Venous valve with sinus

Abstract

A venous valve-with a structural member and valve leaflets that provide a sinus.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation-in Part of U.S. application Ser. No. 11 / 232,403, filed Sep. 21, 2005, the specification of which is incorporated by reference herein.FIELD OF THE DISCLOSURE [0002] The present disclosure relates to vascular medical devices and methods; and more particularly to venous valves and methods for forming the venous valve frame. BACKGROUND OF THE DISCLOSURE [0003] Venous blood flow returns de-oxygenated blood from the distal extremities to the heart via two mechanisms. The first is the perfusion pressure resulting from the arterial blood flow through tissue to the venous circulation system. Where arterial pressure prior to perfusion may be 60 to 200 mm Hg, the resulting venous pressure is typically 10 to 40 mm Hg. The second mechanism is the calf muscle, which, when contracted, compresses the veins (tibial and peroneal) overlying the bone and, through a system of valves, directs blood flow toward the heart. Th...

AI Technical Summary

Benefits of technology

The design enhances antegrade blood flow while reducing retrograde flow, minimizes thrombosis, and maintains valve functionality by preventing leaflet adhesion to the vessel wall, thus effectively addressing the limitations of existing prosthetics in treating venous insufficiency.

Problems solved by technology

In the legs and arms, the transit time of this increased arterial pressure is delayed, resulting in a temporary drop in venous pressure.

Venous pressure drops as blood flow responds to body position change and gravity, thereby reducing the volume of blood available to the heart and possibly reducing the flow of oxygenated blood to the brain.

In such a case, a person could become light headed, dizzy, or experience syncope.

Compromised valves, however, would allow reverse blood flow and pooling in the lower legs resulting in swelling and ulcers of the leg.

The absence of functioning venous valves can lead to chronic venous insufficiency.

Techniques for both repairing and replacing the valves exist, but are tedious and require invasive surgical procedures.

Prosthetic valves can be transplanted into the venous system, but current devices are not successful enough to see widespread usage.

One reason for this is the very high percentage of prosthetic valves reported with leaflet functional failures due to excessive protein deposit, cell growth and thickening, and thrombosis.

These failures have been blamed primarily on improper sizing and tilted deployment of the prosthetic valve.

Such contact or proximity can cause regions of blood stasis or near stasis, and can result in increased thrombus formation.

In addition, contact can result in disruption of endothelial or other tissue at the contact point, further increasing the likelihood of thrombosis or increased tissue deposits or healing response.

Further, such contact or proximity can result in valve leaflet(s) being stuck to the vessel wall, or otherwise unable to move properly, thereby rendering the valve less functional or completely non-functional.

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