ANASTOMOTIC DEVICE

[0001] The various embodiments relate generally to surgical devices for forming an anastomosis between organs, and more particularly, to devices that can be inserted through a natural orifice in the body and used to form an anastomosis between various gastrointestinal organs.

[0002] Access to the abdominal cavity may be required, from time to time, for diagnostic and therapeutic endeavors for a variety of medical and surgical procedures. Historically, abdominal access has required a formal laparotomy, e.g., abdominal surgery through a surgical incision made in the wall of the abdomen to provide adequate exposure. Such procedures, however, require incisions to be made in the abdomen and may not be particularly well-suited for patients having extensive abdominal scarring from previous procedures, persons who are morbidly obese, individuals with abdominal wall infection, and patients with diminished abdominal wall integrity, such as patients with burns and skin grafting. Other patients simply do not want to have a scar if it can be avoided.

[0003] Such conventional open surgical procedures also are employed to address various problems occurring in the gastrointestinal tract, such as the stomach, duodenum, bile duct, jejunum (a portion of the small intestine), colon, ileum, or bowels. Surgical procedures in the gastrointestinal tract are generally performed to treat obese patients, e.g., to decrease absorption of nutrients, and to treat blockages, obstructions, or strictures in the gastrointestinal tact. Blockages, obstructions, or strictures may occur in the duodenum, bile duct, jejunum, or bowels from disease processes such as malignant or benign cancers or tumors and may be treated by using stents or creating an anastomosis between organs in the gastrointestinal tract.

[0004] Conventional surgical procedures are employed to insert stents within a blocked, obstructed, or narrowed viscus to provide palliative relief. The stents are located within the viscus to restore or provide some degree of drainage of fluid through the blocked, obstructed, or narrowed viscus. A limitation of stents is the tendency of occlusion and cholangitis resulting from the development of bacterial biofilm. Plastic stents provide a relatively narrow luminal size and therefore lead to a high occlusion rate. Metal expandable stents, despite having significantly increased patency and longer life than plastic stents, also are prone to occlusion and are extremely expensive. Stents may be located within the bile duct, for example, to provide palliative relief of obstructive jaundice resulting from blockages occurring in the bile duct. Rather than stenting the obstruction, creating a permanent fistula of larger diameter than the bile duct between the bile duct and the duodenum provides greater drainage of bile. Therefore, there is a need to provide a new method and apparatus for forming a biliary duodenal anastomosis. There is also a need for a new method and apparatus for forming a biliary drainage anastomosis by forming a choledochoduodenostomy above the ampulla.

[0005] Anastomosis is the joining of luminal structures within the body by way of collateral channels when the natural channels are blocked. Common examples are colonic anastomosis in which two portions of the colon are joined together. The anastomosis may be formed between various organs in the gastrointestinal tract. A gastro-jejunostomy anastomosis may be created between the stomach and the jejunum to treat blockages in the duodenum or for malabsorption, e.g., gastric bypass surgery. An entero-enteral anastomosis may be created for jejuno-jeunal bariatric purposes, a colon to ileum anastomosis may be created for bypassing colorectal cancer, and a biliary duodenal anastomosis may be created between the bile duct and the duodenum above a malignant or benign obstruction in the bile duct. Some anastomoses are created using compression techniques. Certain procedures also may require large openings in the bowel wall. Anastomoses also may be formed using linear staplers and require two large centimeter sized holes to be formed in the patient. Thus, most gastrointestinal anastomoses are created using open surgical procedures requiring the patient to be placed under general anesthesia and large incisions in the abdominal wall. Attendant disadvantages of such open surgical procedures include the necessity for general anesthesia, increased post-operative pain, intra-abdominal adhesions, as well as in-patient hospitalization with associated inconvenience and costs.

[0006] Some anastomoses may be created by compression or sutureless techniques. A compression anastomosis is formed by necrotic ischemia caused by the occlusion of the blood supply to the tissue. Compression is applied to the tissue using one or more masses to sandwich the tissue in the target area. One compression anastomosis technique employs a compression button that erodes through the bowel wall over several days because of ischemic necrosis resulting in a leak free anastomosis. Another sutureless compression anastomosis technique employs a bio-fragmentable ring to create an anastomosis in the bowel. This technique compared favorably to sutured and stapled anastomosis. Other anastomoses may be created using flexible endoscopy techniques employing spring compression buttons. Flexible endoscopy anastomosis techniques may employ ultrasonography techniques when access is limited to a single endoscopic lumen. Magnets also have been used to form compression anastomoses when access is possible to both transgastric lumens or by passing a device through the jejunum. Magnetic compression gastroenteric anastomosis may be performed by introducing magnets perorally with endoscopic and fluoroscopic guidance and mated across the gastric and jejunal walls. Compression anastomosis may be formed between bile ducts using magnets following duct stenosis in liver transplant patients. In addition to suffering from the limitations discussed above, current open, laparoscopic, and endoscopic surgical techniques fail to provide a convenient way for inserting a distal mass into the gastrointestinal tract and are generally incapable of applying sufficient mass and force to accomplish a clinically acceptable compression anastomosis.

