Abstract:
A method includes selecting a template from a plurality of different sizes of templates based on measurements of the abdominal cavity of a patient; orienting the template on the patient at a location overlying the abdominal cavity to select an appropriate size implant using fluoroscopic imaging; marking an incision location and an indicator of an angle of approach; and removing the template from the patient, wherein marks made by the marking remain on the patient. Methods apparatus, instruments and implants for treating a patient are provided.

Description:
CROSS-REFERENCE 
       [0001]    This application is a continuation-in-part application of co-pending application Ser. No. 12/474,226, filed May 28, 2009, which is a continuation-in-part application of application Ser. No. 11/716,985, filed Mar. 10, 2007 and a continuation-in-part application of application Ser. No. 11/716,986, filed Mar. 10, 2007, and we hereby claim priority to each of the foregoing applications under 35 USC §120. Each of the foregoing applications is also hereby incorporated herein, in its entirety, by reference thereto. 
         [0002]    This application is a continuation-in-part application of co-pending application Ser. No. 12/473,818, filed May 28, 2009, which is a continuation-in-part application of application Ser. No. 11/716,985, filed Mar. 10, 2007 and a continuation-in-part application of application Ser. No. 11/716,986, filed Mar. 10, 2007, and we hereby claim priority to each of the foregoing applications under 35 USC §120. Each of the foregoing applications is also hereby incorporated herein, in its entirety, by reference thereto. 
         [0003]    This application is a continuation-in-part application of co-pending application Ser. No. 12/474,118, filed May 28, 2009, which is a continuation-in-part application of application Ser. No. 11/716,985, filed Mar. 10, 2007 and a continuation-in-part application of application Ser. No. 11/716,986, filed Mar. 10, 2007, and we hereby claim priority to each of the foregoing applications under 35 USC §120. Each of the foregoing applications is also hereby incorporated herein, in its entirety, by reference thereto. 
         [0004]    This application is a continuation-in-part application of co-pending application Ser. No. 11/407,701, filed Apr. 19, 2006 to which application we claim priority under 35 USC §120 and which application is incorporated herein, in its entirety, by reference thereto. 
         [0005]    This application is a continuation-in-part application of co-pending application Ser. No. 11/974,444, filed Oct. 11, 2007 to which application we claim priority under 35 USC §120 and which application is incorporated herein, in its entirety, by reference thereto. 
     
    
     FIELD OF THE INVENTION 
       [0006]    The present invention relates to the field of minimally invasive surgery, and more particularly to methods, devices, tools and systems for abdominal surgical procedures employing an endoscope for at least part of a procedure. 
       BACKGROUND OF THE INVENTION 
       [0007]    There is a current ongoing trend toward the advancement of minimally invasive surgical techniques. Such techniques not only reduce the amount of trauma to the patient, but consequently reduce the amount of recovery time needed for healing, thereby reducing the lengths of hospital stays and, in some cases, even making it possible to perform procedures on an outpatient basis, such as in a physician&#39;s office. 
         [0008]    Examples of existing procedures include laparoscopic procedures, wherein a procedure is conducted transdermally to reach an internal surgical target location. Typically this involves the formation of several (typically three or more) ports or openings through the skin and into the patient, for placement of an endoscope through one opening and tools, instruments, devices through the other openings. 
         [0009]    Other examples of existing procedures include those where an endoscope and/or other instrumentation is inserted through a natural orifice, such as the mouth, anus, vagina, etc. The endoscope/instrument may be advanced along a natural pathway and then used to access the surgical site by piercing through a natural conduit forming the natural pathway. Alternatively, a procedure may be performed within the natural pathway, or on the natural conduit forming the natural pathway. 
         [0010]    In any of these cases, the use of an endoscope may be limited when obstacles are present in a pathway leading to the surgical target location. Such obstacles may be fat or other soft tissue obstruction, tumors, or even the fact that the route from the insertion location of the endoscope/instrument to the surgical target location is very tortuous, making it difficult to establish a pathway to the surgical target location. 
         [0011]    Traditionally, suturing has been performed to attach devices to tissues, to attach tissues to one another and/or to close wounds and incisions. However, successful suturing requires significant skill to perform, is time consuming, and is often difficult, if not impossible to perform in a minimally invasive procedure through a port, or even through multiple ports in a laparoscopic procedure. 
         [0012]    Alternatives to suturing are known, but may result in less desirable outcomes. For example, gastric reduction techniques have been attempted, such as by inserting instruments trans-orally and reducing the volume of the stomach by stapling portions of it together. However, this technique is prone to failure due to the staples pulling through the tissues that they are meant to bind. 
         [0013]    In an example of laparaoscopic hernia repair, multiple instruments are used through multiple ports to conduct the repair, but suturing is often replaced by stapling due to the reduced access space that is not sufficient to successfully carry out the suturing operations. 
         [0014]    It would be desirable to provide instruments and techniques useable in less invasive surgical methods, such as minimally invasive surgical procedures using only one small opening into a patient, or laparaoscopic surgical procedures using two to five small openings into the patient, that provide the capability of fastening by sutures to fasten a device to an anatomical structure, to repair an opening or tear, or to otherwise fasten two or more tissues together. 
       SUMMARY OF THE INVENTION 
       [0015]    The present invention provides methods, apparatus, instruments and/or implants for treating a patient. 
         [0016]    In one aspect of the present invention, a method is provided that includes: selecting a template from a plurality of different sizes of templates based on measurements of the abdominal cavity of a patient; orienting the template on the patient at a location overlying the abdominal cavity to select an appropriate size implant; marking an incision location and an indicator of an angle of approach; and removing the template from the patient, wherein marks made by the marking remain on the patient. 
         [0017]    In at least one embodiment, the method includes using fluoroscopic imaging to facilitate selection of the appropriate size implant. 
         [0018]    In at least one embodiment, the method includes selecting the appropriate size implant from a plurality of different sizes of implants. 
         [0019]    In at least one embodiment, the implants are enlargeable implants. 
         [0020]    In at least one embodiment, the method includes marking the patient at a location overlying a portion of the costal margin, prior to the orienting, and wherein the orienting includes positioning a superior edge of a cutout in the template adjacent to or inferior of a mark made by the marking the location overlying a portion of the costal margin. 
         [0021]    In at least one embodiment, the method includes adhering a marking guide to an indicator location as the indicator of the angle of approach. 
         [0022]    In at least one embodiment, the template includes a cutout indicating a location where the implant is to be attached to the abdominal wall, and wherein the indicator of the angle of approach comprises a mark drawn within bounds of the cutout. 
         [0023]    In at least one embodiment, the method includes adhering a marking guide to the patient so that the marking guide overlies the mark drawn within bounds of the cutout. 
         [0024]    In at least one embodiment, the method includes positioning the template so that a head of the template approximates the diaphragm of the patient, but does not extend superiorly of the diaphragm. 
         [0025]    In at least one embodiment, the method of marking the incision location comprises marking adjacent to a notch in a tail of the template or inferior of the notch, adjacent to a portion of the tail inferior of the notch. 
         [0026]    In at least one embodiment, the method includes adhering a marking guide to a location overlying a portion of the costal margin. 
         [0027]    In at least one embodiment, the method includes adhering a marking guide to the patient, wherein the marking guide overlies a mark made by the marking of the patient at a location overlying a portion of the costal margin. 
         [0028]    In at least one embodiment, the method includes placing a suture marker that extends along the internal surface of the abdominal wall along the inferior edge of a portion of the costal margin of the patient. 
         [0029]    In at least one embodiment, the method includes: making an incision or puncture through the patient&#39;s skin at the marked incision location; establishing a delivery tract through an opening formed by the incision or puncture, subcutaneous fat and fascia and into the patient&#39;s abdominal cavity, but not through the stomach; dilating the opening and placing an introducer cannula along the tract such that the introducer cannula extends from a location outside of the patient to a location within the abdominal cavity; inserting an instrument and the selected enlargeable implant into the introducer cannula, wherein the enlargeable implant is mounted on a distal end portion of the instrument and the enlargeable implant is in a compact configuration; enlarging the implant to an enlarged configuration; attaching the implant to an inner surface of the abdominal cavity; removing the instrument and introducer cannula; attaching an adjustment member to a fill tube in fluid communication with the implant; and closing the opening. 
         [0030]    In at least one embodiment, the method includes, prior to enlarging the implant, retracting the introducer cannula relative to the instrument and implant to expose the implant and a working end of the instrument out of a distal end of the introducer cannula. 
         [0031]    In at least one embodiment, the method includes, prior to attaching the implant, contacting a lowermost rib of the patient with a depression formed in a distal end portion of the instrument extending distally of an end effector of the instrument that is configured to drive stitches. 
         [0032]    In at least one embodiment, the method includes attaching a sealing member mounted on the instrument to a proximal end of the introducer cannula to seal off the introducer cannula; and insufflating the abdominal cavity of the patient. 
         [0033]    In at least one embodiment, the method includes prior to the attaching the implant, verifying a correct positioning of the implant by verifying alignment of the instrument with the indicator of the angle of approach. 
         [0034]    In at least one embodiment, the method includes, prior to attaching the implant, verifying a correct positioning of the implant by verifying alignment of the instrument with at least one of the indicator of the angle of approach and the suture marker. 
         [0035]    In at least one embodiment, the method includes, prior to attaching, verifying a position of a working end of the instrument relative to the marking guide that overlies a portion of the costal margin. 
         [0036]    In at least one embodiment, the method includes verifying, using direct laparoscopic visualization, a location of a distal end of an end effector of the instrument relative to the costal margin of the patient. 
         [0037]    In at least one embodiment, the dilation of the opening and placement of the introducer cannula comprises inserting a distal end of a dilator through the opening, wherein the introducer cannula is mounted over the dilator and a distal end portion of the introducer cannula is passed through the abdominal wall along the tract, and the method further includes removing, the dilator prior to the inserting an instrument and enlargeable implant into the introducer cannula; and insufflating the abdominal cavity. 
         [0038]    In at least one embodiment, the opening is the only opening formed in the patient to carry out the entirety of the method. 
         [0039]    In at least one embodiment, the implant is attached to at least one of fascia, peritoneum, preperitoneal fat and/or posterior rectus sheath. 
         [0040]    In at least one embodiment, the implant is attached to abdominal muscle. 
         [0041]    In at least one embodiment, the instrument comprises an attachment tool and a suturing tool that are releasably connected to one another, wherein the attaching comprises attaching the implant using the attachment tool, and then disconnecting the attachment tool from the suturing tool and removing the attachment tool from the introducer cannula. 
         [0042]    In at least one embodiment, the method includes tightening the attachment of the implant to the inner surface of the abdominal cavity using the suturing tool; and wherein the removing of the instrument comprises removing the suturing tool after completing the tightening of the attachment. 
         [0043]    In at least one embodiment, the method includes removing at least a portion of a falciform ligament. 
         [0044]    In another aspect of the present invention, an apparatus for use in a minimally-invasive abdominal surgical procedure is provided that includes: an elongate introducer cannula having a tubular main body, a distal end, a proximal end and a main lumen extending therethrough; a stitching instrument having at least one elongate shaft insertable through the introducer cannula, the instrument having a length greater than a length of the elongate introducer; a sealing member forming a seal around the at least one elongate shaft of the instrument and configured to form a seal between the instrument and the introducer cannula to seal off the main lumen; and an enlargeable implant releasably attached to a distal end portion of the instrument. 
         [0045]    In at least one embodiment, the stitching instrument comprises an attachment tool and a suturing tool that are releasably connected to one another, wherein the attaching comprises an end effector having needles configured to drive stitches to attach the implant to a patient. 
         [0046]    In another aspect of the present invention, a sealing member for forming a seal between an introducer cannula and an attachment tool configured to attach an implant in the abdominal cavity is provided, the sealing member including: a main body having a generally circular cross-sectional configuration; attachment members configured and dimensioned to attach to a proximal end of the introducer cannula; a sealing ring configured to seal with an opening in fluid communication with a main lumen of the introducer cannula; an opening configured to allow passage of an end effector having a first cross-sectional area, as well as a shaft having a second cross-sectional area different from said first cross-sectional area; and a valve formed around the opening and configured to form a seal with the shaft and the opening. 
         [0047]    In at least one embodiment, the opening comprises a first opening and the valve comprises a first valve, the sealing member comprising a second opening for receiving a tool or instrument therethrough and forming a seal therewith, and a second sealing member formed around the second opening. 
         [0048]    In another aspect of the present invention, an implantable device for treatment of obesity is provided, the device including: an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient wherein the expandable main body member comprises a wall surrounding an internal chamber; an attachment tab interfacing with an outer surface of the wall and extending from the wall of the expandable main body member, the attachment tab configured to fix a portion of the main body member to and in contact with a portion of at least one internal body structure; an inner backing layer interfacing with an inner surface of the wall and bonded thereto; wherein the attachment tab, the wall and the inner backing layer are bonded together. 
         [0049]    In at least one embodiment, the attachment tab and the inner backing layer are bonded together through at least one opening through the wall and each opening is sealed by the bonding together of the attachment tab and the inner backing layer. 
         [0050]    In at least one embodiment, the device further includes a plug bonded to the attachment tab, the wall and the inner backing layer, the plug having placed in an opening in the wall, the plug having been bonded with the attachment tab, wall and inner backing layer, thereby filling the opening in which the plug was inserted prior to having been bonded. 
         [0051]    In another aspect of the present invention, a method of making an implantable device for treatment of obesity is provided, the method including: providing an expandable main body member configured to be positioned adjacent a portion of a stomach of a patient, within the abdominal cavity of the patient wherein the expandable main body member comprises a wall surrounding an internal chamber and an opening through the wall; laying a layer of an attachment tab on an outer surface of the wall over a location of the opening; contacting an inner backing layer to an inner surface of the wall under a location of the opening; and bonding the wall, layer of an attachment tab and inner backing layer together. 
         [0052]    In at least one embodiment, the method further includes inserting a plug in the opening, and the bonding comprises bonding the wall, plug layer of an attachment tab and inner backing layer together. 
         [0053]    In at least one embodiment, the bonding comprises vulcanizing. 
         [0054]    These and other advantages and features of the invention will become apparent to those persons skilled in the art upon reading the details of the methods, apparatus, instruments and implants as more fully described below. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0055]      FIG. 1  illustrates an embodiment of a surgical apparatus that is configured to deliver an implantable device, assembled thereon, from outside of a patient, through an opening and into the patient. 
           [0056]      FIGS. 2A-2B  show a proximal end perspective view and a distal end perspective view of one embodiment of a sealing member according to the present invention. 
           [0057]      FIG. 2C  illustrates the sealing member of  FIGS. 2A-2B  having been installed on an apparatus according to one embodiment of the present invention. 
           [0058]      FIG. 2D  illustrates the working end portions of the apparatus of  FIG. 2C  having been inserted into an introducer cannula, and the sealing member of  FIGS. 2A-2C  having been attached to the proximal end of the introducer cannula. 
           [0059]      FIG. 2E  illustrates the capability of axially advancing the apparatus of  FIG. 2C  relative to the introducer cannula to extend the working ends of the apparatus distally of the distal end of the introducer cannula while maintaining the seal between the proximal end of the introducer cannula and the shafts of the assembly, according to an embodiment of the present invention. 
