WO2004089248A2

WO2004089248A2 - Stent for use in mammalian anastomosis and method and system for implanting said stent

Info

Publication number: WO2004089248A2
Application number: PCT/IL2004/000293
Authority: WO
Inventors: Nachum Erlich; Jacob Gilan
Original assignee: Giler Ltd.
Priority date: 2003-04-09
Filing date: 2004-03-31
Publication date: 2004-10-21
Also published as: WO2004089248A3; IL155305A0

Abstract

The present invention relates generally to the field of intraluminal devices for use in bodily passageways such as blood vessels, the intestines, the esophageal tract, and the urinary tract. More specifically, the present invention relates to a novel stent for surgical mammalian vessel anastomosis comprising an inner tubular sleeve (20) and a substantially tubular cover (30) adapted for being closed over said inner tubular sleeve after two severed body lumen ends have been drawn over ends of said sleeve, such that the body lumen ends are fixed between the tubular sleeve, and the cover. The present invention also relates to a method and a system for implanting said stent.

Description

STENT FOR USE IN MAMMALIAN ANASTOMOSIS AND METHOD AND SYSTEM FOR IMPLANTING SAID STENT

FIELD OF THE INVENTION

The present invention relates generally to the field of intraluminal devices for use in bodily passageways such as blood vessels, the intestines, the esophageal tract, and the urinary tract. More specifically, the present invention relates to a novel stent for providing structural support and reinforcement for a bodily lumen and to a system and method for implanting said stent into the body.

BACKGROUND OF THE INVENTION

A variety of types of stents, vascular grafts, and other stents are known in the art for the repair, support, or reinforcement of bodily vessels or other passageways. As examples, reference is made to U.S. Patent No. 6,355,057 to De Marcus et al., entitled, "Staggered Endoluminal Stent", U.S. Patent No. 5,643,339 to Kavteladze et al., entitled, "Stent for Sustaining a Blood-Vessel or Hollow Organ Lumen", and U.S. Patent No. 5,522,881 to Lentz, entitled, "Implantable Tubular Prosthesis having Integral Cuff." These and other patents have attempted to overcome problems relating to the acceptance of the foreign stent by the body, the difficulty in implanting the device into the body, and the insufficiency of the devices for providing support for bodily vasculature. In spite of all the advances in the related medical technology, there remains a need for a reliable, easily-implanted, and biocompatible stent for use in body passageways.

U.S. 5,141,516 and U.S. 5,464,415 to Detweiler relates to a dissolvable anastomosis stent and to a method for using the same. The stent is comprised of biocompatible, nontoxic material which completely dissolves mammalian body fluids. All of the aforementioned patents are herein incorporated by reference in their entireties. Biofragmentable anastomosis rings (referred to as BAR or Valtrac) developed by David & Geek, American Cyanamid Company, Danbury, Conn. USA are used for intestinal anastomosis in recent years because they are simple, fast and safe to operate and capable of being fragmented and to pass out of the body in two to three weeks. The BAR functions by holding two vessel stumps in contact with one another after securing each of the vessel stumps to the BAR with a purse-string suture and snapping the two BAR pieces together. The BAR anastomosis procedure requires that purse-string sutures be in and remain in the vessel stumps to attach the vessel stumps to the BAR after the surgical procedure has been completed. These sutures may remain in the vessel tissue for several days to several weeks and their presence increases the risk of infection or leakage and edema. Moreover, it is necessary to dilate the inner lumen in order to properly implant the BAR pieces. Furthermore, the BAR anastomosis is only suitable for usage in the intestine.

SUMMARY OF THE INVENTION

Surprisingly, the inventor of the present invention has developed a novel system for implanting a stent into a body lumen that resolves the problems that are prevalent in the art.

It is an object of the present invention to provide a stent for use in an anastomosis procedure that is totally biocompatible, non-toxic and safe.

It is also an object of the present invention to provide a system for implanting said stent between two body lumen ends that does not require any suturing.

It is furthermore an object of the present invention to provide a method for carrying out an anastomosis procedure that is fast, reliable, and that does not result in any undue strain to the body lumen being connected.

