Endovascular delivery system

• US 6,110,191 A
• Filed: 12/01/1998
• Issued: 08/29/2000
• Est. Priority Date: 09/12/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation, W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Yu, Weiyun, White, Geoffrey H., Dehdashtian, Mark, Saravia, Maria Lillian
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/203,998
• Time in Patent Office: 637 Days
• Field of Search: 606/192, 606/194, 606/108, 604/96
• US Class Current: 606/192
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/0653 Perforated disc
• CPC Class Codes: A61M 2039/0686 comprising more than one seal
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

A system for delivering and implanting a radially expandable endoluminal prosthesis within a body lumen (e.g., blood vessel). The system comprises a) an introducer/dilator assembly, and b) a delivery catheter/loader assembly. The introducer/dilator assembly comprises an elongate tubular introducer sheath which may be provided with a valving assembly mounted on the proximal end thereof. Such valving assembly may incorporate i) a hemostatic valve, ii) a first sealing valve and iii) a second sealing valve, positioned in series, to prevent leakage of body fluid out of the proximal end of the introducer and to permit two or more elongate members (e.g., catheters, guidewires) having differing outer diameters to be inserted through the introducer without leakage of body fluid therefrom. A dilator, which has regionalized differences in stiffness, is initially deployable within the lumen of the introducer to facilitate advancement of the introducer to its desired location within the body. Thereafter, the dilator may be removed from the introducer sheath and the delivery catheter/loader assembly may be attached to the introducer, such that the delivery catheter having the prosthesis mounted thereon may advanced through the introducer, to a desired location within the body. Thereafter, the radial expandable endoluminal prosthesis mounted on the delivery catheter is deployed and implanted by an expansion device (e.g., balloon) formed on the delivery catheter. The delivery catheter may incorporate one or more outflow apertures at specific location(s) to facilitate injection of radiographic contrast medium in a manner which will check for leakage around the endoluminal prosthesis, after the endoluminal prosthesis has been radially expanded and implanted.

Claims

1. Apparatus for delivering an endoluminal stent or prosthesis into the vasculature of a patient comprising:

an introducer having a distal end adapted for insertion into the vasculature, a lumen of a first diameter, and a proximal end;

a catheter body having a balloon mounted on one end, the endoluminal stent or prosthesis being collapsed around the balloon;

a tubular loader for placement outside the patient having a lumen with a diameter equal to or less than the first diameter and a distal end engageable with the introducer proximal end, the lumen of the loader containing the balloon and endoluminal stent or prosthesis collapsed therearound; and

a pusher adapted to fit within the lumen of the loader and engage a proximal end of the endoluminal stent or prosthesis;

wherein the introducer proximal end engages with the loader distal end to prevent relative movement of the introducer and the loader; and

wherein the lumen of the loader and the introducer lumen form a continuous lumen upon engagement of the loader and the introducer, the continuous lumen extending from outside the patient to a point of implantation in the vasculature, through which the balloon and endoluminal stent or prosthesis collapsed therearound is pushed by the pusher.

2. The apparatus of claim 1 wherein the pusher includes a pusher body having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough and adapted to receive the balloon catheter such that the balloon protrudes from the distal end of the pusher body.