Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis

• US 9,011,525 B2
• Filed: 02/25/2009
• Issued: 04/21/2015
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: The Florida International University Board of Trustees (State University System of Florida)
• Original Assignee: The Florida International University Board of Trustees (State University System of Florida)
• Inventors: Claiborne, Thomas E. III, Schoephoerster, Richard T., Gallocher, Siobhain L.
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US12/864,166
• Publication Number:
  US 20110295361A1
• Time in Patent Office: 2,246 Days
• Field of Search: 623/2.15, 623/2.19
• US Class Current: 623/2.14
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0023 triangular

Abstract

A heart valve prosthesis includes a collapsible stent and a one-piece multi-leaflet valve. The stent includes at least one length of wire having a series of turns forming a spring-like stent. The one-piece multi-leaflet valve is attached to the stent and includes a cylinder of polyester material secured thereto at three points. The stent is collapsible in a radial direction between a contracted state and an expanded state. The contracted state has a radial dimension smaller than a radial dimension of the expanded state. The stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart. The active state has a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart.

Claims

1. A heart valve prosthesis, comprising:

a collapsible stent comprising a plurality of separate lengths of wire secured together with a plurality of sutures, each length of wire having a series of turns, wherein each length of wire is formed in the shape of a cylinder and axially overlaps with another length of wire of the plurality of lengths of wire such that a first length of the plurality of separate lengths of wire circumscribes a second length of the plurality of separate lengths of wire; and

a one-piece multi-leaflet valve attached to the collapsible stent, the one-piece multi-leaflet valve comprising a cylinder of material secured to the collapsible stent at three points;

wherein the stent is collapsible in a radial direction between a contracted state and an expanded state, the contracted state having a radial dimension smaller than a radial dimension of the expanded state,

wherein the stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart, the active state having a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart,

wherein the series of turns in the plurality of separate lengths of wire define a plurality of alternating peaks, around which a cylindrical cuff of the one-piece multi-leaflet valve is wrapped, the cylindrical cuff for preventing regurgitation during use of the valve.

2. The heart valve prosthesis of claim 1, wherein, each of the first and second lengths of wire occupying a sinusoidal pattern.

3. The heart valve prosthesis of claim 2, wherein the first and second lengths of sinusoidal wires are disposed adjacent to each other and in opposite phase to provide structural integrity to the collapsible stent.

4. The heart valve prosthesis of claim 2, wherein the plurality of lengths of wire further comprises a third length of wire occupying a pattern of alternating bows and attached to the first and second lengths of wires at a location axially offset therefrom, the third length of wire serving to bias the collapsible stent into the expanded state.

5. The heart valve prosthesis of claim 1, further comprising surgical sutures connecting the one-piece multi-leaflet valve to the collapsible stent.

6. A heart valve prosthesis, comprising:

a collapsible stent comprising first and second lengths of wire, each of the first and second lengths of wire being a separate member occupying a wave pattern defining a plurality of alternating peaks and formed in the shape of a cylinder, the second length of wire positioned radially inside of the first length of wire and axially overlapping with the first length of wire such that the first length of wire circumscribes the second length of wire and, in combination, the first and second lengths of wire provide structural rigidity and integrity to the collapsible stent; and

a one-piece multi-leaflet valve attached to the collapsible stent, the one-piece multi-leaflet valve comprising a cylinder of material secured to the collapsible stent at three points and having a cylindrical cuff wrapped around the alternating peaks of the first and second lengths of wire, the cylindrical cuff for preventing regurgitation during use of the valve,

wherein the stent is collapsible in a radial direction between a contracted state and an expanded state, the contracted state having a radial dimension smaller than a radial dimension of the expanded state,

wherein the stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart, the active state having a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart.

7. The heart valve prosthesis of claim 6, wherein the first and second lengths of wire occupy sinusoidal patterns defining the plurality of peaks and also defining a plurality of valleys, the sinusoidal patterns of the first and second lengths of wire being disposed approximately opposite in phase to each other to provide structural integrity to the collapsible stent.

8. The heart valve prosthesis of claim 7, wherein the collapsible stent further comprises a third length of wire occupying a pattern of alternating bows and attached to the first and second lengths of wires at a location axially offset therefrom.

9. The heart valve prosthesis of claim 6, wherein the first and second lengths of wire are secured together with a plurality of sutures.

10. The heart valve prosthesis of claim 6, further comprising surgical sutures connecting the one-piece multi-leaflet valve to the collapsible stent.

11. A heart valve prosthesis, comprising:

a collapsible stent comprising first, second, and third lengths of wire,

the first and second lengths of wire being separate members formed in the shape of cylinders and occupying sinusoidal patterns defining a plurality of peaks and valleys, the sinusoidal patterns of the first and second lengths of wire being disposed approximately opposite in phase to each other,

the second length of wire positioned radially inside of the first length of wire and axially overlapping with the first length of wire such that the first length of wire circumscribes the second length of wire,

the third length of wire being a separate member from the first and second lengths of wire and occupying a wave pattern of alternating peaks and troughs, each peak and each trough including a bow defined by a small loop of wire extending away from the corresponding peak or trough, the third length of wire attached to the first and second lengths of wires at a location axially offset therefrom; and

a one-piece multi-leaflet valve attached to the collapsible stent, the one-piece multi-leaflet valve comprising a cylinder of material secured to the collapsible stent and having a cylindrical cuff wrapped around the alternating peaks of the first and second lengths of wire, the cylindrical cuff for preventing regurgitation during use of the valve,

wherein the stent is collapsible in a radial direction between a contracted state and an expanded state, the contracted state having a radial dimension smaller than a radial dimension of the expanded state,

wherein the stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart, the active state having a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart.