Abstract:
A package is provided for a medical device that a spring-driven button-actuated safety shield. The package includes a tray with a bottom wall and sidewall enclosure that extends upwardly from the bottom wall a distance greater than the height or thickness of the medical device. A flange extends outwardly from edges of the sidewall enclosure opposite the bottom wall. At least two gripping towers are formed unitarily with the bottom wall and project upwardly a distance greater than the thickness or height of the medical implement. Gripping towers are spaced from one another and are configured to grippingly engage the medical implement on opposite respective sides of the actuating button for preventing inadvertent actuation of the safety shield while the medical implement is in the tray. A cover extends removably across the flange and is supported by the gripping towers.

Description:
This application claims priority of U.S. Provisional Patent Application No. 60/323,155 filed Sep. 18, 2001. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The subject invention relates to packaging for a push button blood collection set and to the assembly of a push button blood collection set and its package. The invention also relates to a method for packaging a push button blood collection set. 
     2. Description of the Related Art 
     A push button blood collection set is used to access a blood vessel of a patient and to draw blood from a patient. The blood collection set includes a needle cannula with a proximal end, a sharply pointed distal end and a lumen extending between the ends. The proximal end of the needle cannula is permanently mounted to a plastic hub. The hub is formed with an axial passage that communicates with the lumen through the needle cannula. Flexible tubing of appropriate length is mounted to the end of the hub opposite the needle cannula, and a fitting is mounted to the end of the plastic tubing remote from the needle hub. The fitting may be configured for mating with a container, such as an evacuated blood collection tube or a blood bag. Thus, the blood collection set can be used to deliver a sample of blood from a patient to a container. 
     Many blood collection sets include a safety shield that is retained in a proximal position on the needle hub prior to use of the blood collection set. After use, however, the safety shield is slid distally relative to the needle hub and into a position where the safety shield surrounds the needle cannula. Some such shielding operations are carried out manually. Thus, the user may hold the proximal end of the hub and/or the plastic tubing in one hand and may slide the shield distally with the other hand. The shield locks with structure on the hub to prevent the shield from sliding completely off the hub and to prevent reexposure of the needle cannula. 
     More recent developments in blood collection sets include automatically actuated safety shields. For example, a spring may be disposed between the needle hub and the safety shield. A latch retains the safety shield in the proximal position on the hub and against the force of the spring. However, a push button actuator releases the latch in response to digital pressure by the user. The spring then propels the shield distally and into a shielding disposition around the needle cannula. 
     Many medical devices, including blood collection sets, are packaged in sterile blister packages. The typical prior art blister package includes a plastic tray for storing the medical device and a plastic cover removably secured across peripheral regions of the tray. 
     Prior art blister packages are not structurally sturdy. Thus, there is a significant possibility that the actuator button of the blood collection set will be triggered inadvertently by forces exerted on the blister package during storage or shipment or by forces generated when a user manually grips a blister package. 
     An inadvertent depression of the actuator button will urge the shield distally relative to the needle cannula and will lock the shield in a position that prevents or complicates further use of the needle cannula. Thus, an unused blood collection set may have to be discarded due to an inadvertent actuation of the safety shield caused by ordinary gripping of the blister package in which the blood collection set is sealed. 
     The fitting at the end of the plastic tube opposite the needle hub may include a second needle cannula that can be urged through the seal of an evacuated blood collection tube. Forces on the blister package could deform the blister package sufficiently for the needle to be urged through either the walls of the tray or through the plastic cover of the blister package. A protruding needle cannula would create the risk for an accidental needle stick. 
     Prior art blood collection sets typically require a band to maintain the tubing in an orderly coil within the confines of the blister package. The band works well, but adds to the cost and time to complete the packaging. 
     SUMMARY OF THE INVENTION 
     The subject invention is directed to a blister package assembly for a blood collection set and to an assembly of a blood collection set and a blister package. The subject invention further is directed to a method for packaging a blood collection set. 
     In one embodiment, the blood collection set includes a needle assembly that comprises a needle cannula. The needle cannula has a proximal end, a sharply pointed distal end and a lumen extending between the ends. The needle assembly further includes a plastic hub with a proximal end, a distal end and a passage extending between the ends. The proximal end of the needle cannula is securely mounted in the distal end of the hub. Thus, the lumen through the needle cannula communicates with the passage through the needle hub. 
