MXPA06010460A - Devices and methods for placement of partitions within a hollow body organ - Google Patents

Abstract

Devices and methods for tissue acquisition and fixation, or gastroplasty, are described. 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 a 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. Moreover, the system is configured such that once acquisition of the tissue by the gastroplasty device is accomplished, any manipulation of the acquired tissue is unnecessary as the device is able to automatically configure the acquired tissue into a desired configuration.

Description

DEVICES AND METHODS FOR PLACING PARTITIONS WITHIN A HOLLOW BODY ORGAN FIELD OF THE INVENTION The invention relates generally to medical devices and methods. More particularly, it relates to devices and methods for creating a separation within a hollow organ of the body, particularly a stomach, intestinal tract or other region of the gastrointestinal tract and fixing the tissue. BACKGROUND OF THE INVENTION In cases of severe obesity, patients can currently undergo various types of surgery, either to close by stapling or stapling portions of the large or small intestine or the stomach and / or deriving portions thereof to reduce the amount of food desired by the patient and the quantity absorbed by the gastrointestinal tract. Currently available procedures include laparoscopic tying, where one device is used to "tie up" or constrict a portion of the stomach, vertical tying gastroplasty (VBG = Vertical Banded Gastroplasty), or a more invasive surgical procedure known as Roux-En-Y gastric bypass, to perform permanent surgical reduction of stomach volume and subsequent bowel bypass. Typically, these stomach reduction procedures are performed surgically through an open incision and staples or sutures are applied externally to the stomach or hollow organ of the body. These procedures can also be performed laparoscopically through the use of smaller incisions or gates, through trocar devices and other specialized devices. In the case of laparoscopic tying, an adjustable band is placed around the proximal section of the stomach, reaching the smallest curve of the stomach around the greater curve, thus creating a constriction or "waist" in a vertical shape between the esophagus and the pylorus During a VBG, a small pouch (approximately 20 cc in volume) is constructed by forming a vertical separation of the gastroesophageal junction to the middle of the lower curve of the stomach, externally applying staples, and optionally dividing or resecting a portion of the stomach, followed by by creating a stoma at the exit of the partition to avoid dilation of the exit channel and restrict the consumption or quantity admitted. In a Roux-En-Y gastric bypass, the stomach is surgically divided into a smaller upper pouch connected to the esophageal inflow, and a smaller portion, detached from the upper pouch, but still connected to the intestinal tract, for purposes of secreting the digestive juices. A resected portion of the small intestine is anastomosed using an end-to-side anastomosis for the upper pouch, thereby bypassing most of the intestine and reducing absorption of caloric intake and causing rapid "emptying" of "junk food" or of high caloric content. Although the resulfing of these stomach reduction surgeries leads to a loss of weight of the patient, because patients are physically forced to eat less because of the small size of their stomach, there are several limitations due to the invasiveness of the stomach. procedures, including time, use of general anesthesia, time and pain associated with the healing of the incisions and other complications associated with 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 intervention options, having .

In addition to surgical procedures, there are certain tools for securing tissue such as the stapling devices that are used in the surgical procedures described above and others, such as the treatment of gastroesophageal reflux disease (GERD = Gastroesophageal Reflux Disease). These devices include the GIAMR device (Gastrointestinal Anastomosis Device manufactured by Ethicon Endosurgery, Inc. and a similar product of USSC), and certain clamping and stapling devices as described in US Patents. numbers 5,403,326; 5,571, 116; 5,676,674; 5,897,562; 6,494,888; and 6,506,196 for methods and devices for fundoplication of the stomach into the esophagus for the treatment of gastroesophageal reflux disease (GERD). In addition, certain tools, such as those described in U.S. Pat. numbers 5,788,715 and 5,947,983, detail an endoscopic suture device that is inserted through an endoscope and placed at the site where the esophagus and stomach meet. Vacuum is then applied to acquire the adjacent tissue and a series of seams are placed to create a crease in the sphincter, to reduce the contraflow of stomach acid that ascends 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). There is a need for improved devices and procedures.

In addition, due to the invasiveness of most 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 to more effectively restrict procedures. less invasive hollow organs. COMPENDIUM OF THE INVENTION Devices for tissue acquisition and fixation or gastroplasty are described, which can be used to create a separation within a hollow organ of the body, such as the stomach, esophageal junction and the portions of the gastrointestinal tract. In general, the devices of the system can be advanced in a minimally invasive manner within the body of a patient, for example transorally, endoscopically, percutaneously, etc. to create one or several divisions or plications within the hollow organ of the body. These 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 volume of the stomach, to act essentially as the active stomach such as the pouch resulting from a bypass procedure surgical gastric Roux-En-Y. Examples of placing and / or creating divisions or plications can be seen in greater detail in the U.S. patent application. Serial Number 10 / 188,547 filed on July 2, 2002; and the US patent application. Serial Number 10 / 417,790 filed on April 16, 2003, each of which is hereby incorporated by reference in its entirety. The devices can be advanced within a body through a variety of methods, for example transoral, transnasal, endoscopic, percutaneous, etc., to create one or more divisions or plications within a hollow organ of the body, by example to create a gastric lumen or separation to reduce the effective area of the stomach (for example that which receives the initial volume of food), made from inside the stomach cavity. The creation of this lower gastric lumen can be achieved in a minimally invasive procedure, completely from within the cavity of the stomach. Furthermore, the devices are configured in such a way that once tissue acquisition is achieved, the manipulation of the acquired tissue is unnecessary since the devices are capable of automatically configuring the acquired object in a desired configuration. The devices, in general, may comprise a first reacquisition member and a second acquisition member in opposition to each other on a first longitudinal axis, wherein optionally at least one of the acquisition members is adapted to adhere tissue, so that the fabric is located between the first and second acquisition members, and optionally, wherein at least one of the acquisition members is movable with respect to the first longitudinal axis between a delivery configuration and a deployment configuration. Still further, the system may also comprise a septum or separator, located in a mobile manner between the first and second acquisition members, wherein the least one of the acquisition members is mobile with respect to the septum between a delivery configuration and a configuration. of deployment. A handle can be located at a proximal end of an elongated member or body and is used to manipulate the advanced device within the hollow organ of the body as well as controlling the opening and holding of the acquisition members on the tissue. The elongate body may comprise a series of links, or an extrusion made with various lumens to accommodate the various control mechanisms of the acquisition device. Similarly, the control mechanisms can be grouped together and coated in a thin surface layer liner, such as heat shrink. A working lumen can be fully extended through the elongate member and can be sized to provide access to the far end for various surgical tools, such as an endoscope or other display device, or therapeutic devices such as traps or loops, excision tools, biopsy tools, etc., once the distal end of the assembly is located within the hollow organ of the body. The acquisition members can be joined to the elongated body by a passive or active hinge member, adaptable to locate the assembly. The acquisition members generally may comprise a cartridge member positioned longitudinally as opposed to an anvil member. The cartridge member may contain one or more fasteners, for example staples, fasteners, etc., which may be actuated by controls located in close proximity to the handle assembly. Still further, the septum or barrier can be located removably between the cartridge member and the anvil member and used to minimize or eliminate cross-acquisition of the tissue in the cartridge member and / or anvil member. Methods for placing a partition from within a hollow organ of the body using the devices described herein, in general comprise locating a first acquisition member and a second acquisition member adjacent to a region of tissue within the hollow organ of the body, in wherein the first and second acquisition members are in opposition to each other on 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. This method may also involve pivoting at least one of the acquisition members relative to the longitudinal axis to an open or closed configuration. Another method may also comprise removing a septum between the first acquisition member and the second acquisition member. While the device makes a delivery configuration, i.e. wherein the components of the working portion remote from the device (the cartridge member and anvil member) are positioned such that the cartridge and the anvil are directly opposed to each other. to the septum. Once conveniently located, one or both of the cartridge member and anvil member can be rotated about a pivot or moved translationally in parallel with each other. Next, portions of the stomach wall can be acquired by or thrown in-from their respective openings. The configuration of the cartridge member and anvil member and the location of the device within the stomach, is such that this tissue acquisition procedure also allows the devices to be self-adjusting with respect to the acquired tissue. Furthermore, the devices are configured in such a way that portions of the stomach wall are automatically located to fix upon being acquired and the tissue automatically adjusts or tightens around the perimeter of the working portion distant from the device in the stomach and within the stomach. The interior volume of the working portion will vary, to achieve the desired geometry (for example, small gastric bag or baffle or restrictive separation). Due to the way in which the tissue is acquired, the tissue intimately surrounds the cartridge member and the anvil member to define or calibrate the subsequent volume of the resulting gastric lumen. In this way, the gastric volume can be predetermined by adjusting the volume of the cartridge member and the anvil member, or the use of accessory devices such as a balloon or amplifier. As a result, once the desired volume is known and incorporated into the device, the user can achieve a controlled acquisition without any location or intra-procedural adjustment requirements. The septum can effectively act as a barrier between the openings to facilitate tissue acquisition to their respective openings, while cross-acquisition of the tissue in the cartridge member and / or anvil member is reduced or eliminated. In other alternatives, the septum can be omitted from the device and acquisition of the device can be achieved by sequential activation of vacuum forces within the openings. Once the device has been acquired, the septum can be relieved from between the cartridge member and the anvil member by translation of the septum remotely or proximally from the cartridge member and anvil member or left inside the stomach for later removal. . BRIEF DESCRIPTION OF THE DRAWINGS Figures 1A and 1B show detailed lateral and lateral views, respectively, of a variation of an exemplary gastroplasty device described herein. Figures 2A and 2B show perspective detail views of an exemplary gastroplasty device described herein. Figures 3A and 3B show perspective and end views respectively of a cross-sectional portion of an exemplary gastroplasty device. Figures 4A and 4B show representative illustrations of how a gastroplasty device can be transorally advanced through a patient's esophagus and placed within the stomach cavity. Figures 5A to 5D show end views of an example of how an exemplary gastroplasty device can be used to acquire and hold tissue within a hollow organ of the body. Figure 5E illustrates a resulting subject gastric lumen, which can be formed using the gastroplasty devices described herein.

