Devices, systems, and methods for supplementing, repairing or replacing a native heart valve leaflet

• US 9,610,161 B2
• Filed: 09/08/2011
• Issued: 04/04/2017
• Est. Priority Date: 09/20/2000
• Status: Expired due to Term

• Current Assignee: MVRx, Inc.
• Original Assignee: MVRx, Inc.
• Inventors: Macoviak, John A., Chang, Robert T., Rahdert, David A., Machold, Timothy R., Soss, Rick A.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/227,630
• Publication Number:
  US 20110319990A1
• Time in Patent Office: 2,035 Days
• Field of Search: 623 124, 623 126, 623 212, 623 214, 623 218
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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

Abstract

An implant for supplementing, repairing, or replacing a native heart valve leaflet or leaflets provides a scaffold, which defines a pseudo-annulus. The implant further has at least two struts in generally oppositely spaced apart positions on the scaffold. The scaffold can be placed in an elastically loaded condition in a heart with the struts engaging tissue at or near the leaflet commissures of a heart valve annulus, to reshape the annulus for leaflet coaptation. The implant further provides a neoleaflet element coupled to the scaffold within pseudo-annulus, to provide a one-way valve function.

Claims

1. An implant for supplementing, repairing, or replacing a native heart valve having an annulus and a leaflet or leaflets comprising:

a scaffold, at least a portion of the scaffold defining a pseudo-annulus, said pseudo-annulus having a circumference, the scaffold movable between an undeformed configuration and an elastically deformed condition by the application of external compressive force;

the implant further comprising at least two struts, said struts in generally oppositely spaced apart positions along the circumference of the pseudo-annulus and depending downwardly below the plane of the pseudo-annulus, said struts biased away from each other when said scaffold is placed in said elastically deformed condition wherein when said scaffold is in said elastically deformed condition the struts may be placed in said valve with said pseudo-annulus adjacent said annulus to urge said annulus in an outward direction;

the implant further comprising a neoleaflet element, said neoleaflet element comprising;

a bridge supported by the scaffold, said bridge overlaying less than the full diameter of the pseudo-annulus when said scaffold is in said undeformed configuration; and

a spanning material covering said bridge,

said neoleaflet element being located within the pseudo-annulus when said scaffold is in said undeformed configuration in a manner that will, alone or in conjunction with the native leaflets, allow fluid to flow through the pseudo-annulus in one direction, but obstruct fluid flow in the opposite direction to provide, alone or in conjunction with one or more native leaflets, a one-way valve function within the annulus.

2. An implant for supplementing, repairing, or replacing the leaflets or leaflet of a native heart valve, the native heart valve having an annulus, the implant comprising:

a scaffold, at least a portion of the scaffold defining a pseudo-annulus, the scaffold capable of moving from an elastically unloaded configuration to an elastically loaded configuration, in response to compression forces applied to said scaffold when said scaffold is in said elastically unloaded configuration, said scaffold is placed in said elastically loaded configuration has a spring constant which urges said scaffold toward said unloaded configuration, said scaffold defining a pseudo-annulus when in said unloaded configuration, said pseudo-annulus further having a circumference when in said unloaded configuration;

said implant further comprising at least two struts coupled to the scaffold generally opposite one another along said circumference when the scaffold is in the unloaded configuration, said struts having a distance from one another when attached to said scaffold that is greater than the maximum cross-annulus distance,

the implant further comprising a neoleaflet, said neoleaflet comprising;

a bridge sized and configured to overlay the space of at least a portion of a native heart valve, and said bridge overlaying less than the full diameter of the pseudo-annulus when said scaffold is in said elastically unloaded configuration;

and a spanning material covering said bridge;

said neoleaflet coupled to the elastic scaffold within the pseudo-annulus and being sized and shaped to occupy the space of at least a portion of one native heart valve leaflet to provide, alone or in conjunction with the native heart valve leaflets, a one-way valve function,

wherein, when the scaffold is placed in a chamber of the heart in the elastically unloaded condition and placed into the elastically loaded condition by application of compression forces to reduce the cross-strut distance, and simultaneously the struts are placed into engagement with tissue at or near the annulus, the implant will be held in place within the heart and will provide, alone or in conjunction with the native heart valves, a one-way valve function to the heart valve.

3. A heart valve structure for treating a human or animal heart having an annulus and leaflet commissures, the structure comprising

a scaffold defining a pseudo-annulus, the scaffold having an elastically loaded configuration and including struts for engaging tissue at or near the valve leaflet commissures to reshape the annulus for leaflet coaptation, said struts having a dependent leg attached to said pseudo-annulus and a longitudinal section, said longitudinal section at a spaced apart distance from said pseudo-annulus, the scaffold also including a single neoleaflet element within the pseudo-annulus to provide, alone or in conjunction with the native heart valves, a one-way valve function;

and

said neoleaflet element further comprising

a bridge supported by the scaffold, said bridge sized and configured to overlay the space of at least a portion of a native heart valve, said bridge extending less than the full diameter of said pseudo-annulus; and

a spanning material covering said bridge.