     The needle assembly, in this embodiment, further includes a safety cap with a rigid tubular sidewall and an open proximal end. The open proximal end of the safety cap is telescoped in a distal-to-proximal direction over the needle cannula and is retained frictionally in proximity to the needle hub. However, the safety cap can be separated from the hub to expose the needle cannula immediately prior to use. The needle assembly also includes a safety shield that is telescoped over the needle hub. The safety shield is characterized by oppositely directed flexible wings. The wings can be folded into face-to-face engagement with one another to facilitate digital manipulation of the needle assembly. Alternatively, the wings can be taped into face-to-face engagement with the skin of a patient. The safety shield can be moved from a proximal position where the needle cannula is exposed to a distal position where the needle cannula is protectively enclosed within the safety shield. Locking structures are provided on the hub and the safety shield to prevent movement of the safety shield distally beyond the needle cannula. Additionally, locking structures are provided to prevent reexposure of a properly shielded needle cannula. 
     The safety shield of this embodiment is characterized by an actuating window. A resiliently deflectable actuating button projects from the needle hub and passes into the actuating window when the safety shield is in its proximal position. Release of the resiliently deflectable actuating button from the actuating window permits the needle cannula to move to the proximal position. 
     The needle assembly further comprises a spring disposed between a portion of the needle hub and the safety shield. The spring is disposed to retain stored energy when the needle cannula is in its distal position. However, disengagement of the actuating button from the actuating window releases the stored energy in the spring and enables the spring to propel the cannula into its proximal position surrounding the needle cannula. 
     The blood collection set of the embodiment further includes a length of flexible tubing with a proximal end and a distal end. The distal end of the flexible tubing is securely connected to the proximal end of the needle hub. The blood collection set also includes a fitting securely mounted to the distal end of the flexible tubing. The fitting may be configured to engage another fitting or to receive a second needle cannula. Alternatively, the fitting may have a second needle cannula permanently mounted thereon and engageable with an evacuated blood collection tube. While the package of the invention is particularly useful with push button type blood collection sets, the package is useful for a variety of blood collections sets. 
     A blister package according to an embodiment of the subject invention includes a tray that is molded unitarily from a plastic material such as PVC or PETG. The tray includes a bottom wall, a plurality of unitarily joined sidewalls extending away from the bottom wall and a peripheral flange extending outwardly from the sidewalls and generally parallel to the bottom wall. The distance between the peripheral flange and the bottom wall exceeds the maximum cross-sectional dimension of the needle assembly and the fitting. At least one sidewall may include an overhang spaced from the bottom wall. Thus, at least one sidewall may define a concave region for holding the tubing of the blood collection set within the tray and substantially adjacent the bottom wall. 
     The tray is further characterized by a plurality of towers projecting unitarily upwardly from the bottom wall. The towers comprise at least first and second gripping towers that are spaced apart sufficiently for gripping opposed sides of the needle shield in proximity to the actuating button. The gripping towers may be tapered from a major cross-sectional dimension adjacent the bottom wall to a minor cross-sectional dimension further from the bottom wall. Additionally, the gripping towers may have opposed facing convex surfaces that are configured to deflect as the safety shield of the needle assembly is urged between the gripping towers. 
     The gripping towers define a height greater than the maximum cross-sectional dimension of the safety shield in proximity to the actuator button. In a preferred embodiment, the upper ends of the gripping towers are substantially coplanar with the peripheral flange of the tray. Thus, the gripping towers surround and hold portions of the safety shield that contain the actuating window and the actuating button. Furthermore, the gripping towers extend sufficiently above the actuating button to prevent inadvertent actuation. The tapered configuration of the gripping towers and the convex walls of the gripping towers contribute to the strength of the gripping towers and prevent any local collapsing of the blister package that could inadvertently actuate the safety shield. 
     The tray of the blister package may further include at least one additional tower at a location spaced from the gripping towers. The additional tower may be disposed to position the fitting at the end of the plastic tubing remote from the needle assembly. 
     The blister package further includes a cover that extends unitarily across the peripheral flange of the tray. The cover preferably is formed from a flexible plastic material that can be peeled away from the peripheral flange to access the blood collection set stored therein. 
     The invention further is directed to a method for packaging a blood collection set such as a push button actuated. The method comprises providing a tray with a bottom wall, upstanding sidewalls extending from the bottom wall and a peripheral flange at portions of the sidewalls spaced from the bottom wall. The bottom wall of the tray includes at least first and second spaced apart gripping towers. The method further includes inserting the needle assembly of the blood collection set between the gripping towers of the tray so that the actuating button of the needle assembly is between the gripping towers and below upper ends of the gripping towers. The method proceeds by winding the plastic tubing of the blood collection set around the needle assembly and in the tray. A portion of the tubing may be gripped in a concave region of the sidewall and held reasably adjacent the bottom wall. The method concludes by adhering, bonding or otherwise attaching a removable cover across the peripheral flange of the tray for safely enclosing the blood collection set in the tray. 
