Devices for placement of partitions within a hollow body organ

Description of equivalent WO 2007078988 A2

DEVICES AND METHODS FOR PLACEMENT OF PARTITIONS WITHIN A HOLLOW BODY ORGAN

0002Cross-Reference To Related Application This application is a continuation-in-part of co-pending application Serial

0003No. 10/797,303 filed on March 9, 2004, which is herein incorporated by reference. Background of the Invention

00041. Field of the Invention:

0005The present invention relates generally to medical devices and methods. More particularly, it relates to devices and methods for creating a partition within a hollow hody organ, particularly a stomach, intestinal tract, or other region of the gastrointestinal tract, and affixing the tissue.

00062. General Background and State of the Art: hi cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to "tie off or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass of the intestine.

0007Typically, these stomach reduction procedures are performed surgically through an open incision and staples or sutures are applied externally to the stomach or hollow body organ. Such procedures can also be performed laparoscopically, through the use of smaller incisions, or ports, through trocars and other specialized devices. In the case of laparoscopic banding, an adjustable band is placed around the proximal section of the stomach reaching from. the lesser curve of the stomach around to the greater curve, thereby creating a constriction or "waist" in a vertical manner between the esophagus and the pylorus. During a VBG, a small pouch (approximately 20 cc in volume) is constructed by forming a vertical partition from the gastroesophageal junction to midway down the lesser curvature of the stomach by externally applying staples, and optionally dividing or resecting a portion of the stomach, followed by creation of a stoma at the outlet of the partition to prevent dilation of the outlet channel and restrict intake. In a Roux-En-Y gastric bypass, the stomach is surgically divided into a smaller upper pouch connected to the esophageal inflow, and a lower portion, detached from the upper pouch but still connected to the intestinal tract for purposes of secreting digestive juices. A resected portion of the small intestine is then anastomosed using an end-to-side anastomosis to the upper pouch, thereby bypassing the majority of the intestine and reducing absorption of caloric intake and causing rapid "dumping" of highly caloric or "junk foods."

0008Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, use of general anesthesia, time and pain associated with the healing of the incisions, and other complications attendant to major surgery. In addition, these procedures are only available to a small segment of the obese population (morbid obesity, Body Mass Index > 40) due to their complications, leaving patients who are considered obese or moderately obese with few, if any, interventional options.

0009In addition to surgical procedures, certain tools exist for securing tissue such as the stapling devices used in the above-described surgical procedures and others such as in the treatment of gastroesophageal reflux disease (GERD). These devices include the GIA® device (Gastrointestinal Anastomosis device manufactured by Ethicon Endosurgery, Inc. and a similar product by USSC), and certain clamping and stapling devices as described in U.S. Pat. Nos. 5,403,326; 5,571,116; 5,616,61 A; 5,897,562; 6,494,888; and 6,506,196 for methods and devices for fundoplication of the stomach to the esophagus for the treatment of gastroesophageal reflux disease (GERD). In addition, certain tools, such as those described in U.S. Pat. Nos. 5,788,715 and 5,947,983, detail an endoscopic suturing device that is inserted through an endoscope and placed at the site where the esophagus and the stomach meet. Vacuum is then applied to acquire the adjacent tissue, and a series of stitches are placed to create a pleat in the sphincter to reduce the backflow of acid from the stomach up through the esophagus. These devices can also be used transorally for the endoscopic treatment of esophageal varices (dilated blood vessels within the wall of the esophagus).

0010There is a need for improved devices and procedures. In addition, because of the invasiveness of most of the surgeries used to treat obesity and other gastric disorders such as GERD, and the limited success of others, there remains a need for improved devices and methods for more effective, less invasive hollow organ restriction procedures. Surnmary Of The Invention

0011Devices for tissue acquisition and fixation, or gastroplasty, are described that may be utilized for creating a partition within a hollow body organ, such as the stomach, esophageal junction, and other portions of the gastrointestinal tract. Generally, the devices of the system may be advanced in a minimally invasive manner within a patient's body, e.g., transorally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ. Such divisions or plications can form restrictive barriers within the organ, or can be placed to form a pouch, or gastric lumen, smaller than the remaining stomach volume to essentially act as the active stomach such as the pouch resulting from a surgical Roux-En-Y gastric bypass procedure. Examples of placing and/or creating divisions or plications may be seen in further detail in U.S. Pat. No. 6,558,400; U.S. Pat. App. Serial No. 10/188,547 filed July 2, 2002; and U.S. Pat. App. Serial No. 10/417,790 filed April 16, 2003, each of which is incorporated herein by reference in its entirety.

0012The devices may be advanced within a body through a variety of methods, e.g., transorally, transanally, endoscopically, percutaneously, etc., to create one or several divisions or plications within a hollow body organ, e.g., to create a gastric lumen or partition to reduce the effective active area of the stomach (e.g., that which receives the initial food volume), performed from within the stomach cavity. The creation of this smaller gastric lumen may be achieved in a minimally invasive procedure completely from within the stomach cavity. Moreover, the devices are configured such that once acquisition of the tissue is accomplished, manipulation of the acquired tissue is unnecessary as the devices are able to automatically configure the acquired tissue into a desired configuration.

0013The devices may generally comprise a first acquisition member and a second acquisition member in apposition to one another along a first longitudinal axis, wherein optionally, at least one of the acquisition members is adapted to adhere tissue thereto such that the tissue is positioned between the first and second acquisition members, and optionally wherein at least one of the acquisition members is movable relative to the first longitudinal axis between a delivery configuration and a deployment configuration. Moreover, the system may also comprise a septum, or separator, removably positioned between the first and second acquisition members, wherein at least one of the acquisition members is movable relative to the septum between a delivery configuration and a deployment configuration.

0014A handle may be located at a proximal end of an elongate body or member and used to manipulate the device advanced within the hollow body organ as well as control the opening and clamping of the acquisition members onto the tissue. The elongate body may be comprised of a series of links, or of an extrusion fabricated with various lumens to accommodate the various control mechanisms of the acquisition device. Similarly, the control mechanisms may be grouped together and sheathed in a thin skin sheath, such as a heat shrink. A working lumen may extend entirely through the elongate member and may be sized to provide access to the distal end for various surgical tools, such as an endoscope or other visualization device, or therapeutic devices such as snares, excisional tools, biopsy tools, etc. once the distal end of the assembly is positioned within the hollow body organ. The acquisition members may be joined to the elongate body via a passive or active hinge member, adaptable to position the assembly. The acquisition members may generally comprise a cartridge member placed longitudinally in apposition to an anvil member. The cartridge member may contain one or several fasteners, e.g., staples, clips, etc., which may be actuated via controls located proximally on the handle assembly. Moreover, the septum or barrier may be removably positioned between the cartridge member and anvil member and used to minimize or eliminate cross acquisition of the tissue into the cartridge member and/or anvil member.

0015Methods of placing a partition from within a hollow body organ using the devices disclosed herein generally comprise positioning a first acquisition member and a second acquisition member adjacent to a region of tissue within the hollow body organ, wherein the first and second acquisition members are in apposition to one another along a first longitudinal axis, adhering tissue from the region to each of the first and second acquisition members, and securing the adhered tissue between the first and second acquisition members. Such a method may also involve pivoting at least one of the acquisition members about the longitudinal axis to an open or closed configuration. Another method may also comprise removing a septum from between the first acquisition member and the second acquisition member.

0016While the device is in a delivery configuration, i.e., where the components of the distal working portion of the device (the cartridge member and anvil member) are disposed such that the cartridge and anvil are directly positioned into apposition about the septum. Once desirably positioned, one or both of the cartridge member and anvil member may be rotated about a pivot or translationally moved in parallel to one another. Then, portions of the stomach wall may be acquired by, or drawn within their respective openings. The configuration of the cartridge member and anvil member and the positioning of the device within the stomach are such that this tissue acquisition procedure also enables the devices to be self-adjusting with respect to the acquired tissue. Moreover, the devices are configured such that portions of the stomach wall are automatically positioned for fixation upon being acquired and the tissue becomes automatically adjusted or tensioned around the perimeter of the distal working portion of the device in the stomach and within the distal working portion inner volume, to achieve the desired resulting geometry (e.g., small gastric pouch or restrictive partition or baffle). Because of the manner in which the tissue is acquired, the tissue intimately surrounds the cartridge member and anvil member to define or calibrate the subsequent volume of the resulting gastric lumen. Thus, the gastric volume may be predetermined by adjusting the volume of the cartridge member and anvil member, or the use of accessory devices such as a scope or balloon. As a result, once the desired volume is known and incorporated in the device, the user can achieve a controlled acquisition and without intraprocedural adjustments or positioning requirements.

0017The septum may act effectively as a barrier between the openings to facilitate the acquisition of the tissue to their respective openings while minimizing or eliminating cross acquisition of the tissue into the cartridge member and/or anvil member. In other alternatives, the septum may be omitted from the device and acquisition of the tissue may be accomplished by sequentially activating vacuum forces within the openings. Once the tissue has been acquired, the septum may be removed from between the cartridge member and anvil member by translating the septum distally or proximally of the cartridge member and anvil member or left within the stomach for later removal.

0018The cartridge member of the tissue treatment device may be re-loadable with a removable staple cartridge after forming a plication within the cavity. This allows the same tissue treatment device to form multiple plications within the cavity. A method of treating a stomach cavity may include forming a first plication within the stomach cavity using staples from a. first removable staple cartridge, which is easily removed from the cartridge member. A second removable staple cartridge is then inserted into the cartridge member, and a second plication is formed within the stomach cavity using staples from the second removable staple cartridge. Another method of forming a plication within the stomach cavity may include clamping the cartridge member and the anvil member together twice before firing staples into acquired tissue. This method helps to ensure that the desired tissue is acquired by the tissue treatment device, and that there are not folds or pleats present in the acquired tissue. After inserting the tissue treatment device transorally to the stomach cavity, stomach tissue is acquired at a target region for treatment with the tissue treatment device. The cartridge member and anvil member of the tissue treatment device are then clamped together grasping the acquired target tissue, and the stomach cavity can be insufflated to inspect the acquired target tissue. If the inspection reveals that the tissue acquired is not the targeted tissue or that there are folds or pleats within the acquired tissue, the acquired tissue can be released from the tissue treatment device and re-acquired. If the inspection reveals the acquired tissue would form a desired sleeve, then the stomach cavity can be desufflated once again, and the cartridge member and the anvil member can be undamped into an open configuration, to fully acquire the tissue. The tissue treatment device may include a barrier such as a septum, in which case the barrier would be removed from between the cartridge member and the anvil member. After which, the cartridge member and anvil member are clamped together a second time and the stomach cavity is again insufflated to inspect the acquired tissue. If the inspection reveals a desired formation between the folds of acquired tissue, the cartridge member and anvil member are fully clamped together and the acquired tissue is plicated to form a gastric sleeve within the stomach cavity. Brief Description of the Drawings

0019Figures IA and IB show side and detailed side views, respectively, of one variation of an exemplary gastroplasty device described herein.

0020FIGS. 2A and 2B show perspective detailed views of an exemplary gastroplasty device described herein.

0021FIGS. 3A and 3B show perspective and end views, respectively, of a cross- sectioned portion of an exemplary gastroplasty device.

0022FIGS. 4A and 4B show representative illustrations of how a gastroplasty device may be advanced transorally through the esophagus of a patient and positioned within the stomach cavity of a stomach.

0023FIGS. 5 A to 5D show end views of an example of how an exemplary gastroplasty device may be used to acquire and fasten tissue within a hollow body organ. FIG. 5E illustrates a resulting fastened gastric lumen that may be formed using the gastroplasty devices described herein.

0024FIGS. 5F and 5G demonstrate how a distal working portion of a gastroplasty device, and an inner volume, respectively, help to define the final configuration of the acquired tissue.

0025FIGS. 5H and 51 show perspective and cross sectional views of illustrative tissue configurations that may be formed with the gastroplasty devices and methods described herein.

0026FIGS. 6A and 6B show perspective and end views, respectively, of one variation of a gastroplasty device, wherein the septum is in position.

0027FIGS. 7A and 7B show perspective and end views, respectively, of the device of FIG. 6A in an open configuration.

0028FIGS. 8 A and 8B show perspective and end views, respectively, of the device of FIG. 6A in an open configuration with the septum removed. FIGS. 9A and 9B show perspective and end views, respectively, of the device of

0029FIG. 6A in a closed configuration.

0030FIGS. 1OA to 1OC show end views of the cartridge member and anvil member during delivery, during tissue acquisition, and prior to clamping of the tissue, respectively, in one example of how a clamping cable may be routed with respect to an optional septum. FIGS. HA and HB show perspective and end views, respectively, of another variation of a suitable gastroplasty device.

0031FIGS. HC and HD show perspective views of a gastroplasty device with and without a septum, respectively.

0032FIGS. 12A to 12C show perspective views of yet another variation of a gastroplasty device.

0033FIGS. 13A and 13B show cross-sectioned perspective and end views, respectively, of alternative acquisition pod assembly.

0034FIGS. 13C and 13D show cross-sectioned perspective and end views, respectively, of the device of FIGS. 13A and 13B under a high vacuum pressure. FIGS. 14A to 14D show perspective views of the operation of another variation of a gastroplasty device utilizing parallel pod motion.

0035FIG. 14E shows a cross-sectional perspective view of a portion of the pod members in an open configuration with a septum still in place between the cartridge member and anvil member. FIG. 15 shows a perspective view of yet another variation of a gastroplasty device utilizing a translational trolley plate.

0036FIGS. 16A to 16D show side, end, bottom, and perspective views, respectively, of a variation of a gastroplasty device, which utilizes a static acquisition pod. FIG. 16E shows a bottom view of one variation of a gastroplasty device having an arcuate configuration.

