Method For Replacing Native Valve Function Of A Diseased Aortic Valve

Abstract

Methods for replacing native valve function of a diseased aortic valve are disclosed. In an embodiment, a method for replacing native valve function of a diseased aortic valve in a patient includes: (a) receiving an artificial heart valve assembly mounted about a first mounting position on a catheter system, (b) guiding the artificial heart valve assembly through the vasculature of the patient, (c) while the catheter system having the artificial heart valve assembly mounted thereto is in the patient's vasculature, mounting the artificial heart valve assembly about a second mounting position on the catheter system, (d) delivering the artificial heart valve assembly to the region of the diseased aortic valve, (e) expanding the artificial heart valve assembly in the region of the diseased aortic valve, and (f) withdrawing the catheter system from the patient's vasculature.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]The present application is a continuation of U.S. patent application Ser. No. 10 / 895,272, filed Jul. 20, 2004, which is a continuation of U.S. patent application Ser. No. 09 / 896,259, filed Jun. 29, 2001, now U.S. Pat. No. 6,769,434, which claims priority to U.S. Provisional Pat. App. No. 60 / 215,245, filed Jun. 30, 2000.BACKGROUND OF THE INVENTION[0002]Of all valvular heart lesions, aortic stenosis carries the worst prognosis. Within one year of diagnosis, approximately half of all patients with critical aortic stenosis have died, and by three years, this figure rises to approximately 80%. Currently, the most prominent and effective treatment for patients with aortic stenosis is aortic valve replacement via open heart surgery. Unfortunately, this procedure is a substantial and invasive undertaking for the patient.[0003]While there have been significant advances in heart valve technology over the past 30 years, there has been little progres...

AI Technical Summary

Benefits of technology

The present invention relates to a method and apparatus for positioning a device in the arterial system, specifically an aortic valve prosthesis, without the need for cardiopulmonary bypass. The invention allows for the implantation of a device in the arterial system with minimal risk to the patient and simplifies the placement of the device. The invention also allows for the insertion of a prosthesis or device into a vessel within the arterial system without the need for large incisions. The invention also includes the use of a prosthesis holding apparatus for releasably holding the valve prosthesis during manipulation to its implant site.

Problems solved by technology

Unfortunately, this procedure is a substantial and invasive undertaking for the patient.

While there have been significant advances in heart valve technology over the past 30 years, there has been little progress in the development of safer and less invasive valve delivery systems.

Given the current invasiveness of this procedure and the requirement to utilize cardiopulmonary bypass, aortic valve replacement surgery is associated with a high risk of morbidity and mortality.

Using the technology available at that time, success was limited: the valve area was increased only minimally, and nearly all patients had restenosis within one year.

However, these approaches still require cardiopulmonary bypass and cardiac arrest, which themselves entail significant morbidity and a prolonged post-operative recovery.

Unfortunately, although there has been great progress in the treatment of coronary artery disease without cardiopulmonary bypass (e.g., angioplasty, with or without stenting, and “off-pump” coronary artery bypass grafting), similar advances have not yet been realized in heart valve surgery.

The first challenge is to remove the diseased valve without causing stroke or other ischemic events that might result from the liberation of particulate material while removing the diseased valve.

The second challenge is to prevent cardiac failure during removal of the diseased valve.

However, as the diseased valve is removed, it becomes acutely and severely incompetent, causing the patient to develop heart failure which results in death unless the function of the valve is taken over by another means.

Therefore, any sizable incision made to the aorta in order to insert a standard valve prosthesis into the arterial system creates the potential for uncontrollable bleeding from the incision site.

Furthermore, even if bleeding is successfully controlled, pressures within the aorta may result in weakening of the aorta caused by aortic wall dissection.

In addition, large incisions on the aorta also increase the potential for liberating plaque from the aortic wall that can lead to embolic complications.

Unfortunately, however, none of these relatively flimsy valve prostheses have proven adequate to endure the repetitive stresses undergone by the aortic valve over the ten to twenty years typically required.

In addition to the foregoing, the precise placement of such expandable prosthetic valves in the correct sub-coronary position can be extremely challenging, particularly in view of the high pressure, pulsatile blood flow passing through the aorta.

Furthermore, expandable prosthetic valves would typically be positioned from a remote artery, which would reduce the ability to precisely control the placement and positioning of the device and therefore would increases the risk of obstructing the coronary arteries.

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