Patent Application
20090287049
1. Field of the Invention
The present invention relates to access systems for providing secure access to the abdominal cavity through a wall of a body cavity reached 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
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 provide secure access to the peritoneal cavity through the stomach or another natural orifice. However, there are still significant limitations to the present techniques for manipulating and removing masses of tissue on current access systems.
According to embodiments of the invention, a natural orifice translucent endoscopic surgery access system is provided for enabling and facilitating access to the abdominal cavity through an intragastric or transvaginal approach. In each embodiment, the access system includes a structurally modifiable port body, a proximal handle, an endoscope attachment means at a distal end of the port body to attach the port body to an endoscope, and a securing system at a distal end of the port body that secures the port body within a hole provided in a wall of a body cavity accessible via a natural orifice.
The port body comprises a thin, flexible body preferably made from a lubricious film. The endoscope attachment means preferably includes an elastic collar or an inflatable collar. The securing system preferably includes individually expandable proximal and distal cuffs, permitting fixation of the cuffs on opposite sides of a wall separating a natural orifice from the peritoneal cavity.
According to one embodiment, the port body is constructed with a channel that preferably coils around the port body. The channel can be inflated and deflated to provide relative degrees of rigidity to the port body. In a preferred initial configuration, the channel in the port body is deflated (to provide the port with increased flexibility), and the port body is advanced over an endoscope and secured at its distal end to the endoscope.
For use in an intragastric procedure, the endoscope is used to advance the port body through the gastric interior. Once the port body and the endoscope enter the gastric interior, the port channel is inflated to stiffen the port body. A surgical cutting tool is delivered through the endoscope working channel to incise the gastric wall. A dilation balloon may then be used to enlarge the incision to a size sufficient for the port to enter the peritoneal space. The distal end of the port body is passed through the incision into the peritoneal cavity. The proximal cuff is inflated in the gastric interior, followed by inflation of the distal cuff in the peritoneal cuff to secure the port around the gastric wall. Secured access is provided through the port to the peritoneum for a surgical procedure.
According to another embodiment, the endoscope attachment means is an inflatable internal collar. In a preferred initial configuration of the second embodiment, the port body is provided over an endoscope and the internal collar is inflated to secure the port to the endoscope.
For use in an intragastric procedure, the endoscope is used to advance the port body through the gastric interior. Once the port and the endoscope enter the gastric interior, a surgical cutting tool is delivered to incise the gastric wall. A dilation balloon may then be used to enlarge the incision to a size sufficient for the port to enter the peritoneal space. After that, the distal end of the port is passed through the incision into the peritoneal cavity. The proximal cuff is inflated in the gastric interior, followed by inflation of the distal cuff in the peritoneal cavity to secure the port around the gastric wall. Then, the internal collar is deflated releasing the endoscope from the port. The endoscope is then withdrawn from the patient. Once the endoscope is removed, the port provides secured access to the peritoneum for a surgical procedure. An additional inflatable channel may be provided about the port body to control rigidity of the port from a proximal handle.
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.
A natural orifice translucent endoscopic surgery (NOTES) access system 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 gastric or 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.
Turning now to
In a preferred embodiment, the gastric wall securing system 16 includes proximal and distal inflatable cuffs 22, 24 provided on an external portion of the distal end 18 of the port body 12. The cuffs 22, 24 are in communication with respective valved injection ports 26, 28 at the handle 14 through air channels 29, 30 to permit individual pressurization with a fluid, e.g., air, to fixate the cuffs on opposite sides of the gastric wall. This secures the port body 12 to the gastric wall and provides a seal between the intragastric space and the peritoneal cavity.
The port body 12 distal of the handle 14 is a collapsible tube with a lumen 25 having a diameter D. The port body 12 has length in the range of 20 to 60 inches, with a preferred range of 30 to 45 inches; and a lumen diameter D in the range of about 5 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 port body 12 is constructed of a thin film permitting the body to be longitudinally and laterally flexible. The port body 12 is preferably made from a lubricious polymeric film comprised of a polyester, a polyolefin, a fluoropolymer, or blends thereof. By way of example, and not by limitation, polyethylene, polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET) or polyvinylidene fluoride (PVDF) can be used. These materials facilitate movement of the port body through the natural orifice and instruments and materials through the lumen 25 of the port body. Also, an elastopolymer film can be used, permitting temporary changes in diameter D of lumen 25 along the length of the port body when the port body is subject to internal radial force. This permits passage of materials larger than diameter D through lumen 25. It is, however, understood that the anatomy (e.g., esophagus) may be the limiting factor in the maximum permitted size of material and instruments through the resilient port body 12.