[0007] Therefore, there is a need for an alternative to conventional surgery that eliminates abdominal incisions and incision-related complications to diagnose and treat abdominal pathology. There is a need for a new method and apparatus for forming a compression anastomosis. Also, there is a need for a surgical method and apparatus for forming an anastomosis between luminal structures or organs using a minimally invasive surgical technique. More particularly, there is a need for a surgical apparatus for forming anastomosis between various gastrointestinal organs that can be inserted through a natural orifice in the body using a minimally invasive surgical technique. Further, there is a need for a surgical apparatus that can be introduced into the stomach through the mouth for creating clinically acceptable compression anastomosis between the stomach and the jejunum, the colon and the ileum, and/or the bile duct and the duodenum (e.g., biliary-duodenal anastomosis) using minimally invasive surgical techniques. The foregoing discussion is intended only to illustrate some of the shortcomings present in the field at the time, and should not be taken as a disavowal of claim scope.

[0008] In one embodiment, an apparatus includes an anastomotic portion comprising a first end and a second end. At least one flexible portion protrudes from the first end of the anastomotic portion. The at least one flexible portion comprises a first articulation node located at a predetermined distance from the first end of the anastomotic portion. The articulation node enables the at least one flexible portion to move relative to the anastomotic portion.

[0036] Various embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments and that the scope of the various embodiments is defined solely by the claims. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the claims.

[0037] It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician manipulating an end of an instrument that protrudes out of the mouth of the patient. The term “proximal” refers to the portion closest to the surgeon and the term “distal” refers to the portion located away from the surgeon. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0038] The various embodiments generally provide methods and devices for creating anastomosis at various sites, e.g., target areas or tissue treatment regions, in the gastrointestinal tract. The devices may be introduced via natural orifices and may be combined with trans-organ techniques. In one embodiment, a Natural Orifice Translumenal Endoscopic Surgery (NOTES)™ techniques may be employed to introduce instruments into the patient and carry out the various procedures described hereinbelow. A NOTES™ technique is a minimally invasive therapeutic procedure that may be employed to treat diseased tissue through a natural opening of the patient without making incisions in the abdomen. A natural opening may be the mouth, anus, and/or vagina. Medical implantable instruments may be introduced into the patient to the target area via the natural opening. In a NOTES™ technique, a surgeon inserts a flexible endoscope into one or more natural openings of the patient to view the target area using a camera. During endoscopic surgery the surgeon inserts surgical devices through one or more lumens or working channels of the endoscope to perform various key surgical activities (KSA). These KSAs include forming an anastomosis between organs, and more particularly, forming anastomosis between gastrointestinal organs with devices that can be inserted through a natural opening of the body.

[0039] Although various embodiments described herein refer to for creating an anastomosis between the duodenum and the bile duct by accessing those organs through the mouth and esophagus of a patient, those of ordinary skill in the art will readily appreciate that unique and novel aspects of the various embodiments could be successfully employed in connection with forming anastomosis between other organs by gaining access thereto through other natural openings such as the anus, or the vagina, for example, without departing from the scope of the appended claims.

[0040] FIG. 1 is a diagrammatical view illustrating one embodiment of a minimally invasive surgical device introduced into a natural opening of a patient. In the illustrated embodiment, an endoscope 10 comprising a flexible shaft 12 is introduced into the mouth 14, though the esophagus 16, and into the stomach 18 of a patient 8. The flexible shaft 12 may be passed through a per-oral overtube (a plastic tube of varying length) to protect the esophagus 16 when the flexible shaft 12 of the endoscope 10 is introduced into the patient 8. From the stomach 18, a distal end 26 of the flexible shaft 12 of the endoscope 10 is inserted in the duodenum 20. From the duodenum 20, an anastomotic device may be introduced into a portion of the biliary tree 22 through the sphincter of Oddy ampullary opening 28. In one embodiment, the endoscope 10 may be a side-viewing or front-viewing endoscope. In one embodiment, the endoscope 10 could be used in an endoscopic retrograde cholangio-pancreatography (ERCP) technique to access and image the bile duct 24 endoscopically. In an ERCP technique, a catheter is introduced through the opening 28 of the bile duct 24 from the duodenum 20 via a working channel of a side-viewing flexible ERCP endoscope 10 under X-Ray or fluoroscopic guidance.

[0041] FIG. 2 illustrates a partial cross-sectional view of the duodenum 20, the bile duct 24, and the pancreatic duct 30. The biliary tree 22 connects the gall bladder 21 and the liver (not shown) to the duodenum 20 through the opening 28. The bile duct 24 and the pancreatic duct 30 enter the descending duodenum 20, commonly known together as the hepatopancreatic duct (or pancreatic duct), through the major duodenal papilla 29 and the common orifice 28. The bile duct 24 and the pancreatic duct 30 are in fluid communication with the duodenum 20 through the common opening 28. An anastomotic device may be introduced into the bile duct 24 through the opening 28 after cannulation of the bile duct 24 with the distal end 26 of the endoscope 10. Biliary cannulation and placement of an anastomotic device may be accomplished with both standard forward viewing and side-viewing endoscopes, for example.

