Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Heart valve – Flexible leaflet
Reexamination Certificate
2002-04-30
2004-11-23
McDermott, Corrine (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Heart valve
Flexible leaflet
Reexamination Certificate
active
06821297
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to valve implants, and more particularly to artificial heart valves for repairing damaged heart valves.
A human heart has four chambers which alternately expand and contract to pump blood through the vessels of the body. The heart also includes a check valve at the upstream end of each chamber to ensure that blood flows in the correct direction through the body as the heart chambers expand and contract. These valves sometimes become damaged resulting in their inability to close when the downstream chamber contracts. When the valves do not close, blood flows backward through the valve resulting in diminished blood flow and lower blood pressure. The valves can also become damaged so they do not open sufficiently thereby resulting in diminished downstream blood flow.
Although replacement valves and surgical procedures have been developed to alleviate these conditions, they have significant drawbacks. Many earlier valves require invasive implantation techniques in which the chest is opened, the ribs are spread, the heart is paralyzed, and following cardio-pulmonary bypass, the heart is cut open to implant the valve. These invasive techniques are stressful on the patient, increase the opportunity for infection and slow recovery. As a result, valves which may be implanted with non-invasive techniques have been developed. These valves are implanted by transluminal or endothoracoscopic techniques which reduce many of the drawbacks associated with invasive surgery. However, many of these valves also require the damaged native heart valve be removed prior to implanting the artificial valve. Removing the native valve increases the risk that a portion of the valve will migrate through the body and block vessels downstream from the heart.
Many mechanical and bioprosthetic valves have been developed to replace native heart valves. See C. A. Hufnagel,
Basic Concepts in the Development of Cardiovascular Prostheses,
137 Am. J. of Surg. at 285-300 (1972). See also D. E. Harken et al.,
Partial and Complete Prosthesis in Aortic Insufficiency
, 40 J. Thorac & Cdvsc Surg., no. 6., at 744-62 (1960). These valves include ball-valve prostheses, flap-valve prostheses, polymeric trileaflet synthetic valves, and bioprosthetic valves made from animal allograft tissues such as pig valves and preserved heterologous bovine and porcine pericardial tissue valves. See H. B. Lo et al.,
A Tricuspid Polyurethane Heart Valve as an Alternative to Mechanical Prostheses or Bioprostheses,
34 Trans. Am. Soc. of Art. Int. Organs at 839-44 (1988); and S. L. Hilbert et al.,
Evaluation of Explanted Polyurethane Trileaflet Cardiac Valve Prostheses
, 94 J. Thorac & Cdvsc Surg. at 419-29 (1987). Most of the aforementioned valves require open chest surgery and cardiopulmonary bypass for implantation.
More recently percutaneous and transluminal implantation have been suggested. See Steven R. Bailey,
Percutaneous Expandable Prosthetic Valves
Textbook of Interventional Cardiology, chap. 75 (1995)(referencing work of Andersen et al.) See also Knudsen et al.,
Catheter
-
implanted Prosthetic Heart Valves
, 6 Int'l J. of Art. Organs, no. 5, at 253-62 (1993); Knudsen et al.
Transluminal Implantation of Artificial Heart Valves. Description of New Expandable Aortic Valve and Initial Results With Implantation by Catheter Technique in Closed Chest Pigs
, 13 European Heart J. at 704-08 (1992); and U.S. Pat. No. 5,411,552 (Andersen). The Andersen device includes a heterologous pig valve mounted in an annular ring. Due to the size of this device, it must be implanted by direct abdominal aortic incision and entry. Further, the Andersen device requires a separate inflating balloon for its deployment. U.S. Pat. No. 5,397,351 (Pavcnik) describes an expandable caged poppet for percutaneous implantation in an aortic valve site. However, the size of the Pavcnik device makes percutaneous implantation difficult. U.S. Pat. No. 5,885,601 (Bessler) describes a transluminal valve implantation but does not describe the specific valve construction. The Bessler procedure includes excision, vacuum removal of the native valve, cardio-pulmonary bypass and backflushing of the coronary arterial tree.
SUMMARY OF THE INVENTION
Among the several objects and features of the present invention may be noted the provision of an artificial heart valve which accommodates implantation without removing the damaged native heart valve; the provision of a valve which may be implanted using non-invasive surgery; the provision of a valve which permits implantation without the need for cardio-pulmonary bypass; the provision of a valve which permits implantation by conventional open chest surgery and cardio-pulmonary bypass; provision of a valve which allows for repositioning the valve during implantation; and the provision of a valve which allows for guiding the valve to the point of implantation along a guide.
Generally, an artificial valve of the present invention repairs a damaged heart valve having a plurality of cusps separating an upstream region from a downstream region. The artificial valve comprises a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region. The frame has a plurality of peripheral anchors for anchoring the frame in the position between the upstream region and the downstream region and a central portion located between the plurality of peripheral anchors. A flexible valve element attaches to the central portion of the frame having an upstream side facing the upstream region when the frame is anchored in the position between the upstream region and the downstream region and a downstream side opposite the upstream side facing the downstream region when the frame is anchored in the position between the upstream region and the downstream region. The valve element moves in response to a difference between fluid pressure in the upstream region and fluid pressure in the downstream region between an open position, in which the element permits downstream flow between the upstream region and the downstream region, and a closed position, in which the element blocks flow reversal from the downstream region to the upstream region. The valve element moves to the open position when fluid pressure in the upstream region is greater than fluid pressure in the downstream region, permitting downstream flow from the upstream region to the downstream region. The valve element moves to the closed position when fluid pressure in the downstream region is greater than fluid pressure in the upstream region, preventing flow reversal from the downstream region to the upstream region. An opening extends through at least one of the frame and the valve element for receiving an implement.
In a second embodiment of the present invention, an artificial valve includes a flexibly resilient frame having a plurality of peripheral anchors for anchoring the frame in the position between the upstream and the downstream region. A flexible valve element attaches to the frame having a convex upstream side and a concave downstream side. An opening extends through at least one of the frame and the valve element.
The present invention is also directed to a combination of an artificial valve, including a frame, a valve element, an opening and a flexible, elongate guide sized for receipt within the opening to guide the valve into position.
Another aspect of the present invention is directed to a combination of an artificial valve, including a frame and valve element, and an instrument including a holder, an elongate manipulator and an installer. The holder has a hollow interior sized for holding the artificial valve when the frame is in a collapsed configuration. The elongate manipulator attaches to the holder for manipulating the holder into position between the upstream region and the downstream region. The installer is received within the hollow interior of the holder and is releasably attachable to the frame of the artificial heart valve for maneuvering
Matthews William
McDermott Corrine
Sonnenschein Nath & Rosenthal LLP
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