WO2008092050A2

WO2008092050A2 - Translumenal access device

Info

Publication number: WO2008092050A2
Application number: PCT/US2008/051989
Authority: WO
Inventors: Ali Tavakkolizadeh
Original assignee: Brigham and Womens Hospital Inc
Current assignee: Brigham and Womens Hospital Inc
Priority date: 2007-01-25
Filing date: 2008-01-25
Publication date: 2008-07-31
Anticipated expiration: 2009-07-25
Also published as: WO2008092050A3

Abstract

The present invention relates to a method and device for accessing the peritoneal cavity through a natural orifice and maintaining access to the peritoneal cavity without any leakage of gas, and more particularly, to a translumenal access device and method that enables repeated entry and exit of surgical devices, for example, an endoscope to allow exchange of instruments.

Description

TRANSLUMENAL ACCESS DEVICE

[0001] The application claims benefit under 35 U.S.C. §119(e) of the U.S. Provisional Application No. 60/897,234, filed January 25, 2007, and the content of which is herein incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention:

[0002] The present invention relates to a method and device for accessing the peritoneal cavity through a natural orifice and maintaining access to the peritoneal cavity without any leakage of gas, and more particularly, to a translumenal access device and method that enables repeated entry and exit of surgical devices, for example, an endoscope to allow exchange of instruments.

2. Description of the Related Art:

[0003] The concept of Natural Orifice Translumenal Endoscopic Surgery (NOTES) is an extension of minimally invasive surgery that accesses the peritoneal cavity through one of the natural orifices (vagina, stomach, or rectum). This approach eliminates the need for abdominal incisions, and the short and long-term complications of an incision, including pain, wound infection, dehiscence, scars, as well as hernia formation. With the use of a less invasive technique, intra-abdominal adhesion formation may also be less. Such potential advantages have been the impetus for further exploration of this concept. [0004] Currently progress in the field of translumenal surgery is hampered by technical challenges and instrument shortages. Despite these hindrances, researchers have published papers on transgastric peritoneoscopy and liver biopsy; endoscopic gastrojejunostomy; transoral gastroplasty for obesity; transgastric tubal ligation; oophorectomy; transgastric gallbladder surgery; endoscopic transgastric lymphadenectomy; transgastric splenectomy; and transcolonic cholecystectomy. Although published work in this field has been performed in animal models, there have been unpublished presentations demonstrating its feasibility in humans.

[0005] One of the main technical challenges facing NOTES is access to the peritoneal cavity. To gain access, currently clinicians must make a hole(s) in one of the gastrointestinal organs (stomach or rectum), or reproductive organs (vagina). To achieve this, an endoscope is introduced into the organ, a hole is made in its wall and the endoscope is then pushed in to the peritoneal cavity through this defect. Often the defect in the organ wall is dilated using a balloon dilator. Most investigators working in this area have used this technique. See U.S.

Patent Nos.5,458,131 and 6,030,365 and U.S. patent Publication Nos. 2006/0237022;

2006/0025654; 2005/0107664; and 2005/0277945.

[0006] Once the endoscope is in the peritoneal cavity, a pneumoperitoneum is created.

The endoscope is then maneuvered in the peritoneal cavity, and using instruments that are introduced though the endoscope, various procedures can be attempted.

[0007] The current technique used to access the peritoneal cavity is however imperfect.

The defect in the organ wall, through which the endoscope is introduced, may have an inadequate seal resulting in leakage of gas from the peritoneal cavity. This will hamper efforts to produce a good pneumoperitoneum and adversely affect a clinicians' ability to visualize the intraperitoneal organs. Using the current technique, it is also difficult to remove and reintroduce the endoscope, as it may be difficult to identify the same hole, and when feasible, there is significant trauma to the tissue.

[0008] Thus, an improved way to establish and maintain intraperitoneal access is needed.

SUMMARY OF THE INVENTION

[0009] One aspect of the present invention is to maintain pneumoperitoneum while allowing easy exchange of instruments.

[00010] Another aspect of the present invention is to provide a good seal around the site of entry and prevent gas leaks from the hole or defect in the organ wall.

[001 1] Yet another aspect of the present invention is to prevent the local tissue damage should be decreased.

[0012] By positioning of the access device obliquely a better seal may be produced in the organ wall once the device is removed.

