Devices, systems and methods to treat heart failure

• US 8,172,896 B2
• Filed: 03/08/2010
• Issued: 05/08/2012
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: McNamara, Edward, Celermajer, David, Forcucci, Stephen J., Sugimoto, Hiroatsu, Finch, Matthew J.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/719,840
• Publication Number:
  US 20100249910A1
• Time in Patent Office: 792 Days
• Field of Search: 623/1.11, 623/1.15, 623/1.24, 623/1.26, 623/2.1, 623/2.11, 623/2.38
• US Class Current: 623/1.26
• 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 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 core segment defining a passage;

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

iii. a second annular flange comprising a plurality of second flange segments, each of the second flange segments of said plurality of second flange segments having a substantially similar length with respect to each other;

wherein said second annular flange further comprises at least one second flange segment that is longer than the second flange segments of said plurality of second flange segments,

wherein the core segment has a first diameter when deployed and wherein the core segment is collapsible, enabling the core segment to have a second diameter less than the first diameter thereby enabling percutaneous delivery.

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 at least a portion of at least one of said first and second flange segments is at least one of more flexible and less flexible than at least one of another portion of said first or second flange segments and said core segment.

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

8. The device of claim 1, wherein the first and second flange segments are more flexible than the core segment.

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 in 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 first and second flanges 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 is more flexible than another said at least two leaflets.

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

i. a first annular flange comprising a plurality of first flange segments;

ii. a second annular flange comprising a plurality of second flange segments, each of the second flange segments of said plurality of second flange segments having a substantially similar length with respect to each other, at least one of said second flange segments comprising a distal end adapted to be, when deployed, substantially parallel with the septal wall and contact the septal wall; and

iii. a core segment;

wherein at least an end of the core segment and the at least one of the second flange segments includes a first curved section that extends into the atrium so as to define a space between the at least one of the second flange segments and the septal wall when deployed and a second curved section that extends from the first section toward the septal wall and the distal end of the at least one of the second flange segments, and

wherein said second annular flange further comprises at least one second flange segment that is longer than the second flange segments of said plurality of second flange segments.

18. The device of any one of claims 15-17 further comprising a flow control element having two sides and attached to said core segment.

19. The device of claim 18, wherein said flow control element opens upon an occurrence of a pressure differential between said two sides of said flow control element.

20. The device of claim 18, wherein said flow control element allows fluid to flow through said passage from an area of higher pressure to an area of lower pressure.

21. The device of claim 20, wherein said pressure differential is at least 2 mm Hg.

22. The device of any one of claims 15-17, wherein each of said pluralities of said first or second flange segments comprises a radiopaque marker.

23. The device of claim 18, wherein said core segment comprises a plurality of suture holes and wherein said flow control element is sutured to a selected number of said suture holes.

24. The device of claim 23, wherein said selected number of suture holes defines at least one of an entry and exit profile of the flow control element.

25. The device of claim 18, wherein said flow control element is attached to an inner surface of said core segment and extends partially onto at least one of said first and second flanges and is adapted to provide sealable contact to at least a surface of an atrial septum.

26. The device of claim 18, wherein said flow control element is a valve.

27. The device of claim 26, wherein said valve comprises at least two leaflets.

28. The device of claim 27, wherein at least one of the leaflets is more flexible than another of said at least two leaflets.

16. A device for implanting in an opening of a tissue, comprising:

i. a first annular flange comprising a proximal end and a plurality of first flange segments extending distally away therefrom, each of said first flange segments comprising a distal end; and

ii. a second annular flange comprising a proximal end and a plurality of second flange segments extending distally away therefrom, each of said second flange segments of said plurality of second flange segments having a substantially similar length with respect to each other and comprising a distal end which is substantially parallel with a respective distal end of a respective first flange segment of the first annular flange when deployed; and

wherein the proximal end of the first annular flange and the proximal end of the second annular flange are contiguous and define a core segment having spaced apart apertures, the core segment adapted to maintain atraumatic contact with the opening of said tissue and defining a passage having an opening substantially parallel with a portion of the opening of said tissue, and

wherein said second annular flange further comprises at least one second flange segment that is longer than the second flange segments of said plurality of second flange segments.

17. A device for implanting in an opening of a tissue wall, comprising:

i. a first annular flange comprising a proximal end and a plurality of first flange segments, each of said first flange segments comprising a distal end; and

ii. a second annular flange comprising a proximal end and a plurality of second flange segments, each of said second flange segments of said plurality of second flange segments having a substantially similar length with respect to each other and comprising a distal end that is radially off set from a respective distal end of a respective first flange segment of the first annular flange;

wherein said second annular flange further comprises at least one second flange segment that is longer than the second flange segments of said plurality of second flange segments.