JPH0451175B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to hemostatic clips, and more particularly to hemostatic clips made from biocompatible polymeric materials that can be absorbable or non-absorbable into body tissue.

In many surgical procedures, it is often necessary to ligate many blood vessels within the surgical site. The blood vessel can be cut downstream of the ligated section.
In some cases, the blood vessel can be ligated at spaced intervals and the portion of the blood vessel between the ligations removed. The purpose of ligating blood vessels is to keep the surgical site clear of excess blood and to reduce blood loss to the patient. Also, in certain surgical procedures in which a tumor or the like is to be removed, the tumor or organ must be separated from some blood vessels. Ligate the blood vessels before separation. Completely closing a blood vessel results in cessation of blood flow, a natural blockage at the end of the blood vessel that stops the flow of blood.
Occurs within a few days depending on the blood vessel. Meanwhile, the body, through appropriate capillaries or secondary blood vessels,
Blood continues to flow around the ligated area through the body's natural physiological function of dilating the bypass vessels until adequate blood flow is achieved. Thus, when ligating a blood vessel, a reliable cessation of blood flow in the main vessel must occur. Failure to provide complete cessation can result in blood loss in the patient and may also prevent natural cessation of blood flow and the concomitant creation of new blood flow pathways in the patient.

In the past, closure of this blood vessel was usually accomplished using a ligature; a filament or thread that the doctor tied around the blood vessel to be closed. This is a time consuming procedure and one in which reliable vessel closure is not always achieved. In recent years, hemostatic clips have replaced ligatures in surgical procedures to close blood vessels and other fluid conduits. These hemostatic clips should be thin U- or V-shaped strips of tantalum or stainless steel that are deformable and have sufficient strength to maintain deformation when tightened around a blood vessel. are extremely common. The closing force is caused by the deformation of the metal.

Recently, various clips have been manufactured from biocompatible polymeric materials that are either absorbable or non-absorbable into body tissue. An example of such a clip is the commonly assigned U.S. patent application Ser.
No. 276131, filed on June 22, 1981; No. 282165,
Disclosed in application filed July 31, 1981.

In hemostatic clips, it is important to have a clip with positive locking or closure of the blood vessel. The clips should be kept sterile by the nurse or surgeon during surgery so that they remain sterile when the nurse removes them from their packaging with appropriate instruments, hands them to the surgeon, and places them properly into the patient. It must be easy to handle. Many clips are designed to take advantage of certain physical properties of the material, such as elasticity or deformability. In such cases, the materials that can be used to manufacture the clip are limited. Forming the clip in such a way that a satisfactory clip can be made from any of a variety of biocompatible materials, whether absorbable or non-absorbable into body tissues. That is desirable. The novel clip of the present invention meets all of the above requirements in that it is simple to manufacture and can be made from any of a variety of absorbable or non-absorbable polymeric materials. The novel clip of the present invention produces a positive lock or closure of the vessel to which it is applied and is easily handled by the nurse or surgeon during surgery.

The present invention relates to a sterile, two-part hemostatic clip for occluding blood vessels. The portions are substantially identical in shape and each portion includes a first member having a vessel constricting surface and a second member disposed substantially perpendicularly from the vessel constricting surface at one end of the first member. It consists of two parts. The first member has at its other end a hole adapted to receive a second member of the other portion. Each section includes fixation means for fixing the second member of the mating section to the first member with the respective vessel clamping surfaces facing each other. The securing means consists of an interference fit of one part with a hole in the second member of the other part.

The present invention will be explained in more detail in connection with the drawings.

Referring to the drawings, FIG. 1 shows a clip 10, which will be described below for reference. The clip includes a first portion 11 having a first member 12 with a vessel-clamping surface 13. A second member 14 is disposed from one end of the first member.
The first member and the second member are perpendicular to each other and the second member projects from the vessel-clamping surface of the first member. At the other end of the first member there is a hole 15 passing through this member. The clip includes a second portion 16 that is substantially identical to the first portion. That is, this second part consists of a first member 17 and a second member 18 perpendicular to each other, the first member having a vessel-clamping surface 19 and the second member extending from that surface. It sticks out. The first member of the second part also has a suitable hole 20 at the end opposite that in which the second member is located.

Each of the second members has a plurality of ears 21 on one surface.
That is, it has a beveled extension. Second
As can be seen, both parts are placed on either side of the blood vessel 22 to be occluded, with the vessel-clamping surfaces facing each other. Pushing the second member of one part into the hole in the first member of the other part and pressing both parts together causes the ear to clamp against the surface of the first member of the other part. By interlocking with the side surfaces, both parts can be fixed to each other.

FIG. 3 shows another reference example of the clip. Similarly, clip 25 is comprised of a first portion and a second portion having substantially the same shape. Each section has a first member 26 with a vessel 27 constricting surface and a second member 28 extending from one end of the first member perpendicular to the vessel constricting surface. 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 a hole 31 is located. In use, the vessel-clamping surfaces of both sections are placed on either side of the vessel to be occluded, and the arrowhead-shaped area of the second member of each section is pushed into the hole in the first member of the opposing section. Closing the blood vessels between the surfaces that tighten the blood vessels. In this embodiment, the curvature of member 26 provides adjustable possibilities for use in vessels of different sizes.

