US20110087252A1 - Biliary decompression and anastomosis stent - Google Patents

Abstract

A stent and a method for implanting a stent for decompression and anastomosis formation are provided. The stent includes a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body, a distal opening in the distal portion in fluid communication with the lumen and a proximal opening in the proximal portion in fluid communication with the lumen. The stent further includes a first magnetic element positioned on the distal portion of the tubular body and a second magnetic element movably positionable on the proximal portion of the tubular body. The second magnetic element is configured to surround and move over the proximal portion of the tubular body towards the first magnetic element.

Description

TECHNICAL FIELD
• This invention generally relates to methods and devices for decompression and for forming an anastomosis between two viscera, and more particularly relates to methods and devices including stents and magnets.
BACKGROUND
• Historically, gastro-intestinal (GI) surgery has been performed to create a channel or anastomosis between two viscera for the purpose of redirecting bodily fluids. For example, intestinal contents or bile may be redirected in patients who have developed an obstruction of the bowel or bile duct due to such conditions as tumors, ulcers, inflammatory strictures or trauma. During surgery to form an anastomosis, the two tissues are often brought together using devices such as sutures, staples, or some other fixation means such as adhesives. While the tissues are being brought together during the procedure, various types of surgical instruments may be used to temporarily hold the tissues in place. In open surgery, the temporary holding may be accomplished with graspers, forceps, or other tissue holding instruments that are manipulated by clinicians. In laparoscopic surgery, similar instruments may be used, except that the laprotic access limits the number of instruments that may be inserted into the site making the tissue securing procedure much more challenging.
• When these types of GI surgery are performed, there exists the potential to breech the mural boundary. Thus, extreme care must be taken to prevent contamination of the pleural and abdominal cavities with GI contents, which are laden with bacteria that do not naturally occur in those locations. If significant contamination occurs, then serious infection can set in, which can lead to serious illness or death if not treated early and vigorously.
• To address these limitations and to minimize the invasiveness of such surgeries, magnetic anastomosis devices (MADS) have been developed for forming anastomoses. An exemplary MAD is disclosed in U.S. Pat. No. 5,690,656, the disclosure of which is incorporated herein by reference in its entirety. Generally, the MAD of the '656 patent includes first and second magnet assemblies including magnetic cores that are surrounded by thin metal rims. The first and second magnet assemblies are positioned in the two viscera between which the anastomosis is desired and brought into close proximity to each other. Due to the magnetic attraction between the two magnetic cores, the walls of the two adjacent viscera are compressed between the magnet assemblies and in particular the magnetic rims, resulting in ischemic necrosis of the walls to produce an anastomosis between the two viscera.
• MADs may be delivered through surgical intervention such as laparatomy, over a wire guide using a pushing catheter (and typically under fluoroscopy), by simply swallowing the magnet assemblies of the MAD and using massage under fluoroscopy to align the two magnet assemblies, or endoscopically using grasping forceps. Within about ten days after the visceral tissues surrounding the magnets fuse together, and the magnets and entrapped necrotic tissue subsequently detach from the surrounding tissue to leave an opening between the viscera.
• In some patients, the obstruction may cause painful restriction of fluid flow through a body passage that requires a more immediate opening than is typically provided with the MADs. For example, the flow of bile from the liver may be obstructed through the bile duct due to a tumor or other blockage. There exists a need to rapidly restore the fluid flow to release the bile from the duct. Typically, a blockage in the common bile duct can be alleviated by inserting a drainage stent through the Ampula of Vader into the common bile duct to create an opening through the obstruction. However, drawbacks may arise when using a drainage stent inserted through the Ampula of Vader, including obstruction of the drainage stent. In addition, drainage stents periodically need to be changed to maintain the passage and fluid flow out of the bile duct, requiring additional patient procedures.
• There is a need for devices and methods for immediate decompression of a duct and subsequent anastomosis.
SUMMARY OF THE INVENTION
• Accordingly, it is an object of the present invention to provide a method and a stent having features that resolve or improve on one or more of the above-described drawbacks.
