JPH0130497B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an anastomotic device and method, and more particularly to a surgical clamp and anastomosis of one hollow or tubular member to another, such as separated ends of the intestinal tract after surgery. Regarding how to use it.

Prior art methods for joining separated ends of an intestinal tract include suturing the separated ends of a vessel together or using stapling instruments; All of them have some inherent drawbacks. Technical difficulties in using suturing techniques often arise due to the inaccessibility of one or both of the ends to be joined or the time required for anastomosis. Stapling devices also have some inherent drawbacks.

It is desirable to use a non-permanent connector or joining device to join tube ends in an anastomotic surgical procedure. This is because permanent connectors tend to prevent diameter changes that are necessary for the vital functioning of the intestinal tract. Any foreign body used in anastomotic surgery should ideally disintegrate within a relatively short period of time once healing of the vessel ends has begun.

The present invention satisfies the current demands of anastomotic surgery and provides a safe and easy to use anastomotic device and method.
It was developed to provide a relatively cheap and easy method. It is a degradable anastomotic article with locking features that fit adjacent ends of the tube within the tube wall thickness.

The anastomotic devices and methods of the present invention utilize mating prongs supported by mating prongs joining each of the two ring members to hold the ring members in a preselected relationship with each other after being closed from an open position. Characterized by a possible locking notch.
Because the distance between the ring members can be varied in the manufacturing process to accommodate different thicknesses of the tubular member walls, the device can be used in a variety of different environments. The ring members and attached interlocking forks are designed so that they consist primarily of a single piece that can be injection molded. Two such molded articles can be uncomplicatedly assembled so that the anastomosis device is amenable to mass production and easy assembly.

The invention will be explained in more detail by means of examples shown in the accompanying drawings. In the figures, the same reference numbers refer to the same parts across the several figures.

Referring to the accompanying drawings and in particular to FIG. 1, the free ends 20 and 22 of the two tubular structures shown herein as cut ends of an intestinal tract and designated generally as 24 and 26 are in contoured configuration. The anastomoses were made using the device of the present invention, indicated by the dashed line and generally designated 28.

The first embodiment of the anastomotic device 28 is shown in complete form in FIG. 3, while the single unitary member of which two make up the device 28 is shown generally at 30 and is shown in FIGS. As shown in FIGS. Member 30 is comprised of a ring member 32 having a plurality of slots 34 and an opening 36 around its periphery and supports interlocking forks 38 extending from ring member 32 in a direction substantially parallel to the centerline of the ring member. . An interlocking conical projection 38 extending from the circular ring forms an annular coupling tube 40.
It forms about half of the total. This is because it is attached to about half of the ring member shown in FIG.

Each mating fork 38 supports a locking notch 42 designed and positioned to cooperate with and engage an engagement slot 43 extending outwardly from the ring member 32 as part of the fork 38. The locking jaws 42 are designed with a beveled leading edge 44 to facilitate easy relative movement when the two members 30 are joined and forcefully forced into each other. Notches 42 each have vertical engagement edges 46 that function with slots 43 to lock member 30 in place and form anastomosis device 28.

A second embodiment of the anastomosis device 28 is shown in complete form in FIG. 11, while one unitary member, two of which constitute the device 28, is shown generally as 56 and is shown in FIGS. 10 and 13. shown. The member 56 is comprised of a ring member 58 having a plurality of slots 60 and an opening 62 around its periphery, each having a plurality of mating slots 66.
A pair of oppositely positioned suspension legs 64 are supported. Arranged alternately between the legs 64 and located opposite each other are suspension members 68 which define notch-engaging recesses 70 so that the two unitary members 56 can be connected to each other. They are adapted to cooperatively receive notch 66 when joined to form anastomotic device 28.

The notch 66 supported by the suspension leg 64 is 72
with a partially sloped leading edge to facilitate easy movement when the two unitary members 56 are joined and forced together.

Each tab 66 has a slightly inwardly curved engagement edge 74, shown in FIG. A device 28 is formed.

In a second embodiment of the anastomosis device, the notch 66
is an anastomotic device 2 formed from two members 56 strategically placed on each suspended leg 64 of a single member 56.
8 in a first fixed arrangement as shown in solid lines in FIG. 11 or in a second fixed arrangement with said members closer together as shown in the combination of solid and dashed lines in FIG. position. Obviously any number of notches can be placed on the suspension leg 66 to achieve other desired positions.

The members 30 and 56 forming the device 28 are made of a material that allows for disassembly of the device in a relatively short period of time once fusion of the tube ends has begun.

Acceptable materials for forming the device are, for example, homopolymers of polyhydroxy acetates and their lactide copolymers. Molded surgical articles made of a wide variety of glycolide/lactide copolymers are known and very often used.

