Artificial kidney set with electronic key

• US 20030088203A1
• Filed: 10/17/2002
• Published: 05/08/2003
• Est. Priority Date: 10/26/2000
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: CHF Solutions, Inc.
• Inventors: Gelfand, Mark, OʼMahony, John J.
• Granted Patent: US 6,695,806 B2
• Time in Patent Office: Days
• US Class Current: 604/6.09
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 1/362264 the filter being a blood filter
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 with identification means

Abstract

An integrated disposable set for dialysis or ultrafiltration treatment of blood is disclosed that includes a memory “key” chip. The key contains information relating to the set, including calibration for sensors, model and date of manufacture and a proprietary secret code to prevent unauthorized duplication of a circuit. The key is activated when treatment of a patient begins to prevent reuse of the set and a delay in use of the set that is too long. Patient data and operational information can be stored in the key during treatment. The key can be returned to the manufacturer or entered into hospital database for analysis. The key is preferably an EEPROM chip that can be embedded in an integral circuit sensor or a separate plug in device, such as a code card.

Claims

1. A disposable set for filtration of blood comprising:

a first passage through which flows blood from and to a patient;

a second passage through which flows filtrates removed from the blood;

at least one blood pressure sensor; and

a programmable memory device containing information regarding the disposable set.

2. The disposable set recited in claim 1 further comprising a blood filter.

3. The disposable set as recited in claim 1 wherein the information contained in the memory device relates to the manufacture of the disposable set.

4. The disposable set as recited in claim 1 wherein the information contained in the memory device relates to the operation of the disposable set.

5. The disposable set as recited in claim 1 wherein the memory device receives information regarding a patient being treated using the disposable set.

6. The disposable set recited in claim 1 wherein the memory device further includes information regarding the operation of the disposable set obtained from the treatment of a patient using the disposable set.

7. The disposable set as recited in claim 1 wherein the disposable set is detachably mounted on a console including at least one pump for pumping blood and a microprocessor for controlling the operation of the disposable set in combination with the console.

8. The disposable set as recited in claim 6 further comprising an electrical connection between the memory device and the microprocessor so that the microprocessor can read from or write to the memory device.

9. The disposable set as recited in claim 8 further comprising an electrical connection between the memory device and the microprocessor so that the microprocessor can control operation of the disposable cartridge based on the memory device information.

10. The disposable set as recited in claim 5 further comprising an electrical connection between the memory device and the microprocessor so that the microprocessor can write to the memory device information regarding the patient being treated using the disposable cartridge.

11. The disposable set as recited in claim 3 wherein the memory device information is selected from the group including serial number, model number, hardware revision and software revision of the disposable cartridge.

12. The disposable set as recited in claim 5 wherein the information regarding the operation of the disposable set in connection with the treatment of a patient is selected from the group including the date and time when the treatment started, the duration of the treatment, treatment modality, alarms, user actions, user settings such as blood flow and fluid removal rate, sensor readings, and amount of fluid removed per treatment.

13. The disposable set as recited in claim 5 wherein the information regarding the operation of the disposable cartridge in connection with the treatment of a patient is selected from the group including the date and time when the disposable cartridge was mounted on the pump console, the date and time when the disposable cartridge was dismounted from the pump console, and battery operation.

14. The disposable set as recited in claim 4 wherein the information about a patient being treated using the disposable cartridge stored in the memory device is selected from the group including patient age, sex and weight, diagnosis, medication administered before and during treatment, and blood pressure and blood gauges.

15. The disposable set as recited in claim 1 wherein the memory device information includes a proprietary secret code to prevent unauthorized duplication of a circuit.

16. The disposable set as recited in claim 1 wherein the memory device information includes calibration coefficients for components that are part of the disposable set.

17. The disposable set as recited in claim 1 wherein the memory device information includes the calibration coefficients for single use blood and ultrafiltrate pressure sensors.

18. The disposable set recited in claim 1 wherein the memory device information includes the calibration coefficients for a single use blood optometric leak detector.

19. The disposable set recited in claim 1 wherein the memory device information includes the calibration coefficients for an optical aximery sensor.

20. The disposable set as recited in claim 1 wherein the memory device is an EEPROM that is embedded in a blood circuit sensor used with the disposable cartridge.

21. The disposable set as recited in claim 7 wherein the memory device is a key code card that is plugged into the control panel of the set.

22. The disposable set as recited in claim 1 wherein the disposable set is used for an ultrafiltration of blood.

23. The disposable set as recited in claim 1 wherein the disposable set is used for dialysis.

25. The filtration system recited in claim 21 further comprising an electrical connection between the memory device and the microprocessor so that the microprocessor can access the memory device information for said control of said operation of the disposable cartridge.

26. The filtration system recited in claim 21 wherein the information contained in the memory device relates to the manufacture of the disposable cartridge.

32. The filtration system recited in claim 25 wherein the predetermined information is selected from the group including serial number, model number, hardware revision and software revision of the disposable cartridge.

43. The filtration system recited in claim 1 wherein such system is used for ultrafiltration.

44. The filtration system recited in claim 1 wherein such system includes a port for the introduction of a dialysate into the blood flowing through such system.

24. A blood filtration system comprising:

a filter;

a disposable set comprising;

a first passage through which flows blood to and from a patient;

a second passage through which flows filtrates removed from the blood by the blood filter;

at least one blood pressure sensor; and

a memory device containing information regarding the disposable set; and

a console on which the disposable set is detachably mounted for pumping the blood and the filtrates, the console including a microprocessor for controlling the operation of the disposable set in combination with the console.

