Catheter with controlled release endoluminal prosthesis

• US 6,248,122 B1
• Filed: 02/26/1999
• Issued: 06/19/2001
• Est. Priority Date: 02/26/1999
• Status: Expired due to Fees

• Current Assignee: LeMaitre Vascular, Incorporated
• Original Assignee: Vascular Architects Incorporated
• Inventors: Fogarty, Thomas J., Klumb, Katherine J., Kamdar, Kirti P.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): Priddy, Michael B.
• Application Number:
  US09/258,542
• Time in Patent Office: 844 Days
• Field of Search: 604/96, 604/101, 604/103, 604/171, 604/264, 604/280, 606/108, 606/191, 606/192, 606/194, 606/198, 623/1.11
• US Class Current: 606/194
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A catheter (4) includes a hollow catheter shaft (18), an inflatable balloon (36) surrounding the catheter shaft distal portion, and an expandable endoluminal prosthesis, such as a stent graft (38, 40), surrounding the balloon. The stent is typically a coiled stent having distal ends (58, 48) slidably housed within stent end holders (56, 50) on the catheter shaft. The first stent end is released from its holder by inflating the balloon. The second stent end is selectively released from its holder by other than inflating the balloon, typically by a push wire (30) pushing the second stent end out of its holder. A sheath (8) is moveable between a first position surrounding the stent and a second position spaced-apart from the stent. The stent is prevented from assuming its expanded-diameter state by (1) the engagement of the stent ends with the catheter shaft through the stent end holders, and (2) the sheath being in its first position during the introducing step. The stent may be a straight stent (3 8) or a bifurcated stent (38D).

Claims

1. A catheter including a catheter shaft with a distal portion, an inflatable balloon at the distal portion, the balloon surrounded by an expandable endoluminal prosthesis, the improvement comprising:

the prosthesis having first and second prosthesis portions releasably secured to the catheter shaft;

means for releasing the first prosthesis portion from the catheter shaft by inflating the balloon while the second portion remains unreleased; and

means for selectively releasing the second prosthesis portion from the catheter shaft by other than inflating the balloon.

4. The catheter according to claim 1 wherein the prosthesis comprises a stent.

5. The catheter according to claim 4 wherein the stent is a self-expanding stent.

6. The catheter according to claim 1 wherein the first portion is slidably engagable with the catheter shaft through the first prosthesis portion holder.

7. The catheter according to claim 1 further comprising:

a user-controlled release mechanism, operably coupled to the second prosthesis portion holder, by which a user can selectively disengage the second prosthesis portion from the catheter shaft by other than inflating the balloon.

8. The catheter according to claim 7 wherein the user-controlled release mechanism is a mechanical, user-controlled release mechanism.

9. The catheter according to claim 7 further comprising a sheath slidably mounted around the catheter shaft, said sheath movable between a first position surrounding said prosthesis and a second position spaced-apart from said prosthesis, whereby said prosthesis is prevented from assuming its second, expanded-diameter state by (1) the engagement of the first and second prosthesis portions with the catheter shaft through the first and second prosthesis portion holders, and (2) the sheath being in its first position.

10. The catheter according to claim 1 wherein said prosthesis has first and second distal ends and said first and second prosthesis portions are at said first and second distal ends.

11. The catheter according to claim 1 wherein the first prosthesis portion holder defines an elongate opening into which the first stent portion is slidably housed.

12. The catheter according to claim 1 wherein the balloon surrounds the distal portion.

13. The catheter according to claim 1 wherein the first prosthesis portion holder is free of overlying balloon material.

14. The catheter according to claim 1 wherein the prosthesis is a straight prosthesis.

15. The catheter according to claim 1 wherein the prosthesis is a bifurcated prosthesis having first and second arms.

16. The catheter according to claim 15 further comprising a biasing element coupled to the first and second arms biasing said arms away from one another.

