Abstract:
The preferred methods and devices described herein relate to devices and methods for joining segments of soft tissue together. More particularly this invention relates to partitioning a body cavity or organ by joining together portions of the organ interior walls. This securement is particularly useful in gastric volume reduction surgery whereby the volume of the stomach is reduced by partitioning the stomach into a smaller pouch.

Description:
CLAIM OF PRIORITY 
       [0001]    This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 60/705,087, filed Aug. 3, 2005, the entire contents of which are hereby expressly incorporated by reference. 
     
    
     BACKGROUND 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to devices and methods for joining segments of soft tissue together. More particularly this invention relates to partitioning a body cavity or organ by joining together portions of the organ interior walls. 
         [0004]    2. Description of the Related Art 
         [0005]    Often segments of soft tissue are brought together for the purpose of reseeting tissue, providing anchors for other devices and for creating walls or partitions within a body cavity or an organ having a lumen. Sometimes a single wall of tissue is folded and brought together and other times two portions of soft tissue are grasped separately and then the two portions are brought into close proximity to each other and then joined together either permanently or temporarily. The joining of portions of soft tissue has traditionally been done using clamping, banding, suturing or stapling devices. However, joining segments of tissue together whereby some of these may be exposed to tension post-operatively often does not hold up over time. For example, when two discrete segments of the stomach are sewn together the sutures that hold the segments together are in tension post-operatively. In order to prevent the sutures or other fastening devices from pulling through the stomach wall over time, the sites where the devices puncture the outer wall of the stomach are sometimes reinforced with sections of tear-resistant material called pledgets; otherwise, other techniques must be employed to prevent pull out. 
         [0006]    The placement of staples, sutures and the use of pledgets is not always possible especially when securing the wall of an organ that has a surface not easily accessible during the procedure. As an example, when performing an endoluminal gastroplasty procedure, that is, when sewing the wall of the stomach to itself from within the lumen of the stomach to reduce its volume, only the inner wall is accessible. Sutures that are placed through the wall can be strain-relieved with a pledget or similar device only along the inner surface of the wall, but not along the outer wall (unless a pledget or similar device is passed through the wall, which is generally not practical). Furthermore, when fastening devices such as sutures are exposed to tension, as is the case when a gastroplasty procedure is done to create a gastric restriction, the fastening devices generally pull out over time. Additionally, many procedures requiring endolumenal tissue apposition and securement inside the interior space of an organ like the stomach suffer from the need for impractically complex tissue manipulation mechanisms. 
         [0007]    The only method that has proven useful to create a wall-to-wall adhesion (i.e., from the anterior wall of the stomach to the posterior wall of the stomach) is the multiple-row stapler. However these staples are applied from outside the stomach and thus require some form of surgical invasion of the peritoneal space outside the stomach. The mechanism of action of these staplers is related to the wide band of injury that occurs along the staple line, resulting from a combination of an initial crushing injury followed by a band of necrosis resulting from isehemia induced by the wide row of staples. The piercing effect of the staples may also be important, as may be the foreign body response created by the staples. 
         [0008]    To simulate this type of wall-to-wall securement from within the interior space of an organ like the stomach, one alternative is to secure an invaginated fold from the posterior wall to an invaginated fold from the anterior wall. This approach has been disclosed in the pending patent application 2005/0055038 filed Sep. 9, 2003 entitled “Device and Method for Endoluminal Therapy” the entire contents of which are included by reference. This present application relates to an improvement on the methods and devices disclosed in the 2005/0055038 application that are believed to make the procedure more practical and more durable. 
         [0009]    There is therefore a need for devices and methods that enable wall to wall securement with reduced chance of detachment occurring post-operatively. More specifically, there is a need for devices and methods that join tissue walls together, provide pressure on the joint and promote inner tissue layer intermingling. Additionally, these tissue securement devices need to be delivered endoscopically, as through a rigid endoscope, or endoluminally, as through a flexible endoscope. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    The preferred methods and devices described herein provide for securing a fold or folds of a wall of an organ together. This securement is particularly useful in gastroplasty surgery whereby partitions are created at various locations in the stomach for the purpose of treating conditions such as obesity and gastro-esophageal reflux disease (GERD). In one form of such a procedure, a line of wall-to-wall securements are made along a line from the cardia of the stomach to the lesser curvature. This line of new tissue unions can form a stomach pouch with a restrictive outlet, mimicking similar conventional surgical procedures performed to treat obesity. 
         [0011]    One aspect of the invention is a device to secure folds of an interior wall of an organ together. The device comprises at least one grasping element suitable for grasping one portion of the wall to form a first fold, and at least a second grasping element that is suitable for grasping a second portion of the wall to form a second fold and also suitable for positioning the second fold alongside the first fold with the folds in a side by side relationship. Another aspect of the invention includes a clamping member to secure the folds together. 
         [0012]    Another embodiment of the invention is a device to partition a portion of the interior space of an organ having at least one grasping element suitable for grasping one portion of a wall of the organ to form a first fold and having at least a second grasping element suitable for grasping a second portion of a wall of the organ to form a second fold. The two folds are positioned alongside each other with the folds in a side by side relationship and an elongate clamping member is used to secure the folds together. 
         [0013]    Another aspect of the invention is a method to secure the folds of an interior wall of an organ together including grasping a first portion of the wall to form a first fold and grasping a second portion of the wall to form a second fold with the folds in a side by side relationship. The method further comprises securing the folds together using at least one elongate clamping member positioned about the side by side folds. 
