US20090287045A1 - Access Systems and Methods of Intra-Abdominal Surgery - Google Patents

Abstract

An access system includes a proximal handle, an overtube coupled to the handle, and an endoscope port extending through handle and overtube sized for receiving an endoscope therethrough. The overtube includes anatomic wall securing system that secures a distal portion of the overtube within a hole in the anatomic wall. The overtube is provided with a shaped distal portion or a controllably shapeable distal portion that aids in directing an endoscope inserted through the port to a particular location within the peritoneal cavity. The access system includes a system for insufflating/deflating the peritoneal space separately from the body cavity accessible via a natural orifice. The access system includes a closure system to cinch closed the hole made in the anatomical wall after the access system has been removed from the hole. Methods are provided for inserting the access system through the anatomical wall to perform intra-abdominal surgery.

Description

RELATED APPLICATIONS
• This application is related to U.S. Ser. No. 11/775,996, filed Jul. 11, 2007, and U.S. Ser. No. 12/030,244, filed Feb. 13, 2008, which are hereby incorporated by reference herein in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to access systems for accessing and providing access to the peritoneal cavity via a body cavity accessible through a natural orifice, and methods of performing intra-abdominal surgical procedures through such an access system using an endoscope.
• 2. State of the Art
• Traditional gallbladder removals are either performed via laparoscopic or open surgery techniques Laparoscopic procedures utilize electrocautery electrodes to dissect the gallbladder. These electrodes remain dangerously hot and may cause damage to adjacent viscera. Moreover, the surgical approach requires a large wound or several holes through the abdominal wall.
• The field of gastrointestinal endoscopy has for many years been limited to diagnostic and therapeutic techniques to observe, modify and remove tissues located in the digestive tract. Only recently have there been efforts to expand gastrointestinal endoscopic surgery to within the peritoneal cavity to remove large tissue masses such as the appendix and gallbladder. Generally, in these newer procedures, a natural orifice translucent endoscopic surgery (NOTES) access system is used to gain access to the peritoneal cavity through the stomach or another natural orifice. However, there are still significant limitations to the techniques for visualizing, manipulating and removing masses of tissue on current NOTES systems. In particular, once the NOTES system is in place, an endoscope is used to navigate instrumentation to the subject tissue for removal. Endoscopes are limited in their maneuverability, generally having only a single axis along which they can be bent to direct instrumentation.
• Further, the en bloc removal of large tissue masses, such as the gallbladder, presents numerous problems for current endoscopic tools and techniques. Currently, access to and removal of these types of tissue masses requires tissue separation and dissection that can be particularly difficult from an endoscopic approach. Also, after removal of tissues from the surgical site, current system require extremely skilled closure techniques. These closure techniques can prevent acceptance of such procedures from a large number of even skilled surgeons and also greatly increase the time for completing a procedure and the safety of the patient.
SUMMARY OF THE INVENTION
• According to embodiments of the invention, an access system is provided for enabling and facilitating access to the peritoneal cavity from a body cavity accessible through a natural orifice, such as an intragastric approach or a transvaginal approach. The access system includes a proximal handle, an overtube coupled to the handle, and an endoscope port extending through handle and overtube sized for receiving an endoscope therethrough. The overtube includes a securing system that secures a distal portion of the overtube within a hole in an anatomical wall of a body cavity accessible through a natural orifice. In a preferred embodiment, the securing system includes proximal and distal inflatable cuffs provided on an external portion of the overtube. The cuffs are coupled to discrete injection ports extending from the handle through the overtube that permit individual pressurization to fixate the cuffs on opposite sides of the anatomical wall. The anatomical wall can be captured between the two cuffs to secure the access system to the anatomical wall and provide a seal between the space of the natural orifice accessible body cavity (e.g., intragastric space) and the peritoneal cavity. The overtube is also provided with a shaped distal portion or a controllably shapeable distal portion that aids in directing an endoscope inserted through the port to a particular location within the peritoneal cavity. The access system is optionally provided with means for insufflating/deflating the peritoneal space separately from the body cavity (e.g. intragastric space). In addition, the access system optionally includes a closure means for deploying and acting on fastening to effect closure of the hole made in the anatomical wall in which the access system is secured to seal the hole after the access system has been removed from the hole.
• In one embodiment, the preshaped distal portion of the access system is a preshaped portion of a port separate from the overtube and extendable therethrough. The preshaped port is molded or otherwise formed with a biased shape to aid in directing an endoscope to a particular location within the peritoneal cavity. After the overtube is inserted into the patient, the preshaped port is inserted through the overtube, which initially counters the bias so that the biased distal portion of the port straightens as its passes through the overtube. Once the distal portion of the port exits the distal end of the overtube, the port assumes the shape of its preshape, thereby able to direct an endoscope or other instruments to a designated structure. The port can be rotated within the overtube to redirect the instruments. At the conclusion of the procedure, the port is withdrawn from the overtube and then the overtube is removed from the patient.
• In another embodiment, the preshaped distal portion is configured from an integral tubular element that is cut to define segmental recesses or cut-outs along its length. One or more pull wires extend from the handle of the access system to the distal end. When the appropriate pull wire(s) is/are activated at the handle, the tubular element bends along the cutouts and can be maintained in such configuration to orient the endoscopic port toward the target tissue. If necessary to reconfigure the access port or at the conclusion of the procedure, the handle can be operated to release the tension on the wire(s) and straighten the distal portion to aid in withdrawing the access port from the patient.
• The means to control insufflation/deflation includes a first port extending from the handle to a location intermediate the handle and the proximal cuff, and a second port extending from the handle to a location at or distal the distal cuff. The handle is also provided with a gas control system to inject or evacuate air through the respective first and second ports. In embodiments including means to control insufflation/deflation, the endoscopic port includes a seal sealing valve, preferably located within the handle. In this manner, once the cuffs have separated the natural orifice from the peritoneal space, the pressures in the peritoneal space and natural orifice accessible body cavity can be separately controlled, e.g., to reduce stomach pressure while maintaining peritoneal pressure to provide increase visibility at the surgical site.
• The closure means facilitates rapidly closure of the hole in the anatomical wall. In one embodiment, the closure means includes a cinching system preferably incorporating T-tags. In such embodiment, the access port is operable to implant hollow needles in a spaced apart manner about the hole. The access port is then operable to insert T-tags having a trailing suture through the hollow needles. Then, means are integrated with the access port or an independent tool is operable therewith that cinches the suture of the T-tags together about the hole to effect closure at the appropriate point in the procedure.
