Devices and methods for treating heart failure

• US 10,632,292 B2
• Filed: 07/23/2015
• Issued: 04/28/2020
• Est. Priority Date: 07/23/2014
• Status: Active Grant

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: Corvia Medical, Inc.
• Inventors: Forcucci, Stephen J., Finch, Matthew J., Magnin, Christopher J., McNamara, Edward I., Devellian, Carol A.
• Primary Examiner(s): Deak, Leslie R
• Application Number:
  US14/807,544
• Publication Number:
  US 20160022970A1
• Time in Patent Office: 1,741 Days
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2017/00601 Implements entirely comprised between the two sides of the opening
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/2478 Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2210/125 Heart
• 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 for implanting into an atrial septum of a patient. In some embodiments, the device has a core region to be disposed in an opening in the atrial septum; a distal retention region adapted to engage tissue on a left atrial side of the septal wall; a proximal retention region adapted to engage tissue on a right atrial side of the septal wall; and a retrieval region comprising a plurality of retrieval members, each retrieval member comprising a connector at a proximal end, the connector being adapted to connect to a delivery system. The device has a delivery configuration and a deployed configuration, the core region, distal retention region and proximal retention region each having a smaller diameter in the delivery configuration than in the deployed configuration, the retrieval member connectors being disposed proximal to and radially outward from the opening in the deployed configuration.

Claims

1. A device for implanting into an atrial septum of a patient, the device comprising:

a core region comprising a plurality of core segments surrounding a central opening, the core region being adapted and configured to be disposed in an opening in the atrial septum;

a distal retention region comprising a plurality of distal retention segments extending from the core segments, the distal retention segments being adapted to engage tissue on a left atrial side of the septal wall;

a proximal retention region comprising a plurality of proximal retention segments extending from the core segments, the proximal retention segments being adapted to engage tissue on a right atrial side of the septal wall; and

a retrieval region comprising a plurality of retrieval members each extending from an outward end of the proximal retention segments, each retrieval member comprising a connector at a proximal end, the connector being adapted to connect to a delivery system;

the device further comprising a first configuration and a second configuration, wherein in its first configuration, the distal retention region engaging the atrial septum in the left atrium, and the proximal retention region engaging the atrial septum in the right atrium, while the plurality of retrieval members extend in an elongated profile, and the connectors at the proximal end of each retrieval member are proximate to each other, and wherein in its second configuration, the distal retention region engaging the atrial septum in the left atrium, and the proximal retention region engaging the atrial septum in the right atrium, while the connectors at the proximal end of the retrieval members are disposed radially outward from the central opening of the core region.

2. The device of claim 1 wherein the connectors are disposed more radially inward in the first configuration than in the second configuration.

3. The device of claim 1 wherein the retrieval region comprises two retrieval members.

4. The device of claim 1 wherein the retrieval region comprises four retrieval members.

5. The device of claim 1 wherein the connectors comprise eyelets.

6. The device of claim 1 wherein the connectors extend radially inward from an end of the retrieval members in the second configuration.

7. The device of claim 1 wherein the connectors extend distally from an end of the retrieval members in the second configuration.

8. The device of claim 1 wherein the device further comprises a retrieval configuration in which the connectors are disposed radially inward from second configuration positions and the proximal and distal retention segments are each in substantially same positions as in the second configuration.

9. The device of claim 8 wherein the retrieval members extend further proximally from the proximal retention region in the first configuration than in the retrieval configuration.

10. A method of implanting a pressure relief device in an atrial septum of a patient'"'"'s heart, the device comprising a retrieval portion, a proximal retention region, a distal retention region, and a core region with an opening, wherein the retrieval region has a plurality of retrieval members each extending from an outward end of the proximal retention segments and is proximal to the proximal retention region, the device comprising a first configuration and a second configuration, wherein in its first configuration, the distal retention region engaging the atrial septum in the left atrium, and the proximal retention region engaging the atrial septum in the right atrium, while the plurality of retrieval members extend in an elongated profile, and the connectors at the proximal end of each retrieval member are proximate to each other, and wherein in its second configuration, the distal retention region engaging the atrial septum in the left atrium, and the proximal retention region engaging the atrial septum in the right atrium, while the plurality of retrieval members of the retrieval region is disposed radially outward from the opening of the core region, the method comprising:

expanding the device into its first configuration, wherein the distal retention region, comprising a plurality of flexible retention segments, engages the septal wall in a left atrium of the patient'"'"'s heart, the proximal retention region, comprising a plurality of flexible retention segments, engages the septal wall in a right atrium of the patient'"'"'s heart, and the core region is positioned within an opening in the septal wall between the left atrium and the right atrium of the patient'"'"'s heart;

releasing the retrieval members from the delivery system; and

thereby letting the device transition into its second configuration.

11. The method of claim 10 wherein the moving step comprises moving the retrieval members from a position proximal to the opening and radially inward from an outer boundary of the opening to a position radially outward from the outer boundary of the opening.

12. The method of claim 10 wherein the device further comprises a retrieval configuration in which the retrieval members are in a position in front of the opening and the proximal and distal retention regions are each in substantially same positions as in the second configuration, the method further comprising expanding the device to the retrieval configuration prior to the releasing step, the steps of expanding the distal retention region, core region and proximal retention region to the second configurations being performed after the releasing step.