Patent ID: 12226105

DESCRIPTION OF EMBODIMENTS

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

This present disclosure provides an improved surgical clamp for occluding larger blood vessels, such as arteries or veins, when the surgical space does not permit the use of large clamps. The present disclosure includes drawings, in which like reference numbers refer to like elements throughout the various figures that comprise the drawings. In some embodiments, the disclosed clamp100is an entirely intracorporeal system that may be placed in the body, opened and closed so that the clamp body112encases a bundle of tissue132containing a vessel134and then ratcheted down using an actuating arm128rotatably secured to a first surface114by a hinge126so as to compress the bundle of tissue132containing the vessel134between the actuating arm128and a second surface118.

In some embodiments, the clamp body112contains a minimum of three surfaces: a first surface114connected to a second surface118by a connecting surface120. The three surfaces create a clamp body112that is substantially triangular in shape. In some embodiments, the clamp body112and/or the connecting surface120is resiliently biased such that when it is not subject to any external forces, the first surface114and the second surface118contact each other at an edge124.

The first surface114and the second surface118of the clamp body112may further include a latching mechanism210. This latching mechanism210permits a user to temporarily secure the first surface114to the second surface118at the edge124as demonstrated inFIG.2BandFIG.13B. The latching mechanism210can be used in conjunction with or in place of the clamp body112being resiliently biased. Furthermore, the latching mechanism210can automatically latch without the user's intervention or can require the active intervention of the user to engage or disengage the latching mechanism210.

Although the clamp body112is made up of three surfaces, a clamp body112comprised of more than three surfaces is envisioned. For example, the clamp body112can include four surfaces in a square/rectangular/diamond configuration as disclosed inFIGS.7C and7D. The clamp body112can also include six surfaces in a hexagon configuration as disclosed inFIGS.7A and7B. Furthermore, the surfaces need not be flat, but may be curved. Thus, the clamp body112, with a closed mouth, can take on enclosed shapes that are substantially circular in shape or oval shaped.

In some embodiments, the hinge126is attached to the first surface114at the edge124where the first surface114and the second surface118contact each other. The hinge126connects the first surface114to the actuating arm128but does not limit the angle of rotation between the actuating arm128and the first surface114. Indeed, it is the second surface118that limits the rotation of the actuating arm128as the bundle of tissue132, which includes the vessel134, is compressed between the actuating arm128and the second surface118. In some embodiments, the hinge126does not prohibit the actuating arm128from moving in a direction substantially perpendicular to the axis of rotation, as depicted inFIG.4. For example, the actuating arm128may be wider than a first aperture410located in the first surface114. The hinge126may permit the actuating arm128to be compressed, however, so as to reduce its width so that it may pass through the first aperture410and move forward to compress the tissue bundle132as depicted inFIG.6.

There may be more than one hinge126on the first surface114. Furthermore, a hinge126may be attached to the second surface118so as to permit a second actuating arm714to be rotatably attached to the second surface118.

By applying force to the actuating arm128, the clamp body112deforms from its resting state as depicted inFIGS.2A,13A, and7A. Such a deformation results in the mouth of the clamp100(i.e., the edge124where the first surface114and the second surface118contact) opening. With the mouth open the clamp body112can be placed around the tissue bundle132. Pressure can then be released, resulting in the clamp body112returning to its resting shape, thereby encasing the tissue bundle132with the vessel134inside as depicted inFIGS.1,3, and7C.

As outlined above, the actuating arm128is then rotated through the first aperture410of the first surface114to compress the tissue bundle132between the actuating arm128and the second surface118. In instances where the width of the first aperture410is less than the width of the actuating arm128, the actuating arm128can be resiliently biased in a direction substantially perpendicular to the axis of rotation. As a result, force can be applied to reduce the width of the actuating arm128to permit it to pass through the narrower first aperture410. Once the actuating arm128passes through the first aperture410, the force perpendicular to the axis of rotation of the actuating arm128can be removed, thereby allowing the actuating arm128to return to its original width.