• The access system facilitates methods of getting through the anatomical wall. According to a first method, described with respect to an intragastric approach, an initial piercing is made from the exterior of the stomach to the interior of the stomach. According to a second method, also described with respect to an intragastric approach, an initial piercing is made from the interior of the stomach to the exterior of the stomach. Both methods include the dilatation of the stomach piercing using a balloon catheter. Once inside the peritoneal cavity and sufficiently oriented towards a surgical site a medical procedure can be conducted. By way of example, the gallbladder can be separated from the liver using tunneling and dissection balloons. Such methods are also useable in a transvaginal approach to a medical procedure.
• Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a broken side elevation of a first embodiment of an access system according to the invention.
• FIG. 2 is a broken section view of an overtube of the access system ofFIG. 1.
• FIG. 3 is a cross sectional view across line3-3 inFIG. 2.
• FIG. 4 is a broken side elevation view of a shaped port device of the access system ofFIG. 1, shown in two different configurations.
• FIGS. 5 through 21 illustrate methods of securing the access system ofFIG. 1 within the stomach wall to access the peritoneal cavity.
• FIG. 22 is broken side elevation view of a balloon tunneling device for use with methods of the invention.
• FIG. 23 is an enlarged broken longitudinal section view of the distal end of the balloon tunneling device ofFIG. 22.
• FIG. 24 is broken side elevation view of a balloon dissection device for use with methods of the invention, with the balloon shown in collapsed and expanded states.
• FIG. 25 is an enlarged broken longitudinal section view of the distal end of the balloon dissection device ofFIG. 24.
• FIGS. 26 through 35 illustrate a method of performing an intra-abdominal surgery through the access system secured within the stomach wall.
• FIG. 36 is a broken side elevation of a second embodiment of an access system according to the invention.
• FIG. 36A is a broken side elevation of the access system ofFIG. 36, showing bending of the port into a pre-shape.
• FIG. 37 is an enlarged schematic view of the preshaped port shown in non-actuated and actuated (broken line) configurations.
• FIGS. 38 through 47 illustrate a method of securing the access system ofFIG. 36 within the stomach wall to access the peritoneal cavity.
• FIG. 48 is broken side elevation view of a third embodiment of an access system according to the invention.
• FIG. 48A is a cross-section acrossline48A-48A inFIG. 48.
• FIG. 49 is broken side elevation view of a fourth embodiment of an access system according to the invention.
• FIG. 50 is broken side elevation view of a fifth embodiment of an access system according to the invention.
• FIG. 51 is a broken perspective view of a sixth embodiment of an access system according to the invention.
• FIG. 52 is a enlarged broken perspective view of sixth embodiment of the access system coupled to the stomach wall to access the peritoneal cavity.
• FIG. 53 illustrates the access system being used to deploy hollow needles into the stomach wall.
• FIG. 54 illustrates a T-shaped fasteners in a collapsed configuration being forced through a needle into the opposite side of the stomach wall.
• FIG. 55 illustrates the access system being used to deploy fasteners through the hollow needle and the stomach wall.
• FIG. 56 illustrates the T-shaped fasteners deployed within the stomach wall and the hollow needles retracted within the access system.
• FIG. 57 illustrates the access system being used to cinch the fasteners together about a hole in the stomach wall to provide closure of the hole.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Turning now toFIGS. 1 through 3, a natural orifice translucent endoscopic surgery (NOTES)access system10 is provided for enabling and facilitating access to the peritoneal cavity through an anatomical wall, the anatomical wall separating the peritoneal cavity and a natural orifice accessible body cavity. While the invention is primarily described with respect to a through-the-esophagus transgastric approach for such surgery, where the body cavity is the stomach and the anatomical wall is the stomach wall, the systems and methods described herein are equally applicable to procedures performed transanally, wherein the body cavity is the colon and the anatomic wall is the colon wall, and transvaginally wherein the body cavity is the vagina and the anatomic wall is the vaginal wall.
• Theaccess system10 includes anovertube12 and a discretepreshaped port14 insertable therethrough. Theovertube12 includes a firsttubular member16, acircular lumen18 defined through the center of the first tubular member, and ahandle20 provided at the proximal end of the firsttubular member16. Theovertube12 has length in the range of 10 to 50 inches with a preferred range of 25 to 35 inches; a lumen diameter in the range of about 8 to 18 mm; and an outer diameter in the range of about 10 to 25 mm. Theovertube12 includes a gastric wall securing system that secures a distal portion of the overtube within a hole in the gastric wall. In a preferred embodiment, the gastric wall securing system includes proximal and distalinflatable cuffs22,24 provided on an external portion of thedistal end25 of the firsttubular member16. Thecuffs22,24 are in communication withrespective injection ports26,28 at thehandle20 throughair channels30,32 to permit individual pressurization with a fluid, e.g., air, to fixate the cuffs on opposite sides of the gastric wall. This secures theovertube12 to the gastric wall and provides a seal between the intragastric space and the peritoneal cavity, as described in more detail below.
• The firsttubular member16 is sufficiently longitudinally flexible to assume the contour required for insertion through a patient's esophagus and into the stomach. Notwithstanding the longitudinally flexibility, the first tubular member preferably has sufficient lateral strength and stability to maintain the cross-sectional shape of the lumen along its length. Such strength may be provided by a metal or a polymeric coil or braid reinforcement along its length.
• Referring toFIGS. 1,2 and4, thepreshaped port14 has a proximalinstrument receiving end40 and a secondtubular member42. Theport14 has length in the range of 20 to 60 inches, with a preferred range of 30 to 45 inches; a lumen diameter in the range of about 5 to 16 mm; and an outer diameter in the range of about 8 to 18 mm. The port body length is sufficient to extend from a patient's mouth to a patient's stomach or from any other natural orifice to a body cavity accessible therefrom. The receivingend40 is sized to prevent passage through thelumen18 of theovertube12 and functions as a stop against thehandle20 of theovertube12. The secondtubular member42 has adistal portion44 preshaped so that it is biased to bend in a predetermined direction and preferably by a predetermined amount; i.e., the preshape is a portion biased to curve at a distal portion of the second tubular member42 (as shown in broken lines inFIG. 4). The secondtubular member42 can be molded or extruded, and heat treated, provided with a metal or polymeric shape providing/effecting element, or otherwise formed with such biased shape. The preshape bias is readily overcome such that when thedistal portion44 is inserted through thelumen18 of the firsttubular member16 of theovertube12, the preshapeddistal portion44 straightens or otherwise conforms to the longitudinal shape of the firsttubular member16 of the overtube. However, once the preshapeddistal portion44 extends from the distal end of theovertube16, the preshapeddistal portion44 of theport14 conforms to its bias, thereby able to direct an endoscope or other instrument(s) extending within and through itslumen46 toward a designated anatomical structure. Theport14 can be also rotated within theovertube12 to further direct or redirect the endoscope and/or instrument(s) toward anatomical structures. Theport14 can be withdrawn together with or separately from theovertube12 as the access system is removed from the patient.