           [0060]      FIG. 2F  illustrates the capability of an elastic valve of the sealing member of  FIGS. 2A-2E  to expand while still conforming to the cross-sectional shape of the portion of the instrument extending therethrough, according to an embodiment of the present invention. 
           [0061]      FIG. 2G  illustrates use of a closure member to positively seal off the elastic valve of  FIG. 2F  after complete removal of the tool therefrom. 
           [0062]      FIGS. 3A-3B  show a proximal end perspective view with the first valve in a closed configuration, and with the first valve in an open configuration, respectively, of another embodiment of a sealing member according to the present invention. 
           [0063]      FIG. 3C  shows a distal end perspective view of the sealing member of  FIGS. 3A-3B . 
           [0064]      FIG. 3D  illustrates the sealing member of  FIGS. 3A-3C  having been installed on an apparatus according to one embodiment of the present invention. 
           [0065]      FIG. 3E  illustrates the working end portions of the apparatus of  FIG. 3D  having been inserted into an introducer cannula, and the sealing member of  FIGS. 3A-3D  having been attached to the proximal end of the introducer cannula, according to an embodiment of the present invention. 
           [0066]      FIG. 3F  illustrates the capability of axially advancing the apparatus of  FIG. 3D  relative to the introducer cannula to extend the working ends of the apparatus distally of the distal end of the introducer cannula while maintaining the seal between the proximal end of the introducer cannula and the shafts of the assembly, according to an embodiment of the present invention. 
           [0067]      FIG. 3G  illustrates the capability of a first valve of the sealing member of  FIGS. 3A-2F  to expand while still conforming to the cross-sectional shape of the portion of the instrument extending therethrough, according to an embodiment of the present invention. 
           [0068]      FIG. 3H  illustrates the first valve in a closed configuration to positively seal off the port that it is formed around, after complete removal of the tool therefrom. 
           [0069]      FIGS. 4A-4B  show a proximal end perspective view of another embodiment of a sealing member, with the first valve in a closed configuration, and with the first valve in an open configuration, respectively. 
           [0070]      FIG. 4C  shows a distal end perspective view of the sealing member of  FIGS. 4A-4B . 
           [0071]      FIG. 4D  illustrates the sealing member of  FIGS. 4A-4C  having been installed on an apparatus according to one embodiment of the present invention. 
           [0072]      FIG. 4E  illustrates the working end portions of the apparatus of  FIG. 4D  having been inserted into an introducer cannula, and the sealing member of  FIGS. 4A-4D  having been attached to the proximal end of the introducer cannula, according to an embodiment of the present invention. 
           [0073]      FIG. 4F  illustrates the capability of axially advancing the apparatus of  FIG. 4D  relative to the introducer cannula to extend the working ends of the apparatus distally of the distal end of the introducer cannula while maintaining the seal between the proximal end of the introducer cannula and the shafts of the assembly, according to an embodiment of the present invention. 
           [0074]      FIG. 4G  illustrates the capability of a first valve of the sealing member of  FIGS. 4A-4F  to expand to allow withdrawal of the working end portion of a tool that has a larger cross-sectional area than a shaft thereof. 
           [0075]      FIG. 4H  illustrates the ability of the first valve shown in  FIG. 4G  to close down to a smaller configuration after removal of the working end. 
           [0076]      FIGS. 5A-5B  show a proximal end perspective view and a distal end view of a sealing member, respectively, according to an embodiment of the present invention. 
           [0077]      FIG. 6A  shows a plug that is insertable into a port of a sealing member according to an embodiment of the present invention. 
           [0078]      FIG. 6B  shows another plug that is insertable into another port of the sealing member according to an embodiment of the present invention. 
           [0079]      FIG. 7  illustrates a dilator according to an embodiment of the present invention. 
           [0080]      FIG. 8  illustrates an introducer cannula according to an embodiment of the present invention. 
           [0081]      FIGS. 9A-9D  illustrate an introducer/cannula that is insertable into a patient in a first configuration and then is expandable to a second expanded configuration, according to an embodiment of the present invention. 
           [0082]      FIG. 10  is a partial illustration of a shaft of an introducer/cannula according to another embodiment of the present invention. 
           [0083]      FIG. 11  illustrates an implantable device according to an embodiment of the present invention, configured for delivery and paragastric, extragastric implantation. 
           [0084]      FIG. 12A  is an exploded view of an attachment tab with an alternative layup arrangement for bonding the attachment tab to the expandable member  10   em , according to an embodiment of the present invention. 
           [0085]      FIG. 12B  illustrates an end view of the attachment tab of  FIG. 12A  having been bonded to the expandable member  10   em.    
           [0086]      FIG. 12C  is a longitudinal sectional view taken from  FIG. 12B . 
           [0087]      FIG. 12D  is a detailed view of the vulcanized joint indicated within circle  12 D of  FIG. 12C . 
           [0088]      FIG. 13A  is a partial view of one embodiment an endoscope that may be used in procedures described herein according to the present invention. 
           [0089]      FIG. 13B  shows a longitudinal sectional view of the endoscope in  FIG. 11A . 
           [0090]      FIGS. 14A-14N  illustrate an example of a procedure for directly implanting an extra-gastric device according to an embodiment of the present invention. 
           [0091]      FIGS. 15A-15T  illustrate an example of a procedure for directly implanting an extra-gastric device according to another embodiment of the present invention. 
           [0092]      FIGS. 16A-16F  illustrate events during the preparation of an instrument assembly and enlargeable implant for use according to an embodiment of the present invention. 
           [0093]      FIGS. 17A-17O  illustrate events carried out during template size selection and location device size selection according to an embodiment of the present invention. 
           [0094]      FIGS. 18A-18C  illustrate placement and use of an optional suture marker according to an embodiment of the present invention. 
           [0095]      FIG. 19  illustrate a distal end portion of a suturing instrument according to another embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0096]    Before the present apparatus, devices, systems and methods are described, it is to be understood that this invention is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. 
         [0097]    Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention. 
         [0098]    Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. 
         [0099]    It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a tool” includes a plurality of tools and reference to “the suture” includes reference to one or more sutures and equivalents thereof known to those of ordinary skill in the art, and so forth. 
         [0100]    The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. 
       Definitions 
       [0101]    A “proximal” end of an instrument is the end that is nearer the surgeon when the surgeon is using the instrument for its intended surgical application. 
         [0102]    A “distal” end of an instrument is the end that is further from the surgeon when the surgeon is using the instrument for its intended surgical application. 
         [0103]    An “internal body structure” refers to a structure internal to the skin of a patient, and which can be within the abdominal cavity or other cavity of the patient, or just outside of it, such as including the outer surface of a wall that partially defines the cavity. Further, an internal body structure may be located anywhere in the body internal to the skin. 
         [0104]    A “surgical target location” or “surgical target area” as used herein refers to a location internal of a patient where a surgical procedure is to be performed. Such surgical procedures include, but are not limited to, treatment of existing tissues with one or more tools and/or implantation of one or more devices at the surgical target location. 
       Tools, Devices, Systems and Methods 
       [0105]    The preferred embodiments of the present invention facilitate minimally-invasive procedures for implanting one or more devices within a patient, and/or minimally invasive features for joining tissues or repairing tissue defects such as a hernia, for example. 
         [0106]    Thus, although the majority of the specific embodiments focus on implantation of a device to treat obesity, the present tools and methods are not limited to such procedures, as tools described herein may be used in other minimally invasive procedures, including, but not limited to hernia repair. 
         [0107]    Preferred embodiments include use of an attachment tool that is useable from a location outside of a patient to attach a device internally to a patient or to perform repairs of tissue defects, etc. Advantageously, apparatus provided are configured to and capable of applying sutures to a target arranged substantially in a flat plane or having a slightly curved surface. Thus tissue does not have to be sucked in, folded, bunched up, or otherwise gathered in order to apply sutures as is required for prior art tools. 
         [0108]    In at least one procedural embodiment, a tract is established from an opening in a patient that opens to the outside of the patient, to a surgical target location located internally of the patient. Direct visualization through a preferred device is possible during the establishment of such tract. 
         [0109]    In preferred embodiments, a minimally-invasive procedure includes use of insufflation of the abdominal cavity during performance of one or more procedural steps performed. This application of insufflation allows the procedure to use a fewer number of tools relative to the procedures described in the parent applications that use no or only minimal amounts (e.g., “a puff” or about 0.5 liters or less of carbon dioxide) of insufflation. Preferably, only a single small opening is required for insertion of the tools/devices and optionally, an implantable device. The small opening will generally be less than about 2.5″ in diameter, or less than about 2.2″ in diameter, or less than about 2″ in diameter, or less than about 1.5″, less than about 1.25″ or less. For use with general anesthesia, the opening may be up to about 3 inches in diameter or up to about 3.5 inches in diameter. Alternatively, more than one opening may be used for viewing through and/or inserting additional instruments. 
         [0110]    For weight loss applications, weight loss is achieved by restriction of the stomach and filling of the space into which the stomach normally expands into the abdominal cavity when filled with food. An implantable device expands outwardly when filled to occupy space within the abdominal cavity such that when food is ingested the stomach is restricted from being able to hold any more than a small volume of food. The implantable, outwardly expandable device is implanted outside of the stomach in the left upper quadrant of the abdominal cavity to achieve these functions. The expandable portion of the implantable device does not pierce or encircle nerve tissue or other tissue. The implantable, expandable device may be positioned with direct visualization (i.e., using an endoscope) and/or fluoroscopic visualization. No dissection, suturing, attachment or other invasive manipulation or trauma into or on the stomach is required in order to implant the implantable, expandable device. By appropriate placement of the implantable, expandable device, the device can achieve restriction of the stomach. Further, the volume of the implantable, expandable device is adjustable so that the amount of restriction of the stomach can be adjusted. This can be advantageous over time, as the patient may be able to accept, or require, additional restriction of the stomach as weight loss progresses. Likewise, the loss of fat in the abdominal cavity may require the implantable, expandable device to be increased in volume to occupy additional space that is freed up by the weight loss. Both the shape of the implantable, expandable device and its fill volume, in combination, cause the desired stomach compression. Implant materials are chosen that are compatible with magnetic resonance imaging (MRI), computed tomography (CT) imaging, fluoroscopy, and X-ray imaging. 
         [0111]    Implantation of the implantable, outwardly expandable device is carried out so as not to encircle any muscle or nerve tissue with the expandable member. Various implantable, outwardly expandable device sizes are provided, so that the present invention can treat a wide range of patients, with BMI&#39;s ranging from about 35 to about 50 and above, and including different rib cage dimensions. The present invention minimizes stress to the stomach. 
         [0112]      FIG. 1  illustrates an embodiment of an implantable device  10  (shown in an enlarged or expanded configuration) assembled on a surgical apparatus  500  that is configured to deliver the device  10  from outside of a patient, through an opening and into the patient (e.g., into the abdominal cavity of the patient), and to implant the device  10  by suturing it to a surgical target location within the patient, e.g., the internal wall surface of the abdominal cavity, internal fascia, and/or some other internal body structure. Implant device  10  is inserted into the patient in a compact, non-expanded configuration. Apparatus  500  includes a stitching instrument  4000  releasably coupled with a suturing instrument  5000 . Stitching instrument  4000  includes a working end portion  4010  that is preferably radiolucent so that the needles and suture anchors are easier to visualize when using fluoroscopy, with the working end portion  4010  having been inserted into the patient. Working end portion  4010  is provided at a distal end portion of the instrument from which and into which end effectors (e.g., tissue pins, stitching needles) move, as described in more detail in co-pending U.S. application Ser. Nos. 12/474,226; 12/473,818; and 12/474,118, which were incorporated herein above, in their entireties, by reference thereto. An elongate shaft  4140  extends between working end portion  4010  and handle  4120 . In one embodiment, shaft  4140  has a length from the distal end of handle  4120  to the proximal end of working end portion  4010  of about 20.25″±about 0.25″, where the overall length of the instrument  400  is about 37.2″ (excluding the length of guide  4150 ). With the implant guide  4150 , the overall length is about 40″. All of the foregoing length measurements may vary depending on multiple factors including, but not limited to: the size of the implant  10  to be delivered, the size of the patient, etc. Shaft  4140  has a length sufficient to allow a user to operate the controls on handle  4120  from a location outside of an obese or overweight patient when the working end portion  4010  is contacted to a surgical target area where stitching and suturing are to be performed. Handle  4120  includes an axial portion  4120   a  and a transverse portion  4120   t.  These portions are configured so that the user can apply both hands to the handle  4120  if desired and, by pulling on handle portion  4120   t  and pushing down on handle portion  4120   a  can apply a force to the working end portion  4010  to press it up against a surgical target where stitching and suturing are to be performed. 
         [0113]    The apparatus shown in  FIG. 1  is substantially the same as that used in previous methods described in one or more of the applications that have been incorporated herein where no or only minimal amounts of insufflation are performed. However, the apparatus in  FIG. 1  differs in that a sealing member  1000  is provided abound the shafts  4140  and  5140  of the apparatus  500 . Sealing member  1000  may be configured to function as an end plug to seal off the space between a tubular member and the shafts  4140  and  5140 , as illustrated in  FIG. 1 . Alternatively, sealing member  1000  may be configured as a sliding plug that slides within the annulus of a tubular member to seal off the space between the tubular member and one or more tools or shafts, an example of which is described in more detail below. 
         [0114]    In the embodiment of  FIG. 1 , sealing member  1000  is shown attached to a proximal end of a large cannula or introducer  310 L to seal off the proximal opening of the introducer  310 L by sealing off the space between shafts  4140 ,  5140  and the inner wall of introducer  310 L. In an alternative embodiment, the sealing member  1000  can be used in like manner to seal off a proximal end of a conduit used for delivery of device  10 . 
         [0115]      FIGS. 2A-2B  show a proximal end perspective view and a distal end perspective view of a sealing member  1000  according to an embodiment of the present invention. Sealing member  1000  is configured and dimensioned to form a seal between a tubular member such as introducer cannula  310 L and apparatus  500  and/or one or more other surgical tools or instruments. Sealing member  1000  includes a main body  1002  having a generally circular cross-sectional configuration. Attachment members  1004  are provided to facilitate attachment of the sealing member  1000  to introducer cannula  310 L or other tubular member where a seal is to be formed. As shown, attachment members  1004  are clips that form a snap fit with the distal end of the tubular member or an end cap thereof. 
         [0116]    A sealing ring  1006  (such as an O-ring or the like) is provided on the distal end portion of main body  1000 . the distal end portion of the main body  1000  is configured to slide within the lumen of the introducer cannula  310 L with a close fit and sealing ring  1006  forms a friction fit with the inner wall of the introducer cannula  310 L, thereby forming a seal between the sealing member body  1000  and the inner wall of the introducer cannula. 