The actuating arm128can be a solid piece of material, multiple pieces of material that form a substantially solid surface, or an outline with an internal aperture (e.g., a bent wire). If a wire is used, it will need to have a large enough gauge so as to prevent it, when ratcheted down, from cutting into the tissue bundle132.

To reduce the amount of force required to open the mouth of the clamp100, the second actuating arm714can be attached to the second surface118. To provide for such a lever structure, the length of the actuating arm(s)128,714will be at least longer than the clamp body112.

The actuating arm128should be able to be rotated forward (i.e., away from the second surface118), permitting the actuating arm128to be placed in front of the clamp body112during insertion. This will allow for a reduced height profile of the clamp100during insertion thereby necessitating smaller incisions during surgical procedures.

The clamp100has at least two apertures which permit the actuating arm128to pass through the first surface114and compress the tissue bundle132against the second surface118. The first aperture410is located in the first surface114and the second aperture412is located in the connecting surface120. To permit the actuating arm128to open and close the mouth of the clamp100, the first aperture410is narrower than the actuating arm128. Furthermore, the second aperture412can have a ratchet component described below. The second aperture412need not extend entirely through the connecting surface120. Indeed, in some embodiments, the second aperture412may only extend partway down the connecting surface120, thereby leaving a lip310at the junction122of the second surface118and the connecting surface120. The bundle of tissue132, including the vessel134, can then be compressed against not only the second surface118and the actuating arm128, but the lip310as well. This lip310permits compression of the bundle of tissue132, including the vessel134, from all sides (i.e., the actuating arm128compresses the bundle of tissue132, including the vessel134, against both the second surface118and the lip310).

Just as a clamp body112containing more than three surfaces is outlined in the present disclosure, a clamp body112containing more than two apertures is envisioned. Indeed, the number of apertures can be equal to one less than the number of surfaces. For example, a hexagon-shaped clamp body112can contain up to five apertures with the actuating arm128compressing the bundle of tissue132, including the vessel134, against the sixth surface that does not have an aperture. It will be understood that more than one of the apertures can comprise a ratchet component when paired with the actuating arm128. Furthermore, each surface is not required to have an aperture. Referencing the hexagon-shaped clamp100discussed above, in other embodiments, the clamp body112can contain four apertures. In these embodiments, the sixth surface acts as the surface the vessel134is compressed against and the fifth surface acts as a lip310that provides a secondary surface against which the bundle of tissue132, including the vessel134, may be compressed. These embodiments permit the bundle of tissue132, including the vessel134, to be compressed from all sides. In some embodiments, the compression from all sides may be uniform (i.e., the actuating arm128applies the same compression force against the second surface118as it does against the lip310). In other embodiments the compression from all sides is not uniform (e.g., the actuating arm128applies a stronger compression force against the second surface118than the lip310).

In some embodiments, the ratchet component is formed by the outer edge of an aperture comprising a linear rack of teeth130combined with the actuating arm128acting as a pawl (or click)610that engages the teeth130. In other embodiments, the hinge126may include a ratchet component. Specifically, the hinge126may contain a pawl810that works in conjunction with teeth812on the actuating arm128.

In some embodiments, the teeth130are uniform but asymmetrical, with each tooth having a moderate slope on one edge and a much steeper slope on the other edge as depicted inFIG.9. When the actuating arm128is moving in the unrestricted direction (i.e., rotating towards the second surface118), the actuating arm128or pawl easily slides up and over the gently sloped edges of the teeth130. A spring force then forces the actuating arm128(sometimes with an audible “click”) into the depression between the teeth130as it passes the tip of each tooth130. When the actuating arm128moves in the opposite direction (i.e., away from the second surface118), however, the actuating arm128or pawl will catch against the steeply sloped edge of the first tooth130it encounters, thereby locking it against the tooth130and preventing any further motion in that direction. Such a ratcheting mechanism permits the tension to be dynamically applied to the tissue bundle132containing the vessel134. Furthermore, the teeth130need not be sloped, but may be curved as depicted inFIG.9. Regardless of whether the ratchet component is part of the aperture and/or part of the hinge126, such a ratchet component will be reversible such that the user can directly or indirectly apply a force to an element of the mechanism (e.g., the pawl810or the actuating arm128) to permit the actuating arm128to rotate away from the second surface118, which does not contain an aperture. In some embodiments, the spring force applied to the actuating arm128is the result of the actuating arm128being resiliently biased in a direction substantially perpendicular to the axis of rotation. This permits the user to disengage the ratchet component by compressing the actuating arm128into the center of the aperture and rotating the actuating arm128away from the second surface118.

