Performing an apheresis procedure on a human subject with identity input data

• US 10,130,747 B2
• Filed: 12/08/2017
• Issued: 11/20/2018
• 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): Young, Wayne
• Assistant Examiner(s): Eustaquio, Cal
• Application Number:
  US15/836,227
• Publication Number:
  US 20180099080A1
• Time in Patent Office: 347 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 device having a communication channel in communication with a data storage device remote from the apheresis treatment device, an input device configured to receive an identity input data, wherein the identity input data comprises a combination of data, and a processing circuit. The processing circuit is configured to compare the identity input data to an identity of a human subject downloaded from the data storage device and, if the combination of data is consistent with two or more subject-specific information for a subject data entry, to provide access to an apheresis procedure operated according to the pre-programmed parameters on the apheresis device. The processing circuit is configured to derive an operating parameter for the apheresis procedure based on at least one of the subject-specific information of the human subject and to operate the apheresis procedure using the derived operating parameter.

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 data storage device configured to download an identity 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 parameters comprising 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;

the apheresis treatment device comprising;

an input device configured to receive an identity input data; and

a processing circuit configured to compare the identity input data to the downloaded identity of the human subject and, based at least in part on the result of the comparison, provide access to an apheresis procedure operated according to the pre-programmed parameters on the apheresis treatment device, wherein the processing circuit is configured to modify the subject data entry associated with the identity input data after the apheresis procedure is performed to record a result of the apheresis procedure.

2. The system of claim 1, wherein the processing circuit is configured based on the comparison to generate an error signal that prevents the performance of the apheresis procedure with respect to the human subject associated with the identity input data.

3. The system of claim 1, the input device comprising a card reader configured to read the identity input data from a card and further configured to read a multiple-treatment regimen encoded on the card, wherein the record comprises a result of each treatment in a multiple-treatment regimen over time.

4. The system of claim 1, wherein the subject-specific information 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.

5. The system of claim 1, wherein the input device comprises a touch screen configured to receive user input data from a user.

6. 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 an identity 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 an identity input data, wherein the identity input data comprises a combination of data; and

a processing circuit, wherein the processing circuit is disposed within the apheresis treatment device, the processing circuit configured to compare the identity input data to the downloaded identity of the human subject and, if the combination of data is consistent with two or more subject-specific information for a subject data entry to provide access to an apheresis procedure operated according to the pre-programmed parameters on the apheresis treatment device.

7. The system of claim 6, 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 identity input data does not correspond to a subject data entry.

8. The system of claim 7, 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.

9. The system of claim 6, wherein the input device comprises a wireless transceiver.

10. The system of claim 9, the input device comprising a card reader configured to read the identity input data from a card.

11. The system of claim 10, wherein the card reader comprises a radio frequency ID (RFID) card reader.

12. The system of claim 10, wherein the card reader is further configured to read a multiple-treatment regimen encoded on the card.

13. The system of claim 6, wherein the subject-specific information 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.

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

an apheresis 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, the apheresis device further comprising;

a communication channel in communication with a data storage device remote from the apheresis treatment device,

an input device configured to receive an identity input data, wherein the identity input data comprises a combination of data; and

a processing circuit configured to compare the identity input data to an identity of a human subject downloaded from the data storage device and, if the combination of data is consistent with two or more subject-specific information for a subject data entry, to provide access to an apheresis procedure operated according to the pre-programmed parameters on the apheresis device, wherein the processing circuit is configured to derive an operating parameter for the apheresis procedure based on at least one of the subject-specific information of the human subject and to operate the apheresis procedure using the derived operating parameter.

15. The system of claim 14, wherein the processing circuit is configured to derive the operating parameter based on at least one of the sex and weight of the human subject.

16. The system of claim 14, 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 identity input data does not correspond to a subject data entry.

17. The system of claim 16, 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.

18. The system of claim 14, wherein the combination of identity data comprises a name and a password, a name and a sex, or a name and a medical condition.