         [0117]    Main body  1000  is provided with two ports: a first port  1008  configured and dimensioned to receive the working end  4010  and shaft  4140  of attachment tool  4000  therethrough; and a second port  1010  configured and dimensioned to receive the working end  5010  and shaft  5140  of suturing tool  5000  therethrough. Because shaft  4140  has a different cross-sectional shape than working end  4010 , an elastic valve is sealed around the perimeter of first port  1008  and extends therefrom to provide a sealing valve having variable cross-sectional shapes and dimensions. In the embodiment of  FIG. 2A , the first elastic valve  1012  is a duckbill vale shaped to look substantially like a duck&#39;s bill. That is, elastic valve  1012  tapers from a largest cross-sectional, rectangular shape and dimension to a smallest cross-sectional dimension, which may be rectangular or an elongated slit. The taper progressively reduces in cross-sectional dimension in a direction form the largest end to the end having the smallest cross-sectional dimension. Thus, elastic valve  1012  functions like a sock or glove to conform to the cross sectional dimension of the instrument or portion of an instrument extending through the opening thereof and through the valve. As shown, elastic valve  1012  extends proximally of the proximal end of main body  1000 . Although elastic valve  1012  could extend distally of the proximal end of main body  1000 , the configuration shown in  FIG. 2A  allows for use of a closure member  1014  such as snap clip  1014  to completely close off and seal the opening into the valve  1012  when no instrument is inserted therethrough. Additionally, or alternatively, elastic valve  1012  can be configured to automatically seal off when no instrument is inserted therethrough. An elastic seal  1013  is formed around the perimeter of port  1010  to seal against shaft  5140  when shaft  5140  is inserted through port  1010 . 
         [0118]      FIG. 2C  illustrates sealing member  1000  having been installed on apparatus  500 . Note that the implant  10  does not need to be attached to the apparatus  500  until after sealing member  1000  has been installed on apparatus  500  and therefore the ports  1008 ,  1010  do not need to be designed to accommodate the passage of the implant  10  therethrough.  FIG. 2D  illustrates the working end portions  4010  and  5010  having been inserted into introducer cannula  310 L and sealing member  1000  having been attached to the proximal end of introducer  310 L to seal off the proximal end of the central lumen of cannula  310 L, forming a seal between the inner wall of the cannula  310 L/handle  590   h  and the shafts  4140 ,  5140 . Attachment members  1004  have been snap fitted to the handle/end cap  590   h  of introducer cannula  310 L and seal  1006  (not shown in  FIG. 2D ) forms a seal against the inner wall of the cannula  310 L. The first elastic valve  1012  forms a seal with the shaft  4140  and the elastic seal  1013  forms a seal with the shaft  5140 . 
         [0119]      FIG. 2E  illustrates the capability of axially advancing the apparatus  500  relative to introducer cannula  310 L to extend the working ends  4010 ,  5010  distally of the distal end of cannula  310 L while maintaining the seal between the proximal end of the cannula  310 L and the shafts  5140 ,  4140 .  FIG. 2F  illustrates the capability of elastic valve  1012  to expand while still conforming to the cross-sectional shape of the portion of the instrument extending therethrough. In  FIG. 2F , attachment tool  4000  is being withdrawn form introducer cannula  310 L. As the shaft  4140  clears the valve  1012  and working end  4101  enters the valve  4010 , the elastic valve expands to conform to the cross-sectional shape and dimensions of the working end  4010 , while maintaining a seal therewith.  FIG. 2G  illustrates use of closure member  1014  to positively seal off the elastic valve  1012  after complete removal of the attachment tool  4000  therefrom. As shown, closure member  1014  comprises a snap clip having a hinge  1014   h  at one end and a clasp  1014   c  at the other end to releasably lock the opposing arms  1014   a  together to compresses the jaws of the “duckbill” together, thereby sealing off the opening of the duckbill elastic valve  1012 . Alternative mechanical closure members  1014  may be substituted to accomplish this function. 
         [0120]      FIGS. 3A-3B  show a proximal end perspective view with the first valve in a closed configuration, and with the first valve in an open configuration, respectively, of another embodiment of a sealing member  1000 ′ according to the present invention.  FIG. 3C  shows a distal end perspective view of sealing member  1000 ′. Sealing member  1000 ′ is configured and dimensioned to form a seal between a tubular member such as introducer cannula  310 L and apparatus  500  and/or one or more other surgical tools or instruments. Sealing member  1000 ′ includes a main body  1002  having a generally circular cross-sectional configuration. Attachment members  1004  are provided to facilitate attachment of the sealing member  1000 ′ to introducer cannula  310 L or other tubular member where a seal is to be formed. As shown, attachment members  1004  are clips that form a snap fit with the distal end of the tubular member or an end cap/handle thereof. 
         [0121]    A sealing ring  1006  (such as an O-ring or the like) is provided on the distal end portion of main body  1000 ′. The distal end portion of the main body  1000 ′ is configured to slide within the lumen of the introducer cannula  310 L with a close fit and sealing ring  1006  forms a friction fit with the inner wall of the introducer cannula  310 L, thereby forming a seal between the sealing member main body  1000 ′ and the inner wall of the introducer cannula. 
         [0122]    Main body  1000 ′ is provided with two ports: a first port  1008  is configured and dimensioned to receive the working end  4010  and shaft  4140  of attachment tool  4000  therethrough; and a second port  1010  is configured and dimensioned to receive the working end  5010  and shall  5140  of suturing tool  5000  therethrough. Because shaft  4140  has a different cross-sectional shape than working end  4010 , a first valve  1012 ′ is sealed around the perimeter of first port  1008  and extends therefrom to provide a sealing valve having variable cross-sectional shapes and dimensions. In the embodiment of  FIG. 3A , the first valve  1012 ′ includes a pair of hinged valve leaflets or doors  1012   a,    1012   b.  In the open configuration shown in  FIGS. 3B and 3D , when the doors  1012   a,    1012   b  are open, the ends of the doors  1012   a,    1012   b  closest to the hinges  1012   h   1 ,  1012   h   2  form a circle that seals around the shaft  4140 . As shown, first valve  1012 ′ extends proximally of the proximal end of main body  1000 ′. Alternatively, first valve  1012 ′ could extend distally of the proximal end of main body  1000 ′, but the configuration shown in  FIG. 3A  is preferred. The leaflets  1012   a,    1012   b  are rotationally biased about the hinges  1012   h   1 ,  1021   h   2  to the closed configuration shown in  FIG. 3A . Accordingly, when nothing is inserted through the port  1008  and between the leaflets  1012   a,    1012   b,  the leaflets  1012   a,    1012   b  automatically close, thereby sealing off the port  1008 . Although not shown, a clip  1014  or other locking device may be configured to be locked over leaflets  1012   a,    1012   b  and may optionally be used to lock the sealed off configuration shown in FIG.  3 A. A seal  1013  is formed around the perimeter of port  1010  to seal against shaft  5140  when shaft  5140  is inserted through port  1010 . 
         [0123]      FIG. 3D  illustrates sealing member  1000 ′ having been installed on apparatus  500 . Note that the implant  10  does not need to be attached to the apparatus  500  until after sealing member  1000 ′ has been installed on apparatus  500  and therefore the ports  1008 ,  1010  do not need to be designed to accommodate the passage of the implant  10  therethrough.  FIG. 3E  illustrates the working end portions  4010  and  5010  having been inserted into introducer cannula  310 L and sealing member  1000 ′ having been attached to the proximal end of introducer  310 L to seal off the proximal end of the central lumen of cannula  310 L, forming a seal between the inner wall of the cannula  310 L/handle  590   h  and the shafts  4140 ,  5140 . Attachment members  1004  have been snap fitted to the handle/end cap  590   h  of introducer cannula  310 L and seal  1006  (not shown in  FIG. 3E ) forms a seal against the inner wall of the cannula  310 L. The first valve  1012 ′ forms a seal with the shaft  4140  and the seal  1013  forms a seal with the shaft  5140 . 
         [0124]      FIG. 3F  illustrates the attachment tool  4000 , with working end  4010  having been axially advanced through introducer cannula  310 L to extend the working end  4010  distally of the distal end of cannula  310 L while maintaining the seal between the proximal end of the cannula  310 L and the shafts  4140  via valve  1012 ′. In the first working configuration, valve  1012 ′ has a substantially round opening that forms a seal around the shaft  4140  of tool  4000 . In the second working configuration, illustrated in  FIG. 3G , which is assumed whenever the working end  4010  is inserted through or withdrawn from opening  1008 , valve  1012 ′ forms a substantially rectangular shape that forms a seal with the working end  4010 . Upon withdrawal of the tool  4000  so that nothing is extending through the opening  1008  or valve  1012 ′, valve  1012 ′ assumes a closed configuration, as shown in  FIG. 3H . The closed configuration seals off the opening  1008 , thereby maintaining the opening closed off to substantially prevent insufflation gas from escaping therethrough, for example. 
         [0125]      FIGS. 4A-4B  show a proximal end perspective view of another embodiment of a sealing member  1000 ″, with the first valve  1012 ″ in a closed configuration, and with the first valve  1012 ″ in an open configuration, respectively. The seal  1013  seals around the shaft  5140  and is a simple flap valve that automatically closes when the shaft  5140  is removed from the opening, thereby sealing off the opening.  FIG. 4C  shows a distal end perspective view of sealing member  1000 ″. Sealing member  1000 ″ is configured and dimensioned to form a seal between a tubular member such as introducer cannula  310 L and apparatus  500  and/or one or more other surgical tools or instruments. Sealing member  1000 ″ includes a main body  1002  having a generally circular cross-sectional configuration. Attachment members  1004  are provided to facilitate attachment of the sealing member  1000 ″ to introducer cannula  310 L or other tubular member where a seal is to be formed. As shown, attachment members  1004  are clips that form a snap fit with the distal end of the tubular member or an end cap/handle thereof. 
         [0126]    A sealing ring  1006  (such as an O-ring or the like) is provided on the distal end portion of main body  1000 ″. The distal end portion of the main body  1000 ″ is configured to slide within the lumen of the introducer cannula  310 L with a close fit and sealing ring  1006  forms a friction fit with the inner wall of the introducer cannula  310 L, thereby forming a seal between the sealing member main body  1000 ″ and the inner wall of the introducer cannula. 
         [0127]    Main body  1000 ″ is provided with two ports: a first port  1008  is configured and dimensioned to receive the working end  4010  and shaft  4140  of attachment tool  4000  therethrough; and a second port  1010  is configured and dimensioned to receive the working end  5010  and shaft  5140  of suturing tool  5000  therethrough. Because shaft  4140  has a different cross-sectional shape than working end  4010 , a first valve  1012 ″ is provided to assume variably-sized openings. Valve  1012 ″ includes a rotating hub  1015  that is rotatable clockwise as well as counterclockwise relative to main body  1000 ″. By rotating in a first direction, a flexible sleeve  1017  is twisted down toward a smaller opening configuration, such as illustrated in  FIG. 4A , for example. The flexible sleeve  1017  extends between two cylindrical hubs. When the hubs are relatively rotated in opposite directions then the sleeve twists in a closing direction. By reversing the directions of relative rotations, the sleeve  1017  is opened, as in  FIG. 4B . It is noted that sleeve  1017  is variably and continuously adjustable. For example, in  FIG. 4A , sleeve  1017  is closed down to an extent where it would seal against the shaft of a small endoscope such as a 5 mm endoscope. However, sleeve  1017  can be closed down to other sizes, such as one where it seals against shaft  4140  (e.g., see  FIG. 4F ) or against working end  4010 .  FIG. 4B  shows the rotating hub  1015  having been rotated in the opposite direction as far as possible to open the sleeve  1017  fully. Thus,  FIG. 4B  shows valve  1012 ″ in the fully open position. Sleeve  1017  is continuously adjustable to vary the opening from the fully open position to any smaller size opening, and can even be rotated to completely seal off the opening. A seal  1013  is formed around the perimeter of port  1010  to seal against shaft  5140  when shaft  5140  is inserted through port  1010 .  FIGS. 4A-4B  show seal  1013  in a fully closed configuration and  FIG. 4C  shows valve  1013  in a fully open configuration. Seal  1013  is variably adjustable and may be partially open to form an opening smaller than that shown in  FIG. 4C . 
         [0128]      FIG. 4D  illustrates sealing member  1000 ″ having been installed on apparatus  500 . Note that the implant  10  does not need to be attached to the apparatus  500  until after sealing member  1000 ″ has been installed on apparatus  500  and therefore the ports  1008 ,  1010  do not need to be designed to accommodate the passage of the implant  10  therethrough.  FIG. 4E  illustrates the working end portions  4010  and  5010  having been inserted into introducer cannula  310 L and sealing member  1000 ″ having been attached to the proximal end of introducer  310 L to seal off the proximal end of the central lumen of cannula  310 L, forming a seal between the inner wall of the cannula  310 L/handle  590   h  and the shafts  4140 ,  5140 . Attachment members  1004  have been snap fitted to the handle/end cap  590   h  of introducer cannula  310 L and seal  1006  (not shown in  FIG. 4E ) forms a seal against the inner wall of the cannula  310 L. The first valve  1012 ″ forms a seal with the shaft  4140  and the seal  1013  forms a seal with the shaft  5140 . 
         [0129]      FIG. 4F  illustrates the capability of axially advancing the apparatus  500  relative to introducer cannula  310 L to extend the working ends  4010 ,  5010  distally of the distal end of cannula  310 L while maintaining the seal between the proximal end of the cannula  310 L and the shafts  5140 ,  4140 . 
         [0130]      FIG. 4G  illustrates the withdrawal of working end  4010  from introducer cannula  310 L and through valve  1012 ″. As working end  4010  is pulled out of the rotational valve  1012 ″, the sleeve  1017  untwists to a more open configuration, allowing the working end  4010  to be removed. Sleeve  1017  may untwist automatically after removal of the working end  4010 . Alternatively a latch (not shown) may be provided that the operator releases to unlock the current position of the sleeve  1017  and allow it to unwind.  FIG. 4H  illustrates a configuration where rotating hub has been rotated to close the rotational valve  1012 ″ so that the sleeve  1017  twists down to form a very small opening  1017   o . In this configuration, an endoscope (such as a 5 mm endoscope or larger) can be inserted through opening  1017   o  so that sleeve  1017  forms a seal against the shaft of the endoscope. Sleeve  1017  may be made of silicone, for example. The rotational valve can be closed by further rotating hum  1015 , when nothing is inserted through the opening  1017   o,  to completely close the sleeve to prevent gas/fluids from escaping from the introducer cannula  310 L. This allows insufflation pressure to be maintained in the abdominal cavity even when the introducer remains inserted therein and no tools are extending through the sealing member  1000 ″. 
         [0131]      FIGS. 5A-5B  show a proximal end perspective view and a distal end view of a sealing member  1000 ′″, respectively, according to another embodiment of the present invention. Sealing member  1000 ′″ is configured and dimensioned to form a seal between a tubular member such as introducer cannula  310 L and apparatus  500  and/or one or more other surgical tools or instruments. Sealing member  1000 ′″ includes a main body  1002 ′″ having a generally circular cross-sectional configuration and a greater depth (thickness) dimension  1002   d ′″ than previously described embodiments, that facilitates easier grasping and manipulation by the surgeon/user. Attachment members  1004 ′″ are provided to facilitate attachment of the sealing member  1000 ′″ to introducer cannula  310 L or other tubular member where a seal is to be formed. As shown, attachment members  1004 ′″ are clips that form a snap fit with the distal end of the tubular member or an end cap thereof. 
