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Percutaneous heart valve with inflatable support

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Percutaneous heart valve with inflatable support


An implantable prosthetic valve for a human heart is disclosed. The prosthetic valve has an inflatable tubular annular support structure and at least one moveable occluder that controls the flow of blood through the support structure. The support structure has a flow control valve configured for coupling to an inflation lumen for inflating the support structure with an inflation media. The flow control valve seals after decoupling from the inflation lumen and prevents the inflation media from escaping.

Browse recent Direct Flow Medical, Inc. patents - Santa Rosa, CA, US
Inventors: RANDALL T. LASHINSKI, GORDON B. BISHOP
USPTO Applicaton #: #20120277855 - Class: 623 218 (USPTO) - 11/01/12 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Heart Valve >Flexible Leaflet >Supported By Frame >Resilient Frame

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The Patent Description & Claims data below is from USPTO Patent Application 20120277855, Percutaneous heart valve with inflatable support.

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CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 12/502,164, filed Jul. 13, 2009, which is a continuation of U.S. patent application Ser. No. 11/112,847, filed Apr. 22, 2005, now U.S. Pat. No. 7,641,686, which claims priority under 35 U.S.C. §119(e) to (1) U.S. Provisional Patent Application No. 60/564,708, filed Apr. 23, 2004, (2) U.S. Provisional Patent Application No. 60/568,402, filed May 5, 2004, (3) U.S. Provisional Patent Application No. 60/572,561, filed May 19, 2004, (4) U.S. Provisional Patent Application No. 60/581,664, filed Jun. 21, 2004, (5) U.S. Provisional Patent Application No. 60/586,054, filed Jul. 7, 2004, (6) U.S. Provisional Patent Application No. 60/586,110, filed Jul. 7, 2004, (7) U.S. Provisional Patent Application No. 60/586,005, filed Jul. 7, 2004, (8) U.S. Provisional Patent Application No. 60/586,002, filed Jul. 7, 2004, (9) U.S. Provisional Patent Application No. 60/586,055, filed Jul. 7, 2004, (10) U.S. Provisional Patent Application No. 60/586,006, filed Jul. 7, 2004, (11) U.S. Provisional Patent Application No. 60/588,106, filed Jul. 15, 2004, U.S. Provisional Patent Application No. 60/603,324, filed Aug. 20, 2004, (12) U.S. Provisional Patent Application No. 60/605,204, filed Aug. 27, 2004 and (13) U.S. Provisional Patent Application No. 60/610,269 filed Sep. 16, 2004, the entire contents of which are hereby expressly incorporated by reference herein.

BACKGROUND OF THE INVENTION

According to recent estimates, more than 79,000 patients are diagnosed with aortic and mitral valve disease in U.S. hospitals each year. More than 49,000 mitral valve or aortic valve replacement procedures are performed annually in the U.S., along with a significant number of heart valve repair procedures.

Although mitral valve repair and replacement can successfully treat many patients with mitral valvular insufficiency, techniques currently in use are attended by significant morbidity and mortality. Most valve repair and replacement procedures require a thoracotomy, usually in the form of a median sternotomy, to gain access into the patient\'s thoracic cavity. A saw or other cutting instrument is used to cut the sternum longitudinally, allowing the two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening into the thoracic cavity is thus created, through which the surgical team may directly visualize and operate upon the heart and other thoracic contents. Alternatively, a thoracotomy may be performed on a lateral side of the chest, wherein a large incision is made generally parallel to the ribs, and the ribs are spread apart and/or removed in the region of the incision to create a large enough opening to facilitate the surgery.

Surgical intervention within the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system, and arrest of cardiac function. Usually, the heart is isolated from the arterial system by introducing an external aortic cross-clamp through a sternotomy and applying it to the aorta to occlude the aortic lumen between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the ascending aorta, to arrest cardiac function. The patient is placed on extracorporeal cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood.

A need therefore remains for methods and devices for treating mitral valvular insufficiency, which are attended by significantly lower morbidity and mortality rates than are the current techniques, and therefore would be well suited to treat patients with dilated cardiomyopathy. Optimally, the procedure can be accomplished through a percutaneous, transluminal approach, using simple, implantable devices.

The circulatory system is a closed loop bed of arterial and venous vessels supplying oxygen and nutrients to the body extremities through capillary beds. The driver of the system is the heart providing correct pressures to the circulatory system and regulating flow volumes as the body demands. Deoxygenated blood enters heart first through the right atrium and is allowed to the right ventrical through the tricuspid valve. Once in the right ventrical, the heart delivers this blood through the pulmonary valve and to the lungs for a gaseous exchange of oxygen. The circulatory pressures carry this blood back to the heart via the pulmonary veins and into the left atrium. Filling of the left ventricle occurs as the mitral valve opens allowing blood to be drawn into the left ventrical for expulsion through the aortic valve and on to the body extremities. When the heart fails to continuously produce normal flow and pressures, a disease commonly referred to as heart failure occurs.

