Elongate magnet for a magnetic anastomosis device

A magnetic anastomosis device is provided for forming an anastomosis between two bodily walls. The device includes a first magnet assembly and a second magnet assembly configured to be magnetically coupled to compress the two bodily walls therebetween to form the anastomosis. The first magnet assembly includes a first magnet and a second magnet disposed within a first jacket and the second magnet assembly includes a third magnet and a fourth magnet disposed within a second jacket.

FIELD OF THE INVENTION

The present invention relates generally to magnetic anastomosis devices for forming an anastomosis between two viscera.

BACKGROUND OF THE INVENTION

Magnetic anastomosis devices (MADS) are currently used to create a channel 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 tumor, ulcer, inflammatory strictures or trauma. A magnetic anastomosis device 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 includes first and second magnet assemblies comprising magnetic cores that are surrounded by thin metal rims. Due to the magnetic attraction between the two magnetic cores, the walls of two adjacent viscera may be sandwiched and compressed between the magnet assemblies, resulting in ischemic necrosis of the walls to produce an anastomosis between the two viscera. The viscera treated by MADs include the gall bladder, the common bile duct, the stomach, the duodenum, the jejunum of the small intestine, as well as the large intestine and left and right hepatic ducts.

Typically, immediately after formation of the anastomosis, a stent is delivered in the anastomosis to prevent the anastomosis from closing. Thus, forming an anastomosis with current MAD designs, such as the MAD device disclosed in U.S. Pat. No. 5,690,656, generally involves two interventional procedures, the first being placement of the magnet assemblies to create the anastomosis and the second being placement of a stent within the newly formed anastomosis to prevent it from closing.

BRIEF SUMMARY OF THE INVENTION

The present invention provides a magnetic anastomosis device that is minimally invasive, easily and quickly delivered, and is accurately positioned to improve the delivery procedure. According to one embodiment constructed in accordance with the teachings of the present invention, a magnetic anastomosis device used for forming an anastomosis between two bodily walls includes a first magnet assembly and a second magnet assembly configured to be magnetically coupled to compress the two bodily walls therebetween to form the anastomosis. The first magnet assembly includes a first magnet and a second magnet disposed within a first jacket and the second magnet assembly includes a third magnet and a fourth magnet disposed within a second jacket.

According to another embodiment constructed in accordance with the teachings of the present invention, a magnetic anastomosis device used for forming an anastomosis between two bodily walls includes a first magnet, a second magnet, a third magnet, and a fourth magnet. A first jacket encases the first and second magnets and a second jacket encases the third and fourth magnets. The first and second jackets each have an elongate shape defining a first and a second longitudinal axis, respectively. The first and second magnets are oriented on the first longitudinal axis of the first jacket and the third and fourth magnets are oriented on the second longitudinal axis of the second jacket. The first and second jackets are configured to be magnetically coupled to compress the two bodily walls therebetween to form the anastomosis.

DETAILED DESCRIPTION OF THE INVENTION

Detailed embodiments of the present invention are disclosed herein. It is understood however, that the disclosed embodiments are merely exemplary of the invention and may be embodied in various and alternative forms. The figures are not necessarily to scale; some figures may be configured to show the details of a particular component. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a representative basis with the claims and for teaching one skilled in the art to practice the present invention.

Turning now to the figures,FIG. 1depicts a magnetic anastomosis device20that is used to form an anastomosis between two viscera, specifically bodily walls of two adjacent viscera. In one example, an intestinal bypass anastomosis may be used to treat obesity. Generally, the magnetic anastomosis device20includes first and second magnet assemblies22a,22bconfigured to be magnetically coupled to compress the bodily walls therebetween to form the anastomosis. InFIG. 1, each of the magnet assemblies22a,22bincludes two magnets23a,24aand23b,24bdisposed within a respective elongate jacket26a,26b. Each of the magnets23a,24a,23b,24bincludes a magnetic core29encased within the respective elongate jacket26a,26b. It is also within the scope of the present invention for each magnet23a,24a,23b,24bto include an individual metal or plastic jacket surrounding the magnetic core29, both of which are encased within the respective elongate jacket26a,26b.

