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.

Description:
FIELD OF THE DISCLOSURE 
       [0001]    The present disclosure generally relates to an authentication system for authenticating medical solution containers. More particularly, the present disclosure relates to an authentication system of solution containers used in apheresis or blood processing procedures. 
       BACKGROUND 
       [0002]    Infusion solutions, blood additive solutions, blood component solutions, replacement fluids, and other medical solutions used in apheresis or blood processing procedures are contained in solution containers having closed-off access ports that maximize solution sterility until the container is opened at the time of use. Access ports of different solution containers and different manufacturers come in a variety of types that are accessed through corresponding access tools operated by a human operator. The various types of ports include membrane ports, which are ports that are sealed off by a membrane and punctured by a piercing tool such as a cannula or spike; luer-fitted ports, which are ports fitted with a female luer fitting and breached by a tool with a complementary male fitting; and other fitted ports, which are accessed by corresponding tools that mate with the structure of the port. Generally, an access tool is often part of a set or kit manufactured for a specific type of apheresis or blood processing procedure and is connected by tubing to an intended destination of the solution within the kit. 
         [0003]    In some cases, two or more medical solution containers may be used simultaneously during apheresis or blood processing procedures. For example, various combinations of saline solution bags, anti-coagulant bags, RBC additive bags, platelet additive bags, and/or a variety of replacement fluids, such as albumin, RBCs, platelets, etc. may be used in a single apheresis or blood processing procedure. Although these solutions have very different functions and properties, the containers in which they are held are often quite similar in appearance, and it is up to the human operator to make sure that the correct access tool accesses the correct solution container. 
       SUMMARY 
       [0004]    One embodiment relates to a blood processing system, comprising a blood processing device having a user interface and a memory. The system also comprises a database of medical solutions identifiable by identifiers and a fluid circuit for use with the blood processing device having an inlet for a medical solution. The blood processing device is configured to guide a user through one or more steps of a blood processing procedure including prompting a user to input an identifier of a medical solution, compare the identifier to information within the database, and authorize use of the medical solution upon verification of the identifier within the database. 
         [0005]    Another embodiment relates to a blood processing system, comprising a blood processing device having a user interface and a memory, a database of medical solutions identifiable by identifiers, and a processing circuit. The processing circuit is configured to guide a user through one or more steps of a blood processing procedure including prompting the user via the user interface to execute one or more actions as part of a step, prompt the user via the user interface to input an identifier of a medical solution, receive the identifier of the medical solution via the user interface and identify the medical solution within the database based on the received identifier, and in response to identifying the medical solution within the database, proceeding with a step of the blood processing procedure. 
         [0006]    Another embodiment relates to a blood processing system, comprising a blood processing device having a user interface and a memory, a database of medical solutions identifiable by identifiers, a medical solution port, and a processing circuit. The processing circuit is configured to provide a prompt to a user via the user interface as part of a multi-step blood processing procedure operated by the blood processing system. The processing circuit is also configured to receive an identifier of a medical solution from a user via the user interface before a step in the procedure, to determine whether the identifier is approved in the database for the step, and, based on the determination, to enable the blood processing system to perform the step of the procedure to process the medical solution via the medical solution port. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    Features, aspects, and advantages of the present embodiments will become apparent from the following description, appended claims, and the accompanying exemplary embodiments shown in the drawings, which are briefly described below. 
           [0008]      FIG. 1  is a perspective view of a fluid processing system, according to an exemplary embodiment; 
           [0009]      FIG. 2  depicts a single-use fluid circuit kit for an apheresis or blood processing procedure, according to an exemplary embodiment; 
           [0010]      FIG. 3  is a perspective view of a medical solution container and its labeling components, according to an exemplary embodiment; and 
           [0011]      FIG. 4  is flow diagram of a series of prompts and/or steps displayed in the course of authenticating a medical solution, according to an exemplary embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0012]    There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto. 
         [0013]    In some embodiments, solutions and kits of which the access tools are a part may not need to be procured from the same manufacturer. 
         [0014]    In some embodiments, cross-access or improper intermixing or substitution of critically distinct fluids can be prevented. 