0037FIG. 17 shows a perspective view of a device having an optional feature of projections or serrations which may be defined along the mating surfaces of the cartridge member and/or anvil member. FIGS. 18A and 18B show perspective and cross-sectional end views, respectively, of another optional feature of one or more rotatable shafts which may be integrated into the device.

0038FIGS. 19A and 19B show perspective and detailed perspective views, respectively, of a device having a curved or adjustable segmented staple cartridge. FIGS. 2OA and 2OB show perspective views of a septum assembly having a tapered edge for facilitating removal of the septum from the hollow body organ.

0039FIGS. 21A and 21B show perspective views of an alternative septum assembly having ribbed surfaces.

0040FIG. 21 C shows a side view of one example of how collapse of the septum may be facilitated by withdrawing the septum into a receiving member.

0041FIGS. 22A and 22B show perspective and end views, respectively, of a septum variation having at least two transverse septum members extending to opposite sides of the longitudinal septum member.

0042FIG. 23A illustrates an end view of an extendable septum assembly positioned between pod members and placed against stomach tissue.

0043FIGS. 23B and 23C show side views of variations for extending the septum assembly from a low profile delivery to an extended deployed configuration.

0044FIGS. 24A and 24B show end views of an alternative septum assembly which may be configured to deploy an extendable septum from a rolled-up configuration. FIGS. 25A and 25B show perspective views of an alternative septum assembly having a collapsible septum member.

0045FIGS. 25C and 25D show end views of the septum of FIG. 25A in an expanded or extended configuration and in a collapsed configuration. FIGS. 26 A to 26C show end, bottom, and perspective views, respectively, of yet another alternative septum having radiused corners.

0046FIGS. 27A and 27B show perspective views of an alternative septum assembly having a low profile delivery configuration where the septum may be comprised of two elongate T-shaped members.

0047FIGS. 28A to 28C show perspective views of an example of a clamping mechanism having two cam members.

0048FIG. 29A shows a perspective view of one example of how clamping cables may be routed through a gastroplasty device described herein. FIG. 29B shows a cross-sectioned end view of a parallel clamping device with the septum shown.

0049FIGS. 3OA and 30B show side and edge views of an alternative gastroplasty device, utilizing linked pod members.

0050FIG. 31 shows a perspective view of another variation of a gastroplasty assembly. FIG. 32 shows a perspective view of sliding links joined together that form an elongated tubular member for the gastroplasy assembly.

0051FIG. 33 shows a cross-sectional view taken along line 33-33 of FIG. 32.

0052FIG. 34 shows a variation of a tissue treatment device of a gastroplasty assembly in a delivery configuration with an endoscope alongside. FIG. 35 shows the tissue treatment device of FIG. 34 with jaws opened.

0053FIG. 36 shows the tissue treatment device of FIG. 35 with the jaws opened and a retractor wire and sail in an extended configuration.

0054FIG. 37 shows a backside perspective view of the tissue treatment device of FIG. 36. FIG. 38 shows a variation of a basket that may be disposed within a vacuum pod of the tissue treatment device.

0055FIG. 39 shows a perspective view of a removable staple cartridge.

0056FIG. 40 shows a perspective view of the removable staple cartridge positioned within a cartridge member of the tissue treatment device. FIG. 41 shows a partial cross-sectional side elevational view of the removable staple cartridge positioned within the cartridge member of the tissue treatment device.

0057FIG. 42 shows a planar view of an end ring that is connected to a distal end of the flexible elongated member. FIG. 43 shows a partial cross-sectional view of the tissue treatment device in a closed position.

0058FIG. 44 shows a partial cross-sectional view of the tissue treatment device in an open position. FIG. 45 shows a perspective view of a handle assembly.

0059FIG. 46 shows a partial cross-sectional view of the handle assembly shown in FIG. 45.

0060FIGS. 46 A and 46B show a push/pull mechanism disposed within the handle assembly. FIGS. 47 through 53 A show illustrative views and cross-sectional views of one method of forming a gastric sleeve in a stomach cavity.

0061FIG. 54 shows a perspective view of a variation of a stapler restrictor.

0062FIG. 54A shows a stapler assembly of the stapler restrictor in a closed configuration. FIG. 54B shows the stapler assembly of the stapler restrictor in an open configuration.

0063FIG. 54C shows the stapler assembly of the stapler restrictor with a rubber tip and removable staple cartridge removed.

0064FIG. 54D shows the stapler assembly of the stapler restrictor with an anvil member removed.

0065FIG. 54E shows the removable staple cartridge and rubber tip being loaded into a cartridge member the stapler assembly.

0066FIGS. 55 through 57 A show cross-sectional views of one method of forming a single fold of tissue near a distal stoma of a gastric sleeve to narrow the distal stoma. FIG. 58 shows a cross-sectional view of a gastric sleeve formed with one dual fold plication and restricted with three single fold plications.

0067FIG. 59 shows an illustration of a stomach cavity with two dual fold plications forming a long sleeve and two single fold plications along the lesser curve to narrow the gastric sleeve. FIG. 60 shows an illustration of a stomach cavity with three dual fold plications forming a long sleeve and three single fold plications along the lesser curve to narrow the gastric sleeve.

0068FIG. 61 shows an illustration of a stomach cavity with four dual fold plications forming a long sleeve from the gastroesophageal junction to the pylorus. FIGS. 62 through 65 show another embodiment of a tissue treatment device having a distal clamping wire passed around a distal vertical pulley. Detailed Description of the Preferred Embodiments

0069Gastroplasty devices for tissue acquisition and fixation, and methods of using them are described. In general, the gastroplasty devices described herein may be utilized for creating a partition within a hollow body organ, such as the stomach, esophageal junction, and/or other portions of the gastrointestinal tract. The gastroplasty devices may be advanced within a body through a variety of methods, e.g., transorally, transanally, endoscopically, percutaneously, etc., to create one or several divisions or plications within the hollow body organ, e.g., to create a gastric lumen within the stomach. Further, the gastroplasty devices may be assisted through the use of laparoscopic guidance, in particular, visualization of the external surface of the hollow body organ to assist in placement of the device, or within the organ cavity to monitor the procedure. Similarly, the devices of the present invention may be used in conjunction with other laparoscopic procedures, or may further be modified by an additional step or procedure to enhance the geometry of the partition. For example, upon placement of a partition of the present invention, it may be desirable to perform a secondary step either transorally, or laparoscopically, to achieve the desired gastroplasty geometry, such as the placement of a single fold or plication within the gastric lumen or pouch as described in U.S. Pat. App. Serial No. 10/188,547, which was filed 7/2/2002 and is incorporated by reference herein in its entirety, to further restrict the movement of food through the pouch, or the laparoscopic placement of a band, clip, ring or other hollow reinforcement member at the outlet of the gastric lumen such as is done in a VBG, or lap-band procedure to reinforce or narrow the outlet of the lumen.

0070The gastroplasty devices described here, allow for the creation of a smaller gastric lumen to be achieved in a minimally invasive surgical procedure completely from within the stomach cavity. Moreover, the devices described herein are configured such that once acquisition of the tissue is accomplished, any manipulation of the acquired tissue is unnecessary as the devices are able to automatically configure the acquired tissue into a desired configuration whereby the geometry of the devices regulates or prescribes the resulting tissue geometry at the time of acquisition. In operation, the perimeter of the device, and any openings therein, form the template or mold cavity around and into which tissue flows, thereby creating a tissue structure that reflects the geometry of the mold. That is, as the devices are configured such that portions of the stomach wall are automatically positioned for fixation upon being acquired, and the tissue becomes automatically adjusted or tensioned around the perimeter of the distal working portion of the device in the stomach and within the distal working portion inner volume, to achieve the desired resulting geometry (e.g., small gastric pouch or restrictive partition or baffle). Because of the manner in which the tissue is acquired, the tissue intimately surrounds the cartridge member and anvil member to define or calibrate the subsequent volume of the resulting gastric lumen. Thus, the gastric volume may be predetermined by adjusting the volume of the cartridge member and anvil member. As a result, once the desired volume is known and incorporated in the device, the user can achieve a controlled acquisition and without intraprocedural adjustments or positioning requirements. Subsequent manipulation of the tissue may be performed, if desired, to effect certain configurations; however, this manipulation may be omitted entirely.

0071Turning to the figures, FIG. 1 A shows a side view of one variation of gastroplasty assembly 10. Assembly 10 may be generally comprised of an elongate tubular member 12 having handle assembly 16 connected at a proximal end 14. An integrated access assembly 18 may also be connected at proximal end 14 for providing access to working lumen 22 defined within elongate member 12. Elongate member 12 may have a circular or elliptical cross-sectional area. Alternatively, the cross-sectional area may take on any number of different cross-sectional configurations, e.g., hexagonal, octagonal, etc., provided that it presents an atraumatic surface to the tissue surfaces within the body. In addition, elongate member 12 may be curved, or may comprise a series of links as described in U.S. Pat. App. Serial No. 10/686,326, which was filed on 10/14/2003, and is incorporated by reference in its entirety herein. In this way, a curved or flexible elongate member, or an elongate member comprising a series of links will help to increase the flexibility of the elongate member, and hence increase the ease in which the device is handled and operated. Working lumen 22 may extend entirely through tubular member 12 and may be sized to provide access to distal end 20 for various surgical tools or therapies once distal end 20 of assembly 10 is positioned within a hollow body organ, and in particular may be useful to place an endoscope or other visualization tool. Alternatively, a fiberscope or other type of visualization tool may be integrated within the elongate member. Examples of useful scopes may be the Olympus GIF P 140, the Fujinon EG 25PE₅ and the like. Gastroplasty device 24 is typically positioned at the distal end of tubular member 12 and is also generally configured to be advanced atraumatically through the body of a patient and within a hollow body organ, e.g., esophagus, stomach, etc. Alternatively, an optional separate thin walled oversheath, may also be placed over the acquisition device, including the elongate member, to assist in placement, or may be placed over a guidewire or obturator down the esophagus prior to placement of the gastroplasty device and removed with the gastroplasty device once the procedure is complete. The liner may be made of a thin wall polymer such as polyolefin, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), silicone and the like, having a wall thickness between 0.004" and 0.025". This liner can serve to guide the gastroplasty device, as well as help to limit trauma to the esophagus and other delicate structures.

0072FIG. IB shows a closer detail view of the gastroplasty assembly 10. As shown there, the device comprises a distal working portion, which comprises a cartridge member or pod 26 placed longitudinally in apposition to anvil member or pod 28. As described above, when the device is in use, the tissue of the stomach wall (including, in some instances, the muscular tissue layers) are adjusted or tensioned around the perimeter of the distal working portion, and within the distal working portion inner volume, to achieve a desired resulting geometry (e.g., small gastric pouch or restrictive partition or baffle). Thus, the gastric volume may be predetermined by adjusting the volume of the distal working portion, inner or outer profile. Cartridge member 26 may contain one or several fasteners, e.g., staples, clips, etc., which may be actuated via controls located proximally on handle assembly 16. A septum or barrier 32, described in further detail below, may be removably positioned between cartridge member 26 and anvil member 28 while connection member 30 may connect device 24 to tubular member 12.

0073Handle assembly 16 may be variously configured depending upon the desired functionality to be implemented on assembly 10. In this variation, handle assembly 16 may generally comprise handle 34 for use by the surgeon or physician in advancing, withdrawing, or articulating assembly 10. A control for articulating the device 24 between an open and closed configuration may be located on handle 34, shown as clamping control knob 36, while a separate control mechanism, shown here as fastener firing lever 38, may be utilized for deploying the fasteners located within cartridge member 28. Although specific types of controls are shown, these are intended only to be illustrative of the types of control mechanisms which may be utilized and are not intended to be limiting in scope. Assembly 10 may further have one or several integrated vacuum ports 40 proximally located on elongate member 12 for fluid connection to one or several vacuum pumps (not shown). One or each of cartridge 26 or anvil 28 members may be fluidly connected through a common tube 12 or channel or through individually corresponding tubes or channels through elongate member 12 to vacuum ports 40. Additionally, a scope seal housing 42 configured to provide access to the working lumen 22 may also be optionally provided near or at the proximal end of elongate member 12 for the insertion of various tools and devices through elongate member 12 for accessing the distal end of the assembly 10. An optional auxiliary port 44 may also be provided for allowing fluid communication via a channel or tubing through elongate member 12 between the proximal and distal ends of the assembly 10. Auxiliary port 44 maybe utilized for various purposes, e.g., delivery of fluids or gases into the hollow body organ for transporting drugs or providing insufflation, etc. As noted above, the elongate body may be comprised of a series of links, similar to those described in U.S. Pat. App. Serial No. 10/686,326, or of an extrusion fabricated with various lumens to accommodate the various control wire and mechanisms of the acquisition device. Similarly, the control mechanisms may be grouped together with a flexible band, and then sheathed in a thin skin sheath, such as heat shrink. The elongate member may also be a combination of an extrusion and a thin wall sheath to allow for flexibility, and may utilize braided materials, e.g., stainless steel or superelastic materials such as Nickel-Titanium alloy, integrated in the wall of the sheath to prevent kinking and enhance torqueability.

0074A detailed view of one variation of the gastroplasty devices described herein is shown in the perspective view of FIG. 2A. The cartridge member 26 and anvil member 28, as described above, may extend longitudinally from the distal end of elongate member 12 via connection member 30. The cartridge member 26 and anvil member 28 may be both or singularly articulatable relative to one another or relative to elongate member 12. A pivot 50 longitudinally positioned between cartridge member 26 and anvil member 28 may be configured to enable the device to be pivoted into an open configuration for the acquisition of tissue and a closed or deployment configuration for delivery or advancement of the device into the hollow body organ.