• Turning now toFIG. 5, a method of intra-abdominal surgery on a patient50 using theaccess system10 is now described. Theaccess system10 facilitates methods of accessingtissue54 in theperitoneal cavity56 through thestomach wall52. According to a first method, described below, an initial piercing is made from the exterior of thestomach58 to the interior of the stomach. According to a second method, also described below, an initial piercing is made from the interior of the stomach to the exterior of the stomach. Both methods include the dilatation of the stomach piercing using a balloon catheter to create a hole instomach wall52 of sufficient dimension to receive the distal end of the access system. The distal end of the access system is then anchored within the hole withcuffs22,24 (FIG. 1) at thedistal end25 of the access system. Once a passageway is provided through theaccess system10 to theperitoneal cavity56, the access system can be used to orient anendoscope60 toward atissue54 in theperitoneal cavity56, e.g., using the preshaped port, as described in more detail below. Then, by way of example, the tissue, such as the gallbladder, can be separated from other tissue, such as the liver, using tunneling and dissection balloons or other techniques.
• More particularly, turning now toFIGS. 5 and 6, with the port14 (FIGS. 1 and 4) removed from theaccess system10, asteerable endoscope60 is inserted through the lumen of theovertube12. Theovertube12 andendoscope60 are inserted together into thestomach58 of thepatient50, with theendoscope60 steering the assembly through the natural orifices, esophageal sphincter, and into the stomach. Thedistal end25 of theovertube12 with the endoscope is maneuvered adjacent thestomach wall52.
• Referring toFIGS. 7 and 8, in accord with one embodiment of the method, a piercing catheter (or other preferably tubular piercing/cutting instrument)70 is inserted into the patient'speritoneal cavity56 from outside thestomach wall52. The piercingcatheter70 can be provided into theperitoneal cavity56 by insertion through the abdominal wall, by introduction up the colon via an endoscope and then piercing through the colon into theperitoneal cavity56, or by introduction through the vagina. The piercingcatheter70 is pierced through thestomach wall52 and introduced into thestomach58.
• Referring toFIG. 8, asnare device72 is introduced through the piercingcatheter70 and into thestomach58. Aballoon catheter74 fixed along aguidewire76 is introduced into thestomach58 through theendoscope60. Theguidewire76 is preferably integrated with theballoon catheter74.
• Referring toFIGS. 9 and 10, thesnare device72 and cuttinginstrument70 are operated to grasp theguidewire76 and/orballoon catheter74, and pull theballoon catheter74 through the piercing78 in thestomach wall52. Once theballoon80 on theballoon catheter74 is positioned within the piercing78, thesnare device72 releases theguidewire76 and/orballoon catheter74 so as to decouple thesnare device72 from theballoon catheter74, as shown inFIG. 11.
• Referring toFIGS. 12 through 14, in accord with an alternate embodiment of positioning a balloon catheter within a piercing in the stomach wall, once thedistal end25 of the overtube andendoscope60 are positioned within thestomach58 adjacent thestomach wall52, a cutting instrument (not shown) is advanced through the endoscope (or a port provided within the overtube) to define a piercing78 in thestomach wall52 from the interior of the stomach. Theguidewire76 andballoon catheter74 are then advanced through the piercing to position theballoon80 within the piercing78.
• Then, referring toFIGS. 15 through 17, regardless of the method used to position theballoon80 within the piercing78, theballoon80 is expanded upon activation from outside the patient by pressurizing a fluid through theballoon catheter74. Theballoon80 can be located partially inside thedistal end25 of the overtube (as shown) or completely external the distal end of the overtube. As theballoon80 is expanded, the piercing78 (FIG. 14) is dilated to create ahole82 of sufficient size to receive thedistal end25 of the overtube. Theproximal cuff22 is expanded, and thedistal end25 of the overtube is inserted through thehole82 up tocuff22. Then thedistal cuff24 is expanded to secure thedistal end25 of the overtube to thestomach wall52 between the proximal anddistal cuffs22,24 and to thereby provide a seal between the intragastric space (at the stomach58) and theperitoneal cavity56.
• Referring toFIG. 18, theballoon80 is deflated, and theballoon catheter74 and guide76 are withdrawn from theovertube12. The endoscope60 (FIG. 12) can then be used within theperitoneal cavity56 along with other instruments advanced within the overtube.
• However, referring toFIGS. 19 through 21, in accord with a preferred aspect of the method, the endoscope is also withdrawn from theovertube12 and thepreshaped port14 is advanced through theovertube12 into theperitoneal cavity56. As thepreshaped port14 is advanced to an extent allowing the preshapeddistal portion44 to bend in accord with it preshaped bias, theport14 will provide a predefined (although rotationally orientable) pathway for re-introduction of theendoscope60 into theperitoneal cavity56. Theendoscope60 is then reintroduced through theport14.
• It is appreciated that various surgical procedures can be performed once the endoscope and other instruments are located in the peritoneal cavity. For example, theaccess system10 can be used to perform a cholecystectomy, or dissection of the gallbladder from the liver. In accord with a preferred method of performing a cholecystectomy, tunneling and dissecting instruments, as disclosed in previously incorporated U.S. Ser. No. 11/,775,996, are preferably used in conjunction with theaccess system10. While detailed descriptions of suitable instruments are described in the aforementioned application, it is helpful to generally describe the tunneling and dissection instruments here for a point of reference.
• Referring toFIG. 22, atunneling instrument150 includes acatheter152 having proximal and distal ends and aballoon member154 located adjacent the distal end. Positioned on the exterior ofcatheter152 adjacent the distal end is a series ofmarkers156. These markers may be visible under direct visualization of the endoscope and may be additionally visible under fluoroscopy. Adjacent the proximal end ofcatheter152 is anauxiliary device port158. The proximal end ofcatheter152 is attached toconnector tubing160 to accessinflation port162. Valve assembly164 provides a seal for fluid introduced intoinflation port162. Tether slide166 is slidably positioned onhandle body168. Handlebody168 includesdistance markers170 to gauge the movement of tether slide166. A cross sectioned view of the distal end oftunneling instrument150 is shown in more detail inFIG. 23.Catheter152 has a distal end172 and afirst lumen174. Located withinfirst lumen174 isballoon member154. Theballoon member154 is preferably non-compliant of the type generally known in the art, however,balloon member154 may be of the compliant or semi-compliant type. Theballoon member154 may be formed from biocompatible polymer types such as olefins, elastomers, thermoplastic elastomers, vinyls, polyamides, polyimides, polyesters, fluropolymers, copolymers and blends of any of the aforementioned. The proximal end176 ofballoon member154 is attached to the distal end172 ofcatheter152. Thedistal end178 ofballoon member154 is positioned within thefirst lumen174 in an everted configuration. Atether member180 is connected to thedistal end178 ofballoon member154.Tether member180 is flexible and preferably takes the form of a filament, as shown, howevertether member180 may take the form of a tube. The proximal end oftether member180 is connected to tether slide166 through valve assembly164.Tether member180 aids in initially positioningballoon member154 within thefirst lumen174 ofcatheter152.Catheter152 has asecond lumen182 that extends fromauxiliary device port158 todistal end184.Distal end184 is located proximal to distal end172 ofcatheter152. Slidably disposed withinsecond lumen182 is aneedle knife186 that has a knife tip188.Needle knife186 is preferably of the endoscopic electrosurgical type however any form of incision device that may be operated to form an incision in tissue such as mechanical cutters, water jets or lasers may be suitable.
