Implantable device

• US 20080262518A1
• Filed: 10/04/2007
• Published: 10/23/2008
• Est. Priority Date: 10/05/2006
• Status: Active Grant

• Current Assignee: Pfm Medical AG
• Original Assignee: Pfm Medical AG
• Inventors: Freudenthal, Franz
• Granted Patent: US 9,179,899 B2
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61L 31/08 Materials for coatings

Abstract

In an implantable device (1) for use in the human and/or animal body for closure or partial closure of defect openings (2), cavities, organ passages etc or for providing a defined communicating opening between walls, organs, cavities etc comprising a carrier structure (17) which in a primary form has a large ratio of length to transverse extent along an axis (x) and in a secondary form has a smaller ratio of length to transverse extent along the axis (x), wherein the carrier structure (17) has a proximal and a distal portion (10, 11) and is formed in the manner of a weft and/or mesh and/or layered cloth and/or gauze, at least the one portion (11) in the secondary form has a first part (14) facing outwardly away from the other portion (10) or towards same and a second part (13) which deploys first from the primary form into the secondary form and which is folded back in a direction towards the other portion (10) or inwardly on to the first part (14).

Claims

1. An implantable device (1) for use in the human and/or animal body for closure or partial closure of defect openings (2), cavities, organ passages etc or for providing a defined communicating opening between walls, organs, cavities etc comprising a carrier structure (17) which in a primary form has a large ratio of length to transverse extent along an axis (x) and in a secondary form has a smaller ratio of length to transverse extent along the axis (x), wherein the carrier structure (17) has a proximal and a distal portion (10, 11) and is formed in the manner of a weft and/or mesh and/or layered cloth and/or gauze,

characterised in that

at least the one portion (11) in the secondary form has a first part (14) facing outwardly away from the other portion (10) and a second part (13) which deploys first from the primary form into the secondary form and which is folded back in a direction towards the other portion (10) on to the first part (14).

2. An implantable device (1) as set forth in claim 1 characterised in that provided between the proximal and the distal portions (10, 11) is an intermediate portion (15) of a diameter which is reduced in relation to the proximal and the distal portions (10, 11).

3. An implantable device (1) as set forth in claim 1 characterised in that at least the one portion is of a substantially disk-shaped or bulging configuration at least in its edge region.

4. An implantable device (1) as set forth as set forth in claim 1 characterised in that the one portion is disk-shaped and the other portion is of a bulging configuration.

5. An implantable device (1) as set forth in claim 3 characterised in that the one portion has a carrier structure (17) with a substantially closed end.

6. An implantable device (1) as set forth in claim 4 characterised in that the substantially closed end is in the form of an end which is accommodated in a sleeve element and which brings together weft and/or layered cloth and/or mesh and/or gauze ends of the carrier structure (17).

19. An implantable device (1) as set forth in claim 1 characterised in that the implantable device (1) is shaped to be adapted to the configuration at an implantation location and the configuration is imparted thereto as the secondary form.

20. An implantable device (1) as set forth in claim 1 characterised in that the second part (13) which is folded back in the direction towards the other portion (10, 11) is narrow in the form of a peripherally extending thin edge.

21. An implantable device (1) as set forth in claim 1 characterised in that the diameter of the intermediate portion and/or the diameter of a through opening (16) extending through the implantable device (1) is predeterminably dimensioned for providing the defined communicating opening between walls, organs, cavities in a human and/or animal body.

22. An implantable device (1) as set forth in claim 1 characterised in that the second part (13) which is folded back in a direction towards the other portion (10, 11) extends to close to or to the intermediate portion (15) and in particular comes to bear thereagainst.

23. An implantable device (1) as set forth in claim 1 characterised in that the carrier structure (17) of the implantable device (1) comprises a shape memory material, in particular a metal or a metal alloy, in particular Nitinol, or a plastic material.

29. An implantable device (1) as set forth in claim 1 characterised in that the distal portion (11) of the implantable device (1) is deployable independently of the proximal portion (11) thereof.

30. An implantable device (1) as set forth in claim 1 characterised in that the implantable device (1) is formed from a single one or a plurality of wire-like elements (5).

