Catheter Deliverable Artificial Multi-Leaflet Heart Valve Prosthesis and Intravascular Delivery System for a Catheter Deliverable Heart Valve Prosthesis

• US 20110295361A1
• Filed: 02/25/2009
• Published: 12/01/2011
• 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: Schoephoerster, Richard T., Gallocher, Siobhain L., Claiborne, Thomas E. III
• Granted Patent: US 9,011,525 B2
• Time in Patent Office: Days
• US Class Current: 623/1.26
• 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 at least one length of wire, the wire having a series of turns forming a spring-like 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;

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.

2. The heart valve prosthesis of claim 1, wherein the one-piece multi-leaflet valve further comprises a cylindrical cuff wrapped around an end of the collapsible stent, the cylindrical cuff for preventing regurgitation during use of the valve.

3. The heart valve prosthesis of claim 1, wherein the one-piece multi-leaflet valve comprises a polymer.

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

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

6. The heart valve prosthesis of claim 5, wherein the 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.

7. The heart valve prosthesis of claim 5, 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, the third length of wire serving to bias the collapsible stent into the expanded state.

8. The heart valve prosthesis of claim 1, wherein the collapsible stent comprises a shape memory nickel titanium alloy.

9. The heart valve prosthesis of claim 1, wherein the collapsible stent occupies a generally tapered cylindrical shape at least when in the expanded state.

10. The heart valve prosthesis of claim 1, wherein the multi-leaflet valve comprises a trileaflet valve.

11. A system for intravascular delivery of a heart valve prosthesis, the system comprising:

a handle;

a flexible elongated sheath extending from the handle;

a cavity defined by an end of the elongated sheath that is disposed opposite the handle, the cavity adapted to contain a heart valve prosthesis during intravascular delivery of the heart valve prosthesis;

a tapered tip coupled to the end of the elongated sheath adjacent to the cavity, the tapered tip adapted to guide the elongated sheath during intravascular delivery of the heart valve prosthesis, the tapered tip and the elongated sheath being separable such that the heart valve prosthesis can be released from the cavity in the elongated sheath upon proper positioning of the heart valve prosthesis.

12. The system of claim 11, wherein the elongated sheath has an inner diameter of less than or equal to 7 mm and an outer diameter of less than or equal to 8 mm.

13. The system of claim 11, further comprising a string connected to the elongated sheath at a location adjacent the cavity and extending through the sheath to the handle such that a user can pull the string to bend the elongated sheath to facilitate navigation of the elongated sheath during intravascular delivery of the heart valve prosthesis.

14. The system of claim 11, further comprising a stop plug disposed in the elongated sheath adjacent the cavity, the stop plug preventing the heart valve prosthesis from traveling into the elongated sheath beyond the cavity.

15. The system of claim 11, wherein the elongated sheath is movable mounted to the handle such that movement of the sheath toward the handle separates the elongated sheath and the tapered tip.

16. A device for loading a collapsible heart valve prosthesis into a flexible elongated sheath of an intravascular heart valve delivery system, the device comprising:

a handle;

a pin rotatably mounted to the handle;

a loop of material having a first end fixed to the handle and a second end fixed to the pin, the loop of material adapted to receive a collapsible heart valve prosthesis in an expanded state, the pin rotatable relative to the handle to roll the web onto the pin thereby applying a radial force to collapse the collapsible heart valve prosthesis from the expanded state to a contracted state, wherein a radial dimension of the collapsible heart valve prosthesis in the contracted state is less than a radial dimension of the collapsible heart valve prosthesis in the expanded state such that the collapsible heart valve prosthesis in the contracted state can be loaded into the flexible elongated sheath of the intravascular heart valve delivery system.

17. The device of claim 16, wherein the pin comprises a slot formed therein and receiving the first end of the loop of material.