Covered stent with proximal and distal attachment, delivery catheter, and method of making same

• US 20070050017A1
• Filed: 08/31/2005
• Published: 03/01/2007
• Est. Priority Date: 08/31/2005
• Status: Active Grant

• Current Assignee: Vactronix Scientific, LLC
• Original Assignee: Advanced Bio Prosthetic Surfaces, Ltd.
• Inventors: Sims, Daniel, Mullens, Connor, Steinmetz, Jeffrey
• Granted Patent: US 8,187,318 B2
• Time in Patent Office: Days
• US Class Current: 623/1.440
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: Y10T 29/49947 by applying separate fastener

Abstract

A metallic or pseudometallic covered stent in which the stent component and the cover component are each fabricated of biocompatible metallic or pseudometallic materials, in which the cover and the stent are joined by at least one juncture at each of a proximal and distal end of the stent and the cover. A method of joining the stent and the cover is also disclosed.

Claims

1. An implantable covered-stent, comprising:

a) a stent having a proximal end region having at least one enlarged proximal member projecting therefrom and a distal end region having at least one enlarged distal member projecting therefrom; and

,

b) a cover member having a proximal end region and a distal end region;

wherein the proximal end region of said cover is joined in a first join to the at least one enlarged proximal member, and the distal end region of the cover is joined in a second join to the at least one enlarged distal member.

2. The implantable medical device of claim 1, wherein the stent and the cover have compatible degrees of foreshortening.

3. The implantable medical device of claim 1, wherein said stent and said cover are each composed of at least one material selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloys, nickel-titanium alloys, cobalt-chromium alloys and stainless steel.

4. The implantable medical device of claim 1, wherein the stent further comprises at least one joining member projecting from each of proximal and distal ends of the stent.

5. The implantable medical device of claim 1, wherein the stent has an A_f less than body temperature.

6. The implantable medical device of claim 4, wherein the cover has an A_f between about 60 to 100 degrees Centigrade.

7. The implantable medical device of claim 4, wherein the first join and said second join further comprise welds.

8. The implantable medical device of claim 7, wherein the welds are passivated.

9. The implantable medical device of claim 1, further comprising a constant outer diameter catheter sheath and a guidewire sheath.

10. The implantable medical device of claim 1, said device further comprising a tapered catheter sheath and a guidewire sheath.

11. A method for preparing the implantable medical device of claim 1, said method comprising:

a) loading the stent into a lumen of a loading tube such that a first end region of the stent projects beyond a first terminal end of the loading tube;

b) loading the cover over the terminal end of the loading tube and slidably engaging the cover onto the loading tube such that a first terminal end of the cover is in apposition with the first end region of the stent that projects beyond the first terminal end of the loading tube;

c) joining the first end region of the cover to the first end region of the stent in a first join to form a covered stent assembly having the first join;

d) loading the covered stent assembly having the first join into a restraining tube such that a second end region of the cover and a second end region of the stent project beyond a terminal end of the restraining tube; and

e) joining the second end region of the cover to the second end region of the stent in a second join to form the implantable medical device.

12. The method of claim 11, wherein steps c) and e) further comprise the step of forming the first join and the second join by resistance welding.

13. The method of claim 12, further comprising the step of passivating the covered stent assembly.

14. The method of claim 11, further comprising the step of transferring the covered stent assembly from the restraining tube into a catheter sheath.

15. The method of claim 11, further comprising the steps of:

a) disposing a pusher member within the catheter sheath prior to loading the implantable medical device into the catheter sheath;

b) sliding the implantable medical device into the catheter sheath such that it is at least in adjacent proximity to the pusher member; and

c) disposing a guidewire sheath through a central bore in the pusher member and through a central lumen of the implantable medical device.

16. The method of claim 13, wherein said covering sheath further comprises a tapered catheter sheath.

17. The method of claim 15, further comprising:

a) disposing a pusher member within the tapered catheter sheath prior to loading the implantable medical device into the catheter sheath;

b) sliding the implantable medical device into the tapered catheter sheath such that it is at least in adjacent proximity to the pusher member; and

c) disposing a guidewire sheath through a central bore in the pusher member and through a central lumen of the implantable medical device.

18. A method of joining a stent with a stent cover, comprising the steps of:

a) loading the stent into a lumen of a loading tube such that a first end region of the stent projects beyond a first terminal end the loading tube;

b) loading the cover over the terminal end of the loading tube and slidably engaging the cover onto the loading tube such that a first terminal end of the cover is in apposition with the first end region of the stent that projects beyond the first terminal end of the loading tube;

c) joining the first end region of the cover to the first end region of the stent in a first join to form a covered stent assembly having the first join;

d) loading the covered stent assembly having the first join into a restraining tube such that a second end region of the cover and a second end region of the stent project beyond a terminal end of the restraining tube; and

e) joining the second end region of the cover to the second end region of the stent in a second join to form the implantable medical device.

19. The method of claim 18, wherein steps c) and e) further comprise the step of forming the first join and the second join by resistance welding.

20. The method of claim 19, further comprising the step of passivating the first join and the second join.