SYSTEM AND METHOD FOR PLACING A PERCUTANEOUS VALVE DEVICE

• US 20100179648A1
• Filed: 01/12/2010
• Published: 07/15/2010
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: RICHTER, Jacob, RICHTER, Yoram
• Granted Patent: US 9,681,950 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2250/006 modular

Abstract

A system and process for placing a percutaneous valve device in a body lumen at the location of implantation is provided. The placement system and method are simple and enhance the accuracy of the placement of the valve device. Anchors and placement wires or sutures are used to fix the implantation target and guide the device to the implantation site. The system and method are applicable to pre-assembled percutaneous valve devices as well as a modular prosthetic valve device, which modular device is also provided. The modular valve device comprises two or more device modules and is designed to be delivered unassembled and then assembled in the body lumen at or near the site where implantation occurs. The device modules may be assembled before or after the implantation target is fixed with the anchor, and then placed using the placement system in a manner similar to how a pre-assembled percutaneous valve device may be placed in accordance with the invention.

Claims

1. A system comprising:

a prosthetic valve device;

an anchor; and

a delivery device.

2. The system of claim 1, wherein said anchor is selected from the group consisting of:

a button, a rivet-type device, a hook, and interconnecting geometries, and wherein said system further comprises a placement wire, wherein said placement wire is capable of being threaded through a portion of said valve device.

3. The system of claim 1, wherein said anchor is a leading suture, wherein said leading suture is capable of being threaded through a portion of said valve device.

4. The system of claim 1, wherein said prosthetic valve device comprises an anchor interface unit, and said anchor is an anchor docking apparatus, wherein said anchor interface unit and said anchor docking apparatus are designed to engage.

5. The system of claim 1, wherein said valve device is a modular valve device comprising a plurality of device modules, wherein the plurality of device modules are selected from the group consisting of:

a support structure and a plurality of valve sections; and

a support structure and a leaflets substructure.

6. A method of placing a prosthetic valve device in a body lumen in need thereof, comprising:

affixing an anchor in a body lumen at a location of valve implantation; and

positioning said prosthetic valve device at said location of valve implantation using said anchor.

7. The method of claim 6, wherein said anchor is connected to a placement wire, said method further comprising:

threading said placement wire through a portion of said valve device;

loading said valve device into a delivery device; and

guiding said threaded portion along said placement wire to said location of valve implantation.

8. The method of claim 7, wherein said threading step further includes threading said placement wire through a portion of a delivery system and attaching said placement wire thereto, said delivery system comprising a catheter and a device for facilitating expansion of said valve device

9. The method of claim 6, wherein said anchor is connected to a placement wire, said placement wire having been threaded through a portion of said valve device prior to loading said valve device into a delivery system;

wherein said positioning step includes guiding said threaded portion of said valve device along said placement wire to said location of valve implantation.

10. The method of claim 9, wherein said placement wire is threaded through a portion of said delivery system, said delivery system comprising a catheter and a device for facilitating expansion of said valve device.

11. The method of claim 6, wherein said anchors comprise leading sutures, said method further comprising:

threading said leading sutures through a portion of said valve device;

loading said valve device into a delivery system; and

wherein said positioning step includes guiding said threaded portion of said valve device along said leading sutures to said location of valve implantation.

12. The method of claim 6, wherein said anchor comprises leading sutures, said leading sutures having been threaded through a portion of said valve device prior to loading said valve device into a delivery system;

and

wherein said positioning step includes guiding said threaded portion of said valve device along said leading sutures to said location of valve implantation.

13. The method of claim 12, wherein said leading suture is threaded through a portion of said delivery system, said delivery system comprising a catheter and a device for facilitating expansion of said valve device.

14. The method of claim 7-13, comprising:

inserting percutaneously into said body lumen said delivery system containing said valve device;

advancing said delivery system to a deployment site; and

deploying said valve device into said lumen.

