Access disconnection system and method using signal metrics

• US 10,413,654 B2
• Filed: 12/22/2015
• Issued: 09/17/2019
• Est. Priority Date: 12/22/2015
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Funkhouser, Chloe Marie
• Primary Examiner(s): Klein, Benjamin J
• Application Number:
  US14/978,954
• Publication Number:
  US 20170173253A1
• Time in Patent Office: 1,365 Days
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/16 with back-up system in case of failure
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission

Abstract

Renal failure therapy system includes a blood filter, a blood pump, a dialysis fluid pump, a blood line connecting to a patient, a transmitter for receiving a transmit signal and transmitting a wave into blood flowing through the blood line, a receiver for receiving the wave and emitting a corresponding received signal, and a processor for initiating the transmit signal and for receiving the received signal, configured to convert the transmit and received signals into a frequency domain, extract spectral values for the converted transmit and received signals, calculate at least one of a reflection coefficient (R) or an impedance ratio (I) using the spectral values, and analyze an imaginary part of at least one of R or I to determine if an access disconnection event concerning fluid communication between the blood line and the patient has occurred.

Claims

1. A renal failure therapy system comprising:

a blood filter;

a blood pump in fluid communication with the blood filter;

a dialysis fluid pump in fluid communication with the blood filter;

a blood line for connection to a patient, the blood line in fluid communication with the blood filter;

a transmitter positioned and arranged to receive a transmit signal and to transmit a wave into blood flowing through the blood line, the wave based on the transmit signal;

a receiver positioned and arranged to receive the wave and to emit a received signal based on the received wave; and

at least one processor for initiating the transmit signal and for receiving the received signal, the processor configured to

convert the transmit and received signals into a frequency domain,

extract spectral values for the converted transmit and received signals,

calculate a real part and an imaginary part of at least one of a reflection coefficient (R) or an impedance ratio (I) using the spectral values,

determine at least one first baseline value for the imaginary part of at least one of R or I at a beginning of a treatment,

determine at least one second baseline value for the real part of at least one of R or I at the beginning of the treatment, and

compare the imaginary part of at least one of R or I to the at least one first baseline value and compare the real part of at least one of R or I to the at least one second baseline value to determine if an access disconnection event concerning fluid communication between the blood line and the patient has occurred.

2. The renal failure therapy system of claim 1, wherein the at least one processor analyzes imaginary parts of both the reflection coefficient (R) and the impedance ratio (I) to determine if an access disconnection event concerning fluid communication between the blood line and the patient has occurred.

3. The renal failure therapy system of claim 1, wherein the at least one processor further analyzes at least one of a phase shift of at least one of R or I or a magnitude of at least one of R or I to determine if an access disconnection event concerning fluid communication between the blood line and the patient has occurred.

4. The renal failure therapy system of claim 3, wherein the phase shift is provided as an angular value in degrees.

5. The renal failure therapy system of claim 1, wherein the at least one processor determines the at least one first baseline value and the at least one second baseline value for a period of at least 30 seconds from the beginning of the treatment.

6. The renal failure therapy system of claim 1, wherein the spectral values are calculated at a specified frequency.

7. The renal failure therapy system of claim 6, wherein the specified frequency is in a range of 10 Hz to 12 Hz.

8. The renal failure therapy system of claim 6, wherein the specified frequency corresponds to a frequency at a peak spectral value.

9. The renal failure therapy system of claim 1, wherein the at least one processor determines the at least one first baseline value and the at least one second baseline value for analysis during a period of time at the beginning of the treatment.

10. The renal failure therapy system of claim 1, wherein the converted transmit and received signals each include real and imaginary parts, leading to the imaginary parts of R and I.

11. The renal failure therapy system of claim 1, wherein the imaginary parts of the reflection coefficient (R) and the impedance ratio (I) are provided as unitless numerical values.

12. The renal failure therapy system of claim 1, which is a plasmapherisis, hemodialysis (“

HD”

), hemofiltration (“

HF”

), hemodiafiltration (“

HDF”

) or continuous renal replacement therapy (“

CRRT”

) system, and wherein the blood filter is a dialyzer or hemofilter.

