Implantable device for use in the human and/or animal body to replace an organ valve

• US 9,655,721 B2
• Filed: 08/05/2013
• Issued: 05/23/2017
• Est. Priority Date: 08/15/2012
• Status: Active Grant

• Current Assignee: Pfm Medical AG
• Original Assignee: Pfm Medical AG
• Inventors: Freudenthal, Franz
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US14/421,638
• Publication Number:
  US 20150216653A1
• Time in Patent Office: 1,387 Days
• Field of Search: 623 124, 623 126, 623 214, 623 218
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

The invention relates to an implantable device for use in the human and/or animal body to replace an organ valve, comprising a main body having a first end and a second end, wherein the first end and the second each have an opening to provide a fluid connection through the main body between the first end and the second end; a first membrane element arranged inside or at one end of the main body, wherein the membrane element is formed in such a manner that it allows the fluid connection through the main body in a first flow direction and blocks the same in a second flow direction opposite the first flow direction; wherein the main body has a large ratio of length to transverse expansion along the longitudinal axis of the main body in a first operating state (primary form) and a smaller ratio of length to transverse expansion along the longitudinal axis of the main body in a second operating state (secondary form); and wherein the main body can be reversibly transferred from the secondary form to the primary form counter to elastic material forces by the application of a force; and wherein the main body is formed from a single wire-like element or from a plurality of wire-like elements connected to each other by means interlocking winding and/or twisting and/or weaving in the manner of a woven and/or layered fabric and/or net.

Claims

1. An implantable device for use in the human and/or animal body to replace an organ valve, comprising:

a main body having a first end and a second end, wherein the first end and the second end each have an opening to provide a fluid connection through the main body between the first end and the second end;

a first membrane element arranged inside or at one end of the main body, wherein the membrane element is formed in such a manner that it allows the fluid connection through the main body in a first flow direction and blocks the same in a second flow direction opposite the first flow direction;

wherein the main body has a large ratio of length to transverse expansion along the longitudinal axis of the main body in a first operating state (primary form) and a smaller ratio of length to transverse expansion a long the longitudinal axis of the main body in a second operating state (secondary form); and

wherein the main body can be reversibly transferred from the secondary form to the primary form counter to elastic material forces by the application of a force;

wherein the main body is formed from a single wire-like element or from a plurality of wire-like elements connected to each other by means of interlocking winding and/or twisting and/or weaving in the manner of a woven and/or layered fabric and/or net;

wherein the implantable device is formed stent-like, wherein the first end and/or the second end is folded on each other to a double-layer in the second operating state (secondary form);

wherein the implantable device has sections with different material thickness;

wherein the implantable device has areas of different rigidity; and

wherein the areas of different rigidity are formed by differently interlocking winding and/or twisting and/or weaving or by a wire-like element with different cross-sections, particularly round, oval and/or polygonal.

2. The implantable device according to claim 1, wherein the double-layer of the first end and/or the second end is formed by a backfolding into the implantable device and/or outwardly onto the implantable device.

3. The implantable device according to claim 1, wherein the main body has in the second operating state (secondary form) at the first end and/or second end at least one radially outwardly of the main body extending anchoring member for anchoring the device in a organ and/or in a vessel.

4. The implantable device according to claim 3, wherein the at least one radially outwardly of the main body extending anchoring member is circumferentially provided at the circumference of the main body at the first end and/or second end.

5. The implantable device according to claim 4, wherein an area with lesser rigidity is located between areas with higher rigidity.

6. The implantable device according to claim 5, wherein the area with lesser rigidity is located at the main body outside of the at least on anchoring member.

7. The implantable device according to claim 1, wherein the main body has at least one opening in its circumferential wall, to provide a fluid connection between the inner of the main body and a vessel of the human and/or animal body.

8. The implantable device according to claim 7, wherein the at least one opening has a diameter corresponding to a coronary artery.

9. The implantable device according to claim 8, wherein the main body has two openings in its circumferential wall, which in the implanted state of the device are arranged in such a way, that the two openings overlap with coronary arteries.

10. The implantable device according to claim 1, wherein the at least one opening in the circumferential wall of the main body is located outside of the at least one anchoring member.

11. The implantable device according to claim 1, wherein the at least one opening in the circumferential wall of the main body is built by a further winding and/or twisting and/or weaving of the single wire-like element of the main body, wherein by the further winding and/or twisting and/or weaving of the single wire-like element of the main body in the area of the at least one opening in the circumferential wall of the main body a wider mesh size is achieved compared to the remaining parts of the circumferential wall of the main body.

12. The implantable device according to claim 1, wherein the implantable device comprises at least one radio-opaque marker, particularly in the form of a marker tag, marking or marker wire.

13. The implantable device according to claim 1, wherein the implantable device completely or partially consists of a shape memory material, particularly of Nitinol or a plastic with memory shape effect.

14. The implantable device according to claim 1, wherein the implantable device completely or partially consists of an absorbable material.

15. The implantable device according to claim 1, wherein the first membrane element consist of a synthetic or biological material, particularly of polyurethane.

16. The implantable device according to claim 1, wherein the first membrane element has a coating for establishing a biostability, particularly a titanium coating.