According to a preferred aspect of this embodiment of the invention, the port body 12 is constructed with or otherwise provided with an channel 32 that can be inflated or deflated to alter the rigidity of the port. The channel 32 preferably coils around the port body 12. The channel 32 can be integrated within the port body, e.g., defined between two layers of the film comprising the port body, or a separate tubular construct bonded to the inner or outer surfaces of the film or between layers of the film. The handle 14 is provided with a port 34 that communicates with the channel 32 to control inflation of the channel with a fluid, e.g., air, to inflate the channel. Multiple channels can be used.
Upon inflation of the channel 32, the channel expands to state 32a as shown by broken line in
With the rigidity of the port body 12 controllable throughout a procedure, as described in more detail below, specific advantage is provided during port body insertion and removal. With the port body deflated, the highly flexible port body can accommodated through the natural orifice (e.g., esophagus) while providing protection of the natural orifice lining (e.g., esophageal lining). With the port body channel 32 inflated, the port body 12 provides a well-defined secure channel through which an intragastric surgical procedure can be conducted.
Further, the flexible port body 12 provides adaptability for removing tissue en masse therethrough. Where a resilient film is used, constraints presented by prior art ports having a fixed diameter along their length and high lateral and/or longitudinally rigidity throughout a procedure are eliminated.
Referring to
Referring to
Then, in use, the endoscope 50 is used to maneuver the port body 12 into the gastric interior 52 (
The port body can also be introduced transanally and up the colon to enter the peritoneal cavity at a location other than through the stomach. Further, while the access system can be used intragastrically, it can also similarly be used transvaginally to perform a surgical procedure. To that end, it is coupled at its distal end to an endoscope that is introduced transvaginally, introduced through a wall of the vagina into the abdominal cavity and secured in the vaginal wall to provide secure access for a surgical procedure. The rigidity of the port body of the access system is modifiable via controlled inflation and deflation of the channel of the port body.
Turning now to
The port body 112 is a collapsible tube with a lumen 125 having a diameter D. The port body 112 is constructed of a thin film permitting the port body to be longitudinally and laterally flexible. The port body 112 is preferably made from a lubricious polymeric film comprised of a polyester, a polyolefin, a fluoropolymer, elastopolymer, or blends thereof.
The gastric wall securing system 116 includes proximal and distal inflatable cuffs 122, 124 provided on an external portion of the distal end 118 of the port body 112. The cuffs 122, 124 are in communication with respective injection ports 126, 128 at the handle 114 through air channels 129, 130 to permit individual pressurization with a fluid, e.g., air, to fixate the cuffs on opposite sides of the gastric wall. This secures the distal end 118 of the port body 112 to the gastric wall and provides a seal between the intragastric space and the peritoneal cavity.
The endoscope attachment means includes an inflatable collar 120 preferably within the distal end 118 of the port body 112, shown inflated as 120a. A valved injection port 140 is provided at the handle 114, and fluid conduit 142 extends along the film from the port 140 to the collar 120. The conduit 142 can be integrated within the port body, e.g., defined between two layers of the film comprising the port body, or a separate tubular construct bonded to the inner or outer surfaces of the film or between layers of the film. The pressurization of the collar 120 (and coupling and decoupling of the access system to the endoscope) can be actuated from the handle 114.
An inflatable channel, similar to channel 26 (
Access system 110 is used substantially the same of the access system 10. In a preferred initial configuration, the access system is fed over an endoscope and the collar 120 is inflated to engage the distal end 118 of the port body 112 to an endoscope. The endoscope is inserted into an anatomical cavity through a natural orifice and advanced according to methods described herein through a hole in a wall of the anatomical cavity. The cuffs 122, 124 are inflated to secure the distal end 118 of the port body relative to the anatomical wall and create a fluid tight seal between the anatomical cavity and the abdominal cavity. The collar 120 can then be deflated, and the endoscope maneuvered further into the abdominal cavity or withdrawn, as necessary. If the access system 110 is provided with an inflatable channel along port body length, such channel can be inflated to provide the port lumen 124 with increased rigidity. An access port is thereby provided into the abdominal cavity of the patient through a natural body orifice.
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 particular means of attaching the distal end of a port body to an endoscope have been described, it will be appreciated that means in addition to elastics and inflatable collars can be used as well. In addition, 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. Further, while particular types of instruments for the cutting and piercing tissue, and drawing a balloon from a natural orifice accessible body cavity to within an anatomical wall of the body cavity wall have been disclosed, it will be understood that other suitable instruments can be used as well. 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.
