Functional isolation of upgradeable components to reduce risk in medical treatment devices

• US 7,771,379 B2
• Filed: 11/03/2003
• Issued: 08/10/2010
• Est. Priority Date: 05/24/2001
• Status: Active Grant

• Current Assignee: ABB Research Ltd. (ABB Ltd.), Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Treu, Dennis M.
• Primary Examiner(s): Deak; Leslie R
• Assistant Examiner(s): Wiest; Philip R
• Application Number:
  US10/699,921
• Publication Number:
  US 20040249330A1
• Time in Patent Office: 2,472 Days
• Field of Search: 604 8- 10, 604 401- 616, 604/66, 604/67, 600/300, 600/573, 607 66- 75, 128/897, 128903-905, 12820014-20022
• US Class Current: 604/4.01
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/1698 Blood oxygenators with or without heat-exchangers intracorporal A61M1/1678; manufacturing of membranes therefor B01D67/00; semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi-permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3444 in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A medical treatment system isolates more risk-sensitive equipment from less risk-sensitive components of a treatment device to allow upgrades to be made to the latter more easily without an concomitant increase in risk to a patient caused by upgrades. For example, the latter may serve a pure monitoring function while the former encapsulates the treatment functions thereby preventing errors from the latter from propagating into the treatment-sensitive portions of the device.

Claims

1. A medical treatment device comprising:

a single treatment unit configured to administer a medical treatment to a patient, the treatment unit including user-accessible controls configured to permit control of the administration of the medical treatment and indicators configured to show status information relating to the medical treatment, the treatment unit having a programmable processor;

a programmable monitor unit with at least one display and at least one control configured to permit the selection of information to be shown on the display, the programmable monitor unit further having a memory for storing executable instructions thereon;

the monitor unit being configured to process treatment data from the treatment unit responsively to the executable instructions stored in its memory,

the monitor unit being positioned adjacent the treatment unit such that a single user has simultaneous physical access to the treatment unit controls and indicators and the monitor unit controls and display; and

a one-way communication mechanism operatively connecting the treatment unit to the monitor unit such that the monitor unit is prevented from sending signals to the treatment unit at all times during operation of the medical treatment device and such that the monitor unit receives data from the treatment unit,

the monitor unit being configured to output at least data relating to a status of the medical treatment being administered by the treatment unit;

the monitor unit being configured to receive changes to instructions stored in the memory from a remote device by which the monitor unit'"'"'s function is modified;

the monitor unit being configured to process the treatment data from the single treatment unit, exclusively.

2. The device of claim 1, wherein the treatment unit and the monitor unit are connected to a common control panel with inputs and outputs, each connected such that any signals from the monitor unit are prevented from being transmitted to the treatment unit.

3. The device of claim 2, wherein the treatment unit, the monitor unit, and the control panel are located within a common housing.

4. The device of claim 1, wherein the monitor unit is configured to output on the display at least one of a time-series of sensor signals received over the one-way communication mechanism, a graphical representation of sensor signals received over the one-way communication mechanism, maximum and minimum sensor signal values received over the one-way communication mechanism, text adding information to information received over the one-way communication mechanism, and troubleshooting information responsive to information received over the one-way communication mechanism.

5. The device of claim 1, wherein signals from the monitor unit are physically prevented from being transmitted to the treatment unit.

6. The device of claim 1, wherein the one-way communication mechanism lacks the ability to transmit signals to the treatment unit.

7. The device of claim 1, wherein the monitor unit and treatment unit are configured to be located adjacent the patient being treated.

8. The device of claim 1, wherein the monitor unit at least one control includes multiple controls and the display includes a graphical display.

9. The device of claim 1, wherein the one-way communication mechanism is an opto-isolator that only permits signals to be transmitted from the treatment unit to the monitor unit.

10. The device of claim 1, wherein the monitor unit is further configured to transfer treatment information to a remote device.

11. The device of claim 10, wherein the monitor unit is further configured to permit it to be controlled by the remote device.

12. A medical treatment device comprising:

a treatment unit configured to administer a medical treatment to a patient, the treatment unit including user-accessible controls configured to permit the control of the administration of the medical treatment and indicators configured to show status information relating to the medical treatment, the treatment unit having a memory and a programmable processor configured to execute software instructions stored in the memory;

a programmable monitor unit with at least one display and at least one control configured to permit the selection of information to be shown on the display, the programmable monitor unit further having a memory for storing executable instructions thereon;

the monitor unit being configured to process treatment data from the treatment unit responsively to the executable instructions stored in its memory; and

a one-way communication mechanism configured to provide a dedicated connection for transmitting treatment data from the treatment unit to the monitor unit such that signals from the treatment unit are received by the monitor unit but such that signals from the monitor unit are permanently prevented from being received by the treatment unit,

the monitor unit being dedicated exclusively to the treatment unit such that it receives treatment data exclusively from the treatment unit;

the monitor unit being configured to receive changes to instructions stored in the memory by a remote device by which the monitor unit'"'"'s function is modified;

the treatment unit outputting at least data relating to a status of the medical treatment administered by the treatment unit.

