Tissue-acquisition and fastening devices and methods

Abstract

Devices and methods for acquiring and fastening tissues folds within an internal organ, such as the stomach, and for applying the methods and devices to producing reductions in organ volume or repair of bariatric procedures, are disclosed. An exemplary method for forming a continuous laterally extending tissue fold involves forming a succession of laterally extending folds having adjacent overlapping fold portions. One exemplary tissue-acquisition device has an open-end roller-and-arm structure that allows individual tissue folds to be formed and fastened, then advanced to an adjacent region within the stomach, for capture of a new fold that will form an extension of the existing fold(s).

1 . A method of treating an obesity-related eating disorder in a patient, comprising
 (a) intraorally placing within the patient's stomach, a tissue-acquisition device capable of acquiring and fastening a laterally extending two-layer tissue fold;   (b) placing the tissue-acquisition device against a selected region of the interior of the stomach's anterior wall, posterior wall, or fundus;   (c) operating the device to acquire and fasten a laterally extending two-layer tissue IOU   (d) moving the tissue-acquisition to place it against a new selected interior stomach region adjacent the fastened tissue fold formed in step (c), such that the device, when operated to acquire a tissue fold, will form a single continuous laterally extending tissue fold that includes a portion of the fold formed in step (c), and which extends along a region of the stomach's anterior wall, or posterior wall, or fundus; and   (e) repeating steps (c) and (d) until a single, continuous two-layer tissue fold composed of at least three individually-fastened folds formed in steps (c) is formed in the stomach's anterior wall, posterior wall, or fundus.   
     
     
         2 . The method of  claim 1 , wherein step (c) for acquiring and fastening a tissue fold is carried out by a tissue-acquisition device having a fastener mechanism integrated into its structure. 
     
     
         3 . The method of  claim 1 , wherein step (c) for acquiring and fastening a tissue fold is carried out by a tissue-acquisition device and an independently operated fastening device. 
     
     
         4 . The method of  claim 1 , wherein step (e) is carried out until the total volume of the stomach interior has been reduced by at least 40%. 
     
     
         5 . The method of  claim 1 , wherein step (e) is carried out until a length of tissue fold effective to substantially reduce stomach motility, as evidenced by a reduction in measured periodic motor activity after eating, is created. 
     
     
         6 . The method of  claim 1 , wherein the tissue-acquisition device used to acquire and fasten tissue in step (c) includes an elongate open-end roller device having a roller, a roller-confronting arm, and a clamping mechanism activatable to move the arm between open and closed conditions; step (d) includes activating the clamping mechanism to its open and closed positions, respectively, before and after moving the device to a position in which the open end of the device embraces a portion of a previously acquired and fastened tissue fold; and step (c) includes rotating the roller in a direction effective to draw a tissue fold between the roller and arm. 
     
     
         7 . The method of  claim 6 , wherein said roller has a plurality of elongate tissue-capture chambers distributed radially about the roller, and said device is operable to connect an external vacuum source to successive capture chambers as the roller is rotated in a tissue-advancing direction, such that applying a vacuum to said roller while rotating the roller in the tissue-advancing direction functions to draw a tissue fold between the roller and arm by successive capture and release of tissue in successive tissue-capture chambers. 
     
     
         8 . The method of  claim 6 , wherein the tissue-acquisition device includes a pusher operable to eject a fastener through a tissue fold formed between the roller and arm of the device; and step (c) includes activating the pusher to place a fastener between the layers of a tissue fold. 
     
     
         9 . The method of  claim 1 , wherein the tissue-acquisition device used to acquire and fasten tissue in step (c) includes a pair of side-by side augur blades that are open at their distal ends, and a drive mechanism for rotating at least one of the two blades in a selected direction, for acquiring a tissue fold between the two blades when the at least one blade is rotated, step (c) includes activating the drive mechanism to form a tissue fold between the auger blades, and fastening the tissue fold, and step (d) includes moving the tissue acquisition device such that the blades are in contact with a portion of a previously acquired and fastened tissue fold. 
     
     
         10 . The method of  claim 9 , wherein the blades are mounted on a frame for movement toward and away from one another under a biasing force that biases the two blades toward one another. 
     
     
         11 . The method of  claim 9 , wherein the tissue acquisition device includes, as a fastening mechanism, structure for electing pre-formed wire coils from one of said blades into tissue captured between the two blades. 
     