17. The catheter according to claim 1 wherein the prosthesis is a coil-type stent having first and second ends.

18. The catheter according to claim 17 wherein the coil-type stent is in coiled, torqued compression in the first, reduced-diameter state.

19. The catheter according to claim 17 wherein the first end of the coil-type stent constitutes the first stent portion and the first stent portion holder has a hollow interior which is sized for receipt of the first end of the coil-type stent.

20. The catheter according to claim 17 wherein the second stent portion holder is configured for receipt of the second end of the coil-type stent.

21. The catheter according to claim 20 further comprising an elongate element, extending along the catheter shaft, having a distal portion operably engagable with the second end of the coil-type stent to permit a user to mechanically disengage said second end from the second stent portion holder.

22. The catheter according to claim 20 wherein said coil-type stent comprises a plurality of turns, at least one turn effectively directly contacting the catheter shaft between the second stent portion holder and the balloon.

23. The catheter according to claim 19 wherein the second prosthesis portion holder is positioned proximally of the balloon.

24. The catheter according to claim 1 further comprising a graft material associated with the prosthesis.

25. The catheter according to claim 24 wherein the graft material comprises a selected one of a strip or tube of the graft material.

26. The catheter according to claim 25 wherein the graft is positioned within the prosthesis.

27. The catheter according to claim 25 wherein the graft material comprises a chosen one of porous PTFE or ePTFE.

28. The catheter according to claim 25 further comprising a strip of material securing the stent and the graft to one another.

29. The catheter according to claim 1 further comprising a manipulator element extending along the catheter shaft and coupled to the distal portion to permit the distal portion to be steered.

30. The catheter according to claim 1 wherein the prosthesis comprises a coiled stent covered by a graft material to create a coiled stent graft with gaps between adjacent turns thereof.

31. The catheter according to claim 30 wherein said gaps and said turns both have longitudinal dimensions, said longitudinal dimensions of said gaps being at least as great as the longitudinal dimensions of the turns.

32. The catheter according to claim 30 wherein the coiled stent graft comprises a ladder-like stent with the edge elements comprising side rail elements and connector elements, connecting the edge elements, comprising rung elements.

2. A catheter including a catheter shaft with a distal portion, an inflatable balloon at the distal portion, the balloon surrounded by an expandable endoluminal prosthesis, the improvement comprising:

the prosthesis having first and second prosthesis portions;

the catheter shaft comprising first and second prosthesis portion holders;

the prosthesis capable of assuming a second, expanded-diameter state from a first, reduced-diameter state;

a sheath slidably mounted around the catheter shaft;

the first and second prosthesis portions being releasably secured to the catheter shaft by the first and second prosthesis portion holders, said first portion being releasable from the catheter shaft by inflating the balloon while the second prosthesis portion remains unreleased; and

said sheath being movable between a first position surrounding said prosthesis and a second position spaced-apart from said prosthesis;

whereby said prosthesis is prevented from assuming its second, expanded-diameter state by (1) the engagement of the first and second prosthesis portions with the first and second prosthesis portion holders, and (2) the sheath being in its first position.

3. A catheter comprising:

a catheter shaft having a distal portion;

an inflatable balloon mounted to the distal portion and inflatable from a deflated condition to an inflated condition;

an endoluminal prosthesis, capable of assuming a second, expanded-diameter state from a first, reduced-diameter state, surrounding the balloon in the first, reduced-diameter state;

the distal portion of the catheter shaft having a first prosthesis portion holder and a second prosthesis portion holder; and

the prosthesis having a first portion releasably engagable with the first prosthesis portion holder and a second prosthesis portion releasably engagable with the second prosthesis portion holder, said first portion being releasable from the catheter shaft by placing the balloon in the inflated condition while the second prosthesis portion remains unreleased.