• The foregoing object is obtained in one aspect of the present invention by providing a stent for decompression and anastomosis formation. The stent includes a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body; a distal opening in the distal portion in fluid communication with the lumen, and a proximal opening in the proximal portion in fluid communication with the lumen, the body being configured to be disposed at least partially within an internal bodily duct and facilitate the passage of bodily fluid therethrough. The stent further includes a first magnetic element positioned on the distal portion of the tubular body, the first magnetic element having an opening formed therethrough so that the first magnetic element surrounds a portion of the tubular body, and a second magnetic element movably positionable on the proximal portion of the tubular body, the second magnetic element having an opening formed therethrough so that the second magnetic element is configured to surround and move over the proximal portion of the tubular body towards the first magnetic element.
• In another aspect of the present invention, a method for forming an anastomosis between two body cavities is provided. The method includes providing an opening through a wall of a first bodily cavity and a second bodily cavity and inserting a stent through the opening. The stent includes a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body; a distal opening in the distal portion in fluid communication with the lumen, and a proximal opening in the proximal portion in fluid communication with the lumen. The stent further includes a first magnetic element positioned on the distal portion of the tubular body, the first magnetic element having an opening formed therethrough so that the first magnetic element surrounds a portion of the tubular body. The method further includes positioning the first magnetic element and the distal portion within the second bodily cavity and positioning the proximal portion within the first bodily cavity so that the lumen is in fluid communication between the first bodily cavity and the second bodily cavity, and then placing the second magnetic element over the proximal portion so that the second magnetic element is movable towards the first magnetic element.
• In another aspect of the present invention, a method for forming an anastomosis between two body cavities is provided. The method includes inserting a delivery device through a wall of a first bodily cavity and a wall of a second bodily cavity and delivering a stent over the delivery device to position the stent between the first bodily cavity and the second bodily cavity and to establish fluid flow therebetween. The stent includes a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body; a distal opening in the distal portion in fluid communication with the lumen, and a proximal opening in the proximal portion in fluid communication with the lumen and a first magnetic element positioned on the distal portion of the tubular body, the first magnetic element having an opening formed therethrough so that the first magnetic element surrounds a portion of the tubular body. The method further includes positioning the stent with the proximal portion extending into the first bodily cavity and the distal portion extending into the second bodily cavity, the first magnetic element being positioned in the second bodily cavity on the distal portion, delivering the second magnetic element to the proximal portion of the stent, and creating an anastomosis using the attraction forces of the first magnetic element and the second magnetic element.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a stent according to the present invention showing the magnetic elements spaced apart;
• FIG. 2 is a perspective view of the stent according to the present invention with the magnetic elements contacting each other;
• FIG. 3 is a perspective view of the stent according to the present invention with a magnetic element removed from the stent;
• FIG. 4 is a partial view of an embodiment of the magnetic elements according to the present invention;
• FIG. 5 is a partial view of an alternative embodiment of the magnetic elements according to the present invention;
• FIG. 6 is a diagrammatic view of a delivery system within the GI tract for placement of the stent;
• FIG. 7 is a diagrammatic view of the placement of the stent between the common bile duct and the duodenum;
• FIG. 8 is a diagrammatic view of the placement of the second magnetic element onto the stent within the duodenum;
• FIG. 9 is a diagrammatic view of the second magnetic element moving distally towards the first magnetic element on the stent; and
• FIG. 10 is a diagrammatic view of the second magnetic element contacting the first magnetic element.
DETAILED DESCRIPTION OF THE EMBODIMENTS
• The invention is described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of this invention are better understood by the following detailed description. However, the embodiments of this invention are not limited to the embodiments illustrated in the drawings. It should be understood that the drawings are not to scale, and in certain instances details have been omitted which are not necessary for an understanding of the present invention, such as conventional fabrication and assembly.