         [0014]    In another aspect of the invention is a method to create a passageway along an interior wall of the stomach which comprises a) grasping one portion of the wall to form a first fold and b) grasping a second portion of the wall to form a second fold and positioning the second fold alongside the first fold with the folds in a side by side relationship and c) securing the folds together. The method further comprises repeating steps a, b and c to form a series of secured folds of the wall along a line running from the cardia towards the lesser curvature of the stomach. The method further comprises clamping the folds with an elongate clamping member wherein one end of the elongate clamping member is positioned against the cardia as a pivot point such that when the clamping member is positioned over the folds, the pivot point maintains at least one end of the clamping device against the stomach wall. The method further comprises a detachable pusher element attached to the clamping member that is adapted to retain an opposite end of the elongate clamping member in a desired position while positioning the clamping member over the folds. 
         [0015]    Certain objects and advantages of the invention are described herein. Of course, it is to be understood that not necessarily all such objects or advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. 
         [0016]    All of these embodiments are intended to be within the scope of the present invention herein disclosed. However, despite the foregoing discussion of certain embodiments, only the appended claims (and not the present summary) are intended to define the invention. The summarized embodiment, and other embodiments of the present invention, will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments having reference to the attached figures, the invention not being limited to any particular preferred embodiment(s) disclosed. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]      FIG. 1  is a perspective view showing the desired location of an approximated fold of stomach tissue to create a partition in the stomach; 
           [0018]      FIG. 2  is a perspective view of a clamping member; 
           [0019]      FIG. 3  is a perspective view of another embodiment of a clamping member; 
           [0020]      FIG. 4A  is a drawing of a clamping member showing an articulated hinge; 
           [0021]      FIG. 4B  is a drawing of a clamping member that is bent at the hinge point; 
           [0022]      FIG. 4C  is a drawing of a clamping member placed into the mouth of a patient; 
           [0023]      FIG. 5  is a drawing of a grasping element showing a grasping head, connecting element, and actuator assembly; 
           [0024]      FIG. 6  is a perspective view showing a clamping member positioned about two grasping elements; 
           [0025]      FIG. 7A  is a drawing of a pushing element detachably coupled to a clamping member; 
           [0026]      FIG. 7B  is a view of grasping elements and a clamping member shown in the esophagus of a patient; 
           [0027]      FIG. 8  is a cutaway view of a preferred embodiment of grasping elements and the clamping member in a stomach; 
           [0028]      FIG. 9  is a drawing showing several folds of soft tissue after being drawn up into the clamping member; 
           [0029]      FIG. 10  is a drawing showing the proper placement of the graspers to effect the desired partition in a stomach; 
           [0030]      FIG. 11A  is a section view of a retention member on the clamping member; 
           [0031]      FIG. 11B  is a section view of an alternative embodiment of the retention member, showing the tissue flaps being pulled through it; 
           [0032]      FIG. 11C  is a section view of the retention member shown in  FIG. 11   b , showing the engagement of the retention member with the tissue flaps after they have been released; 
           [0033]      FIG. 12  is a drawing of a user activated clamping mechanism; 
           [0034]      FIG. 13  is a drawing of a clamping member with an integral stapling mechanism; 
           [0035]      FIG. 14  is a side view of a clamping member with an interrupted clamping surface; 
           [0036]      FIG. 15  is a drawing of a clamping member with integral tissue cutter; 
           [0037]      FIG. 16A  is a drawing showing designs to enhance the adhesion of the clamped layers; 
           [0038]      FIG. 16B  is a drawing showing alternate designs to enhance the adhesion of the clamped layers; 
           [0039]      FIG. 16C  is a drawing showing alternate designs to enhance the adhesion of the clamped layers; 
           [0040]      FIG. 17A  is a drawing of an alternate clamping member used to approximate tissue near the fundus; 
           [0041]      FIG. 17B  is a side view of a clamping member securing three folds of tissue; 
           [0042]      FIG. 18  is a drawing of a clamping element and spacer to maintain an opening in the stomach; 
           [0043]      FIG. 19A  is a drawing of an integral clamp and grasping element with the grasping element retracted; 
           [0044]      FIG. 19B  is a drawing of an integral clamp and grasping element with the grasping element deployed; 
           [0045]      FIG. 20  is an end view of an endoscope showing a typical auxiliary channel for the positioning of accessory elements as described in prior art; 
           [0046]      FIG. 21A  is an end view of an endoscope with a preferred embodiment auxiliary channel for the positioning of multiple grasping elements; 
           [0047]      FIG. 21B  is a side view of an endoscope showing two instruments sharing a single working channel; 
           [0048]      FIG. 22  is a drawing showing a method to locate the lesser curvature in the stomach; 
           [0049]      FIG. 23A  is a drawing of an articulated clamping member in a stomach; 
           [0050]      FIG. 23B  is a drawing of the tissue union line as a result of using an articulated clamping member; 
           [0051]      FIG. 24A  is a side view of an apparatus having a pulley element; 
           [0052]      FIG. 24B  is a close-up view of an apparatus having a pulley element; 
           [0053]      FIG. 25A  is a schematic view of a clamp assembly; 
           [0054]      FIG. 25B  is a schematic view of the clamp assembly of  FIG. 25A  in a stomach; 
           [0055]      FIG. 25C  is a schematic view of the clamp assembly positioned over a partition in the stomach. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0056]    The devices and methods described may provide a better way to partition the interior of an organ or body cavity. The resultant remodeled interior space will be formed by one or a series of wall-to-wall tissue unions that may be formed using graspers and securement devices. As shown in  FIG. 1 , one preferred goal is to partition the stomach  10  having an interior space  12  such that a separate region  14  is formed. At the entrance to the stomach  10  is located the distal end  16  of the esophagus. The distal end  16  of the esophagus terminates at the lower esophageal sphincter  18  before entering the stomach  10 . The upper portions of the stomach are defined by the fundus  20 , cardia  22  and the lesser curvature of the stomach  24 , which is the shortest wall between the lower esophageal sphincter  18  and the distal opening of the stomach, the pylorus  26 . The approximate position of a partition wall  28  is shown. The present invention is designed to be able to form partition wall  28  by drawing together folds of tissue from the interior of the stomach and then clamping them together. The basic steps consist of a) grabbing portions of the anterior and posterior stomach or other organ wall with tissue grasping elements, b) positioning a clamping device in the desired location along the stomach wall c) pulling the grasping elements such that portions of the wall of the stomach or organ are pulled through the clamping device and d) then releasing the grasping elements. 
