Self-growing heart valves
Described herein are artificial valves that have a frame and leaflets that grow or expand with a patient. Upon placing the valve inside the patient, the valve expands as the annulus of the patient expands. The frame of the valve is configured to expand which in turn causes the leaflets to expand (e.g., to grow). The valve includes a thin undulating wire embedded inside the leaflets. As the annulus of the patient grows, the frame expands, and as the frame expands, the leaflets grow. The growth or expansion of the leaflets is configured so that the valve continues to operate properly (e.g., the leaflets continue to coapt) with expansion of the annulus. The change in size of the valve can be configured to accommodate changes in size of the annulus from an infant or child to an adult.
1 . A method of treating a defective heart valve, the method comprising:
advancing a delivery catheter to a target heart valve of a patient;
deploying a self-growing heart valve device from the delivery catheter within an annulus of the target heart valve, the heart valve device including a self-growing tubular frame and a plurality of self-growing leaflets coupled to the self-growing frame;
permitting the self-growing heart valve device to expand within the annulus to thereby implant the heart valve device;
withdrawing the delivery catheter from the patient; and
maintaining the self-growing heart valve device within the annulus to thereby allow the self-growing tubular frame and the plurality of self-growing leaflets to grow along with the annulus of the target heart valve.
2 . The method of claim 1 , wherein said permitting the self-growing heart valve involves expanding the self-growing heart valve with a balloon.
3 . The method of claim 1 , wherein the plurality of self-growing leaflets include undulated wires.
4 . The method of claim 1 , wherein the plurality of self-growing leaflets are dimensioned such that in a partially-expanded state, the leaflets coapt to a greater degree than in a fully-expanded state.
5 . A method of treating a defective heart valve, the method comprising:
delivering a self-growing heart valve device to a target heart valve of a patient, the self-growing heart valve device including a self-growing frame and a plurality of self-growing leaflets coupled to the self-growing frame, the self-growing frame configured to change in diameter after implantation to accommodate growth of the patient, the plurality of self-growing leaflets configured to increase in size with an increase in size of the diameter of the self-growing frame such that the plurality of self-growing leaflets are adapted to coapt in a range of diameters of the self-growing frame, the range of diameters extending from an initial expanded state to a post-operative expanded state; and
deploying the self-growing heart valve device within an annulus of the target heart valve such that the self-growing frame is expanded to the initial expanded state and attached to the annulus; and
expanding the self-growing heart valve device to a post-operative expanded state, expansion of the self-growing heart valve due to growth of the patient that causes the annulus to increase in size,
wherein the diameter of the self-growing frame in the initial expanded state is less than 14 mm,
wherein the diameter of the self-growing frame in the post-operative expanded state is greater than 50 mm,
wherein the plurality of self-growing leaflets each include a structural support that provides structure to the plurality of self-growing leaflets at a range of sizes that covers the range of diameters from the initial expanded state to the post-operative expanded state,
wherein expansion of the self-growing frame causes points along a peripheral edge of each leaflet of the plurality of self-growing leaflets to be pulled apart axially to expand the structural support along coaptation edges of each leaflet of the plurality of self-growing leaflets such that the plurality of self-growing leaflets coapt in the range of diameters of the self-growing frame from the initial expanded state to the post-operative expanded state.
6 . The method of claim 5 further comprising crimping the self-growing frame to a crimped state prior to delivering the self-growing heart valve device.
7 . The method of claim 6 further comprising inserting the self-growing heart valve device into a sheath of a delivery device to restrain the self-growing heart valve device in the crimped state.
8 . The method of claim 7 further comprising advancing the self-growing heart valve device from the sheath to allow the self-growing tubular frame to produce the radially outward force to be implanted at the target heart valve.
9 . The method of claim 5 , wherein the structural support comprises undulated wires.
10 . The method of claim 5 , wherein expansion of the annulus due to patient growth radially expands the self-growing frame and expands a peripheral edge and a coaptation edge of each of the plurality of self-growing leaflets.
11 . The method of claim 5 , wherein the self-growing frame is adapted to exert a radially outward force in each state between the initial expanded state and the post-operative expanded state.
12 . The method of claim 5 , wherein expansion of the self-growing heart valve device from the initial expanded state to the post-operative expanded state includes radial expansion and longitudinal contraction of the self-growing frame.
13 . The method of claim 5 , wherein the self-growing frame is adapted to conform to a shape of the target heart valve.
14 . The method of claim 5 , wherein the structural support is along a peripheral edge and a coaptation edge of each of the plurality of self-growing leaflets.
15 . A method of treating a defective heart valve, the method comprising:
compressing a self-growing heart valve device to a low-profile configuration, the self-growing heart valve being in a crimped state in the low-profile configuration, the self-growing heart valve device including a self-growing frame and a plurality of self-growing leaflets coupled to the self-growing frame;
delivering the self-growing heart valve device in the crimped state to a target heart valve of a patient; and
deploying the self-growing heart valve device within an annulus of the target heart valve, the self-growing heart valve adapted to expand to an initial expanded state such that the self-growing frame exerts a radially outward force against the annulus of the target valve to implant the self-growing heart valve device at the target heart valve,
wherein, after deployment, the self-growing frame exerts a radially outward force such that the self-growing heart valve device is adapted to expand from the initial expanded state to a post-operative expanded state to accommodate growth of the annulus of the target heart valve due to growth of the patient,
wherein the plurality of self-growing leaflets is adapted to continue to coapt with expansion of the self-growing heart valve from the initial expanded state to the post-operative expanded state.
16 . The method of claim 15 further comprising compressing the self-growing heart valve device to a low-profile configuration that is less than or equal to 2 mm in diameter to fit within a catheter designed for vasculature of a child.
17 . The method of claim 15 further comprising using transcatheter access to implant the self-growing heart valve device in an infant or child.
18 . The method of claim 17 , wherein, in the crimped state, the self-growing heart valve device is less than 5 French.
19 . The method of claim 15 , wherein a diameter of the self-growing frame in the initial expanded state is between about 10 mm and 14 mm.
20 . The method of claim 15 , wherein the diameter of the self-growing frame in the post-operative expanded state is between 14 mm and 50 mm.