Interactive systems and methods for supporting hemofiltration therapies

• US 6,673,314 B1
• Filed: 02/25/2000
• Issued: 01/06/2004
• Est. Priority Date: 02/14/1997
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Treu, Dennis M., Burbank, Jeffrey H., Fulkerson, Barry N., White, Steven A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/513,771
• Time in Patent Office: 1,411 Days
• Field of Search: 604/4.01, 604/5.01, 604/5-2-, 604/6.09, 604/28-29, 604/507-8, 604/65, 604/67, 422/44-48, 210/645-47, 210/650-52, 210/321.6, 210/321-1-3, 210/321.75, 210/929, 210/739, 128/898, 128/920, 128/923-24, 128/903-5, 600/300-1, 607/60, 705/45, 705/46, 705/52, 705/55, 705/59, 705/61, 705/924, 705/932, 705/934, 705/10, 714/100, 714/48, 714/25-33, 379/101-1-1, 379/101-5-1, 379/102.01, 379/106-1-1, 379/900
• US Class Current: 422/44
• CPC Class Codes: A61M 1/1639 linked by membranes
• 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 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• 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 1/3448 by mechanically linked pumps in both ultra-filtrate and substitution flow line
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• 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 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• 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 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3639 : Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/367 : Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• 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 2205/3553 : 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 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 39/0208 : Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: Y10S 128/92 : Computer assisted medical diagnostics
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes

Abstract

A hemofiltration machine at a local treatment site is linked to a remote main data base server by a local transmitting/receiving device. The machine acts as a satellite of the main data base server. The machine performs specified therapy tasks while monitoring basic safety functions and providing the person at the treatment location notice of safety alarm conditions for resolution. Otherwise, the machine transmits procedure data to the main data base server. The main data base server relieves the machine from major data processing tasks and related complexity. The main data base server, remote from the machine, controls the processing and distribution of the data, including the flow of information and data to the person undergoing therapy.

Claims

1. A system for conducting hemofiltration, comprising:

a hemofiltration machine including a controller having at least one selectable therapy function for carrying out a hemofiltration task, and generating a data output based upon the hemofiltration task, and an interface coupled to the controller having an input for an operator to select the therapy function;

a transmitting/receiving device linked to the controller adapted for receiving the data output of the controller and transmitting corresponding data to a remote location; and

a main database server installed at the remote location, the server adapted to receive the corresponding data from the transmitting/receiving device and to process the corresponding data to generate a processed output; and

at least one satellite server installed at a site remote from the location of the hemofiltration machine and the main database server and linked to the main database server, including a function to receive the processed output.

3. A system according to claim 1 or 2, wherein the transmitting/receiving device is linked to the controller by means including electrically, phone lines, optical cable connection, infrared light, or radiofrequency, using cordless phone/modem, cellular phone/modem, or cellular satellite phone/modem, or combinations thereof.

4. A system according to claim 1 or 2, wherein the transmitting device includes a laptop computer, or a handheld PC device, or web tablet, or cell phone, or combinations thereof.

5. A system according to claim 1 or 2, wherein the transmitting/receiving device is linked to the main database server by means including a local area network and the Internet.

6. A system according to claim 1 or 2 wherein the satellite server comprises an inventory server operative to generate a responsive output based upon the processed output including equipment inventory information.

7. A system according to claim 6

further including at least one remote component supply facility linked to the inventory server to receive the equipment inventory information.

8. A system according to claim 1 or 2 wherein the satellite server comprises a service server operative to generate a responsive output based upon the processed output including component status information.

9. A system according to claim 8

wherein the service server includes a function to process the component status information according to preprogrammed rules and generate service-related output including a diagnostic report, or a service request, or a maintenance schedule, or combinations thereof.

10. A system according to claim 9

further including at least one remote service facility linked to the service server to receive the component status information.

11. A system according to claim 1 or 2 wherein the satellite server comprises a treatment monitoring server operative to generate a responsive output based upon the processed. output including treatment information.

12. A system according to claim 11

further including at least one remote monitoring facility linked to the treatment monitoring server to receive the treatment information.

