Apparatus and method for treating cardiovascular diseases

• US 9,480,552 B2
• Filed: 03/10/2014
• Issued: 11/01/2016
• Est. Priority Date: 04/26/2006
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Oberti, Carlos M.
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US14/202,790
• Publication Number:
  US 20140194872A1
• Time in Patent Office: 967 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching

Abstract

A removable apparatus is provided for temporary implantation in a pulmonary vein for ablating atrial tissue surrounding the antrum of the pulmonary vein to treat atrial fibrillation in a subject. The apparatus comprises an electrically-insulated expandable support member and a retrieval mechanism. The support member has oppositely disposed proximal and distal end portions and a main body portion extending between the end portions. The proximal end portion includes at least one annularly disposed wing member, and has a free end defined by oppositely disposed first and second major surfaces. The at least one wing member includes at least one ablation element located at the free end thereof. The retrieval mechanism is for removing the support member and for energizing the at least one ablation element. The retrieval mechanism includes at least one electrically-conductive wire, which is separately connected to the at least one wing member.

Claims

1. A removable apparatus for temporary implantation in a pulmonary vein for ablating atrial tissue surrounding the antrum of the pulmonary vein to treat atrial fibrillation in a subject, said apparatus comprising:

an electrically-insulated expandable support member having a first mesh-like configuration, oppositely disposed proximal and distal end portions, and a main body portion extending between said end portions for positioning in the pulmonary vein, said proximal end portion including at least one annularly disposed wing member that extends from said main body portion, said at least one wing member having a free end and being defined by oppositely disposed first and second major surfaces, said at least one wing member independently comprising a second mesh-like configuration, said distal end portion adapted for insertion into the pulmonary vein to accurately position said proximal end portion at the antrum;

when temporarily implanted, said first major surface for facing the interior of the atrial chamber and said second major surface having a shape configured to conform to the surface topography of the antrum of the pulmonary vein;

said at least one wing member including at least one ablation element for delivering electrical energy to the atrial tissue, said at least one ablation element being located at said free end of said at least one wing member; and

a retrieval mechanism for removing said expandable support member, said retrieval mechanism including at least one electrically-conductive wire, said at least one wire being separately connected to said at least one wing member.

2. The apparatus of claim 1, wherein said main body portion comprises at least one continuous, W-shaped segment.

3. The apparatus of claim 1, wherein said main body portion comprises a flexible, ring-shaped member.

4. The apparatus of claim 1, wherein said first and second surfaces of each of said at least one wing member extend radially from said main body portion when said apparatus is implanted.

5. The apparatus of claim 1, wherein said at least one ablation element is also capable of electrophysiological mapping.

6. The apparatus of claim 1, wherein said at least one wing member includes a first ablation element and second mapping electrode.

7. The apparatus of claim 1, wherein said at least one ablation element is horseshoe-shaped and located at said free end of said at least one wing member.

8. The apparatus of claim 1, wherein said at least one wing member has a length of between about 5 mm and 12 mm.

9. The apparatus of claim 1, wherein electrical energy is delivered to said at least one ablation element via an RF energy source.

10. The apparatus of claim 9, wherein said RF energy source is located external to the subject.

11. The apparatus of claim 1, wherein each of said at least one wire of said retrieval mechanism is separately connected to a respective one of said at least one ablation element.

12. The apparatus of claim 1, wherein said retrieval mechanism further includes at least one coiled wire disposed within said expandable support member.

13. The apparatus of claim 1, wherein said retrieval mechanism further includes an inflation member operably connected to a shaft.

14. The apparatus of claim 1, wherein only said at least one wing member includes said at least one ablation element.

19. The apparatus of claim 1, wherein said retrieval mechanism is for energizing said at least one ablation element.

15. A method for treating atrial fibrillation in a subject, said method comprising the steps of:

providing a removable apparatus comprising an electrically-insulated expandable support member and a retrieval mechanism, the expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions, the proximal end portion including at least one annularly disposed wing member that extend from the main body portion, each of the at least one wing member having a free end and being defined by oppositely disposed first and second major surfaces, each of the at least one wing member including at least one ablation element located at the free end thereof, the retrieval mechanism including at least one electrically-conductive wire, the at least one wire being separately connected to the at least one wing member;

inserting the expandable support member into a pulmonary vein so that the distal end portion of the main body portion is disposed in the lumen of the pulmonary vein;

deploying the at least one wing member so that the second surface of the at least one wing member extends substantially radial to the main body portion of the expandable support member and firmly engages the atrial tissue surrounding the pulmonary vein;

delivering electrical energy to the at least one ablation element to substantially ablate the atrial tissue;

operating the retrieval mechanism to collapse the expandable support member; and

withdrawing the expandable support member from the pulmonary vein.

16. The method of claim 15, wherein said step of delivering electrical energy to the at least one ablation element further includes the steps of:

mapping abnormal electrophysiological activity in the atrial tissue; and

selectively delivering electrical energy to the at least one ablation element based on the mapped electrophysiological activity.

17. The method of claim 15, wherein said step of operating the retrieval mechanism to collapse the expandable support member further comprises the step of withdrawing the at least one wire to radially collapse the wing members and the main body portion of the expandable support member.

18. The method of claim 17, wherein said step of inserting the expandable support member into the pulmonary vein is done percutaneously via an intravascular catheter.