         [0057]    In a particular embodiment for creating a partition in the stomach, a clamping device  40  is shown in  FIG. 2 . In this embodiment the clamping device  40  is made from two elongated beam elements  42   a  and  42   b . The beam elements  42   a  and  42   b  should preferably be constructed of strong material so that when tissue is clamped between the two beam elements  42   a  and  42   b , the clamping force is evenly distributed across the length of the beam element. The beam elements may have rounded or chamfered ends  46  and  47  so as to ease the insertion of the clamping device through a hollow passageway such as the esophagus. In one version the beam may be round and rotate like a roller but this rolling is not required for proper function. The clamping device  40  is secured at both ends  46  and  47  with a retainer  48 . The retainer  48  may be captured in a notch  50  formed near the ends  46  and  47  of the beam elements  42   a  and  42   b , The retainer may be made from elastomeric elements such as rubber bands or o-rings. Instead of an elastomeric element, other elements are readily conceivable to those knowledgeable in the art, such as metal springs, superelastic devices such as Nitinol and the like. The retainer  48  is designed to keep the beam elements  42   a  and  42   b  together in a closed configuration but ideally should allow the beam elements to separate to an open configuration whereby a small slot is opened between the beam elements. In this open configuration, the clamping device  40  can receive graspers attached to folds of tissue and then move to the closed configuration to securely clamp the folds of tissue together. 
         [0058]    Referring now to  FIG. 3 , one end of clamping device  40  could be hinged  61  and the other ends  62  and  64  could be closeable with a closure mechanism such as a pin and clasp. As shown in  FIG. 3 , a pin  66  is located at one of the open ends  62  and a receiving receptacle or clasp  68  is positioned opposite on end  64 . This embodiment shows a ratcheting option, which may not be required in all cases. Other closure mechanisms such as bayonet, slip fit, etc. are also possible. In this configuration, the clamping device  40  could be placed around a fold of tissue and then the two ends  62  and  64  closed by the operator by pushing on an actuator (not shown). The hinge  61  may be constructed as a conventional hinge with a hffigepin or other elements know to those skilled in the art, or it may be a living hinge, molded in one piece along with both beams. 
         [0059]    Some important parameters are clamping force and the size and shape of the clamping surface. Clamping force needs to be enough to occlude the blood supply in the tissue, and this may range from less than one PSI to 20 PSI, by way of example. The clamping surface should have a width similar to that used for staplers, ranging from about 2 mm to 10 mm, and it may be substantially flat across the clamped tissue. Alternatively, it may have a stepped surface. 
         [0060]    The clamping device  40  may be passed trans-esophageally to the stomach. It may also need to be long enough to create a full-width partition across the stomach, so preferably it should be from about 2 inches to about 4 inches in length. However it is difficult to pass something this long around the crycopharyngeal junction which is a location in the esophagus where the esophagus makes a severe turn accompanied with a slight narrowing. So it will preferably articulate as it passes through certain anatomical features. One approach is to have the clamping device  40  be hinged, so that it may articulate or bend in one place, and preferably in one direction only, but in no other places. It is important that the clamp is stiff along the plane that is parallel with the midline between the clamping elements (where the tissue will be clamped), so that the tissue is clamped with relatively even pressure across the clamping surfaces. 
         [0061]    An example of a simple hinge design is shown in  FIG. 4A . As shown the beam elements  42   a  and  42   b  are shown with a secondary hinge  70  and hinge pin  72 . In this embodiment, the clamping device  40  remains rigid along clamping surfaces  74 , but can bend in an orthogonal plane. This is better shown in  FIG. 4B  where the hinge is shown in a side view taken along plane A-A. Preferably the clamping device  40  cannot bend backwards from this position past the straight line B. In this regard the hinged clamping member resembles a locking knee. The reason for this feature is that it relates to the need to pull against the clamping device  40  without it buckling, as will be explained later. With this design, clamping device  40  can be delivered through the esophagus  76  to the stomach  10  and be able to navigate tortuous portions of the esophageal passageway. 
         [0062]    In a preferred method, the grasping elements  78  are placed in desired locations under visual guidance by use of an endoscope or other means. In this method, the stomach  10  may be insufflated and the endoscope&#39;s articulation features may be used to position the grasping elements  78  in their desired locations. This method allows visual verification that the grasping elements  78  have adequately grasped the tissue, by pulling back on the graspers and testing the degree of grasping. The grasping elements  78  are comprised of a grasping head  80 , a connecting element  82  and an actuator assembly  84  as shown in  FIG. 5 . Connecting element  82  is preferably flexible and torqueable. The grasping head  80  is shown as a clamping jaw that is activated with a linkage extending down the connecting element to the activator assembly which is a mechanical handle. However many other clamping head types are possible such as a corkscrew that is rotated and driven into the tissue with a spiral motion. The clamping head  80  may also be a barb or hook that snares the tissue and pulls the tissue against the hooked end. Other tissue grabbers common to those in the art are anticipated. 
         [0063]    By way of example, either two or four grasping elements  78  may be used to create a stomach partition. When just two are used, one is used to grasp the middle of the desired partition zone on the anterior wall, and the other is used to grasp the middle of the desired partition on the posterior wall. When four are used, two grasping elements  78  are used to pull on the outer ends of the desired partition zone on the anterior wall, and two on the posterior wall, Preferably the grasping elements  78  have a locking feature, similar to a hemostat, that keeps a firm grasp of the tissue once the grasping elements  78  are properly positioned, without requiring constant actuating pressure from the operator. 
