WO2013090190A1

WO2013090190A1 - Luminal overtube and method of accessing a portion of the lumen

Info

Publication number: WO2013090190A1
Application number: PCT/US2012/068754
Authority: WO
Inventors: Randal S. Baker; Frederick J. Walburn
Original assignee: Bfkw, Llc
Priority date: 2011-12-14
Filing date: 2012-12-10
Publication date: 2013-06-20

Abstract

A luminal access overtube and method of accessing a portion of a lumen includes positioning in the lumen an overtube including a tube that is configured to the size and shape of a portion of the lumen and having a portal at a proximal end portion of the tube. The portal facilitates passage of instruments through the tube and a portion of the lumen is insufflated. The portal resists flow of the insufflating fluid from the lumen.

Description

LUMINAL OVERTUBE AND METHOD OF ACCESSING

A PORTION OF A LUMEN BACKGROUND OF THE INVENTION

The present invention is directed to an overtube that provides access to a portion of a lumen, such as the gastrointestinal tract, uterus, or the like, through a natural orifice, such as the mouth, anus, or vagina, thereby allowing instruments to be passed through the overtube to that portion of the lumen, or moved within the overtube and a method of accessing that portion of the lumen.

Certain procedures are performed at various locations in the GI tract, such as at the stomach or the gastroesophageal region. To allow an instrument, such as an endoscope, to be passed through the esophagus to the stomach, an overtube is inserted in the esophagus to protect it against damage from movement of the instrument. The stomach is insufflated in order to enlarge the stomach to allow manipulations to be performed and visualized.

Some procedures require multiple instruments to be placed in the GI tract at the same time. This creates additional difficulties in design and use of the overtube.

SUMMARY OF THE INVENTION

The present invention provides an overtube and method for providing access to a portion of a lumen or organ, such as the GI trace, including insufflating that portion of the lumen while allowing instruments to be passed to that portion of the lumen without dissipating the insufflating gas through the overtube.

An access overtube and method of accessing a portion of a lumen, such as the gastrointestinal tract, according to an aspect of the invention, includes positioning in the lumen an overtube including a tube that is configured to the size and shape of a portion of the lumen and having a portal at a proximal end portion of the tube. The portal defines an inlet facilitating passage of instruments through the tube. Instruments are passed through the tube and a portion of the lumen is insufflated. The portal resists flow of the insufflating fluid from the lumen.

The portal may have at least a partial seal in the form of a fluid curtain. The fluid curtain may include at least one nozzle and a source of a fluid. Fluid from the source of fluid is conveyed to the nozzle(s) and directed with the nozzle(s) radially inwardly thereby resisting flow of fluid past the portal. A plurality of nozzles may be arranged around the inlet. A plenum may be provided to convey fluid from the fluid source through the plenum to the nozzles.

A common source of fluid may be used to insufflate the portion of the lumen distal of the tube and to define the fluid curtain. The source of fluid may be a gas source, such as an air source.

The portal may have at least a partial seal in the form of an outer member, an inner member inward of the outer member and a chamber between the inner member and the outer member. The chamber may receive material that causes the inner member to form around an instrument in the overtube. The material may be from a source of fluid that is selectively supplied between the inner and outer members. The source of fluid may be a source of liquid, such as a source of saline.

The inner member may be a flexible film that is radially inward of the outer member. The material may be a viscous material that is pliable thereby allowing the film to moveably form around an instrument in the overtube. The outer member may be flexible.

Pressure level in the tube may be sensed and used to adjust the amount of resistance in order to regulate the pressure level in the tube.

The portal may have at least a partial seal in the form of a barrier and a plurality of inlets defined in the barrier. Flow of a fluid is resisted with the barrier proximally past the portal, and instruments are positioned through at least some of the lumens into the tube.

The tube may be configured to the size and shape of a portion of the lumen.

The overtube may define a passage with insufflating fluid directed distal of the tube through the passage.

These and other objects, advantages and features of this invention will become apparent upon review of the following specification in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a side elevation of a gastrointestinal access overtube, according to an aspect of the invention;

Fig. 2 is a side elevation of an embodiment of a gastrointestinal access overtube; Fig. 3 is a sectional view taken along the lines III- III in Fig. 2;

Fig. 4 is a side elevation of another embodiment of a gastrointestinal access overtube;

Fig. 5 is a perspective view of a portal;

Fig. 6 is a perspective view of the portal in Fig. 5 from a different direction; and