[0042] FIGS. 3-5 illustrate one embodiment of an apparatus for forming a compression anastomosis. In the illustrated embodiment, an anastomotic device 32 comprises a general longitudinal tubular structure suitable for positioning within a hollow viscus to drain fluid through a central lumen to palliate an obstruction within the hollow viscus. The anastomotic device 32 may be introduced into a hollow viscus using a flexible endoscope over a guide-wire and can be pushed into position with a catheter or pusher tube. In one embodiment, the anastomotic device 32 is shaped like a thin flexible catheter that can be inserted into the hollow viscus requiring anastomosis. The positioning of the anastomotic device 32 may be conducted under direct vision with an endoscope. The anastomotic device 32 may be introduced into the hollow viscus of the bile duct 24 through the opening 28 after the bile duct 24 is cannulated with the distal end 26 of the endoscope 10. Once positioned in the bile duct 24, the anastomotic device 32 performs the function of a biliary stent to palliate a blockage, obstruction, or stricture in the bile duct 24. The anastomotic device 32 also comprises articulation nodes that enable flexible portions of the anastomotic device 32 to move relative to other more rigid portions of the anastomotic device 32. When the flexible portions of the anastomotic device 32 are in flexion, the anastomotic device 32 can pass through the anastomosis once it is formed.

[0043] In one embodiment, the anastomotic device 32 comprises a first portion 36 having a first and second end. In one embodiment, at least a first flexible portion 38a protrudes from one end. In another embodiment, the anastomotic device 32 may comprise a second flexible portion 38b protruding from the other end. The first portion 36 is generally substantially rigid relative to the first and second flexible portions 38a, b, although in some embodiments, the first portion 36 may be formed of flexible materials. In one embodiment, the first and second flexible portions 38a, b may be fastened, linked, associate together, joined, connected, or attached to the first portion 36. In another embodiment, the first and second flexible portions 38a, b may be formed integrally with the first portion 36 as a continuous component. For conciseness and clarity, the first portion 36 is referred to herein as the anastomotic portion 36. The anastomotic portion 36 comprises an anastomotic surface, which is defined as the portion of the anastomotic device 32 that contacts one side of the tissue to be anastomosed. In the illustrated embodiment, the anastomotic portion 36 is in fluid communication with the first flexible portion 38a on one end and is in fluid communication with the second flexible portion 38b on the other end. In other words, in one embodiment, the anastomotic portion 36 is located between the first and second flexible portions 38a, b and the three portions are in fluid communication by way of a central lumen 34 for conducting fluid. In the illustrated embodiment, the anastomotic portion 36 and the first and second flexible portions 38a, b have a generally cylindrical form with the central lumen 34 fluidically coupling the three portions to conduct fluid therethrough. In one embodiment, the central lumen 34 may be eliminated and the anastomotic device 32 may be comprised of a solid material. This embodiment may be employed in applications that do not require fluid to be drained through the anastomotic device 32.

[0044] In one embodiment, the anastomotic portion 36 may be formed of any one of a ferrous, magnetic, or paramagnetic material. It will be appreciated by those skilled in the art that paramagnetism is a form of magnetism which occurs only in the presence of an externally applied magnetic field. Accordingly, paramagnetic materials are attracted to magnetic fields, and hence have a relative magnetic permeability greater than one (or, equivalently, a positive magnetic susceptibility). In other embodiments, the anastomotic portion 36 may comprise magnets or magnetic material attached thereto. In other embodiments, the anastomotic portion 36 may be formed of non-ferrous material having magnets formed integral therewith or attached thereto. In various other embodiments, the anastomotic portion 36 may be formed of ferrous, magnetic, or paramagnetic material. In various embodiments, the anastomotic portion 36 may be formed of quaternary Iron, Neodymium, Iron, Boron, and/or Samarium materials. In one embodiment, the anastomotic portion 36 may be encased in a protective plastic. In one embodiment, the anastomotic portion 36 may comprise a coating such as plated Chromium. In one embodiment, the first portion 36 also may be formed of rubber plastic magnetic strips which may be flexible. In various embodiments, the rubber magnetic strips may be formed by incorporating Neodymium, Iron, and/or Boron particles in a rubber or plastic material.

[0045] In one embodiment, the first and second flexible portions 38a, b are formed of flexible tubular plastic material. The plastic tubes may be formed of a polymeric material such as polyethylene. The first and second flexible portions 38a, b may be tapered or untapered. In one embodiment, the flexible portions 38a, b may be tapered towards the free end to aid introduction of the anastomotic device 32 into the hollow viscus. In one embodiment, a conical element may be attached to either one or both of the first and second plastic portions 38a, b to assist introduction of the anastomotic device 32 in a narrow opening. The conical element may comprise a lumen to conduct fluid therethrough. In one embodiment, the first and second flexible portions 38a, b may be hollow plastic tubes or may be a solid material.

