JPH0135658B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to hemostatic clips and clip application devices, and more particularly to hemostatic clips made from absorbable or non-absorbable polymeric materials and for applying such clips to blood vessels and the like. It is related to the appliance.

Hemostatic clips are utilized in surgical procedures to close severed blood vessels and other small fluid vessels. Conventionally, hemostasis clips have been made of tantalum or stainless steel that can deform when the blood vessel is clamped and are strong enough to withstand the deformation.
It was a V-shaped or V-shaped strip. The clips are generally applied using a forceps type instrument provided with grooves or other suitable means for holding the clip open. Representative hemostatic clips and clip applicators of the prior art include U.S. Pat.
Best described in 3363628, 3312216 and 3270745.

The prior art suggests, for example, in US Pat. No. 3,439,523, that hemostatic clips may be made of inexpensive plastic or other materials that are slowly absorbed by the body. Unfortunately, conventional U- and V-shaped hemostatic clips, when constructed from known plastic materials, do not have the strength or deformability required to successfully clamp around blood vessels. Thus, although the need and desire to provide inexpensive plastic ligation clips made of both absorbable and non-absorbable materials has been recognized for several decades, no practical method exists to satisfy this need. I didn't.

US Pat. No. 3,926,195 describes a small, plastic clip designed for temporary or permanent closure of the human fallopian tubes and vas deferens. These clips preferably have a clamping surface of 6 to 10 mm in length and 3 to 6 mm in width. Therefore,
The dimensions of such clips are relatively larger than desired for hemostatic clips. Additionally, U.S. Patent No.
Although the clip of No. 3926195 serves the purpose described in the patent, it would not be suitable for surgical procedures that require rapid placement of multiple hemostasis clips to stop bleeding from a severed blood vessel. .

SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a plastic ligation clip that is effective in constricting small blood vessels and other fluid vessels in the body. It is a further object of the present invention to provide a plastic ligation clip which can be made of both absorbable and non-absorbable materials. It is a further object of the present invention to provide a plastic ligation clip that is quickly and easily applied to broken blood vessels and other fluid conduits with a single forceps type instrument such as is used when using metal clips. It is.

The ligation clip of the present invention consists of two hinged legs that interlock at opposite ends when closed. The first leg member has an open oval shape with an elongated vessel constriction portion that is folded back at each tip. The second leg member is shaped to conform to the inner surface of the oval. The two leg members are joined at one end by an integrally molded hinge that extends from the distal end of the first leg member to a point on the second leg member adjacent the distal end when the clip is closed.

A sharp turn at the distal tip or free end of the first leg member forms a flexible barb. The distal tip of the second leg member is configured to flex and engage the barb when the clip is closed by pivoting the two leg members about their hinge points.

The proximal or hinged tip of the first leg also forms a barb. The proximal tip of the second leg member is configured to rotate toward and engage the barb when the clip is closed.

The clip initially opens at a substantially right angle about the leg member. The open clip includes a means for maintaining the clip open until it is extended outwardly closed, such as a thin web extending from the proximal tip of the second leg member to a point proximal to the inner surface of the first leg member. and the web is readily sheared when a closing force is applied to the clip.

The open clip is placed over the vessel to be ligated so that the vessel is approximately centered within the oval shape of the first leg member.

In addition, the second leg member ensures that the blood vessel is compressed between the two leg members so that both ends of the second leg member are connected to the first leg member.
It pivots about the hinge point until it engages the hook-shaped portion of the leg member. A forceps-type ligation clip application device is provided for applying and closing the clip.

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

Additionally, the clips of the present invention can be made from any suitable biocompatible polymer by extrusion, injection molding, or other known molding methods. The polymer may be a resorbable material such as a homopolymer or copolymer of lactide, glycolide or p-dioxanone, or a non-resorbable material such as nylon or polypropylene.

Referring now to FIG. 1, there is shown a hemostatic clip comprised of two leg members 11 and 12 joined at their proximal tips by a hinge portion 13. At the opposite (referred to as distal) tip of the leg member 11, substantially the inner surface 1 of the leg member 11
6 is folded back to form a hook-shaped portion 14 having an inner surface 15 parallel to 6. The leg member 12 is connected to the leg member 12 via an arcuate surface 17 at its distal tip.
The distal end surface 19 is continuous with the inner surface 18 of. Distal surface 19 extends to an outer surface 20 that is substantially parallel to inner surface 18 . The length of the outer surface 20 is substantially the same as the length of the inner surface 15 to provide positive latching of the clip as described below.

