Apparatus and methods for placement and repositioning of intraluminal prostheses

• US 6,350,278 B1
• Filed: 10/18/1999
• Issued: 02/26/2002
• Est. Priority Date: 06/08/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Watanabe, Gwendolyn A., Zarins, Christopher K., Evans, Michael A., Lenker, Jay A., Ryan, Timothy J., Murphy, Richard O., Freislinger, Kirsten
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/420,618
• Time in Patent Office: 862 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 606/108
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• 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 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A delivery catheter for a radially compressible tubular prosthesis comprises an elongate shaft slidably received within an elongate sheath. The prosthesis is carried over the distal end of the shaft where it is contained in a radially compressed configuration by the sheath. After introducing the catheter to a desired target location within a body lumen, the prosthesis may be released by proximally retracting the sheath. The prosthesis will remain anchored to the shaft during at least part of the release procedure, permitting the user to recapture the prosthesis by distally advancing the sheath.

Claims

1. A delivery catheter for positioning a radially compressible prosthesis, said catheter comprising:

an elongate flexible shaft having a proximal end and a distal end;

a retaining structure near the distal end of the shaft which releasably holds the axial position of the prosthesis on the shaft; and

a sheath slidably received over the shaft to cover the prosthesis while the prosthesis is axially held on the shaft by the retaining structure, wherein the sheath has a fixed or deployable outwardly flared distal end to facilitate proximal and distal motion over the prosthesis.

2. A delivery catheter as in claim 1, further comprising means on the sheath for reconfiguring the distal end of the sheath between a non-flared configuration and a flared configuration.

3. A delivery catheter as in claim 2, wherein the reconfiguring means comprises an inflatable bladder and means for inflating said bladder, wherein the bladder flares the distal tip of the sheath outward when inflected.

4. A delivery catheter as in claim 1, wherein the distal end of the catheter comprises a resilient structure having a fixed flared configuration.

5. A delivery catheter as in claim 4, further comprising an axially translatable cap structure which in a proximal position captures the distal end to hold it in a non-flared configuration.

6. A delivery catheter as in claim 4, further comprising a containment sleeve slidably disposed over the sheath wherein the sleeve closes the flared end when distally advanced and allows the flared end to open when proximally retracted.

7. A delivery catheter as in claim 1, the flared distal end of the sheath comprises a structure including heat memory alloy components which define the flared structure of the distal end of the sheath at body temperatures and which assume a non-flared configuration at below body temperature.

8. A delivery catheter for positioning a radially compressible prosthesis, said catheter comprising:

an elongate flexible shaft having a proximal end and a distal end;

a retaining structure near the distal end of the shaft which releasably holds the axial position of the prosthesis on the shaft;

a sheath slidably received over the shaft to cover the prosthesis while the prosthesis is axially held on the shaft by the retaining structure; and

a tubular member attached at one end of the shaft at a location proximal of the retaining structure and at the other end to the inside of the sheath, wherein the membrane envelops the prosthesis when the prosthesis is radially compressed within the sheath and wherein the membrane everts as the sheath is retracted proximally relative to the shaft.

9. A delivery catheter for positioning a radially compressible prosthesis, said catheter comprising:

an elongate flexible shaft having a proximal end and a distal end;

a retaining structure near the distal end of the shaft which releasably holds the axial position of the prosthesis on the shaft;

a sheath slidably received over the shaft to cover the prosthesis while the prosthesis is axially held on the shaft by the retaining structure; and

a journal sleeve slidably disposed over the sheath, wherein the journal sleeve permits external anchoring of the catheter while the sheath can still be translated relative to the shaft.

10. A delivery catheter as in claim 9 further comprising a lock which selectively fixes the shaft relative to the journal sleeve while permitting the sheath to be axially translated relative to the shaft and journal sleeve.

11. A method for positioning a radially compressible tubular prosthesis within a body lumen, said method comprising:

positioning a shaft having a radially compressed prosthesis on its distal end at a target location within the lumen;

radially releasing the prosthesis from the shaft by removing a cover which is detachably secured over the prosthesis to permit radial expansion of the prosthesis, while the prosthesis remains axially anchored on the shaft;

axially releasing the prosthesis from the shaft after the prosthesis has been substantially entirely radially released.

12. A method as in claim 11, wherein the radially releasing step comprises proximally retracting a sheath from over the prosthesis so that the sheath can optionally be distally advanced to recompress and recapture the prosthesis.

13. A method as in claim 11, wherein the removing step is selected from the group of steps consisting of (a) drawing proximally on a cord to axially or spirally split the cover, (b) axially translating an end cap to radially release a plurality of resilient, radially outwardly flared axial elements of the cover, and (c) axially separating two halves of the cover.

14. A method as in claim 12, wherein the body lumen is a blood vessel.

15. A method as in claim 14, wherein the shaft and sheath are percutaneously introduced into the vasculature.

16. A method for positioning a radially compressible tubular prosthesis within a body lumen, said method comprising:

positioning, at a target location within the lumen, a shaft having on its distal end a sheath slidably received over the shaft with a radially compressed prosthesis therein;

radially releasing the prosthesis from the shaft by proximally retracting the sheath from over the prosthesis to permit radial expansion of the prosthesis and flaring a distal end of the sheath to facilitate retraction and optional advancement of the sheath, while said prosthesis remains axially anchored on the shaft; and

axially releasing the prosthesis from the shaft after the prosthesis has been substantially entirely radially released.

17. A method as in claim 16, wherein flaring comprises inflating a bladder disposed at the end of the sheath.

18. A method as in claim 16, wherein flaring comprises retracting a sleeve proximally over the sheath to permit resilient outward expansion of the distal end of the sheath.

19. A method as in claim 16, wherein flaring comprises axially translating a cap structure to permit resilient outward expansion of the distal end of the sheath.

20. A method as in claim 16 wherein flaring results from a temperature transition which causes heat memory alloy components in the distal end of the sheath to expand.

21. A method for positioning a radially compressible tubular prosthesis within a body lumen, said method comprising:

positioning, at a target location within the lumen, a shaft having on its distal end a sheath slidably received over the shaft with a radially compressed prosthesis therein;

radially releasing the prosthesis from the shaft by everting a tubular membrane which covers the prosthesis within the sheath as the sheath is proximally retracted, wherein the membrane prevents direct contact between the sheath and the prosthesis to permit radial expansion of the prosthesis, while said prosthesis remains axially anchored on the shaft; and

axially releasing the prosthesis from the shaft after the prosthesis has been substantially entirely radially released.

22. A method as in claim 21, wherein the tubular membrane is attached at one end to the shaft at a location proximal of the prosthesis and at the other end to the inside of the sheath, wherein everting occurs when the sheath is retracted.

23. A method for positioning a radially compressible tubular prosthesis within a body lumen, said method comprising:

positioning, at a target location within the lumen, a shaft having on its distal end a sheath slidably received over the shaft with a radially compressed prosthesis therein;

radially releasing the prosthesis from the shaft to permit radial expansion of the prosthesis, while said prosthesis remains axially anchored on the shaft, wherein the prosthesis is anchored to the shaft by at least one locking stay disposed on the shaft which extends through the prosthesis and engages an inner surface of the sheath; and

axially releasing the prosthesis from the shaft after the prosthesis has been substantially entirely radially released, wherein the prosthesis is released by proximally retracting the sheath past the at least one locking stay.

24. A method as in claim 23, wherein the prosthesis is anchored to the shaft by a plurality of circumferentially spaced-apart locking stays disposed over the shaft.