Fig. 7 is the same view as Fig. 4 of yet another embodiment of a gastrointestinal access overtube.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings and the illustrative embodiments depicted therein, an overtube 10 that is adapted to providing access to a portion of a lumen, such as the gastrointestinal tract, uterus, or the like, through a natural orifice, such as the mouth, anus, vagina, or the like, and having a distal end 16 includes a tube 12 that is configured to the size and shape of a portion of the lumen and having a distal end portion 16 and a portal 18 at a proximal end portion 14 of tube 12 (Fig. 1). Portal 18 facilitates passage of instruments 32 through tube 12 and/or manipulating tools passing through tube 12 while resisting flow of a fluid through a distal end portion 16 of tube 12 and proximally past portal 18. This may be accomplished by portal 18 having an inlet 20 of a size to pass as many instruments that may be required for the procedure and at least a partial seal 22 to resist the passage of insufflating fluid. This allows the physician to, for example, insufflate the portion of the lumen, such as the

gastrointestinal tract distal of tube 12 in order to allow the physician to visualize and perform procedures at that portion of the lumen while reducing the flow of insufflating fluid out of that portion of the lumen through overtube 10. This greatly reduces the volume of insufflating fluid needed during a period of time. Also, the physician can pass multiple instruments through inlet 20 and tube 12.

Some procedures require that multiple instruments 32 be placed through the overtube at a time, thereby making it difficult to seal against the outflow of insufflating fluid. For example, placement of a bariatric device of the type disclosed in commonly assigned U.S. Pat. Nos. 7,846,174 B2 and 8,100,931 B2 and U.S. Pat. Application Publication No. 2010/0030017 Al and deployment tools, such as disclosed in U.S. Pat. Application Ser. No. 61/635,477, filed Apr. 19, 2012, filed by Baker for an INTRALUMINAL DEVICE DELIVERY TECHNIQUE, the disclosures of which are hereby collectively incorporated herein by reference, requires a deployment instrument to deploy the bariatric device as well as an endoscope to provide visualization and insufflation of the stomach. Also, a tether deployment tool of the type disclosed in commonly assigned U.S. Patent Application Publication No. 2010/0063518 Al entitled MEDICAL DEVICE FIXATION TOOL AND METHOD OF FIXATION OF A MEDICAL DEVICE, the disclosure of which is hereby incorporated herein by reference, may also be placed in overtube 10 either concurrently with or after the deployment device is removed. Of course, it should be understood that overtube 10 could, alternatively, be used with only one instrument passing through tube 12 and can be used both to pass instruments back and forth to the lumen, such as to the stomach, or to move instruments within tube 12.

In the illustrated embodiment, overtube 10 is configured to the size and shape of at least a portion of the lumen, for example, to provide access to the stomach and gastroesophageal (GE) junction. As such, tube 12 is made of a flexible material, such as a flexible polymer, Nitinol, carbon fiber, or the like, in order to allow the tube to conform to the curvature of the lumen. However, it should be understood that the overtube could be configured to the size and shape of other portions of the

gastrointestinal tract, such as the colon. It may also find application to procedures at other lumens accessible through natural orifices, such as the vagina, urethra, bile duct, and the like. Tube 12 may be sized to extend fully to the gastro esophageal junction to provide access to the GE junction or stomach while protecting the esophagus from the instruments. However, tube 12 may be sized to extend only a portion of the esophagus if the instruments are sufficiently soft and compliant to avoid the need for protection of the esophagus.

In one embodiment, an overtube 110 includes a tube 112 configured to the size and shape of a portion of a lumen, such as the esophagus, and a portal 118 having an inlet 120 and at least a partial seal 122 in the form of a fluid curtain 124 (Figs. 2 and 3). Fluid curtain 124 includes one or more nozzles 126 and a source 128 of a fluid.

Nozzle(s) 126 directs fluid from fluid source 128 radially inwardly. This tends to create turbulence in the vicinity of the nozzles, as well as tends to flow the fluid distally along tube 112, either or both of which tend to resist flow of fluid proximally past portal 118. Source of fluid 128 may be the same fluid source used to insufflate the stomach, such as air, or another fluid source may be provided for this purpose. Portal 118 may further include a plenum 130 that provides a flow path from fluid source 128 to nozzles 126. In the illustrated embodiment, the source of fluid 128 may be a gas source, such as a compressed air or nitrogen source, but may be a liquid source or a source of a different type of gas.

In use, overtube 110 is deployed in the gastrointestinal tract. Fluid source 128 is actuated and applied to nozzles 126, such as with a valve or fitting (not shown), in order to establish fluid curtain 124 either before or after instruments are placed in tube 112. Conveniently, instruments can be placed, removed and replaced or repositioned without the necessity of interrupting fluid source 128. Nozzles 126 may be arranged in a single row to establish a single fluid curtain or may be arranged in a plurality of rows to establish a plurality of fluid curtains 124. For example, one fluid curtain may be at a proximal end of overtube 110 as shown and another at a middle or distal portion of overtube 110. Also, nozzles 126 may be directed radially inwardly as illustrated in Fig. 2 or may be angled to have a distal or proximal component in addition to a radial component. Also, the overtube may have a flow of fluid to the distal end of tube 112 to insufflate the stomach or other lumen. Of course the insufflating fluid could be supplied from an endoscope, or the like.