[0046] Each of the first and second flexible portions 38a, b comprise articulation nodes 40a, b situated at some distance from either end of the anastomotic portion 36. Each of the articulation nodes 40a, b forms a movable joint between the anastomotic portion 36 and each of the flexible portions 38a, b. One or both of the flexible portions 38a, b may comprise the articulation nodes 40a, b to enable the flexible portions 38a, b of the anastomotic device 32 to move relative to the anastomotic portion 36 and allowing a limited angle of rotation between the anastomotic portion 36 and the flexible portions 38a, b. The articulation nodes 40a, b enable the flexible portions 38a, b to move (e.g., flex, rotate over a limited angle, fold, bend, buckle, collapse, deform, or otherwise change shape) relative to the anastomotic portion 36. For example, the articulation nodes 40a, b enable the flexible portions 38a, b to move from a continuous longitudinally extending tube to a “U-shaped” tube. In flexion, the anastomotic device 32 can fall through the anastomosis. In the illustrated embodiment, the articulation nodes 40a, b are formed as weaknesses on the flexible portions 38a, b. The substantially elongated tubular first and second flexible portions 38a, b bend, collapse, or deform at the articulation nodes 40a, b when the anastomotic portion 36 is magnetically coupled to a larger mass to enable the anastomotic device 32 to fall through a mature anastomosis toward the side having a larger mass. In the embodiments illustrated in FIGS. 15-26, for example, the articulation nodes 40a, b form a collapsible biliary anastomotic device 32 to create a compression anastomosis between the biliary tree 22 and the duodenum 20. The first and second flexible portions 38a, b begin to move as the anastomosis matures and the anastomotic portion 36 is magnetically attracted to a larger mass and falls through the compression anastomosis leaving a fistula above the papilla 29. In other embodiments, the articulation nodes 40a, b may be formed such that the flexible portions 38a, b fall apart or release from the anastomotic portion 36 after the anastomotic device 32 is positioned within the hollow viscus, e.g., the bile duct 24.

[0047] In the illustrated embodiment, the central lumen 34 extends along a longitudinal axis A. The central lumen 34 is suitable for conducting fluid within the hollow viscus during the period required for the translumenal anastomosis to mature. For example, in one application, the anastomotic device 32 may be positioned in the bile duct 24 across an area of obstruction to form a biliary duodenal anastomosis. While the anastomosis matures (generally a few days), the central lumen 34 drains bile from the bile duct 24 to the duodenum 20.

[0048] The anastomotic device 32 also may comprise serrations to retain the anastomotic device 32 positioned within the hollow viscus to minimize the opportunity of the anastomotic device 32 falling out of the hollow viscus. The serrations also may serve to control how far the anastomotic device 32 can be introduced into the hollow viscus. In one embodiment, the anastomotic device 32 may comprise a proximal thread, which can be grasped with a clamp-like end effect or introduced through the working channel of the endoscope 10, to retract the anastomotic device 32 in case it is pushed too far within the hollow viscus.

[0049] FIGS. 6-8 illustrate one embodiment of a surgical instrument for forming a compression anastomosis. In the illustrated embodiment, an anastomotic device 42 comprises at least one anastomotic portion 46 and the at least one flexible portion 38a. The anastomotic portion 46 may be formed of ferrous or non-ferrous materials and may comprise at least one magnet 48 attached thereto. In the illustrated embodiment, the anastomotic portion 46 comprises a plurality of magnets 48 and is sandwiched between the first and second flexible portions 38a, b as described above with reference to FIGS. 3-5. In one embodiment, the magnets 48 may be discrete magnets embedded and spaced apart in plastic to allow the anastomotic portion 46 to bend to a certain degree. In various embodiments, the anastomotic portion 46 also may be formed of magnetic flexible rubber plastic strips, which may be formed by incorporating Neodymium, Iron, and/or Boron particles in a rubber or plastic material.

[0050] In various embodiments, the anastomotic devices 32, 42 may comprise a guide-wire running through the central lumen 34, a second lumen formed through the body portions of the anastomotic devices 32, 42 (e.g., the anastomotic portion 36, the anastomotic portion 46, and the first and second portions 38a, b), or in a tract along the outside the anastomotic devices 32, 42. In one embodiment, the anastomotic devices 32, 42 also may comprise a guide-wire along a portion of its length exiting on the side in a monorail configuration. In one embodiment, the ends of the anastomotic devices 32, 42 may be straight or curled (pigtail) in shape. In one embodiment the anastomotic device 32, 42 also could be impregnated with a drug, for example a chemotherapeutic drug, which could be placed in an obstructed viscus, e.g., a bile duct obstructed from biliary or pancreatic cancer, and deliver treatment to the tumor for several days while the anastomosis is forming. In one embodiment, the anastomotic devices 32, 42 also could be radioactive and be used for treating the tumors of the gastrointestinal tract. In one embodiment, the anastomotic devices 32, 42 also could be biodegradable and reduce the possibility of the magnet and/or anastomotic device 32, 42 assembly getting stuck in the gastrointestinal tract.

[0051] In one embodiment, the anastomotic device 32, 42 may be placed across a tumor and magnetic “seeds” embedded with a chemotherapeutic or radioactive material may be employed to deliver drug or radiation to the tumor. A magnet 50, 60 (FIGS. 9-14) may be subsequently located in the stomach 18 or bowel to form an anastomosis.

