Needle dislodgement detection systems and methods

Patent metadata

Field	Value
Publication number	US-12390571-B2
Application number	US-202418925370-A
Country	US
Kind code	B2
Filing date	Oct 24, 2024
Priority date	Oct 27, 2023
Publication date	Aug 19, 2025
Grant date	Aug 19, 2025

Abstract

This disclosure teaches a system and method for monitoring an extracorporeal blood circuit of a patient and identifying a needle dislodgement. The method includes identifying a potential needle dislodgement event based on changes in pressure of the extracorporeal blood circuit, searching for a heart rate of a patient by analyzing an optical backscatter signal from an optical sensor attached to the extracorporeal blood circuit or by analyzing a pressure signal representative of the pressure in the extracorporeal blood circuit, and verifying the potential needle dislodgement event is a needle dislodgement based on the absence of the heart rate.

First claim

What is claimed is:

1. A method of monitoring an extracorporeal blood circuit of a patient and identifying a needle dislodgement, the method comprising:
identifying a potential needle dislodgement event based on changes in pressure of the extracorporeal blood circuit;
searching for a heart rate of a patient by analyzing an optical backscatter signal from an optical sensor attached to the extracorporeal blood circuit; and
verifying the potential needle dislodgement event is a needle dislodgement based on the absence of the heart rate.

2. The method of claim 1 , wherein the potential needle dislodgement event is identified by an algorithm that calculates a needle dislodgement value based on a maximum arterial pressure difference, a venous pressure change, the arterial pressure, and the venous pressure, and when the needle dislodgement value is below a threshold value the algorithm identifies the potential needle dislodgement event.

3. The method of claim 1 , wherein the heart rate of the patient is searched for using an algorithm that analyzes the optical backscatter signal by:
filtering data from the optical backscatter signal to produce filtered optical backscatter data (FOBD);
computing a peak to peak (PTP) value by subtracting min FOBD from max FOBD;
computing a prominence value based on PTP value;
identifying and indexing peaks from the FOBD with a prominence above a prominence threshold (PT) and a distance between each peak above a minimum peak distance (min PD);
calculating peak times when more than one peak is indexed; and
calculating the heart rate based on the peak times.

4. The method of claim 3 , further comprising verifying the potential needle dislodgement event is not a needle dislodgement based on the presence of the heart rate (HR) within a set HR range, a variance of the FOBD within a set variance range, and a blood pump rate (BPR) within a set BPR range.

5. The method of claim 4 , further comprising identifying an arterial heart rate of the patient by analyzing changes in the arterial pressure of the extracorporeal blood circuit, wherein the set HR range is determined based on the identified arterial heart rate.

6. The method of claim 5 , wherein verifying the potential needle dislodgement event is further based on the presence of the arterial heart rate with a set arterial HR range.

7. The method of claim 1 , wherein the optical sensor is attached to a venous line of the extracorporeal blood circuit and the needle dislodgement is a venous needle dislodgement.

8. A system for detecting a needle dislodgement of an extracorporeal blood circuit of a patient, the system comprising:
a computing device;
a processor;
a memory comprising instructions, when executed by the processor cause the system to:
receive a venous pressure signal, an arterial pressure signal, and an optical backscatter signal from an optical sensor attached to a venous line of the extracorporeal blood circuit;
identify a potential needle dislodgement event based on changes in the arterial pressure signal and the venous pressure signal;
search for a heart rate of the patient by analyzing the optical backscatter signal; and
verify the potential needle dislodgement event is a needle dislodgement based on the absence of the heart rate.

9. The system of claim 8 , wherein the memory comprising instructions, when executed by the processor cause the system to:
reduce a speed of a blood pump for the extracorporeal blood circuit when the potential needle dislodgement event is identified; and
search for the heart rate of the patient while the blood pump is at the reduced speed.

10. The system of claim 9 , wherein the speed of the blood pump is reduced to a blood flow rate between about 50-120 mL/min when the potential needle dislodgement event is identified.

11. The system of claim 9 , wherein the memory comprising instructions, when executed by the processor cause the system to verify the potential needle dislodgement event is not a needle dislodgement based on the presence of the heart rate.

12. The system of claim 11 , wherein the memory comprising instructions, when executed by the processor cause the system to return the blood pump to a previous speed following verification that the potential needle dislodgement event is not a needle dislodgement.

13. The system of claim 8 , wherein the memory comprising instructions, when executed by the processor cause an algorithm to calculate a needle dislodgement value based on a maximum arterial pressure difference, a venous pressure change, an arterial pressure, and a venous pressure, and when the needle dislodgement value is below a threshold value the algorithm identifies the potential needle dislodgement event.

14. The system of claim 8 , wherein the memory comprising instructions, when executed by the processor cause an algorithm to search for the heart rate of the patient by analyzing the optical backscatter signal, the steps of the algorithm comprise:
filtering data from optical backscatter signal to produce filtered optical backscatter data (FOBD);
computing a peak to peak (PTP) value by subtracting min FOBD from max FOBD;
computing a prominence value based on PTP value;
identifying and indexing peaks from the FOBD with a prominence above a prominence threshold (PT) and a distance between each peak above a minimum peak distance (min PD);
calculating peak times when more than one peak is indexed; and
calculating the heart rate based on the peak times.

15. The system of claim 14 , wherein the memory comprising instructions, when executed by the processor, cause the system to verify the potential needle dislodgement event is not a needle dislodgement based on the presence of the heart rate (HR) within a set HR range, a variance of the FOBD within a set variance range, and a blood pump rate (BPR) within a set BPR range.

16. A dialysis machine, comprising:
a blood pump;
an extracorporeal blood circuit configured to connect the blood pump and a dialyzer to a patient;
an arterial pressure monitor and a venous pressure monitor;
an optical sensor attached to a venous line of the extracorporeal blood circuit;
a computing device comprising a processor and a memory, the computing device being configured to:
receive a venous pressure signal from the venous pressure monitor, an arterial pressure signal from the arterial pressure monitor, and an optical backscatter signal from the optical sensor;
identify a potential needle dislodgement event based on changes in the arterial pressure and venous pressure;
search for a heart rate of a patient by analyzing the optical backscatter signal; and
verify the potential needle dislodgement event is a needle dislodgement based on the absence of the heart rate.

Assignees

• Fresenius Medical Care Holdings Inc
• Awe Tech Llc
• Fresenius Medical Care Deutschland Gmbh

Inventors

• Sinha Dipen N
• Schaefer Robert
• Osterhoudt Curtis
• Espina Peter G
• Crnkovich Martin J
• Wang Fei
• Bowman Steve M
• Urban Martin

Classifications

• A61M1/1601

  Control or regulation · CPC title

• A61M2230/06

  Heartbeat rate only · CPC title

• A61M2205/15

  Detection of leaks · CPC title

• A61M2205/18

  with alarm · CPC title

• A61M2205/3344

  Measuring or controlling pressure at the body treatment site · CPC title