33. A method for placing an endoluminal prosthesis within a body comprising:

introducing a distal portion of a catheter at a chosen position within a body, the distal catheter portion comprising an inflatable balloon surrounded by a prosthesis, first and second prosthesis portions of the prosthesis releasably secured to the catheter shaft at first and second positions along the catheter shaft;

inflating the balloon thereby releasing the first prosthesis portion from the catheter shaft while the second prosthesis portion remains secured to the catheter shaft;

releasing the second prosthesis portion from the catheter shaft by other than inflating the balloon;

deflating the balloon; and

removing the catheter shaft and the deflated balloon therewith from the body leaving the expanded prosthesis within the body.

34. The method according to claim 33 wherein the inflating step comprises the step of expanding at least the first prosthesis portion.

35. The method according to claim 33 wherein the introducing step is carried out within a blood vessel.

36. The method according to claim 33 wherein the introducing step is carried out using a catheter in which the distal portion of the catheter comprises a generally Y-shaped catheter shaft, balloon and stent at a generally Y-shaped region within the body.

37. The method according to claim 33 wherein the introducing step is carried out with the chosen position being along a straight section of a blood vessel.

38. The method according to claim 33 wherein the inflating step is carried out by:

partially inflating the balloon causing the first stent portion to release from the catheter shaft; and

then

at least partially deflating the balloon; and

then

at least partially inflating the balloon.

39. The method according to claim 33 wherein the first prosthesis portion releasing step is carried out by the inflation of the balloon causing the first prosthesis portion to pull out of a first receptacle at the first position.

40. The method according to claim 33 wherein the second prosthesis portion releasing step is carried out by mechanically releasing the second prosthesis portion from the catheter shaft.

41. The method according to claim 40 wherein the mechanically releasing step is carried out after the first prosthesis portion releasing step.

42. The method according to claim 40 wherein the mechanically releasing step comprises longitudinally moving a releaser along the catheter shaft causing a distal end of the release wire to push the second prosthesis portion from a second receptacle at the second position along the catheter shaft.

43. The method according to claim 33 further comprising pulling a sheath, initially surrounding the balloon and prosthesis, from the balloon and prosthesis after the introducing step.

44. The method according to claim 43 further comprising pushing the sheath over the balloon prior to the removing step to facilitate the removing step.

45. The method according to claim 33 wherein the introducing step is carried out with the prosthesis comprising a graft material associated with a stent.

46. The method according to claim 45 wherein the introducing step is carried out with a tube of the graft material positioned generally concentrically with regard to the stent.

47. The method according to claim 46 wherein the introducing step is carried out with the tube of graft material surrounding the stent.

48. A catheter comprising:

a catheter shaft having a distal portion;

an inflatable balloon mounted to the distal portion and inflatable from a deflated condition to an inflated condition;

an endoluminal prosthesis, capable of assuming a second, expanded-diameter state from a first, reduced-diameter state, surrounding the balloon in the first, reduced-diameter state;

the distal portion of the catheter shaft having a first prosthesis portion holder;

the prosthesis having a first portion releasably engagable with the first prosthesis portion holder, said first portion being releasable from the catheter shaft when the balloon is placed in the inflated condition;

a second prosthesis portion holder, the prosthesis comprising a second portion releasably engaging the catheter shaft through the second prosthesis portion holder;

a user-controlled release mechanism, operably coupled to the second prosthesis portion holder, by which a user can selectively disengage the second prosthesis portion from the catheter shaft by other than inflating the balloon; and

a sheath slidably mounted around the catheter shaft, said sheath movable between a first position surrounding said prosthesis and a second position spaced-apart from said prosthesis, whereby said prosthesis is prevented from assuming its second, expanded-diameter state by (1) the engagement of the first and second prosthesis portions with the catheter shaft through the first and second prosthesis portion holders, and (2) the sheath being in its first position.

