Performing an apheresis procedure on a human subject with identity confirmation

• US 10,431,334 B2
• Filed: 10/17/2018
• Issued: 10/01/2019
• Est. Priority Date: 05/18/2011
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Case, Brian C., Nguyen, Lan T.
• Primary Examiner(s): Syed, Nabil H
• Assistant Examiner(s): Eustaquio, Cal J
• Application Number:
  US16/162,867
• Publication Number:
  US 20190103186A1
• Time in Patent Office: 349 Days
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 1/3403 Regulation parameters
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: G06F 21/31 User authentication
• CPC Class Codes: G08B 3/10 using electric transmission; using electromagnetic transmission
• CPC Class Codes: G08B 5/22 using electric transmission; using electromagnetic transmission
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system for performing an apheresis procedure on a human subject includes an apheresis treatment device and a remote data storage device. The remote data storage device communicates with the apheresis treatment device over a network. The remote data storage device is programmed with a plurality of subject data entries, each subject data entry comprising subject-specific information. The remote data storage device downloads subject-specific information comprising a name and a birth date from the subject data entry and programs the apheresis treatment device with a plurality of parameters for the apheresis medical procedure. The apheresis treatment device includes a touch screen and a controller, the controller confirming an identity of the human subject based on an input. Based on the result of the confirmation access is provided to an apheresis procedure operated according to the programmed parameters on the apheresis treatment device.

Claims

1. A system for performing an apheresis procedure on a human subject, comprising:

an apheresis treatment device configured to draw blood from a human subject, separate the blood by blood component, and return at least one of the components to the human subject; and

a remote data storage device located remotely from the apheresis treatment device and configured to communicate with the apheresis treatment device over a network, the remote data storage device programmed with a plurality of subject data entries, each subject data entry associated with a human subject, each subject data entry comprising subject-specific information, the remote data storage device configured to download subject-specific information comprising a name and a birth date from the subject data entry and further configured to program the apheresis treatment device with a plurality of parameters for the apheresis medical procedure;

the apheresis treatment device comprising;

a wireless circuit configured to communicate with the remote data storage device;

a touch screen configured to receive an input; and

a controller configured to confirm an identity of the human subject based on the input and, based at least in part on the result of the confirmation, provide access to an apheresis procedure operated according to the programmed parameters on the apheresis treatment device.

2. The system of claim 1, wherein the processing circuit is configured to generate an error signal that prevents the performance of the apheresis procedure with respect to the human subject in the case where the identity of the human subject is not confirmed.

3. The system of claim 1, wherein the subject-specific information further comprises sex and weight of each human subject, wherein the apheresis treatment device is configured to operate the apheresis procedure based at least in part on a parameter derived from at least one of the sex and weight of the human subject upon which the apheresis procedure is performed.

4. The system of claim 1, wherein the remote data storage device is configured to retrieve the subject data entry from another remote database.

5. The system of claim 1, wherein if the controller confirms the identity of the human subject, the controller commands the treatment device to perform the apheresis procedure.

6. The system of claim 5, wherein if the controller confirms the identity of the human subject, the controller is configured to retrieve the plurality of parameters for the apheresis medical procedure from the remote data storage device.

7. The system of claim 1, wherein if the controller does not confirm the identity of the human subject, the controller is configured to respond by disabling or declining to proceed with the apheresis procedure and by triggering an audible and/or visual alarm or alert.

8. The system of claim 7, wherein the alarm or alert comprises a text error message displayed on the touch screen.

9. The system of claim 1, further comprising a bar code reader coupled to the apheresis treatment device.

10. The system of claim 1, wherein the remote data storage device is pre-programmed with the subject-specific information at a time prior to the system carrying out the apheresis procedure on the human subject.

11. The system of claim 1, wherein at least one of the parameters used to program the apheresis treatment device for the apheresis medical procedure is stored in the subject data entry.

12. A system for performing an apheresis procedure on a human subject, comprising:

an apheresis treatment device configured to draw blood from a human subject, separate the blood by blood component, and return at least one of the components to the human subject; and

a remote data storage device located remotely from the apheresis treatment device and configured to communicate with the apheresis treatment device over a network, the remote data storage device programmed with a plurality of subject data entries, each subject data entry associated with a human subject, each subject data entry comprising subject-specific information, the data storage device configured to download a plurality of the subject-specific information of the human subject from the subject data entry and further configured to pre-program the apheresis treatment device with a plurality of parameters for the apheresis medical procedure;

the apheresis treatment device comprising;

an input device configured to receive a user input; and

a processing circuit, wherein the processing circuit is disposed within the apheresis treatment device, the processing circuit configured to confirm the human subject based on the received user input and using the plurality of subject-specific information downloaded from the data storage device to provide access to an apheresis procedure on the apheresis treatment device operated according to the pre-programmed parameters.

13. The system of claim 12, wherein the processing circuit is configured to operate the apheresis procedure based on a default operational parameter instead of a parameter unique to the subject in the event the user input does not confirm the human subject.

14. The system of claim 13, wherein the default operational parameter is indicative of at least one of a rate at which fluid may be drawn from the subject and a rate at which fluid may be returned to the subject.

15. The system of claim 14, wherein the apheresis treatment device is configured to download the plurality of subject-specific information wirelessly.

16. The system of claim 12, wherein the downloaded plurality of subject-specific information comprises name, sex, weight and birthdate of the human subject, wherein the apheresis treatment device is configured to operate the apheresis procedure based at least in part on a parameter derived from at least one of the sex and weight of the human subject upon which the apheresis procedure is performed.

17. A system for performing an apheresis procedure on a human subject, comprising:

an apheresis treatment device configured to draw blood from a human subject, separate the blood by blood component, and return at least one of the components to the human subject; and

a remote data storage device located remotely from the apheresis treatment device and configured to communicate with the apheresis treatment device over a network, the remote data storage device programmed with a plurality of subject data entries, the remote data storage device configured to retrieve the subject data entries from a remote database, each subject data entry associated with a human subject, each subject data entry comprising subject-specific information, wherein the remote data storage device is pre-programmed with the subject-specific information at a time prior to the system carrying out the apheresis procedure on the human subject, the remote data storage device configured to download subject-specific information comprising a name and a birth date from the subject data entry and further configured to program the apheresis treatment device with a plurality of parameters for the apheresis medical procedure;

the apheresis treatment device comprising;

a bar code reader coupled to the apheresis treatment device;

a wireless circuit configured to communicate with the remote data storage device;

a touch screen configured to receive an input; and

a controller configured to confirm an identity of the human subject based on the input and, based at least in part on the result of the confirmation, provide access to an apheresis procedure operated according to the programmed parameters on the apheresis treatment device, wherein if the controller does not confirm the identity of the human subject, the controller is configured to respond by declining to proceed with the apheresis procedure and by triggering an audible and/or visual alarm or alert.

18. The system of claim 17, wherein if the controller confirms the identity of the human subject, the controller commands the treatment device to perform the apheresis procedure.

19. The system of claim 17, wherein the alarm or alert comprises a text error message displayed on the touch screen.

20. The system of claim 17, wherein at least one of the parameters used to program the apheresis treatment device for the apheresis medical procedure is stored in the subject data entry.