Acoustic access disconnection systems and methods

• US 9,138,528 B2
• Filed: 12/04/2013
• Issued: 09/22/2015
• Est. Priority Date: 02/09/2007
• Status: Expired due to Fees

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Roger, Rodolfo, Childers, Robert, Kelly, Thomas D.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US14/096,929
• Publication Number:
  US 20140088484A1
• Time in Patent Office: 657 Days
• Field of Search: 604 401- 616, 604 8- 10, 604 65- 67, 604 27- 31, 604/122, 604/149, 600485-490, 210644-650, 422 44- 48
• US Class Current: 1/1
• 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 1/3607 Regulation parameters
• 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 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3375 Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

An access disconnection system includes a blood treatment machine including a housing, an access site detection housing separate from the blood treatment machine housing, a transmitter positioned in the access site housing and configured to transmit an ultrasound wave into a blood stream of a patient, a receiver positioned in the access site housing and configured to receive a reflection of the ultrasound wave from the blood stream of the patient; and electronic circuitry in communication with the transmitter and the receiver. The electronic circuitry is supported by the access site detection housing, and the transmitter is configured to send a wireless disconnection output to the blood treatment machine. The disconnection output is indicative of a change in the reflected ultrasound wave received by the receiver sufficient to expect that an access disconnection of one of the arterial line and the venous line has occurred.

Claims

1. An access disconnection system comprising:

a blood treatment machine including an enclosure;

an access site detection housing separate from the blood treatment machine enclosure;

a transmitter positioned in the access site detection housing and configured to transmit an ultrasound wave into the blood stream of a patient;

a receiver positioned in the access site detection housing and configured to receive a reflection of the ultrasound wave within the blood stream of the patient; and

electronic circuitry in communication with the transmitter and the receiver, the electronic circuitry supported by the access site detection housing, the transmitter configured to send a disconnection output to the blood treatment machine, the disconnection output indicative of a change in the reflected ultrasound wave received by the receiver sufficient to expect that an access disconnection of one of an arterial line or a venous line has occurred.

2. The access disconnection system of claim 1, which upon the disconnection output 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.

3. The access disconnection 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.

4. The access disconnection system of claim 1, wherein the disconnection output is 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.

5. The access disconnection system of claim 1, which is a redundant system that combines the transmitter, the receiver and the electronic circuitry with one of:

(i) an optical blood leak detector, (ii) a capacitive sensing pad detector or (iii) a conductive blanket detector.

6. The access disconnection system of claim 1, wherein the access site detection housing further supports a power supply for powering the electronic circuitry, the transmitter and the receiver.

7. An access disconnection system comprising:

a blood treatment machine including an enclosure;

an access site detection housing separate from the blood treatment machine enclosure;

a transmitter positioned in the access site detection housing, the transmitter configured to transmit an ultrasound wave into the blood stream of a patient;

a receiver positioned in the access site detection housing, the receiver configured to receive a reflection of the ultrasound wave within the blood stream of the patient; and

electronic circuitry supported by the access site detection housing, the electronic circuitry coupled to the transmitter, the transmitter configured to send a disconnection output, the disconnection output indicative of a change in the reflected ultrasound wave received by the receiver sufficient to expect that an access disconnection of one of an arterial line or a venous line has occurred.

8. The access disconnection system of claim 7, wherein the transmitter is positioned in the access site detection housing parallel with an arm and corresponding tissue of the patient, and the receiver is positioned in the access site detection housing at an angle relative to the arm and tissue of the patient.

9. The access disconnection system of claim 7, wherein the receiver is positioned at an angle of about forty-five degrees relative to an arm and corresponding tissue of the patient.

10. The access disconnection system of claim 7, wherein the disconnection output includes at least one of an audio or visual alarm.

11. The access disconnection system of claim 7, which includes at least one band having at least one fastener, the band and fastener positioned and arranged to enable the access site detection housing to be secured to the patient.

12. The access disconnection system of claim 7, wherein the disconnection output is sent to the blood treatment unit, and the blood treatment unit is configured to, upon receipt of the disconnection output, cause the blood treatment unit to at least one of:

(i) shut down a blood pump, (ii) activate a venous line clamp, or (iii) alert the patient of the disconnection.

13. The access disconnection system of claim 7, which includes a rechargeable battery electrically connected to the electronic circuitry, the rechargeable battery configured to supply power to the electronic circuitry.

14. The access disconnection system of claim 7, wherein the ultrasound wave includes a frequency in the Mega-Hertz range.

15. The access disconnection system of claim 7, wherein the disconnection output is a wireless output, and which includes a wireless receiver positioned in the blood treatment unit housing and configured to receive the wireless disconnection output.

16. The access disconnection system of claim 7, wherein the disconnection output is of at least one type selected from the group consisting of:

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

17. The access disconnection system of claim 7, wherein the change in the reflected ultrasound wave is a change in a signature response produced by the reflected ultrasound wave.

18. An access disconnection system comprising:

a blood treatment machine including an enclosure;

an access site detection housing separate from the blood treatment machine enclosure;

a transmitter configured to transmit an ultrasound wave into a blood stream of a patient;

a receiver configured to receive a reflection of the ultrasound wave from the blood stream of the patient, wherein at least one of the transmitter and the receiver is supported by the access site detection housing; and

electronic circuitry supported by the access site detection housing, the electronic circuitry configured to send a disconnection output to a receiver of the blood treatment machine, which indicates to the machine that an access disconnection of one of an arterial line or a venous line has occurred.

19. The access disconnection system of claim 18, wherein the access site detection housing is a first separate housing, and which includes a second housing separate from the blood treatment machine housing, wherein one of the ultrasound transmitter and the ultrasound receiver is positioned in the first housing and the other of the ultrasound transmitter and the receiver is positioned in the second housing.

20. The access disconnection system of claim 19, wherein the access site disconnection housing is connected to a portion of one of the arterial line or the venous line and the second separate housing is connected to a portion of the other of the arterial line or the venous line.