The present invention relates to a stent for surgical mammalian vessel anastomosis comprising an inner tubular sleeve having a proximal end and a distal end, and a substantially tubular cover adapted for being closed over said inner tubular sleeve after two severed body lumen ends have been drawn over said proximal and distal ends of said sleeve (one end being drawn over the proximal end, and the other being drawn oγer the distal end), such that the body lumen ends are fixed between the tubular sleeve, and the cover. The stent is comprised of a biocompatible, non-toxic material. Preferably, the inner tubular sleeve is formed from a biodegradable material, and the cover is formed from a bio-absorbable material.

According to preferred embodiments of the present invention, the proximal end of the sleeve comprises at least one circular protrusion on the outer surface thereof. Preferably, the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and the second edge configured at an obtuse angle with respect to the outer surface of the sleeve. More preferably, the proximal end of said sleeve comprises two circular protrusions.

According to preferred embodiments of the present invention, the distal end of the sleeve comprises at least one circular protrusion on the outer surface thereof. Preferably, the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and the second edge configured at an obtuse angle with respect to the outer surface of the sleeve. More preferably, the distal end of said sleeve comprises two circular protrusions.

Further according to preferred embodiments of the present invention, the cover comprises an upper arc-shaped section and a lower arc-shaped section. Preferably, each of said upper arc shaped sections comprise two longitudinal edges, and opposite longitudinal edges of the upper section and the lower section are adapted for being interlocked with one another. The interlocking may be accomplished through any suitable means lαiown in the art, such as a pin/groove mechanism. Preferably, locking is one-way, such that the two sections cannot be easily taken apart from one another. As described below, a specialized gripping device is used to interlock the two sections of the cover together.

Additionally according to preferred embodiments of the present invention, the cover further comprises a plurality of pointed pins located on the inner surface thereof.

It is appreciated that the stent of the present invention is useful for any bodily lumen, including, with the intestinal lumen, the blood vessels, the urinary tract lumen, and the esophageal tract lumen. The stent may be designed and adapted through ways known to those skilled in the art, so as to fit any body lumen.

The present invention relates to a system for performing surgical mammalian vessel anastomosis, comprising;

(a) a stent comprising an inner tubular sleeve having a proximal end and a distal end, and a substantially tubular cover adapted for being closed over the inner tubular sleeve after two one severed body lumen ends have been drawn over said proximal and distal ends of said sleeve, such that said body lumen ends are is fixed in between the tubular sleeve and the cover, wherein the stent is formed from a biocompatible material, and; (b) means for applying a compressive force to said cover for causing closing of said cover over said inner tubular sleeve.

It is appreciated that in most procedures, two severed ends of a body lumen will be drawn over the opposite ends of the tubular sleeve. It will be readily appreciated, however, that the stent is also useful in cases where only one luminal end is drawn over one end of the sleeve (in this case, the lumen may be drawn only over a portion of the sleeve, or alternatively, over the entire sleeve), or in other situations as are known in the art. The stent may be adapted in accordance to the characteristics of lumen involved. For example, in some preferred embodiments, the inner tubular sleeve may be bifurcated (branched), and, in a corresponding manner, the cover will be adapted for being closed over the bifurcated sleeve. Likewise, the construction of the stent components may be adapted in accordance with specific considerations involved in the surgical procedure.

According to preferred embodiments of the present invention, the inner tubular sleeve is formed from a biodegradable material. Preferably, the cover is formed from a bio-absorbable material. As examples for acceptable materials and acceptable means for the formation of the stent, reference is made to U.S. Patent 4,787,900 to Yannas, entitled, "Process for Forming Multilayer Bioreplaceable Blood Vessel Prosthesis" and to U.S. Patent 4,902,289 to Yannas, entitled, "Multilayer Bioreplaceable Blood Vessel Prosthesis" (both patents are herein incorporated by reference). It is appreciated that the inner tubular sleeve of the present invention will be designed so as to degrade in the body over a short time span (for example, 21 days), whereas the cover will remain intact for a longer period of time, until healthy new tissue has proliferated around said cover. Each of said tubular sleeve and said cover may be formed from a single, or more preferably, multiple layers of suitable biocompatible material(s). Additionally, suitable antibiotics or other drugs may be incorporated into the stent so as to protect against side effects of implantation of the stent, and to promote acceptance of the stent by the body. In some preferred embodiments, barium sulfate (preferably 10%) is incorporated into the stent. This allows the surgeon to track the degradation of the stent in the body by means of x-ray. Those skilled in the art will recognize a multitude of drugs and other substances that could be incorporated into the stent for various purposes. Further according to preferred embodiments of the present invention, the proximal end of said sleeve comprises at least one circular protrusion on the outer surface thereof. The circular protrusion has a first edge and a second edge, the first edge which is configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and the second edge which is configured at an obtuse angle with respect to the outer surface of the sleeve. Preferably, the proximal end of said sleeve comprises two circular protrusions, though it is appreciated that any number of protrusions may be present. The protrusions serve to ensure that once drawn over the proximal end of the tubular sleeve, the body lumen stay in place on the sleeve.