• Further, referring toFIG. 24, a dissectinginstrument270 is provided and includes adissection catheter272 having adistal end274 and adissection balloon276 having a large diameter expandeddissection balloon configuration276athat operates to separates adjacent tissues. Thedissection balloon276 can be non-compliant of the type generally known in the art ordissection balloon276 may be of the compliant or semi-compliant type. Thedissection balloon276 may be formed from biocompatible polymer types such as olefins, elastomers, thermoplastic elastomers, vinyls, polyamides, polyimides, polyesters, fluropolymers, copolymers and blends of any of the aforementioned. Thedissection catheter272 hasinsertion markers278 positioned along its shaft. The proximal end ofdissection catheter272 includes both aninflation port280 that is in fluid communication withdissection balloon276, and avalve assembly282.
• In an embodiment seen fromFIGS. 24 and 25, the dissectinginstrument270 is provided with tunneling capability to operate as a tunneling dissecting instrument. Atunneling catheter284 is slidably disposed throughvalve assembly282 and extends within a lumen of thedissection catheter272. The tunneling catheterdistal end286 may extend beyond the dissection catheterdistal end274.Tunneling catheter284 includes aninflation port288 andvalve assembly290. A tether slide member292 is slidably disposed onhandle body294 withdistance markers296.FIG. 26, illustrates a detailed cross section of the distal portion of thetunneling dissecting instrument270. The distal end298 andproximal end300 ofdissection balloon276 are connected to the exterior ofdissection catheter272. An inflation device connects toinflation port280 to inflatedissection balloon276.Tunneling catheter284 is slidably disposed within thelumen306 ofdissection catheter272. Positioned within the lumen308 oftunneling catheter284 there is an evertedexpandable tunneling balloon310. Thetunneling balloon310 is preferably non-compliant of the type generally known in the art, however, tunnelingballoon310 may be of the compliant or semi-compliant type. Thetunneling balloon310 may be formed from biocompatible polymer types such as olefins, elastomers, thermoplastic elastomers, vinyls, polyamides, polyimides, polyesters, fluropolymers, copolymers and blends of any of the aforementioned. The distal end oftunneling balloon310 is connected to a tether member312 which has a proximal end that is connected to tether slide292.
• The operation of thetunneling dissecting instrument270 to form a tunnel and large dissected area is similar to the operation of the separate instruments. Thetunneling catheter284 is pressurized with fluid to linearly expandtunneling balloon310. The temperature of thetunneling balloon310 may be modified, e.g., cooled, via the fluid introduced therein to reduce bleeding. Once a tunnel has been formed,tunneling balloon310 may be deflated anddissection catheter272 may be advanced through the opening into the tunnel. Themarkers278 may be used to determine the depth in which thedissection catheter272 has been advanced into the tunnel. Once thedissection catheter272 has been properly positioned within the tunnel it may be operated. By applying pressurized fluid toinflation port280,dissection balloon276 is dilated to an expandeddissection balloon276aconfiguration. During the expansion, a dissected area is created. The temperature of thedissection balloon276 may be modified, e.g., cooled, via the fluid used therein to reduce bleeding.
• Other embodiments of tunneling and dissecting instruments disclosed in U.S. Ser. No. 11/775,996 can also be used. Now with reference to such tunneling and dissecting instruments, an exemplar embodiment of a cholecystectomy procedure according to the invention is now described. First, access is provided to the peritoneal cavity using the access system, as described above.
• Then, referring toFIG. 26, a preferablymultilumen device88 is inserted through the shapedport14 to a location such that the axis of a lumen of the device is directed between thegallbladder90 and theliver92.Multilumen device88 preferably integrates an endoscope or includes a lumen for receiving an endoscope. Aneedle knife186 is advanced through the lumen of thedevice88 to define a small hole between thegallbladder90 andliver92. Atunneling instrument150 is advanced into the hole in the tissue preferably through another lumen in the multilumen device88 (FIG. 27). Theneedle knife186 andtunneling instrument150 may be integrated. Thetunneling instrument150 is operated to advance anelongate balloon member154 to define an elongate tunnel in the tissue between the gallbladder and the liver (FIG. 28). If thetunneling instrument150 is a separate instrument from the dissecting instrument, it is removed from the tunnel so that the dissectinginstrument270 can then be (and is) advanced into through another lumen of the multilumen device and into the tunnel (FIG. 29). The dissectinginstrument270 is then operated to expand thedissection balloon276 within the tunnel to separate the tissues surrounding the balloon (FIG. 30).
• Referring toFIGS. 31 through 35, the process is then repeated with theneedle knife186, tunnelinginstrument150, and dissectinginstrument270 in different locations to substantially fully separate thegallbladder90 from theliver92. If necessary, an electrocautery knife, may be used to separate any remaining connection tissue. Themultilumen device88 permits multiple instrument use without requiring the physician to repeatedly change out the instruments. Of course, two or more of the instruments may be integrated into a single assembly. Further, the use of balloons to dissect the gallbladder (rather than electrocautery) is substantially safer and does not pose a threat to surrounding viscera.
• The gallbladder may be completely resected by utilizing additional surgical instruments such ligators, electrocautery knives, and scissors for sealing off and separation of the cystic duct. The resected gallbladder may be placed in an endoscopically delivered specimen retrieval bag using tissue graspers. Once the gallbladder is secured in the retrieval bag, the bag may be withdrawn through the port lumen with the endoscope. Alternatively, if the specimen is too large for removal through the port, the specimen may be positioned adjacent the port distal end and withdrawn along with the port from the body.
• Anyinstruments150,270,184 remaining within the patient, themultilumen device88, and thepre-shaped port14 are removed from theovertube12. Then thedistal cuff24 is deflated, permitting retraction of the overtube into the stomach. Theproximal cuff22 is also deflated. Appropriate instrumentation or means are also used to close the hole in the stomach wall. For example, clips, staples, sutures, other closures, ligatures and ligating bands, etc., can be used. Also, closure means integrated with the access system, as discussed below, can be integrated into any of the access systems described herein. Further, the instruments described can be used to perform dissections of other organs adhered to the abdominal wall or dissections of other tissues from organs. For example, the appendix can be removed by a similar procedure.
• Turning now toFIGS. 36 through 37, another embodiment of anaccess system410 according to the invention is shown. Theaccess system410 includes anovertube412, apreshaped port414 coupled at a distal end of the overtube (distal of cuff424), and ahandle420 at a proximal end of theovertube412. Theovertube412 includes a gastric wall securing system, preferably as described with respect to accesssystem10, i.e. withcuffs422,424 expandable viainjection ports426,428 at thehandle420.
• As shown inFIGS. 36 and 37, thepreshaped port414 is configured from a preferably unitary tubular element and most preferably an extruded polymeric tube. Breaks, cuts orsuperficial recesses440 are provided along the tube to provide flexibility. Asilicone lining442 covers both the outer surface of the tube to prevent tissue from catching in the breaks. Asilicone lining444 may also be provided to the inner surface of the tube to provide a smooth lumen for endoscope passage. One ormore control elements446, e.g., wires or cables, pass through respective conduits within the tube wall. Eachcontrol element446 has adistal end448 coupled at adistal portion450 of thetube414 and a proximal end that is coupled to an actuator, such asknob452 on thehandle420. When theactuator452 is operated, the associatedcontrol element446 is tensioned to cause thetube414 to bend, e.g., up to 180°, along the breaks and to assume a preshape configuration as shown in broken lines inFIG. 36A. Thepreshaped port414 can be maintained in such preshaped configuration to orient an endoscope inserted through the overtube toward a target tissue. If more than one control element is provided within the access system for actuation of the preshaped port (e.g., three control elements), more complex directional control of thepreshaped port414 can be provided. It is appreciated that additional actuators can be provided for each such control element. If necessary to reconfigure the access port or at the conclusion of the procedure, thehandle420 can be operated to release the tension on the control element(s)446 and straighten thepreshaped port414 to aid in reconfiguring or withdrawing theaccess system410 from the patient.
