Abstract:
A safety transport box is provided with an inner enclosure configured for releasably engaging specimen collection equipment. The safety transport box further includes an outer enclosure for protectively enclosing the inner enclosure. The inner and outer enclosures are spaced from one another for preventing contact related damage to the specimen collection equipment. Both the inner and outer enclosures are selectively openable for accessing the specimen collection equipment.

Description:
BACKGROUND OF THE INVENTION 
   1. Field of the Invention 
   The invention relates to a box for convenient storage and transport of medical equipment required to obtain biological specimens from a patient and to store and transport the biological specimens after collection from the patient. 
   2. Background of the Invention 
   Many medical procedures require a sample of a bodily fluid to be obtained from a patient and transported to a laboratory for analysis. For example, many medical tests require samples of blood. The samples of blood typically are drawn by using the combination of a needle assembly, a needle holder and a plurality of evacuated tubes. The needle assembly may include a needle cannula with sharply pointed proximal and distal ends and a lumen extending between the ends. A plastic hub may be securely mounted to the needle cannula at a location between the proximal and distal ends. The hub may include an array of threads or other structure for mounting the needle assembly to the needle holder. The needle assembly may further include caps and/or shields for protectively enclosing the needle cannula prior to use and, when the shield is an integrated safety feature, after use. 
   The needle holder typically is a tubular plastic structure with a widely open proximal end and a partly closed distal end. The distal end includes a small opening configured for releasable engagement with the hub of the needle assembly. Thus, the proximal needle will extend into the region bounded by the tubular side wall of the needle holder. The distal end of the needle cannula, however, will project distally beyond the needle holder. 
   The evacuated tubes typically are formed from glass in view of the ability of a glass tube to retain a vacuum. Each glass tube include a cylindrical side wall, a closed bottom and an open top. A needle pierceable stopper is affixed in the open top of the glass tube. 
   The above-described blood collection assemblies are employed by mounting the needle assembly to the needle holder and placing the distal end of the needle cannula into communication with the blood vessel of a patient. An evacuated tube then is urged into the open proximal end of the needle holder so that the pointed proximal end of the needle pierces the stopper of the evacuated tube to permit a flow of blood into the evacuated tube. The evacuated tube is withdrawn from the needle holder after a selected volume of blood has been collected. A second evacuated tube then may be inserted into the open proximal end of the needle holder for drawing a second sample of blood. The procedure may be repeated several times for collecting the required number of samples. The tubes with the fluid samples are marked or labeled to identify the patient and are transported to a laboratory for analysis. 
   Fluid samples often are collected in a hospital, and the equipment for collecting the sample may be stored on carts that can be wheeled from one location to another in the hospital. After the appropriate number of specimens have been collected, the equipment used to collect the specimens must be discarded or stored for recycling in an appropriately and safe manner. For example, exposed portions of the used needle cannula may be shielded by an integrated safety shield, separated from the needle holder and deposited in a sharps receptacle. The needle holder may be transported to a location for sterilization and recycling. Alternatively, the assembly of the needle and the needle holder may be discarded in their assembled condition and without first separating the needle from the holder. The collected fluid samples then may be placed in racks that can be transported from the location where the samples are collected to the laboratory of the hospital for analysis. 
   Fluid samples are not always collected in a hospital. For example, many fluid samples are collected at a doctor&#39;s office or clinic and must be transported to a laboratory for analysis. In many other instances, fluid samples are collected at the patient&#39;s residence, in an ambulance or at some other location remote from any health care facility. In these situations, the health care worker must bring the specimen collection equipment to the patient, store the collection equipment after the specimen has been collected and arranged for safe transport of the collected specimen to the laboratory. 
   The equipment to collect a fluid sample must be stored in a manner for convenient access by the health care worker. This storage also must prevent both breakage of the evacuated glass tubes and damage to the small fragile needles prior to use. Furthermore, specimen collection tubes must be stored in a manner that will permit safe and convenient transportation to the laboratory. 
   SUMMARY OF THE INVENTION 
   The subject invention is directed to a safety transport assembly for safe and efficient storage and transportation of equipment required to collect fluid samples from a patient and for safe and efficient transportation of the equipment and specimens to a laboratory after the samples have been collected. The assembly includes an inner enclosure and an outer enclosure. The inner enclosure has an inner base for safely storing a plurality of specimen collection containers, such as a plurality of specimen collection tubes. In one embodiment, the inner base includes a rigid peripheral frame and a top support wall formed from a resilient or elastomeric material. The top support wall may include a plurality of apertures dimensioned and configured for resilient gripping of a corresponding plurality of specimen collection containers. Thus, the specimen collection containers can be separated from the inner base merely by exerting a sufficient pulling force to overcome resilient gripping forces exerted by the resilient or elastomeric top support wall of the inner base. 
   The inner base may further include means for releasably retaining other equipment that may be required to collect the specimens. For example, the inner base may include means for releasably gripping a needle holder and/or at least one needle assembly. The means for gripping a needle holder may include a generally cylindrical projection dimensioned for removable insertion into the open proximal end of a needle holder. Thus, the needle holder can be separated from the inner base of the assembly merely by exerting a sufficient pulling force on the needle holder to overcome the resilient gripping forces between the needle holder and the inner base. 
