CA1157334A

CA1157334A - Plastic ligating clips

Info

Publication number: CA1157334A
Application number: CA000354029A
Authority: CA
Inventors: Robert W. Mericle
Original assignee: Ethicon Inc
Current assignee: Ethicon Inc
Priority date: 1979-06-18
Filing date: 1980-06-16
Publication date: 1983-11-22
Also published as: ES265371Y; BR8003750A; HK44783A; IN151996B; GB2054026A; NL190980B; DE3022087A1; MY8400249A; NL8003418A; PH21076A; ATA319680A; AT389043B; CH648476A5; ES265656U; SE449295B; JPS563048A; ES265371U; NL190980C; DE3022087C2; FR2459038A1

Abstract

ABSTRACT

PLASTIC LIGATING CLIPS
Plastic ligating clips of absorbable or nonabsorbable mate-rials are formed by two legs joined with a resilient hinge.
One leg terminates in a hook member which secures the other leg when the clip is closed. Each leg of the clip is pro-vided with a raised cylindrical boss extending across its width near the distal end which secures the clip in the ap-plier and allows the clip to rotate about its hinge during closure. The clip applier is a forceps-type instrument hav-ing channeled jaws especially adapted to receive and close the plastic clip.

Description

:
1 1573~4 PLASTIC LIGATING CLIPS

BACXGROUND OF THE INVENTION

The present invention relates to hemostatic clips and clip appliers, and, more particularly, to hemostatic clips 5 fabricated from absorbable or nonabsorbable polymeric materials and to instruments for applying such clips to blood vessels and the like.

Hemostatic clips are utilized in surgical procedures to 10 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 15 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;
20 3,439,522; 3,363,628; 3,312,216; and 3,270,745.

It has been suggested in the prior art, as in U.S. Patent No. 3,439,523, for example, that hemostatic clips might be formed of inexpensive plastics or materials which are 25 slowly absorbable in the body. Unfortunately, conventional U-and V-shaped hemostatic clips do no t possess the required strength or deformability when constructed of known plastic materials to be successfully 11573~4 clamped about a blood vessel. Thus, although the need and desirability of providing inexpensive plastic ligating elips of both absorbable and non-absorbable materials has been recognized for over ten years, there has been no practieal way to satisfy this need.

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 width. The size of sueh elips are aeeordingly considerably larger than is desirable for hemostatic clips.
Additionally, clips of U.S. 3,926,195 require the use of several complex tools to apply the elips whieh are aeeept-able for the purposes deseribed in the referenee 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 ~essels.

It is accordingly an object of the present invention to provide a plastie ligating elip effective for elamping off small blood vessels and other fluid duets in the body. It is a further object of this invention to provide plastie ligating clips of both absorbable and non-absorbable materials. It is yet a further objeet of this invention to provide plastie ligating elips whieh are quickly and easily applied to severed blood vessels and other fluid ducts with a single forceps-type instrument used in applying metallic clips.

