Systems and methods for endoluminal valve creation
A device for manipulating tissue at a vessel includes an elongated member having a proximal end and a distal end, a guide member at the distal end of the elongated member, the guide member having a blunt distal tip for engagement against an interior wall of the vessel, and a tissue cutting device at the distal end of the elongated member, wherein the tissue cutting device has a sharp tip that is proximal to the blunt distal tip of the guide member.
1. A system for creating an autologous leaflet at a dissection plane between two layers of tissue in a wall of a blood vessel, the system comprising:
a conduit mechanism having a longitudinal axis, a proximal portion, a distal portion, and a wall tensioning mechanism at the distal portion, wherein the distal portion includes a slanted surface extending across a cross-section of the conduit mechanism that forms an acute angle with respect to the longitudinal axis, and wherein the conduit mechanism has a lumen therethrough that terminates distally at a port positioned along the slanted surface;
a sub-intimal access mechanism comprising an elongated member having a sharp distal end, wherein the sub-intimal access mechanism is configured to be slideably disposed through the lumen of the conduit mechanism;
a sub-intimal pocket creation mechanism comprising (a) an elongated shaft configured to be slideably disposed through the lumen of the conduit mechanism, and (b) an expandable portion at a distal portion of the shaft, wherein the expandable portion includes an arm and a cutting element extending along and projecting outwardly from a proximal portion of the arm and having a sharp edge that faces proximally when the arm is deployed,
wherein, in a collapsed state, the sub-intimal pocket creation mechanism is sized for insertion through an opening at an interior surface of the wall of the blood vessel to access the dissection plane, and wherein actuation of the sub-intimal pocket creation mechanism while positioned within the wall causes at least a portion of the arm to extend outwardly away from a longitudinal axis of the shaft within the dissection plane to create a sub-intimal pocket between the two layers of tissue; and
wherein, when the cutting element is in a deployed state—
the cutting element includes a body having a first part disposed at a first distance from the longitudinal axis of the shaft and a second part distal to the first part and disposed at a second distance from the longitudinal axis of the shaft, the second distance being greater than the first distance, and
the cutting element is configured to make a cut that extends away from either side of the opening in a circumferential direction, thereby widening the opening to transform the sub-intimal pocket into a leaflet.
2. The system of claim 1 , wherein, when the sub-intimal pocket creation mechanism is in the collapsed state, the longitudinal axis of the arm is generally parallel with a longitudinal axis of the shaft.
3. The system of claim 1 , wherein the arm is rotatably coupled to the shaft.
4. The system of claim 1 , wherein the arm is a first arm, and wherein the sub-intimal pocket creation mechanism further comprises a second arm.
5. The system of claim 4 , wherein the first arm is positioned circumferentially opposite the second arm about the shaft.
6. The system of claim 4 , wherein the first arm and the second arm are rotatably coupled to the shaft.
7. The system of claim 1 , wherein the angle of the cut as measured along the circumference of the wall is between 90 degrees and 330 degrees.
8. The system of claim 1 , wherein the angle of the cut as measured along the circumference of the wall is between 160 degrees and 240 degrees.
9. The system of claim 1 , wherein the angle of the cut as measured along the circumference of the wall is between 190 degrees and 220 degrees.
10. The system of claim 1 , wherein the shaft has a lumen.
11. A system for creating an autologous leaflet at a dissection plane between two layers of tissue in a wall of a blood vessel, the system comprising:
a conduit mechanism having a longitudinal axis, a proximal portion, a distal portion, and a wall tensioning mechanism at the distal portion, wherein the distal portion includes a slanted surface extending across a cross-section of the conduit mechanism that forms an acute angle with respect to the longitudinal axis, and wherein the conduit mechanism has a lumen therethrough that terminates distally at a port positioned along the slanted surface;
a sub-intimal access mechanism comprising an elongated member having a sharp distal end, wherein the sub-intimal access mechanism is configured to be slideably disposed through the lumen of the conduit mechanism;
a shaft having a longitudinal axis, a proximal portion, and a distal portion, wherein the shaft is configured to be slideably received through the lumen, and wherein the distal portion of the shaft is configured to extend distally from the port through an opening at an interior surface of a wall of a blood vessel to access a dissection plane between two layers of tissue in the wall;
first and second arms coupled to the distal portion of the shaft, wherein:
in a collapsed state, the first and second arms extend generally parallel to the longitudinal axis of the shaft and are configured to be inserted through the opening at the interior surface of the wall of the blood vessel to access the dissection plane, and
in a deployed state, at least a portion of each of the arms extends outwardly away from the longitudinal axis of the shaft such that, when the first and second arms are transformed from the collapsed state to the deployed state within the dissection plane, the first and second arms separate the two layers of tissue to create a sub-intimal pocket between the two layers of tissue; and
a first cutting element extending along and projecting outwardly from a proximal portion of the first arm, the first cutting element including a sharp edge that faces proximally when the first arm is in the deployed state,
a second cutting element extending along and projecting outwardly from a proximal portion of the second arm, the second cutting element including a sharp edge that faces proximally when the second arm is in the deployed state,
wherein, when the first and second arms are in the deployed state, the first and second cutting elements are configured to cut vessel wall tissue at the interior surface of the vessel wall along a line that extends away from either side of the opening in a circumferential direction, thereby widening the opening to transform the sub-intimal pocket into a leaflet.
12. The system of claim 11 , wherein the first arm is positioned circumferentially opposite the second arm about the shaft.
13. The system of claim 11 , wherein the first and second arms are rotatably coupled to the shaft.
14. The system of claim 11 , wherein the angle of the cut as measured along the circumference of the wall is between 90 degrees and 330 degrees.
15. The system of claim 11 , wherein the angle of the cut as measured along the circumference of the wall is between 160 degrees and 240 degrees.
16. The system of claim 11 , wherein the angle of the cut as measured along the circumference of the wall is between 190 degrees and 220 degrees.
17. The system of claim 11 , wherein the shaft has a lumen.