         [0132]    A sealing ring  1006 ′″ (such as an extension made of an elastomeric material, or a more rigid material with an O-ring or the like) is provided on the distal end portion of main body  1000 ′″. The distal end portion of the main body  1000 ′″ is configured to slide within the lumen of the introducer cannula  310 L with a close fit and sealing ring  1006 ′″ forms a friction fit with the inner wall of the introducer cannula  310 L, thereby forming a seal between the sealing member body  1000 ′″ and the inner wall of the introducer cannula  310 L. 
         [0133]    Main body  1000 ′″ is provided with two ports: a first port  1008 ′″ configured and dimensioned to receive the working end  4010  and shaft  4140  of attachment tool  4000  therethrough; a second port  1010 ′″ configured and dimensioned to receive the working end  5010  and shaft  5140  of suturing tool  5000  therethrough. Optionally, a third port  1042  may be provided with this embodiment (or with any of embodiments  1000 ,  1000 ′ or  1000 ″ in like manner) to enable insufflation gas to be inputted therethrough, from a location proximal of sealing member  1000 ′″ to a location distal of sealing member  1000 ′″. Optionally a fourth port may be present to allow the implant tubing to pass through the seal without allowing leakage. Seal  1012 ′″ is configured to create a sliding seal around the shaft  4140 , and a seal to main body  1000 ′″. When the attachment tool  4000  is removed, seal  1012 ′″ is configured to slide along the shaft  4140  and, when the end effector  4010  collides with the seal  1012 ′″, the seal  1012 ′″ is configured to release from the main body  1000 ′″, allowing the attachment tool  4000  to be completely removed from the body of the patient. This detachment/release of the seal  1021 ′″ from the main body  1000 ′″ leaves a hole in the main body  1000 ′″ which is plugged with plug  1044  to regain a seal and insufflation. As shown, seal  1012 ′″ has a conical shape. Elastic seal  1010 ′″ is sealed around the perimeter of first port  1008 ′″ and extends distally therefrom. As shown, elastic seal  1012 ′″ extends distally of the port  1008 ′″. Alternatively, seal  1012 ′″ could extend proximally of port  1008 ′″. 
         [0134]    Although not shown, sealing member  1000 ′″ is installed on apparatus  500  in similar manner to that shown in  FIG. 2C , prior to inserting apparatus  500  into cannula  310 L. Note that the implant  10  does not need to be attached to the apparatus  500  until after sealing member  1000 ′″ has been installed on apparatus  500  and therefore the ports  1008 ′″,  1010 ′″ do not need to be designed to accommodate the passage of the implant  10  therethrough. 
         [0135]    In this embodiment, when attachment tool  4000  is withdrawn from introducer cannula  310 L, as shaft  4140  clears the elastic member  1012 ′″ working end  4101  contacts the tapered-down distal end of seal  1012 ′″, As the working end is withdrawn from the port  1008 , it will typically pull the seal  1012 ′″ along with it, at which time the seal  1012 ′″ detaches from the port  1008 ′″. In order to seal off the port  1008 ′″ again, plug  1044  ( FIG. 6B ) is inserted into the port  1008 ′″, where it functions as a stopper by closing and sealing off the opening  1008 ′″. Plug  1044  includes a handle  1046  that facilitates grasping by a user, and a main body  1048  dimensioned to fit in port  1008 ′″ and form a seal therewith. Plug  1044  may be made of a substantially rigid plastic or rubber, and port  1008 ′″ may include an elastic seal that deforms elastically around body  1048  as body  1048  is inserted into the port, to form an airtight, pressure-tight seal. 
         [0136]    When suturing/stitching tool  5000  is withdrawn from introducer cannula  310 L, in order to seal off the port  1010 ′″ again, plug  1054  ( FIG. 6A ) is inserted into the port  1010 ′″, where it functions as a stopper by closing and sealing off the opening  1010 ′″. Plug  1054  includes a handle  1056  that facilitates grasping by a user, and a main body  1058  dimensioned to fit in port  1010 ′″ and form a seal therewith. Plug  1054  may be made of a substantially rigid plastic or rubber, and port  1010 ′″ (as well as any of ports  1010 ,  1010 ′ and  1010 ″ described above) may include an elastic seal  1015  that deforms elastically around body  1058  as body  1058  is inserted into the port, to form an airtight, pressure-tight seal. Optionally, these features can allow the attachment tool  4000  and suturing/stitching tool  5000  to be reintroduce into the abdomen; or can allow another device or tool that is configured to establish a seal within  1008 ′″ or  1010 ′″ to be introduced, for example, an endoscope or graspers, or two devices/tools at one time can be introduced/reintroduced.** 
         [0137]      FIG. 7  shows one embodiment of a dilator  570  that may be used in procedures according to the present invention as described herein and  FIG. 8  shows one embodiment of an introducer cannula (large cannula)  310 L that can be used in procedures according to the present invention as described herein. These tools can be used, inter alia, to enlarge an opening formed through the fascia leading into the abdominal cavity. However, these techniques are not limited to enlarging an opening into the abdominal cavity, as they can also be used to enlarge an opening into the thoracic cavity, or to enlarge another opening leading into the patient. 
         [0138]    Dilator  570  is tapered, and is similar to the dilators  570  described in application Ser. Nos. 12/474,226; 12/473,818; and 12/474,118, but lacks threads on the tapered portion  570   t  and is instead smooth surfaced along the tapered portion. Additionally, the outside diameter of the non-tapered portion  570   n  is somewhat smaller than previous embodiments and the overall length of the dilator shown in  FIG. 7  is somewhat greater than that of previous embodiments. Still further, that is no opening at the distal end of the tapered portion, so that there is not a central lumen that extends all the way through the tool, from proximal end to distal end. By closing off the distal end, this equips the dilator to prevent loss (or at least rapid or substantial loss) of insufflation pressure in the abdominal cavity when the dilator  570  and introducer cannula  310 L extend into the abdominal cavity during procedures performed under insufflation as described in detail below. 
         [0139]    In at least one embodiment, the tapered portion has an angle of taper such that the outer surface of the tapered portion  570   t  relative to a central longitudinal axis of the dilator  570  is in the range of about seven degrees to about 13 degrees, typically about eight degrees to about 12 degrees. In one embodiment, the angle was about 10.5 degrees (or 21 degrees measured from outer surface to opposite outer surface of the cone). 
         [0140]    In at least one embodiment, the outside diameter of the non-tapered portion is about 1.35″ to about 1.75″. The distal end of dilator  570 , where the tapered portion begins has an outside diameter of about 0.6″ to about 0.7″ and tapers to the cross-sectional dimension of the non-tapered section  570   n,  which may, for example, have an outside diameter of about 1.0 inches to about 1.5 inches. In another example, the outside diameter of the non-tapered portion  570   n  was about 1.2 inches. Dilator  570  and introducer cannula  310 L each can be made from one or more of the following materials: a relatively rigid, but optionally lubricious polymer, such as DELRIN® (acetal copolymer) or other acetal copolymer, or other suitable biocompatible polymer, such as an injection moldable polycarbonate, glass-filled polycarbonate, glass-filled nylon, Grilamid® (semi-lubricious nylon product) Grivory® (semi-lubricious nylon product), polyetheretherketone (PEEK), Teflon® (polytetrafluoroethylene) or other injection molded, biocompatible plastic. Either or both dilator  570  and introducer cannula  310 L may be provided with or without a radiopaque filler or radiopaque marker band. 
         [0141]    Dilator  570  additionally includes an enlarged handle  570   h  at a proximal end thereof that is configured to be grasped by a user to facilitate an increase in the amount of torque and/or axial force the user can apply to the dilator  570  by rotating and/or pushing on handle  570   h.  Thus, handle  570   h  has a larger outside diameter than the non-tapered cylindrical portion  570   n  of dilator  570 . Further, handle  570   h  can be provided with knurls  570   k  or other features that render handle  570   h  less smooth or otherwise increase friction, to prevent the user&#39;s hand from slipping during torquing. 
         [0142]    The introducer cannula  310 L of  FIG. 8  is configured to slide over dilator  570  with a close, but freely sliding fit (e.g., inside diameter of introducer/large cannula  310 L is about 0.005″±about 0.002″ greater than outside diameter of portion  570   n  and introducer cannula  310 L has a length such that when handle  590   h  contacts handle  570   h,  the tapered portion  570   t  of dilator  570  extends distally of the distal end of introducer cannula  310 L in the same manner as described and shown in the previous applications incorporated by reference above. In another embodiment, the close, but freely sliding fit is provided wherein the inside diameter of large cannula  310 L is about 0.012″±about 0.005″ greater than outside diameter of portion  570   n.  In one embodiment, where the dilator had a length of about 8.67″, the portion  570   n  had an outside diameter of about 0.995″, the large cannula  310 L had a length of about 6.375″, an inside diameter of about 1.055″ and an outside diameter of about 1.105″). In another embodiment, where the dilator had a length of about 16.16″, and inside diameter of about 0.505″ and the portion  570   n  had an outside diameter of about 1.588″, the large cannula  310 L had a length of about 11.855″, an inside diameter of about 1.610″ and an outside diameter of about 1.690″. In another particular embodiment, the dilator had a length of about 8.67″ and the same inside diameter as the previous embodiments, but an outside diameter of about 1.060″ and the large cannula had a length of about 6.375″, an inside diameter of about 1.065″ and an outside diameter of about 1.115″). In another embodiment the outside diameter of cannula  310 L is about 3.4 cm. In all embodiments, the inside diameter of the distal end of the large cannula  310 L forms a close fit with the outside diameter of the portion of the dilator  570  that it interfaces with to allow free sliding between the components, but to prevent snagging of tissue between the distal end of large cannula  310 L and dilator  570  as these components are inserted into the body. Proximal of this interface, the dilator tubing can be much smaller and could even be a solid rod having an outer diameter much less than the inner diameter of the large cannula  310  (in one example, about 0.5″ outer diameter), thus leaving a large gap between the inner walls of the large cannula  310 L and the outer diameter of the dilator tubing, at locations proximal of the distal end interface described above. The distal end portion of introducer cannula  310 L may comprise a radiopaque material or may be provided with a radiopaque feature for enhanced visibility under fluoroscopy. Likewise, the distal end portion of dilator  570  may comprise a radiopaque material or may be provided with a radiopaque feature for enhanced visibility under fluoroscopy. 
         [0143]    Large cannula  310 L, like dilator  570 , has a smooth outer surface to render it less traumatic to tissues as it is inserted into the body. Handle  570   h  may be provided with at least one fastening component  570   f  and handle  590   h  may be provided with at least one mating fastening component (not shown, in  FIG. 8 , but shown in previous applications incorporated herein), one for each respective fastening component  570   f.  As shown in  FIG. 7 , handle  570   h  includes two male fastening components  570   f.  However, one or more than two such components may be provided on handle  570   h,  with corresponding, mating components in handle  590   h.  Further, the male component(s) can be provided on handle  590   h  and the female components can be provided in handle  570   h.  Still further, although bayonet couplings  570   f  and mating female receptacles  590   f  are used in the embodiments shown in  FIGS. 5-6 , alternative mating components may be used, such as shafts with ball and detent arrangements, or any of a number of mating, releasable mechanical fixtures. The mating mechanical members, when connected, maintain the large cannula  310 L fixed relative to the dilator  570 , both in the axial direction, as well as rotationally. A release mechanism may be provided that the user can actuate to release the mechanical fixation members and then the operator can remove the dilator  570  from the large cannula  310 L in a manner shown and described in application Ser. No. 12/474,226. Handles  570   h,    590   h  can have substantially the same size/outside diameter, but this is not necessary. 
         [0144]    The distal end portion of introducer cannula  310 L may be chamfered  590   d  so that it tapers towards the dilator  570  when assembled thereover, thereby further reducing the risk of snagging tissue (e.g., fascia) as the tools are advanced into the body. Alternatively, the tip  590   d  may be flexible and tapered to a smaller diameter to create intimate contact and smooth transition with the dilator  570 . In this embodiment, the tip  590   d  could be composed of an elastomeric material or a more rigid material where the tip  590   d  is radially interrupted to allow the stiffer material to flex radially outwards to allow an interference fit that slides under low force. 
         [0145]    Large cannula/introducer  310 L includes a transparent main body tube with a handle portion  590   h.  The handle  590   h  and distal end portion of introducer  310 L may be opaque, but alternatively, can be transparent. Preferably, the inside wall of the main body tube is coated with a lubricious coating, such as LUBRILAST™, from AST Products. 
         [0146]    In the dilator embodiment of  FIG. 7 , non-tapered portion  570   n  is transparent. Tapered portion  572  is opaque and handle  570   h  is opaque. The transparent tubes  310   t  and  570   n  can be extruded parts (e.g., extruded from polycarbonate) and the opaque components  590   h,    590   t,    570   t  and  570   h  can be molded (e.g., molded from polycarbonate). 
         [0147]      FIGS. 9A-9D  illustrate an introducer/cannula  3300  that is insertable into a patient in a first configuration and then is expandable to a second expanded configuration. In a first or initial configuration ( FIGS. 9A-9C ), introducer/cannula  3300  has a cross-sectional area that is significantly smaller than when introducer/cannula  3300  is in an expanded, configuration ( FIG. 9D ).  FIG. 9A  shows introducer/cannula  3300  in the first configuration. Introducer trocar  3302  is shown installed in introducer/cannula  3300  in  FIG. 9A , in a configuration ready to be inserted into the abdominal cavity of the patient. As shown in  FIG. 9A , trocar  3302  has a circular cross-section and an outer diameter that is only slightly less than the inside diameter of introducer/cannula  3300 , so that the trocar  3302  can be readily slid into the lumen of introducer/cannula  3300 , but so that the space between the lumen of the introducer/cannula  3300  and the distal portion of trocar  3302  where it extends from the distal end of introducer/cannula  3300  is small, to prevent capturing tissue between the introducer/cannula  3300  and trocar  3302  as they are advanced along the tract into the abdominal cavity. Dimensions of  3300  I.D. and  3302  O.D. may be similar to those discussed with regard to components  570  and  310 L of  FIGS. 7-8   
         [0148]    Optionally, handle  3302 H may releasably lock or latch to handle  3300 H to help keep the components together as they are being advanced into the patient. Such latching or locking may be performed in the same or equivalent manner to that described with latching or locking  570   h  and  570   f  as described herein or in applications incorporated by reference herein. 
         [0149]    Once introducer/cannula  3300  has been inserted into its desired position (which may include handle  330 H in abutment with the skin of the patient, or in abutment with the fascia or external abdominal wall of the patient, or a position in which handle  330 H is proximal of and out of contact with the skin trocar  3302  is withdrawn proximally out of introducer/cannula  3300  (after first releasing the latching or locking between handles  3302 H and  3300 H, if applicable) as illustrated in  FIG. 9B , while introducer/cannula  3300  is held stationary. 