   The assembly may further comprise an inner cover for mounting over the inner base and for enclosing the equipment stored in the inner base. The cover may include a plurality of interconnected side walls, a top wall and an open bottom that is dimensioned to engage the inner base. The side walls of the inner cover include a plurality of inner surfaces. At least one inner surface of the inner cover may be provided with an absorbing material that is capable to absorb the fluid from a tube in the event that one or more tubes break during transit. The inner cover may further include at least one hydrophobic filter extending through the wall in the inner cover. The hydrophobic filter enables an equalization of pressure across the walls of the inner cover without risk of leaking fluid from the space bounded by the inner cover. This feature can be important under any circumstance where the transport box is transported in a low pressure environment, such as in a airplane. The inner cover may further include a pattern of surface irregularities configured to provide a selected degree of rigidity for the inner cover and surface structures configured to facilitate digital manipulation of the inner cover. 
   The assembly further comprises an outer enclosure. The outer enclosure may include an outer base surrounding at least portions of the inner base. The outer cover may further include first and second opposed shells hingedly connected to the outer base. The shells may be of generally clam-shell construction with a front or rear wall, side walls and a top wall. The shells may be connected to the outer base for hinged rotation approximately 90° from an open position where the shells are spaced from one another to a closed position where the shells engage one another. The shells may be formed with releasable locking means for holding the shells in the closed position. Outer surface regions of the shell also may be provided with planar panels for carrying indicia to indicate, for example, the name of a laboratory or other health care provider. The inner surface of at least one shell may be configured for releasably retaining a plurality of sheets of paper or similar such flexible sheet material. The sheets may include certain medical data prepared by the health care technician or instructions on proper use of the equipment stored in the assembly. 

   
     4. BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a perspective view of a safety transport box in accordance with the subject invention. 
       FIG. 2  is a top plan view of the closed safety transport box. 
       FIG. 3  is a perspective view of the safety transport box in a partly open condition and an erect orientation. 
       FIG. 4  is an exploded perspective view of the safety transport box in a fully open condition. 
       FIG. 5  is a cross-sectional view taken along line  5 — 5  in FIG.  2 . 
       FIG. 6  is a,cross-sectional view taken along line  6 — 6  in FIG.  3 . 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   A safety transport box in accordance with the subject invention is identified generally by the numeral  10  in  FIGS. 1-6 . Safety transport box  10  includes an outer enclosure identified generally by the numeral  12  in  FIGS. 1-6  and an inner enclosure identified generally by the numeral  14  in  FIGS. 3-6 . 
   Outer enclosure  12  is unitarily molded from a rigid thermoplastic material and includes an upwardly concave outer base  16  with a generally planar bottom wall  18 , upwardly curved side walls  20  and  22 , an upwardly curved front wall  24  and an upwardly curved rear wall  26 . Outer enclosure  12  further includes front and rear shells  28  and  30 . Front shell  28  includes a front panel  32 , first and second side panels  34  and  36  and a top panel  38 . Front panel  32  is connected unitarily to front wall  24  of outer base  16  along living hinge  40 . Front panel  36  includes a planar region that may be imprinted with indicia to identify the source or owner of safety transport box  10 . First and second parallel L-shaped ribs  42  and  44  project from the inner surface of front panel  32  and are configured for slidable receipt of printed sheet material, such as medical charts pertaining to the patient from whom the specimens will be taken or instructions for a laboratory. Top wall  40  of front shell  28  is formed with male and female latches  46  and  48 . 
   Rear shell  30  is structurally similar to front shell  28 . More particularly, rear shell  30  includes a rear panel  50 , first and second side panels  52  and  54  and a top panel  56 . Rear panel  50  is connected unitarily to rear wall  26  of outer base  16  along living hinge  58 . Top panel  56  includes female and male latches  60  and  62  that are structurally similar to female and male latches  50  and  48  on front shell  28 . 
   Front and rear shells  28  and  30  can be rotated hingedly about living hinges  40  and  58  and relative to outer base  16 . More particularly, in an open rotational orientation, front and rear panels  32  and  50  are substantially coplanar to expose inner enclosure  14  and inner regions of outer enclosure  12 . However, front and rear shells  28  and  30  can be rotated approximately 90° from the  FIG. 3  open orientation into the closed orientation shown in  FIGS. 1 ,  2  and  5 . In the closed orientation, male and female latches  46  and  48  of front shell  28  releasably engage female and male latches  60  and  62  respectively of rear shell  30 . Additionally in the closed condition, first side panel  34  of front shell  28  is flush with first side panel  52  of rear shell  30 . Similarly, second side panel  36  of front shell  28  is flush with second side panel  54  of rear shell  30 . A label may extend across the first side panels  34  and  52  or across the second side panels  36  and  54 . The labels provide a tamper indication so that a user of safety transport box  10  knows immediately whether the box has been used previously. 
