GB2128478A - Two identical piece hemostatic clip - Google Patents

Abstract

A two-piece, hemostatic clip wherein the pieces 11, 16, are substantially identical. Each piece has a first member, 12, 17, with a vessel clamping surface 13, 19, and a second member 14, 18, perpendicularly disposed from the first member. The pieces interlock in openings 15, 20, to occlude a vessel placed between the vessel clamping surfaces. <IMAGE>

Description

SPECIFICATION Two identical piece hemostatic clip The present invention relates to hemostatic clips and more particularly to hemostatic clips fabricated from bio-compatible, polymeric materials which may be absorbable or nonabsorbable in body tissue.

Background of the Invention In many surgical procedures, it is often necessary to ligate a plurality of vessels within the surgical site. The vessels may be severed downstream of the ligated portion. In some instances, the vessels may be ligated in spaced apart areas and the portion of the vessel between the ligations removed. The purpose of ligating vessels is to maintain the surgical site free from an excess of blood and reduce blood loss in the patient. Also, in certain surgical procedures where tumors and the like are to be removed, the tumor or organ may have to be separated from certain vessels. Before separation, the vessels are ligated.

Once a blood vessel is completely shut off, hemostasis, that is, the natural closing of the end of the vessel so as to stop blood flow, will occur in several days depending on the vessel. The body, in the meantime, will continue to allow blood flow around the ligated area through appropriate capillaries and secondary vessels, with the natural physiological function of the body enlarging the bypass vessels until adequate blood flow is obtained. Hence, when ligating the vessel, there should be positive stoppage of the blood flow in the main vessel. Failure to provide complete stoppage may cause blood loss in the patient and may also disrupt the natural hemostasis and concurrent manufacture of new passages of blood flow in the patient.

In the past, this closing of the vessel was usually accomplished using ligatures; i.e., filaments or thread which the doctor tied around the vessel to be closed. This is a time-consuming process and one wherein positive closure of the vessel is not always accomplished. In recent years hemostatic clips have replaced ligatures in surgical procedures to close blood vessels and other fluid ducts. Very often these hemostatic clips are narrow U or V shaped strips formed of tantalum or stainless steel which are capable of being deformed and possess sufficient strength to retain the deformation when clamped about a blood vessel. The closing forces are developed by the deformation of the metal.

Recently, various types of clips have been made from bio-compatible polymeric materials which are absorbable or non-absorbable in body tissue.

Examples of such clips are disclosed in co-pending commonly assigned patent applications, Serial Nos. 276,131 filed June 22, 1981; 282,165 filed July 1981;and (ETH 532).

In hemostatic clips, it is important to have a clip with a positive lock or a positive closure of the vessel. The clip should be easily handled by the nurse and surgeon during the procedure so that it will remain sterile when taken from its package by the nurse with a suitable instrument, handed to the surgeon, and placed appropriately in the patient. Many clips are desinged to take advantage of certain physical properties of materials such as resiliency or deformability.

When this is done, the materials which may be used to make the clips are limited. It is desirable to configure a clip in such a manner that a satisfactory clip may be produced from any of the various bio-compatible materials whether they be absorbable or non-absorbable in body tissue. Our new clip meets all of the above requirements in that it is simple to manufacture and can be made from any of the various absorbable or nonabsorbable polymeric materials. Our new clip produces a positive lock or closure of the vessel to which it is applied and is readily manipulated by the nurse or surgeon during the procedure.

Summary of the Present Invention A sterile, two-piece hemostatic clip for occluding vessels. The pieces are substantially identical in configuration and each piece comprises a first member having a vessel clamping surface and a second member disposed substantially perpendicular from one end of said first member from said vessel clamping surface.

The first member has disposed at its opposite end an opening adapted to accept the second member of the other piece. Each piece includes means for locking the second member of the opposite piece to the first member with the vessel clamping surfaces of the pieces facing each other. In certain embodiments of the hemostatic clips of the present invention, the locking means may be adjustable to allow the clip to be used for various size vessels. Also, in some embodiments of the hemostatic clips of the present invention, the locking means may include an interference fit between the second member of one piece and the opening in the first member of the opposite piece.