In FIG. 4, an embodiment of the clip of the present invention is shown. The hemostatic clip 35 consists of two parts of substantially identical shape. Each section has a first member 36 with a blood vessel clamping surface 37. A second member 38 projects from one end of the blood vessel clamping surface perpendicularly thereto. The other end of the first member has a hole 39 extending through the blood vessel clamping surface.
exists. The hole may have a raised area on its inner surface to provide an interference fit between it and the second member of the other portion, or the second member may have a It may have ridges 40 on its surface to provide such an interference fit. In use, the vessel-clamping surfaces of the first member are placed on either side of the blood vessel 41 to be occluded, and the second member is inserted into the hole in the other portion, thereby forming a gap between the vessel-clamping surfaces. Close blood vessels. In any embodiment of the clip, the parts may be fastened together by a suitable strap 42 or band that interconnects the parts at any location, if desired. Such a strip is shown in the embodiment of FIG.

FIG. 5 shows a forceps-shaped clip applicator 43 consisting of two handle members 44 and 45 that intersect at a hinge point 46 and are normally held in the open position by a spring 47. One handle extends beyond the hinge to form a jaw member 48, while the extension of the other handle forms a corresponding jaw member 49. As shown more clearly in FIG. 6, the jaw members 48 and 49 are substantially mirrorless and have grooves 50 and 51 for guiding the clips extending rearwardly from the tips of the respective jaws. . The parts 52 and 53 of the clip are held in their grooves by a frictional engagement between the sides of the grooves and the sides of the parts. Each groove has a hole 54 suitably positioned so that when the clip closes the vessel, the second member of each section held in the opposing groove can enter the hole. It's summery. The jaws of the applicator are positioned over the blood vessel to be occluded, the jaws are closed and the clip is secured over the blood vessel. The friction is insufficient to hold both parts of the clip fixed, so that when the jaws are reopened, the clip remains on the blood vessel and the applicator can be easily removed.

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 and less than 1.5 mm wide, and have a blood vessel clamping surface that is about 3 mm long. The size of the clip can be reduced by about 50% for use in certain microsurgical procedures. Special hemostasis large clips can be approximately twice the size of typical clips. It is preferred to match clips of various sizes with individual applicators having jaws matched to the size of the clip for best results.

It is clear that the improved ligation clip configuration of the present invention allows the clip to be manufactured from almost any material. The novel clips of the present invention can be made from both elastic and non-elastic materials and deformable or non-deformable materials. A final clip made from any of these materials is also capable of adequately closing a blood vessel for a sufficient period of time to effect cessation of blood flow, thus providing a suitable hemostatic clip.

The clips of the present invention may also be advantageously molded from physiologically acceptable polymeric materials that can be absorbable or non-absorbable into body tissues. Suitable absorbent polymers and copolymers include glycolide, lactide and (p)dioxanone. Suitable non-absorbable polymers include nylon, polyester and polypropyne. All of these materials have been demonstrated to be physiologically acceptable when used as sutures or other implantable medical devices.

The clips of the present invention are sterilized by known sterilization methods, which generally depend on the material used to manufacture the clip. Examples of suitable sterilization methods that can be used in the clips of the invention include ethylene oxide sterilization, radiation irradiation, such as cobalt irradiation, electron beam, heat or steam sterilization.

The clips of the present invention can be easily and economically manufactured by injection molding and other known molding methods. As can be easily recognized,
Due to the identical shape of the two parts of the clip, molding is simple and requires only one mold configuration.

In addition, in the hemostasis clip of the reference example, one of the fixing means had a number of serrated ears or an arrowhead shape, so continuous and smooth tightening of blood vessels could not be expected, but the fixing means of the present invention is a so-called frictional fit between the raised area provided on the inner surface of the hole and the second member, or between the protrusion provided on the inner surface of the hole and the surface of the second member,
Since it is configured with an interference fit, smooth and reliable tightening of blood vessels and delicate tightening adjustments are possible.

Although the invention and specific embodiments have been described herein, it will be apparent to those skilled in the art that many changes and modifications can be made to the invention without departing from the spirit and scope of the invention. would be obvious.

[Brief explanation of the drawing]

FIG. 1 is an enlarged reference perspective view of a two-part clip showing both parts in the open position. Figure 2 shows the first tube in position to close the blood vessel.
FIG. 2 is an enlarged perspective view of the clip of the figure. FIG. 3 is an enlarged reference perspective view of a two-part clip, separate from FIG. 1, with both parts separated from each other. FIG. 4 is an enlarged perspective view of an embodiment of the novel clip of the present invention in which both parts are separated from each other. FIG. 5 is a side view of an instrument for applying the clip of the present invention. Figure 6 shows the fifth
2 is an enlarged perspective view showing the clip of the present invention in the jaws of the instrument shown; FIG. 10, 25, 35: Clip; 12, 17, 2
6, 36: first member; 14, 18, 28, 3
8: Second member; 13, 19, 27, 37: Surface that tightens the blood vessel; 15, 20, 31, 39: Hole.

Claims (1)

[Scope of Claims] 1. A sterile two-part hemostasis clip for occluding a blood vessel, the two parts being substantially identical in shape, each part having a blood vessel-clamping surface. and a second member disposed from one end of the first member substantially perpendicular thereto and on the same side as the vessel-clamping surface; The other end is disposed with a hole adapted to receive a second member of the other section, and each section is connected to the first section of the first section when the vessel-clamping surfaces of both sections face each other. securing means for securing the second member to the first member of the other part, the securing means comprising an interference fit between the second member of the one part and the hole of the other part; A hemostatic clip, characterized in that the interference fit is formed by providing a protrusion on the surface of the second member or by providing a raised area on the inner surface of the hole. 2. The hemostatic clip according to claim 1, which includes a member that connects both members to each other. 3. A hemostatic clip according to claim 1, comprising an absorbable polymeric material. 4. The hemostatic clip of claim 3, wherein the absorbable polymeric material is a polymer or copolymer of lactide, glycolide, or p-dioxanone.