[0052] The anastomotic devices 32, 42 may be employed in combination with an external mass, e.g., magnets 50, 60 (FIGS. 9-14), to form a compression anastomosis at a wide range of target areas. The combination of the anastomotic device 32, 42 and the magnet 50, 60 is referred to herein as a magnet assembly 86 (FIGS. 20-26). In the embodiment illustrated in FIGS. 21, 22, and 24-26, an anastomosis 84 is formed by coupling the anastomotic device 42 with the magnet 50 to compress tissue above the ampullary opening 28 between the duodenum 20 and the bile duct 24. In one embodiment, the combination of the anastomotic device 32, 42 and the magnet 50, 60, e.g., the magnet assembly 86, may be employed to form anastomosis using a variety of surgical techniques including, for example, a NOTES™ procedure, a laparoscopy, a or laparotomy. The types of anastomosis that may be formed using the magnet assembly 86 comprised of any combination of the anastomotic devices 32, 42 and the magnets 50, 60 include entero-enteral anastomoses to treat blockages in the bile duct, jejuno-jeunal anastomoses for bariatric purposes, and/or colon to ileum anastomoses for bypassing colorectal cancer, among others. The magnet assembly 86 also may be employed to form biliary duodenal anastomoses between the bile duct 24 and the duodenum 20 above malignant or benign obstructions. The magnet assembly 86 can form anastomoses with a diameter that is much larger than the diameter of a conventional stent. A compression anastomosis formed of epithelialized tissue is not likely to result in a biofilm blockage, which is likely to occur with most conventional stents within a few weeks and thus will require replacement. In other embodiments, the magnet assembly 86 may be employed to form compression anastomoses without making large holes in the intestine. For example, the magnet assembly 86 may be employed to form two holes in the bowel that may be less than 3 mm in diameter. The magnet assembly 86 can be used with flexible instruments to form entero-enteral anastomosis having a length of about 3 mm to about 10 mm.

[0053] The magnetic compression magnet assembly 86 (FIGS. 20-26) also may be used to form anastomoses using an intralumenal endoscope (or radiological) to access the lumen of a first limb of an anastomosis and transgastric gastroscope to access the lumen of a second of the limb of the anastomosis. This may be accomplished by inserting the intralumenal endoscope in the rectum to access the first limb and inserting the transgastric gastroscope into the small intestine through a very small incision (e.g., keyhole, pinhole) and then pushing the gastroscope inside the intestine to connect with magnets held by the intralumenal endoscope. The magnet assembly 86 can be used with flexible instruments to form entero-enteral anastomosis using a double channel endoscope in a NOTES™ procedure.

[0054] FIGS. 9-11 illustrate one embodiment of a magnetic mass for forming a compression anastomosis. Employing a minimally invasive surgical technique, e.g., a NOTES™ procedure, the magnet 50 is introduced into a hollow organ or lumen adjacent to the target area where the anastomosis is to be formed. In one embodiment, the magnet 50 may be introduced into the lumen using an endoscope. In one embodiment, the magnet 50 is placed in the duodenum 20, for example, to work in conjunction with either one of the anastomotic device 32, 42 to form a biliary duodenal compression anastomosis. The magnet 50 is generally cylindrical in shape and may comprise a longitudinal lumen or opening 52. A guide-wire engages the opening 52 to locate the magnet 50 in the target area, e.g., the duodenum 20. In the embodiment illustrated in FIGS. 9-11, the opening 52 is offset from the central axis B. In the embodiment illustrated in FIGS. 12-14, the opening 52 may be centered about a central axis B. In one embodiment, the shape of the magnet 50 or its casing is capsular with radii 54, 56 formed on either end thereof. The rounded capsular geometry enables safe passage of the magnet 50 through the gastrointestinal tract. In one embodiment, the radii 54, 56 may have a substantially equal radius. In one embodiment, the magnet 50 may comprise a coating 65 such as plastic or plated in Chromium to resist corrosion in the body. The magnet 50 may be formed of Neodymium, Iron, Boron, and/or Samarium materials.

[0055] The strength of the magnet 50 should be sufficient to exert an attractive magnetic force to the anastomotic portion 36, 46 across the thickness of the tissue to be anastomosed. As an example, the tissue of the small intestine or colon is approximately 1 mm to 1.5 mm. Thus, in forming an anastomosis between the small intestine and the colon, the strength of the magnet 50 should be sufficient to exert an attractive magnetic force across tissue having a thickness of about 2 mm to about 3 mm. The strength of the magnet 50 should be suitable to exert a sufficient compressive force to tissue positioned (e.g., sandwiched) between the magnet 50 and the anastomotic portion 36, 46 to cause ischemic necrosis of the tissue. The compressive force generated by the magnetic attractive force on the tissue sandwiched between the magnet 50 and the anastomotic portion 36, 46 should be adequate to cause ischemic necrosis, fistulization, and the formation of an anastomosis therethrough. In one embodiment, the tissue compressed between the magnet 50 and the anastomotic portion 36, 46 may be a wall 58 of the bile duct 24 and a wall 68 of the duodenum 20 located just above the papilla 29 (FIGS. 15-26).

[0056] The polarities of the magnet 50 and the anastomotic portion 36, 46 should be oriented to create a suitable attractive magnetic force therebetween. In one embodiment, the anastomotic portion 36 and/or the magnet 50 may have markings indicative of the magnetic poles formed thereon to assist the user orient the devices. The magnet 50 and the anastomotic portion 36, 46 should be oriented to create a suitable attractive force between the magnet 50 and the anastomotic portion 36, 46 to line up and attract along the length of the desired anastomosis.

[0057] With reference now also to FIGS. 2-5, length of the magnet 50 should correspond substantially to the length of the anastomotic portion 36, 46 such that a suitable magnetic field develops therebetween to couple the two components substantially along the length of the anastomotic portion 36, 46 and the magnet 50. In one embodiment, the length of the magnet 50 may be the same as the length of the anastomotic portion 36, 46. In one embodiment, the magnet 50 and the anastomotic portion 36, 46 may be substantially similar.

