Intra-atrial implants having variable thicknesses to accommodate variable thickness in septum

• US 10,413,286 B2
• Filed: 05/14/2012
• Issued: 09/17/2019
• 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 W
• Application Number:
  US13/471,415
• Publication Number:
  US 20120289882A1
• Time in Patent Office: 2,682 Days
• 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

The invention is a septal implant that can accommodate variable thicknesses of the patient'"'"'s atrial septum as well the variable thicknesses of septums across a population. The invention is able to accomplish this result by having flexible annular flanges that define a gap into which the septum fits. Due to the flexible nature of the annular flanges, the gap is adjustable.

Claims

1. A device for directing blood flow across in the atrial septum in a heart of a patient, the device comprising:

a. a core segment having a length greater than the atrial septum and defining a passage, the core segment having a first diameter when deployed;

b. a first flexible annular flange joining a first end of the core segment, wherein the first flexible annual flange is configured to form a substantially flat surface that contacts one side of the atrial septum, forming a first contacting surface; and

c. a second flexible annular flange joining a second end of the core segment;

wherein a distal portion of the second flexible annular flange is formed to lie at a parallel angle to and to contact the other side of the atrial septum, forming a second contacting surface, and wherein the first contacting surface is greater than the second contacting surface;

a flow control element attached to the core segment, wherein the device is collapsible, enabling the core segment to have a second diameter less than the first diameter thereby enabling percutaneous delivery of the device to the heart of the patient, wherein at least a portion of the first and second annular flanges define an annular gap, and wherein said annular gap is smaller than the length of the core segment.

2. The device of claim 1 wherein the annular gap is has a width less than a thickness of the septum.

3. The device of claim 1 wherein the annular gap has a width greater than a thickness of the septum.

4. The device of claim 1 wherein at least one of the first annular flange and the second annular flange is more flexible than the core segment.

5. The device of claim 1 wherein at least one of the first annular flange and the second annular flange comprises a plurality of flange segments.

6. The device of claim 5 wherein at least one of the plurality of flange segments is longer than another one of the flange segments.

7. The device of claim 5, wherein at least one of said plurality of flange segments comprises a radiopaque marker.

8. The device of claim 1 wherein the device is self-expandable upon deployment.

9. The device of claim 1 wherein the device is balloon-expandable.

10. The device of claim 1 wherein the core segment comprises a substantially open mesh.

11. The device of claim 10 wherein the core segment is comprised of a nonbraided material.

12. The device of claim 1, wherein said flow control element opens upon an occurrence of a pressure differential between said two sides of said flow control element.

13. The device of claim 12 wherein said flow control element allows fluid to flow through said passage from an area of higher pressure to an area of lower pressure.

14. The device of claim 13, wherein said pressure differential is at least 2 mm Hg.

15. The device of claim 1, wherein said flow control element is a valve.

16. The device of claim 15, wherein said valve comprises at least two leaflets.

17. The device of claim 1, wherein the flow control element is configured to allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure.