Apparatus and methods for placement and repositioning of intraluminal prostheses

• US 5,824,041 A
• Filed: 06/28/1996
• Issued: 10/20/1998
• Est. Priority Date: 06/08/1994
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Evans, Michael A., Lenker, Jay A., Watanabe, Gwendolyn A., Ryan, Timothy J., Zarins, Christopher K., Murphy, Richard O., Freislinger, Kirsten
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/683,806
• Time in Patent Office: 844 Days
• Field of Search: 623/1, 623/12, 606/194, 606/195
• US Class Current: 606/195
• 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 resilient, tubular, radially compressible endoluminal prosthesis having a proximal end and a distal end, said catheter comprising:

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

a retaining structure attached near the distal end of the shaft for releasably holding the axial position of the prosthesis on the shaft; and

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

wherein the retaining structure is disposable radially over an outer surface of the prosthesis and radially within an inner surface of the sheath, the retaining structure extending distally over the prosthesis from the proximal end of the prosthesis to the distal end of the prosthesis while the sheath covers the retaining structure.

2. A delivery catheter as in claim 1, wherein the shaft has a coupling mechanism spaced proximally of the distal end and the sheath has a coupling mechanism proximally of a distal end of the sheath, whereby a distal end of the catheter including the distal end of the shaft and the distal end of the sheath are detachable and alternative distal ends of the catheter may be attached.

3. A delivery catheter as claimed in claim 1, wherein the retaining structure comprises a plurality of resilient, radially outwardly flarable axial elements.

4. A delivery catheter for positioning a resilient, tubular, radially compressible endoluminal prosthesis having at least one radial aperture, said catheter comprising:

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

a retaining structure attached near the distal end of the shaft for releasably holding the axial position of the prosthesis on the shaft; and

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

wherein the retaining structure comprises at least one locking stay extending radially from the shaft so as to extend through the aperture of the prosthesis and hold the prosthesis axially in place relative to the shaft as the sheath is axially translated relative to the shaft and a portion of the prosthesis expands resiliently.

5. A delivery catheter as in claim 4, wherein the locking stay is disposed over the shaft and extends radially outward by a distance sufficient to engage an interior surface of the sheath.

6. A delivery catheter as in claim 5, wherein the retaining structure comprises at least two circumferentially spaced-apart locking stays disposed over the shaft.

7. A delivery catheter for positioning a resilient, tubular, radially compressible endoluminal prosthesis having a proximal end and a distal end, said catheter comprising:

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

a retaining structure attached near the distal end of the shaft for releasably holding the axial position of the prosthesis on the shaft; and

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

wherein the retaining structure is disposable between the prosthesis and the sheath so that the retaining structure extends axially over the prosthesis from its proximal end to its distal end while the sheath covers the retaining structure, the retaining structure comprising a cover which is detachably secured over the radially compressible prosthesis and means operable from the proximal end of the flexible shaft for detaching the cover from over the prosthesis to release said prosthesis.

8. A delivery catheter as in claim 7, wherein the cover is a cylinder and the detaching means is a mechanism selected from the group consisting of (a) a cord for splitting the cylinder along at least one axial or spiral line by drawing proximally on the cord, (b) an axially translatable end cap which captures a plurality of resilient, radially outwardly flared axial elements of the cylinder, and (c) means for axially separating two halves of the cylindrical cover.

9. A catheter system comprising:

a resilient, radially compressible endoluminal prosthesis having a proximal end and a distal end;

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

a retaining structure attached 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 said prosthesis is axially held on the shaft by the retaining structure;

wherein the retaining structure extends distally over the prosthesis and within the sheath from a proximal end of the prosthesis beyond the distal end of the prosthesis while the sheath covers the retaining structure.

10. A catheter system as in claim 9, wherein the prosthesis is axially anchored by the retaining structure and is radially compressed by the sheath.

11. A catheter system as in claim 9, wherein the prosthesis is axially anchored and radially compressed by the retaining structure.

12. A delivery catheter as claimed in claim 9, wherein the cover comprises a plurality of resilient, radially outwardly flarable axial elements.

13. A delivery catheter for use with a prosthesis cartridge including a shaft extension having a distal end and a proximal end, a sheath extension slidably received over the shaft extension, the sheath extension having a distal end and a proximal end, and a prosthesis radially compressed over the shaft extension and within the sheath extension, said delivery catheter comprising:

an elongate flexible shaft having a proximal end, a distal end, and a coupling member at the distal end for coupling to the proximal end of the shaft extension of the prosthesis cartridge; and

an elongate member slidably attached to the shaft and having a proximal end, a distal end, and a coupling member at the distal end for coupling to the proximal end of the sheath extension of the prosthesis cartridge so that the compressed prosthesis can be stored separately from the delivery catheter.

14. A delivery system comprising:

a resilient, radially compressible endoluminal prosthesis;

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

a sheath slidably received over the shaft and prosthesis to radially restrain the prosthesis; and

a plurality of resilient, radially outwardly flarable axial elements attached near the distal end of the shaft and extending distally over the prosthesis and within the sheath, resilient expansion of the prosthesis against the axial elements releasably holds the axial position of the entire prosthesis relative the shaft when the sheath slides relative to the axial elements.