IP Library Granted Patent US 8,197,431
Granted Patent B2
US 8,197,431 · App. 11/859,561 · Granted Jun 12, 2012

Acoustic access disconnect detection system

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Quick Facts
Patent No.
US 8,197,431
App. No.
11/859,561
Granted
Jun 12, 2012
Kind
B2
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 (33)

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.

Assignments (6)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2025
From: BAXTER INTERNATIONAL INC.
To: VANTIVE US HEALTHCARE LLC
Reel/Frame 073413/0198 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2025
From: BAXTER HEALTHCARE SA
To: VANTIVE HEALTH GMBH
Reel/Frame 074046/0342 →
SECURITY INTEREST Recorded Jan 31, 2025
From: VANTIVE US HEALTHCARE LLC; GAMBRO RENAL PRODUCTS, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 070076/0701 →
CHANGE OF ADDRESS Recorded May 8, 2012
From: BAXTER HEALTHCARE S.A.
To: BAXTER HEALTHCARE S.A.
Reel/Frame 028177/0390 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 16, 2007
From: BENNISON, CORRIE
To: BATTELLE MEMORIAL INSTITUTE
Reel/Frame 020126/0940 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 16, 2007
From: BATTELLE MEMORIAL INSTITUTE
To: BAXTER INTERNATIONAL INC.; BAXTER HEALTHCARE S.A.
Reel/Frame 020127/0049 →