0075If both members 26,28 are articulatable, they may be configured to be either simultaneously or sequentially articulatable. The cartridge member 26 may contain a cartridge 52 container fasteners along an outer edge of the member 26 while the anvil member 28 may have an anvil positioned along an outer edge of the member 26 such that the anvil corresponds to the number and position of fasteners within cartridge 52. One or both members 26,28 may also define openings 56,58, respectively, along a portion of the length or the entire length of each of the members 26,28. One or both of these openings 56,58 may be connected via tubing through vacuum lumens 60,62, respectively, defined through elongate member 12 to the vacuum ports 40 located at the proximal end of member 12. Alternatively, a central vacuum lumen may supply both ports, or may bifurcate at the proximal or distal end of member 12. Elongate member 12 may also define various cable lumens 64,66 for the passage of cables for controlling the opening and closing of members 26,28 as well as additional cable lumen 6S for the passage of cables for actuating deployment of the fasteners from within cartridge 52. Moreover, cable lumen 70 may be used for the passage of cables used for controlling the clamping of the members 26,28 towards one another.

0076Each of the members 26,28 may have openings 12,1 A and 76,78, respectively, defined at the outer corners of each member opposite pivot 50 to allow for the routing and passage of clamping cables through the device for enabling cartridge member 26 and anvil member 28 to be clamped closed towards one another. FIG. 2B shows a perspective view of the acquisition and fixation device of FIG. 2 A with the vacuum tubing and cables routed through the device. As shown, vacuum tubing 80,82 may be routed through elongate member 12 into a proximal end of one or each of cartridge member 26 and/or anvil member 28 for fluid connection with respective openings 56,58. Cables 84,86 may be utilized for opening and closing the cartridge member 26 and anvil member 28 and cable 88, which may be routed into cartridge member 26, may be positioned and utilized, e.g., for pulling or pushing a wedge mechanism, to deploy fasteners out of cartridge 52. Moreover, clamping cables 90 may be passed through elongate member 12 and routed through cartridge member 26 and anvil member 28 such that cables 92,94 are passed through openings 72,74 and 76,78 for clamping cartridge member 26 and anvil member 28 closed. Cables 84 and 86 may be replaced by torque shafts connected to handles at the proximal end of the device, to open and close the cartridge and anvil members.

0077FIGS. 3A and 3B show perspective and end views, respectively, of a cross- sectioned portion 100 of a suitable gastroplasty device. As may be seen, septum 32 may be positioned to extend from pivot 50 effectively separating vacuum openings 56,58 within cartridge member 26 and anvil member 28, respectively. Adjacent to opening 56 is fastener cartridge 52 and adjacent to opening 58 is anvil 54 positioned such that when septum 32 is removed or displaced, the articulation of cartridge member 26 and anvil member 28 towards one another about pivot 50 positions cartridge 52 in apposition to anvil 54. Alternatively, anvil member 28 cartridge member 26 may be nonmovable or in a fixed position relative to the longitudinal axis of the device. In this configuration, fastener cartridge 52 and optionally anvil 54, may be actuated to eject from their respective housings to fasten the acquired tissue.

0078FIGS. 4A and 4B show representative illustrations of how gastroplasty device 24 may be advanced transorally through the esophagus ES of a patient and positioned within stomach cavity SC of stomach 110. Making reference now to FIG. 4A, device 24 may be articulated outside the patient via handle 16 so that the proximal portion of elongate member 12 may be positioned such that the spine of the device is placed against a portion of lesser curvature LC and opposite greater curvature GC. In this way, the device 24 extends between the gastroesophageal junction GEJ towards pylorus PY. In addition FIG. 4 A depicts the use of a flexible endoscope EN alongside the device 10 to allow direct visualization of the procedure, including the fixation step whereby the scope can then be removed, leaving additional volume remaining in the smaller gastric pouch that may be helpful when removing or detaching the gastroplasty device 24 from the acquired tissue once it has been fixed. If no direct visualization is required, but additional removal volume is desired, an optional expandable balloon, or other expandable member EM may be used alongside the spine of the gastroplasty device, or may be integrated into the spine of the gastroplasty device using known techniques. FIG. 4B shows the positioning of gastroplasty device 10 without the aid of an endoscope, or other direct visualization technique.

0079FIG. 5 A shows an end view of device 24 positioned within stomach cavity SC with pivot 50 placed against stomach wall 120, for instance, against lesser curvature LC in one example of how the device 10 may be used to effect the creation of a gastric lumen or partition within stomach cavity SC. The device is advanced through the esophagus ES while in a deployment configuration, i.e., where the distal working portion of the device DWP is configured so that cartridge member 26 and anvil member 28 are closed such that openings 56,58 and cartridge 52 and anvil 54 are directly positioned in apposition about septum 32. When desirably positioned, one or both of cartridge member 26 and anvil member 28 may be rotated about pivot 50 in the direction of the arrows shown. FIG. 5B shows cartridge member 26 and anvil member 28 rotated at an angle with a vacuum force activated within openings 56,58. In certain embodiments where no pivoting or movement of the cartridge member 26 or anvil member 28 is necessary, the device is advanced in a static state. As seen, portions of the stomach wall 120 may be acquired and drawn within respective openings 56,58. The configuration of cartridge member 26 and anvil member 28 and the positioning of the device 24 within stomach cavity SC are such that this tissue acquisition procedure also enables the device 24 to be self-adjusting with respect to the acquired tissue 122,124. More particularly, the device 24 is configured such that portions of the stomach wall 120 are automatically positioned for fixation upon being acquired and the device 24 becomes automatically adjusted within stomach cavity SC relative to the stomach wall 120. Furthermore, because of the manner in which the tissue is acquired, the tissue intimately surrounds the cartridge member 26 and anvil member 28, i.e., the distal working portion of the device DWP, by being tensioned or held around the perimeter PT of the distal working portion of the device and within the inner volume IV of the distal working portion of the device to define the subsequent volume or resulting geometry RG resulting gastric lumen as shown by the diagonal and hatched lines respectively in FIGS. 5F and 5 G. An illustrative depiction of a cross section of a resulting tissue geometry is provided in FIG. 5E. Other depictions of resulting tissue geometries are provided in FIGS. 5H and 51. Shown there are front views of the distal working portion of the device, and cross sectional views (along lines A-A and B-B respectively) of the resulting tissue geometries. In FIG. 5H, the distal working portion has been configured to provide one plication P, whereas in FIG. 51, the distal working portion has been configured to provide more than one plication. Multiple plications may be useful, for example, to help increase the ease in which the distal working portion of the device is removed from a patient after tissue has been acquired and fixed. Thus, as these FIGS, illustrate, the gastric volume may be predetermined by adjusting the volume of the cartridge member 26 and anvil member 28, or geometry of the distal working portion of the device, e.g., the distal working portion of the device may be configured so that the gastric tissue has results in the geometries described, for example, in U.S. Pat. App. Serial No. 10/417,790, which was filed on April 16, 2003 and is hereby incorporated by reference in its entirety.

0080Optional septum 32 may act effectively as a barrier between openings 56,58 to facilitate the acquisition of the tissue 122,124 into their respective openings 56,58 while minimizing or eliminating cross acquisition of the tissue into cartridge member 26 and/or anvil member 28. In another alternative, septum 32 may be omitted from the device 24 and acquisition of the tissue may be accomplished by sequentially activating vacuum forces within openings 56 and 58. That is, the cartridge and anvil members may be orient towards the tissue surface in a sequential fashion, acquiring the tissue adjacent thereto. However, when a septum is employed, it may be removed from between cartridge member 26 and anvil member 28 by translating the septum 32 distally, laterally, or proximally of cartridge member 26 and anvil member 28, after the tissue has been acquired. Alternatively, the septum may be left within stomach cavity SC for later removal, or as will be described in more detail below, may be left within the stomach cavity to biodegrade. FIG. 5C shows septum 32 having been removed so that cartridge member 26 and anvil member 28 may be pivoted from the open configuration back to its closed configuration in the direction of the arrows shown. Because the septum 32 has been removed, tissue region 126 may now be presented for clamping between cartridge 52 and anvil 54.

0081As shown in FIG. 5D, cartridge member 26 and anvil member 28 may be simply clamped over tissue region 126 and fastened by deploying one or several fasteners from within cartridge 52. In acquiring the tissue 122,124, manipulation of the tissue region 126 or the acquired tissue 122,124 may be eliminated entirely due to the automatic positioning of the tissue for fastening. Once the clamped tissue has been fastened, the device 24 may be withdrawn entirely from the stomach cavity SC, as shown in FIG. 5E. As seen, one or several fasteners 128, e.g., a line of staples, may hold the tissue in its fastened configuration to result in the creation of a partition, creating a restriction, or when desired, creating a gastric lumen or pouch 130, separate from the remainder of the stomach cavity. Alternative variations of gastroplasty device 24 may also be utilized. For instance,

0082FIG. 6A shows a perspective view of another variation in device 140 partly cross- sectioned for the sake of clarity. In this variation, cartridge member 142 and anvil member 144 may define a curved or arcuate shape. The septum may also be configured to have a longitudinal barrier portion 146 with a first transverse barrier 152 and a second optional transverse barrier 154. One or both barriers 152,154 may extend in a curved or arcuate shape from the longitudinal septum 146 such that an atraumatic surface is presented to tissue during advancement within the patient. The septum may be retained between cartridge member 142 and anvil member 144 via septum detent 148 being slidably positioned within septum retaining channel 150, which extends longitudinally between cartridge member 142 and anvil member 144. Longitudinal septum 146 may partition openings 156,158, which may function in the same manner as described above for adhering tissue. It may be advantageous to house a pressure transducer 159 near or within the pod(s) or opening(s), to allow the device user to accurately gauge measurement of pressure at the site of tissue adhesion. A drop of pressure within the pod or opening signals to the user that the vacuum seal has been compromised, and therefore the amount of tissue adhered to the system is not optimal. Readings from the transducer can serve as feedback to the user that sufficient vacuum pressure has been maintained, and therefore be a "go-nogo" trigger to the user. FIG. 6B shows a cross-sectional end view of the variation 140 from FIG. 6 A. As illustrated, cartridge 162 may retain one or several fasteners 166, shown in this variation as staples, in corresponding apposition to anvil 164 when cartridge member 142 and anvil member 144 are in the closed or delivery configuration. It should be noted that while a rectangular staple jaw is depicted, it may be desirable to provide a curved track or wedge to facilitate the placement of a curved line of staples, from the rectangular jaw. Pivoting member or plate 168, which may function to facilitate the pivoting the device, may be seen as placed over the outer surface of cartridge member 142 and anvil member 144.

0083Fig 7 A shows a perspective view of an open configuration 170 of the device of FIGS. 61 and 6B for receiving tissue within openings 156,158. Septum 146 may be removed from the device by translating the septum 146 longitudinally in the direction of the arrow. As shown in the end view in FIG. 7B₅ pivoting region 160 may be seen expanded via pivoting plate 168, which may be made from various biocompatible materials, e.g., stainless steel, polymers, etc., and which is sufficiently flexible to enable the device to transition between the open and closed configurations. FIG 8A shows the open configuration 180 in which the septum 146 has been removed from the device. As described above, the septum may be removed once the tissue has been acquired within their respective openings. FIG. 8B shows an end view of the device with the septum removed. The tissue acquired within open region 182 may be clamped by articulating cartridge member 142 and anvil member 144 in the direction of the arrows to result in the configuration shown in FIG. 9A, which shows the device 190 ready for fastening the clamped tissue within clamping region 192. FIG. 9B shows an end view of the device configured into its closed configuration for fastening the tissue within clamping region 192. As described above, because the stomach tissue may be automatically configured for fastening once the tissue has been acquired, manipulation of the tissue is rendered unnecessary during clamping and fastening of the tissue.

0084In facilitating the clamping of cartridge member 142 and anvil member 144 onto the tissue, clamping cables may be utilized, as described above. FIGS. 1OA to 1OC show end views of cartridge member 142 and anvil member 144 during delivery, during tissue acquisition, and prior to clamping of the tissue, respectively, and one example of how clamping cable 200 may be routed with respect to septum 146. FIG. 1OA shows septum 146 in position between cartridge member 142 and anvil member 144 with clamping cable 200 routed within a cable constraining slot 202 defined in an adjacent portion of septum 146. The clamping cable 200 may extend between cartridge member 142 and anvil member 144 through clamping cable openings 204 defined in both cartridge member 142 and anvil member 144. Once the septum 146 is removed, as shown in FIG. 1OC, the clamping cable 200 may be released from slot 202 and tensioned to bring cartridge member 142 and anvil member 144 towards one another, as described in further detail below. Other mechanisms of clamping are also suitable, for example, the tissue may be clamped using hydraulic, pneumatic, or electropneumatic mechanisms, all of which are well known in the art.

0085FIGS. HA and 11B shows perspective and end view of another alternative gastroplasty device 210. This variation shows cartridge member 212 and anvil member 214 in a closed configuration with extension member 218 connected to longitudinal pivot 216. The septum, in this variation, may comprise a longitudinal septum member 220 and a perpendicularly positioned transverse septum member 222, which may extend partially over the openings 228, 230 when cartridge member 212 and anvil member 214 are in an open configuration, as shown in FIG. HC. Respective vacuum tubing 224,226 may be fiuidly connected to one or both openings 228,230 defined within their respective members 212,214. FIG. HD illustrates the device with the septum translated distally showing a clearer view of opening 230.

0086FIGS. 12A to 12C show perspective views of yet another variation of gastroplasty device 240. In this variation, cartridge member 242 and anvil member 244 may be pivotally connected via longitudinally defined pivot 246. Similar to the variation of FIGS. 11A and HB, the septum may also comprise a longitudinal septum member 248 positionable between members 242,244 and an optional perpendicularly configured transverse septum member 250. Also seen are vacuum tubing 252,254 fluidly coupled to their respective openings 260,262. As discussed above, because the resulting gastric lumen may be defined by the shape and volume of the device, cartridge member 242 and anvil member 244 may each define tapered distal ends 256,258, respectively, to provide an atraumatic surface for advancement within the patient and to facilitate formation of a gastric lumen having a tapered distal region. The proximal shoulder of the members may also be tapered to facilitate removal of the device once the procedure has been completed. Moreover, this variation also shows openings 260,262 which may be elongated to extend over a majority of the length of their respective members 244,242.

