Abstract:
A system is provided comprising first and second parts that are brought together for each occasion the system is used. The first part comprises a label having a plurality of discrete magnetic portions arranged in a predetermined pattern unique to the first part, and the second part comprises a magnetic reader for identifying the magnetic pattern on the first part and generating a signal indicative of the pattern. The second part also includes a programmable controller configured to receive signals from the reader to confirm the identity of the first part and permit further operation of the system upon a positive identification of the first part.

Description:
BACKGROUND 
     The present disclosure relates to a system and method for ensuring that only genuine authorized and suitable components are used in a system comprising two components and, more particularly, to such a system and method in the context of a device for performing a medical procedure comprising a single use disposable component and a durable, reusable hardware component. 
     Many systems in use include one or more disposable or replaceable components in combination with a durable reusable component. Oftentimes, the use of a genuine or authorized disposable or replaceable component is critical to the safe and proper functioning of the system. This is especially true in the context of devices for performing medical processes and procedures in order to protect both the patient and system operator from potentially hazardous biomaterials. Indeed, single-use disposable devices and components are ubiquitous in the medical field, and quality control to insure proper manufacture and traceability is crucial. Thus, there is a compelling need to insure that components intended for a single use are, in fact, authentic and suitable for use with the durable hardware component for performing the desired procedure. 
     SUMMARY 
     The present subject matter has a number of aspects which may be used in various combinations, and a disclosure of one or more specific embodiments is for the purpose of disclosure and description, and not limitation. This summary highlights only a few of the aspects of this subject matter, and additional aspects are disclosed in the drawings and the more detailed description that follows. 
     In accordance with one aspect of the present disclosure, a system comprising first and second parts that are brought together for each occasion the system is used is provided in which the first part comprises a label having a plurality of discrete magnetic portions arranged in a predetermined pattern unique to the first part, and the second part comprises a magnetic reader for identifying the magnetic pattern on the first part and generating a signal indicative of the pattern, and a programmable controller configured to receive signals from the reader to confirm the identity of the first part and permit further operation of the system upon a positive identification of the first part. 
     In accordance with another aspect, the first part of the system comprises a single-use disposable component and the second part comprises a durable reusable hardware component, in which the disposable component is associated with the hardware component to perform a medical procedure. 
     In accordance with a further aspect, the first part of the system further comprises packaging for the single-use disposable component, and the label is associated with one of the packaging and the disposable component. 
     In accordance with another aspect, the label associated with the disposable component comprises a grid with the magnetic portions associated with selected areas of the grid arranged to uniquely identify the first part, and the reader comprises a matching grid having a sensor associated with each area of the grid. 
     In accordance with a further aspect, the label may be formed separately from the disposable component and affixed thereto, or the label may be formed directly on the disposable component. 
     In accordance with another aspect, the packaging for the disposable component comprises a tray configured to nest in a predetermined orientation on the durable reusable hardware component during mounting of the disposable component on the hardware component, the predetermined orientation aligning the grids on the label and the reader. 
     In accordance with a further aspect the sensors for the reader may comprise magnetic switches activated by proximity to a magnetic field. Additionally, the magnetic portions of the label may comprise magnetic ink. 
     In accordance with another aspect, the label may be associated with the disposable component so as to be obscured from sight. Similarly, the reader may be associated with the reader so as to be obscured from sight. 
     In accordance with another aspect of the disclosure, a method is provided for verifying that the first part of the system may be properly used with the second part of the system in which the first part is brought into proximity with the second part so that the magnetic reader can read the magnetic portions on the label associated with the first part. The reader then sends a signal to the controller corresponding to the pattern on the label, and the controller then determines whether the pattern corresponds to that of an authentic first part. The controller then permits further operation of the system only upon confirmation that the first part is authentic. In accordance with another aspect of the method, an operator is required to input to the controller identification of a selected procedure to be performed to confirm the suitability of the first part for performing the selected procedure. Then, further operation of the system is permitted only upon the controller confirming that the first part is capable of performing the selected procedure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other aspects of the present subject matter are described in the following detailed description and shown in the attached figures, in which: 
         FIG. 1  is a schematic exploded view of a representative two-part system showing the verification system and method of the present disclosure. 