• As used in the specification, the terms proximal and distal should be understood as being in the terms of a physician delivering the stent to a patient. Hence the term “distal” means the portion of the stent that is farthest from the physician and the term “proximal” means the portion of the stent that is nearest to the physician.
• FIGS. 1 and 2 illustrate astent10 in accordance with embodiments of the present invention. Thestent10 includes a non-expandable, generallytubular body14 having aproximal portion20 and adistal portion30. Alumen32 extends through at least a portion of thetubular body14 of thestent10 between aproximal opening21 and adistal opening31. Thestent10 further includes a firstmagnetic element40 and a secondmagnetic element42. The firstmagnetic element40 is positioned distal to the secondmagnetic element42 on thestent10. The secondmagnetic element42 is movably positionable over theproximal portion20 of thestent10. In some embodiments, the firstmagnetic element40 is fixed in position on thestent10. Thestent10 may also include a stoppingmember55 to prevent the firstmagnetic element40 from moving further distally toward the distal end of thestent10. As shown inFIG. 3, the secondmagnetic element42 is configured to be positioned over theproximal portion20 of thestent10 and moved distally towards the firstmagnetic element40 and eventually connect to the firstmagnetic element40 to form an anastomosis as described in more detail below. The attractive force between the firstmagnetic element40 and the secondmagnetic element42 will draw themagnetic elements40,42 together. As shown inFIG. 3, the secondmagnetic element42 is configured to move distally so that the secondmagnetic element42 is drawn to toward themagnetic element40 over thetubular body14 of thestent10.FIG. 3 also illustrates adistal end portion56 that is conically shaped to facilitate insertion of the firstmagnetic element40 into a bodily location.
• The firstmagnetic element40 and the secondmagnetic element42 may have any shape and size that allows for themagnetic elements40,42 to be positioned on atubular stent10 and to allow at least the secondmagnetic element42 to move distally toward the firstmagnetic element40. The first and secondmagnetic elements40,42 may also be self centering, although thestent10 also helps to position the first and secondmagnetic elements40,42 for mating. In some embodiments, the first and secondmagnetic elements40,42 may be shaped to nest together to form the anastomosis.
• An exemplary view of the firstmagnetic element40 and the secondmagnetic element42 is shown inFIG. 4 without the stent is shown to illustrate the mating of themagnetic elements40,42. The firstmagnetic element40 and the secondmagnetic element42 are disc shaped with the firstmagnetic element40 having a smallerouter diameter46 that nests within theouter diameter48 of the secondmagnetic element42. A contactinginterface50 is formed when the firstmagnetic element40 contacts the secondmagnetic element42 at a first contactingface52 of the firstmagnetic element40 and a second contactingface54 of the secondmagnetic element42. The secondmagnetic element42 may include an overlappingrim58 that extends at least partially over a portion of the firstmagnetic element40. When themagnetic elements40,42 are implanted within the body, tissue is pressed between the first contactingface52 and the second contactingface54 of the first and secondmagnetic elements40,42 as themagnetic elements40,42 move closer together to form the anastomosis. The first and secondmagnetic elements40,42 may be formed having atraumatic surfaces that are exposed to the tissue to inhibit irritation within the body as the magnetic elements move closer together and form the anastomosis.
• FIG. 5 illustrates alternative shapes for the firstmagnetic element40 and the secondmagnetic element42 where the firstmagnetic element40 includes a bullet-shaped first contactingface52 and the secondmagnetic element42 is shaped to mate with the firstmagnetic element40 and the second contactingface54 is shaped to mate with bullet-shaped first contactingface52. One skilled in the art will recognize that many alternative shapes are possible for themagnetic elements40,42. In addition, the firstmagnetic element40 may include adistal end portion56 that is shaped to facilitate insertion of the firstmagnetic element40 into a bodily location. By way of non-limiting example, the firstmagnetic element40 may be tapered at thedistal end portion56 or the entiremagnetic element40 may be tapered from aproximal end57 to adistal end59. Although one skilled in the art will recognize that any shape maybe used for either of themagnetic elements40,42.
• As shown inFIGS. 4 and 5, the firstmagnetic element40 includes anopening60 formed through themagnetic element40 that is sized and shaped to surround thedistal portion30 of thetubular body14. The firstmagnetic element40 may be secured to thestent10 so that the firstmagnetic element40 is fixed in position in relation to thestent10 and the secondmagnetic element42 moves in relation to thestent10 and the firstmagnetic element40. The firstmagnetic element40 may be fixed to thestent10 using any means known to one skilled in the art, for example, with an adhesive. The secondmagnetic element42 includes anopening62 formed through themagnetic element42 that is sized and shaped to surround thetubular body14 of thestent10 and to be movable over thestent10 distally toward the firstmagnetic element40.
