certain instruments (such as a vitrector or retinal scissors or some other standard instrument used in surgery) may be introduced into the eye while retaining sufficient intraocular pressure within the eye during the surgical procedure.

[0054] While not limited to any particular dimensions, the following dimensions illustrate one particular embodiment of the device shown in Figures 12A-12B used to selectively seal an incision in the eye. As shown in Figure 12A, the spring 254 has an inner radius d of about 4-6 mm, e.g., 5 mm. 1 while the inner radius of the finger grip is about 3-5 mm, e.g., 4 mm inner diameter d 2 The jaws are curved with a radius of curvature R of about 10 to 14 mm, e.g., 12 mm, and each jaw has a width L 3 is about 1 to 3 mm, for example, 1.5 mm, and the distance L between the barbs 272 is 4 The width of the jaws is about 1-3 mm, e.g., 2 mm. The diameter of the opening 237 is about 0.6-1 mm, e.g., 0.8 mm. As shown in FIG. 12B, the curve of the jaws raises them through an arc out of the plane of the guide channel formed by the middle portion 238.

[0055] FIG. 14A illustrates the clamp 230 with the jaws 218, 220 open for insertion of a tubular implantation instrument between the open jaws. FIG. 14B illustrates how the clamp 230 would be positioned on a generally spherical eye surface with the curved arms of the jaws substantially conforming to the curvature of the eye surface and stabilizing the instrument while pressure is applied to its legs to maintain the clamp in the open position shown. FIG. 14C illustrates the use of the clamp 230 with a smaller diameter instrument such as a vitrector (scalpel). The diameter of the instrument shown is smaller than the diameter of the opening 237 so that the vitrector is inserted through the opening 237 without opening the jaws. FIG. 14D illustrates how the clamp 230 would be positioned on the eye surface with the subsurface curvature of the jaws conforming to the curved surface of the eye and resting thereon to close the underlying incision in the eye while an instrument is placed through the jaws.

[0056] The illustrated surgical clamp may be used in many different types of surgeries and medical procedures. In the eye, for example, the clamp may be used to deliver cell-based therapies or retinal stimulation implants to treat eye diseases such as age-related macular degeneration (AMD), geographic atrophy (GA), retinitis pigmentosa (RP), etc., by delivering a layer of retinal pigment epithelium (RPE), retina and / or choroid such as newly grown RPE, or artificial blood-retinal barrier implants. These surgeries are performed through large sclerotomy in the eye to deliver sufficient tissue into the eye, however, large sclerotomy presents an increased risk of eye collapse, retinal detachment, and bleeding due to loss of intraocular pressure (IOP). IOP can be maintained by infusion of fluid into the eye, but it is advantageous not to infuse excessive amounts of fluid during surgery. Unfortunately, large incisions often must be left open for extended periods of time to introduce, remove, and reintroduce instruments into the eye at intervals during the surgical procedure. The clamps disclosed herein minimize the risks associated with this procedure by providing a tool that can rapidly close large eye wounds, maintain and stabilize IOP, help stop bleeding, maintain precise tissue alignment of the wound margins, and provide a guide for suture placement with a controlled depth and distance from the tissue margins.

[0057] Examples of particular procedures in which clamps may be used are illustrated in the examples below. EXAMPLES

[0058] Example 1 Surgical technique for scaffold implantation This example illustrates a procedure for implanting or transplanting retinal tissue or scaffolds into the eye. This specific example illustrates the implantation of a retinal pigment epithelium layer on a biodegradable scaffold into the subretinal space (Figures 13A-13H). This specific example is a procedure in a pig eye, but the same or similar procedure can be used to perform the surgery in subjects of different species, such as humans. The example includes a method for creating a retinotomy at the base of a retinal detachment, which is then repaired by implantation of a choroidal / retinal pigment epithelium scaffold, from which a three-dimensional retinal tissue can develop.

[0059] Five to seven days prior to surgery, blood vessels are cauterized with a surgical laser using an indirect ophthalmoscope in the area of ​​the choroid at the site of the intended large sclerotomy. Cauterization of the blood vessels reduces bleeding at the site of the subsequent large sclerotomy.

