Medical apparatus comprising a machine for treatment of fluids

• US 8,905,959 B2
• Filed: 04/02/2009
• Issued: 12/09/2014
• Est. Priority Date: 04/04/2008
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Basaglia, Gianni
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US12/935,851
• Publication Number:
  US 20110028881A1
• Time in Patent Office: 2,077 Days
• Field of Search: 604 401- 616, 700/90, 705 2- 3, 715/771
• US Class Current: 604/4.01
• 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 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

A medical apparatus comprises a machine for treatment of fluids provided with means (3) for treating a patient'"'"'s blood which exhibit a control unit (4) for sending command signals and receiving information relating to the treatment under way on the patient. A remote unit (7) is included which enable the remote unit (7) to selectively take control of a predetermined number of functions of the medical machine. The control unit (4) of the medical machine is predisposed to selectively inhibit the remote control means (10) from taking or maintaining control of the functions of the medical machine in consequence of the operating configuration of the machine.

Claims

1. A medical apparatus comprising at least a medical machine for fluid treatment configurable in a plurality of operating configurations, the medical machine exhibiting:

means for treating a fluid including a predetermined number of sensors for detecting functioning parameters of the medical machine and a predetermined number of actuators for intervening in order to modify functioning parameters of the medical machine;

a control unit at least for sending command signals and for receiving information from the means for treating a fluid, the control unit sending command signals to the actuators and receiving data from the sensors in order to set the operating configuration of the machine;

a device for entering data to be supplied to the control unit for enabling a user to generate the command signals for the means for treating a fluid;

a display for viewing at least a part of the information received from the control unit relating to the means for treating a fluid;

remote access and control means for enabling a remote control unit to take control of a predetermined number of functions of the medical machine for treatment of a fluid, the remote access and control means being configured to receive in input at least one identification datum coming from the remote control unit, the control unit of the medical machine being configured to selectively enable or inhibit the remote access and control means from taking control of at least a part of the predetermined number of functions of the medical machine according to the at least one identification datum received;

wherein the control unit of the medical machine is further configured so that (a) if control has been granted to the remote access and control means and (b) if the medical machine is thereafter in a preselected operating configuration, the control unit can selectively inhibit the remote access and control means from maintaining said control of at least a part of one or more of the predetermined number of functions of the medical machine whereby the remote access and control means loses said control of said at least a part of one or more of the predetermined number of functions of the medical machine.

2. The apparatus of claim 1, wherein the plurality of operating configurations comprise one or more operating configurations critical for security, and wherein the control unit inhibits the remote access and control means from taking control of the predetermined number of functions of the medical machine at least when the medical machine is configured in an operating configuration critical for security.

3. The apparatus of claim 2, wherein the one or more operating configurations critical for security are selected from a group consisting of a configuration in which a patient is connected to the medical machine, a treatment configuration, a blood return configuration to the patient at end of treatment, and a disconnecting configuration of the patient from the machine.

4. The apparatus of claim 1, wherein the remote access and control means enable the remote control unit to take complete control of all the functions of the medical machine for fluid treatment in operating configurations in which the control unit does not inhibit the control means from maintaining control of the medical machine.

5. The apparatus of claim 4, wherein in the operating configurations in which the control unit does not inhibit the control means from maintaining control of the medical machine, a remote operator can send, via a device for entering command data of a remote control unit, same command signals as those which can be sent by means of the device for entering data belonging to the medical machine.

6. The apparatus of claim 1, wherein the medical machine further comprises a web server operatively cooperating with the control unit and configured for publishing a predetermined number of web pages, the web pages being remotely accessible by connecting means and being consultable via a web browser, the web server being configured to receive in input the at least an identification datum coming from the remote control unit.

7. The apparatus of claim 1, wherein the medical machine comprises a list of predefined identification data, each of which identification data being assigned respective access faculties to the medical machine, the control unit comparing the identification datum received with the predefined list of identification data in order to establish a correspondence, and once the correspondence has been established, selectively enabling the remote access and control means to take control of a predetermined number of functions of the medical machine for fluid treatment according to the associated access faculty.

