Patent Abstract:
A medical treatment device includes an elongate member having an internal volume, a proximal end, and a distal end, the internal volume extending from the proximal end to the distal end. The medical treatment device further includes a first coupler and a second coupler, the first coupler and the second coupler coupled to the internal volume of the elongate member; a first joining member and a second joining member, the first joining member coupled to the first coupler and the second joining member coupled to the second coupler. The first joining member is configured to attach to a first biological matter location, and the second joining member is configured to attach to a second biological matter location, the second location being distal to the first location. The second coupler is configured for manipulation to align relative the first coupler such that the second biological matter location relocates adjacent the first biological matter location. The first joining member and the second joining member are configured to join the first biological matter location to the second biological matter location.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 61/304,295, which was filed on Feb. 12, 2010, and U.S. Provisional Application No. 61/329,507, which was filed on Apr. 29, 2010. The entirety of each of the priority applications is hereby incorporated by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention is directed to surgical methods and apparatus and more particularly to a gastric bypass procedure and apparatus to perform the same. 
         [0004]    2. Description of the Related Art 
         [0005]    The need for surgical procedures to address an increasing obesity problem among today&#39;s population continues to grow. A common procedure involves a gastric bypass procedure that decreases the digestive system capacity by shortening the digestive tract, in particular the small intestine. This procedure bypasses the duodenum and the upper segment of the jejunum, resulting in segregation of food (chyme) from digestive juices and enzymes. The high-glucose absorption area of the small intestine, located in the post-pyloric segments of the jejunum, is being bypassed at the same time. Existing procedures for performing such a gastric bypass procedure are either performed as open or laparoscopic procedures, and attempt to reduce the risks inherent to the procedure associated with digestive system leakage, recovery time associated with the procedure itself, and obtaining access to the digestive system. However, there is still a need for improved methods of the bypass procedure to reduce the various associated risks. 
         [0006]    Accordingly, there is a need for an improved method and apparatus to perform a gastro-jejunal bypass to bypass the duodenum and the upper jejunum to improve recovery time and reduce risk of collateral injury. 
       SUMMARY OF THE INVENTION 
       [0007]    Methods and devices are described herein for performing bypass surgeries within the digestive tract. In one embodiment, the surgical method includes endoluminal and/or transluminal methods based on surgical principles. In one embodiment, a method of digestive tract bypass surgery is provided, comprising advancing a first device to a first target site within a digestive tract of a patient and manipulating the first device inside and/or outside the patient to move the first target site approximate to a second target site within the digestive tract. In one embodiment, the first target and the second target site are joined together to form a junction with a periphery. An opening is formed within the periphery of the junction. 
         [0008]    In one embodiment, a method of treating diabetes is provided, comprising inserting an elongate member orally through the digestive tract, wherein the elongate member includes an internal volume, a proximal end, and a distal end, the internal volume extending from the proximal end to the distal end. A first biological matter location and a second biological matter location are located with the distal end of the elongate member. A first coupler is deployed at the first biological matter location and a second coupler is deployed at the second biological matter location from the distal end of the elongate member, the first coupler and the second coupler deploying from the internal volume of the elongate member and maintaining a coupling to the internal volume. A first protrusion coupled to the first coupler is attached to the first biological matter location and a second protrusion coupled to the second coupler is attached to the second biological matter location. The second coupler is maneuvered adjacent the first coupler by directionally maneuvering an external coupler about the second coupler. The first coupler is aligned with the second coupler, and the first biological matter location is joined to the second biological matter location by activating a first joining member coupled to the first coupler and a second joining member coupled to the second coupler. The joined portion of the first biological matter location and the second biological matter location is opened to provide for flow of bodily fluid. Disengaging and retracting the couplers from the first and second biological matter locations, and removing the elongate member from the digestive tract. 
         [0009]    In one embodiment a medical treatment device is provided, comprising an elongate member having an internal volume, a proximal end, and a distal end, the internal volume extending from the proximal end to the distal end. The device can include a first coupler and a second coupler, the first coupler and the second coupler coupled to the internal volume of the elongate member. There is a first joining member and a second joining member, the first joining member coupled to the first coupler and the second joining member coupled to the second coupler. The first joining member is configured to attach to a first biological matter location, and the second joining member is configured to attach to a second biological matter location. The second location is distal to the first location, and the second coupler is configured for manipulation to align relative the first coupler such that the second biological matter location relocates adjacent the first biological matter location. The first joining member and the second joining member are configured to join the first biological matter location to the second biological matter location. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a front view schematic of the internal organs of the natural human digestive system. 
           [0011]      FIG. 2A  is a perspective view of an insertion device locating and anastomosis apparatus in accordance with one embodiment. 
           [0012]      FIG. 2B  is a cross-section view of the insertion device locating and anastomosis apparatus illustrated in  FIG. 2A . 
           [0013]      FIG. 3A  is a front view schematic of the insertion device locating and anastomosis apparatus illustrated in  FIG. 2A  inserted orally to a target location of the jejunum. 
           [0014]      FIG. 3B  is an expanded view of the distal portion of the insertion device of  FIG. 2A . 
           [0015]      FIG. 4A  is a cross-section side view of a distal end of the insertion device illustrated in  FIG. 2A . 
           [0016]      FIG. 4B  is a side view of a coupler of the insertion device illustrated in  FIG. 2A . 
           [0017]      FIG. 4C  is a bottom view of the coupler of  FIG. 4B . 
           [0018]      FIG. 5A  is a side view of the distal end of the insertion device of  FIG. 2A . 
           [0019]      FIG. 5B  is a side view of a coupler of the insertion device of  FIG. 2A  anchored in tissue. 
           [0020]      FIG. 5C  is a schematic view of the attached couplers at a first target and a second target of the insertion device of  FIG. 2A . 
