Performing an apheresis procedure on a donor with identity confirmation

• US 10,643,748 B2
• Filed: 08/20/2019
• Issued: 05/05/2020
• 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:
  US16/545,962
• Publication Number:
  US 20190371459A1
• Time in Patent Office: 259 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
• CPC Class Codes: H05K 999/99 dummy group

Abstract

A method of performing an apheresis procedure on a donor includes receiving donor information used to identify a donor and storing the donor information into a data entry of a database. The database stores data entries for a plurality of different donors. The method includes transmitting the donor information comprising a name and a birth date from the database to an apheresis treatment device. The method includes transmitting a plurality of parameters to the apheresis treatment device to program the apheresis treatment device for an apheresis procedure. The method includes receiving an input from a touch screen of the apheresis treatment device, confirming an identity of the donor based on the input, and performing the apheresis procedure according to the programmed parameters on the apheresis treatment device based on confirming the identity of the donor.

Claims

1. A method of performing an apheresis procedure on a donor, comprising:

receiving donor information used to identify a donor;

storing the donor information into a data entry of a database, the database comprising data entries for a plurality of different donors;

transmitting the donor information comprising a name and a birth date from the database to an apheresis treatment device;

transmitting a plurality of parameters to the apheresis treatment device to program the apheresis treatment device for an apheresis procedure;

receiving an input from a touch screen of the apheresis treatment device;

confirming an identity of the donor based on the input; and

performing the apheresis procedure according to the programmed parameters on the apheresis treatment device based on confirming the identity of the donor.

2. The method of claim 1, generating an error signal that prevents the performance of the apheresis procedure with respect to the donor in the case where the identity of the donor is not confirmed.

3. The method of claim 1, wherein the donor information further comprises sex and weight of each different donor, further comprising operating the apheresis procedure based at least in part on a parameter derived from at least one of the sex and weight of the donor upon which the apheresis procedure is performed.

4. The method of claim 1, further comprising retrieving the data entry from another database remote from the apheresis treatment device.

5. The method of claim 1, wherein if the identity of the donor is confirmed, the method comprises commanding the treatment device to perform the apheresis procedure.

6. The method of claim 5, wherein the plurality of parameters for the apheresis procedure are transmitted after the identity of the donor is confirmed.

7. The method of claim 1, wherein if the identity of the donor does not match the input, the apheresis treatment device responds by disabling or declining to proceed with the apheresis procedure and by triggering an audible and/or visual alarm or alert.

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

9. The method of claim 1, further comprising receiving data from a bar code reader coupled to the apheresis treatment device.

10. The method of claim 1, wherein receiving and storing the donor information occurs at a time prior to carrying out the apheresis procedure on the donor.

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

12. A method of performing an apheresis procedure on a human subject, comprising:

receiving over a network donor information comprising a plurality of donor-specific information;

receiving over the network a plurality of parameters for an apheresis procedure;

receiving a user input from a touch screen to confirm a donor based on the plurality of donor-specific information;

in response to confirming the donor, proceeding with an apheresis procedure operated according to the plurality of parameters, the apheresis procedure comprising drawing blood from a human subject, separating the blood by blood component, and returning at least one of the components to the donor.

13. The method of claim 12, further comprising operating 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 donor.

14. The method 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 method of claim 12, wherein the plurality of donor-specific information are received wirelessly.

16. The method of claim 12, wherein the downloaded plurality of donor-specific information comprises name, sex, weight and birthdate of the donor, wherein the apheresis procedure is operated 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 method of performing an apheresis procedure on a human subject, comprising:

storing a plurality of subject data entries in a data storage device located remotely from an apheresis treatment device, 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;

downloading subject-specific information comprising a name and a birth date from a subject data entry;

programming the apheresis treatment device with a plurality of parameters for the apheresis medical procedure;

receiving an input from a touch screen; and

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

18. The method of claim 17, further comprising retrieving the plurality of subject data entries from a remote storage device before storing them in the data storage device.

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

20. The method 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 and downloaded from the subject data entry.