         [0015]    In some embodiments, a practicable and low-cost manner for operators working with products from different manufacturers can be provided. 
         [0016]    Some embodiments may allow for a standardized fail safe that could be implemented across multiple product lines and manufacturers. 
         [0017]      FIG. 1  depicts a generalized embodiment of a fluid processing system  10 , which serves as an operation and connection center to various medical solution containers  20   a - 20   d  and a single-use fluid circuit kit  12  of  FIG. 2  appropriate for a blood processing procedure, such as an apheresis procedure. The single-use fluid circuit kit  12  has tubings  30   a - 30   d  that are pre-connected to a plurality of cassettes  16 , which are placed onto cassette holders  94  on a sloped front panel  96  of the fluid processing system  10  during operation of the blood processing procedure. An exemplary fluid processing system and fluid circuit kit are described in U.S. Patent Application Publication No. 2014/0045671, which is hereby incorporated by reference herein, although any suitable fluid processing system and fluid circuit kit may be used. 
         [0018]    While described with reference to an apheresis system, the subject matter presented herein may be applied to other blood processing systems (e.g., dialysis machines, etc.) or other medical systems (e.g., internal or external infusion pumps, enteral feeding pumps, etc.). In some embodiments, the teachings herein could be used on any medical system that involves connecting a specific medical solution at a particular time or step within a multi-step procedure. 
         [0019]    Referring to  FIG. 1 , the fluid processing system  10  may include a centrifuge or spinning membrane (not illustrated) used to separate blood components. The fluid processing system  10  may be programmed to separate blood into a variety of components (e.g., platelets, platelet-rich plasma, platelet-poor plasma, white cells, and red cells). Fluid procedures that may be processed include therapeutic plasma exchange procedures, RBC exchange procedures, and mononuclear cell collections, among many other blood processing procedures. 
         [0020]    Referring to  FIG. 2 , the fluid circuit kit  12  contains a plurality of medical solution access tools  40   a - 40   d  that serve as inlets into the fluid circuit  12  for various medical solutions used in blood processing procedures, including but not limited to anticoagulant solutions, saline solutions, platelet additives, red cell additives, a variety of replacement fluids, etc. Medical solutions may comprise blood products or not comprise blood products. In alternative embodiments, medical solutions may comprise medicaments, nutrients, food, or other medical solutions. The medical solutions, which may or may not have been manufactured by the same entity as that of the fluid circuit  12 , are contained in solution containers  20   a - 20   d,  each having a respective access port  25   a - 25   d  to which a respective access tool  40   a - 40   d  connects during the procedure. In turn, each access tool  40   a - 40   d  is connected to the plurality of cassettes  16  by a respective tubing  30   a - 30   d  that allows for each solution to reach its intended destination within the fluid circuit  12  for processing. 
         [0021]    In one embodiment, the flow circuit  12  may be a “two needle” system, which includes a pair of blood source access devices  14  and  14   a  (e. g., phlebotomy needles) for fluidly connecting a blood source with the flow circuit  12 . The blood source access devices  14  and  14   a  may be connected by tubing to a left cassette  16 . One of the blood source access devices  14  may be used to draw blood from the blood source into the flow circuit  12  and is connected to the left cassette  16  by a y-connector  18 . The other leg of the y-connector  18  is connected to tubing  31  which leads to a middle cassette  16   a.  The tubing  31  is connected, through the middle cassette  16   a,  to additional tubing  30   c,  which includes a container access tool  40   c  (e.g., a sharpened cannula or spike connector) for accessing the interior of a container  20   c.  During a blood processing procedure, a medical solution from the container  20   c  may be added to the blood from the blood source at the y-connector  18  prior to entering the left cassette  16 . 
         [0022]    The other blood source access device  14   a  may be used to deliver or return blood, a blood component, and/or some other medical solution to the blood source and is also connected to the left cassette  16  by a y-connector  29 . The other leg of the y-connector  29  is connected to tubing  28  connected at its other end to a container access device  40   a.  The container access device  40   a  is associated with a container  20   a  having an amount of fluid (e.g., saline) that may be used to prime the flow circuit  12  and/or may be delivered to the blood source via the blood source access device  14   a.    