In accordance with the present invention, there is thus provided a sterile, hemostatic ligating clip made from absorbable or non-absorbable polymeric materials for appli-cation using a clip applying instrument having a pair of jaws for holding the clip, placing the clip about the vessel ~5 to be ligated and closing the clip to ligate the vessel.
The clip of the invention comprises first and second leg members joined at their proximal ends by resilient hinge means and terminating at their distal ends in latch means, each leg member having an outer surface and a vessel clamp-ing innerface. The vessel clamping innerface is in opposition to a vessel clamping innerface of the other leg member. The first leg member terminates at the distal end thereof in a portion of the latch means, which portion comprises a deflectable hook member extending from the innerface of the leg member, the hook member having an inner-face spaced from the innerface of the hook member and substantially parallel thereto, the end face of the hook member being beveled so as to form an acute angle with the innerface of the hook member. The first leg member also has a boss disposed on a portion of its outer surface opposite the vessel clamping innerface, the boss having a cylindrical shape with the axis of the cylinder extending across the width of the leg member. The boss is adapted to fit into a first jaw of the clip applying instrument and is spaced from the opposite side of the leg member. The second leg member terminates at the distal end thereof in a complementary portion of the latch means, which portion comprises an end face of the leg member having a ~evel complementary on the bevel to the end face of the hook member, the complementary bevel forming an obtuse angle with the innerface of the second leg member and adapted to enter the space between the innerface of the hook member and the innerface of the first leg member with the end face of the leg member being enclosed by the hook member. The second leg member has a boss disposed on a portion of its outer surface opposite the vessel clamping innerface, the boss having a cylindrical shape with the axis of the cylinder extending across the width of the leg member. The boss is adapted to fit into the second jaw of the clip applying instrument and is spaced from the proximal end of the leg member. ~len the pair of jaws of the clip applying ~ I 1 57334 3a instrument having the clip therein are closed, the bosses of the clip rotate with the jaws of the instrument and allow the first and second leg members to pivot about the hinge means and the distal end of the second leg member to deflect and engage the hook member of the first leg member to lock the clip in a closed position.
The clips of the present invention may be applied by using a forceps-type instrument which constitutes a further aspect of the invention, wherein each jaw is channeled to receive the width and length of the clip and a cylindrical recess is provided across the base of each channel to receive the boss on each leg of the clip. The depth of the channel in each jaw forward of the cylindrical recess (between the cylindrical recess and the tip of the jaw) is greater than to the rear of the cylindrical recess. When the open clip is placed between the jaws of the applier, it is held firmly in place with the boss of each leg in the recess of each jaw. As the jaws are closed, the boss of each leg rotates in the recess of the jaw until the distal end of the second leg bypasses and locks under the hook member of the first leg.
The clips may be formed of plastic by injection molding or other suitable technique, and may be composed of a non-absorbable material such as polypropylene or an absorbable material such as a homopolymer or copolymer of lactide and glycolide. The clips are formed in a normally open position and constructed with a small amount of material to minimize tissue reaction. The clips are readily applied with a forceps-type applier using conventional surgical techniques.
DESCRIPTION OF DRAWINGS
FIGURE 1 is a greatly enlarged view in perspective of a surgical clip according to the present-invention.

`- 1157334 FIGURE 2 illustrates the clip of FIGURE 1 clamped about a blood vessel.

FIGURE 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.

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

DESCRIPTION OF PREFERRED EMBODIMENTS
Referring now to FIGURE 1, there is illustrated hemostatic clip 10 constructed of two leg segments 11 and 12 connected at the proximal ends thereof by hinge section 13. Leg 11 terminates at the distal end thereof in hook 20 member 14 having inner face 15 substantially parallel to inner face 16 of leg 11 and forming an acute angle with end face 17. Leg member 12 terminates at the distal end in end face 19 which forms an obtuse angle with inner face 18 of leg 12. End face 19 is offset at 23 to form a notch 25 approximately midway between surfaces 18 and 20, and additionally is squared off at face 25 to form a substantially right angle with surface 20.

The length and width of faces 16 and 18 are substantially 30 equal, and face 15 of hook 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 i,nto opposition, hook 14 is deflected by surface 19 of 35 leg 12 until the distal end of leg 12 snaps under hook 14 and is thereby locked in place. End face 17 of hook 14 and end face 19 of leg 12 are angled as illustrated to facilitate the passage of leg 12 past hook 14 during clip closure.

' ETH-464 When the clip is closed over a tubular vessel as illustrated in FIGURE 2, surfaces 16 and 18 engage and compress vessel 27 to close the lumen thereof. Surfaces 16 and 18 may be smooth as illustrated in FIGURE 1, or may be provided with ridges or grooves to increase vessel holding power. Leg 11 may also be undercut at the juncture of hook member 14 and surface 16 as illustrated at 26 in FIGURE 1 to increase the deflectability of hook member 14 and increase the space between the hook member 14 and leg 11, thereby compensating for any inward deflection of hook 14 during closure which might reduce the clearance between surfaces 15 and 16 and otherwise interfere with the latching of the clip.

