System and method for assembling a folded percutaneous valve

• US 9,642,702 B2
• Filed: 05/14/2013
• Issued: 05/09/2017
• 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 LAUREN
• Application Number:
  US13/894,293
• Publication Number:
  US 20130310917A1
• Time in Patent Office: 1,456 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, said plurality of valve leaflets attached to said valve frame;

wherein said valve frame comprises a first ring member, a second ring member and a plurality of masts connected to and disposed between said first and second ring members, wherein one of said plurality of masts is a longitudinally split mast having a first mast half and a second mast half;

wherein said valve frame has a folded unassembled delivery configuration and is assembled into a working configuration after deployment from a delivery device;

wherein said first and second ring members are substantially collinear with said masts in said folded unassembled delivery configuration.

2. The valve module of claim 1, wherein said valve leaflets are attached to said first ring member and suspended from said second ring member.

3. The valve module of claim 1, wherein said valve leaflets are attached to said first ring member and suspended from said plurality of masts.

4. 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.

5. The valve module of claim 4, wherein said second material is Dacron.

6. The valve module of claim 1, wherein said first ring member is wider than said second ring member along a longitudinal axis of said working configuration valve module.

7. The valve module of claim 1, wherein said connections between said plurality of masts and said first and second ring members are pivot points.

8. The valve module of claim 7, wherein said pivot points are S-shaped.

9. The valve module of claim 7, wherein said pivot points comprise a horseshoe connection and diagonal connection.

10. The valve module of claim 1, wherein said folded unassembled delivery configuration comprises said valve leaflets and said substantially collinear first and second ring members and plurality of masts are spirally wound around a guide wire.

11. The valve module of claim 1, wherein said valve frame further comprises a plurality of wire guides.

12. A modular percutaneous valve device comprising the valve module of any one of claims 1-11, 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 support module in said expanded working configuration.

13. The modular valve device of claim 12, 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.

14. The modular valve device of claim 13, wherein at least one of said spears includes a spearhead at said first end and a spear cross at said second end.

15. The modular valve device of claim 13, wherein at least one complementary shaft and spear comprises a ring shaft and a hybrid spear.

16. The modular valve device of claim 13, 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.

17. The modular valve device of claim 13, wherein at least one complementary shaft and spear comprises a ring shaft having a first internal diameter, a shaft having a second internal diameter, and a one-sided hybrid spear.

18. The modular valve device of claim 13, wherein said shafts are located on said masts of said valve frame and said spears are located on said support module, each spear aligned with one of said plurality of masts.

19. The modular valve device of claim 13, wherein said first mast half of said valve frame includes a first shaft, said second mast half includes a second shaft, said first shaft located proximal of said second shaft along a longitudinal axis of said valve module, said first and second shafts designed to lock to a single corresponding spear on said support module.

20. A system for deploying the percutaneous modular valve device of any one of claims 12-19, comprising:

a delivery device;

a plurality of assembly wires; and

a plurality of pusher members;

wherein each assembly wire is threaded through one of said pusher members, and said valve module and support module in said delivery configurations.

21. The system of claim 20, wherein said valve frame includes said plurality of wire guides, said wire guides comprising a plurality of first wire guides attached to said first ring member and a plurality of second wire guides attached to said second ring member, said assembly wire threaded through said first and second wire guides.

22. The system of claim 20, wherein said complementary locking members are selected from the group consisting of:

(a) shaft and spear, (b) ring shaft and hybrid spear, (c) first ring shaft having a first diameter, second ring shaft having a second diameter and single groove hybrid spear, and (d) combinations thereof;

wherein said shafts, ring shafts, and first and second ring shafts are located on said masts of said valve frame and said spears are located on said support module, each spear, hybrid spear and single groove-hybrid spear having an eyelet at said first end, said assembly wire threaded through said eyelet.

23. A method of assembling a modular percutaneous valve device using the system of any one of claims 20-22, the method including:

deploying said support module from said delivery device;

deploying said folded unassembled valve module from said delivery device;

sliding said valve module along said assembly wires into said support module using said pusher members; and

locking said valve module within said support module to form a working configuration valve module.

24. The method of claim 23, further comprising:

guiding each of said plurality of shafts over said complementary spears using said pusher members to lock said valve module to said support module.