Still further according to preferred embodiments of the present invention, the distal end of said sleeve comprises at least one circular protrusion on the outer surface thereof. The circular protrusion has a first edge and a second edge, said first edge being configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge being configured at an obtuse angle with respect to the outer surface of the sleeve. Preferably, the distal end of said sleeve comprises two circular protrusions, though it is appreciated that any number of protrusions may be present.

Additionally according to preferred embodiments of the present invention, the cover comprises an upper arc-shaped section and a lower arc-shaped section, and the opposite longitudinal edges of said upper section and said lower section are adapted for being interlocked with one another. Thus, the cover is formed by two semi-circular components that interlock with one another in order to form a substantially tubular- shaped cover that encircles the inner sleeve, after the body lumen has been drawn over the sleeve. It will be appreciated that the cover can be properly placed by the surgeon in a very fast, efficient and convenient manner, thus obviating the need for timely and complicated suturing. The cover allows of the secure, and reliable placement of the stent in a straightforward manner that was heretofore unknown in the art.

Further according to preferred embodiments of the present invention, the means for compressing and closing the cover over the sleeve comprises a gripping device for gripping the upper section and lower section of the cover and for causing the opposite longitudinal edges of the upper section and lower sections to become interlocked with one another over the sleeve. The gripping device preferably comprises an upper gripper and a lower gripper, for holding the upper and lower sections, respectively, of the stent, and for bringing the two sections together, and interlocking their longitudinal edges over the inner sleeve, during a surgical procedure. It is appreciated that the gripping device is easy for the surgeon to use, and allows for the cover to be securely placed on the sleeve and the body lumen in a quick and efficient manner. In one preferred embodiment, the gripping device is adapted for allowing the surgeon to deteimine, depending on the diameter of the stent, the amount of compressive force that is applied. The force should be just sufficient enough to interlock the two sections of the cover with one another. This is important since it assures that no extra strain is applied to the body lumen, and that blood can flow through them easily. It is appreciated, however, that in some preferred embodiments, the surgeon may carry out closing of the cover using his hands, without the use of a gripping device. The gripping device greatly facilitates closing of the cover, though it is not absolutely necessary.

It is further appreciated that the stent of the present invention provides internal support, as well as external support for the body lumen that is being anastomed.

Still further according to preferred embodiments of the present invention, the cover further comprises a plurality of pins located on the inner surface thereof. The pins serve to facilitate holding of the tissue in place in the prosthesis. The pins are adapted for piercing the tissue so as to provide additional support though it is appreciated that they do not put undo pressure on the tissue so as to result in the formation of holes or tears. Preferably, each of the upper and lower sections of the cover comprises four pins, though it is appreciated that other numbers of pins may be present as well. In the case of an intestinal anastomosis, the pins are about 0.4 millimeters in length, though the size may vary. It is appreciated that the pins pierce the body lumen, but they do not penetrate through the lumen.

The system of the present invention is useful for surgical procedures conducted in the intestinal lumen, the blood vessels, the urinary tract lumen, and the esophageal tract lumen, though it is appreciated that the system could be adapted for use with virtually all passageways of the body.

The present invention also relates to a method for implanting a stent between two severed ends of a body lumen, comprising; (a) providing a stent comprising an inner tubular sleeve having a proximal end and a distal end, and a substantially tubular cover adapted for being closed over the inner tubular sleeve after two severed body lumen ends have been drawn over the proximal and distal ends of said sleeve (one lumen being drawn over the proximal end and the other lumen being drawn over the distal end), such that said body lumen ends are fixed in between the tubular sleeve and the cover, wherein the stent is formed from a biocompatible material, and wherein the cover comprises an upper arc- shaped section and a lower arc-shaped section having longitudinal edges that are adapted for being interlocked with one another;

(b) providing a gripping device for closing said cover over said inner tubular sleeve by interlocking of said longitudinal edges of said upper and lower sections of said cover with one another;

(c) drawing a first severed lumen end over the proximal end of the sleeve and drawing a second severed lumen end over the distal end of the sleeve, and;

(d) interlocking, through the use of said gripping device, the upper section and the lower section of the cover with one another over said sleeve so as to form a cover over said sleeve and said lumen ends.

