Valve prosthesis systems and methods

• US 7,753,949 B2
• Filed: 10/10/2007
• Issued: 07/13/2010
• 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: Nguyen, Tuan Anh, Lamphere, David G., Herrmann, Howard C.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US11/869,972
• Publication Number:
  US 20080208332A1
• Time in Patent Office: 1,007 Days
• Field of Search: 623/2.11, 623/1.24, 623/1.26, 623/2.1, 623/1.15, 623 236- 242, 623 212- 235
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments

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 trans-catheter techniques, and may be positioned/repositioned until proper alignment and positioning is achieved. 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 defining a first tissue engaging region and a second tissue engaging region spaced from the first tissue engaging region. The positioning elements are adapted to substantially completely invert by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed for engaging tissue. The valve prosthesis may also include a valve skirt mounted with respect to the resilient ring.

Claims

1. A valve prosthesis, comprising:

a. a resilient ring defining an annular opening;

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 first tissue engaging region, a connecting region, and a second tissue engaging region spaced from the first tissue engaging region, wherein the connecting region connects the first and second tissue engaging regions;

wherein each positioning element of the plurality of positioning elements is inverted by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed towards the annular opening for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed towards an anatomical wall for engaging tissue; and

wherein each positioning element of the plurality of positioning elements is inverted by rotating in a first direction away from the first position and toward and into the second position to define an inversion plane.

2. The valve prosthesis according to claim 1, wherein each of the first and second tissue engaging regions defines a tissue engaging arc.

3. The valve prosthesis according to claim 1, wherein each of the first and second tissue engaging regions defines a plurality of tissue engaging spikes.

4. The valve prosthesis according to claim 1, wherein each of the first and second tissue engaging regions defines a plurality of tissue engaging teeth.

5. The valve prosthesis according to claim 1, wherein the positioning elements are resilient and are adapted to resiliently deflect to engage tissue disposed between the first and second tissue engaging regions.

6. The valve prosthesis according to claim 5, wherein each of the positioning elements defines a V shape, and the first and second tissue engaging regions form respective opposing flexible arms of the V shape for engaging a tissue disposed between the opposing flexible arms.

7. The valve prosthesis according to claim 5, wherein each of the positioning elements defines a set of spaced jaws adapted to move with respect to each other, and the first and second tissue engaging regions are defined by respective opposing jaw portions directed toward each other for engaging tissue disposed therebetween.

8. The valve prosthesis according to claim 1, wherein at least one of the first and second tissue engaging regions defines a resilient coil, wherein the resilient coil is adapted to be uncoiled as against a coiling bias to permit an outwardly directed end of the uncoiled coil to engage tissue.

9. The valve prosthesis according to claim 1, wherein each of the positioning elements includes a third tissue engaging region disposed between the first and second tissue engaging region thereof that is outwardly facing in the second position.

10. The valve prosthesis according to claim 9, wherein the third tissue engaging region defines a plurality of tissue engaging holes.

11. The valve prosthesis according to claim 9, wherein the third tissue engaging region defines a plurality of tissue engaging spikes.

12. The valve prosthesis according to claim 9, wherein the third tissue engaging region defines a plurality of tissue engaging holes and a plurality of tissue engaging spikes.

13. 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 a gap within the hoop plane.

14. The valve prosthesis according to claim 1, wherein the resilient ring includes multiple instances of a hoop segment defining a hoop plane and a corresponding number of instances of a coupling segment extending vertically relative to the hoop plane.

15. The valve prosthesis according to claim 1, wherein the resilient ring includes multiple instances of a hoop segment defining a hoop plane and a corresponding number of instances of a coupling segment, wherein each coupling segment includes a spring having two leaves joined at a bend region for imparting an elastic force on the hoop segments.

16. The valve prosthesis according to claim 1, wherein the resilient ring includes a plurality of suture-accommodating notches for use in securing a corresponding leaflet membrane of the plurality of leaflet membranes with respect thereto.

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

18. The valve prosthesis according to claim 1, wherein each positioning element of the plurality thereof is biased in favor of rotating away from the first position and toward the second position.

19. The valve prosthesis according to claim 1, wherein each positioning element of the plurality thereof is further adapted to be rotated further within the inversion plane in the first direction from the second position to a third position in which a distal one of the first and second tissue engaging elements is directed substantially downward for dilating obstructing tissue during a process of advancing the valve prosthesis downward into an anatomical annulus for implantation with respect thereto.

