Method and apparatus for performing transgastric procedures

• US 20050148818A1
• Filed: 02/03/2005
• Published: 07/07/2005
• Est. Priority Date: 11/23/1999
• Status: Active Grant

• Current Assignee: Sameh Mesallum
• Original Assignee: Sameh Mesallum
• Inventors: Mesallum, Sameh
• Granted Patent: US 8,070,680 B2
• Time in Patent Office: Days
• US Class Current: 600/116
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00269 endoscopic mucosal resection EMR
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00488 Esophagus
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 5/285 Endotracheal, oesophageal or gastric probes
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Apparatus for performing a transgastric procedure includes an elongated tubular main access device having the first lumen with open proximal end and a side opening distal end, and a second lumen with open ends. A balloon having a wall on the outside of the device surrounds the distal end and a fluid conduit extends along the device for inflating the balloon so that when the device is inserted into a patient'"'"'s esophagus and the balloon is inflated, the portion of the esophagus opposite the distal end is isolated from the remainder of the esophagus. The apparatus may also include a side access unit having an elongated flexible coaxial inner and outer tubes having proximal and distal ends and being movable relatively in the axial direction. First seals are mounted to the distal end of the outer tube, and second seals are mounted to the distal end of the inner tube, an actuator adjacent to the proxable ends of the tubes move the tubes relatively so as to vary the axial spacing the first and second seals. Various methods for using the apparatus are also disclosed.

Claims

1. Apparatus for performing a transgastric procedure via the mouth and disgestive tract of a patient, said apparatus comprising

an elongated tubular access device having a proximal end, a distal end and a wall extending between said ends;

a first lumen extending along the access device, said first lumen having an open proximal end and an opening in said wall near said distal end;

expandable sealing means on the outside of said access device and extending above and below said opening, and expanding means extending along said access device for expanding said sealing means so that when the access device is inserted into said tract and the sealing means are expanded, the portion of the tract opposite said opening is isolated from the remainder of the tract above and below the opening.

2. The apparatus defined in claim 1 wherein the length of the access device is such that said opening may be located in the esophagus opposite the heart of said patient.

3. The apparatus defined in claim 1 wherein the length of the access device is such that said opening may be located in the stomach of said patient.

4. The apparatus defined in claim 1 and further including

a second lumen extending along said access device, said second lumen having a proximal end for connection to a vacuum source and a distal end which opens adjacent to said opening so that fluid may be sucked from said isolated portion of the said tract.

5. The apparatus defined in claim 1 and further including

a second lumen having a rigid outer wall and a collapsible inner wall, said second lumen being adapted to slidably receive an elongated probe or surgical device, and

means for introducing a fluid between said inner and outer walls to collapse the inner wall against the probe or surgical device received in the second lumen.

6. The apparatus defined in claim 1 and further including

perforated fluid channels formed in the outside of said device above and below said opening, and

at least one conduit extending along the device for conducting fluid to and/or from said channels.

7. The apparatus defined in claim 1 and further including a side access unit comprising

elongated flexible coaxial inner and outer tubes said tubes having proximal and distal ends and being movable relatively in the axial direction and said inner tube having at least one lumen extending between said ends;

a first clamping device mounted to the distal end of the outer tube;

a second clamping device mounted to the distal end of the inner tube, and

means adjacent to the proximal ends of said tubes for moving said tubes relatively so as to vary the axial spacing of said first and second clamping devices.

8. The apparatus defined in claim 7 wherein the first and second clamping devices comprise balloons or flanges.

9. The apparatus defined in claim 7 wherein the first clamping device comprises

a plurality of flexible, axially extending flaps mounted to the distal end of the outer tube, said flaps being movable between a collapsed position wherein the flaps are nested against the outer tube and an extended position wherein the flaps project out from the outer tube, and

means for moving the flaps between said collapsed and extended positions.

10. The apparatus defined in claim 9 wherein the moving means comprise

elongated rotatable needles extending from the proximal end of the outer tube into said flaps, said needles having segments in said flaps which are offset so that rotation of said needles moves the flaps between said collapsed and extended positions, and

means at said proximal end of the inner tube for rotating said needles.

11. The apparatus defined in claim 9 and further including cooperating means on the distal ends of said first and second tubes for forming a purse string suture.