The use of the anastomosis device according to the invention is illustrated in FIGS. 10-14.
, in which the free ends 20 and 22 of the two tubular members 24 and 26 are sutured together by a purse string suture 52 . The use of this suture allows the suture material to be pulled by manipulating the top of a purse or string-closed bag;
It is then possible to engage the very edge of the free end of the tube wall so that the tube end can be greatly contracted. Ends 20 and 22 are then pulled over ring member 32 to tighten the sutures and tubes 24 and 2 are pulled over ring member 32 to tighten the sutures.
The ends 20 and 22 of 6 are folded inwardly over ring member 32 as shown in FIG. The members 32 are then forced together until the notches 42 are engaged within the slots 43, thus forming the connected annular coupling tube 40 of the device 28. The member 32 is an annular coupling tube 4
When brought into proper relationship by the formation of a positioned.

Device 28 provides a large space in which members 32 are forced together and interdigitating prongs 38 engage each other to form an annular coupling tube 40 to achieve a posterior anastomosis. Bowel tissue is mechanically held together by the force of the purse string suture against the annular coupling tube 40;
The clamping force of the ring member then compresses the two ends together.

Different diameters and spacing for the ring members and different diameters for the annular coupling tube are desirable to provide the necessary versatility of use within the necessary dimensions for animals and humans. Furthermore, certain abnormal tubular shapes in humans and animals may make better use of similar anastomotic devices having an oval shaped ring member and an annular coupling tube obtained rather than the circular shape shown in the accompanying drawings. It has a shape. Such aspects are considered to be within the scope of this disclosure and the claims.

It should be understood that an anastomotic device made from the materials described above can be designed to be time-resolved over a period of time. Other materials that can be designed to decompose over a given period of time are
For example, it includes mixtures comprising up to about 50% by weight of inert fillers and polymers having glycolate linkages and which can be hydrolyzed to non-toxic, tissue-compatible, absorbable components. Such materials offer many advantages over conventional anastomosis devices and allow simple and rapid anastomoses in difficult areas. For example, it usually requires a temporary colostomy which is extremely time consuming and difficult and possibly necessary or even impossible and in this case requires permanent colostomy. low rectosigmoid colon
Allows easier anastomosis in anastomosis.

The invention essentially consists of two single unitary members having a non-separable ring member and connected interlocking conical projections which cooperatively unite to form the embodiment described above. However, the invention in its broader aspects is not limited to the particular embodiments shown and described herein, and without departing from the principles of the invention and without sacrificing its principal benefits. Departures may be made from the invention without making any changes.

[Brief explanation of drawings]

FIG. 1 is a perspective view of an anastomosis device according to the invention shown in broken lines in the closed position and positioned to join the free ends of the tubular members adjacent to each other;
2 is a plan view of a single member of an anastomosis device according to the present invention; FIG. 3 is a plan view of a single member of an anastomosis device according to the invention, shown in solid lines in the engaged but unlocked position and in dashed lines in the engaged and locked position; FIG. 4 is a side view of the single member of FIG. 2 with a single ring member and associated interlocking forks in which a locking notch is designed; FIG. 6 is an enlarged partial view of a locking notch supported by a mating fork according to FIG. 4; FIG. 7 is an isolated view of the receiving slot of a single member according to FIG. 8 is a cross-sectional view of a first embodiment of an anastomosis device of the invention connecting the free ends of a tubular member with the device in an open or unlocked position;
Figure 9 is a cross-sectional view of a first embodiment of an anastomosis device of the invention connecting the free ends of a tubular member with the device in the closed position; Figure 10 is a cross-sectional view of a second embodiment of an anastomosis device of the invention; A plan view of the members, FIG. 11, shows the first part of an anastomotic device according to the invention shown in solid lines in the engaged but unlocked position and in dashed lines in the engaged and locked position. 12 is a side view of the single member of FIG. 2 having a single ring member and associated interlocking prongs in which a locking notch is designed; FIG. 13 is a side view of the single member of FIG. 14 is a partial cross-sectional view of the single member shown in FIG. 5 taken along line 14-14; FIG. 15 is a partial cross-sectional view of the single member shown in FIG. Isolated side view of the single member shown in FIG. 5 cut along and FIG. 16 according to the present invention joining the free ends of the tubular member with the device in the open or unlocked position. FIG. 17 is a cross-sectional view of a first embodiment of an anastomotic device of the present invention joining the free end of the tubular member with the device in a closed position;
18 is a perspective view of an anastomotic device forming the present invention functionally displaced from the free end of the tubular member to which it is to be attached; FIG. 19 is a perspective view of the anastomotic device attached to one end of the tubular member; and FIG. A similar perspective view, FIG. 20, is a perspective view similar to FIGS. 10 and 11 in which one end of the tubular member is secured by a purse string suture around the anastomotic device forming the present invention. Figure 21 is a perspective view of an anastomosis device forming the present invention with the second end of the separated tubular member being pulled across the free ring member for subsequent connection; Figure 22 is in the closed position; 1 is a perspective view of an anastomosis device forming the present invention positioned operatively to join the free ends of tubular members for coupling in FIG. In the figure, 24, 26... tubular tissue member, 2
8... Anastomosis device, 30... One single member, 32
... ring member, 34 ... slot, 36 ... opening, 38 ... interlocking fork, 42 ... locking notch, 44 ... beveled front edge, 46 ... vertical engagement edge.