         FIG. 2  is a perspective view of a two-part centrifugal processing system in which the system and method of the present disclosure may be advantageously used, the system centrifugal processing system comprising a durable, reusable centrifuge assembly having a single-use, disposable fluid processing assembly associated therewith. 
         FIG. 3  is an exploded perspective view of the single-use, disposable fluid processing assembly of  FIG. 2  in combination with an organizer tray for packaging the kit. 
         FIG. 4  shows one of the steps by which a user sets up the tray-mounted fluid processing assembly shown in  FIG. 3  on the centrifuge assembly shown in  FIG. 2 . 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     A more detailed description of the systems and methods in accordance with the present disclosure is set forth below. It should be understood that the description below of specific devices and methods is intended to be exemplary, and not exhaustive of all possible variations or applications. Thus, the scope of the disclosure is not intended to be limiting, and should be understood to encompass variations or embodiments that would occur to persons of ordinary skill. 
     Turning to  FIG. 1 , there is seen a system, generally indicated  10 , comprising a first replaceable or single-use part  12  and a second durable or reusable part  14 . In accordance with one aspect of the disclosure, the first part  12  includes an identification element, such as, but not limited to, a label  16  that includes a plurality of discrete magnetic portions  18  arranged in a predetermined sequence or pattern that uniquely identifies the first part  12  as being a genuine component intended for use in combination with the second part  14  to form the system  10 . As used herein, “label” is broadly construed to include the magnetic portions  18  being part of, or formed integrally with, the first part  12 , or formed on a separate substrate  20  that is affixed (e.g., by adhesive) to the first part. 
     In a non-limiting example, the label  16  may comprise a grid  22  with magnetic portions  18  associated with selected spaces on the grid, while other spaces on the grid are “blank”. As shown in  FIG. 1 , the grid  22  has a square configuration, with four rows and four columns. However, the grid  22  may take any configuration that has discrete locations with which the magnetic portions  18  may be selectively associated to form the predetermined pattern that uniquely identifies the first part  12  to confirm that it is genuine. 
     The second part  14  of the system  10  comprises a magnetic reader, generally designated  24 , that is configured to identify the pattern of the magnetic portions  18  forming the label  16  on the first part  12 , and then generate a signal indicative of the pattern on the label. The second part  14  includes a programmable controller  26  configured to receive the signals from the magnetic reader and identify the first part  12  as either genuine or counterfeit. The controller  24  permits further operation of the system  10  only upon identifying the first part  12  as genuine. 
     Referring again to  FIG. 1 , the reader  24  comprises a series of magnetic switches  28  (such as Hall effect sensors) arranged in a grid  30  matching the grid  22  on the label  16 . The magnetic switches  28  are activated when the grid  22  on the first part  12  is brought into proximity and alignment with the grid  30  on the reader  24 . To this end, the first part  12  may be configured to nest on the second part  14 , such that the label  16  is brought into the proper position relative to the reader  24  for the magnetic portions  18  on the label  16  to activate the corresponding switches/sensors  28  of the reader  24 . 
     By way of example, the magnetic portions  18  may comprise pole magnets, with the poles having various orientations, and/or the magnetic portions  18  may be of different strengths, to add complexity to the pattern and, thus, security to the system. Further, the magnetic portions  18  may comprise magnetic ink, and may be either printed directly on the first part  12 , or printed on the substrate  20  that is affixed to the first part  12 . Further, the patterns of magnetic portions can be changed periodically, and the controller  24  reprogrammed accordingly, to further enhance security. 
     The achievement purposes of the verification system of the present disclosure may be additionally facilitated if the presence of the system is not readily apparent, so that a potential counterfeiter would not be aware and try to defeat the system. To this end, the label  16  and/or reader  22  may be obscured from view. In the case of the label  16 , this may be achieved by an additional sheet  32  of an opaque material affixed to the first part  12  so as to overlay the label  16 . In the case of the magnetic reader  22 , this may be achieved by mounting the reader  22  inside the housing  34  of the second part  14 . 
     While the verification system described above may be used in any system having single-use or replaceable parts, it may find particular applicability in systems for performing medical procedures in which the systems include a single-use disposable component and a durable reusable hardware component. In such a use, the pattern of magnetic portions on the disposable component can additionally provide information, such as the procedure for which the disposable component is to be used, lot number, expiration date, etc. 
