IP Library Granted Patent US 12,022,998
Granted Patent B2
US 12,022,998 · App. 17/527,804 · Granted Jul 2, 2024

Methods and apparatus for inverting a hollow sleeve and thereafter reverting an inverted hollow sleeve

Inventors: David Gaddy (Portsmouth, NH); Niklas Helmick (Allston, MA); Jonathan E. Wilson (Mattapoisett, MA); Jack Hale (Bristol, CT)
Assignee: Lumendi Ltd.
A61B1/00089A61B1/00082A61B1/0011A61M25/0045A61M25/0074
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Quick Facts
Patent No.
US 12,022,998
App. No.
17/527,804
Granted
Jul 2, 2024
Kind
B2
Abstract

Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising: a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube; wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube; and further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.

Claims (131)

1. Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:

a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;

an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube; and

at least one flexible mandrel configured to be passed through at least one support tube formed on an exterior surface of the elongated flexible tubular sleeve;

wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube;

and further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.

2. The apparatus of claim 1 further comprising a lever for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod.

3. The apparatus of claim 1 wherein the distal end of the elongated rod comprises an opening for receiving the at least one flexible mandrel.

4. The apparatus of claim 1 further comprising a clamp disposed adjacent to the proximal end of the hollow tube, the clamp being configured to clamp the elongated flexible tubular sleeve adjacent to the proximal end of the hollow tube.

5. The apparatus of claim 1 further comprising an intermediate clamp disposed intermediate the distal end and the proximal end of the hollow tube, the intermediate clamp being configured to clamp the elongated flexible tubular sleeve intermediate the distal end and the proximal end of the hollow tube.

6. The apparatus of claim 1 wherein the sleeve plug secures the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube through an interference fit.

7. The apparatus of claim 1 wherein the sleeve plug comprises an expandable plug and a holding collar, the expandable plug being mounted to the distal end of the elongated rod.

8. The apparatus of claim 7 wherein the expandable plug comprises a first portion and a second portion, wherein the second portion is configured to be moved into the first portion to expand the outer diameter of the expandable plug.

9. The apparatus of claim 1 further comprising a handle, wherein the handle is configured to be mounted over the proximal end of the elongated flexible tubular sleeve for pulling the elongated flexible tubular sleeve distally.

10. A method for inverting an elongated, flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the method comprising:

providing an apparatus comprising:

a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end; and

an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube;

disposing the elongated flexible tubular sleeve over the hollow tube;

moving the elongated rod proximally, whereby to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube;

pulling the proximal end of the elongated flexible tubular sleeve distally toward the distal end of the elongated flexible tubular sleeve, whereby to invert the elongated flexible tubular sleeve; and

applying a hydrophilic coating to the inverted flexible tubular sleeve.

11. The method according to claim 10 further comprising a lever for selectively moving the elongated rod distally or proximally relative to the distal end of the hollow tube, wherein the lever is mounted to the proximal end of the elongated rod.

12. The method of claim 10 wherein the elongated flexible tubular sleeve comprises at least one support tube formed on the exterior surface of the elongated flexible tubular sleeve, wherein the apparatus further comprises at least one flexible mandrel, and further wherein the method further comprises passing the at least one flexible mandrel through the at least one support tube prior to inverting the elongated flexible tubular sleeve.

13. The method of claim 12 wherein the distal end of the elongated rod comprises an opening for receiving the at least one flexible mandrel.

14. The method of claim 10 further comprising a clamp disposed adjacent to the proximal end of the hollow tube, and clamping the elongated flexible tubular sleeve adjacent to the proximal end of the hollow tube prior to clamping the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube.

15. The method of claim 10 further comprising an intermediate clamp disposed intermediate the distal end and the proximal end of the hollow tube, and clamping the elongated flexible tubular sleeve intermediate the distal end and the proximal end of the hollow tube prior to clamping the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube.

16. The method of claim 10 wherein the sleeve plug secures the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube through an interference fit.

17. The method of claim 10 wherein the sleeve plug comprises an expandable plug and a holding collar, the expandable plug being mounted to the distal end of the elongated rod, and further wherein the method further comprises:

positioning the expansion plug within the distal end of the elongated flexible tubular sleeve;

positioning the holding collar over the distal end of the elongated flexible tubular sleeve and the expandable plug; and

expanding the expandable plug to secure the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube.

18. The method of claim 17 wherein the expandable plug comprises a first portion and a second portion, wherein the second portion is configured to be moved into the first portion to expand the outer diameter of the expandable plug.

