Implantable heart valve devices, mitral valve repair devices and associated systems and methods

• US 10,111,747 B2
• Filed: 05/20/2014
• Issued: 10/30/2018
• Est. Priority Date: 05/20/2013
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Gifford, III, Hanson
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US14/892,171
• Publication Number:
  US 20160089234A1
• Time in Patent Office: 1,624 Days
• Field of Search: None
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0025 : differing in roughness
• CPC Class Codes: A61F 2250/003 : differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0051 : differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61F 2250/0069 : Sealing means
• CPC Class Codes: A61F 2250/0096 : Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

Systems, devices and methods for repairing a native heart valve. In one embodiment, a repair device (100) for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle comprises a support (110) having a contracted configuration and an extended configuration. In the contracted configuration, the support is sized to be inserted under the posterior leaflet between a wall of the left ventricle and chordae tendineae. In the extended configuration, the support is configured to project anteriorly with respect to a posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet.

Claims

1. A heart valve repair device to treat a native valve of a patient, the repair device comprising:

a frame have a first end configured to be placed at least proximate a first commissure of the native valve, a second end configured to be placed at least proximate a second commissure of the native valve, and a curved region between the first and second ends; and

an extension unit coupled to the frame and expandable from a contracted configuration to an expanded configuration, wherein

the extension unit is configured to push at least a portion of a leaflet towards an opposing leaflet of the native valve when in the expanded configuration,

the extension unit includes a plurality of projections and depressions, and

the projections expand between and engage chordae tendineae attached to the leaflet,

wherein the heart valve repair device has a triangular or polygonal cross-section and is configured to engage a backside of the leaflet of the native heart valve so as to reposition the leaflet such that the leaflet at least partially coapts with the opposing leaflet of the native valve.

2. A repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, the repair device comprising:

a support having (a) a contracted configuration in which the support is sized to be inserted under the posterior leaflet between a posterior wall of the left ventricle and chordae tendineae and (b) an extended configuration in which the support projects anteriorly with respect to the posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet sufficiently to improve coaptation of the posterior and anterior leaflets,

wherein the support comprises a spine and an extension unit coupled to the spine, and wherein

the extension unit is expandable from the contracted configuration to the extended configuration,

the extension unit is configured to push the at least a portion of the posterior leaflet towards the anterior leaflet of the native mitral valve when in the extended configuration,

the extension unit includes a plurality of projections and depressions,

the extension unit is preformed to include the plurality of projections when in the extended configuration, and

the projections expand between and engage chordae tendineae attached to the posterior leaflet.

3. The repair device of claim 2 wherein the extension unit comprises an inflatable or fillable member.

4. The repair device of claim 2 wherein the extension unit is substantially more flexible than the spine in the contracted configuration.

5. The repair device of claim 2 wherein the spine has a longitudinal axis and the extension unit is configured to expand in a direction transverse to the longitudinal axis.

6. The repair device of claim 2 wherein the spine is curved in an unconstrained state and the extension unit is configured to expand in a radial direction relative to the spine.

7. The repair device of claim 2 wherein the extension unit comprises a flexible cover extending around the spine.

8. The repair device of claim 7 wherein the flexible cover is inflatable or fillable with a fluid.

9. The repair device of claim 2 wherein the extension unit includes at least one bladder configured to receive filler material, and wherein the extension unit is expandable with the filler material to form the plurality of projections when the repair device is in the extended configuration.

10. A repair device for repairing a native mitral valve having an anterior leaflet and a posterior leaflet between a left atrium and a left ventricle, the repair device comprising:

a support having (a) a contracted configuration in which the support is sized to be inserted under the posterior leaflet between a posterior wall of the left ventricle and chordae tendineae and (b) an extended configuration in which the support projects anteriorly with respect to the posterior wall of the left ventricle by a distance sufficient to position at least a portion of the posterior leaflet toward the anterior leaflet sufficiently to improve coaptation of the posterior and anterior leaflets,

wherein the support comprises a spine and an extension unit coupled to the spine, and wherein

the extension unit is expandable from the contracted configuration to the extended configuration,

the extension unit is configured to push the at least a portion of the posterior leaflet towards the anterior leaflet of the native mitral valve when in the extended configuration,

the extension unit includes a plurality of projections and depressions,

the projections expand between and engage chordae tendineae attached to the posterior leaflet; and

wherein the repair device has a triangular or polygonal cross-section.