         [0150]    Next, enlarging trocar  3304  is inserted into introducer/cannula  3300 , as illustrated in  FIGS. 9C-9D . As shown in  FIG. 9C , enlarging trocar  3302  has an oval cross-section and a cross-sectional area that is substantially greater than the cross-sectional area of introducer/cannula  3300  in the first configuration. The outer perimeter of trocar  3304  is configured and dimensioned to slide within handle  3300 H. Dimensions of  3300 H I.D. and  3304  O.D. may be similar to those discussed with regard to components  570  and  310 L of  FIGS. 5-6 . The distal tip of trocar  3304  is blunt and tapered so as to be configured to be inserted into the lumen of introducer/cannula  3300 . As trocar  3304  is advanced into the lumen of introducer/cannula  3300 , it expands introducer/cannula  3300  to the expanded configuration as illustrated in  FIG. 9D . Accordingly, the lumen of introducer/cannula  3300  in the expanded configuration is greatly increased in cross-sectional area compared to its cross-sectional area prior to expansion thereof. In the example shown, the expanded lumen of introducer/cannula  3300  is substantially oval in shape (although the present invention is not limited to this shape) and is large enough to receive an endoscope  330  side-by-side of a tool. The introducer/cannula  3300  may be made from a variety of polyurethanes or the like. Once the introducer/cannula  3300  has been expanded as desired (typically over the full length of the tubular shaft), trocar  3304  is removed proximally from the expanded introducer/cannula  3300  and the introducer/cannula  3300  is held stationary during the removal. The introducer/cannula  3300  is then ready to receive an endoscope and tool as described. 
         [0151]      FIG. 10  is a partial illustration of a shaft of introducer/cannula  3300 ′ according to another embodiment of the present invention. In this embodiment, introducer/cannula  3300 ′ functions in substantially the same manner as introducer/cannula  3300  described above. However, rather than being constructed as described above with regards to  FIGS. 9A-9D , the shaft of introducer/cannula  3300 ′ is constructed with hard shell cannula portions  3312  (which can be made from polycarbonate, for example) and expandable intermediate portions  3314  (which can be made from polyurethane, for example). When in the initial configuration, hard shell components  3313  may abut or nearly abut one another, thereby forming a substantially circular cross-section like the cross-section of  3300  in the initial, unexpanded configuration. After insertion of trocar  3304 , the lumen of introducer/cannula  3300 ′ assumes the expanded shape and configuration as illustrated in  FIG. 10 . 
         [0152]      FIG. 11  illustrates an embodiment of an implantable device  10  according to the present invention, configured for delivery and paragastric, extragastric implantation. Device  10  includes enlargeable member  10   em  (shown in an enlarged configuration in  FIG. 11 ), a filling tube  12  in fluid communication with enlargeable member  10   em  and having sufficient length to extend out of an opening formed in a patient, through which the device  10  is delivered, when device  10  has been anchored to a surgical target such as the internal wall surface of the abdominal wall, peritoneum and/or fascia. Device  10  further includes an attachment tab  150  bonded to enlargeable member  10   em , and having suture retainers  1520  embedded in a top mesh layer  1510  of attachment tab  150 . Sutures  444  extend through the suture retainers  1520 . Further details about implants  10  that may be used in practicing the present invention can be found in application Ser. Nos. 12/474,226; 12/473,818; 12/474,118; 11/716,986; 11/716,985; and 11/407,701. 
         [0153]      FIG. 12A  is an exploded view of another embodiment of attachment tab  150  with an alternative layup arrangement for bonding the attachment tab  150  to the expandable member  10   em . In this embodiment, an inner backing layer  1522  comprising a non-vulcanized polymer (preferably, but not limited to non-vulcanized silicone) is provided against the inner surface of the expandable member  10   em . Optionally, a reinforced, non-vulcanized inner backing layer  1524  (preferably, but not limited to non-vulcanized silicone reinforced with mesh (reinforced silicone) may be layered against the inner surface of inner backing layer  1522 . Openings  1526  are formed through the expandable member  10   em . Plugs of non-vulcanized polymer (preferably, but not limited to the same non-vulcanized material that layer  1522  is made of preferably, but not limited to non-vulcanized silicone) are provided to fill the openings  1522  and are placed in the openings so that, when laid up, they contact the outer surface of layer  1522  and the inner surface of main backing and shell layer  1530 . Main backing and shell layer  1530  is preferably made of, but not limited to the same non-vulcanized material that plugs  1528  are made of (preferably, but not limited to non-vulcanized silicone). The plugs form an interlock between the bonding members inside and outside when vulcanized. A reinforced backing layer  1532  (made of a material preferably, but not limited to non-vulcanized silicone) is laid on the outside surface of layer  1530 . 
         [0154]    A wing forming bond layer  1534  (made of a material preferably, but not limited to non-vulcanized silicone) is laid on the outside surface of layer  1532  and a reinforced wing backing layer  1536  (made of a material preferably, but not limited to non-vulcanized silicone reinforced with mesh (i.e., reinforced silicone) is laid on the outside surface of layer  1534 . A wing backing layer  1538  (made of a material preferably, but not limited to non-vulcanized silicone) is laid on the outside surface of layer  1538  and a lower ingrowth bond layer  1540  (made of a material preferably, but not limited to non-vulcanized silicone) is laid on the outside surface of layer  1536 . As shown, lower ingrowth bond layer  1540  is U-shaped so as to be open at one end to a window for contacting tissue that allows tissue ingrowth into tissue ingrowth encouraging material  1542  (such as velour, or the like) inside the window. Alternatively, layer  1540  does not need to be U-shaped, but could be closed, while still maintaining the tissue ingrowth encouraging window so that layer  1542  can contact the tissue. 
         [0155]    A lower ingrowth layer  1542  (preferably, but not necessarily made of a layer of velour, such as DACRON® (polyester fiber) configured and dimensioned to encourage tissue growth into it) is laid on the outside surface of layer  1540  and an upper ingrowth layer  1510  (preferably, but not necessarily formed of ingrowth mesh (e.g., polyethylene terephthalate (PET), having a less dense weave than layer  1540  with less aggressive tissue ingrowth encouragement, resulting in relatively less scarring) configured in a weave pattern to which suture retainers  1520  are fixed and through which sutures  444  are threaded. Sutures  444  weave through one layer of the mesh and are threaded through the mesh to the suture lock and then back out of the mesh. Upper ingrowth layer  1510  is laid over the outer surface of layer  1542 . An upper ingrowth bond layer  1544  (preferably, but not necessarily having the same shape as lower ingrowth bond layer  1540  and preferably, but not necessarily formed of non-vulcanized silicone) is laid on upper ingrowth layer  1510  such that it is on the outside of the lower ingrowth layer  1542  and creates contact with wing layers  1538  and  1540 . Upper ingrowth bond layer  1540  is U-shaped, or otherwise open at one end to accommodate sliding the suture tool out below it. 
         [0156]    With all layers laid up as described, pressure and heat are applied so as to vulcanize the non-vulcanized materials, thereby integrating the previously separate layers into a non-separable vulcanized unit. In one non-limiting embodiment, the layers are vulcanized in a vulcanizing press at about 175° C. and about 100 pounds per square inch (psi) pressure for about twenty minutes, although these temperatures, pressures and times may vary.  FIG. 12B  illustrates an end view of the attachment tab  150  having been bonded to the expandable member  10   em .  FIG. 12C  is a longitudinal-sectional view, taken along line B-B in  FIG. 12B , of the layers having been bonded together to form the attachment tab  150  on the expandable member  10   em .  FIG. 12D  is a detailed view of the vulcanized joint indicated within circle  12 D of  FIG. 12C . Note that the layers  1524 ,  1522 ,  1528 ,  10   em  have become mechanically interlocked (through openings  1526 ) as well as chemically interlocked (through vulcanization). An alternative embodiment could omit the plugs, and instead, during the vulcanization, allow the inner layer to flow into the holes and the outer layer to flow into the holes, thereby connecting and vulcanizing together the inner and outer layers. 
         [0157]      FIG. 13A  is a partial view of one embodiment of an endoscope  330  that may be inserted into a port, cannula or tool to provide visualization during performance of one or more steps of a procedure as described herein. Although  FIG. 13A  shows one embodiment of such an endoscope  330 , it is noted that other endoscopes may be substituted therefore to provide visualization during a procedure as described herein. It is further noted that various, different sized endoscopes may be used during different steps or a procedure as described herein.  FIG. 13B  shows a longitudinal sectional view of the endoscope shown in  FIG. 13A . The elongated shaft  332  is only partially shown in  FIGS. 13A and 13B , so as to be able to show the views in a larger scale while still allowing them to fit on the page. The proximal portion  332   p  of shaft  332  is rigid, while the proximal portion  332   d  is flexible. The lengths of each portion  332   p  and  332   d  may vary. In one embodiment, the length of rigid portion was about sixteen inches and the length of the distal portion  332   d  plus tip  334  was about twenty-seven inches. Alternatively, the elongated shaft  332  may be a rigid shaft over both proximal and distal portions. 
         [0158]    Light post  336  is configured in the proximal handle portion  330   h  of the endoscope. An eve cup  330   e  is provided at the proximal end of the endoscope  330 . Bevels  330   b  may be provided at the junctures of proximal with distal portions  332   p,    332   d  and distal portion with distal tip  330   d,    334 . The maximum diameter of the elongated shaft  332  (including tip  334 ) in one embodiment, is less than or equal to about five millimeters. In the same embodiment, the working length of the elongated shaft  332  (including tip  334 ) is about 42 inches to about 44 inches. The flexibility of distal flexible portion allows it to bend and therefore the distal tip  334  can be delivered along a non-straight pathway, and it provides imaging to the surgeon so that the surgeon can see where the distal tip  334  is being driven to, and can see the pathway that it is taking, as it travels along the pathway. Additionally, the rigid portion  332   p  provides some stiffening support to facilitate pushing the distal tip  334  into the patient. 
         [0159]    Illumination fibers  330   m  extend through the main lumen of endoscope  330  and are connectable at a proximal end thereof to a light source (not shown) via light post  336  to deliver light out the distal tip  334  of endoscope  330 . Lenses  330 L are provided in the main lumen at the location of the distal tip  334  and proximal portion of the handle  330   h  to provide an image of the light reflected off of the environment as the illumination light exits the tip  334 , reflects off objects and is reflected back into tip  334 . Imaging fiber(s) connect the distal lens  330 L with the proximal lens  330 L arrangement in the handle  330   h.  A camera (not shown) may be connected to the endoscope for providing the ability to display images on a computer screen, provide image prints, etc. 
         [0160]      FIGS. 14A-14N  illustrate an example of a procedure for implanting an extra-gastric, paragastric device  10  according to an embodiment of the present invention. The attachment tool  4000 , suturing/stitching tool  5000 , introducer cannula  310 L, dilator  570  and endoscope  330  are not limited to the type of procedure described with regard to  FIGS. 14A-14N , but this procedure is described in detail to facilitate a detailed understanding of the present invention, including use of these instruments and devices. After preparing the patient  1  for surgery, an incision or puncture  223  is made and an optical trocar/cannula  320 / 310  with an endoscope  330  inserted therein (e.g., a VISIPORT™ trocar with VERSAPORT™ PLUS trocar sleeve from Covidien may be used, or an OPTIVIEW® trocar from Ethicon Endosurgery, Inc. may be used, and a 10 mm endoscope may be used, wherein the shaft of the endoscope has 10 mm outside diameter) are inserted into the incision and advanced under visualization by endoscope  330  and/or by fluoroscopic visualization to enter the peritoneal cavity. 
         [0161]    In this embodiment, incision  223  is made midline at a predetermined distance inferior of the xiphoid process. For example, the distance below the xiphoid process may be about 15 cm, although this distance may vary depending upon a number of factors, including, but not limited to the size of the patient and the body mass index of the patient. Alternatively, the incision  223  may be made at a predetermined distance (e.g., about 15 cm) inferior of the xiphoid process and at a predetermined distance (e.g., about 6 cm) to the patient&#39;s right of midline. FIG. 63A of application Ser. No. 12/474,226 illustrates an example of placement of the incision  223  to the right of midline. Initially, the trocar  320 , cannula  310  and endoscope  330  are inserted into incision  223  at a substantially perpendicular orientation to the surface of the skin  125 , as schematically illustrated in  FIG. 14A .  FIG. 14B  illustrates the placement of a second port/cannula  311  into incision  223 , which placement may be facilitated by a second trocar  321 . The second port/cannula  311  is smaller than the first port/cannula  310 . In at least one embodiment, the second port/cannula has an inside diameter of about five mm. 
         [0162]    Once the sharpened tip of the trocar  320  has passed through the fascia/abdominal muscle of the patient  1  and it and the distal tip of the cannula  310  have entered the abdominal cavity, the distal tip of the second cannula  311  (delivery of which may be facilitated by a sharpened tip of trocar  321 ) enter the abdominal/peritoneal cavity through the same opening through the skin, but a different opening through the fascia/abdominal muscle, alongside cannula  311 . Next, the trajectories of the cannulae  310 ,  311  trocars  320  (and optionally,  321 ) and endoscope  330  are flattened relative to the skin  125  of the patient  1  surrounding the incision  223 , as schematically illustrated in  FIG. 14C . In  FIG. 14C , trocar  320  has been removed and endoscope  330  has been inserted back into the cannula  310 . Trocar  321  has been removed from cannula  311  in order to allow the working end of any tools inserted therethrough to extend beyond the distal end of the cannula  311 . The flattening of the trajectory angle forms an angle relative to the original, perpendicular orientation of greater than about 60 degrees, typically greater than about 80 degrees, and, in some embodiments, 90 degrees or more. Before or after angling the cannulae  310 , 311  as described above, but after the distal ends thereof have entered the abdominal/peritoneal cavity the trocar  320  and endoscope  330  can be removed from the cannula  310  and the endoscope  330  can then be reinserted into cannula  310 . If a trocar  321  was used, it can be removed from the cannula  311  at this time. 
         [0163]    By viewing provided through the endoscope  330 , the surgeon can locate the falciform ligament and visually determine whether it is obscuring or attaching to the “landing zone”, where the term “landing zone” refers to the location where ingrowth material of the attachment tab  150  will contact tissue for attachment thereto and ingrowth thereby. If it is determined that the falciform ligament is obstructing or attached to the landing zone, then an instrument  370  can be inserted through cannula  311  and the working end of the instrument  370  can be extended out of the distal end of cannula  311  and manipulated to remove a portion of the falciform ligament that is obstructing the landing zone and/or a pathway along which the implant  10  is to be delivered. In  FIG. 14C , the instrument  370  that is being used is a cauterizing grasper. Alternatively, cauterizing scissors may be used, or endoscopic scissors, or other alternative endoscopic tool sized to be inserted through cannula  311  and configured to perform the cutting operations required. It is preferable that the tool cauterizes as well as cuts or ablates. 
         [0164]    Once there is a pathway toward the surgical target (implantation site) clear of the falciform ligament, the cannula  310  and endoscope  330  are removed from the patient  1  and the same or a different endoscope  330  (e.g., in the case where a relatively larger endoscope was used in cannula  310  and a relatively smaller endoscope  330  is needed to fit within cannula  311 ) is inserted into cannula  311  (after having removed any instruments that may be present in cannula  311 , such as instrument  370 ). The dilator/introducer cannula assembly  570 / 310 L are then inserted through opening  223  and through the opening in the fascia, while visually monitoring the advancement of the assembly  570 / 301 L via visualization provided through endoscope  330  inserted through cannula  311  and/or by fluoroscopic visualization, and while providing insufflation to the abdominal cavity according to standard laparoscopic procedure used by surgeons, as schematically illustrated in  FIG. 14D . 
