System and method for detection of disconnection in an extracorporeal blood circuit

• US 8,535,522 B2
• Filed: 02/12/2010
• Issued: 09/17/2013
• Est. Priority Date: 02/12/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Fulkerson, Barry Neil, Braig, James R.
• Primary Examiner(s): Kim, John
• Application Number:
  US12/705,054
• Publication Number:
  US 20100234786A1
• Time in Patent Office: 1,313 Days
• Field of Search: 210/85, 210/90, 210/97, 210/103, 210/109, 210/134, 210/141, 210/143, 210/321.6, 604/4.01, 604/30, 604/65, 604/67
• US Class Current: 210/143
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• 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 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2230/06 Heartbeat rate only

Abstract

The present invention is directed to a dialysis system with a disconnection monitor for determining if a blood line connection to a patient has been disconnected. It includes a blood circuit in fluid communication with a patient and a dialysis circuit, a pressure transducer for generating a signal indicative of a pulse signal in the blood circuit, a cardiac reference signal generator for generating a signal indicative of the patient'"'"'s pulse and a disconnection monitor. The disconnection monitor includes a pressure transducer data receiver for receiving the signal indicative of the pulse signal in the blood circuit, a cardiac reference signal receiver for receiving the signal indicative of the patient'"'"'s pulse, and a processor for cross-correlating the signal indicative of the pulse signal in the blood circuit and the signal indicative of the patient'"'"'s pulse to generate data indicative of a disconnection of the blood line connection to the patient.

Claims

1. A dialysis system having a disconnection monitor for determining if a blood line connection to a patient has been disconnected, comprising:

a. A blood circuit in fluid communication with a patient and a dialysis circuit;

b. A pressure transducer in pressure communication with said blood circuit wherein said pressure transducer generates a signal indicative of a pulse signal in said blood circuit;

c. A cardiac reference signal generator, wherein said cardiac reference signal generator detects and generates a signal indicative of said patient'"'"'s pulse;

d. The disconnection monitor comprising;

i. A pressure transducer data receiver, wherein said pressure transducer data receiver receives said signal indicative of the pulse signal in said blood circuit;

ii. A cardiac reference signal receiver, wherein said cardiac reference signal receiver receives said signal indicative of the patient'"'"'s pulse; and

iii. A processor, wherein said processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient'"'"'s pulse to generate data indicative of a disconnection of the blood line connection to the patient.

2. The dialysis system of claim 1 further comprising a controller, wherein said controller triggers an alarm based upon said data indicative of a disconnection of the blood line connection to the patient.

3. The dialysis system of claim 1 further comprising a controller, wherein said controller shuts down a dialysis pump based upon said data indicative of a disconnection of the blood line connection to the patient.

4. The dialysis system of claim 1 wherein said pressure transducer non-invasively generates a signal indicative of a pulse signal in said blood circuit.

5. The dialysis system of claim 4 wherein, along the length of said blood line to said patient, said pressure transducer is separated from said patient by a pinch valve and an air bubble detector.

6. The dialysis system of claim 1 wherein the cardiac reference signal generator is a pulse oximeter.

7. The dialysis system of claim 1 wherein the processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient'"'"'s pulse by computing a sum of products of corresponding pairs of points of the signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient'"'"'s pulse within a specified time frame.

8. The dialysis system of claim 1 further comprising programmatic instructions for directing a patient to first attach said cardiac signal reference generator prior to starting a dialysis pump.

9. The dialysis system of claim 1 further comprising programmatic instructions for directing the system to capture said signal indicative of the pulse signal in said blood circuit prior to starting a dialysis pump.

10. The dialysis system of claim 1 wherein the processor comprises an amplifier.

11. A dialysis system having a manifold in data communication with a disconnection monitor for determining if a blood line connection to a patient has been disconnected, comprising:

a. The disposable manifold having a blood circuit in fluid communication with a patient and a dialysis circuit;

b. A pressure transducer integrated within said manifold and in non-invasive pressure communication with said blood circuit wherein said pressure transducer generates a signal indicative of a pulse signal in said blood circuit;

c. A cardiac reference signal generator, wherein said cardiac reference signal generator detects and generates a signal indicative of said patient'"'"'s pulse;

d. The disconnection monitor comprising;

i. A pressure transducer data receiver, wherein said pressure transducer data receiver receives said signal indicative of the pulse signal in said blood circuit;

ii. A cardiac reference signal receiver, wherein said cardiac reference signal receiver receives said signal indicative of the patient'"'"'s pulse; and

iii. A processor, wherein said processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient'"'"'s pulse to generate data indicative of a disconnection of the blood line connection to the patient.

12. The dialysis system of claim 11 further comprising a controller, wherein said controller triggers an alarm based upon said data indicative of a disconnection of the blood line connection to the patient.

13. The dialysis system of claim 11 further comprising a controller, wherein said controller shuts down a dialysis pump based upon said data indicative of a disconnection of the blood line connection to the patient.

14. The dialysis system of claim 11 wherein said pressure transducer non-invasively generates a signal indicative of a pulse signal in said blood circuit and wirelessly communicates said signal indicative of a pulse signal in said blood circuit to the pressure transducer data receiver.

15. The dialysis system of claim 14 wherein, along the length of said blood line to said patient, said pressure transducer is separated from said patient by a pinch valve and an air bubble detector.

16. The dialysis system of claim 11 wherein the cardiac reference signal generator is a pulse oximeter and wirelessly communicates said signal indicative of the patient'"'"'s pulse to the cardiac reference signal receiver.

17. The dialysis system of claim 11 wherein the processor cross-correlates said signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient'"'"'s pulse by computing a sum of products of corresponding pairs of points of the signal indicative of the pulse signal in said blood circuit and said signal indicative of the patient'"'"'s pulse within a specified time frame.

18. The dialysis system of claim 11 further comprising programmatic instructions for directing a patient to first attach said cardiac signal reference generator prior to starting a dialysis pump.

19. The dialysis system of claim 11 further comprising programmatic instructions for directing the system to capture said signal indicative of the pulse signal in said blood circuit prior to starting a dialysis pump.

20. The dialysis system of claim 11 wherein the processor comprises an amplifier.