At the proximal or hinged tip of the clip, the leg member 11 is folded to form a barb 21 having an inner surface 22 substantially parallel to the inner surface 16. Leg member 12 terminates in an arcuate surface 23 extending to an outer surface 24 that is substantially parallel to inner surface 18 . The inner surface 22 and the outer surface 24 are of substantially the same length and are separated by a cylindrical relief hole 25 forming the hinge portion 13.

As shown in FIG. 1, the clip 10 extends the shortest distance from the distal tip of the leg member 12 to the inner surface 16 of the leg member 11 when the leg members 11 and 12 are at a substantially right angle. It includes an extending web 26. Web 26 is an optional structure for stabilizing the clip in the open configuration until a closing force is gently applied to the clip to shear it.

The lengths and widths of inner surfaces 16 and 18 are substantially the same, with inner surface 15 of barb 14 extending a distance corresponding to the thickness of leg member 12 between the plane of inner surface 18 and outer surface 20. It is spaced from the inner surface 16 of the leg member 11. When the leg members 11 and 12 rotate about the hinge part 13 and the inner surfaces 18 and 16 face each other,
The barb 14 is deflected by the distal end surface 19 of the leg member 12 until the distal tip of the leg member 12 snaps under the barb 14, thereby locking it in place. At the same time, the proximal tip of the leg member 12 rotates about the hinge section 13 to bring the barb 21 of the leg member 11 into contacting engagement with the inner surface 22 and the outer surface 24. If present, web 26 is sheared during the clip closure operation. Thus, the proximal tip of the clip is mechanically secured by a barb and latch interaction comparable to the action that locks the distal tip of the clip. In order to facilitate the deflection of the hook and facilitate the passage of the leg member 12 during the clip closing operation, the distal end surface of the hook 14 is shaped as shown in FIG.
Preferably, it is chamfered.

The shape of the clip when closed from above the blood vessel is as shown in FIG. In FIG. 2, the inner surfaces 16 and 18 of the clip are engaged, compressing the blood vessel 32 and closing its lumen. The inner surfaces 16 and 18 may be smooth, as shown in FIG. 1, or may have protrusions or grooves to increase blood vessel retention. The hinge 13 extends from the tip of the hook 21 to a point on the leg member 12 adjacent to the tip of the hook 21 when the clip is in the closed position.

Referring again to FIG. 1, the leg member 12 has a clip applicator near its distal tip in the form of a groove 27 forming projections 28 and 29 extending across the width of the clip. and means for holding it. Leg member 11 similarly includes lobes 30 and 31 near its distal tip.

The function of these structural features is to place the clip in a clip applicator and apply it to the vessel to be ligated.
More details are provided below in connection with the figures and FIG.

In FIG. 3, they intersect at pivot point 43 and spring 46
A forceps-type ligating clip applicator 40 is shown consisting of two ring handle members 41 and 42 which are normally maintained in an open position by a handle. Ring handle 41 is pivot point 4
3 to form a jaw member 44, while the extension of the ring handle 42 forms a jaw member 45. Pin 38 extends from ring handle 42 to a blind hole 39 in ring handle 41 to limit the maximum opening of jaw members 44 and 45 to the size required to receive the open clip.

FIG. 4 shows details of the construction of jaw members 44 and 45 of clip application instrument 40 and their interaction with the clip of FIG. Jaw members 44 and 45 are of identical design and have grooves 47 and 48, respectively, extending from the tips of the jaw members. The width of each groove is sufficient to accommodate the width of a clip, and each groove has gear-like teeth 49 and 50 across the bottom of the groove in an area extending rearwardly from the tip of the jaw member. The size and spacing of the teeth 49 and 50 correspond to the size and spacing of the corresponding protrusions on the clip, so that when the open clip is held in the clip application instrument, the protrusions on the clip apply the clip as shown in FIG. Interlocks with the teeth of the instrument. Since the jaw members of the clip application device have the same structure,
There is no need to align the clip application device with the clip when loading or using the clip application device.