31. An implantable device (1) as set forth in claim 30 characterised in that the at least one wire-like element (5) is of a round or flat cross-sectional shape or is of any combination of a flat and round cross-sectional shape.

32. An implantable device (1) as set forth in claim 30 characterised in that the ends of the one wire-like element (5) are woven together in the surface of the carrier structure (17).

33. An implantable device (1) as set forth in claim 31 characterised in that the carrier structure (17) of the implantable device (1) forms one or more loops (87) at the end.

34. An implantable device (1) as set forth in claim 33 characterised in that the loops (87) go into a twisted or interwoven portion (88), in the direction of the remaining part of the carrier structure (17).

44. An implantable device as set forth in claim 1 characterised in that the at least one portion (10, 11) of the carrier structure (17) is wound up in a helix-like configuration.

45. An implantable device (1) as set forth in claim 44 characterised in that both portions (10, 11) are wound up in a helix-like configuration.

46. An implantable device (1) as set forth in claim 44 characterised in that the at least one portion (11) which is wound up in a helix-like configuration has a plurality of parts (13, 133) facing towards the respective other portion (10) and a plurality of parts (14, 144) facing away from the other portion (10).

47. An implantable device (1) as set forth in claim 44 characterised in that the other portion (10) is of a different configuration from the portion (11) which is wound up in a helix-like configuration.

48. An implantable device (1) as set forth in claim 47 characterised in that the other portion (10) is of a substantially flat and/or partially bulging configuration and/or is of a curved configuration.

49. An implantable device (1) as set forth in claim 48 characterised in that the other portion (10) is provided with a through opening.

50. An implantable device (1) as set forth in claim 47 characterised in that the other portion (10) is substantially closed.

51. An implantable device (1) as set forth in claim 1 characterised in that the implantable device (1) is for implantation in relation to a persistent ductus arteriosus is of a hat-shaped configuration with at least one double-layer hat brim-shaped portion (26).

52. An implantable device (1) as set forth in claim 51 characterised in that the double-layer hat brim-shaped portion (26) is in the form of a portion (10) having at least two parts (13, 14) which are folded on to each other.

53. An implantable device (1) as set forth in claim 51 characterised in that the head part-shaped portion (27) of the implantable device (1), which portion is in opposite relationship to the hat brim-shaped portion (26), is turned over inwardly into the interior of the implantable device (1).

54. An implantable device (1) as set forth in claim 1 characterised in that at least the one portion (11) in the secondary form includes two parts (13, 14) of which the one is deployed first from the primary form into the secondary form and is folded in a direction away from the other portion (10) on to the second part (14) which is directed towards said other portion (10).

55. An implantable device (1) as set forth in claim 54 characterised in that the folded-over part (13) is folded back inwardly into the implantable device (1).

56. An ejection system for an implantable device (1) as set forth in claim 1 and ejecting the same in an implantation procedure, comprising at least one guide or ejection wire (40) and at least one holding wire (41),

characterised in that

the at least one ejection wire (40) is provided with a very thin tip.

57. An ejection system as set forth in claim 56 characterised in that the very thin tip is of a diameter of between about 0.1 and 0.3 mm.

58. An ejection system as set forth in claim 56 characterised in that the holding wire (41) forms at least one loop for passing the ejection wire (40) therethrough.

59. An ejection system as set forth in claim 58 characterised in that the holding wire (51), for fixing to the implantable device (1), can be threaded through end loops (87) of the carrier structure (17) of the implantable device (1).

60. An ejection system as set forth in claim 58 characterised in that the holding wire (41) can be threaded through a carrier ring (85) interconnecting end loops (87) of the implantable device (1).

61. An ejection system as set forth in claim 56 characterised in that the implantable device (1) is rotatable and floatable about the at least one ejection wire (40) and the at least one holding wire (41).

