FRACTURING CALCIFICATIONS IN HEART VALVES

• US 20120253358A1
• Filed: 12/03/2010
• Published: 10/04/2012
• Est. Priority Date: 12/05/2009
• Status: Active Grant

• Current Assignee: Pi-Cardia Ltd.
• Original Assignee: PI-R-Squared, Ltd.
• Inventors: Golan, Erez
• Granted Patent: US 9,554,816 B2
• Time in Patent Office: Days
• US Class Current: 606/128
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

A device for fracturing calcifications in heart valves including an expandable stabilizer (14) and expandable impactor arms (20) assembled on and deployed by a delivery system (10), wherein the delivery system (10) is operable to move the impactor arms (20), while in an expanded position, with respect to the stabilizer (14) with sufficient energy so as to fracture a calcification located in tissure which is sandwiched between the stabilizer (14) and the impactor arms (20).

Claims

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

an expandable stabilizer and expandable impactor arms assembled on and deployed by a delivery system, wherein said delivery system is operable to move said impactor arms, while in an expanded position, with respect to said stabilizer with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between said stabilizer and said impactor arms.

2. The device according to claim 1, wherein said delivery system comprises a catheter, in which are disposed said expandable stabilizer, an internal shaft and an impactor shaft on which are mounted said impactor arms, and wherein said internal shaft is movable to cause said impactor arms to expand outwards and be locked in an expanded shape, and wherein an impacting element is movable to cause said impactor arms, while in the expanded shape, to move with respect to said stabilizer with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between said stabilizer and said impactor arms.

3. The device according to claim 2, wherein said impacting element comprises said internal shaft which is connected to a distal portion of said impactor arms and which is operative to move relative to said impactor shaft to expand said impactor arms outwards and to cause said impactor arms, while in the expanded shape, to move towards said stabilizer with the sufficient energy.

4. The device according to claim 2, wherein said internal shaft is lockable relative to said impactor shaft so that said impactor arms are fixed.

5. The device according to claim 1, wherein the sufficient energy is associated with moving said impactor arms towards said stabilizer at a speed of at least 1 msec and an amplitude of at least 0.5 mm.

6. The device according to claim 2, wherein said impacting element comprises a weight and a biasing device, wherein said biasing device urges said weight towards said impactor arms with the sufficient energy.

7. The device according to claim 6, wherein said weight is mounted on said biasing device which is fixed to a distal tip of said catheter.

8. The device according to claim 6, wherein said weight is fixed to said internal shaft of said catheter.

9. The device according to claim 1, wherein said stabilizer comprises a stabilizer structure covered by a stabilizer cover.

10. The device according to claim 1, wherein said stabilizer comprises a stabilizer structure covered by a covering balloon.

11. The device according to claim 10, wherein an inflate/deflate tube is inserted into said covering balloon.

12. The device according to claim 1, further comprising a first pressure sensor located near said stabilizer and a second pressure sensor located near said impactor arms.

13. The device according to claim 1, wherein said stabilizer is positioned distal to said impactor arms.

14. The device according to claim 1, wherein said stabilizer comprises stabilizer arms which are expandable outwards.

15. The device according to claim 6, wherein said biasing device comprises a pneumatic energy source connected to a pressurized air source.