Devices, systems and methods to treat heart failure

• US 8,157,860 B2
• Filed: 03/08/2010
• Issued: 04/17/2012
• 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:
  US12/719,843
• Publication Number:
  US 20100256753A1
• Time in Patent Office: 771 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
• 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.

Claims

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

a body element comprising;

a core segment defining a passage;

a first annular flange comprising a plurality of flange segments adapted to engage a first surface of said atrial septum;

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

a flow control element comprising a tube within said passage and adapted to extend therethrough in an axial direction a distance of at least 1 mm beyond said second annular flange into a lumen of said heart,

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, wherein at least one of said annular flanges comprises a radiopaque marker.

3. The device of claim 1, wherein said distance is at least 3 mm.

4. The device of claim 1, wherein said distance is at least 1 cm.

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

6. The device of claim 1, wherein said second annular flange further comprises at least one flange segment that is longer than said plurality of second flange segments.

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

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

ii. 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

iii. a core segment;

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 the atrium so as to define a space between the at least 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, and

wherein said device further comprises a flow control element comprising a tube within said passage and adapted to extend therethrough in an axial direction a distance of at least 1 mm beyond said first curved section into a lumen of said heart.

10. The device of any one of claims 7-9, wherein each of said plurality of flange segments comprises a radiopaque marker.

11. The device of any one of claims 7-9, 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.

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

i. 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; and

ii. 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

iii. a flow control element comprising a tube within said passage and adapted to extend therethrough in an axial direction a distance of at least 1 mm beyond said second annular flange into a lumen of said heart;

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.

9. 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 flange segments, each of said flange segments comprising a distal end;

ii. 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

iii. a flow control element comprising a tube within said passage and adapted to extend therethrough in an axial direction a distance of at least 1 mm beyond said second annular flange into a lumen of said heart.