19. A method according to claim 10 further comprising curing the hydrophilic coating with UV light.

20. The method of claim 19 further comprising everting the inverted elongated flexible tubular sleeve.

21. The method of claim 20 wherein the apparatus further comprises a handle, and further wherein the method further comprises mounting the handle over the proximal end of the inverted elongated flexible tubular sleeve and pulling the elongated flexible tubular sleeve distally to evert the inverted elongated flexible tubular sleeve.

22. The method of claim 10 further comprising moving the elongated rod distally to release the distal end of the elongated flexible tubular sleeve from the hollow tube.

23. Apparatus comprising:

a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope, wherein the interior surface of the sleeve lumen comprises a hydrophilic coating; and

at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween, and further wherein the at least one support channel is configured to receive an instrument.

24. The apparatus of claim 23 wherein the hydrophilic coating is applied to the interior surface of the sleeve lumen by:

inverting the sleeve;

applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;

allowing the hydrophilic coating to cure; and

reverting the sleeve.

25. The apparatus of claim 23 wherein the sleeve is flexible.

26. The apparatus of claim 23 wherein the at least one support channel is disposed external to the sleeve lumen.

27. The apparatus of claim 23 wherein the channel proximal end is disposed adjacent to the sleeve proximal end, and wherein the channel distal end is disposed adjacent to the sleeve distal end.

28. The apparatus of claim 23 further comprising at least one push tube slidably mounted to the sleeve.

29. The apparatus of claim 28 wherein the at least one push tube is slidably mounted within the at least one support channel.

30. The apparatus of claim 23 further comprising at least one push tube fixedly mounted to the sleeve.

31. The apparatus of claim 30 wherein the at least one push tube is fixedly mounted within the at least one support channel.

32. The apparatus of claim 23 further comprising:

a balloon secured to the sleeve; and

an inflation/deflation tube carried by the sleeve and in fluid communication with an interior of the balloon.

33. The apparatus of claim 32 wherein the channel distal end is disposed distal to the balloon.

34. A method for applying a hydrophilic coating to a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises:

a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior of the endoscope so as that the interior surface of the sleeve lumen substantially covers 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; and

at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween, and further wherein the at least one support channel is configured to receive at least one from the group consisting of an instrument and a push tube;

wherein the method comprises:

inverting the sleeve;

applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;

allowing the hydrophilic coating to cure; and

reverting the sleeve.

35. Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:

a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;

an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube; and

a clamp disposed adjacent to the proximal end of the hollow tube, the clamp being configured to clamp the elongated flexible tubular sleeve adjacent to the proximal end of the hollow tube;

wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube;

and further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.

36. Apparatus for inverting an elongated flexible tubular sleeve having a proximal end, a distal end and a central lumen extending between the proximal end and the distal end, the apparatus comprising:

a hollow tube comprising a proximal end, a distal end and a central lumen extending between the proximal end and the distal end;

an elongated rod movably disposed within the central lumen of the hollow tube, the elongated rod having a proximal end and a distal end, wherein the distal end of the elongated rod comprises a sleeve plug for securing a distal end of an elongated flexible tubular sleeve to the distal end of the hollow tube; and

an intermediate clamp disposed intermediate the distal end and the proximal end of the hollow tube, the intermediate clamp being configured to clamp the elongated flexible tubular sleeve intermediate the distal end and the proximal end of the hollow tube;

wherein, when the elongated flexible tubular sleeve is disposed over the hollow tube, (i) the sleeve plug of the elongated rod is configured to be moved proximally to clamp the distal end of the elongated flexible tubular sleeve to the distal end of the hollow tube, and (ii) the sleeve plug of the elongated rod is configured to be moved distally to release the distal end of the elongated flexible tubular sleeve from the distal end of the hollow tube;

and further wherein when the distal end of the elongated flexible tubular sleeve is clamped to the distal end of the hollow tube, the proximal end of the elongated flexible tubular sleeve can be pulled toward the distal end of the hollow tube to invert the elongated flexible tubular sleeve.

37. Apparatus comprising:

a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope, wherein the interior surface of the sleeve lumen comprises a hydrophilic coating;

at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween; and

at least one push tube slidably mounted to the sleeve.

38. The apparatus of claim 37 wherein the hydrophilic coating is applied to the interior surface of the sleeve lumen by:

inverting the sleeve;

applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;

allowing the hydrophilic coating to cure; and

reverting the sleeve.