     
         12 . The method of  claim 1 , wherein the wherein the tissue-acquisition device used to acquire and fasten tissue in step (c) includes a scissor-arm cage covered by a flexible membrane that is open at one side of the cage only; the cage is expandable from a collapsed condition for step (a) to an expanded condition operable to draw a two-layer tissue fold into the cage, when the cage's open side is placed against a selected stomach region in steps (b) or (d), and a vacuum is applied to the interior of the cage in step (c). 
     
     
         13 . A method of restoring a vertical sleeve gastrectomy (VSG) which has failed in a patient because the patient's stomach has expanded and regained a significant portion of its pre-surgical volume, by incorporating the vertical stomach seam formed in the initial VSG operation into an elongate fold in the stomach, by the steps of:
 (a) intraorally placing within the patient's stomach, a tissue-acquisition device capable of acquiring a two-layer tissue fold by vacuum and fastening the fold to form a plication;   (b) placing the tissue-acquisition device against a region of the stomach adjacent the seam brined during the vertical sleeve gastrectomy;   (c) operating the device to acquire and fasten a two-layer tissue fold that contains a section of the VSG seam,   (d) moving the tissue-acquisition to place it against a new selected interior stomach region adjacent the fastened tissue fold formed in step (c), and   (e) repeating steps (c) and (d) until the VSG volume of the stomach has been restored.   
     
     
         14 . A tissue acquisition device for acquiring a tissue fold, comprising in operative condition
 a support frame;   an elongate roller mounted on the frame for rotation about the roller's long axis, said roller including tissue-engaging structure for engaging tissue and advancing the engaged tissue in the direction of roller rotation;   a roller driver for rotating the roller in a tissue-advancing direction;   an arm mounted on said frame at a position spaced from and confronting said roller, between which a two-layer tissue fold is formed, as tissue is advanced into and through the device as the roller is rotated; and   a vacuum conduit in said frame for connecting an external vacuum source to said roller or to said arm, to hold one layer of a two-layer tissue fold by vacuum adherence, as tissue is being advanced into and through the device by rotation of the roller.   
     
     
         15 . The device of  claim 14 , for use in forming a tissue fold in within the interior of the gastrointestinal tract, which further includes an elongate shaft having a distal end at which the device frame is attached and a proximal end having user controls by which a user can control the operation of the device outside the patient's body after intraoral placement of the device within the patient's gastrointestinal tract. 
     
     
         16 . The device of  claim 14 , wherein said tissue engaging structure in the roller includes a plurality of elongate tissue-capture chambers formed in said roller and distributed radially about the roller, and said vacuum conduits are operable to connect an external vacuum source to successive capture chambers as the roller is rotated, in a tissue-advancing direction, such that a tissue fold tissue is drawn into and through said device by successive capture and release of tissue in successive tissue-capture chambers. 
     
     
         17 . The device of  claim 16 , wherein said frame includes a post on which the roller is rotatably mounted about an axis; said post has a fixed plate with a vacuum port in said vacuum conduit that is offset from said axis; said roller includes a rotatable plate that confronts and contacts the fixed plate when the roller is rotated; and said rotatable plate includes a plurality of elongate recesses in said vacuum conduit, each of which moves in an out of fluid communication with the vacuum port in the first plate as the roller is rotated, to successively communicate each tissue-capture chambers in the roller with the vacuum port through the associated elongated recess in the roller plate. 
     
     
         18 . The device of  claim 11 , which is open at one end, and which further includes a clamping mechanism activatable to move the arm between an open position in which the arm and roller can embrace a side region of an already formed tissue fold and a closed condition in which a tissue fold can be formed in the device by rotating the roller. 
     
     
         19 . A tissue acquisition device for acquiring a tissue fold, comprising
 (i) a frame,   (ii) a pair of helical-surface augur blades that are mounted on the frame for rotation about the blade axes and for movement toward and away from one another by a biasing force that biases the blades toward one another, and   (iv) a drive mechanism for rotating at least one of the two blades in a selected direction.   
     
     
         20 . The device of  claim 19 , wherein each auger blade has a proximal section of relatively low pitch, a distal section of relatively high pitch, and a center region of intermediate pitch, where the width of the each blade in the proximal section is tapered on progressing toward the proximal end of the blade. 
     