49. A catheter comprising:

a catheter shaft having a distal portion;

an inflatable balloon mounted to the distal portion and inflatable from a deflated condition to an inflated condition;

a coil-type stent having first and second ends, capable of assuming a second, expanded-diameter state from a first, reduced-diameter state, surrounding the balloon in the first, reduced-diameter state;

the distal portion of the catheter shaft having a hollow interior sized for receipt of the first end of the stent;

the first end of the stent releasably engagable with the hollow interior, said first end being releasable from the catheter shaft when the balloon is placed in the inflated condition;

the distal portion of the catheter shaft having a second stent portion holder configured for receipt of the second end of the stent; and

an elongate element, extending along the catheter shaft, having a distal portion operably engagable with the second end of the stent to permit a user to mechanically disengage said second end from the second stent portion holder.

50. A method for placing an endoluminal prosthesis within a body comprising:

introducing a distal portion of a catheter along a straight section of a blood vessel within a body, the distal catheter portion comprising an inflatable balloon surrounded by a prosthesis, first and second prosthesis portions of the prosthesis releasably secured to the catheter shaft at first and second positions along the catheter shaft;

inflating the balloon thereby releasing the first prosthesis portion from the catheter shaft;

releasing the second prosthesis portion from the catheter shaft by other than inflating the balloon;

deflating the balloon; and

removing the catheter shaft and the deflated balloon therewith from the body leaving the expanded prosthesis within the body.

51. A method for placing an endoluminal prosthesis within a body comprising:

introducing a distal portion of a catheter at a chosen position within a body, the distal catheter portion comprising an inflatable balloon surrounded by a prosthesis, first and second prosthesis portions of the prosthesis releasably secured to the catheter shaft at first and second positions along the catheter shaft;

partially inflating the balloon causing the first prosthesis portion to release from the catheter shaft;

then at least partially deflating the balloon;

then at least partially inflating the balloon;

releasing the second prosthesis portion from the catheter shaft by other than inflating the balloon;

deflating the balloon; and

removing the catheter shaft and the deflated balloon therewith from the body leaving the expanded prosthesis within the body.

52. A method for placing an endoluminal prosthesis within a body comprising:

introducing a distal portion of a catheter at a chosen position within a body, the distal catheter portion comprising an inflatable balloon surrounded by a prosthesis, first and second prosthesis portions of the prosthesis releasably secured to the catheter shaft at first and second positions along the catheter shaft;

inflating the balloon which causes the first prosthesis portion to pull out of a first receptacle at the first position, thereby releasing the first stent portion from the catheter shaft;

releasing the second prosthesis portion from the catheter shaft by other than inflating the balloon;

deflating the balloon; and

removing the catheter shaft and the deflated balloon therewith from the body leaving the expanded prosthesis within the body.

53. A method for placing an endoluminal prosthesis within a body comprising:

introducing a distal portion of a catheter at a chosen position within a body, the distal catheter portion comprising an inflatable balloon surrounded by a prosthesis, first and second prosthesis portions of the prosthesis releasably secured to the catheter shaft at first and second positions along the catheter shaft;

inflating the balloon thereby releasing the first prosthesis portion from the catheter shaft;

longitudinally moving a release wire along the catheter shaft causing a distal end of the release wire to push the second prosthesis portion from a second receptacle at the second position along the catheter shaft, thereby releasing the second prosthesis portion from the catheter shaft;

deflating the balloon; and

removing the catheter shaft and the deflated balloon therewith from the body leaving the expanded prosthesis within the body.

54. A method for placing an endoluminal prosthesis within a body comprising:

introducing a distal portion of a catheter at a chosen position within a body, the distal catheter portion comprising an inflatable balloon surrounded by a prosthesis, first and second prosthesis portions of the prosthesis releasably secured to the catheter shaft at first and second positions along the catheter shaft;

pulling a sheath, initially surrounding the balloon and prosthesis, from the balloon and prosthesis after the introducing step;

inflating the balloon thereby releasing the first prosthesis portion from the catheter shaft;

releasing the second prosthesis portion from the catheter shaft by other than inflating the balloon;

deflating the balloon; and

removing the catheter shaft and the deflated balloon therewith from the body leaving the expanded prosthesis within the body.

55. The method according to claim 54, further comprising pushing the sheath over the balloon prior to the removing step to facilitate the removing step.