Heart failure simply defined is the inability for the heart to produce output sufficient to demand. Mechanical complications of heart failure include free-wall rupture, septal-rupture, papillary wall rupture or dysfunction aortic insufficiency and tamponade. Mitral, aortic or pulmonary valve disorders lead to a host of other conditions and complications exacerbating heart failure further. Other disorders include coronary disease, hypertension, and a diverse group of muscle diseases referred to as cardiomyopothies. Because of this syndrome establishes a number of cycles, heart failure begets more heart failure.

Heart failure as defined by the New York Heart Association in a functional classification.

Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Patient with cardiac disease resulting in slight limitation of physical activity. These patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Patients with cardiac disease resulting in marked limitation of physical activity. These patients are comfortable at rest. Less than ordinary physical activity causes fatigue palpitation, dyspnea, or anginal pain.

Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Congestive heart failure is described as circulatory congestion including peripheral edema. The major factor in cardiac pulmonary edema is the pulmonary capillary pressure. There are no native valves between the lungs and the left atrium therefore fluctuations in left atrial pressure are reflected retrograde into the pulmonary vasculature. These elevations in pressure do cause pulmonary congestion. When the heart, specifically the mitral valve, is operating normally correct flow and pressures throughout the circulatory system are maintained. As heart failure begins these pressures and flow rates decrease or increase depending upon the disease and vascular location.

Placement of valves between the lung and the left atrium will prevent retrograde flow and undesired pressure fluctuations to the pulmonary vasculature. Mechanical valves may be constructed of conventional materials such as stainless steel, nickel-titanium, cobalt-chromium or other metallic based alloys. Other materials used are biocompatible-based polymers and may include polycarbonate, silicone, pebax, polyethylene, polypropylene or floropolymers such as Teflon. Mechanical valves may be coated or encapsulated with polymers for drug coating applications or favorable biocompatibility results.

There are many styles of mechanical valves that utilize both polymer and metallic materials. These include single leaflet, double leaflet, ball and cage style, slit-type and emulated polymer tricuspid valves. Though many forms of valves exist, the function of the valve is to control flow through a conduit or chamber. Each style will be best suited to the application or location in the body it was designed for.

Bioprosthetic heart valves comprise valve leaflets formed of flexible biological material. Bioprosthetic valve or components from human donors are referred to as homografts and xenografts are from non-human animal donors. These valves as a group are known as tissue valves. This tissue may include donor valve leaflets or other biological materials such as bovine pericardium. The leaflets are sewn into place and to each other to create a new valve structure. This structure may be attached to a second structure such as a stent or cage for implantation to the body conduit.

Description of the Related Art

The concept of placing a percutaneous valve in the pulmonary veins was first disclosed by Block et all in U.S. Pat. No. 5,554,185. A specific windsock valve for this application was later described by Shaknovich in U.S. Pat. No. 6,572,652.

SUMMARY

OF THE INVENTION

There is provided in accordance with one aspect of the present invention, a flow controlled device dimensioned for implantation in a human pulmonary vein. The device comprises an inflatable support structure in at least one movable occluder that controls the flow of blood into and out of the pulmonary veins. Implantation of the valve between the left atrium and the lung within the pulmonary vein reduces the likelihood and/or the severity of regurgitant flow increasing the pulmonary pressure which may lead to pulmonary edema and congestion.

In accordance with a further aspect of the present invention, a method of monitoring a patient comprises monitoring blood flow through the pulmonary veins during the implantation of the device of Claim 1. In accordance with a further aspect of the present invention, there is provided a method of monitoring blood pressure comprising monitoring blood pressure through the pulmonary veins during the implantation of the pulmonary vein valve.

In accordance with a further aspect of the present invention, there is provided a method of treating a patient comprising rerouting blood flow from the pulmonary veins into a prosthetic chamber, and then back into a portion of the heart. The prosthetic chamber may include at least one valve, and may serve as a manifold for combining the flow of the pulmonary veins into a single return conduit, which may be placed into communication with the left ventrical.

Further features and advantages of the present invention will become apparent to those of skill in the heart in view of the detailed description of preferred embodiments which follows, when considered together with the attached drawings and claims.



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Industry Class:
Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor
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stats Patent Info
Application #
US 20120277855 A1
Publish Date
11/01/2012
Document #
13450356
File Date
04/18/2012
USPTO Class
623/218
Other USPTO Classes
International Class
61F2/24
Drawings
18



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