         [0064]    In one embodiment of the invention, once the grasping elements  78  are in place, the clamping device  40  is slid into position in the stomach  10 . Preferably the clamping device  40  is positioned around the connecting elements  82  of the graspers. When two grasping elements  78  are utilized, the grasping elements  78  are first applied to the tissue as has been described and then the clamping device  40  is placed around the grasping elements outside the patient&#39;s mouth as shown in  FIG. 6 . The clamping device  40  may be placed in a first open configuration to facilitate placement around the grasping element  78  or if it is normally open as with an open ended clamp similar to the one shown in  FIG. 3  simply placed around the connecting elements  82  and then the clasp may be at least partially closed. The clamping device  40  is then slid along the connecting element, down the esophagus and into place in the stomach. It may be pushed along by a pusher element  90  as shown in  FIG. 7A . In this embodiment the pusher is detachably connected to the elongated beams  42   a  and  42   b  at point D. The pusher element  90  may have a wishbone distal end portion  91  so that a single pusher element  90  may be attached to both beams. The wishbone should be large enough to accommodate any flap of tissue that may be drawn into the clamping device  40 . The clamping device  40  may also be carried by an endoscope or it may be tugged into the stomach by a string that goes around a pulley anchored in the stomach as will be explained later. Preferably it is pushed along by an attached pusher element  90  which may include actuating or connecting elements as shown in  FIG. 7   b . The position and angle of attachment of the pusher element  90  relative to the clamping device  40  may be important in order to properly position the clamp in the stomach. This angle may be adjustable or may be fixed. 
         [0065]    When the clamping device  40  enters the stomach, preferably an endoscope is then inserted at least to the lower esophageal sphincter  18  to help position the clamp. Positioning may be accomplished by torquing the pusher element  90  and/or manipulating the connecting elements  82  of the grasping elements  78 . As shown in  FIG. 8 , the desired location for the clamping device  40  is to have one end  92  at the fundus  20  and the other end  94  near the lesser curvature. If four grasping elements  78  are used as shown, the clamp may be easier to align. With just two grasping elements  78 , there may be a tendency for the clamping device  40  to tilt 90° to align with the plane intersecting the points of attachment of the grasping elements  78  to the anterior and posterior walls of the stomach  10 . 
         [0066]    In any case, once the clamping device  40  is positioned, it may be held in place by applying traction to the pusher element  90 . The idea is to use the anatomy of the stomach  10 , in particular, the angle of His  96  and the cardia  22 , to wedge one end  92  of the clamping member  40 . This end  92  of the clamping member  40  can then be used as a pivot point. With one end  92  essentially fixated at the cardia  22  and angle of His  96 , pulling on the pusher element  90  will keep the clamping member  40  in correct alignment and position. As shown in  FIG. 9 , once the clamp is in place, and possibly being held by traction on the pusher element  90  in the direction of arrow A, the grasping elements  78  can be pulled, either individually or in groups, in order to drag a flap of tissue from an anterior stomach wall  100  and a posterior stomach wall  102  through the clamping member  40 . Once tugging is complete, which may be confirmed visually with an endoscope, the grasping elements  78  are released and the pusher element  90  is detached from the clamping member  40 . 
         [0067]    Over the next few days or weeks, the clamping member  40  may induce ischemia in the tissue flaps and induce muscle-to-muscle and serosa-to-serosa healing of the anterior  100  and posterior  102  walls. This technique for clamp-induced securement of tissue to tissue was disclosed in a co pending U.S. Non Provisional application Ser. No. 11/418,691, filed May 6, 2006 entitled “Methods and Apparatus for Creating a Wall-to-Wall Adhesion from within an Organ Having a Lumen” the entire contents of which are included by reference. 
         [0068]    One important consideration is the placement of the grasping elements  78 . In the example shown in  FIG. 8 , the graspers were shown further down the stomach, below the clamping/partition site. This was to clearly show the basic method. In reality, it would be preferable to grasp closer to the site of the desired partition. Otherwise, if grasped farther down the stomach as shown in  FIG. 8 , after the grasping elements  78  are pulled through the clamping member  40 , and the clamping member  40  and grasping elements  78  are released, the clamping member may tend to be dislocated to where stretching of the stomach is minimized. This location may be back to the point where the peak of the anterior  100  and posterior  102  flaps were pulled from. So, the preferred location for grasping member  40  in the case of an anti-obesity partition would be more like at point A as shown in  FIG. 10  when two grasping elements  78  are utilized or a points B when a four grasping elements  78  are utilized. 
         [0069]    It will be appreciated that the beam elements  42   a  and  42   b  could be made up of magnets, or could use magnets to create or augment the clamping force. The clamping force of the clamping member  40  could be pre-loaded by a retainer such as element  48  in  FIG. 2  or some other force-generating means, and member  40  could be held open by use of a spacer element or multiple spacers, which are then pulled-out after the tissue is pulled through the clamp, thereby activating the clamping force against the tissue. 
         [0070]    The ideal clamp design has rounded edges so it is easy to pass through the esophagus without injury, and so when it is in traction it does not injure the fundus or cardia or lesser curvature. Preferably the clamp is comprised of at least some elements that are biodegradable, so that after a period of time, the parts will lose their strength, fall apart, and the remnants will pass through the GI tract without incident. Some parts may not be biodegradable, such as hinge pins and the like which require higher strength than biodegradable materials may provide. Such non-degradable parts will have smooth features and be small enough to pass without incident. 