The term “elongate” as used herein to describe the shape of the jackets26a,26b, or magnet assemblies22a,22b, is intended to include an elliptical shape including an ellipse having a major axis and a minor axis; an oval or ovoid shape; an egg shape; a kidney shape; a figure eight shape; or any oblong shape having a continuous peripheral surface. For example, “elongate” may include a rectangle with rounded corners. In another example, the ends of the jackets26a,26bmay have a tapered rounded nose shape similar to the distal ends of typical dilator catheters known in the art. It is believed that such shapes provide greater comfort and ease during swallowing and/or positioning of the magnet assemblies22a,22bwithin the body of the patient.

As illustrated inFIG. 1, each of the elongate jackets26a,26bdefines a longitudinal axis32a,32band a lateral axis34a,34b. In this embodiment, the magnets23a,24aare oriented on the longitudinal axis32aof the jacket26aof the first magnet assembly22a. Similarly, the magnets23b,24bare oriented on the longitudinal axis32bof the jacket26bof the second magnet assembly22b. In other words, the magnets23a,24aand23b,24b, are disposed along the respective longitudinal axis32a,32bin a side-by-side arrangement (i.e., as opposed to on top of one another or overlapping). As shown inFIG. 2, the magnets23a,24aand23b,24bare spaced apart from one another on different sides of the respective lateral axis34a,34b, defining a space or gap25a,25bbetween the magnets23a,24aand23b,24b. The gap25a,25bbetween the magnets23a,24aand23b,24bmay be a small gap, i.e., about 0.5 mm to about 3 mm, or a larger gap as shown inFIG. 6and described in more detail below. Alternatively, the magnets23a,24aand23b,24bmay be immediately adjacent within their respective jacket26a,26bsuch that there is no space in between the magnets23a,24aand23b,24b.

Referring toFIGS. 2 and 3, each jacket26a,26bincludes a body portion45having first and second opposing planar surfaces42and44and a peripheral surface46extending therebetween. Each body portion45includes two cavities48formed therethrough by any suitable means in the art. Each cavity48is formed through the body portion45through the opposing planar surfaces42and44and is dimensioned to receive one of the magnets23a,24a,23b,24bsuch that when the magnets23a,24a,23b,24bare disposed within their respective jacket26a,26bthe magnets23a,24a,23b,24bare recessed from the planar surfaces42and44. The magnets23a,24a,23b,24bare held within the cavities48by any suitable means in the art, for example, via a press-fit engagement or an adhesive.

Preferably, each of the magnet assemblies22a,22bincludes a lumen75formed therethrough to accommodate a suture or a wire guide for delivery purposes, as discussed in further detail below.FIGS. 2 and 3show the lumen75extending through each of the magnet assemblies22a,22b, i.e., through the jackets26a,26band each of the magnets23a,24a,23b,24b. It is noted that, although the lumen75extending through of the magnets23a,24a,23b,24bmakes it appear as though there are four separate magnets within each of the magnet assemblies22a,22b, only two magnets23a,24aare shown within the magnet assembly22aand only two magnets23b,24bare shown within the magnet assembly22b.

As shown inFIGS. 2 and 3, the magnets23a,24ahave opposing faces27aand28aand the magnets23b,24bhave opposing faces27band28b. The faces28aof the magnets23a,24adisposed within the jacket26aof the first magnet assembly22ahave a magnetic attraction to the faces28bof the magnets23b,24bdisposed within the jacket26bof the second magnet assembly22b. Preferably, one of the faces28aof the magnets23a,24ais north pole and the other is south pole. Similarly, one of the faces28bof the magnets23b,24bis north pole and the other is south pole, the north pole face28aconfigured to mate with the south pole face28band the south pole face28aconfigured to mate with the north pole face28b. Alternatively, both faces28aof the magnets23a,24amay be north pole and both faces28bof the magnets23b,24bmay be south pole, or vice versa, in which case either of the two magnets23a,24acan mate with either of the two magnets23b,24b. The magnetic attraction between the magnets23a,24aand the magnets23b,24bcauses the magnet assemblies22a,22bto move toward one another, thereby capturing a portion of the walls10,12between them. The dual magnets aid in alignment and centering of the magnet assemblies22a,22bwith respect to one another.

