Delivery apparatus for a self-expanding stent

• US 6,019,778 A
• Filed: 03/13/1998
• Issued: 02/01/2000
• 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, Wilson, David J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US09/042,276
• Time in Patent Office: 690 Days
• Field of Search: 606/1, 606/108, 606/191, 606/194, 606/198, 606/200, 623/1, 623/12, 898/898, 604/96, 604/282
• US Class Current: 606/198
• 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 2/966 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 includes an outer sheath, which is an elongated tubular member having distal and proximal ends. The outer sheath is made from an outer polymeric layer, an inner polymeric layer, and a braided reinforcing layer between the inner and outer layers. The reinforcing layer is more rigid than the inner and outer layers. The apparatus further includes an inner shaft located coaxially within the outer sheath. The shaft has a distal end, extending distal to the distal end of the sheath, and a proximal end, extending proximal to the proximal end of the sheath. The shaft further includes a stop attached thereto. The stop is proximal to the distal end of the sheath. Lastly, the apparatus includes a self-expanding stent located within the sheath. The stent makes frictional contact with the inner layer of the sheath. The stent is located between the stop and the distal end of the sheath, with a portion of the shaft disposed coaxially within a lumen of the stent. The stent makes contact with the stop during deployment of the stent.

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, said outer sheath comprising 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;

b) an inner shaft located coaxially within said outer sheath, said shaft having a distal end, extending distal to said distal end of said sheath, and a proximal end, extending proximal to said proximal end of said sheath, said shaft further including a stop attached thereto, said stop being proximal to said distal end of said sheath; and

c) a self-expanding superelastic nickel-titanium alloy stent located within said sheath, said stent making frictional contact with and exerting an outward force on said inner layer of said sheath, said stent located between said stop and said distal end of said sheath with a portion of said shaft disposed coaxially within a lumen of said stent, said stent makes contact with said stop during deployment of said stent.

2. The apparatus of claim 1 wherein said wire reinforcing layer comprises braids of metallic wire.

3. The apparatus of claim 2 wherein said wire comprises stainless steel.

4. The apparatus of claim 1 wherein said wire reinforcing layer comprises a metallic coil.

5. The apparatus of claim 1 wherein said braided reinforcing layer extends along a predetermined of length of a distal portion of said outer shaft.

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

10. The apparatus of claim 9 wherein said distal tip of said shaft is radiopaque.

11. The apparatus of claim 1 wherein said stop is radiopaque.

12. The apparatus of claim 11 wherein said distal end of said sheath is radiopaque.

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

14. The apparatus of claim 1 wherein said shaft further includes a reinforcing sleeve extending along a predetermined length of said shaft proximal to said stop.

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, said outer sheath comprising an outer polymeric layer, and inner polymeric layer, and a braided metallic wire reinforcing layer between said inner and outer layers, said reinforcing layer being more rigid than said inner and outer layers;

b) an inner shaft located coaxially within said outer sheath, said shaft having a distal end, extending distal to said distal end of said sheath, and a proximal end, extending proximal to said proximal end of said sheath, said shaft further including a stop attached thereto, said stop being proximal to said distal end of said sheath; and

c) a self-expanding superelastic nickel-titanium alloy stent located within said sheath, said stent making frictional contact with and exerting an outward force on said inner layer of said sheath, said stent located between said stop and said distal end of said sheath with a portion of said shaft disposed coaxially within a lumen of said stent, said stent makes contact with said stop during deployment of said stent.

16. The apparatus of claim 15 wherein said braided metallic wire reinforcing layer comprises stainless steel.

17. The apparatus of claim 15 wherein said braided reinforcing layer extends along a predetermined of length of a distal portion of said shaft.

18. The apparatus of claim 15 wherein said stop makes no substantial frictional contact with said outer sheath.

19. The apparatus of claim 15 wherein said shaft has a proximal portion made from a metallic material selected from a group comprising:

stainless steel, nickel titanium alloys.

20. The apparatus of claim 15 wherein said stent is made from a superelastic nickel-titanium alloy.

21. The apparatus of claim 15 wherein said distal tip includes a radiopaque marker disposed thereon.

22. The apparatus of claim 15 wherein said stop is radiopaque.

23. The apparatus of claim 22 wherein said distal end of said sheath has a radiopaque marker disposed thereon.

24. The apparatus of claim 15 wherein said shaft has an increasing durometer along its length from its distal end to its proximal end.

25. The apparatus of claim 15 wherein said shaft further includes a reinforcing sleeve extending along a predetermined length of said shaft proximal to said stop.

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

a) an outer sheath, comprising an elongated tubular member having distal and proximal ends, said outer sheath comprising an outer polymeric layer, and inner polymeric layer, and a braided metallic wire reinforcing layer between said inner and outer layers, said reinforcing layer being more rigid than said inner and outer layers, said sheath having a plurality of sections having increasing durometers from its distal end to its proximal end, said sheath having a radiopaque marker disposed at its distal end;

b) an inner shaft located coaxially within said outer sheath, said shaft having a distal end, extending distal to said distal end of said sheath, and a proximal end, extending proximal to said proximal end of said sheath, said shaft having a radiopaque stop attached thereto, said stop being proximal to said distal end of said sheath, said shaft further including a distal tip, said distal tip having a proximal end having an outer diameter which is not less than an outer diameter of said sheath, said tip having a radiopaque marker disposed thereon; and

c) a self-expanding superelastic nickel-titanium alloy located within said sheath, said stent making frictional contact with and exerting an outward force on said inner layer of said sheath, said stent located between said stop and said distal end of said sheath with a portion of said shaft disposed coaxially within a lumen of said stent, said stent makes contact with said stop during deployment of said stent.

27. The apparatus of claim 26 wherein said braided metallic wire reinforcing layer comprises stainless steel.

28. The apparatus of claim 26 wherein said braided reinforcing layer extends along a predetermined of length of a distal portion of said shaft.

29. The apparatus of claim 26 wherein said stop makes no substantial frictional contact with said outer sheath.

30. The apparatus of claim 26 wherein said shaft has a proximal portion made from a metallic material selected from a group comprising:

stainless steel, nickel titanium alloys.

31. The apparatus of claim 26 wherein said shaft further includes a reinforcing sleeve extending along a predetermined length of said shaft proximal to said stop.