Figures 5F and 5G demonstrate how a working portion distant from a gastroplasia device and a lower lumen respectively, help to define the final configuration of the acquired tissue. Figures 5H and 51 show perspective and cross-section visions of illustrative tissue configurations that can be formed with the gastroplasty devices and methods described herein. Figures 6A and 6B show perspective and end views respectively of a variation of a gastroplasy device in which the septum is in position. Figures 7A and 7B show perspective and end views respectively of the device of Figure 6A in an open configuration. Figures 8A and 8B show perspective and end views respectively of the device of Figure 6A in an open configuration with the septum removed. Figures 9A and 9B show perspective and end views respectively of the device of Figure 6A in a closed configuration. Figures 10A to 10C show end views of the cartridge member and anvil member during delivery, during tissue acquisition and before fastening the tissue respectively, in an example how a holding wire can be directed with respect to an optional septum. Figures 11A and 11B show perspective and end views respectively of another variation and convenient gas-replacement device. Figures 11C and 11D show perspective views of a gastroplasty device with and without a septum, respectively.

Figures 12A to 12C show perspective views of yet another variation of a gastroplasty device. Figures 13A and 13B perspective views in cross-section and in front respectively of an alternate acquisition cover. Figures 13C and 13D show perspective cross-section and end views, respectively of the device of Figures 13A and 13B with high vacuum pressure. Figures 14A to 14D show perspective views of the operation of another variation and a gastroplasy device that uses the movement of the parallel cover. Figure 14E shows a cross-sectional perspective view of a portion of the cover members in an open configuration with a septum still in place, between the cartridge member and the anvil member. Figure 15 shows a perspective view of yet another variation of a gastroplasty device, which uses a translational support plate. Figures 16A to 16D show side, end, bottom and perspective views respectively of a variation of a gastroplasty device using a static acquisition cover. Figure 16E shows a bottom view of a variation of a gastroplasty device having an arcuate configuration. Figure 17 shows a perspective view of a device having an optional feature of projections or grooves, which can be defined on the mating surface of the cartridge member and / or anvil member.

Figures 18A and 18B show perspective and end views in cross section respectively of another optional feature of one or more rotating arrows that can be integrated into the device. Figures 19A and 19B show perspective and detailed perspective views, respectively, of a device having a segmented, adjustable or curved staple cartridge. Figures 20A and 20B show perspective views of a septum assembly having a tapered edge to facilitate removal of the septum from the hollow organ of the body. Figures 21 A and 21 B show perspective views of an alternate septum assembly having finned surfaces. Figure 21 C shows a side view of an example of how collapse of the septum can be facilitated by removing the septum in a recipient member. Figures 22A and 22B show views in perspective and end respectively of a septum variation having at least two transverse septum members extending on opposite sides of the longitudinal septum member. Figure 23A illustrates an end view of an expandable septum assembly located between cover members and positioned against tissue of the stomach. Figures 23B and 23C show side views of variations for extending the septum assembly from a low profile supply to a deployed configuration, extended.

Figures 24A and 24B show end views of an alternate septum assembly that can be configured to deploy an expandable septum from a coiled configuration. Figures 25A and 25B show perspective views of an alveolar septum assembly having a collapsible or collapsible septum member. Figures 25C and 25D show end visions of the septum of Figure 25A in an expanded or extended configuration and a collapsed configuration. Figures 26A to 26C show end, bottom and perspective views, respectively, of yet another alternate septum having radiated corners. Figures 27A and 27B show perspective views of an alternative septum assembly having a low profile delivery configuration, wherein the septum may comprise two elongated T-shaped members. Figures 28A to 28C show perspective views of an example of a clamping mechanism having two cam members. Figure 29A shows a perspective view of an example of how fastening cables can be directed through a gastroplasty device described herein. Figure 29B shows a cross-sectional end view of a clamping device parallel with the septum shown. Figures 30A and 30B show side and edge views of an alternate gastroplasty device using articulated cover members. DETAILED DESCRIPTION OF THE INVENTION Gastroplasty devices for tissue acquisition and fixation and methods for using them are described. In general, the gastroplasty devices described herein can be used to create a partition within a hollow organ of the body, such as the stomach, esophageal junction or other portions of the gastrointestinal tract. Gastroplasty devices can be advanced within a body through a variety of methods, for example transoral, transanal, endoscopic, percutaneous, etc., to create one or more divisions or plications within the hollow organ of the body, for example to create a gastric lumen inside the stomach. In addition, gastroplasty devices can be assisted through the use of laparoscopic guidance, in particular visualization of the external surface of the hollow organ of the body, to aid in placement of the device or within the cavity of the organ to monitor the procedure. Similarly, the devices of the present invention may be used in conjunction with other laparoscopic procedures or may also be modified by a further step or procedure to improve the geometry of the partition. For example, when placing a partition of the present invention, it may be convenient to perform a secondary stage either transorally or laparoscopically, to achieve the desired gastroplasty geometry, such as the placement of a single fold or plication within the lumen or gastric pouch as described in the US patent application Serial Number 10 / 188,547, which was filed in 2/7/2002 and herein incorporated by reference in its entirety, to further restrict the movement of food through the pouch, or the laparoscopic placement of a band, fastener, ring, or other hollow reinforcing member at the outlet of the gastric lumen as performed in a VBG procedure, or overlap band to reinforce or narrow the exit of the lumen.

