Method and apparatus for fine adjustment of a percutaneous valve structure

• US 8,998,982 B2
• Filed: 01/12/2010
• Issued: 04/07/2015
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Richter, Jacob, Weisz, Ety
• Primary Examiner(s): Snow, Bruce E
• Assistant Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US12/686,340
• Publication Number:
  US 20100179649A1
• Time in Patent Office: 1,911 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.17, 623/2.18
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• 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

Abstract

The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

Claims

1. 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 valve member and said device frame together make up said valve device, said percutaneous valve device having a first configuration for percutaneous delivery and a second configuration as a working configuration; and

wherein said first adjustment structure has a configuration that fits together in a complementary manner with a configuration on said second adjustment structure to control the relative movement between the valve member and device frame and select one position from a plurality of positions along a longitudinal axis of said valve device between said valve member and said device frame in said second configuration after delivery and deployment from a percutaneous delivery device.

2. The apparatus of claim 1, wherein said first and second adjustment structures are selected from the group consisting of:

buttons and harbors;

snap-fit pads and openings;

ring and ratchet post;

angular ribs and angular grooves;

helix rail and rollers; and

helix groove and protrusions.

3. The apparatus of claim 1, further comprising a position-maintaining means.

4. The apparatus of claim 1, wherein said valve device is a modular valve device, said valve member is a valve module, and said device frame is a stent;

and wherein said valve module and said stent are configured for assembly into said valve device after deployment from a delivery device.

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

providing a delivery device containing a percutaneous valve device, said valve device comprising a first adjustment structure on said valve member and a second adjustment structure on a device frame, wherein said valve member and said device frame together make up said valve device, said percutaneous valve device having a first configuration for percutaneous delivery and a second configuration as a working configuration, and wherein said first adjustment structure has a configuration that fits with a configuration on said second adjustment structure in a complementary manner to permit controlled relative movement between the valve member and device frame;

deploying said valve device from said delivery device and expanding said valve device to form said second configuration;

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

6. The method of claim 5, wherein said valve device is a modular valve device, said valve member is a valve module, and said device frame is a support structure;

wherein said deploying step includes deploying said valve module and deploying said support structure;

said method further comprising assembling said valve module and said support structure into said valve device.

7. The method of claim 5, wherein said valve device further comprises a position-maintaining means, said method further comprising:

locking said first and second adjustment structures together via said position-maintaining means.

8. The method of claim 5, wherein said device further comprises a pull wire;

said method comprising using said pull wire to adjust said position of said valve member relative to said device frame.

9. The method of claim 6, wherein said method further comprises locking said valve module and said stent together using a locking mechanism.

10. 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 valve member and said device frame together make up said valve device, said percutaneous valve device having a first configuration for percutaneous delivery and a second configuration as a working configuration; and

wherein said first adjustment structure has a configuration that fits together in a complementary manner with a configuration on said second adjustment structure to control the relative movement between the valve member and device frame and select one position from a plurality of positions between said valve member and said device frame;

said apparatus being configured to allow adjustment of an angular position of said valve member relative to said device frame.

11. A system comprising:

a percutaneous valve device, said valve device comprising a first adjustment structure on a valve member, and a second adjustment structure on a device frame;

wherein said valve member and said device frame together make up said percutaneous valve device, said percutaneous valve device having a first configuration for percutaneous delivery and a second configuration as a working configuration; and

wherein said first adjustment structure has a configuration that fits with a configuration on a second adjustment structure in a complementary manner to control the relative movement between the valve member and device frame and select one position from a plurality of positions along a longitudinal axis of said valve device between said valve member and said device frame in said second configuration; and

a delivery device for percutaneously delivering and deploying said valve device.

12. The system of claim 11, wherein said first and second adjustment structures are selected from the group consisting of:

buttons and harbors;

snap-fit pads and openings;

ring and ratchet post;

angular ribs and angular grooves;

helix rail and rollers; and

helix groove and protrusions.

13. The system of claim 11, further comprising a position-maintaining means.

14. The system of claim 11, wherein said valve device is a modular valve device, said valve member is a valve module and said device frame is a support structure;

and wherein said valve module and said support structure are configured for assembly to form said valve device after deployment from said delivery device.

15. The system of claim 11, wherein said delivery device is a catheter.