[0060] On the day of surgery, the pig's eyes are cleaned using povidone-iodine 5%, while the surrounding skin is cleaned using povidone-iodine 10%. A temporary canthotomy is performed using scissors, and the nictitating membrane is retracted using 4-0 braided silk, if necessary, to increase the exposed area. A surgical port is created 3.5 mm from the limbus using a 25G valved cannula. A posterior vitreous detachment is performed within the laser-injury area (see Example 3), and a vitrectomy is performed. Blood pressure is measured to determine whether it is within the desired range. If necessary, antihypertensive drugs are administered to reduce systolic blood pressure to <100 mmHg.

[0061] As shown in Figure 13A, a local retinal detachment is induced using a 38G polyamide cannula and injection of Hank's balanced salt solution (HBSS). A scissor retinotomy is performed at the base of the retinal detachment, and the detachment is reinforced with 0.21% Healon GV using a blunt tip cannula. A second small posterior retinotomy is performed using a 25G endoscopic cautery tip accompanied by a momentary action of a vitreous scalpel (Figure 13B) to create an implant entry port.

[0062] The sclera is exposed by a conjunctival (nasal) periotomy around a port that accommodates an enlarged implantation tool, such as the implantation tool described in WO 2016 / 007852. An incision is made in the sclera (FIG. 13C) to allow the implantation tool to be inserted into the ocular cavity. A clamp is applied to the sclerotomy site to maintain intraocular pressure. Because a relatively large sclerotomy is made to introduce the implantation instrument described above, the disclosed clamp helps to maintain a pressurized eye when the implantation tool is not within the eye. The clamp is partially opened and a 2.5 mm sclerotomy is made at the site of the surgical port to accommodate the implantation tool cannula. The handle of the tool is manipulated (e.g., compressed) to partially open the jaws and allow the sclerotomy to be performed. Tissue-grasping protrusions on the bottom faces of the jaws may help to keep the opposing edges of the sclerotomy wound relatively close together while the incision is being made. The compressive force on the handles may then be released when needed, for example, during loading of material for implantation into the tool, to completely close the wound.

[0063] The tool is loaded with material for implantation (such as a scaffold or tissue or implant) and the clamp is fully opened to introduce the tip of the implantation tool through the sclerotomy. The tool comprises a handle and a flat-shaped tip. A layer of tissue or implant may be drawn into the delivery opening of the tip where the tissue is selectively retained by suction force (FIG. 13D). The clamp is then removed from the sclerotomy and the injector portion is advanced into the eye and the tool tip is aligned with the incision in the retina. The implant tip is then placed subretinal (FIG. 13E) and the implant is ejected from the tool into the formed subretinal space. The tool discontinues the vacuum and instead delivers the retained tissue to the site of implantation by applying an injection force through the opening. The scaffold or tissue or implant is fully ejected using the VFI function and the pedal switch (FIG. 13E). After implantation is completed, the implantation tool is retracted and the clamp is then quickly reapplied to the sclerotomy (FIG. 13F).

[0064] Heavy fluid solution (e.g., PERFLUORON®) or fluid-air exchange is used to flatten the retina over the transplanted area (FIG. 13G) and the retinotomy is closed by light apposition of the retinotomy borders without retinopexy. A first / central sclerotomy suture is applied through the suture guide slot of the clamp with Nylon 8-0. The clamp is removed and the sclerotomy site is completely sutured with Nylon 8-0. All valved cannulas are removed from the eye, the nasal conjunctiva is sutured with Vicryl 7-0, and the canthotomy is closed with Vicryl 5-0 (FIG. 13H).

[0065] Immediately after surgery, 0.1 mL of Depo-Medrol (20 mg / mL) and 0.4 mL of Gentamicin (100 mg / mL) is administered. Ketoprofen 3 mg / kg IM is administered for 3 days starting the day after implantation, and Triple Antibiotic Ophthalmic Ointment is applied topically to the surgical eye twice daily for 5 days. An eye patch is applied to protect the postoperative eye for 12 hours. Valium (5 mg / ml) is administered at 1 mg / kg in a slow intravenous drip.