17. The implantable device according to claim 1, wherein the main body and the first membrane element are detachable or inseparable connected or connectable to each other, particularly by gluing, welding, sewing, fusing, dip-coating or another joining technology.

18. The implantable device according to claim 1, wherein the first membrane element has a ring portion and/or a valve portion connected to ring portion.

19. The implantable device according to claim 18, wherein the valve portion comprises three leaflet elements.

20. The implantable device according to claim 1, wherein the first membrane element is located in the second operating state (secondary form) at the first end of the main body, at the second end of the main body or between the first end and the second end of the main body, preferably centrally between the first end and the second end of the main body along the longitudinal axis of the main body.

21. The implantable device according to claim 1, wherein the main body has in the second operating state (secondary form) at the first end and/or at the second end at least a second membrane element, to partially close the opening at the first end and/or second end for fluids.

22. The implantable device according to claim 21, wherein the first membrane element and the second membrane element are located adjacent to each other at the first end of the main body or the second end of the main body.

23. The implantable device according to claim 1, wherein the implantable device is relocatable and/or explantable.

24. The implantable device according to claim 1, wherein the implantable device is in the second operating state (secondary form) between the first end and the second end of the main body at least partially, preferably completely, deformable in a radial direction, such that the main body can adapt to a vessel wall and/or circumference of an opening and/or edge of a defect organ valve.

25. The implantable device according to claim 1, wherein the multiple to each other connected wire-like elements consist of a single wire, a wire strand of at least two single wires and/or a multiple wire, particularly that the implantable device in areas with different rigidity consists of different wire-like elements, particularly of a single wire, a wire strand of at least two single wires and/or a multiple wire.

26. The implantable device according to claim 1, wherein the single wire-like element consists of a single wire, a wire strand of at least two single wires and/or a multiple wire.

27. The implantable device according to claim 1, wherein both ends of the wire-like element are located at the first end or the second end or in a side surface of the longitudinal main body.

28. The implantable device according to claim 1, wherein the at least one anchoring member is in the second operating state (Secondary form) disc-shaped or umbrella-shaped.

29. The implantable device according to claim 1, wherein the at least one or a further anchoring member is bulgy and/or curved.

30. The implantable device according to claim 1, wherein the main body in the second operating state (secondary form) has two anchoring members each extending in radial direction of the main body.

31. The implantable device according to claim 30, wherein the first anchoring member is at the first end of the main body and the second anchoring member is at the second end of the main body.

32. The implantable device according to claim 30, wherein the main body has an intermediate member between the first anchoring member and the second anchoring member, which has a smaller diameter as the first anchoring member and the second anchoring member.

33. The implantable device according to claim 1, wherein the diameter of the two anchoring members is equal or different.

34. The implantable device according to claim 1, wherein the at least one anchoring member in the second operating state (secondary form) of the main body has a first sub-portion and a second sub-portion, wherein the first sub-portion extends in a radial direction of the main body outwardly and the second sub-portion is folded backwards in a radial direction of the main body inwardly or outwardly, particularly in such a way, that the first sub-portion and the second sub-portion are folded onto another to a double-layer.

35. The implantable device according to claim 1, wherein the at least one anchoring member is coiled in the second operating state (secondary form) of the main body, particularly helical.

36. The implantable device according to claim 34, wherein the backfolding or coiling of the at least one anchoring member is directed towards the middle of the main body or away from the middle of the main body.

37. The implantable device according to claim 1, wherein a rim area of the implantable device provides a reinforcement area.

38. The implantable device according to claim 1, wherein the first end and/or the second end of the main body has one or multiple slings or loops interlaced with each other and/or located adjacent to each other and/or intertwined with each other.

39. The implantable device according to claim 38, wherein the slings or loops form a regular rim.

40. The implantable device according to claim 38, wherein the slings or loops form a irregular rim.

41. The implantable device according to claim 40, wherein the irregular rim is formed by slings or loops of different sizes.

42. The implantable device according to claim 41, wherein the irregular rim is formed by slings or loops of two different sizes.

43. The implantable device according to claim 42, wherein the arrangement of slings or loops with different sizes is regular, for example one big sling or loops after three small slings or loops.

44. The implantable device according to claim 1, wherein the main body in the first operating state (primary form) is stent like.

45. The implantable device according to claim 1, wherein both ends of the wire-like element are connectable or connected to each other, particularly by using an additional element, by twisting, gluing, welding, soldering, or another joining technology.

46. The implantable device according to claim 1, wherein the implantable device has a round or oval cross-section in the first operating state (primary form).

47. The implantable device according to claim 1, wherein the implantable device in the second operating state (secondary form) has a round or oval cross-sections in areas where no anchoring members are located.

48. The implantable device according to claim 1, wherein the diameter of the implantable device in the second operating state (secondary form) in areas outside of the anchoring members is about 35 mm.

49. The implantable device according to claim 1, wherein the length of the implantable device in the second operating state (secondary form) is max 50 mm.

50. The implantable device according to claim 1, wherein the main body has one or multiple layers.

51. The implantable device according to claim 1, wherein the main body and the first membrane element are built integrally.