In an alternative embodiment, an overtube 210 includes a tube 212 configured to the size and shape of a portion of the GI tract and a portal 218 (Figs. 4-6). Portal 218 includes an outer member, such as a housing 234, an inner member, such as a flexible film 236 radially inward of housing 234, and a material between inner and outer members 234, 236 to cause the inner member to envelope the instruments 232 in tube 212 thereby forming at least a partial seal. In one embodiment, the material between the inner and outer members may be a fluid provided by a source 238 of a fluid that is selectively supplied to a plenum 230 between film 236 and housing 234. Fluid from fluid source 238 causes flexible film 236 to form around an instrument 232 in tube 212. Fluid source 228 may be a source of liquid, such as a source of saline. In the illustrated embodiment, fluid source 228 is a fitting 239 with a stopcock 240 to first receive and then retain the fluid in plenum 230 between housing 234 and film 236. Saline may be applied, for example, using a syringe of fluid applied to fluid source 238.

In use, tube 212 is inserted in the lumen, such as the GI tract, and one or more instruments 232 inserted past portal 218 and through tube 212. Fluid is applied to fluid source 228 in order to form flexible film 236 around the instruments in the portal. Once the film is formed around the instruments, stopcock 240 is closed to retain the fluid in plenum 230. This allows the film to remain formed around the instruments, even after fluid is no longer being supplied to the fluid source. However, when an instrument is to be withdrawn or repositioned, the fluid is withdrawn from plenum 230 in order to allow flexible film 236 to become flaccid. This may be accomplished by connecting an empty syringe to fitting 239 opening stopcock 240 and withdrawing the saline from plenum 230. Instruments may then be withdrawn or repositioned and replaced as needed. In order to re-engage the seal, fluid is once again applied from fluid source 238 to plenum 230.

Alternatively, outer member 234 and inner member 236 may both be flexible and the material between the inner and outer members may be a viscous material such as a viscous-elastic gel or the like thereby defining at least a partial seal whereby portions of the inner member are biased toward each other. This structure allows the inner member to form around instruments passing though the portal while allowing the portions of the inner member to be separated sufficiently to allow passage of the instruments through the portal while maintaining a partial seal against the instruments.

In another embodiment, a gastrointestinal access overtube 310 includes a tube 312 configured to the size and shape of a portion of the GI tract and a portal 318. Portal 318 may be configured in a similar fashion to portal 118 or 218. However, portal 318 may include a channel 346 to conduct insufflating gas through tube 312 from a source 345 of insufflating gas. This may allow the portion of the GI tract to be more rapidly insufflated than may be accomplished using a conventional insufflating function provided, for example, with an endoscope, or the like.

A feedback mechanism (not shown) may be provided that senses the pressure of the fluid in tube 12, 112, 212, 312 and regulate the resistance of the at least partial seal provided by respective portal 18, 118, 218, 318 as a function of the pressure of the fluid in the tube. In this manner, as the pressure in the tube drops, indicating a greater proximal flow of the insufflating fluid, the amount of resistance offered by the at least partial seal in the portal can be increased to reduce such flow and vice versa. Such feedback mechanism may be pneumatic, electronic, or a combination of both.

Other embodiments will be apparent to the skilled artisan. For example, the portal may be in the form of a barrier, such as a rigid piece covering the tube and having a plurality of lumens defined in the barrier. The barrier resists flow of a fluid proximally past the portal while each of the lumens defined in the barrier provide passages for an instrument through the tube.

While the foregoing description describes several embodiments of the present invention, it will be understood by those skilled in the art that variations and

modifications to these embodiments may be made without departing from the spirit and scope of the invention, as defined in the claims below. The present invention encompasses all combinations of various embodiments or aspects of the invention described herein. It is understood that any and all embodiments of the present invention may be taken in conjunction with any other embodiment to describe additional embodiments of the present invention. Furthermore, any elements of an embodiment may be combined with any and all other elements of any of the embodiments to describe additional embodiments.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A luminal access overtube, comprising:

a tube that is configured to the size and shape of a portion of the lumen; and a portal at a proximal end portion of said tube, said portal defining an inlet facilitating passage of instruments through said tube and at least a partial seal resisting flow of a fluid proximally past said portal.

2. The overtube as claimed in claim 1 wherein said seal comprises a fluid curtain.

3. The overtube as claimed in claim 2 wherein said fluid curtain comprises at least one nozzle and a source of a fluid, said at least one nozzle directs fluid from said source of fluid having at least a radially inward component thereby resisting flow of fluid past said portal.

4. The overtube as claimed in claim 3 wherein said at least one nozzle has an axial component thereby directing fluid proximally or distally.

