Loading systems for collapsible prosthetic heart valve devices and methods thereof
Inventors
Diedering, Jason S. • Kumar, Saravana B.
Assignees
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Publication Number
US-12232991-B2
Publication Date
2025-02-25
Expiration Date
Abstract
Loading systems for prosthetic heart valve devices are disclosed. A loading funnel is provided within a watertight interior space that is at least partially filled or fillable with biocompatible fluid. Funnel may have a cylindrical end to which is connected a delivery catheter having a lumen that will receive the collapsed prosthetic heart valve device. An expanded prosthetic heart valve device may be placed within the funnel and pushed or pulled into the funnel which provides a predictable, reliable and repeatable surface for collapsing the prosthetic heart valve device. Ultimately the prosthetic heart valve device is collapsed and translated into the lumen of the delivery catheter for further translation therealong and release into the heart chamber of interest.
Core Innovation
The invention provides a loading system for an expandable and collapsible prosthetic heart valve device that includes a loading funnel shaped to hold the prosthetic heart valve device therein. A receptacle is configured to be coupled to the loading funnel to define a watertight interior, and a fluid infusion line transmits biocompatible fluid to the watertight interior to fill the watertight interior with biocompatible fluid to immerse the prosthetic heart valve device and to eliminate air from the watertight interior.
The system further includes a delivery catheter that is removably engaged with the loading funnel to position a lumen of the delivery catheter in fluid communication with a lumen of the loading funnel. A pull wire is removably connected with the prosthetic heart valve device, and in operation extends through the lumen of the delivery catheter and beyond a distal end of the delivery catheter. The pull wire is configured to pull the prosthetic heart valve device through the lumen of the loading funnel and into the lumen of the delivery catheter.
Described embodiments refine the watertight interior and coupling between the receptacle and the loading funnel, including a resealable container or bag with an access opening and self-sealing material. Other embodiments describe a watertight funnel having a connecting top for coupling, and a funnel-to-base or cap arrangement with magnetic coupling. Additional refinements include an optional valve in the funnel to prevent air or fluid entry and loading funnel geometries having conical and cylindrical portions that support removable catheter engagement.
Claims Coverage
The partial content identifies one independent claim (clm-00001). Its inventive features cover an air-eliminating, watertight funnel-based loading arrangement using biocompatible fluid immersion, removably engaged delivery catheter lumens in fluid communication, and pull-wire-based transfer of the prosthetic heart valve device into the catheter lumen.
Watertight funnel with fluid infusion to immerse and eliminate air
A loading funnel shaped to hold the prosthetic heart valve device therein; a receptacle configured to be coupled to the loading funnel to define a watertight interior; and a fluid infusion line configured so that biocompatible fluid is transmitted to the watertight interior to fill the watertight interior with biocompatible fluid to immerse the prosthetic heart valve device and to eliminate air from the watertight interior.
Removably engaged delivery catheter lumen in fluid communication with funnel
A delivery catheter configured to be removably engaged with the loading funnel to position a lumen of the delivery catheter in fluid communication with a lumen of the loading funnel.
Pull wire extending through catheter and pulling valve through funnel into catheter lumen
A pull wire removably connected with the prosthetic heart valve device, configured so that in operation the pull wire extends through the lumen of the delivery catheter and beyond a distal end of the delivery catheter, wherein the pull wire is configured to pull the prosthetic heart valve device through the lumen of the loading funnel and into the lumen of the delivery catheter.
Across the identified independent claim, the core claim coverage is directed to immersing an expandable and collapsible prosthetic heart valve device in a watertight interior defined by a coupled receptacle and loading funnel using a fluid infusion line that eliminates air, while transferring the valve into a removably engaged delivery catheter lumen using a pull wire that passes through and beyond the catheter.
Stated Advantages
Eliminates air from the watertight interior during immersion of the prosthetic heart valve device.
Improves loading reliability by reducing air introduction during catheter loading (as described in the background).
Provides predictable and repeatable collapsing and loading orientation such that an inner valve support enters the catheter before an outer stent frame (as described in a dependent refinement).
Documented Applications
Loading of an expandable and collapsible prosthetic heart valve device for subsequent catheter delivery, including configurations relevant to transapical, transfemoral, transatrial, or transseptal delivery (as described in the background).
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