0087Yet another variation of an alternative acquisition pod assembly 270 is shown in the cross-sectioned perspective view of FIG. 13 A. This variation may generally comprise pod walls 272,274 each defining an undercut section 276,278 having projections or serrations 280,282 along their edges directed or angled towards one another. The assembly 270 may be comprised of a biocompatible material, e.g., polymers, polycarbonates, etc., which has an elastic bending modulus sufficiently low to allow for plastic deformation of the pod assembly 270 to occur. A barrier 286 having a plurality of openings 288 defined over its surface may be positioned between pod walls 212,21 A such that tissue acquisition chamber 284 is defined as shown. A vacuum chamber 290 may be located beneath barrier 286 with vacuum plenum 292 defined by chamber 290 and barrier 286.

0088In operation, as shown in FIG. 13B, tissue 294 may be acquired against or within acquisition chamber 284 by the application of a relatively low pressure vacuum force applied through plenum 292, which may create a low vacuum within chamber 284 through openings 288. Once the tissue 294 has been first acquired, a higher pressure vacuum force may be applied through plenum 292 such that pod walls 212,21 A and undercut sections 276,278, respectively, are plastically deformed and drawn towards one another in the direction of the arrows, as shown in FIG. 13C. As the undercut sections 276,278 are drawn inwards and shown in FIG. 13D, the acquired tissue 294 may become pinched at retained tissue region 296 resulting in a temporary mechanical fixation of the tissue. A cessation of the high vacuum force may then result in a relaxation of the 20 pod walls 272,274 and ultimately of the release of the acquired tissue 294 when the vacuum force is ceased altogether. Spearing mechanisms or a plurality of sharp hooks may also be used, in conjunction with, or in lieu of, the undercut sections described above.

0089Yet another variation of a gastroplasty device 300 is shown in the perspective views of FIGS. 14A to 14D. This particular variation may utilize a parallel translational motion in moving the cartridge member 306 and anvil member 308 between the open and closed configuration rather than a pivoting motion, as described above in other variations. As shown in FIG. 14A, device 300 may comprise pod assembly 302 connected at the distal end of elongate tubular member 304. Septum 310 may be removably positioned between cartridge member 306 and anvil member 308. A groove plate 312 defining a longitudinally extending slot may be positioned adjacent to cartridge member 306 and anvil member 308 on a side opposite to that of septum 310.

0090FIG. 14B shows cartridge member 306 and anvil member 308 articulated away from one another into an open configuration while maintaining a parallel orientation relative to one another. In this open configuration, tissue may be acquired and drawn into respective pod members 302 on opposite sides of septum 310. Groove plate 312, which may be comprised of various biocompatible materials, e.g., stainless steel, polycarbonate, various polymers, etc., may be held stationary relative to pod assembly 302 and may further help maintain cartridge member 306 and anvil member 308 in their parallel orientation during reconfiguration. FIG. 14C shows septum 310 removed from between cartridge member 306 and anvil member 308 by being translated distally via septum control member 314, which may be articulated from a proximal end of elongate member 304. Once the septum 310 has been removed, cartridge member 306 and anvil member 308 may be articulated to clamp onto the tissue while maintaining their parallel configuration, as shown in FIG. 14D. Once the tissue has been clamped, cartridge member 306 may be actuated to fasten the tissue. FIG. 14E shows a cross-sectional perspective view of a portion of pod members 302 in an open configuration with septum 310 still in place between cartridge member 306 and anvil member 308. As shown, cartridge member 306 and anvil member 308 along with acquisition chambers 316,318, respectively, may be seen maintaining a parallel configuration relative to one another.

0091FIG. 15 shows a perspective view of yet another variation of a gastroplasty device 320 positioned upon the distal end of elongate tubular member 336. Similar to the device of FIG. 14A₅ cartridge member 322 and anvil member 324 may be configured to open and close while maintaining a parallel configuration relative to one another. Optional septum 326 may also be positionable between members 322,324. However, device 320 may comprise a translationally movable trolley plate 328 which may be advanced or retracted longitudinally. At least two wedging members 330,332 may protrude from plate 328 at an angle which correspondingly abuts with the distal ends of members 322,324 such that when plate 328 is longitudinally translated, wedging members 330,332 may drive cartridge member 322 and anvil member 324 towards one another in a parallel configuration to clamp onto any tissue which may have been acquired by device 320. A septum groove 334 may be defined longitudinally along the plate 328 so as to enable unhindered movement relative to the septum 326. Cartridge member 322 and anvil member 324 may also be configured such that when trolley plate 328 compresses the members 322,324 onto tissue, fasteners are automatically deployed into the tissue to fasten it.

0092FIGS. 16A to 16C show side, end, and bottom views, respectively, of another variation of gastroplasty device 340. Generally, while other variations have enabled movement of respective pod members, this variation may maintain a static acquisition pod. Vacuum pod 342 may be comprised of a variety of biocompatible materials, e.g., polycarbonate, etc., shaped into opposing walls having vacuum plenums 348,350 defined along the lengths of the opposing walls. While two vacuum plenums are depicted, it should be understood that any number of vacuum plenums may be employed as well. For example, a single vacuum plenum may be used. Similarly, three or more vacuum plenums may be used. A septum having a longitudinal member 346 and an optional perpendicularly positioned transverse member 344 may be positioned to fit within vacuum pod 342 such that at least two tissue acquisition chambers 352,354 are formed along the length of pod 342. Alternatively, the septum may only include longitudinal member 346, and may omit any transverse members entirely, which may aid in reducing the overall profile of the distal working end of the device. The septum may generally be comprised of a similar material as vacuum pod 342 and may be further coated with a layer of a lubricious material, such as Teflon®. Furthermore, the septum may be formed of a bioabsorbable material that may either dissolve upon exposure to gastric fluids after tissue has been acquired, or may be releaseably attached to pods or chambers and fixed in place between tissue folds (e.g. left behind) once device is removed. The septum may also have end member 356 at one end of the septum which may act as a stop for the device 340. FIG. 16D shows a perspective view of acquisition device 340 revealing the vacuum plenum defined along the bottom of pod 342. While rectangular devices are depicted in FIGS. 16A-16D, it should be understood that the device 343 can have a curved or arcuate shape as well, as shown in FIG. 16E. Also depicted there are optional septum 345 and a single vacuum plenums 347.

0093To facilitate the acquisition of the tissue, various features may be incorporated into any of the variations described herein. For instance, one optional feature may be seen in FIG. 17, which shows a perspective view of gastroplasty device 360 having a plurality of projections or serrations 366,368 defined along the mating surfaces of cartridge member 362 and/or anvil member 364. Serrations 366,368 may be positioned adjacent to the cartridge and/or anvil to provide additional mechanical support of the tissue positioned between clamped members of the acquisition device 360 during tissue fixation. Altematively clearance cuts (not shown) on the cartridge may be included to reduce the surface area and required clamping force for fixation, as well as adding traction to the system. As described above, spearing mechanisms, or sharp projections may be used as well. Another optional feature which may be integrated with the devices herein is shown in the perspective view of gastroplasty device 370 of FIG. 18A. A single pod member 372 is shown for illustrative purposes as the feature of a rotatable shaft may be integrated into any of the devices described herein. Pod member 372 may define an opening 374 along its length for receiving tissue therein, as described above; however, the device may also comprise at least one rotatable shaft 376 positioned longitudinally within the pod member 372 adjacent to the opening 374. The rotatable shaft 376 may define one or several projections or serrations 378 along its surface such that tissue drawn into the opening 376 via a vacuum force may also be mechanically acquired by rotation of the shaft 376 in a first direction to allow serrations 378 to become affixed to the tissue. The shaft 376 may be rotated in a second opposite direction to release the acquired tissue. Moreover, the pod member 372 may acquire the tissue with the vacuum force alone, as described above, with the rotatable shaft 376 alone, or with a combination of both the vacuum force and shaft 376 operated in conjunction with one another. FIG. 18B shows a cross-section of pod member 372 having a second rotatable shaft 380 also defining projections or serrations 382 along its surface. In the case of two shafts utilized together, they may be configured to be counter-rotating such that the acquired tissue 384 is optimally retained within opening 374. Likewise, to release the acquired tissue 384, the shafts 376,380 may be counter-rotated in the opposite direction.

0094Yet another feature which may be integrated with the devices herein is shown in the perspective view of FIG. 19A, which illustrates acquisition and fixation device 390 having a single pod member for the sake of clarity. Also shown are septum 400 and opening 402. A segmented staple cartridge 392 having an adjustable curvature and height may be integrated into any number of the devices described above. Cartridge 392 may be comprised of one or more staple cartridge segments 394 which are pivotally connected to one another via joints 396 which may allow not only pivotal side-to-side motion between segments 394 but also height adjustments relative to one another.

0095Each staple cartridge segment 394, as seen in the detail perspective view of FIG. 19B, may each define staple openings 398. In connecting with adjacent cartridge segments 394, a radiused pivot member 404 may extend from one side of the segment 394 and a receiving cavity 406 may be defined in the opposite side of the segment 394. Each pivot member 404 may extend away from segment 394 such that when positioned into a corresponding receiving cavity 406, adequate spacing exists between segments 394 such that side-to-side motion is possible between the segments 394 to define a curvature of the resulting cartridge 392. Moreover, because of the transiational fit between pivot member 404 and cavity 406, the heights of different segments 394 may be varied to define a curve in the height of cartridge 392, as shown by height differential Z in FIG. 19A and the height differences between adjacent segments 394 in FIG. 19B. Accordingly, cartridge 392 may be varied in length by varying the number of segments utilized, as well as varied in curvature and in height. The corresponding anvil member may be adjusted to accordingly match the curvature of the cartridge 392.

0096In addition to variations on types of pod members and tissue acquisition enhancements, the septum may also be adjusted in various ways to accommodate different devices and desired results. For instance, gastroplasty device 410 may be seen in the perspective view of FIG. 2OA with one variation of septum assembly 412 positioned between pod members 422,424. Septum assembly 412 may be seen in better detail in the perspective view of FIG. 2OB. In this variation, the septum may have a transverse septum member 414 perpendicularly positioned relative to longitudinal septum member 416 extending from extension member 420, as described above. However, this variation may define a tapered edge 418 along the proximal edge of longitudinal septum member 416. This tapered edge 418 may extend at an acute angle from extension member 420 towards transverse septum member 414 to facilitate removal of the septum assembly 412 from within the hollow body organ.

0097Another alternative on septum variations is shown in the perspective views of FIGS. 21A and 21B. Ribbed septum assembly 430 may generally comprise transverse septum member 432, longitudinal septum member 434, tapered edge 440 extending between extension member 438 and transverse septum member 432. However, the septum members 432,434 may be ribbed 436 to facilitate collapse of the septum assembly 430 when withdrawn from the hollow body organ. The hardness and geometry of the septum assembly 430 may be accordingly configured to provide adequate strength during vacuum- assisted tissue acquisition yet flexible enough to collapse when removed from the patient. FIG. 21C shows one example of how collapse of the septum may be facilitated by withdrawing the septum into a receiving member 442 having a tapered opening 444. As the septum assembly 430 is pulled into channel 446, the ribbed surfaces may collapse into a smaller configuration for withdrawal.

0098Another alternative septum variation 450 is shown in the perspective view of FIG. 22A. Longitudinal septum member 452 may have at least two transverse septum members 454,458 extending to opposite sides of longitudinal septum 452. Each of the transverse septum members 454,458 may define a helical tapered edge 456,460, respectively, such that removal of the septum assembly 450 from the hollow body organ is facilitated. FIG. 22B shows an end view of the septum assembly 450 positioned between pod members 462,464. Rather than using a perpendicularly-configured septum, an alternative may be to utilize a septum member having only a longitudinally extending member which extends sufficiently high so as to prevent cross-acquisition of tissue into the pod members. FIG. 23 A illustrates an end view of an extendable septum assembly 470 positioned between pod members 472,474 placed against stomach tissue 476. FIG. 23B shows a side view of one variation for extending the septum assembly 478 from a low profile delivery configuration to an extended deployed configuration. Once septum assembly 478 has been advanced into a hollow body organ in its low profile configuration, the assembly 478 may be deployed into its expanded configuration. An extension septum member 480 may have a number of projections 482,484 protruding from either side of extension 480. A corresponding longitudinal septum base 486 may define channels 488,490 through which projections 482,484 located on extension 480, respectively, maybe translated within. Moreover, channels 488,490 may be angled relative to a longitudinal axis defined by septum base 486 such that distally advancing extension 480 relative to septum base 486 raises extension 480 a distance away from base 486, effectively increasing a height of the septum assembly 478. Projections 482,484 and channels 488,490 may be covered so that travel of the extension 480 is uninhibited by surrounding tissue.

0099Similarly, FIG.23C shows a side view of another septum assembly variation 492 in which extension septum member 494 is extendable from base septum member 496. When advanced distally relative to longitudinal septum base 496, extension 494 may travserse channels 498, which form ramped channel portion 500, defined within base 496 to extend into a septum assembly 492 having an increased height.

0100FIG. 24 A shows another alternative septum assembly 510 which may be configured to deploy an extendable septum from a rolled-up configuration. As seen in the end view, septum assembly 510 is in a deployed configuration between pod members 512,514. Retractable septum 520, may be extended from a rolled-up configuration within drum 516, which may be positioned between opposing transverse septum members 518. Cables 522 may extend from transverse septum members 518 for attachment to pod members 512,514. After the tissue has been acquired, retractable septum 520 may be retracted into drum 516 via manipulation of control cable 524, as seen in FIG. 24B, to assume.a low profile for withdrawal from the patient.

