Endoprosthesis stent/graft deployment system

• US 5,522,883 A
• Filed: 02/17/1995
• Issued: 06/04/1996
• Est. Priority Date: 02/17/1995
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Meadox Medicals, Inc. (Boston Scientific Corporation)
• Inventors: Byrne, Brian P., Slater, Andrea T.
• Primary Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US08/390,049
• Time in Patent Office: 473 Days
• Field of Search: 623/1, 623/11, 623/12, 606/108, 606/191, 606/194, 606/195, 606/198, 604/96, 604/104, 604/281
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

Abstract

A deployment system for transcutaneous insertion of an implantable tubular prosthesis is provided. The deployment system includes a flexible, elongated, tubular, delivery catheter with at least one inner lumen, and an opening extending through the catheter to the inner lumen. Positioned over the catheter is an implantable endoprosthesis capable of radial expansion and having a proximal and a distal end extent. A support assembly removably maintains the endoprosthesis in a compressed state, and is located at a position adjacent the catheter opening. The support assembly includes an arm which extends through the catheter opening into the inner lumen. A release mechanism is insertable through the inner lumen and includes a distal tip engageable with the arm of the support assembly. The release mechanism is manipulatable within the inner lumen so as to remove the support assembly from the endoprosthesis, permitting radial expansion of the endoprosthesis for implantation.

Claims

1. An implantable endoprosthesis deployment system comprising:

a flexible elongated tubular delivery catheter, said catheter having an inner lumen extending therethrough and an opening through said catheter in communication with said inner lumen;

an elongated implantable radially expandable endoprosthesis positioned over said catheter, said endoprosthesis having a proximal end extent and an opposed distal end extent;

a removable endoprosthesis support assembly for maintaining said endoprosthesis in a compressed state, said support assembly being located adjacent said catheter opening, said support assembly including an arm extending through said catheter opening into said inner lumen; and

a release mechanism insertable through said inner lumen of said catheter, said release mechanism including a distal tip engageable with said arm of said support assembly, said release mechanism being manipulatable within said inner lumen so as to remove said support assembly from said endoprosthesis, permitting subsequent radial expansion of said endoprosthesis.

2. A deployment system as in claim 1, wherein said endoprosthesis includes a vascular graft.

3. A deployment system as in claim 2, wherein said endoprosthesis includes a stent.

4. A deployment system as in claim 1, wherein said support assembly includes a boot.

5. A deployment system as in claim 1, wherein said support assembly includes a distal support member maintaining said distal end extent of said endoprosthesis in a compressed state.

6. A deployment system as in claim 5, further comprising a proximal support member for removably maintaining said proximal end extent of said endoprosthesis in a compressed state, said proximal support member being anchored to said catheter.

7. A deployment system as in claim 6, wherein said proximal end extent and said distal end extent of said endoprosthesis are separate members.

8. A deployment system as in claim 1, wherein said release mechanism includes a release rod.

9. A deployment system as in claim 1, wherein said release mechanism includes a clip at said distal tip, said clip capable of attachment to said arm.

10. A deployment system as in claim 1, wherein said catheter includes a proximal portion and a distal portion.

11. A deployment system as in claim 10, wherein said proximal portion and said distal portion of said catheter are separate portions connected by a connector portion.

12. A deployment system as in claim 11, wherein said opening through said catheter is through said connector portion.

13. A deployment system as in claim 1, further comprising a guidewire insertable through said inner lumen.

14. A deployment system as in claim 1, wherein said catheter includes a first inner lumen and a second inner lumen.

15. A deployment system as in claim 14, wherein said opening extends through to said first inner lumen, said release mechanism is insertable through said first lumen, and said guidewire is insertable through said second lumen.

16. A deployment system as in claim 1, further comprising a retractible outer sheath disposed over said catheter, said sheath further maintaining said endoprosthesis in a compressed state.

