Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same

• US 9,986,893 B2
• Filed: 02/11/2015
• Issued: 06/05/2018
• Est. Priority Date: 12/15/2009
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Cornhill, John Frederick, Milsom, Jeffrey, Sharma, Sameer, Nguyen, Tuan Anh, Dillon, Christopher, Greeley, Gabriel, Sathe, Rahul, DeNardo, Matthew, Whitney, Ashley, Van Hill, Jeremy, Assal, Anthony Z.
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US14/619,845
• Publication Number:
  US 20150150436A1
• Time in Patent Office: 1,210 Days
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 1/00154 using guiding arrangements for insertion
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

Apparatus comprising: a sleeve adapted to be slid over the exterior of an endoscope; a proximal balloon secured to the sleeve; an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the proximal balloon; a push tube slidably mounted to the sleeve; and a distal balloon secured to the distal end of the push tube, the interior of the distal balloon being in fluid communication with the push tube, wherein the distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when the distal balloon is in its deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and when the distal balloon is in its inflated condition, the axial opening is closed down.

Claims

1. Apparatus comprising:

a sleeve adapted to be slid over an exterior of an endoscope;

a proximal balloon secured to said sleeve;

an inflation/deflation tube carried by said sleeve and in fluid communication with an interior of said proximal balloon;

a push tube slidably mounted to said sleeve, the push tube having a distal end and a proximal end; and

a distal balloon secured to the distal end of said push tube, an interior of said distal balloon being in fluid communication with said push tube, wherein said distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when said distal balloon is in its deflated condition, an axial opening extends therethrough, said axial opening being sized to receive the endoscope therein, and when said distal balloon is in its inflated condition, said axial opening is closed down.

2. Apparatus according to claim 1 wherein the endoscope is a steerable endoscope comprising an articulating portion, and further wherein said proximal balloon is secured to said sleeve proximal to the articulating portion of the steerable endoscope.

3. Apparatus according to claim 1 wherein said distal balloon comprises a body having a proximal opening and a distal opening, a proximal extension having a key-shaped cross-section comprising a lobe, and a distal extension having a circular cross-section, and further wherein said distal balloon is formed by everting said proximal extension into the interior of said body and thereafter everting said distal extension into the interior of said proximal extension.

4. Apparatus according to claim 3 wherein said push tube is disposed in said lobe before said proximal extension is everted into the interior of said body.

5. Apparatus according to claim 1 wherein the endoscope comprises a distal end and a proximal end, wherein the proximal end comprises a handle, and further wherein said sleeve is sized so as to substantially cover the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.

6. Apparatus according to claim 1 wherein said sleeve is configured to make a close fit with the exterior of the endoscope such that said sleeve slides easily over the endoscope during mounting thereon but remains in place during use of the endoscope.

7. Apparatus according to claim 1 wherein the sleeve comprises a distal end and a proximal end, and further wherein the sleeve comprises a base secured to the sleeve at the proximal end of the sleeve.

8. Apparatus according to claim 1 wherein said inflation/deflation tube is formed integral with said sleeve.

9. Apparatus according to claim 1 wherein said sleeve comprises a passageway for receiving said push tube.

10. Apparatus according to claim 9 wherein said passageway is formed integral with said sleeve.

11. Apparatus according to claim 9 wherein said passageway receives a support tube which receives said push tube.

12. Apparatus according to claim 1 wherein the distal end of said push tube is atraumatic.

13. Apparatus according to claim 1 comprising a second push tube slidably mounted to said sleeve.

14. Apparatus according to claim 13 wherein said second push tube is diametrically opposed to said push tube.

15. Apparatus according to claim 1 wherein said sleeve comprises a lumen for receiving an instrument.

16. Apparatus according to claim 15 wherein said lumen is formed integral with said sleeve.

17. Apparatus according to claim 15 wherein said lumen receives an instrument guide tube which receives an instrument.

18. Apparatus according to claim 1 wherein at least one of said sleeve, said proximal balloon, said push tube and said distal balloon comprises a visualizable marker.

19. A method for performing a procedure in a body lumen and/or body cavity, said method comprising:

providing an apparatus comprising;

a sleeve adapted to be slid over an exterior of an endoscope;

a proximal balloon secured to said sleeve;

an inflation/deflation tube carried by said sleeve and in fluid communication with an interior of said proximal balloon;

a push tube slidably mounted to said sleeve, the push tube having a distal end and a proximal end; and

a distal balloon secured to the distal end of said push tube, an interior of said distal balloon being in fluid communication with said push tube, wherein said distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when said distal balloon is in its deflated condition, an axial opening extends therethrough, said axial opening being sized to receive the endoscope therein, and when said distal balloon is in its inflated condition, said axial opening is closed down;

positioning said apparatus in the body lumen and/or body cavity;

inflating said proximal balloon;

advancing said push tube distally;

inflating said distal balloon; and

performing the procedure.

20. A method according to claim 19 wherein the endoscope is a steerable endoscope comprising an articulating portion, and further wherein said proximal balloon is secured to said sleeve proximal to the articulating portion of the steerable endoscope.