FIG. 3illustrates the first and second magnet assemblies22a,22bcoming together to compress the two bodily walls10,12therebetween to form an anastomosis between two hollow organs. Due to the magnetic attraction between the two magnet assemblies22a,22b, via the magnets23a,24aand23b,24b, the bodily walls10,12of two adjacent hollow organs may be sandwiched and compressed between the magnet assemblies22a,22b, resulting in ischemic necrosis of the bodily walls10,12to produce the anastomosis. As the magnet assemblies22aand22bare drawn toward one another, the peripheral edge40of the magnet assembly22acontacts the wall10of the viscera and the peripheral edge52of the magnet assembly22bcontacts the wall12of the viscera, bringing the walls10,12together to form the anastomosis.

As best illustrated inFIG. 4, depicting the magnet assemblies22a,22bmagnetically coupled together outside of a body, one of the magnet assemblies22a,22bmay be larger than the other. In this embodiment, the magnet assembly22bis larger than the magnet assembly22a. For example, the jacket26bmay be between about 1 mm and 5 mm longer in the longitudinal direction than the jacket26aand between about 1 mm and 5 mm wider in the lateral direction than the jacket26a. One reason for the difference in the length of the jackets26a,26bis the difference in placement of each jacket26a,26b. For example, if the magnetic anastomosis device20is used to form an anastomosis with the walls of the duodenum17and the stomach16, the larger magnet assembly22bwould be placed in the stomach16and the smaller magnet assembly22awould be placed in the duodenum17.

In one embodiment, as shown inFIG. 1, the magnets23a,24a,23b,24bare circular including an outer periphery having a radius of curvature. In this embodiment, the elongate jackets26a,26bhave two side portions31joined by two curved portions33, each of which has a radius curvature substantially the same as the radius of curvature of the outer peripheries of the magnets23a,24aand23b,24bdisposed within the respective jackets26a,26b.

The magnets23a,24a,23b,24bcan be circular, cubular, cylindrical, polygonal, oval or ovoid, square, rectangular or the like as long as they are dimensioned to fit within the jackets26a,26b. Preferably, each magnet23a,24a,23b,24bhas a general disc shape (i.e., has an axial height which is less than the outer diameter) with an outer diameter in the range of about 5 mm to about 20 mm, and more preferably in the range of about 12 mm to about 18 mm.

The magnets23a,24aand23b,24bare preferably a rare-earth magnet, such as Neodymium-iron-boron, cobalt, etc. The jackets26a,26bare preferably formed from a nonferrous metal which is press fit or adhesively coupled to the magnets23a,24a, and23b,24b. In one example, the jackets26a,26bare formed from stainless steel. The jackets26a,26bmay also be formed from any suitable plastic known in the art. The magnet assemblies22a,22bmay include a protective coating which may be formed of various materials such as polymers like Teflon® or Paralene® for protection of the magnets23a,24aand23b,24bfrom the corrosive effects of digestive acids or other bodily fluids depending upon the bodily structure involved.

WhileFIGS. 1-4depict each magnet assembly22a,22bhaving two magnets23a,24aand23b,24b, a magnet assembly may include three or more magnets without falling beyond the scope of the present invention. For example, as shown inFIG. 5, the magnet assembly122ahas three magnets including a first magnet123a, a second magnet124a, and a third magnet136adisposed therebetween, all of which are encased within the elongate jacket126a. A magnet assembly122ain accordance with the teachings of the present invention may comprise more than three magnets, however, as the number of magnets within each magnet assembly122aincreases, the length of the elongate jacket126aincreases, affecting the comfort and ease of delivery of the magnet assembly within the patient. Thus, it may be desirable to use smaller magnets in magnet assemblies having three or more magnets.

By using an elongate magnet assembly22a,22bwith at least two magnets in each assembly, a larger anastomosis or opening can be formed while assuring proper orientation of one magnet assembly relative to the other. At the same time, the lateral width still allows the assemblies22a,22bto be placed perorally, as discussed later herein. Accordingly, the length of each jacket26a,26bdepends upon the size and number of magnets23a,24aand23b,24bwithin each respective magnet assembly22a,22b. Each jacket26a,26bmay have a major axis (longitudinal dimension) in the range of about 12 mm to about 60 mm and a minor axis (lateral dimension) in the range of about 6 mm to about 22 mm. In one preferred embodiment, each jacket26a,26bincludes two magnets23a,24aand23b,24b, respectively, and has a major axis in the range of about 26 mm to about 36 mm and a minor axis in the range of about 12 mm to about 18 mm.