According to preferred embodiments of the present invention, the inner tubular sleeve is formed from a biodegradable material. Preferably, the cover is formed from a bio-absorbable material.

Further according to preferred embodiments of the present invention, the proximal end of said sleeve comprises at least one circular protrusion on the outer surface thereof. The circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve. Preferably, the proximal end of said sleeve comprises two circular protrusions, though it is appreciated that any number of protrusions may be present.

Still further according to preferred embodiments of the present invention, the distal end of said sleeve comprises at least one circular protrusion on the outer surface thereof. The circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve. Preferably, the distal end of said sleeve comprises two circular protrusions, though it is appreciated that any number of protrusions may be present.

Still further according to preferred embodiments of the present invention, the cover further comprises a plurality of pins located on the inner surface thereof. The pins serve to facilitate holding of the tissue in place in the prosthesis. The pins are adapted for piercing the tissue so as to provide additional support though they do not put too much pressure on the tissue so as to result in the formation of holes or tears. Preferably, each of the upper and lower sections of the cover comprises four pins, though it is appreciated that other numbers of pins may be present as well.

Still further according to preferred embodiments of the present invention, the gripping device comprises an upper gripper and a lower gripper, for gripping said upper section and said lower section, respectively, of said cover and for causing said opposite longitudinal edges of said upper section and said lower section to become interlocked with one another.

The method of the present invention is useful for surgical procedures conducted in the intestinal lumen, the blood vessels, the urinary tract lumen, and the esophageal tract lumen, though it is appreciated that the system could be adapted for use with virtually all passageways of the body.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described, by way of example only, with reference to the accompanying drawings, wherein;

Figure 1 is an isometric side view of a preferred embodiment of a stent for use in the system of the present invention. The stent comprises an inner tubular sleeve and a cover having an upper section and a lower section.

Figure 2 is a side view of the inner tubular sleeve of the stent of Figure 1.

Figure 3 is an isometric side view of the cover of the stent of Figure 1, shown with the upper and lower sections of the cover interlocked with one another. Figure 4a is a side view, taken from the outside, of the upper section of the cover shown in Figure 3. Figure 4b is a cross-sectional view of the upper section illustrated in Figure 4a.

Figure 5a is a side view, taken from the outside, of the lower section of the cover shown in Figure 3. Figure 5b is a cross-sectional view of the lower section illustrated in Figure 5 a.

Figure 6 is a cross-sectional side view of a section of body lumen fixed in between the inner tubular sleeve and the cover of the stent of Figure 1.

Figure 7 is a schematic side view of a mechanical gripping device for closing the cover of the stent of Figure 1 onto the inner tubular sleeve of the stent of Figure 1.

DETAILED DESCRIPTION OF THE DRAWINGS

It is appreciated that the description herein provided is intended only to illustrate certain preferred embodiments of the present invention. It is in no way meant to limit the scope of the invention, as is set out in the appended claims.

Referring first to Figure 1, the system of the present invention comprises a stent having two main components: an inner tubular sleeve (20) and a cover (30). The inner tubular sleeve (20) is implanted in the interior of two severed body lumen ends whereas the cover is positioned over said body lumen ends. The construction of the stent allows for maximal support of a body lumen. The cover (30) comprises an upper arc-shaped section (15) and a lower arc-shaped section (25). The sleeve (20) is adapted for being implanted on the internal side of a body lumen whereas the cover (30) is adapted for being secured over the sleeve, after two severed body lumens have been drawn onto the outer surface of the sleeve, so as to provide a new conduit between the two severed ends. As seen in Figures 1 and 2, the tubular sleeve (20) has a proximal end (12) and a distal end (14), each end being adapted for receiving a severed end of body lumen over the outer surface of said sleeve (20). As indicated by arrow (a) and arrow (b), severed body lumen stumps are drawn over the proximal end (12) and distal end (14) of the sleeve (20). Circular protrusions (23a) (23b) (24a) (24b), located on each of said proximal and distal ends, serve to maintain the tissue on the sleeve (20) after the tissue has been drawn over said sleeve (20). Each protrusion (23a) (23b) (24a) (24b) has a first edge (9) and a second edge (7), said first edge (9) being configured at a substantially 90° angle with respect to the tubular sleeve (20) and said second edge (7) being configured at an obtuse angle with respect to the tubular sleeve (20). Each end of the sleeve (20) preferably comprises two circular protrusions, though it appreciated that any suitable number may be employed.

