Intra-atrial implants made of non-braided material

• US 9,358,371 B2
• Filed: 01/18/2013
• Issued: 06/07/2016
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: McNamara, Edward, Celermajer, David, Forcucci, Stephen J., Sugimoto, Hiroatsu
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/744,791
• Publication Number:
  US 20130231737A1
• Time in Patent Office: 1,236 Days
• Field of Search: 623/1.26
• US Class Current: 1/1
• 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 devices, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure devices presented allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms. The intra-cardiac pressure devices are made of a non-braided material.

Claims

1. A device for implanting in an opening in a septal wall in a heart of a patient, comprising:

i. a first annular flange comprising a plurality of flange segments, each of said flange segments of the first annular flange having a first end and a second end;

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

iii. a core segment having a first diameter when deployed, said core segment defining a passage adapted to permit fluid to flow therethrough from one side of said septal wall to another side of said septal wall,

wherein the first ends of the first annular flange and the first ends of the second annular flange are contiguous with and define the core segment,

wherein at least one of the flange segments of the second annular flange includes a first section that extends into the atrium and a second section that extends from the first section toward the septal wall,

wherein the second end of the at least one of the flange segments of the second annular flange is adapted to be in contact with the septal wall,

wherein at least a portion of at least one of said flange segments is more flexible than a portion of said core segment, 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 each 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 said selected number of suture holes defines at least one of an entry and exit profile of the flow control element.

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

10. The device of claim 9, wherein said valve comprises at least two leaflets.

11. The device of claim 10, wherein at least one of the leaflets is more flexible than another of said at least two leaflets.

12. The device of claim 1, wherein said septal wall is the atrial septum of said patient'"'"'s heart.