• Thestent10 may also include one or more modifications to help retain thestent10 in position within the bodily location. For example, as shown inFIGS. 1 and 2, one ormore retaining members70 may be included on thetubular body14. The retainingmember70 may be a flap that extends a length of about 4-8 mm from thetubular body14. Other lengths for the retaining member may be possible and may depend on the size of the duct opening, the flexibility of the retaining member, the length of the stent and the amount of time thestent10 is to remain implanted within the duct. The retainingmember70 may be formed from thetubular member14 with a longitudinal cut in the wall of thetubular member14. Alternatively, the retainingmember70 may be formed by molding with thebody14 or addition to thetubular body14 or any method known to one skilled in the art. One ormore openings72 may be included in thetubular body14 as shown inFIG. 3. Theopenings72 are configured to facilitate drainage through thestent10. Additional modifications such as one or more pigtails may also be included on thestent10. Thefirst magnet40 may also be shaped to help retain thestent10 in position against the ductal wall.
• Thestent10 may be of any size suitable for implantation into a bodily duct and will vary depending on the size of the duct. Thestent10 may have an outer diameter of about 3-15 Fr. The length of the stent may be 5-30 cm. Shorter or longer stents may also be used. These sizes are merely exemplary and other sizes may be used.
• The stent may be made from materials so that the stent is soft enough to conform to the curvature of the duct and eliminate or reduce irritation at the implantation site that occurs with a rigid stent, thus reducing the risk of irritation, morphological or ductal changes. The materials should also have sufficient strength to maintain a lumen through the stent when the stent is positioned within the duct. Exemplary materials for thestent10 include, but are not limited to the following, SOF-FLEX™, a type of polyether urethane, silicone, block co-polymers, urethanes, polyethylene, polystyrene, polytetrafluoroethylene (PTFE), FEP and the like and combinations thereof. In some embodiments, thestent10 may be formed from biodegradable materials. A number of bioabsorbable homopolymers, copolymers, or blends of bioabsorbable polymers are known in the medical arts. These include, but are not necessarily limited to, polyesters including poly-alpha hydroxy and poly-beta hydroxy polyesters, polycaprolactone, polyglycolic acid, polyether-esters, poly(p-dioxanone), polyoxaesters; polyphosphazenes; polyanhydrides; polycarbonates including polytrimethylene carbonate and poly(iminocarbonate); polyesteramides; polyurethanes; polyisocyantes; polyphosphazines; polyethers including polyglycols polyorthoesters; expoxy polymers including polyethylene oxide; polysaccharides including cellulose, chitin, dextran, starch, hydroxyethyl starch, polygluconate, hyaluronic acid; polyamides including polyamino acids, polyester-amides, polyglutamic acid, poly-lysine, gelatin, fibrin, fibrinogen, casein, collagen.
• The magnetic elements may be formed from any material having magnetically attractable materials. As used herein, magnetic refers to all magnetically attractable materials, such as magnets and magnetically charged members, as well as ferrous materials such as iron, nickel cobalt, steel and various alloys that are attractable to a magnet. For example the magnets may be rare-earth magnets, such as Neodymium-iron-boron, cobalt, etc. Although the first and second magnetic elements have been depicted as magnets, it will be recognized by one skilled in the art that only one of the magnetic elements may be a magnet where the other magnetic element is a ferrous material or other material that is simply attracted to the one magnet. The magnetic elements may also include a protective coating to protect the magnetic elements from the potentially corrosive effects of the bodily fluids. By way of non-limiting example, the magnetic elements may be coated with a polymeric coating such as parylene, polyesters, polyurethanes, polyethylenes, polyamides, and silicone. The coating may also be formed of various metals or alloys, such as TEFLON® and PARALENE® and the like.
• An exemplary method of delivering and implanting thestent10 of the present invention will be illustrated with reference to thedelivery system100. By way of non-limiting example, a method of forming an anastomosis between the common bile duct and the duodenum is shown. One skilled in the art will understand that an anastomosis may be formed between other ducts and the duodenum or other portions of the GI tract using the stent and the magnetic elements of the present invention. As shown inFIGS. 6-10, thedelivery system100 may be used to place thestent10 in thecommon bile duct120. With reference toFIG. 6, the relative positions of several organs of the abdominal cavity are shown, including thepancreatic duct102 of thepancreas110, theduodenum122, thecystic duct124 and thegall bladder126. Amass130 is also shown obstructing the opening of thecommon bile duct120 and thus blocking fluid flow out of the common bile duct.