39. The apparatus of claim 37 wherein the sleeve is flexible.

40. The apparatus of claim 37 wherein the at least one support channel is disposed external to the sleeve lumen.

41. The apparatus of claim 37 wherein the channel proximal end is disposed adjacent to the sleeve proximal end, and wherein the channel distal end is disposed adjacent to the sleeve distal end.

42. The apparatus of claim 37 wherein the at least one support channel is configured to receive an instrument.

43. The apparatus of claim 37 wherein the at least one push tube is slidably mounted within the at least one support channel.

44. The apparatus of claim 37 further comprising:

a balloon secured to the sleeve; and

an inflation/deflation tube carried by the sleeve and in fluid communication with an interior of the balloon.

45. The apparatus of claim 44 wherein the channel distal end is disposed distal to the balloon.

46. Apparatus comprising:

a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope, wherein the interior surface of the sleeve lumen comprises a hydrophilic coating;

at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween; and

at least one push tube fixedly mounted to the sleeve.

47. The apparatus of claim 46 wherein the hydrophilic coating is applied to the interior surface of the sleeve lumen by:

inverting the sleeve;

applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;

allowing the hydrophilic coating to cure; and

reverting the sleeve.

48. The apparatus of claim 46 wherein the sleeve is flexible.

49. The apparatus of claim 46 wherein the at least one support channel is disposed external to the sleeve lumen.

50. The apparatus of claim 46 wherein the channel proximal end is disposed adjacent to the sleeve proximal end, and wherein the channel distal end is disposed adjacent to the sleeve distal end.

51. The apparatus of claim 46 wherein the at least one support channel is configured to receive an instrument.

52. The apparatus of claim 46 wherein the at least one push tube is fixedly mounted within the at least one support channel.

53. The apparatus of claim 46 further comprising:

a balloon secured to the sleeve; and

an inflation/deflation tube carried by the sleeve and in fluid communication with an interior of the balloon.

54. The apparatus of claim 53 wherein the channel distal end is disposed distal to the balloon.

55. Apparatus comprising:

a sleeve adapted to be slid over the exterior of an endoscope, wherein the sleeve comprises a sleeve proximal end, a sleeve distal end and a sleeve lumen extending therebetween, and further wherein the sleeve is configured to be slid over the exterior surface of the endoscope so as that the interior surface of the sleeve lumen substantially covers the exterior surface of the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope, wherein the interior surface of the sleeve lumen comprises a hydrophilic coating;

at least one support channel carried by the sleeve, wherein the at least one support channel comprises a channel proximal end, a channel distal end and a channel lumen extending therebetween;

a balloon secured to the sleeve; and

an inflation/deflation tube carried by the sleeve and in fluid communication with an interior of the balloon.

56. The apparatus of claim 55 wherein the hydrophilic coating is applied to the interior surface of the sleeve lumen by:

inverting the sleeve;

applying the hydrophilic coating to the inverted interior surface of the sleeve lumen;

allowing the hydrophilic coating to cure; and

reverting the sleeve.

57. The apparatus of claim 55 wherein the sleeve is flexible.

58. The apparatus of claim 55 wherein the at least one support channel is disposed external to the sleeve lumen.

59. The apparatus of claim 55 wherein the channel proximal end is disposed adjacent to the sleeve proximal end, and wherein the channel distal end is disposed adjacent to the sleeve distal end.

60. The apparatus of claim 55 wherein the at least one support channel is configured to receive an instrument.

61. The apparatus of claim 55 further comprising at least one push tube slidably mounted to the sleeve.

62. The apparatus of claim 61 wherein the at least one push tube is slidably mounted within the at least one support channel.

63. The apparatus of claim 55 further comprising at least one push tube fixedly mounted to the sleeve.

64. The apparatus of claim 63 wherein the at least one push tube is fixedly mounted within the at least one support channel.

65. The apparatus of claim 55 wherein the channel distal end is disposed distal to the balloon.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 18, 2025
From: LUMENDI LTD.
To: LUMENDI AG
Reel/Frame 072572/0602 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 20, 2024
From: HELMICK, NIKLAS
To: LUMENDI LTD.
Reel/Frame 067467/0734 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2024
From: HALE, JACK
To: LUMENDI LTD.
Reel/Frame 067448/0435 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2024
From: WILSON, JONATHAN E.
To: LUMENDI LTD.
Reel/Frame 067448/0538 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 17, 2024
From: GADDY, DAVID
To: LUMENDI LTD.
Reel/Frame 067448/0721 →
Continuity (2)
Provisional Application 63114070 · Nov 16, 2020
Related Publication 20220218182A1 · Jul 14, 2022