           [0021]      FIG. 6A  is a cross-section side view of a method of location adjustment of the insertion device of  FIG. 2A . 
           [0022]      FIG. 6B  is a cross section of a portion of the insertion device of  FIG. 2A . 
           [0023]      FIG. 7A  is a cross-section view of the couplers and indicators of the insertion device of  FIG. 2A . 
           [0024]      FIGS. 7B and 7C  are cross-section views of the couplers and indicators of the insertion device of  FIG. 2A  shown with captive tissue located therebetween. 
           [0025]      FIG. 8  is a schematic view of an alternative insertion device in accordance with an embodiment. 
           [0026]      FIG. 9A  is a side view of a portion of an alternative insertion device in accordance with the insertion device of  FIG. 8 . 
           [0027]      FIG. 9B  is a side view of a portion of an alternative insertion device of  FIG. 9A  in a deployed configuration. 
           [0028]      FIGS. 10A-10B  re schematic views of an alternative insertion device in accordance with an embodiment. 
           [0029]      FIG. 11A  is a side view of an alternative joining member in an undeployed configuration in accordance with an embodiment. 
           [0030]      FIG. 11B  is a top view of the joining member of  FIG. 11A  in a deployed configuration. 
           [0031]      FIG. 11C  is a side view of the joining member of  FIG. 11B . 
           [0032]      FIG. 12  is a side view of the joining members of  FIGS. 11A-C  in a joining configuration. 
           [0033]      FIG. 13  is a schematic of a control profile of input energy for the joining member of  FIGS. 11A-C . 
           [0034]      FIG. 14A  is a top view of the joining member of the insertion device of  FIG. 2A . 
           [0035]      FIG. 14B  is a side view of the joining member of  FIG. 14A . 
           [0036]      FIG. 15  is a cross-section schematic of the joining of tissues by a first joining member and a second joining member of the insertion device of  FIG. 2A . 
           [0037]      FIGS. 16A-16D  are cross-section schematics of an obstructing device in accordance with an embodiment. 
           [0038]      FIG. 17  is a side view of a device to deploy a coupler shown in an undeployed configuration in accordance with an embodiment. 
           [0039]      FIG. 18  is a side view of an LED marker device in accordance with an embodiment. 
           [0040]      FIGS. 19A-B  illustrate another embodiment of a coupler device in accordance with an embodiment. 
           [0041]      FIG. 20  is a side view of a device to deploy a coupler shown in an undeployed configuration in accordance with an embodiment. 
           [0042]      FIG. 21  is a side view of a device to deploy a coupler shown in an undeployed configuration in accordance with an embodiment. 
           [0043]      FIGS. 22A-C  illustrate a coupler device and a support frame in accordance with an embodiment. 
           [0044]      FIGS. 23A-B  illustrate a side view of a device to deploy a coupler shown in an undeployed and deployed configuration in accordance with an embodiment. 
           [0045]      FIGS. 24A-B  illustrate a cross-section view of a pair of deployed coupler devices in accordance with an embodiment. 
           [0046]      FIGS. 25A-D  illustrate a side view of a device and method to deploy a coupler in accordance with an embodiment. 
           [0047]      FIGS. 26A-B  illustrate a side view of a delivery device to deploy a coupler shown in an undeployed and undeployed configuration in accordance with an embodiment. 
           [0048]      FIGS. 27A-B  illustrate a side view of a portion of a delivery device to deploy a coupler shown in an undeployed and deployed configuration in accordance with an embodiment. 
           [0049]      FIGS. 28A-C  illustrate a side view of a portion of a delivery device to deploy a coupler shown in an undeployed and deployed configuration in accordance with an embodiment. 
           [0050]      FIGS. 29A-C  illustrate a side view of a portion of a delivery device to deploy a coupler shown in an undeployed and deployed configuration in accordance with an embodiment. 
           [0051]      FIGS. 30A-B  illustrate a side view of a portion of a delivery device to deploy a coupler shown in a partially deployed and deployed configuration in accordance with an embodiment. 
           [0052]      FIG. 31  is a side view of a valvular device configuration formed in accordance with an embodiment. 
           [0053]      FIGS. 32A-B  illustrate a top view of tissue forming a valvular device in accordance with an embodiment. 
           [0054]      FIG. 33  is a side view of a valvular device configuration formed in accordance with an embodiment. 
           [0055]      FIGS. 34A-B  illustrate a top view and side view of tissue forming a valvular device in accordance with an embodiment. 
           [0056]      FIGS. 35A-B  illustrate a coupler device and method in accordance with an embodiment. 
           [0057]      FIGS. 36A-B  illustrate a coupler device in accordance with an embodiment. 
           [0058]      FIG. 37  is a top view of a welded tissue region formed in accordance with an embodiment. 
           [0059]      FIGS. 38A-B  illustrate a coupling device and method in accordance with an embodiment. 
           [0060]      FIG. 39  is a perspective view of a coupler device in accordance with an embodiment. 
           [0061]      FIG. 40  illustrates a coupling device and method in accordance with an embodiment. 
           [0062]      FIG. 41  is a side view of a coupler device in accordance with an embodiment. 
           [0063]      FIG. 42  is a side view of a portion of a coupler device in accordance with an embodiment. 
           [0064]      FIG. 43  is a side view of a coupler device in accordance with an embodiment. 
           [0065]      FIG. 44  is a side view of a valvular device in accordance with an embodiment. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0066]    In the following description of the preferred embodiments, reference is made to the accompanying drawings which form a part thereof, and in which is shown by way of illustration a specific embodiment. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention. 
         [0067]      FIG. 1  illustrates the human digestive system with a first target  116  and a second target  118  identified for the locations within the digestive system that will be anastomosed to provide for a bypass of the duodenum and subsequent portions of the digestive tract. The digestive tract shows the esophagus  102  entering into the stomach  100  pouch. The stomach leads into the fundus  104 , the corpus, and the pylorus  106 , which subsequently transitions to the small intestine, that comprise the duodenum  108 , the jejunum  110 , and the ileum. 