12. The apparatus defined in claim 7 wherein said second clamping device comprises

an umbrella mounted to the outside of the inner tube, said umbrella being moveable between a retracted position wherein the umbrella nests against the inner tube within the outer tube and an extended position wherein the umbrella extends radially out from the inner tube beyond the distal end of the outer tube, and

means for moving the umbrella between its retracted and extended positions.

13. Apparatus for performing a transgastric procedure via the digestive tract, said apparatus comprising

an elongated flexible tubular shaft having a proximal end, a distal end and a side wall extending between said ends;

a first lumen extending along the shaft, said lumen having an open proximal end near the proximal end of the shaft and a distal end opening in said side wall;

first expandable sealing means on the side wall of the shaft and extending above and below said opening;

expanding means extending along the shaft for expanding said first sealing means so that when the shaft is inserted into said tract and the first sealing means are expanded, a portion of the tract opposite the opening is isolated from the remainder of the tract above and below the opening;

a fiberoptic endoscope extending along the shaft, said endoscope having a proximal end adapted for connection to a light source and a distal end located adjacent to said opening for viewing the portion of said tract opposite the opening, and

an ultrasound probe in said shaft and extending near the distal end thereof.

14. The apparatus defined in claim 13 wherein the first sealing means comprise at least one inflatable balloon and the expanding means include a first fluid conduit extending along the shaft for conducting an inflation fluid to and from said at least one balloon.

15. The apparatus defined in claim 14 and further including at least one vacuum port in the shaft wall adjacent to said opening, and

a second conduit extending along the shaft, said second conduit having a proximal end for connection to a vacuum source and being in fluid communication with said at least one vacuum port so that a vacuum can be drawn in the isolated portion of the tract.

16. The apparatus defined in claim 15 and further including additional vacuum ports in the shaft wall spaced above and below said opening, said additional vacuum ports also being in fluid communication with said vacuum source.

17. The apparatus defined in claim 13 and further including fluid supply ports in the shaft wall spaced above and below said opening, said supply ports also being in fluid communication with a fluid source.

18. The apparatus defined in claim 13 and further including

a light source connected to the proximal end of the endoscope, and

an ultrasound transceiver connected to said probe.

19. The apparatus defined in claim 13 and further including an elongated probe or surgical device received in said first lumen, said elongated probe or surgical device having a working end which is deployable from said opening.

20. Apparatus for performing a transgasteric procedure to guide an endoscope or a therapeutic device into a body cavity via the gastrointestinal tract to conduct an observation or a therapeutic treatment in said body cavity, said apparatus comprising

an insertion section including a flexible guide tube which has a proximal end, a distal end and a central axis extending between said ends and which is capable of being inserted into a body through the mouth, and

a fixing device arranged in the vicinity of the distal end of the guide tube for fixing said distal end to a portion of said tract.

21. The apparatus defined in claim 20 wherein the fixing device comprises a pair of flaps which clamp the tract portion therebetween.

22. The apparatus defined in claim 20 wherein the fixing device comprises one or more inflatable balloons for engaging the tract portion.

23. The apparatus defined in claim 20 and further including a penetration device received in the guide tube, said penetration device having a distal end for projecting through the distal end of the guide tube for penetrating the tract portion at a selected penetration site.

24. The apparatus defined in claim 23 wherein the fixing device establishes a seal between the distal end of the penetration device and the tract portion around the penetration site.

25. The apparatus defined in claim 23 wherein the penetration device comprises a needle with an overlying dilator sheath.

26. A apparatus according to claim 20 wherein the insertion section has an outer diameter of 5 to 10 mm.

27. The apparatus according to claim 20 wherein the insertion section can be bent in at least one direction from said central axis.

28. Apparatus for performing a transgastric procedure to guide an endoscope or a therapeutic device into a body cavity through the mouth to conduct an observation or a therapeutic treatment in the body cavity, said apparatus comprising

an insertion section including a guide tube which has a distal end which is capable of being inserted into a body through the mouth and guiding said device to a selected cavity site,

wherein the guide tube has a distal end portion which is flexible so that the said device can be bent as it is guided to said site.