27. The filtration system recited in claim 24 wherein the predetermined information contained in the memory device includes information regarding the operation of the disposable cartridge.

28. The filtration system recited in claim 24 wherein the memory device further includes information regarding a patient being treated using the disposable cartridge.

29. The filtration system recited in claim 24 wherein the memory device further includes information regarding the operation of the disposable cartridge obtained from a patient being treated using the disposable cartridge.

30. The filtration system recited in claim 24 further comprising an electrical connection between the memory device and the microprocessor so that the microprocessor can access the predetermined information contained in the memory device.

31. The filtration system recited in claim 27 further comprising an electrical connection between the memory device and the microprocessor so that the microprocessor can store in the memory device information regarding the patient being treated using the disposable cartridge.

33. The filtration system recited in claim 28 wherein the information regarding the operation of the disposable cartridge in connection with the treatment of a patient is selected from the group including the date and time when the treatment started, the duration of the treatment, treatment modality, alarms, user actions, user settings such as blood flow and fluid removal rate, sensor readings, and amount of fluid removed per treatment.

34. The filtration system recited in claim 28 wherein the information regarding the operation of the disposable set in connection with the treatment of a patient is selected from the group including the date and time when the disposable set was mounted on the pump console, the date and time when the disposable set was dismounted from the pump console, and battery operation.

35. The filtration system recited in claim 28 wherein the information about a patient being treated using the disposable set stored in the memory device is selected from the group including patient age, sex and weight, diagnosis, medication administered before and during treatment, and blood pressure and blood gauges.

36. The filtration system recited in claim 24 wherein the information contained in the memory device includes a proprietary secret code to prevent unauthorized duplication of a circuit.

37. The filtration system recited in claim 24 wherein the information contained in the memory device includes calibration coefficients for components that are part of the disposable set.

38. The filtration system recited in claim 24 wherein the memory device information includes calibration coefficients for single use blood and ultrafiltrate pressure sensors.

39. The filtration system recited in claim 24 wherein the memory device information includes calibration coefficients for a single use blood optometric leak detector.

40. The filtration system recited in claim 24 wherein the memory device information includes calibration coefficients for an optical aximery sensor.

41. The filtration system recited in claim 24 wherein the memory device is an EEPROM that is embedded in a blood circuit sensor used with the disposable cartridge.

42. The filtration system recited in claim 24 wherein the memory device is a key code card that is plugged into the control panel of the set.

45. A disposable set for filtration of blood to be used on a single patient comprising:

an electronic memory device for storing information about the set; and

a tubing set for mounting on a roller blood pump including;

a plurality of pump segment loops for compression by rollers, and

a plurality of tubes leading to and from the patient blood access.

46. The disposable set of claim 45 wherein the tubing set further includes at least one electronic sensor attached to the tubing.

47. The disposable set of claim 45 wherein the memory device is a programmable memory device.

48. A method of preventing reuse or delayed use of a single use extracorporeal blood circulation set comprising:

providing an electronic memory device with the set;

connecting the electronic memory device to a blood pump controller that controls activation of the set;

reading the memory device to ascertain whether and when the set has been previously activated;

if the set has been previously activated and the amount of time that has elapsed since such activation has exceeded a predetermined amount of time, precluding the set from being used to treat a patient.

49. The method recited in claim 48 wherein if the set has been previously activated and the amount of time that has elapsed since such activation has not exceeded a predetermined amount of time, allowing the set to be used to treat a patient.

50. The method recited in claim 48 wherein if the set has not been previously activated, writing information to the memory indicating the date and time that the set has been initially activated.

51. A method of operating a single use extracorporeal blood circulation set comprising:

providing with the set a memory device containing information regarding the set;

connecting a memory device to a controller that controls the operation of the set;

reading the information in the memory device relating to operation of the set.

52. The method of operating a set recited in claim 51 wherein the information contained in the memory device relates to the manufacture of the set to determine whether the set is operable with a pump console to which the set is connected.

53. The method of operating a set recited in claim 52 wherein the information contained in the memory device is selected from the group of serial number, model number, hardware revision and software revision of the set.

54. The method of operating a set recited in claim 51 wherein the information contained in the memory device relates to the time during which a patient is treated using the set to determine whether the set can be used for such treatment.

55. The method of operating a set recited in claim 51 wherein the information contained in the memory device includes a proprietary secret code to prevent unauthorized use of the set.

56. The method of operating a set recited in claim 51 further comprising the step of writing information to the memory device relating to the treatment of a patient using the set.

57. The method of operating a set recited in claim 56 wherein the information written into the memory device is selected from the group including the date and time when the treatment started, the duration of the treatment, treatment modality, alarms, user actions, user settings such as blood flow and fluid removal rate, sensor readings, and amount of fluid removed per treatment.

58. The method of operating a set recited in claim 56 wherein the information written into the memory device is selected from the group including the date and time when the disposable cartridge was mounted on the pump console, the date and time when the disposable cartridge was dismounted from the pump console, and battery operation.

59. The method of operating a set recited in claim 56 wherein the information written into the memory device is selected from the group including patient age, sex and weight, diagnosis, medication administered before and during treatment, and blood pressure and blood gauges.