Claims (1)

[Scope of Claims] 1. An anastomosis device for use in the surgical joining of the free ends of two tubular members to be anastomosed, comprising: ring members, each ring member having an inner and outer surface, and an annular connection means joined to each of the ring members for cooperatively interlocking to connect the ring members. , means associated with the annular connecting means for allowing the ring members to be mounted in a fixed relationship at a predetermined distance from each other; and each tubular member free over the ring member and in the connecting means. connecting the ends so that the free ends of the tubular member are placed in contact with each other over the ring member and around the connecting means to allow the free ends to coalesce and approach the outer surface of the tubular member; An anastomosis device characterized by comprising means for enabling. 2. The annular connecting means comprises at least two interlocking forks joined to the ring member and extending substantially parallel to the centerline of the ring member, the interlocking groups being cooperatively connected to each other to form an annular Apparatus according to claim 1 for forming a coupling tube. 3. The means enabling said attachment are a locking notch and an engagement slot carried by each of said interlocking forks, which are positioned in mutually cooperative engagement to preselect said forks and ring members from one another. Claim 2 comprising a locking notch and an engagement slot for accommodating the free ends of the two annular members by identifying them in a preselected relationship, thereby holding the ring members at a preselected distance from each other. The device described. 4. The connecting means extends around the free end of each tubular member drawing it in intimate engagement with said annular coupling tube and contacts the free end of the other tubular member, thereby causing the tubular member to 4. The device of claim 3, including a purse string mating portion to allow the free ends of the members to fuse together. 5 the connecting means extends around the free end of each tubular member pulling the free end in intimate engagement with said annular connecting means and contacts the free end of the other tubular member, thereby causing the free end of the tubular member to 2. The device of claim 1, including a purse string suture to allow the ends to fuse. 6. The device of claim 1, wherein said ring member, said annular coupling tube, said means for enabling fixation and said free end connecting means are formed from a degradable material. 7. The apparatus of claim 4, wherein said locking notches are engageable to position said ring members at a preselected distance from each other. 8. Each of the mating prongs includes a locking notch and a mating slot, and the mating lip and the receiving slot cooperate to mate to couple the ring member with each other when the annular coupling tube is formed. 5. A device according to claim 4 for holding in a fixed relationship. 9. The device of claim 8, wherein said ring member, said annular coupling tube, and said purse string suture are formed from a removable material. 10. The device of claim 9, wherein said ring member, said annular coupling tube, and said purse string suture are formed of an integral material. 11 the annular connecting means has cooperatively positioned legs depending from the ring member interconnecting to form an annular coupling tube;
2. The device of claim 1, further comprising a pair of notch-receiving recesses. 12. Each of the ring members has two opposed suspension legs and two opposed suspension members attached thereto, each of the suspension legs being selectively positioned thereon. one or more engagement notches, and each of the engagement legs has a notch-receiving recess therein, whereby the opposed suspension legs and members cooperate with each other. Claim 11 for engaging and securing the ring members in a predetermined relationship with each other.
Apparatus described in section. 13. In an anastomotic device used to surgically join the free ends of two tubular members to be anastomosed, a pair of ring members for attachment to each free end of the tubular members to be anastomosed; the free ends of the tubular members each have a distal edge; a tubular member joined to each of the ring members that cooperatively interlocks to connect the ring members and to facilitate the anastomosis; An annular member forming an internal passageway providing the only flow path through the device, wherein the internal passageway is free of the free end edge of the tubular member, such that the free end of the anastomotic device and the tubular member means associated with said annular connecting means for securing said ring members at first and second constant and predetermined distances from each other; such that the free end of the tubular member is ultimately positioned adjacent the ring member and the annular connecting means, and the ring members are fixed at first and second constant and predetermined distances from each other. means extending around each tubular member for retaining said free end in close proximity to said ring member and said annular connecting means; holding in contact with the free end of the annular member and allowing said free end to heal without substantial necrosis in an atmosphere outside the channel of the tubular member to be anastomosed and near the outer surface of the tubular member; An anastomosis device characterized in that it is provided with means that enable it to do so.