Medical solution authentication

• US 10,172,996 B2
• Filed: 08/21/2015
• Issued: 01/08/2019
• Est. Priority Date: 08/22/2014
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Case, Brian C., Katz, Steven R.
• Primary Examiner(s): Drodge, Joseph W
• Application Number:
  US14/832,849
• Publication Number:
  US 20160051746A1
• Time in Patent Office: 1,236 Days
• Field of Search: 210645, 210646, 210 91, 210143, 2103216, 604 401, 604 501, 604 601, 604 19, 604 30, 604 65, 604 67, 604 9301, 604189, 604403, 604404
• CPC Class Codes: A61M 1/265 inducing Taylor vortices
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3455 Substitution fluids
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 2202/0413 Blood
• CPC Class Codes: A61M 2202/0474 haemodiluting
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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: G06F 16/24 Querying
• CPC Class Codes: G06F 16/242 Query formulation
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system of authenticating a medical solution used in a blood processing procedure, comprising a blood processing system having a user interface and access to a database of medical solutions identifiable by identifiers, wherein the blood processing system guides a user through steps of the procedure and the user interface prompts the user to execute an action as part of a step; a fluid circuit having an inlet for a medical solution, wherein the fluid circuit is coupled to the fluid processing system; wherein a step of the blood processing procedure comprises drawing a solution into the circuit, wherein the interface receives a user input of an identifier of the solution prior to the fluid processing system executing the step; wherein the fluid processing system is configured to compare the received identifier to medical solution identifiers within the database and, based on a result of the comparison, executing the step.

Claims

1. A system for authenticating a medical solution during a biological fluid processing procedure, the system comprising:

a biological fluid processing device, comprising a first pump, a user interface, and a separator, configured to convey a source biological component from an inlet of the separator for separation into a first component and a second component;

a fluid circuit configured to associate with the biological processing device, wherein the fluid circuit comprises;

a first container containing a first fluid comprising at least one of an infusion solution, blood additive solution, anticoagulant solution, saline solution, blood component solution, and replacement fluid, for combination with the source biological component, the first component, and/or the second component during a first step of the fluid processing procedure;

a second container containing a second fluid comprising at least one of an infusion solution, blood additive solution, anticoagulant solution, saline solution, blood component solution, and replacement fluid, for combination with the source biological component, the first component, and/or the second component during a second step of the fluid processing procedure;

a plurality of fluid pathways connecting the separator, the first container, and the second container, wherein fluid flow is actuated through the plurality of fluid pathways by the pump;

a microprocessor controller in communication with the user interface of the biological fluid processing device and configured for communication with a local and/or remote database of approved medical solution identifiers, wherein the biological processing device is configured to process in the first step the first fluid from the first container having at least one identifier and to process in the second step the second fluid from the second container having at least one identifier;

wherein the microprocessor controller is programmed with a first set of identifiers approved for the first step and a second set of identifiers approved for the second step;

wherein the microprocessor controller is configured to;

display a prompt to a user via the user interface at the first step to input a first identifier from the first container having at least one identifier;

compare the first identifier to the first set of identifiers;

proceed with the first step only if the first identifier is a match with any identifier within the first set, wherein the first step comprises flowing the first fluid from the first container via the first pump and combining the first fluid with the source biological component, the first component, and/or the second component;

display a prompt to a user via the user interface at the second step to input a second identifier from the second container having at least one identifier;

compare the second identifier to the second set of identifiers; and

proceed with the second step only if the second identifier is a match with any identifier within the second set, wherein the second step comprises flowing the second fluid from the second container via the first pump or a second pump and combining the second fluid with the source biological component, the first component, and/or the second component.

2. The system of claim 1, wherein the microprocessor controller is further configured to trigger an alert via the user interface if the first identifier is not a match with any identifier within the first set or if the second identifier is not a match with any identifier within the second set.

3. The system of claim 1, wherein the first fluid and/or the second fluid comprises at least one of an infusion solution, blood additive solution, anticoagulant solution, saline solution, blood component solution, and replacement fluid.

4. The system of claim 1, wherein the first set and/or the second set of identifiers comprises identifiers associated with at least one of a manufacturer name, solution name, solution contents, content details, product code, bar code, and active or passive RFID tag.

5. The system of claim 1, wherein the biological fluid processing device further comprises a memory within which the database is disposed and wherein the database is configured to be updated over a network.

6. The system of claim 1, wherein the microprocessor controller is configured to read the first identifier or the second identifier via at least one of a data card, a radio frequency identifier, a bar code, a personal digital assistant, a mobile phone, and a disk-based medium.

7. The system of claim 1, wherein the biological fluid processing device further comprises a memory within which the database of approved medical solution identifiers is located.

8. The system of claim 1, wherein the user interface includes at least one of a screen, keyboard, touchscreen, buttons, print-out, voice input, and voice output.

9. The system of claim 1, wherein the biological fluid processing device is configured to communicate with the database of approved medical solution identifiers over a network.

