Devices, systems and methods to treat heart failure

• US 8,252,042 B2
• Filed: 03/08/2010
• Issued: 08/28/2012
• 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
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US12/719,834
• Publication Number:
  US 20100249909A1
• Time in Patent Office: 904 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. In embodiments, the device comprises a core segment, an annular flange to engage one surface of the atrial septum and two other annular flanges to engage another surface of the atrial septum.

Claims

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

a body element comprising;

a core segment having an axial length and defining a passage;

a first annular flange comprising a plurality of flange segments having substantially similar lengths and adapted to engage a first surface of said atrial septum;

a second annular flange comprising a plurality of flange segments having substantially similar lengths and adapted to engage a second surface of said atrial septum; and

a third annular flange disposed between the first annular flange and the second annular flange along the core segment axial length, the third annular flange comprising a plurality of flange segments having substantially similar lengths and less than the lengths of said plurality of flange segments of said second annular flange, said plurality of flange segments of said third annular flange also adapted to engage said second surface of said atrial septum;

wherein the first, second, and third annular flange are at least one of attached to and extending from the core segment, and 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 one segment of said plurality of flange segments comprises a radiopaque marker.

7. The device of claim 2, 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.

8. The device of claim 7, wherein suture holes are selected based upon 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 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.

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

12. The device of claim 11, wherein said valve comprises at least two leaflets.

13. The device of claim 12, wherein at least one of the leaflets is more flexible than another of said at least two leaflets.

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

i. a core segment having an axial length;

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

iii. a second annular flange comprising a plurality of flange segments, at least one of said flange segments of said second annular flange comprising a distal end adapted to be, when deployed, substantially parallel with the septal wall and contact the septal wall; and

iv. a third annular flange disposed between the first annular flange and the second annular flange along the core segment axial length, the third annular flange comprising a plurality of flange segments, said flange segments of the third annular flange having substantially similar lengths to the other flange segments of the third annular flange, said lengths of said flange segments of the third annular flange being less than the lengths of said plurality of flange segments of said second annular flange;

wherein at least an end of the core segment and the at least one of the flange segments of the second annular flange includes a first curved section that extends into an atrium of the heart so as to define a space between the one of the flange segments of the second annular flange 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 flange segments of the second annular flange.

17. The device of any one of claims 14-16 further comprising a flow control element having two sides and attached to said core segment.

18. The device of claim 17, wherein said flow control element opens upon an occurrence of a pressure differential between said two sides of said flow control element.

19. The device of claim 17, wherein said flow control element allows fluid to flow through said passage from an area of higher pressure to an area of lower pressure.

20. The device of claim 19, wherein said pressure differential is at least 2 mm Hg.

21. The device of any one of claims 14-16, wherein each of said plurality of flange segments of said first, second, and third flanges comprises a radiopaque marker.

22. The device of claim 17, 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.

23. The device of claim 22, wherein said selected number of suture holes defines at least one of an entry and exit profile of the flow control element.

24. The device of claim 17, 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 a surface of an atrial septum.

25. The device of claim 17, wherein said flow control element is a valve.

26. The device of claim 25, wherein said valve comprises at least two leaflets.

27. The device of claim 26, wherein at least one of the leaflets is more flexible than another of said at least two leaflets.

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

i. a core segment having an axial length;

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

iii. a second annular flange comprising a proximal end and a plurality of flange segments extending distally away therefrom, each of said flange segments comprising a distal end substantially parallel with respective distal ends of the flange segments of the first annular flange when deployed; and

iv. a third annular flange disposed between the first annular flange and the second annular flange along the core segment axial length, the third annular flange comprising a plurality of flange segments, said flange segments of the third annular flange having substantially similar lengths to the other flange segments of the third annular flange, said lengths of said flange segments of the third annular flange being less than the lengths of said plurality of flange segments of said second annular flange,

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

wherein the third annular flange is at least one of attached to and extending from said core segment.

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

i. a core segment having an axial length;

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

iii. a second annular flange comprising a proximal end and a plurality of flange segments, each of said flange segments comprising a distal end radially off set from respective distal ends of the flange segments of the first annular flange; and

iv. a third annular flange disposed between the first annular flange and the second annular flange along the core segment axial length, the third annular flange comprising a plurality of flange segments, said flange segments of the third annular flange having substantially similar lengths to the other flange segments of the third annular flange, said lengths of said flange segments of the third annular flange being less than the lengths of said plurality of flange segments of said second annular flange.