Abstract:
The present invention relates to a method of loading a plurality of medical devices into a plurality of medical device packages, said method comprising providing an apparatus including a pusher plate, a medical device retaining member, a transfer member and a package support member, wherein said device retaining member and said transfer member include a plurality of grooves for receiving and removably retaining a plurality of medical devices and wherein said package support member includes a plurality of recesses for receiving and removably retaining said plurality of medical device packages therein, loading a plurality of packages into said package support member recesses, loading a plurality of integrated medical devices into the retaining member grooves, transferring said plurality of integrated medical devices from said retaining member to said transfer member, urging the transfer member into alignment with said package support member, inserting said plurality of integrated medical devices in said transfer member into said plurality of packages in said support member and removing said packages from said apparatus for further processing.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     The present invention relates, in general, to medical devices containing an integrated lancet and sensor and, more particularly, to a process for packaging the medical devices including integrated lancets.  
         [0002]     The determination of analyte concentration in physiological samples is of ever increasing importance to today&#39;s society. Such assays find use in a variety of application settings, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in the diagnosis and management of a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol for monitoring cardiovascular conditions, drugs for monitoring levels of therapeutic agents, and identifying illegal levels of drugs, and the like. In response to this growing importance of analyte characteristic (e.g., concentration) determination, a variety of analyte characteristic determination protocols and devices for both clinical and home testing have been developed.  
         [0003]     In determining the concentration of an analyte in a physiological sample, a physiological sample must first be obtained. Obtaining and testing the sample often involves cumbersome and complicated procedures. Unfortunately, successful manipulation and handling of test elements, such as test strips, lancing members, meters and the like is to a great extent dependent on the visual acuity and manual dexterity of the user, which in the case of people with diabetes is subject to deterioration over the course of the disease state. In extreme cases people that have significant loss of sight and sensation, testing procedures can become significantly difficult and requires additional assistance from ancillary devices or personnel.  
         [0004]     A typical procedure for making a glucose measurement with the use of a test strip involves multiple actions or steps. One manner of reducing the number of actions is by the use of integrated medical devices that combine multiple functions in order to minimize the handling of sensor and/or lancing components that may lead to contamination of the components and/or injury to the user. An example of such an integrated medical device that includes a test strip and lancet is described in International Application No. PCT/GB01/05634 (published as WO 02/49507 on Jun. 27, 2002; Docket No. DDI-12.1 PCT) and U.S. patent application Ser. No. 10/143,399 (Docket No. LFS-145; published as 2003/0143113 A2 on Jul. 31, 2003), both of which are fully incorporated herein by reference.  
         [0005]     Technological advancements have been made in test strip fabrication in which both sensor and lancing functions and the structures to provide such functions are provided on a single fully integrated medical device, as described in the aforementioned U.S. patent application Ser. No. 10/143,399. Integrated medical devices are typically in the form of strips. Web-based methods can be used to make such fully integrated medical devices which are singulated after fabrication prior to being collectively packaged in a cartridge, magazine, cassette or the like. Examples of web-based methods for making such medical devices are disclosed in U.S. patent application Ser. No. 10/142,409 (Docket No. LFS-143; published as 2003/0211619 A1 on Nov. 13, 2003) and European Patent Application EP 1360932 A1, both of which are fully incorporated herein by reference.  
         [0006]     Integrated medical devices can be singly or collectively loaded into a storage container (s) or package(s) manually. However, this is difficult due to the small size of the devices, is time consuming, can possibly damage the lancing portion (e.g., micro-needle) as the device is inserted into the container, and can result in improper alignment of the device within the container. Examples of containers for integrated medical devices are described in co-pending U.S. patent application Ser. No. 10/666,154 (Docket No. DDI-5016), which is fully incorporated herein by reference.  
         [0007]     Still needed in the field, therefore, is an automated method of loading an integrated medical device into a container without damaging the micro-needle while ensuring that the device is at the proper orientation for subsequent extraction by a user.  