Referring again to FIGU~E 1, leg 12 of clip 10 includes an outside cylindrical boss 21 extending across the width of the leg near the distal end thereof. Boss 21 is spaced from surface 25 a distance sufficient to permit full engagement of hook member 14 by leg 12 when the clip is in a closed and latched position. Cylindrical bosses 21 and 22 are equidistant from hinge means 13 so that when the clip is closed, bosses 21 and 22 define a line perpendicular to the major axis along the length of the clip as best illustrated in FIGURE 5.
The distal end of leg 12 forward of lug 21 is of reduced thickness relative to the thickness immediately to the rear of lug 21, thereby forming step 24 between lug 21 and surface 20. The significance of this clip configuration 30 will be appreciated in connection with the instrument used to apply and close the clip as illustrated in FIGURES 3 through 5.

FIGURE 3 illustrates a forceps-type ligating clip applier 30 comprising two handle members 31 and 32 crossing at hinge point 33 and maintained in a normally open position by spring 38. Handle 31 extends beyond hinge 33 forming jaw member 34 while the extension of handle 32 forms jaw member 35.

- `~` 1 1 57334 FIGURE 4 illustrates the detail o~ the construction of jaws 34 and 35 and the interaction of the jaws with the clip of FIG~RE 1. Jaws 34 and 35 are of identical design and are provided respectively with channels 36 and 37 5 extending rearwardly from the tips of the jaws. Each channel is provided with a cylindrical recess 38 and 39 rèspectively across the width of the channel and near the distal end thereof. Recesses 38 and 39 are in alignment when the jaws of the applier are closed and are sized to 10 receive the cylindrical lugs 21 and 22 of the clip.
Channels 36 and 37 forward of recesses 38 and 39 are deeper than to the rear of the recesses as illustrated in FIGURE 4. When the open clip is held in the applier, the cylindrical lugs on the clip extend into the cylindrical 15 recesses in each jaw. Due to the angle of the clip in the applier, the distal ends of legs 11 and 12 extend into the deeper forward channel section of each jaw. The reduced thickness of leg 12 at the distal tip prevents interference between the tip and the channel of the 20 applier when the clip is held in the open position as illustrated in FIGURE 4.

Clip 10 is initially loaded in applier 30 in the open position as illustrated in FIGURE 4. After moving the 25 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 the vessel as illustrated in FIGURE 5. As the clip is closed, the cylindrical lugs of legs 11 and 12 rotate in the 30 cylindrical recesses of jaws 37 and 36 until the outer surface of leg 12 rests on the base of channel 36 as illustrated in FIGURE 5. At this point, the distal end of leg 12 has rotated away from the base of the channel and sufficient space exists for hook 14 to bypass leg 12 and 35 latch over the outer surface thereof. After the clip has been securely latched over the~vessel to be ligated, the jaws of the applier are opened to release the clip and vessel and a new clip is loaded in the applier. Since the jaws of the applier are identical, it is not necessary to orient the applier to the clip when loading the applier.

Many variations in the clip design other than the 5 embodiments disclosed herein will be apparent to those skilled in the art and are contemplated within the scope of the present invention. For example, the undercut at the juncture of hook 14 and surface 16 of leg 11 may be omitted, and the inner surface of leg 12 may be beveled at 10 the distal end as indicated by bro~en line a in FIGURE 1 to compensate for downward deflection of hook 14 during closure which might reduce the clearance under face lS and interfere with the latching of leg 12. Offset 23 in end face 19 of leg 12 provides an intermediate latching 15 position and effectively increases the length of face 18 at the distal end of leg 12, but may be omitted if desired. These and other modifications in the configuration of the clip may be employed without departing from the spirit and scope of the present 20 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, 25 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 30 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 most conveniently molded of biologically acceptable plastic materials which may be absorbable or nonabsorbable. Preferred absorbable polymers include homopolymers and copolymers of glycolide , ~ . .
.
.

