Mitral valve system

• US 8,070,802 B2
• Filed: 02/08/2008
• Issued: 12/06/2011
• Est. Priority Date: 02/23/2007
• Status: Active Grant

• Current Assignee: Endovalve, Inc. (Micro Interventional Devices, Inc.), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Original Assignee: Endovalve, Inc. (Micro Interventional Devices, Inc.), Trustees Of The University Of Pennsylvania (University of Pennsylvania)
• Inventors: Lamphere, David G., Nguyen, Tuan Anh, Herrmann, Howard C., Tomba, Todd C., Gorman, Robert C., Gorman, Joseph H. III
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US12/028,572
• Publication Number:
  US 20080221672A1
• Time in Patent Office: 1,397 Days
• Field of Search: 623/1.15, 623/1.36, 623/1.24, 623/1.26, 623/2.14, 623/2.18, 623/2.1, 623/2.12
• US Class Current: 623/2.14
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/008 paraboloidal

Abstract

Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via transcatheter techniques. The valve prosthesis may include a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. Each of the positioning elements defines respective proximal, intermediate, and distal tissue engaging regions cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure, including respective first, second, and third elongate tissue-piercing elements. The proximal, distal, and intermediate tissue-engaging regions are cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure so as to stabilize a position of the valve prosthesis with respect to the anatomical structure, including wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, at least one of the first, second, and third elongate tissue-piercing elements is pointed at least partially opposite the direction of blood flow, and at least another thereof is pointed at least partially along the direction of blood flow. The valve prosthesis may also include a skirt mounted with respect to the resilient ring for sealing a periphery of the valve prosthesis against a reverse flow of blood around the valve prosthesis.

Claims

1. A valve prosthesis, comprising:

a. a resilient ring;

b. a plurality of leaflet membranes mounted with respect to the resilient ring; and

c. a plurality of positioning elements movably mounted with respect to the resilient ring, each of the positioning elements defining a proximal tissue engaging region including a first elongate tissue-piercing element, a distal tissue engaging region spaced apart from the proximal tissue engaging region along a direction of blood flow through the valve prosthesis and including a second elongate tissue-piercing element, and an intermediate tissue engaging region disposed between the proximal and distal tissue engaging region and including a third elongate tissue-piercing element;

wherein the proximal, distal, and intermediate tissue-engaging regions are cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure so as to stabilize a position of the valve prosthesis with respect to the anatomical structure, including wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, at least one of the first, second, and third elongate tissue-piercing elements is pointed at least partially opposite the direction of blood flow, and at least another thereof is pointed at least partially along the direction of blood flow; and

wherein at least one of the proximal and distal tissue engaging regions further defines an arcuate surface for engaging the corresponding area of tissue so as to limit a depth to which the respective first or third elongate tissue-piercing element may become lodged therewithin.

2. The valve prosthesis according to claim 1, wherein at least one of the first and third elongate tissue-engaging elements is a fork tine.

3. The valve prosthesis according to claim 1, wherein the second elongate tissue-piercing element is chevron-shaped barb.

4. The valve prosthesis according to claim 1, wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, the first elongate tissue-piercing element is pointed at least partially opposite the direction of blood flow, and the second elongate tissue-piercing element is pointed at least partially along the direction of blood flow.

5. The valve prosthesis according to claim 1, wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, the third elongate tissue-piercing element is pointed at least partially opposite the direction of blood flow, and the second elongate tissue-piercing element is pointed at least partially along the direction of blood flow.

6. The valve prosthesis according to claim 1, wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, two of the first, second, and third elongate tissue-piercing elements are pointed at least partially opposite the direction of blood flow, and the other thereof is pointed at least partially along the direction of blood flow.

7. The valve prosthesis according to claim 1, wherein each of the plurality of positioning elements is adapted to substantially completely invert by rotating relative to the resilient ring between a first position in which the at least two of the first, second, and third elongate tissue-piercing elements point at least partially along the direction of blood flow for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which the at least two of the first, second, and third elongate tissue-piercing elements point at least partially opposite the direction of blood flow for engaging tissue.