         [0071]    Ideally, the clamping member  40  should have features which allow the tissue to be pulled easily through the clamping member  40 , such as a chamfered leading edge  108  to reduce tissue trauma. It is also preferable that clamping member  40  resists backward movement of the tissue once it is pulled through the clamping member. Many solutions to this are readily known to those skilled in the art. Examples are shown in  FIGS. 11A-C  whereby clamping member  40  utilizes a retention element  110  of various designs. In  FIG. 11A  the retention element  110  is a tooth  112  that, as tissue is pulled in the direction of the arrows by the grasping elements  78  through the clamping member  40 , the tooth permits the tissue to freely pass. However once tension on the tissue is released as the grasping elements  78  are released, the tooth digs into the tissue and retards backwards movement. The device may utilize multiple teeth or rows of teeth as necessary. The teeth may also be longer elements as shown in  FIG. 11B  that utilize long teeth  114   a  and  114   b  and pivot points  116  and  117  that actively pivot and pierce the tissue. In this embodiment, the tissue may get pierced and pinned against the opposite long tooth if the tissue moves backwards as shown in  FIG. 11C . 
         [0072]    The clamp may have a user-activated clamping mechanism which may augment or replace the elastomeric or spring member discussed previously. For example as shown in  FIG. 12 , one end  120  of the clamping member  40  has a hinge  122 . This hinge  122  could be a hinge and hinge pin design, or a living hinge as discussed previously, or it may utilize an elastomeric or spring element. The opposite ends  124  and  125  are essentially open and utilize a user-activated pull-wire to close. The pull-wire mechanism may be similar to that used in biopsy forceps; i.e., a central pull-wire  126  housed in a coil-spring  128 , wherein coil spring  128  provides column strength to push against the pulling force of the pull-wire  126 . It will be apparent that more substantial clamping force may be possible with the pull-wire approach as opposed to a passive non-user activated design. It will be further apparent that two pull-wires could also be used, with one on each end of the clamping member  40 . The two pull-wire embodiment may provide for a more evenly distributed force across the clamping surface. The pull-wire  126  and coil  128  may need to have a release mechanism so they could be detached after clamping. This could be done with a screw-in anchor that is unseated by twisting the pull-wire  126  and coil spring  128 . Or there could be a separate release wire, which when pulled, would unseat the pull-wire  126 , allowing it to be removed, along with the coil spring  128 . Alternatively, the pull-wire  126  could have a certain threshold of pull force above which the pull-wire  126  pops out of its anchor. That would provide an upper-end to the applied clamping force which might be beneficial. In embodiments where pull-wire  126  and coil-spring  128  are removable, clamping member  40  would incorporate a catch mechanism such as demonstrated by elements  66  and  68  shown in  FIG. 3 , or equivalent, in order to hold one or both ends of the clamping member  40  closed after the pull-wire  126  has been actuated and removed. 
         [0073]    The clamping member  40  may have additional elements to further improve the healing response. These elements may be spikes, needles, wires, blades, teeth, pins or the like, and may be applied to the tissue passively, as in the case of the teeth shown in  FIGS. 11A-C , or may be actively driven into the tissue. One simple way of driving elements in the tissue is by pulling a wedge across one or more tissue-piercing elements loaded inside either or both of the elongated beams as shown in  FIG. 13 . In this Figure, a clamping member  40  is shown with an integrated stapler system. In this example, rows of staples are incorporated into one side of the clamp, and forming anvils are located on the opposite side. The clamping member  40  is shown with two elongated beams  42   a  and  42   b  as previously described with unformed staples  130  recessed into pockets  132  formed in the upper beam  42   a . The unformed staples  130  are slidably loaded into these pockets  132  and a wedge  134  is dragged across the staples  130  to force them out through the tissue  133  with the ends of the staples formed by the anvils  136  positioned opposite in the lower beam member  42   b . The wedge may be activated by a pull-wire  139  encased in a spring coil  140 . The formed staples  138  are formed across the folds of the organ wall and secure the two folds together. Multiple staples can be seen in  FIG. 13  for it has been found that multiple staples secure the folds better than a single staple. Staplers such as this require significant force, so it is preferred that a fixed/ratcheting clamping member  40  be used as shown in  FIG. 3  instead of or along with the elastomeric retainer elements  48  shown. In addition to staples it will be appreciated that wires, pins, needles, teeth, tags, tie wraps etc. may be driven into the tissue using similar or alternative mechanisms. 
         [0074]    In the configuration disclosed thus far, the flaps of tissue that are pulled through the clamp that extend beyond the clamping surface of clamping member  40  will necrose, erode and eventually pass. In the case where the application is used to create a gastric restriction, the flaps, prior to necrosing, may initially provide an advantage in creating additional restriction to food flow and a feeling of fullness. Therefore, an alternative preferred embodiment comprises a clamp device which has an interrupted clamping surface as shown in  FIG. 14 . The intent is to allow enough blood supply to the flaps so that they remain viable and intact and therefore continue to provide resistance to food flow. One design factor to consider is the width of the interrupted clamping sections, indicated as “w” in the  FIG. 14 . After the clamp has eroded through the flaps and the clamp material has been biodegraded, there will be “windows” through the flap/partition proportioned to the width of the clamping surfaces. These windows should be small enough to minimize the amount of food that flows through them. By way of example, the windows may be about 2 mm to about 12 mm. It will be appreciated that these window features may be used advantageously to adjust the amount of food flow allowed. For example, by making the windows small enough, only liquid will flow through them, whereas by making them large, a portion of the food stream may flow through them. It will be appreciated that some or all of the windows may be plugged or unplugged with removable silicone plugs delivered endoscopically in order to decrease or increase food flow, respectively. 