Brief Description of the Drawings The present invention will be more fully described in conjunction with the accompanying drawings wherein; Figure 1 is an enlarged perspective view of one embodiment of the two-piece clip of the present invention depicting the pieces in an open position; Figure 2 is an enlarged perspective view of the clip of Figure 1 disposed closing a blood vessel; Figure 3 is an enlarged perspective view of another embodiment of the clip of the present invention with the pieces disposed from each other; Figure 4 is an enlarged perspective view of another embodiment of the new clip of the present invention with the pieces disposed from each other; Figure 5 is a side view showing an instrument for applying the clips of the present invention; and Figure 6 is an enlarged perspective view showing a clip of the present invention in the jaws of the instrument depicted in Figure 5.

Detailed Description of the Drawings Referring to the drawings, in Figure 1 there is shown a clip 10 of the present invention. The clip comprises a first piece 11 having a first member 12 with a vessel clamping surface 13. Disposed from one end of this member is a second member 14. The first and second member are perpendicular to each other and the second member is disposed from the vessel clamping surface of the first member. Disposed at the opposite end of the first member is an opening 1 5 through the member. The clip includes a second piece 16 substantially identical to the first piece in that the second piece comprises a first member 17 and second member 1 8 perpendicular to each other with the first member having a vessel clamping surface 19 and the second member disposed from that surface.The first member of the second piece also includes an appropriate opening 20 disposed at the opposite end from which the second member is disposed.

Each of the second members includes a plurality of ears 21 or beveled extensions on one surface. As may be seen in Figure 2, the pieces are placed on opposite sides of the vessel 22 to be occluded with the vessel clamping surfaces facing each other. The second member of one piece is inserted into the opening in the first member of the other piece and the pieces urged together allowing the ears to lock the pieces together by engaging the opposite surface 23 from the vessel clamping surface of the first member of the other piece.

In Figure 3 there is shown another embodiment of the clip of the present invention. Again, the clip 25 comprises a first piece and a second piece which are substantially identical in configuration Each piece has a first member 26 with a clamping surface 27 and disposed from one end of the first member perpendicular to the vessel clamping surface is a second member 28. The second member terminates in an arrowhead shaped area 29. At the opposite end of each first member is a widened area 30 in which there is an opening 31.

In use, the vessel clamping surfaces are placed on opposite sides of the vessel to be occluded and the arrowhead shaped portion of the second member of each piece forced through the opening in the first member of the opposite piece to close the vessel between the vessel clamping surfaces.

In this embodiment adjustability for use with vessels of varying size is attained through deflection of members 26.

In Figure 4 there is shown yet another embodiment of the hemostatic clip of the present invention. The hemostatic clip 35 comprises two pieces of substantially identical configurations.

Each piece has a first member 36 with a vessel clamping surface 37. Disposed from one end of the vessel clamping surface and perpendicular thereto is a second member 38. Disposed at the opposite end of that first member and through the vessel clamping surface is an opening 39. The opening may have raised areas disposed on its inner surface to provide an interference fit between the opening and the second member of the opposite piece or the second member may include protrusions 40 on its surface to provide such an interference fit. In use, the vessel clamping surfaces of the first members are placed on opposite sides of the vessel 41 to be occluded and the second member is inserted into the opening of the opposite piece to close the vessel between the vessel clamping surfaces.In any embodiments of the clips, the two pieces may be attached if desired by a suitable strip 42 or band connecting the pieces together at any of a number of various positions. Such a strip is shown in the embodiment in Figure 4.

