Actively Controllable Heart Valve Implant and Method of Controlling Same

• US 20160367360A1
• Filed: 06/22/2016
• Published: 12/22/2016
• Est. Priority Date: 06/22/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Greene, James L., Cartledge, Richard, Deville, Derek Dee, Smith, Kevin W., Jimenez, Jorge
• Granted Patent: US 10,226,335 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A mitral valve implant includes a force-expanding mitral valve lattice having an interior orifice and a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice. The mitral valve lattice is self-expandable to a first configuration and force expandable from the first configuration to a second configuration. The configurations can be circular or D-shaped. The mitral valve lattice comprises jack screws adjusting configurations of the mitral valve lattice. The valve trampoline has a cylindrical central region comprising valve leaflets. An outwardly flaring implant skirt is attached to the mitral valve lattice exterior. Wall-retaining wires are attached to the mitral valve lattice, are petal-shaped, and have a pre-set, radially outward, memory shape. The wires and skirt impart a force on a respective side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.

Claims

1. A mitral valve implant, comprising:

a force-expanding mitral valve lattice having an interior orifice; and

a self-expanding valve trampoline attached at the interior orifice of the force-expanding mitral valve lattice.

2. The implant according to claim 1, wherein the force-expanding mitral valve lattice is:

self-expandable to a first configuration; and

force-expandable from the first configuration to a second configuration.

3. The implant according to claim 2, wherein the first configuration is one of circular and D-shaped.

4. The implant according to claim 3, wherein the second configuration corresponds in shape to the one of circular and D-shaped first configuration.

5. The implant according to claim 1, wherein the mitral valve lattice comprises a plurality of jack screws configured to adjust a configuration of the mitral valve lattice.

6. The implant according to claim 1, wherein the mitral valve lattice is made of a shape memory material set shape to a given shape.

7. The implant according to claim 1, wherein the valve trampoline has a cylindrical central region comprising valve leaflets.

8. The implant according to claim 7, wherein the valve trampoline comprises a D-shaped portion.

9. The implant according to claim 8, wherein:

the valve leaflets have an inflow side; and

the D-shaped portion is located on an inflow side of the valve leaflets.

10. The implant according to claim 1, wherein the mitral valve lattice has an exterior and further comprising an outwardly flaring implant skirt attached to the exterior of the mitral valve lattice and shaped to be positioned on a side of a native mitral valve.

11. The implant according to claim 10, further comprising wall-retaining wires attached to the mitral valve lattice and shaped to be positioned on a side of the native mitral valve.

12. The implant according to claim 11, wherein the wall-retaining wires are in the shape of petals and have a pre-set, radially outward, memory shape to impart a force on the side of the native mitral valve when the mitral valve lattice is expanded within an annulus of the native mitral valve.

13. The implant according to claim 12, wherein:

the implant skirt is a left ventricle implant skirt shaped to be positioned on a ventricular side of the native mitral valve when the mitral valve lattice is expanded within the annulus of the native mitral valve; and

the wall-retaining wires are left-atrium wall-retaining wires shaped to be positioned on an atrial side of the native mitral valve when the mitral valve lattice is expanded within the annulus of the native mitral valve.

14. The implant according to claim 12, wherein:

the implant skirt is a left atrium implant skirt shaped to be positioned on an atrial side of the native mitral valve when the mitral valve lattice is expanded within the annulus of the native mitral valve; and

the wall-retaining wires are left-ventricle wall-retaining wires shaped to be positioned on a ventricular side of the native mitral valve when the mitral valve lattice is expanded within the annulus of the native mitral valve.

15. The implant according to claim 1, wherein:

the mitral valve lattice has an inlet end and an outlet end; and

the valve trampoline is attached to the inlet end of the interior orifice.

16. The implant according to claim 1, wherein:

the mitral valve lattice has an inlet end and an outlet end; and

the valve trampoline is attached to the outlet end of the interior orifice.