0101Another variation of septum assembly 530 is further shown in the perspective views of FIGS. 25A and 25B. Septum assembly 530 may comprise transverse septum member 532 and collapsible septum member 534, which may be configured between a collapsed configuration and an extended configuration. Transverse septum 532 may be elevated and lowered relative to pod members 548,550 during delivery and deployment of septum assembly 530, e.g., via crossmembers 536,538 which may be configured into a scissors-type mechanism. Cross-members 536,538 may have its proximal ends connected to control cable 542, which may be routed through extension member 544, while an intermediate portion of both cross-members 536,538 may be pivotally connected to one another via pivot 540. Thus, articulation of control cable 542 from its proximal end by the surgeon or physician may actuate the scissors mechanism to either raise or lower transverse septum 532 in the directions of the arrow as shown. Transverse septum 532, when positioned between pod members 548,550, may be secured via cables 546, as shown in FIG. 25B.

0102FIGS. 25C and 25D show end views of transverse septum 532 and the collapsible septum member in an expanded or extended configuration 552 and in a collapsed configuration 554. The collapsible septum member may be enclosed by a biocompatible material to prevent pinching of tissue by the cross-members 536,538. Moreover, the material covering the collapsible septum may also be distensible, if desired. Various materials may be utilized, e.g., nylon, polymeric materials, woven materials made from various polymers, latex, elastomers, etc.

0103FIGS. 26A to 26C show end, bottom, and perspective views of yet another alternative septum 560. This particular septum 560 may be utilized with the device 340 of FIGS. 16A to 16D. As shown, longitudinal septum 562 may be perpendicularly and integrally connected with transverse septum member 564 at one end and base septum member 566 at an opposing end of longitudinal septum 562. Transverse septum member 564 may define radiused corners 568 at each of its four corners such that an atraumatic surface is presented to the tissue during use within a patient. Moreover, septum 560 may be extruded or formed from a singular piece of biocompatible material (any of the biocompatible materials suitable for such a structure as discussed herein may be utilized) such that a uniform structure is created.

0104FIGS. 27A and 27B show perspective views of an alternative septum assembly 570 which may also be utilized particularly with the device 340 as discussed above. FIG. 27A shows septum 570 in a low profile delivery configuration where septum 570 may generally be comprised of two elongate T-shaped members. Each of the T-shaped members may be further comprised of longitudinal septum members 572,572' and transverse septum members 574',574', respectively. Each of the two elongate T-shaped members need not be uniform with one another depending upon the device into which the septum assembly 570 is placed, but each member may be pivotally connected to one another via pivot 576 at a corner of adjacent longitudinal members 572,572'. Thus, during delivery of the device and septum 570 into the patient body, the low profile configuration of FIG. 27A may be maintained and prior to or during tissue acquisition and fixation, one of the members, e.g., septum members 572',574' may be pivoted in the direction of the arrow such that the longitudinal portions of the septum 572,572' contact one another to form an acquisition configuration 578 for the septum assembly, as shown in FIG. 27B. After tissue acquisition and fixation, the septum may be reconfigured into its low profile configuration for removal from the patient. The septum in any of the above embodiments may be formed of a bioabsorbable and/or biocompatible material such as polyester (e.g., DACR.ON® from E. L Du Pont de Nemours and Company, Wilmington, DE), polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ether ketone (PEEK), nylon, extruded collagen, silicone, polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), or polyglycolic acid (PGA). Furthermore, it may be flexible, biocompatible material which can either be left behind within the partition or expelled distally, and either absorbed within the stomach, or digested and expelled through the patient's gastrointestinal tract.

0105As discussed above, once the gastroplasty device has acquired the appropriate tissue, the device may be clamped upon the tissue to be fastened. Clamping multiple layers of tissue to one another may require a clamping mechanism which is configured to deliver a high degree of clamping pressure. One example of such a clamping mechanism 580 is shown in the perspective views of FIGS. 28 A to 28C, which show one variation for opening the clamp. Clamping mechanim 580 may have attachment members 582,584 for secure connection to each of a pod member. Each of the attachment members 582,584 may be connected to one another via rotatable cams 586,588, where each cam may have a rotatable pivot, 590,592, respectively, protruding therefrom. FIG. 28A shows clamping mechanism 580 in a closed and clamped configuration while FIG. 28B shows the mechanism 580 being initially opened. To open (or close) the mechanism 580, cam 586 may be rotated by actuating a control cable 600, which may be routed, for instance, through a tubular member 596 positioned within the elongate member 12, from its proximal end. Cam 588 may then be rotated by actuating control cable 602, which may be routed within tubular member 598 also through tubular member 596. Because attachment members 582,584 rotate about pivot 590, a channel 594 may be defined in member 582 within which pivot 592 may translate when cam 588 is rotated to effectuate clamping or opening of the pod members.

0106In addition to a cam mechanism 580, clamping cables may also be utilized, as discussed above. FIG. 29A shows a perspective view of one example of how clamping cables may be routed through an acquisition and fixation device 610. As seen, device 610 having pod members 612,614 may be pivotable about longitudinal pivot 616. Although a pivoting device is shown in this variation, the routing of cables may be utilized in any of the other acquisition and fixation devices utilizing pivoting motion as well as parallel clamping. A first clamping cable 620 may be routed into one of the pod members, e.g., pod member 614, through positioning member 630 mounted on pod member 614 and routed over pulley or radiused member 622, also contained within pod member 614. First cable 620 may be looped 632 adjacent to pivot 616 to allow for placement of the septum (not shown for clarity) and then anchored to clamping cable anchor 618. Likewise, second clamping cable 626 may be routed through positioning member 630 adjacent to first clamping cable 620 and through pod member 614 and over pulley or radiused member 628, also contained within pod member 614. Second cable 626 may also be looped 632 adjacent to pivot 616 to allow for placement of the septum and then anchored to clamping cable anchor 624.

0107FIG. 29B shows a cross-sectioned end view of a parallel clamping device with the septum 634 shown. Like features are similarly numbered as corresponding features from FIG. 29 A. As in the pivoting variation, first 620 and second 626 clamping cables may be routed through corresponding tubular members 640 and the cables may be looped through one or more slots 642 defined in septum 634 and subsequently routed into the opposing pod member for anchoring. Clamping cables 620,626 are preferably routed to facilitate the unhindered translation of septum 634 as well as to ensure unobstructed access to openings 636,638 for the tissue to be acquired and fastened.

0108In yet another clamping variation, FIGS. 30A and 30B show side and edge views of an alternative gastroplasty device 650 utilizing linked pod members. Cartridge member 652 and anvil member 654 may be connected to one another via linking arms 656,658 pivotally attached to one another via pivot 660 at one end of the device 650 and via linking arms 662,664 also pivotally attached to one another via pivot 666 at the opposite end of the device 650. Clamping cables 672 may be routed through tubular member 670 into the device 650 and over pulleys 674,676, as described above, for moving anvil member 654 between an open and closed configuration when acquiring tissue within acquisition region 668. Firing cable 678 may be manipulated to deploy the fasteners from within cartridge member 652 when anvil member 654 is clamped over the acquired tissue. Deployment of the fasteners from cartridge member 652 may be achieved by incorporation of the firing wedge and other mechanisms as taught in U.S. Patent No. 4,610,383, which is hereby incorporated by reference in its entirety, hi addition, clamping may be accomplished via hydraulic, pneumatic, or electropneumatic mechanisms, as discussed above.

0109Another variation of a gastroplasty assembly 700 is shown in FIG. 31. Assembly 700 may be generally comprised of an elongate tubular member 702 having a proximal end 704 and a distal end 706 with a lumen 708 defined within the elongate member. As shown in FIG. 31, a handle assembly 710 is connected at the proximal end 704 of the elongate member, and a tissue treatment device 712 is attached at the distal end 706 of the elongate member. The tissue treatment device is used to form either single or dual fold plications within a stomach cavity.

0110The elongate member 702 may have a circular or elliptical cross-sectional area. Alternatively, the cross-sectional area may take on any number of different cross-sectional configurations, e.g., hexagonal, octagonal, etc., provided that it presents an atraumatic surface to the tissue surfaces within the body. In the embodiment shown, the elongate member 702 is a flexible shaft including a series of sliding links 714 that increase the flexibility of the elongate member, and hence increase the ease in which the device is handled and operated. The lumen 708 may extend entirely through tubular member 702 and may be sized to provide access to the distal end 706 for various surgical tools or therapies once the distal end of assembly 700 is positioned within a hollow body organ, and in particular may be useful to place an endoscope or other visualization tool. Alternatively, a fiberscope or other type of visualization tool may be integrated within the elongate member. Alternatively, an optional separate thin walled oversheath, may also be placed over the acquisition device, including the elongate member, to assist in placement, or may be placed over a guidewire or obturator down the esophagus prior to placement of the gastroplasty device and removed with the gastroplasty device once the procedure is complete. The liner may be made of a thin wall polymer such as polyolefin, polytetrafhioroethylene (PTFE), expanded PTFE (ePTFE), silicone and the like, having a wall thickness between 0.001" and 0.025". This liner can serve to guide the gastroplasty device, as well as help to limit trauma to the esophagus and other delicate structures.

0111FIG. 32 shows a perspective view of three sliding links 714 attached to one another. Several sliding links 714 are attached to one another depending on the desired length of the elongate member 702. Typically, the length of the elongate member is determined by the anatomic length on a patient such that the distal end of the device reaches into the patient's stomach while the proximal end extends out of the patient's mouth for a length sufficient to enable the user to manipulate the controls of the device, approximately 30 cm - 80 cm long, for example 50 cm - 70 cm. Each sliding link 714 includes a circular outer surface 716 with a first end 718 and a second end 720. In one embodiment, the first end 718 of the sliding link includes four slots 721, and the second end 720 includes four legs 722 that project parallel to the axis of the circular outer surface of the links. The links are joined together by inserting the legs on one link into the slots of the adjacent link, and then two legs 722a opposite each other of one sliding link are bonded or adhered in the slots of the adjacent link. The remaining two legs 722b of an individual sliding link not bonded into slots are free to move within the slot of the adjacent link when the elongate member 702 is curved as shown in FIG. 32. To allow for maximum flexibility, the position of the bonded legs 722a alternates with each sliding link 714. In other words, since all of the legs 722 of the sliding links are in-line with each other and there are four sets of legs that are in-line with each other, every other leg in one of the four sets is bonded to the adjacent link. When flexed, the bonded legs 722a flex at a joint 724 which also improves flexibility. The design of the sliding links 714 also allow them to transmit torque along the length of the elongate member 702. In one embodiment, a polyethylene tape is wrapped around the outer surface of the elongate member 702 to limit trauma to the esophagus and other delicate structures, while still allowing the elongate member to flex while limiting extensibility of the shaft. Other materials that may be used as coverings may include silicone, urethanes, or other polymers. In a further embodiment, such coatings may be sprayed on or applied as a coating or sheath, rather than wound as tape. However, it has also been contemplated that the elongated member 702 may be formed using braided, molded, or slotted material, such as any metal or polymer. The elongated member may even be formed with a polymer that does not includes links..

0112Referring now to FIG. 33, which is a cross-sectional view taken along line 33-33 of FIG. 32, the internal cavity of the sliding link 714 is shown to include an inner arch 726 that divides the lumen 708 into an endoscope lumen 728 and a working lumen 730. The endoscope lumen is sized so that an endoscope may pass there through. In one embodiment, the inner arch is only formed within every other sliding link in the chain that forms that elongate member 702 to help increase the flexibility of the elongate member. However, in another embodiment, the inner arch may be formed within every sliding link. The working lumen 730 provides a passage for various cables for controlling the opening and closing of members 732 and 734 as well as additional cables for actuating deployment of the fasteners/staples from within the staple cartridge. Moreover, the working lumen 730 may be used for the passage of vacuum tubes connected to vacuum pods formed within the members 732 and 734, and for the passage of retractor wires and septum wire (used to remove septum from between the members 732 and 734). These passages provided by the working lumen 730 prevent gross movements of the cables and coil pipes, and also keep the endoscope free from entanglement. The working lumen within the elongated member allow small movements of the cables and coil pipes which may be important during bending of the shaft.

0113Referring back to FIG. 31, the tissue treatment device 712 attached to the distal end 706 includes a cartridge member or jaw 732 placed longitudinally in apposition to anvil member or jaw 734. When the tissue treatment device is in use, the tissue of the stomach wall (including, in some instances, the muscular tissue layers) are adjusted or tensioned around the perimeter of the distal working portion, and within the distal working portion inner volume, to achieve a desired resulting geometry (e.g., small gastric pouch or restrictive partition or baffle). Thus, the gastric pouch volume may be predetermined by adjusting the volume of the tissue treatment device, inner or outer profile. Cartridge member 732 may contain one or several fasteners, e.g., staples, clips, etc., which may be actuated via controls located proximally on handle assembly 710. A septum or barrier 736, may be removably positioned between cartridge member 732 and anvil member 734 while connecting member or pin 738 may connect the device 712 to the tubular member 702. An atraumatic distal tip 740 can also be attached to the distal end of the tissue treatment device to limit trauma to the esophagus and stomach cavity. In this embodiment, the atraumatic distal tip is a split flexible tip that opens and closes with the jaws 732 and 734 of the tissue treatment device. There is also a retractor wire 742 attached to a sail 744 that is extendible above the septum. The tissue treatment device including the retractor wire and sail are described in more detail with reference to FIGS. 76-80 of U.S. Patent Application Serial No. 11/282,320, which was filed on November 17, 2005, and is hereby incorporated by reference in its entirety.

