Blood flow control devices, systems, and methods

Patent metadata

Field	Value
Publication number	US-12251111-B2
Application number	US-202318193369-A
Country	US
Kind code	B2
Filing date	Mar 30, 2023
Priority date	Mar 16, 2020
Publication date	Mar 18, 2025
Grant date	Mar 18, 2025

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; and
a syringe pump in fluid communication with the balloon and releasably coupled to the housing of the controller, wherein the syringe pump comprises a barrel and a plunger, and is configured to be:
manually actuated for at least an initial manual actuation;
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,
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, and 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.

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

3. The blood flow control system of claim 1 , wherein the system comprises a motor configured to actuate the plunger when the controller adjusts the volume of the balloon.

4. The blood flow control system of claim 3 , wherein the system further comprises one or more of a position sensor and a motion sensor.

5. The blood flow control system of claim 4 , wherein the system comprises the position sensor and wherein the position sensor is configured to monitor a position of a portion of the pump.

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

7. The blood flow control system of claim 4 , wherein the system comprises the motion sensor and wherein the motion sensor is configured to monitor movement of the motor when the plunger 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 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.

12. 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.

13. 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.

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

15. 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.

16. 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; and
a syringe pump in fluid communication with the balloon, wherein the syringe pump is configured to be manually actuated for at least an initial manual actuation, and
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 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, and to automatically control the size of the balloon 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.

17. The blood flow control system of claim 16 , wherein the one or more controllers comprise a housing, and wherein a barrel of the syringe pump is detachably coupled to the housing.

18. The blood flow control system of claim 17 , 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.

19. The blood flow control system of claim 16 , 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.

20. The blood flow control system of claim 16 , wherein the syringe pump comprises a motor operably coupled to the plunger in the second mode to actuate the plunger.

21. The blood flow control system of claim 20 , wherein the system further comprises a motion sensor and wherein the motion sensor is configured to monitor movement of the motor when the plunger is actuated using the motor in the second mode.

22. The blood flow control system of claim 16 , wherein the system further comprises a third mode in which the one or more controllers is configured to control the size of the balloon based on user input received at the controller.

23. The blood flow control system of claim 16 , wherein the target blood pressure or blood pressure range is a mean arterial pressure or mean arterial pressure range.

24. The blood flow control system of claim 16 , wherein the elongate body comprises an inflation lumen, and wherein the syringe pump is coupled to the inflation lumen via tubing.

25. The blood flow control system of claim 16 , wherein the one or more controllers further comprises a barometer configured to measure ambient pressure.

Assignees

• Certus Critical Care Inc
• Univ Wake Forest Health Sciences

Inventors

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

Classifications

• A61B2017/00075

  Motion · CPC title

• A61B2090/064

  for measuring force, pressure or mechanical tension · CPC title

• A61B34/20

  Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis · CPC title

• A61B2017/00557

  inflatable (A61B2017/22051 takes precedence) · CPC title

• A61B2017/00119

  alarm; indicating an abnormal situation · CPC title