Acoustic access disconnect detection system

• US 8,197,431 B2
• Filed: 09/21/2007
• Issued: 06/12/2012
• Est. Priority Date: 09/21/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Bennison, Corrie
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Wiest, Philip R
• Application Number:
  US11/859,561
• Publication Number:
  US 20090082676A1
• Time in Patent Office: 1,726 Days
• Field of Search: 600485-490, 604 401- 616, 604 8- 10, 604 65- 67, 604 27- 31, 210644-650, 422 44- 48
• US Class Current: 604/6.06
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 Details of valves
• 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 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247

Abstract

An acoustic access disconnect detection system is useful for detecting when an access needle has become dislodged or when blood is leaking. The acoustic disconnect detection system includes an acoustic transmitter and one or more acoustic sensors placed upstream of an access site of a patient, the sensors suitable for generating and detecting an acoustic signal that is intended to pass unobstructed through the access site. The acoustic transmitter may be placed on a therapy machine for generating an acoustic signal. The acoustic sensor is mounted downstream of the transmitter, such as on the therapy machine where blood is pumped to or returned from the patient, on the patient, or on the therapy machine where blood is entering the therapy machine. The therapy machine, such as a dialysis machine, may be programmed not to start or continue operation unless the acoustic signal is within certain parameters.

Claims

1. An access disconnect detector for use with an extracorporeal circuit, the detector comprising:

an acoustic transmitter for producing an acoustic signal and configured for mounting on a venous side of the extracorporeal circuit;

an acoustic sensor for sensing a signal from the acoustic transmitter, the acoustic sensor mounted on the venous side of the extracorporeal circuit; and

a controller configured for (i) sensing a signal from the acoustic transmitter and the acoustic sensor and for sending an alert upon a change in the signal detected from the acoustic transmitter or the acoustic sensor, (ii) calculating a baseline acoustic reflection coefficient for the signal, wherein the reflection coefficient includes a reflected acoustic pressure divided by an incident acoustic pressure, and (iii) calculating a change from the baseline coefficient to determine when a leak or a disconnect has occurred, wherein the controller is in communication with or is part of a therapy machine for receiving blood and returning blood to the venous access site.

2. The access disconnect detector of claim 1, wherein the acoustic transmitter is configured for sending signals from about 5 Hz to about 30 Hz.

3. The access disconnect detector of claim 1, wherein at least one of the transmitter and the sensor are mounted on a cassette for a hemodialysis machine, and further comprising the cassette and the dialysis machine.

4. The access disconnect detector of claim 1, further comprising a hemodialysis machine mounting the transmitter, sensor and controller.

5. The access disconnect detector of claim 1, wherein further comprising a second acoustic sensor mounted adjacent the acoustic sensor, wherein the acoustic sensor and the second acoustic sensor are configured for continuously sensing the signal.

6. The access disconnect detector of claim 1, wherein the controller further comprises a computer program for a signal processing program consisting of one or more programs selected from the group consisting of peak detection, power in band, cross spectrum, and auto spectrum.

7. The access disconnect detector of claim 1, wherein the controller is further configured to stop pumping from the therapy machine to a patient or from the patient to the therapy machine when the leak or disconnect has occurred.

8. The access disconnect detector of claim 1, wherein at least one of the acoustic transmitter and the acoustic sensor are mounted on a flexible membrane of a cassette for a therapy machine, and further comprising the cassette.

9. The access disconnect detector of claim 1, wherein the acoustic transmitter is selected from the group consisting of a piezoelectric actuator and a speaker with a moving coil.

10. A system for use with an extracorporeal circuit and an access disconnect detector, the system comprising:

a therapy machine;

a pumping cassette operated by the therapy machine;

an acoustic transmitter mounted on the therapy machine adjacent the cassette of the therapy machine on a venous side of the extracorporeal circuit, the transmitter configured for pulsing a flexible membrane of the cassette to produce an acoustic signal;

at least one acoustic sensor for sensing a signal from the acoustic transmitter, the acoustic sensor mounted on the venous side of the extracorporeal circuit; and

a controller configured for (i) sensing a signal from the acoustic transmitter and the acoustic sensor and for sending an alert upon a change in the signal from the acoustic transmitter or the acoustic sensor, (ii) calculating a baseline acoustic reflection coefficient for the signal, wherein the reflection coefficient includes a reflected acoustic pressure divided by an incident acoustic pressure, and (iii) calculating a change from the baseline coefficient to determine when a leak or a disconnect has occurred, wherein the controller is in communication with or is part of a therapy machine for receiving blood and returning blood to a patient.

11. The system of claim 10, wherein the acoustic transmitter is a piezoresistive transducer.

12. The system of claim 10, wherein the acoustic transmitter comprises a sine-wave or square-wave generator.

13. The system of claim 10, wherein the acoustic transmitter is mounted downstream of a drip chamber of the therapy machine.

14. A method for detecting an access disconnection, the method comprising:

sending an acoustic signal in a venous line of an extracorporeal circuit, the venous line communicating fluidly with a venous access device;

detecting the acoustic signal via an acoustic sensor in the venous line of the extracorporeal circuit;

comparing the detected acoustic signal with baseline detected acoustic signals;

deciding whether the detected acoustic signal is significantly different from the baseline detected acoustic signals;

sending an alert if the detected acoustic signal is significantly different from the baseline acoustic signals;

calculating a baseline acoustic reflection coefficient for the detected acoustic signal, wherein the reflection coefficient includes a reflected acoustic pressure divided by an incident acoustic pressure; and

determining when an access leak or disconnect has occurred when a change from the baseline acoustic reflection coefficient occurs.

15. The method of claim 14, wherein the acoustic signal is detected between the point of origin of the acoustic signal and:

i. the venous access device;

or, ii. a point on a therapy machine.

16. The method of claim 14, wherein the detecting of the acoustic signal is via a controller in communication with or part of a therapy machine for receiving blood and returning blood to the venous access site, and comprising:

programming the controller to stop blood pumping from the therapy machine to a patient or from the patient to the therapy machine.

17. The method of claim 14, wherein the signal that is sent is from about 5 Hz to about 50 Hz.