8. The apparatus of claim 7, wherein the faculties of access comprise at least a passive faculty of viewing access and an active faculty of control, the remote access and control means taking control of a predetermined number of functions of the medical machine for fluid treatment should the identification datum received correspond to an identification datum in the predefined list which datum is associated to the active faculty of control access and wherein the control unit inhibits the remote access and control means from taking control of the predetermined number of functions of the medical machine for fluid treatment when the identification datum received corresponds to an identification datum in the predefined list associated to the faculty of passive access of viewing.

9. The apparatus of claim 1, wherein the remote access and control means comprise at least a central control program configured to allow remote administration of the predetermined number of functions of the medical machine.

10. The apparatus of claim 9, wherein the medical machine comprises at least a memory store which cooperates with the control unit, the central control software being resident in the memory store in order to be used by the control unit.

11. The apparatus of claim 9, wherein the remote access and control means further comprise a client control program, the client control program being configured to interact with the central control software in order to enable an exchange of data between the control unit and the remote control unit.

12. The apparatus of claim 11, wherein the central control program is a VNC server and the client control program is a VNC client.

13. The apparatus of claim 1, further comprising at least a remote unit for distance control of the medical machine for fluid treatment, the remote control unit exhibiting:

a device for entering at least command data;

a display for viewing at least a part of data relating to the fluid treatment means;

a processing unit for receiving the command data from the entering device and sending them via the remote access and control means and the connecting means, to the control unit of the medical machine.

14. The apparatus of claim 13, wherein the remote control unit comprises at least a memory cooperating with the processing unit, the client control program being resident in the memory.

15. The apparatus of claim 1, wherein the display of the medical machine shows, in use, a graphic user interface configured to show, in an intuitively-understandable form, at least a part of the data received from the control unit relating to the means for fluid treatment and wherein the remote access and control means enable a reproduction on the display of the remote control unit of the graphic user interface shown by the display of the medical machine.

16. The apparatus of claim 15, wherein reproduction of the graphic user interface on the display of the medical machine and on the display of the remote control unit is substantially done contemporaneously.

17. The apparatus of claim 1, further comprising connecting means which set in communication, for exchange of data, the remote control unit with the medical machine for fluid treatment, wherein the connecting means are chosen in a group comprising a computer network, an internet network, an Ethernet network and a wireless network, in order to set the remote control unit in connection with the machine for fluid treatment.

18. The apparatus of claim 1, wherein the medical machine further comprises a web server which operatively cooperates with the control unit and a predetermined number of web pages published by the web server, the web pages being remotely accessible by connecting means and being consultable by means of a web browser, at least a web page reproducing a graphic user interface shown on the display of the medical machine, the web pages further publishing a plurality of further data relating to the medical machine.

19. The apparatus of claim 18, wherein the web server is an internet web server consultable remotely by means of a web browser and wherein the remote access and control means enable reproduction of the web pages in the web server of a graphic user interface shown on the display.

20. The apparatus of claim 19, wherein the remote access and control means enable reproduction of the graphic user interface in the web pages, substantially in real-time, the reproduction of the graphic user interface being updated at each predetermined time interval.

21. The apparatus of claim 19, wherein the remote access and control means enable reproduction of the graphic user interface in the web pages, substantially in real-time, the reproduction of the graphic user interface being updated at each predetermined variation of at least a parameter represented in the graphic user interface.

22. The apparatus of claim 21, wherein the graphic user interface is subdivided into a plurality of regions and in that the updating of the reproduction of each region of the graphic user interface is performed at each predetermined variation of at least a parameter shown in the region, without updating the regions where the predetermined variation has not taken place.

23. The apparatus of claim 18, wherein the remote access and control means comprise at least a central control program and at least a client control program, the client control program being destined to interact with the central control program in order to enable an exchange of data between the control unit and the web server such that the graphic user interface shown on the display can be reproduced in the web pages.

24. The apparatus of claim 23, wherein the web pages of the web server comprise the client control program.

25. The apparatus of claim 23, wherein the client control program is not resident in, or downloaded by, a remote control unit for access to the graphic user interface of the web pages of the web server.

