CA1162126A

CA1162126A - Double-latched plastic ligating clip

Info

Publication number: CA1162126A
Application number: CA000371451A
Authority: CA
Inventors: Stephen J. Jewusiak
Original assignee: Ethicon Inc
Current assignee: Ethicon Inc
Priority date: 1980-02-25
Filing date: 1981-02-23
Publication date: 1984-02-14
Also published as: BR8101122A; SU1324576A3; MX151148A; DE3106851A1; NL188451C; AR225492A1; DE3106851C2; NL188451B; NL8100899A; FR2476478B1; ES265280Y; JPH0135658B2; JPS56151034A; ES265280U; FR2476478A1; GB2069848A; GB2069848B

Abstract

ABSTRACT

DOUBLE-LATCHED PLASTIC LIGATING CLIPS

Ligating clips of absorbable or nonabsorbable polymeric materials are formed by two hinged leg members which interlock at both ends when the clip is closed. One leg is configured as an open oval with sharp return bends on either end. The second leg is configured to conform to the interior of said oval. The clip is applied to blood vessels or the like with a conventional, forceps-type instrument.

Description

~TH-4/1 ~l16212~i DOUBLE-L~TC~ED PLASTIC LIGATIN~ CLIPS

BACKGROUND OF THE INVENTION

The present invention relates to hemostatic clips and clip appliers, and, more particularly, to hemostatic clips fabricated from absorbable or nonabsorbable polymeric materials and to instruments for applying such clips to blood vessels and the like.
Hemostatic clips are utiliæed in surgical procedures to close severed blood vessels and other small fluid ducts.
In the past, hemostatic clips have been narrow U-shaped 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 clips are generally applied using a forceps-type device having jaws channeled or otherwise adapted to hold the open clip. Representative hemostatic clips and appliers of the prior art are best illustrated in U.S. Patents Nos. 3,867,944; 3,631,707; 3,439;523;
3,439,522; 3,363,628; 3,312,216; and 3,270,745.

It has been suggested in the prior art, as in u.l. Patent ~ 25 No. 3,439,523, for example, that hemostatic clips might be ! formed of inexpensive plastic or materialq w~hich are slowly absorbable in the body. Unfortunately, convention-al U- and V-shaped hemostatic clips do not possess the required strength or deformability when constructed of known plastic materials to be successfully clamped about a blood vessel. Thus, although the need and desirability of providing inexpensive plastic ligating clips of both absorbable and nonabsorbable materials has been recogni~ed for over ten years, there has been no practical way to satisfy this need.

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U.S. 3,926,195 describes a small, plastic clip designed for the temporary or permanent close of the oviduct and vas deferens in humans. These clips preferably have a clamping surface of from 6 to 10 mm in length and 3 to 6 mm in wid~h. The size of such clips are accordingly considerably larger than is desirable for hemostatic clips. Additionally, clips of U.S~ Patent No. 3,926,195 require the use of several complex tools to apply the clips which are acceptable for the purposes described in the reference but would be unacceptable in a surgical procedure requiring the rapid placement of a large number of hemostatic clips to stem the flow of blood from severed vessels.

It is accordingly an object of the present invention to provide a plastic ligating clip effective for clamping off small blood vessels and other fluid ducts in the body. It is a further object of this invention to provide plastic ligating clips of b,oth absorbable and nonabsorbable materials. It is yet a further object of this invention to provide plastic ligating clips which are quickly and easily applied to severed blood vessels and other fluid ducts with a single forceps-type instrument as used in applying meta-llic clips.
! 25 SUMMARY
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The ligating clips of the present invention comprise two hinged leg members which interlock at both ends when the clip is closed. The ~irst leg is configured as an open oval having an elongated vessel clamping portion termin-ating at each end in a return bend. The second leg is configured to conform to the interior of said oval. The two leg members are conne~cted at one end by an integral molded hinge extending from the end of the first leg member to a point on the second leg member adjoining ~162~

said end of first leg member when the clip is in a closed configuration.

The sharp return bend at the distal or free end of the first leg forms a defiectable hook member. The distal end of the second leg is adapted to deflect and engage said hook member when the clip is closed by pivoting the two legs about the hinge point.

The proximal or hinged end of the first leg also forms a hook member. The proximal end of the second leg is adapted to rotate into and engage this hook member when the clip is closed.