Referring toFIG. 6, a magnetic anastomosis device220constructed in accordance with the teachings of the present invention is illustrated without magnets disposed within the magnet assemblies222a,222b.FIG. 6illustrates an embodiment of the invention having a description similar to that ofFIGS. 1-4and in which similar components are denoted by similar reference numerals increased by 200. As shown, each magnet assembly222a,222bincludes a respective elongate jacket226a,226b, each of which includes a body portion245having opposing planar surfaces242,244and a peripheral surface246extending therebetween. The planar surface244of the magnet assembly222band the planar surface242of the magnet assembly222aare shown inFIG. 6. In this embodiment, each body portion245includes two cavities248formed therethrough for receiving magnets therein and a third cavity250formed therethrough and disposed in between the cavities248, providing a larger gap225separating the magnets. The cavities248may be formed by any suitable means in the art and may comprise a circular shape, as shown, or any other suitable shape configured to accommodate the magnets (not shown). The magnets (not shown) are configured to be received within the cavities248such that they are flush with the planar surfaces242,244of their respective jacket226a,226b.

In this embodiment, the cavity250does not receive a magnet therein. Rather, the cavities250of the jackets226a,226bare left open such that when the magnet assemblies222a,222bare in alignment the cavities250define a through-hole to create an immediate anastomosis. In one example, once the magnet assemblies222a,222bhave mated, and the cavities250are aligned, a needle is disposed through the cavities250of the magnet assemblies222a,222b, and thus through the tissue disposed within the cavities250, and a wire guide is disposed through the needle. The needle may be removed, leaving the wire guide in place. Thereafter, a dilation balloon may be positioned therein and the balloon may be dilated to form an opening in the tissue. Alternatively, a cutting device, e.g., an electro-cautery device or a cutting forceps, may be inserted within the cavities250to cut the tissue disposed therein to form the immediate anastomosis. The cavity250may be formed by any suitable means in the art and may comprise a rectangular shape, as shown, or any other suitable shape for receiving an appropriate medical device therein to form an opening within the tissue disposed therein.

As further illustrated inFIG. 6, the peripheral surface246of the magnet assembly222bprotrudes beyond the planar surface244to define a peripheral rim262. Although not visible inFIG. 6, the peripheral surface246of the magnet assembly222apreferably protrudes beyond the planar surface242. Additionally, the peripheral surface246of each magnet assembly222a,222bpreferably protrudes in the opposite direction beyond the opposing planar surfaces (the planar surface opposing the planar surface242of magnet assembly222aand the planar surface opposing the planar surface244of magnet assembly222b). Further, each jacket226a,226bincludes a series of transverse holes260formed therethrouh along a longitudinal axis of each jacket226a,226b. These holes260align with transverse holes formed through the magnets (not shown) that are configured to be received within the jackets226a,226bso as to define a lumen which extends through each of the magnet assemblies222a,222bfor receiving a wire guide or a suture used in positioning of the magnetic anastomosis device220, an example of which will be discussed in further detail below.

FIG. 10illustrates a magnetic anastomosis620device constructed in accordance with further teachings of the present invention having a description similar to that ofFIG. 6, in which similar components are denoted by similar reference numerals increased by 400. Each magnet assembly622a,622bincludes a respective elongate jacket626a,626b, each of which includes a body portion645having opposing planar surfaces642and644and a peripheral surface646extending therebetween. In this embodiment, each body portion645includes two cavities formed therethrough for receiving magnets623a,624a,623b,624btherein and a third cavity650formed therethrough and disposed in between the magnets623aand624aof the magnet assembly622a, and in between the magnets623band624bof the magnet assembly622b. The magnets623a,624a,623b,624bare sized to be received within the cavities of each body portion645such that they are flush with the planar surfaces642,644of their respective jacket626a,626b.