The gastroplasty devices described herein allow the creation of a minor gastric lumen to be achieved in a minimally invasive surgical procedure, completely from within the cavity of the stomach. Moreover, the devices described herein are configured in such a way that once tissue acquisition is achieved, any manipulation of the acquired tissue is unnecessary since the devices are able to automatically configure the acquired tissue in a desired configuration, thereby 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 of the openings therein, form the template or mold cavity around and within which tissue flows, thereby creating an embossed structure that reflects the geometry of the mold. That is, as the devices are configured such that portions of the stomach wall are automatically located to fix upon acquisition, and the tissue automatically adjusts or tightens around the perimeter of the working portion distant from the device in the stomach and within the volume inner portion of the distant working portion, to achieve the desired resultant geometry (e.g. small gastric pouch or restrictive baffle or partition). Due to the manner in which the tissue is acquired, the tissue intimately surrounds the cartridge member and the anvil member to define or calibrate the subsequent volume of the resulting gastric lumen. In this way, the gastric volume can be predetermined by adjusting the volume of the cartridge member and the anvil member. As a result, once the desired volume is known in the device, the user can achieve a controlled acquisition without intra-procedure adjustments or location requirements. Subsequent manipulation of the tissue can be done if desired, to effect certain configurations; however, this manipulation can be omitted altogether. Turning to the Figures, Figure 1A shows a side view of a variation of the gas-plating assembly 10. The assembly 10 can generally comprise an elongate tubular member 12 having a handle assembly 16 connected to a proximal end 14. A mounting Integrated access 18 may also be connected at a proximal end 14, to provide access to the working lumen 22 defined within the elongate member 12. The elongate member 12 may have a circular or elliptical cross-sectional area. Alternatively, the cross-sectional area can take any number of different cross-sectional configurations, for example hexagonal, octagonal, etc., as long as it has an atraumatic surface to the tissue surfaces within the body. In addition, the elongated member 12 may be curved, or it may comprise a series of links as described in the US patent application. Serial Number 10 / 686,326, which was filed on 10/14/2003, and is incorporated by reference here entirely. In this way, a flexible or curved elongated member or an elongate member comprising a series of links, will help to increase the flexibility of the elongated member, and thereby increase the ease in which the device is operated and operated. The working lumen 22 can be fully extended through the tubular member 12 and can be dimensioned to provide access to the distal end 20 for various surgical tools or therapies, once the distal end 20 of the monache 10 is located within a hollow organ of the body. , and in particular it can be useful to place an endoscope or other visualization tool. Alternatively, a fibroscope or other type of visualization tool can be integrated into the elongated member. Examples of useful display apparatus may be the Olympus GIF P140, the Fujinon EG 25PE, and the like. The gastroplasty device 24 is typically located at the distal end of the tubular member 12 and is also generally configured to advance atraumatically through the body of a patient and into a hollow organ of the body, eg, esophagus, stomach, etc. Alternatively, an optional separate thin-walled cover liner can also be placed over the acquisition device, including the elongate member, to assist in placement, or it can be placed over a guide wire or obturator by the esophagus, prior to placement of gastroplasty device and withdraw with the gastroplasty device once the procedure is completed. The liner can be made of a thin-walled polymer such as polyolefin, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), silicone and the like, having a wall thickness between .1016 and .635 mm (.004 and .025"). This liner can serve to guide the gas-plyplasty device, as well as to help in limiting trauma to the esophagus and other delicate structures Figure 1 B shows a closer detail view of the gastroplasty assembly 10. As shown there, the The device comprises a remote working portion, comprising a cartridge member or cover 26 positioned longitudinally opposite the anvil member or cover 28. As described above, when the device is in use, the wall of the stomach (FIG. including, in some cases, the layers of muscle tissue), fits or fences around the perimeter of the distant working portion and within the inner volume of the distant working portion, to achieve a desired resulting geometry (for example small gastric pouch or restrictive baffle or partition). In this way, the gastric volume can be predetermined by adjusting the volume of the portion of the distant work, profile, interior or exterior. The cartridge member 26 can contain one or several holders, for example staples, fasteners, etc. which can be actuated by controls located proximally in the handle assembly 16. A septum, diaphragm or barrier 32, described in more detail below can be located removably between the cartridge member 26 and the anvil member 28, while the coalition member 30 can connect the device 24 to the tubular member 12. The handle assembly 16 can be configured in a variety of ways depending on the desired functionality implemented in the assembly 10. In this variation, the handle assembly 16 can generally comprise the handle 34 for use by the surgeon or the physician to advance, withdraw or articulate the assembly 10. A control for articulating the device 24 between an open and closed configuration can be located on the handle 34, shown as the holding control knob 36 , while a separate control mechanism, here shown as a fastener release lever 38, can be used to deploy fasteners located within or cartridge member 28. Although specific types of controls are illustrated, they are intended only as illustrative of the types of control mechanisms that may be used and are not intended to be limiting in scope. The assembly 10 may further have one or more integrated vacuum gates 40, located proximate to the elongated member 12 for fluid connection with one or more vacuum pumps (not shown). One or each of the cartridge members 26 or anvil 28 can be fluidly connected through a common tube 12 or channel or through correspondingly individual tubes or channels through the elongate member 12 with the vacuum gates 40. Additionally, a seal housing of an amplification or display apparatus 42, configured to provide access to the work lumen 22, can also optionally be provided near or at the proximal end of the elongate member 12 for insertion of various tools and devices through the elongated member 12 to access the remote exhère of the assembly 10. An optional auxiliary damper 44 may also be provided to allow fluid communication by means of a channel or tube through the elongated member 12 between the exits proximal and distal of the assembly 10. The auxiliary damper 44 may be used for various purposes, for example supplying fluids or gases within the hollow body organ for transporting drugs or providing insufflation, etc. As noted above, the elongate body may comprise a series of joints, similar to those described in the co-pending US patent application. Serial number 10 / 686,326, or an extrusion made with various lumens, to house the various control wires and mechanisms of the acquisition device. Similarly, the control mechanisms can be grouped together with a flexible band and then coated in a thin-film liner, such as thermo-encoglble. The elongated member may also be a combination of an extrusion and a thin-walled liner, to allow flexibility and may use interwoven materials, for example stainless steel or superelastic materials, such as Nickel-Titanium alloy, embedded in the lining wall , to avoid twisting and improve the ability to apply torque. A detailed list of a variation of the gas-replacement devices described herein is shown in the perspective view of Figure 2A. The cartridge member 26 and the anvil member 28 as described above, may extend longitudinally from the distal end of the elongated member 12 via the connecting member 30. The cartridge member 26 and the anvil member 28 both may be or may be uniquely articulated to each other or to the elongate member 12. A pivot 50 located longitudinally between the cartridge member 26 and the anvil member 28 can be configured to allow the device to be rotated in an open configuration for tissue acquisition and a closed or deployment configuration for supplying or advancing the device in the hollow organ of the body. If both members 26, 28 can be articulated, they can be configured either for simul- taneous or sequential articulation. The cartridge member 26 may contain a cartridge 52 that contains fasteners on an outer edge of the member 26 while the anvil member 28 may have an anvil located on an outer edge of the member 26, such that the anvil corresponds to the number and position of fasteners within the cartridge 52. One or both members 26, 28 can also define openings 56, 58 respectively over a portion of the length or the entire length of each of the members 26, 28. One or both of those openings 56 , 58 can be connected by pipe through the vacuum lumens 60, 62 respectively, defined through the elongated member 12 to the vacuum gates 40 located at the proximal end of the member 12. Alternatively, a central vacuum lumen can provide both gates or may be bifurcated at the proximal or distal end of the member 12. The elongate member 12 may also define various cable lumens 64, 66 for the passage of wires to control the opening and closing of the members 26, 28 as well as the additional cable lumen 68 for the passage of cables to drive the deployment of the fasteners from the interior of the cartridge 52. Furthermore, the lumen of cable 70 can be used for the passage of cables used to control the fastening of members 26, 28 to each other. Each of the members 26, 28 can have openings 72, 74 and 76, 78, respectively, defined in the outer corners of each opposite pivot member 50, to allow the direction and passage of fastening cables through the device, to allow having a cartridge 26 and the anvil member 28 are held close together. Figure 2B shows a perspective view of the acquisition and fixing device of Figure 2A, with vacuum tubes and cables directed through devices. As shown, the vacuum tubes 80, 82 can be directed through the elongated member 12 at a proximal end of one or each of the cartridge member 26 and / or the anvil member 28 for fluid connection with respective openings 56, 68 The cables 84, 86 can be used to open and close the cartridge member 26 and anvil member 28 and the cable 88, which can be directed within the cartridge member 26, can be located and used for example to pull or push a mechanism of wedge, to deploy fasteners out of the cartridge 52. Furthermore, the fastening members 90 can be passed through the elongated member 12 and directed through the cartridge member 26 and anvil member 28 such that the cables 92, 94 pass through the openings 72, 74 and 76, 78, to clamp closing the cartridge member 26 and the anvil member 28. The cables 84 and 86 can be replaced by torque arrows connected to handles or handles on the end next device, to open and close the cartridge and anvil members. Figures 3A and 3B show perspective and end views respectively of a cross-sectional portion 100 of a convenient gastroplasty device. As can be seen, the septum 32 can be positioned to extend from the pivot 50 effectively by separating the vacuum openings 56, 68 within the cartridge member 26 and the anvil member 28, respectively. Adjacent the opening 56 is the clamping cartridge 52 and adjacent the opening 58 is the anvil 54 positioned such that when the septum 32 is withdrawn or displaced, the articulation of the cartridge member 26 and the anvil member 28 toward each other with respect to the pivot 50, locates the cartridge 52 in opposition to the anvil 54. Alternatively, the anvil member 28 and the cartridge member 26 may be immovable or be in a fixed position with respect to the longitudinal axis of the device. In this configuration, the clamping cartridge 52 and the optional anvil 54 can be actuated to eject from their respective housings to clamp the acquired tissue. Figures 4A and 4B show representative illustrations of how the gastroplasty device 24 can be advanced trans-orally through the esophagus ES of a patient and located within the cavity SC of the stomach 110. Referring now to Figure 4A, the device 24 can be articulated outside the patient by the handle 16, such that the proximal portion of the elongate member 12 can be positioned so that the spine of the device is positioned against a portion of smaller LC curvature and opposite the greater curvature GC . In this way, the device 24 extends between the gastroesophageal junction GEJ towards the pylorus PY. In addition, Figure 4A shows the use of a flexible endoscope EN along the device 10 to allow direct visualization of the procedure, including the fixation step with which the instrument for visualization can then be removed, leaving the remaining additional volume in the smaller gastric pouch that can help when the gastroplasty device 24 is removed or detached from the acquired tissue, once it has been fixed. If direct visualization is not required, but additional volume removal is desired, an optional expansion balloon or other EM expandable member may be employed along the spine of the gas-filling device, or may be integrated into the spine of the gastroplasty device using techniques known. Figure 4B shows the location of the gastroplasty device 10 without the aid of an endoscope or other direct visualization technique. -. Figure 5A shows an end view of the device 24 located within the cavity of the stomach SC with the pivot 50 positioned against the wall of the stomach 120, for example against the minor curvature LC in an example of how the device 10 can be used to effect the creation of a gastric lumen or partition within the stomach cavity SC. The device is advanced through the esophagus ES while it is in a deployment configuration, i.e. where the remote work portion of the DWP device is configured such that the cartridge member 26 and the anvil member 28 are closed from each other. Such that the openings 56, 68 and the cartridge 52 and the anvil 54, are located directly opposite to the septum 32. When conveniently located, one or both of the cartridge member 26 and the anvil member 28 can be rotated. with respect to the pivot 50 in the direction of the arrows shown. Figure 5B shows a cartridge member 26 and the anvil member 28 rotated at an angle with an activated vacuum force within the openings 56, 68. In certain embodiments when rotation or movement of the cartridge member 26 or member is not necessary. from anvil 28 the device is advanced in a static state. As seen, portions of the wall of the stomach 120 can be acquired and directed into respective aperture 56, 68 ?. The configuration of the cartridge member 26 and the anvil member 28 and the location of the device 24 within the stomach cavity SC are such that this procedure of acquisition of tissue also allows the device 24 to be self-adjustable with respect to the acquired tissue 122, 124. More particularly, the device 24 is configured such that portions of the wall of the stomach 120 are automatically located to fix upon acquisition and the device 24 automatically fits within the stomach cavity SC relative to the stomach wall 120. In addition , due to the way in which the tissue is acquired, the tissue intimately surrounds the cartridge member 26 and the anvil member 28, i.e. the workpiece remote from the DWP devices, when tensioned or held around the perimeter PT of the working portion distant from the devices and inside the inner volume IV of the remote working portion of the device to define r the subsequent volume or gastric lumen resulting from the resulting geometry RG as shown by the diagonal and the shaded lines respectively in Figures 5F and 5G. An illustration of a cross section of the resultant tissue geometry is provided in Figure 5E. Other illustrations of resultant tissue geometries are provided in the Figures 5H and 51. There are shown frontal visions of the working portion distant from the device, and cross-section views (on lines A-A and B-B respectively) of the resultant tissue geometries. In Figure 5H, the remote work portion has been configured to provide a Plication, while in Figure 51 and, the remote work portion has been configured to provide more than one plication. Multiple plications may be useful, for example, to help increase the ease at which the remote working portion of the device is removed from a patient after the tissue has been acquired and fixed. Thus, as these Figures illustrate, the gastric volume can be predetermined by adjusting the volume of the cartridge member 26 and the anvil member 28, or the geometry of the remote working portion of the device, for example the remote working portion. of the device can be configured in such a way that the gastric tissue has resulted in the geometries described, for example in the US patent application Serial number 10 / 417,790, which was filed on April 16, 2003 and is hereby incorporated by reference in its entirety. The optional septum 32 can effectively act as a barrier between the openings 56, 68 to facilitate acquisition of the tissues 122, 124 in their respective openings 56, 68 while minimizing or eliminating cross-acquisition of the tissue in the cartridge member. 26 and / or the anvil member 28.

