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-11452628-B2
Publication Date
2022-09-27
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 relates to a loading system for an expandable and collapsible prosthetic heart valve device. The system loads the prosthetic heart valve device into a delivery catheter by using a loading funnel that holds the expanded prosthetic heart valve device and includes a lumen therethrough with a self-sealing access opening. A connecting top connects to an upper opening of the loading funnel to define a substantially watertight interior so that the prosthetic heart valve device is immersed during loading.
The loading system further includes a fluid infusion line in fluid communication with the substantially watertight interior. The fluid infusion line infuses biocompatible fluid into the substantially watertight interior, fills the substantially watertight interior with the biocompatible fluid to immerse the prosthetic heart valve device, and eliminates air from the substantially watertight interior.
In operative connection with the lumen of the loading funnel, the delivery catheter includes a proximal end in fluid communication with the substantially watertight interior. A pull wire is connected with an expanded expandable and collapsible prosthetic heart valve device disposed within the loading funnel and extends through the lumen of the delivery catheter to extend distally beyond a distal end of the delivery catheter.
The pull wire is detachable from the prosthetic heart valve and is configured to collapse and pull the expandable and collapsible prosthetic heart valve device through the lumen of the loading funnel and into the lumen of the delivery catheter. The expandable and collapsible prosthetic heart valve device comprises an outer stent frame and an inner valve support disposed within the outer stent frame, and the loading system provides predictable and repeatable collapsing of both the outer stent frame and the inner valve support.
Claims Coverage
The partial content provides one independent claim. It includes five principal inventive features.
Loading funnel with self-sealing access opening
A loading funnel adapted to hold the expanded expandable and collapsible prosthetic heart valve device therein and comprising a lumen therethrough with a self-sealing access opening.
Connecting top defining a substantially watertight interior
A connecting top adapted to connect to an upper opening of the loading funnel, thereby defining a substantially watertight interior.
Fluid infusion line to immerse valve and eliminate air
A fluid infusion line in fluid communication with the substantially watertight interior adapted to infuse biocompatible fluid into the substantially watertight interior and configured to fill the substantially watertight interior with the biocompatible fluid to immerse the prosthetic heart valve device and to eliminate air from the substantially watertight interior.
Delivery catheter operatively connected to funnel lumen
A delivery catheter comprising a lumen in operative connection with the lumen of the loading funnel, the delivery catheter having a proximal end that is in fluid communication with the substantially watertight interior.
Detachable pull wire configured to collapse and pull valve
A pull wire connected with an expanded expandable and collapsible prosthetic heart valve device disposed within the loading funnel and extending through the lumen of the delivery catheter and extending distally beyond a distal end of the delivery catheter, wherein the pull wire is detachable from the prosthetic heart valve and configured to collapse and pull the expandable and collapsible prosthetic heart valve device through the lumen of the loading funnel and into the lumen of the delivery catheter, wherein the expandable and collapsible prosthetic heart valve device comprises an outer stent frame and an inner valve support disposed within the outer stent frame.
Independent claim covers a loading system that combines a self-sealing loading funnel and a connecting top forming a substantially watertight interior, uses a fluid infusion line to immerse the prosthetic heart valve and eliminate air, and uses a detachable pull wire to collapse and pull the valve into a delivery catheter, with predictable and repeatable collapsing of both the outer stent frame and inner valve support.
Stated Advantages
Eliminate air from the substantially watertight interior.
Provide predictable and repeatable collapsing of both the outer stent frame and the inner valve support.
Documented Applications
No documented applications found
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