Aortic valve repair

• US 20060229659A1
• Filed: 12/09/2005
• Published: 10/12/2006
• Est. Priority Date: 12/09/2004
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: The Foundry Inc.
• Inventors: Deem, Mark E., Gifford, Hanson, Boyd, Stephen
• Granted Patent: US 7,803,168 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 cardiac valve repair, the treatment catheter comprising:

a catheter body comprising a proximal end and a distal end;

means near the distal end of the catheter body for creating an embolic containment region over a localized calcific site on or near a cardiac valve; and

a working element adapted to disrupt the calcific site, said working element being positionable within the embolized containment region.

2. The treatment catheter of claim 1 wherein the working element comprises an energy delivery element such as ultrasonic element delivering energy under conditions selected to disrupt calcific deposits at the calcific site.

3. The treatment 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.

4. The treatment catheter of claim 1 further comprising a positioning structure on the catheter body for positioning and/or stabilizing the working element adjacent the calcific site.

5. The treatment catheter of claim 1 wherein the embolic containment creating means comprise a shaped balloon, a basket, or a filter.

6. The treatment catheter of claim 5 wherein the embolic containment means comprise a filter located on the treatment catheter, a perfusion balloon linked with an aspiration device, a suction catheter, a separate filter device either at the treatment site or downstream from the treatment site, or an external filter and perfusion system.

7. The treatment catheter of claim 6 wherein the protection device comprises a filter that is shaped to allow the treatment catheter to access a location to be treated, while still allowing flow through the diseased aortic valve.

8. The treatment catheter of claim 1 comprising a protection device that traps and/or evacuates debris from a treatment site around the diseased aortic valve.

9. The treatment catheter of claim 1 further comprising an imaging assembly.

10. The treatment catheter of claim 9 wherein the imaging element comprises an intracardiac echocardiography (ICE) assembly, transesophageal echocardiography (TEE) assembly, intravascular ultrasound assembly, or angioscopy assembly.

11. A system comprising the treatment catheter of any of claims 1 to 10, further comprising a guide catheter comprising an inner lumen that is configured to receive the treatment catheter.

12. The system of claim 11 further comprising a secondary positioning catheter that is positionable within the inner lumen of the guide catheter and around the treatment catheter.

13. The treatment catheter of claim 1 wherein the working element comprises an RF electrode.

14. The treatment catheter of claim 1 wherein the working element comprises a rotatable tip.

15. The treatment catheter of claim 14 wherein the rotatable tip comprises a coil.

16. The treatment catheter of claim 14 wherein the rotatable tip comprises an impeller.

17. The treatment catheter of claim 14 wherein the rotatable tip comprises a grinder.

18. The treatment catheter of claim 14 comprising a sheath that is disposed over the rotatable tip.

19. The treatment catheter of claim 1 wherein the distal end of the catheter body comprises a suction housing.

20. An intravascular implant for placement within a valve annulus, supra annular, sub annular, or a combination thereof, to assist in maintaining a functional valve orifice, the intravascular implant comprising at least one coil or ring of material.

21. The intravascular implant of claim 20 wherein the coil or ring comprises a pharamacological agent to increase efficacy by reducing restenosis, and otherwise aiding valve function.

22. The intravascular implant of claim 20 wherein the intravascular implant is introduced via a retrograde approach, from the femoral artery, into the aorta and across the valve from the ascending aorta, or through the antegrade approach—

transeptal, across the mitral valve, through the left ventricle and across the aortic valve.

23. The intravascular implant of claim 20 wherein the at least one coil or ring of material comprises a supra valvular ring and a sub annular ring that is connected by a single strut.

24. The intravascular implant of claim 20 wherein the at least one coil or ring of material comprises one or more sinusoidal rings.

25. The intravascular implant of claim 24 comprising one or more struts that extend to seat against an annulus of the aortic valve to provide structure or further disseminate a pharmacologic coating to the aortic valve.

26. The intravascular implant of claim 20 wherein the at least one coil of material comprises multiple loops.

27. The intravascular implant of claim 26 wherein the multiple loops comprise three loops that are disposed 120 degrees from each other.

28. A method for treating a cardiac valve having one or more calcific sites, said method comprising:

creating an embolic containment region over the calcific site; and

delivering energy to the calcific site to disrupt said site and potentially create emboli which are contained in said containment region.

29. A method as in claim 28, further comprising removing emboli from the containment region.

30. A method as in claims 28 or 29, wherein creating the embolic containment region comprises positioning a structure over the region, wherein the structure does not span an associated blood vessel.

31. A method as in claim 30, wherein the structure comprises a housing, balloon, basket, or filter.

32. A method as in claims 28 or 29, wherein creating the embolic containment region comprises aspirating emboli from the region around the calcific site without positioning a structure.

33. A method as in any of claims 28-32, wherein the energy is ultrasound, radiofrequency, microwave, mechanical, or cryogenic.