MODULAR PERCUTANEOUS VALVE STRUCTURE AND DELIVERY METHOD

• US 20160361162A1
• Filed: 06/28/2016
• Published: 12/15/2016
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: RICHTER, Yoram, RICHTER, Jacob
• Granted Patent: US 10,517,718 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A modular prosthetic valve device for implantation in a patient and a system for and method of delivering such a modular valve device and assembling it in vivo are disclosed. The valve device is designed as two or more modules to be delivered unassembled, spatially separate, and combined into an assembled valve device in the body at or near the site of implantation. The valve device of the invention is deliverable as modules, providing a smaller delivery diameter than pre-assembled percutaneous valves, permitting use of a delivery device of reduced diameter, and increasing the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The modules of the valve device may be connected by pull wires for delivery sequentially, and then assembled by remote manipulation using the pull wires. Various locking mechanisms are provided for attaching the device modules together.

Claims

1. A modular prosthetic percutaneous valve device, comprising a plurality of device modules, said device modules including an expandable support structure and a valve module, wherein said support structure has a compressed, unexpanded delivery configuration spatially separate from said valve module, and said valve module has an unassembled delivery configuration, and said valve module is one of:

rolled along one axis or squashed to form said unassembled delivery configuration;

wherein said device modules are assembled into said valve device after deployment from a percutaneous delivery device, wherein said valve module is a one-piece valve module selected from the group consisting of;

a leaflets substructure, said leaflets substructure being one layer of material, and a leaflets-ring.

2. The valve device of claim 1, wherein said valve module has an apex-base aspect, a circumferential axis and a height axis, and, to form said unassembled delivery configuration, is rolled in a manner selected from the group consisting of:

from apex to base, around said circumferential axis in the direction of said height axis, around said height axis in the direction of said circumferential axis, and overlapping.

3. The valve device of claim 1, wherein said valve module includes a leaflets substructure having first and second locking members which interlock in the deployment configuration.

4. The valve device of claim 3, wherein said first locking member is formed on a first edge of said leaflets substructure and said second locking member is formed on a second edge of said leaflets substructure.

5. The valve device of claim 3, wherein said first locking member is formed on an inner surface of a first end of the leaflets substructure and said second locking members is formed on an outer surface of a second end of the leaflets substructure, wherein the leaflets substructure is partially overlapped in the deployment configuration.

6. The valve device of claim 1, wherein said valve module includes a plurality of valve sections, each valve section having first and second locking members, wherein a first locking member of a first one of the plurality of valve sections interlocks with a second locking member of an adjacent one of the plurality of valve sections in the deployment configuration.

7. The valve device of claim 6, wherein said first locking member is formed on a first edge of each of the valve sections and said second locking member is formed on a second edge of each of the valve sections.

8. The valve device of claim 6, wherein said first locking member is formed on an inner surface of a first end of each of the valve sections and said second locking members is formed on an outer surface of each of the valve sections.

9. The valve device of claim 3 or 6, wherein the locking mechanism is a one of a curvilinear groove mechanism or a zip-lock mechanism.

10. The valve device of claim 3 or 6, further comprising a pull-wire.

11. The valve device of claim 3 or 6, further comprising a push-rod.

12. The valve device of claim 1, further comprising a self-assembly member.

13. The valve device of claim 1, wherein the leaflets-ring is plastically deformable.

14. A modular percutaneous prosthetic valve device, comprising a plurality of device modules, said device modules including a valve module, said valve module having an unassembled configuration and a folded, unassembled delivery configuration for mounting in a delivery device, wherein said unassembled valve module is one of (a) rolled along one axis or (b) squashed to form a flattened configuration and rolled along one axis to form said folded unassembled configuration;

wherein said valve module is assembled into a working configuration and said device modules are assembled into said valve device after deployment from a percutaneous delivery device;

wherein said valve module has an apex-base aspect, a circumferential axis and a height axis and, to form said folded unassembled delivery configuration, is rolled in a manner selected from the group consisting of;

from apex to base and from base to apex.

15. The valve device of claim 14, wherein the valve module comprises a plastically deformable member having a straight delivery configuration, the plastically deformable member being adapted to assist in transforming the valve module to as assembled working configuration.

16. The valve device of claim 15, wherein the plastically deformable member is a linear component.

17. The valve device of claim 15, wherein the plastically deformable member is a ring-shaped component, the ring-shaped component having bent ends which hold the valve module in the flattened configuration.

18. The valve device of claim 14, further comprising one or more of a pull wire, a push-rod and a balloon-catheter to assist in transforming the valve module to the assembled working configuration.

19. The valve device of claim 14, wherein said device modules into an expandable support structure, wherein said support structure has a compressed, unexpanded delivery configuration spatially separate from said valve module.

20. A method of assembling a modular percutaneous valve device using a system comprising a percutaneous delivery device containing a plurality of spatially separate device modules each in a delivery configuration, wherein said device modules include an expandable support structure and a valve module, said support structure having a compressed, unexpanded delivery configuration, said valve module having an unassembled delivery configuration formed by one of:

rolling said valve module along one axis, said valve module comprising an apex-base aspect, a circumferential axis and a height axis or by squashing said valve module, the method comprising;

deploying said device modules from said delivery device to form an expanded support structure;

unfolding said valve module to form a working configuration valve component; and

combining said expanded support structure and working configuration valve component to form said valve device.