The clip is provided in an initially open configuration with the axis of the legs at approximately right angles.
- The open clip is optionally provided with means for maintaining the clip in an open position until the clip is extentionally closed, such as a thin web extending from the proximal end of t~le second leg to a near point on the interior surface of the first leg, which web is readily sheared when a closing force is applied to the cl`ip.
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The open clip is positioned over the vessel to b ligated with the vessel approximately centered in the oval of the first leg. The second leg is thereupon pivoted about the hinge point until the ends of the second leg are engaged by the hook members of the first leg with the vessel securely compressed between the two leg members. A
forceps-type ligating clip applier is useful for position-ing and closing the clip.

The clip of the present invention is unique in that once closed, the clip is mechanically locked on both ends, and security of the clip does not depend on the integrity of the hinge element which is the weakest part of the clip.

The clips of the present invention are formed of any suitable, biocompatible polymer by extrusion, injection molding, or other conventional fabrication process. The polymer may be an absorbable material such as homopolymers or copolymers of lactide, blycolide, or p-dioxanone, or a nonabsorbable material such as nylon or polypropylene.

According to a further broad aspect of the present inven-tion there is provided a hemostatic clip comprising first and second leg members. Each leg member has an elongated vessel clamping portion in opposition to a vessel clamping portion of the other leg member. The first leg member terminates at each end in a return bend forming a hook member portion. The second leg memher terminates at each end in a configuration adapted Eor engagement by the hook members of the first leg. One of the hook members of the first leg member is an extension of one end of the second leg mem~er and forms a resilient hinge therewith to perma-nently join the first and second leg members. The first and second leg members are pivoted about the hinge means from an open posltion to a closed position with the end,s of the second leg member being engaged by the corresponding hook members of the first leg member as the leg members are pivoted to a closed position.

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- 4a -DESCRIPTION _F DRAWINGS

FIGURE 1 is a greatly enlarged view in perspective of a surgical clip according to the present invention.

FIGURE 2 illustrates the clip of FIGURE 1 clamped about a blood vess~l.

FIGUR~ 3 illustrates a forceps-type applier useful with the clips of the present invention.

FIGURE 4 illustrates the open clip of FIGURE 1 retained in the jaws of a forceps-type clip applier.

FIGURE 5 illustrates the clip of FIGURE 4 closed and locked over a blood vessel in the jaws of the applier.

FIGURE 6 illustrates an open clip of a modified design retained in the jaws of a forceps-type clip applier.

DESCRIPTION OF PREFERRED EMBODIME~T

Referring now to FIGURE 1, there is illustrated hemostatic clip 10 constructed of two leg members 11 and 12 connected at the proximal ends thereof by hinge section 13. Leg 11 terminates at the distal end thereof in a return bend forming hook member 14 having inner face 15 substantially parallel to inner face 16 of leg 11. Leg member 12 B

~ Ll~--'i / 1 terminates at the distal end in end face 19 which joins inner face 18 o~ leg 12 through radial surface 17. End face 19 extends to outer surface 20 which is substantially parallel to surface 18. The :Length of surface 20 is sub-stantially equal to the length of surface 15 to provide secure latching of the clip as hereinafter described.

At the proximal or hinged end of the clip, leg 11 termin-ates in a return bend forming hook member 21 having an inner face 22 substantially parallel to inner face 16.
Leg 12 terminates in radial surface 23 extending to outer surface 24 which is substantially parallel to inner sur-face 18. Surfaces 22 and 24 are of substantially equal lengths and are separated by cylindrical relief bore 25 defining hinge 13.

As illustrated in FIGURE 1, clip 10 includes web 26 extending from the proximal end of leg 12 to the nearest point on surface 16 of leg 11 when legs 11 and 12 are at - 20 substantially right angles. Web 26 is an optional structure which functions to stabilize the clip in its open configuration until the web is sheared by a closing force deliberately applied to the clip.
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The length and width of faces 16 and 18 are substantially equal, and face 15 of haok 14 is spaced from face 16 of leg 11 by a distance corresponding to the thickness of leg 12 between the plane of face 18 and surface 20. When legs 11 and 12 are pivoted about hinge 13 to bring faces 18 and 16 into opposition, hook 14 is deflected by surface 19 of leg 12 until the distal end of leg 12 snaps under hook 14 and is thereby locked in place. Simultaneously, the proximal end of leg 12 rotates about hinge 13 to engage hook 21 of leg 11 with surfaces 22 and 24 in contact. Web 26, if present, is sheared during closure. The proximal end of the clip is thereby mechanically secured by a hook ~1~6 and latch interaction comparable to that securing the distal end of the clip. The end face of hook member 14 is preferably beveled as illustrated in FIGURE 1 to facili-tate deflection of the hook to allow passage of leg 12 during clip closure.

