Delivery system for a device such as a stent

• US 20060282152A1
• Filed: 06/14/2005
• Published: 12/14/2006
• Est. Priority Date: 06/14/2005
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated, Guidant Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Pienknagura, Carla Rosa, Beyerlein, Dagmar, Feezor, Christopher, Stamberg, Barbara, Burns, Denise Horrilleno, Osman, Karim
• Granted Patent: US 8,435,279 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A delivery system for a medical device. The delivery system comprises an inner member, a retractable sheath disposed over the inner member and being slideable over the inner member, and a retraction member coupled to the retractable sheath and disposed at least in portion within the retractable sheath, the retraction member being slideable over the inner member. An axial movement of the retraction member retracts or actuates the retractable member.

Claims

1. A catheter assembly comprising:

an outer member;

an inner member disposed within the outer member;

a retractable sheath disposed over the inner member, the retractable sheath being slideable over the inner member; and

a flexible intermediary member coupling to the retractable sheath and coupling to the outer member, the flexible intermediary member having a portion that is foldable within the outer member, wherein a seal is provided between the flexible intermediary member and the outer member; and

wherein the flexible intermediary member is configured to retract or actuate the retractable sheath coupled thereto.

2. The catheter assembly of claim 1 wherein applying a negative pressure into said catheter assembly causes the portion that is foldable within the outer member to fold more into the outer member and to cause the retractable sheath to retract in a direction of the negative pressure.

3. The catheter assembly of claim 2 further comprising:

a medical device supported by the inner member, wherein retracing the retractable sheath deploys the medical device.

4. The catheter assembly of claim 3 further comprising:

a stopper disposed over the inner member and proximal to the medical device.

5. A catheter assembly comprising:

an inner member;

a retractable sheath disposed over the inner member, the retractable sheath being slideable over the inner member; and

a compressible member coupling to the retractable sheath, and slideably disposed on the inner member, a portion of the compressible member is disposed within the retractable sheath;

wherein one of axially expanding the compressible member and axially compressing the compressible member performs one of retracting the retractable sheath relative to the inner member and actuating the retractable sheath relative to the inner member.

6. The catheter assembly of claim 5 further comprising:

an outer member that houses said inner member, said retractable sheath, and said compressible member.

7. The catheter assembly of claim 5 wherein the retractable sheath is directly coupled to a portion of the compressible member.

8. The catheter assembly of claim 5 wherein the expansion or compression of the compressible member is done through a lumen provided in the compressible member.

9. The catheter assembly of claim 5 wherein the compressible member includes a bellows section.

10. The catheter assembly of claim 5 further comprising:

a medical device supported by the inner member, wherein retracting the retractable sheath deploys the medical device.

11. The catheter assembly of claim 10 further comprising:

a stopper disposed over the inner member and proximal to the medical device.

12. The catheter assembly of claim 5 further comprising:

a balloon disposed within the compressible member, wherein the balloon is configured to expand or compress the compressible member into a desired shape.

13. The catheter assembly of claim 5 wherein the retractable sheath retraction rate is controlled by a fluid injection rate into the compressible member.

14. The catheter assembly of claim 5 wherein in an initial state, the compressible member is compressed and in an actuated state, the compressible member is axially expanded to cause the retractable sheath to retract over the inner member.

15. The catheter assembly of claim 5 wherein in an initial state, the compressible member is axially expanded and wherein axially compressing the compressible member causes the retractable sheath to retract over the inner member.

16. The catheter assembly of claim 5 wherein the retractable sheath has a compressible portion and is connected to the compressible member to at least a portion of the retractable sheath.

17. The catheter assembly of claim 5 wherein the compressible member includes a distal pleated section.

18. The catheter assembly of claim 5 wherein said compressible member includes a compressible spring structure.

19. The catheter assembly of claim 18 further comprising:

a protective member disposed outside the compressible spring member and within the retractable sheath.

20. The catheter assembly of claim 18 further comprising:

a locking mechanism disposed on the inner member, the locking mechanism being configured to hold the compressible spring member in a compressed form wherein unlocking by the locking mechanism allows the spring member to axially expand.

21. The device of claim 20 wherein the locking mechanism includes an inflatable balloon and a stopper, wherein inflating the balloon allows the stopper to prevent expansion of the compressible spring member and wherein deflating the balloon allows the stopper to slide and allows the compressible spring member to expand.

22. The device of claim 20 wherein the locking mechanism includes a latching member and a stopper, wherein the latching member allows the stopper to prevent expansion of the compressible spring member and wherein removing the latching member allows the stopper to slide and allows the compressible spring member to expand.

23. The device of claim 20 wherein the locking mechanism includes an electromagnetic system, the electromagnetic system able to maintain the compressible spring member in a compressed state and to allow the compressible spring member to expand.

24. The device of claim 20 wherein the locking mechanism includes an inflatable member and a stopper, wherein inflating the inflatable member allows the stopper to prevent expansion of the compressible spring member and wherein deflating the inflatable member allows the stopper to slide and allows the compressible spring member to expand.

25. The device of claim 20 wherein the locking mechanism includes an expandable cage.

26. The device of claim 5 further comprising:

a constraint member disposed outside the compressible member, the constraint member defining an radial expansion limit for the compressible member and allowing for the axial expansion of the compressible member.