21. A method according to claim 19 further comprising, after inflating said distal balloon, at least partially deflating said distal balloon, and withdrawing said push tube proximally so as to position said distal balloon over the endoscope.

22. A method according to claim 19 wherein said distal balloon comprises a body having a proximal opening and a distal opening, a proximal extension having a key-shaped cross-section comprising a lobe, and a distal extension having a circular cross-section, and further wherein said distal balloon is formed by everting said proximal extension into the interior of said body and thereafter everting said distal extension into the interior of said proximal extension.

23. A method according to claim 22 wherein said push tube is disposed in said lobe before said proximal extension is everted into the interior of said body.

24. A method according to claim 19 wherein the endoscope comprises a distal end and a proximal end, wherein the proximal end comprises a handle, and further wherein said sleeve is sized so as to substantially cover the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.

25. A method according to claim 19 wherein said sleeve is configured to make a close fit with the exterior of the endoscope such that said sleeve slides easily over the endoscope during mounting thereon but remains in place during use of the endoscope.

26. A method according to claim 19 wherein the sleeve comprises a distal end and a proximal end, and further wherein the sleeve comprises a base secured to the sleeve at the proximal end of the sleeve.

27. A method according to claim 19 wherein said inflation/deflation tube is formed integral with said sleeve.

28. A method according to claim 19 wherein said sleeve comprises a passageway for receiving said push tube.

29. A method according to claim 28 wherein said passageway is formed integral with said sleeve.

30. A method according to claim 28 wherein said passageway receives a support tube which receives said push tube.

31. A method according to claim 19 wherein the distal end of said push tube is atraumatic.

32. A method according to claim 19 comprising a second push tube slidably mounted to said sleeve.

33. A method according to claim 32 wherein said second push tube is diametrically opposed to said push tube.

34. A method according to claim 19 wherein said sleeve comprises a lumen for receiving an instrument.

35. A method according to claim 34 wherein said lumen is formed integral with said sleeve.

36. A method according to claim 34 wherein said lumen receives an instrument guide tube which receives an instrument.

37. A method according to claim 19 wherein at least one of said sleeve, said proximal balloon, said push tube and said distal balloon comprises a visualizable marker.

38. A method according to claim 19 further comprising, after inflating said distal balloon, advancing said push tube distally so as to cause said push tube to bow outwardly.

39. Apparatus comprising:

a sleeve adapted to be slid over an exterior of an endoscope, wherein the endoscope comprises a distal end and a proximal end, wherein the proximal end comprises a handle, and further wherein the sleeve is slid over the exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope;

a proximal balloon secured to said sleeve;

an inflation/deflation tube carried by said sleeve and in fluid communication with an interior of said proximal balloon;

a push tube slidably mounted to said sleeve, the push tube having a distal end and a proximal end; and

a distal balloon secured to the distal end of said push tube, an interior of said distal balloon being in fluid communication with said push tube, wherein said distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when said distal balloon is in its deflated condition, an axial opening extends therethrough, said axial opening being sized to receive the endoscope therein, and when said distal balloon is in its inflated condition, said axial opening is closed down.

40. Apparatus according to claim 39 wherein the endoscope is a steerable endoscope comprising an articulating portion, and further wherein said proximal balloon is secured to said sleeve proximal to the articulating portion of the steerable endoscope.

41. Apparatus according to claim 39 wherein said sleeve is configured to make a close fit with the exterior of the endoscope such that said sleeve slides easily over the endoscope during mounting thereon but remains in place during use of the endoscope.

42. Apparatus according to claim 39 further comprising a base secured to said sleeve at the proximal end of said sleeve.

43. Apparatus according to claim 39 wherein said inflation/deflation tube is formed integral with said sleeve.

44. Apparatus according to claim 39 wherein said sleeve comprises a passageway for receiving said push tube.

45. Apparatus according to claim 44 wherein said passageway is formed integral with said sleeve.

46. Apparatus according to claim 44 wherein said passageway receives a support tube which receives said push tube.

47. Apparatus according to claim 39 wherein the distal end of said push tube is atraumatic.

48. Apparatus according to claim 39 comprising a second push tube slidably mounted to said sleeve.

49. Apparatus according to claim 48 wherein said second push tube is diametrically opposed to said push tube.

50. Apparatus according to claim 39 wherein said sleeve comprises a lumen for receiving an instrument.

51. Apparatus according to claim 50 wherein said lumen is formed integral with said sleeve.

52. Apparatus according to claim 50 wherein said lumen receives an instrument guide tube which receives an instrument.

53. Apparatus according to claim 39 wherein said distal balloon comprises a body having a proximal opening and a distal opening, a proximal extension having a key-shaped cross-section comprising a lobe, and a distal extension having a circular cross-section, and further wherein said distal balloon is formed by everting said proximal extension into the interior of said body and thereafter everting said distal extension into the interior of said proximal extension.

54. Apparatus according to claim 53 wherein said push tube is disposed in said lobe before said proximal extension is everted into the interior of said body.

55. Apparatus according to claim 39 wherein at least one of said sleeve, said proximal balloon, said push tube and said distal balloon comprises a visualizable marker.

