Granted Patent
B2
US 12,616,593 · App. 17/377,254 · Granted May 5, 2026
Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system
Inventors:
Stefan Schreck (Duvall, WA); Hussain Rangwala (Villa Park, CA); Payam Saffari (Aliso Viejo, CA); Makensley Lordeus (Phoenix, AZ); Vincent Ming Hai Chow (Irvine, CA); Kevin Han Tang Chu (Tustin, CA)
Assignee:
JenaValve Technology, Inc.
A61F2/966A61F2/0095A61F2/243A61F2/2436A61F2002/9505A61F2/9522A61F2002/9665A61F2250/0062A61F2250/0064A61F2250/0092
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Abstract
The present disclosure relates to a delivery catheter and the stepwise release of a stent from the catheter into the vasculature of a patient, as well as a loading device for a transcatheter heart valve (THV) prosthesis.
Claims (23)
1 . A system for repairing a cardiac valve, the system comprising:
a valve prosthesis
a delivery system comprising a handle at a proximal end of the delivery system, an end region at a distal end of the delivery system, and a catheter extending between the handle and the end region of the delivery system,
the end region of the delivery system comprising a distal sleeve configured to constrain a distal portion the valve prothesis and a proximal sleeve configured to constrain, together with a stent holder disposed within the proximal sleeve, a proximal portion of the valve prosthesis, the stent holder configured to be removably coupled to the proximal portion of the valve prosthesis and to selectively move with respect to the proximal sleeve, and
the valve prosthesis is configured to be sequentially released using the handle in mechanical communication with the end region of the delivery system, the valve prosthesis being self-expandable,
wherein the proximal sleeve of the delivery system and the distal sleeve of the delivery system are configured to constrain the valve prosthesis such that an exposed portion of the valve prosthesis extends between the proximal sleeve of the delivery system and the distal sleeve of the delivery system when the distal sleeve of the delivery system is in a proximal-most position and the proximal sleeve of the delivery system is in a distal-most position, the exposed portion self-expanding radially beyond the proximal sleeve of the delivery system and the distal sleeve of the delivery system, and
wherein the distal sleeve is configured to move distally to release the distal portion of the valve prosthesis and the stent holder is configured to move distally, subsequent to the distal sleeve moving distally, to fully release the valve prosthesis from the delivery system.
2 . The system of claim 1 , wherein the valve prosthesis is configured to transition from a radially collapsed state to a radially expanded state.
3 . The system of claim 1 , wherein the valve prosthesis is stored in a liquid for transport.
4 . The system of claim 1 , further comprising a steering system, wherein the delivery system and the steering system are releasably connectable.
5 . The system of claim 1 , wherein the proximal sleeve is axially fixed with respect to the catheter.
6 . The system of claim 1 , wherein the stent holder is in mechanical communication with the distal sleeve.
7 . The system of claim 6 , wherein a cable connects stent holder to the distal sleeve.
8 . A method for preparing a system for repairing a cardiac valve, the system comprising a valve prosthesis that is self-expandable and a first segment of a delivery system comprising a handle at a proximal end of the delivery system, an end region at a distal end of the delivery system, and a catheter extending between the handle and the end region of the delivery system, the end region of the delivery system comprising a distal sleeve configured to constrain a distal portion the valve prothesis and a proximal sleeve configured to constrain, together with a stent holder disposed within the proximal sleeve, a proximal portion of the valve prosthesis, the stent holder configured to be removably coupled to the proximal portion of the valve prosthesis and to selectively move with respect to the proximal sleeve, the method comprising:
engaging the stent holder of the delivery system with the valve prosthesis,
engaging the distal sleeve of the delivery system with the distal portion of the valve prosthesis; and
wherein the proximal sleeve of the delivery system and the distal sleeve of the delivery system are configured to contact and constrain the valve prosthesis such that an exposed portion of the valve prosthesis extends between the proximal sleeve of the delivery system and the distal sleeve of the delivery system when the distal sleeve of the delivery system is in a proximal-most position and the proximal sleeve of the delivery system is in a distal-most position, the exposed portion self-expanding radially beyond the proximal sleeve of the delivery system and the distal sleeve of the delivery system, and
wherein the distal sleeve is configured to move distally to release the distal portion of the valve prosthesis and the stent holder is configured to move distally, subsequent to the distal sleeve moving distally, to fully release the valve prosthesis from the delivery system.
9 . The method of claim 8 , wherein engaging the valve prosthesis with the stent holder of the delivery system comprises coupling the valve prosthesis to the stent holder of the delivery system.
10 . The method of claim 8 , further comprising connecting the delivery system to a steering system adapted to align the valve prosthesis with the cardiac valve.
11 . The method of claim 8 , wherein the proximal sleeve is axially fixed with respect to the catheter.
12 . The method of claim 8 , wherein the stent holder is in mechanical communication with the distal sleeve.
13 . The method of claim 12 , wherein a cable connects stent holder to the distal sleeve.
Assignments (3)
INTELLECTUAL PROPERTY SECURITY AGREEMENT
Recorded Jan 28, 2022
From: JENAVALVE TECHNOLOGY, INC.
To: INNOVATUS LIFE SCIENCES LENDING FUND I, LP
Reel/Frame 058894/0788 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 19, 2021
From: SCHRECK, STEFAN; RANGWALA, HUSSAIN; SAFFARI, PAYAM; LORDEUS, MAKENSLEY; CHOW, VINCENT MING HAI
To: JENAVALVE TECHNOLOGY, INC.
Reel/Frame 056906/0148 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Jul 19, 2021
From: CHU, KEVIN HAN TANG
To: JENAVALVE TECHNOLOGY, INC.
Reel/Frame 056906/0186 →
Continuity (4)
Continuation
16099793
Provisional Application
62491391
· Apr 28, 2017
Provisional Application
62336153
· May 13, 2016
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