• It is appreciated that because thepreshaped port414 is operator manipulatable while within the patient's body, it has steerability that is not provided with access system1O. Thus, while the use ofaccess system410 in a surgical procedure is generally similar toaccess system10, the integration ofpreshaped port414 withovertube412 permits some differences.
• As such, turning now toFIGS. 38 through 47, variations in a surgical procedure withaccess system410 relative to the procedure previously described withaccess system10 are now described. Theaccess system410 is introduced into the stomach and advanced adjacent the stomach wall (FIG. 38). An endoscope (not shown) is preferably used within theaccess system410 for visualization, but the endoscope for this portion of the procedure is not required to be steerable, as thepreshaped port414 can be actuated to steer the assembly. In accord with an embodiment of the method, a piercingcatheter70 is inserted into the patient'speritoneal cavity56 from outside thestomach wall52, pierced through thestomach wall52, and introduced into the stomach58 (FIGS. 39 and 40). Asnare device72 is introduced through the piercingcatheter70 and into thestomach58. Aballoon catheter74 fixed along aguidewire76 is introduced into thestomach58 through the preshaped port414 (FIG. 41).
• Thesnare device72 and cuttinginstrument70 are operated to grasp theguidewire76 and/orballoon catheter74, and pull theballoon catheter74 through the piercing78 in the stomach wall52 (FIGS. 41 and 42). Once theballoon80 on theballoon catheter74 is positioned within the piercing78, thesnare device72 releases theguidewire76 and/orballoon catheter74 so as to decouple thesnare device72 from theballoon catheter74, as shown inFIG. 43.
• Alternatively, the cutting instrument can be advanced through the access system and preshaped port thereof to define a piercing78 in thestomach wall52 from the interior of the stomach. Theguidewire76 andballoon catheter74 are then advanced through the piercing to position theballoon80 within the piercing78.
• Then, once theballoon80 is situated within the piercing, the balloon is expanded upon activation from outside the patient by pressurizing a fluid through theballoon catheter74. Theballoon80 can be located partially inside thedistal end450 of thepreshaped port414 or completely external the distal end of the port. As theballoon80 is expanded, the piercing is dilated to create ahole82 of sufficient size to receive thepreshaped port414 of the access system410 (FIG. 44). Theport414 is advanced through thehole82 and then thedistal end425 of theovertube412 is advanced up to theproximal cuff422, which is expanded (FIG. 45). Then thedistal cuff424 is expanded to secure the access system to thestomach wall52 at thedistal end425 of theovertube412 to the between the proximal anddistal cuffs422,424 with thepreshaped port414 extending within the peritoneal cavity56 (FIG. 46).
• Theballoon80 is deflated, and theballoon catheter74 and guide76 are withdrawn from theaccess system410. Thepreshaped port414 is then actuated from the handle420 (FIGS. 36 and 38) to cause the port to assume a curved or bent configuration. Anendoscope60 and other instruments are then advanced through theport414 and directed to pertinent tissue, as previously described, for performing and concluding a surgical procedure on tissue within the peritoneal cavity (FIG. 47).
• Referring now toFIGS. 48 and 48A, another embodiment of an access system710 is shown. The system includes an overtube712, as described above with respect toovertube12, and a port714. Port714 includes atubular member742 having a proximal end definingmultiple lumen743a,743b.The distal end of port714 divides at a Y to include a plurality of pre-shaped tubulardistal portions744a,744b,each similar to pre-shapeddistal portion44. Eachdistal portion744a,744bis preferably associated with one oflumen743a,743b.Each of the pre-shapeddistal portions744a,744bcan be provided with a different shape to direct instruments positioned therethrough toward anatomical structure.
• Turning now toFIG. 49, another embodiment of anaccess system810 is shown. The system includes anovertube812, as described above with respect toovertube12, and a plurality ofports814a,814bpositionable therethrough. Eachport814a,814bis generally similar toport14, through smaller in diameter to permit the multiple ports to be received within theovertube812 at once.
• Referring now toFIG. 50, another embodiment of an access system910 is shown. The system includes anovertube812 with a plurality ofpreshaped port814a,814bcoupled at a distal end of the overtube, and ahandle820 at a proximal end of theovertube812. The arrangement ofsystem810 is similar tosystem410, with multiple ports at the distal end of the overtube. The handle includes two actuators852a,852b,to apply and release tension on control elements extending from the handle to the distal end of the respective ports to control shaping of theports814a,814binto respective predetermined shapes.
• Turning now toFIGS. 51 and 52, another embodiment of anaccess system510 according to the invention is shown. The access system includes anovertube512 and aproximal handle520. Theovertube512 is provided with a gastric wall securing system preferably as described above, i.e., with expandable proximal anddistal cuffs522,524 adjacent itsdistal end525 and the requisite structural and functional elements to effect such expansion and contraction. Thedistal tip525a is tapered to facilitate driving insertion through the anatomical passageway and through the hole created in the stomach wall, as previously described above according to the method. In addition, theovertube512 includes acoil reinforcement527 for lateral wall support. Theovertube512 may be used with or integrated with a preshaped port, as described above. According to aspects ofaccess system510, the access system is provided with a system (means) for insufflating/deflating the peritoneal space separately from the gastric space, and a closure system (means) integrated into the access system to close the hole made in the intragastric wall in which the access system is secured to seal the hole after the access system has been removed from the hole. Either of such systems (means) may be individually provided in any access system in accord with the invention.
• Referring toFIGS. 51 and 52, the system to control insufflation/deflation includes a seal and/or valve, collectively560 and first andsecond ports562,564 extending at least partially through the overtube. The seal/valve560 is preferably a self-sealing valve560 within thelumen518 of the overtube512 (e.g., at the handle). Thefirst port562 is a pressure controlled port extending from thehandle520 to anexit location566 intermediate thehandle520 and theproximal cuff522. Thesecond port564 is a pressure controlled port extending from thehandle520 to anexit location568 at or distal thedistal cuff524. Thehandle520 is also provided with apressure control system570 to inject or evacuate air through the respective first andsecond ports562,564. For example,control system570 may include buttons572a-dto activate injection or evacuation of air through each of the first andsecond ports562,564 (four buttons572a-d). Thepressure control system570 preferably also includesmonitoring system574 to monitor the pressure in at least one of, and preferably both of, the stomach and the peritoneal cavity, and to provide feedback of such pressure(s) to the access system operator.