     Further, the controller may be programmed so that, after confirming that the disposable component is genuine, the operator is required to input an identification of the specific procedure to be performed to confirm the suitability of the disposable component for performing the procedure and to continue with operation of the system. Once the disposable component is confirmed as genuine and is suitable for performing the desired procedure, the controller may automatically fill the fields for various procedure parameters that would otherwise be manually input by the operator. 
     Turning to  FIGS. 2-4 , the system and method of the present disclosure will be described in the context of a blood processing system of the type routinely used to perform apheresis, in which whole blood is separated by centrifugation into its various therapeutic components, such as red blood cells, platelets, and plasma. The system  110  is as shown in described in Giesler et al. U.S. Pat. No. 5,868,696, incorporated herein by reference, and in commercially embodied in the Amicus® separator, available from Fenwal, Inc., of Lake Zurich, Ill. 
     The system  110  includes a centrifuge assembly  112  that is intended to be durable and of long-term use, and a fluid processing assembly  114  that is intended to be a single-use, disposable item loaded on the centrifuge assembly  112  at the time of use (as shown in  FIG. 2 ). The centrifuge assembly  112  includes a programmable processing controller  246 , including an integrated input/output terminal  248  that receives and displays information relating to the processing procedure. 
     The fluid processing assembly  114  includes a processing chamber  116  (best seen in  FIG. 3 ) that is rotated by the centrifuge assembly  112  to centrifugally separate blood components, an array of flexible tubing that forms a fluid circuit  118 , containers  120  to dispense and receive liquids during processing, and cassettes  122 A,  122 B,  122 C that serve in association with pump and valve stations on the centrifuge assembly  112  to direct liquid flow. 
     As seen in  FIGS. 2 and 3 , the entire processing assembly  114  is packaged for use within an organizer tray  126  that holds the processing chamber  116 , the containers  120 , the cassettes  122 A,  122 B,  122 C, and fluid circuit  118  in an orderly, compact package before use. The organizer tray  126  is preferably made of vacuum-formed plastic material, and includes four side panels  138  and a bottom panel  140 . 
     As seen in  FIG. 2 , the organizer tray  126  mounts or nests on the centrifuge assembly  112  during use. In accordance with the present disclosure, the bottom of the organizer tray includes a magnetic label, such as label  16  described above, and the centrifuge assembly  112  includes a magnetic reader, such as the magnetic reader  24  described above, beneath the top panel  238  of the housing  228  on which the tray  126  mounts. Thus, the magnetic portions  18  on the label  16  and the sensors  28  of the reader  24  are automatically brought into proper alignment when the tray  126  is mounted on the centrifuge assembly  112 . 
     Accordingly, with a system as described above, a method for verifying that the first part of the system may be properly used with the second part is provided. With reference to  FIG. 4 , the operator by first places the organizer tray  126  for the single-use processing assembly  114  onto the top panel  238  of the housing  228  for the centrifuge assembly  112 . This brings the label  16  on the tray  126  into proximity with the reader  24  of the centrifuge assembly  112 . 
     The reader  24  then sends a signal corresponding to pattern of the magnetic portions  18  on the label  16  to the controller  246 , and the controller  246  determines whether the pattern detected by the reader  24  corresponds to that of a genuine or authentic processing assembly  114 . The controller  246  then permits further operation of the system  110  only upon confirming that the processing assembly mounted thereon is genuine. 
     To provide further safeguards as to performance of the intended procedure, the controller may then require the operator to input an identification of the procedure that is to be performed to confirm that the processing assembly  114  is suitable for performance of that procedure. Further operation of the system  110  would be permitted by the controller  246  only upon confirmation that the processing assembly  114  is that for performing the intended procedure. 
     Thus, a system and method has been provided for ensuring that only genuine authorized components are used in a system comprising two components and, more particularly, to such a system and method in the context of a device for performing a medical procedure comprising a single use disposable component and a durable, reusable hardware component. While the system and method have been described in connection with certain preferred embodiment, this is for illustrative purposes, and is not intended to indicate limitation of the use of the system and method with any particular type of devices.