29. The apparatus according to claim 28 and further including a pair of spaced-apart inflatable balloons arranged in the vicinity of the distal end of the guide tube which balloons may be clamped to opposite sides of a wall portion of the body cavity.

30. Apparatus for performing a transgastric procedure to guide an endoscope or a therapeutic device into a body cavity through the mouth, said apparatus comprising

an insertion section including a guide tube and which can be inserted into said cavity, the insertion section having

a distal end arranged in the body and at least one lumen through which the endoscope or therapeutic device can be inserted;

a proximal end which is connected to the guide tube and is arranged at the outside of the body;

a needle which is moveably attached to the guide tube and which has an engaging portion capable of engaging a suture therewith, and

a driving force transmitting member which has one end connected to the needle and the other end arranged at said proximal end,

wherein said distal end is capable of being fixed to a required portion in the body cavity to suture tissue by operating the driving force transmitting member on the outside of the body.

31. An apparatus for performing a transgastric procedure, said apparatus comprising

an endoscope which is capable of being inserted into a lumen inside a body through the mouth;

a guide tube through which the endoscope is capable of being inserted, and

an introducing tube into which the endoscope inserted through the guide tube is capable of being inserted.

32. The apparatus defined in claim 31 wherein the guide tube forms an opening member for inserting the endoscope into a body cavity through said lumen at a wall portion of said lumen.

33. An apparatus for performing a transgastric procedure, said apparatus comprising

an elongated, hollow, flexible tube having an interior passage sized to received and allow the passage of an endoscope, said tube having an open distal end portion;

a pair of spaced-apart inflatable balloon structures defined adjacent said distal end portion of the tube, and

an inflation conduit extending from said first and second balloon structures to respective inflation ports disposed adjacent a proximal end of said tube for selective inflation and deflation of said balloons.

34. A method for performing a transgastric procedure via the digestive track of a patient, said method comprising the steps of

positioning an elongated flexible tube to extend from an exterior of the patient through the mouth into and along at least a portion of the digestive track to a target wall segment in the digestive tract;

forming an incision in said target wall segment;

advancing a distal end of said tube so that the distal end of the tube extends through said wall segment;

anchoring said distal end with respect to said wall segment;

advancing an endoscope through said tube so that a distal end of said endoscope is disposed adjacent or distal to said distal end of the conduit;

viewing at least one of a tissue and an organ within said cavity;

releasing said anchor, and

withdrawing said conduit and said endoscope through said wall and closing said incision.

35. The method as in claim 34 and further including, after the step of forming an incision and said step of advancing the conduit, dilating said incision to facilitate passage of the conduit therethrough.

36. The method as in claim 34 wherein said flexible conduit has a pair of anchoring balloons defined adjacent a distal end thereof, and wherein said anchoring step comprises inflating said anchoring balloons so that a proximal one of said balloons is disposed within said digestive track and a distal one of said balloons is disposed in the cavity, thereby to capture said wall there between.

37. The method as in claim 34 and further comprising, after said viewing step, performing at least one endoscopic surgical procedure in said cavity.

38. The method as in claim 34 wherein the step of forming an incision comprises forming an incision with an endoscopic knife device.

39. The method as in claim 34 wherein said target wall segment is a portion of the esophagus.

40. The method as in claim 34 wherein the said target wall segment is a portion of the stomach.

41. The method as in claim 34 wherein said step of positioning said flexible conduit comprises positioning said flexible conduit through the patient'"'"'s mouth and esophagus.

42. Apparatus for performing a transgastric procedure via the mouth and digestive track of a patient, said apparatus comprising a flexible guide tube which guides an endoscope or a therapeutic device into a body cavity via the mouth and stomach to conduct an observation or a therapeutic treatment in said cavity, said guide tube including an insertion section which has a distal end, a peripheral section, and a central axis which is capable of being inserted into a body through the mouth, and

first and second extendable clamping devices arranged in the vicinity of said distal end at a predetermined distance from each other in the axial direction on the periphery of the insertion section.

43. The apparatus defined in claim 42 wherein said first and second clamping devices comprise expandable balloons.

44. The apparatus defined in claim 42 wherein the insertion section includes

a wall section restricting an inner bore through which the endoscope or therapeutic device is inserted, and

means for collapsing said wall section against the endoscope or therapeutic device.

