IL135368A - Device for performing a quick anastomosis in blood vessels or other biological tubes - Google Patents

Description

Version 3 135368 nvypn A DEVICE FOR PERFORMING A QUICK END TO SIDE OR END TO END ANASTOMOSIS OF BLOOD VERSEL OR ANY BIOLOGICAL TUBES FIELD OF THE INVENTION The present invention relates to a device for performing a quick end to end or end to side anastomosis of blood vessels or any other biological tubes.

BACKGROUND OF THE INVENTION At present, anastomoses of two biological tubes are generally performed by suturing or stapling. An anastomosis must be done precisely and accurately, and requires a great deal or expertise and experience to perform correctly.

The difficulties associated with anastomotic procedures may be illustrated by examining the problems associated with vascular anastomosis. Arteries in mammals have three coats: the outer coat (the adventitia), consisting of a strong fibrous sheath; the middle coat (the media), consisting of muscular fibers; and the inner coat (the intima), consisting of a smooth layer of elastic tissue lined with endothelial cells. When a vessel is severed, inordinate time and skill is required to ensure that the intimal layers of the two vessels being anastomosed are joined in intimate contact to prevent blood clot formation and vascular occlusion and to ensure proper healing of the blood vessel. A vascular occlusion at the site of anastomosis can lead to disastrous results including loss of organ or loss of life.

Despite the fact that major advances have occurred in the last couple of years in anastomosis techniques, none have adequately met the requirements for a quick and reliably-performed anastomosis. Methods used for performing anastomoses need to be as atraumatic as possible. Furthermore, anastomotic methods should provide secure intimae contact between the inner lumina (the intima) while not damaging the walls of the blood vessels. This will minimize thrombosis at the anastomotic site or bleeding due to leakage and will promote healing.

Many attempts have been made to provide an anastomotic method having the aforementioned criteria. All of them, however, leave much to be desired in that they demand great technical skill and require a long time to accomplish.

U.S. patent 5755775 to Trerotola et al. describes a percutaneous stent-graft for restoring blood flow between blood vessels. The stent-graft has a body implantable device and first and second retaining elements. Also disclosed are methods for deploying the stent-graft.

In an effort to improve the efficiency and reliability of anastomoses, the present invention describes an expandable device build at the end of a graft for end to end anastomosis and also describes a T shape prosthetic device to perform an end to side anastomosis between blood vessel or other biological tubes (e.g. bowel).

Using the device of the present invention eliminates the exposure of the foreign materials to the blood within the blood vessels, produces a secure anastomotsis thereby reducing leakage and thrombosis. The use of the present invention also provides for fast and simple performance of an anastomosis, not requiring the level of advanced skill on the part of the surgeon that is required by most other methods. Other advantages of the present invention will become apparent in the summary of the invention and the detailed description of the drawings that follow.

SUMMARY OF THE INVENTION The present invention relates to a device build at the end of a graft or as a connecting module at a "T" shape, angle shape or any shape needed at the body. A device with expandable ends for performing a quick anastomosis between two vascular vessels or two biological hollow tubes, the device is build of the following; a short stent encircling the connecting tubular member at its end with the edge folded back over the stent, inserting the device into an open end of a blood vessel and inflating a balloon expands the stent and the tubular member to create a perfect anastomosis.

Folding the ends of the connecting tubular member over the stent creates a situation in which the stent never comes into contact with the inner lining of the tubular member.

In one preferred embodiment, expanding the stent comprises inserting a balloon catheter into the blood vessel (or other tubular member) through the stent and then inflating the balloon, achieving the desired stent diameter. Thereafter, the balloon is deflated and the catheter withdrawn from the site of the anastomosis.

In another preferred embodiment, the method further includes the step of securing the anastomosis by any appropriate means to prevent disruption. The securing may be accomplished through suturing, applying biological glue, stapling, or by a tie of the second tubular member to the first tubular member after inflating the anastomosis.

In another embodiment one more stent is inserted over the second tubular member, after said second tubular member has been fitted over the everted portion of the first tubular member. This stent will prevent the second tubular member from slipping (and disrupting the anastomosis) if tension on the anastomosis is expected.

In one preferred embodiment, the first tubular member comprises a first portion of a severed blood vessel and the second member comprises a second portion of said severed blood vessel. The use of a stent allows that the innermost endothelial layers of the blood vessels grow together for a continuous, uninterrupted lining of the entire vessel.

Alternatively, the first tubular member may comprise a severed blood vessel while the second tubular member comprises a replacement vessel removed from another part of the body.

Alternatively, the first tubular member may comprise a severed blood vessel while the second tubular member comprises a prosthesis. Prosthetics are commonly used in bypass surgery or in cases of traumatized vessels or vessels severely effected by atherosclerosis. The problem of performing an end-to-side anastomosis can be solved by using a ready-made prosthesis. The prosthesis may be substantially "T"-shaped, having a variable angle between the two segments of the "T", thus establishing an end to side anastomosis.

