IP Library Granted Patent US 9,717,513
Granted Patent B2
US 9,717,513 · App. 13/055,507 · Granted Aug 1, 2017

Fracturing calcifications in heart valves

Inventor: Erez Golan (Rehovot, IL)
Assignee: Pi-Cardia Ltd.
A61B17/22012A61B17/320725A61F2/2427A61B2017/00243A61B2017/00535A61B2017/00783A61B2017/22051A61B2017/22069A61B2017/22097A61B2017/22098A61B2017/320716A61F2/2418
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Quick Facts
Patent No.
US 9,717,513
App. No.
13/055,507
Granted
Aug 1, 2017
Kind
B2
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 (30)

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, wherein said energy source is located at a proximal portion of said catheter.

2. 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.

3. The device according to claim 2 , wherein said impact-producing arms are retractable into said external housing of said catheter.

4. The device according to claim 2 , wherein said impact-producing arms are connected to an internal shaft that is movable proximally and distally to alternatively contract and expand said impact-producing arms.

5. The device according to claim 2 , wherein said impact-producing arms have adjustable angular positions.

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 hard tissue.

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

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

9. The device according to claim 8 , wherein said protection means is shaped like a sleeve and comprises flexible anchoring arms extendable therefrom.

10. The device according to claim 9 , further comprising a sub-coronary net that extends from a distal portion of said sleeve.

11. The device according to claim 10 , wherein said sub-coronary net has a distal ring whose diameter matches a diameter of a native valve in a closed position.

12. The device according to claim 9 , further comprising a retractable sheath into which said protection sleeve is retractable.

13. The device according to claim 9 , 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 hard tissue.

14. 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.

15. 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.

16. 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.

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

18. 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, wherein said energy source is located at a distal portion of said catheter.

19. 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.

Assignments (6)
SECURITY INTEREST Recorded Feb 23, 2026
From: PI-CARDIA LTD.
To: KREOS CAPITAL VI (EXPERT FUND) LP
Reel/Frame 074485/0605 →
SECURITY INTEREST Recorded Jun 3, 2025
From: PI-CARDIA LTD.
To: KREOS CAPITAL VI (EXPERT FUND) LP
Reel/Frame 071463/0524 →
SECURITY INTEREST Recorded Jan 8, 2024
From: PI-CARDIA LTD
To: KREOS CAPITAL VI (EXPERT FUND) L.P.
Reel/Frame 066208/0842 →
SECURITY INTEREST Recorded Oct 25, 2021
From: PI-CARDIA LTD.
To: KREOS CAPITAL VI (EXPERT FUND) L.P.
Reel/Frame 057888/0869 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 11, 2020
From: PI-R-SQUARED LTD.
To: PI-CARDIA LTD.
Reel/Frame 051775/0438 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 24, 2011
From: GOLAN, EREZ
To: PI-R-SQUARED LTD.
Reel/Frame 025683/0373 →
Continuity (4)
Provisional Application 61083934 · Jul 27, 2008
Provisional Application 61096061 · Sep 11, 2008
Provisional Application 61162343 · Mar 23, 2009
Related Publication 20110118634A1 · May 19, 2011