Delivery system and method for deploying an endovascular prosthesis

• US 6,641,606 B2
• Filed: 12/20/2001
• Issued: 11/04/2003
• Est. Priority Date: 12/20/2001
• Status: Expired due to Fees

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Clair, Daniel G., Ouriel, Kenneth
• Primary Examiner(s): Truong, Kevin T.
• Assistant Examiner(s): Bui, Vy Q.
• Application Number:
  US10/029,068
• Publication Number:
  US 20030120330A1
• Time in Patent Office: 684 Days
• Field of Search: 606/200, 606/108, 606/192, 606/194, 606/195, 606/198, 606/191, 623/1--, 604/96-100
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

The present invention relates to an apparatus (300) for delivering an endovascular prosthesis within a blood vessel. The apparatus (300) includes a sheath (302) having a first end (310), a second end (308), an inner lumen (316) for receiving an endovascular prosthesis, and an outer lumen (322) for receiving a guide wire. The inner lumen (316) extends along a central axis (313) between the first end (310) and the second end (308). The outer lumen (322) is radially spaced from the inner lumen (316) and extends along an outer axis (323) between the ends (308 and 310).

Claims

1. An apparatus for delivering an endovascular prosthesis within a blood vessel, said apparatus comprising a sheath with a first end, a second end, an inner lumen for receiving an endovascular prosthesis, and an outer lumen for receiving a guide wire, said inner lumen extending along a central axis between said first end and said second end, said outer lumen being radially spaced from said inner lumen and extending along an outer axis between said ends;

and

a nosecone connected to a stiff wire, said nosecone having an outer diameter that is greater than the diameter of a first opening in said first end of said sheath.

2. The apparatus of claim 1 wherein said sheath includes a tubular wall that extends between said first end and said second end, said tubular wall being sufficiently flexible that said tubular wall readily bends as said sheath is fed through a blood vessel.

3. The apparatus of claim 2 wherein said outer lumen extends through said tubular wall of said sheath adjacent the outer periphery of said sheath.

4. A delivery system for placing an endovascular prosthesis within a blood vessel, said delivery system comprising:

a sheath having a first end, a second end, an inner lumen for receiving an endovascular prosthesis, and an outer lumen for receiving a guide wire;

said inner lumen extending along a central axis between a first opening in said first end and a second opening in said second end, and said outer lumen extending along an outer axis between said first end and said second end of said sheath, said outer lumen being radially spaced from said inner lumen and extending parallel to said inner lumen; and

a nosecone connected to a stiff wire, said nosecone having an outer diameter that is greater than the diameter of said first opening in said distal end of said sheath.

5. The delivery system of claim 4 wherein said sheath includes a tubular wall that extends between said first end and said second end, said tubular wall being sufficiently flexible that said tubular wall readily bends as said cartridge sheath is fed through a blood vessel.

6. The delivery system of claim 5 wherein said outer lumen extends through said tubular wall of said sheath adjacent the outer periphery of said sheath.

7. The delivery system of claim 6 wherein said stiff wire extends through said inner lumen and is slidable within said inner lumen of said sheath for longitudinal movement of said stiff wire and said nosecone relative to the sheath.

8. The delivery system of claim 7 wherein, said nosecone is incapable of being withdrawn through said first opening of said sheath.

9. The delivery system of claim 8 wherein said nosecone has a distal end with a frustoconical shape and a proximal end, said proximal end being sized to fit against said first opening of said sheath so as to axially align said nosecone with said sheath in a mated condition and seal said first opening of said sheath.

10. The delivery system of claim 9 wherein said nosecone includes a guide wire lumen that extends from a first opening in said distal end of said nosecone to a second opening in said proximal end of said nosecone.

11. The delivery system of claim 10 wherein said first opening of said guide wire lumen is at a tip of said distal end of said nosecone and said second opening is at a point on said proximal end of said nosecone coaxial with said outer lumen of said sheath when said proximal end of said nosecone is mated to said first end of said sheath.

12. The delivery system of claim 4 further including a pusher rod, said pusher rod being co-axially disposed with said inner lumen of said sheath, said pusher rod including a distal end, said distal end being sized to engage an endovascular prosthesis disposed in said inner lumen.

13. A delivery system for placing an endovascular prosthesis within a blood vessel, said delivery system comprising:

a sheath having a first end, a second end, an inner lumen for receiving an endovascular prosthesis, and an outer lumen;

said inner lumen extending along a central axis between a first opening in said first end and a second opening in said second end, said outer lumen extending along an outer axis between said first end and said second end, said outer lumen being radially spaced from said inner lumen and extending parallel to said inner lumen; and

a nosecone having a proximal end, a distal end, and a guide wire lumen extending between said proximal end and said distal end, said proximal end of said nosecone being detachable from and connectable to said first end of said sheath allowing said guide wire lumen to communicate with said outer lumen of said sheath.

14. The delivery system of claim 13 further wherein said nosecone is connected to a stiff wire, said stiff wire extending through said inner lumen of said sheath and being slidable within said inner lumen of said sheath for longitudinal movement of said stiff wire and said nosecone relative to said sheath.

15. The delivery system of claim 14 wherein said nosecone has an outer diameter that is greater than the diameter of said first opening in said first end of said sheath, said nosecone being incapable of being withdrawn through said first opening of said sheath.

16. The delivery system of claim 15 wherein said distal end of said nose cone has a frustoconical shape and said proximal end of said nosecone is sized to fit against said first opening of said sheath so as to axially align said nosecone with said sheath in a mated condition and seal said first opening of said sheath.

17. The delivery system of claim 13 further including a pusher rod, said pusher rod being co-axially disposed within said inner lumen of said sheath, said pusher rod including a distal end, said distal end being sized to engage an endovascular prosthesis disposed in said inner lumen.