0114In this embodiment, both members 732 and 734 of the tissue treatment device 712 also define openings 741 and 743, respectively, along a portion of the length or the entire length of each of the members 732, 734. One or both of these openings 741, 743 may be connected via tubing through elongate member 702 to the vacuum ports located at the handle assembly 710. Alternatively, a central vacuum lumen may supply both ports, or may bifurcate at the proximal or distal end of flexible member 702. Targeted tissue can be sucked into these openings 741, 743 when a vacuum is applied. To prevent tissue from becoming caught or snagged onto the edges of the openings 741, 743, baskets 749 with holes can be placed within the openings 741, 743. One embodiment of a basket 749 is shown in FIG. 38, that has rows of three holes per side, and with each individual hole measuring about 0.70 inch in width and about 0.060 inch in height. Baskets 749 with any number of rows of holes per side and with a variety of sizes have also been contemplated. Also, to prevent "snagging" of tissue, the outside of the tissue treatment device is designed to be as smooth as possible. This allows tissue to "flow" around the device and into the openings. It may also be desired to effect the outside shape so that the acquisition slows the flow of certain tissue to acquire more of a particular target tissue, i.e. slow the flow of mucosa into the pod to allow more serosa to be gathered.

0115A detailed view of one embodiment of the tissue treatment device 712 is shown in FIGS. 34 through 36. The cartridge member 732 and anvil member 734 may be both or singularly articulatable relative to one another or relative to elongate member 12. A hinge 745 longitudinally positioned between cartridge member 732 and anvil member 734 may be configured to enable the device to be pivoted into an open configuration for the acquisition of tissue and a closed or deployment configuration for delivery or advancement of the device into the hollow body organ. In one embodiment, the retractor wire 742 extends from the proximal end 704 of the elongate member 702 to the tissue treatment device and through the hinge 745 that pivots the members 732 and 734. In an alternative embodiment, the wire retractor extends through a strap 766 that is attached to the backside of the tissue treatment device. As best shown in FIG. 36, a first end 746 of the retractor wire is curved and includes an eyelet 747 that provides an attachment point for an end of a tether wire 748, which is attached to the sail 744 and the optional septum 736 located between the cartridge member and anvil member. In an alternative embodiment, the sail element may serve the function of the septum in its extended form. With the first end of the retractor wire secured to the tissue treatment device, the remaining portion of the retractor wire loops around the tissue treatment device and through the flexible elongate member 702, where the second end (not shown) is positioned at the proximal end 704 of the device 700. In the extended configuration as shown in FIG. 36, the sail acts as a barrier and ensures that the target tissue enters the appropriate vacuum pod without crossing over into the other vacuum pod. It has also been contemplated that that the tissue treatment device does not include a septum, and the sail 744 is attached between the jaws of the tissue treatment device. In this embodiment, the sail may be attached to the tissue treatment device with a pin or wire through the hinge located between jaws 732 and 734. When the tissue treatment device 712 is in the delivery position with the jaws 732 and 734 closed as shown in FIG. 34, the first end of the wire retractor rests inside a gap or slit 752 (see FIG. 35) formed in the split flexible tip 740 and the sail is in a collapsed position so that it is folded between jaws 732 and 734. In use, when the tissue treatment device is positioned within the stomach, the retractor wire 742 is extended by pushing the wire distally, and since the first end of the wire is anchored to the tissue treatment device via the tether, excess wire forms a loop 750 or other space occupying geometry within the stomach cavity. In this retraction position as shown in FIG. 36, the loop formed with the wire retractor pushes or blocks unwanted tissue away from the tissue treatment device. In some embodiments, the wire retractor is a nitinol wire, although any material, including stainless steel or a comparatively stiff polymer, can be used to form the wire structure. Extending the retractor wire 742 also raises the sail 744 by pulling the tether 748 away from the tissue treatment device. Targeted tissue is drawn into vacuum pods located in the cartridge member 732 and the anvil member 734 when a vacuum is created, and the extended sail 744 acts as a barrier to prevent tissue from crossing over from one pod to the other. This helps to ensure that the plication or staple line formed in the stomach cavity is continuous without any gaps or holes.

0116In one embodiment, the shape of the sail 744 is defined by the tether wire 748, which as shown in FIG. 36 is a triangle, although other shapes may be used such as circular, oval, or any polygonal shape. The sail may be formed of any flexible material, for example polyethylene tape including polyethylene film with an acrylic adhesive, that is wrapped around and secured to the tether, which in one embodiment may be a Kevlar aramid line. Other materials that can be used to form the sail include any plastic or flexible material, for example the sail element may be cut from a sheet of material, or molded to a particular shape. Such other materials may include polyester (e.g., DACRON® from E. I. du Pont de Nemours and Company, Wilmington, DE), polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), nylon, or silicone. In one embodiment, the tether 748 is also secured through holes of the septum 736, however, the sail 744 may be attached directly to the septum. It has also been contemplated that the first end 746 of the retractor wire 742 is directly attached to the sail without the use of a tether wire. Still in another embodiment, the retractor wire may be attached to the septum with the sail attached to the retractor wire and the septum, as shown in one embodiment of U.S. Patent Application Serial No. 11/282,320, which has already been incorporated by reference. As shown in FIGS. 34-36, the split flexible tip 740 includes a cylindrical body with a proximal end 754 and a distal end 756. The split or gap 752 is formed at the proximal end of the cylindrical body and is wide enough to house the first end 746 of the retractor wire 742 when the device is in its delivery configuration. The cylindrical body includes a progressive taper towards the distal end for insertion through the esophagus. Also, the cylindrical body may include a guide wire lumen 758 so the device can track along a guide wire that has been positioned within the stomach cavity. The proximal end 754 of the split flexible tip 740 can be attached to the distal end of the tissue treatment device 712 with an adhesive and/or mechanically with pins or a post extending from the tissue treatment device. If adhesive is used, the surface area at the cross section of the proximal end of the cylindrical body should be nearly as large as the surface area of the ends of the jaws 732 and 734. The split or gap 752 allows the split flexible tip 740 to open (see FIG. 35) and close (see FIG. 34) with the tissue treatment device 712, and provides a space for the retractor wire to extend through. In order for the split flexible tip to open and close and be atraumatic to the tissue of the patient, it is formed of a flexible elastomeric material, such as silicone rubber.

0117As best shown in FIG. 37, an endoscope shroud or sleeve 760 is attached to the backside of the tissue treatment device 712. The shroud 760 provides a passageway for an endoscope EN, and the passageway starts from the distal end 706 of the flexible shaft or elongate tubular member 702 and ends along the backside of the tissue treatment device 712. It is possible for the shroud to extend any length along the tissue treatment device, and it may even extend past the distal end of the tissue treatment device. In one embodiment, the tubular structure of the shroud is formed by layers of tape, such as polyester tape including polyester film with an acrylic adhesive, although any flexible material may be used to form the shroud. Other materials include polyethylene tape including polyethylene film with an acrylic adhesive, or polyimide tubing. In some embodiments the shroud may be molded or formed over a mandrel and then attached to the tissue treatment device. It is preferable that the shroud surface be smooth and flexible to be atraumatic to the esophagus when passed to the treatment area. A collar 762 is attached to an end ring 764 located at the distal end 706 of the flexible shaft 702, and the proximal end of the shroud is attached to or wrapped around the collar as shown in FIG. 37. The shroud is then attached to the tissue treatment device by being wrapped around a strap 766 attached to the backside of the tissue treatment device 712 that may also provide a passageway for the retractor wire in some embodiments. In other embodiments that do not include the strap 766, the shroud 760 can be adhesively attached to the tissue treatment device. In use, the shroud tube lumen directs the endoscope EN around the jaws of the tissue treatment device for viewing the procedure. Also, the shroud 760 cradles or contains the endoscope to prevent the scope from torqueing or extending out of the insertion plane or extending into the lesser curve of the stomach organ which would affect the placement of the tissue treatment device, or in a variety of directions that may impact the resulting geometry of the gastroplasty or pouch.

0118In one embodiment, the cartridge member 732 may contain a removable staple cartridge 768 containing fasteners along an outer edge of the member 732 while the anvil member 734 may have an anvil positioned along an outer edge of the member 734 such that the anvil corresponds to the number and position of fasteners within removable staple cartridge 768. The cartridge 768, which is shown in FIG. 39, is removable so that during a procedure, more than one staple line may be formed within the stomach cavity using the same gastroplasty assembly 700. Referring to FIG. 39, the staple cartridge 768 includes a staple housing 770 that stores the staples, with a top end 772 and a bottom end 774. The top end includes staple apertures 776 where the staples are ejected from tissue. To lock the removable cartridge 768 into the cartridge member 732, the housing 770 includes a locking pin 778 attached to a flexing beam 780 that is attached to the housing as shown in

0119FIG. 39. There is also a lift shelf 782 disposed within the housing 770 that provides an area to grab and lift the staple cartridge out of the cartridge member 732. Referring now to FIG. 40, the removable cartridge 768 is locked in position within the cartridge member 732. As shown, the cartridge member 732 includes a lock hole 784 that receives the flexible locking pin 778 of the removable cartridge 768. The cartridge member 732 also includes a lift clearance 786 that provides access to the lift shelf of the removable cartridge 768. To remove a dispensed cartridge 768 from the cartridge member 732, an instrument can be inserted through the lock hole 784 to press or move the locking pin 778 away from and out of the lock hole. At the same time, another instrument can be inserted into the lift shelf 782 to pry the cartridge 768 out of the cartridge member 732. A full cartridge may then be placed into the cartridge member 732 so that the locking pin 778 snaps into position within the lock hole 784.

0120To deploy the staples housed within the cartridge 768, a wedge 788 may be pulled proximally through the cartridge member 732 via a staple actuation wire 790. The actuation wire 790 may be manipulated at the handle assembly 710 when staples are to be deployed into the tissue. In one embodiment, as the wedge 788 is pulled proximally, the wedge engages a staple pusher 792 that is disposed over corresponding staples 794, a single staple pusher may be configured to engage multiple staples in adjacent rows. FIG. 41 shows the wedge 788 coming in contact with the staple pusher 792. Pushers may be designed so that staples contact the anvil at different times optimizing the required force to fire the staples. Alternatively, the spacing may be derived from tissue healing properties. Or a combination of the two may effect the design of the pushers. The staple pusher 792 may include a sloped surface 796 for slidingly engaging the sloped surface of the wedge. As the wedge engages the sloped surface 796 of the staple pusher, the staple pusher is pushed towards staples as the pusher is guided via one or more guides 798 to fire the staples. Still referring to FIG. 41, the wedge 788 is disposed along a wedge insert 800, which is near the distal end of the cartridge member 732. The wedge insert 800 includes guides 802 that the wedge 788 follows when it is initially pulled proximally to fire the staples. Before the device is activated and the staples are fired into tissue, the wedge 788 is stored along the wedge insert 800 where it does not engage or begin to push the stapler pusher 792 toward the staples. While the wedge 788 is in this starting position, it is also held in place during handling by a shear pin 804 that is molded into the staple cartridge 768. The shear pin 804 ensures that the wedge 788 does not begin to contact the staples in the cartridge. In one embodiment, to move the wedge 788 proximally out of the wedge insert 800 and past the shear pin 804, sufficient force is provided to the wedge to break the shear pin away from the cartridge 768 so that the wedge is free to move proximally along the cartridge member 732. If after firing the staples of one staple cartridge 768 and the tissue treatment device 712 is to be reloaded with another staple cartridge 768, the staple cartridge is removed as described above and the wedge is pushed distally along the cartridge member 732 until it is positioned back into its starting position within the wedge insert 800. It is important that the wedge is pushed back to the starting position, otherwise, when another cartridge is loaded into the device staples may be pre-fired due to the position of the wedge. Then, another staple cartridge is loaded into the cartridge member 732, and the shear pin 804 molded into this staple cartridge will hold the wedge in its starting position during handling.

0121The tissue treatment device 712 is connected to the distal end of the elongate member 702 by connecting member 738 that is attached to an end ring 808 disposed at the distal end of the elongate member. A cross-sectional view of the end ring is shown in FIG. 42 and shows several apertures 810 disposed through the end ring to provide a passageway for the endoscope, vacuum tubes and wires. In one embodiment, the apertures are designated as follows: aperture 810a is a passageway for the endoscope, aperture 810b is a passageway for the cartridge member vacuum tube, aperture 810c is a passageway for the anvil member vacuum tube, aperture 81Od engages the connecting member 806 that is attached to the tissue treatment device, aperture 810e is a passageway for the septum wire (discussed below), aperture 810f is a passageway for the retractor wire, aperture 810g is a passageway for the opening cable (discussed below), aperture 810h is a passageway for the outer clamping cable (discussed below), aperture 81Oi is a passageway for the inner clamping cable (discussed below), and aperture 81Oj is a passageway for the staple actuation wire 790. In other embodiments, the apertures may be rearranged in any design and additional apertures may be disposed through the end ring for additional wires.

0122Each of the members 732, 734 may have openings to allow for the routing and passage of clamping cables through the device for enabling cartridge member 732 and anvil member 734 to be clamped together and opened. FIGS. 43 and 44 show partial cross-sectional views taken along the tissue treatment device 712 with the vacuum tubing and cables routed through the device. As shown, cartridge vacuum tube 812 and anvil vacuum tube 814 may be routed through elongate member 702 into a proximal end of each cartridge member 732 and anvil member 734 for fluid connection with respective openings 741, 743. Outer clamping cable 816 and inner clamping cable 818 may be passed through elongate member 702 around vertical pulleys 817 in the cartridge member 732 and across to the anvil member 734 where the ends may be held in the anvil member with ball crimps. To clamp cartridge member 732 and anvil member 734 closed, the cables 816 and 818 are pulled proximately. The closed configuration of the tissue treatment device 712 is shown in FIG. 43. Opening cable 822 may be passed through elongate member 702 around the horizontal pulley 823 in the cartridge member 732 and around an open cam 825 to the anvil member 734, where the end is held in the anvil member with a ball crimp. Members 732, 734 may be opened with respect to one anther by pulling or tensioning the opening cable 822 proximately. This open configuration is shown in FIG. 44.