45. Apparatus for performing a transgastric procedure via the mouth and digestive track of a patient, said apparatus comprising

an insertion section which can be inserted into a body through the mouth, the insertion section having a distal end arranged in the body and at least one lumen through which the endoscope or therapeutic device can be inserted;

a proximal end which is connected to the insertion section and is arranged on the outside of the body;

a shaft;

a curved needle which is rotatably attached to the shaft and which has an engaging portion capable of engaging a suture therewith, and

a driving force transmitting member which has one end connected to the curved needle and the other end arranged at said proximal end,

wherein the distal end is capable of being fixed to a required portion in the body cavity to suture tissue by operating the driving force transmitting member on the outside of the body.

46. An endoscopic inserting system comprising:

an endoscope which is inserted into a lumen inside a body through a natural opening of a human body;

an opening member which forms an opening for inserting the endoscope into a thoracic cavity or an abdominal cavity from the lumen inside the body at a wall portion of the lumen; and

a retracting member which, when forming the opening, retracts the wall portion of the lumen.

47. An endoscopic inserting system according to claim 46 and further comprising an introducer into which the endoscope is capable of being inserted.

48. An inserting system according to claim 46 wherein the retracting member is provided at the introducer.

49. An inserting system according to clam 46 wherein the retracting member comprises:

a sucker which provides a negative pressure; and

a tubular member to maintain a negative pressure at a region in which the opening member acts.

50. An endoscopic inserting system comprising:

an endoscope which is capable of being inserted into a lumen inside a body through a natural opening of a human body;

an over-tube through which the endoscope is capable of being inserted; and

an introducer into which the endoscope inserted through the over-tube is capable of being inserted.

51. The endoscopic inserting system according to claim 50 and further comprising:

an opening member which forms an opening for inserting the endoscope into a thoracic cavity or an abdominal cavity through a lumen inside a body at a wall portion of the lumen; and

a retracting member which, when forming the opening, retracts the lumen wall.

52. A method for accessing an interior of a cavity of a patient, said method comprising:

positioning an elongated flexible conduit to extend from an exterior of the mammal through a natural orifice into an and along at least a portion of the digestive tract to a target wall segment in the digestive tract;

forming an incision in said target wall segment;

advancing a distal end of said flexible conduit so that the distal end of said conduit extends through said wall;

anchoring said distal end with respect to said wall;

advancing an endoscope through said conduit so that a distal end of said endoscope is disposed adjacent or distal to said distal end of said conduit;

viewing at least one of a tissue and an organ within said cavity;

releasing said anchor;

withdrawing said conduit and said endoscope through said wall; and

closing said incision.

53. A method as in claim 52, wherein an endoscope is disposed with said conduit during said positioning step and wherein said endoscope is manipulated to guide and direct said flexible conduit to said target wall segment.

54. A method as in claim 52, wherein said flexible conduit has a pair of anchoring balloons defined adjacent a distal end thereof, and wherein said anchoring step comprises inflating said anchoring balloons so that a proximal said balloon is disposed within said digestive tract and a distal said balloon is disposed in the cavity, thereby to capture said wall therebetween.

55. A method as in claim 52, further comprising, after said viewing step, performing at least one endoscopic surgical procedure in said cavity.

56. A method as in claim 52, wherein said step of forming an incision comprises forming an incision with an endoscopic knife device.

57. A method as in claim 56, wherein said endoscopic knife device comprises a needle-knife.

58. A method as in claim 57, wherein said endoscopic knife device is operatively coupled to an electrical source for heating said needle-knife.

59. A method as in claim 52, wherein said target wall segment is a portion of the stomach wall.

60. A method as in claim 52, wherein said step of positioning said flexible conduit comprises positioning said flexible conduit through the patient'"'"'s oral cavity and esophagus.

61. An endoscopic access device comprising:

an elongated, hollow, flexible tube having an interior passage sized to receive and allow the passage of an endoscope, said tube having an open distal end;

first and second inflatable balloon structures defined adjacent said distal end of said tube; and

an inflation conduit extending respectively from said first and second balloon structures to respective inflation ports disposed adjacent a proximal end of said tube for selective, independent inflation and deflation of said balloon structures.