         [0068]      FIG. 1  illustrates a gastro-jejunal bypass procedure to bypass the duodenum and the upper segment of the jejunum. In one embodiment, this bypass procedure can be used to treat and/or reverse type 2 diabetes mellitus (T2DM) and/or treat other conditions.  FIG. 1  illustrates that the first target  116  and the second target  118  have been joined, or anastomosed at a first location  120 , and a third  122  and a fourth target  124  have been joined, or anastomosed at a second location  130 . Various methods and apparatus for marking, moving and joining these targets  116 ,  118 ,  122 ,  124  according to certain embodiments will be described in further detail below. As illustrated in  FIG. 1 , the joining of the first target  116  and the second target  118  creates a bypassed region, or anisoperistaltic loop  114 , downstream of the pylorus and upstream of the joint occurring between the first and second targets  116 ,  118 . The first target is generally located in the portion of the intestine approximately 60 cm downstream from the pylorus, however, the location can range from 30 cm to 120 cm. The downstream portion of the jejunum, or isoperistaltic portion, becomes the alimentary loop  112 . In modified embodiments, the first and second targets can be located at different positions and/or additional targets can be identified and used. In another embodiment, the anisoperistaltic loop can be lined with a liner to allow for food or chyme passage as well in addition to the previously described alimentary loop. In yet another embodiment, either of the two loops may be narrowed down using some kind of application of energy to the intestinal wall with the goal of shrinking its lumen, making it less amenable for the transportation of food or chyme. In another embodiment, either one of the two lumina can be fitted with a one way valve by means of tissue reconfiguration, which prevents chyme from passing in one of the two lumina. 
         [0069]      FIGS. 2-7  illustrate one embodiment of the system having an insertion device  200  that can be delivered transorally to a patient to perform the gastro-jejunal bypass procedure endoluminally, or from within the hollow organ. In the illustrated embodiment, the insertion device  200 , otherwise referred to as a catheter, can include a shaft-like tube that further includes supports  206 . The catheter  200  has a proximal end  270  and a distal end  272 . In one embodiment, the supports  206  include two counter-helical coils that provide strength to the structural body of the catheter  200 . The structural strength advantageously provides for the capability to house, transport, and control a viewing mechanism  250 , an inflation member  240 , and couplers  218 , all of which can be utilized by the system to perform the bypass procedure. The catheter can include separate internal lumens  224 ,  226 ,  228  that individually house the described features, the camera, the inflation gas, and the magnet driveshaft and electrical connections, respectively, for at least a portion of the catheter length. The internal lumens  224 ,  226 ,  228  can be attached to the inner diameter surface of the catheter  200 . In another embodiment, the internal lumens  224 ,  226 ,  228  can be freely disposed in the catheter  200 . 
         [0070]    The catheter  200  can include length markings  274  along the length of the lubricious outer diameter surface  276  that can provide an indication of how far the catheter has travelled during insertion into the patient. The catheter  200  system can further include an inflation member  240 , or a balloon, that is coupled to an upstream inflation lumen  242 . The balloon  240  can be coupled to the external surface of the catheter  200  distal end  272 . Inflation lumen  242  provides a conduit for a gaseous or liquid pressure source to inflate/deflate the balloon  240 . The gaseous source can be any suitable medical grade gas, e.g. helium, carbon dioxide, ambient air, liquid sterile water, saline, gels, or the like. 
         [0071]    The viewing mechanism  250 , or camera, can be disposed within the catheter  200 . The camera  250  can provide a side-looking view via the application of a 90° optic tip that is directed through a second aperture  214 , or camera window. In other embodiments, the camera  250  can view in the distal direction via a 180° optic tip. The camera  250 , its viewing tip, and the camera window  214  are located within the catheter  200  adjacent the distal end  272 . The camera  250  can be coupled to a viewing connector  252 , or camera cable, that extends proximally to the controller  216 . The orientation of the camera  250  can be controlled by the controller  216  via the camera cable  252 . In one embodiment, the camera  250  includes an articulating head that can be controlled by the controller  216 . In another embodiment, the camera  250  can be controlled by an external control mechanism not associated with the controller  216 . 
         [0072]    In the illustrated embodiment, the system further includes mechanisms to attach, locate, and/or mark the target spots. In the illustrated embodiment, the system can include three couplers  218 , or magnets. In some embodiments, the system can include 2, 4, 5, or more magnets  218 . The magnets  218  can include protrusions  222 , or hooks, or other attachment mechanism that provide a positive attachment function to the tissue at the desired target locations. In this arrangement, the hook  222  can include a free end and a coupled end, where the free end generally urges away from the magnet  218  bottom surface, or outer diameter directed surface, in a spring-like manner. In other embodiments, the magnets can be glued to the surface using tissue glues. In other embodiments, magnets can be attached to the internal organ surface with the help of a specialized surface, e.g. Velcro or the like. In other embodiments, the magnets  218 , or markers, can be clipped to the tissue surface. The free end of the hook  222  is captively retained against the catheter  202  or internal lumen  224  wall. The magnets  218  are located adjacent the distal end  272  and are controlled by connector  220 , or the magnet driveshaft. The magnets  218  can be coupled to power members  232 , which provide an electrical connection for a joining member  230 , otherwise referred to as an electrode. As will be explained below, the electrodes  230  can be utilized to perform the anastomosis via tissue welding of the tissue walls for the two target locations to be anastomosed. The magnets  218  can be temporarily stored in the deployment compartment  210  located adjacent the distal end  272 . The magnets  218  can be deployed from the catheter  200  distal end  272  through a first aperture  212 , or deployment window. 