As shown in FIG. 4, the clip 10 initially
Clip application instrument 40 is loaded in the normally open position. After the jaws of the clip applicator and the clip are brought into position on the vessel to be ligated, the jaws of the clip applicator are closed and the clip is locked in place over the vessel as shown in FIG. When the jaw members of the clip application instrument are closed, the leg members of the clip 10 are such that the distal tips of the leg members 12 are connected to the barbs 14.
in the groove of the jaw member until it engages with the jaw member. As shown in Figure 5, once the clip is fully closed and locked onto the blood vessel, the jaws of the clip applicator are opened, the clip applicator is removed from its position, and another clip is reloaded. .

FIG. 6 shows another embodiment of the clip and clip application device of the present invention. Leg members 11 and 12 each have a groove 52 extending across the width of the clip near its distal tip. The jaw members 44 and 45 of the clip application instrument have corresponding projections 51 adapted to engage grooves 52 when an open clip is placed between the jaw members. Additionally, the grooves in the jaw members 45 are recessed at 53 to accommodate the barbs 14 of the clip when the clip is closed between the jaw members. As shown, the grooves in jaw member 44 are similarly recessed to eliminate the hassle of aligning the clip application instrument to the clip.

Although the illustrations and descriptions are limited to certain specific embodiments of the ligation clip of the present invention, numerous variations in clip design will be apparent to those skilled in the art and may be considered within the scope of the present invention. For example, the gripping means between the jaws of the clip application instrument and the clip, ie the teeth and protrusions of FIG. 4 or the protrusions and grooves of FIG. 6, are preferred but optional and may be omitted. The clip may be made with a smooth outer surface and the jaws of the clip application instrument may be provided with a smooth groove for receiving the clip. Additionally, the grooves in the clip application device can be tailored to the outside of the clip for securing the clip between the jaw members. These and other clip shape modifications may be employed without departing from the spirit and scope of the invention.

The clip of the present invention can be constructed in various sizes depending on its intended function. Hemostasis clips are typically less than 6 mm long, approximately 1.5 mm wide, and approximately 3 mm long.
It has a blood vessel clamping surface of mm. The size of the clip can be reduced by about 50 percent in microsurgery for certain applications. Larger clips used for special hemostatic applications and other purposes such as closure of the fallopian tubes or vas deferens can be approximately twice the size of typical hemostatic clips. Clips of various sizes are preferably matched to individual clip application instruments having jaws tailored to the size of the clip for best results.

The clips of the present invention are typically molded from absorbable or non-absorbable biologically acceptable plastic materials. Preferred absorbable polymers include homopolymers and copolymers of glycolide, lactide and p-deoxanone. Preferred non-absorbable polymers include nylon, polyester and polypropylene. All of these materials have been demonstrated to be biologically acceptable when used as suturing devices or other implanted medical devices. The clip can also be made of solid polymeric material or aluminum,
It can also be cast or machined from metals such as magnesium, stainless steel, tantalum, and various alloys thereof, some of which can be absorbed by biological tissues.

[Brief explanation of drawings]

FIG. 1 is an enlarged perspective view of a surgical clip according to the present invention. Figure 2 shows the clip of Figure 1 tightened around a blood vessel. FIG. 3 shows a forceps-type clip application instrument for use with the clip of the present invention. FIG. 4 shows the open clip of FIG. 1 held in the jaws of a forceps-type clip application instrument. FIG. 5 shows the clip of FIG. 4 closed and locked onto the jaws of the same clip application instrument from above the blood vessel.
FIG. 6 shows an open clip of a modified design held in a forceps-type clip application instrument. 10... Hemostatic clip, 11, 12... Leg member, 13... Hinge part, 14, 21... Hook-shaped part, 1
5, 16, 18, 22...inner surface, 17, 23...
...Arc-shaped surface, 19...Tip surface, 20, 24...
...Outer surface, 25...Cylindrical relief hole, 26...
Web, 27, 47, 48, 52...Groove, 28,
29, 30, 31... protrusion, 38... pin, 3
9...hidden hole, 40...clip application device, 4
1, 42...Ring handle member, 43...Pivot point, 44, 45...Jaw member, 46...Spring, 49, 50...Gear-shaped teeth, 51...Protrusion.