62. A method of ejecting an implantable device (1) at an implantation location in a human or animal body using an ejection system as set forth in claim 56 characterised in that

at one holding wire (41) is threaded through loops (87) arranged at the end on a carrier structure (17) of the implantable device (1) and/or a carrier ring (85) connecting loops (87) arranged at the end on a carrier structure (17) of the implantable device (1) and an end loop is formed on the holding wire,

an ejection wire (40) is threaded through the end loop of the holding wire (41) and the implantable device (1) and the holding wire (41) is thereby fixed to the ejection wire (40),

the ejection wire (40) together with the implantable device (1) is advanced through a catheter (23) along the ejection wire (40) together with the holding wire (41) to the implantation location and the implantable device (1) is deployed there,

for ejection of the implantable device (1) the ejection wire (40) is pulled back in the proximal direction and pulled out of the end loop of the holding wire (41), and

the holding wire is pulled out of the loops (87) of the implantable device (1) and pulled back through the catheter.

63. A method as set forth in claim 62 characterised in that the ejection wire (40) and the holding wire (41) are arranged in a sheathing element (42) within the catheter (23) to facilitate the advance movement.

64. A method of deploying the implantable device as set forth in claim 1 from a primary form into a secondary form,

characterised in that

a) the implantable device (1) is arranged in an elongate primary form in a catheter (23),

b) the implantable device (1) is pushed out of the catheter (23) in order to deploy into its secondary form with a low ratio of length to transverse extent,

c) a part (13), which is pushed first out of the catheter (23), of a first portion (11) of the implantable device (1) is deployed and when a further part (14) adjacent thereto of the portion (11) of the implantable device (1) is pushed out of the catheter (23) is folded rearwardly in a direction towards the catheter (23), and

d) the implantable device (1) is completely deployed upon being further pushed out of the catheter (23).

65. A method as set forth in claim 64 characterised in that the part (13) which folds rearwardly in a direction towards the catheter (23) is folded substantially flat on to the other part (14).

66. A method as set forth in claim 64 characterised in that the part (13) which folds rearwardly in a direction towards the catheter (23) is wound up in a helix-like configuration around itself.

67. A method as set forth in claim 64 characterised in that in step d) when the implantable device (1) is further pushed out of the catheter (23) an intermediate portion (15) of the implantable device (1) of a diameter which is reduced in relation to the first portion (11) is deployed.

7. An implantable device (1) for use in the human and/or animal body for the closure or partial closure of defect openings (2), cavities, organ passages etc comprising a carrier structure (17) which can be reproducibly converted from a primary form into a secondary form which is imparted thereto, wherein the carrier structure (17) has a proximal and a distal portion (10, 11) and is formed in the manner of a weft and/or mesh and/or layered cloth and/or gauze and wherein the one portion is of an outwardly opening form and the other portion is of a bulging closed form, closed in particular by a sleeve element,

characterised in that

the portion (11) provided with the opened form has at least two parts (13, 14) which are folded on to each other.

8. An implantable device (1) as set forth in claim 7 characterised in that at least one membrane element (4) is provided in the region of the proximal and/or distal portion (10, 11) and/or between the proximal and distal portions (10, 11).

9. An implantable device (1) as set forth in claim 8 characterised in that the membrane element (4) is fixed to the weft, mesh, layered cloth or gauze of the carrier structure (17) of the implantable device (1).

10. An implantable device (1) as set forth in claim 8 characterised in that the fixing between the membrane element (4) and the carrier structure (17) is provided by sewing in the region of the outer edge (18) of the carrier structure.

11. An implantable device (1) as set forth in claim 8 characterised in that the fixing of the membrane element (4) to the carrier structure (17) is provided by looping around an edge of the membrane element (4) and edge loops of the carrier structure (17) with a thread-like element (19) and the provision of at least one knotting at an edge loop of the carrier structure (17).

12. An implantable device (1) as set forth in claim 8 characterised in that the dimensions of the membrane element (4) approximately correspond to those of a defect opening (2) to be closed.

13. An implantable device (1) as set forth in claim 8 characterised in that the membrane element (4) is so dimensioned and fixed to the implantable device (1) that the membrane element (4) in the secondary form of the implantable device (1) substantially completely covers it over and in particular substantially completely covers over the distal portion (11).

14. An implantable device (1) as set forth in claim 7 characterised in that the weft and/or gauze and/or mesh and/or layered cloth of the carrier structure (17) of the implantable device is so dense that the carrier structure (17) acts as a membrane element.

