Atrial pressure regulation with control, sensing, monitoring and therapy delivery

• US 10,413,284 B2
• Filed: 04/18/2012
• 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, Finch, Matthew J., Sugimoto, Hiroatsu, Forcucci, Stephen, Rajagopalan, Harith
• Primary Examiner(s): Schall, Matthew W
• Application Number:
  US13/450,244
• Publication Number:
  US 20120265296A1
• Time in Patent Office: 2,708 Days
• Field of Search: 623 126
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• 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 2017/00597 Implements comprising a membrane
• 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 2017/1139 Side-to-side connections, e.g. shunt or X-connections
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/144 Wire
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 : Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2493 : Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/966 : with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 : V-shaped
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0001 : Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0002 : for data transfer
• CPC Class Codes: A61F 2250/0013 : for adjusting fluid pressure
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 31/022 : Metals or alloys

Abstract

The present disclosure relates to improved capabilities for stabilizing and regulating atrial pressure with a shunt in the atrial septum or a stent in the coronary sinus. The disclosure also includes sensing, monitoring, drug therapy and control capabilities to provide improved treatment of patients with heart disease and other cardiac related conditions.

Claims

1. A system for treating a heart condition in a patient comprising:

a body element comprising;

a cylindrical core segment defining a passage;

a first annular flange adapted to engage a first surface of an atrial septum of the patient;

a second annular flange adapted to engage a second surface of the atrial septum of the patient; and

a motor mounted to the body element includes a stationary portion and a movable portion, wherein the movable portion of the motor is anchored to a movable flap,

wherein the movable flap is configured to move away from the stationary portion of the motor, forming an opening of the atrial septum, and allowing blood flow between left atrium and right atrium.

2. The system of claim 1 further comprises a sensor that detects data related to at least one of blood chemistry, blood pressure, temperature, electrical characteristics of the patient'"'"'s heart, chemical characteristics of the blood and biomarkers in the blood.

3. The system of claim 2, further comprising a microprocessor in communication with the sensor.

4. The system of claim 3, wherein the sensor is mounted within the patient remotely from the microprocessor and communicates wirelessly with the microprocessor.

5. The system of claim 3 further comprising a wireless communications facility that receives and transmits data detected by the sensor and data generated by the microprocessor.

6. The system of claim 5 wherein the wireless communication facility transmits the data from the sensors and the data generated by the microprocessor to an externally-located monitor.

7. The system of claim 3 further comprising a therapeutic facility mounted within the patient, the therapeutic facility in communication with at least one of the microprocessor and sensor.

8. The system of claim 7, wherein the therapeutic facility dispenses therapy based on at least one instruction received from the microprocessor and the data detected by the sensor.

9. The system of claim 8 wherein the therapy comprises administration of a drug.

10. The system of claim 3, wherein the microprocessor is mounted to or integral with at least one of said core segment, the first annular flange and the second annular flange.

11. The system of claim 1, wherein the cylindrical core segment has a size of a first diameter when deployed, and wherein the cylindrical core segment is collapsible, enabling the cylindrical core segment to have a second diameter less than a size of the first diameter, thereby enabling percutaneous delivery of the system.

12. The system of claim 1, wherein the second annular flange comprises a plurality of flange segments and wherein at least a portion of one of the flange segments of the second annular flange is more flexible or less flexible than another flange segment of the second annular flange.

13. The system of claim 1, wherein the second annular flange comprises a plurality of flange segments, and wherein at least one of the flange segments of the second annular flange comprises a distal end adapted to be substantially parallel with and contact a septal wall when deployed, and wherein at least one end of the cylindrical core segment and the at least one of the flange segments of the second annular flange includes a first curved section that extends into an 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 curved section toward the septal wall and a distal end of at least one of the flange segments of the second annular flange.

14. The system of claim 1, wherein each of the first and second annular flanges comprises a plurality of flange segments and wherein the first annular flange is adapted to engage a first surface of the atrial septum and wherein the second annular flange is adapted to engage a second surface of the atrium septum, and further comprising

a third annular flange disposed between the first annular flange and the second annular flange along an axial length of the cylindrical core segment, the third annular flange comprising a plurality of flange segments having substantially similar lengths and less than lengths of the plurality of flange segments of the second annular flange, said plurality of flange segments of said third annular flange also adapted to engage said second surface of the atrial septum,

wherein the first, second and third annular flanges are at least one of attached to and extending from the cylindrical core segment and wherein the cylindrical core is collapsible, enabling the cylindrical core segment to have a second diameter less than a first diameter of the cylindrical core segment when deployed, enabling percutaneous delivery of the system.

15. The system of claim 1, wherein the second annular flange comprises a plurality of flange segments and wherein at least one flange segment of the plurality of flange segments of the second annular flange is longer than others of the plurality of flange segments of the second annular flange.

22. The system of claim 3, wherein the microprocessor is configured to receive the information from the sensor and communicate the information to the valve element.

23. The system of claim 1, wherein moving of the valve comprises partial opening of the valve.

24. The system of claim 1, wherein moving of the valve comprises partial closing of the valve.

25. The device of claim 23, wherein the microprocessor is configured to receive information from the sensor and communicate the information to the flow control device.

26. The device of claim 1, further comprising a drug administering element adapted to administer a drug to the patient.

28. The device of claim 2, wherein the sensor is mounted to any portion of the body element, including, for example, the first annular flange, the second annular flange, or the core segment.

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

a flow control device that comprises a stationary portion and a movable flap valve for mounting on an atrial septum of the patient;

means for mounting the device on the atrial septum, wherein the means for mounting includes portions within the left atrium and portions within the right atrium of the patient; and

a sensor mounted within the patient and in communication with the flow control device,

wherein the movable flap valve is configured to move closer or away from the stationary portion of the flow control device based on information obtained by the sensor.

17. The device of claim 16, further comprising a microprocessor in communication with the sensor.

18. The device of claim 17, wherein the sensor is mounted within the patient in wireless communication with the microprocessor.

19. The device of claim 16, wherein the sensor is adapted to be read by a device external to the patient.

20. The device of claim 16, wherein the flow control device comprises a motor or actuator for moving a portion of the flow control device for controlling a flow of blood through the flow control device.

21. The device of claim 16, further comprising a piezo actuator mounted to manipulate a portion of the flow control device for controlling a flow of blood through the atrial septum of the patient.

27. The device of claim 16, further comprising a drug administering element adapted to administer a drug to the patient.