         [0023]    Additional tubing may be connected from one port of a cassette to another port of the same cassette, so as to form tubing loops  50  which interact with a fluid flow element or pump to flow fluid through the flow circuit  12 . 
         [0024]    As indicated, the fluid circuit  12  has a predetermined number of circuitries, and the fluid processing system  10  controls fluid flow according to pre-programmed settings ascribed to the specific blood processing procedure to be conducted. Therefore, it is desirable that the correct access tool  40   a - 40   d  connect to the correct solution container  20   a - 20   d.  A failsafe feature is thus included in this embodiment that prevents solution processing from proceeding any further if an incorrect solution container is connected at a particular processing step. 
         [0025]    The failsafe feature of the fluid processing system  10  is based on recognition by the system  10  of each medical solution that it processes. Medical solution bags  20 , regardless of specific manufacturer, generally have components listed in or referred to in their labeling. Referring to  FIG. 3 , these components may include manufacturer name  51 , solution name  52 , solution contents  53 , content details  54 , one or more product codes  55 , a bar code  56 , an active or passive RFID tag  57  for the product, and/or a photo-recognizable image, etc. The manufacturer name  51  may be a company name, trade name, etc. The solution name  52  may be a brand name or generic name. The solution contents  53  may include ingredients, composition state (e.g., emulsification), etc. The content details  54  may include details regarding any of the ingredients or details regarding any aspect of content (e.g., pH, osmolarity, temperature, tonicity, etc). Product code(s)  55  may be a manufacturer product code or a code designated by an end-user. Recognition by the system  10  of a medical solution may be achieved by the system  10  having access to a database containing one or more of the aforementioned components. The database may be located offline (i.e., not on a network) within the hard drive or memory of system  10  itself, or it may be located online on a network to which system  10  is linked. The fluid processing system  10  may contain a pre-populated medical solution database which is programmed into memory at the time of manufacturing of fluid processing system  10 ; or a database may be uploaded, manually entered by a user, or automatically entered (e.g., without requiring specific user input). The programming, upload, entry, or population of the database may occur at any time, such as prior to running a blood processing procedure, during the procedure, after running the procedure, etc. 
         [0026]    Referring to  FIG. 1 , when a human operator runs a fluid processing procedure on the fluid processing system  10 , the operator interacts with a user interface  98 , which may include a screen, a keyboard, touchscreen, buttons, print-out, voice input/output, or any suitable interface. At each step of the procedure, orchestrated by a processing circuit within system  10 , the interface  98  may prompt the human operator to execute one or more actions as part of the step. Such actions may include fitting one or more cassettes  16  into cassette holder  94 , connecting a tubing  30  to a solution container  20 , opening or closing off a tubing connection, accessing a blood source, etc. The failsafe feature may be incorporated into this series of steps as an authentication step that allows the fluid processing system  10  to recognize and approve or disapprove a particular medical solution for the particular step of the procedure. 
         [0027]      FIG. 4  illustrates an exemplary methodology operable by a processing circuit of the fluid processing system  10  to provide one or a series of prompts to a human operator in the course of authenticating a medical solution or otherwise operating system  10 . At step  1   a,  a user or technician inputs unique identifier information for one or more medical solution into a medical solution database using a suitable input device (e.g., barcode, active or passive RFID, keypad, touchscreen, etc.). The database information can be used to classify and categorize the types of solutions that are compatible with different types of procedures (e.g., what are authorized and what are not authorized depending on different procedure types). At step  1   b,  the user interface  98  prompts the operator to input a unique identifier of the medical solution container used in a fluid processing procedure for the system to authenticate. At step  2 , the user inputs the unique identifier of the medical solution into the medical device. As shown in  FIG. 3 , the unique identifier may include one or more of the manufacturer name  51 , solution name  52 , solution contents  53 , content details  54 , product code  55 , a bar code  56 , an active or passive RFID tag  57 , a photo-recognizable image, or other identifier. In the case of a bar code  56 , active or passive RFID tag  57 , or a photo-recognizable image, the system  10  may be equipped with a scanner that scans and recognizes the bar code  56  or tag  57 . At step  3 , the system  10  communicates with the medical solution database (e.g., over a network, Wi-Fi, serial cable, etc.) and determines if the correct medical solution is being used for the particular procedure. At step  4 , if the solution is an accepted or authorized solution for the particular procedure, the process moves to step  5   a  and the medical procedure may proceed. However, if the solution is not an accepted or authorized solution for the particular procedure, the process moves to step  5   b  where the user is provided feedback that the incorrect medical solution is being used and/or inputted and the process returns to step  1   b  so that the user can input the same solution again or try inputting information for a different solution. In the event that the inputted medical solution is actually a correct solution but is not contained in the database, the corrective action may include the operator simply scanning or manually entering the new medical solution&#39;s unique identifiers into the database and configuring the solution as an approved, listed, or recognized solution by storing the identifier or identifiers in a list in the database, as shown in step  1   a.    