The stent may made from any suitable biocompatible material known in the art (such as stainless steel or other material), having length and expandability suitable for the blood vessels (or other tubular members) to be anastomosed. The stent may contain spikes around its outer surface for keeping the second blood vessel (or other tubular member) in place after the stent is expanded.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention may be better understood with reference to the accompanying drawings wherein: Figure 1A, IB, IC, and ID illustrate a step-by-step the building of the device for the anastomosis according to the present invention.

Figure 2,3 illustrates the device build as a "T" shape prosthesis for an end to side anastomosis.

DETAILED DESCRIPTION OF THE DRAWINGS Figures 1A, IB, IC, and ID illustrate a step-by-step building the device for performing an anastomosis according to the present invention between two severed blood vessels (or other tubular organs).

Referring now to Figure 1A, there is illustrated the connecting members (1,2) which is build of a short blood vessels, either biological or artificial and a small peace of a stent (3) sleeted on the edge of one of them.

Figure IB illustrates everting the edge (4) of the connecting member (1) over the stent (3).

Figure 1C illustrates the edge (4) of member (1) with the stent (3) introduced into the other cut end (5) of the blood vessel (2) for anastomosis between the two members (1) and (2).

Figure ID illustrates a final step in which suitable balloon catheter (6) is inserted into the lumen of the blood vessels where the stent (3) is located.

Balloon (6) dilatation of the prosthesis to its maximal diameter will create a complete and perfect anastomosis between the blood vessel (1) and the blood vessel ( 2). Thereafter, the balloon is deflated and the catheter (6) is withdrawn from the anastomosis. The anastomosis may also be further secured by suturing or gluing the anastamosed blood vessels ( 1) and (2) to the device.

Optionally the stent (3) may contain spikes (not shown) located thereon so as to prevent slipping and subsequent separation of the anastomosis. Alternatively, a second stent may be introduced over the second blood vessel (2) after said second blood vessel has been fitted over the everted portion of the device (4) in order to secure the anastomosis.

Figure 2 illustrates a prosthesis having a "T" shape for use in an end-to-side anastomosis. It should be appreciated that the angle of the arms of the "T" need not be ninety degrees, and the prosthesis used need not be in the exact shape of a "T". In Figure 2, the device is made of a ready made prosthesis at a shape of a "T" made of biological or artificial material (7) on which ends a stent (3) is slide over and the edge of each end of the "T" is everted over the stent.

The prosthesis is now ready to be introduced between two cut ends of a blood vessel (1) and (2) or using as a "T shape prosthesis to create a side to side anastomosis between the device and a blood vessel (8). figure 3.

Figure 3 represent the most common way of end to side anastomosis in vascular surgery of which a by pass graft is anastomosed to a recipient vessel; a T shaped prosthesis with the stents sitting under its everted ends (4) is introduced to an opening in the recipient vessel (8). Inflating a balloon through the stents, will create a perfect end to side anastomosis between the blood vessel and the prosthesis.

Furthermore, a third vessel (not shown) or graft may be anastomosed to the bottom of the "T" in order to direct blood flow (or other fluid) to the desired manner.

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Claims (12)

1. A device with expandable ends for performing a quick anastomosis between two vascular vessels or two biological hollow tubes, the device is build of the following: a short stent encircling the connecting tubular member at its end with the edge folded back over the stent, inserting the device into an open end of a blood vessel and inflating a ballon expands the stent and the tubular member as to create a perfect anastomosis.

2. A device according to claim 1 wherein expanding of the stent comprises inserting a balloon catheter into the anastomosis site and inflating the balloon to achieve the desired stent diameter, thereafter deflating the balloon and withdrawing said catheter from said site of the anastomosis.

3. A device according to claim 1 wherein the anastomosis will be performed between two parts of a severed blood vessel.

4. A devise according to claim 1 wherein the anastomosis is performed between the first tubular member which is a severed blood vessel and the second tubular member comprises a replacement blood vessel removed from another part of the body.

5. A device according to claim 1 wherein the first tubular member comprises a severed blood vessel and wherein the second tubular member comprises a biological or artificial prosthesis. Version 3

6. A device according to claim 5, wherein the prosthesis is substantially "T"- shaped having a variable angle between two arms of the "T", thus establishing an end to side anastomosis.

7. A device according to claim 1 wherein the stent is made from biocompatible material.

8. A device according to claim 1 wherein the stent is made from biodegradable material.

9. A device according to claim 1 wherein the stent contains spikes around its outer surface for preventing sliding of said second tubular member when the anastomosis is completed.

10. A device according to claim 1, further comprising the step of introducing a second stent over the second tubular member, after said second tubular member has been fitted over the everted portion of the first tubular member.

11. 1 1. A device according to claim 1, further comprising the step of securing the anastomosis through any appropriate means to prevent disruption of the anastomosis.

12. A device according to claim 11, wherein the appropriate means are selected from suturing, stapling, gluing, or tying the second tubular member to the first tubular member after inflating the anastomosis.