System and method for detecting access disconnection

• US 8,192,388 B2
• Filed: 07/25/2008
• Issued: 06/05/2012
• Est. Priority Date: 07/25/2008
• Status: Active Grant

• Current Assignee: Baster International Incorporated, Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Hogard, Michael
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Wiest, Philip R
• Application Number:
  US12/180,331
• Publication Number:
  US 20100022934A1
• Time in Patent Office: 1,411 Days
• Field of Search: 604/4.01, 604/6.11, 604 29- 31, 604/90, 604/118, 604/119, 604/122, 604/149, 210/646, 210/739, 210/741
• US Class Current: 604/6.11
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• 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 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• 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 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/279 Peristaltic pumps, e.g. roller pumps
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 : using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/531 : using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/554 : of blood pressure

Abstract

A dialysis system includes: a blood filter; a dialysate pump connected to a dialysate portion of the blood filter; a blood pump connected to a blood portion of the blood filter, the blood pump including a diaphragm that is moved in cycles to pump the blood, the cycles having a flow period and a no-flow period; a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a first characteristic of a property when the patient access device is lodged in a patient and a second characteristic of the property when the patient access device is dislodged from the patient; and a logic implementer configured to determine that the patient access device has been dislodged from the patient when the second characteristic of the parameter is detected.

Claims

1. A dialysis system comprising:

a blood filter;

a dialysate pump connected to a dialysate portion of the blood filter;

a blood pump connected to a blood portion of the blood filter, the blood pump including a diaphragm that is moved in cycles to pump the blood, the cycles having a flow period and a no-flow period;

a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a first characteristic of a property when the patient access device is lodged in a patient and a second characteristic of the property when the patient access device is dislodged from the patient; and

a logic implementer configured to determine that the patient access device has been dislodged from the patient when the second characteristic of the property is detected.

2. The dialysis system of claim 1, wherein the blood filter is of a type selected from the group consisting of:

a hemodialyzer and a hemofilter.

3. The dialysis system of claim 1, wherein the patient access device is a blood-return access device.

4. The dialysis system of claim 1, wherein the blood pump is connected to an arterial line connected to the blood portion of the blood filter.

5. The dialysis system of claim 1, wherein the patient access device includes a needle.

6. The dialysis system of claim 1, wherein the property is time, the first characteristic is a shorter amount of time and the second characteristic is a longer amount of time.

7. The dialysis system of claim 1, wherein the property is blood pressure, the first characteristic being a higher blood pressure, the second characteristic being a lower blood pressure.

8. The dialysis system of claim 1, the logic implementer further configured to lengthen the no-flow period so as to enhance a difference between the first and second characteristics of the property.

9. The dialysis system of claim 1, which includes a pressure sensor positioned to measure pressure in a blood line connected to the patient access device, the pressure sensor sending a signal to the logic implementer, the signal indicative of the property.

10. The dialysis system of claim 9, the property being blood pressure, the signal indicative of the pressure of blood in the patient.

11. The dialysis system of claim 1, the property being a time period, and which includes an air pressure sensor positioned to measure a pressure of air used to drive the diaphragm, the pressure sensor sending a signal to the logic implementer, the signal indicative of a length of the time period.

12. The dialysis system of claim 1, which includes a flow sensor positioned to measure flow in a blood line connected to the patient access device, the flow sensor sending a signal to the logic implementer, the property being a time of the no-flow period as indicated by the signal.

13. The dialysis system of claim 1, the property being a first property, the no-flow period further having a first characteristic of a second property when the patient access device is lodged in the patient and a second characteristic of the second property when the patient access device is dislodged from the patient, the logic implementer configured to determine that the patient access device has been dislodged from the patient when the second characteristics of both the first and second properties are detected.

14. The dialysis system of claim 13, wherein the first property is time of the no-flow period and the second property is a blood pressure during the no-flow period.

15. The dialysis system of claim 1, the property being a first property, the no-flow period further having a first characteristic of a second property when the patient access device is lodged in the patient and a second characteristic of the second property when the patient access device is dislodged from the patient, the logic implementer configured to determine that the patient access device has been dislodged from the patient when the second characteristic of either the first and second properties is detected.

16. The dialysis system of claim 15, wherein the first property is time of the no-flow period and the second property is a blood pressure during the no-flow period.