         [0028]    Each time a solution container  20  is to be connected to the system  10 , the human operator may be prompted to follow one or more stages of these authentication procedures. These features may be implemented across different manufacturers and product lines. In the event that the solution is not approved by the system  10 , the user may be prompted in step  5   b  using a number of different methods, including for example, an alarm, a prompt for the user to re-enter, a lock on the machine to prevent further use, a prompt for the user to enter the identifier, perhaps with an approval code from a manager, a termination of the procedure, a suspension of the procedure, a suspension of activity until the user corrects the error, etc. In the event that the solution is approved by the system in step  5   a,  the system  10  may, for example, provide a positive alert to the user, move to the next step of the procedure, increment a record of the number of times this container has been used on the system, etc. 
         [0029]    According to an exemplary embodiment, the methodology shown in  FIG. 4  may be implemented by a processing circuit of the system  10  illustrated in  FIG. 1  in the course of a procedure such as a plasma exchange procedure. At a step in which the plasma exchange procedure requires connecting to an anticoagulant solution, the user interface  98  may prompt the operator to input a unique identifier of the anticoagulant container for the system  10  to authenticate, as shown in step  1   b.  The unique identifier the operator elects to input may be a manufacturer name  51  and product code  55 , although it may be any other identifier. Following the input of the manufacturer name  51  and product code  55  of the anticoagulant solution container at step  2 , the system  10  may source information from an online or offline database of medical solutions, as indicated in step  3 . If the anticoagulant solution is within a category of accepted solutions for the anticoagulant step of the procedure, as determined by the information from the database, the system  10  is configured to approve the anticoagulant solution and/or proceed to drawing the anticoagulant solution into the fluid circuit  12  at step  5   a . However, if the anticoagulant solution is not within a category of accepted anticoagulant solutions for the step in the procedure, the system  10  may prompt the user, e.g., with the sound of an alarm, that an unapproved or unlisted or unrecognized solution has been inputted and will not proceed to the next step of the procedure until corrective action has been taken, as shown in step  5   b.  In the event that the inputted medical solution is actually a correct anticoagulant solution but is not contained in the database, the corrective action may include the operator simply scanning or manually entering the new anticoagulant solution&#39;s unique identifiers into the database and configuring the solution as an approved, listed, or recognized anticoagulant solution by storing the identifier or identifiers in a list in the database, as shown in step  1   a.  In the event that the inputted medical solution is actually an incorrect anticoagulant solution or not an anticoagulant solution at all, the operator will be placed on notice of the mistake and will take corrective action by returning to step  1   b  and choosing a correct anticoagulant solution. 
         [0030]    The processing circuit of system  10  may comprise one or more analog and/or digital electronic components, such as a microprocessor, microcontroller, application-specific integrated circuit, programmable logic, etc., configured to carry out one or more of the steps described herein. The processing circuit may be programmed with an algorithm stored in a memory device configured to cause the processing circuit to carry out the steps. System  10  may further comprise a network interface circuit configured to communicate over a network (e.g., a wired or wireless network, an Ethernet, a local area network, a wide area network, a personal area network, an IEEE 802.11x network, etc.). The network interface circuit may comprise analog and/or digital components configured for communication. 
         [0031]    The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.