56. A method for performing a procedure in a body lumen and/or body cavity, said method comprising:

providing an apparatus comprising;

a sleeve adapted to be slid over an exterior of an endoscope, wherein the endoscope comprises a distal end and a proximal end, wherein the proximal end comprises a handle, and further wherein the sleeve is slid over the exterior of the endoscope so as to substantially cover the exterior of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope;

a proximal balloon secured to said sleeve;

an inflation/deflation tube carried by said sleeve and in fluid communication with an interior of said proximal balloon;

a push tube slidably mounted to said sleeve, the push tube having a distal end and a proximal end; and

a distal balloon secured to the distal end of said push tube, an interior of said distal balloon being in fluid communication with said push tube, wherein said distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when said distal balloon is in its deflated condition, an axial opening extends therethrough, said axial opening being sized to receive the endoscope therein, and when said distal balloon is in its inflated condition, said axial opening is closed down;

positioning said apparatus in the body lumen and/or body cavity;

inflating said proximal balloon;

advancing said push tube distally;

inflating said distal balloon; and

performing the procedure.

57. A method according to claim 56 wherein the endoscope is a steerable endoscope comprising an articulating portion, and further wherein said proximal balloon is secured to said sleeve proximal to the articulating portion of the steerable endoscope.

58. A method according to claim 56 wherein said sleeve is configured to make a close fit with the exterior of the endoscope such that said sleeve slides easily over the endoscope during mounting thereon but remains in place during use of the endoscope.

59. A method according to claim 56 further comprising a base secured to said sleeve at the proximal end of said sleeve.

60. A method according to claim 56 wherein said inflation/deflation tube is formed integral with said sleeve.

61. A method according to claim 56 wherein said sleeve comprises a passageway for receiving said push tube.

62. A method according to claim 61 wherein said passageway is formed integral with said sleeve.

63. A method according to claim 61 wherein said passageway receives a support tube which receives said push tube.

64. A method according to claim 56 wherein the distal end of said push tube is atraumatic.

65. A method according to claim 56 comprising a second push tube slidably mounted to said sleeve.

66. A method according to claim 65 wherein said second push tube is diametrically opposed to said push tube.

67. A method according to claim 56 wherein said sleeve comprises a lumen for receiving an instrument.

68. A method according to claim 67 wherein said lumen is formed integral with said sleeve.

69. A method according to claim 67 wherein said lumen receives an instrument guide tube which receives an instrument.

70. A method according to claim 56 wherein said distal balloon comprises a body having a proximal opening and a distal opening, a proximal extension having a key-shaped cross section comprising a lobe, and a distal extension having a circular cross-section, and further wherein said distal balloon is formed by everting said proximal extension into the interior of said body and thereafter everting said distal extension into the interior of said proximal extension.

71. A method according to claim 70 wherein said push tube is disposed in said lobe before said proximal extension is everted into the interior of said body.

72. A method according to claim 56 wherein at least one of said sleeve, said proximal balloon, said push tube and said distal balloon comprises a visualizable marker.

73. A method according to claim 56 further comprising, after inflating said distal balloon, at least partially deflating said distal balloon, and withdrawing said push tube proximally so as to position said distal balloon over the endoscope.

74. A method according to claim 56 further comprising, after inflating said distal balloon, advancing said push tube distally so as to cause said push tube to bow outwardly.

75. Apparatus comprising:

a sleeve adapted to be slid over an exterior of an endoscope;

a proximal balloon secured to said sleeve;

an inflation/deflation tube carried by said sleeve and in fluid communication with an interior of said proximal balloon;

a pair of push tubes slidably mounted to said sleeve, each of the push tubes in the pair of push tubes having a distal end and a proximal end; and

a distal balloon secured to the distal ends of said pair of push tubes, an interior of said distal balloon being in fluid communication with said pair of push tubes, wherein said distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when said distal balloon is in its deflated condition, an axial opening extends therethrough, said axial opening being sized to receive the endoscope therein, and when said distal balloon is in its inflated condition, said axial opening is closed down.

76. Apparatus according to claim 75 wherein said pair of push tubes are independently movable relative to said sleeve.

77. A method for performing a procedure in a body lumen and/or body cavity, said method comprising:

providing apparatus comprising;

a sleeve adapted to be slid over an exterior of an endoscope;

a proximal balloon secured to said sleeve;

an inflation/deflation tube carried by said sleeve and in fluid communication with an interior of said proximal balloon;

a pair of push tubes slidably mounted to said sleeve, each of the push tubes in the pair of push tubes having a distal end and a proximal end; and

a distal balloon secured to the distal ends of said pair of push tubes, an interior of said distal balloon being in fluid communication with said pair of push tubes, wherein said distal balloon is capable of assuming a deflated condition and an inflated condition, and further wherein when said distal balloon is in its deflated condition, an axial opening extends therethrough, said axial opening being sized to receive the endoscope therein, and when said distal balloon is in its inflated condition, said axial opening is closed down;

positioning said apparatus in the body lumen and/or body cavity;

inflating said proximal balloon;

advancing said pair of push tubes distally;

inflating said distal balloon; and

performing the procedure.