MINIMALLY INVASIVE DELIVERY DEVICES AND METHODS

• US 20110061659A1
• Filed: 09/17/2009
• Published: 03/17/2011
• Est. Priority Date: 09/17/2009
• Status: Abandoned Application

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Swann, Betsy, Cruzada, Julian, Stout, Christopher
• Application Number:
  US12/562,057
• Publication Number:
  US 20110061659A1
• Time in Patent Office: Days
• US Class Current: 128/831
• CPC Class Codes: A61F 6/18 Inserters or removers ; Apparatus for loading an intra-uterine device into an insertion tube
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Transcervical pathway systems and methods are described. The system may include a delivery sheath having a first longitudinal opening and a second longitudinal opening. A visualization system, such as a hysteroscope, is deliverable through the first longitudinal opening of the delivery sheath. An implant delivery system is deliverable through the second longitudinal opening of the sheath. The implant delivery system may include a guide and an implant delivery system moveably (e.g. slideably) engaged with the guide.

Claims

1. A system for delivering an implant to a fallopian tube of a female body comprising:

a delivery sheath having a first longitudinal opening and a second longitudinal opening, wherein the first longitudinal opening is configured to receive a visualization system;

an implant delivery device having an implant sheath positionable within the second longitudinal opening and a delivery catheter deliverable through the implant sheath, wherein the implant delivery device is lockable to the delivery sheath and wherein the delivery catheter is movable longitudinally relative to the delivery sheath when the implant delivery device is locked to the delivery sheath.

2. The system of claim 1, wherein the visualization system comprises a hysteroscope and wherein the implant, disposed at a distal end of the delivery catheter, is movable rotationally relative to the delivery sheath such that the delivery sheath and the hysteroscope can be held still while the implant is moved longitudinally, and optionally rotationally, toward the ostium of the fallopian tube, and wherein the implant comprises an expandable tubular member and a tissue in-growth promoting agent.

3. The system of claim 1, wherein the delivery sheath is re-sterilizable.

4. The system of claim 1, further comprising an interlocking device connecting the delivery sheath and the implant delivery device.

5. The system of claim 4, wherein the implant delivery device comprises a ball and socket to allow rotational movement of the delivery catheter relative to the delivery sheath.

6. The system of claim 1, wherein the delivery sheath further comprises a fluid inlet and a fluid outlet.

7. The system of claim 1, wherein the delivery sheath further comprises a combined fluid inlet and fluid outlet.

8. The system of claim 1, wherein the implant comprises an inner coil and an expandable outer coil, the implant releasably coupled with the delivery catheter.

9. The system of claim 8, wherein the implant further comprises a tissue in-growth agent.

10. A system for delivering an implant to a fallopian tube of a female body comprising:

a delivery sheath having a first longitudinal opening and a second longitudinal opening, wherein the first longitudinal opening is configured to receive a visualization system;

an implant delivery device having a protective sheath and an implant sheath positionable within the second longitudinal opening and a delivery catheter deliverable through the protective sheath, wherein the delivery catheter and the implant sheath are more flexible than the protective sheath.

11. The system of claim 10, wherein the visualization system comprises a hysteroscope and wherein the implant sheath is retraced proximally to uncover the implant and allow the implant to be released, and wherein the implant comprises an expandable tubular member and a tissue in-growth promoting agent.

12. The system of claim 10, wherein the delivery sheath is re-sterilizable.

13. The system of claim 10, further comprising an interlocking device connecting the delivery sheath and the implant delivery device.

14. The system of claim 13, wherein the implant delivery device comprises a ball and socket to allow rotational movement of the delivery catheter relative to the delivery sheath.

15. The system of claim 10, wherein the delivery sheath further comprises a fluid inlet and a fluid outlet.

16. The system of claim 10, wherein the delivery sheath further comprises a combined fluid inlet and fluid outlet.

17. The system of claim 10, wherein the implant comprises an inner coil and an expandable outer coil, the implant releasably coupled with the delivery catheter.

18. The system of claim 17, wherein the implant further comprises a tissue in-growth agent.

19. An implant delivery system comprising:

a sheath having a first end and a second end;

a first longitudinal opening in the sheath having a port at the first end of the sheath to receive an implant delivery system, the port having an interlocking element to lock the implant delivery system to the sheath wherein the implant delivery system is locked to the sheath while still retaining the ability to move a deliverable implant longitudinally and rotationally relative to the sheath when it is stationary; and

a second longitudinal opening in the sheath to receive an implant viewing system.

20. The system of claim 19, wherein the implant viewing system comprises a hysteroscope and wherein the implant comprised an expandable tubular member and a tissue in-growth promoting agent.

21. The system of claim 19, wherein the sheath is re-sterilizable.

22. The system of claim 19, wherein the interlocking element comprises a tab that engages with a groove on the implant delivery system.

23. The system of claim 19, wherein the interlocking element comprises a ball and socket to allow rotational movement of the implant delivery system relative to the sheath.

24. The system of claim 19, wherein the sheath further comprises a fluid inlet and a fluid outlet and wherein the sheath is configured to accept a plurality of different hysteroscopes.