         [0165]    The dilator/introducer assembly  570 / 310 L is advanced, while maintaining insufflation of the abdominal cavity and with visual monitoring via endoscope  330  and/or by fluoroscopic visualization, to a location where the distal tip  570   d  of the dilator  570  touches or nearly touches (approximates) the approximate target location where the implant device  10  is to be placed (i.e., the diaphragm  116  of the patient  1 , as illustrated in  FIG. 14E ). This positions the distal end of the introducer cannula  310 L appropriately for placement of the device  10  in the vicinity of the landing zone, roughly in the appropriate location for implantation. 
         [0166]    When the distal tip of the dilator  570  has been positioned as desired as shown in  FIG. 14E , the dilator  570  is next decoupled and removed from introducer cannula  310 L, while maintaining the introducer cannula  310 L fixed in the position established in the prior step ( FIGS. 14E-14F ). Once the dilator has been removed ( FIG. 14F ), the insufflation pressure is eliminated or greatly reduced due to the outflow of insufflation fluid/gas through the annulus of the large cannula which is now open at the proximal end, as illustrated in  FIG. 14F . 
         [0167]    Prior to this, the assembly  500  will have been prepared for use (an embodiment of such preparation is described in detail below with regard to  FIGS. 16A-16F , having a sealing member ( 1000  as shown; alternatively  1000 ′,  1000 ″ or  1000 ′″ may be substituted) provided over shafts  4140 ,  5140  and having device  10  mounted thereto in a compact (non-enlarged) configuration, as illustrated in  FIG. 14F . Although reference numeral  1000  has been used in  FIG. 14F  and throughout the  FIG. 14  series to denote the sealing member, it is noted that this procedure is not limited to sealing member  1000 , as any of the other variants of sealing member (e.g.,  1000 ′,  1000 ″,  1000 ′″) described herein could be substituted. Likewise, other introducers/cannulae could be substituted for cannula  310 L. The distal end of assembly  500 , including implant  10  are then inserted into the introducer cannula  310 L as indicated by the arrow in  FIG. 14F . 
         [0168]    Once the implant  10  has been fully inserted into the introducer cannula  310 L and the proximal end thereof is distal of the proximal end of the introducer cannula/handle  310 L/ 590   h  by at least the length to the sealing member  1000 , the sealing member  1000  is advanced distally and attached to the proximal end/handle of the introducer cannula  310 L/ 590   h  in a manner as described above or below herein. This seals off the proximal end of the introducer cannula  310 L and allows insufflation pressure to be reestablished in the abdominal cavity. Once full insufflation pressure has been achieved (or substantially achieved), assembly  500  is advanced distally while maintaining the position of introducer cannula  310 L. The assembly  500  is advanced until the implantable device  10  contacts or nearly contacts (approximates) the approximate target location where the implant device  10  is to be implanted (i.e., the diaphragm  116 , as illustrated in  FIG. 14G ). This can be visually confirmed by visualizations obtained through endoscope  330  and/or by fluoroscopic visualization. 
         [0169]    Next, the introducer cannula  310 L is retracted proximally while maintaining the position of the device  10  and assembly  500  as illustrated in  FIG. 14H . Insufflation pressure is maintained during this step, and the retraction of the cannula  310 L can be visually monitored through endoscope  330 . Cannula  310 L is retracted until at least the enlargeable portion  10   em  of the device  10  is fully exposed (i.e., extends distally of the distal end of cannula  310 L), as shown in  FIG. 14H . 
         [0170]    Alternatively, the cannula  310 L can be made shorter than in the above embodiment, so that retraction thereof is not necessary. In this alternative embodiment the device  10  and assembly  500  are simply advanced relative to cannula  310 L until at least the enlargeable portion  10   em  of the device  10  is fully exposed (i.e., extends distally of the distal end of cannula  310 L), without the need to retract the cannula  310 L. 
         [0171]    Next the implantable device  10  is enlarged from its compact configuration to an enlarged configuration, as illustrated in  FIG. 14I . In the embodiment shown, the device  10  is enlarged by filling it with fluid (e.g., saline) through filling tube  12 . Although filling tube  12  is shown only schematically in  FIG. 14I , in actuality it extends further proximally from the enlargeable member  10   em  so as to extend out of the patient&#39;s body  1 , where it can be connected with a pressurized fluid source. Preferably, the device  10  is filled until the top of the device  10  contacts the patient&#39;s diaphragm, or until it has reached the volume that has been predetermined to be appropriate for the patient (through the use of MRI imaging and/or the template assessment at the beginning of the procedure). Further details about filling tube  12  can be found in application Ser. Nos. 12/474,226; 12/473,818; 12/474,118; 11/716,986; 11/716,985; and 11/407,701. It is further noted, that although the device  10  embodiment shown in this example is a tillable or inflatable device  10 , that the present invention is not limited to this type of device as other types of enlargeable devices could be substituted, such as a mechanically enlargeable device, a hybrid device that includes both mechanical and fillable enlargement features, etc. 
         [0172]    While still under full insufflation, the positioning of the enlarged device  10  is visually inspected through endoscope  330 . During this inspection, careful attention is paid to the location and orientation of the attachment tab  150  and to ensure that no obstructions or other tissues are located between the attachment tab and the attachment site (abdominal wall, fascia). The placement and orientation of the enlarged member  10   em  are also noted. If repositioning is needed, device  10  can be reduced in size by partial up to total deflation and assembly  500  can be manipulated to reposition the implant, after which it is enlarged again to the state shown in  FIG. 14I . This process can be iterated as many times as necessary to establish satisfactory placement and orientation of the device  10  and attachment tab  150 . Once satisfactory placement and orientation has been achieved, insufflation pressure is reduced by an amount according to the surgeon&#39;s choice, typically being reduced to a level that is about one half to about three-quarters of the previous pressure, or reduce to zero insufflation pressure, or anywhere in between, while maintaining device  10  in the enlarged configuration shown in  FIG. 14I . 
         [0173]    Optionally, an endoscope  330  may be inserted into a left side lumen (not shown, see application Ser. No. 12/474,226 for details) that extends from a proximal end portion of instrument  4000  to a location just proximal of working end portion  4010  and to a location alongside of the working end portion  4010 , and endoscope  330  is used to view between the abdominal wall (e.g., fascia/peritoneum) and the working end portion  4010  to ensure that no omentum, bowel or other organs or tissues are in the pathway along which the stitching needles are to be driven into and out of the fascia/peritoneum, abdominal wall. 
         [0174]    In one embodiment, when it has been determined that the pathways for the stitching needles on the left side of the working end portion  4010  are clear to be advanced, then the endoscope  330  is removed from left side lumen and inserted into a lumen on the right side of the instrument (also shown and described in application Ser. No. 12/474,226). The right side lumen extends from a proximal end portion of instrument  4000  to a location just proximal Of working end portion  4010  and alongside of working end portion  4010 , such that endoscope, when inserted therein, is used to view between the abdominal wall  127  (e.g., fascia/peritoneum  127   f ) and the working end portion  4010  to ensure that no omentum, bowel or other organs or tissues are in the pathway along which the stitching needles on the right side of the working end portion  4010  are to be driven into and out of the fascia/peritoneum, abdominal wall. Thus, endoscopic visualization via endoscope  330  through cannula  311  and/or the left and right lumens along the sides of tool  4000 , is used to confirm that the attachment location is clear of omentum, bowel, etc., e.g., that the tool  4000  and portion of the device  10  to be attached are positioned so that a clear pathway to the attachment site exists, such that no bowel, excessive fat, or other obstruction exists between the attachment tab  150  and the attachment location, such as the abdominal wall, costal cartilage, or other internal body structure to which device  10  is to be attached. 
         [0175]    In another embodiment, the direct delivery allows the endoscope  330  to be inserted through cannula  311  to be manipulated to provide a view above the end effector to assess both sides. 
         [0176]    When the “landing zone” has been visually confirmed as being clear, a local anesthetic, such as Lidocaine, Marcaine, or the like can be delivered to the target implantation site (e.g., at least one of fascia, peritoneum, preperitoneal fat and/or posterior rectus sheath) through a lumen in tool  4000 , such as through one of lumens used to insert the endoscope for viewing, after removal of the endoscope, for example, or by needle and syringe, trans-abdominally. Attachment tool  4000  is next actuated to perform the initial attachment of device  10  to the patient&#39;s body, and to thereby anchor the sutures  444  to suture anchors or traps as described in application Ser. No. 12/474,226. Light counter pressure can be applied to the patient on the skin over the landing zone and/or the distal end of tool  4000  can be raised up against the inside of the patient to help ensure that the stitching needles can penetrate easier and as deep as possible into the tissue. Although the attachment tool, as described in application Ser. No. 12/474,226 and as used herein preferably rotates the stitching needles toward a distal end of the tool  4000 , an alternative embodiment can be used wherein the stitching needles are rotated toward the proximal end of the tool. After completion of this initial attachment/stitching, tool  4000  is separated from tool  5000  and removed from the patient  1  and out of the introducer cannula  310 L. Once completely removed, the first valve  1012  (or  1012 ′,  1012 ″ or stopper  1012 ′″) is automatically or manually closed so that sealing member  1000  maintains the sealing off of the proximal end of introducer cannula ( FIG. 14J ) to substantially maintain the current level of insufflation or at least to allow any insufflation pressure lost during removal of the tool  4000  to be quickly reinstated. 
         [0177]    Next, the sutures are cinched in the direction of the arrow in  FIG. 14J  (sutures not shown in  FIG. 14J , but shown and described in detail in application Ser. No. 12/474,226), secured by suture retainers (not shown) and the excess proximal portions of the sutures  444  are cut off. This process can be visually monitored by visualization through cannula  311  using endoscope  330 , as illustrated in  FIG. 14J , and insufflation pressure is maintained as facilitated by sealing member  1000 . 
         [0178]    The suturing instrument  5000  is then removed from the patient  1 , leaving the introducer cannula  310 L and cannula/endoscope  311 / 330 . The sealing member  1000  remains attached to the cannula  310 L. Next, a cap  1001  is attached to the proximal end of the introducer cannula  310 L, as shown in  FIG. 14K , to seal it off. Alternatively, when sealing member  1000 ′″ is used, the ports  1008 ′″ and  1010 ′″ are sealed off using plugs  1044  and  1054 , respectively ( FIGS. 6B and 6A ) and cap  1001  is not needed. Next, under full insufflation, or a lesser level of insufflation pressure, according to the surgeon&#39;s choice, the attachment of the attachment tab to the tissues is inspected, using the endoscope  330  inserted through the cannula  311 . 
         [0179]    Once it has been determined that the attachment of the attachment tab  150  and thus the device  10  has been performed satisfactorily, the cannula  310 L and cannula  311 /endoscope  330  are removed from the patient leaving only the implanted device  10  in the patient  1  ( FIG. 14L ) and allowing the abdominal cavity to desufflate. 
         [0180]    Filling tube  12  extends proximally out of opening  223 , as illustrated in  FIG. 14M . At  FIG. 14N , filling tube  12  is cut to the appropriate length to join adjustment member  80  thereto and to reduce any excessive length of filling tube  12  that might otherwise exist. After securing adjustment member  80  to the fascia/abdominal wall to both anchor it as well as to close the opening through the fascia, any adjustment of the volume of expandable member  10   em  can be performed as needed, and then the patient can be closed, including closing of opening  223  to complete the procedure. Adjustment member  80  can be installed/attached to the abdominal wall/fascia at a location other than the opening  223 . In such cases, opening  223  is closed around the fill tube  12  extending therefrom, and the adjustment member  80  is attached to the fascia and/or abdominal muscle at another location, so that attachment member  80  does not need to perform the closure function for closing the opening  223 . Further details of this and other procedures that can be performed with the devices of the present invention are described in application Ser. No. 61/130,244, which is hereby incorporated herein, in its entirety, by reference thereto, and in co-pending application Ser. Nos. 12/474,226; 12/473,818; and 12/474,118. 
         [0181]      FIGS. 15A-15T  illustrate an example of a procedure for implanting an extra-gastric, paragastric device  10  according to another embodiment of the present invention. This embodiment is substantially similar to the embodiment described above with regard to  FIGS. 14A-14N , except that the incision or puncture  223  is made inferior of the xiphoid process and to the right (patient&#39;s right) of midline. After preparing the patient  1  for surgery, an incision  223  is made and an optical trocar/cannula  320 / 310  with an endoscope  330  inserted therein are inserted into the incision and advanced under visualization by endoscope  330  (see  FIG. 15A ). Insufflation is applied via a standard, laparoscopic trocar port. 
         [0182]    Optionally, a template is used to determine the incision location, as illustrated in  FIGS. 15B-15C . In this embodiment, incision or puncture  223  is made at a predetermined distance inferior of the xiphoid process and a predetermined distance to the right of midline of the patient  1 , see  FIG. 15A . For example, the distance below the xiphoid process may be about 15 cm and the distance to the right of midline may be about 6 cm, although these distances may vary. Initially, the trocar  320 , cannula  310  and endoscope  330  are inserted into incision  223  at a substantially perpendicular orientation to the surface of the skin  125 . Once the sharpened tip of the trocar  320  has passed through the fascia/abdominal muscle and it and the distal tip of the cannula  310  have entered the abdominal cavity, the trajectory of the cannula  310 , trocar  320  and endoscope  330  is flattened relative to the skin of the patient surrounding the incision/puncture  223  to form an angle  331  relative to the original, perpendicular orientation of greater than about 60 degrees, typically greater than about 80 degrees, and, in some embodiments, 90 degrees or more. 
         [0183]    Optionally, as illustrated in  FIGS. 15B-15C , a positioning template  6000  may be used to locate where, on the patient&#39;s  1  abdomen, to make the incision or puncture  223 . At  FIG. 15B , after using fluoroscopy and a radiopaque marker to mark the approximate level of the diaphragm  116  on the skin, as identified using the fluoroscopy, the positioning template  6000  is placed on the patient  1  with the top portion aligned with the diaphragm  116  according to which implant  10  size is to be used (see application Ser. No. 12/474,226 for a detailed description of the provision of implants of various sizes from which a selection can be made). For example, in  FIG. 15B , the top edge  6002  of the template  6000  is aligned with the diaphragm  116  when the largest available device  10 /enlargeable member  10   em  is to be used (e.g., “implant size F”). In the example shown in  FIG. 15B , the user is planning to implant the next smaller size device  10 /enlargeable member  10   em  (e.g., “implant size E”) and therefore the notch at  6004  has been aligned with the marking that indicates the level of the diaphragm  116 . An additional notch  6006  is provided below notch  6004  for use when a yet smaller sized implant is to be implanted (e.g., implant size B, C or D). Additionally, the template is adjusted so that the left vertical edge  6008  of template  6000  is substantially aligned with the patient&#39;s spine. 