26. The apparatus of claim 23, wherein the client control program resides in the web pages of the web server in a language interpretable by a web browser.

27. The apparatus of claim 23, wherein the client control program resides in the web pages of the web server in a form of a scripting language.

28. The apparatus of claim 18, wherein the plurality of further data published on the web pages of the web server comprises data chosen in the group including data relating to maintenance of the medical machine, data relating to configuration of the medical machine, data relating to a history of alarms issued by the medical machine, data relating to a history of the disinfection operations performed on the medical machine, data relating to a history of functionality checks performed on the medical machine, graphs relating to time and evolution of predetermined parameters of the medical machine.

29. A method for remotely accessing and controlling a medical machine for treatment of fluids, the medical machine being configurable in a plurality of different operating configurations, the method comprising the following stages:

predisposing at least a medical machine for treatment of fluids, exhibiting;

means for treatment of a fluid including a predetermined number of sensors for detecting functioning parameters of the medical machine and a predetermined number of actuators for intervening in order to modify functioning parameters of the medical machine;

a control unit configured at least to send command signals and receive information from the means for treatment of fluids, the control unit sending command signals to the actuators and receiving data from the sensors in order to set the operating configuration of the machine;

a device for entering data to be supplied to the control unit in order to enable a user to generate the command signals for the means for treatment of fluids;

a display for viewing at least a part of the data received from the controlled unit relating to the means for treatment of the fluid;

remote access and control means for enabling a remote control unit to take over control of a predetermined number of functions of the medical machine for treatment of fluid;

predisposing at least a remote control unit for distance-control of the medical machine for treatment of fluids, exhibiting;

a device for entering at least command data;

a display for viewing at least a part of the data relating to means for treatment of fluid;

setting the remote control unit in communication with the medical machine for treatment of fluids via connecting means for an exchange of data and for receiving in input at least one identification datum coming from the remote control unit;

comparing, via the control unit of the medical machine, the at least one identification datum received with a list of predefined identification data, each of the identification data being assigned with respective faculties of access to the medical machine;

establishing a correspondence between the at least one identification datum received and the predefined list of identification data and associating a respective access faculty;

selectively enabling or inhibiting the remote access and control means to take control of a predetermined number of functions of the medical machine for treatment of fluids according to the at least one identification datum or according to the associated access faculty;

establishing the operative configuration of the medical machine via the control unit using the data received from the means for treatment of the fluid;

remotely controlling the medical machine by means of the remote control entering command data via the entering device, the connecting means enabling transmission of the command data and the remote access and control means enabling the remote control unit to take control of a predetermined number of functions of the medical machine for treatment of a fluid;

comparing the predetermined operating configuration in order to establish whether the predetermined operating configuration belongs to a predetermined group of operating conditions, critical for security;

in a case in which the medical machine is in an operating condition belonging to a group of the critical operating conditions for security, inhibiting the remote access and control means from taking or maintaining control of the predetermined number of functions of the medical machine and the remote access and control means losing said control of one or more of the predetermined number of functions of the medical machine.

30. The method of claim 29, wherein the access faculties comprise at least a passive access to viewing and an active access to control, the remote access and control means taking control of a predetermined number of functions of the medical machine for treatment of fluid should the identification datum received correspond to an identification datum of the predefined list associated to the active access to control faculty.

31. A medical apparatus comprising at least a medical machine for fluid treatment configurable in a plurality of operating configurations, the medical machine exhibiting:

means for treating a fluid including a predetermined number of sensors for detecting functioning parameters of the medical machine and a predetermined number of actuators for intervening in order to modify functioning parameters of the medical machine;

a control unit at least for sending command signals and for receiving information from the means for treating a fluid, the control unit sending command signals to the actuators and receiving data from the sensors in order to set the operating configuration of the machine;

a device for entering data to be supplied to the control unit for enabling a user to generate the command signals for the means for treating a fluid;

a display for viewing at least a part of the information received from the control unit relating to the means for treating a fluid;

