Apparatus and methods for placement and repositioning of intraluminal prostheses

• US 6,126,685 A
• Filed: 07/31/1998
• Issued: 10/03/2000
• 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:
  US09/127,666
• Time in Patent Office: 795 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194
• US Class Current: 623/1.11
• 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 method for preparing a prosthesis delivery catheter, said method comprising:

providing a delivery catheter including;

(a) an elongate flexible shaft having a proximal end, a distal end, and a coupling member at the distal end; and

(b) an elongate member slidably attached to the shaft and having a proximal end, a distal end, and a coupling member at the distal end;

providing a prosthesis cartridge including;

(a) a shaft extension having a proximal end, a distal end, and a coupling member at the proximal end;

(b) a sheath extension having a proximal end, a distal end and a coupling member at the proximal end; and

(c) a prothesis radially compressed over the shaft extension and within the sheath extension; and

attaching the coupling member on the shaft extension to the coupling member on the flexible elongate shaft and attaching the coupling member on the sheath extension to the coupling member on the elongate member.

2. A prosthesis cartridge for use with a delivery catheter including an elongate flexible shaft having a proximal end and a distal end, and an elongate member slidably attached to the shaft, the elongate member having a proximal end and a distal end, said prosthesis cartridge comprising:

a shaft extension having a proximal end, a distal end, and a coupling member at the proximal end for coupling to a distal end of the elongate flexible shaft of the delivery catheter;

a sheath extension having a proximal end, a distal end, and a coupling member at the proximal end for coupling to a distal end of the elongate member of the delivery catheter; and

an endoluminal prosthesis radially compressed over the shaft extension and within the sheath extension.

4. A prosthesis cartridge as in claim 2, wherein the cartridge is contained in a sterile package.

3. A set of alternative, selectable prosthesis cartridges for use with a delivery catheter including an elongate flexible shaft having a proximal end and a distal end, and an elongate member slidably attached to the shaft, the elongate member having a proximal end and a distal end, the set comprising:

a plurality of prosthesis cartridges, wherein each prosthesis cartridge comprises;

a shaft extension having a proximal end, a distal end, and a coupling member at the proximal for coupling to the distal end of the elongate flexible shaft of the delivery catheter;

a sheath extension having a proximal end, a distal end, and a coupling member at the proximal end for coupling to the distal end of the elongate member of the delivery catheter; and

an endoluminal prosthesis radially compressed over the shaft extension and within the sheath extension;

wherein at least some of said cartridges comprise prostheses having different lengths, wherein the shaft extension coupling members are interchangeably coupleable to the distal end of the elongate flexible shaft while the sheath extension coupling members are interchangeably coupleable to the distal end of the elongate member.

5. An endoluminal prosthesis delivery system comprising:

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

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

a cover attached near the distal end of the shaft, the cover extending distally from the shaft and over the radially compressible prosthesis from the proximal end of the prosthesis to the distal end of the prosthesis; and

a sheath slidably received over the shaft, the sheath covering the cover while said cover releasably radially restrains the prosthesis.

6. A delivery system as in claim 5, further comprising a mechanism operable from the proximal end of the shaft which releases the cover from over the prosthesis so that at least a portion of the prosthesis resiliently expands within a body lumen, wherein the cover maintains radial compression of a portion of the prosthesis during operation of the mechanism, and wherein an alternative portion of the prosthesis expands and conforms to the interior surface of the body lumen.

7. An endoluminal prosthesis delivery system comprising:

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

a resilient radially compressible endoluminal prosthesis;

a cover attached near the distal end of the shaft, the cover releasably disposed over the radially compressible prosthesis; and

a sheath slidably received over the shaft, the sheath covering the cover while said cover radially restrains the prosthesis;

wherein the cover comprises a plurality of distally oriented axial elements.

8. An endoluminal prosthesis delivery system comprising:

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

a plurality of axial elements attached near the distal end of the shaft;

a resilient tubular endoluminal prosthesis radially compressed between the axial elements; and

a sheath slidably disposed over the axial elements.

9. A delivery system as in claim 8, further comprising an endcap which releasably restrains the distal ends of the axial elements.

10. A delivery system as in claim 8, wherein the axial elements axially restrain the prosthesis when the sheath is withdrawn proximally to release the prosthesis.

11. A delivery system as in claim 10, wherein the axial elements resiliently flex outward to release the prosthesis.

12. A delivery system as in claim 8, wherein the axial elements axially restrain the prosthesis after a portion of the prosthesis expands so that advancing the sheath distally compresses the expanded portion of the prosthesis.

13. A delivery system comprising:

a prosthesis cartridge comprising;

a shaft extension having a proximal end, a distal end, and a coupling member at the proximal end;

a sheath extension having a proximal end, a distal end, and a coupling member at the proximal end; and

an endoluminal prosthesis radially compressed over the shaft extension and within the sheath extension; and

a delivery catheter which is separated from and securable to the prosthesis cartridge, the 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 coupling member 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 coupling member of the sheath extension of the prosthesis cartridge.

14. A prosthesis system comprising:

a delivery catheter including an elongate flexible shaft having a proximal end and a distal end, and an elongate member slidably attached to the shaft, the elongate member having a proximal end and a distal end;

a plurality of prosthesis cartridges, wherein each prosthesis cartridge comprises;

a shaft extension having a proximal end, a distal end, and a coupling member at the proximal for coupling to the distal end of the elongate flexible shaft of the delivery catheter;

a sheath extension having a proximal end, a distal end, and a coupling member at the proximal end for coupling to the distal end of the elongate member of the delivery catheter; and

an endoluminal prosthesis radially compressed over the shaft extension and within the sheath extension;

wherein at least some of said cartridges comprise prostheses having different lengths, wherein the shaft extension coupling members are interchangeably coupleable to the distal end of the elongate flexible shaft while the sheath extension coupling members are interchangeably coupleable to the distal end of the elongate member.

15. An endoluminal prosthesis delivery system comprising:

a tubular sheath having a proximal end and a distal end and a lumen therebetween;

a resilient tubular endoluminal prosthesis radially compressed within the lumen of the sheath;

a plurality of axial elements disposed between the endoluminal prosthesis and the sheath, the axial elements extending from proximally of the prosthesis to distally of the prosthesis; and

an elongate flexible shaft extending proximally from the axial elements;

wherein the axial elements axially restrain the prosthesis when the sheath is withdrawn proximally, and wherein the axial elements flex radially outward to release the prosthesis.