25. The system of claim 19, wherein the sheath further comprises a combined fluid inlet and fluid outlet.

26. A system for delivering an implant to a fallopian tube of a female body comprising:

a guide;

a protective sheath extending from the guide;

a handle moveable engaged with the guide;

a release catheter having a proximal end and a distal end, the proximal end of the release catheter connected to the handle, the release catheter slideable through the protective sheath; and

an implant releasably coupled with the distal end of the release catheter.

27. The implant delivery system of claim 26, wherein the implant comprises an expandable tubular member and a tissue in-growth promoting agent and wherein the implant can be moved longitudinally, relative to the guide, by moving the handle along the guide.

28. The implant delivery system of claim 27, wherein the handle comprises a first actuator and a second actuator.

29. The implant delivery system of claim 28, wherein the first actuator is configured to retract proximally an implant sheath, to expose the implant and wherein the second actuator is configured to release the implant from the release catheter.

30. The implant delivery system of claim 29, further comprising a socket moveably coupled to the guide, and wherein the handle comprises a ball movably coupled to the socket to allow rotational movement of the handle and the implant.

31. The implant delivery system of claim 30, wherein the implant sheath and the release catheter are more flexible than the protective sheath.

32. The implant delivery system of claim 31, wherein the protective sheath is metallic and wherein the implant sheath and the release catheter comprise a flexible polymer.

33. The implant delivery system of claim 27, wherein the handle comprises a first actuator and a second actuator and wherein the first actuator is configured to extend the implant distally away from the handle, and wherein the second actuator is configured to release the implant from the release catheter.

34. The implant delivery system of claim 26, wherein the guide is lockable with a delivery sheath which includes a port to receive a visualization system.

35. The implant delivery system of claim 26, wherein the guide restrains the longitudinal movement of the handle.

36. The implant delivery system of claim 26, wherein the guide comprises a body, a rail connected to the body and a stopper on the rail, and wherein the handle is slideable on the rail between the body and the stopper.

37. A method of using a fallopian tube implant device, the method comprising:

attaching the fallopian tube implant device to a hysteroscope sheath;

attaching a hysteroscope to the hysteroscope sheath;

moving a handle which is moveable coupled to a guide which is coupled to the hysteroscope, wherein moving the handle moves longitudinally an implant coupled to a distal end of a release catheter, a proximal end of the release catheter being coupled to the handle.

38. The method as in claim 37 wherein the fallopian tube implant device is attached to the hysteroscope sheath by inserting a protective sheath of the fallopian tube implant device into a first lumen of the hysteroscope sheath and the hysteroscope is attached to the hysteroscope sheath by inserting the hysteroscope into a second lumen of the hysteroscope sheath, and wherein the implant comprises an expandable tubular member and a tissue in-growth promoting agent, and wherein the method further comprises;

actuating an actuator which is configured, when actuated, to release the implant from the release catheter.

39. A delivery system for delivering an implant to a fallopian tube, the delivery system comprising:

a port configured to be coupled to a working channel of a hysteroscope assembly and configured to allow passage of an implant sheath and a release catheter through a lumen of the port;

a handle coupled to the port;

a control moveably coupled to the handle and configured to move, longitudinally, when the control is moved, a fallopian tube implant which is coupled to the release catheter, the release catheter being coupled to the control, wherein the fallopian tube implant is moved, relative to the handle, by movement of the control.

40. The delivery system as in claim 39 wherein the control is moved by longitudinally displacing the control relative to the handle, and wherein the fallopian tube implant moves in response to movement of the control without requiring that a valve on the working channel be released.

41. The delivery systems as in claim 40, the delivery system further comprising:

a protective sheath coupled to the port, the protective sheath having a lumen which is in fluid communication with the lumen of the port, the protective sheath configured to protect the implant sheath and the release catheter, and wherein the protective sheath extends into the working channel of the hysteroscope assembly, and wherein movement of the control moves the release catheter and the fallopian tube implant within the protective sheath.

42. The delivery system as in claim 41 wherein a distally retracted position of the control on the handle positions the fallopian tube implant within the protective sheath and wherein the port is rotatably coupled to the working channel and wherein the hysteroscope assembly comprises a hysteroscope sheath configured to receive a hysteroscope.

43. The delivery system as in claim 42 further comprising:

an adapter configured to be coupled to the working channel and configured to be rotatably coupled to the port and wherein the port comprises a ball designed to attach to the adapter.

44. The delivery system as in claim 42 wherein the fallopian tube implant can be rotated, relative to the hysteroscope, without rotating the hysteroscope and can be moved longitudinally relative to the hysteroscope without moving the hysteroscope.

45. The delivery system as in claim 44 where the fallopian tube implant comprises an expandable tubular member and a tissue in-growth promoting agent, and wherein the handle comprises a first actuator configured to retract proximally, when actuated, the implant sheath to expose the fallopian tube implant, and wherein the handle comprises a second actuator configured to release the release catheter from the fallopian tube implant, and wherein the implant sheath and the release catheter are more flexible than the protective sheath.