Method and apparatus for stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/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 9,924,853 B2
• Filed: 11/13/2014
• Issued: 03/27/2018
• Est. Priority Date: 12/15/2009
• Status: Active Grant

• Current Assignee: Cornell University
• Original Assignee: Cornell University
• Inventors: Milsom, Jeffrey, Riina, Howard, Cornhill, J. Frederick, Dickinson, Edward, Strohl, Clair, Mahoney, James J., Coppola, Pat
• Primary Examiner(s): STRANSKY, KATRINA MARIE
• Application Number:
  US14/540,355
• Publication Number:
  US 20150133774A1
• Time in Patent Office: 1,230 Days
• Field of Search: 606190-199, 600114-118, 600129, 600137, 600104, 600106, 604 9601, 60410101-10105
• 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 1/31 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 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system

Abstract

The present invention comprises the provision and use of a novel endoscopic device which is capable of stabilizing, straightening, expanding and/or flattening the side wall of a body lumen and/or body cavity so as to better present the side wall tissue for examination and/or treatment during an endoscopic procedure. The present invention also comprises the provision and use of a novel endoscopic device capable of steadying and/or stabilizing the distal tips and/or working ends of instruments inserted into a body lumen and/or body cavity, whereby to facilitate the use of those instruments.

Claims

1. Apparatus comprising:

an endoscope comprising a shaft having a distal end and a proximal end, and a handle attached to the proximal end of the shaft of the endoscope, wherein the longitudinal axis of the shaft of the endoscope defines a shaft axis of the endoscope;

a sleeve disposed over the exterior of the shaft of the endoscope, wherein the sleeve comprises a distal end and a proximal end, wherein the sleeve extends over the exterior of the shaft of the endoscope from the distal end of the shaft of the endoscope to the proximal end of the shaft of the endoscope, and wherein the longitudinal axis of the sleeve defines a sleeve axis, the sleeve axis being in fixed disposition relative to the shaft axis of the endoscope, and further wherein the sleeve comprises at least one lumen extending through the sleeve, the lumen having a longitudinal axis which defines a lumen axis, the lumen axis being in fixed disposition relative to the sleeve axis and the shaft axis of the endoscope;

a proximal balloon secured to the sleeve near the distal end of the sleeve;

a pusher element having a distal end and a proximal end, the longitudinal axis of the pusher element defining a pusher element axis, the pusher element axis being in fixed disposition relative to the lumen axis, the sleeve axis and the shaft axis of the endoscope, wherein the pusher element is longitudinally slidably mounted in the at least one lumen of the sleeve such that the distal end of the pusher element can be advanced distally beyond the distal end of the sleeve, the pusher element being substantially flexible and having substantial column strength; and

a distal balloon secured to the distal end of the pusher element.

2. Apparatus according to claim 1 further comprising means mounted in the at least one lumen of the sleeve for moving the pusher element relative to the sleeve.

3. Apparatus according to claim 2 wherein the means comprises a double pull mechanism, wherein the double pull mechanism comprises a double pull line attached to the pusher element at an attachment point, and further wherein the double pull line comprises a retract line which extends proximally from the attachment point and an extend line which extends distally from the attachment point.

4. Apparatus according to claim 3 further comprising a bearing structure attached to the sleeve distal to the attachment point, and further wherein the extend line extends distally from the attachment point, around the bearing structure and then proximally from the bearing structure.

5. Apparatus according to claim 3 further comprising a motorized drive system configured to (i) selectively apply a pulling force to the retract line, (ii) selectively apply a pulling force to the extend line, or (iii) hold the retract line and extend line against movement.

6. Apparatus according to claim 2 wherein the means is moved proximally to move the pusher element relative to the sleeve.

7. Apparatus according to claim 1 wherein the pusher element comprises a tube.

8. Apparatus according to claim 7 wherein the tube is formed out of a superelastic material.

9. Apparatus according to claim 8 wherein the pusher element is configured to slidably receive a guidewire therein.

10. Apparatus according to claim 9 further comprising a guidewire disposed in the pusher element.

11. Apparatus according to claim 1 wherein the sleeve is configured to make a close fit with the exterior of the shaft of the endoscope such that the sleeve will slide easily over the shaft of the endoscope during mounting thereon but will remain in place during use.

12. Apparatus according to claim 1 further comprising a handle secured to the sleeve at the proximal end of the sleeve.

13. Apparatus according to claim 1 wherein the sleeve includes a lubricious coating on at least one of its interior surface and its exterior surface.

14. Apparatus according to claim 1 wherein the proximal balloon is spaced from the distal end of the sleeve by a distance which is substantially equal to a length of a flexible portion of an endoscope.

15. Apparatus according to claim 1 wherein at least one of the sleeve and the proximal balloon comprises a radiopaque marker.

16. Apparatus according to claim 1 wherein the distal balloon comprises a radiopaque marker.

17. Apparatus according to claim 1 further comprising a rip sleeve for selectively covering at least one of the proximal balloon and the distal balloon prior to inflation.