As shown inFIG. 10, the peripheral surface646of each jacket626a,626bprotrudes beyond the planar surfaces642,644to define a peripheral rim662. In this embodiment, one magnet assembly622ais smaller than the other magnet assembly622b. The smaller magnet assembly622ais sized and configured to fit within the space defined by the peripheral rim662of the larger magnet assembly622b, as depicted inFIG. 10. Thus, when the magnet assemblies622a,622bcome together by virtue of their magnetic attraction to compress the two bodily walls10,12, the peripheral rim662of the larger magnet assembly622bwill ensure that the smaller magnet assembly622ais centered relative to the larger magnet assembly622a. Accordingly, the smaller magnet assembly622ais designed to nest within the larger magnet assembly622b, the peripheral rim662of the larger magnet assembly622baiding in self-centering alignment, eventually producing the anastomosis by ischemic necrosis. Each of the jackets626a,626bpreferably includes a series of transverse holes (not shown), like the holes260ofFIG. 6, to define a lumen which extends through each of the magnet assemblies622a,622bfor receiving a wire guide or a suture used in positioning of the magnetic anastomosis device620.

Referring toFIG. 7, a magnetic anastomosis device constructed in accordance with further teachings of the present invention is illustrated therein and designated at320.FIG. 7illustrates an embodiment of the invention having a description similar to that ofFIGS. 1-4and in which similar components are denoted by similar reference numerals increased by 300. In this embodiment, the cavities348formed within the body portion345of at least one of the jackets326a,326bof the respective magnet assemblies322a,322bare formed through only one of the planar surfaces342or344. As illustrated inFIG. 7, the cavities348of the jackets326a,326bare formed through the planar surface342and the magnets323a,324a,323b,324bare disposed on the surface at the bottom of the cavity348formed within the body portion345.

In this embodiment, the magnets323a,324aare disposed within the cavities348of the jacket326asuch that the faces328aof the magnets323a,324aprotrude beyond the planar surface342approximately 1 mm, thus defining a peripheral recess350. As shown inFIG. 7, the cavities are dimensioned such that, with the magnets323b,324bdisposed therein, the peripheral surface346of the magnet assembly322bprotrudes approximately 1 mm above each of the faces328b(i.e., the planar surface342of the jacket326bis spaced approximately 1 mm from the faces328bof the magnets323b,324b), thus defining a peripheral edge352.

InFIG. 7, the magnet assemblies322aand322bcome together to compress the two bodily walls10and12therebetween to form the anastomosis. As the magnet assemblies322aand322bare drawn toward one another, each of the cavities348formed within the magnet assembly322bis sized to receive a portion of the face328aof one of the magnets323a,324aof the magnet assembly322a. In particular, when the magnet assemblies322a,322bare delivered, the faces328aof the magnets323a,324aof the magnet assembly322acontact the wall10of the viscera and the peripheral edge352contacts the wall12of the adjacent viscera and helps to initiate the ischemic necrosis of the tissue captured between the first and second magnet assemblies322a,322b. The space or gap325aprovided between the magnets323a,324aof the first magnet assembly322ahelps to trap tissue between the magnet assemblies322a,322bto promote tissue necrosis.

It is also within the scope of the present invention for the magnets323a,324aand323b,324bto be disposed within respective jackets326a,326bsuch that the faces328a,328bare flush with the planar surfaces242of each of the respective jackets326a,326b.

Referring toFIGS. 8a-b, a magnetic anastomosis device constructed in accordance with further teachings of the present invention is illustrated therein and designated at420.FIGS. 8a-billustrate an embodiment of the invention having a description similar to that ofFIGS. 1-4and in which similar components are denoted by similar reference numerals increased by 400. In this embodiment, the magnetic anastomosis device includes a suture464which aids in the delivery of device as will be described in more detail below. The suture464is disposed through a lumen475formed through one of the magnet assemblies422b(i.e., formed through the jacket426band the magnets423b,424bencased therein). The ends of the suture464are joined by an end member465. As discussed in greater detail below, during positioning of the device420, the end member465may be grasped to manipulate the positioning of the magnetic assembly422brelative to the magnetic assembly422a. It is noted that the suture464may be attached to the jacket426bby any other suitable means known in the art. The suture464may comprise stainless steel wire or any suitable biocompatible suture material or rope known in art and preferably has a length a little over two times the length of the jacket426bso that the ends can be joined together by the end member465with enough slack to be capable of being grasped by a medical grasping device.