15. An implantable device (1) as set forth in claim 7 characterised in that the implantable device (1) is of a concentric or eccentric form.

16. An implantable device (1) as set forth in claim 7 characterised in that the carrier structure (17) of the implantable device (1) automatically adapts to the configuration at an implantation location.

17. An implantable device (1) as set forth in claim 16 characterised in that the carrier structure (17) automatically adapts to the configuration of an implantation location with the at least one part (13) of the one portion (11), which part is folded back in the direction towards the other portion (10) in the secondary form.

18. An implantable device (1) as set forth in claim 16 characterised in that the carrier structure (17) is adapted to or is designed to be adaptable to the implantation location in any direction in which it extends.

24. An implantable device (1) as set forth in claim 8 characterised in that the membrane element (4) comprises a plastic material, in particular polyester.

25. An implantable device (1) as set forth in claim 8 characterised in that at least one of the surfaces of the implantable device (1), in particular of the carrier structure (17) and/or of the membrane element (4), is coated or treated with at least one functional material.

26. An implantable device (1) as set forth in claim 25 characterised in that the functional material is selected from the group consisting of inorganic materials, ceramic materials, synthetic polymers, human biopolymers, medication coatings, medication-liberating polymers, biomolecules, functional groups and genetic materials.

27. An implantable device (1) as set forth in claim 26 characterised in that the functional material is selected from the group consisting of gold, biogold, diamond-like carbon (DLC), diamond-like nanocomposite (DLN), iridium oxide, nanoporous Al₂O₃, silicon carbide, hydroxylapatite, titanium nitrite oxide, poly(2-chloro-p-xylylene), polybutylmethacrylate, phosphorylcholine, polyethylene, polyethylene vinylacetate, polyhexymethacrylate, poly[bis](trifluoroethoxy)phosphazene, polytetrafluoroethylene, polyurethane, collagen, chondroitin sulfate, elastin, fibrin, hydraluronic acid, abciximab, heparin, paclitaxel, abciximab-liberating cellulose, angiopeptin-liberating phosphorylcholine, DNA-liberating polyethylene vinylacetate or polybutylmethacrylate, a medication-liberating or substance-liberating poly(L-lactide), paclitaxel or hirudin or iloprost-liberating polylactide, viral vector-liberating polylactide-phosphorylcholine, forskolin-liberating polyurethane and stem cells.

28. An implantable device (1) as set forth in claim 25 characterised in that the at least one surface of the implantable device (1) is treated by plasma treatment, a PVD process, a CVD process, ion implantation, sputtering, an ion beam process, a laser process, a thermal process, spin coating, dip coating, etching or electropolishing.

35. An implantable device as set forth in claim 7 characterised in that the carrier structure (17) of the implantable device (1) has twisted wire-like elements (5) which are woven together or interlaced or mutually twisted portions of wire-like elements (5) which are woven through each other at intersection points individually or in the form of twisted elements.

36. An implantable device as set forth in claim 7 characterised in that the carrier structure (17) is formed from at least one wire-like element (5) in a single-layer, double-layer or multi-layer configuration.

37. An implantable device (1) as set forth in claim 36 characterised in that the carrier structure (17) is formed of individual layers or strata comprised of the same material.

38. An implantable device (1) as set forth in claim 36 characterised in that the carrier structure (17) is formed of individual layers or strata comprised of different materials.

39. An implantable device (1) as set forth in claim 37 characterised in that at least one of the layers comprises Nitinol, at least one of the layers comprises polyester and at least one of the layers comprises PTFE.

40. An implantable device (1) as set forth in claim 37 characterised in that at least one membrane element (4) is arranged between at least two layers of the carrier structure (17).

41. An implantable device as set forth in claim 7 characterised in that there is provided at least one element (52) as a marker for visually indicating the implantable device (1) under a monitoring apparatus during an implantation procedure.

42. An implantable device (1) as set forth in claim 41 characterised in that the at least one element (52) is a microspiral provided at the edge (18) on the implantable device (1).

43. An implantable device (1) as set forth in claim 41 characterised in that the at least one element (52) comprises an X-ray-visible material, in particular a material containing between 70 and 90% platinum and between 30 and 10% iridium.