     The blister design also has the added benefit of orientating the push button blood collection set in the blister and between the towers in such a way as to facilitate removal and prevent activation during removal. The location of the towers relative to the push button and shield are such that the user is guided to remove the pbbcs by graphing either the wings or proximal shield. This prevents the button from being activated during removal and orientates the pbbcs in the hand for immediate use. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a top plan view of a blister package in accordance with the subject invention. 
         FIG. 1B  is a top plan view of a second blister package in accordance with the invention. 
         FIG. 2  is a cross-sectional view taken along line  2 — 2  in  FIG. 1 . 
         FIG. 3  is a cross-sectional view taken along line  3 — 3  in  FIG. 1 . 
         FIG. 4  is a perspective view of a tray of a blister package in accordance with the subject invention. 
         FIG. 5  is a perspective view of the bottom of the tray shown in  FIG. 3 . 
         FIG. 6  is a top plan view of the tray. 
         FIG. 7  is a side elevational view of the tray. 
         FIG. 8  is an end elevational view of the tray. 
         FIG. 9  is a bottom plan view of the tray. 
         FIGS. 10A and 10B  are top plan views of third and fourth blister packages of the subject invention. 
     
    
    
     DETAILED DESCRIPTION 
     A first blister package in accordance with the subject invention is identified generally by the numeral  10   a  in  FIG. 1A . Blister package  10   a  includes a tray  12 , a cover  14  and blood collection set  16   a.    
     Blood collection set  16   a  includes a needle assembly  18 , a length of flexible tubing  20  and a fitting  22   a . Needle assembly  18  includes a needle cannula and a needle hub, neither of which are illustrated. However, both may be of conventional prior art design. Needle assembly  18  further has a rigid tubular safety cap  24  telescoped over the needle cannula and frictionally engaged on the needle hub. Safety cap  24  can be removed from needle assembly  18  by pulling safety cap  24  away from remaining portions of needle assembly  18  to expose the needle cannula. 
     Needle assembly  18  further includes a safety shield  26 . Safety shield  26  is a generally tubular structure with a proximal end  28 , a distal end  30  and a hollow space between ends  28  and  30  for accommodating the needle hub and/or portions of the needle cannula. Safety shield  26  includes a top  32 , sides  34  and  36  and a bottom  38  as shown in  FIGS. 1A and 2 . The terms top and bottom are not intended to imply a required gravitational orientation, but are provided merely for reference. Flexible wings  40  and  42  project transversely from safety shield  26  at locations near proximal end  30  and from portions of sides  34  and  36  adjacent bottom  38  of safety shield  26 . Wings  40  and  42  can be folded into face-to-face engagement for facilitating digital manipulation of needle assembly  18 . Alternatively, wings  40  and  42  can be laid flat taped against the skin of a patient. 
     Safety shield  26  further includes an actuating opening  44  that extends through top  32  of safety shield  26  at a location proximally of wings  40  and  42 . An actuating button  46  extends from the needle hub and is engaged in actuating opening  44 . Actuating button  46  holds safety shield  26  in the fixed position relative to the needle hub and the needle cannula illustrated in  FIG. 1A . However, actuating button  46  can be depressed relative to needle shield  26  to release needle shield  26  from the needle hub and the needle cannula. Needle assembly  18  further includes a coil spring disposed in safety shield  26  and surrounding the needle hub. The spring functions to propel the needle hub proximally within the assembly  18 . 
     Safety shield  26  is cross-sectionally reduced in portions adjacent actuating opening  44  as shown in  FIGS. 1 and 2 . The cross-sectional reduction includes concave arcuate reductions around all sides of safety shield  26  to facilitate the manipulation and actuation of needle assembly  18 . Needle shield  26  defines a maximum height “a” as shown in  FIG. 2 . However, as shown in  FIG. 2 , actuating button  46  is recessed relative to portions of needle shield  26  defining maximum height “a”. Needle shield  26  further defines a minimum width “b” at locations aligned with actuating opening  44 , as shown in  FIG. 1A . 
     Flexible tubing  20  extends from the needle hub for a selected distance. The embodiment of blood collection set  16  shown in  FIGS. 1A and 1B  depicts a 12″ length of tubing  20 . An alternate blood collection set described further below includes a shorter tube. Fitting  22  is mounted to the end of tubing  20  remote from needle assembly  18 . Fitting  22  shown in  FIG. 1A  includes a second needle assembly configured to be placed in communication with an evacuated blood collection tube. Fittings of other configurations may be provided, as explained further below. 