         [0073]    The magnets  218 , driveshaft  220 , balloon  240 , camera  250 , and catheter  200  are directed, and can be administered via controller  216  located at the catheter  200  proximal end  270 . In one embodiment, the magnets  218  can include an indicator  260 , or sensor, that provides a signal and feedback to a controller module to determine distance and intermediate obstacles between an adjacently located indicator  260  on a separate magnet  218 . Alternatively, the sensor  260  is only located on one of two adjacently located magnets  218 . 
         [0074]    In the illustrated arrangement, the magnet  218  can include a flat oblong geometry with the hook  222  being steel-spring fish-hook type protrusion coupled to the outer diameter adjacent surface of the magnet  218 . The hook  222  can be coupled at an angle and restrained with a pre-load adjacent the magnet  218  outer diameter surface. The three magnets  218  can be stored in a single-file series fashion within the catheter storage compartment. 
         [0075]    It should be appreciated while magnets  218 , driveshaft  220 , balloon  240 , camera  250 , and other components are illustrated as part of a single catheter  200 , in modified embodiments, these components can be rearranged and positioned into separate components or catheters. 
         [0076]    A method of performing the gastro-jejunal bypass according to one embodiment will now be explained in detail. In one arrangement, the procedure is performed transorally (see e.g.,  FIG. 3A ) in order to reduce the risk of complications from surgical intervention and reduce the recovery time of the patient. The procedure can be performed using the catheter  200  described above or with a modified system configured to perform the methods and steps described below. As will be described below, in one arrangement one or more target sites are marked, the target sites are approximated (i.e., brought in close spatial relationship to each other), and then the tissues are anastomosed. In certain embodiments, a second anastomosis can be performed, obstructions can be placed in the bypassed tissue lumens, the anastomosis can be protected intraluminally, and/or the security of the anastomoses can be tested. 
         [0077]    In one embodiment, the catheter system  200  is deployed through a guide catheter  278  ( FIG. 6B ). The catheter  200  deploys and attaches the magnets  218 , maneuvers the second target  118  adjacent the first target  116 , anastomoses the adjacent first and second targets  116 ,  118 , slits the tissue encompassed by the anastomosis periphery, and blocks the pylorus  106  exit from the stomach  100 . The catheter  200  system distal end  272  can be inserted through the mouth and through the esophagus, stomach, and then the pylorus with a simple guide catheter. Natural motility of the intestine in combination with the motive force of operator pushing the driveshaft  220  via controller  216  can assist in delivery of the catheter distal end  272  tip at the second target  118 . 
         [0078]    The distal progress of the catheter  200  distal tip can be monitored by observing the length markings, by diaphanoscopy, by fluoroscope or ultrasound imaging, or the like. The catheter shaft can be rotated by the controller  216  such that the camera  250  can observe the tissue wall to aid in determining the vascularity of said adjacent tissue wall. The magnet  218  can be deployed in to the tissue wall with the least vascularity by directing the camera at the optimal wall location and fully inflating the balloon  240 , which can be mounted 180° opposite the deployment compartment  210 . In other embodiments, the magnet  218  can be deployed into the tissue wall at any distal length location, e.g. based on a proportion of overall digestive tract length, or the like. 
         [0079]    In the illustrated embodiment, the operator can deploy the magnet  218  by pushing the magnet  218  distally by exerting a distally directed force on the driveshaft  220 , thereby placing the magnet  218  into the deployment compartment. As the magnet exits the catheter  200  deployment window  212 , the hook  220  springs in a radially outward direction and engages the tissue wall. The catheter  202  can then be withdrawn to anchor the magnet into the tissue wall. The balloon can be deflated and the catheter is disengaged from the magnet. A cable for each of the three magnets can extend from the magnet back into the catheter  200  and to the controller  216 . In other embodiments, different methods of attaching the magnet  218  to the tissue wall can be accomplished, e.g. a balloon attached to a hinged needle (see  FIG. 17 ), multiple spring pins located distally and proximally on the magnet  218  extending longitudinally at opposing angles to each other (see  FIGS. 19A-19B ), or the like. In other embodiments, the magnets  218  can be permanently or semi-permanently attached to the catheter  202  (see  FIGS. 23A-B ), and the catheter would be attached to the tissue wall with the magnet  218 . The placement of a second magnet  218  adjacent first target  116  can be accomplished by repeating the above process, such that a magnet  218  is attached, or anchored, to the tissue at both the first and second targets  116 ,  118  (see  FIG. 5C ). 
         [0080]    The embodiment depicted in  FIG. 17  shows the catheter  202  with an injection lumen  228  connected at an angle to the spring  300  retracted injection needle  302  in at an at-rest, or unloaded, condition. The needle  302  can be deployed through the deployment window  212  by the inflated balloon  240  into the tissue. The balloon  240  can also push a hinge to drive the needle  302  out of its lumen/housing  228  and into the target. A volume of dye can be injected by a syringe attached to the lumen  228 . Dye can be visible to an observer inside and outside the lumen  228 , for example by laparoscope or open surgical access. 
         [0081]    In other embodiments, the marker can be a component of something other than an electromagnet. For example, in one embodiment, a metallic or radiopaque polymeric object can be visually detected or detected by external imaging devices. Another marker embodiment can include an LED marker  308  (see  FIG. 18 ) with batteries  316  to provide a light-emitting beacon. The LED device  308  can include a circuit board  312  and LED&#39;s  314  powered by batteries  316  and visible through a clear housing  310  encasing and forming the LED device  308 . In other embodiments, the marker can comprise an RFID tag (not shown). In yet another embodiment, a marker can comprise a piezo device (not shown) to deliver a sound beacon. In the embodiments described above, the magnet can comprise a constant magnet, rather than an electromagnet. The dye can also comprise a liquid containing magnetic filings. 
