Endovascular delivery system

• US 6,379,372 B1
• Filed: 10/23/2000
• Issued: 04/30/2002
• 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 Corporation
• Inventors: Saravia, Maria Lillian, Yu, Weiyun, White, Geoffrey H., Dehdashtian, Mark
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/694,736
• Time in Patent Office: 554 Days
• Field of Search: 606/192, 606/194, 606/195, 604/96.01, 604/103.05, 604/164.13, 604/164.1, 128/898
• 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. A method for delivering an endoluminal stent or prosthesis into the vasculature of a patient comprising:

inserting an introducer having a distal end, an introducer lumen having a first introducer diameter, and a proximal end, into the vasculature;

providing a catheter body having a balloon mounted on one end and collapsing an endoluminal stent or prosthesis around the balloon;

placing the catheter body within a pusher body having a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough so that the balloon protrudes from the distal end of the pusher body; and

placing the balloon portion of the catheter body and the distal end of the pusher body within the lumen of a tubular loader which is maintained outside the patient, the tubular loader having a lumen diameter equal to or less than the first introducer diameter;

engaging the distal end of the loader with the introducer proximal end to prevent relative movement of the introducer and the loader and to form a continuous lumen extending from outside the patient to a point of implantation in the vasculature;

engaging the distal end of the pusher body with a proximal end of the endoluminal stent or prosthesis and pushing the catheter body and the pusher through the continuous lumen to the point of implantation.

2. The method of claim 1 further comprising the following steps:

proximally retracting the distal end of the pusher body relative to the catheter body;

inflating the balloon and radially expanding the endoluminal stent of prosthesis to implant the endoluminal stent or prosthesis;

de-pressurizing and collapsing the balloon; and

proximally retracting the balloon catheter.