[0013] In accomplishing these and other aspects of the present invention, there is provided a natural orifice translumenal endoscopic surgery method comprising the steps of making a hole or defect in a wall of an organ located in a peritoneal cavity of a patient, introducing an endoscope through a natural orifice and positioning the endoscope within the organ. A translumenal access device is mounted on a guidewire and the guidewire is positioned within the organ and the hole in the organ wall. The translumenal access device is positioned in the hole in the organ wall, such that the translumenal access device transverses the organ wall. The translumenal access device includes a tubular outer member and an expandable inner frame located therein. The endoscope is positioned in the peritoneal cavity through the translumenal access device. Endoscopic surgical instruments can then be introduced through the translumenal access device into the peritoneal cavity to perform a surgical procedure.

[0014] In accomplishing these and other aspects of the present invention, there is also provided a method for the intraperitoneal placement of a translumenal access device in an organ wall comprising the steps of mounting a translumenal access device on a guidewire, positioning the guidewire within an organ located within a peritoneal cavity and through a hole in the organ wall; and positioning the translumenal access device in the hole in the organ wall. The translumenal access device transverses the organ wall and includes a tubular outer member and an expandable inner frame located therein. The inner frame and outer tubular wall are expanded to position the translumenal access device within the organ wall. [0015] These and other objects, features, aspects, and advantages of the present invention will become more apparent from the following detailed description of the preferred embodiment relative to the accompanied drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Fig. 1 is a perspective view of the translumenal access device of the present invention.

[0017] Fig. 2 is a partial cross-sectional view of the translumenal device of the present invention positioned within an organ wall in the peritoneal cavity.

[0018] Fig. 3. is a cross-section of the translumenal access device of the present invention in an expanded condition

[0019] Fig. 4 is an enlarged cross-sectional view of the translumenal device of the present invention positioned within an organ wall in the peritoneal cavity.

[0020] Fig. 5 is cross-sectional view of the translumenal device of the present invention and endoscope and/or endoscopic instruments positioned within the peritoneal cavity.

[0021] Fig. 6 is an enlarged cross-sectional view of another embodiment of the translumenal device of the present invention positioned within an organ.

[0022] Fig. 7 is a cross-sectional view of another embodiment of the translumenal access device of the present invention.

[0023] Fig. 8 is an enlarged cross-sectional view of the translumenal access device of Fig.

7. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0024] Fig. 1 illustrates a translumenal access device 10 according to the present invention. As will be described fully herein, access device 10 is designed to be used in NOTES to access the peritoneal cavity through one of the natural orifices (vagina, stomach, or rectum). Although described in relation to surgical procedures that occur in the peritoneal cavity, it should be appreciated that the present invention contemplates other natural orifice endoscopic surgery procedures.

[0025] As shown in Fig. 2, device 10 is introduced into a lumen or natural orifice 17 of an organ of interest 18 using an endoscope 14. A hole or defect 16 is made in an organ wall 20 by known means and methods. Access device 10 is positioned on a guidewire 12. Guidewire 12 is then pushed through the organ wall in to the peritoneal cavity and positioned such that the mounted device 10 is traversing the organ wall. An outer sheath (not shown) can be positioned over the access device 10. The outer sheath can be removed once the guidewire and device are positioned.

[0026] Access device 10 is positioned within defect 16 and expanded, as discussed herein, to provide a passage for the endoscope and surgical instruments into a peritoneal cavity 22 formed by peritoneum 24. To aid in positioning device 10, guidewire 12 can include markings 13 disposed along its length.

[0027] Referring to Fig. 3, translumenal access device 10 is formed of a tubular member 30 made of a soft expandable material, for example, polytetrafluoroethylene (ePTFE). It should be appreciated that expandable member 30 can be made of a variety of materials. [0028] Member 30 has opposed ends 32 and 34 and an inner and outer surface 36, 38 respectively. Inner and outer surfaces 36, 38 can be lubricated to allow easier passage of the device through organ wall 20 and of endoscopic instruments through device 10. [0029] Device 10 includes an expandable frame 40 located within member 30 for expanding member 30 to a predetermined outer diameter once the device is located within the defect of the organ wall. Frame 40 can be made of a shape retaining memory material such as Nitonol^® or the like. Frame 40 can also incorporate a variety of geometrical shapes as taught by conventional stent structures that are currently marketed as biliary and other implants including the Racer™ Over-the-Wire biliary stent system manufactured by Medtronic, Inc. and Luminexx™ biliary stent system by C. R. Bard, Inc.

[0030] Tubular member 30 and frame 40 can be concentrically positioned about a catheter balloon 42 mounted on a balloon catheter. As is known in the art, balloon 42 can be expanded by a pressurized fluid to dilate frame 40 and member 30 to a predetermined diameter. Once the frame and member are expanded to the desired size, i.e., to an inner diameter large enough to enable the endoscope and instrumentation to pass through, the balloon catheter can be removed. The device will be held within hole 16 due to the radial expansion of the device. Moreover, damage to the organ wall is limited due to the nature of the expansion of device 10.