10. A method of authenticating a medical solution during a biological fluid processing procedure, the method comprising:

providing a biological fluid processing device, comprising a first pump, a user interface, and a separator, configured to convey a source biological component from an inlet of the separator for separation into a first component and a second component;

providing a fluid circuit configured to associate with the biological processing device, wherein the fluid circuit comprises

     1) a first container containing a first fluid,

     2) a second container containing a second fluid, and

     3) a plurality of fluid pathways connecting the separator, the first container, and the second container, wherein fluid flow is actuated through the plurality of fluid pathways by the first pump;

providing a microprocessor controller in communication with the user interface of the biological fluid processing device and configured for communication with a local and/or remote database of approved medical solution identifiers, wherein the biological processing device is configured to process in a first step the first fluid from the first container having at least one identifier and to process in a second step the second fluid from the second container having at least one identifier

requesting at the first step of the biological fluid processing procedure via the microprocessor controller and the user interface a first identifier from the first container;

receiving via the user interface the first identifier from the first container;

comparing via the microprocessor controller the first identifier from the first container and a first set of approved identifiers for the first step programmed for the microprocessor controller;

performing the first step only if the first identifier from the first container is a match with any of the first set of approved identifiers for the first step, wherein the first step comprises flowing the first fluid from the first container via the first pump and combining the first fluid with the source biological component, the first component, and/or the second component;

requesting at the second step of the biological fluid processing procedure via the microprocessor controller and the user interface a second identifier from the second container;

receiving via the user interface the second identifier from the second container;

comparing via the microprocessor controller the second identifier from the second container and a second set of approved identifiers for the second step programmed for the microprocessor controller; and

performing the second step only if the second identifier from the second container is a match with any of the second set of approved identifiers for the second step, wherein the second step comprises flowing the second fluid from the second container via the first pump or a second pump and combining the second fluid with the source biological component, the first component, and/or the second component.

11. The method of claim 10, further comprising alerting the user via the user interface if the first identifier is not a match with any of the first set of approved identifiers for the first step.

12. The method of claim 10, wherein the first fluid and/or the second fluid comprises at least one of an infusion solution, blood additive solution, anticoagulant solution, saline solution, blood component solution, and replacement fluid.

13. The method of claim 10, wherein the first set and/or the second set of identifiers comprises identifiers associated with at least one of a manufacturer name, solution name, solution contents, content details, product code, bar code, and active or passive RFID tag.

14. The method of claim 10, wherein the biological fluid processing device further comprises a memory within which the database is disposed, wherein and the database is configured to be updated over a network.

15. The method of claim 10, wherein the microprocessor controller is configured to read the first identifier or the second identifier via at least one of a data card, a radio frequency identifier, a bar code, a personal digital assistant, a mobile phone, and a disk-based medium.

16. The method of claim 10, wherein the microprocessor controller is configured to communicate with the database of approved medical solution identifiers stored within a memory of the biological fluid processing device.

17. The method of claim 10, wherein the user interface includes at least one of a screen, keyboard, touchscreen, buttons, print-out, voice input, and voice output.

18. The method of claim 10, wherein the biological fluid processing device is configured to communicate with the database of approved medical solution identifiers over a network.

19. A system for authenticating a medical solution during a biological fluid processing procedure, the system comprising:

a biological fluid processing device, comprising a first pump, a user interface, and a separator, configured to convey a source biological component from an inlet of the separator for separation into a first component and a second component;

a fluid circuit configured to associate with the biological processing device, wherein the fluid circuit comprises;

a first container containing a first fluid for combination with the source biological component, the first component, and/or the second component during a first step of the fluid processing procedure;

a second container containing a second fluid for combination with the source biological component, the first component, and/or the second component during a second step of the fluid processing procedure;

a plurality of fluid pathways connecting the separator, the first container, and the second container, wherein fluid flow is actuated through the plurality of fluid pathways by the pump;

a microprocessor controller in communication with the user interface of the biological fluid processing device and configured for communication with a local and/or remote database of approved medical solution identifiers, wherein the biological processing device is configured to process in the first step the first fluid from the first container having at least one identifier and to process in the second step the second fluid from the second container having at least one identifier;

wherein the microprocessor controller is programmed with a first set of identifiers approved for the first step and a second set of identifiers approved for the second step;

wherein the microprocessor controller is configured to;

receive at the first step a first identifier of the first container having at least one identifier;

compare the first identifier of the first container to the first set of identifiers approved for the first step;

proceed with the biological fluid procedure only if the first identifier of the first container is a match with any identifier within the first set of identifiers approved for the first step, wherein the biological fluid procedure comprises flowing the first fluid from the first container via the first pump and combining the first fluid with the source biological component, the first component, and/or the second component;

receive at the second step a second identifier of the second container having at least one identifier;

compare the second identifier of the second container to the second set of identifiers approved for the second step; and

proceed with the biological fluid procedure only if the second identifier of the second container is a match with any identifier within the second set of identifiers approved for the second step, wherein the biological fluid procedure comprises flowing the second fluid from the second container via the first pump or a second pump and combining the second fluid with the source biological component, the first component, and/or the second component.

20. The biological fluid processing system of claim 19, wherein the microprocessor controller is configured to communicate with the database of approved medical solution identifiers located in a memory remote from the biological fluid processing device over a network interface device.

21. The biological fluid processing system of claim 19, wherein the biological fluid processing system comprises an apheresis system.