         [0075]    The flaps may also in certain cases provide too much resistance to the flow of food, so it may be desirable to cut them off. This may be done using auxiliary tools after deployment of the clamp, using tools such as a cauterizing sphincterotomy wire or knife, or it may be done by the clamp itself by incorporating a cutting element in the clamp. In one such embodiment, the cutting element may extend across one or more of the proximal edges of the clamping surfaces, similar to the embodiment shown in  FIG. 11A , only instead of element  112  comprising one or more teeth, it comprises a sharp edge or pair of sharp edges. Alternatively, the cutting element may be a sliding blade  150  that is moved across the long axis of the clamping member  40 , using a pull-wire  152  very similar to that shown in  FIG. 13 . In this case the wedge  134  has been replaced with the sliding blade  150 , whose blade extends out through the clamped tissue. It will be appreciated that the cutting of the tissue may stimulate a more aggressive healing response, which may improve the degree of muscle-to-muscle healing that occurs between the clamped tissue layers. The sliding blade  150  may be centered along the longitudinal axis of the beam or it may be off axis. In yet another embodiment, a cutting element may be configured to pull through the center of the two opposed flaps of tissue, with a blade on the top and bottom of the element arranged to cut through both flaps. In a variant of this embodiment, the blades may be of insufficient depth to cut through the flaps, and therefore configured only to create an injury down to a certain depth of tissue (e.g., through the mucosa to the muscle layer) in order to provoke an aggressive muscle-to-muscle healing response without cutting off the flaps. It will be appreciated that alternatives to a blade-type cutting element may be readily conceived to create a similar injury, such as a ball with spikes on it, a rasp element, or the like. The latter embodiments would not require axial alignment as they are drawn through the flaps of tissues, and may therefore be simpler to employ. 
         [0076]    It will be appreciated that multiple clamping surfaces and/or devices may be used to create a wall-to-wall adhesion. For example, two clamps may be used or the clamps may be different sizes or shapes with different purposes in that they may have different clamping properties and/or one may have a cutting element, or one may have both. The use of more than one clamping member  40  approach may improve the ability to keep the tissue from sliding back through the clamp or clamps. 
         [0077]    To enhance the adhesion of the clamped tissue layers, it may be beneficial to use one or more of the following to induce thermal injury to the folded tissue. Thermal heating using a heated filament, resistive heating induced by passing electrical current such as Radio Frequency (RF) through the tissue or microwave heating may be utilized and applied as a separate step or included in the clamping member design. Many configurations of electrode shape and location are apparent to those skilled in the art. For example  FIG. 16A-C  shows several configurations of electrodes that might be suitable for use in combination with the clamping member  40 . It will be appreciated that the design in  FIG. 16B  has the benefit of inducing a heated/cauterized tissue zone on the flap side, leaving more tissue between the clamped surfaces for potential healing. The current and/or voltage applied to the tissue may be either DC or AC, as is well understood by those skilled in the art. Further, the energy delivery electrodes may be paired as shown in  FIGS. 16A and 16C . These type of electrodes are sometimes referred to as “bipolar”, or there may be single electrode or an array of electrically-common electrodes located on the clamping member  40  and a remote electrode attached to the patient&#39;s body at a separate location. The latter configuration is often called “monopolar”. The energy delivery electrodes may also be the same as the cutting elements described in  FIG. 14 , thereby enabling cutting and cauterizing with a common element. This would minimize the chance of bleeding and potentially exacerbate the inflammatory and healing response of the tissue. 
         [0078]    With the methods and devices described for creating a partition in the upper stomach, there is a chance that a significant (≧10 mm diameter) residual opening  160  will remain between the end of the formed partition and the wall of the fundus  162 . One method to minimize this residual opening  160  is to use the four grasper approach rather than the dual grasper approach. Alternatively, a fifth grasper could be used to grab the wall of the fundus  162  and drag it through the clamping member  40 , or to drag it into a special feature on the end of the clamping member  40  designed to close off the residual opening  160 . As shown in  FIGS. 17A-B , the primary folds may be formed with grasping elements A, B, C and D as previously described. A fifth grasping element E may be employed to draw into the clamping member  40  a third fold of tissue to close the residual opening  160 . The wall of the fundus  162  may be drawn into the clamping member  40  and secured along with the anterior fold  164  and the posterior fold  165 . The fundus wall fold  166  may be clamped along with these other layers of tissue. The fundus gap  160  could also be closed with a secondary procedure whereby tissue in the gap is gathered and cinched, plicated, glued or otherwise held together. One example would be to use a device made by Boston Scientific called the Speedband Litigator, which suctions tissue into an endcap on an endoscope and then puts a rubber band around the base of the sucked-in tissue. Another choice would be the NDO Plicatior, or a smaller version thereof. 
         [0079]    In certain cases, when an ideal partition is created near the cardia and significant flaps of tissue are clamped, too much resistance to food flow may be created resulting in inability for the patient to eat. A potential mitigation for this complication is to add a spacer element  170  to the clamping member  40  which will ensure an opening for food flow. The spacer  170  is preferably along the lesser curvature of the stomach wall  24 , since it has been shown that the lesser curvature  24  is less apt to dilate over time, and therefore has been used as the primary outlet path for conventional gastric restriction procedures such as vertical banded gastroplasty (VBG). One example of such a spacer would be a silicone ring designed to remain patent. This patency could be accomplished by using a material such as silicone that has a high material durometer to keep the ring open. Other materials such as flexible wire, Nitinol wire, coiled springs and various polymeric compounds could also be used. It may be configured to pass readily in one or more pieces or to degrade on its own after the clamping member  40  has been removed or biodegraded. 
         [0080]    It will be appreciated that in conjunction with, or in addition to, the partition-creating methods and devices disclosed herein, the method and devices disclosed and claimed on the pending patent application 2005/0055038 filed Sep. 9, 2003 entitled “Device and Method for Endoluminal Therapy” may be utilized to create a more effective restrictive outlet. Note that the same methods may be applied to an alternate or secondary outlet located along the fundus. 
