Access Systems and Methods of Intra-Abdominal Surgery

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.

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 to  claim 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 to  claim 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 to  claim 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 to  claim 1 , wherein:
 said anatomical wall securing system includes proximal and distal inflatable cuffs provided on said overtube.   
     
     
         6 . An access system according to  claim 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 to  claim 1 , wherein:
 said first flexible tubular member includes a coil to provide lateral reinforcement.   
     
     
         8 . An access system according to  claim 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 to  claim 8 , wherein:
 said tubular port includes a portion formed with a biased shape to aid in directing the endoscope.   
     
     
         10 . An access system according to  claim 9 , wherein:
 said tubular port is rotatable within the overtube.   
     
     
         11 . An access system according to  claim 8 , wherein:
 said tubular port includes a proximal stop larger than said lumen of said overtube.   
     
     
         12 . An access system according to  claim 1 , wherein:
 said tubular port is fixed to said distal end of said overtube.   
     
     
         13 . An access system according to  claim 12 , wherein:
 said tubular port includes a portion that defines recesses or cut-outs along its length.   
     
     
         14 . An access system according to  13 , 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 to  claim 14 , wherein:
 said at least one control element includes a plurality of control elements.   
     
     
         16 . An access system according to  claim 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 to  claim 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 to  claim 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 to  claim 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 to  claim 20 , further comprising:
 a seal for surrounding an endoscope in said lumen of said overtube.   
     
     
         22 . An access system according to  claim 20 , further comprising:
 a self-sealing valve in said lumen of said overtube.   
     
     
         23 . An access system according to  claim 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 to  claim 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 to  claim 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 to  claim 25 , wherein:
 said access system is pre-loaded with a plurality of fasteners.   
     
     
         28 . An access system according to  claim 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 to  claim 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 to  claim 30 , wherein:
 the anatomic wall is the vaginal wall.   
     
     
         32 . A method according to  claim 30 , wherein:
 the anatomic wall is a wall of intragastric system.   
     
     
         33 . A method according to  claim 32 , wherein:
 the anatomic wall is the stomach wall.   
     
     
         34 . A method according to  claim 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 to  claim 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 to  claim 29 , further comprising:
 inserting a tunneling instrument through the port to form a tunnel between first and second tissues.   
     
     
         37 . A method according to  claim 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 to  claim 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 to  claim 37 , wherein:
 the dissecting instrument and tunneling instrument are integrated into a single instrument.   
     
     
         40 . A method according to  claim 37 , wherein:
 the first tissue is the gallbladder and the second tissue is the liver.   
     
     
         41 . A method according to  claim 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 to  claim 29 , wherein:
 the access system has a proximal handle, and the port is removable from said overtube at the handle.   
     
     
         43 . A method according to  claim 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 to  claim 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 to  claim 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 to  claim 45 , wherein:
 the anatomic wall is the vaginal wall.   
     
     
         48 . A method according to  claim 45 , wherein:
 the anatomic wall is a wall of intragastric system.   
     
     
         49 . A method according to  claim 48 , wherein:
 the anatomic wall is the stomach wall.   
     
     
         50 . A method according to  claim 45 , wherein:
 both of said tunneling and dissecting instruments include expandable balloons.   
     
     
         51 . A method according to  claim 45 , wherein:
 said first tissue is the gallbladder and the second tissue is the liver.   
     
     
         52 . A method according to  claim 45 , wherein:
 the dissecting instrument and tunneling instrument are integrated into a single instrument.   
     
     
         53 . A method according to  claim 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 to  claim 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 to  claim 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 to  claim 57 , wherein:
 said surgical procedure includes separating the gallbladder from the liver.