IP Library › Granted Patent US 12,419,644
Granted Patent B2
US 12,419,644 · App. 17/203,742 · Granted Sep 23, 2025

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

Inventors: Michael Austin Johnson (Holladay, UT); David Poisner (Carmichael, CA); Melanie Mcwade (Portland, OR); Timothy Williams (Winston-Salem, NC); Lucas Neff (Winston-Salem, NC)
Assignees: Certus Critical Care, Inc.; Wake Forest University Health Sciences
A61B17/12136A61B5/02158A61B5/4836A61B17/12109A61B34/25A61B2017/00022A61B2017/00075A61B2017/00119A61B2017/00557A61B34/20A61B2090/064
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Quick Facts
Patent No.
US 12,419,644
App. No.
17/203,742
Filed
Mar 16, 2021
Granted
Sep 23, 2025
Kind
B2
Art Unit
3771
USPC
606/194
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.

Claims (77)

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 flow control device through a blood vessel of a patient, wherein the blood flow control device comprises an expandable member and a proximal sensor proximal to the expandable member, and a distal sensor distal to the expandable member;

receiving, from each of the proximal and distal sensors, data indicative of a physiologic condition of the patient;

comparing the received data with target data;

identifying at least one error based on the comparison; and

in response to identifying the error, inhibiting at least one function of the blood flow control device,

wherein the received data is proximal blood pressure from the proximal sensor and distal blood pressure from the distal sensor.

32. A blood flow control system comprising:

a blood flow control device configured to be placed within a portion of a body of a patient, wherein the blood flow control device comprises an expandable member and a proximal sensor proximal to the expandable member, and a distal sensor distal to the expandable member;

a pump operably coupled to the expandable member; and

one or more controllers communicably coupled to the blood flow control device and the pump, the one or more controllers configured to:

automatically control inflation of the expandable member using the pump in an automatic mode based on proximal blood pressure data from the proximal sensor and distal blood pressure data from the distal sensor;

identify an error in the blood flow control system; and

upon identification of the error, automatically transition the blood flow control system from the automatic mode to a manual mode so as to inhibit automatic control of the expandable member with the one or more controllers.

33. The method of claim 31 , wherein the proximal blood pressure is proximal mean arterial pressure and the distal blood pressure is distal mean arterial pressure.

34. The method of claim 31 , wherein the identified error is an error in the placement of the blood flow control device.

35. The method of claim 31 , wherein the identified error indicates an electrical interference from another device.

36. The method of claim 31 , wherein the identified error is an error in a pressure gradient between the proximal sensor and the distal sensor.

37. The method of claim 31 , wherein the error indicates an error in functionality with at least one of the proximal sensor and the distal sensor.

38. The method of claim 31 , wherein the error indicates damage to the sensor.

39. The blood flow control system of claim 32 , wherein the proximal blood pressure data is proximal mean arterial pressure data from the proximal sensor and the distal blood pressure data is distal mean arterial pressure data from the distal sensor.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2022
From: JOHNSON, MICHAEL AUSTIN; POISNER, DAVID; MCWADE, MELANIE
To: CERTUS CRITICAL CARE, INC.
Reel/Frame 061648/0246 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 3, 2022
From: WILLIAMS, TIMOTHY; NEFF, LUCAS
To: WAKE FOREST UNIVERSITY HEALTH SCIENCES
Reel/Frame 061648/0304 →
Continuity (2)
Provisional Application 62990302 · Mar 16, 2020
Related Publication 20210322026A1 · Oct 21, 2021
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