DEVICES, SYSTEMS, AND METHODS TO TREAT HEART FAILURE HAVING AN IMPROVED FLOW-CONTROL MECHANISM

• US 20100298755A1
• Filed: 07/30/2010
• Published: 11/25/2010
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Finch, Matthew J., McNamara, Edward, Forcucci, Stephen J., Celermajer, David, Sugimoto, Hiroatsu
• Granted Patent: US 10,188,375 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0237 for heart surgery endoscopic heart surgery A61B2017/00243; endoscopic access devices, i.e. trocars, A61B17/34
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1132 End-to-end connections
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

Several unique intra-cardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure vents presented remain partially open under normal intra-cardiac pressures to allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms, and also limit the amount of flow from the right atrium to the left atrium by closing when the pressure in the right atrium exceeds the pressure in the left atrium by a predetermined amount.

Claims

1. A device for treating a heart condition in a patient, said device implanted into the atrial septum of the patient'"'"'s heart, the patient'"'"'s heart comprising a left atrium and a right atrium, the device comprising:

a body element comprising;

a cylindrical core segment defining a passage;

a first annular flange adapted to engage a first surface of the atrial septum;

a second annular flange adapted to engage a second surface of the atrial septum,

a flow control element adapted to be partially open when the pressure in the left atrium is substantially equal to the pressure in the right atrium.

2. The device of claim 1 wherein the flow control element comprises a valve.

3. The device of claim 1 wherein the first surface of the atrial septum in the right atrium.

4. The device of claim 1 wherein the second surface of the atrial septum in the left atrium.

5. The device of claim 2 wherein the valve is further adapted to be flappable during the cycle of the heart.

6. The device of claim 2 wherein the valve is further adapted to resonate with the cycle of the heart.

7. The device of claim 1 wherein said flow control is adapted to close upon an occurrence of a pressure differential between the left and the right atrium.

8. The device of claim 7 wherein the pressure in the right atrium is greater than the pressure in the left atrium.

9. The device of claim 8, wherein said pressure differential is at least 2 mm Hg.

10. A method of decreasing blood pressure in the heart of a patient, comprising:

implanting a device comprising a flow control element between a left atrium and a right atrium of the heart thereby enabling blood flow between the left atrium and the right atrium;

with the flow control element, allowing an amount of blood suitable to reduce blood pressure in the left atrium to flow from the left atrium to the right atrium when the pressure in the left atrium is substantially equal to the pressure in the right atrium; and

with the flow control element, preventing blood flow from the right atrium to the left atrium when the pressure in the right atrium exceeds the pressure in the left atrium by a pre-determined amount.

11. The method of claim 10, wherein the blood flow between said left atrium and the right atrium is enabled by the flow control element, wherein the flow control element comprises a valve.

12. The method of claim 11, wherein the valve is kept partially open to effect the step of allowing an amount of blood suitable to reduce blood pressure in the left atrium to flow from the left atrium to the right atrium when the pressure in the left atrium is substantially equal to the pressure in the right atrium.

14. The method of claim 11, wherein the valve closes to effect the step of preventing blood flow from the right atrium to the left atrium when the pressure in the right atrium exceeds the pressure in the left atrium by a pre-determined amount.

15. The method of claim 14, wherein said valve closed wherein said pre-determined amount is greater than 2 mmHg.