Granted Patent B2

US 12,611,306 · App. 18/024,011 · Granted Apr 28, 2026

Inventors: J. Brent Ratz (Winchester, MA); Arshad Quadri (West Hartford, CT); Christopher Stivers (Somerville, MA); Devin Marr (Westford, MA)

Assignee: inQB8 Medical Technologies, LLC

A61F2/2439A61F2/2418A61F2/2436A61F2002/9534A61F2210/0014A61F2220/0075A61F2220/0083A61F2230/001A61F2250/0039A61F2250/0069

Abstract

Claims (59)

1 . A delivery system for delivering a prosthetic heart valve to a native heart valve of a heart, the system comprising:

a shaft portion;

a handle portion coupled to a proximal end of the shaft portion;

a capsule portion coupled to a distal end of the shaft portion and configured to house the prosthetic heart valve; and

at least one shaft, at least one steering wire, and at least one pull wire,

wherein the at least one shaft, at least one steering wire, and/or the at least one pull wire is configured to extend from the handle portion through the shaft portion to the capsule portion of the delivery system,

wherein the capsule portion comprises a tubular portion that comprises an expandable frame comprising a plurality of frame members,

wherein the plurality of frame members comprises an expandable support structure, and wherein the expandable support structure is configured to attach to one or more portions of the prosthetic heart valve,

wherein the native heart valve comprises a plurality of native leaflets, and wherein the delivery system is configured to deploy the prosthetic heart valve such that the prosthetic heart valve grasps the plurality of native leaflets without directly attaching to a native annulus and/or without directly attaching to a native chord of the native heart valve such that the prosthetic heart valve may be retrieved and/or repositioned within the native heart valve by the delivery system, and

wherein, upon deployment, the prosthetic heart valve is axially stabilized within the native heart valve by grasping the plurality of native leaflets of the native heart valve,

wherein, after deployment, at least one portion of the delivery system is capable of re-engaging the prosthetic heart valve to reposition the prosthetic heart valve within the native heart valve and/or retrieve the prosthetic heart valve into the capsule portion of the delivery system.

2 . The delivery system of claim 1 , wherein:

the plurality of frame members further comprises one or more fasteners configured to attach to a corresponding fastener on the prosthetic heart valve.

3 . The delivery system of claim 2 , further comprising one or more tubes configured to maintain contact between one or more fasteners of the delivery system and the prosthetic heart valve.

4 . The delivery system of claim 3 , wherein the at least one pull wire is attached to the one or more tubes.

5 . The delivery system of claim 1 , wherein an inner shaft extends through the shaft portion, and a distal portion of the inner shaft is disposed in a lumen of the tubular portion.

6 . The delivery system of claim 5 , wherein the tubular portion comprises a tapered head member coupled to the distal portion of the inner shaft.

7 . The delivery system of claim 6 , wherein at least a portion of the tapered head member is disposed in the tubular portion.

8 . The delivery system of claim 5 , wherein the shaft portion further comprises a plurality of nested shafts, and the plurality of nested shafts comprise the inner shaft.

9 . The delivery system of claim 8 , wherein at least one shaft of the plurality of nested shafts further comprises an outer shaft.

10 . The delivery system of claim 1 , wherein the tubular portion is configured to adjust a position of the prosthetic heart valve relative to the handle portion.

11 . The delivery system of claim 1 , wherein the at least one steering wire is configured to flex the shaft portion to an angle up to approximately 125 degrees from a longitudinal axis of the handle portion.

12 . The delivery system of claim 1 , wherein the at least one steering wire is configured to flex the shaft portion to an angle up to approximately 30 degrees from a longitudinal axis of the handle portion.

13 . The delivery system of claim 1 , wherein:

the at least one steering wire comprises a first steering wire and a second steering wire,

the first steering wire is configured to flex the shaft portion in a first plane from a longitudinal axis of the handle portion, and

the second steering wire is configured to flex the shaft in a second plane from the longitudinal axis.

14 . The delivery system of claim 1 , wherein a proximal end of the at least one pull wire is disposed within the handle portion, and

a distal end of the at least one pull wire is disposed within the capsule portion.

15 . The delivery system of claim 1 , wherein the at least one pull wire is configured to control release of the prosthetic heart valve from the delivery system.

16 . The delivery system of claim 1 , further comprising at least one tether for coupling the shaft portion to the prosthetic heart valve.

17 . The delivery system of claim 16 , wherein the at least one shaft comprises:

an inner shaft disposed within a lumen of an outer shaft, wherein:

the inner shaft comprises at least one pin to which at least one thread is coupled,

the outer shaft comprises at least one aperture through which the at least one thread is disposed, and

a displacement of the inner shaft within the outer shaft decouples the at least one thread from the at least one pin.

18 . The delivery system of claim 1 , wherein the capsule portion comprises a flexible tube configured to flex within at least one plane.

19 . The delivery system of claim 18 , wherein:

the flexible tube comprises a metal tube defining a first plurality of apertures along a first side and a second plurality of apertures along a second side, and

the first side is opposite the second side.

20 . The delivery system of claim 1 , wherein the at least one portion of the delivery system is configured to access a native blood vessel to deliver the prosthetic heart valve to the heart.

21 . The delivery system as in claim 1 , wherein the delivery system is configured to biodynamically fix the prosthetic heart valve to the native leaflets of the native heart valve.

22 . A delivery system, comprising:

a shaft portion comprising at least one shaft, at least one steering wire, and at least one pull wire;

a handle portion coupled to a proximal end of the shaft portion; and

a capsule portion coupled to a distal end of the shaft portion and configured to house an implant,

wherein at least one portion of the delivery system is configured to be engaged with the implant while the implant is deployed within a subject such that the implant may be repositioned after deployment,

wherein the delivery system comprises one or more pins, one or more apertures, and one or more thread-like elements,

wherein the delivery system is configured to deploy the implant such that the implant grasps a plurality of native leaflets of a native heart valve without directly attaching the implant to a native annulus and/or native chords of the native heart valve,

wherein the implant is configured to move within the native heart valve in response to alternating pressure differentials on either side of the native heart valve during cardiac cycles of the heart, and

wherein, upon deployment, the implant is axially stabilized within the native heart valve by grasping the plurality of native leaflets of the native heart valve.

23 . A method for delivering a prosthetic heart valve to a native heart valve of a heart, the method comprising:

advancing, by a delivery system comprising a capsule portion housing the prosthetic heart valve, the prosthetic heart valve through a native blood vessel and in proximity to the native heart valve; and

implanting the prosthetic heart valve in the native heart valve,

wherein the native heart valve comprises a plurality of leaflets,

wherein the delivery system deploys the prosthetic heart valve such that the prosthetic heart valve grasps the plurality of leaflets of the native heart valve without directly attaching the prosthetic heart valve to a native annulus and/or without directly attaching to a native chord of the native heart valve,

wherein the prosthetic heart valve is axially stabilized within the native heart valve by grasping the plurality of leaflets of the native heart valve,

wherein the prosthetic heart valve moves within the native heart valve in response to alternating pressure differentials on either side of the native heart valve during cardiac cycles of the heart, and

wherein, after deployment, the delivery system is capable of repositioning the prosthetic heart valve within the native heart valve and/or retrieving the prosthetic heart valve into the capsule portion of the delivery system.

Assignments (1)

Continuity (3)

References Cited (81)