APPARATUS AND METHODS FOR TRANSFEMORAL DELIVERY OF PROSTHETIC MITRAL VALVE
First Claim
1. A method, comprising:
- inserting a leader tube through an access site at an apex of the heart of a patient and positioning a distal end portion of the leader tube in the left atrium of the heart;
inserting a snare device into an entry site of a femoral vein of the patient and into the left atrium of the heart;
capturing the leader tube with the snare device;
pulling the snare device and leader tube out of the femoral vein such that the leader tube extends between the apex of the heart and the entry site of the femoral veininserting a delivery sheath through the entry site of the femoral vein of the patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart, the delivery sheath having a prosthetic mitral valve disposed in a collapsed configuration within a lumen of the delivery sheath;
moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve assumes a biased expanded configuration; and
positioning the prosthetic mitral valve within a mitral annulus of the heart.
1 Assignment
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Accused Products
Abstract
Apparatus and methods are described herein for use in the transfemoral delivery and deployment of a prosthetic mitral valve. In some embodiments, a method includes inverting an outer frame of a prosthetic mitral valve when in a biased expanded configuration. After inverting the outer frame, the prosthetic mitral valve is inserted into a lumen of a delivery sheath such that the mitral valve is moved to a collapsed configuration. The delivery sheath is inserted into a femoral vein and moved through the femoral vein and a septum of a heart until a distal end of the delivery sheath is disposed in the left atrium of the heart. The prosthetic mitral valve is moved distally out of the delivery sheath such that the inverted outer frame reverts and the prosthetic mitral valve assumes its biased expanded configuration. The prosthetic mitral valve is then positioned within a mitral annulus of the heart.
170 Citations
15 Claims
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1. A method, comprising:
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inserting a leader tube through an access site at an apex of the heart of a patient and positioning a distal end portion of the leader tube in the left atrium of the heart; inserting a snare device into an entry site of a femoral vein of the patient and into the left atrium of the heart; capturing the leader tube with the snare device; pulling the snare device and leader tube out of the femoral vein such that the leader tube extends between the apex of the heart and the entry site of the femoral vein inserting a delivery sheath through the entry site of the femoral vein of the patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart, the delivery sheath having a prosthetic mitral valve disposed in a collapsed configuration within a lumen of the delivery sheath; moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve assumes a biased expanded configuration; and positioning the prosthetic mitral valve within a mitral annulus of the heart. - View Dependent Claims (2, 3, 4)
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5. A method, comprising:
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inserting the prosthetic mitral valve into a lumen of a delivery sheath such that the prosthetic mitral valve is moved to a collapsed shape, the prosthetic valve having a tether coupled thereto; inserting the delivery sheath through an entry site of a femoral vein of a patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart; moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve is moved to a biased expanded shape; positioning the prosthetic mitral valve within a mitral annulus of the heart; coupling an epicardial pad device to the tether; and securing the epicardial pad device to the apex of the heart. - View Dependent Claims (6, 7, 8)
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9. A method, comprising:
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inserting a prosthetic mitral valve into a lumen of a delivery sheath inserting a balloon dilator device through an access site at the apex of the heart of a patient, through the heart, through the femoral vein and out the femoral entry site; coupling a balloon member of the balloon dilator device to a distal end portion of the delivery sheath such that the balloon member is at least partially disposed outside the lumen of the delivery sheath; inflating the balloon member; inserting the delivery sheath through an entry site of a femoral vein of the patient and moving the delivery sheath through the femoral vein and through a septum of a heart of the patient until a distal end portion of the delivery sheath is disposed in the left atrium of the heart; deflating the balloon and removing the balloon dilator device from the patient; and moving the prosthetic mitral valve distally out of the delivery sheath such that the prosthetic mitral valve assumes a biased expanded shape; and positioning the prosthetic mitral valve within a mitral annulus of the heart. - View Dependent Claims (10, 11, 12, 13, 14, 15)
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Specification