The configuration of the clip when closed over a tubular vessel as illustrated in FIGURE 2 wherein surfaces 16 and 18 of the clip engage and compress vessel 32 to close the lumen thereof. Surfaces 16 and 18 may be smooth as illus-trated in F-IGURE 1, or may be provided with ridges or grooves to increase vessel holding power. Hinge 13 is seen to extend from the end of hook 21 to a point on leg member 12 adjoining the end of hook 21 when the clip is in a closed position.

~ Referring again to FIGURE 1, leg 12 is provided with applier gripping means near the distal end thereof in the form of channel 27 which forms ridges 28 and 29 extending 20 across the width of the clip. Leg 11 is similarly pro-vided with applier gripping means in the form of ridges 30 and 31 near the distal end thereof. The function of these structural features in positioning the clip in the applier i ¦ and applying the clip to the vessel being ligated is more 25 fully described hereinafter in regard to FIGURES 4 and 5.

FIGUR~ 3 illustrates a forceps-type ligating clip applier 40 comprising two ring handle members 41 and 42 crossing at hinge point 43 and maintained in a normally open 30 position by spring 46. Handle 41 extends beyond hinge 43 forming jaw member 44 while the extension of handle 42 forms jaw member 45. Pin 38 extends from handle 42 into a blind slot 39 in handle 41 and limits the maximum opening of jaws 44 and 45 to that required to accommodate the open 35 clip.

fl l ~2,~ I~ L ~L--4 / --FIGURE 4 illustrates the detail of the construction of jaws 44 and 45 of applier 40 and the interaction of the jaws with the clip of FIGURE 1. Jaws 44 and 45 are of identical design and are provided respectively with channels 47 and 48 extending rearwardly from the tips of the jaws. The width of each channel is sufficient to accommodate the width of the clip, and each channel is provided with gear-like teeth 49 and 50 across the bottom of the channel over an area extending rearward from the tips of the jaws. The size and spacing of channel teeth 49 and 50 correspond to the size and spacing of the corresponding ridges on the clip, and when the open clip is held in the applier, the ridges of the clip mesh with the teeth of the applier as illustrated in FIGURE 4.
Since the jaws of the applier have identical structure, there is no need to orient the applier to the clip when loading or using the applier.

Clip 10 is initially loaded in applier 40 in the normally open position as illustrated in FIGURE 4. After moving the jaws of the applier and the clip into position over the vessel to be ligated, the jaws of the applier are closed and the clip is locked in position over thle vessel as illustrated in FIGURE 2. As the jaws~of thel applier are closed, the legs of clip 10 rotate in the channels of the jaws until the distal end of leg 12 is engaged by hook member 14. Once the clip is fully closed and locked onto the vessel as illustrated in FIGURE 5, the jaws of the applier are opened and the applier withdrawn from the site to be reloaded with another clip.

Referring now to FIGURE 6, there is illustrated another embodiment of a clip and applier in accordance with the present invention wherein legs 11 and 12 are each provided with a channel 52 extending across the width of the clip near the distal end thereof. Jaws 44 and 45 of the applier are provided with corresponding raised bosses 51 adapted to engage channels 52 when the open clip is positioned between the jaws. The channel of jaw 45 is additionally recessed at 53 to accommodate hook 14 of the clip when the clip is closed between the jaws. As illus-trated, the channel of jaw 44 is similarly recessed to eliminate the necessity for orienting the applier to the clip .
Although the illustrations and description have been limited to certain specific embodiments of the ligating clip of the present invention, many variations in clip design will be apparent to those skilled in the art and are contemplated in the scope of the present invention.
For example, the gripping means between the applier jaws and the clip, i.e., the teeth and ridges of FIGURE 4 or the boss and channels of FIGURE 6 are preferred but optional and may be omitted. The clips may be fabricated with a smooth outer surface and the jaws of the applier may have smooth channels to accept the clip. Addition-ally, the channels of the applier may be contoured to the outer configuration of the clip in order to orient and secure the clip between the jaws. These and other modifications in the configuration of the clip may be employed without departing from the spirit and scope of the pr-esent invention.