In another alternative, the septum 32 can be omitted in the device 24 and tissue acquisition can be achieved by sequential activation of vacuum forces within the openings 56 and 58. That is, the cartridge and anvil members can face the surface of tissue sequentially, acquiring the adjacent tissue. However, when a septum is employed, it can be removed from between the cartridge member 26 and the anvil member 28 by moving the septum 32 in a laterally or proximally distant manner from the cartridge member 26 and the anvil member 28, after the tissue has been acquired. Alternately, the septum can remain inside the stomach wall SC for lateral removal or as described in more detail below, it can be left inside the stomach cavity to biodegrade. Figure 5C shows the septum 32 that has been removed such that the cartridge member 26 and the anvil member 28 can pivot from the open configuration back to its closed configuration in the direction of the arrows shown. Because the septum 32 has been removed, the tissue region 126 can now be presented to be held between the cartridge 52 and the anvil 54. As shown in Figure 5D, the cartridge member 26 and the anvil member 28 can simply be fasten over the region of tissue 126 and be sure to deploy one or more fasteners from inside the cartridge 52. Upon acquisition of the fabric 122, 124, manipulation of the tissue region 126 or the acquired fabric 122, 124 can be totally eliminated due to the automatic location of the fabric to hold. Once the subject tissue has been secured, the device 24 can be completely removed from the stomach cavity SC, as shown in Figure 5E. As seen, one or more fasteners 128, for example a line of staples, can hold the tissue in its secured configuration to result in the creation of a partition, create a restriction, or when desired, create a lumen or gastric bag 130, separated from the rest of the stomach cavity. Alternate variations of the gastroplasty device 24 can also be used. For example, Figure 6A shows a perspective view of another variation of device 140, partially in cross section for reasons of clarity. In this variation, the cartridge member 142 and the anvil member 144 can define a curved or arcuate shape. The septum can 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 152154 may extend in a curved or arcuate shape from the longitudinal septum 146 such that an a-traumatic surface is presented to tissue during advancement within the patient. The septum can be retained between the cartridge member 142 and the anvil member 144 by the septum seal 148 which is slidably disposed within the septum retaining channel 150, which extends longitudinally between the cartridge member 142 and the member. of anvil 144. The longitudinal septum 146 can divide openings 156, 168, which can operate in the same manner as described above to adhere tissue. It may be advantageous to house the pressure transducer 159 near or within the covers or openings, to allow the user of the device to accurately gauge the pressure measurement in the tissue adhesion site. A pressure drop inside the cover 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 has maintained sufficient vacuum pressure and therefore an activator "device all-or-nothing test" for the user. Figure 6B shows a cross-sectional view of the variation 140 of Figure 6A. As illustrated, the cartridge 162 may retain one or more fasteners 166, shown in this variation as staples, in opposition to the anvil 164 when the cartridge member 142 and the anvil member 144 are in the closed or delivery configuration. It will be noted that while the rectangular staple clamp is illustrated, it may be convenient to provide a wedge or curved track to facilitate placement of a curved line of staples from the rectangular clamp. The plate or pivoting member 168, which can function to facilitate the pivoting of the device, can be placed on the outer surface of the cartridge member 142 and the anvil member 144. Figure 7A shows a perspective view of an open configuration 170 of the Figure 61 and 6B device for receiving tissue within the openings 156, 168. The septum 146 can remove the device by moving the septum 146 longitudinally in the direction of the arrow. As shown in the extruded view in Figure 7B, the pivoting region 160 can be seen expanded by the pivoting plate 168, which can be made from various biocompatible materials, for example stainless steel, polymers, etc., and that is sufficiently Flexible to allow the device to transit between open and closed configurations. Figure 8A shows the open configuration 180 where the septum 146 has been removed from the device. As described above, the septum can be removed once the tissue has been acquired within its respective openings. Figure 8B shows an end view of the device with the severed septum. The acquired part of the open region 182 can be clamped by articulating the cartridge member 142 and the anvil member 144 in the direction of the arrows to result in the configuration shown in Figure 9A, which shows the device 190 ready to hold the tissue within the holding region 192. Figure 9B shows an end view of the device configured in its closed configuration to hold the tissue within the holding region 192. As described above, drunk to the stomach tissue can automatically set to hold once the fabric has been acquired, it becomes unnecessary to manipulate the fabric during fastening and securing the fabric. To facilitate clamping of the cartridge member 142 and the anvil member 144 in the tissue, fastening cables may be employed, as described above. Figures 10A to 10C show end views of the cartridge member 142 and the anvil member 144 during delivery, during acquisition of tissue and before fastening the fabric, respectively and an example of how the fastening cable 200 can be directed with respect to the septum 146. FIG. 10A shows a septum 146 in position between the cartridge member 142 and the anvil member. 144 with the fastening cable 200 directed into a cable restriction slot 202 defined in an adjacent portion of the septum 146. The fastening cable 200 can extend between the cartridge member 142 and the anvil member 144 through the opening of the cable. clamping cable 204 defined both in the cartridge member 142 and the anvil member 144. Once the septum 146 is removed, as shown in FIG. 10C, the clamping cable 200 can be released from the slot 202 and tensioned for carrying the cartridge member 142 and the anvil member 144 with each other towards each other, as described in greater detail below. Other clamping mechanisms are also suitable, for example the fabric can be clamped using hydraulic, pneumatic or electro-pneumatic mechanisms, all of which are well known in the art. Figures 11A and 11B show extreme perspective view of another alternating gasplastic 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. septum, in this variation may comprise a longitudinal septum member 220 and a perpendicularly located transverse septum member 222, which may extend partially over the openings 228, 230, when the cartridge member 212 and the anvil member 214 are in a configuration open as shown in Fig. 110 respective vacuum tubes 224, 226 can be fluidly connected to one or both openings 228, 230 defined within their respective members 212, 214. Figure 11B illustrates the device with the distal moved septum showing a clear view of the aperture 230. Figures 12A to 12C show perspective views of yet another variation of the gastroplasty device 240. In this variation, the member of cartridge 242 and anvil member 244 can be rotatably connected by a longitudinally defined pivot 246. Similar to the variation of Figures 11A and 11B, the septum can also comprise a longitudinal septum member 248 that can be located between members 242 , 244 and an optional perpendicularly configured transverse septum member 250. Vacuum tubes 252, 254 are also fluidly coupled with their respective openings 260, 262. As discussed above, because the resulting gastric lumen can be defined by the shape and volume of the device, the cartridge member 242 and the anvil member 244 each can define the tapering tapered ends 256, 258 respectively to provide an a-traumatic surface for the advancement of the patient and facilitate the formation of a gastric lumen having a tapered distant region. The proximal shoulder of the limbs may also taper to facilitate the removal of the device once the procedure is completed. Still further, this variation also shows the openings 260, 262 which may be elongated to extend over a majority of the length of their respective members 244, 242. Still another variation of an alternate acquisition cover assembly 270 is shown in the foregoing perspective in cross section of Figure 13A. This variation can generally comprise cover walls 272, 274 each defining a notched section 276, 278 having projections or grooves 280, 282 on their edges directed or angled to each other. The assembly 270 may comprise a biocompatible material, for example polymers, polycarbonates, etc., having a sufficiently low elastic bending modulus to allow plastic deformation of the cover assembly 270 to occur. A barrier 286 having a plurality of apertures 288 defined on its surface, it can be located between cover walls 272, 274 in such a way that the tissue acquisition chamber 284 is defined as shown. A vacuum chamber 290 can be located below the barrier 286 with a vacuum thrust chamber 292, defined by the chamber 290 and the barrier 286. In operation, as shown in Figure 13B, the unit 294 can be purchased against or within the acquisition chamber 284 by the application of a relative low pressure vacuum force applied through the plenum chamber 292, which can create under vacuum within the chamber 284 through the openings 288. Once the 294 has been acquired first, a higher pressure vacuum force can be applied through the plenum chamber 