13. A system according to claim 1 or 2

wherein the main data base server includes a function to transmit the processed output to the local transmitting/receiving device, and

wherein the transmitting/receiving device includes a function for displaying or printing the processed output.

14. A system according to claim 1 or 2

wherein the main data base server includes a function to download to the local transmitting and receiving device a control program to execute a specified task function using the machine, and

wherein the controller includes a function to download the control program from the local transmitting and receiving device for execution by the machine.

15. A system according to claim 1 or 2

wherein several hemofiltration machines, each at a different treatment site, are individually linked to the main data base server through a local transmitting/receiving device, and

wherein the main data base server generates a processed output specific to each treatment site.

16. A system according to claim 15

wherein the main data base server generates a consolidated output based upon the processed outputs specific to each treatment site.

2. A system for conducting hemofiltration, comprising:

a hemofiltration machine including a controller having at least one selectable therapy function for carrying out a henofiltration task, and generating a data output based upon the hemofiltration task, the controller also having a safety monitoring function which generates a safety alarm output, and an interface coupled to the controller having an input for an operator to select the therapy function and an output for notifying the operator of the safety alarm output;

a transmitting/receiving device linked to the controller adapted for receiving the data output and safety alarm output of the controller and transmitting data corresponding to the data output and safety alarm output to a remote location; and

a main database server installed at the remote location, the server adapted to receive the corresponding data from the transmitting/receiving device and to generate a processed output based on the corresponding data; and

at least one satellite server installed at a site remote from the location of the hemofiltration machine and the main database server and linked to the main database server, including a function to receive the processed output.

17. A system for conducting hemofiltration, comprising

a hemofiltation machine including (a) a controller having a safety monitoring function which generates a safety alarm output and underlying safety data, (b) an interface coupled to the controller having an output for notifying the operator of the safety alarm output, and (c) a transceiver adapted to receive the safety alarm output and underlying safety data from the controller and to transmit corresponding data;

and

a main database server installed at a remote location, the server adapted to (a) receive the corresponding data from the transceiver, (b) process the corresponding data to generate context-sensitive help data pertaining to the alarm condition, and (c) transmit the context-sensitive help data to the transceiver,

wherein the transceiver receives the context-sensitive help data, and

wherein the hemofiltration machine generates a context-sensitive help display or printout based on the context-sensitive help data received by the transceiver.

18. A system according to claim 17, wherein the transmitting receiving device is linked to the controller by means including electrically, phone lines, optical cable connection, infrared light, or radio frequency, using cordless phone/modem, cellular phone/modem, or cellular satellite phone/modem, or combinations thereof.

19. A system according to claim 17, wherein the transmitting/receiving device includes a laptop computer, or handheld PC device, or web tablet, or cell phone, or combinations thereof.

20. A system according to claim 17, wherein the transmitting/receiving device is linked to the main database server by means including a local area network and the Internet.

21. A method for hemofiltration, comprising the steps of:

providing at a fist location a hemofiltation machine and a communicating device linked to the hemofiltration machine;

providing at a second location a main database server;

operating the hemofiltration machine at the first location to receive blood from a patient at a flow rate, pass the blood through a filter, remove waste and ultrafiltrate from the blood, restore replacement fluid to the blood, and infuse the blood into the patient;

communicating data to the main database server at the second location, the data including at least one of a signal indicating that treatment was performed, a measured flow rate, an amount of waste and ultrafiltrate collected, an amount of replacement fluid used, or a difference between the amount of waste and ultrafiltrate collected and the amount of replacement fluid used;

processing the data to generate an output; and

comparing the amount of replacement fluid used with a known inventory at the first location to monitor a patient'"'"'s stock of replacement fluid.

22. The method of claim 21, wherein data is communicated to the main database server by means including electrically, phone lines, optical cable connection, infrared light, or radio frequency, using cordless phone/modem, cellular phone/modem, or cellular satellite phone/modem, or combinations thereof.

23. The method of claim 21, further comprising the step of scheduling a delivery of replacement fluid to the patient based on the comparison of the amount of replacement fluid used with the known inventory at the first location.

24. The method of claim 21, further comprising the step of monitoring patient compliance with a prescribed treatment regimen by comparing the signal indicating that treatment was performed with a prescribed treatment schedule.