         [0082]    A coupler  320  can include a multiple spring pin embodiment as depicted in  FIGS. 19A-B  that can include two opposed spring-steel pins  322 ,  324  that can deploy at angles of about 30 to 45 degrees, although other angles are possible, with one pin longer than the other and at a greater pitch. The pins  322 ,  324  can be set by first drawing the catheter back to set the long pin  324 , and then pushing forward to set the shorter pin  322 . This apparatus of attachment can be readily extracted from the wall without tissue tearing. 
         [0083]    In some embodiments, as depicted in  FIG. 20 , a suture  330  can be deployed by a puncture into the wall, leaving two exposed tails as, for example, a method of marking the location. This can be done with a hinge mechanism and cutting needle  302  driven by the balloon  240  inflation, as described above. In some embodiments, the catheter can use welding as a marking device. In other embodiments, an electrical resistance heater, an arc generator, a fiberoptic for delivering laser energy, or a lumen for delivering chemical etchant can leave scarred or even charred tissue behind as a mark. 
         [0084]    In other embodiments, as depicted in  FIG. 21 , the marker  218  can be discharged from a discharge cylinder  340  at high velocity into the wall of the lumen, rather than applying force with a balloon. For example, an inelastic, flexible lumen  342  such as stainless steel or polyimide or PEEK, can deliver high pressure air to a projectile such as a miniature harpoon type needle  344  configuration. The harpoon  344  can be attached, or tethered, to the marker  218  by a suture. The harpoon  344  can puncture into the tissue due to the immense pressure developed at its tip, but would not appreciably displace tissue due to the minimal momentum generated. In other embodiments, conventional, FDA-cleared clips, metal or plastic, radio opaque or not, or the like, can be deployed as tissue markers  218 . 
         [0085]    In other embodiments, as depicted in  FIG. 22 , the marker  350  can have a particular shape that can be deployed as a combination of marker and engineered anastomosis design orifice template  350 . The shape of an optimized anastomotic orifice  350  can be oblong with the long axis along the axis of the lumen for optimal welding. The length and end radii of the oblong shape  350  can further be optimized to prevent tearing and to ensure good chyme movement, such that the oblong shape can become circular and near to the original lumen in diameter, under the influence of the hoop tension in the lumen after the anastomotic opening is formed. The shaped marker  350  can also have walls designed to ensure leak-proof joints during the welding process. The shaped marker  350  can include or be a stent  352  externally mounted on the catheter to be deployed by the balloon  240 . A stent  352  can maintain the lumen opening and prevent inadvertent contact with unintended walls during the welding process. The stent  352  can also have the benefit of advantageously creating a barrier to prevent leakage from the lumen to the abdominal cavity. The material can be a long-term implant such as steel or nitinol, plastics such as PTFE, or carbon fiber, or a bioresorbable material, or can be removed after the procedure. The material can also be any combination of the above, e.g. with absorbable and non-absorbable components, of which the non-absorbable components remain in place for a certain period of time or for the long-term. 
         [0086]    A method of approximating the two targets  116 ,  118  according to one embodiment is illustrated in  FIG. 6 . In the illustrated embodiment, the distally attached magnet  218  at the second target  118  is manipulated to bring the second target  118  proximally adjacent the first target  116 . The two targets  116 ,  118  can be brought together for anastomosis by a combination of insufflation, and magnetic manipulation. For example, in one embodiment, with the patient in a supine position, the balloon  240  on the catheter can be inflated with the inflation gas, e.g. helium, carbon dioxide, or the like. The balloon inflation can lift the target intestine loop anteriorly. An external, hand-held magnet  280  can be used to attract the distal magnet  218  and the target anisoperistaltic loop  114  further anteriorly and cephalad to the stomach  100 . 
         [0087]    The stomach  100  can optionally (or in addition) be moved caudally with a pushing element  290 , not shown, mounted slidably on the catheter. The two magnets  218  can be brought into proximity to each other with the external magnet  280 . The electromagnets can be switched on and off to prevent undesired movement, or to select which of the anchored magnets  218  to move, during the manipulation procedure. Manual manipulation through the abdominal wall, position changes (e.g. Trendelenburg and anti-Trendelenburg) and shaking of the patient, and other gross physical manipulation can be used to assist in mobilizing and approximating the target organs. The force required to move the bowel, or second target  118 , is minimal, within the range of 0-20, and more particularly 0-10, pounds force. 
         [0088]    In the illustrated embodiment of  FIGS. 7A-7C , the indicators  260 , or Hall effect sensors, can be utilized after the target tissues at locations  116 ,  118  are generally approximated. The sensors  260  can be coupled to, or adjacent to, the magnets  218 , and operate to measure the distance between the anastomosis sites. The distance measurement can be used by the operator to ensure or check that no additional tissue, e.g. an unintended, deflated loop of intestine, is captured between the approximators, or magnets  218  (see  FIG. 7B ). The joining sites, or first and second targets  116 ,  118 , can be disengaged, moved, and reengaged until correctly positioned opposite each other if the sensors indicate extra tissue is captured. In other embodiments, a light indicator, or photo detector  360 , that evaluates intensity or color of, for example, an LED  314 , when shone through the anastomosis site, rather than a Hall effect sensor configuration, can be used to indicate distance or captive tissue (see  FIG. 24A ). In other embodiments, an acoustic sensor configuration, such as a PZT source  370  and a PZT microphone  372 , can be used to indicate distance or captive tissue (see  FIG. 24B ). In still other embodiments, a simple electrical impedance measurement can indicate tissue wall thickness, and thus reveal the existence of extra tissue. If omentum is captured between the two target tissues the omentum can be left in place and welded through (see  FIG. 7C ). Welding through the omentum leaves a perforation in the omentum that will tend to close and heal around the anastomosis, advantageously improving the leak-proof characteristics of the tissue joining joint. After the two magnets  218  are sufficiently located the target areas are ready for tissue welding. 
