Localized fusion of native leaflets using activated adhesive
Disclosed is a delivery device, kit, system, method, etc. for localized fusion of leaflets of a tissue valve, for example, a native heart valve, using an adhesive. The delivery device can have one or more capture features for capturing separate leaflets, for example, the anterior and posterior mitral leaflets. An applicator can be configured to apply a biocompatible adhesive between the captured leaflets, and one or more curing elements can be configured to cure the applied biocompatible adhesive. The kit can have the aforementioned delivery device, and the biocompatible adhesive used therewith. The method can include positioning the aforementioned delivery device adjacent the anterior and posterior mitral leaflets, capturing the mitral leaflets between the paddles of the delivery device, applying a biocompatible adhesive between the captured mitral leaflets via the applicator, and curing the applied biocompatible adhesive via the energy elements to locally fuse the mitral leaflets.
1. A transcatheter applicator system for application of an adhesive between native leaflets for localized fusion thereof, the transcatheter system comprising:
a delivery catheter comprising a capsule at the distal end of the delivery catheter, wherein the capsule comprises a cartridge or is in connection with a cartridge, wherein the cartridge comprises an adhesive therein;
an applicator for dispensing an adhesive, wherein the applicator protrudes from an outer surface of the capsule and is configured to dispense adhesive from the cartridge;
one or more capture features in connection with the capsule, wherein the one or more capture features are configured for capturing two or more native leaflets such that the applicator can dispense adhesive between the two or more native leaflets when captured by the one or more capture features; and
one or more curing elements in connection with the capsule, the one or more curing elements configured to cure the adhesive after the adhesive has been dispensed upon native leaflets.
2. The system of claim 1 , wherein at least one of the one or more curing elements is configured to deliver thermal energy.
3. The system of claim 1 , wherein at least one of the one or more curing elements is configured to deliver light energy.
4. The system of claim 3 , wherein the at least one of the one or more curing elements configured to delivery light energy is a fiber optic.
5. The system of claim 1 , wherein the applicator comprises a porous material through which the adhesive is applied.
6. The system of claim 5 , wherein the wherein the porous material is further light transmissive; wherein at least one of the one or more curing elements is configured to transmit light through the porous material.
7. The system of claim 1 , wherein the adhesive comprises at least one pre-polymer and at least one initiator, each stored within its own chamber within the cartridge.
8. The system of claim 7 , wherein the at least one pre-polymer is activated by one or more functional groups that can be reacted to form crosslinks between polymer chains.
9. The system of claim 8 , wherein the at least one pre-polymer is activated by one or more functional groups that can be reacted to form crosslinks between polymer and tissue.
10. The system of claim 8 , wherein the at least one pre-polymer is not activated by biological fluids.
11. The system of claim 7 , wherein the at least one initiator is a photoinitiator.
12. The system of claim 1 , wherein the one or more capture features comprise opposing paddles, each paddle configured to articulate between an open and closed configuration to capture native leaflets.
13. The system of claim 1 , wherein the one or more capture features comprise a pair of balloons, wherein each balloon of the pair comprises an end portion to yield a pair of balloon end portions, wherein inflation of the pair of balloons is configured to capture native leaflets by narrowing a distance between the pair of balloon end portions.
14. The system of claim 1 , wherein the one or more capture features comprise at least four steerable clips, wherein at least two clips are configured to capture a first native leaflet and at least two clips are configured to capture a second native leaflet.
15. The system of claim 1 , wherein the adhesive comprises tissue growth enhancers or growth factors.
16. The system of claim 1 further comprising an expandable scaffold coupled to at least a portion of the capsule or at least a portion of the arm, wherein the expandable scaffold is configured to stabilize the delivery device during application of the adhesive between the native leaflets.
17. The system of claim 1 , wherein the applicator is detachable.
18. The system of claim 1 , wherein the applicator is configured to retract within a cavity of the capsule or detach from the capsule.
19. The system of claim 1 further comprising a handle in connection with the delivery catheter, wherein the handle comprises controls to actuate the one or more capture features, to apply the adhesive, or to activate the one or more curing elements.
20. The system of claim 1 further comprising a delivery sheath, wherein the capsule is retractable within a lumen of the delivery sheath.
21. The system of claim 1 , wherein the one or more curing elements are positioned from an outer surface of the capsule.