0123Referring now to FIGS. 45 and 46, the handle assembly 710 will be discussed in detail. As shown in FIG. 45, the handle assembly 710 includes a housing 824 having a transition knuckle 826 that attaches to the elongate tubular member 702. There is a scope tube and seal mount 828 which allows entry of an endoscope into the elongate member 702, and a vacuum tube adapter 830 which holds vacuum tubes 812, 814 and an insufflation tube (not shown) so that the tubes may be connected to a vacuum device. In one embodiment, this distal portion of the handle assembly 710 including the transition knuckle 826, the scope tube seal mount 828, and the vacuum tube adapter 830 is sealed pressure tight. A clamp/open knob 832 is located at the proximal end of the handle assembly and is in connection with clamping and opening cables 816, 818, and 822. Twisting the clamp/open knob in a counter-clockwise direction opens the member 732, 734 of the tissue treatment device 712, and twisting the clamp/open knob in a clockwise direction clamps the members 732, 734 of the tissue treatment device closed. In one embodiment, there are markings, such as, colored bands and/or numbers disposed on the housing 824 of the handle assembly adjacent the clamp/open knob 832 to indicate the force being applied at the tissue treatment device 712. There is also a wedge fire knob 834 in this embodiment that is in connection with the staple actuation wire 790. Turning the wedge fire knob in a clockwise directions causes the wedge 788 to move proximally with in the cartridge member 732 to fire the staples 794. A wedge lock 836 is disposed on the housing 284 near the wedge fire knob and is used to lock the staple actuation wire 790 in position to prevent the wedge 788 from being moved prior to forming a staple line within the stomach. In other embodiments, the wedge fire knob may be replaced with a lever or other activation means to pull the wedge within the cartridge member 732. The handle assembly 710 also includes a retractor seal 838 to allow entry of the retractor wire 742 into the elongate member 702 (while maintaining the sealed portion of the handle). A proximal end of the retractor wire extends out of the retractor seal and the user may push or pull the retractor wire during the procedure to extend and retract the retractor wire within the stomach cavity. A groove 840 is also disposed on the housing 824 that tracks a septum push-off knob 842 that may be tightened to secure a septum wire attached to the septum 736. The septum push-off knob can be moved along the groove 840 to push the septum wire distally, thereby removing the septum 736 from between the members 732, 734 when needed, as will be described below. In one embodiment, a septum key or lock is disposed near the proximal end of the tissue treatment device between members 732, 734 and fits within a key slot created along the proximal edge of the septum. The septum key or lock prevents unwanted motion of septum during shaft flexing or accidental actuation. Referring now to FIGS. 46 through 46B, a push/pull mechanism 848 that is in connection with the clamp/open knob 832 and the cables 814, 816 and 822 will be described. FIG. 46A shows the push/pull mechanism in an opened configuration when the jaws 732, 734 of the tissue treatment device 712 are opened. To open the jaws, the opening cable 822 is tensioned with respect to an open coil pipe 850. Tensioning is accomplished by turning knob 832 counterclockwise, which pushes a balance bar pivot 852 against a slide link 854. This pushes a cross pin 856 distally, which moves the open coil pipe distally and has the effect of tensioning the opening cable 822. When the knob 832 is turned counterclockwise, a lead screw 858, which is fixed rotationally, translates with the balance bar pivot and is pushed distally. Once the balance bar pivot comes in contact with the slide link, an open thrust bearing 860 begins to compress open springs 862 in a spring holder 864. A colored line on the outside of the handle housing 824 is used to determine the amount of compression and therefore the amount of tension on the open cable.

0124FIG. 46B shows the push/pull mechanism 848 in a closed configuration when the jaws 732, 734 of the tissue treatment device 712 are clamped together. To close or clamp the jaws, the outer and inner clamping cables 816, 818 are tensioned with respect to clamp coil pipes 864. Tensioning is accomplished by turning the knob 832 clockwise, which pulls the balance bar pivot 852 and the clamping cables 816, 818 proximally, and redirects the cables through guide block 866. When the knob 832 is turned clockwise, the lead screw 858 is pulled proximally to tension the clamping cables 816, 818. Once the clamp cables begin to tension, a clamp thrust bearing 868 begins to compress clamp springs 870. A colored line on the outside of the handle housing 824 is used to determine the amount of compression and therefore the amount of tension on the clamp cables 816, 818. Once the lead screw is pulled proximally so that the balance bar comes out of contact with the slide link(s), the tension on the open cables is released. Lead screws can have various thread pitches to create different clamp/open profiles. For example, constant thread pitch would cause the jaws to close at a consistent rate, but a varying pitch (along the lead screw) could generate sections of the travel to act quicker or slower, i.e. open fast, close slow, etc. Referring to FIG. 46, the wedge fire knob 834 is attached to a wedge fire mechanism 872 that is attached to the staple actuation wire 790. To fire the staples at the tissue treatment device 712, the knob 834 is turned clockwise to pull a lead screw 874 proximally into the knob. The lead screw is rotationally fixed, but it is free to translate. Attached to the lead screw is a wedge wire adaptor 876 that tensions the staple actuation wire 790 and pulls the wedge 788 proximally. Before firing the staples, the wedge lock 836 should first be loosened and removed from a guide pin located between the lead screw and the wedge wire adaptor.

0125In one embodiment, the gastroplasty assembly 700 may be transorally delivered through the esophagus to create one or more plications within the stomach cavity. With reference to FIGS. 47-53 A, one method of using the gastroplasy device will be described to form a sleeve or pouch within the stomach cavity.

0126In one embodiment, an endoscope EN my be introduced transorally to the stomach cavity to inspect the upper gastrointestinal tract and the stomach cavity. A guide wire GW may then be introduced through the endoscope to the stomach cavity and the endoscope may be removed from the patient. With the guide wire in position, a bougie dilator (not shown) is introduced over the guide wire to dilate the esophagus and the gastroesophageal junction ("GEJ"). The bougie dilator is removed and the proximal end of the guide wire is passed through the guide wire lumen 758 of the distal tip -740 and the tissue treatment device 712 is introduced through the esophagus and into the stomach cavity until the tissue treatment device is about 5 cm beyond the Z-line location as shown in FIG. 47. In one embodiment, there may be markings along the jaws 732 and 734 to properly position the tissue treatment device. Next, the guide wire GW is removed and the endoscope EN is inserted through the scope tube seal mount 828 of the handle assembly 710, the elongate member 702, and the shroud 760. As shown in FIG. 48, the endoscope EN exits the shroud 760 and is retroflexed to view the tissue treatment device 712 to verify that the proximal end of the jaws 732, 734 are at the GEJ. In some embodiments, the stomach may be insufflated using the insufflation tube for easier viewing with the endoscope.

0127With the endoscope EN still in position to view the tissue treatment device 712, the jaws 732 and 734 are opened by rotating the clamp/open knob 832 counterclockwise. At this time the backside of the tissue treatment device 712, the side including the shroud 760, should be positioned against the lesser curve ("LC") of the stomach cavity. Next, the retractor wire 742 is advanced by pushing the proximal end of the retractor wire through retractor seal 838 to retract the greater curvature ("GC") of the stomach with the excess loop of wire 750. This action also deploys the sail 744 as shown in FIG. 49. At this stage, the vacuum tubes 812, 814 are clamped off and connected to a vacuum pump, which is then turned on. When the pump is stabilized at full vacuum, (between approximately 25 inHg - 30 inHg, preferably 27 inHg - 29.5 inHg), the stomach is slowly desufflated and then the vacuum tubes 814, 816 are opened to acquire tissue in each opening 741, 743 of the cartridge and anvil members 732, 734. It is preferred that the vacuum tubes 814, 816 are opened simultaneously, however, the vacuum tubes may be opened at different times as well. The extended sail 744 and septum 736 organize the target tissue into the appropriate member 732, 734. FIG. 49A depicts a cross-sectional view taken along line 49a-49a of FIG. 49, with folds of tissue being acquired in the openings 741,743. At this point, the members 732, 734 are lightly clamped together by rotating the clamp/open knob 832 in a clockwise direction. It may be desired to clamp off the vacuum tubes 814, 816 and then insufflate the stomach to view the acquired tissue that is being held with the members 732, 734. It is desirable that the acquired tissue have no large folds or pleats so that a smooth double sleeve can be formed with the device. The stomach may then be desufflated once again and the vacuum tubes 814, 816 are undamped to re-apply vacuum that holds the tissue within the openings of the members 732, 734. Next, the retractor wire 742 is retracted almost completely, until the first end 746 is near the distal tip 740 and the sail is collapsed as shown in FIG. 50. The members 732, 734 are undamped by rotating the clamp/open knob 832 counterclockwise, and the septum 736 is ejected from between the members. The septum is ejected by unlocking the septum push-off knob 842, sliding the knob 842 about an inch back or proximally in the groove 840, tightening the knob 842 to capture a septum wire 844, and sliding the knob 842 forward to advance the septum distally. This procedure is repeated until the septum 736 is fully advance away from the tissue treatment device 712 as shown in FIG. 51. Once again, the members 732, 734 may be lightly clamped together, the vacuum lines 814, 816 are clamped off, and the stomach is insufflated to inspect the clamp tissue to ensure the septum 736 is clear of the targeted tissue and that no large tissue folds of pleats are present in the clamp line, and that the sleeve staple line does not show signs of a large proximal stoma. If the appearance of the acquired tissue is acceptable, the stomach cavity is desufflated and the vacuum lines 814, 816 are undamped to re-apply vacuum. After desufflation, the members 732, 734 are fully clamped together using the clamp/open knob 832. With tissue clamped between the members of the tissue treatment device 712, the dual folds of the tissue are stapled together by rotating the wedge fire knob 834 clockwise, which moves the wedge 788 proximally within the cartridge member 732 to fire the rows of staples. FIG. 51 A depicts a cross-sectional view taken along line 51a- 51a of FIG. 51, and shows the two folds of tissue being stapled together with the tissue treatment device. Once completed, the jaws of the tissue treatment device 712 are opened by rotating the clamp/open knob counterclockwise, and the vacuum pump connected to tubes 814, 816 is turned off. To remove the acquired tissue from the tissue treatment device, the acquired tissue may be flushed from the openings 741, 743 of the members 732, 734 with a sterile water bolus delivered via vacuum tubes 814, 816 with a syringe. Once the tissue is freed from the tissue treatment device, the endoscope EN is straightened as shown in FIG. 52, and the members 732, 734 are closed together with the septum still in the trailing position. The endoscope is removed from the gastroplasty assembly 700, and then the entire assembly is removed from the stomach cavity, leaving a sleeve 846 within the stomach as shown in FIGS. 53 and 53A.

0128If a long sleeve, two or more sleeves or staple lines, is to be disposed within the stomach cavity, the removable staple cartridge 768 can be replaced with a fresh staple cartridge, as described above, and the entire procedure can be repeated to form another sleeve. It is preferred that there are no gaps between individual staple lines that form a long sleeve, and in one embodiment the staple lines of a long sleeve may be overlapped (end to end) to minimize gaps between staple lines.

0129Also, it is possible to reload the tissue treatment device 712 of the gastroplasty assembly 700 and then turn the tissue treatment device towards the lesser curve of the stomach to form a dual fold staple line down the lesser curve of the stomach. This procedure will narrow the sleeve formed by the two dual fold staple lines. In yet another embodiment, the tissue treatment device 712 can be used to form a single fold staple line within the stomach cavity. In this embodiment, after forming a dual fold staple line, the tissue treatment device may be turned toward the lesser curve of the stomach to form another staple line. However, in this embodiment, a vacuum is only created in one of the vacuum openings 741 or 743 so that only one fold of tissue is acquired and then stapled to form a single fold staple line. This single fold staple line may be used to further restrict the sleeve formed by the initial dual fold staple line. After forming plications within the stomach cavity using the gastroplasty device 700, a restrictor stapler 900 can then be used to perform a secondary step in a gastric sleeve or pouch formation procedure. The restrictor stapler may be similar to the endoscopic stapler described in U.S. Patent Application Serial No. 11/107,382, which is incorporated by reference in its entirety. There are multiple uses for the restrictor stapler, such as forming additional plications in the distal end of a gastric sleeve, and in some situations close a stoma or fistula created by a gastric sleeve.

0130Referring to FIG. 54, the restrictor stapler 900 includes a stapler assembly 902 or cartridge assembly connected via a flexible shaft 904 or elongated body having a proximal end and a distal end to a stapler handle 906. The stapler assembly includes a fixation member having a staple cartridge member 908, within which one or more staples are housed, and an anvil 910 in apposition to stapler cartridge member used to provide a staple closure surface when tissue to be affixed is adequately positioned between staple cartridge member and anvil. An optional smooth rubber tip 912 with a guide wire channel 914 may be attached to the distal end of the staple cartridge member. The atraumatic tip 912 prevents injury to tissue when the device is advanced down the esophagus, and the guide wire channel allows the fixation assembly to track down a guide wire. The staple assembly also includes an acquisition member for acquiring tissue. In one embodiment a vacuum pod 916 is attached or integrated into the staple cartridge member 908, and a vacuum line or tubing 917 extends from the vacuum pod, along the shaft 904 and to the handle 906. It is preferred that the overall insertion diameter of the stapler assembly and flexible shaft plus endoscope is equal to or less than 54 Fr. In one embodiment, with the jaws 908, 910 closed, the maximum perimeter of the device is equivalent to about 15.1 mm diameter (0.595 inch or 45 Fr diameter). With the jaws 908, 910 opened, the maximum perimeter of the device is equivalent to about 17 mm diameter (0.668 inch or 51 Fr diameter).

