DEVICES FOR REDUCING LEFT ATRIAL PRESSURE, AND METHODS OF MAKING AND USING SAME
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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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1-26. -26. (canceled)
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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 patient'"'"'s atrial septum; a biocompatible material disposed on the stent in the neck and the second flared end region, but not on a portion of the first flared end region; and an opening within the stent 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 opening having an outlet at the first flared end region and an inlet at an edge of the biocompatible material, the biocompatible material adapted to inhibit excessive tissue ingrowth into the opening and channel blood flow through the opening. - View Dependent Claims (28, 29, 30, 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, an opening within the device, and a biocompatible material disposed on the stent, but not on a portion of the first flared end region; deploying the device across a puncture through the atrial septum 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, 38, 40, 41, 44, 46, 47, 48)
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36-37. -37. (canceled)
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39. (canceled)
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42-43. -43. (canceled)
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45. (canceled)
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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; and coating the neck and the second flared end region, but not a portion of the first flared end region, with a biocompatible material. - View Dependent Claims (50, 51, 52)
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53. (canceled)
Specification