     
         21 . The device of  claim 20 , having a fastener mechanism that includes a conduit through which a plurality of pre-formed metal wire segments can be advanced, and a pusher which is operable to advance the segments within the conduit, wherein the wire segment forms a coil-wire loop as it exits the conduit. 
     
     
         22 . A tissue acquisition device for acquiring and fastening a tissue fold, comprising
 (i) a scissor-arm cage having an opening on one side thereof;   (ii) a flexible membrane covering said cage and optionally, a portion of said opening;   (iii) an expansion mechanism for expanding the cage from a collapsed-arm condition to an expanded-arm condition in which the cage defines a tissue-capture chamber covered by the membrane, and   (iv) a vacuum port through which vacuum can be supplied to the tissue-capture chamber, with the cage in its expanded-arm condition, to draw a tissue fold into the chamber through said opening.   
     
     
         23 . A tissue acquisition device for acquiring and fastening a tissue fold, comprising
 (i) an elongate hollow tube into which tissue can be drawn with application of a vacuum to the tube, and   (ii) a stapler head carried at the distal end of the tube, and movable between an open condition defining a chamber through which tissue can be drawn into the tube, and a closed condition in which a stapler assembly in the stapler head can be operated to fasten a tissue fold drawn into the tube.   
     
     
         24 . The device of  claim 23 , wherein the stapler assembly in the stapler head is constructed to hold a plurality of stacked staples, and has a staple ejector for ejecting individual staples from the assembly, where the head also includes an anvil frame on which the stapler assembly is pivotally mounted and which provides an anvil surface for crimping staples ejected from the stapler assembly. 
     
     
         25 . A stapling device for applying a linear array of staples to a tissue, comprising
 (i) a housing;   (ii) a staple cartridge contained within said housing for holding a plurality of staples in a linear array;   (ii) a pusher assembly having a plurality of pusher surfaces arrayed to simultaneously engage respective staples held in said cartridge, to eject the staples from the cartridge as the pusher assembly moves in a bottom-to-top direction within the housing between lowered and raised positions, and a linear array of pins extending along at least one side of the pusher assembly;   (iii) an ejector assembly having an elongate drive plate disposed within said housing for movement in an end-to-end direction between load and retracted positions, said drive plate having a linear array of angled slots formed in a side thereof, and in which pins in the pusher assembly ride, such that movement of the drive plate in the ejector assembly from its load toward its retracted position forces the pusher assembly from its lowered to its raised condition; and   (iv) an anvil disposed adjacent the top surface of the housing, for crimping staples ejected from the cartridge when the drive plate is moved from its load to its retracted.   
     
     
         26 . A multi-fire fastening device for fastening two or more layers of material together, comprising
 an arm,   an elongate slot formed in the arm,   disposed in said slot, one or more U-shaped fasteners, each having a pair of elongate, side-by-side legs that are preformed to adopt the shape of a loops when the fastener is ejected from the slot, and   a pusher for ejecting individual fasteners from the slot.   
     
     
         27 . A multi-fire fastening device for fastening two or more layers of material together, comprising
 (a) a feed tube;   (b) a wire dimensioned for linear advancement within said tube, said wire having a plurality of coil segments interspersed with breakaway segments designed to break when the wire is subject to a selected bending force,   (c) a deflection member carried at the distal end of said tube for bending a coiled segment of the wire into a coil, as the distal end portion of the wire is advanced out of the feed tube, where each coil segment is dimensioned to form at least a full-circle coil before the next-in-line breakaway segment is bent and breaks as it passes over the deflection member, and   (d) a pusher for advancing the wire within the tube.   
     
     
         28 . The device of  claim 27 , wherein said breakaway segments are tapered in wire diameter on progressing in a distal direction, such that the region of greatest susceptibility to breaking is the interface between a coil segment and its trailing breakaway segment, whereby each successive coil segment has a tapered-diameter end as it is advanced out of the tube. 
     
     
         29 . The device of claim  57 , which further includes an anvil having a curved deflection surface. 
     
     
         30 . A multi-fire fastening device for fastening two or more layers of material together, comprising
 (a) a distal-end clamp having first and second clamping arms that can be moved toward and away from a closed, clamping condition, and   (b) first and second anchor channels that are operable to deliver one of a linear array of first and second anchor components to the clamping arms, respectively;   where the first and second anchor components are locked together to form a tissue anchor when clamped together.