       SUMMARY OF THE INVENTION  
       [0008]     In one embodiment the present invention is directed to a method of loading a plurality of medical devices into a plurality of medical device packages. In this embodiment of the invention, the method includes the steps of providing an apparatus including a pusher plate, a medical device retaining member, a transfer member and a package support member. In this embodiment of the invention, the device retaining member and the transfer member include a plurality of grooves for receiving and removably retaining a plurality of medical devices and the package support member includes a plurality of recesses for receiving and removably retaining the plurality of medical device packages therein. In one embodiment of the present invention, the method includes the steps of loading a plurality of packages into the package support member recesses, loading a plurality of integrated medical devices into the retaining member grooves, transferring the plurality of integrated medical devices from the retaining member to the transfer member, urging the transfer member into alignment with the package support member, inserting the plurality of integrated medical devices in the transfer member into the plurality of packages in the support member and removing the packages from the apparatus for further processing. In one embodiment of the present invention, the transferring step includes the steps of transferring every other medical device from the retaining member to the transfer member. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0009]     A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (wherein like numerals represent like elements), of which:  
         [0010]      FIGS. 1A and 1B  are simplified perspective and exploded perspective views of an apparatus according to an embodiment of the present invention;  
         [0011]      FIG. 2  is a simplified perspective view of a medical device package that can be used with exemplary embodiments of the apparatus according to the present invention;  
         [0012]      FIG. 3  is a simplified perspective view of a medical device that can be used with exemplary embodiments of the apparatus according to the present invention;  
         [0013]      FIG. 4  is a flow chart illustrating an exemplary sequence of steps in a process for loading a plurality of integrated medical devices into a plurality of packages using the loading apparatus according to an exemplary embodiment of the present invention; and  
         [0014]      FIGS. 5A-5F  are simplified schematic, perspective views depicting various stages of a process for loading medical devices into packages according to an embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0015]      FIGS. 1A and 1B  are perspective and exploded views, respectively of an apparatus  100  for loading a plurality of integrated medical devices into a plurality of medical device packages according to an exemplary embodiment of the present invention. Generally rectangular in shape, apparatus  100  includes a pusher plate  102  which is generally detachable from apparatus  100 . Pusher plate  102  includes a plurality of protrusions  104 , a medical device retaining member  106 , a medical device transfer member  108 , a package support member  110  and an optional base  112  which may not be necessary in some embodiments of the present invention. Pusher plate  102  and transfer member  108  are movable in the Y direction relative to base  112 , as shown by arrows A 1  and A 2 , respectively, in  FIGS. 1A and 1B . Medical device retaining member  106  is movable in the X direction relative to base  112 , as shown by arrow A 3  in  FIGS. 1A and 1B . Package support member  110  is fixedly mounted on base  112  by, for example, welding or at least one screw. Base  112  is depicted in  FIGS. 1A and 1B  as including a first base member  113  and a second base member  114 . One skilled in the art will recognize that base  112  can also be formed as one piece by, for example, machining or molding processes.  
         [0016]     Apparatus  100  further includes an optional means for moving pusher plate (e.g., a rod  115  which may be, for example, a telescoping rod permanently mounted on base  112 ) and an optional shield  116  (which may be, for example, clear plastic that covers retaining member  106 ) and transfer member  108 . Those skilled in the art will recognize that pusher plate  102  can also be moved manually. Apparatus  100  is typically formed of metal and can also be formed of relatively rigid plastic including, for example polycarbonate, polyester, or polystyrene.  
         [0017]      FIG. 2  is a simplified perspective view of a non-limiting example of a medical device package  200  that can be used in conjunction with apparatus  100  according to one aspect of the present invention. Medical device package  200  includes a main cap member  210  and a minor cap member  211 . Main cap member  210  includes a proximal end  212 , a distal end  214  and a cavity (not shown) therein. The cavity has an opening  216  at proximal end  212  of main cap member  210  and is configured to receive, and to securely and removably retain, a medical device (e.g., integrated medical device  300 , illustrated in  FIG. 3 ) at least partially therein. Opening  216  is bounded by a rim  218  of sufficient surface area to enable minor cap member  211  to be adhered to rim  218  by processes known to those skilled in the art, including, for example heat sealing processes. In this manner, minor cap member  211  and main cap member  210  of medical device package  200  provide a sterility barrier and humidity protection for a medical device contained therein. Rim  218  includes a first outer rim surface  219  and a second outer rim surface  220 , either and/or both of which can be engaged by transfer member  108  during use of apparatus  100 , as will be described below. Main cap member  210  further includes a first peripheral edge  222 , a second peripheral edge  224  and a main cap upper surface  226 . First and second peripheral edges  222  and  224  are truncated to end at a distal edge  221  of rim  218 . Main cap upper surface  226  optionally includes a directional marker  230  that is discontinuous with (e.g., raised above or, alternatively, recessed below) the remainder of main cap upper surface  226 . A plurality of medical device packages  200  can be at least partially attached to each other (i.e., by removably attaching at least a portion of first peripheral edge  222  of one medical device package  200  to at least a portion of second peripheral edge  224  of another package) to form a “chain” of medical device packages  200 . Further descriptions of medical device packages  200  that can be used in conjunction with apparatus  100  according to the present invention are in the aforementioned co-pending U.S. patent application Ser. No. 10/666,154.  