8. The valve prosthesis according to claim 1, wherein the resilient ring includes multiple instances of a hoop segment defining a hoop plane and separated by a corresponding number of instances of gap within the hoop plane.

9. The valve prosthesis according to claim 1, wherein the resilient ring includes multiple instances of a hoop segment defining a hoop plane for coupling with a separate respective one of the plurality of leaflet membrane and a corresponding number of instances of a retainer for forming a separate respective interface between respective adjacent ones of the plurality of leaflet membranes.

10. The valve prosthesis according to claim 1, wherein the resilient ring defines a circular or elliptical peripheral geometry.

11. The valve prosthesis according to claim 1, wherein the resilient ring is adapted to be implanted with respect to a diseased heart valve such that the first tissue-piercing element lodges within tissue associated with an annulus of the diseased heart valve, and the second tissue-piercing element lodges within tissue associated with a leaflet of the diseased heart valve.

12. The valve prosthesis according to claim 1, further comprising a skirt mounted with respect to the resilient ring for at least partially sealing against a reverse flow of blood around a periphery of the valve prosthesis.

13. A valve prosthesis comprising:

a. a resilient ring;

b. a plurality of leaflet membranes mounted with respect to the resilient ring; and

c. a plurality of positioning elements movably mounted with respect to the resilient ring, each of the positioning elements defining a proximal tissue engaging region including a first elongate tissue-piercing element, a distal tissue engaging region spaced apart from the proximal tissue engaging region along a direction of blood flow through the valve prosthesis and including a second elongate tissue-piercing element, and an intermediate tissue engaging region disposed between the proximal and distal tissue engaging region and including a third elongate tissue-piercing element;

wherein the proximal, distal, and intermediate tissue-engaging regions are cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure so as to stabilize a position of the valve prosthesis with respect to the anatomical structure, including wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, at least one of the first, second, and third elongate tissue-piercing elements is pointed at least partially opposite the direction of blood flow, and at least another thereof is pointed at least partially along the direction of blood flow;

a hub disposed substantially centrally with respect to a peripheral geometry of the resilient ring, and

a plurality of legs directed radially with respect to the resilient ring and mounted with respect to (i) the hub and (ii) a corresponding positioning element of the plurality thereof.

14. The valve prosthesis according to claim 13, wherein at least one leg of the plurality of legs is mounted with respect to the positioning element such that the positioning element is substantially rotationally fixed with respect to the leg.

15. The valve prosthesis according to claim 13, wherein at least one leg of the plurality of legs includes an intermediate joint and corresponding leg lengths extending from the joint for allowing the leg to collapse against itself for facilitating positioning of the valve prosthesis within a delivery catheter.

16. A valve prosthesis comprising:

a. a resilient ring;

b. a plurality of leaflet membranes mounted with respect to the resilient ring; and

c. a plurality of positioning elements movably mounted with respect to the resilient ring, each of the positioning elements defining a proximal tissue engaging region including a first elongate tissue-piercing element, a distal tissue engaging region spaced apart from the proximal tissue engaging region along a direction of blood flow through the valve prosthesis and including a second elongate tissue-piercing element, and an intermediate tissue engaging region disposed between the proximal and distal tissue engaging region and including a third elongate tissue-piercing element;

wherein the proximal, distal, and intermediate tissue-engaging regions are cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure so as to stabilize a position of the valve prosthesis with respect to the anatomical structure, including wherein for purposes of so simultaneously engaging the separate corresponding areas of tissue, at least one of the first, second, and third elongate tissue-piercing elements is pointed at least partially opposite the direction of blood flow, and at least another thereof is pointed at least partially along the direction of blood flow; and

wherein each positioning element of the plurality thereof includes a pair of apertures for permitting the positioning element to be releasably engaged by a corresponding filament looped through the apertures of the pair thereof for remotely controlling a rotational position of the positioning element during implantation of the valve prosthesis.