[0058] In one embodiment, the magnet 50 may be formed as a single magnetic component. In other embodiments, the magnet 50 may comprise a stack of two or more hollow magnets preferably with a flexible tapered introducer. In one embodiment, the magnet 50 may be asymmetrical comprising more massive portions on a particular side to bias the way the combination of the magnet 50 and the anastomotic device 32, 42 falls through the anastomosis. For example, with the anastomotic device 32 located in the bile duct 24, it would be preferable to locate the more massive magnet 50 in the duodenum 20 to bias the anastomotic device 32 and urge it to pass from the wall 58 of the bile duct 24 through the wall 68 of the duodenum 20 and into jejunum and further into the small intestine. If a small intestinal colonic anastomosis is desired, it would be preferable to locate the anastomotic device 32, 42 in the small intestine and to locate a more massive magnet 50 in the colon.

[0059] As shown in FIGS. 17-26, once the anastomosis 84 has matured, the magnet assembly 86 falls into the duodenum 20. The magnetic force between the magnet 50 and the anastomotic portion 46 in combination with the peristaltic force (the squeezing propulsive force from the walls of the duodenum) is sufficient to pull the anastomotic device 42 through the wall 58 of the bile duct 24 and the wall 68 of the duodenum 20. As the magnet assembly 86 falls through the anastomosis 84 into the duodenum 20, the first and second flexible portions 38a, b of the anastomotic device 42 move to enable the magnet assembly 86 to pass through the anastomosis 84 and into the duodenum 20. Subsequently, the magnet assembly 86 is passed through the gastrointestinal tract and exits the body through the anus typically within 72 hours to a week later.

[0060] FIGS. 12-14 illustrate one embodiment of a magnetic mass for forming a compression anastomosis. The magnet 60 can be positioned in the target area employing a minimally invasive technique. In combination with the anastomotic device 32, 42 described above the magnet 60 is used to form a compressive anastomosis. The magnet 60 is generally cylindrical in shape and may comprise a longitudinal lumen or opening 52 centered about a central axis B. The magnet 60 also may comprise a tube 62 attached thereto. The tube 62 comprises an opening 63 for receiving a guide-wire therethrough to position the magnet 60 in the target area, e.g., the duodenum 20. The shape of the magnet 60 or its casing will be preferably capsular with radii 64, 66 formed on either end thereof to enable safe passage of the magnet 60 through the gastrointestinal tract. In one embodiment, the radii 64, 66 may have a substantially equal radius. In one embodiment, the magnet 60 may comprise a coating 65 such as plastic or plated Chromium to resist corrosion in the body. The magnet 60 may be formed of Neodymium, Iron, Boron, and/or Samarium materials.

[0061] The anastomosis 84 (FIGS. 21-26) may have a length ranging from about 5 mm to about 10 mm, although greater or shorter lengths may be desired and may be obtainable by controlling the length of the anastomotic device 32, 42 and the magnet 50, 60. For example, the length of the anastomosis 84 may be determined based on the length of the magnet 50, 60 relative to the anastomotic portion 36, 46 or may be determined based on the length of the anastomotic portion 36, 46 relative to the magnet 50, 60. The length of the anastomosis 84 also may be determined by the number of the magnets 48 on the anastomotic portion 46 of the anastomotic device 42. Either the length of the magnet 50, 60 or the length of the anastomotic portion 36, 46 may be adjusted to obtain an anastomosis 84 of a suitable length. Accordingly, anastomoses having lengths similar to those achievable with linear staplers may be achieved by adjusting the lengths of the magnet 50, 60 and/or the corresponding anastomotic portions 36, 46.

[0062] FIGS. 15-22 illustrate one embodiment of a minimally invasive endoscopic method of forming a compression anastomosis. FIGS. 23-26 illustrate the anastomosis formation process in more detail. In one embodiment, the minimally invasive endoscopic method may be a NOTES™ procedure. In the method illustrated in FIGS. 15-26, the anastomosis 84 is formed between the bile duct 24 and the duodenum 20 using the magnet 50 and the collapsible biliary anastomotic device 42 previously described with reference to FIGS. 6-11. The illustrated method is a technique for forming a biliary drainage anastomosis by forming a choledochoduodenostomy above the ampulla using one embodiment of the anastomotic device 42 and the magnet 50. This procedure may be employed to treat selected patients with retained, recurrent, and impacted bile duct stones; strictures of the bile ducts; stenosis of the sphincter of Oddi; pancreatitis associated with biliary disease; choledochal cysts; fistulas of the bile duct; and biliary obstruction, either benign or malignant, for example. The illustrated method for forming a compression anastomosis 84 provides several advantages over standard biliary stenting techniques. A choledochoduodenostomy may be formed by appropriately positioning the anastomotic device 42 and the magnet 50. The size of the choledochoduodenostomy may range from approximately 1 cm to approximately 3 cm and may be determined by the length of the anastomotic portion 46 and the magnet 50. A compression anastomosis 84 is formed by ischemic necrosis through tissue compressed between the anastomostic device 42 and the magnet 50 when they are magnetically coupled. The articulation nodes 40a, b enable the flexible portions 38a, b to collapse and allow the magnetically coupled anastomotic device 42 and the magnet 50, e.g., magnet assembly 86, to fall through the compression anastomosis 84 and subsequently is excreted through the gastrointestinal tract. The anastomotic device 42 decreases the likelihood of prosthetic material being left in the bile duct 24 with subsequent biofilm build up. The anastomosis 84 formed using the illustrated method provides an essentially leak free anastomosis. Placement of the anastomotic device 42 in the bile duct 24 enables biliary drainage through the central lumen 34 during the formation of the anastomosis 84. The transpapillary drainage during this period serves to minimize any untoward (e.g., unfavorable) effects from minor anastomotic leaks, for example.

[0063] FIG. 15 illustrates the introduction of an endoscope into the target area. In the illustrated embodiment, the endoscope 10 is a side viewing endoscope and is inserted in the duodenum 20. The distal end 26 of the flexible shaft 12 of the endoscope 10 is introduced into the duodenum 20 in an area adjacent to the ampullary opening 28 opposite the bile duct 24.

[0064] FIG. 16 illustrates the introduction of one embodiment of a collapsible biliary anastomotic device 42 into the bile duct 24 through the distal end 26 of the endoscope 10 via a guide-wire 70. In other embodiments, the anastomotic device 42 may be delivered to the target area translumenally. The anastomotic device 42 is positioned in the bile duct 24 endoscopically through the flexible shaft 12 of the endoscope 10 over the guide-wire 70. The bile duct 24 is cannulated using the distal end 26 of the endoscope 10. The anastomotic device 42 is inserted into the bile duct 24 through the ampullary opening 28 of the papilla 29 in the duodenum 20 after the bile duct 24 has been cannulated with the distal end 26 of the endoscope 10. The guide-wire 70 is then inserted into the bile duct 24. The anastomotic device 42 is inserted over the guide-wire 70 and a pusher tube is used to position the anastomotic device 42 into the bile duct 24 under direct vision. This procedure may be conducted using an ERCP endoscope or any suitable viewing endoscope. The anastomotic device 42 may be positioned into the bile duct 24 over the guide-wire 70 in a straight configuration. The flexible portions 38a, b of on either side of the articulation nodes 40a, b facilitate the positioning of the anastomotic device 32 over the guide-wire 70 into the bile duct 24. In the illustrated method, one end 72a of the anastomotic device 42 is located in the dilated ampullary opening 28 and the other end 72b of the anastomotic device 42 is located within the bile duct 24. Once the anastomotic device 42 is positioned in the bile duct 24, its position can be checked using fluoroscopy (X-Rays) and subsequently the guide-wire 70 is withdrawn.

[0065] As previously stated, once positioned within the bile duct 24, the anastomotic device 42 allows passage of bile through the dilated ampullary opening 28 into the duodenum 20 until the anastomosis 84 matures. Bile from the liver (not shown) or the gall bladder 21 flows through the central lumen 34 of the anastomotic device 42 past an obstruction in the bile and into the duodenum 20 to relieve the patient of jaundice. The flexible portions 38a, bmove to allow the anastomotic device 42 to fall through the anastomosis into the duodenum 20.

[0066] FIG. 17 illustrates the introduction of the magnet 50 through the stomach 18 using a pusher 82 and a forward viewing endoscope 100 comprising a flexible shaft 80. FIG. 18 illustrates the introduction of the magnet 50 into the duodenum 20 using the pusher 82 and the forward viewing endoscope 100 comprising the flexible shaft 80. With reference to FIGS. 17 and 18, the pusher 82 may be a catheter or piece of tubing for pushing the magnet 50 ahead using the forward looking endoscope 100. The flexible shaft 80 may be passed through a per-oral overtube, for example, to protect the esophagus. The magnet 50 is pushed along the gastrointestinal tract with the pusher 82 until it is positioned within the duodenum 20 near the ampullary opening 28. Within the duodenum 20, the magnet 50 is manipulated and aligned so as to be properly oriented to attract the anastomotic portion 46 of the anastomotic device 42 previously positioned in the bile duct 24. When properly aligned, the wall 68 of the duodenum 20 and the wall 58 of the bile duct 24 are compressed (e.g., sandwiched) between the magnet 50 and the anastomotic portion 46 of the anastomotic device 42. The flexible shaft 80 and the pusher 82 are withdrawn when the magnet 50 is magnetically coupled to the anastomotic device 42.

[0067] FIG. 19 illustrates the magnet 50 aligned and attracted to the anastomotic portion 46 of the anastomotic device 42. The wall 68 of the duodenum 20 and the wall 58 of the bile duct 24 are compressed between the magnet 50 and the anastomotic portion 46 of the anastomotic device 42.

[0068] FIG. 20 illustrates the formation of necrotic ischemia of the compressed region of the wall 68 of the duodenum 20 and the wall 58 of the bile duct 24. A compression anastomosis 84 is formed between the duodenum 20 and the bile duct 24 after a period of time. The magnetic attractive force exerted by the relatively more massive magnet 50 attracts the anastomotic portion 46. This action tends to move the flexible portion 38a, b of the anastomotic device 42 at the articulation nodes 40a, b as the anastomotic device 42 erodes through the compressed tissue. As previously discussed, the peristaltic force also assist the magnet assembly 86 to eventually fall through the mature anastomosis 84 into the duodenum 20.