17. A method of endoprosthetic deployment comprising:

a. providing a deployment system comprising a flexible elongated tubular delivery catheter, said catheter having an inner lumen extending therethrough and an opening through said catheter in communication with said inner lumen;

an elongated implantable radially expandable endoprosthesis positioned over said catheter, said endoprosthesis having a proximal end extent and an opposed distal end extent;

a removable endoprosthesis support assembly for maintaining said endoprosthesis in a compressed state, said support assembly being located adjacent said catheter opening and said support assembly including an arm extending through said catheter opening into said inner lumen; and

a release mechanism insertable through said inner lumen of said catheter, said release mechanism including a distal tip engageable with said arm of said support assembly, said release mechanism being manipulatable within said inner lumen so as to remove said support assembly from said endoprosthesis, permitting subsequent radial expansion of said endoprosthesis;

b. inserting said deployment system intraluminally;

c. positioning said deployment system at an area of implantation;

d. engaging said release mechanism with said arm of said support member;

e. manipulating said release mechanism within said inner lumen, thereby removing said support member from said endoprosthesis and permitting radial expansion thereof; and

f. removing said deployment system from said area of implantation.

18. A method as in claim 17, wherein said providing step a. further includes providing said support assembly including a distal support member for maintaining said distal end extent of said endoprosthesis in a compressed state.

19. A method as in claim 18, further comprising providing a proximal support member for removably maintaining said proximal end extent of said endoprosthesis in a compressed state, said proximal support member being anchored to said catheter.

20. A method as in claim 19, wherein said removing step e. removes said distal support member, thereby permitting radial expansion of said distal end extent of said endoprosthesis.

21. A method as in claim 17, wherein said providing step a. further includes providing said proximal end extent and said distal end extent of said endoprosthesis as separate members.

22. A deployment system as in claim 17, comprising providing a retractible outer sheath disposed over said catheter.

23. A deployment system as in claim 22, further comprising the step of retracting said outer sheath after said positioning step c.

24. A stent-prosthesis deployment system comprising:

a flexible elongated tubular delivery catheter having a proximal portion, a distal portion, an inner lumen, and an opening through said catheter in communication with said inner lumen;

an implantable prosthesis positioned over said catheter;

a radially expandable stent supporting said prosthesis, said stent having a proximal end extent and an opposed distal end extent;

a removable endoprosthesis support assembly for maintaining said stent in a compressed state, said support assembly being located adjacent said catheter opening, said support assembly further including an arm extending through said catheter opening into said inner lumen; and

a release mechanism insertable through said inner lumen of said catheter, said release mechanism including a distal tip engageable with said arm of said support assembly, said release mechanism being manipulatable within said inner lumen so as to remove said support assembly from said stent, permitting subsequent radial expansion of said stent.

25. A deployment system as in claim 24, wherein said prosthesis includes a vascular graft.

26. A deployment system as in claim 24, wherein said support assembly includes a boot.

27. A deployment system as in claim 24, wherein said support assembly includes a distal support member maintaining said distal end extent of said stent in a compressed state.

28. A deployment system as in claim 27, further comprising a proximal support member for removably maintaining said proximal end extent of said stent in a compressed state.

29. A deployment system as in claim 24, wherein said proximal end extent and said distal end extent of said stent are separate members.

30. A deployment system as in claim 24, wherein said release mechanism includes a release rod.

31. A deployment system as in claim 24, wherein said release mechanism includes a clip, said clip capable of attachment to said arm.

32. A deployment system as in claim 24, wherein said proximal portion and said distal portion of said catheter are separate portions connected by a connector portion.

33. A deployment system as in claim 32, wherein said opening through said catheter is through said connector portion.

34. A deployment system as in claim 24, further comprising a guidewire insertable through said inner lumen.

35. A deployment system as in claim 24, wherein said catheter includes a first inner lumen and a second inner lumen.

36. A deployment system as in claim 24, wherein said opening extends through to said first inner lumen, said release mechanism is insertable through said first lumen, and said guidewire is insertable through said second lumen.

37. A deployment system as in claim 24, further comprising a retractible outer sheath disposed over said catheter.