     Tray  12  of blister package  10   a  is molded unitarily from a thermoplastic material such as PVC or PETG. More particularly, tray  12  is molded as shown in  FIGS. 4–9  to include a substantially planar bottom wall  50  and a unitary sidewall enclosure  51  extending generally upward from bottom wall  50 . Sidewall enclsoure  51  comprises lateral walls  52  and  54 , end walls  56  and  58  and corner walls  60  and  62 . A peripheral flange  64  extends outwardly from sidewall enclosure  51  and defines a plane that is substantially parallel to bottom wall  50  and spaced from bottom wall  50  by distance “c”. Distance “c” exceeds maximum height “a” of needle shield  26  as shown in  FIG. 2 . 
     Central portions of lateral walls  52  and  54  define overhangs adjacent peripheral flange  64 . The overhangs define concave regions  52   a  and  54   a  at locations on lateral walls  52  and  54  adjacent bottom wall  50 . Concave regions  52   a  and  54   a  are dimensional to grip a section of tubing  20 , as shown in  FIG. 3 . 
     Tray  12  is further characterized by gripping towers  66  and  68  that project upwardly from bottom wall  50  at locations spaced from one another and spaced from the sidewall enclosure  51 . Gripping towers  66  and  68  include top walls  70  and  72  that are substantially coplanar with peripheral flange  64 . Gripping towers  66  and  68  are further characterized by opposed facing convex walls  74  and  76  respectively. Convex walls  74  and  76  are substantially orthogonal to bottom wall  50  and are spaced from one another by a minimum distance “d” as shown in  FIG. 6 . Distance “d” is less than minimum width “b” on portions of safety shield  26  adjacent actuating opening  44 . Gripping towers  66  and  68  further include non-gripping sidewalls  78  and  80  that are aligned to bottom wall  50  at acute angles. Thus, gripping towers  66  and  68  taper to smaller cross sections at locations further from bottom wall  50 . The tapered configuration of gripping towers  66  and  68  makes gripping towers  66  and  68  resistant to deformation in response to downward forces on top walls  70  and  72 . However, the convex configuration of facing walls  74  and  76  facilitates inward resilient deflection or dimpling of convex walls  74  and  76 , and hence secure resilient gripping of needle shield  26 . 
     Tray  12  is further characterized by a positioning tower  82  that projects from bottom wall  50  at a location spaced from gripping towers  66  and  68 . Positioning tower  78  has a planar top wall  84  that is located below the plane defined by peripheral flange  64  in the illustrated embodiment. 
     Needle assembly  18  of blood collection set  16   a  can be mounted in tray  12  by urging the narrowed portion of safety shield  26  adjacent actuating opening  44  into the space between gripping towers  66  and  68 . More particularly, needle assembly  18  is urged into tray  12  such that bottom surface  38  of safety shield  26  faces bottom wall  50  of tray  12 . The necked down portion of safety shield  26  adjacent actuating opening  44  is aligned with the space between gripping towers  66  and  68 . Minimum width “d” between gripping towers  66  and  68  is less than minimum width “b” of safety shield  26 . Hence, opposed convex facing surfaces  74  and  76  of gripping towers  66  and  68  will deflect resiliently inwardly to grip needle assembly  18  and hold needle assembly  18  substantially adjacent bottom wall  50  of tray  12 . In this position, wings  40  and  42  will be substantially adjacent and parallel to bottom wall  50 . Tubing  20  then is coiled within tray  12  and substantially adjacent bottom wall  50 . More particularly, tubing  20  is retained in concave spaces  52   a  and  54   a  beneath the overhang defined on lateral walls  52  and  54 . Thus, the overhangs retain tubing  20  in proximity to bottom wall  50  without a separate band. Fixture  22  is disposed between lateral wall  54  and positioning tower  78 . Accordingly, lateral wall  54  and positioning tower  78  limit movement of fixture  22  within tray  12 . 
     Blister package  10   a  is completed by applying cover  14  to peripheral flange  64 . Cover  14  is adhered or bonded removably to peripheral flange  64 . Cover  14  will be supported around its periphery by peripheral flange  64 . Additionally, central portions of cover  14  will be supported by top walls  70  and  72  of gripping towers  66  and  68 . 
