Self-expandable medical instrument for treating defects in a patient's heart

• US 8,062,355 B2
• Filed: 11/03/2006
• Issued: 11/22/2011
• Est. Priority Date: 11/04/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Figulla, Hans-Reiner, Ferrari, Markus
• Primary Examiner(s): Sweet; Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/592,369
• Publication Number:
  US 20070142906A1
• Time in Patent Office: 1,845 Days
• Field of Search: 623/1.3, 623/1.31, 623/1.24, 623/1.26, 623 21- 219
• US Class Current: 623/2.1
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

The invention relates to a self-expandable medical instrument (100) for treating defects in a patient'"'"'s heart, in particular for the transvascular implantation of a prosthetic heart valve (30), wherein the medical instrument (100) is introducible into the body of a patient in a minimally-invasive procedure using a catheter system (40) and comprises a stent (1) made of a flexible mesh (2) of thin wires or filaments (2′). In order to realize a positioning of medical instrument (100) in the patient'"'"'s heart which is as precise as possible and to securely anchor same there, it is provided for the stent (1) composed of the flexible mesh (2) to exhibit in the expanded state of the medical instrument (100) a distal retention area (10) with a laterally-inverted beaded portion (12) which is engageable in at least one pocket (51) of the patient'"'"'s defective heart valve (50), a proximal retention area (20), and a center area (15) positioned between the distal and the proximal retention area (10, 20).

Claims

1. A replacement valve for use within a human body comprising:

a valve component; and

a stent component comprising a first section having a first state during insertion of the stent component and a second, laterally-inverted inside-out state when deployed, a second section for housing the valve component, and a third section,

wherein the first section, when in the second, laterally inverted inside-out state, is configured to be positioned on a first side of a leaflet of a native valve radially outward of the leaflet and radially inward of a vessel wall when the third section is positioned on a second side of the native valve, opposite the first side, and

wherein the second section has a cross sectional size smaller than the cross sectional size of the first section and the cross sectional size of the third section.

2. The replacement valve of claim 1, wherein the stent component is further configured such that the second section is capable of engaging an annulus of the native valve.

3. The replacement valve of claim 1, wherein the valve component comprises a biological valve.

4. The replacement valve of claim 1, wherein the valve component comprises a synthetic valve.

5. The replacement valve of claim 1, wherein the stent component is self-expandable.

6. The replacement valve of claim 1, wherein the second section of the stent component follows a contour of the valve component.

7. The replacement valve of claim 1, wherein the stent component comprises a lattice structure comprising a plurality of cells and substantially all of the cells of the stent component are closed cells.

8. The replacement valve of claim 1, wherein the second section is formed from a plurality of independently bendable elements, wherein each bendable element comprises a bending deformation the location of which is determined by the lengths of an attached pair of struts.

9. The replacement valve of claim 1, wherein the first section, the second section, and the third section are positioned at different positions along a central axis of the stent component.

10. The replacement valve of claim 9, wherein the stent component is further configured such that at least a portion of the native valve is pressed against a vascular wall by the second section when the first section is positioned on the first side of the leaflet of the native valve radially outward of the leaflet and radially inward of the vessel wall.

11. The medical device of claim 9, wherein:

the stent component includes a collapsed state when being inserted into a patient and an expanded state when implanted.

12. A replacement valve for use within a human body comprising:

a valve component; and

a stent component comprising a first section, a second section having a first state during insertion of the stent component and a second, laterally-inverted inside-out state when deployed, and a third section,

wherein the first section comprises an annular groove, and at least a portion of the second section, when in the second, laterally inverted inside-out state, is configured to be positioned on a first side of a leaflet of a native valve radially outward of the leaflet and radially inward of a vessel wall when at least a portion of the third section is positioned on a second side of the native valve opposite the first side.

13. The replacement valve of claim 12, wherein the annular groove is configured to receive and secure circumferentially to an annulus of the native valve.

