GB2124502A

GB2124502A - Surgical clips

Info

Publication number: GB2124502A
Application number: GB08320711A
Authority: GB
Inventors: Donald Max Golden
Original assignee: Ethicon Inc
Current assignee: Ethicon Inc
Priority date: 1982-08-02
Filing date: 1983-08-01
Publication date: 1984-02-22
Also published as: DE3327722C2; GB8320711D0; JPS5985654A; CA1207623A; DE3327722A1; GB2124502B

Abstract

A sterile hemostatic clip 10 for occluding vessels comprises spaced apart leg members 11, 12 with facing vessel clamping surfaces 13, 14. The leg members are connected at one end by adjustable means so that the distance between the vessel clamping surfaces may be controllably decreased to occlude a vessel placed between them. The adjustable means may be a ratchet and pawl 15, 18. <IMAGE>

Description

SPECIFICATION Non-metallic, bio-compatible hemostatic clips (ratchet lock 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 separating, the vessels are ligated.

Once the 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 these 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 stoppage may cause blood loss in the patient and also disrupt the natural hemostasis and concurrent manufacture of new paths of blood flow in the patient.

In the past, this closing of the vessel was usually acomplished using ligatures; that is, filaments or threads which the doctor tied around the vessel to be closed. This is a time-consuming process and one where 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. Even more recently, hemostatic clips have been developed from bio-compatible polymeric materials which are absorbable or nonabsorbable in body tissue.Such clips are more fully described in copending commonly assigned patent applications Serial Nos. 276,131 filed June 22,1981,282,165 filed July 31, 1981,and (ETH 532).

In making the polymeric clips, it is desirable that they be configured so they can be made from any of the absorbable or non-absorbable polymers. They should be able to be made from materials that are resilient or non-resilient, and deformable or non-deformable, etc. The clips should be configured so that they are positively locked in place once closed about the blood vessel to be occluded. The clip should be relatively easy to manufacture and inexpensive to produce. Also, the clip should be relatively simple to manipulate by the nurse and/or surgeon during the operative procedure. The clip should be easily removed from its package, placed in an applier and manipulated during the surgical precedure with ease and without loss of sterility.

What we have discovered is an improved ligating clip which allows the clip to be made from virtually any material, whether the material is resilient, non-resilient, deformable, or nondeformable. Our new clip is configured to positively lock in place and occlude a vessel placed between the vessel clamping surfaces of the clip. Our new clip is readily and easily manipulated. The clip can be picked up in a positive manner by a nurse, held in an instrument with little chance of falling out of the instrument.

The instrument may be passed to the surgeon, again with little chance of the clip falling out of the instrument, and the surgeon apply the clip about the vessel to be occluded in a simple manner, all the time maintaining the sterility of the clip.

Summary of the Present Invention A sterile hemostatic clip for occluding vessels comprising a pair of spaced apart leg members.

Each leg member has a vessel clamping surface with the vessel clamping surfaces disposed parallel and facing each other. One end of the leg members is open to allow for the vessel clamping surfaces to be placed on opposite sides of the vessel to be occluded. The opposite end of the leg members is connected by an adjustable ratchet and pawl means or equivalent means whereby the spacing between the vessel clamping surfaces may be controllably decreased to occlude a vessel placed between the surfaces. In some embodiments of the clip of the present invention, the outer surfaces of the leg members are also parallel over a portion of the outer surfaces to aid in urging the vessel clamping surfaces towards each other.

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 a new clip of the;present invention in the open position; Figure 2 is an enlarged perspective view of the clip of Figure 1 closed about a blood vessel; Figure 3 is a side view showing an instrument for applying the clips of the present invention; and Figure 4 is an enlarged perspective view showing the jaws of an instrument used for applying clips of the present invention with the clips and jaws in the open position.