• In use, once the access system has been secured to the stomach wall to separate the intragastric space from the peritoneal space, the pressures in the peritoneal space and stomach can be separately controlled. With the access system so secured, thefirst port exit566 lies within the stomach and thesecond port exit568 is located within the peritoneal cavity. In addition, the esophageal sphincter forms a relatively air tight seal about the exterior of theovertube512. Air can then be evacuated fromfirst port562, to reduce air pressure within the stomach, while air can be injected to or maintained within the peritoneal cavity to increase or maintain peritoneal pressure. The result will be that the stomach will collapse to increase visibility at the surgical site. Later, peritoneal air pressure can be decreased if desired or the stomach air pressure can be increased as desired.
• In addition, theaccess system510 includes a closure system that facilitates rapid closure of thehole82 in thestomach wall52 after removal of the overtube from the hole. (See, e.g.,FIG. 17.) According to an exemplar embodiment, the closure system generally includes a needle deployment and retraction system, a tissue fastener deployment system able to deploy fasteners through needles deployed in tissue, and a cinching mechanism adapted to cinch the proximal ends of multiple tissue fasteners together to close the hole in the tissue, as described hereinafter. The various systems are preferably actuatable from discrete or integrated actuators, e.g., levers580,582,584 on thehandle520, or instruments coupled to the handle or inserted throughperipheral lumen576,578 exterior to thecentral lumen518 of theovertube512. The actuators operate control members to operate effectors to advance, retract, deploy and cinch, as required. The actuators are coupled to control members required for such operations can be those described in U.S. Pat. No. 6,824,548, U.S. Pub. No. 20040249395, U.S. Pub. No. 20050261708, U.S. Pub. No. 20060004409 and/or U.S. Pub. No. US2006/0004410 which are hereby incorporated by reference herein in their entireties. Such patent and publications describe flexible endoscopic instruments adapted to provide significant pushing force at their distal ends, and the mechanisms therein can be incorporated into the access system to advance (and retract) one or more needles and fasteners in the manner now described. In general, the actuators (e.g., levers) are preferably coupled to the effectors (e.g. needle, push rod) in a simple mechanical arrangement such that depression of a particular lever causes the axial movement of the respective effector. For instance a first actuator coupled to a needle may be actuated to extend the needle from a lumen of the overtube to thereby pierce tissue. A second actuator coupled to a pushrod, which is coaxially positioned within the lumen of the needle, may be actuated to advance the push rod axially within the needle lumen.
• More particularly, referring toFIGS. 53 and 54, theaccess system510 includes at least one extendable hollow needle, and preferably a plurality of extendablehollow needles590,592 from itsdistal end525. Theneedles590,592 are initially retracted within thedistal end525 of theaccess system510. Upon actuation of an associatedactuator580, theneedles590,592 are extended from thedistal end525. As shown, theneedles590,592 can then be pierced through thestomach wall52. This step is done prior to any hole formation in thestomach wall52 of sufficient size to permit passage of thedistal end525 ofovertube512. It is appreciated that a piercing instrument and grasper may optionally be inserted from the peritoneal cavity into the stomach may be used in conjunction with the access system to stabilize thedistal end525 during needle insertion.
• Referring toFIGS. 54 and 55, after theneedles590,592 have been inserted into thestomach wall52 and while such needles are within the stomach wall, theappropriate actuator582 is manipulated to axially advance apush rod583 positioned within the needle lumen to deployfasteners594,596 through theneedles590,592 so as to have a portion which extends through to the other side of the stomach wall (within the peritoneal cavity56). According to a preferred aspect of the invention, thefasteners594 are T-shaped tags (in a deployed configuration) having ashaft598 with ahead600 transverse to the shaft at one end, and aneye602 or other suture engaging structure at the other end.Suture material604 is coupled to theeye602. The tag594 (as shown inFIG. 54) is collapsible into a pre-deployed configuration within each needle, with thehead600 substantially parallel to theshaft598 and preferably retained within the needles (although the distal end of the head may extend from the needle). Upon deployment, thetag594 is forced out of the needle,head600 first, through the stomach wall (and onto the peritoneal side of the stomach wall), while the shaft extends within the tissue and thesuture material604 remains coupled to the access system. Thetag594 may assume a T-shape after deployment by an inherent bias between thehead600 andshaft598, or by retraction of theshaft598 relative to thehead600. T-shapedtags594 of this design are described in detail in previously incorporated U.S. Ser. No. 12/030,244. Other tag configurations or fasteners could also be used. For example one alternate tag configuration may be a modification oftag594 in whichshaft598 is formed entirely of suture material and coupled directly to a mid portion ofhead600.Multiple fasteners594,596 may be deployed at once throughmultiple needles590,592 provided to theaccess system510. Alternatively, where the access system includes a single needle, individual fasteners may be deployed sequentially using a single needle with a store of fasteners, with the access system rotated between deployments for polar displacement of the fasteners about a subsequent hole for thedistal end525. After the fasteners have been deployed, a procedure through the stomach wall is performed as described above. Referring toFIG. 57, at the conclusion of the procedure, once the access system is withdrawn from a hole in the stomach wall, thethird actuator584 on thehandle520 is operated to pull on thesuture material604 and cinch thefasteners594,596 together about thehole82 to close the hole. The T-shaped tag provides a small profile aiding deployment and provides strong resistance to pull-out during cinching. Thesuture material604 of the fasteners is then clipped, knotted or otherwise secured to maintain closure of the hole. Preferably a cinch delivery assembly is used to grasp the suture connecting the T-tags and pull the suture lines within the cinch while drawing the T-tags and associated tissue into close apposition thereby closing a hole. The cinch preferably contains a one way mechanism such that the suture lines may be drawn taught and not allow them to loosen. Various cinch designs such as those described in U.S. Pat. App. Pub. Nos. 20040249395, 20050261708 and 20060004409 are suitable for performing the closure operation.
• There have been described and illustrated herein several embodiments of an access system and methods of performing intra-abdominal surgery. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while a particular gastric wall securing system has been disclosed, it will be appreciated that other gastric wall securing system can be used as well, including mechanically expandable systems. In addition, while particular types of instruments for the cutting and piercing tissue, and drawing a balloon from the stomach cavity to within the stomach wall have been disclosed, it will be understood that other suitable instruments can be used as well. Also, while a preferred system of tunneling and dissection balloons has been disclosed for separation of the tissues within the abdomen, it will be recognized that other tissue tunneling and/or dissection instruments can be used instead. Furthermore, while an exemplar mechanism for operating the closure system has been disclosed, it is understood that other suitable mechanism and handles for operation thereof can be similarly used. Moreover, while a T-shaped tag is preferred for effecting closure of a hole through which the access system is inserted, it is appreciated that other suitable fasteners can be used as well. In addition, while the access system has been described with respect to providing access from the intragastric space to the peritoneal cavity through the stomach, it can likewise be used through the anus and colon. Moreover, it can also be used as an access system into the peritoneal space through the vagina. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims (58)