         [0089]    In other embodiments, illustrated in  FIGS. 25A-25D , in order to anastomose the jejunum to the stomach without sandwiching the omentum, for example in patients with obesity, where the omentum has been demonstrated to be thick (frequently in obese males), a needle  380 /guide wire  382  assembly can be inserted through a side-directed lumen  228  and be delivered across the two walls and the catheter  202  can be removed. A specialized balloon catheter  384  can be advanced and placed over the guide wire  382 . The guide wire  382  can be removed and the balloon  384  inflated to dilate the omentum. Insufflated, the balloon shape can be like a sphere, an ovoid, a doughnut or a red blood cell, or a figure-8 profile with a waist, or two adjacent balloons, or the like, helping to do a controlled blunt dissection (or circular tear) into the omentum between the two apposed walls of stomach and jejunum. In some embodiments, a two-balloon configuration, see  FIG. 25D , can form a waist to capture omentum. Once the maximum size is reached (approximately the size of a half dollar), and the stomach and the jejunum are adequately apposed, the welding or other anastomosing can begin. In this case, or in the case of the anastomosis, tissue glue can be injected through the injection needle  380  into the space between the tissues to further seal the anastomosis on the outside. The omentum serves the immune defense in the abdominal cavity and is used in surgery to cover and protect delicate anastomoses. Thus, the procedure described above provides a natural protective element being added to the anastomosis. 
         [0090]    In other embodiments, illustrated in  FIG. 8 , a two-balloon technique, applying a two-balloon device  800 , can be used to bring the second target  118  close to the first target  116 . A two-balloon surgical technique uses a first balloon  802  to anchor the intestine, a co-axial sliding second balloon  804  catheter to anchor a second distal location. Egress of the second balloon toward the first balloon foreshortens the intestine loop. 
         [0091]    In other embodiments, a standard shape can be predetermined for the catheter  200 , such that the catheter  200  can be deployed in a first flexible state, and then activated to become the predetermined shape. Simple tension lines  902 , illustrated in  FIG. 9 , within a spring shaft can be activated to force the predetermined shape. Thus, the catheter  200  can be made to bend, with the tip coming to rest alongside its own shaft. With the tip in one lumen and the shaft in another, this action would bring the two sites together to be anastomosed. In one embodiment, the predetermined shape catheter  200  can be combined with the two-balloon device  800  technique (see  FIG. 10 ) such that the distance to be traversed is reduced, a rigid proximal length of catheter can be used for leverage, and the arc traversed by the deploying catheter  200  can be minimized. 
         [0092]    In other embodiments, illustrated in  FIGS. 26A-B , hydraulic or pneumatic devices can be used to inflate the catheter, rigidizing the catheter  390  into its predetermined shape.  FIG. 26B  shows the catheter  390  inflated. The shape can be a balloon with walls containing flexible, high tensile strength, low denier threads, such as a braid of Kevlar or UHDPE, or the like. High tension threads laid along stress lines are highly flexible when uninflated. Inflation of the catheter  390  causes the shorter thread to form an inside radius of a curve, or bend, in the catheter  390  shape. In other embodiments, illustrated in  FIGS. 27A-B , electronically activated actuators  400  on a series of joints  402  can be individually operated to allow a catheter  202  to move in a predetermined sequence. These joints  402  can have a single degree of freedom, since only one turn is required. In still other embodiments, illustrated in  FIGS. 28A-C , a sheath  410  can be slidably placed externally to the catheter  202  and forced into a bent position to form an elbow in place. The sheath  410  can include a tension line  412  that can be tensioned to form the bent position. The catheter  202  can then pass through this directing elbow of the sheath  410 . In other embodiments, illustrated in  FIGS. 29A-C , a shaft with a single elbow  420  can be positioned with the elbow relaxed, then the elbow can be bent and an accordion, or pleats  422 , on the other side of the elbow can be deployed ( FIG. 29B ). In all these ways, a catheter can be made to bend, with the tip coming to rest alongside its own shaft. With the tip in one lumen and the shaft in another, this action would bring the two sites together to be anastomosed. In particular, in the case of the multiple articulated catheter with electronic actuators, the tip can be bent around a very small radius (see  FIG. 30A-B ), and then pushed forward. The radius can remain in position relative to the tissue, while progressing proximally relative to the catheter. As the catheter  202  is pushed forward the actuators  400  are operate independently to maintain a bend at an anatomical location. 
         [0093]    The joining members, or electrode  230 , are the welding members that are activated at the target site to perform the tissue welding. In the illustrated embodiment of  FIGS. 14A and 14B , the electrodes  230  can take any desired shape suitable for deployment and coupling to the electromagnets, or magnets  218 . The electrode  230  can be flat with an exterior dimension defining the weld pattern and the width of the weld. The shape can be optimized for the tissue welding process, and to control the flow of chyme (valve) and mitigate the risk of contamination and collateral risk during the surgical procedure. In one embodiment, the electrode  230  can include end radii, e.g. an oval or equivalent rounded shape, to prevent tissue tearing during the deployment and anastomosis procedure. In one embodiment, the electrode can be a semi-rigid structure, or alternatively, be flexible to allow for adjustment of the shape during the approximating operations. 
         [0094]    In another embodiment, illustrated in  FIGS. 11A-11C , the weld member electrodes  230  can be flat with an exterior dimension defining the weld pattern and the width of the weld, as described above. The exterior dimension can be a pair of jointed bands  1106  joined by a deployment driveshaft  1102 . The joints  1104  of the jointed band  1106  can include electromagnets  218  used for the approximation process of aligning the first and second targets  116 ,  118 . Application of tension on the driveshaft  1102  can cause the jointed bands, or arms  1106  to flare outward and form an oval-like shape. The joints  1104  electromagnets can be activated to force the opposing elements of the two facing electrodes  230  to lay flat against each other for welding of the tissue. 