Referring now to Figures 3, 4a and 4b, and 5a and 5b, the upper section (15) and the lower section (25) of the cover are adapted for being interlocked with one another so as to form a substantially tubular cover that becomes enclosed over the sleeve during implantation of the stent. Once the cover is positioned, the tissue is securely sandwiched between the sleeve (20 and the cover (30). Various means may be employed for enabling interlocking of the longitudinal edges of the upper and lower sections of the cover. In the preferred embodiment illustrated, the upper section (15) of the cover comprises a plurality locking pins (17a-h) positioned on the two longitudinal edges of said cover. Each edge preferably comprises four locking pins, though it is appreciated that the cover could be configured with any suitable number of pins. The locking pins (17a-h) are adapted in shape for being inserted into a plurality of grooves (18) (seen in Figure 1 and in Figure 5b) that are located on the longitudinal edges of the lower section (25) of the cover. Preferably, the pin/groove lock is a one-way lock, which cannot be readily undone, but which requires a specialized device in order to unlock, if it is necessary to take off the cover. It is appreciated however, that various other appropriate locking mechanisms could also be employed for interlocking the upper and lower sections of the cover with one another. In some embodiments, the locking may be adapted for being accomplished manually by the surgeon. Preferably, however, a gripping device (to be described in Figure 7) is employed for facilitating the interlocking of the two sections of the cover over the sleeve. The gripping device allows for closing of the cover to be carried out in a fast, efficient, and reliable manner.

As seen in Figures 3, 4a, 4b, 5a, and 5b, each of the upper section (15) and lower section (25) of the cover comprises a plurality of pointed pins (13a) (13b) (13c) (13d) that protrude from the inner surface of the cover sections (15) (25) (see Figures 4b and 5b). The pins function to hold the cover in place on the body tissue and the inner sleeve once said cover has been locked over the sleeve by the gripping device. The pins (13) may have any appropriate size, though it is appreciated that are designed so as provide additional support while not putting too much pressure on the tissue held by the stent (so that the tissue will not tear or become weakened due to the pins). The pins are sized so as not to penetrate completely through the tissue, but they are sufficient so as prevent movement of the tissue. In anastomosis of intestinal lumen, the pins will be approximately 0.4mm in length.

Referring to Figure 6, a section of body tissue (22) is illustrated between the inner tubular sleeve (20) and the cover (30) of the stent, following the positioning of the tissue (22) on the sleeve (20), and subsequent closing of the cover (30) on top of the sleeve (20). A pointed pin (13), on the inner surface of the cover (30), pierces the tissue (22), so as to help keep the body lumen in place in the stent. Also seen is a cross-sectional view of one of the circular protrusions (23) on the outer surface of the inner tubular sleeve (20) for preventing the tissue from coming off of the sleeve (20).

Reference is now made to Figure 7, and to a preferred embodiment for a gripping device (32) for locking the cover of the stent onto the inner tubular sleeve of said stent. The gripping device (32) preferably comprises an upper gripper (36a) and a lower gripper (36b), each having a semi-circular shape, for holding the upper and lower sections, respectively, of the cover. The gripping device (32) is equipped with a mechanism (38) for effecting the upward and downward movement of the upper and lower grippers (36a) (36b). In the preferred embodiment illustrated, the mechanism (38) includes an upper arm (37a) and a lower arm (37b) to which the grippers are respectively coupled. The two arms (37a) (37b) are each coupled to a main gear (39). Said main gear (39) is in turn operably coupled to an actuating rod (40) that is adapted for moving back and forth along the longitudinal axis of the device. The mechanism (38) is coupled to a locking handle (34) that is adapted for being pulled by the user, for actuating said mechanism. A stopper (35) restricts pulling back of the handle (34) to the necessary amount. The device is also equipped with a tension regulator (44), which regulates the amount of compressive force applied by the upper gripper (36a) and the lower gripper (36b) to the cover. Thus, the surgeon can decide, depending on the size of the stent being used, and/or the type of body tissue, the exact extent to which the grippers move in the inward direction (towards one another), when using the device. The regulator (44) can be easily set by the surgeon so as to adjust the height of the stopper (35), thereby determining the extent to which the handle (34) can be pulled and the extent to which the grippers (36a) (36b) move. It is appreciated that the gripping device described is adapted for being adjusted for use with stents having varying diameters. In some cases, however, stents constructed in different sizes may be provided, which each size stent having its own disposable gripping device, specifically designed for applying the appropriate amount of pressure for closing the cover over the sleeve of the particular stent.