• As shown inFIG. 6, thedelivery system100, typically an endoscope or an endoscopic ultrasound (EUS) device that utilizes high frequency sound waves to create an image of living tissue or an echogenic surface, is positioned in theduodenum122. AnEUS device100 is shown inFIG. 6 having aneedle140 extending from theEUS device110 and through the wall of theduodenum122 and through the wall of thecommon bile duct120. As shown inFIG. 7, thestent10 is being delivered over awire guide142 that has been inserted through the walls of theduodenum122 and thecommon bile duct120. Thedistal end portion30 of thestent10 is positioned in thecommon bile duct120 so that the firstmagnetic element40 is positioned within thecommon bile duct120. Thestent10 extends between thecommon bile duct120 and theduodenum122 creating opening via thelumen21 of thestent10 for fluid to flow out of thecommon bile duct120 into theduodenum122 providing immediate decompression of the biliary blockage.
• As shown inFIG. 8, the secondmagnetic element42 may be delivered to thestent10 using thesame delivery system100. Alternatively, as will be understood by one skilled in the art, a second delivery system may be used to place the secondmagnetic element42 of theproximal end20 of thestent10. As shown inFIG. 8, a pushingcatheter144 may be used to push themagnetic element42 into position on thestent10 over thewireguide110. Similarly, alternative types of introducer catheters may be used to deliver the secondmagnetic element42 into position on thestent10 within theduodenum122.
• FIG. 9 illustrates thestent10 in position and forming the opening for fluid flow out of thecommon bile duct120 and into theduodenum122. The secondmagnetic element42 is movably positioned over theproximal end portion20 of thestent10 and is advancing towards themagnetic element40. The attractive force between the firstmagnetic element40 and the secondmagnetic element42 is sufficient to prevent the second magnetic element form falling off of thestent10, for example during movement of the GI tract. Thestent10 may also include aprotrusion70 proximal to the position of the secondmagnetic element42 that also helps to prevent release of themagnetic element42 from thestent10. The arrows shown inFIG. 8 indicate the direction of movement of the secondmagnetic element42 towards the firstmagnetic element40 that also brings the wall of the duodenum122 into proximity with the wall of thecommon bile duct120.
• FIG. 10 illustrates the joining of the secondmagnetic element42 to the firstmagnetic element40 on thestent10. The tissue between the first and secondmagnetic elements40,42 dies and necroses to form an anastomosis between the duodenum122 and thecommon bile duct120 to create a permanent opening for drainage of the fluid from thecommon bile duct20. The anastomosis may be created within about 10 days. Eventually, thestent10 and the first and secondmagnetic elements40,42 fall out of the opening and pass naturally though the GI system. Thestent10 with themagnet elements40,42 preferably passes without additional intervention by the physician, such as would be required to replace a stent that has been inserted into thecommon bile duct120 through the Ampula ofVader114.
• Thestent10 may also be placed between thecommon bile duct120 and theduodenum122 using adelivery system100 using an alternative entry position. Thedelivery system100 may be positioned in theduodenum122 and awireguide142 is inserted into thecommon bile duct120 through the Ampula ofVader114. An ECRP endoscope may be used to access thecommon bile duct120 in the event that the obstruction prevents the wireguide142 from entering the common bile duct. Thewireguide142 or theneedle140 may be inserted into thecommon bile duct120 and through the walls of both thecommon bile duct120 and theduodenum122. Thestent10 may be inserted over the wire guide through thecommon bile duct120 and out of the holes through the walls of the common bile duct and the duodenum so that the proximal portion of thestent10 extends in the duodenum. The first magnetic element is placed within thecommon bile duct120 with thedistal end portion30 of thestent10. The secondmagnetic element42 is advanced over theproximal end portion20 of thestent10 as described above.
• The above Figures and disclosure are intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in the art. All such variations and alternatives are intended to be encompassed within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the attached claims. For example, the invention has been described in the context of the biliary system for illustrative purposes only. Application of the principles of the invention to any other bifurcated lumens or vessels within the body of a patient, including areas within the digestive tract such as the pancreatic system, as well as areas outside the digestive tract such as other vascular systems, by way of non-limiting examples, are within the ordinary skill in the art and are intended to be encompassed within the scope of the attached claims.