17. A mitral heart valve implant system, comprising:

a valve delivery system comprising;

a controller;

a guidewire lumen connected to the controller and having a distal nosecone;

a hollow external sheath surrounding the guidewire lumen, having a proximal end connected to the controller, and configured to retract proximally from an extended, valve-installed position;

a given number of implant drive wires each having a distal drive wire connector; and

hollow connector lumens equal in number to the given number and each;

respectively threaded on one of the drive wires; and

having a distal hollow connector sleeve;

a self-expanding and forcibly expanding mitral valve frame defining a central axis and comprising;

proximal and distal jack screw strut pairs equal in number to the given number and disposed parallel to the central axis;

intermediate struts equal in number to the given number and disposed parallel to the central axis, each intermediate strut disposed between two adjacent ones of the jack screw strut pairs;

arms respectively connecting adjacent ones of the jack screw strut pairs and the intermediate struts; and

a plurality of jack screws;

each rotatably connected to one jack screw strut pair;

forming, together with the jack screw strut pairs, the intermediate struts, and the arms, an adjustable stent lattice having a ventricle side and an atrial side;

configured to reversibly forcibly expand and contract the adjustable stent lattice between a compressed state and an enlarged state for implantation of the mitral valve frame into a native mitral valve; and

each having a driving connector shaped to removably mate and connect to the distal drive wire connector of one of the drive wires and be held connected thereto when the hollow connector sleeve is disposed about the mated driving connector and distal drive wire connector such that rotation of the drive wires correspondingly rotates the jack screws to forcibly expand or contract the adjustable stent lattice;

a self-expanding implant skirt attached to the ventricle side of the adjustable stent lattice, the implant skirt configured to compress and be stored inside the external sheath and, when released from the external sheath at a native mitral valve, to self-expand and sealably position on tissue at a ventricular side of the native mitral valve;

wall-retaining wires attached to the atrium side of the adjustable stent lattice and configured to compress and be stored inside the external sheath and, when released from the external sheath at a native mitral valve, to self-expand on tissue at an atrial side of the native mitral valve;

a self-expanding valve trampoline lattice disposed inside and connected to the adjustable stent lattice and comprising;

an expandable outer trampoline portion having a circumferential exterior connected to the interior of the adjustable stent lattice and a circumferential interior; and

an inner circumferential valve portion;

connected to the circumferential interior and extending inwardly from the circumferential interior to define an interior cylindrical portion; and

having a circular valve with internal valve leaflets disposed at the interior cylindrical portion.

18. The system according to claim 17, wherein:

the adjustable stent lattice has a pre-set D-shaped cross-section; and

the exterior of the expandable outer trampoline portion is pre-set to a circumferential D-shape.

19. The system according to claim 17, wherein the controller has a torque-determining device operatively associated with the drive wires, determining a torque applied to the drive wires when the drive wires are rotated, and indicating when rotation of the drive wires is to be stopped based upon a pre-set value of the determined torque.

20. A mitral heart valve implant system, comprising:

a mitral valve lattice having a pre-set D-shaped cross-sectional configuration, defining an internal orifice, and comprising a plurality of jack screws configured to forcibly expand and contract the mitral valve lattice reversibly between a compressed configuration and an enlarged configuration;

an outwardly flaring, self-expanding implant skirt attached to an exterior of the mitral valve lattice, the implant skirt shaped to be positioned on a ventricular side of a native mitral valve to secure the mitral valve lattice in the annulus of the native mitral valve;

radially outwardly biased wall-retaining wires attached to the mitral valve lattice and shaped to be positioned on an atrial side of the native mitral valve to secure the mitral valve lattice in the annulus of the native mitral valve;

a self-expanding valve trampoline lattice containing interior valve leaflets, the valve trampoline lattice disposed within the internal orifice of the mitral valve lattice and having a D-shape portion attached to the mitral valve lattice and a substantially cylindrical interior portion, wherein the valve leaflets are attached to the substantially cylindrical interior portion; and

a delivery system comprising a plurality of implant drive wires temporarily connectable to the jack screws such that, when connected, rotation of the drive wires in one direction forcibly expands the mitral valve lattice towards the enlarged configuration and rotation of the drive wires in a direction opposite the one direction forcibly contracts the mitral valve lattice towards the compressed configuration.

21. A method for implanting a mitral heart valve, which comprises:

contracting a self-expanding and forcibly-expanding mitral valve of a shape-memory material set to a given shape to a reduced implantation size with a delivery system having drive wires, the mitral valve having an adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the mitral valve occurs;

inserting the contracted mitral valve into a native mitral valve annulus in which the mitral valve is to be implanted;

rotating the drive wires with the delivery system to forcibly expand the mitral valve into the native annulus;

while rotating the drive wires, determining with the delivery system a torque applied to the drive wires; and

stopping rotation of the drive wires based upon a value of the determined torque.