18. A method of deploying an endovascular prosthesis, which is expandable from a collapsed condition to an expanded condition within a vasculature, said method comprising the steps of:

providing a guide wire having a distal end and a proximal end, said distal end of said guide wire extending within the vasculature;

providing a delivery system, said delivery system including a sheath having a first end, a second end, an inner lumen for receiving said endovascular prosthesis in the collapsed condition, and an outer lumen for receiving a guide wire, said inner lumen extending along a central axis between a first opening in said first end and a second opening in said second end, said outer lumen extending along an outer axis between said first end and said second end of said sheath, said outer lumen being radially spaced from said inner lumen and extending parallel to said inner lumen said delivery system further including a nosecone connected to a stiff wire, said nosecone having an outer diameter that is greater than the diameter of said first opening in said distal end of said sheath;

loading said endovascular prosthesis in the collapsed condition into said inner lumen of said sheath;

inserting said proximal end of said guide wire through said outer lumen of said sheath;

advancing said sheath, with said loaded endovascular prosthesis in collapsed condition, over said guide wire within the vasculature; and

maneuvering said endovascular prosthesis from said inner lumen of said sheath.

19. The method of claim 18 wherein said stiff wire extends through said inner lumen of said sheath and is slidable within said inner lumen of said sheath for longitudinal movement of said stiff wire and said nosecone relative to said sheath.

20. The method of claim 19 wherein said nosecone is incapable of being withdrawn through said first opening of said sheath.

21. The method of claim 20 wherein said nose cone has a distal end with a frustoconical shape and a proximal end, said proximal end being sized to fit against the first opening of said sheath so as to axially align said nosecone with said sheath in a mated condition and seal said first opening of said sheath.

22. The method of claim 21 wherein said nosecone includes a guide wire lumen that extends from a first opening in the said distal end of said nosecone to a second opening in said proximal end of said nosecone.

23. The method of claim 22 wherein said first opening of said guide wire lumen is at a tip of said distal end of said nosecone and said second opening is at a point on said proximal end of said nosecone coaxial with said outer lumen of said sheath when said proximal end of said nosecone is mated to said first end of said sheath.

24. The method of claim 23 wherein said proximal end of said guide wire is inserted through said guide wire lumen of said nosecone before being inserted through said outer lumen of said sheath.

25. The method of claim 18 wherein said delivery system further includes a pusher rod, said pusher rod having a distal end, said endovascular prosthesis being maneuvered from said sheath with said pusher rod.

26. The method of claim 25 wherein said endovascular prosthesis is maneuvered from said inner lumen of said sheath by the following steps:

advancing said pusher rod through said inner lumen of said sheath until said distal end of said pusher rod engages said endovascular prosthesis in collapsed condition; and

withdrawing said sheath from said vasculature while said pusher rod is maintained against said endovascular prosthesis.

27. A method of deploying an endovascular prosthesis, which is expandable from a collapsed condition to an expanded condition within a vasculature, said method comprising the steps of:

providing a guide wire having a distal end and a proximal end, said distal end of said guide wire being positioned within the vasculature;

providing a delivery system, said delivery system comprising a sheath and a nosecone, said sheath having a first end, a second end, an inner lumen for receiving an endovascular prosthesis, and an outer lumen, said inner lumen extending along a central axis between a first opening in said first end and a second opening in said second end and said outer lumen extending along an outer axis between said first end and said second end, said outer lumen being radially spaced from said inner lumen and extending parallel to said inner lumen, said nosecone having a proximal end, a distal end, and a guide wire lumen extending between said proximal end and said distal end, said proximal end of said nosecone being detachable from and connectable to said first end of said sheath allowing said guide wire lumen to communicate with said outer lumen of said sheath;

loading said endovascular prosthesis in the collapsed condition into said inner lumen of said sheath;

inserting said proximal end of said guide wire through said guide wire lumen of said nosecone and said outer lumen of said sheath;

advancing said nosecone and said sheath, with said loaded endovascular prosthesis in the collapsed condition, over said guide wire within the vasculature; and

maneuvering said endovascular prosthesis from said inner lumen of said sheath.

28. The method of claim 27 wherein said delivery system further includes a stiff wire, said stiff wire being connected to said proximal end of said nosecone and being slidable within said inner lumen of said sheath for longitudinal movement of said stiff wire and said nosecone relative to said sheath.

29. The method of claim 27 wherein said nosecone has an outer diameter that is greater than the diameter of said first opening in said first end of said sheath, said nosecone being incapable of being withdrawn through said first opening of said sheath.

30. The method of claim 27 wherein said distal end of said nosecone has a frustoconical shape and said proximal end of said nosecone being sized to fit against said first opening of said sheath so as to axially align said nosecone with said sheath in a mated condition and seal said first opening of said sheath.

31. The method of claim 27 wherein said guide wire lumen of said nosecone extends from a first opening in a tip of said distal end of said nosecone to a second opening at a point on said proximal end of said nosecone coaxial with said outer lumen of said sheath when said proximal end of said nosecone is mated to said sheath.

32. The method of claim 27 wherein said delivery system further includes a pusher rod having a distal end, and wherein said endovascular prosthesis is maneuvered from said sheath with said pusher rod.

33. The method of claim 32 wherein said endovascular prosthesis is maneuvered from said inner lumen of said sheath by the following steps:

advancing said pusher rod through said inner lumen of said sheath until said distal end of said pusher rod engages said endovascular prosthesis in the collapsed condition; and

withdrawing said sheath from the vasculature while said pusher rod is maintained against said endovascular prosthesis.