Devices and methods for percutaneous access, hemostasis, and closure

Abstract

The present invention provides methods and devices for obtaining percutaneous access, maintaining hemostasis, and providing closure of openings in tissues of the body. In particular, the present invention provides methods and devices for maintaining hemostasis and providing closure surgical incisions of the left ventricular apex of the heart.

Description

[0001]The present application claims priority to U.S. Provisional Patent Application Ser. No. 61 / 037,255 filed Mar. 17, 2008, the entire disclosure of which are herein incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention provides methods and devices for obtaining percutaneous access, maintaining hemostasis, and providing closure of openings in tissues of the body. In particular, the present invention provides methods and devices for maintaining hemostasis and providing closure surgical incisions of the left ventricular apex of the heart.BACKGROUND OF THE INVENTION[0003]Historically, human heart valves have been replaced using open heart surgery involving the heart / lung machine and excision of the native aortic valve and suture placement of the new valve prosthesis. New technology has been developed to enable valve replacement “percutaneously,” or through a “transapical” procedure, using a device with a valve inside a stent placed within the pat...

AI Technical Summary

Benefits of technology

The present invention provides a medical closure device that can be used to occlude blood flow through an opening in a body tissue, such as a surgical incision. The device comprises one or more elements that can expand and contract to create a seal that can be inserted into the opening. The device has a cylinder element with inner and outer surfaces, and a distal expanded element that can fit into the cylinder element and expand within the opening. The device can be made of a metal fabric or a blood-impermeable skin, and may contain a one-way valve to limit the flow of blood. The device can be assisted by a delivery device, such as a catheter. The technical effects of the invention include the ability to create a secure and effective seal for medical procedures, as well as the ability to provide access for medical instruments through the sealed opening.

Problems solved by technology

The use of minimally invasive approaches, however, introduces new complexities to surgery.

An inherent difficulty in the minimally invasive percutaneous approach is the limited space that is available within the vasculature.

Consequently, the introduction of tools and prosthetic devices becomes a great deal more complicated as compared to open-chest surgeries.

One route of access, through the femoral arteries, is limited because of vascular disease involving these vessels and the size of the devices to be placed is largely relative to the small diameter vessels.

Transapical placement, through the apex of the left ventricle, has been the preferred approach in many patients because there are less vascular complications, but there are problems such as bleeding from the left ventricular apex requiring difficult suture closure, and a thoracotomy incision that can be painful and lead to difficult recovery and prolonged hospital stay for the patient.

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