Delivery apparatus for a self-expanding stent

• US 6,743,219 B1
• Filed: 08/02/2000
• Issued: 06/01/2004
• Est. Priority Date: 08/02/2000
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Mathis, Mark L., Davila, Luis A., Feller, Frederick III, Wilson, David J., Dwyer, Clifford J.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/631,002
• Time in Patent Office: 1,399 Days
• Field of Search: 606/108, 606/200, 606/151, 606/191, 606/192, 606/194, 606/195, 606/198, 623/1.11, 623/1.23, 604/93.01, 604/104, 604/506-510, 604/264, 604/271, 604/523-530
• US Class Current: 604/525
• 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

A delivery apparatus for self-expanding stents may be utilized to safely deliver stents to a target site. The apparatus has an outer sheath forming an elongated tubular member having distal and proximal ends and an inside and outside diameter. The apparatus also includes an inner shaft located coaxially within the outer sheath. The inner shaft has a distal end, a proximal end and a longitudinal axis extending therebetween. At least a portion of the inner shaft is made from a flexible coiled member. The shaft preferably includes a stop attached thereto, the stop being proximal to the distal end of the sheath. Lastly, the apparatus includes a self-expanding stent located within the outer sheath, wherein the stent makes frictional contact with the outer sheath and the shaft is disposed coaxially within a lumen of the stent. During deployment of the stent, the stent makes contact with the stop.

Claims

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

a. an outer sheath comprising an elongated tubular member having distal and proximal ends; and

b. an inner shaft, defining a longitudinal axis, located coaxially within said outer sheath, said shaft having a distal portion and a distal end and a proximal portion and a proximal end, said inner shaft further including a body portion between said distal portion and said proximal portion, said body portion being formed from a flexible coiled member capable of stretching and compressing along said longitudinal axis said distal portion and said proximal portion being formed from non-coiled members.

2. The delivery apparatus of claim 1, wherein said coiled member is made from stainless steel.

3. The delivery apparatus of claim 1, wherein said coiled member is made from a nickel-titanium alloy.

4. The delivery apparatus of claim 1 wherein said outer sheath comprises an outer polymeric layer, an 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.

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 sheath has an increasing durometer along its length from its distal end to its proximal end.

7. A delivery apparatus for expanding stent, said apparatus comprising:

a. an outer sheath comprising an elongated tubular member having distal and proximal ends and an inside and outside diameter;

b. an inner shaft, defining a longitudinal axis, located coaxially within said outer sheath, said shaft having a distal portion and a distal end and a proximal portion and a proximal end, said inner shaft further including a body portion between said distal portion and said proximal portion, said body portion being formed from a flexible coiled member capable of stretching and compressing along said longitudinal axis, said distal portion and said proximal portion being formed from non-coiled members, said shaft further including a stop attached thereto, said stop being proximal to said distal end of said sheath; and

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

8. The delivery apparatus of claim 7, wherein said coiled member is made from stainless steel.

9. The delivery apparatus of claim 7, wherein said coiled member is made from a nickel-titanium alloy.

10. The delivery apparatus of claim 7 wherein said outer sheath comprises an outer polymeric layer, an 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.

11. The delivery apparatus of claim 7, 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.

12. The apparatus of claim 7 wherein said stop makes substantially no frictional contact with said outer sheath.

13. The apparatus of claim 7 wherein said stent is made from a superelastic nickel-titanium alloy.

14. The apparatus of claim 7 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.

15. The apparatus of claim 14 wherein said distal tip is radiopaque.

16. The apparatus of claim 7 wherein said stop is radio-opaque.

17. The apparatus of claim 7 wherein said sheath has an increasing durometer along its length from its distal end to its proximal end.

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

a. an outer sheath comprising an elongated tubular member having distal and proximal ends and an inside and outside diameter;

b. an inner shaft, defining a longitudinal axis, located coaxially within said outer sheath, said shaft having a distal portion and a distal end and a proximal portion and a proximal end, said inner shaft further including a body portion between said distal portion and said proximal portion, said body portion being formed from a flexible coiled member capable of stretching and compressing along said longitudinal axis, said distal portion and said proximal portion being formed from non-coiled members, said coiled member having a thin layer covering on an exterior thereof, said shaft further including a stop attached thereto, said stop being proximal to said distal end of said sheath; and

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

19. The delivery apparatus of claim 18, wherein said coiled member is made from stainless steel.

20. The delivery apparatus of claim 18, wherein said thin layer covering is a polymer.

21. The delivery apparatus of claim 18 wherein said outer sheath comprises an outer polymeric layer, an 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.

22. The delivery apparatus of claim 18, 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.

23. The apparatus of claim 18 wherein said stent is made from a superelastic nickel-titanium alloy.

24. The apparatus of claim 18 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.

25. The apparatus of claim 18 wherein said sheath has an increasing durometer along its length from its distal end to its proximal end.