Localized fusion of native leaflets using activated adhesive
Inventors
Cao, Hengchu • Shen, Shih-Hwa • Hsu, Holly Kung Jung • Lai, Krystal Ya-Fong
Assignees
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Publication Number
US-12419622-B2
Publication Date
2025-09-23
Expiration Date
Abstract
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.
Core Innovation
The invention provides a transcatheter applicator system for application of an adhesive between native leaflets for localized fusion thereof. The system includes a delivery catheter with a capsule at a distal end, where the capsule comprises a cartridge or is in connection with a cartridge, and the cartridge comprises an adhesive. An applicator protrudes from an outer surface of the capsule and is configured to dispense adhesive from the cartridge between native leaflets when captured.
Capture features are provided in connection with the capsule and are configured for capturing two or more native leaflets so that the applicator can dispense adhesive between the two or more native leaflets when captured. The system further includes one or more curing elements in connection with the capsule, configured to cure the adhesive after the adhesive has been dispensed upon native leaflets.
The disclosure also describes biocompatible activated adhesive delivered to locally fuse native tissue valve leaflets, including capture and delivery arrangements for anterior/posterior mitral leaflets, with curing using energy elements such as UV, light, and thermal energy. Adhesive may be stored in a multi-component arrangement with a pre-polymer and initiator in separate chambers/capsule-cartridge components, and curing may occur after adhesive dispensing, including curing through a light-transmissive porous applicator.
Claims Coverage
The partial content includes one independent claim and dependent claims that narrow or refine the independent claim. Across the dependent claims shown, five core inventive features are specified beyond the independent claim: thermal-energy curing, fiber-optic light curing, light-transmissive porous applicator curing, multi-component adhesive storage in separate chambers, and specific leaflet-capture mechanisms.
Transcatheter adhesive applicator system for localized fusion of native leaflets
A transcatheter applicator system for application of an adhesive between native leaflets for localized fusion thereof, including a delivery catheter with a distal capsule and a cartridge comprising the adhesive.
Protruding applicator for dispensing adhesive from the cartridge between captured leaflets
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.
Capture features configured to capture two or more native leaflets for adhesive dispensing between them
One or more capture features in connection with the capsule configured for capturing two or more native leaflets such that the applicator can dispense adhesive between the two or more native leaflets when captured.
Curing elements configured to cure the adhesive after dispensing
One or more curing elements in connection with the capsule, configured to cure the adhesive after the adhesive has been dispensed upon native leaflets.
Thermal-energy curing element
At least one curing element configured to deliver thermal energy.
Fiber-optic light-energy curing element
At least one curing element configured to deliver light energy, wherein the curing element that delivers light energy is a fiber optic.
Multi-component adhesive stored in separate chambers
An adhesive made from at least one pre-polymer and at least one initiator, with the pre-polymer and initiator stored in separate chambers within a cartridge.
Opposing articulating paddle leaflet-capture mechanism
Capture features implemented as opposing paddles configured to capture native leaflets with an articulating open and closed configuration.
Balloon-based leaflet-capture with distance narrowing by inflated end portions
Capture features implemented as a pair of balloons having end portions configured such that inflating the end portions captures native leaflets by narrowing the distance between the pair of balloon end portions.
Claim coverage centers on a transcatheter system that dispenses an adhesive from a distal capsule cartridge onto two or more captured native leaflets for localized fusion, followed by curing via capsule-connected curing elements. The dependent claim refinements shown specify curing modality, adhesive chemistry storage architecture, and example leaflet-capture mechanisms.
Stated Advantages
Enables localized fusion of native leaflets by dispensing adhesive between captured native leaflets and curing after dispensing.
Documented Applications
Transcatheter treatment involving localized fusion of native tissue valve leaflets, including mitral valve leaflets (anterior/posterior).
Use as a transcatheter applicator system with a capsule-cartridge adhesive and curing elements for curing adhesive after dispensing upon native leaflets.
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