         [0018]      FIG. 3  is a simplified perspective view of an exemplary integrated medical device  300  that can be loaded into medical device package  200  using apparatus  100  according to one aspect of the present invention. Integrated medical device  300  includes a test strip  304  and a dermal tissue penetration member  302 . Test strip  304  has a reaction area (not shown) and electrical contacts  306  that terminate on a proximal end  310  of integrated medical device  300 . Electrical contacts  306  are made of any suitable conductive material, such as gold, silver, platinum or carbon. Dermal tissue penetration member  302  includes a lancet  320  adapted to pierce a user&#39;s skin and draw blood into the reaction area. Further descriptions of integrated medical devices  300  that can be loaded into medical device package  200  using assembly apparatus  100  according to the present invention are in the aforementioned International Application No. PCT/GB01/65634 and U.S. patent application Ser. No. 10/143,399.  
         [0019]     Referring again to  FIGS. 1A and 1B , medical device retaining member  106  includes a first side  117 , a second side  118 , a first end  120 , a second end  122 , an upper surface  124  and a lower surface  126 . A plurality of grooves  128  is located on upper surface  124  of medical device retaining member  106  for the plurality of protrusions  104  to move therethrough. The function of protrusions  104  is to move through grooves  128 , thereby pushing integrated medical devices  300  retained in grooves  128  onto transfer member  108  during the manufacturing process, as will be described in more detail below (see  FIGS. 4 and 5 D). Grooves  128  are each bound by at least one wall  130  approximately perpendicular to upper surface  124  (i.e., in the Z direction). Near the top of each wall  130  is at least one ledge  132  for receiving and removably retaining integrated medical device  300  at least partially within the upper region of each groove  128 . The width of groove  128  above ledge  132  (i.e., in the X direction) is marginally larger (e.g., about 1-3%) than the width of integrated medical device  300  such that integrated medical device  300  fits snugly therein. The number of grooves  128  can range from 10 to 100 and typically ranges from 20 to 50. Retaining member  106  can move reversibly in the X direction to index by one device width during the device loading process, as will be described below (see  FIG. 4 ).  
         [0020]     Medical device transfer member  108  is adjacent to retaining member second side  118  and is intended to shuttle medical devices from retaining member  106  to package support member  110  such that protrusions  104  can then urge the devices into medical device packages  200 . Transfer member  108  includes a first side  134 , a second side  136 , a first end  138 , a second end  140 , an upper surface  142  and a lower surface  144 . A plurality of upper grooves  146  is located on upper surface  142  of transfer member  108 , each of which is bound by at least one wall  148  approximately perpendicular to upper surface  142  (i.e., in the Z direction). Near the top of each wall  148  is at least one ledge  150  for receiving and removably retaining integrated medical device  300  at least partially within each upper groove  146 . The number of upper grooves  146  typically can range from  5  to  10 , although other ranges are possible. The maximum number of upper grooves  146  is dictated by how far away from the center of opening  216  integrated medical device  300  can be delivered. As the number of upper grooves  146  increases, loading accuracy decreases across the plurality of medical device packages  200 . The width of upper grooves  146  above ledge  150  (i.e., in the X direction) is marginally larger (e.g., about 1-3%) than the width of integrated medical device  300  such that integrated medical device  300  fits snugly therein. This snug fit minimizes side-to-side movement of the device during the package loading process.  
         [0021]     Transfer member  108  further includes at least one protuberance  152  (e.g., a pin) and at least two projections  154  (e.g., lugs) (see  FIG. 1B ). Protuberance  152  engages with at least one indentation on retaining member second side  118  for receiving protuberance  152  such that grooves  128  and upper grooves  146 , are held in alignment during the package loading process. Projections  154  are intended to mate with first outer rim surfaces  219  and second outer rim surface  220  of at least one medical device package  200  or of at least two adjacent medical device packages  200  such that integrated medical device  300  is centered within opening  216  of all packages during the loading process, within the tolerance range required for effective loading (see  FIG. 5D ).  
         [0022]     Grooves  128  and  146  and ledges  132  and  150  can be formed by processes known to those skilled in the art including, but not limited to, spark erosion and electrical discharge machining (EDM). Types of EDM include, for example, wire, sinker and small hole EDM.  
         [0023]     Package support member  110  is adjacent to transfer member second side  136 .  
         [0024]     Support member  110  includes a first side  158 , a second side  160 , a first end  162 , a second end  164 , an upper surface  166  and a lower surface  168 . A plurality of recesses  170  for supporting a plurality of packages  200  is located on upper surface  166 .  
