IP Library › Granted Patent US 12,385,163
Granted Patent B2
US 12,385,163 · App. 17/649,304 · Granted Aug 12, 2025

Rotary fibrous material application to medical devices

Inventors: Jingjia Han (Irvine, CA); Hao Shang (Irvine, CA)
Assignee: EDWARDS LIFESCIENCES CORPORATION
D01D5/18A61F2/2415A61F2/2418A61F2/2463D01D5/0084D01D7/00A61F2210/0076A61F2230/0054A61F2250/0039D10B2509/06
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Quick Facts
Patent No.
US 12,385,163
App. No.
17/649,304
Granted
Aug 12, 2025
Kind
B2
Abstract

A method of applying fibrous material to a medical device component involves coupling a medical device component a holder device, rotating a reservoir device containing a liquid polymeric solution to expel at least a portion of the liquid polymeric solution from an orifice of the reservoir device, the expelled at least a portion of the liquid polymeric solution forming one or more strands of fibrous material in a deposition plane, and rotating the holder device at least partially within the deposition plane to apply at least a first portion of the one or more strands of fibrous material to one or more surfaces of the medical device component, thereby forming a fibrous covering on the one or more surfaces of the medical device component.

Claims (53)

1. A method of applying fibrous material to a medical device component, the method comprising:

coupling a surgical heart valve device to a holder device, the surgical heart valve device including:

a non-expandable sealing ring;

a plurality of commissure posts projecting in an outflow direction on an outflow side of the sealing ring; and

an expandable skirt frame extending on an inflow side of the sealing ring;

rotating a reservoir device to expel at least a portion of a first liquid polymeric solution from an orifice of the reservoir device, the expelled at least a portion of the first liquid polymeric solution forming one or more first strands of fibrous material in a first deposition plane;

rotating the holder device at least partially within the first deposition plane to apply at least a portion of the one or more first strands of fibrous material to the sealing ring and the plurality of commissure posts of the surgical heart valve device, thereby forming a first fibrous covering having a first set of characteristics on the sealing ring and the plurality of commissure posts;

rotating the reservoir device to expel at least a portion of a second liquid polymeric solution from the orifice of the reservoir device, the expelled at least a portion of the second liquid polymeric solution forming one or more second strands of fibrous material in a second deposition plane; and

rotating the holder device at least partially within the second deposition plane to apply at least a portion of the one or more second strands of fibrous material to the skirt frame of the surgical heart valve device, thereby forming a second fibrous covering having a second set of characteristics on the skirt frame.

2. The method of claim 1 , wherein the holder device is a component of a collection assembly further comprising:

a rotary motor; and

a mandrel that is mechanically coupled to the holder device and the rotary motor.

3. The method of claim 2 , further comprising translating the collection assembly along a vertical axis while expelling the at least a portion of the first liquid polymeric solution.

4. The method of claim 1 , wherein the holder device is an at least partially cylindrical spacer form.

5. The method of claim 4 , further comprising applying an additional portion of the one or more second strands of fibrous material to a surface of the holder device, thereby forming a surplus fibrous covering portion on the surface of the holder device.

6. The method of claim 5 , further comprising:

decoupling the surgical heart valve device from the holder device; and

folding the surplus fibrous covering portion over an inflow edge of the skirt frame to cover at least a portion of an inside surface of the skirt frame.

7. The method of claim 1 , wherein the holder device comprises a plurality of arms configured to be coupled to the skirt frame.

8. The method of claim 7 , wherein said coupling the skirt frame to the holder device comprises suturing the skirt frame to the plurality of arms of the holder device.

9. The method of claim 1 , wherein rotating the reservoir device and the holder device is performed at least in part using control circuitry communicatively coupled to a collection assembly associated with the holder device and a deposition assembly associated with the reservoir device.

10. The method of claim 1 , wherein the holder device comprises an at least partially cylindrical spacer form.

11. The method of claim 10 , wherein the spacer form has a non-uniform longitudinal diameter.

12. A method of applying fibrous material to a medical device, the method comprising:

coupling a leaflet spacer device to a holder device, the leaflet spacer device including:

a main spacer body and;

a plurality of clip members configured to be movable to capture one or more leaflets of a heart valve between the plurality of clip members and the main spacer body;

opening the plurality of clip members to a straightened-out configuration exposing inside surfaces of the main spacer body and the plurality of clip members;

rotating a reservoir device to expel a first portion of fibrous material in a first deposition plane; and

rotating the holder device at least partially within the first deposition plane to apply the first portion of fibrous material to the inside surfaces of the main spacer body and the plurality of clip members of the leaflet spacer device, thereby forming a fibrous covering on the inside surfaces of the main spacer body and the plurality of clip members.

13. The method of claim 12 , further comprising:

closing the plurality of clip members; and

covering outside surfaces of at least a portion of the plurality of clip members with a second portion of fibrous material expelled from the reservoir device when the plurality of clip members are in a closed configuration.

14. The method of claim 12 , wherein:

the leaflet spacer device includes a hub member; and

coupling the leaflet spacer device to the holder device involves clipping the holder device at least partially around the hub member.

15. The method of claim 12 , further comprising transitioning the leaflet spacer device from the straightened-out configuration to a folded configuration after said forming the fibrous covering on the inside surfaces of the main spacer body and the plurality of clip members.

16. A method of applying fibrous material to a medical device component, the method comprising:

coupling a holder device to a rotatable mandrel;

coupling a prosthetic heart valve to the holder device, the prosthetic heart valve including:

a sealing ring;

a first frame including a plurality of commissure posts; and

a second frame extending on an inflow side of the sealing ring;

rotating a reservoir device to expel a first portion of liquid polymeric solution in a first deposition plane;

rotating the holder device at least partially within the first deposition plane to apply the first portion of liquid polymeric solution to the sealing ring, thereby forming a first fibrous covering having a first set of characteristics on the sealing ring;

rotating the reservoir device to expel a second portion of liquid polymeric solution in a second deposition plane; and

rotating the holder device at least partially within the second deposition plane to apply the second portion of liquid polymeric solution to the second frame, thereby forming a second fibrous covering having a second set of characteristics that are different from the first set of characteristics on the second frame.

17. The method of claim 16 , wherein:

the holder device comprises a plurality of arms; and

said coupling the prosthetic heart valve to the holder device involves coupling the second frame to the plurality of arms.

18. The method of claim 16 , further comprising: withdrawing the prosthetic heart valve from the holder device.

19. The method of claim 16 , further comprising folding a portion of the second fibrous covering over an inflow edge of the prosthetic heart valve.

20. The method of claim 16 , wherein the holder device comprises a spacer form.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 3, 2022
From: HAN, JINGJIA; SHANG, HAO
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 058883/0127 →
Continuity (3)
Continuation PCTUS2020044412 · Jul 31, 2020
Provisional Application 62882352 · Aug 2, 2019
Related Publication 20220154370A1 · May 19, 2022
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