AORTIC VALVE REPAIR

• US 20130345715A1
• Filed: 12/03/2012
• Published: 12/26/2013
• Est. Priority Date: 12/09/2004
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: The Foundry Inc.
• Inventors: Gifford, Hanson S., Deem, Mark E., Boyd, Stephen
• Granted Patent: US 9,414,852 B2
• Time in Patent Office: Days
• US Class Current: 606/128
• 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 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61N 2007/0039 : using microbubbles
• CPC Class Codes: A61N 7/022 : intracavitary

Abstract

The present invention provides devices and methods for decalcifying an aortic valve. The methods and devices of the present invention break up or obliterate calcific deposits in and around the aortic valve through application or removal of heat energy from the calcific deposits.

Claims

1. A treatment catheter for repairing a cardiac valve, said catheter comprising:

a catheter body having a proximal end, a distal end and a lumen extending therebetween;

a containment structure near the distal end of the catheter body for creating an embolic containment region over a localized calcific size on or near a cardiac valve adjacent a blood vessel, wherein the containment structure is configured to deploy across a single leaflet of the cardiac valve and trap particles released therefrom, the containment structure having a collapsed configuration positionable within the lumen of the catheter body and a deployed configuration sized and shaped to cover the single leaflet of the cardiac valve without inhibiting movement of other leaflets of the cardiac vavlve; and

a working element adapted to disrupt the calcific site, the working element being advanceable beyond the distal end of the catheter body and positionable within the embolic containment region, wherein the working element is adapted to remove calcifications only from the single leaflet of the cardiac valve while the containment structure is deployed over the single leaflet.

2. The catheter of claim 1, wherein the catheter body is steerable or otherwise positionable to allow a user to direct the distal end toward the calcific site.

3. The catheter of claim 1, further comprising a positioning structure coupled to the catheter body for positioning or stabilizing the working element adjacent the calcific site.

4. The catheter of claim 1, wherein the working element is movable to mechanically remove the calcifications.

5. The catheter of claim 1, wherein the working element rotates to remove the calcifications.

6. The catheter of claim 5, wherein the working element rotates eccentrically.

7. The catheter of claim 1, wherein the working element oscillates to remove the calcifications.

8. The catheter of claim 1, wherein the working element delivers ultrasonic vibrations to remove the calcifications.

9. The catheter of claim 1, wherein the working element delivers radiofrequency energy to remove the calcifications.

10. The catheter of claim 1, wherein the working element has a distally-facing working portion configured to remove calcifications from an upstream surface of the single leaflet.

11. The catheter of claim 1, wherein the containment structure is configured to engage and conform to a surface of the single leaflet.

12. The catheter of claim 1, wherein the containment structure comprises a balloon.

13. The catheter of claim 1, wherein the containment structure comprises a basket.

14. The catheter of claim 1, wherein the containment structure comprises a filter that allows blood flow through the cardiac valve while the calcific site is being disrupted by the working element.

15. The catheter of claim 1, further comprising an imaging assembly.

16. The catheter of claim 15, wherein the imaging assembly comprises an intracardiac echocardiography assembly, a transesophageal echocardiography assembly, an intravascular ultrasound assembly, or an angioscopy assembly.

17. A system for repairing a cardiac valve, said system comprising:

a catheter having a containment structure near a distal end of the catheter and a working element, wherein the containment structure is adapted to create an embolic containment region over a localized calcific site on or near a single valve leaflet of a cardiac valve, the containment structure also adapted to trap particles released from the calcific site, and wherein the working element is adapted to remove calcifications from the single leaflet while the containment structure is disposed thereover; and

a monitoring or imaging device for imaging the single valve leaflet.

18. The system of claim 17, wherein the monitoring or imaging device comprises one of an intracardiac echocardiography (ICE) assembly, a transesophageal echocardiography (TEE) assembly, an intravascular ultrasound (IVUS) assembly, and an angioscopy assembly.

19. The system of claim 17, further comprising a media for amplifying the effect of the working element on the calcific site.

20. The system of claim 19, wherein the media comprises microspheres or microbubles.

21. The system of claim 17, further comprising an anti-restenosis agent delivered by the catheter to the calcific site.

22. A method for treating a cardiac valve having a calcific site, said method comprising:

providing a catheter having an embolic containment region and a working element;

positioning the embolic containment region over a single valve leaflet of the cardiac valve;

decalcifying only calcification on the single valve leaflet with the working element; and

capturing debris from the single valve leaflet with the embolic containment region.

23. The method of claim 22, wherein decalcifying comprises mechanically removing the calcification.

24. The method of claim 23, wherein mechanically removing the calcification comprises rotating the working element.

25. The method of claim 22, wherein decalcifying comprises ultrasonically vibrating the working element to remove the calcification.

26. The method of claim 22, wherein decalcifying comprises removing the calcification with radiofrequency energy delivered from the working element.

27. The method of claim 22, further comprising imaging the single valve leaflet.

28. The method of claim 27, wherein imaging comprises imaging the single valve leaflet with an intracardiac echocardiography (ICE) assembly, a transesophageal echocardiography (TEE) assembly, an intravascular ultrasound (IVUS) assembly, or an angioscopy assembly.

29. The method of claim 22, further comprising delivering an anti-restenosis agent from the catheter to prevent or minimize restenosis of the single valve leaflet.

30. The method of claim 22, wherein bloodflow through the cardiac valve remains unblocked while the decalcifying is performed.