Claims (20)

1. A stent for decompression and anastomosis formation, the stent comprising:

a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body; a distal opening in the distal portion in fluid communication with the lumen, and a proximal opening in the proximal portion in fluid communication with the lumen, the body being configured to be disposed at least partially within an internal bodily duct and facilitate the passage of bodily fluid therethrough;

a first magnetic element positioned on the distal portion of the tubular body, the first magnetic element having an opening formed therethrough so that the first magnetic element surrounds a portion of the tubular body; and

a second magnetic element movably positionable on the proximal portion of the tubular body, the second magnetic element having an opening formed therethrough so that the second magnetic element is configured to surround and move over the proximal portion of the tubular body towards the first magnetic element.

2. The stent ofclaim 1, wherein the first magnetic element is configured to be disposed within the internal bodily duct and the second magnetic element is configured to be positioned in an internal bodily cavity, the internal bodily cavity being in fluid communication with the internal bodily duct via the lumen of the tubular body.

3. The stent ofclaim 1, wherein the first magnetic element comprises a tapered distal end portion to facilitate placement of the first magnetic element into the internal bodily duct.

4. The stent ofclaim 1, wherein the first magnetic element comprises an end portion having one of a protruding surface or a recessed surface and the second magnetic element comprises an end portion having the other of a protruding surface or a recessed surface.

5. The stent ofclaim 1, wherein the first and second magnetic elements define first and second rims projecting axially from the first and second magnetic elements.

6. The stent ofclaim 5, wherein the first magnetic element is sized to nest at least partially within the second magnetic element.

7. The stent ofclaim 1, wherein the first magnetic element and the second magnetic element comprise atraumatic engagement surfaces.

8. The stent ofclaim 1, wherein the first magnetic element is fixed in position in relation to the tubular body.

9. The stent ofclaim 1, wherein the stent further comprises a retaining member extending outward from the tubular body.

10. The stent ofclaim 1, wherein the tubular body comprises a plurality of body openings operably connected to the lumen.

11. A method for forming an anastomosis between two body cavities, the method comprising:

providing an opening through a wall of a first bodily cavity and a second bodily cavity;

inserting a stent through the opening; the stent comprising:

a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body; a distal opening in the distal portion in fluid communication with the lumen, and a proximal opening in the proximal portion in fluid communication with the lumen; and

a first magnetic element positioned on the distal portion of the tubular body, the first magnetic element having an opening formed therethrough so that the first magnetic element surrounds a portion of the tubular body;

positioning the first magnetic element and the distal portion within the second bodily cavity and positioning the proximal portion within the first bodily cavity so that the lumen is in fluid communication between the first bodily cavity and the second bodily cavity;

placing the second magnetic element over the proximal portion so that the second magnetic element is movable towards the first magnetic element.

12. The method ofclaim 11, further comprising advancing the second magnetic element distally toward the first magnetic element using the attractive forces between the first and second magnetic elements to advance the second magnet.

13. The method ofclaim 11, further comprising compressing a portion of the wall of the first bodily cavity and a portion of the wall of the second bodily cavity between the first and second magnetic elements to create an anastomosis.

14. The method ofclaim 11, further comprising delivering the second magnetic element using an introducer catheter.

15. The method ofclaim 11, comprising providing the opening through the walls of the first and second bodily cavities using a needle device.

16. The method ofclaim 11, wherein the first magnetic element is placed into a common bile duct and the second magnetic element is placed into the duodenum.

17. A method for forming an anastomosis between two body cavities, the method comprising:

inserting a delivery device through a wall of a first bodily cavity and a wall of a second bodily cavity;

delivering a stent over the delivery device to position the stent between the first bodily cavity and the second bodily cavity and to establish fluid flow therebetween; the stent comprising:

a non-expandable, generally tubular body having a proximal portion and a distal portion, a lumen extending through at least a portion of the body; a distal opening in the distal portion in fluid communication with the lumen, and a proximal opening in the proximal portion in fluid communication with the lumen; and

a first magnetic element positioned on the distal portion of the tubular body, the first magnetic element having an opening formed therethrough so that the first magnetic element surrounds a portion of the tubular body;

positioning the stent with the proximal portion extending into the first bodily cavity and the distal portion extending into the second bodily cavity, the first magnetic element being positioned in the second bodily cavity on the distal portion;

delivering the second magnetic element to the proximal portion of the stent; and

creating an anastomosis using the attraction forces of the first magnetic element and the second magnetic element.

18. The method ofclaim 17, wherein the stent is removable and fluid flow is established through the anastomosis.

19. The method ofclaim 18, wherein the stent is removable without further surgical intervention.

20. The method ofclaim 17, wherein the stent is delivered over a wireguide.

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