The clips of the present invention may be constructed in various sizes according to their intended function.
Hemostatic clips are typically less than 6 mm in length, about 1.5 mm in width, and have a vessel clamping surface about 3 mm in length. The dimensions of the clip may be reduced by about 50 percent for certain applications in microsurgery. Larger clips for special hemostatic applications and other functions such as closure of -~2~2~

oviducts or vas deferens may have dimensions of about double those of a typical hemostatic clip. The various sizes of clips are preferably matched with individual appliers having jaws tailored to the size of the clip for best performance.

The clips of the present invention are conveniently molded of biologically acceptable plastic materials which may be ! absorbable or nonabsorbable. Preferred absorbable poly-mers include homopolymers and copolymers of glycolide, lactide, and ~-dioxanone. Preferred nonabsorbable poly-mers 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 also be cast or machined from solid polymeric materials or from metals such as aluminum, magnesium, stainless steel, tantalum, and various alloys of these, some of which may also be absorb-able in biological tissue.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A hemostatic clip comprising first and second leg members, each leg member having an elongated vessel clamping portion in opposition to a vessel clamping portion of the other leg member, said first leg member terminating at each end in a return bend forming a hook member portion;
said second leg member terminating at each end in a confi-guration adapted for engagement by said hook members of said first leg; one of said hook members of said first leg member being an extension of one end of said second leg member and forming a resilient hinge therewith to perma-nently join said first and second leg members, said first and second leg members being pivoted about said hinge means from an open position to a closed position with the ends of said second leg member being engaged by the corres-ponding hook members of the first leg member as said leg members are pivoted to a closed position.

2. A clip of claim 1 wherein said first and second leg members are connected by a shearable web extending from the vessel clamping portion of the first leg to the proximal end of the second leg when said clip is in an open position, said web being sheared during closure of the clip.

3. A clip of claim 1 wherein each of said hook members of said first leg have an inner face spaced from and substantially parallel to the opposing surface of said vessel clamping portion.

4. A clip of claim 1 wherein said hinge means defines a cylindrical relief bore extending between said first and second leg members at the end of said hook member.

5. A clip of claim 1 wherein said first and second leg members include applier gripping means on the outer surfaces at the distal ends thereof.

6. A clip of claim 5 wherein said applier gripping means comprises at least one channel extending transversely across the width of said leg members.

7. A clip of claim 6 wherein said applier gripping means comprise at least one ridge extending transversely across the width of said leg members.

8. A clip of claim 1 composed of a biologically acceptable absorbable polymer

9. A clip of claim 8 wherein said polymer is selected from the group consisting of homopolymers and copolymers of glycolide, lactide and p-dioxanone.

10. A clip of claim 1 composed of a biologically acceptable nonabsorbable polymer.

11. A clip of claim 10 wherein said polymer is selected from the group consisting of nylon, polyester and polypropylene.

12. A hemostatic clip comprising hinged first and second leg members, each leg member having an elongated vessel clamping portion having an inner face in opposition to the vessel clamping portion of the other leg member;
said first leg member being configured as an open oval having at each end a return bend forming a hook member extending from said vessel clamping portion, each of said hook members having an inner face spaced from and substantially parallel to the inner face of said leg member;
said second leg member being configured to con-form to the interior of said oval of said first leg member, each end of said second leg member being adapted for engagement by said hook members of said first leg member;
said first and second leg members being joined by hinge means extending from the free end of one hook member to the adjoining surface of said second leg member when said second leg member is engaged by said hook member;
said first and second leg members being pivotable about said hinge from an open position to a closed position with the hinged end of said second leg member rotating into engagement with the corresponding hook member of said first leg and the other end of said second leg member deflecting and being engaged by the other hook member to mechanically secure said leg members in a closed position.

13. A clip of claim 12 wherein said first and second leg members are connected by a shearable web extending from the vessel clamping portion of the first leg member to the proximal end of the second leg member when said clip is in an open position, said web being sheared during closure of the clip.

14. A clip of claim 12 wherein the end of said hook member extending from the free distal end of said first leg member is bevelled to facilitate the deflection of said hook member to bypass and subsequently engage the corresponding distal end of said second leg member.

15. A clip of claim 12 wherein said first and second leg members include applier gripping means on the outer surfaces at the distal ends thereof.

16. A clip of claim 15 wherein said applier gripping means comprise at least one ridge extending transversely across the width of said leg members.