METHOD OF DEPLOYING A PERCUTANEOUS REPLACEMENT HEART VALVE
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Accused Products
Abstract
A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.
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Citations
47 Claims
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1-33. -33. (canceled)
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34. A method of deploying a percutaneous replacement heart valve in a patient where a bioprosthetic heart valve is indicated, comprising:
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providing a replacement heart valve device and a delivery and implantation system; the replacement heart valve device including; a stent member that is collapsible, expandable and configured for percutaneous delivery; and a valve attached to the stent member, the valve including two to four individual leaflets; the delivery and implantation system including; a balloon catheter and a moveable sheath, wherein the balloon catheter includes a lumen for receiving a guide wire, wherein the moveable sheath includes a lumen configured for receiving the balloon catheter, and wherein the replacement heart valve device is collapsed onto the balloon catheter to reside in a collapsed configuration on the balloon catheter and is restrained in a collapsed configuration by the moveable sheath; after the providing step, guiding the delivery and implantation system over the guide wire within the patient to position the replacement heart valve device for deployment within the patient, wherein the replacement heart valve device remains collapsed onto the balloon catheter and continues to be restrained in the collapsed configuration by the moveable sheath; after the guiding step, partially deploying a distal portion of the replacement heart valve device within the patient by partially exposing the replacement heart valve device from the moveable sheath; after the partially deploying step, restraining the replacement heart valve device so that it does not pop out and is held for controlled release, with a potential that the replacement heart valve device can be recovered if there is a problem with positioning; and after the restraining step, the replacement heart valve device is at the desired position, slightly retracting the moveable sheath to release the replacement heart valve device from the moveable sheath to allow the replacement heart valve device to fully expand. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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Specification