FRACTURING CALCIFICATIONS IN HEART VALVES

• US 20110118634A1
• Filed: 07/27/2009
• Published: 05/19/2011
• Est. Priority Date: 07/27/2008
• Status: Active Grant

• Current Assignee: Pi-Cardia Ltd.
• Original Assignee: PI-R-Squared, Ltd.
• Inventors: Golan, Erez
• Granted Patent: US 9,717,513 B2
• Time in Patent Office: Days
• US Class Current: 601/4
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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

Abstract

A device for fracturing calcifications in heart valves including a catheter (12, 22, 42) configured for percutaneous delivery to a heart valve, an fracture-producing element (14, 26, 46, 64, 66,82, 124, 152) disposed at a distal portion of the catheter and operative to vibrate and mechanically fracture calcifications when brought into contact with a calcification at a leaflet of the heart valve, and an energy source (34, 47, 79, 98, 152) operative to vibrate the fracture-producing element so that the fracture-producing element fractures the calcification without necessarily removing the calcification from the leaflet. The device may further comprise a valvuloplasty balloon (30), an embolic protection net (56) and a protective sleeve (110, 130).

Claims

1. A device for fracturing calcifications in heart valves comprising:

an impactor catheter configured for percutaneous delivery to a heart valve;

an impact-producing element disposed at a distal portion of said catheter and operative to vibrate and create a mechanical impact when deployed out of an external housing of said catheter and brought into contact with a calcification at a leaflet of said heart valve;

an energy source operative to vibrate said vibrating impact-producing element so that said impact-producing element fractures the calcification without necessarily removing the calcification from the leaflet; and

an anvil against which the calcification is struck by said impact-producing element.

2. The device according to claim 1, wherein said energy source is located at a proximal portion of said catheter.

3. The device according to claim 1, wherein said energy source is located at a distal portion of said catheter.

4. The device according to claim 1, wherein said impact-producing element comprises one or more impact-producing arcuate arms that extend from a distal end thereof.

5. The device according to claim 4, wherein said impact-producing arms are retractable into said external housing of said catheter.

6. The device according to claim 1, further comprising a valvuloplasty balloon mounted on a balloon shaft arranged with respect to said impact-producing element such that inflation and deflation of said balloon modifies a pressing force between said impact-producing element and the hard tissue.

7. The device according to claim 4, wherein said impact-producing arms are connected to an internal shaft that is movable proximally and distally to alternatively contract and expand said.

8. The device according to claim 1, wherein said energy source comprises an electromagnetic impact source, wherein a sliding magnet creates impact percussions.

9. The device according to claim 1, further comprising an embolic protection means disposed on said impactor catheter.

10. The device according to claim 1, wherein said impact-producing element comprises a weight connected off-axis to a rotating element and a motor operative to rotate said rotating element.

11. The device according to claim 1, wherein said impact-producing element comprises a weight mounted on a cylindrical magnet arranged to move back and forth within a coil disposed in said catheter, and a voltage/current generator operative to power said coil, thereby causing said weight to vibrate back and forth at a selected amplitude and frequency.

13. The device according to claim 4, wherein said impact-producing arms have adjustable angular positions.

14. The device according to claim 1, further comprising a percutaneous retrieving device for retrieving a native valve, wherein said percutaneous retrieving device comprises a mesh with a central lumen adapted for passing through a center of a native valve and to expand to allow implantation of a new valve within the central lumen, and semi-lunar extensions folded outwards from said mesh and adapted to fit into sinuses of the native valve.

16. The device according to claim 9, wherein said protection means is shaped like a sleeve and comprises flexible anchoring arms extendable therefrom.

17. The device according to claim 16, further comprising a sub-coronary net that extends from a distal portion of said sleeve.

18. The device according to claim 16, further comprising a retractable sheath into which said protection sleeve is retractable.

19. The device according to claim 17, wherein said sub-coronary net has a distal ring whose diameter matches a diameter of a native valve in a closed position.

20. The device according to claim 16, further comprising a valvuloplasty balloon mounted on a balloon catheter arranged with respect to said impact-producing element such that inflation and deflation of said balloon modifies a pressing force between said impact-producing element and the hard tissue.

21. The device according to claim 1, wherein said anvil comprises a balloon.

12. (canceled)

15. (canceled)

22. A device for fracturing calcifications in heart valves comprising:

an impactor catheter configured for percutaneous delivery to a heart valve;

an impact-producing element disposed at a distal portion of said catheter and operative to vibrate and create a mechanical impact when deployed out of an external housing of said catheter and brought into contact with a calcification at a leaflet of said heart valve; and

an energy source operative to vibrate said vibrating impact-producing element so that said impact-producing element fractures the calcification without necessarily removing the calcification from the leaflet, wherein said impact-producing element comprises one or more impact-producing arcuate arms that extend from a distal end thereof, said arcuate arms being flexible enough to be deliverable in a retracted state within said external housing, and then upon reaching the valve, said arcuate arms are expandable into the valve.