Delivery apparatus for a self-expanding stent

• US 6,773,446 B1
• Filed: 08/02/2000
• Issued: 08/10/2004
• 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): Calvert, John J.
• Assistant Examiner(s): MUROMOTO JR, ROBERT H
• Application Number:
  US09/631,026
• Time in Patent Office: 1,469 Days
• Field of Search: 606/108, 606/198, 606/194, 606/27, 606/113-115, 606/127, 606/128, 606/200, 606/41, 604/106-108
• US Class Current: 606/191
• 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 a self-expanding stent is disclosed. 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 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 located coaxially within said outer sheath, said outer sheath covering substantially all of said inner shaft, said shaft having a distal end, a proximal end and a longitudinal axis extending therebetween, said shaft further including a distal tip having a proximal end attached to said distal end of said shaft and a distal end extending therefrom, said distal tip including a proximal end having a diameter equal to the inner diameter of the outer sheath, a distal end having a diameter less than the inner diameter of the outer sheath, a rounded section having a diameter greater than the inside diameter of the outer sheath and configured to prevent said outer sheath from moving distally over the distal tip positioned between the proximal end and the distal end, and a proximally tapered section, extending between the rounded section and the distal end, said distal tip being configured to have a flexible leading edge that gradually decreases in flexibility in the proximal direction.

2. The delivery apparatus of claim 1 wherein said shaft further includes a lumen extending from said distal end of said distal tip to said proximal end of said shaft.

3. The delivery apparatus of claim 1, wherein said shaft has a proximal section made from a tube of stainless steel, a body section made from a coiled member, and a distal section made from a polymer.

4. The delivery apparatus of claim 1 wherein said distal tip is hollow, and wherein its thickness increases from its distal end to its proximal end.

5. The apparatus of claim 4 wherein distal tip is made from a polymer.

6. The delivery apparatus of claim 1 wherein said outer 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.

7. 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.

9. 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.

8. A delivery apparatus for a self-expanding stent, with 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 located coaxially within said outer sheath, said outer sheath covering substantially all of said inner shaft, said shaft having a distal end, a proximal end and longitudinal axis extending therebetween, said shaft further including a distal tip having a proximal end attached to said distal end of said shaft and a distal end extending thereform, said distal tip including a proximal end having a diameter equal to the inner diameter of the outer sheath, a distal end having a diameter less than the inner diameter of the outer sheath, a rounded section having a diameter greater than the inside diameter of the outer sheath and configured to prevent said out sheath from moving distally over the distal tip positioned between the proximal end and the distal end, and a proximally tapered section, extending between the rounded section and the distal end, said distal tip being configured to have a flexible leading edge that gradually decreases in flexibility in the proximal direction, 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.

10. The delivery apparatus of claim 8, wherein said shaft has a proximal section made from a tube of stainless steel, a body section made from a coiled member, and a distal section made from a polymer.

11. The delivery apparatus of claim 8 wherein said distal tip is hollow, and wherein its thickness increases from its distal end to its proximal end.

12. The apparatus of claim 11 wherein distal tip is made from a polymer.

13. The apparatus of claim 11 wherein distal tip is made from a polymer.

14. The delivery apparatus of claim 8, 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.

15. 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 located coaxially within said outer sheath, said outer sheath covering substantially all of said inner shaft, said shaft having a distal end, a proximal end and a longitudinal axis extending therebetween, said shaft having a proximal section made from a tube of stainless steel, a body section made from a coiled member, and a distal section made from a polymer, said shaft having increasing flexibility from its proximal end to its distal end, said shaft further including a distal tip having a proximal end attached to said distal end of said shaft and a distal end extending therefrom, said distal tip including a proximal end having a diameter equal to the inner diameter of the outer sheath, a distal end having a diameter less than the inner diameter of the outer sheath, a rounded section having a diameter greater than the inside diameter of the outer sheath and configured to prevent said outer sheath from moving distally over the distal tip positioned between the proximal end and the distal end, and a proximally tapered section, extending between the rounded section and the distal end, said distal tip being configured to have a flexible leading edge that gradually decreases in flexibility in the proximal direction, 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.

16. The delivery apparatus of claim 15 wherein said shaft further includes a lumen extending from said distal end of said distal tip to said proximal end of said shaft.

17. The delivery apparatus of claim 15 wherein said shaft has a proximal section made from a tube of stainless steel, a body section made from a coiled member, and a distal section made from a polymer.

18. The delivery apparatus of claim 15 wherein said distal tip is hollow, and wherein its thickness increases from its distal end to its proximal end.

19. The apparatus of claim 18 wherein distal tip is made from a polymer.

20. The delivery apparatus of claim 15 wherein said outer 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.

21. The delivery apparatus of claim 15 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.