0131With stapler assembly 902 connected at the distal end of flexible shaft 904, the handle 906 is connected at the proximal end of shaft. The flexible shaft 554 is configured to be curved, and in one embodiment can achieve a 4 inch bend radius with a low application of force. The handle 906 may include a housing and grip 920 in apposition to an actuation handle 922. In use, the handle 906 allows the surgeon or user to hold and manipulate the restrictor stapler 900 with grip 920 while articulating stapler assembly 902 between an open and close configuration via the actuation handle 922. A lever or staple deployment actuator 924 is also disposed on the handle 906 and is used to deploy staples from the stapler assembly 902. Moreover, the configuration of the handle 906 allows the surgeon or user to articulate the stapler assembly 902.

0132In one embodiment, the anvil 910 may be pivotally connected via a pivot 926 to the end of flexible shaft 904 as shown in FIG. 54 A. The staple cartridge member 908 may be configured to remain stationary relative to the flexible shaft 904 while anvil 910 may be manipulated into an open and closed configuration with respect to flexible shaft and staple cartridge member. However, in another embodiment, the staple cartridge member may be pivotally connected to the flexible shaft and the anvil remains stationary. In yet another embodiment, both the anvil and the staple cartridge member can pivot into an open and. closed configuration relative to the flexible shaft. To manipulate the anvil 560 to an open and closed configuration, a circular or disk-shaped cam may be pivotally attached about rotational pivot located on the side of the proximal end of stapler assembly 902, as described with reference to FIG. 31 in U.S. Patent Application Serial 11/107382. Actuation wires or cables may be wound about cam such that when cable is pulled, cam is urged to rotate clock-wise about rotational pivot. Actuation cables may be manipulated from their proximal ends by the user. As cam is rotated in a clock-wise direction, a portion of staple cartridge member 908 may be engaged by the cam thereby forcing the anvil 910 to pivot into an open configuration. An additional cam may also be affixed on the opposite side of stapler assembly 902 such that dual cams are configured to open and close simultaneously in parallel. As shown in FIG. 54B, when dual cams are used and the jaws 908, 910 are opened, the surfaces of the jaws 908, 910 remain parallel to one another. This allows for better tissue acquisition between the jaws 908, 910.

0133In one embodiment as shown in FIG. 54C, the anvil 910 includes an anvil extension 928 disposed at the distal end of the anvil. The anvil extension contacts the ceiling of a pocket 930 disposed in the proximal end of the rubber tip 912 as shown in FIG. 54D. This keeps the distal end of the anvil in plane and forces the stapler cartridge 908 and anvil 910 to open in parallel as shown in FIG. 54B. Referring to FIG. 54C, the staple cartridge member 908 includes a cartridge extension 932 that engages a cutout 934 (see FIG. 54E) located at the proximal end of the rubber 912 to secure the rubber tip to the stapler assembly 902.

0134In one embodiment of the restrictor stapler 900, there are two rows of staple apertures 936 defined over the surface of the staple cartridge member 908, as best shown in FIG. 54D. Staples are deployed through the apertures in a similar manner as described with reference to FIGS. 22A to 23C of U.S. Patent Application Serial No. 11/107,382, by pulling a staple actuation wire that in turn, moves a wedge in contact with a staple pusher to fire a staple. In this embodiment, the lever or staple deployment actuator 924 is depressed to pull the actuation wire in order to fire the staples from the stapler assembly. The jaws 908, 910 of the stapler assembly 902 are closed, as shown in FIG. 54A, using the actuation handle 922, and then the staples may be deployed into the acquired tissue. Other variations may utilize fewer or greater than two rows of staple apertures.

0135In one embodiment of the restiictor stapler 900, the staple cartridge member 908 can be re-loaded with a removable staple cartridge 938. As shown in FIG. 54E, the removable staple cartridge may be integrated with the rubber tip 912, so that they are loaded and unloaded from the staple cartridge member 908 together. The removable staple cartridge 938 includes a detent pin 940 located near its distal end, that when placed into the staple cartridge member 908, locks into a lock hole 942 located near the distal end of the staple cartridge member. To load the removable staple cartridge 938 into the restrictor stapler 900, the jaws 908,910 of the stapler assembly 902 are opened, and the lever or staple deployment actuator 924 is raised to push a staple firing wedge to the distal end of the device. If the wedge does not travel to the end of the device, the wedge may be manually pulled using forceps. In one embodiment, firing cable struts can be disengaged from the lever and the lever can be lowered without moving the wedge from the distal location. The proximal end of the removable staple cartridge 938 may be inserted into the staple cartridge member 908 and slid back, ensuring wedge does not pre-fire the staples. Once the removable staple cartridge 938 is about 90% in place, the jaws of the stapler assembly are slowly closed to allow the anvil extension 928 to nest in the pocket 930 of the rubber tip. The removable staple cartridge 938 is then pushed down and back to ensure it is completely in the staple cartridge member 908, and the jaws 908, 910 are completely closed. As the rubber tip/removable staple cartridge are loaded onto the stapler assembly 902, cartridge extension 932 will engage the cutout 934 of the rubber tip 912 and the anvil extension 928 will fit into the pocket 930 of the rubber tip, and the detent pin 940 will snap into the lock hole 942. To unload or remove the rubber tip/removable staple cartridge, the jaws are opened and the detent pin 940 is pushed away from the lock hole 942 and the rubber tip/removable staple cartridge is removed by the user. The removable staple cartridges 938 may include two rows of six staples, each having 4.8 mm leg length with 3 mm backspan. The staple line length in this embodiment is about 25.0 mm (0.984 inch), although the length of the staple line may range from about 12.5 mm (0.492 inch) to about 50.0 mm (1.97 inch). Generally, as shown in FIG. 55 the restrictor stapler 900 is advanced over a guide wire through the guide wire channel 914 of the rubber tip 912 and down the esophagus to the stomach cavity, the stapler assembly 902 is preferably in a closed configuration. Further, the restrictor stapler may be compatible with the side-by-side insertion of a 8.6 mm diameter flexible endoscope EN or similar scope. The device will be axially located by referencing external markings on the shaft of the device, or visually by using markings on the head of the stapler assembly 902 relative to the "z-line." In terms of radial location, the device will be rotated and placed while under direct visualization. Alternatively, the user may rely on markings on the handle to rotationally orient the device. Once the stapler assembly 902 is in the desired position within the stomach cavity for placing a plication along the stomach wall, the guide wire is removed, and the stapler assembly may be articulated into an open configuration as shown in FIG. 54B. A vacuum may then be created at the vacuum pod 916 to acquire a fold of tissue 918 between the staple cartridge member 908 and the anvil 910. It is preferred that a vacuum device be used to achieve a vacuum level of about 27 inHg to about 29.5 inHg. After the vacuum level has stabilized, the jaws of the stapler assembly 902 are then clamped closed over the tissue as shown in FIG. 56. The vacuum, created at the vacuum pod 916 is shut-off, and the stomach cavity is insufflated to inspect and verify that the restrictor stapler is in the desired position relative to the distal end of the sleeve. If the position is acceptable, the stomach cavity is desufflated and vacuum is again created at the vacuum pod. The jaws of the stapler assembly 902 are then fully opened to complete the tissue acquisition and then held until the vacuum stabilizes. Once stabilized, the jaws of the stapler assembly are then clamped closed over the tissue. It is preferred that the user waits fifteen seconds and then the staples are deployed into the acquired tissue to form a single fold plication. Vacuum is then released and the stapler assembly 902 is opened and the device is slightly advanced and rotated to allow for the gastric tissue to pull free from the vacuum pod, or vacuum may be reversed to expel the tissue from the pod. Once the tissue is free, the device is withdrawn leaving the geometry shown in FIGS. 57 and 57A, which is a cross-sectional view taken along line 57a-57b of FIG. 57. FIG. 57 is an illustrative view showing the longitudinal plication or dual fold sleeve 846 and the single fold of tissue 918 created by the restrictor stapler 900 to decrease the diameter of the distal stoma DS. The staple cartridge member may be reloaded with another removable staple cartridge 940 for another firing if necessary. Multiple plications may be positioned using the restrictor stapler 900 anywhere within the stomach cavity or newly created gastric sleeve or pouch. For example, three additional single folds of tissue 918 may be created near the distal stoma created by the dual fold sleeve 846 as shown in FIG. 58.

0136By placing a single fold plication at the distal stoma of a sleeve, the restrictor stapler 900 may reduce the diameter of the distal stoma from about 0.5 cm to about 1.5 cm. For example, in a wet lab test using canine tissue, a 19 mm diameter sleeve (57 Fr or 0.75 inch diameter) was reduced to 11.7 mm diameter (35 Fr or 0.46 inch diameter) by placing two restrictor plications adjacent to each other at the distal end of the 19 mm diameter sleeve. Therefore, these two restrictor plications removed 7.3 mm (22 Fr or 0.29 inch) from the sleeve diameter. The final size of the distal stoma was smaller than the perimeter of the stapler assembly. In a further example, the restrictor stapler places a plication that takes-up 15 mm (0.59 inches) of linear tissue. This would yield a 4.8 mm diameter reduction (14.3 Fr or 0.188 inch diameter).

0137The gastroplasty device 700 and the restrictor stapler 900 can be used together to form a variety of geometries, some of which are disclosed in U.S. Patent Application Serial No. 11/107,382, which has already been incorporated by reference. In addition, multiple dual fold sleeves 846 may be placed consecutively in the stomach cavity to form a longer gastric sleeve, and multiple single folds of tissue 918 can be positioned within the longer gastric sleeve to reduce the diameter of the stoma. For example, FIG. 59 depicts two dual fold sleeves 846 placed consecutively in the stomach cavity, with two single folds of tissue 918 each placed near the distal end of the individual sleeves 846. FIG. 60 depicts three consecutively placed sleeves 846 and three single folds of tissue 918 each placed near the dial end of the individual sleeves 846. Although not shown, the single folds of tissue 918 can be placed anywhere along the lesser curve LC or circumferentially within the formed pouch to further restrict the diameter of the pouch. In another example as shown in FIG. 61, multiple sleeves 846 have been created within the stomach cavity from the GEJ to the pylorus. No single folds of tissue are shown in this example, however, it may be desirable to place multiple single folds of tissue along the lesser curve LC of the stomach.

0138In other embodiments, the distal stoma DS of the gastric sleeve or pouch may be further restricted by cinching the distal stoma together as disclosed in U.S. Patent Application Serial No. 11/056,327, which is hereby incorporated by reference in its entirety. In this embodiment, anchors may be placed circumferentially around the distal stoma, and then cinched together using a wire attached to all of the anchors. In another embodiment, an intragastric band may be placed at the distal stoma to further reduce its diameter as described in U.S. Patent Application Serial No. 11/067,598, which is hereby incorporated by reference in its entirety. Here, the intragastric band is attached circumferentially around the distal stoma, and then the band itself cinches the distal stoma. It should be recognized that once the gastric sleeve or pouch is created, many methods may used to further restrict the diameter of the distal stoma created by the sleeve or pouch.

0139Referring now to FIGS. 62 through 65, another embodiment of a tissue treatment device 712 is shown to include a distal clamping cable 950 to help close or clamp the members 732, 734 together, hi the embodiment shown, a proximal end of the distal clamping cable 950 is attached at the handle 710 and a distal end of the distal clamping cable is attached to the distal end of the tissue treatment device. As shown in FIG. 62, cartridge vacuum tube 812 and anvil vacuum tube 814 may be routed through elongate member 702 into a proximal end cap 952 of each cartridge member 732 and anvil member 734 for fluid connection with respective openings 741, 743. Proximal outer clamping cable 816 and proximal inner clamping cable 818 may be passed through elongate member 702 around proximal vertical pulleys 817 in the cartridge member 732 and across to the anvil member 734 where the ends may be held in the anvil member with ball crimps. FIG. 64 shows the proximal end of the tissue treatment device with the proximal end cap 952 removed showing the proximal vertical pulleys 817, and the proximal inner and outer clamping cables 816, 818 including coilpipes 958. In this embodiment, the distal clamping cable 950 is also passed through the elongate member 702 into the tissue treatment device 712 around a distal vertical pulley 954 in a distal end cap 956 of the cartridge member 732 and across to the anvil member 734 where the end may be held in the anvil member with a ball crimp. FIG. 63 shows the distal end of the tissue treatment device with the distal end cap 956 removed to show the distal vertical pulley 954. To clamp cartridge member 732 and anvil member 734 closed, cables 816, 818 and 950 are pulled proximately. While the proximal cables 816 and 818 provide a clamping force at the proximal end of the tissue treatment device, the distal cable 950 provides a clamping force at the distal end of the tissue treatment device to provide a more even clamping force across the entire length of the tissue treatment device. Proximal opening cable 822 may be passed through elongate member 702 around the proximal horizontal pulley as discussed above with reference to FIGS. 43 and 44.

0140In another embodiment, one of the proximal clamping cables 816 or 818 can be rerouted to the distal vertical pulley 954 to become the distal clamping cable 950. This embodiment still provides a clamping force at the distal end of the tissue treatment device without having to add an additional cable to the system. Further, by not adding an additional cable, the mechanism in the handle assembly 710 would be the same as disclosed above with reference to FIGS. 46A and 46B.

0141In describing the system and its components, certain terms have been used for understanding, brevity, and clarity. They are primarily used for descriptive purposes and are intended to be used broadly and construed in the same manner. Having now described the invention and its method of use, it should be appreciated that reasonable mechanical and operational equivalents would be apparent to those skilled in this art. Those variations are considered to be within the equivalence of the claims appended to the specification.