Supportless atrioventricular heart valve and minimally invasive delivery systems thereof

• US 20030163194A1
• Filed: 05/02/2002
• Published: 08/28/2003
• Est. Priority Date: 02/28/2002
• Status: Active Grant

• Current Assignee: Medtronic 3F Therapeutics, Inc. (Medtronic Plc)
• Original Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Inventors: Nguyen, Than, Tu, Hosheng, Quijano, Rodolfo C.
• Granted Patent: US 6,974,464 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

A supportless atrioventricular valve intended for attaching to a circumferential valve ring and papillary muscles of a patient comprising a singular flexible membrane of tissue or synthetic biomaterial, wherein a minimally invasive delivery system is provided through a percutaneous intercostal penetration and a penetration at the cardiac wall into a left atrium of the heart.

Claims

1. A method for minimally invasively delivering a supportless atrioventricular valve made of a singular membrane of tissue into a patient, said method comprising folding said valve within a lumen of delivery means for delivering said valve through a cardiac wall into a left atrium of the patient.

2. The method of claim 1, wherein said valve comprising a sewing ring having an opening defined by a perimeter including at least a first and a second straight side portions thereof, an anterior cusp hinged continuously from said first straight side portion, a posterior cusp hinged continuously from said second straight side portion opposite said anterior cusp, wherein said anterior cusp and said posterior cusp are an integral part of a continuum from said singular membrane configured to form a substantially tubular shape for use as the supportless atrioventricular valve.

3. The method of claim 2, wherein said singular membrane of tissue is chemically treated to reduce antigenicity of said membrane.

4. The method of claim 3, wherein said membrane of tissue is pericardium tissue selected from a group consisting of equine, bovine, porcine, and ovine.

5. The method of claim 1 further comprising steps of:

(a) advancing a delivery apparatus of the delivery means through a percutaneous intercostal penetration and reaching the cardiac wall, wherein said delivery apparatus comprises a cup balloon at a distal section of the delivery apparatus having a plurality of suction ports at a balloon rim of said cup balloon;

(b) deploying the cup balloon and applying suction to said plurality of suction ports to create an isolated enclosure around a distal region of the delivery apparatus;

(c) introducing a sharp-end inner medical device inside said delivery apparatus toward the cardiac wall and creating a passthrough opening on said wall;

(d) withdrawing the sharp-end inner medical device from said delivery apparatus;

(e) introducing a second inner medical device having the folded supportless atrioventricular valve through the passthrough opening into the left atrium; and

(f) delivering the atrioventricular valve suitable out of said second inner medical device for implanting at a heart valve location.

6. The method of claim 1 wherein the delivery means is introduced through a cannula positioned in a percutaneous intercostal penetration.

7. The method of claim 1 further comprising a step of removing at least a portion of a patient'"'"'s atrioventricular valve by means of a cutting tool introduced through a percutaneous intercostal penetration and through an internal penetration on the cardiac wall.

8. The method of claim 7 further comprising fastening the supportless atrioventricular valve within the left atrium by means of an instrument introduced through the percutaneous intercostal penetration and through the internal penetration.

9. The method of claim 8 wherein the supportless atrioventricular valve is introduced through a cannula positioned in the percutaneous intercostal penetration.

10. The method of claim 7 wherein the percutaneous intercostal penetration is created in a right lateral portion of a patient'"'"'s chest.

11. A delivery apparatus for accessing a left atrium of a patient through a cardiac wall, said delivery apparatus comprising a cup balloon located at a distal section of said delivery apparatus, wherein said cup balloon having a balloon rim configured for defining an isolated enclosure bordered by said balloon rim of said cup balloon and said cardiac wall.

12. The delivery apparatus of claim 11, wherein said delivery apparatus further comprises a plurality of suction ports located along the balloon rim of said cup balloon adapted for releasably securing said balloon rim onto said cardiac wall.

13. The delivery apparatus of claim 12, wherein a suction pressure of the plurality of suction ports is in the range of −

5 to −

100 mmHg.

14. The delivery apparatus of claim 12, wherein the cup balloon is made of a material selected from a group consisting of silicone, polyurethane, latex, and mixture thereof.

15. The delivery apparatus of claim 11, wherein a pressure for inflating said cup balloon is in the range of 10 to 100 mmHg.

16. The delivery apparatus of claim 11, wherein the delivery apparatus is made of a material selected from a group consisting of polyethylene, polypropylene, polycarbonate, nylon, polytetrafluoroethylene, polyurethane, stainless steel, Nitinol, titanium, polyimide, and polyester.

17. A method of treating atrial fibrillation using a medical device with at least one radiofrequency electrode, the method comprising introducing said medical device through an intercostal penetration and an opening on a cardiac wall into a left atrium of a patient, wherein radiofrequency energy is provided through said at least one electrode to ablate at least one pulmonary vein in the left atrium.

18. The method of claim 17, wherein a trocar is placed at the intercostal penetration for said medical device to pass through.

19. The method of claim 17, wherein the opening on the cardiac wall is created by a delivery system having a delivery apparatus and a sharp-end inner medical device for creating said opening, the delivery apparatus comprising a cup balloon located at a distal section of said delivery apparatus configured for defining an isolated enclosure bordered by said cup balloon and said cardiac wall.

20. The method of claim 19, wherein said delivery apparatus further comprises a plurality of suction ports located along a balloon rim of said cup balloon adapted for releasably securing said rim onto said cardiac wall.