Rolling membrane stent delivery system

• US 6,059,813 A
• Filed: 11/06/1998
• Issued: 05/09/2000
• Est. Priority Date: 11/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Smith, Scott R., Vrba, Anthony C., Monroe, Lance A., Sogard, Dave J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/187,947
• Time in Patent Office: 550 Days
• Field of Search: 606/198, 606/192, 606/194, 606/108, 604/96
• US Class Current: 606/198
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing 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
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61M 25/0119 Eversible catheters

Abstract

A medical device delivery system, having a rolling retractable sheath covering a medical device mounting region on the system is disclosed. The rolling retractable sheath comprises an inner wall and an outer wall and may be formed of one or more materials, optionally porous. Optionally, a lubricant may be applied selectively to the interior and exterior walls of the stent.

Claims

1. A medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon,

a rolling retractable sheath for retaining a medical device on the inner tube, the sheath having a proximal end and a distal end, the sheath disposed about the inner tube, the sheath including a rolling double walled member, the double walled member having an inner wall attached to the inner tube proximal to the medical device mounting region and an outer wall, the inner wall having a greater tendency to rollingly move upon the application of a rolling force than the outer wall, the inner wall extending distally and attached to the outer wall, the sheath in the delivery position covering at least a portion of the medical device mounting region.

2. The medical device delivery system of claim 1 further comprising a retraction device operably connected to the outer wall of the rolling retractable sheath for retraction of the retractable sheath, the retraction device moving the outer wall in a proximal direction relative to the inner wall to expose a medical device mounting region.

3. The medical device of claim 2 wherein the retraction device comprises a catheter having proximal and distal ends and a lumen therein for receiving the inner tube therein, the distal end of the inner tube extending beyond the distal end of the catheter, the outer wall of the rolling retractable sheath attached to the distal end of the catheter.

4. The medical device of claim 2 wherein the retraction device comprises a catheter having proximal and distal ends and a lumen therein for receiving the inner tube therein, the catheter terminating at the distal end in a pull collar, the distal end of the inner tube extending beyond the distal end of the catheter, the outer wall of the rolling retractable sheath attached to the pull collar.

5. The medical device delivery system of claim 1 wherein the inner and outer walls are adhesively bonded together at an end of the rolling double walled member.

6. The medical device delivery system of claim 1 wherein the inner and outer walls are mechanically joined together at an end of the rolling double walled member.

7. The medical device delivery system of claim 1 wherein the inner wall of the rolling retractable sheath is formed of at least a first material and the outer wall is formed of at least a second material different from the first material.

8. The medical device delivery system of claim 7 wherein the first material rolls on retraction of the sheath and the second material does not roll on retraction.

9. The medical device delivery system of claim 7 wherein the second material has a higher hoop strength than the first material.

10. The medical device delivery system of claim 7 wherein the outer wall of the sheath in the unretracted position has a higher tensile strength than the inner wall of the sheath.

11. The medical device delivery system of claim 1 wherein the outer wall of the sheath and the inner wall of the sheath are made of the same material, the outer wall thicker than the inner wall.

12. The medical device delivery system of claim 1 wherein the outer wall of the sheath is thicker than the inner wall of the sheath.

13. The medical device delivery system of claim 1 wherein the outer wall of the sheath is thinner than the inner wall of the sheath.

14. The medical device delivery system of claim 1 wherein the inner and outer walls of the sheath are obliquely disposed relative to each other.

15. The medical device delivery system of claim 1 wherein one or more of the inner and outer walls is formed of a porous material.

16. The medical device delivery system of claim 1 further comprising a lubricant applied to at least a portion of one or more of the inner and outer walls so as to reduce friction between the inner and outer walls.

17. The medical device delivery system of claim 1 further comprising a medical device selected from the group consisting of stents, grafts and vena cava filters, the medical device mounted on the medical device mounting region of the inner tube.

18. The medical device delivery system of claim 17 wherein the medical device is a stent and the stent is self-expandable.

