Prosthesis and a method and means of deploying a prosthesis

• US 7,435,253 B1
• Filed: 11/24/1999
• Issued: 10/14/2008
• Est. Priority Date: 05/26/1997
• Status: Expired due to Fees

• Current Assignee: William A. Cook Australia Pty. Ltd (Cook Group Incorporated)
• Original Assignee: William A. Cook Australia Pty. Ltd (Cook Group Incorporated)
• Inventors: Lawrence-Brown, Michael, Hartley, David
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US09/449,270
• Time in Patent Office: 3,247 Days
• Field of Search: 623 11- 135, 606190-195
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

An introducer (1) adapted for the introduction of a self-expanding endovascular prosthesis (20) in a lumen of a patient. The introducer has attachment devices (10,30) to hold each end of the prosthesis so that each can be moved independently. An end ovascular prosthesis (20) is also claimed with stents at the proximal and distal ends being within the graft. The remainder of the stents are positioned on the outside of the graft body.

Claims

1. An introducer for the introduction of a prosthesis into a lumen of a patient, the prosthesis comprising a proximal end and a distal end, and at least one self-expanding stent the introducer comprising an external manipulation section which is arranged to remain external of the patient and,

a. a proximal attachment device attachable to the proximal end of the prosthesis,

b. a distal attachment device attachable to the distal end of the prosthesis,

c. each of the proximal and distal attachment devices being attachable to the prosthesis in such a manner that the prosthesis can be held in tension therebetween and that each end of the prosthesis can individually be moved in proximal and distal directions be rotated, and

d. proximal releasing means associated with the proximal attachment device and distal releasing means associated with the distal attachment device for enabling selective releasing of the proximal and distal ends of the prosthesis, and

e. a proximal trigger wire extending from the proximal attachment device to the manipulation section, the proximal trigger wire activating the proximal releasing means.

2. An introducer as in claim 1 wherein the proximal attachment device has a long flexible extension on its proximal end to facilitate insertion of the introducer into a body lumen and its advancement along the lumen.

3. An introducer as in claim 2 wherein the proximal attachment device is mounted on a flexible thin walled tube which extends in a distal direction from the proximal attachment device to the external manipulation section.

4. An introducer as in claim 3 wherein the thin walled metal tube includes fluid connection means external of the patient to enable the introduction of a medical reagent therethrough.

5. An introducer as in claim 4 wherein the long flexible extension includes a hollow tube therethrough in fluid communication with the thin walled metal tube and a plurality of side holes to enable dispersion of the medical reagent proximal of the prosthesis.

6. An introducer as in claim 3 wherein the distal attachment device is mounted on a flexible thick walled tube and the thick walled tube is coaxial on the thin walled tube and extending in a distal direction to the external manipulation section and mounted such that the respective tubes can be moved together or independently.

7. An introducer as in claim 6 including a haemostatic seal between the thin walled tube and the thick walled tube in the manipulation section.

8. An introducer as in claim 7 including means to introduce a medical reagent into an annular space defined between the thin walled tube and the thick walled tube.

9. An introducer as in claim 6 including an external sheath extendable from external of the patient to cover and compress the prosthesis during insertion of the introducer into a patient and movable longitudinally from outside the patient to expose the prosthesis.

10. An introducer as in claim 9 wherein the external sheath is coaxial with and in a sliding fit on the thick walled tube.

11. An introducer as in claim 10 wherein the external sheath has a proximal end which is tapered and smoothed to present a low resistance to advancement of the introducer during insertion.

12. An introducer as in claim 9 wherein the proximal end of the external sheath has a tight fit on to the proximal attachment device.

13. An introducer as in claim 9 wherein the distal attachment device is of a streamlined shape and is arranged to be advanced to the proximal attachment device whereby to allow smooth retrieval through the released prosthesis and into the external sheath for removal from a patient.

14. An introducer as in claim 1 including a distal trigger wire extending from the distal attachment device to the manipulation section, the distal trigger wire activating the distal releasing means.

15. An introducer as in claim 14 including an external release mechanism on the manipulation section for each of the proximal trigger wire and distal trigger wire, the external release mechanism arranged to prevent accidental release of the trigger wires.

16. An introducer as in claim 15 including a haemostatic seal around the respective trigger wires in the manipulation section.

17. An introducer as in claim 1 wherein the prosthesis is a bifurcated prosthesis.

18. An introducer as in claim 1 wherein the lumen of the patient is an aorta and the prosthesis is adapted to repair an aortic aneurism.