Turning now toFIGS. 9a-b, a delivery system568for delivering a magnetic anastomosis device in accordance with the teachings of the present invention is illustrated. The delivery system568is shown with the magnet assembly422bof the magnetic anastomosis device420ofFIGS. 8a-b, however, the delivery system568may be used to deliver any magnetic anastomosis device in accordance with the teachings of the present invention. The delivery system568uses a catheter570and a wire guide572to deliver the magnet assemblies422a,422b. As shown inFIGS. 9aand9b, the catheter570has two holes, a proximal hole574and a distal hole576through which the wire guide572is placed. The proximal574and distal576holes are sufficiently spaced apart to accommodate one of the magnet assemblies422bbetween them. The holes574,576are about 25 mm to about 100 mm apart or any subcombination of ranges therein. The preferred distance between the holes574,576will depend on the length, or major axis, and size of the magnet assemblies422a,422b. These holes574,576are located in the distal part of the catheter570and are appropriately spaced to accommodate magnet assemblies422a,422bof various sizes in length. The location of the holes574,576in the wire guide lumen may be modified as required to accommodate the various sizes of the magnet assemblies422a,422b, examples of which are provided above. It is noted that the catheter570may include more than one lumen, for example, the catheter570may include a second lumen for the insertion of a medical grasping instrument or for the insertion of contrast media.

As provided above, for use with this delivery system, the magnet assemblies422a,422binclude a lumen475formed therethrough to accommodate the wire guide572. Thus, the jackets426a,426band each of the magnets423a,424a, and423b,424bdisposed within respective jackets426a,426bhave a transverse hole formed therethrough. The holes formed through the magnets423a,424aand the jacket426aare aligned and the holes formed through the magnets423b,424band the jacket426bare aligned in order to receive the wire guide572through the magnet assembly422a,422b. In this embodiment, one of the magnet assemblies422a,422bincludes a suture464to aid in the positioning of the magnet assembly422bwith respect to the other magnet assembly422a. The suture464is disposed through the lumen475, which is the same lumen through which the wire guide572is received. Thus, the lumen475of the magnet assembly422bis sized and configured to receive both the suture464and the wire guide572. Alternatively, the magnet assembly422bmay include two separate lumens, one for the wire guide572and another for the suture464.

A radiopaque marker578is placed on the catheter570in the vicinity of the magnet assembly422bto mark the magnet assembly422blocation when viewed through fluoroscopy. A radiopaque marker578can be placed underneath the magnet assembly422bon the catheter570to mark the location of the magnet assembly422bwhen viewing the delivery system from the side.

The wire guide572holds the magnet assembly422bin place on the distal end of the catheter570. InFIGS. 9aand9b, the wire guide572is shown protruding from the proximal hole574, going through the lumen475of the magnet assembly22b, and re-entering the catheter570at the distal hole576. The wire guide572and the catheter570may include radiopaque markers578that permit tracking of the delivery system for accurate positioning of the magnet assembly422b. It may be preferred that a radiopaque marker578be placed immediately distal to the magnet assembly422b. The catheter570may be used alone or in conjunction with other wire guide cannulae for navigation of the bodily lumens and delivery of a magnet assembly.

It will be recognized by those skilled in the art that the magnetic anastomosis device20employing the magnet assemblies22a,22bdescribed herein not only preserves the benefits of improving the time of the procedure to place the magnet assemblies22a,22b, but further provides a small delivery configuration which may be easily located within the body for accurate delivery. The delivery systems described herein also provide for insertion of the magnet assemblies22a,22bthrough natural orifices. As such, there is also a method for delivering the magnet assemblies22a,22bto a position for forming an anastomosis between two viscera.FIG. 11shows the relative positions of several viscera in the abdominal cavity, including the gall bladder14, the common bile duct15, the stomach16, the duodenum17, and the jejunum18of the small intestine. Although not shown, the delivery system568described herein can also be used to implant anastomosis-forming magnet assemblies in the colon for possible use in gastric bypass procedures. The delivery system568described herein can be used, for example, to create an anastomosis between the stomach16and the jejunum18of the small intestine. The delivery system568can also be used as a part of procedure where forceps are used to place one of the magnet assemblies.