19. The medical device delivery system of claim 1 wherein a sealed chamber is formed by the inner and outer walls of the sheath, at least a portion of the inner tube and the portion of the retraction device which is distal to the point of attachment of the outer wall to the retraction device.

20. The medical device delivery system of claim 1 wherein a sealed chamber is formed by the inner and outer walls of the rolling retractable sheath, at least a portion of the inner tube and the portion of the retraction device which is distal to the point of attachment of the outer wall to the retraction device.

21. The medical device delivery system of claim 20 wherein a lubricant is present in the sealed chamber.

22. The medical device delivery system of claim 20 wherein at least one of the inner wall and the outer wall has a lubricant applied to at least a portion thereof interior to the sealed chamber.

23. The medical device delivery system of claim 20 wherein the retraction device comprises a catheter having proximal and distal ends and a lumen therein for receiving the inner tube therein, the distal end of the inner tube extending beyond the distal end of the catheter, the outer wall of the rolling retractable sheath attached to the distal end of the catheter.

24. The medical device delivery system of claim 23 wherein the catheter further comprises a pull-collar mounted at the distal end of the catheter.

25. The medical device delivery system of claim 1 configured for use a in a mode selected from the group consisting of fixed-wire mode, over-the-wire mode and rapid-exchange mode.

36. A method of delivering a stent to a desired bodily location comprising the steps of:

providing a medical device delivery system as in claim 1;

providing a self-expanding stent;

mounting the stent on the medical device mounting region of the medical device delivery system;

percutaneously inserting the medical device delivery system in a bodily lumen containing a bodily fluid, the bodily fluid passing through the sheath so as to prime the medical device delivery system,

traversing the bodily lumen until the desired bodily location is reached;

retracting the rolling retractable sheath proximally so as to expose the stent to self-expand; and

withdrawing the medical device delivery system from the bodily lumen.

26. A medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon,

a rolling retractable sheath for retaining a medical device on the inner tube, the sheath having a proximal end and a distal end, the sheath disposed about the inner tube, the sheath including a rolling double walled member, the double walled member having an inner wall attached to the inner tube proximal to the medical device mounting region and an outer wall attached to a retraction means, the inner wall having a greater tendency to rollingly move upon the application of a rolling force than the outer wall the inner wall extending upward and attached to the outer wall, the sheath in the delivery position covering at least a portion of the medical device mounting region; and

a retraction means operably connected to the rolling retractable sheath for retraction of the retractable sheath.

27. A self-priming medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon,

a rolling retractable sheath for retaining a medical device on the inner tube, the sheath having a proximal end and a distal end, the sheath disposed about the inner tube, the sheath including a rolling double walled member, the double walled member having an inner wall attached to the inner tube proximal to the medical device mounting region and an outer wall attached to a retraction device, the sheath formed of a material porous enough to allow fluids through, the sheath in the delivery position covering at least a portion of the medical device mounting region; and

a retraction device operably connected to the rolling retractable sheath for retraction of the retractable sheath, the retraction device moving the outer wall in a proximal direction relative to the inner wall to expose the medical device mounting region.

28. The medical device delivery system of claim 27 wherein both the inner and outer walls are formed of a porous material.

29. The medical device delivery system of claim 27 wherein a lubricant is present on at least a portion of the sheath.

30. The medical device delivery system of claim 27 the outer wall having an inside facing the inner wall, wherein one or more lubricants is applied to at least a portion of the inside of the outer wall so as to reduce friction between the inner and outer walls and thereby facilitate retraction of the rolling retractable sheath.

31. The medical device of claim 27 wherein the retraction device comprises a catheter having proximal and distal ends and a lumen therein for receiving the inner tube therein, the distal end of the inner tube extending beyond the distal end of the catheter, the outer wall of the rolling retractable sheath attached to the distal end of the catheter.

32. The medical device of claim 27 wherein the retraction device comprises a catheter having proximal and distal ends and a lumen therein for receiving the inner tube therein, the catheter terminating at the distal end in a pull collar, the distal end of the inner tube extending beyond the distal end of the catheter, the outer wall of the rolling retractable sheath attached to the pull collar.