20. The valve prosthesis according to claim 19, wherein each positioning element of the plurality thereof is biased in favor of rotating away from the third position and toward the second position within the inversion plane when the positioning element is in the third position.

21. The valve prosthesis according to claim 19, further comprising 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, wherein each leg includes an intermediate joint and corresponding leg lengths extending from the joint for forming a spring to bias the positioning element away from the third position and back toward the second position when the positioning element is in the second position.

22. The valve prosthesis according to claim 21, further comprising a joint between the hub and each leg for forming an additional spring to bias the positioning element away from the third position and back toward the second position when the positioning element is in the second position.

23. The valve prosthesis according to claim 1, 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 urging the positioning element to rotate within a plane defined by the inversion.

24. The valve prosthesis according to claim 1, wherein the plurality of leaflet membranes are fabricated from a xenographic material.

25. The valve prosthesis according to claim 1, wherein the resilient ring is adapted to be implanted with respect to an anatomical annulus such that the first tissue engaging region engages tissue associated with a proximal portion of the anatomical annulus, and the second tissue engaging portion engages tissue associated with a distal portion of the anatomical annulus.

26. The valve prosthesis according to claim 1, further comprising a valve skirt mounted with respect to the resilient ring.

27. The valve prosthesis according to claim 26, wherein the valve skirt extends to an elevation below that of the resilient ring.

28. The valve prosthesis according to claim 27, wherein the valve skirt further extends to an elevation above that of the resilient ring.

29. The valve prosthesis according to claim 26, wherein the valve skirt defines a variable thickness.

30. The valve prosthesis according to claim 26, wherein the valve skirt defines a tapered thickness.

31. A valve prosthesis, comprising:

a. a resilient ring defining an annular opening;

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 first tissue engaging region, a connecting region, and a second tissue engaging region spaced from the first tissue engaging region, wherein the connecting region connects the first and second tissue engaging regions;

wherein each positioning element of the plurality of positioning elements is inverted by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed towards the annular opening for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed towards an anatomical wall for engaging tissue; and

wherein each positioning element of the plurality thereof is inverted at least in part by rotating outward and away from the first position, and toward and into the second position, in an overturning motion with respect to the resilient ring.

32. The valve prosthesis according to claim 31, further comprising 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.

33. The valve prosthesis according to claim 32, wherein the leg is mounted with respect to the positioning element such that the positioning element is substantially rotationally fixed with respect to the leg.

34. The valve prosthesis according to claim 32, wherein the leg includes an intermediate joint and corresponding leg lengths extending from the joint for allowing the leg to collapse against itself to facilitate the positioning element assuming the first position.

35. The valve prosthesis according to claim 32, wherein the leg includes an intermediate joint and corresponding leg lengths extending from the joint for forming a spring to bias the positioning element outward and away from the first position and toward the second position when the positioning element is in the first position.

36. The valve prosthesis according to claim 35, wherein the hub is disposed at an elevation below that of the resilient ring when the positioning element is in the first position and, upon the positioning element rotating away from the first position and into the second position, the hub shifts upward to an elevation even with or above that of the resilient ring.

37. The valve prosthesis according to claim 32, wherein the leg includes an intermediate joint and corresponding leg lengths extending from the joint for forming a spring to bias the positioning element away from the second position and back toward the first position when the positioning element is in the second position.

38. The valve prosthesis according to claim 37, further comprising a joint between the hub and the leg for forming a second spring to bias the positioning element away from the second position and back toward the first position when the positioning element is in the second position.

39. The valve prosthesis according to claim 32, wherein the leg includes an intermediate joint and corresponding leg lengths extending from the joint for forming a spring to bias the positioning element either outward and away from the first position and toward the second position, or away from the second position and back toward the first position, depending on whether the positioning element is in the first position or the second position, respectively.

40. A valve prosthesis, comprising:

a. a resilient ring defining an annular opening;

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 first tissue engaging region, a connecting region, and a second tissue engaging region spaced from the first tissue engaging region, wherein the connecting region connects the first and second tissue engaging regions;

wherein each positioning element of the plurality of positioning elements is inverted by rotating relative to the resilient ring between a first position in which each of the first and second tissue engaging regions is inwardly directed towards the annular opening for facilitating positioning of the valve prosthesis within a delivery catheter, and a second position in which each of the first and second tissue engaging regions is outwardly directed towards an anatomical wall for engaging tissue; and

wherein at least the resilient ring and each positioning element of the plurality thereof are adapted to be collapsed to an extent sufficient to permit the same to be lodged together in a catheter lumen of 26 French or less.