It is appreciated that device described above could be readily modified while still functioning to achieve the same purpose, namely, locking the cover over the tubular sleeve. It is also appreciated that the use of a mechanical device for interlocking the sides of the cover with one another obviates the need for suturing during the surgical process, and allows for implantation of the stent to be accomplished in a faster, and more efficient manner. In some preferred embodiments, the cover may be adapted for being closed directly by the hands of the surgeon.

It is further appreciated that the stent of the present invention could be readily modified without departing from the scope of the invention as set out in the claims. For example, the material from which the stent is made could be selected so as to provide a stent that has a flexible nature, thereby enabling the surgeon to manipulate the stent easily for proper implantation into the body. Also, the stent diameter could change over the length of the stent. Alternatively, two stents having two different diameters could be used for one surgical procedure, with a conical connector serving to connect the two stents together. In some preferred embodiment, the stent may be bent or may have a certain angle, in order to fit particular types of body vasculature.

Claims

1. A stent for surgical mammalian vessel anastomosis comprising an inner tubular sleeve having a proximal end and a distal end, and a substantially tubular cover adapted for being closed over said inner tubular sleeve after two severed body lumen ends have been drawn over said proximal and distal ends of said sleeve, such that said body lumen is fixed between said tubular sleeve, and said cover, wherein the stent is comprised of a biocompatible, non-toxic material.

2. A stent according to claim 1 , wherein the inner tubular sleeve is formed from a biodegradable material.

3. A stent according to claim 1, wherein the cover is formed from a bio- absorbable material.

4. A stent according .to claim 1, wherein the proximal end of said sleeve comprises at least one circular protrusion on the outer surface thereof.

5. A stent according to claim 4, wherein the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve.

6. A stent according to claim 5, wherein said proximal end of said sleeve comprises two circular protrusions.

7. A stent according to claim 1, wherein said distal end of said sleeve comprises at least one circular protrusion on the outer surface thereof.

8. A stent according to claim 7, wherein the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve.

9. A stent according to claim 8, wherein said distal end of said sleeve comprises two circular protrusions.

10. A stent according to claim 1, wherein the cover comprises an upper arc-shaped section and a lower arc-shaped section.

11. A stent according to claim 10, wherein each of said upper arc shaped sections comprise two longitudinal edges, and wherein opposite longitudinal edges of said upper section and said lower section are adapted for being interlocked with one another.

12. A stent according to claim 11, wherein the upper section and the lower section are interlocked with one another using a pin/groove one-way locking mechanism.

13. A stent according to claim 1, wherein the cover further comprises a plurality of pins located on the inner surface thereof.

14. A stent according to claim 1 , for use with the intestinal lumen.

15. A stent according to claim 1 , for use with a blood vessel.

16. A stent according to claim 1 , for use with urinary tract lumen.

17. A stent according to claim 1, for use with the esophageal tract lumen.

18. A system for performing surgical mammalian vessel anastomosis, comprising;

(a) a stent comprising an inner tubular sleeve having a proximal end and a distal end, and a substantially tubular cover adapted for being closed over the inner tubular sleeve after two one severed body lumen ends have been drawn over said proximal and distal ends of said sleeve, such that said body lumen ends are is fixed in between the tubular sleeve and the cover, wherein the stent is formed from a biocompatible material, and;

(b) means for applying a compressive force to said cover for causing closing of said cover over said inner tubular sleeve.

19. A system according to claim 18, wherein the inner tubular sleeve is formed from a biodegradable material.

20. A system according to claim 18, wherein the cover is formed from a bio- absorbable material.

21. A system according to claim 18, wherein the proximal end of said sleeve comprises at least one circular protrusion on the outer surface thereof.