15. The method of claim 14, wherein said valve device is a modular valve device comprising a plurality of device modules, and wherein said plurality of device modules is selected from the group consisting of:

a support structure and a plurality of valve sections; and

a support structure and a leaflets substructure;

wherein said threaded portion of said valve device is located on said support structure.

16. The method of claim 6, wherein said anchor is attached to a placement wire, prior to loading said valve device into a device system said placement wire having been threaded through a portion of a component from the group consisting of:

said valve device where said valve device is a pre-assembled valve device;

a device module of said valve device where said valve device is a modular valve device;

a support structure of said valve device where said device module is a modular valve device;

a valve module of valve device where said valve device is a modular valve device;

a support structure and a valve module of said valve device where said valve device is a modular valve device;

said delivery system;

the method further comprising;

inserting percutaneously into said body lumen said delivery system containing said valve device;

advancing said delivery system to a deployment site; and

deploying said valve device into said lumen.

25. The method of claim 6, wherein said anchor is an anchor docking apparatus;

said method further comprising;

inserting percutaneously into said body lumen a delivery device containing a valve device comprising an anchor interface unit;

advancing said delivery device to said location of valve implantation; and

deploying said valve device from said delivery device;

wherein said positioning step includes engaging said anchor interface unit and said anchor docking apparatus.

26. The method of claim 25, wherein said valve device is a modular valve device comprising a support structure and a plurality of valve sections, said anchor interface unit being attached to said support structure;

said deploying step further comprising;

i) deploying said support structure so as to engage said anchor interface unit and said anchor docking apparatus and place said support structure at said location of valve implantation; and

ii) deploying said plurality of valve sections;

said method further comprising;

assembling said valve sections to form a valve assembly; and

combining said valve assembly and said support structure to form an assembled valve device.

27. The method of claim 25, wherein said valve device is a modular valve device comprising a support structure and a leaflet substructure, said anchor interface unit being attached to said support structure;

said deploying step further comprising;

i) deploying said support structure so as to engage said anchor interface unit and said anchor docking apparatus and place said support structure at said location of valve implantation; and

ii) deploying said leaflets substructure;

said method further comprising;

assembling said leaflets substructure into a valve component; and

combining said valve component and said support structure to form an assembled valve device.

17. A method of placing a prosthetic valve device in a body lumen in need thereof, comprising:

inserting percutaneously into said body lumen a first delivery device containing a valve device, an anchor and a placement wire, said placement wire being attached at one end to said anchor, said placement wire also being threaded through a portion of said valve device;

advancing said delivery device to location of valve implantation;

affixing said anchor to said location of valve implantation;

retracting said delivery device from said location of valve implantation to a site of deployment;

deploying said valve device; and

wherein said positioning step includes guiding said threaded portion of said valve device along said placement wire to said location of implantation.

18. The method of claim 17, wherein said valve device is a modular valve device comprising a plurality of device modules, wherein one of said device modules is a support structure and said threaded portion of said valve device is located on said support structure.

19. The method of claim 18, further comprising the step of assembling said device modules into an assembled valve device prior to said advancing step.

20. The method of claim 6 or 17, wherein said anchor is selected from the group consisting of:

a hook;

a button-type device;

a rivet-type device; and

interconnecting geometries.

21. The method of claim 6 or 17, wherein said body lumen is an aorta, and said affixing step includes attaching said anchor to an aorta wall.

22. The method of claim 6 or 17, wherein said body lumen is an aorta having native valve, said native valve comprising native valve leaflets having aortic surfaces;

and wherein said affixing step includes attaching said anchor to said aortic surfaces of said native valve leaflets.

23. The method of claim 6 or 17, wherein said body lumen is an aorta having native valve, said native valve comprising native valve leaflets having ventricular surfaces;

and wherein said affixing step includes attaching said anchor to said ventricular surfaces of said native valve leaflets.

24. The method of claim 6 or 17, further comprising:

securing said valve device to said location of valve implantation using at least in part said anchor.