. ETH-464 1 1573~4 and lactide, and poly(2-dioxanone). PreSerred nonabsorbable polymers include nylon and polypropylene.
All these materials have been demonstrated to be biologically acceptable when used as sutures or other 5 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 absorbable in biological tissue.

Claims

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

1.- A sterile, hemostatic ligating clip made from absorbable or non-absorbable polymeric materials for application using a clip applying instrument having a pair of jaws for holding said clip, placing said clip about the vessel to be ligated and closing said clip to ligate said vessel, said clip comprising first and second leg members joined at their proximal ends by resilient hinge means and terminating at their distal ends in latch means, each leg member having an outer surface and a vessel clamping inner-face, said vessel clamping innerface being in opposition to a vessel clamping innerface of the other leg member, said first leg member terminating at the distal end thereof in a portion of the latch means, said portion comprising a deflectable hook member extending from the inner-face of said leg member, said hook member having an innerface spaced from the innerface of said hook member and substantially parallel thereto, the end face of said hook member being beveled so as to form an acute angle with the innerface of said hook member, said leg member having a boss disposed on a portion of its outer surface opposite the vessel clamping innerface, said boss having a cylindrical shape with the axis of the cylinder extending across the width of the leg member, said boss adapted to fit into a first jaw of the clip applying instrument, said boss being spaced from the opposite side of the leg member, said second leg member terminating at the distal end thereof in a complementary portion of the latch means, said portion comprising an end face of said leg member having a bevel complementary on the bevel to the end face of said hook member, said complementary bevel forming an obtuse angle with the innerface of said second leg member and adapted to enter the space between the innerface of said hook member and the innerface of said first leg member with the end face of said leg member being enclosed by said hook member, said second leg member having a boss disposed on a portion of its outer surface opposite the vessel clamp-ing innerface, said boss having a cylindrical shape with the axis of the cylinder extending across the width of the leg member, said boss adapted to fit into the second jaw of the clip applying instrument, said boss being spaced from the proximal end of the leg member, whereby when the pair of jaws of the clip applying instrument having the clip therein are closed, the bosses of said clip rotate with the jaws of the instrument, and allow said first and second leg members to pivot about said hinge means and the distal end of the said second leg member to deflect and engage the hook member of the first leg member to lock the clip in a closed portion.

2.- The hemostatic clip of claim 1, wherein the ends of the cylindrical shaped bosses on the first and second leg members are coplanar with the sides of their respective leg members.

3.- The hemostatic clip of claim 1 or 2, wherein there is a notch disposed in the beveled end of the second leg member, said notch extending the width of said beveled end.

4.- The hemostatic clip of claim 1 or 2, wherein the raised cylindrical boss of said second leg member is spaced from the distal end of said second leg member by a distance corresponding to at least the length of the inner surface of said hook member.

5.- The hemostatic clip of claim l, wherein the raised cylindrical bosses of said first and second leg members are spaced equidistantly from said hinge means.

6.- The hemostatic clip of claim 2, wherein the raised cylindrical bosses of said first and second leg members are spaced equidistantly from said hinge means.

7.- The hemostatic clip of claim 1, wherein said hinge means is defined by a line of minimum clip thickness at the junction of the innerfaces of said first and second leg members.

8.- The hemostatic clip of claim 6, wherein said hinge means is defined by a line of minimum clip thickness at the junction of the innerfaces of said first and second leg members.

9.- The hemostatic clip of claim 7 or 8, wherein said hook member is spaced from the plane of said inner face of said first leg member by a distance equal to at least the thickness of the distal end of said second leg member forward of said cylindrical boss.

10.- The hemostatic clip of claim 1 or 2, wherein the thickness of the distal end of said second leg member is reduced forward of said cylindrical boss thereby forming a step on the outside surface of said leg member.

11.- The hemostatic clip of claim 1 or 2, wherein said first leg member is undercut at the juncture of said hook member and said innerface of said leg member.

12.- The hemostatic clip of claim 1 or 2, wherein the leg members having identical cross-sections commencing at the hinge means and extending to the bosses on said leg members.