Delivery apparatus for a self-expanding stent

• US 6,425,898 B1
• Filed: 02/03/1999
• Issued: 07/30/2002
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Johnson, Kirk L., Querns, Stephen J., Davila, Luis A., Feller, Frederick III, Wilson, David J.
• Primary Examiner(s): O'Connor, Cary E.
• Application Number:
  US09/243,750
• Time in Patent Office: 1,273 Days
• Field of Search: 606/108, 606/198, 606/184-187, 606/190-194, 623/11-12, 623/1.11, 623/1.12, 604/264, 604/282, 604/280
• US Class Current: 606/108
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• 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

Abstract

In accordance with the present invention there is provided a delivery apparatus for a self-expanding stent. The apparatus has an outer sheath which is an elongated tubular member with distal and proximal ends and inside and outside diameters. The outer sheath has an enlarged section adjacent its distal end. The enlarged section has a greater inside and outside diameter than the inside and outside diameter of the sheath proximal to the enlarged section. The apparatus also includes an inner shaft located coaxially within the outer sheath. The shaft has a distal end and a proximal end. The shaft further includes a stop attached thereto which is proximal to the distal end of the sheath. Lastly, the apparatus includes a self-expanding stent located within the enlarged section of the outer sheath and makes frictional contact with the outer sheath. The shaft is disposed coaxially within a lumen of the stent, whereby the stent makes contact with the stop during deployment.

Claims

1. A delivery apparatus for a self-expanding stent, said apparatus comprising:

a) a sheath including an elongated substantially tubular member having distal and proximal ends, a proximal section having a first outside diameter, an enlarged section proximate said distal end having a second outside diameter, the second outside diameter being greater than the first outside diameter, said sheath having an increasing durometer along its length from its distal end to its proximal end;

b) a shaft located coaxially within said sheath, said shaft having a distal end and a proximal end, said shaft further including a radiopaque stop attached thereto, said stop being positioned proximate to said distal end of said sheath;

c) a radiopaque fluid injection annular gap extending between a guiding catherer having an inside diameter greater than the first outside diameter of said proximal section of said sheath; and

d) a self-expanding stent located within said enlarged section of said sheath, said stent making frictional contact with said sheath, said shaft disposed coaxially within a lumen of said stent, whereby said stent makes contact with said stop during deployment of said stent.

2. The delivery apparatus of claim 1 wherein said sheath comprises an outer polymeric layer, and inner polymeric layer, and a wire reinforcing layer between said inner and outer layers, said reinforcing layer being more rigid than said inner and outer layers.

3. The apparatus of claim 2 wherein said wire reinforcing layer comprises braids of metallic wire.

4. The apparatus of claim 3 wherein said wire comprises stainless steel.

5. The delivery apparatus of claim 1, wherein said distal end of said shaft extends distal to said distal end of said sheath, and said proximal end of said shaft extends proximal to said proximal end of said sheath.

6. The apparatus of claim 1 wherein said stop makes no substantial frictional contact with said sheath.

7. The apparatus of claim 1 wherein said shaft has a proximal portion made from a metallic material.

8. The apparatus of claim 7 wherein said proximal portion is made from material selected from a group comprising:

stainless steel, nickel titanium alloys.

9. The apparatus of claim 1 wherein said stent is made from a superelastic nickel-titanium alloy.

10. The apparatus of claim 1 wherein said shaft further includes a distal tip, said distal tip has a proximal end having an outer diameter which is not less than an outer diameter of said sheath.

11. The apparatus of claim 10 wherein said distal tip is radiopaque.

12. The apparatus of claim 1 wherein said distal end of said shaft has a radio-opaque marker disposed thereon.

13. The apparatus of claim 1 wherein said sheath has an increasing durometer along its length from its distal end to its proximal end.

14. The apparatus according to claim 1 wherein said shaft further includes a reinforcing sleeve attached to said shaft immediately proximal to said stop.

15. A delivery apparatus for a self-expanding stent, said apparatus comprising:

a) a sheath comprising an elongated tubular member having distal and proximal ends, a proximal section having a first outside diameter, an enlarged section proximate said distal end having a second outside diameter and a tapered section therebetween, the second outside diameter being greater than the first outside diameter, said sheath having an increasing durometer along its length from its distal end to its proximal end;

b) a shaft located coaxially within said sheath, said shaft having a distal end and a proximal end, said shaft further including a radiopaue stop attached thereto, said stop being positioned proximate to said distal end of said sheath;

c) a radiopaque fluid injection annular gap extending between a guiding catherer having an inside diameter greater than the first outside diameter of said proximal section of said sheath; and

d) a self-expanding stent located within said enlarged section of said sheath, said stent making frictional contact with said sheath, said shaft disposed coaxially within a lumen of said stent, whereby said stent makes contact with said stop during deployment of said stent.

16. A delivery apparatus for a self-expanding stent, said apparatus comprising:

a) a sheath comprising an elongated tubular member having distal and proximal ends, a proximal section having a first outside diameter, an enlarged section proximate said distal end having a second outside diameter and a tapered section therebetween, the second outside diameter being greater than the first outside diameter;

b) a shaft located coaxially within said sheath, said shaft having a distal end and a proximal end, said shaft further including a radiopaue stop attached thereto, said stop being positioned proximate to said distal end of said sheath;

c) a radiopaque fluid injection annular gap extending between a guiding catheter having an inside diameter greater than the first outside diameter of said proximal section of said sheath; and

d) a self-expanding stent located within said enlarged section of said sheath, said stent making frictional contact with said sheath, said shaft disposed coaxially within a lumen of said stent, whereby said stent makes contact with said stop during deployment of said stent.

17. The delivery apparatus of claim 16 wherein said sheath comprises an outer polymeric layer, and inner polymeric layer, and a wire reinforcing layer between said inner and outer layers, said reinforcing layer being more rigid than said inner and outer layers.

18. The apparatus of claim 17 wherein said wire reinforcing layer comprises braids of metallic wire.

19. The apparatus of claim 17 wherein said wire comprises stainless steel.

20. The delivery apparatus of claim 16, wherein said distal end of said shaft extends distal to said distal end of said sheath, and said proximal end of said shaft extends proximal to said proximal end of said sheath.

21. The apparatus of claim 16 wherein said stop makes no substantial frictional contact with said sheath.

22. The apparatus of claim 16 wherein said shaft has a proximal portion made from a metallic material.

23. The apparatus of claim 22 wherein said proximal portion is made from material selected from a group comprising stainless steel, nickel titanium alloys.

24. The apparatus of claim 16 wherein said stent is made from a superelastic nickel-titanium alloy.

25. The apparatus of claim 16 wherein said shaft further includes a distal tip, said distal tip has a proximal end having an outer diameter which is not less than an outer diameter of said sheath.

26. The apparatus of claim 25 wherein said distal tip is radiopaque.

27. The apparatus of claim 16 wherein said distal end of said shaft has a radio-opaque marker disposed thereon.

28. The apparatus of claim 16 wherein said sheath has an increasing durometer along its length from its distal end to its proximal end.