5. The overtube as claimed in claim 3 or claim 4 wherein said at least one nozzle comprises a plurality of nozzles arranged around said lumen.

6. The overtube as claimed in claim 5 including a plurality of fluid curtains.

7. The overtube as claimed in claim 1 including a source of fluid to insufflate a portion of the lumen distal of said tube.

8. The overtube as claimed in claim 7 wherein said source of fluid is used to insufflate the portion of the lumen distal of said tube and to define said fluid curtain.

9. The overtube as claimed in claim 7 or claim 8 wherein said source of fluid comprises a gas source.

10. The overtube as claimed in claim 9 wherein said gas source comprises an air source.

11. The overtube as claimed in claim 1 wherein said portal comprises an outer member, an inner member inward of said outer member and a chamber between said inner member and said outer member, wherein the chamber is adapted to receive a material to cause said inner member to form around an instrument in the overtube.

12. The overtube as claimed in claim 12 wherein said material comprises a source of fluid that is selectively supplied between said inner member and said outer member.

13. The overtube as claimed in claim 12 wherein said source of fluid comprises a source of liquid.

14. The overtube as claimed in claim 13 wherein said source of liquid comprises a source of saline.

15. The overtube as claimed in any of claims 11 through 14 wherein said inner member comprises a flexible film that is radially inward of said outer member.

16. The overtube as claimed in claim 14 wherein said material comprises a viscous material.

17. The overtube as claimed in claim 16 wherein said viscous material is pliable thereby allowing said film to moveably form around an instrument in said overtube.

18. The overtube as claimed in claim 17 wherein said outer member comprises a flexible member.

19. The overtube as claimed in claim 1 including a feedback sensor, said feedback sensor sensing pressure level in said tube and adjusting said partial seal to regulate the pressure level in said tube.

20. The overtube as claimed in claim 1 wherein said portal comprises a barrier and a plurality of inlets defined in said barrier, wherein said barrier resists flow of a fluid proximally past said portal and wherein each said inlet provides passages for an instrument through said tube.

21. The overtube as claimed in claim 1 wherein said tube is configured to the size and shape of a portion of the lumen.

22. The overtube as claimed in claim 1 wherein said overtube defines a passage to direct insufflating fluid distal of said tube to the lumen.

23. A method of accessing a portion of a lumen, said method comprising:

positioning in the lumen an overtube comprising a tube that is configured to the size and shape of a portion of the lumen and having a portal at a proximal end portion of said tube, said portal facilitating passage of instruments through said tube;

passing instruments through said tube;

insufflating a portion of the lumen; and

resisting flow of the insufflating fluid from the lumen with said portal.

24. The method as claimed in claim 23 wherein said portal comprises at least one fluid curtain.

25. The method as claimed in claim 24 wherein said at least one fluid curtain comprises a plurality of nozzles and a source of a fluid, said method including conveying fluid from said source of a fluid to said nozzles and directing fluid with said nozzles with at least a radially inward component thereby resisting flow of fluid past said portal.

26. The method as claimed in claim 24 wherein each of said nozzles also have an axial component thereby directing fluid axially proximal or distal.

27. The method as claimed in claim 25 or claim 26 including using a common source of fluid to insufflate the portion of the lumen distal of said tube and to define said fluid curtain.

28. The method as claimed in claim 25 wherein said source of fluid comprises a gas source.

29. The method as claimed in claim 28 wherein said gas source comprises an air source.

30. The method as claimed in claim 23 wherein said portal comprises an outer member, an inner member inward of said outer member and a chamber between said inner member and said outer member, including supplying a material to said chamber to cause said inner member to form around an instrument in the overtube.

31. The method as claimed in claim 30 including selectively supplying said material from a source of fluid to between said inner and outer members.

32. The method as claimed in claim 31 wherein said source of fluid comprises a source of liquid.

33. The method as claimed in claim 32 wherein said source of liquid comprises a source of saline.

34. The method as claimed in any of claims 30 through 33 wherein said inner member comprises a flexible film that is radially inward of said outer member.

35. The method as claimed in claim 34 wherein said material comprises a viscous material.

36. The method as claimed in claim 35 wherein said viscous material is pliable thereby allowing said film to moveably form around an instrument in said overtube.

37. The method as claimed in claim 36 wherein said outer member comprises another flexible film.

38. The method as claimed in claim 23 including sensing pressure level in said tube and adjusting said resisting to regulate the pressure level in said tube.

39. The method as claimed in claim 23 wherein said portal comprises a barrier and a plurality of lumens defined in said barrier, said method further including resisting flow of a fluid with said barrier proximally past said portal and positioning instruments through at least some of said lumens into said tube.

40. The method as claimed in claim 23 wherein said tube is configured to the size and shape of a portion of the esophagus.

41. The method as claimed in claim 23 wherein said overtube defines a passage and wherein said method includes directing insufflating fluid distal of said tube through said passage.