18. Apparatus according to claim 17 further comprising a rip cord for selectively opening the rip sleeve.

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

providing an apparatus comprising;

an endoscope comprising a shaft having a distal end and a proximal end, and a handle attached to the proximal end of the shaft of the endoscope, wherein the longitudinal axis of the shaft of the endoscope defines a shaft axis of the endoscope;

a sleeve disposed over the exterior of the shaft of the endoscope, wherein the sleeve comprises a distal end and a proximal end, wherein the sleeve extends over the exterior of the shaft of the endoscope from the distal end of the shaft of the endoscope to the proximal end of the shaft of the endoscope, and wherein the longitudinal axis of the sleeve defines a sleeve axis, the sleeve axis being in fixed disposition relative to the shaft axis of the endoscope, and further wherein the sleeve comprises at least one lumen extending through the sleeve, the lumen having a longitudinal axis which defines a lumen axis, the lumen axis being in fixed disposition relative to the sleeve axis and the shaft axis of the endoscope;

a proximal balloon secured to the sleeve near the distal end of the sleeve;

a pusher tube having a distal end and a proximal end, the longitudinal axis of the pusher element defining a pusher element axis, the pusher element axis being in fixed disposition relative to the lumen axis, the sleeve axis and the shaft axis of the endoscope, wherein the pusher tube is longitudinally slidably mounted in the at least one lumen of the sleeve, such that the distal end of the pusher tube can be advanced distally beyond the distal end of the sleeve, the pusher tube being substantially flexible and having substantial column strength and the pusher tube being configured to slidably receive a guidewire therein; and

a distal balloon secured to the distal end of the pusher tube;

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

inflating the proximal balloon;

advancing a guidewire through the pusher tube;

advancing the pusher tube along the guidewire;

inflating the distal balloon; and

performing the procedure.

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

providing an apparatus comprising;

an endoscope comprising a shaft having a distal end and a proximal end, and a handle attached to the proximal end of the shaft of the endoscope, wherein the longitudinal axis of the shaft of the endoscope defines a shaft axis of the endoscope;

a sleeve disposed over the exterior of the shaft of the endoscope, wherein the sleeve comprises a distal end and a proximal end, wherein the sleeve extends over the exterior of the shaft of the endoscope from the distal end of the shaft of the endoscope to the proximal end of the shaft of the endoscope, and wherein the longitudinal axis of the sleeve defines a sleeve axis, the sleeve axis being in fixed disposition relative to the shaft axis of the endoscope, and further wherein the sleeve comprises at least one lumen extending through the sleeve, the lumen having a longitudinal axis which defines a lumen axis, the lumen axis being in fixed disposition relative to the sleeve axis and the shaft axis of the endoscope;

a proximal balloon secured to the sleeve near the distal end of the sleeve;

a pusher element having a distal end and a proximal end, the longitudinal axis of the pusher element defining a pusher element axis, the pusher element axis being in fixed disposition relative to the lumen axis, the sleeve axis and the shaft axis of the endoscope, wherein the pusher element is longitudinally slidably mounted in the at least one lumen of the sleeve such that the distal end of the pusher element can be advanced distally beyond the distal end of the sleeve, the pusher element being substantially flexible and having substantial column strength; and

a distal balloon secured to the distal end of the pusher element;

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

inflating the proximal balloon;

advancing the pusher element distally relative to the sleeve;

inflating the distal balloon; and

performing the procedure.

21. A method according to claim 20 further comprising means mounted in the at least one lumen of the sleeve for moving the pusher element relative to the sleeve.

22. A method according to claim 21 wherein the means comprises a double pull mechanism, wherein the double pull mechanism comprises a double pull line attached to the pusher element at an attachment point, and further wherein the double pull line comprises a retract line which extends proximally from the attachment point and an extend line which extends distally from the attachment point.

23. A method according to claim 22 further comprising a bearing structure attached to the sleeve distal to the attachment point, and further wherein the extend line extends distally from the attachment point, around the bearing structure and then proximally from the bearing structure.

24. A method according to claim 22 further comprising a motorized drive system configured to (i) selectively apply a pulling force to the retract line, (ii) selectively apply a pulling force to the extend line, or (iii) hold the retract line and extend line against movement.

25. A method according to claim 21 wherein the means is moved proximally to move the pusher element relative to the sleeve.

26. A method according to claim 20 wherein the pusher element comprises a tube.

27. A method according to claim 26 wherein the tube is formed out of a superelastic material.

28. A method according to claim 27 wherein the pusher element is configured to slidably receive a guidewire therein.

29. A method according to claim 28 further comprising a guidewire disposed in the pusher element.

30. A method according to claim 20 wherein the sleeve is configured to make a close fit with the exterior of the shaft of the endoscope such that the sleeve will slide easily over the shaft of the endoscope during mounting thereon but will remain in place during use.

31. A method according to claim 20 further comprising a handle secured to the sleeve at the proximal end of the sleeve.

32. A method according to claim 20 wherein the sleeve includes a lubricious coating on at least one of its interior surface and its exterior surface.

33. A method according to claim 20 wherein the proximal balloon is spaced from the distal end of the sleeve by a distance which is substantially equal to a length of a flexible portion of an endoscope.

34. A method according to claim 20 wherein at least one of the sleeve and the proximal balloon comprises a radiopaque marker.

35. A method according to claim 20 wherein the distal balloon comprises a radiopaque marker.

36. A method according to claim 20 further comprising a rip sleeve for selectively covering at least one of the proximal balloon and the distal balloon prior to inflation.

37. A method according to claim 36 further comprising a rip cord for selectively opening the rip sleeve.