25. The method of claim 24, wherein one of said plurality of masts is a split mast having a first mast half and a second mast half, said first mast half having a first shaft, said second mast half having a second shaft, said first shaft located proximal of said second shaft along a longitudinal axis of said valve module, said first and second shafts designed to connect to a single complementary spear;

wherein said guiding step includes guiding said first and second shafts of said split mast over said corresponding spear to close said first and second ring members to lock closed said working configuration valve module.

26. A modular percutaneous valve device comprising:

a valve module, said valve module including a valve frame and a plurality of valve leaflets attached thereto, said valve frame including at least one ring member and a plurality of masts connected thereto, wherein said valve module has a folded unassembled delivery configuration and an assembled working configuration, each ring member having a substantially straight delivery configuration with a first end and a second end;

wherein in said folded unassembled delivery configuration each ring member extends in the same general direction as said plurality of masts, said plurality of masts substantially orthogonal to said ring member in said assembled working configuration;

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

a plurality of sets of locking members designed to lock said valve module to said expanded support module, each set of locking members comprising a spear and a corresponding shaft having a lumen, wherein said spear has a first spear end and a second spear end, and a spearhead at said first spear end, said spearhead including an eyelet and an elongated aperture; and

a plurality of wire guides located on said ring member.

27. The valve device of claim 26, wherein said at least one ring member comprises a first ring member and a second ring member, said plurality of masts disposed therebetween, and said valve leaflets are attached to said first ring member and suspended from said second ring member.

28. The valve device of claim 26, wherein said valve leaflets are attached to a first ring member and suspended from said plurality of masts.

29. The valve device of claim 26, wherein one of said plurality of masts includes a split mast having a first mast half connected to said first end of said ring member and a second mast half connected to said second end of said ring member.

30. The valve device of claim 26, 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.

31. The valve device of claim 26, wherein said spear further comprises a spear-cross at said second spear end, said corresponding shaft designed to lock between said spearhead and said spear-cross.

32. The valve device of claim 26, wherein said spear is a hybrid spear, wherein said spearhead further includes a groove;

and wherein said shaft comprises a ring shaft having lumenal diameter comparable to a width of said spearhead at said groove.

33. The valve device of claim 32, wherein said groove is located on only one side of said hybrid spear, said hybrid spear further comprising a stem;

and wherein said ring shaft comprises a first ring shaft having a first lumenal diameter comparable to a width of said spear at said stem and a second ring shaft having a second lumenal diameter comparable to said spearhead width at said groove.

34. The valve device of claim 32, wherein said groove is located on only one side of said hybrid spear, said hybrid spear further comprising a stem;

and wherein said shaft further comprises a first shaft and a second shaft, said first and second shaft having a first lumenal diameter comparable to a width of said spear at said stem, said ring shaft having a second lumenal diameter comparable to said spearhead width at said groove.

35. The valve device of claim 26, wherein one of said plurality of masts is a split mast having a first half connected to said first end of said ring member and a second half connected to said second end of said ring member, and wherein said first split mast half includes a first shaft, said second split mast half includes a second shaft, said first shaft located proximal of said second shaft along a longitudinal axis of said valve frame, said first and second shafts designed to lock to a single corresponding spear.

36. A system for deploying a percutaneous modular valve device, comprising:

the modular valve device of any one of claims 26-34, and 35;

a delivery device;

a plurality of pusher members; and

a plurality of assembly wires;

each assembly wire threaded through at least one of said plurality of pusher members, at least one of said wire guides and at least one of said eyelets, to guide said valve module to said support module by advancing said pusher member, at least one of said wire guides having a surface for said pusher member to exert force and engage said sets of first and second locking members.

37. A method of assembling a modular percutaneous valve device using the system of claim 36, the method including:

deploying said support module from said delivery device;

deploying said folded unassembled valve module from said delivery device;

guiding said valve module along said assembly wires into said support module using said pusher member; and

engaging said first and second locking member sets using said pushing member to close said valve module to form a working configuration valve module and lock said valve module within said support module.

38. The method of claim 37, wherein one of said plurality of masts is a split mast having a first half and a second half, said first split mast half having a first shaft, said second split mast half having a second shaft, said first shaft located proximal of said second shaft along a longitudinal axis of said valve module in the assembled working configuration, said first and second shafts designed to lock to a single corresponding spear;

wherein said guiding step includes guiding said first and second shafts of said split masts over said corresponding spear to close said at least one ring member.