292, such that the cover walls 272, 274 and the notched sections 276, 278 respectively are deformed in a plastic manner and direct a towards another in the direction of the arrows, as shown in Figure 13C. As the notched sections 276, 278 are directed inwardly and illustrated in Figure 13D, the acquired tissue 294 may be apprehended in the region of retained tissue 296, resulting in a temporary mechanical fixation of the tissue. A cessation of the high vacuum force may result in a relaxation of the cover walls 272, 274 and finally the release of the acquired tissue 294, when the vacuum force is completely stopped. Drilling mechanisms or a plurality of sharp hooks may also be employed in conjunction with, or in lieu of, the notched sections described above. Yet another variation of a gastroplasty device 300 is illustrated in the perspective views of Figures 14A to 14D. This particular variation can use a parallel translation movement to move the cartridge member 306 and anvil member 308 between the open and closed configuration, instead of a rotary movement, as described earlier in other variations. As shown in Figure 14A, the device 300 may comprise the cover assembly 302 connected at the distal end of the elongated tubular member 304. The septum 310 may be located removably between the cartridge member 306 and the anvil member 308. A slot plate 312 defining a longitudinally extending slot may be located adjacent the cartridge member 306 and anvil member 308 on a side opposite the septum 310. FIG. 14B shows a cartridge member 306 and an anvil member. 308 articulated separate from each other and in an open configuration, while maintaining a parallel orientation with each other. In this open configuration tissue can be acquired and addressed to respective cover members 302 on opposite sides of the septum 310. The slot plate 312 which can comprise various biocompatible materials, eg stainless steel, polycarbonate, various polymers, etc., can be held stationary respects the cover assembly 302 and may further assist in maintaining the cartridge member 306 and the anvil member 308 in their parallel orientation during configuration. Figure 14C shows the septum 310 withdrawn from between the cartridge member 306 and the anvil member 308 when moved remotely by the septum control member 314, which can be articulated from a proximal end of the elongated member 304. Once the septum 310 has been removed, the cartridge member 306 and the anvil member 308 can be articulated to hold onto the tissue, while maintaining their parallel freezing, as shown in Figure 14D. Once the tissue has been fastened, the cartridge member 306 can be actuated to hold the tissue. Figure 14E shows a cross-sectional perspective view of a portion of the cover members 302 in an open configuration with the septum 310 still in place between the cartridge member 306 and the anvil member 308. As shown, the member of cartridge 306 and anvil member 308 June with acquisition chambers 316, 318 respectively can be seen to maintain a parallel configuration between them. Figure 15 shows a perspective view of still further variation of a gastroplasty device 320 located on the distal end of the elongated tubular member 336. Similar to the device of Figure 14A, the cartridge member 322 and the anvil member 324 can be configured to open and close while maintaining a parallel configuration with each other. The optional septum 326 may also be located between the members 322, 324. However, the device 320 may comprise a mobile movable support plate 328 that can be advanced or retracted longitudinally. At least two wedge members 330, 332 may project from the plate 328 at an angle abutting correspondingly with the disigning ends of the members 322, 324, such that when the plate 328 moves longitudinally, the members of wedge 330, 332 can direct the cartridge member 322 and the anvil member 324 to each other in a parallel configuration, to hold onto any tissue that may have been acquired by the device 320. A septum groove 334 can be defined longitudinally on the plate 328, to allow unimpeded movement relative to the septum 326. The cartridge member 322 and the anvil member 324 can also be configured such that when the support plate 328 compresses the members 322, 324 on the tissue, the fasteners automatically they unfold in the fabric to hold it. Figures 16A to 16C show side, end and bottom views respectively of another variation of the gastroplasty device 340. In general, while other variations have allowed movement of respective cover members, this variation can maintain a static acquisition cover. The vacuum cover 342 may comprise a variety of biocompatible materials, for example polycarbonate, etc., configured in opposing walls having vacuum impeller chambers 348, 350, defined on the lengths of the opposing walls. - Mills which are illustrated two. Vacuum plenums, it should be understood that any number of vacuum plenums can be used equally. For example, a single vacuum plenum can be used. Similarly, three or more vacuum plenums may be employed. A septum having a longitudinal member 346 and a perpendicularly located transverse member 344, may be positioned to fit within the vacuum cover 342, such that at least two tissue acquisition chambers 352, 354 are formed over the length of the cover 342. Alternatively, the septum may only include longitudinal member 346, and may accept any fully transverse members, which may assist in reducing the overall profile of the remote working end of the device. The septum can generally be made of a similar material as the vacuum cover 342 and can additionally be coated with a layer of lubricant material, such as Teflon ™. In addition, the septum can be formed of a bio-absorbing material that can already be dissolved upon exposure to gastric fluids after the tissue has been acquired or can be releasably connected to covers or chambers and fixed in place between tissue folds (e.g. it is left behind) once the device is removed. The septum can also end member 356 at one end of the septum that can act as a stop for device 340. Figure 16D shows a perspective view of acquisition device 340, which reveals the vacuum plenum chamber defined on the bottom. of the cover 342. While the rectangular devices are illustrated in Figures 16A-16D, it should be understood that the device 343 may have a curved or arched shape as illustrated in Figure 16E. Also illustrated is an optional septum 346 and single vacuum plenum chambers 347. To facilitate tissue acquisition, various features may be incorporated in any of the variations described herein. For example, an optional feature can be seen in Figure 17, which shows a perspective view of the gastroplasty device 360 having a plurality of projections or grooves 366, 368 defined on the mating surfaces of the cartridge member 362 and / or member. of anvil 364. The splines 366, 368 may be located adjacent the cartridge and / or anvil to provide additional mechanical support for the tissue located between the subject members of the acquisition device 360 during anchoring. Alternatively, separation cuts (unmasked) in the cartridge can be included to reduce the surface area and clamping force required for fixation, as well as add traction to the system. As described above, perforation mechanisms or sharp projections can be used equally. Another optional feature that can be integrated with the present devices is illustrated in the perspective view of the gastroplasty device 370 of Figure 18A. A single cover member 372 is shown for illusory purposes, since the characteristic of a rotary arrow can be integrated into any of the devices described herein. The cover member 372 may define an opening 374 over its length to receive tissue there, as described above.; however, the device may also comprise at least one rotary arrow 376 located longitudinally within the cover member 372 adjacent the opening 374. The rotary shaft 376 may define one or more projections or grooves 378 on its surface, such that the fabric directed to the opening 376 by vacuum force can also be acquired mechanically by rotating the arrow 376 in a first direction, to allow the grooves 378 are fixed to the tissue. The arrow 376 can be rotated in a second opposite direction to release the acquired tissue. Still further, the cover member 372 can acquire the fabric with the vacuum force alone, as described above, with the rotary shaft 376 alone or with a combination of both the vacuum force and the arrow 376 operated as a whole. Figure 18B shows a cross section of the cover member 372 having a second rotating arrow 380, which also defines projections or ribs 382 on its surface. In the case of two arrows used as a whole, they can be configured to rotate in such a way that the acquired tissue 384 is optimally retained within the opening 374. Similarly, to release the acquired tissue 384, the arrows 376, 380 can be turned in the opposite direction, in the opposite direction. Still another feature that can be integrated with the present devices is illustrated in the perspective view of Figure 19A, which illustrates the acquisition and fixing device 390 having a single cover member, for reasons of clarity. Sept 400 and aperture 402 are also illustrated. A segmented staple cartridge 392 having adjustable curvature and height can be integrated in any number of the devices described above. The cartridge 392 may comprise. one or more staple cartridge segments 394 that are rotatably connected to each other by seals 396 that can allow not only rotating side-to-side movement between the segments 394 but also height adjustments to each other. Each segment of the staple cartridge 394, as seen in the detailed perspective view of FIG. 19B, can each define staple openings 398. In connection with adjacent cartridge segments 394, a staple member 398 is provided. • radiated pivot 404 may extend