Blood flow control devices, systems, and methods and error detection thereof

Patent metadata

Field	Value
Publication number	US-12419644-B2
Application number	US-202117203742-A
Country	US
Kind code	B2
Filing date	Mar 16, 2021
Priority date	Mar 16, 2020
Publication date	Sep 23, 2025
Grant date	Sep 23, 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 for placement within a body of a patient, the blood flow control device comprising an expandable member, a proximal sensor proximal to the expandable member, and a distal sensor distal to the expandable member, wherein each of the proximal and distal sensors is configured to measure a physiologic condition of the patient; and
one or more controllers communicably coupled to each of the proximal and distal sensors and configured to:
receive data indicative of the physiologic condition of the patient from the proximal and distal sensors;
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,

wherein the received data is proximal blood pressure from the proximal sensor and distal blood pressure from the distal sensor, and the one or more controllers is further configured to compare at least one of the proximal blood pressure and the distal blood pressure to a target value.

2. The blood flow control system of claim 1 , wherein the system further comprises a pump to control a volume of the expandable member.

3. The blood flow control system of claim 1 , wherein the at least one function comprises automatic control of the expandable member.

4. The blood flow control system of claim 3 , wherein the one or more controllers is configured to inhibit automatic control of the expandable member by transitioning the blood flow control system from an automatic mode of operation to a manual mode of operation.

5. The blood flow control system of claim 1 , wherein the at least one error indicates an error in the placement of the blood flow control device.

6. The blood flow control system of claim 1 , wherein the proximal blood pressure is proximal mean arterial pressure from the proximal sensor and the distal blood pressure is distal mean arterial pressure from the distal sensor, and
the one or more controllers is further configured to compare at least one of the proximal mean arterial pressure and the distal mean arterial pressure to a target value.

7. The blood flow control system of claim 1 , wherein the at least one error indicates electrical interference from another device.

8. The blood flow control system of claim 7 , wherein
the one or more controllers is further configured to compare the proximal blood pressure to a first threshold value and the distal blood pressure to a second threshold value.

9. The blood flow control system of claim 7 , wherein:
the received data further comprises a heart rate of the patient, and
the one or more controllers is further configured to compare the heart rate to a target heart rate range.

10. The blood flow control system of claim 7 , wherein in response to the electrical interference exceeding a threshold time, the one or more controllers is configured to transition the blood flow control system to the manual mode.

11. The blood flow control system of claim 1 , wherein the at least one error indicates an error in pressure gradient between the proximal sensor and the distal sensor.

12. The blood flow control system of claim 11 , wherein:
the proximal blood pressure is proximal mean arterial pressure from the proximal sensor and the distal blood pressure is distal mean arterial pressure from the distal sensor, and
the one or more controllers is further configured to compare distal pulsatility to a target distal pulsatility.

13. The blood flow control system of claim 1 , wherein:
the error indicates an error in functionality with at least one of the proximal sensor and the distal sensor.

14. The blood flow control system of claim 13 , wherein:
the received data is proximal mean arterial pressure from the proximal sensor and distal mean arterial pressure from the distal sensor, and
the one or more controllers is further configured to compare the proximal mean arterial pressure to the distal mean arterial pressure.

15. The blood flow control system of claim 1 , wherein the one or more controllers is configured to inhibit the at least one function by shutting down the blood flow control system.

16. The blood flow control system of claim 1 , wherein the error indicates damage to the sensor.

17. The blood flow control system of claim 16 , wherein:
the received data further comprises expandable member pressure, and
the one or more controllers is further configured to compare at least one of the proximal blood pressure, the distal blood pressure, and the expandable member pressure to at least one target value.

18. The blood flow control system of claim 1 , wherein the error indicates damage to the expandable member.

19. The blood flow control system of claim 18 , wherein the received data further comprises expandable member pressure and the one or more controllers is further configured to compare the expandable member pressure to a target value.

20. The blood flow control system of claim 1 , wherein the error indicates that the expandable member has reached a maximum volume.

21. The blood flow control system of claim 20 , wherein:
the received data further comprises expandable member pressure, and
the one or more controllers is further configured to compare the expandable member pressure to a maximum threshold value.

22. The blood flow control system of claim 1 , wherein the system further comprises a user interface communicably coupled to the one or more controllers.

23. The blood flow control system of claim 22 , wherein the one or more controllers is further configured to transmit an alert to a user via the user interface.

24. The blood flow control system of claim 23 , wherein the target data comprises a user-inputted target value, and wherein the alert indicates an error in the target value.

25. The blood flow control system of claim 24 , wherein:
the received data further comprises proximal systolic blood pressure, and
the one or more controllers is configured to compare the proximal systolic blood pressure to the target value.

26. The blood flow control system of claim 1 , wherein the one or more controllers is further configured to:
initiate a counter to determine a number of automatic inflations of the expandable member, and
compare the number of automatic inflations to reach a target value to a threshold count, the target value indicating a target blood pressure measurement.

27. The blood flow control system of claim 1 , wherein the one or more controllers is further configured to:
initiate a counter to determine a number of automatic deflations of the expandable member, and
compare the number of automatic deflations to reach a target value to a threshold count, the target value indicating a target blood pressure measurement.

28. The blood flow control system of claim 23 , wherein the alert indicates an unsafe occlusion time.

29. The blood flow control system of claim 28 , wherein the unsafe occlusion time is based on a total time at occlusion.

30. The blood flow control system of claim 28 , wherein the unsafe occlusion time is based on a duration of most recent uninterrupted time at occlusion.

31. A method for controlling blood flow in a patient, the method comprising:
advancing a blood f

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