Blood flow control devices, systems, and methods

Patent metadata

Field	Value
Publication number	US-11633192-B2
Application number	US-202117365932-A
Country	US
Kind code	B2
Filing date	Jul 1, 2021
Priority date	Mar 16, 2020
Publication date	Apr 25, 2023
Grant date	Apr 25, 2023

Abstract

Systems and methods for blood flow control are described herein. In some variations, a blood flow control system may comprise a blood flow control device. The blood flow control device may be placed within a body of a patient and may comprise an expandable member and a sensor. The sensor may be configured to measure at least one of a physiologic condition of the patient and a pressure associated with the expandable member. The blood flow control system may include at least one controller communicably coupled to the sensor to: receive data indicative of at least one of the physiologic condition of the patient and the pressure associated with the expandable member from the sensor, compare the received data with target data, identify at least one error based on the comparison, and in response to identifying the error, inhibit at least one function of the blood flow control system.

First claim

The invention claimed is:

1. A blood flow control system comprising:
a blood flow control device comprising an elongate body, a balloon coupled to an end portion of the elongate body, a first sensor coupled to the elongate body proximal to the balloon, and a second sensor coupled to the elongate body distal to the balloon, wherein the balloon is configured for placement within a blood vessel of a patient;
a controller communicably coupled to the first and second sensors, wherein the controller comprises a housing;
a pump in fluid communication with the balloon and releasably coupled to the housing of the controller; and
a motor configured to actuate the pump,
wherein the pump is configured to be: decoupled from the housing of the controller and manually actuated to adjust a volume of the balloon and coupled to the housing of the controller and actuated by the controller to adjust the volume of the balloon, and
wherein the controller is configured to automatically adjust a volume of the balloon based on: a) measurements from one or more of the first sensor and the second sensor and b) a target blood pressure or blood pressure range contained on the controller and to determine a change in the volume of the balloon based on movement of the motor.

2. The blood flow control system of claim 1 , wherein the housing comprises an open cavity, and wherein at least a portion of the pump is contained within the open cavity when the pump is coupled to the housing.

3. The blood flow control system of claim 1 , wherein the motor is a stepper motor.

4. The blood flow control system of claim 1 , wherein the system further comprises one or more of a position sensor and a motion sensor.

5. The blood flow control system of claim 1 , wherein the system further comprises a position sensor and wherein the position sensor is configured to monitor a position of a portion of the pump when the pump is coupled to the housing.

6. The blood flow control system of claim 5 , wherein the pump is a syringe pump comprising a plunger and the position sensor is configured to measure a position of the plunger.

7. The blood flow control system of claim 1 , wherein the system further comprises a motion sensor and wherein the motion sensor is configured to monitor movement of the motor when the pump is actuated using the motor.

8. The blood flow control system of claim 1 , wherein the controller comprises a system controller and the blood flow control system further comprises a blood flow control device controller coupled to the elongate body of the blood flow control device.

9. The blood flow control system of claim 1 , wherein the elongate body comprises an inflation lumen, and wherein the pump is coupled to the inflation lumen via tubing.

10. The blood flow control system of claim 1 , wherein the system further comprises a barometer configured to measure ambient pressure.

11. The blood flow control system of claim 1 , wherein the target blood pressure or blood pressure range is a mean arterial pressure or mean arterial pressure range.

12. The blood flow control system of claim 1 , wherein the controller is further configured to adjust the volume of the balloon based on user input received at the controller.

13. The blood flow control system of claim 12 , wherein the system further comprises a user interface comprising an input device, wherein the user input is received via the user input device.

14. A blood flow control system comprising:
a blood flow control device comprising an elongate body, a balloon coupled to an end portion of the elongate body and configured for placement within a blood vessel of a patient, a proximal blood pressure sensor, and a distal blood pressure sensor;
one or more controllers communicably coupled to the proximal and distal blood pressure sensors;
a syringe pump in fluid communication with the balloon; and
a motor configured to actuate the syringe pump,
wherein the system comprises:
a first mode in which a plunger of the syringe pump is manually adjustable by a user to control a size of the balloon; and
a second mode in which the one or more controllers is configured to automatically control the size of the balloon using the motor based on: a) measurements from one or more of the proximal blood pressure sensor and the distal blood pressure sensor and b) a target blood pressure or blood pressure range contained on the controller and to determine a change in the size of the balloon based on movement of the motor.

15. The blood flow control system of claim 14 , wherein the one or more controllers comprise a housing, and wherein a barrel of the syringe pump is detachably coupled to the housing.

16. The blood flow control system of claim 15 , wherein the housing of the one or more controllers comprises an open cavity, and wherein the barrel of the syringe pump is contained within the open cavity when coupled to the housing.

17. The blood flow control system of claim 14 , wherein the one or more controllers comprises a blood flow control device controller coupled to the elongate body of the blood flow control device and a system controller.

18. The blood flow control system of claim 14 , wherein the motor is a stepper motor operably coupled to the plunger in the second mode to actuate the syringe pump.

19. The blood flow control system of claim 18 , wherein the system further comprises a motion sensor and wherein the motion sensor is configured to monitor movement of the motor when the pump is actuated using the motor in the second mode.

20. The blood flow control system of claim 14 , wherein the system further comprises a third mode in which the one or more controllers is configured to control the size of the balloon using the motor based on user input received at the controller.

21. The blood flow control system of claim 14 , wherein the target blood pressure or blood pressure range is a mean arterial pressure or mean arterial pressure range.

22. The blood flow control system of claim 14 , wherein the elongate body comprises an inflation lumen, and wherein the syringe pump is coupled to the inflation lumen via tubing.

23. The blood flow control system of claim 14 , wherein the one or more controllers further comprises a barometer configured to measure ambient pressure.

24. The blood flow control system of claim 1 , wherein the system further comprises a user interface, and wherein the controller is further configured to receive the target blood pressure or the target blood pressure range from a user via the user interface.

25. The blood flow control system of claim 7 , wherein the pump is a syringe pump comprising a plunger and the motion sensor is configured to monitor movement of the motor when the plunger is actuated via the motor.

26. The blood flow control system of claim 1 , wherein the pump is a syringe pump configured to be manually actuated for at least an initial manual actuation, and wherein the controller is configured to determine a maximum allowable inflation level for the balloon for a procedure based on a position of the pump when a barrel of the pump is coupled to the housing after the initial manual actuation.

27. The blood flow control system of claim 14 , wherein the syringe pump is configured to be manually actuated for at least an initial manual actuation, and wherein the controller is configured to determine a maximum allowable inflation level for the balloon

Assignees

• Certus Critical Care Inc
• Univ Wake Forest Health Sciences

Inventors

• Johnson Michael Austin
• Poisner David
• Mcwade Melanie
• Williams Timothy
• Neff Lucas

Classifications

• A61B2017/00725

  Calibration or performance testing · CPC title

• A61B2560/0257

  using atmospheric pressure · CPC title

• A61B17/12109

  in a blood vessel · CPC title

• A61M60/295

  Balloon pumps for circulatory assistance · CPC title

• A61B2017/00734

  battery operated · CPC title