Delivery system for a stentless valve bioprosthesis

Abstract

The current invention discloses a catheter and a method for delivering a stentless bloprosthesis in a body channel, the method comprising percutaneously introducing a catheter into the body channel, wherein the catheter contains said stentless bloprosthesis at a retracted state; and disengaging said stentless bioprosthesis out of a distal opening of the catheter by a pulling mechanism associated with the catheter structure.

Description

[0001] This application claims priority to U.S. Utility application Ser. No. 09 / 853,463, filed May 10, 2001, the entirety of which is hereby incorporated by reference.TECHNICAL INVENTION[0002] The present invention generally relates to a tubular prosthesis and methods for delivery into a body channel. More particularly, the present invention relates to an improved delivery system for delivering a stentless bioprosthesis comprising a collapsible elastic valve or a biological graft at a desired anatomical site of the body channel for implantation.[0003] A prosthetic heart valve may be used to replace a diseased natural heart valve in a human patient. Similarly, a prosthetic venous valve may be used to replace a dysfunctional natural venous valve in a patient. Mechanical heart valves typically have a rigid orifice ring and rigid hinged leaflets coated with a blood compatible substance such as pyrolytic carbon. Other configurations, such as ball-and-cage assemblies, have also been used ...

AI Technical Summary

Benefits of technology

[0007] Porter in U.S. Pat. No. 5,064,435 discloses a catheter-based apparatus and methods for releasing a self-expandable prosthesis by a conventional pushing mechanism. The above-mentioned approaches are satisfactory for delivering a stented prosthesis having an external rigid support adapted for receiving the pushing force. A self expanding prosthesis often is preferred over a plastically deformed device. Resilient prosthesis can be deployed without dilatation balloons or other stent expanding means. A self-expanding prosthesis can be preselected in accordance with the diameter of the body channel or other anatomic site for fixation. While deployment requires skill in positioning the prosthesis, the added skill of properly dilating the balloon to plastically expand a prosthesis to a selected diameter is not required. Also, the self-expanding prosthesis remains at least slightly compressed after fixation, and thus has a restoring force which facilitates acute fixation.

[0009] The main disadvantage to stentless valves has been in their difficulty of deployment and implantation, particularly in a catheter-based percutaneous route. With recent scientific advancements in robotics, instrumentation and computer technology, a minimally invasive catheter-based delivery system for a stentless bioprosthesis is imminent. There is currently a clinical need for deploying a tubular stentless prosthesis, such as a stentless valve or a vascular graft without a rigid support, into a body channel, preferably by a percutaneous approach. The catheter-based percutaneous delivery system as compared to an open-cavity surgery will greatly reduce the patient's hospital stay and improve recovery.

Problems solved by technology

Inevitably, however, a stent limits interactions with aortic wall dynamics and tends to inhibit natural valve movement.

This results in post-operative transvalvular gradients with resultant additional work burden on the heart.

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