         [0095]    In the illustrated embodiment of  FIG. 12 , the two electrodes  230  are deployed and aligned opposite the tissue walls to be welded. Once deployed, the welding arms can be activated with RF energy to weld the two target sites  116 ,  118  together along the perimeter of the electrodes  230 . In one embodiment, the tissue welding can be performed without injecting tissue adhesives  432  into the captive site, or newly formed serosal cavity, for anastomosis. In other embodiments, a tissue adhesive can be injected into the captive site for anastomosis (see  FIG. 35B ). In other embodiments, the welding arms of electrode  230  can include multiple electrode leaflets  430  establishing more than one circumferential weld pattern (see  FIG. 35A ). Tissue welding parameters can include such variables as time, temperature, and pressure to obtain an adequate welding of adjacent tissue. The required compression pressure can be obtained via the electromagnets. Time, frequency, and power for welding can be controlled by a standard RF generator via the controller  216 , or an alternate external control mechanism (see  FIG. 13 ) to the parameters of, for one embodiment, a control profile  292 . In other embodiments, illustrated in  FIGS. 36A-36B , alternative energy sources for welding include DC electricity, light, microwave, and ultrasound. Additionally, alternative deploying arms can be fiberoptic arrays, piezo arrays, or microwave antennae (see  FIGS. 36A-B ). The deploying arm can include round wire antenna for microwave or RF energy delivery. The electrodes can include a tension element  440  that can be tensioned to deploy the antenna. In some embodiments, the electrode can include magnets at hinge points. In some embodiments, the electrode can include a fiberoptic bundle coupled, or potted, in the arm elements of the electrode at various positions about the arms of the electrode and which are flexible and expandable to the deployed position of the arms. The fiberoptics can be potted into the arms of the electrode  230   
         [0096]    In one embodiment, the opposing deploying arms  230  can be part of a single circuit, passing current through the tissue for welding (see  FIG. 15 ). Once the anastomosis is completed the tissue will be opened by cutting the tissue internal to the tissue weld regions  450 . In one embodiment, the tissue is cut using ablative heating. The electromagnet approximators can have a second band surrounding their outer diameter. This second band can be heated with a DC current to a temperature that will char a ring of tissue. Once charring is complete, the electromagnets  230  will be withdrawn together in the oral direction to ensure that ablation has completely freed a tissue disc. The electromagnets  230  can be disengaged and retracted by their power members  232 , or electrical connections, after the opening is complete. Alternative anastomotic opening shapes can be implemented, e.g. a slit, a cross, a T-shaped opening, a rectilinear opening, or the like (see  FIG. 37 ). The sharp-angled end points of such opening shapes can be strengthened by application of a suture, a staple  452 , an additional larger radius such as a hole-punch diameter  454 , to mitigate a stress riser geometry, provide a stress relief, and prevent tearing of the tissue (see  FIG. 37 ). 
         [0097]    In other embodiments, illustrated in  FIGS. 38A-38B , rather than welding the two tissues together, two corkscrew needles  460  can be screwed into the wall to hold the two tissues together, and the tissue between the needle can be opened. The needles can be metal such as stainless steel, or can be a rigid polymer such as PEEK, or can be a rigid bioresorbable polymer such as poly (lactic acid) stereocopolymer. Alternatively, the arms can be magnets and can remain in place. 
         [0098]    In still other embodiment, illustrated in  FIG. 39 , the arms can be magnets  470  and a tightly sealed ring can be formed. An adhesive  432  can be injected into the external serosal pocket, filling the pocket. Subsequently the opening can be formed as before, and the magnets retracted. Rather than glue, an irritant can be injected into the serosal pocket, such as hydrochloric acid or other FDA-cleared irritants. Fibrin release will form a bond between the two tissue surfaces, and a collagen scar will bind the two surfaces. A perforation can be formed with a second procedure when scarring is complete. Alternatively, stents  352  can be deployed with a specific anastomosis shape, as described above. These stents can include an obstructive element at one end. 
         [0099]    In some embodiments, illustrated in  FIG. 40 , an alternative to burning to establish the opening is provided by a simple cutting tool that can be deployed with visualization. Alternatively, an implanted form, implant  480 , can produce the desired opening shape. One of the other openings, such as a slit  482  or cross or T can be formed and the implant can be forced across the opening, such as an x-shaped slit. The implant  480  would provide a permanent, fixed, optimized opening shape that includes a permanent flanged orifice. The implant  480  can be a metal or polymer acceptable for long term implantation. It can be in the form of a grommet. To provide an inner seal for the anastomosis and to prevent leakage or even promote healing, a flexible (possibly funnel-shaped) sheath  484  with an oral stabilizer ring  486 , or flanged orifice, previously inserted in a collapsed form, can be placed into the anastomosis or stoma (see  FIG. 41 ). The flexible sheath can cover the inside of the anastomosis to about 3-5 cm. The advantage of such a stent is to provide a secure channel to cross between two lumina. 
         [0100]    Advantageously, performing the anastomoses via the described method allows the tissue to be joined prior to the opening in the tissue being created. Joining before cutting prevents spillage of the contents of the digestive system, or tract, into the peritoneal cavity. The described method, therefore, mitigates the risk of persisting leaks of digestive tract spillage, which can be life-threatening. The described apparatus and method of anastomosis also advantageously eliminates the need to dissect the omentum to allow bowel or stomach approximation for the selected anastomosis sites. Additionally, the magnet  218  and the electrode  230  can be designed to define the actual anastomotic orifice for optimal performance, including flow performance and prevention of obstruction. 