         [0081]    It will be appreciated that the grasping elements  78  referred to throughout this application may be integrated with the clamping member  40 . Certain advantages of procedural simplification may be achieved by having grasping elements  78  loaded at spaced locations on the clamping member  40 . Such grasping elements  78  are preferably in a collapsed orientation during trans-esophageal insertion, then deployed to an outwardly-directed orientation to grasp tissue.  FIGS. 19A-13  illustrate an embodiment similar to that shown in  FIG. 2 , with the addition of grasping elements integrally located within the clamping member  40 . The top beam  42   a  of clamping member  40  has openings  180  in the body of the beam  42   a . The grasping elements  78  are shown collapsed or retracted into the openings  180  in a position suitable for introduction of the clamping member  40  into the esophageal passageway. The grasping elements  78  can be deployed from these openings  180  to grab tissue and draw it into the clamp as in previously disclosed methods. A four grasper version is shown but other numbers of grasping elements may be used. 
         [0082]    With this method, once the clamping member  40  is positioned and the graspers are deployed, air may be removed from the stomach to collapse the walls and bring them into contact with the grasper jaws. Methods for unfolding rugal folds in order to get a deeper grasp of muscle may be utilized; such methods and devices are described and claimed in pending application 2005/0055038 previously mentioned. 
         [0083]    Alternatively, the clamping member/grasping element assembly could be linked to a steerable component such as an endoscope, and, with the stomach at least partially insufflated, could be guided first to one wall where a pair of grasping elements  78  are deployed, and then to the other wall, where the remaining grasping elements  78  are deployed. 
         [0084]    The adhesion of layers of clamped tissue may be improved by the insertion of an element between the layers of tissue, particularly between the opposed faces of anterior wall mucosa and posterior wall mucosa. Adhesion may also be improved by mechanically, electronically, or otherwise altering the tissues of that interface in order to trigger a more aggressive inflammatory response and subsequent healing effect. Simple mechanical removal of the mucosa and submucosa will allow better muscle-to-muscle adhesion. This may be accomplished with endoscopic mucosectomy methods and tools known to those skilled in the art. Elements that may be inserted at that tissue interface include those that have mechanical properties to disrupt the tissue, such as spike strips or strips with chemical irritants such as sodium morrhuate or silver nitrate, or the like. Elements, may also comprise mesh-type strips such as Marlex mesh (C. R. Bard) which promote tissue ingrowth, or elements made from a biomaterial such as KS (small intestinal submucosa, Cook Biotech) which has been shown to promote ingrowth in GI applications. Such elements or agents may be inserted into the interface endoscopically after the tissue flaps have been pulled through the clamping member  40 , but before the clamping member is activated. Alternatively, these elements may be injected into the clamped interfaced, or wicked-in, or just applied along the exposed edge. 
         [0085]    Throughout this disclosure, the tissue grasping elements  78  have been shown as endoscopic forceps-type devices, by way of simplicity and example only. However, it is important that the graspers bite or attack deep enough into the wall to be able to pull the tissue with adequate traction to get it through the clamp. Certain rat-tooth grasping forceps are available from companies such as Olympus and they may be adequate if used properly. Alternatives include corkscrew-type devices, such as used by the NDO Plicator device, or T-tag type anchors which are known to those skilled in the art. It will be appreciated that when manually placing the graspers and pulling on the tissue under visual guidance, multiple attempts to grasp and pull the tissue are not unreasonable since it will be obvious when the tissue has been successfully pulled into place. 
         [0086]    Many of the embodiments thus far described utilize more than one grasping element  78 . Conventionally a single accessory at a time is passed down a working channel of an endoscope. If additional accessories (such as graspers) must be used, the endoscope must be removed from the patient while leaving the grasping end  80  and the connecting means  82  in place, thereby requiring the detachment of any activation elements like handles or pull rings from the proximal end of the accessories so that the endoscope can be removed. The endoscope must be then passed back down the esophageal passageway, repositioned in the body and another accessory such as a grasper passed down the working channel and deployed. However, accessories with removable proximal elements are not typical, and the process of disassembling them and reassembling them for purposes of passing the endoscope into the patient multiple times is unwieldy. In order to simplify the process of placing multiple grasping devices sequentially, without having to remove the endoscope and without having to have a grasping element  78  with a detachable proximal activator assembly, a novel modified auxiliary working channel is hereby disclosed. 
         [0087]    The modified auxiliary working channel is similar to that used with the Bard Endo-Cinch device, which straps onto the outside of the endoscope  190  with a cross-section shown in  FIG. 20 . However, this auxiliary channel  192  can only accommodate one device at a time. It will be appreciated that the conventional endoscope  190  with a single working channel  194  shown combined with the auxiliary working channel  192 , could be used to place two grasping elements  78 . However, the endoscope  190  would not be able to be removed to enable insertion of the clamping member  40  without having to disassemble the proximal elements of grasping elements  78 . Similarly, if a two-channel scope (such as is available from Olympus) is used, that scope could not be removed either, unless the grasping elements  78  have detachable activators. 
         [0088]    There is, therefore, a need for an auxiliary working channel which allows placement of multiple accessories sequentially and allows for the removal of the endoscope from the patient without having to remove an accessory extending through the working channel. The novel solution to this need is an auxiliary channel with the profile shown in  FIGS. 21A-B . This auxiliary channel  200  is placed around a conventional endoscope  201  using a strap  202 , a series of straps or a formed elastomeric clip  203 . The auxiliary channel  200  has an open seam  204  that normally stays closed such that accessories are contained along the channel  200 . However, when a first accessory is successfully placed and a second is desired, the proximal end of the first one can be moved out through the seam  204  at the proximal end  205  of the channel, allowing room for the tip of a second one to be inserted into the channel  200  and advanced, forcing the first accessory out through the seam  204  as it moves along. To remove an accessory from the auxiliary channel  200  in order to remove the endoscope  201 , any other accessory may be used to push out the accessory already in the channel, then the other (pusher) accessory is simply pulled back out and the endoscope  201  is removed. 