from one side of segment 394 and a receiving pocket 406 may be defined on the opposite side of segment 394. Each pivot member 404 may extend away from segment 394, such that when it is located in a receiving cavity. corresponding 406, there is adequate spacing between the segments 394 such that side-to-side movement between the segments 394 is possible, to define a curvature of the resulting cartridge 392. Even more, due to the translation adjustment between the pivot member 404 and the cavity 406, the heights of different segments 394 can be varied to define a curve in the height of the cartridge 392, as shown by the height differential Z in Figure 19A and the height differences between adjacent segments 394 in Figure 19B. Accordingly, the cartridge 392 can be varied in length by varying the number of segments employed, as well as varying in curvature and in height. The corresponding anvil member can be adjusted to engage respectively the curvature of the cartridge 392. In addition to variations in types of cover members and improvements in tissue acquisition, the septum can also be adjusted in various ways, to allow different devices and desired results. For example, the gastroplasty device 410 can be seen in the perspective view of Figure 20A with a variation of the septum assembly 412 located between the cover members 422, 424. The septum assembly 412 can be seen in better detail in the view in perspective of Figure 20B. In this variation, the sepium may have a transverse septum member 414, located perpendicularly to the longitudinal limb member 416, which extends from the extension member 420, as described above. However, this variation may define a tapered edge 418 on the proximal edge of the longitudinal septum member 416. This tapered edge 418 may extend at an acute angle from the extension member 420 to the transverse septum member 414 to facilitate removal of the tapered member. moníaje de sepío 412 from inside the hollow organ of the body. Another alternative in septum variations is illustrated in the perspective views of Figures 21 A and 21 B. The finned septum assembly 430, generally comprising the transverse septum member 432, longitudinal septum member 434, tapered edge 440 extending between the extension member 438 and the transverse septum member 432. However, the septum members 432,434 may have fins 436. to facilitate the collapse of the septum assembly 430 when they are removed from the hollow organ of the body. The hardness and geometry of the septum assembly 430 can be configured in accordance to provide adequate strength during vacuum assisted tissue acquisition yet flexible enough to collapse when removed from the patient. Figure 21 C shows an example of how collapse of the septum can be facilitated by removing the septum in a receiving member 442 having a tapered opening 444. As the septum assembly 430 is directed into the channel 446, the finned surfaces can collapse into a smaller configuration to remove. Another variation of alternating septum 450 is illustrated in the perspective view of Figure 22A. The longitudinal septum member 452 may have at least two transverse septum members 454, 458 extending on opposite sides of the longitudinal septum 452. Each of the transverse septum members 454, 458 may define a helical tapered edge 456, 460, respectively, such that the removal of the septum assembly 450 from the hollow organ of the body is facilitated. Figure 22B shows an end view of the septum assembly 450 located between the cover members 462, 464. Instead of using a perpendicularly configured septum, an alternative may be to use a septum member having only one longitudinally extending member. , which extends high enough to avoid cross acquisition of tissue in the cover members. FIG. 23A illustrates an end view of an expandable septum assembly 470 located between the cover members 472, 474 positioned against the stomach tissue 476. FIG. 23B shows a side view of a variation for extending the septum assembly 478 to FIG. from a low-profile provisioning configuration to an extended deployed configuration. Once the septum monoma 478 is advanced into a hollow organ of the body in its low profile configuration, the assembly 478 can be deployed to its expanded configuration. A septum extension member 480 may have a number of projections 482, 484 projecting from either side of the extension 480. A corresponding longitudinal septum base 486 may define channels 488, 490 through which the projections 482, 484 located at extension 480, respectively, can be moved inside. Still further, the channels 488, 490 may be angled to a longitudinal axis defined by the septum base 486, such that the distally advancing extension 480 -respect to the septum base 486 elevates the extension 480 to a distance away from the base 486, effectively increasing a height of the septum assembly 478. The projections 482,484 and the channels 488,490 can be covered such that the path of the extension 480 is not inhibited by the surrounding tissue. Similarly, Figure 23C shows a side view of another septum mount variation 492 wherein an extension septum member 494 extends from the base septum member 496. When advancing distally relative to the septum base 496, extension 494 may travel channels 498, which form a ramp channel portion 500, defined within base 496 to extend into a septum assembly 492 that has an increased height. Figure 24A shows another alternative septum assembly 510 that can be configured to deploy an expandable septum from a wound configuration. As seen in the end view, the septum assembly 510 is in a deployed configuration between the cover members 512, 514. The retractable septum 520, may extend from a coiled configuration within the drum 516, which may be located between opposing transverse septum members 518. The cables 522 can extend from the transverse septum members 518 for connection to the cover members 512, 514. After the tissue has been acquired, the retractable septum 520 can be retracted into the drum 516 by manipulation of the control cable 524, as seen in Figure 24B, to acquire a low profile to withdraw from the patient. Further variation of the septum assembly 530 is further shown in the perspective views of Figures 25A and 25B. The septum assembly 530 may comprise the transverse septum member 532 and the collapsible septum member 534, which may be configured between a collapsed configuration and an extended configuration. The transverse septum 532 can be raised and lowered relative to the cover members 548, 550 during delivery and deployment of the septum assembly 530, for example, by transverse members 536, 538 that can be configured in a scissor mechanism. The transverse members 536, 538 may have their proximal ends connected to the control cable 542, which may be directed through the exertion member 544, while an intermediate portion of both transverse members 536,538 may be rotatably connected to another by pivot 540. Of this In this manner, the articulation of the control cable 542 from its proximal end by the surgeon or physician can actuate the mechanism of collapsing the transverse septum 532 in the directions of the arrow as shown. The transverse septum 532, when positioned between the cover members 548, 550, can be secured by cables 546, as shown in FIG. 25B. Figures 25C and 25D show transverse septum end views 532 and the collapsible septum member in an expanded or extended configuration 552, and in a collapsed configuration 554. The collapsible septum member can be circumscribed by a bio-shareable material to avoid punctured by tissue by the cross members 536,538. Furthermore, the material covering the collapsible septum can also be distensible, if desired. Various materials can be used, for example nylon, polymeric materials, woven materials made of various polymers, latex, elastomers, etc. Figures 26A to 26C show end, bottom and perspective views of yet another alternate septum 560. This particular septum 560 may be used with device 340 of Figures 16A 16D. As shown, the longitudinal septum 562 may be connected perpendicularly and integrally with the transverse septum member 564 at one end and the base septum member 566 at an opposite end of the longitudinal septum 562. The transverse septum member 564 may define corners radiated 568 in each of its four corners, so that an a-traumatic surface is present to the patient during the use of the patient. Still further, the septum 560 may be extruded or formed from a single piece of biocompatible material (any of the biocompatible materials suitable for this structure as discussed herein, may be employed) such that a uniform structure is created. Figures 27A and 27B show perspective views of an alternative septum assembly 570 that can also be used particularly with the device 340 as discussed above. Figure 27A shows septum 570 in a low profile delivery configuration where the septum 570 can generally comprise two elongated T-shaped members. Each of the T-shaped members may further comprise longitudinal septum members 572, 572 'and transverse septum members 574, 574', respectively. Each of the two elongated T-shaped members does not need to be a report to each other depending on the device in which the septum assembly 570 is placed, but each member can be rotated relative to each other by the pivot 576 at a corner of adjacent longitudinal members. 572, 572 '. In this way, during the delivery of the device and the septum 570 in the patient's body, the configuration below profile of Figure 27A can be maintained and before or during acquisition and fixation of tissue, one of the members, for example, the members of septum 572 ', 574' can be rotated in the direction of the arrow, such that the longitudinal portions of the arrow. Septum 572, 572 'contact each other to form an acquisition configuration 578 for the septum assembly, as shown in Figure 27B.