22. A system according to claim 21, wherein the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve.

23. A system according to claim 22, wherein said proximal end of said sleeve comprises two circular protrusions.

24. A system according to claim 18, wherein said distal end of said sleeve comprises at least one circular protrusion on the outer surface thereof.

25. A system according to claim 24, wherein the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve.

26. A system according to claim 24, wherein said distal end of said sleeve comprises two circular protrusions.

27. A system according to claim 18, wherein the cover comprises an upper arc- shaped section and a lower arc-shaped section.

28. A system according to claim 27, wherein each of said upper arc shaped sections comprise two longitudinal edges, and wherein opposite longitudinal edges of said upper section and said lower section are adapted for being interlocked with one another.

29. A system according to claim 28, wherein the upper section and the lower section are interlocked with one another using a pin/groove one-way locking mechanism.

30. A system according to claim 28, wherein the means comprises a gripping device comprising an upper gripper and a lower gripper, for gripping said upper section and said lower section, respectively, of said cover and for causing said opposite longitudinal edges of said upper section and said lower section to become interlocked with one another.

31. A system according to claim 30, wherein the gripping device is adapted for being disposable.

32. A system according to claim 30, wherein the gripping device is adapted for allowing the surgeon to determine the compressive force applied by the upper gripper and the lower gripper.

33. A system according to claim 18, wherein the cover further comprises a plurality of pointed pins located on the inner surface thereof.

34. A system according to claim 18, for use with the intestinal lumen.

35. A system according to claim 18, for use with a blood vessel.

36. A system according to claim 18, for use with urinary tract lumen.

37. A system according to claim 18, for use with the esophageal tract lumen.

38. A method for performing a surgical mammalian vessel anastomosis, comprising;

(a) providing a stent comprising an inner tubular sleeve having a proximal end and a distal end, and a substantially tubular cover adapted for being closed over the inner tubular sleeve after two one severed body lumen ends have been drawn over said proximal and distal ends of said sleeve, such that said body lumen ends are is fixed in between the tubular sleeve and the cover, wherein the stent is formed from a biocompatible material, and wherein the cover comprises an upper arc-shaped section and a lower arc- shaped section having longitudinal edges that are adapted for being interlocked with one another;

(b) providing a gripping device for closing said cover over said inner tubular sleeve by interlocking of said longitudinal edges of said upper and lower . sections of said cover with one another;

(c) drawing a first severed lumen end over the proximal end of the sleeve and drawing a second severed lumen end over the distal end of the sleeve;

(d) interlocking, through the use of said gripping device, the longitudinal edges of the upper section of the cover and the lower section of the cover with one another over said sleeve so as to form a cover over said sleeve and said lumen ends.

39. A method according to claim 38, wherein the inner tubular sleeve is formed from a biodegradable material.

40. A method according to claim 38, wherein the cover is formed from a bio- absorbable material.

41. A method according to claim 38, wherein said proximal end of said sleeve comprises at least one circular protrusion on the outer surface thereof.

42. A method according to claim 41, wherein the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve.

43. A method according to claim 41, wherein said proximal end of said sleeve comprises two circular protrusions.

44. A method according to claim 38, wherein said distal end of said sleeve comprises at least one circular protrusion on the outer surface thereof.

45. A method according to claim 44, wherein the circular protrusion has a first edge and a second edge, said first edge configured at a substantially ninety degree angle with respect to the outer surface of the sleeve, and said second edge configured at an obtuse angle with respect to the outer surface of the sleeve.

46. A method according to claim 44, wherein said distal end of said sleeve comprises two circular protrusions.

47. A method according to claim 38, wherein the cover further comprises a plurality of pointed pins located on the inner surface thereof.

48. A method according to claim 38, wherein the gripping device comprises an upper gripper and a lower gripper, for gripping said upper section and said lower section, respectively, of said cover and for causing said opposite longitudinal edges of said upper section and said lower section to become interlocked with one another.

49. A method according to claim 48, wherein the gripping device is adapted for being disposable.

50. A method according to claim 48, wherein the gripping device is adapted for allowing the surgeon to determine the compressive force applied by the upper gripper and the lower gripper.

51. A method according to claim 38, for use with the intestinal lumen.

52. A method according to claim 38, for use with a blood vessel.

53. A method according to claim 38, for use with urinary tract lumen.

54. A method according to claim 38, for use with the esophageal tract lumen.