         [0184]    Next, using the marking pen a line is drawn on the patient&#39;s abdomen along the trajectory edge  6010  of the template as indicated in  FIG. 15C  to indicate the intended trajectory for placement of the assembly  500 . The center of the abdominal incision/puncture  223  should be made where the line formed along  6010  crosses the right linea semiluminaris. A short-action local anesthetic (e.g., Lidocaine or the like) can be applied prior to making the incision/puncture  223 . Incision/puncture  223  is made to have a length/radius of approximately 5 cm in the location shown in  FIG. 15C . Once the incision/puncture  223  is made, the procedure continues as described above with regard to  FIGS. 15A ,  15 D and  15 E. 
         [0185]      FIG. 15F  illustrates the placement of a second port/cannula  311  into incision/puncture  223 , which placement may be facilitated by a second trocar  321 . The second port/cannula  311  is smaller than the first port/cannula  310 . In at least one embodiment, the second port/cannula has an inside diameter of about five mm. 
         [0186]    Once the sharpened tip of the trocar  320  has passed through the fascia/abdominal muscle of the patient  1  and it and the distal tip of the cannula  310  has entered the abdominal cavity, the distal tip of the second cannula  311  (delivery of which may be facilitated by a sharpened tip of trocar  321 ) enters the abdominal/peritoneal cavity through the same opening through the fascia/abdominal muscle, alongside cannula  311 . By viewing provided through the endoscope  330 , the surgeon can locate the falciform ligament and visually determine whether it is obscuring or attaching to the “landing zone”. If it is determined that the falciform ligament is obstructing or attached to the landing zone, then an instrument  370  can be inserted through cannula  311  and the working end of the instrument  370  can be extended out of the distal end of cannula  311  and manipulated to remove a portion of the falciform ligament that is obstructing the landing zone and/or a pathway along which the implant  10  is to be delivered. In  FIG. 150 , the instrument  370  that is being used is a cauterizing grasper. Alternatively, cauterizing scissors may be used, or endoscopic scissors, or other alternative endoscopic tool sized to be inserted through cannula  311  and configured to perform the cutting operations required. It is preferable that the tool cauterizes as well as cuts or ablates. 
         [0187]    Optionally a third cannula/port  313  may be inserted through the incision/puncture  223  as illustrated in  FIG. 15H , to allow additional instrumentation, such as graspers, endoscope, electrocautery tool, or other instrument, to be inserted therethrough. Third cannula/port  313  is typically of the same size as second cannula/port  311 , but need not be. Once there is a pathway toward the surgical target (implantation site) clear of the falciform ligament, the landing zone can be marked (such as by electrocautery). The cannula  310  and endoscope  330  are removed from the patient  1 , the tool  370  is removed from cannula  311 , and the same or a different endoscope  330  (e.g., in the case where a relatively larger endoscope was used in cannula  310  and a relatively smaller endoscope  330  is needed to fit within cannula  311 ) is inserted into cannula  311  (after having removed any instruments that may be present in cannula  311 , such as instrument  370 ), as illustrated in  FIG. 15I . 
         [0188]    The dilator/introducer cannula assembly  570 / 310 L are then inserted through opening  223  and through the opening in the fascia, while visually monitoring the advancement of the assembly  570 / 301 L via visualization provided through endoscope  330  inserted through cannula  311  and/or by fluoroscopic visualization, and while providing insufflation to the abdominal cavity, in an amount according to the surgeon&#39;s choice, such as typical in standard laparoscopic procedures,  FIG. 15J . 
         [0189]    The dilator/introducer assembly  570 / 310 L is advanced, while maintaining insufflation of the abdominal cavity and with visual monitoring via endoscope  330  and/or by fluoroscopic visualization, to a location where the distal tip  570   d  of the dilator  570  touches or nearly touches (approximates) the approximate target location where the implant device  10  is to be placed (e.g., the diaphragm  116  or costal margin  116   c  of the patient  1 , as illustrated in  FIG. 15K ). This positions the distal end of the introducer cannula  310 L appropriately for placement of the device  10  in the vicinity of the landing zone roughly in the appropriate location for implantation. 
         [0190]    When the distal tip of the dilator  570  has been positioned as desired as shown in  FIG. 15K , the dilator  570  is next decoupled and removed from introducer cannula  310 L, while maintaining the introducer cannula  310 L fixed in the position established in the prior step. Once the dilator has been removed ( FIG. 15L ), the insufflation pressure is eliminated or greatly reduced due to the outflow of insufflation fluid/gas through the annulus of the large cannula  310 L which is now open at the proximal end, as illustrated in  FIG. 15L . 
         [0191]    Prior to this, the assembly  500  will have been prepared for use, (an embodiment of such preparation is described in detail below with regard to  FIGS. 16A-16F , having a sealing member ( 1000 ′″ as shown; alternatively  1000 ,  1000 ′ or  1000 ″ may be substituted) provided over shafts  4140 ,  5140  and having device  10  mounted thereto in a compact (non-enlarged) configuration, as illustrated in  FIG. 15L . Although reference numeral  1000 ′″ has been used in  FIG. 15L  and throughout the  FIG. 10  series to denote the sealing member, it is noted that this procedure is not limited to sealing member  1000 ′″, as any of the other variants of sealing member (e.g.,  1000 ,  1000 ′,  1000 ″) described herein could be substituted. The distal end of assembly  500 , including implant  10  are then inserted into the introducer cannula  310 L as indicated by the arrow in  FIG. 15L . 
         [0192]    Once the implant  10  has been fully inserted into the introducer cannula  310 L and the proximal end thereof is distal of the proximal end of the introducer cannula/handle  310 L/ 590   h  by at least the length of the sealing member  1000 ′″, the sealing member  1000 ′″ is advanced distally and attached to the proximal end/handle of the introducer cannula  310 L/ 590   h  in a manner as described above or by forming a simple friction fit in the way that a stopper forms a friction fit with a flask. This seals off the proximal end of the introducer cannula  310 L and allows insufflation pressure to be reestablished in the abdominal cavity. Once full insufflation pressure has been achieved (or substantially achieved), assembly  500  is advanced distally while maintaining the position of introducer cannula  310 L. The assembly  500  is advanced until the implantable device  10  contacts or nearly contacts (approximates) the approximate target location where the implant device  10  is to be implanted (i.e., the diaphragm  116 , as illustrated in  FIG. 15M ). This can be visually confirmed by visualizations obtained through endoscope  330  and/or by fluoroscopic visualization. 
         [0193]    Next, the introducer cannula  310 L is retracted proximally while maintaining the position of the device  10  and assembly  500  as illustrated in  FIG. 15N . The sealing member  1000 ′″ slides along the shafts  4140 ,  5140  of assembly  500  as introducer cannula  310 L is retracted relative to assembly  500 , thereby maintaining insufflation pressure in the abdominal cavity. Thus, insufflation pressure is maintained during this step, and the retraction of the cannula  310 L can be visually monitored through endoscope  330  and/or via fluoroscopy. Cannula  310 L is retracted until at least the enlargeable portion  10   em  of the device  10  is fully exposed (i.e., extends distally of the distal end of cannula  310 L), as shown in  FIG. 15N . 
         [0194]    Next the implantable device  10  is enlarged from its compact configuration to an enlarged configuration, as illustrated in  FIG. 15O . In the embodiment shown, the device  10  is enlarged by filling it with fluid (e.g., saline) through filling tube  12 . Although filling tube  12  is shown only schematically in  FIG. 15O , in actuality it extends further proximally from the enlargeable member  10   em  so as to extend out of the patient&#39;s body  1 , where it can be connected with a pressurized fluid source. Further details about filling tube  12  can be found in application Ser. Nos. 12/474,226; 12/473,818; 12/474,118; 11/716,986; 11/716,985; and 11/407,701. It is further noted, that although the device  10  embodiment shown in this example is a finable or inflatable device  10 , that the present invention is not limited to this type of device as other types of enlargeable devices could be substituted, such as a mechanically enlargeable device, a hybrid device that includes both mechanical and fillable enlargement features, etc. 
         [0195]    While still under full insufflation, the positioning of the enlarged device  10  is visually inspected through endoscope  330 . During this inspection, careful attention is paid to the location and orientation of the attachment tab  150  and to ensure that no obstructions or other tissues are located between the attachment tab and the attachment site (abdominal wall, fascia). The placement and orientation of the enlarged member  10   em  are also noted. If repositioning is needed, device  10  can be reduced in size by partial up to nearly total deflation and assembly  500  can be manipulated to reposition the implant, after which it is enlarged again to the state shown in  FIG. 15O . This process can be iterated as many times as necessary to establish satisfactory placement and orientation of the device  10  and attachment tab  150 . Once satisfactory placement and orientation has been achieved, insufflation pressure is reduced by an amount according to the surgeon&#39;s choice, typically being reduced to a level that is about one half to about three-quarters of the previous pressure, or reduced to zero insufflation pressure, or anywhere in between (in one example pressure is reduced from about 15 mmHg to about 3 mmHg), while maintaining device  10  in the enlarged configuration shown in  FIG. 15O . 
         [0196]    Optionally, an endoscope  330  may be inserted into a left side lumen (not shown, see application Ser. No. 12/474,226 for details) that extends from a proximal end portion of instrument  4000  to a location just proximal of working end portion  4010  and to a location alongside of the working end portion  4010 , and endoscope  330  is used to view between the abdominal wall (e.g., fascia/peritoneum) and the working end portion  4010  to ensure that no omentum, bowel or other organs or tissues are in the pathway along which the stitching needles are to be driven into and out of the fascia/peritoneum, abdominal wall. When it has been determined that the pathways for the stitching needles on the left side of the working end portion  4010  are clear to be advanced, then the endoscope  330  is removed from left side lumen and inserted into a lumen on the right side of the instrument (also shown and described in application Ser. No. 12/474,226). The right side lumen extends from a proximal end portion of instrument  4000  to a location just proximal of working end portion  4010  and alongside of working end portion  4010 , such that endoscope, when inserted therein, is used to view between the abdominal wall (e.g., fascia/peritoneum) and the working end portion  4010  to ensure that no omentum, bowel or other organs or tissues are in the pathway along which the stitching needles on the right side of the working end portion  4010  are to be driven into and out of the fascia/peritoneum, abdominal wall. Thus, endoscopic visualization via endoscope  330  through cannula  311  and/or the left and right lumens along the sides of tool  4000 , is used to confirm that the attachment location is clear of omentum, bowel, etc., e.g., that the tool  4000  and portion of the device  10  to be attached are positioned so that a clear pathway to the attachment site exists, such that no bowel, excessive fat, or other obstruction exists between the attachment tab  150  and the attachment location, such as the abdominal wall, costal cartilage, or other internal body structure to which device  10  is to be attached. 
         [0197]    As an alternative option, the direct delivery allows the endoscope  330  to be inserted through cannula  311  to be manipulated to provide a view above the end effector to assess both sides. 
         [0198]    When the landing zone has been visually confirmed as being clear, a local anesthetic, such as Lidocaine, Marcaine, or the like can be delivered to the target implantation site (e.g., the fascia/peritoneum and abdominal wall) through a lumen in tool  4000 , such as through one of lumens used to insert the endoscope for viewing, after removal of the endoscope, for example. Attachment tool  4000  is next actuated to perform the initial attachment of device  10  to the patient&#39;s body, and to thereby anchor the sutures  444  to suture anchors or traps as described in application Ser. No. 12/474,226. Light counter pressure can be applied to the patient&#39;s skin over the landing zone and/or the distal end of the tool  4000  can be raised up against the inside of the patient to help ensure that the stitching needles can penetrate easier and as deep as possible into the tissues. After completion of this initial attachment/stitching, tool  4000  is separated from tool  5000  and removed from the patient  1  and out of the introducer cannula  310 L, as illustrated in  FIG. 15P . Once completely removed, the first port  1008  (see  FIG. 15Q ) of the sealing member  1000 ′″ is sealed off by inserting plug/stopper  1012 ′″ therein, as illustrated in  FIG. 15R . Alternatively, if one of the other embodiments of sealing member  1000 ′″ is used, first valve  1012 ,  1012 ′ or  1012 ″ is automatically or manually closed. In any case, sealing member  1000 ′″ (or  1000 ,  1000 ′, or  1000 ″) then maintains the sealing off of the proximal end of introducer cannula ( FIG. 15R ) to substantially maintain the current level of insufflation or at least to allow any insufflation pressure lost during removal of the tool  4000  to be quickly reinstated. 
         [0199]    Next, the sutures are cinched in the same manner as described above with regard to  FIG. 14J  and described in detail in application Ser. No. 12/474,226, secured by suture retainers (not shown) and the excess proximal portions of the sutures  444  are cut off. This process can be visually monitored by visualization through cannula  311  using endoscope  330 , and insufflation pressure is maintained as facilitated by sealing member  1000 ′″. 
         [0200]    The suturing instrument  5000  is then removed from the patient  1 , leaving the introducer cannula  310 L and cannula/endoscope  311 / 330 , as illustrated in  FIG. 15S . Sealing member  1000  remains attached to cannula  310 L. Next, a cap  1001  is attached to the proximal end of the introducer cannula  310 L, as shown in  FIG. 15T  (or, alternatively, plugs  1044  and  1054  are used to plug and seal the ports of the sealing member), to seal it off and full insufflation is reintroduced to the abdominal cavity. Next, under insufflation, the attachment of the attachment tab  150  to the tissues is inspected, using the endoscope  330  inserted through the cannula  311 . 
         [0201]    Once it has been determined that the attachment of the attachment tab  150  and thus the device  10  has been performed satisfactorily, the cannula  310 L and cannula  311 /endoscope  330  are removed from the patient leaving only the implanted device  10  in the patient  1  (like shown in  FIG. 14L ) and allowing the abdominal cavity to desufflate. 
         [0202]    Filling tube  12  extends proximally out of opening  223 , as illustrated in  FIG. 14M  (except that opening  23  is to the right of midline). Like described above with regard to  FIG. 14N , the filling tube  12  is cut to the appropriate length to join adjustment member  80  thereto and to reduce any excessive length of filling tube  12  that might otherwise exist. After securing adjustment member  80  to the fascia/abdominal wall to both anchor it as well as to close the opening through the fascia, any adjustment of the volume of expandable member  10   em  can be performed as needed, and then the patient can be closed, including closing of opening  223  to complete the procedure. Adjustment member  80  can be installed/attached to the abdominal wall/fascia at a location other than the opening  223 . In such cases, opening  223  is closed around the fill tube  12  extending therefrom, and the adjustment member  80  is attached to the fascia and/or abdominal muscle at another location, so that attachment member  80  does not need to perform the closure function for closing the opening  223 . Further details of this and other procedures that can be performed with the devices of the present invention are described in application Ser. No. 61/130,244, which is hereby incorporated herein, in its entirety, by reference thereto, and in co-pending application Ser. Nos. 12/474,226; 12/473,818; and 12/474,118 
         [0203]      FIGS. 16A-16F  are now referred to by the following description of preparation of the assembly  500  and device  10  for use according to an embodiment of the present invention.  FIG. 16A  shows the device  10  connected to the distal end of the assembly  500 . In a preferred embodiment, the assembly  500  and device  10  will be shipped to the end user in this configuration. Alternatively, when the assembly  500  and device  10  are received separately, then device  10  is attached to the assembly  500  at the commencement of preparation, and inflated (if not already inflated, although, typically, device  10  will be shipped in an inflated state to prevent creasing), as shown in  FIG. 16A . The preparer ensures that the sealing member  1000 ,  1000 ′,  1000 ″,  1000 ′″ is positioned at a predetermined distance (e.g., about 6 cm, or some other predetermined distance found to be optimal) from the proximal end of working end portion/end effector  4010 . If the sealing member  1000 ,  1000 ′,  1000 ″,  1000 ′″ is not positioned at the predetermined distance, than the preparer can slide it into the location where it is separated by the predetermined distance. 