         [0025]      FIG. 4  is a flow chart illustrating a sequence of steps in a process  400  for loading a plurality of integrated medical devices (e.g., integrated medical device  300  of  FIG. 3 ) into a plurality of medical device packages (e.g., medical device packages  200  of  FIG. 2 ) according to an exemplary embodiment of the present invention. Process  400  is described below utilizing  FIGS. 5A-5F  (schematic, perspective views depicting various stages of process  400 ).  
         [0026]     Process  400  includes first providing an apparatus  100  according to the present invention and as described above, as set forth in  FIG. 4  (see  FIG. 5A ). The provided apparatus  100  includes a detachable medical device pusher plate  102  with a plurality of protrusions  104 , a medical device retaining member  106 , a medical device transfer member  108 , a package support member  110  and a base  112 . Further, a plurality of medical device packages  200  which may be interconnected or unitary is retained in package support member  110 .  
         [0027]     Next, a plurality of previously fabricated integrated medical devices  300  is placed in a plurality of grooves  128  in retaining member  106  (see  FIGS. 5B and 5C ). Integrated medical devices  300  used in process  400  can be assembled, for example, by a process as described in co-pending U.S. patent application Ser. No. ______, filed ______ (Attorney Docket Number LFS-5049).  
         [0028]     As set forth, upper protrusions  104  next urge every other integrated medical device  300  into a plurality of upper grooves  146  on an upper surface of transfer member  108  (see  FIG. 5D ). Transfer member  108  is then moved toward package support member  110  until at least two projections  154  on a second side  136  of transfer member  108  engage a first outer rim surface  219  on at least one medical device package  200  and a second outer rim surface  220  on at least another medical device package  200  retained in support member such that integrated medical devices  300  are centered in an opening  216  in each medical device package  200  within the required tolerances (see  FIG. 5E ). The at least two projections  154  can also engage first and second outer rim surfaces  219  and  220  on the at least one medical device package  200 . Centering integrated medical devices  300  in at least one opening  216  beneficially accommodates variations in the dimension in the X direction such that the plurality of integrated medical devices  300  are accurately loaded into each of the plurality of medical device packages  200 .  
         [0029]     Next, each integrated medical device  300  is urged into the opening  216  of each medical device package  200  until each medical device package  200  is inserted into the package cavity and is fully retained therein, as set forth (see  FIG. 5F ). The packages containing medical devices are then removed for further processing.  
         [0030]     As set forth, the protrusions  104  of pusher plate  102  are retracted, a plurality of empty packages is placed in recesses  110 , and the device retainer member is indexed one device in the X direction (e.g., to the left). The remaining devices are then loaded into the plurality of packages by repeating the steps above.  
         [0031]     Including twice the number of grooves in retaining member  106  relative to transfer member  108  and package support member  110  beneficially increases process efficiency because loading twenty integrated medical devices  300  into retaining member  106  and then transferring ten integrated medical devices  300 , for example, at a time twice from retaining member  106  is faster than loading ten integrated medical devices  300  into retaining member  106  at the start of each loading sequence.  
         [0032]     Each of the steps of process  400  can be performed, for example, either manually by a user or with the aid of a mechanical and/or electrical device.  
         [0033]     Once apprised of the present disclosure, one skilled in the art will recognize that a variety of medical devices can be used in the present invention. Such medical devices include, but are not limited to, integrated medical devices that include a combination of a test strip and a lancet, examples of which are described in the aforementioned International Application No. PCT/GB01/05634 (published as WO 02/49507 on Jun. 27, 2002) and U.S. patent application Ser. No. 10/143,399, both of which are fully incorporated herein by reference. One skilled in the art will also recognize that such test strips may have, but are not limited to, an electrochemical or photometric configuration. For illustrative purposes only, medical devices in various figures of the present disclosure were depicted as having an electrochemical configuration.  
         [0034]     Moreover, those skilled in the art will appreciate that medical devices according to embodiments of the present invention can be adapted for the measurement of, for example, glucose, ketones, glycated albumin, coagulation parameters and cholesterol of a sample.  
         [0035]     In addition, one skilled in the art will recognize that medical devices according to the present invention may be contained within a combined sample collection and metering system designed for in-situ testing. Examples of such systems designed for in-situ testing are disclosed in International Patent Application No. PCT/US01/07169 (published as WO 01/64105 A1 on Sep. 7, 2001) and International Patent Application No. PCT/GB02/03772 (published as WO 03/015627 A1 on Feb. 27, 2003), each of which is fully incorporated herein by reference.  
         [0036]     It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.