1. An access system for accessing a patient's peritoneal cavity from a body cavity accessible through a natural orifice, the peritoneal cavity and body cavity separated by an anatomical wall, said access system for use with an endoscope, said access system comprising:

a) an overtube having a proximal portion and a distal portion with a distal end, and a length therebetween sufficient to extend from a patient's mouth to a patient's stomach, said overtube defining a lumen for receiving the endoscope therethrough;

b) an anatomical wall securing system at said distal portion of said overtube that temporarily secures said distal portion of said overtube within a hole in the anatomical wall;

c) a handle at said proximal portion of said overtube for operating said securing system; and

d) a tubular port extending from said distal end of said overtube and having a lumen sized to receive an endoscope therethrough, said tubular port having a shape portion with a determinable shape, said shape portion adapted to be in a plurality of shaped configurations including a first shaped configuration when said shape portion is within the body cavity and a second shaped configuration when said shape portion is within the peritoneal cavity.

2. An access system according toclaim 1, further comprising:

a system to at least one of insufflate and desufflate the body cavity and peritoneal cavity separately from the other.

3. An access system according toclaim 2, further comprising:

a closure system at said distal end of said overtube for deploying fasteners into the anatomical wall and to effect closure of the hole in the anatomical wall by acting on the fasteners.

4. An access system according toclaim 1, further comprising:

a closure system at said distal end of said overtube for deploying fasteners into the anatomical wall and to effect closure of the hole in the anatomical wall by acting on the fasteners.

5. An access system according toclaim 1, wherein:

said anatomical wall securing system includes proximal and distal inflatable cuffs provided on said overtube.

6. An access system according toclaim 5, wherein:

said proximal and distal cuffs are coupled to discrete injection ports extending from said handle and through said overtube.

7. An access system according toclaim 1, wherein:

said first flexible tubular member includes a coil to provide lateral reinforcement.

8. An access system according toclaim 1, wherein:

said tubular port is separable from said overtube and can be withdrawn from and inserted into said overtube while said anatomical wall securing system is coupled to the anatomical wall of the patient.

9. An access system according toclaim 8, wherein:

said tubular port includes a portion formed with a biased shape to aid in directing the endoscope.

10. An access system according toclaim 9, wherein:

said tubular port is rotatable within the overtube.

11. An access system according toclaim 8, wherein:

said tubular port includes a proximal stop larger than said lumen of said overtube.

12. An access system according toclaim 1, wherein:

said tubular port is fixed to said distal end of said overtube.

13. An access system according toclaim 12, wherein:

said tubular port includes a portion that defines recesses or cut-outs along its length.

14. An access system according to13, further comprising:

at least one control element extending from said handle to said shape portion, wherein when said control element is tensioned by actuation from at said handle, said shape portion moves from said first shape configuration to said second shape configuration.

15. An access system according toclaim 14, wherein:

said at least one control element includes a plurality of control elements.

16. An access system according toclaim 1, wherein:

said tubular port includes a second shape portion with a determinable shape, said second shape portion adapted to be in a plurality of shaped configurations including a first shaped configuration when said second shape portion is within the body cavity and a second shaped configuration when said second shape portion is within the peritoneal cavity.

17. An access system according toclaim 8, wherein:

said tubular port includes a second shape portion with a determinable shape, said second shape portion adapted to be in a plurality of shaped configurations including a first shaped configuration when said second shape portion is within the body cavity and a second shaped configuration when said second shape portion is within the peritoneal cavity.

18. An access system according toclaim 12, wherein:

said tubular port includes a second shape portion with a determinable shape, said second shape portion adapted to be in a plurality of shaped configurations including a first shaped configuration when said second shape portion is within the body cavity and a second shaped configuration when said second shape portion is within the peritoneal cavity.

19. An access system according toclaim 1, further comprising:

a second tubular port extending from said distal end of said overtube, said tubular port having a shape portion with a determinable shape, said shape portion adapted to be in a plurality of shaped configurations including a first shaped configuration when said shape portion is within the body cavity and a second shaped configuration when said shape portion is within the peritoneal cavity.

20. An access system for accessing a patient's peritoneal cavity through a from a body cavity through a natural orifice, the peritoneal cavity and natural orifice separated by an anatomical wall of the natural orifice, said access system for use with an endoscope, said access system comprising:

a) an overtube including a first flexible tubular member having a proximal portion and a distal portion with a distal end, and a length therebetween sufficient to extend from a patient's mouth to a patient's stomach, said tubular member defining a lumen for receiving the endoscope therethrough;

b) an anatomic wall securing system at said distal portion of said overtube that temporarily secures said distal portion of said overtube within a hole in the anatomic wall;

c) a handle at said proximal portion of said overtube for operating said securing system; and

d) an inflation system integrated into said handle and overtube, said inflation system to at least one of insufflate and desufflate the intragastric space and peritoneal cavity separately from the other, said inflation system including,

a first gas port extending from said handle to a location intermediate said handle and said anatomic wall securing system,

a second gas port extending from said handle to a location at or distal said anatomic wall securing system, and

a gas control at said handle to control injection or evacuation of a gas through the respective first and second gas ports.

21. An access system according toclaim 20, further comprising:

a seal for surrounding an endoscope in said lumen of said overtube.

22. An access system according toclaim 20, further comprising:

a self-sealing valve in said lumen of said overtube.

23. An access system according toclaim 20, further comprising:

a closure system at said distal end of said overtube for deploying fasteners into the anatomic wall and to effect closure of the hole in the anatomic wall by acting on the fasteners, said closure system actuated at said handle.

24. An access system for accessing a patient's peritoneal cavity through a natural orifice accessible body cavity, the peritoneal cavity and body cavity separated by an anatomic wall, said access system for use with an endoscope, said access system comprising:

a) an overtube including a first flexible tubular member having a proximal portion and a distal portion with a distal end, and a length therebetween sufficient to extend from a patient's mouth to a patient's stomach, said tubular member defining a lumen for receiving the endoscope therethrough;

b) an anatomic wall securing system at said distal portion of said overtube that temporarily secures said distal portion of said overtube within a hole in the anatomic wall;

c) a handle at said proximal portion of said overtube for operating said securing system; and

d) a closure system at said distal end of said overtube for deploying fasteners into the anatomic wall and to effect closure of the hole in the anatomic wall by acting on the fasteners.

25. An access system according toclaim 24, wherein:

said closure system includes,

i) a hollow needle deployment and retraction system adapted to insert at least one hollow needle into tissue and thereafter retract said at least one needle from the tissue,

ii) a tissue fastener deployment system able to deploy at least one tissue fastener through a needle deployed in the tissue, the fastener having a flexible element attached at a proximal end thereof,

the needle deployment and retraction system operable to retract a hollow needle from the tissue and over the fastener after or as the fastener has been deployed into the tissue, and

iii) a cinching mechanism adapted to cinch together the flexible elements of multiple fasteners deployed through needles into the tissue to close the hole in the tissue.