[0069] FIGS. 21-22 illustrate the formation of the compression anastomosis 84 and the magnet assembly 86 passing through the anastomosis 84 into the duodenum 20 and the remaining portions of the gastrointestinal tract. The compression anastomosis 84 is formed by necrotic ischemia caused by the occlusion of blood supply to the tissue (e.g., the wall 68 of the duodenum 20 and the wall 58 of the bile duct 24) compressed between the magnet 50 and the anastomotic portion 46 of the anastomotic device 42. Once the compression anastomosis 84 is formed between the bile duct 24 and the duodenum 20, the more massive magnet 50 attracts the anastomotic device 42 through the anastomosis 84 into the duodenum 20. The flexible portions 38a, b of the anastomotic device 42 move at the respective articulation nodes 40a, b to enable the anastomotic device 42 to fit through the anastomosis 84 and pass into the duodenum 20. FIG. 21 illustrates one embodiment of the folded anastomotic device 42 attached to the magnet 50 (e.g., magnet assembly 86) passing through the anastomosis 84 formed between the bile duct 24 and the duodenum 20. FIG. 22 illustrates one embodiment of the anastomotic device 42 with the flexible portions 38a, b folded and the magnet assembly 86 passing through the duodenum 20 and through the remaining portions of the gastrointestinal tract. Within a few days the magnet assembly 86 passes through the gastrointestinal tract and exits the body from the anus. A typical period for passing the magnet assembly 86 is about 72 hours to about a week after the anastomosis 84 matures.

[0070] FIGS. 23-26 illustrate the formation of the compression anastomosis 84 and the magnet assembly 86 passing through the anastomosis 84 into the duodenum 20. FIG. 23 illustrates the magnet 50 magnetically coupled to the anastomotic portion 46 of the anastomotic 42 compressing the tissue layers of the wall 68 of the duodenum 20 and the wall 58 of the bile duct 24. FIG. 24 illustrates the formation of the anastomosis 84 after a few days of compression of the tissue layers of the wall 68 of the duodenum 20 and the wall 58 of the bile duct 24. As previously discussed, the anastomosis 84 is formed by ischemic necrosis as a result of compression between the magnet 50 and the anastomotic device 42. Also, once the anastomosis 84 is formed the magnet 50 and the anastomotic device 42 are directly coupled and form the magnet assembly 86. FIG. 25 illustrates the magnet assembly 86 passing through the anastomosis 84 from the bile duct 24 to the duodenum 20 as the first and second flexible portions 38a, b of one embodiment of the anastomotic device 42 fold at the articulation nodes 40a, b from the force exerted on the anastomotic portion 46 of the anastomotic device 42. The force exerted on the anastomotic device 42 may include the magnetic attractive force exerted by the magnet 50 as well as the peristaltic force, e.g., the squeezing propulsive force from the walls 68 of the duodenum 20. FIG. 26 illustrates the first and second flexible portions 38a, b of one embodiment of the anastomotic device 42 folded and the magnet assembly 86 passing through the anastomosis 84.

[0071] In one embodiment, in a NOTES™ procedure an entero-enteral anastomosis may be formed by inserting the anastomotic device 32, 42 and magnet the 50, 60 to the target area using a translumenal double channel gastroscope. A TAS device may be employed to hold two loops of bowel together. A grasper holds one side of the bowel and a needle knife penetrates the small intestine with passage of a guide-wire. The anastomotic device 32, 42 can be pushed through into the small intestine through a hole of only 7F in size with a pusher. Subsequently the guide-wire and the pusher are withdrawn. The process may be repeated on the other side of the bowel to insert the magnet 50. Slightly bigger holes may be required to properly insert the anastomotic device 32, 42 and the magnet 50, 60. The small holes may be closed with clips or stitches.

[0072] While several embodiments have been illustrated and described, and while several illustrative embodiments have been described in considerable detail, the embodiments are not intended to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. Those of ordinary skill in the art will readily appreciate the different advantages provided by these various embodiments. While the various surgical instruments have been herein described in connection with the formation of an entero-enteral anastomosis through the mouth, those of ordinary skill in the art will readily appreciate that the unique and novel features of the various embodiments may be effectively employed in connection with forming an anastomosis between other organs which may be accessed through other natural orifices in the patient. In addition, it is conceivable that the various embodiments could have utility in some laparoscopic surgical procedures and therapies.

[0073] While several embodiments have been described, it should be apparent, however, that various modifications, alterations and adaptations to those embodiments may occur to persons skilled in the art with the attainment of some or all of the advantages of the embodiments. For example, according to various embodiments, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to perform a given function or functions. This application is therefore intended to cover all such modifications, alterations and adaptations without departing from the scope of the appended claims.

[0074] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include a combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those of ordinary skill in the art will appreciate that the reconditioning of a device can utilize a variety of different techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0075] Preferably, the embodiments described herein will be processed before surgery. First a new or used instrument is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or higher energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

[0076] Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[0077] The embodiments are not to be construed as limited to the particular embodiments disclosed. The embodiments are therefore to be regarded as illustrative rather than restrictive. Variations and changes may be made by others without departing from the scope of the claims. Accordingly, it is expressly intended that all such equivalents, variations and changes that fall within the scope of the claims be embraced thereby.

[0078] In summary, numerous benefits have been described which result from employing the concepts described herein. The foregoing description of the one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or limiting to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments were chosen and described in order to illustrate principles and practical application to thereby enable one of ordinary skill in the art to utilize the various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the claims submitted herewith define the overall scope.