Figure 5 illustrates a forceps type ligating clip applier 43 comprising two handle members 44 and 45 crossing at a hinge point 46 and maintained in a normally open position by a spring 47. One handle extends beyond the hinge forming a jaw member 48 while the extension of the other handle also forms a corresponding jaw member 49. As is more clearly shown in Figure 6, the jaw members 48 and 49 are substantially mirror images and are provided with channels 50 and 51 extending rearwardly from the tip of the jaws to guide the clip. The two pieces 52 and 53 of the clips are held in these channels by frictional engagement between the sides of the channel and the sides of the pieces. Each channel includes an appropriately disposed opening 54 to allow the second member of the piece held in the opposite channel to pass through that opening when the clip is closed about a blood vessel.The jaws of the applier are moved or positioned over the vessel to be occluded and the jaws of the applier closed and the clip locked on to the vessel. The friction is insufficient to hold the locked pieces of the clip and when the jaws are reopened the clip is left on the vessel and the applier readily removed.

The clips of the present invention may be constructed in various sizes according to their intended function. Hemostatic clips are usually less than 6 millimeters in length and 1 2 millimeters in width and have a vessel clamping surface of about 3 millimeters in length. The dimension of the clip may be reduced by about 50% for certain applications in microsurgery.

Larger clips for special hemostatic applications may be about double the size of a typical hemostatic clip. The various sizes of the clip may be preferably matched with individual appliers having jaws tailored to the size of the clip for best performance.

As can be appreciated, the configuration of our improved ligating clips allows the clip to be made from virtually any material. Our new clips may be made from both resilient and non-resilient materials as well as deformable and nondeformable materials. The final clip made from any of these materials adequately closes a blood vessel for a sufficient period of time to provide hemostatis and provides a suitable hemostatic clip.

The clip of the present invention is most conveniently molded of biologically acceptable polymeric material which may be absorbable or non-absorbable in body tissue. Preferred absorbable polymers and copolymers include those of glycolide, lactide, and (p)dioxanone.

Preferred non-absorbable polymers include nylon, polyester, and polypropylene. All of these materials have been demonstrated to be biologically acceptable when used as sutures or other implantable medical devices.

The clips of the present invention are sterilized by any of the known sterilization techniques generally depending on the material used to make the clip. Examples of suitable sterilization techniques which may be used with our clips are ethylene oxide sterilization, radiation sterilization, such as cobalt irradiation, electron beam, heat or steam sterilization, etc., and the like.

The clips of the present invention may be easily and economically manufactured by injection molding and other suitable molding techniques well known in the art. As may be appreciated, because of the identical configuration of the twopieces of the clip, the molding is simple and only one mold shape is required.

Having now described the present invention and certain specific embodiments, it will be readily apparent to those skilled in the art that many variations and modifications may be made to the present invention without departing from the spirit and scope thereof.

Claims (8)

1. A sterile, two-piece hemostatic clip for occluding vessels, said pieces being substantially identical in configuration, each piece comprising a first member having a vessel clamping surface and a second member disposed from one end of said first member and substantially perpendicular thereto and on the same side as said vessel clamping surface, said first member having disposed at its opposite end an opening adapted to accept the second member of the other piece and means for locking the second member of one piece to the first member of the other piece with the vessel clamping surfaces of the pieces facing each other.

2. A sterile, two-piece hemostatic clip according to Claim 1 wherein the locking means is adjustable to allow for adjusting the distance between the vessel clamping surfaces when the two pieces are locked together.

3. A sterile, two-piece hemostatic clip according to Claim 1 or 2 wherein the locking means comprises an interference fit between the second member of one piece and the opening of the other piece.

4. A sterile, two-piece hemostatic clip according to Claim 1 or 2 including a member connecting the two-pieces together.

5. A sterile, two-piece hemostatic clip according to Claim 2 wherein the adjustable locking means comprises a plurality of ears extending from the surface of each of the second members and disposed to pass through the opening of the first member and contact the opposite surface of said first member from said vessel clamping surface when the clip is closed.

6. A sterile, two-piece hemostatic clip according to Claims 1,2 or 5 made from an absorbable polymeric material.

7. A sterile, two-piece hemostatic clip according to Claim 6 wherein the absorbable polymeric material is a polymer or copolymer of lactide, glycolide or p-dioxanone.

8. A sterile, two-piece hemostatic clip according to Claim 1, substantially as described with reference to Figures 1 and 2, or Figure 3 or Figure 4, of the accompanying drawings.