[0031] Once the defect or hole in an organ wall is enlarged pneumopritoneum, the presence of gas or air in the peritoneal cavity, is created. Accordingly, referring to Figs. 4 and 5, the device of the present invention includes a valve 50 that prevents gas leaks from the hole or defect in the organ wall.

Valve 50 can be a one way flap valve made of a flexible material. Valve 50 can be made of the same FEP/Eptfe material as member 30. Valve 50 can be a ring of material located within frame 40 and attached to either frame 40 or member 30.

[0032] As shown in Fig. 5, the device of the present also allows repeated entry and exit of the endoscope to allow exchange of instruments. Valve 50 is movable to allow the endoscope/instrumentations to move therethrough while still maintaining a seal.

[0033] As shown in Fig. 6, device 10 could include a flange 56 located at the inner end

32 to hold the device in place against wall 22, such that it is not pushed to far forward into peritoneal cavity 22.

[0034] Referring to Fig. 7, in another embodiment of the present invention, the expandable frame 40 is positioned over tubular member 30. An outer sheath 60 can be positioned over frame 40. When sheath 60 is removed, frame 40 and member 30 can expand.

The outer sheath can take on a variety of configurations, such as taught by the Gore Viabil^® biliary endoprosthesis stent manufactured by W.L. Gore & Assoc, Inc.

[0035] As shown in Fig. 8, the valve of device 10 can be a diaphragm 70 having a slit 72 that is lubricated to allow the instruments to pass therethrough.

[0036] According to a method of the present invention endoscope 14 is introduced through a natural orifice 17 and positioned within organ 18. A hole or defect 16 can be made wall 20 of the organ. The translumenal access device 10 is mounted on guidewire 12.

Guidewire 12 can be positioned through the defect in the organ wall using endoscope 14.

Translumenal access device 10 is positioned in the hole 16 of the organ wall so that it transverses the organ wall as shown in Figs. 4 and 5.

[0037] The translumenal device can than be dilated using the balloon catheter or by some other means to expand its diameter. The balloon catheter is then removed. Alternatively, if an outer sheath is used, the sheath can be removed and the frame expanded. As the device 10 expands it forms a seal against the organ wall. The endoscope can be pushed into peritoneal cavity 22 through the expanded translumenal access device 10. Thereafter, various endoscopic surgical instruments can also be inserted through the translumenal access device into the peritoneal cavity to perform a surgical procedure. It should be appreciated the device 10 can have a variety of diameters depending on the targeted surgical procedure and the instruments that will be inserted therethrough.

[0038] Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A natural orifice translumenal endoscopic surgery method comprising the steps of: making a hole or defect in a wall of an organ located in a peritoneal cavity of a patient; introducing an endoscope through a natural orifice and positioning the endoscope within the organ; mounting a translumenal access device on a guidewire; positioning the guidewire within the organ; positioning the translumenal access device in the hole in the organ wall, wherein the translumenal access device transverses the organ wall and includes a tubular member and an expandable frame in communication with the tubular member; positioning the endoscope in the peritoneal cavity through the translumenal access device; and introducing endoscopic surgical instruments through the translumenal access device into the peritoneal cavity to perform a surgical procedure.

2. The method of claim 1, further comprising the step of dilating the translumenal access device after the step of positioning the device within the organ wall.

3. The method of claim 2, wherein the step of dilating the translumenal access device comprises expanding the frame and member of the device.

4. The method of claim 1, wherein the translumenal access device includes a valve positioned within an inner diameter of the device and further comprising the step of preventing gas within the peritoneal cavity from passing through the translumenal device into the organ.

5. A method for the intraperitoneal placement of a translumenal access device in an organ wall comprising the steps of: mounting a translumenal access device on a guidewire; positioning the guidewire within an organ located within a peritoneal cavity; positioning the translumenal access device in the hole in the organ wall, wherein the translumenal access device transverses the organ wall and includes a tubular member and an expandable frame communicating therewith; and expanding the frame and the tubular wall to position the translumenal access device within the organ wall.

6. The method of claim 1, wherein the translumenal access device includes a valve positioned within an inner diameter of the device and further comprising the step of preventing gas within the peritoneal cavity from passing through the translumenal device into the organ.

7. A translumenal access device for placement in a wall of an organ located in the peritoneal cavity, comprising: an expandable frame; an expandable tubular member positioned concentric with the frame; and a valve located within the outer member for preventing gas from passing from the peritoneal cavity through the outer member and into the organ.

8. The translumenal access device of claim 7, wherein the tubular member is expandable to a predetermined diameter for receiving an endoscope and endoscopic instruments therethrough.