Method of delivering a transcutaneous dual valve replacement device to a patient and device therefor

1 . A method of replacing a heart valve comprising:

providing a valve replacement device comprising:

a first segment comprising a first expandable outer stent tube configured to be deployed in a mitral valve of a heart of a patient;

a second segment comprising a second expandable outer stent tube configured to be deployed in a left ventricular outflow tract of the heart of the patient; and

a hinge connecting the first segment to the second segment, the first segment and the second segment being at least partially pivotable with respect to each other, wherein the hinge further comprises a stretchable fabric connected to each of the first segment and the second segment

wherein the first segment includes a first collapsible prosthetic valve housed within the first expandable outer stent tube, and the second segment does not include a collapsible prosthetic valve;

guiding the valve replacement device into the heart of the patient; and

deploying the valve replacement device such that the first expandable outer stent tube is positioned within the mitral valve of the heart of the patient, the second expandable outer stent tube is positioned within the left ventricular outflow tract of the heart of the patient in a position that does not interfere with the function of an aortic valve of the heart of the patient, and an anterior mitral valve leaflet of the heart of the patient is entrapped between the first expandable outer stent tube and the second expandable outer stent tube.

2 . The method of claim 1 , wherein, when the valve replacement device is deployed in the heart of the patient, the first segment and the second segment are disposed at an angle of less than 90° with respect to each other.

3 . The method of claim 1 , wherein deploying the valve replacement device comprises expanding the first segment of the valve replacement device in the mitral valve and expanding the second segment of the valve replacement device in the aortic valve.

4 . The method of claim 1 , wherein the first segment is deployed before the second segment.

5 . The method of claim 1 , wherein a length of the first segment in a direction of blood flow is greater than a length of the second segment in the direction of blood flow.

6 . The method of claim 1 , wherein the hinge comprises a memory shape material.

7 . A method of replacing a heart valve comprising:

providing a valve replacement device comprising:

a first segment comprising a first expandable outer stent tube configured to be deployed in a mitral valve of a heart of a patient;

a second segment comprising a second expandable outer stent tube configured to be deployed in a left ventricular outflow tract of the heart of the patient; and

a hinge connecting the first segment to the second segment, the first segment and the second segment being at least partially pivotable with respect to each other,

wherein the first segment includes a first collapsible prosthetic valve housed within the first expandable outer stent tube, and the second segment does not include a collapsible prosthetic valve;

guiding the valve replacement device into the heart of the patient; and

deploying the valve replacement device such that the first expandable outer stent tube is positioned within the mitral valve of the heart of the patient, the second expandable outer stent tube is positioned within the left ventricular outflow tract of the heart of the patient in a position that does not interfere with the function of an aortic valve of the heart of the patient, and an anterior mitral valve leaflet of the heart of the patient is entrapped between the first expandable outer stent tube and the second expandable outer stent tube,

wherein the hinge further comprises a wing protrusion for the purpose of containing at least a portion of the anterior mitral leaflet to prevent LVOT obstruction.

8 . The method of claim 1 , wherein guiding the valve replacement device into the heart of the patient comprises:

advancing a guide catheter into the heart of the patient;

advancing a support wire through the guide catheter and across the mitral valve of the heart of the patient;

advancing a delivery sheath over the support wire and across both the aortic valve and the mitral valve of the heart of the patient;

advancing the valve replacement device over the support wire and through the delivery sheath; and

removing the delivery sheath to deploy the valve replacement device.

9 . The method of claim 8 , further comprising removing the support wire and removing the guide catheter after deployment of the valve replacement device.

10 . A method of replacing a heart valve comprising:

providing a valve replacement device comprising:

a first segment comprising a first expandable outer stent tube configured to be deployed in a mitral valve of a heart of a patient;

a second segment comprising a second expandable outer stent tube configured to be deployed in a left ventricular outflow tract of the heart of the patient; and

a hinge connecting the first segment to the second segment, the first segment and the second segment being at least partially pivotable with respect to each other,

wherein the first segment includes a first collapsible prosthetic valve housed within the first expandable outer stent tube, and the second segment does not include a collapsible prosthetic valve;

guiding the valve replacement device into the heart of the patient; and

deploying the valve replacement device such that the first expandable outer stent tube is positioned within the mitral valve of the heart of the patient, the second expandable outer stent tube is positioned within the left ventricular outflow tract of the heart of the patient in a position that does not interfere with the function of an aortic valve of the heart of the patient, and an anterior mitral valve leaflet of the heart of the patient is entrapped between the first expandable outer stent tube and the second expandable outer stent tube,

wherein guiding the valve replacement device into the heart of the patient comprises:

advancing a guide catheter into the heart of the patient;

advancing a support wire through the guide catheter and across the mitral valve of the heart of the patient;

advancing a delivery sheath over the support wire and across both the aortic valve and the mitral valve of the heart of the patient;

advancing the valve replacement device over the support wire and through the delivery sheath; and

removing the delivery sheath to deploy the valve replacement device,

wherein advancing the guide catheter into the heart of the patient further comprises introducing the guide catheter into the left ventricle of the heart of the patient, and rotating the guide catheter posteriorly to face the mitral valve.

11 . The method of claim 8 , wherein advancing the valve replacement device comprises pivoting the first segment with respect to the second segment in order to dispose the first segment in the mitral valve of the heart of the patient and the second segment in the aortic valve in the mitral valve of the heart of the patient.

12 . A method of replacing a heart valve comprising:

providing a valve replacement device comprising:

a first segment comprising a first expandable outer stent tube configured to be deployed in a mitral valve of a heart of a patient;

a second segment comprising a second expandable outer stent tube configured to be deployed in a left ventricular outflow tract of the heart of the patient; and

a hinge connecting the first segment to the second segment, the first segment and the second segment being at least partially pivotable with respect to each other,

wherein the first segment includes a first collapsible prosthetic valve housed within the first expandable outer stent tube, and the second segment does not include a collapsible prosthetic valve;

guiding the valve replacement device into the heart of the patient; and

deploying the valve replacement device such that the first expandable outer stent tube is positioned within the mitral valve of the heart of the patient, the second expandable outer stent tube is positioned within the left ventricular outflow tract of the heart of the patient in a position that does not interfere with the function of an aortic valve of the heart of the patient, and an anterior mitral valve leaflet of the heart of the patient is entrapped between the first expandable outer stent tube and the second expandable outer stent tube,

wherein guiding the valve replacement device into the heart of the patient comprises:

advancing a guide catheter into the heart of the patient;

advancing a support wire through the guide catheter and across the mitral valve of the heart of the patient;

advancing a delivery sheath over the support wire and across both the aortic valve and the mitral valve of the heart of the patient;

advancing the valve replacement device over the support wire and through the delivery sheath; and

removing the delivery sheath to deploy the valve replacement device, and

advancing a second support wire through a side port of the guide catheter and into the left ventricle of the heart of the patient, wherein the side port is positioned between the first segment and the second segment.

13 . The method of claim 8 , further comprising:

advancing an anchor balloon into a pulmonary vein of the patient; and

inflating the anchor balloon.

14 . The method of claim 8 , wherein advancing the delivery sheath further comprises employing a tapered flexible dilator to facilitate smooth delivery of the delivery sheath.

15 . The method of claim 8 , further comprising pulling the guide catheter before the guide catheter is removed in order to anchor the anterior mitral leaflet and push it close to the aortic-mitral continuity.

16 . A valve replacement device comprising:

a first segment comprising a first expandable outer stent tube configured to be deployed in a mitral valve of a heart of a patient;

a second segment comprising a second expandable outer stent tube configured to be deployed in an aortic valve of the heart of the patient, the second segment being apart from the first segment; and

a hinge connecting the first segment to the second segment, the first segment and the second segment being at least partially pivotable with respect to each other, wherein the hinge further comprises a stretchable fabric connected to each of the first segment and the second segment, an

wherein the first segment includes a first collapsible prosthetic valve housed within the first expandable outer stent tube, and the second segment does not include a collapsible prosthetic valve.

17 . The valve replacement device of claim 16 , wherein a length of the first expandable outer stent tube is less than a length of the second first expandable outer stent tube.

18 . The valve replacement device of claim 16 , wherein the hinge comprises a memory shape material, and the hinge has a memory angle that disposes the first segment and the second segment at an angle of less than 90° with respect to each other.