         [0089]    It is sometimes difficult to correctly identify anatomic landmarks in the stomach when performing endoscopy. For the procedure described, it is important to identify the lesser curvature correctly. To aid in this process, a catheter or guidewire with an inflatable tip may be anchored beyond the pylorus, and then held in traction in order to highlight the lesser curvature.  FIG. 22  shows a stomach  10  with a catheter  210  positioned through the esophagus, through the lower esophageal sphincter  18  along the lesser curvature of the stomach  24  and through the pylorus  26 . The distal end of the catheter  210  has an inflatable balloon  212  that is shown inflated. Once the balloon  212  has been inflated, the proximal end of the catheter  210  can be pulled to put the catheter  210  in traction. This catheter  210  can be seen with an endoscope and thus the lesser curvature can be identified. Such a method may be used in combination with the other novel methods described herein. 
         [0090]    The clamping member  40  may have a more complex shape or geometry in order to form varied tissue partition configurations other than the straight-line partition as previously described. For example, the hinge feature for the clamping member  40  described previously may be used to further advantage, aside from easing trans-esophageal insertion, in order to create a bi-directional partition as shown in  FIGS. 23A-B . In this application the clamping member  40  is articulated as previously described at point P by a hinge  220  at an angle α. This divides the clamping member  40  into two segments  222  and  224 . The segments can be the same or different lengths depending on the partition shape desired as will be shown. Also shown are four grasping elements  78  attached to tissue flaps at four positions. Two of the grasping elements  78  are attached to a posterior tissue flap  225  and two are attached to an anterior tissue flap  226 . As can be seen in  FIG. 23B , the articulated clamping member  40  may create a line of tissue union that has a shape roughly corresponding to the angle of the clamping member a shown in  FIG. 23A . The resultant tissue line  228  has a shape that may be more suited for a restrictive outlet. The advantage of a two-partition clamping member  40  such as this is, for example, to create one partition  230  with clamp portion  224  which essentially creates a pouch from the cardia near the lower esophageal sphincter (LES), and to create a second partition  232  with clamp portion  222  which essentially creates a restrictive outlet  233  to the pouch. Such methods are described and claimed in the pending application 2005/0055038 previously mentioned. Alternatively, the clamp may be curved to suit whatever shape partition is desired. 
         [0091]    If it is desired that the partition(s) created using the methods and devices described herein be removed, conventional endoscopic tools may be used, such as RF energy-delivering tools that cut and cauterize (Gold Probe, Boston Scientific; Sphincterotome, Wilson-Cook). Alternatively, a non-RF tool such as a cutting blade or wire may be used. Another approach is to use a dilatation balloon (such as Wilson-Cook&#39;s Achalasia Dilitation balloon). The balloon would be positioned near the partition and expanded until the partition slowly rips apart. This approach may be appropriate only for certain small, thin-walled partitions under visualization. A novel method which is an additional object of the present invention is to use an endoscopically-placed clamp placed along the long axis of partition to necrose through the tissue of the partition. The important feature of this method is that the clamp is placed such that it erodes through only the “curtain” of tissue which makes up the partition and does not create an opening or ulceration in the wall of the hollow organ. This gives the method a distinct advantage over the previously described methods which use conventional tools and which run the risk of cutting or cauterizing a hole in the wall of the organ, or tearing a hole in the wall. As with the other clamp devices described elsewhere, the clamp may be made from biodegradable materials. The clamp is preferably open on one end, and has a spring element (or elastomeric element, or user-activated ratcheting element) in the non-closed end. This invention is disclosed in more detail in  FIGS. 25A-C . In  FIG. 25A , clamp assembly  304  is comprised of clamp  306  and guide element  308 , which may be a wire or coil spring or the like. In  FIG. 25B  clamp assembly  304  is shown inserted through the esophagus into stomach  10 , where a partition  312  had been previously formed. The opening of clamp  306  is aligned with one end of the partition and pushed onto it as shown in  FIG. 25C . Once clamp  306  is positioned along the length of partition  312  and activated (if it is a user-activated clamp; otherwise it will already have a clamping force exerting onto the partition), guide element  308  may be removed from its coupling point  310  using mechanisms and methods previously described for similar elements elsewhere. 
         [0092]    In another embodiment of the invention shown in  FIGS. 24A-B , in order to pull the clamp through the esophagus, or to pull any device or accessory described, without having to have a stiff pusher element attached, a pulley-based accessory may be deployed beyond the described delivery location. In the ease of the methods and devices disclosed previously, a pulley element  299  may be added to one of the grasping elements  78 , or it may be added to the balloon-tipped guidewire or catheter  210 . Before either element is deployed, it may be rigged with a string  300  or other suitable device through a pulley  302  which may be a low friction structure with or without a rolling element. Once the element is anchored, the two ends of the string are outside the patient&#39;s mouth, and one end can be attached to the device to be pulled through the esophagus by pulling on the other end of the string. 
         [0093]    It will be appreciated that while the methods and devices disclosed herein may be used in the specific manner described to create a partition in the upper stomach which is effective in treating obesity, similar methods and devices may be used to treat GERD. In particular, the creation of a partition as shown in  FIG. 1  has been shown to provide an effective treatment for GERD in clinical trials (Swain CP. (1999). Endoscopic suturing. Baillieres Best Pract Res Clin Gastroenterol, 13(1):97-108). Further, the general methods and devices disclosed may be used to create partitions in any hollow organ or inside any body lumen. By way of example, this apparatus and method might be used in the colon to treat incontinence and it might be preferably useful in thinner more compliant organs. This apparatus and method might also be used for circumferential closure of an internal opening or anastomosis. It might be effective to do a sleeve resection internally or to close the stomach in gastric bypass. 
         [0094]    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 and/or uses of the invention and obvious modifications and equivalents thereof. Thus it is intended that the scope of the present invention herein 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.