         [0204]    The device  10  is next immersed into sterile saline to check for leaks. If any leak is found, it needs to be replaced with a new device  10 , or an entirely new assembly  500  and device  10  and retested. When no leaks are found, the leak free device is deflated by opening stopcock  13  and withdrawing fluid from the device  10  using a syringe  15 , for example. While deflating the device  10 , the user/preparer will ensure that the device  10  is flattened in a manner to minimize the amount of material of the device extending beyond the ends of the working end  4010 , see  10 M in  FIG. 16B . When all or substantially all fluid has been removed from device  10 , stopcock  13  is closed to maintain the deflated condition of device  10 .  FIG. 16C  illustrates the hand  2  of the user/preparer manipulating the shape of device  10  as it is deflated, to ensure that no portion of the device extends above the end effector  4010  and so as to minimize the amount  10 M of device  10  that extends beyond the edges of end effector  4010 . 
         [0205]    Next, the user folds/wraps device  10  about the end effector  4010  to further reduce the cross-sectional area of the end effector  4010  and device  10 , see  FIG. 16D . Care must be taken to ensure that no part of the folded device  10  extends above the top  4010 T of the end effector  4010 , as this would present the risk of damage to the device  10  by the stitching needles. 
         [0206]    At this time, the folded device  10  and attachment system  500  are inserted into the introducer  301 L as illustrated in  FIG. 16E  The sealing member  1000 ,  1000 ′,  1000 ′,  1000 ′″ is secured to the proximal end of the introducer  310 L as shown in  FIG. 16F  and the procedure continues on such as described with regard to  FIGS. 14G-14N  or  FIGS. 15M-15T , for example. 
         [0207]      FIGS. 17A-17O  are now referred to for a description of templates, template size selection and device size selection that can be practiced according to an embodiment of the present invention. Templates and procedures described can be used in combination with the procedures described in  FIGS. 14A-14N  or  FIGS. 15A-15T , as well as any other implantation procedures described in any of the references that have been incorporated herein that do not conflict with this procedure as described. 
         [0208]      FIG. 17A  illustrates an abdominal magnetic resonance imaging (MRI) scan  1700  (cross-section) of a patient  1  to be treated by implantation of device  10 . The cross-section  1700  is an axial view at the level of the gastroesophageal (GE) junction of the patient  1 . A lateral measurement  1702  is made from the midline  1702  to the inside surface of the abdominal wall  27  at a height of the top of the spinal column  1706  in a direction perpendicular to the midline  1702 . An AP (anterior to posterior) measurement  1708  is made from the posterior inside rib cage to the anterior inside rib cage perpendicular to the lateral measurement line  1702 , midway of the midline  1704  and interior surface of the abdominal wall  27 . 
         [0209]    Referring to the sizing chart  1730  shown in  FIG. 17B , the measurements are plotted on the chart  1730  to determine the appropriate size of the template(s) to be selected for the patient&#39;s  1  implantation procedure. In the example shown in  FIG. 17A , the Lateral measurement  1702  is about 15 cm and the AP measurement  1708  is about 18 cm. By plotting these values on the chart  1730 , as shown by  1732  (or simply looking up the values, using the chart  1730  as a look up chart), the user notes that these measurements indicate the selection of template group 2. If the plotted measurement values fall on a line between two template groupings, the larger template grouping is selected.  FIG. 17C  is a correlation chart  1740  that correlates Template Group  1742  to implant size  1744 , showing various sizes of device  10  and which ones correlate to which template group size. 
         [0210]      FIGS. 17D  illustrates various sizes of enlargeable members  10   em B,  10   em D,  10   em C,  10   em M,  10   em E and  10   em F from which various sized devices can be constructed. The minimum fill volumes for the enlargeable members are about 790 cc for  10   em B, about 950 cc for  10   em C, about 1,200cc for  10   em M, about 1,440 cc for  10   em E and about 2200 cc for  10   em F. The approximate depth and length dimensions of the enlargeable members in their nominal (mandrel sized) configurations are as follows: size B: about 11 cm×about 16 cm; size D: about 13 cm×about 17 cm; size C: about 11 cm×about 20 cm; size M: about 12 cm×about 21 cm; size E: about 13 cm×about 22 cm; and size F: about 16 cm×about 23 cm. The appropriate size of enlargeable member to be used is selected by taking the lateral and AP measurements of the patient  1  as described above, referencing the chart in  FIG. 17B  to identify where the lateral and AP measurements intersect on the chart to identify which of Groups 1-3 is to be used. Next, using the chart in  FIG. 17C , the various templates that are included in the Group that was identified are physically overlaid on the patient  1  to determine which one appears to fit the best, with the aid of fluoroscopic landmarks that are compared against the template when it is overlaid. The template  1750  that appears to fit the best is then referenced to identify the depth and length dimensions  1754 ,  1752  that are marked upon it. These dimensions match one of the enlargeable member sizes, and the size that matches is the size that is selected for use. Alternatively or additionally of the marking of the depth and length dimensions  1754 ,  1752  on the template  1750 , the enlargeable member size (e.g., B,D,C,M,E or F) may be printed otherwise marked on the template  1750 . Further alternatively or additionally, the templates  1750  may be color coded to match with corresponding sizes of enlargeable member that can be correspondingly color-coded. 
         [0211]    After or before selecting the appropriate size template  1750  and device  10 , the patient  1  is prepared for surgery, which may be according to standard laparoscopy protocol, for example. The patient  1  may be positioned supine on the procedure table with the arm on the side of the fluoroscope tucked. Mild reverse Trendlenberg positioning may help placement after sizing of the device.  FIG. 17E  is an illustration of a positioning template  1750  that is useable to help determine device  10  sizing and placement. The head  1752  of the template  1750  indicates the distal end of the device  10 , and a size indication  1754  may be included on the head  1752  to indicate the device  10  size that the selected template  1750  facilitates positioning of. An attachment area cutout is provided for marking the patient in a manner described below. The tail  1758  of the template  1750  indicates the proximal end of the device  10 . Handle  1760  indicates the trajectory that the attachment system  500  will take during the implantation procedure. Notch  1762  is used to indicate the proximal-most incision location, and the length and position of tail  1764  indicates the range for the incision location. 
         [0212]    Referring to  FIG. 17F , the left (patient&#39;s left) hemi-diaphragm  116  of the patient is located using visualization equipment such as fluoroscopy (e.g., C-arm fluoroscopy). The left hemi-diaphragm  116  is marked at end inspiration, on the outside of the patient  1 , using a surgical marker. The surgeon may palpate the patient&#39;s let lower costal margin  116   c  and mark  116 M the margin&#39;s inferior edge, on the outside of the patient  1 , with a surgical marker, as illustrated in  FIG. 17F . Next, a radiopaque, adhesive marker or marking guide  1770 , such as a radiopaque adhesive ruler is adhered over the top of the costal margin mark  116 M as illustrated in  FIGS. 17G-17H . The tic marks  1772  of the marker  1770  are aligned with the inferior edge of the costal margin  116   c.    
         [0213]    In  FIG. 17I , a template size (having the same dimensions as one of the “Implant Sizes”  1744  in  FIG. 17C ) is selected from group of implant sizes  1744  corresponding to the template group  1742  number ( FIG. 17C ) that was determined using the anatomical measuring described with regard to  FIG. 17A  above and use of chart  1730  described above with reference to  FIG. 17B . It is noted that eight implant size entries are made in  1744  because two of the sizes appear in two different template groups  1742  because those sizes fall on borders between two Groups. Following the example described with regard to  FIGS. 17A-17C , a 12 cm×21 cm template was selected as illustrated in  FIG. 17E . 
         [0214]    In  FIG. 17I , the template  1750  is placed on the patient  1  with the distal edge  1756 D of the cutout  1756  adjacent to the inferior edge of the tic marks  1772 , and with the handle  1760  oriented at a predetermined angle  1774  to the imaginary horizontal line  1776  that is substantially perpendicular to the midline or spinal column. Predetermined angle  1774  is preferably about forty-five degrees, but the present invention is not limited to this specific angle as the predetermined angle could be within a range of about forty to fifty degrees. The described placement is designed to prevent the stitching needles of the assembly  500  from overlapping with the costal margin  116   c  during attachment of the device  10 . The template  1750  should be placed as close as possible to the xiphoid process without violating the aforementioned placement parameters. It is preferable that the head  1752  of the template  1750  does not intersect (overlie) any portion of the spine  1753 , as internal body structures located near midline in the patient  1  may displace the device  10  out of its intended position if the intended position indicated by template  150  intersects the spine  1753 . Non-intersecting placement of the head  1752  can be confirmed by fluoroscopic visualization, as illustrated in  FIG. 17J . If it is not possible not to place the head  1752  so that it does not intersect  1753 , then the amount of intersection should be minimized. Desired positioning may require rotating the template  1750  slightly, or moving the template  1750  slightly inferiorly and laterally, or along the edge of the costal margin  116   c.  The handle  1760  may cross the midline/intersect the spine  1753 , as also shown in  FIG. 17J . 
         [0215]    In  FIG. 17K , visualization such as fluoroscopy is used to determine whether the template head  1752  reaches the diaphragm  116 , preferably also without intersecting the spine  1753 .  FIG. 17K  shows proper sizing and orientation/placement of template  1750 . If, on the other hand, it is observed that the head  1752  of the template  1750  extends above the diaphragm  116 , then the user adjusts the placement by moving the template  1750  inferiorly until the head  1752  is adjacent to the diaphragm, but does not extend superiorly of it. This would also result in the cutout area  1756  and distal edge  1756 D of the cutout area being located somewhat below the costal margin  116   c  and tic marks  1772 . If this inferior adjustment results in the edge  1756 D being placed more than or equal to a predetermined distance (typically about 4 cm, although this may vary) below the costal margin, then a shorter template  1750  should be selected and the procedure described with regard to  FIGS. 17I-17K  should be repeated. The selection and repetition of the procedure should be iterated until a satisfactory lit of the template  1750  to the patient  1  has been achieved, wherein a satisfactory fit satisfies the requirements described with regard to  FIGS. 17I-17K . 
         [0216]    If the visualization performed in  FIG. 17K  reveals that head  1752  (superior end) is significantly below (e.g., about four centimeters or more), the diaphragm  116 , then a longer template  1750  is selected and the procedure described with regard to  FIGS. 17I-17K  is be repeated. The selection and repetition of the procedure should be iterated until a satisfactory fit of the template  1750  to the patient  1  has been achieved, wherein a satisfactory fit satisfies the requirements described with regard to  FIGS. 17I-17K . 
         [0217]    Care should be taken not to oversize the device  10  used for implantation into the patient, as this may cause malpositioning of the device  10  when it settles into place after attachment to the patient  1 . Once the size of the device  10  to be used has been determined and the location for placement and attachment of the device  10  has been determined, a surgical marking pen can be used to mark the device attachment area on the skin of the patient  1  by drawing a line lengthwise in the center of cutout area  1756  as shown in  FIG. 17L . Additionally, the surgical marking pen can be used to make a mark  1782  on the skin of the patient at the notch  1762  ( FIG. 17M ) or at a location proximal (inferior) to the notch  1762  along tail  1764 . The mark should not be made closer to the costal margin  116   c  than the distance separating the notch  1762  and the costal margin  116   c,  as this may not allow the attachment system  500  to function properly. 
         [0218]    After accomplishing the markings  1780  and  1782 , the template  1750  is removed and another adhesive marker  1770  can be adhered to the skin of the patient overlying mark  1780 , as shown in  FIG. 17N . To identify the location of the incision to be made, a line is drawn (such as with a surgical marker) wherein the line is centered at the incision mark  1782 , see  FIG. 17O . Optionally, local anesthetic may be applied to the skin over the location of the incision to be made. An incision is next made and the procedure continues as described with regard to  FIGS. 14A-14N  or FIGS.  15 A and  15 D- 15 T, for example. The marker  1770  at the costal margin  116   c  helps the surgeon to visually identify when the tip of the dilator  570  ( FIGS. 14E and 15K ) is at (or slightly above) the costal margin  116   c.  Direct visualization using endoscope  330  can also be used to assist in the visualization. The marker  1770  over line  1780  and line  1780  are used to visualize alignment with the cannula  310 L to ensure that cannula  310 L maintains alignment with line  1780  at all times. 
         [0219]    Alternative or in addition to the placement of mark  116 M and/or marker  1770  over the costal margin, a suture marker  1790  may be placed as illustrated in  FIGS. 18A-18C . A suture is placed as suture marker  1790 , for example, using laparoscopic techniques. A suture passer instrument  1792  is used to puncture the skin and abdominal wall of the patient  1  at the inferior edge of costal margin  116   c,  with the abdomen of the patient  1  under insufflation, as illustrated in  FIG. 18A . Another instrument, such as graspers  1794  are inserted through a laparoscopic port and the working end of the instrument  1794  is operated to grasp the suture  1790 . The instrument  1794  is next used to draw the suture  1790  laterally (or medially, depending upon which side of the mark that the suture passer  1792  entered on) along the inferior edge of the costal margin  116   c . The suture passer  1792  is then reinserted at the opposite end of the mark to engage the suture  1790  and draw it back out of the patient&#39;s abdomen, leaving a portion of the suture extending between the entry and exit locations to form the suture marker  1790  as illustrated in  FIG. 18B . Thus the suture marker is located along the inferior edge of the costal margin  116   c  when viewed by fluoroscopy. The suture marker  1790  is typically placed to have a length that is approximately equal to the width of the working end  4010  of attachment tool  4000 . The suture marker  1790  marks the distal edge of the position (landing zone) where the attachment tab  150  will be attached. When the device  10  and assembly  500  are introduced into the abdominal cavity, the distal end of  4010  can be positioned adjacent marker  1790  as shown in  FIG. 18C . 
         [0220]      FIG. 19  is a partial view showing a distal end portion of stitching instrument  4000  that employs an alternative implant guide  4150 ′ according to an embodiment of the present invention. Guide  4150 ′ has a notch, concavity or depression  4152  its proximal end portion, adjacent to the proximal end that joins the distal end of end effector (working end)  4010 . Depression  4152  is configured and dimensioned to conform to the lowermost rib of the patient at the costal margin  116   c  so as to function as a jig to properly distance the end effector  4010  (and stitches subsequently placed thereby) from the costal margin. Thus, as the end effector  4010  approached the costal margin  116   c  as illustrated in  FIG. 18C , the surgeon can direct the distal end of the assembly  500  upward and feel when depression  4152  engages the lower most rib. This, in addition to the visualization techniques already described, further facilitates appropriate placement of the stitches and attachment of the device  10  in the desired location. 
         [0221]    While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, too, instrument, device, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.