[0066] When the animal begins to breathe unassisted, it is placed in a holding cage and placed in a lateral decubitus position with the surgical eye up. Immediately prior to extubation, acepromazine (10 ml) is given intramuscularly at a dose of 1 mg / kg. By dinner at 6 pm (or earlier if sedation is deemed insufficient), the animal receives oral acepromazine 1.5 mg / kg, oral diphenhydramine 4 mg / kg, and oral lorazepam 0.15 mg / kg. These three oral drugs are further administered twice daily at the same doses.

[0067] Example 2 Postoperative suppression To minimize postoperative rejection of the implant and inflammation, an immunosuppressive protocol may be used. The immunosuppressive protocol is started at least one week prior to surgery to effectively suppress the immune system before the xenograft or allograft is introduced into the eye. The protocol may use a mixture of immunomodulatory drugs such as antibiotics and corticosteroids to suppress microglial infiltration and other immunosuppressants (such as MTOR inhibitors). Such a protocol may be performed as follows (BID means twice a day, SID means once a day, IM means intramuscular). Any subset or combination of these drugs may also be administered, but in this particular non-limiting example, all of the following drugs are administered as part of the immunosuppressive protocol. Doxycycline (100 mg / tablet): 2 tablets BID (400 mg / day) until the day of euthanasia [Antibiotic that also inhibits microglial infiltration] Minocycline (100 mg / tablet): 2 tablets BID (400 mg / day) until the day of euthanasia [antibiotic that also inhibits microglial infiltration]. Depo-Medrol (methylprednisolone) (40mg / ml): One injection of 5mg / kg IM given on day 1 [steroid for congenital immune suppression] Prednisone (50 mg / tablet): 5 mg / kg SID starting on day 2 of the immunosuppression regimen. This dose is continued for 4 weeks postoperatively, which is tapered over 2-week cycles [steroids for congenital immunosuppression] · Rapamycin (Sirolimus) (1 mg / tablet): 2 tablets SID on day 1 of the immunosuppression schedule, then 2 tablets SID (0.5 mg / tablet) until the day of euthanasia [long-term immunosuppressant for adaptive tolerance]. Tacrolimus (0.5 mg / tablet): 1 tablet SID [sustained release immunosuppressant for adaptive tolerance] until the day of euthanasia

[0068] Example 3 Laser injury Five to seven days prior to surgery, blood vessels are cauterized with a surgical laser using an indirect ophthalmoscope in the area of ​​the choroid at the site of the planned sclerotomy incision, as described in Example 1. Alternatively, diathermy may be used. Cauterization of blood vessels reduces bleeding at the site of the subsequent sclerotomy.

[0069] A separate laser procedure is used to selectively damage the RPE or RPE and retina or RPE, retina, and choroidal vessels at the site of implantation of an implant, such as implantation of an artificial blood-retinal barrier implant or a retina or retinal prosthesis. This procedure requires titration of the volume of laser injury to achieve its desired effect. For example, an IQ 532™ nm micropulse laser (Iridex, USA) with a TxCell™ scanning laser delivery system is used to selectively damage the retinal pigment epithelium (RPE). A "threshold test" is performed on each eye. The micropulse power is identified that is sufficient to obtain barely visible whitening of the laser-treated retina in a 3×3 fused test grid. This threshold depends on the pigmentation of the eye and is therefore used in this example to produce the laser injury. A 330 ms exposure time and a 1% duty cycle are used to allow delivery of 33 micropulses per series of 10 ms micropulses (0.100 on 9.900 ms off). For the purposes of illustrating the method, a laser lesion is induced in the optic striatum (the site of high density of cones) adjacent to the optic nerve head. A 200 μm diameter laser spot is created using a 7 × 7 fusion grid of 25, measuring 38.5 mm 2 A Volk HR foveal contact lens mounted on a metal handle is used to avoid hand movement during the procedure.

[0070] At the completion of the procedure, a nonsteroidal anti-inflammatory drug (NSAID) such as Ketoprofen (100 mg / mL) 3 mg / kg IM is administered. Triple Antibiotic Ophthalmic Ointment is applied topically to the post-laser lesion with SID for 3 days.

[0071] In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.

Claims

[Claim 1] A device, system, method, etc.

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