IP Library › Granted Patent US 12,611,302
Granted Patent B2
US 12,611,302 · App. 18/300,036 · Granted Apr 28, 2026

Prosthetic heart valve device and associated systems and methods

Inventor: Katherine Miyashiro (San Francisco, CA)
Assignee: Twelve, Inc.
A61F2/2418A61F2/243A61F2/2436A61F2002/9534A61F2002/9665A61F2220/0008A61F2220/0016A61F2230/0034A61F2230/005A61F2230/0052A61F2230/0054A61F2230/0067A61F2250/0039A61F2250/0069A61F2250/0096
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Quick Facts
Patent No.
US 12,611,302
App. No.
18/300,036
Granted
Apr 28, 2026
Kind
B2
Abstract

A prosthetic heart valve device includes a valve support, a prosthetic valve assembly disposed within the valve support, and an anchoring member. The anchoring member includes a base attached to a first region of the valve support, a plurality of arm units projecting laterally outward from the base and inclined in a direction away from the first region in a deployed state, and a fixation structure extending from the arm units. Each arm unit includes a first portion coupled to the base and a second portion coupled to the fixation structure. The fixation structure includes a plurality of struts that define an annular engagement surface configured to press outwardly against a native annulus of a native heart valve. The first portion of each arm unit has a first flexibility greater that a second flexibility of the second portion of each arm unit.

Claims (42)

1 . A prosthetic heart valve device comprising:

a valve support having a first region and a second region;

a prosthetic valve assembly disposed within the valve support; and

an anchoring member comprising:

a base attached to the first region of the valve support;

a plurality of arm units projecting laterally outward from the base and inclined in a direction away from the first region in a deployed state, each arm unit including a first portion coupled to the base and a second portion; and

a fixation structure extending from the second portion of the arm units, the fixation structure having a plurality of struts that define an annular engagement surface configured to press outwardly against a native annulus of a native heart valve;

wherein the first portion of each arm unit has a first flexibility and the second portion of each arm unit as a second flexibility, wherein the first flexibility is greater than the second flexibility.

2 . The prosthetic heart valve device of claim 1 , wherein each arm unit is a V-shaped arm unit having two arms coupled to the base, the two arms extending laterally away from each other from the base to the fixation structure, each of the two arms having the first portion with the first flexibility and the second portion with the second flexibility.

3 . The prosthetic heart valve device of claim 2 , wherein the first portion of each arm is serpentine.

4 . The prosthetic heart valve device of claim 1 , wherein each arm unit is a Y-shaped arm unit having a trunk coupled to the base and two arms extending from the trunk to the fixation structure.

5 . The prosthetic heart valve device of claim 4 , wherein the trunk is the first portion of the arm unit and the two arms are the second portion of the arm unit.

6 . The prosthetic heart valve device of claim 5 , wherein only the trunk is serpentine.

7 . The prosthetic heart valve device of claim 1 , wherein the first region is an outflow region of the valve support and the second region is an inflow region of the valve support.

8 . The prosthetic heart valve device of claim 1 , further comprising a sealing member coupled to an inner surface of the anchoring member.

9 . The prosthetic heart valve device of claim 8 , wherein the arm units include eyelets, wherein sutures pass through the eyelets to attach the sealing member to the inner surface of the anchoring member.

10 . The prosthetic heart valve device of claim 9 , wherein eyelets are coupled to the inner surface of the arm units.

11 . The prosthetic heart valve device of claim 9 , wherein eyelets are coupled to an outer surface of the arm units.

12 . A prosthetic heart valve device comprising:

an inner stent having a first region and a second region;

a prosthetic valve assembly disposed within the inner stent; and

an outer stent comprising:

a base attached to the first region of the inner stent;

a plurality of arms projecting laterally outward from the base and inclined in a direction away from the first region in a deployed state, each arm including a first portion coupled to the base and a second portion; and

a fixation structure extending from the second portion of the arms, the fixation structure having a plurality of struts that define an annular engagement surface configured to press outwardly against a native annulus of a native heart valve;

wherein the first portion of each arm has a first flexibility and the second portion of each arm as a second flexibility, wherein the first flexibility is greater than the second flexibility.

13 . The prosthetic heart valve device of claim 12 , wherein each arm is a V-shaped arm unit having two struts coupled to the base, the two struts extending laterally away from each other from the base to the fixation structure, each of the two struts having the first portion with the first flexibility and the second portion with the second flexibility.

14 . The prosthetic heart valve device of claim 13 , wherein the first portion of each strut is serpentine.

15 . The prosthetic heart valve device of claim 12 , wherein each arm unit is a Y-shaped arm unit having a trunk coupled to the base and struts extending from the trunk to the fixation structure.

16 . The prosthetic heart valve device of claim 15 , wherein only the trunk is serpentine.

17 . The prosthetic heart valve device of claim 12 , wherein the first region is an outflow region of the inner stent and the second region is an inflow region of the inner stent.

18 . A prosthetic heart valve device comprising:

an inner stent;

a prosthetic valve assembly disposed within and coupled to the inner stent;

an outer stent comprising a fixation structure configured to press against a native annulus of a native heart valve; and

a plurality of arms connecting the outer stent to the inner stent, wherein each of the arms extends radially outward from the inner stent to the outer stent, each of the plurality of arms comprising:

a first end;

a second end;

a first portion adjacent the first end; and

a second portion disposed between the first portion and the second end, wherein the first portion of each arm is a single strut and the second portion of each arm is two struts such that each arm is Y-shaped, wherein the first portion is a serpentine strut and the second portion is a non-serpentine strut.

19 . The prosthetic heart valve device of claim 18 , wherein the first end is coupled to the inner stent and the second end is coupled to the outer stent.

20 . The prosthetic heart valve device of claim 18 , wherein the non-serpentine strut is straighter than the serpentine strut.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2023
From: MIYASHIRO, KATHERINE
To: TWELVE, INC.
Reel/Frame 063316/0572 →
Continuity (3)
Continuation 16904250 · Jun 17, 2020
Division 15490047 · Apr 18, 2017
Related Publication 20230248515A1 · Aug 10, 2023
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