33. The medical device delivery system of claim 27 further comprising a medical device selected from the group consisting of stents, grafts and vena cava filters, the medical device mounted on the medical device mounting region of the inner tube.

34. The medical device delivery system of claim 33 wherein the medical device is a stent and the stent is self-expandable.

35. A self-priming medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon,

a rolling retractable sheath for retaining a medical device on the inner tube, the sheath having a proximal end and a distal end, the sheath disposed about the inner tube, the sheath including a rolling double walled member, the double walled member having an inner wall attached to the inner tube proximal to the medical device mounting region and an outer wall attached to a retraction means, the sheath formed of a material porous enough to allow fluids through, the sheath in the delivery position covering at least a portion of the medical device mounting region; and

a retraction means operably connected to the rolling retractable sheath for retraction of the retractable sheath.

37. A medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon,

a rolling retractable sheath for retaining a medical device on the inner tube, the sheath having a proximal end and a distal end, the sheath disposed about the inner tube, the sheath including a rolling double walled member, the double walled member having an inner wall attached to the inner tube proximal to the medical device mounting region and an outer wall attached to a retraction device, the inner wall formed of at least a first material, the outer wall formed of at least a second material different from the first material, the inner wall extending upward and attached to the outer wall, the sheath in the delivery position covering at least a portion of the medical device mounting region; and

a retraction device operably connected to the rolling retractable sheath for retraction of the retractable sheath.

38. A medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon,

a rolling retractable sheath for retaining a medical device on the inner tube, the rolling sheath formed of a rolling double walled member closed on itself, the rolling retractable sheath having a proximal end and a distal end, the rolling sheath disposed about the inner tube, the proximal end of the rolling sheath secured to the inner tube proximal of the medical device mounting region, the distal end of the rolling sheath attached to a retraction device; and

a retraction device operably connected to the distal end of the rolling retractable sheath for retraction of the retractable sheath.

39. The medical device delivery system of claim 38 wherein the proximal end of the rolling sheath is secured to the inner tube via a bumper concentrically disposed about and secured to the inner tube, the bumper proximal to the medical device mounting region, the bumper further secured to the proximal end of the rolling sheath.

40. The medical device delivery system of claim 38 wherein the proximal end of the rolling sheath is fixedly attached to the inner tube.

41. The medical device delivery system of claim 38 wherein the retraction device comprises a pull collar attached to the distal end of the rolling sheath, the pull collar having a pull wire attached thereto and extending proximally therefrom.

42. The medical device delivery system of claim 38 wherein the retraction device comprises an outer sheath attached to the distal end of the rolling sheath, the outer sheath disposed about the inner tube and coaxial with the inner tube, the outer sheath extending in a proximal direction.

43. The medical device delivery system 38 of wherein the rolling sheath is made of a plurality of different materials joined together.

44. A medical device delivery system comprising:

an inner tube, having a distal region and a proximal region, the inner tube having a medical device mounting region at the distal region for mounting a medical device thereon, the medical device mounting region characterized by a medical device mounting length;

a rolling retractable sheath for retaining a medical device on the inner tube, the rolling retractable sheath having a proximal end and a distal end, the rolling sheath disposed about the inner tube, the proximal end of the rolling sheath secured to the inner tube proximal of the medical device mounting region,

the rolling sheath in an unretracted state characterized by a first length as defined by the distance between the proximal-most point on the unretracted sheath and the distal-most point on the unretracted sheath;

the rolling sheath upon retraction characterized by a second length as defined by the distance between the proximal-most point on the retracted sheath and the distal-most point on the retracted sheath, the difference between the second length and the first length less than the medical device mounting length the rolling sheath further operably connected to a retraction device for retraction of the retractable sheath.

45. The medical device delivery system of claim 44 wherein the difference between the second length and the first length second length is less than half of the medical device mounting length.

46. The medical device delivery system of claim 44 wherein the second length is substantially equal to the first length.

47. The medical device delivery system of claim 44 wherein the second length is less than or equal to twice the medical device mounting length.

48. The medical device delivery system of claim 44 wherein the second length is less than or equal to twice the first length.