Aortic valve repair

• US 7,803,168 B2
• Filed: 12/09/2005
• Issued: 09/28/2010
• 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
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Ganesan; Suba
• Application Number:
  US11/299,246
• Publication Number:
  US 20060229659A1
• Time in Patent Office: 1,754 Days
• Field of Search: 128/898, 606/37, 606/127, 606/200, 606/128, 606/159, 606/7, 606/13, 606/20, 606/21, 606/41, 606/169
• US Class Current: 606/159
• 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 method for treating a cardiac valve having one or more calcific sites, said method comprising:

creating an embolic containment region over a single valve leaflet having a calcific site while the remaining leaflets continue to function; and

delivering energy to the calcific site to disrupt calcifications at said site under conditions expected to create emboli which are contained in said containment region,

wherein creating the embolic containment region comprises positioning a structure over the region, wherein the structure does not span an associated blood vessel,

wherein positioning the structure comprises approximating the structure against the periphery of the single valve leaflet,

wherein delivering energy comprises rotating an element within the structure to mechanically remove the calcifications without delivering electrical current to the valve leaflet, and

wherein the structure delivers energy to said single valve leaflet only within said containment region.

2. The method as in claim 1, further comprising removing emboli from the containment region.

3. The method as in claim 1, wherein the structure comprises a housing, balloon, basket, or filter.

4. The method as in claim 1, further comprising aspirating emboli from the region around the calcific site.

5. The method as in claim 1, wherein the structure is shaped to engage no more than a single valve leaflet.

6. The method as in claim 5, wherein the structure is shaped to engage no more than a single coronary leaflet, non-coronary leaflet, or center non-coronary leaflet of an aortic valve.

7. The method as in claim 5, wherein the structure is shaped to engage no more than a single mitral valve leaflet.

8. The method as in claim 1, wherein said containment region and said calcific site are completely enclosed by positioning said structure against said periphery of said single valve leaflet.

9. The method as in claim 1, wherein the element is rotated in a non-ultrasonic range of operation.

10. The method as in claim 1, wherein the element is rotated in an axis which ranges from 0-90 degrees with respect to a vertical axis of the structure.

11. The method as in claim 1, wherein the element does not contact the valve leaflet and removes the qualifications by creating a vortex.

12. The method as in claim 1, wherein the element is rotated eccentrically.

13. The method as in claim 1, further comprising:

stopping or slowing rotating the element when element becomes loaded with the calcification.

14. The method as in claim 1, further comprising:

injecting a cooling fluid to the valve leaflet while delivering energy.

15. The method as in claim 1, further comprising:

pacing a heart of the valve leaflet at an increased rate to hold valve leaflet in a relatively fixed position.

16. The method as in claim 1, wherein the structure comprises a suction cup.

17. The method as in claim 16, wherein positioning the structure comprises moving the suction cup from a retracted position to an expanded position.

18. The method as in claim 1, wherein the structure includes longitudinal stabilizing elements.

19. The method as in claim 18, wherein positioning the structure comprises using the longitudinal stabilizing elements to seat the structure against the valve leaflet.

20. The method as in claim 19, wherein the longitudinal stabilizing elements comprise pleats, rings, or hemispherical elements on a suction cup.