13. The device of claim 12, wherein the treatment unit and the monitor unit are connected to a common control panel with inputs and outputs, each connected such that any signals from the monitor unit are prevented from being transmitted to the treatment unit.

14. The device of claim 12, wherein the monitor unit is configured to output on the display at least one of a time-series of sensor signals received over the one-way communication mechanism, a graphical representation of sensor signals received over the one-way communication mechanism, maximum and minimum sensor signal values received over the one-way communication mechanism, text adding information to information received over the one-way communication mechanism, and troubleshooting information responsive to information received over the one-way communication mechanism.

15. The device of claim 12, wherein signals from the monitor unit are physically prevented from being transmitted to the treatment unit.

16. The device of claim 12, wherein the one-way communication mechanism lacks the ability to transmit signals to the treatment unit.

17. The device of claim 12, wherein the monitor unit and treatment unit are configured to be located adjacent the patient being treated.

18. The device of claim 12, wherein the one-way communication mechanism is an opto-isolator which only permits signals to be transmitted from the treatment unit to the monitor unit.

19. The device of claim 12, wherein the monitor unit is further configured to transfer treatment information to a remote device.

20. The device of claim 19, wherein the monitor unit is further configured to permit it to be controlled by the remote device.

21. A medical treatment device comprising:

a single treatment module configured to administer a medical treatment to a patient, the treatment module including at least one user-accessible control which enables control of administration of the medical treatment, the treatment module having a programmable processor configured to execute software instructions stored in a memory, and

a dedicated monitoring module having a memory for storing executable instructions thereon;

the monitoring module being configured to process treatment data from the treatment unit responsively to the executable instructions stored in its memory and further being configured to receive the treatment data exclusively from the treatment module and to output at least data relating to a status of the medical treatment being administered,

the monitoring module being signally connected to the treatment module exclusively so as to enable data transfer from the treatment module to the monitoring module, and

the monitoring module being operatively isolated from the treatment module such that signals from the monitoring module are physically prevented from being transmitted to the treatment module;

the monitoring module being configured to receive treatment data exclusively from the single treatment module;

the monitoring module being configured to receive changes to instructions stored in the memory by a remote device by which the monitor module'"'"'s function is modified.

22. The device of claim 21, wherein the monitoring module is signally connected to the treatment module by a communication device configured to permit signals to only travel from the treatment module to the monitoring module at all times.

23. The device of claim 21, wherein the monitoring module is signally connected to the treatment module by an opto-isolator which only permits signals to travel from the treatment module to the monitoring module at all times.

24. The device of claim 21, wherein the treatment module includes a transmit-only device, the monitoring module includes a receiving-only device, and the treatment module is signally connected to the monitoring module by a communication link between the transmit-only device and the receiving-only device.

25. The device of claim 21, wherein the treatment module is incapable of receiving signals from the monitoring module during operation of the medical treatment device.

26. The device of claim 21, wherein the monitoring module is incapable of sending signals to the treatment module during operation of the medical treatment device.

27. The device of claim 21, wherein the treatment module has a transmitter without a corresponding receiver, the monitoring module has a receiver, and the monitoring module is connected to the treatment module by way of a signal connection between the treatment module transmitter and the monitoring module receiver.

28. The device of claim 27, wherein the transmitter is an optical emitter or an RF transmitter.

29. The device of claim 21, wherein the treatment and monitoring modules are connected to a common control panel with inputs and outputs, each connected such that the monitoring module is operatively isolated from the treatment module so as to prevent the monitoring module from sending signals to the treatment module at all times.

30. The device of claim 21, wherein the monitoring module includes at least one display and at least one control configured to permit the selection of information to be shown on the display.

31. The device of claim 30, wherein the monitoring module is positioned adjacent to the treatment module such that a single user has simultaneous access to the at least one control of the treatment unit and the at least one display and at least one control of the monitoring module.

32. The device of claim 21, wherein the treatment module is a dialysis machine and the medical treatment is a dialysis treatment of blood from a patient.

33. The device of claim 21, wherein the treatment module is configured to operate as a stand-alone device without any input from said monitoring module.

34. The device of claim 21, wherein the treatment module includes at least one sensor for monitoring the administered medical treatment and the data signals sent to the monitoring module include a measurement by the at least one sensor.

35. The device of claim 21, wherein the treatment module includes at least one sensor configured to measure at least one of patient blood pressure, blood temperature, red blood cell count, volume of blood removed from the patient, and volume of fluid returned to the patient.

36. The device of claim 21, wherein the monitoring module is further configured to transfer treatment information to a remote device.

37. The device of claim 36, wherein the monitoring module is further configured to permit it to be controlled by the remote device.