27. The catheter assembly of claim 26 further comprising:

a spring member disposed on a portion of the inner member, the spring member providing a flexible and bendable portion.

28. The catheter assembly of claim 5 further comprising:

a spring member disposed on a portion of the inner member, the spring member providing a flexible and bendable portion.

29. A device comprising:

an outer member;

a delivery member disposed within the outer member; and

an expandable member configured to have prongs when non-fully inflated state and no prongs when fully inflated, the prongs of the expandable member configured to hold a medical device in a non-deployed state when the expandable member is in the non-fully inflated state, the expandable member being coupled to the delivery member.

30. The device of claim 29 further comprising:

adhesive disposed at one or more prongs to enhance holding of the medical device within the expandable member.

31. The device of claim 29 wherein pressure is used to fully expand the expandable member, wherein the pressure fully expands the expandable member and unlocks the medical device, wherein the medical device is deployed when the prongs are released.

32. The device of claim 29 wherein the expandable member is deflated to remove from the device.

33. The device of claim 29 further comprising:

a medical device disposed within the outer member and releasably coupled to the delivery member.

34. A method comprising:

releasably supporting a medical device using a catheter assembly, the catheter assembly including an inner member, a retractable sheath disposed over the inner member and slideable over the inner member, and a retraction system coupled to the retractable sheath and disposed at least in portion within the retractable sheath, wherein the medical device is supported by the inner member and contained by the retractable sheath;

tracking the medical device supported by the catheter assembly to a treatment site; and

retracting the retractable sheath in a proximal direction relative to the medical device.

35. The method of claim 34 wherein the catheter assembly includes an outer member housing the inner member, the retractable sheath, and the retraction system during delivery.

36. The method of claim 35 wherein the retraction system includes a flexible intermediary member coupling to the retractable sheath and coupling to the outer member, the flexible intermediary member having a portion that is foldable within the outer member, wherein a seal is provided between the flexible intermediary member and the outer member.

37. The method of claim 36 wherein retracting the retractable sheath further comprises applying a negative pressure into said catheter system to cause the portion that is foldable within the outer member to fold more into the outer member and to cause the retractable sheath to retract.

38. The method of claim 35 wherein the retraction system includes a longitudinally compressible member coupling to the retractable sheath and slideably disposed on the inner member with a portion of the longitudinally compressible member being disposed within the retractable sheath.

39. The method of claim 38 wherein retracting the retractable sheath further comprises axially expanding the longitudinally compressible member to retract the retractable sheath, wherein prior to expanding, the longitudinally compressible member is in a compressed state and axially expanding the longitudinally compressible member retract the retractable sheath.

40. The method of claim 38 wherein retracting the retractable sheath further comprises axially compressing the longitudinally compressible member to retract the retractable sheath, wherein prior to compressing, the compressible member is in an expanded state and axially compressing the compressible member retract the retractable sheath.

41. The method of claim 35 wherein the retraction system includes a compressible spring member.

42. The method of claim 41 wherein the retraction system further includes a protective member disposed outside the compressible spring member and within the retractable sheath.

43. The method of claim 42 wherein the retraction system further includes a locking mechanism disposed on the inner member, the locking mechanism configured to hold the compressible spring member in a compressed form wherein unlocking by the locking mechanism allows the spring member to axially expand.

44. The method of claim 43 wherein the locking mechanism includes an inflatable balloon and a stopper, wherein inflating the balloon allows the stopper to prevent expansion of the compressible spring member and wherein deflating the balloon allows the stopper to slide and allows the compressible spring member to expand.

45. The method of claim 43 wherein the locking mechanism includes a latching member and a stopper, wherein the latching member allows the stopper to prevent expansion of the compressible spring member and wherein removing the latching member allows the stopper to slide and allows the compressible spring member to expand.

46. The method of claim 43 wherein the locking mechanism includes an electromagnetic system, the electromagnetic system able to maintain the compressible spring member in a compressed state and to allow the compressible spring member to expand.

47. The method of claim 43 wherein the locking mechanism includes an inflatable member and a stopper, wherein inflating the inflatable member allows the stopper to prevent expansion of the compressible spring member and wherein deflating the inflatable member allows the stopper to slide and allows the compressible spring member to expand.

48. The method of claim 34 further comprising:

controlling a retraction rate for the retractable sheath.

49. A method comprising:

placing a slide tube over a mandrel, said mandrel defining a lumen for said slide tube;

compressing the slide tube over the mandrel to create an accordion-like section on said slide tube;

treating said slide tube to form a compressible member having the accordion-like section that is expandable and compressible and a lumen extended therethrough.

50. The method of claim 49 further comprising:

coupling the compressible member to a retractable sheath; and

placing the retractable sheath over an inner member, wherein the inner member supports a medical device, and

wherein the compressible member is compressed at the accordion-like section.

51. The method of claim 50 further comprising:

axially expanding the compressible member to retract the retractable sheath.

52. The method of claim 49 further comprising:

coupling the compressible member to a retractable sheath; and

placing the retractable sheath over an inner member, wherein the inner member supporting a medical device, and

wherein the compressible member is expanded.

53. The method of claim 52 further comprising:

axially compressing the compressible member to retract the retractable sheath.