A method for delivering a magnet assembly to form an anastomosis comprises introducing the delivery system568into an endoluminal vessel.FIG. 11shows the system568being advanced to the jejunum18. The delivery of the magnet assembly422afollows once the wire guide572has been positioned adjacent the first wall10of a first viscus. InFIG. 11, the first viscus is the jejunum18. The magnet assembly422ais placed on the catheter570as shown inFIGS. 9aand9band held in place on the catheter570by the wire guide572. The wire guide572is loaded through the catheter570, passing through distal hole576in the catheter570lumen, through the lumen475of the magnet assembly422a, and then reentering the catheter570lumen through proximal hole574. Using the radiopaque markers578as a guide, the catheter570is advanced such that the magnet assembly422ais placed adjacent to the wall10of the jejunum18as shown inFIG. 12.

The delivery system568with magnet assembly422aremains in position as a second delivery system569is introduced into the stomach16as shown inFIG. 12. The magnet assembly422bis positioned adjacent the wall12of the stomach16that borders the jejunum18near the location of the magnet assembly422a. The magnetic forces of the magnets423a,424aand423b,424bdisposed therein attract the magnet assemblies422a,422btogether, compressing the walls10,12together of the jejunum18and the stomach16. To release the magnet assemblies422a,422b, the operator removes the wire guide572and then the catheter570. As described in more detail above,FIG. 3illustrates an enlarged view of a magnetic anastomosis device20compressing the walls10,12together.

The magnetic forces of the magnets423a,424aand423b,424bdraw the magnet assemblies422a,422btoward one another, preferably so that each of the magnets432aand424aopposes one of the magnets423band424b. In the instance where the magnet assemblies422a,422bdo not align in this fashion, for example, inFIGS. 8aand8b, where only one of the magnets424bof the magnet assembly422bopposes only one of the magnets423a(not shown) of the magnet assembly422a, the suture464may be used to place the magnet assemblies422a,422bin proper alignment. In this fashion, a grasping forceps or any other suitable medical grasping device (not shown) may be used to manipulate the magnet assembly422brelative to the magnet assembly422aby grasping the end member465of the suture464and either pulling, pushing, or rotating the magnet assembly422brelative to the magnet assembly422ato place the magnet assemblies422a,422bin proper alignment.

The radiopaque markers578can be used as a guide to help position the magnet assemblies422a,422bin the correct orientation under fluoroscopy. As will be recognized by those skilled in the art, placement of the magnet assemblies422a,422bmay be aided by fluoroscopy, ultrasound, fiber optic imaging or other well known guidance techniques.

Once the necrosis of the walls10,12of the jejunum and the stomach is complete, an anastomosis is formed. The magnet assemblies422a,422bcan then pass through the body naturally or can be removed by means such as laparotic removal, endoscopic removal, or other procedure.

It will be recognized by those skilled in the art that the larger, elongate magnet assemblies22a,22bof the present invention are capable of being delivered with the same small delivery configuration as prior art magnet assemblies, but also provide the advantage of reducing the probability of the anastomosis being closed over time and eliminating the need to intervene the patient for a second procedure to place a stent in the anastomosis to prevent closure thereof. Moreover, those skilled in the art will recognize the centering and alignment advantages of having two magnets23a,24aand23b,24bdisposed within each of the respective magnet assemblies22a,22b.

It will be recognized by those skilled in the art that, while the devices and methods described above generally include placing the devices in tissue through an internal bodily lumen, it will be recognized that the systems, devices and methods may be used on any layer of material (e.g. fabrics, cloth, polymers, elastomers, plastics and rubber) that may or may not be associated with a human or animal body and a bodily lumen. For example, the systems, devices and methods can find use in laboratory and industrial settings for placing devices through one or more layers of material that may or may not find application to the human or animal body, and likewise forming/connecting holes or perforations in layers of material that are not bodily tissue. Some examples include sewing or stitching and related manufacturing, working with synthetic tissues, connecting or repairing polymeric sheets, animal studies, veterinary applications, and post-mortem activities.