DEVICES, SYSTEMS AND METHODS TO TREAT HEART FAILURE

• US 20100249910A1
• Filed: 03/08/2010
• Published: 09/30/2010
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: Finch, Matthew J., McNamara, Edward, Forcucci, Stephen J., Celermajer, David, Sugimoto, Hiroatsu
• Granted Patent: US 8,172,896 B2
• Time in Patent Office: Days
• US Class Current: 623/1.260
• 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
• CPC Class Codes: A61B 2017/0237 for heart surgery
• 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 intracardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intracardiac pressure vents presented allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms but also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombus or other embolic material from entering the arterial circulation. Retrievability during deployment is improved, in part, by providing at least one segment or portion of the device that is retained within the placement catheter while all other segments or portions of the device are deployed.

Claims

1. A device for treating a heart condition in a patient comprising:

a. a body element comprising;

i. a cylindrical core segment defining a passage;

ii. a first annular flange comprising a plurality of flange segments having substantially similar lengths;

iii. a second annular flange comprising a plurality of flange segments having substantially similar lengths,

wherein said second annular flange further comprises at least one flange segment that is longer than said plurality of flange segments having substantially similar lengths.

2. The device of claim 1 further comprising a flow control element having two sides and attached to said core segment.

3. The device of claim 2, wherein said flow control element opens upon an occurrence of a pressure differential between said two sides of said flow control element.

4. The device of claim 3, wherein said flow control element allows fluid to flow through said passage from an area of higher pressure to an area of lower pressure.

5. The device of claim 4, wherein said pressure differential is at least 2 mm Hg.

6. The device of claim 1, wherein each of said plurality of flange segments comprises a radiopaque marker.

7. The device of claim 2, wherein said core segment comprises a plurality suture holes and wherein said flow control element is sutured to a selected number of said suture holes.

8. The device of claim 7, wherein suture holes are selected based upon the at least one of a desired entry and exit profile of the flow control element.

9. The device of claim 7, wherein said selected number of suture holes defines at least one of an entry and exit profile of the flow control element.

10. The device of claim 2, wherein said core segment is adapted to be placed the atrial septum of said patient'"'"'s heart, said septum comprising a first and a second surface and wherein said first annular flange is adapted to engage said first surface of said atrial septum and said second annular flange is adapted to engage said second surface of said atrial septum.

11. The device of claim 10, wherein said flow control element is attached to an inner surface of said core segment and extends partially onto at least one of said flange segments and is adapted to provide sealable contact to at least one of said surfaces of said atrial septum.

12. The device of claim 2, wherein said flow control element is a valve.

13. The device of claim 12, wherein said valve comprises at least two leaflets.

14. The device of claim 13, wherein at least one of the leaflets more flexible than another said at least two leaflets.

15. A method to deploy a device for treating a heart condition in a patient, said method providing for improved ability to retrieve said device during deployment, said method comprising:

containing an implantable device within a placement device, said implantable device comprising a plurality of segments having substantially similar lengths and at least one extended segment that is longer than said plurality of segments;

deploying said plurality of segments having substantially similar lengths; and

retaining said at least one extended segment while said plurality of segments is deployed.

16. The method of claim 15, further comprising:

determining that said device is correctly positioned; and

deploying said at least one extended segment upon said determination.

17. The method of claim 15, further comprising:

determining that said device is incorrectly positioned; and

retrieving said device into said placement catheter by retracting said retained at least one extended segment based on said determination.

18. A delivery system for a device for treating a heart condition in a patient, said delivery system providing for improved ability to retrieve said device during deployment, said system comprising:

a placement catheter comprising—

an outer sheath, and

an inner shaft situated within said outer sheath and adapted to engage an implantable device,

wherein said outer sheath in cooperation with said inner shaft is adapted to contain said engaged implantable device within said placement catheter when said outer sheath covers said engaged implantable device,

wherein said implantable device comprises—

a first annular flange comprising a plurality of flange segments having substantially similar lengths and at least one extended flange segment longer than said plurality, said flange segments extending in a direction substantially perpendicular to said placement catheter upon deployment, and

a second annular flange comprising a plurality of flange segments having substantially similar lengths and at least one extended flange segment longer than said plurality, said flange segments extending in a direction substantially perpendicular to said placement catheter upon deployment, and

wherein said at least one extended flange segment of said first annular flange is retained within said placement catheter when said at least one flange segment of said second annular flange is deployed.

19. The system of claim 18, wherein said outer sheath comprises an angular opening.

20. The system of claim 19, wherein said angular opening provides an portion of said sheath to retain said at least one extended flange segment of said first annular flange within said placement catheter when said at least one flange segment of said second annular flange is deployed.