Temporary valve and valve-filter

• US 10,595,980 B2
• Filed: 03/13/2014
• Issued: 03/24/2020
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Weisz, Ety, Schwarz, Boaz
• Primary Examiner(s): Schwiker, Katherine H
• Application Number:
  US14/207,844
• Publication Number:
  US 20140277096A1
• Time in Patent Office: 2,203 Days
• Field of Search: 606200
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A temporary percutaneous valve-filter device having valve portions non-porous to blood and filter portions non-porous to emboli but at least in part porous to blood. In one embodiment, the device has a substantially flat valve unit and a substantially flat filter unit. In another embodiment, the device has at least one open umbrella deployed configuration. In one aspect, the device has a unitary construction with one umbrella canopy with one or more filter areas with flaps allowing unidirectional blood flow. In another aspect, the device has a valve unit and filter unit, the umbrella canopies oriented in opposite directions, and the valve unit “closes” and opens to allow blood to flow to one direction. Also provided is a temporary valve system, including a core having an inverted delivery configuration and everted deployed configuration, that may be used with or without a filter unit, and a method of deployment.

Claims

1. A percutaneous temporary valve system for use in percutaneous cardiovascular procedures, comprising a temporary valve having a central core, and a sheath for containing and delivering said temporary valve and said central core;

said temporary valve comprising a valve body and a plurality of lines, each line of said plurality of lines connected at a first end to a rim of said valve body and at a second end to said central core;

said central core having an inverted delivery configuration and connected to said sheath.

2. The system of claim 1, further comprising a pusher.

3. The system of claim 1 or 2, wherein said central core includes a pushing surface.

4. The system of claim 1, wherein each of said temporary valve and said central core has an open center region.

5. The system of claim 1, wherein said sheath includes a filter unit.

6. The system of claim 1, wherein said temporary valve comprises a valve structure impermeable to blood and a filter structure permeable to blood but impermeable to emboli, said temporary valve designed for simultaneously regulating flow of blood and collecting emboli.

7. The system according to claim 6, wherein said valve structure and said filter structure are separate units.

8. The system according to claim 1, wherein said temporary valve has an inverted delivery configuration.

9. The system according to claim 8, wherein said temporary valve has an umbrella-shaped canopy.

10. A method of deploying a temporary valve comprising:

providing a sheath containing a temporary valve having a central core, said temporary valve comprising a valve body and plurality of lines, wherein said plurality of lines connects a peripheral rim of said valve body to said central core, and said central core has a folded delivery configuration forming a folded central core wherein said folded central core is inverted within said sheath and connected to said sheath;

pushing said folded central core and said temporary valve from said sheath using a pusher, while said sheath remains static; and

everting said central core into a deployed configuration, said temporary valve thereby assuming a deployed configuration.

11. The method of claim 10, wherein said central core comprises a shape memory material and said sheath constrains said central core in said delivery configuration.

12. The method of claim 10, wherein said sheath further contains a filter unit, said method including pushing said filter unit from said sheath to a deployed configuration, said filter unit located adjacent said valve body.

19. A system comprising the valve-filter device of any one of claims 12, 13, 14, 15, 16, and 17 and a first delivery device, said valve-filter device mounted in said first delivery device.

20. The system according to claim 19, further comprising a second delivery device and a percutaneous valve device for implantation in a blood vessel.

21. The system according to claim 20, wherein said first delivery device has a lumen having an internal diameter sufficiently large for said second delivery device to pass therethrough.

22. The system according to claim 20, further comprising a valve repair tool for repairing a native valve.

13. A percutaneous temporary valve-filter device for use in percutaneous cardiovascular procedures, comprising a valve structure impermeable to blood and a filter structure permeable to blood but impermeable to emboli, said valve-filter device designed for simultaneously regulating flow of blood and collecting emboli, said valve structure comprising a temporary valve having a central core, and a sheath for containing, delivering, and housing said temporary valve and said central core, said temporary valve comprising a valve body and a plurality of lines, each line of said plurality of lines connected at a first end to a rim of said valve body and at a second end to said central core;

said central core having an inverted delivery configuration and connected to said sheath.

14. The device according to claim 13, wherein said filter structure comprises a substantially flat portion.

15. The device according to claim 13, wherein said filter structure comprises an umbrella-shaped canopy;

said umbrella-shaped canopy having an apex, a base, an open shape in a deployed working configuration, and a closed shape in a delivery configuration, said base comprising a rim, said umbrella-shaped canopy having a convex surface and a concave surface in said deployed working configuration.

16. The device according to claim 13, wherein said filter structure has a porosity in a range of 10-2000 μ

m diameter.

17. The device according to claim 13, wherein said porosity is in a range of 50-500 μ

m diameter.

18. The device according to claim 13, wherein said porosity is in a range of 80-200 μ

m diameter.

23. The device according to claim 13, wherein said temporary valve has an inverted delivery configuration.

24. The device according to claim 23, wherein said temporary valve has an umbrella-shaped canopy.

25. The device according to claim 13, wherein said valve structure and said filter structure are separate units.

26. A method of deploying a temporary percutaneous valve-filter device for use in percutaneous cardiovascular procedures, comprising:

introducing into a vessel, a system comprising;

a valve-filter device mounted on a first delivery device having a lumen, said valve-filter device having a radially collapsed delivery configuration, said valve-filter device comprising;

a temporary valve having a central core, and said first delivery device for containing and delivering said temporary valve and said central core,

said temporary valve comprising a valve body and a plurality of lines, each line of said plurality of lines connected at a first end to a rim of said valve body and at a second end to said central core;

said central core having an inverted delivery configuration and connected to said first delivery device;

advancing said valve-filter device to a target site;

deploying said valve-filter device from said first delivery device; and

expanding radially said valve-filter device to a working configuration designed for simultaneously regulating flow of blood and collecting emboli.

27. The method of claim 26, wherein said system further comprises a second delivery device and a percutaneous valve device for implantation, said lumen of said first delivery device having an internal diameter sufficiently large for said second delivery device to pass therethrough, said method further comprising after said expanding:

extending said second delivery device through said first delivery device;

deploying and implanting said percutaneous valve device; and

retracting said second delivery device.

28. The method of claim 26, wherein said system further comprises a second delivery device and a percutaneous valve repair tool, said lumen of said first delivery device having an internal diameter sufficiently large for said second delivery device to pass therethrough, said method further comprising after said expanding:

extending said second delivery device through said first delivery device;

deploying said valve repair tool and repairing a native valve;

retracting said repair tool; and

retracting said second delivery device.