21. The method of claim 20, wherein said unassembled delivery configuration has been formed by rolling said valve module in a manner selected from the group consisting of:

from apex to base, around said circumferential axis in the direction of said height axis, around said height axis in the direction of said circumferential axis, and overlapping.

22. The method of claim 21, wherein said working configuration valve component is formed outside said support structure.

23. The method of claim 20, wherein said system further comprises one or more pull wires, said one or more pull wires connecting said device modules;

said assembling step further including;

forming said working configuration valve component using said pull wires.

24. The method of claim 20, wherein said system further comprises push-rods;

said method further comprising;

combining said device modules using said push rods.

25. The method of claim 20 or 23, wherein said system further comprises push-rods;

said method further comprising;

forming said working configuration valve component using said push rods.

26. An apparatus for adjusting the position of a valve member of a percutaneous valve device, comprising:

a first adjustment structure located on said valve member; and

a second adjustment structure located on a device frame, wherein said first adjustment structure fits together in a complementary manner with said second adjustment structure, said second adjustment structure having a plurality of positions at least along a longitudinal axis of the valve device to control the relative movement between said valve member and said device frame after delivery and deployment from a percutaneous delivery device.

27. The apparatus of claim 26, wherein said percutaneous valve device has a first compressed configuration for percutaneous delivery and a second expanded configuration as a working configuration.

28. The apparatus of claim 27, wherein said second adjustment structure fits together with said first adjustment structure in said second expanded configuration.

29. The apparatus of claim 26, further comprising a locking mechanism.

30. The apparatus of claim 29, wherein the valve member further comprises a plurality of device modules and said locking mechanism is not integral to said plurality of device modules.

31. The apparatus of claim 30, wherein the locking mechanism comprises a pin having a head at one end and a radially enlarged portion at a second end.

32. The apparatus of claim 31, wherein the radially enlarged portion is selected from the group consisting of:

first and second prongs, pegs, rivets and stud-and-tube connectors.

33. The apparatus of claim 31, wherein the first adjustment structure includes a plurality of first openings and the second adjustment structure includes a plurality of second openings, wherein the first and second openings are brought into longitudinal alignment with one another to lockingly receive the pin therethrough.

34. The apparatus of claim 33, wherein the first openings are formed on a pin tab formed on a base of the valve member.

35. The apparatus of claim 34, wherein the base is selected from the group consisting of:

a self-assembly member and plastically deformable ring.

36. A method of adjusting the position of a valve member of a percutaneous valve device comprising:

providing a percutaneous valve device, said valve device comprising a first adjustment structure located on said valve member and a second adjustment structure located on a device frame, wherein said first adjustment structure fits together in a complementary manner with said second adjustment structure;

adjusting a position of said valve member relative to a position of said device frame via said first and second adjustment structures, wherein said first and second adjustment structures cooperate in a complementary manner to control the relative movement between said valve member and said device frame; and

selecting one position from a plurality of positions between said valve member and said device frame along a longitudinal axis of said valve device after delivery and deployment from a percutaneous delivery device.

37. A method according to claim 36, wherein said method further comprises locking said valve member and said device frame together using a locking mechanism, wherein the locking mechanism is a pin having a head at one end and a radially enlarged portion at a second end.

38. A system for assembling a modular prosthetic percutaneous valve device into a unitary valve, comprising:

a valve device comprising a plurality of device modules, said device modules including an expandable support structure and a valve module, wherein said support structure has a compressed, unexpanded delivery configuration spatially separate from said valve module prior to delivery, said valve module having an unexpanded delivery configuration;

wherein said device modules are assembled into said unitary valve device after deployment from a percutaneous delivery device; and

a pull wire connecting the support structure to the valve module.

39. The system of claim 38, wherein the valve module is a one-piece valve module selected from the group consisting of:

a leaflets substructure, said leaflets substructure being one layer of material, and a leaflets-ring.

40. The system of claim 38, wherein the pull wire is threaded through the valve module and support structure.

41. The system of claim 40, further comprising a loop through which the pull wire is threaded.

42. A method of assembling a modular prosthetic percutaneous valve device into a unitary valve, said valve device comprising a plurality of device modules, said device modules including an expandable support structure and a valve module, said support structure and said valve module each having a compressed, unexpanded delivery configuration spatially separate from the other prior to delivery, said method comprising:

deploying said device modules to form an expanded support structure;

pulling a pull wire connecting the support structure to the valve module, said pulling causing the valve module to move distally into the expanded support structure; and

combining said expanded support structure and said valve module to form said unitary valve device.

43. The method of claim 42, wherein the valve module and support structure are delivered in tandem.

44. The method of claim 42, further comprising the step of adjusting a position of the valve module within the support structure via said pull wire.

45. The method of claim 42, wherein the pull wire is threaded through the valve module and support structure.

46. The method of claim 42, wherein the device modules are assembled into said valve device after deployment from a percutaneous delivery device.

47. The method of claim 42, wherein both free ends of the pull wire are pulled to move the valve module into the support structure.

48. The method of claim 42, further comprising the step of locking the valve module to the support structure.

49. The method of claim 42, further comprising the step of pulling one free end of the pull wire for removal.

50. The method of claim 42, wherein said valve module in said delivery configuration has a reduced outer profile.