remote access and control means for enabling a remote control unit to take control of a predetermined number of functions of the medical machine for treatment of a fluid, the remote access and control means being configured to receive in input at least one identification datum coming from the remote control unit, the control unit of the medical machine being configured to selectively enable or inhibit the remote access and control means from taking control of at least a part of the predetermined number of functions of the medical machine according to the at least one identification datum received;

wherein the control unit of the medical machine is further configured so that (a) if control has been granted to the remote access and control means and (b) if the medical machine is thereafter in a preselected operating configuration, the control unit can selectively inhibit the remote access and control means from maintaining said control of at least a part of one or more of the predetermined number of functions of the medical machine whereby the remote access and control means loses said control of said at least a part of one or more of the predetermined number of functions of the medical machine, and wherein the plurality of operating configurations comprises two or more of;

an operating configuration for start-up of the medical machine,

an operating configuration for conducting an operability check of the medical machine,

an operating configuration for setup, preferably comprising application of single-use disposable components to the medical machine,

an operating configuration for priming,

an operating configuration for preparation of treatment fluid,

an operating configuration for connecting a patient to the machine,

an operating configuration in which the patient is connected to the medical machine,

an operating configuration for treatment,

an operating configuration for returning blood to the patient,

an operating configuration for disconnecting the patient from the machine,

an operating configuration for rinsing,

an operating configuration for disinfection,

an operating configuration for cleaning.

32. The apparatus of claim 31, wherein the control unit inhibits the remote access and control means from taking control of at least a part of the predetermined number of functions of the medical machine at least in the following operating configurations:

an operating configuration for preparation of treatment fluid,

an operating configuration for connecting a patient to the medical machine,

an operating configuration in which the patient is connected to the medical machine,

an operating configuration for treatment,

an operating configuration for returning blood to a patient,

an operating configuration for disconnecting the patient from the medical machine.

33. A medical apparatus comprising at least a medical machine for fluid treatment configurable in a first set of operating configurations and in a second set of operating configurations, the medical machine having a current operating configuration, the medical machine exhibiting:

means for treating a fluid including a predetermined number of sensors for detecting functioning parameters of the medical machine and a predetermined number of actuators for intervening in order to modify functioning parameters of the medical machine;

a control unit at least for sending command signals and for receiving information from the means for treating a fluid, the control unit sending command signals to the actuators and receiving data from the sensors in order to set the current operating configuration of the machine;

a device for entering data to be supplied to the control unit for enabling a user to generate the command signals for the means for treating a fluid;

a display for viewing at least a part of the information received from the control unit relating to the means for treating a fluid;

remote access and control means for enabling a remote control unit to take control of a predetermined number of functions of the medical machine for treatment of a fluid, the remote access and control means being configured to receive in input at least one identification datum coming from the remote control unit, the control unit of the medical machine being configured to selectively enable or inhibit the remote access and control means from taking control of at least a part of the predetermined number of functions of the medical machine according to the at least one identification datum received;

wherein the control unit of the medical machine is further configured to selectively;

inhibit the remote access and control means from controlling at least a part of the predetermined number of functions of the medical machine if the current operating configuration of the medical machine is comprised in the second set of operating configurations, and

allow the remote access and control means to control the predetermined number of functions of the medical machine if the current operating configuration of the medical machine is comprised in the first set of operating configurations.

34. The apparatus of claim 33, wherein the first set of operating configurations comprises one or more of:

an operating configuration for start-up of the medical machine,

an operating configuration for conducting an operability check of the medical machine,

an operating configuration for setup, preferably comprising application of single-use disposable components to the medical machine,

an operating configuration for priming,

an operating configuration for rinsing,

an operating configuration for disinfection,

an operating configuration for cleaning.

35. The apparatus of claim 33, wherein the second set of operating configurations comprises one or more of:

an operating configuration for preparation of treatment fluid,

an operating configuration for connecting a patient to the medical machine,

an operating configuration in which the patient is connected to the medical machine,

an operating configuration for treatment,

an operating configuration for returning blood to a patient,

an operating configuration for disconnecting the patient from the medical machine.