Devices and methods for the treatment of heart failure

• US 10,624,621 B2
• Filed: 11/07/2007
• Issued: 04/21/2020
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Celermajer, David Stephen
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US12/447,617
• Publication Number:
  US 20100057192A1
• Time in Patent Office: 4,549 Days
• Field of Search: 623 124, 623 126, 604 8
• 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

A device (10) for treating heart failure in a patient. The device (10) comprising a body (12), at least one passage (18) through the body (12), at least one one way valve (20) in the passage (18) and a mounting means (14) adapted for mounting the body (12) in an opening provided in the patient'"'"'s atrial septum. In use, the device (10) is oriented such that, when the patient'"'"'s left atrial pressure exceeds the patient'"'"'s right atrial pressure by a predetermined amount, the one way valve(s) (20) opens to allow blood flow through the passage(s) from the left atrium to the right atrium to thereby reduce the left atrial pressure.

Claims

1. A device for treating a heart condition in a patient, the device comprising:

a body comprising an inner lumen defining at least one passageway with a first end and a second end, wherein the body has a collapsed configuration with a reduced diameter for passing through a catheter, and an expanded configuration with a larger diameter;

a first flange and a second flange positioned on either end of the body, wherein both the first and the second flange have a collapsed tubular configuration with a first portion joining the body at a first end of the first portion and a second portion joining the first portion at a second end of the first portion, and an expanded flange configuration with the first portion of both flanges forming a first exterior face and the second portion of both flanges forming a second exterior face,

wherein, in the expanded configuration, the first and second flanges are adapted for mounting the body in an opening in the patient'"'"'s atrial septum each with the first exterior face contacting the atrial septum, and the second exterior face facing away from the atrial septum, and wherein, in the collapsed configuration, both exterior faces of the first and second flanges extend away from one another causing the first and second flanges to lengthen and resume the tubular configuration; and

at least one valve disposed inside the passageway, the valve positioned closer to a central portion of the passageway than the first or second ends of the passageway, along a longitudinal axis of the passageway,

wherein the at least one valve is adapted to open and allow blood flow through the passageway from the left atrium to the right atrium to thereby reduce the left atrial pressure when the patient'"'"'s left atrial pressure exceeds the patient'"'"'s right atrial pressure by a predetermined amount and prevent flow from the right atrium to the left atrium when the right atrial pressure exceeds the left atrial pressure.

2. The device recited in claim 1, wherein the valve is one of a duckbill valve, a leaflet valve, a flap valve, a disc in cage type valve and a ball in cage type valve.

3. The device recited in claim 2, wherein the valve is biased in a closed position.

4. The device as recited in claim 2, wherein the valve is constructed of a resilient material and is biased to the closed position by the force applied by the resilient material.

5. The device as recited in claim 1, wherein the valve opens when the predetermined amount of pressure differential is approximately 2 mm Hg.

6. The device as recited in claim 1, wherein the valve opens when the predetermined amount of pressure differential is approximately 5 to 25 mm Hg.

7. The device as recited in claim 1, wherein the valve opens when the predetermined amount of pressure differential is approximately 5 to 15 mm Hg.

8. The device as recited in claim 1 wherein body defines a single passageway into which a valve is disposed.

9. The device as recited in claim 8, wherein the body includes a central axis and the single passageway is located along the central axis of the body.

10. The device as recited in claim 8, wherein the body includes a central axis and the single passageway is located off the central axis of the body.

11. The device as recited in claim 1, wherein the body defines a plurality of passageways through the body and further comprising a one way valve in each passageway.

12. The device as recited in claim 11, wherein the device includes a central axis and the plurality of passageways are located off the central axis of the body.

13. The device as recited in claim 1, wherein the device is flexible and is deliverable to an implant site via a catheter.

14. The device as recited in claim 13, wherein the device is formed from a material which can be deformed but later return to its original shape.

15. The device as recited in claim 14, wherein the device is formed at least in part from Nitinol.

16. The device as recited in claim 1, wherein the device includes a first configuration that has a reduced cross sectional profile and a second configuration that is adapted for implantation in the body, the first configuration being adapted to deliver the device via a catheter.

17. The device as recited in claim 1, wherein the device is collapsible to a size able to pass through an opening made in the patient'"'"'s atrial septum and adapted to return to a shape where at least some of the device would be unable to pass through the opening in the patient'"'"'s atrial septum.

18. The device as recited in claim 17, wherein the device is formed at least in part by a Nitinol mesh.

19. The device as recited in any one of the claim 1, wherein at least one of the first and second flange has a radial dimension larger than the opening in the patient'"'"'s septum.

20. The device as recited in claim 1, wherein the first and second flanges have a dimension larger than the opening in the patient'"'"'s septum.

21. The device as recited in claim 1, wherein the first and second flanges are adapted for attaching to the patient'"'"'s septum by one of gluing, suturing, stapling and pinning.

22. The device as recited in claim 1, wherein the flanges are spaced apart by about the thickness of the patient'"'"'s atrial septum and are adapted to position the patient'"'"'s atrial septum between the flanges.

23. The device as recited in claim 1, wherein the flanges are spaced apart by about the thickness of the patient'"'"'s atrial septum and are adapted to grip the patient'"'"'s atrial septum between the flanges.

24. The device of claim 1, wherein the valve is disposed substantially in the center of the passageway.

25. The device of claim 1, wherein the valve is disposed away from both ends of the passageway.