Claims (1)

[Scope of Claims] 1. The first leg member includes a first leg member and a second leg member, each leg member having an elongated blood vessel tightening portion opposite to the blood vessel tightening portion of the other leg member, the first leg member is folded at each distal end to form a hook-like portion extending outwardly from the blood vessel constriction portion, and the second leg member is adapted to engage the hook-like portion of the first leg member at each distal end. a hinge means connecting the first leg member and the second leg member at a proximal end of the leg member, the leg member being pivoted to a closed position; When the first leg member and the second leg member are closed from the open position about the hinge means such that both ends of the second leg member are engaged with corresponding hook-shaped portions of the first leg member. A hemostatic clip that is characterized by being able to rotate into position. 2. The hemostasis clip according to claim 1, wherein when the first and second leg members are in the open position, the blood vessel clamping portion of the first leg member extends from the proximal portion of the second leg member. The clip is joined by a shearable web extending to the tip, the web being sheared during the clip closing operation. 3. The hemostatic clip of claim 1, wherein each of the barbs of the first leg member has a substantially parallel inner surface spaced from an opposite surface of the vessel constriction portion. something that is characterized by 4. The hemostatic clip according to claim 1, when the leg member is in the closed position,
wherein the hinge means extends from the tip of one of the hooks to a point on the second leg member adjacent to the tip of the hook. 5. The hemostatic clip according to claim 1, wherein the hinge means forms a cylindrical escape hole extending between the first and second leg members at the distal end of the hooked portion. What to do. 6. The hemostatic clip of claim 1, wherein the first and second leg members include means for retaining a clip application instrument at their distal tips on their outer surfaces. . 7. A hemostatic clip as claimed in claim 6, wherein said clip applicator retaining means includes at least one groove extending transversely to the width of said leg member. 8. The hemostatic clip of claim 7, wherein said clip applicator retaining means includes at least one protrusion extending transversely to the width of said leg member. 9. A hemostatic clip according to claim 1, comprising a biologically acceptable absorbable polymer. 10. A hemostatic clip according to claim 9, characterized in that the polymer is selected from the group consisting of homopolymers and copolymers of glycolide, lactide and p-dioxanone. 11. A hemostatic clip according to claim 1, characterized in that it is made of a biologically acceptable, non-absorbable polymer. 12. A hemostatic clip according to claim 11, characterized in that said polymer is selected from the group consisting of nylon, polyester and polypropylene. 13. The hemostatic clip according to claim 1, which comprises hinged first and second leg members, each leg member having an inner surface facing the blood vessel tightening portion of the other leg member. the first leg member having an open oval shape with a fold at each end thereof forming a hook extending from the blood vessel tightening portion; each having an interior surface spaced apart from and substantially parallel to the interior surface of the first leg member, the second leg member being shaped to conform to the oval interior surface of the first member; each tip of the second leg member is formed to engage a hook-shaped portion of the first leg member; and the first and second leg members are configured such that the second leg member engages the hook-shaped portion. when connected by hinge means extending from the free end of one barb to an adjacent surface of the second leg member, the hinged tip of the second leg member being rotated to accommodate the corresponding first leg member; the second leg member such that the other end of the second leg member is deflected and engaged with the other barb member to mechanically secure the leg member in the closed position. The first and second leg members are characterized in that they pivot about the hinge portion from an open position to a closed position. 14. The hemostasis clip according to claim 13, wherein the first and second leg members are arranged such that when the leg members are in the open position, the blood vessel tightening portion of the first leg member is connected to the hemostatic clip of the second leg member. a shearable web extending to the proximal tip, the web being sheared while the leg member is in the closed position. 15. The hemostatic clip according to claim 13, wherein the tip of the hooked portion extending from the distal free end of the first leg member facilitates deflection of the hooked portion. chamfered for passage and subsequent engagement of the distal corresponding tip of the second leg member. 16. The hemostatic clip of claim 13, wherein said first and second leg members include clip application instrument retention means on the outer surfaces of their distal tips. 17. The hemostatic clip of claim 16, wherein said clip applicator retaining means includes at least one protrusion extending transversely to the width of said leg member.