17. A dialysis system comprising:

a blood filter;

a dialysate pump connected to a dialysate portion of the blood filter;

a blood pump connected to a blood portion of the blood filter, the blood pump including a diaphragm that is moved in cycles to pump the blood, the cycles having a flow period and a no-flow period;

a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a first duration when the patient access device is lodged in a patient and a second duration when the patient access devices is dislodged from the patient; and

a logic implementer configured to determine that the patient access device has been dislodged from the patient when the second duration is detected.

18. The dialysis system of claim 17, wherein the first duration is less than the second duration.

19. A dialysis system comprising:

a blood filter;

a dialysate pump connected to a dialysate portion of the blood filter;

a blood pump connected to a blood portion of the blood filter, the blood pump including a diaphragm that is moved in cycles to pump the blood, the cycles having a flow period and a no-flow period;

a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a characteristic duration when the patient access device is lodged in a patient; and

a logic implementer configured to determine that the patient access device has been dislodged from the patient when the characteristic duration of the no-flow period is exceeded.

20. The dialysis system of claim 19, the logic implementer configured to determine that the patient access device has been dislodged when the characteristic duration is exceeded by a certain amount.

21. A dialysis system comprising:

a blood filter;

a dialysate pump connected to a dialysate portion of the blood filter;

a blood pump connected to a blood portion of the blood filter, the blood pump operated so as to have a flow period and a no-flow period;

a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a first blood pressure when the patient access device is lodged in a patient and a second blood pressure when the access devices is dislodged from the patient; and

a logic implementer configured to determine that the patient access device has been dislodged from the patient when the second blood pressure is detected.

22. The dialysis system of claim 21, wherein the first blood pressures is a patient characteristic blood pressure.

23. The dialysis system of claim 21, the logic implementer further configured to lengthen the no-flow period so as to enhance a difference between the first and second blood pressures.

24. The dialysis system of claim 23, the logic implementer configured to set the no-flow period upon an indication that the blood pressure is changing from the first blood pressure to the second blood pressure.

25. The dialysis system of claim 21, the first and second blood pressures being first and second blood pressure ranges.

26. A dialysis system comprising:

a blood filter;

a dialysate pump connected to a dialysate portion of the blood filter;

a blood pump connected to a blood portion of the blood filter, the blood pump operated so as to have a flow period and a no-flow period;

a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a characteristic blood pressure when the patient access device is lodged in a patient; and

a logic implementer configured to determine that the patient access device has been dislodged from the patient when the characteristic blood pressure of the no-flow period is lowered.

27. The dialysis system of claim 26, the logic implementer configured to determine that the patient access device has been dislodged when the characteristic blood pressure is lowered by a certain amount.

28. A dialysis system comprising:

a blood filter;

a dialysate pump connected to a dialysate portion of the blood filter;

a blood pump connected to a blood portion of the blood filter, the blood pump operated so as to have a flow period and a no-flow period;

a patient access device in fluid communication with the blood portion of the blood filter, the no-flow period having a first characteristic of a property when the patient access device is lodged in a patient and a second characteristic of the property when the patient access device is dislodged from the patient; and

a logic implementer configured to determine that the patient access device has been dislodged from the patient when the second characteristic of the property is detected.

29. The dialysis system of claim 28, the blood pump a peristaltic blood, a pump roller of the peristaltic pump stopped to create the no-flow period.

30. The dialysis system of claim 28, the blood pump including a diaphragm, the diaphragm stopped to create the no-flow period.

31. An access disconnection system for a dialysis machine operable with a blood filter, the dialysis machine including a dialysate pump connectable to a dialysate portion of the blood filter and a blood pump connectable to a blood portion of the blood filter, and a patient access device in fluid communication with the blood portion of the blood filter, the access disconnection system comprising:

a logic implementer programmed to;

(i) operate the blood pump so as to have a flow period and a no-flow period, the no-flow period having a first characteristic of a property when the patient access device is lodged in a patient and a second characteristic of the property when the patient access device is dislodged from the patient, and

(ii) determine that the patient access device has been dislodged from the patient when the second characteristic of the property is detected.

32. An access disconnection system for a dialysis machine operable with a blood filter, the dialysis machine including a dialysate pump connectable to a dialysate portion of the blood filter, a blood pump connectable to a blood portion of the blood filter, the blood pump operated so as to have a flow period and a no-flow period, and a patient access device in fluid communication with the blood portion of the blood filter, the access disconnection system comprising:

a logic implementer programmed to;

(i) store a first characteristic of a property during the no-flow period when the patient access device is lodged in a patient and a second characteristic of the property during the no-flow period when the patient access device is dislodged from the patient, and

(ii) determine that the patient access device has been dislodged from the patient when the second characteristic of the property is detected.