After tissue acquisition and fixation, the septum can be reconfigured in its low profile configuration for patient removal. The septum in any of the above embodiments can be formed of a bioabsorbable and / or biocompatible material such as polyester (eg DACRON® from El Du Poní de Nemours and Company, Wilmington, DE), polypropylene, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyester ether ceione (PEEK), nylon, extruded collagen, silicone, polylactic acid, (PLA), poly (lactic-co-glycolic acid) (PLGA), or polyglycolic acid (PGA). In addition, a flexible biocompatible material that can be left behind within the separation or expelled dissolves and either absorbed from the stomach or digested and expelled through the patient's gastrointestinal tract. As discussed above, once the gastroplasty device has acquired the appropriate tissue, the device can be clamped over the tissue to be secured. Clamping or firmly clamping multiple layers of tissue together may require a clamping mechanism that is configured to provide a high degree of clamping pressure. An example of this clamping mechanism 580 is illustrated in the perspective views of Figures 28A to 28C, which show a variation for opening the clamp. The clamping mechanism 580 may have connecting members 582, 584 for a secure connection to each of a cover member. Each of the connecting members 582, 584 can be connected to each other by rotating cams 586, 588, where each cam can have a pivot pivot 590, 592, respectively, projecting therefrom. Figure 28A shows the clamping mechanism 580 in a closed and clamped configuration, while Figure 28B shows the mechanism 580 initially open. To open (or close) the mechanism 580, the cam 586 can be rotated by operating a control cable 600 which can be directed, for example, through a tubular member 596 located within the elongated member 12, from its proximal end. The cam 588 can then be rotated by actuating the conirol wire 602, which can be directed within the tubular member 598 also through the annular member 596. Because the connecting members 582,584 rotate relative to the pivot 590, a channel 594 can be defined in FIG. the member 582 within which the pivot 592 can be moved when the cam 588 is rotated to effect clamping or opening of the cover members. In addition to a 580 cam mechanism, clamping cables can also be employed as discussed above. Figure 29A shows a perspective view of an example of how the fastening cables can be routed through an acquisition and fixing device 610. As seen, the device 610 having the cover members 612, 614 can be rotatable relative to to the longitudinal pivot 616. Although a turning device is illustrated in this variation, the routing of cables can be used in any of the other acquisition and fixing devices using rotational movement as well as parallel clamping. A first clamp wire 620 can be directed into one of the cover members, for example, the cover member 614, through the location member 630 mounted on the cover member 614, and directed over the pulley member or radiated 622, also contained within the cover member 614. The first wire 620 may be looped 632 adjacent the pivot 616 to allow positioning of the septum (not shown for clarity) and then anchored to hold the anchor wire 618. Similarly, the second fastening cable 626 can be directed through location member 630 adjacent to first fastening cable 620 and through cover member 614 and onto pulley or radiator member 628, also confined to cover member 614. Second cable 626 It may also run in loop 632 adjacent the pivot 616 to allow placement of the septum and then anchored to the anchor of the fastening cable 624. FIG. 29B shows a view of cross section end of a parallel clamping device, with the septum 634 shown. We have numbers similar to the corresponding characteristics of Figure 29A. As in the rotary variation, the first clamping wires 620 and second 626 can be directed through corresponding tubular members 640 and the wires can be looped through one or more slots 642 defined in the septum 634 and subsequently directed to the clamping member. opposite cover for anchoring. The securing cables 620,626 are preferably directed to facilitate the unimpeded translation of the septum 634 as well as to ensure unobstructed access to the openings 636, 638 so that the tissue is acquired and secured. In yet another clamping variation, Figures 30A and 30B show and edge views of an alternating gastroplasty device 650 using the hinged cover members. The cartridge member 652 and the anvil member 654 can be connected to each other by hinge arms 656, 658, rotatably connected to each other by the pivot 660 at one end of the device 650 and by the hinge arms 662, 664, also rotatingly connected to each other by the pivot 666 at the opposite end of the device 650. The fastening cables 672 can be directed through the tubular member 670 within the device 650 and on the pulleys 674, 676, as described above, to move the member of anvil 654. between an open and closed configuration when tissue is acquired within the acquisition region 668. The firing cable 678 can be manipulated to deploy the holders from in the cartridge member 652, when the anvil member 654 is held about the acquired item. The deployment of the cartridge member holders 652 can be achieved by incorporating the firing wedge and other mechanisms as illustrated in US Pat. No. 4,610,383, which is hereby incorporated by reference only. In addition, the fastening can be achieved by hydraulic, pneumatic, or electro-pneumatic mechanisms, as discussed above. In describing the system and its components, certain terms have been used for understanding, brevity and clarity. Primarily used for descriptive purposes and are intended to be widely used and built in the same way. Having now described the invention and its method of use, it will be appreciated that reasonable mechanical and operational equivalents will be apparent to those skilled in the art. These variations are conred within the equivalence of the claims appended to the specification.