         [0101]    In one embodiment of the illustrated method, the second location  130  is also anastomosed between the third location  122  and the fourth location  124 . Using any of the above described apparatuses and/or methods, the third location  122  and the fourth location  124  are identified and marked with magnets  218 , at least one magnet  218  at each of the two locations. The magnets  218  are then manipulated adjacent one another, as described above, and joined together via tissue welding as described above. The magnets  218  at the third location  122  and the fourth location  124  can be deployed from the catheter  200 . In some embodiments, the magnets can be deployed from a second, separate, insertion device. In some embodiments, one of the magnets  218  at either third location  122  or fourth location  124  can be deployed from the catheter  200  and the other magnet  218  can be deployed from a second, separate, insertion device. The second location  130  can be manipulated and joined after the first location  120  is anastomosed and the opening cut, thereby allowing access through the opening to either or both of the third location  122  and the fourth location  124 . After the second location  130  is joined, the area of tissue internal to the region of tissue welding can form an opening, e.g. by cutting the tissue. In some embodiments, the tissue can remain without an opening. In one embodiment, one or more deployment catheters can be inserted through the opening formed at the first location  116  such that the catheter, the duodenum  108 , and the jejunum  110  can be bypassed. 
         [0102]    In other embodiments, illustrated in  FIGS. 31-34 , creation of a valvular mechanism through specific anastomotic features will prevent “marginal” or stoma ulceration by preventing jejuno-gastric reflux. This can be achieved by inverting the stomach wall  490  into the jejunum, preferably only the alimentary loop, creating a one-way valve mechanism  490 , or by creating uneven stomata at the anastomotic site with a large alimentary or efferent loop stoma and a narrow afferent loop stoma, by welding or suturing/stapling the afferent loop into a flap that occludes the afferent stoma.  FIG. 32A  illustrates an incision for the tissue flap  500  in an internal top view.  FIG. 32B  illustrates a top view of the tissue flap  500  collapsing to partially obscure the efferent loop. A specific and asymmetric incision of the welded or approximated anastomosed tissue can result in an opening favoring the efferent loop and keeping the afferent loop largely blocked. Though complete closure can be beneficial, a small orifice can be useful to provide drainage. Injection of suture material  502  or other FDA-cleared biocompatible materials like steel or nitinol beads, silicone and other polymers, or the like, into the submucosal space can also narrow the afferent loop stoma.  FIG. 32C  illustrates a side view with suture  502  injected submucosal to obstruct the efferent loop.  FIGS. 34A-B  illustrates a tissue pleat  510  formed wherein the tissue pleat encroaches on efferent stoma. 
         [0103]    In addition to the anastomosis and the opening, two sites must be occluded, as illustrated in  FIGS. 16A-16B , in order to prevent or significantly reduce flow to ensure the proper directionality of chyme travel. Complete occlusion is not necessary, but variation in performance of the type 2 diabetes effect may not be predictable if the occlusion is not complete. Thus, complete occlusion and therefore complete segregation of the secretion arm from chyme or the alimentary arm is preferred. The obstruction to establish the occlusion may be formed by scar tissue created by use of a heating element and visualization via a camera. The pylorus is thick-walled and can be the preferred target for the obstructive damage. In other embodiments, a heated blade can be used to weld the tissues together (see  FIG. 43 ). 
         [0104]    In other embodiments, illustrated in  FIGS. 16A-16D  and  42 - 44 , a volume of non-resorbing biocompatible material such as suture can be injected into the wall of the lumen to form an obstructive bulge. Other materials such as stainless steel or nitinol beads, silicone, or other well-characterized polymers can be injected. Alternatively, a sclerosing agent such as alcohol can be injected into the wall to cause retraction and scarring. Alternatively, a ring of mucosa  520  can be abraded with an abrasive tool, and the ring can be forced closed to heal into an obstruction. The ring can be forced closed with staples, suture, pins, clips, or rivets. Laser energy can weld the abraded tissues  520  together (see  FIG. 42 ). A flat heated blade  540  can be withdrawn while heating the tissue with the use of an endoscope  542 . Alternatively an obstructive implant  530 , such as a ball, sponge, or an umbrella with anchor hooks (see  FIG. 44 ), can be placed into the lumen, or deployed at the pylorus. These can be placed after the mucosa has been abraded, to cause healing adhesion. The obstruction  530  can have anchor hooks or protrusions to prevent dislodgement. Alternatively, the obstructive implant  530  can be a combination of a physical implant such as a electroconducting ball or mesh that is being brought into position, energy is turned on and as the mucosa is being partially or totally ablated, the lumen shrinks around the implant, the electrode is being decoupled from the implant and withdrawn, while the implant is left behind. 
         [0105]    The occlusion should be positioned such that a long column of immobile chyme will not form, as this may stagnate. In addition, reverse flow through the anisoperistaltic loop may not be likely, due to its natural motility and peristaltic motion. However, it is important that bile not leak into the anastomotic site, as it will erode tissues. The length of the anisoperistaltic loop can prevent bile-induced erosion of the anastomotic site. Chyme that travels in the antiperistaltic direction in this loop will not cause any reduction in the type 2 diabetes cure effect. 
         [0106]    In light of the disclosure herein, in some embodiments, one can varying lengths of bowel at which the anastomosis is placed intraluminally and extraluminally, which allows for dialing in different levels of control of different types of severity of diabetes and/or obesity. Accordingly, some arrangements, comprise selecting different lengths of the jejunal portions between anastomses ⅓ and 2/4, resulting in different length of bypassed upper intestines (see  FIG. 1 ). In addition, the length and materials (bioabsorbable/degradable and permanent/non-absorbable) for the lumen-crossing sleeves that a) protect the anastomoses, can be varied to allow for fine-tuning of absorption control. 
         [0107]    Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. For example, the embodiments disclosed above can be used with gastric bypass procedures targeting other locations of the digestive system for anastomosis. In addition, while a number of variations of the invention have been shown and described in detail, other modifications, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is also contemplated that various combinations or subcombinations of the specific features and aspects of the embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the disclosed invention. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Technology Classification (CPC): 0