     Bottom wall  50  of tray  12  and central portions of cover  14  are relatively flexible and can be moved toward one another in response to digital pressure. However, gripping towers  66  and  68  are relatively rigid and resist forces that would urge central portions of cover  14  toward bottom wall  50  of tray  12 . Additionally, gripping towers  66  and  68  are disposed on opposite respective sides of actuator button  46  and project from bottom wall  50  a distance “c” that is greater than the maximum height “a” of needle assembly  18 . Hence, gripping towers  66  and  68  prevent inadvertent actuation of needle shield  26  that could make blood collection set  16  unusable. Additionally, gripping towers  66  and  68  releasably fix needle assembly  18  at a central position in tray  12 , and therefore prevent any movement that might cause safety cap  24  to project through cover  14 . 
     Positioning tower  82  does not perform a direct holding function. However, positioning tower  78  facilitates spooling of tubing  20  and limits movement of fitting  22 . 
     Blood collection set  16   a  can be accessed merely by peeling cover  14  from peripheral flange  64  substantially in a conventional manner for blister packages. A user then grips portions of needle assembly  18  near proximal end  28  of safety shield  26  and lifts needle assembly  18  upwardly away from bottom wall  50 . The resiliency of convex facing walls  74  and  76  enables needle assembly  18  to be released from gripping towers  66  and  68 . Continued lifting force will cause tubing  20  to deflect and separate from recesses  52   a  and  54   a  formed by the overhang on lateral walls  52  and  54 . Fitting  22  also will be moved from the space between tower  82  and sidewall  54 . Thus, blood collection set  16  can be used substantially in a conventional manner. 
       FIG. 1B  shows an alternate blister package  10   b . Blister package  10   b  includes a tray  12  and cover  14  identical to the tray and cover described with respect to the embodiment of  FIG. 1A . Blister package  10   b  safely holds a blood collection set  16   b . Blood collection set  16   b  includes a needle assembly  18  and a length of tubing  20 , both of which are identical to needle assembly  18  and tubing  20  described with respect to blood collection set  16   a  of  FIG. 1A . However, blood collection set  16   b  includes a fitting  22   b  that differs from the fitting  22   a  described with respect to the embodiment of  FIG. 1A . In particular, the fitting  22   b  does not include a second needle cannula and is configured for mating with other portions of an IV system. 
     Blister packages  10   a  and  10   b  shown in  FIGS. 1A and 1B  are intended for use with a blood collection set having a 12″ length of tubing  20 . Some blood collection sets, however, include a shorter length of tubing, and in particular a 7″ length of tubing.  FIG. 10A  shows a blister package  10   c  for accommodating a blood collection set  16   c  with a needle assembly  18 , a 7″ length of tubing  20   c , and a fitting  22 . Needle assembly  18  of blister package  10   c  is identical to needle assembly  18  of blister package  10   a  shown in  FIG. 1A . Fitting  22  of blister package  10   c  also is identical to fitting  22  of blister package  10  shown in  FIG. 1A . Thus, detailed descriptions of these components are not provided. 
     Blister package  10   c  includes a tray  12   c  that is very similar to tray  12  in blister package  10   a  in  FIG. 1A . However, tray  12   c  includes gripping towers  66   c  and  68   c  that are positioned on bottom wall  50  at a location closer to tower  82 . Needle assembly  18  can be positioned between gripping towers  66   c  and  68   c  substantially as described with respect to the embodiments of  FIGS. 1A and 1B . However, distal end  30  of safety shield  26  projects toward end wall  56  and away from tower  78 . Tubing  20   c  is positioned in recesses  52   a  and  54   a  under the overhang defined on lateral wall  52 . Hence, tubing  20   c  does not undergo a complete loop within tray  12   c . However, the overhang still functions to hold tubing  20  in proximity to bottom wall  50  of tray  12   c . Additionally, tower  82  functions to limit movement of fitting  22 , and hence helps to keep blood collection set  20   c  in the coiled condition shown in  FIG. 10A . 
       FIG. 10B  shows a blister package  10   d  with a tray  12   c  identical to the tray  12   c  shown in  FIG. 10A . Blister package  10   d  includes a blood collection set  16   d  with a needle assembly  18  and tubing  20  identical to the needle assembly and tubing of the embodiment shown in  FIG. 10A . However, fitting  22   b  does not have a needle cannula and is identical to the fitting  22   b  described with respect to the embodiment of  FIG. 1B . 
     The preceding embodiments have illustrated the tray as used with a blood collection set. However, a tray in accordance with the subject invention also can be used with a catheter insertion unit that has a spring-driven, button-actuated safety shield, or with other type of blood collection sets or catheter or guide wire insertion device.