13. The renal failure therapy system of claim 1, wherein the blood filter, the blood pump, and the dialysis fluid pump are housed in a machine, and the transmitter and the receiver are housed in a separate unit that communicates wirelessly with the machine.

14. The renal failure therapy system of claim 1, wherein the blood filter, the blood pump, and the dialysis fluid pump are housed in a machine, and the transmitter and the receiver are located at the machine.

15. The renal failure therapy system of claim 1, wherein the at least one processor is part of a housing for the transmitter and the receiver, the housing configured to be attached to the blood line.

16. The renal failure therapy system of claim 1, wherein the at least one processor is a first processor, and which includes a second, redundant at least one processor for receiving the transmit and received signals, the second processor configured to convert the transmit and received signals into the frequency domain, extract spectral values for the converted transmit and received signals, calculate at least one of the reflection coefficient (R) or the impedance ratio (I) using the spectral values, and analyze the imaginary part at least one of R or I to determine if the access disconnection event concerning fluid communication between the blood line and the patient has occurred.

17. The renal failure therapy system of claim 1, wherein the blood line is a venous blood line.

18. The renal failure therapy system of claim 1, wherein the at least one processor is configured to perform at least one of:

(i) shutting down a blood pump, (ii) activating a venous line clamp, and (iii) alerting the patient of the disconnection upon the disconnection event.

19. The renal failure therapy system of claim 1, wherein the transmitter and the receiver are of at least one type selected from the group consisting of:

a single transducer, multiple transducers, piezoelectric, electromagnetic, or any suitable combination thereof.

20. The renal failure therapy system of claim 1, wherein the disconnection event includes an output of at least one type selected from the group consisting of:

an electrical output, a radio frequency output, a microwave output, a continuous output, an intermittent output, an output occurring upon the change, a wireless output, or any suitable combination thereof.

21. A renal failure therapy system comprising:

a blood filter;

a blood pump in fluid communication with the blood filter;

a dialysis fluid pump in fluid communication with the blood filter;

a blood line for connection to a patient, the blood line in fluid communication with the blood filter;

a transmitter positioned and arranged to receive a transmit signal and to transmit a wave into blood flowing through the blood line, the wave based on the transmit signal;

a receiver positioned and arranged to receive the wave and to emit a received signal based on the received wave; and

at least one processor for initiating the transmit signal and for receiving the received signal, the processor configured to

convert the transmit and received signals into a frequency domain,

extract spectral values for the converted transmit and received signals,

calculate a real part and an imaginary part of at least one of a reflection coefficient (R) or an impedance ratio (I) using the spectral values,

determine at least one first baseline value for the imaginary part of at least one of R or I at a beginning of a treatment,

determine at least one second baseline value for the real part of at least one of R or I at the beginning of the treatment, and

compare plural ones of (i) the imaginary part of at least one of R or I to the at least one first baseline value, (ii) a phase shift of R, (iii) a phase shift of I, (iv) the real part of at least one of R or I to the at least one second baseline value, (v) a magnitude of R, and (vi) a magnitude of I, and apply an algorithm to the analyzed plural ones of (i) to (vi) to determine if an access disconnection event concerning fluid communication between the blood line and the patient has occurred.

22. The renal failure therapy system of claim 21, wherein the algorithm includes determining that an access disconnection event concerning fluid communication between the blood line and the patient has occurred if at least (i) and (iv) indicate the access disconnection event.

23. The renal failure therapy system of claim 21, wherein the algorithm includes determining that an access disconnection event concerning fluid communication between the blood line and the patient has occurred if each of the plural ones of (i) to (vi) indicates the access disconnection event.

24. The renal failure therapy system of claim 21, wherein the algorithm includes determining an access disconnection event concerning fluid communication between the blood line and the patient has occurred if multiple ones of the plural ones of (i) to (vi) indicate the access disconnection event.