Detailed Description of the Drawings Referring to the drawings, in Figure 1 there is shown clip 10 of the present invention in the open position. The clip comprises a pair of leg members 11 and 12. The leg members have vessel clamping surfaces 13 and 14 respectively with the vessel clamping surfaces being disposed parallel and facing each other. One end of the leg members is open while at the opposite end there is a ratchet mechanism. The ratchet mechanism comprises a member 15 extending perpendicular from one of the leg members with said member having disposed along opposite surfaces suitable teeth 16 or indentations. The opposite leg member carries a complementary opening 18 for accepting the perpendicular extension of the first leg member.The opening includes a suitable ledge 19 or pawl type protrusion to accept the teeth of the extension and lock the two leg members with respect to each other at a given position. In certain embodiments of the clip, this ledge or pawl may be formed by the outer surface 20 of the leg member. As may be more clearly seen in Figure 2, the vessel 22 to be occluded is placed between the vessel clamping surfaces 13 and 14 and the two leg members urged towards one another to occlude the vessel. The leg members are closed by urging the leg members towards one another over the ratchet mechanism which locks the legs in the closed position. While we have shown a ratchet and pawl type mechanism any similar gear type mechanism comprising intermeshing units which allow for movement in one direction but prevent movement in the opposite direction or return movement may be used.

Figure 3 illustrates a forceps type ligating clip applier 25 comprising two handle members 26 and 27 crossing at a hinge point 28 and maintained in a normally open position by a spring 29. One handle extends beyond the hinge forming a jaw member 30 and the extension of the other handle also forms a corresponding jaw member 31. As is more clearly shown in Figure 4, the jaw members 30 and 31 are identically designed and contain channels 32 and 33 respectively extending rearwardly from the tips of the jaws.

These channels hold the leg members of the clip 34 and 35 in place by frictional engagement with the sides of the leg members. The clip is initially loaded in the applier in its open position. 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 locking of the clip is sufficient to overcome the frictional engagement of the clip with the sides of the channel and, hence, when the applier is opened it is readily removed from the applier jaws and the clip allowed to remain with the blood vessel.

The clips of the present invention may be constructed in various sizes according to their intended function. Hemostatic clips are usually less than six millimeters in length and one and one-half millimeters in width and have a vessel clamping surface of about three 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 have about double the size of a typical hemostatic clip. The various sizes of the clips may be preferably matched with individual appliers having jaws tailored to the size of the clip for best performance.

The clips of the present invention are most conveniently molded of biologically acceptable polymeric materials which may be absorbable or non-absorbable in body tissue. Preferred absorbable polymers and copolymers include those of glycolide, lactide, and poly(p)dioxanone, Preferred non-absorbable polymers include nylon, polyester, and polypropylene. All these materials have been demonstrated to be biologically acceptable when used as sutures or other implantable medical devices.

The clips may be sterilzed by any of the well known techniques and the sterilization technique will generally depend on the type of polymer used in producing the clip. The clips may be sterilised by heat or steam sterilization, radiation sterilization, such a cobalt irradiation, electron beam and the like, by ethylene oxide sterilization and by other techniques well known in the art.

The clips of the present invention may be easily and economically manufactured by injection molding or other suitable molding techniques well known in the art.

Having now described the present invention and certain specific embodiments therein, 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

1. A sterile, hermostatic clip for occluding a vessel, said clip comprising a pair of spaced apart leg members having vessel clamping surfaces disposed parallel and facing each other, one end of said leg members being open to allow for said vessel clamping surfaces to be placed on opposite sides of the vessel to be occluded, the opposite end of said leg members being connected by adjustable means whereby the spacing between the vessel clamping surfaces may be controllably decreased to occlude the vessel placed between said vessel clamping surfaces.

2. A sterile hemostatic clip according to Claim 1 wherein at least a portion of the outer surfaces of the leg members are parallel with respect to each other.

3. A sterile hemostatic clip according to Claim 1 or 2 wherein the adjustable means comprises a ratchet attached from the vessel clamping surface at one end of one of the leg members and a complementary pawl disposed at one end of the other leg member, said pawl being such to only allow for movement to decrease the space between the vessel clamping surfaces of the leg members.

4. A sterile hemostatic clip according to Claim 1 or 3 made from an absorbable polymeric material.

5. A sterile hemostatic clip according to Claim 4 wherein the absorbable polymeric material is a copolymer of lactide and glycolide.

6. A clip according to claim 1, substantially as described with reference to Figs. 1, 2 and 4 of the accompanying drawings.