System and method for assembling a folded percutaneous valve

• US 10,537,425 B2
• Filed: 04/05/2017
• Issued: 01/21/2020
• Est. Priority Date: 05/15/2012
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Weisz, Ety, Schwarz, Boaz, Reuven, Eran, Jassby, Eran, David, Yaron, Harel, Amir
• Primary Examiner(s): Fishback, Ashley L
• Application Number:
  US15/479,703
• Publication Number:
  US 20170202665A1
• Time in Patent Office: 1,021 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

The invention provides a multi-component (modular) percutaneous valve device that includes a valve module having valve leaflets and a valve frame. The valve frame includes one or more, for example two, ring members and a plurality of masts. Also provided is a valve frame having specially designed pivot points at the connection between masts and first and second ring members to assist folding the valve module and minimizing delivery diameter. The valve frame may also include wire guides to facilitate combining the valve module with a support module. The masts or a ring of the valve frame may also include locking members, such as shafts for closing the valve module and securing the valve module to the support module. The support module includes corresponding locking members, such as spears that align with the shafts on the valve module for assembly and locking the valve module to the support module.

Claims

1. A valve module for a percutaneous modular valve device, comprising:

a valve frame; and

a plurality of valve leaflets attached to said valve frame;

wherein said valve frame comprises a first ring member and a plurality of masts connected to and extending from said first ring member, wherein connections between said plurality of masts and said first ring member are pivot points;

wherein said valve frame has a folded unassembled delivery configuration and is designed to be assembled into a working configuration after deployment from a delivery device.

2. The valve module of claim 1, wherein one of said plurality of masts is a longitudinally split mast having a first mast half and a second mast half.

3. The valve module of claim 2, wherein said valve leaflets are attached to the longitudinally split mast and are not attached to the other masts.

4. The valve module of claim 1, wherein said valve leaflets are scrunched in said folded unassembled delivery configuration.

5. The valve module of claim 1, wherein said pivot points are contained in said plurality of masts.

6. The valve module of claim 1, wherein the valve frame further comprises a second ring member, said plurality of masts connected to said second ring member, said plurality of masts disposed between said first ring member and said second ring member, wherein connections between said plurality of masts and said second ring member are pivot points.

7. The valve module of claim 6, wherein said valve leaflets are attached to said first ring member and suspended from said second ring member.

8. The valve module of claim 7, wherein said valve leaflets are sewn to said first ring member.

9. The valve module of claim 7, further comprising a leaflet loop coupling said valve leaflets to said second ring member.

10. The valve module of claim 9, wherein said leaflet loop is formed of the same material as said valve leaflets.

11. The valve module of claim 6, wherein said first and second ring members are substantially linear in said folded unassembled delivery configuration.

12. The valve module of claim 6, wherein said first ring member is wider than said second ring member along a longitudinal axis of said working configuration valve module.

13. The modular valve of claim 6, wherein one or both of said first and second ring members comprises a wire guide.

14. The valve module of claim 1, wherein said valve frame is biased to said working configuration.

15. The valve module of claim 14, wherein said valve frame is formed of a shape-memory material.

16. The valve module of claim 1, wherein said valve leaflets comprise a first material and are attached to said valve frame via a sandwich attachment with a second material.

17. The valve module of claim 1, wherein said pivot points are selected from the group consisting of S-shaped and horseshoe shaped.

18. The valve module of claim 1, wherein said plurality of masts are spirally wound around a guide wire in said folded unassembled delivery configuration.

19. A modular percutaneous valve device comprising the valve module of any one of claims 1-18, further comprising:

a support module, said support module having a compressed delivery configuration and an expanded working configuration; and

a plurality of complementary locking members for locking said valve module and said expanded support module to one another.

20. The modular valve device of claim 19, wherein each of said complementary locking members comprises a spear and a shaft, said spear having a first end and a second end, said shaft fitting over said spear.

21. The modular valve device of claim 20, wherein at least one of said spears includes a spearhead at said first end and a spear cross at said second end.

22. The modular valve device of claim 21, wherein said spearhead has a shape selected from the group consisting of:

a diamond-shape, a rhombus, a trapezoid, a kite, a circle, a rectangle, an oval, an arrowhead, a sphere, an ovoid, and a bulb.

23. The modular valve device of claim 20, wherein at least one complementary shaft and spear comprises a ring shaft and a hybrid spear.

24. The modular valve device of claim 23, wherein the spear further comprises an eyelet on a free end thereof, the eyelet configured to receive an assembly wire therethrough.

25. A percutaneous modular valve device, comprising:

a valve frame comprising a first ring member and a plurality of masts;

a support module having a compressed delivery configuration and an expanded working configuration; and

a plurality of complementary locking members, wherein each of said complementary locking members comprises a spear located on said support module and a shaft located on a complementary mast of the plurality of masts of said valve frame, said shaft fitting over said spear to lock said valve frame and said support module to one another.

26. The modular valve device of claim 25, wherein at least one of said spears includes a spearhead at a first end and a spear cross at a second end.

27. The modular valve device of claim 25, wherein at least one complementary shaft and spear comprises a ring shaft and a hybrid spear.

28. The modular valve device of claim 25, wherein at least one complementary shaft and spear comprises a first ring shaft having a first internal diameter, a second ring shaft having a second internal diameter, and a one-sided hybrid spear.

29. The modular valve device of claim 25, wherein said valve frame further comprises a second ring member, said plurality of masts connected to and disposed between said first and second ring members.

30. The modular valve device of claim 29, wherein one of said plurality of masts is a longitudinally split mast having a first mast half and a second mast half, wherein said first mast half includes a first shaft and said second mast half includes a second shaft, said first shaft located proximal of said second shaft along a longitudinal axis of said valve frame.

31. The modular valve device of claim 25, wherein said spear is a hybrid spear comprising an elongated aperture extending therethrough and a first groove extending along a first side thereof, and wherein the shaft is a ring shaft.

32. The modular valve device of claim 31, wherein said hybrid spear comprises a second groove located on a second side thereof.

33. The modular valve device of claim 31, wherein said hybrid spear comprises a spear stop sized to prevent movement of the shaft therepast.