Claims (58)

1. CLAIMS 1. A gastroplasty device, characterized in that it comprises: a first acquisition member and a second acquisition member in opposition to each other on a first longitudinal axis, wherein at least one of the acquisition members is adapted to adhere to it, In this way, the tissue is located between the first and second acquisition members.
2. 2. The gastroplasty device according to claim 1, characterized in that at least one of the acquisition members is movable with respect to the first longitudinal axis between a delivery configuration and a deployment configuration.
3. 3. The gastroplasty device according to claim 1, characterized in that it further comprises an elongated body that is connected to the acquisition apparatus.
4. 4. The gastroplasty device according to claim 1, characterized in that a longitudinal axis defined by the elongated body is parallel with a longitudinal axis defined by the apparatus.
5. 5. The gastroplasty device according to claim 1, characterized in that each of the first and second acquisition memberS is adapted to adhere to the tissue.
6. 6. The gastroplasty device in accordance with the claim 1, characterized in that it also comprises a septum located removably between the first and second acquisition member.
7. 7. The gastroplasty device according to claim 6, characterized in that each of the first and second acquisition members is movable relative to the septum between the delivery configuration and the deployment configuration.
8. 8. The gastroplasty device according to claim 6, characterized in that each of the first and second acquisition members is movably rotatable relative to the septum.
9. 9. The gastroplasty device according to claim 6, characterized in that each of the first and second acquisition members is movable in a radial direction with respect to the septum.
10. 10. The gas-filling device according to claim 6, characterized in that the first and second acquisition members are mobile simul- taneously.
11. The gastroplasty device according to claim 6, characterized in that the first and second acquisition members are sequentially mobile.
12. 12. The gastroplasty device according to claim 6, characterized in that the first and second acquisition members are movable independently of each other.
13. 13. The gastroplasty device according to claim 6, characterized in that the septum comprises a first longitudinally extending barrier between the first and second acquisition members.
14. 14. The gastroplasty device according to claim 13, characterized in that the septum comprises a second barrier transverse to the first barrier, such that the second barrier is in opposition to the first and second acquisition members.
15. 15. The gas-replacing device according to claim 14, characterized in that the second barrier is planar.
16. 16. The gastroplasty device according to claim 14, characterized in that the second barrier is curved with respect to each of the first and second acquisition members.
17. 17. The gastroplasty device according to claim 14, characterized in that the second barrier extends in opposition to a portion of the first acquisition member and in opposition to a portion of the second acquisition member.
18. 18. The gastroplasty device according to claim 14, characterized in that the second barrier is adjustable in height with respect to the first barrier.
19. 19. The gastroplasty device according to claim 14, characterized in that the second barrier is adjustable extensible from the first barrier.
20. 20. The gastroplasty device according to claim 14, characterized in that the first and second barriers are collapsible between a delivery configuration and a deployment configuration.
21. 21. The gastroplasty device. according to claim 6, characterized in that at least one acquisition member is movably rotatable with respect to the septum.
22. 22. The gastroplasty device according to claim 6, characterized in that at least one acquisition member is movable in a radial direction relative to the septum.
23. 23. The gas-phase arrangement according to claim 6, characterized in that a proximal portion of the part is tapered.
24. 24. The gastrophore device according to claim 6, characterized in that the septum comprises a finned surface, such that the septum is configurable from an expanded configuration to a collapsed configuration.
25. 25. The gastroplasty device according to claim 6, characterized in that the septum comprises a bioabsorbable material.
26. 26. The gastroplasty device according to claim 25, characterized in that the bioabsorbable material is selected from the group consisting of polylactic acid (PLA), poly (lactic-co-glycolic acid) (PLGA), and polyglycolic acid (PGA) .
27. 27. The gastroplasty device according to claim 6, characterized in that the septo is configured to be left in the deployment site.
28. 28. The gastroplasty device according to claim 1, characterized in that at least one of the acquisition members has a curved outer surface.
29. 29. The gastroplasty device according to claim 1, characterized in that at least one of the acquisition members defines an atraumatic tip at its distal end.
30. 30. The gas-replacing device according to claim 1, characterized in that the first acquisition member comprises a cartridge assembly containing at least one fastener to fix the tissue.
31. 31. The gastroplasty device according to claim 30, characterized in that the cartridge assembly is straight on the first acquisition member.
32. 32. The gastroprosthetic device according to claim 30, characterized in that the cartridge mon- arch is bent over the first acquisition member.
33. 33. The gastroplasty device according to claim 30, characterized in that the second acquisition member comprises an anvil assembly.
34. 34. The gastroplasty device according to claim 1, characterized in that it further comprises a vacuum pump in fluid communication with at least one of the acquisition members.
35. 35. The gastroplasty device according to claim 1, characterized in that the first and second acquisition members each define at least one opening that is in fluid communication with a proximal end of the apparatus.
36. 36. The gastroplasty device according to claim 35, characterized in that the first and second acquisition members are adapted to rotate with respect to each other depending on a vacuum force applied through the opening at least.
37. 37. The gastroplasty device according to claim 1, characterized in that at least one of the acquisition members comprises grooves on the acquisition member.
38. 38. The gastroplasty device according to claim 1, characterized in that at least one of the acquisition members comprises elongate fastening members adapted to pass through the adhered tissue.
39. 39. The gastroplasy device according to claim 1, characterized in that it further comprises at least one rotatable member with a denier of at least one acquisition member, wherein the rotating member has an outer surface defining ridges for holding the tissue within the acquisition member when rotated with respect to a longitudinal axis.
40. 40. The gastroplasty device according to claim 1, characterized in that it further comprises an extraction cable connected to the first and second acquisition members for driving the apparatus between a delivery configuration and a deployment configuration.
41. 41. The gastroplasty device according to claim 1, characterized in that it further comprises a torque rod coupled to the first and second acquisition members for driving the apparatus between a delivery configuration and a deployment configuration.
42. 42. The gas-replacing device according to claim 1, characterized in that the first and second acquisition members are hydraulically actuated between a delivery configuration and a deployment configuration.
43. 43. The gastroplasty device according to claim 1, characterized in that the first and second acquisition members are pneumatically operated between a delivery configuration and a deployment configuration.
44. 44. The gastroplasty device according to claim 1, characterized in that the first and second acquisition members comprise a plurality of articulated links.
45. 45. A gastroplasty device for forming a gastric pouch, characterized in that it comprises: a distant working portion having a longitudinal axis, a perimeter and an interior volume, and furthermore it has a tissue acquisition member on the longiudinal axis, adapted to adhere tissue so that the tissue is located within the interior volume and with respect to the perimeter of the distant working portion to define a gastric pouch.
46. 46. The gastroplasty device according to claim 45, characterized in that the remote working portion has a rectangular configuration.
47. 47. The gastroplasty device according to claim 45, characterized in that the remote working portion has an arcuate configuration.
48. 48. The gastroplasty device according to claim 45, characterized in that it further comprises an elongate body that is connected to the distant working portion.
49. 49. The gastroplasty device according to claim 45, characterized in that it also comprises a septum.
50. 50. The gastroplasty device according to claim 45, characterized in that the tissue acquisition member is movable with respect to the longitudinal axis between one. Supply configuration and a deployment configuration.
51. 51. The gastroplasty device according to claim 45, characterized in that it also comprises an expandable element.
52. 52. The gastroplasty device according to claim 45, characterized in that the expandable element is selected from the group consisting of an instrument for examining or visualizing, a balloon and a wire form.
53. 53. The gastroplasty device according to claim 45, characterized in that it is adapted for use with an endoscope.
54. 54. The gastroplasty device according to claim 45, characterized in that it also comprises a transducer.
55. 55. The gastroplasty device according to claim 49, characterized in that the tissue acquisition member is rotatably movable relative to the septum.
56. 56. The gastroplasty device according to claim 49, characterized in that the septum comprises a bioabsorbable material.
57. 57. The gastroplasty device according to claim 56, characterized in that the bio-absorbable material is selected from the group consisting of polylactic acid (PLA), poly (lactic-co-glycolic acid) (PLGA), and polyglycolic acid ( PGA).
58. 58. The gastroplasty device according to claim 45, characterized in that the tissue acquisition member comprises a cartridge assembly that contains at least one fastener to fix the tissue.