In any of the embodiments described herein, any of the edges described herein can be rounded or curved so as to not provide a sharp edge that may be harmful to a patient. In some embodiments, one or more of the components of the tensionable surgical clamps described herein can be covered with a protective coating such as, for example, a polymer. In some embodiments, one or more of the components of the tensionable surgical clamps described herein can be covered with a protective coating such as, for example, an anti-bacterial coating or anti-inflammatory coating.

To further assist with compression of the tissue bundle132, an inflatable balloon710can be attached to the interior of the clamp body112. The balloon710can be inflated by the user to further compress the tissue bundle132, including the vessel134, as depicted inFIG.7D. In some embodiments, the inflatable balloon710can be inflated by a pump800. A representative pump is depicted inFIGS.11A and11B. Referring toFIGS.11A and11B, the pump800comprises two pivoting members820and830, encompassing a billow840. Upon compression of the two pivoting members820and830towards each other, the billow840is compressed and forces air out an export terminal850through a connection hose (not shown) to the balloon710. Upon releasing the two pivoting members820and830, such that they move away from one another, the billow840is expanded and draws air in from an import terminal860, thus refilling the billow840.

For certain procedures, the disclosed clamp100will be applied with an applicator900. The applicator900may be an elongated tool comprising a handle902and an arm904. The handle902permits the user to manipulate the applicator900. The arm904engages the clamp100and can apply the necessary force to the clamp100to open the mouth of the clamp100to permit the clamp body112to encircle the tissue bundle132, including the vessel134, or be removed from the surgical area. One example of an applicator900is depicted inFIG.10. The applicator900may also be used to assist with ratcheting or releasing the actuating arm128. The applicator900may be further attached to the balloon710, thereby permitting the surgeon to inflate or deflate the balloon710as necessary.

The disclosed applicator900may be removable. Specifically, the applicator900can be temporarily attached to at least one anchor point712of the clamp100. The anchor point(s)712can be located on the actuating arm128. The anchor point(s)712can be located on the clamp body112. In some embodiments, the anchor point(s)712are located on the side of the body112that does not contain an aperture. In this configuration, the applicator900may act as a second actuating arm128to provide the leverage required to open the mouth of the clamp100to permit the tissue bundle132containing the vessel134to be encircled. Once the clamp100is positioned, the applicator900may be removed. The removal of the applicator900can provide additional room for the surgeon to operate.

It will be understood that the clamp100can be constructed of any material which can be sterilized for surgical use including, but not limited to, stainless steel, chrome, titanium, vanadium, plastics, and polymer composites, or any combinations thereof. The clamp materials used may render the clamp100disposable. Specifically, the disclosed clamp100may be capable of being sterilized only prior to initial use. In addition, the clamp materials used may reusable (i.e., capable of being sterilized after initial use). To assist with such sterilization, the actuating arm128may be removably attached to the body112, thereby permitting the actuating arm128to be separated from the body112. Such separation may assist with sterilization.

Certain embodiments of a tensionable surgical clamp have been described herein. It is to be understood that other embodiments and variations can be devised by others skilled in the art without departing from the spirit and scope of the claimed subject matter. All such modifications and other embodiments are intended to be within the scope of the above description and in the following claims.

Various modifications of the described subject matter, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. Each reference (including, but not limited to, journal articles, U.S. and non-U.S. patents, patent application publications, international patent application publications, gene bank accession numbers, and the like) cited in the present application is incorporated herein by reference in its entirety.