DEVICES FOR REDUCING LEFT ATRIAL PRESSURE, AND METHODS OF MAKING AND USING SAME
First Claim
1. A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the device comprising:
- a stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient'"'"'s atrial septum; and
a one-way tissue valve having an outlet coupled to a first portion of the first flared end region and an inlet coupled to a second portion of the first flared end region proximal to the neck region, the valve configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium.
1 Assignment
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Accused Products
Abstract
A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium comprises an hourglass-shaped stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient'"'"'s atrial septum; and a one-way tissue valve coupled to the first flared end region and configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. The inventive devices may reduce left atrial pressure and left ventricular end diastolic pressure, and may increase cardiac output, increase ejection fraction, relieve pulmonary congestion, and lower pulmonary artery pressure, among other benefits. The inventive devices may be used, for example, to treat subjects having heart failure, pulmonary congestion, or myocardial infarction, among other pathologies.
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Citations
53 Claims
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1. A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the device comprising:
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a stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient'"'"'s atrial septum; and a one-way tissue valve having an outlet coupled to a first portion of the first flared end region and an inlet coupled to a second portion of the first flared end region proximal to the neck region, the valve configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A device for regulating blood pressure between a patient'"'"'s left atrium and right atrium, the device comprising:
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a stent comprising a neck region and first and second flared end regions, the neck region disposed between the first and second end regions and configured to engage the fossa ovalis of the patient'"'"'s atrial septum; a biocompatible material disposed on the stent in the neck and the second flared end region and a portion of the first flared end region; and a one-way tissue valve configured to shunt blood from the left atrium to the right atrium when blood pressure in the left atrium exceeds blood pressure in the right atrium, the valve having an outlet coupled to the first flared end region and an inlet coupled to an edge of the biocompatible material, the valve and the biocompatible material defining a continuous sheath that inhibits excessive tissue ingrowth into the valve and channels blood flow through the valve. - View Dependent Claims (28, 29)
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30. A device configured for implantation in a fossa ovalis between a patient'"'"'s left atrium and right atrium without loss of patency, the device comprising:
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an hourglass-shaped stent having a neck region and first and second flared end regions; a one-way tissue valve disposed in the first flared end region; and a biocompatible material disposed on the stent, the valve and the biocompatible material defining a continuous sheath that smoothly channels blood flow from the left atrium to the right atrium through the tissue valve substantially without high shear rates, stagnation points, or turbulence, the biocompatible material configured to promote ingrowth of a neointima layer to a thickness of less than 0.2 mm so as to render the material inert and inhibit hyperplasia. - View Dependent Claims (31)
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32. A method of treating a subject with heart pathology, the subject having a heart with an atrial septum having a fossa ovalis therein, the method comprising:
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providing a device having first and second flared end regions and a neck region disposed therebetween, and a tissue valve coupled to the first flared end region; deploying the device across a puncture through the fossa ovalis such that the neck region is positioned in the puncture, the first flared end region is disposed in, and engages, the atrial septum, and the second flared end region is disposed in, and flanks, the atrial septum; and reducing left atrial pressure and left ventricular end diastolic pressure by shunting blood from the left atrium to the right atrium through the device when the left atrial pressure exceeds the right atrial pressure. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. A method of making a device, the method comprising:
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providing a tube of shape-memory metal; expanding the tube on a mandrel to define first and second flared end regions and a neck therebetween, and heating the expanded tube to set the shape; coating the neck, the second flared end region, and a portion of the first flared end region with a biocompatible material; providing a valve of animal pericardial tissue having leaflets in a normally closed position; and securing an inlet of the valve to an edge of the biocompatible material proximal to the neck region and securing an outlet of the valve proximal to an end of the first flared end region. - View Dependent Claims (50, 51, 52, 53)
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Specification