Tissue clamp and implantation method

Inventors

Khristov, Vladimir R.Charles, Steven T.Amaral, Juan A.Maminishkis, ArvydasBharti, Kapil

Assignees

US Department of Health and Human Services

Publication Number

US-11717298-B2

Publication Date

2023-08-08

Expiration Date

2037-11-08

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Abstract

A surgical clamp for aligning the margins of incised or wounded tissue has jaws with parallel clamping faces, and a handle 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 through the jaws assist in the placement of precisely placed sutures across the incision. The disclosed surgical clamp is particularly suited for selectively closing and reopening surgical incisions, such as a sclerotomy incision in the eye. Methods are disclosed for using the clamp during intraocular and other surgical or minimally invasive procedures. In one example the clamp is used during implantation into the retina of a scaffold on which choroid and retinal pigment epithelium cells and retina grow in a three-dimensional matrix that mimics the native structure of the retina.

Core Innovation

The invention relates to a surgical clamp designed to align and selectively close surgical incisions or wounds by clamping opposing edges with jaws having parallel clamping faces. It features a resiliently biased handle that maintains the clamp jaws in a normally closed position and allows opening by compressing the handle. The clamp includes prongs projecting from the inferior surface of the jaws that engage tissue margins to aid in aligning the wound edges. Additionally, the clamp contains suture guide slots through the jaws to assist in precise suture placement.

The handle is typically a continuous metal or alloy wire configured to open the jaws by compression while maintaining the clamping surfaces in substantially parallel alignment. An alignment guide, such as interdigitating alignment members on the jaws, prevents torque that might misalign the jaws during opening and closing. The clamp provides a means to repeatedly open and close surgical incisions, preserving intraocular pressure during eye surgery and facilitating minimally invasive procedures.

The background reveals that minimally invasive surgery demands tools that effectively close multiple small incisions to prevent complications like fluid loss. Existing clamps do not efficiently and reversibly secure wound edges, often requiring time-consuming suturing that risks tissue damage. The invention addresses this need by offering a clamp that selectively opens and closes incisions with secure alignment, suitable for fragile and variable wounds, including large sclerotomies in vitreoretinal surgery where fluid-tight closure is critical to prevent eye collapse, bleeding, and retinal detachment.

Claims Coverage

The patent includes four independent claims describing surgical instruments with features related to clamp structure, handle mechanism, alignment guides, prongs, and suture guide slots.

Clamp having jaws with aligned clamping surfaces and resiliently biased handle

The surgical instrument has first and second jaws forming opposing clamping surfaces connected by a handle with a resilient bias that holds the jaws closed to clamp tissue. The handle can be compressed to open the jaws while maintaining the clamping surfaces substantially aligned and parallel.

Alignment guide comprising interdigitating alignment members

The instrument features an alignment guide formed by interdigitating members on the respective jaws that resist torque and maintain the clamping surfaces in an aligned relationship during opening and closing of the clamp.

Compression prongs extending downward from inferior jaw surfaces

The clamp jaws include compression prongs extending downwardly from their inferior surfaces toward the incision to be closed, aiding tissue engagement and wound margin alignment.

Suture guide slot defining needle trajectory through jaws

The clamp has a suture guide slot extending transversely through the jaws that defines a controlled needle trajectory for precise suture placement across the closed incision, with bevels at slot ends guiding the needle.

Handle formed of continuous resilient wire with arm and leg portions

The handle is a one-piece continuous metal or alloy wire comprising substantially parallel arms connected to the jaws and non-parallel legs joined at an apex. Compression of the legs opens the jaws while keeping the clamping surfaces parallel and aligned.

The claims cover a surgical clamp combining a resiliently biased, compressible handle that maintains parallel jaw alignment via an alignment guide, includes tissue engaging prongs from inferior surfaces, and features suture guide slots for precise suture placement, thus enabling selective opening and closing of incisions with secure tissue apposition.

Stated Advantages

Minimizes risks during minimally invasive surgical procedures by maintaining fluid-tight closure of incisions to prevent complications such as eye collapse, retinal bleeding, and detachment.

Allows repeated selective opening and closing of incisions for instrument access without compromising wound sealing or tissue alignment.

Facilitates precise tissue margin alignment and offers suture guide slots that assist in controlled depth and placement of sutures.

Improves hemostasis by using prongs that compress tissue margins reducing perfusion and bleeding.

Adaptable to various anatomical surfaces and surgical procedures, including intraocular surgery and transplantation techniques.

Documented Applications

Used in vitreoretinal surgery to close sclerotomy incisions in the eye for maintaining intraocular fluid pressure and minimizing complications.

Assists in implantation of retinal tissue or scaffolds for cell-based therapies such as retinal pigment epithelium or choroid transplantation via sclerotomy incisions.

Provides rapid closure of penetrating traumatic injuries to the eye or other anatomical structures including blood vessels and hollow viscera.

Enables repeated opening/closing of wounds during procedures requiring multiple instrument introductions through incisions, such as vitrectomy and cell transplantation.

Useful in surgeries involving large scleral incisions for delivery of retinal implants, prostheses, or tissue grafts, aiding hemostasis and tissue alignment.

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