26. An access system according toclaim 25, wherein:

said handle includes first, second and third actuators, said first actuator to operate said deployment and retraction system, said second actuator to operate said fastener deployment system, and said third actuator to operate said cinching mechanism.

27. An access system according toclaim 25, wherein:

said access system is pre-loaded with a plurality of fasteners.

28. An access system according toclaim 27, wherein:

said fasteners each have a shaft with a head at a one end and said flexible element at an opposite end, said fastener assuming a loaded first configuration and a deployed second configuration, wherein

in said loaded first configuration, said head is substantially parallel to said shaft such that said fastener can be loaded into and pushed through said needle, and

in said deployed second configuration, said head is transverse to said shaft.

29. A method of intra-abdominal surgery, comprising:

a) inserting a distal end of a natural orifice translucent endoscopic surgery (NOTES) access system into a hole in an anatomic wall, the access system having an overtube with a distal end;

b) securing the access system to the anatomic wall at the hole;

c) inserting an endoscope through the overtube of the access system; and

d) using a port having a shaped portion at the distal end of the overtube to direct the endoscope along a determined trajectory, the endoscope extending through the port.

30. A method according toclaim 29, further comprising: before inserting the access system into the hole in the anatomic wall,

i) making a piercing through the anatomic wall,

ii) inserting a balloon into the piercing; and

iii) expanding the balloon to dilate the piercing and define the hole in the anatomic wall.

31. A method according toclaim 30, wherein:

the anatomic wall is the vaginal wall.

32. A method according toclaim 30, wherein:

the anatomic wall is a wall of intragastric system.

33. A method according toclaim 32, wherein:

the anatomic wall is the stomach wall.

34. A method according toclaim 33, wherein:

said making a piercing includes piercing the stomach wall from an exterior of the intragastric space to the interior of the intragastric space.

35. A method according toclaim 33, wherein:

said making a piercing includes piercing the gastric wall from an interior of the intragastric space to the exterior of the intragastric space.

36. A method according toclaim 29, further comprising:

inserting a tunneling instrument through the port to form a tunnel between first and second tissues.

37. A method according toclaim 36, further comprising:

inserting a dissecting instrument into tunnel and expanding the dissecting instrument to dissect the first and second tissues from each other.

38. A method according toclaim 37, wherein:

at least one of the tunneling instrument and the dissecting instrument includes a balloon which upon expansion tunnels and/or dissects.

39. A method according toclaim 37, wherein:

the dissecting instrument and tunneling instrument are integrated into a single instrument.

40. A method according toclaim 37, wherein:

the first tissue is the gallbladder and the second tissue is the liver.

41. A method according toclaim 29, further comprising:

inserting a multilumen device through said port; and

inserting instruments through a plurality of lumen of said multilumen device.

42. A method according toclaim 29, wherein:

the access system has a proximal handle, and the port is removable from said overtube at the handle.

43. A method according toclaim 29, wherein:

changing the shape of the shape portion of the port before the endoscope is within the port but while the port is within the patient.

44. A method according toclaim 29, further comprising:

changing the shape of the shape portion of the port while the endoscope is within the port.

45. A method of intra-abdominal surgery, comprising:

a) inserting a distal end of a natural orifice translucent endoscopic surgery (NOTES) access system into a hole in wall of a body cavity accessible through a natural orifice, the access system having an overtube with a distal end;

b) securing the access system to the wall at the hole;

c) inserting a tunneling instrument through the overtube to form a tunnel between first and second tissues within the peritoneal space; and

d) inserting a dissecting instrument through the overtube and into the tunnel and expanding the dissecting instrument to dissect the first and second tissues from each other, wherein at least one of the tunneling instrument and the dissecting instrument includes a balloon which upon expansion tunnels and/or dissects.

46. A method according toclaim 45, further comprising:

before inserting the access system into the hole,

i) making a piercing through the wall,

ii) inserting a balloon into the piercing, and

iii) expanding the balloon to dilate the piercing and define the hole in the wall.

47. A method according toclaim 45, wherein:

the anatomic wall is the vaginal wall.

48. A method according toclaim 45, wherein:

the anatomic wall is a wall of intragastric system.

49. A method according toclaim 48, wherein:

the anatomic wall is the stomach wall.

50. A method according toclaim 45, wherein:

both of said tunneling and dissecting instruments include expandable balloons.

51. A method according toclaim 45, wherein:

said first tissue is the gallbladder and the second tissue is the liver.

52. A method according toclaim 45, wherein:

the dissecting instrument and tunneling instrument are integrated into a single instrument.

53. A method according toclaim 46, wherein:

said making a piercing includes piercing the wall from an exterior of the body cavity to the interior of the body cavity.

54. A method according toclaim 46, wherein:

said making a piercing includes piercing the wall from an interior of the body cavity to the exterior of the body cavity.

55. A method according toclaim 45, further comprising:

using a port at the distal end of the overtube to direct the endoscope along a predetermined trajectory, the endoscope extending through the port.

56. A method of modifying the gas pressure between a body cavity accessible through a natural orifice and the peritoneal cavity of the human body, comprising:

a) securing a natural orifice translucent endoscopic surgery (NOTES) access system within a hole in the wall between the body cavity and the peritoneal cavity, the access system having

i) an overtube including a flexible tubular member having a proximal portion and a distal portion with a distal end, said tubular member defining a lumen for receiving the endoscope therethrough,

ii) an anatomic wall securing system at said distal portion of said overtube that temporarily secures said distal portion of said overtube within a hole in the wall,

iii) a handle at said proximal portion of said overtube for actuating said securing system; and

iv) an inflation system integrated into said handle and overtube to insufflate and deflate the body cavity separately from the peritoneal cavity, said inflation system including,

a first gas port extending from said handle to a location intermediate said handle and the wall securing system,

a second gas port extending from said handle to a location at or distal said anatomic wall securing system, and

a gas control at said handle to control injection or evacuation of a gas through the respective first and second gas ports; and

b) injecting or evacuating gas through said overtube to modify the gas pressure within the one of the body cavity and the peritoneal cavity.

57. A method of intra-abdominal surgery within the peritoneal cavity, comprising:

a) introducing a natural orifice translucent endoscopic surgery (NOTES) access system into a body cavity accessible through a natural orifice, the access system having a proximal end including a handle, and a distal end with a closure system;

b) deploying a plurality of hollow needles from the closure system into an anatomic wall separating the body cavity and the peritoneal cavity;

c) inserting a plurality of tissue fasteners through the needles, the fasteners each having a flexible element attached at a proximal end thereof;

d) retracting the needles from the anatomic wall after each fastener is inserted therethrough;

e) defining a hole in the anatomic wall between the inserted fasteners;

f) securing the access system within the hole in the anatomic wall;

g) performing a surgical procedure within the peritoneal cavity;

h) removing the access system from the hole in the anatomic wall; and

i) closing the hole in the anatomic wall by cinching together the flexible elements at the proximal ends of the fasteners.

58. A method according toclaim 57, wherein:

said surgical procedure includes separating the gallbladder from the liver.

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