14. The replacement valve of claim 12, wherein the valve component comprises a biological valve.

15. The replacement valve of claim 12, wherein the valve component comprises a synthetic valve.

16. The replacement valve of claim 12, wherein the stent component is self-expandable.

17. The replacement valve of claim 12, wherein the second section of the stent component follows a contour of the valve component.

18. The replacement valve of claim 12, wherein the stent component comprises a lattice structure comprising a plurality of cells.

19. The replacement valve of claim 12, wherein the stent component includes a collapsed state when being inserted into a patient and an expanded state when implanted.

20. The replacement valve of claim 19, wherein the third section includes a laterally-inverted inside-out state when the stent component is in the expanded state.

21. The replacement valve of claim 19, wherein the stent component is configured to be inserted via a catheter, and the second section is configured to be expanded before the first section.

22. The replacement valve of claim 12, wherein the annular groove extends around the circumference of the stent and has a diameter less that the diameter of the second section and less than the diameter of the third section.

23. A medical device, comprising:

a valve component; and

a stent component, including;

a first portion supporting the valve component,

a second portion connected at a distal end of the first portion having a first state during insertion of the stent component and a second, laterally-inverted inside-out state when deployed, at least a part of the second portion, when in the second, laterally inverted inside-out state, configured to be positioned on a first side of a native valve radially outward of a valve leaflet and radially inward of a vessel wall, and

a third portion connected at a proximal end of the first portion, at least a part of the third portion configured to be positioned on a second side of the native valve, opposite the first side such that the valve leaflet is clamped by the part of the second portion positioned on the first side of the native valve and by the part of the third portion positioned on the second side of the native valve.

24. The medical device of claim 23, wherein the second portion forms the distalmost portion of the stent component, and the third portion forms the proximalmost portion of the stent component.

25. The medical device of claim 23, wherein the stent component is self-expandable.

26. The medical device of claim 23, wherein the valve component is includes a biological valve.

27. The medical device of claim 23, wherein the valve component includes a synthetic valve.

28. The medical device of claim 23, wherein the stent component includes a lattice structure comprising a plurality of expandable cells.

29. The medical device of claim 23, wherein:

the stent component includes a collapsed state when being inserted into a patient and an expanded state when implanted.

30. The medical device of claim 23, wherein the stent component is configured to be inserted into a patient via a catheter.

31. The medical device of claim 23, wherein the stent component is configured to be explanted from a patient via a catheter.

32. The medical device of claim 31, wherein the stent further includes an explantation element configured to be selectively engaged by the catheter to explant the stent component.

33. The medical device of claim 32, wherein the explantation element is a ring connected to the third portion.

34. A medical device, comprising:

a valve component; and

a stent component including a distal section having a first state during insertion of the stent component and a second, laterally-inverted inside-out state when deployed, proximal section, and a middle section disposed between the distal and proximal sections and supporting the valve component;

wherein a portion of the distal section, when in the second, laterally inverted inside-out state, is configured to be positioned on a first side of a native valve radially outward of a valve leaflet and radially inward of a vessel wall, a portion of the middle section is configured to be positioned within the annulus of the native valve, and a portion of the proximal section is configured to be positioned on a second side of the native valve, opposite the first side; and

wherein the valve leaflet is clamped by the portion of the distal section positioned on the first side of the native valve and by the portion of the proximal section positioned on the second side of the native valve.

35. The medical device of claim 34, wherein the stent component is configured to compress the native valve against a vascular wall.

36. The medical device of claim 34, wherein the middle section includes an annular groove.

37. The medical device of claim 34, wherein the stent component is self-expandable.

38. The medical device of claim 34, wherein the valve component includes a biological valve.

39. The medical device of claim 34, wherein the valve component includes a synthetic valve.

40. The medical device of claim 34, wherein the valve stent includes a lattice structure including a plurality of expandable cells.

41. The medical device of claim 34, wherein the middle section has a cross sectional size that is smaller than the cross sectional size of the distal and proximal sections.

42. The medical device of claim 34, wherein the stent component includes a collapsed state when being inserted into a patient and an expanded state when implanted.