   Inner enclosure  14  includes an inner base  64  that is locked into engagement with outer base  16 . Inner base  64  defines an upwardly open rectangular enclosure having a bottom wall  65  opposed first and second inner side walls  66  and  68 , an inner front wall  70  and an inner rear wall  72 . A peripheral flange  74  is formed unitarily with inner base  64  and extends upwardly and outwardly from first and second inner side wall  66  and  68 , inner front wall  70  and inner rear wall  72 . Thus, an upwardly open peripheral channel  76  extends around inner base  64 . Inner base  64  is formed with arrays of radially aligned support fins  77  that extend up from bottom wall  65 . Support fins  77  in each array are spaced apart sufficiently to receive the bottoms of specimen containers of different diameters. 
   Inner base  64  further includes an elastomeric support  78 . The elastomeric support  78  includes a peripheral wall with a downwardly open peripheral channel  80  and an upwardly open peripheral channel  82 . Downwardly open peripheral channel  80  is configured for nesting over the open top edges of inner side walls  66  and  68 , inner front wall  70  and inner rear wall  72  of inner base  64 . Additionally, portions of elastomeric support  78  adjacent downwardly open peripheral channel  80  nest in upwardly open peripheral channel  76  of inner base  64 , as shown in  FIGS. 5 and 6 . Thus, a watertight seal is provided between inner base  64  and elastomeric support  78 . 
   Elastomeric support  78  further includes a top wall  84  aligned substantially parallel to bottom wall  65  of inner base  64 . Top wall  84  is formed with a plurality of apertures  86  with irregular edges dimensioned for releasable engagement of outer surfaces of a tube  88 , as shown most clearly in  FIGS. 4-6 . The apertures  86  register with the respective arrays of radially aligned fins  77 . Additionally, elastomeric support  78  is formed to include an upwardly opening rectangular recess  90  and a cylindrical projection  92  that projects upwardly in recess  90 . Cylindrical projection  92  is configured for resilient and frictional engagement of interior surface regions of a needle holder  94 . 
   Inner enclosure  14  further includes a downwardly open inner cover  96  unitarily molded from a rigid plastic. Inner cover  96  includes opposed front and rear walls  98  and  100 , a first end  102 , a second end wall  104  and a top wall  106 . Lower edge regions of front and rear walls  90  and  100  and first and second side walls  102  and  104  are dimensioned to telescope into upwardly open peripheral channel  82  of elastomeric support  78 . Thus, a watertight seal is achieved between inner cover  96  and elastomeric support  78 . In this manner, inner enclosure  14  a substantially leak-proof enclosure that prevents leakage of body fluids that may have been collected and stored in inner enclosure  14 , as explained further herein. Inner cover  96  is dimensioned to be spaced from front and rear shells  28  and  30  when shells  28  and  30  are in the closed condition, as shown in FIG.  5 . Thus, a protective air space exists between outer enclosure  12  and inner enclosure  14 . Inner cover  96  is characterized by first and second upwardly open receptacles  108  and  110  respectively formed on outer regions of first and second inner end walls  102  and  104 . The receptacles  108  and  110  are configured for releasable engagement of a needle assembly, as explained further below. Inner cover  96  is characterized further by at least one sheet of absorbent material  112  internally disposed adjacent at least rear wall  100 . More particularly, absorbent material  112  may be formed from cellulous fibers that will absorb material that may be released from tubes  88  in response to breakage or leakage. Absorbent material  112  functions to absorb any bodily fluid that may escape from a fluid collection tube stored therein. Such leakage might occur, for example, due to pressure differentials across the walls of the fluid collection tube or due to breakage of the tube. Inner cover  96  further includes at least one and preferably several hydrophobic filters  113  extending through walls defined by inner cover  96 . Hydrophobic filters  113 , by their nature, are permeable to air but impermeable to water and other liquids. Thus, hydrophobic filters  113  permit a flow of air across the walls of inner cover  96  for equalizing pressure. However, fluids, such as bodily fluids collected in tubes disposed within inner enclosure  14  will not flow through hydrophobic filters  113 . This feature makes safety transport box particularly useful for environments where a pressure differential is likely to be created. For example, inner cover  96  may be sealingly engaged with elastomeric support  78  in a relatively high pressure environment. However, safety transport box then may be transported by plane or moved to a laboratory or health care facility at a higher elevation. Hydrophobic filters  113  enable an equalization of air pressure without an outward flow of bodily fluid. 
   Safety transport box  10  can be used to store and transport laboratory supplies and equipment that are needed to collect samples of bodily fluid, such as blood. Additionally, safety transport box  10  can be used to store certain printed material including medical reports about a particular patient, instructions for a laboratory or instructions to advise a health care technician how to use the equipment stored in safety transport box  10 . Safety transport box  10  also can be used to transport specimens and used safety needle/holder assemblies for safe removal and elimination at a laboratory. For example, with reference to  FIG. 4 , specimen collection tubes can be engaged releasably in apertures  86  in top wall  84  of elastomeric support  78 , such that the bottom of each tube  88  is nested in an array of radially aligned ribs  77 . The elastomeric material from which inner support  78  is formed will cushion tube  88  from contact against safety transport box  10  during use or transportation. Similarly, a needle holder  94  can be retained frictionally on cylindrical projection  92  within rectangular recess  90  formed in elastomeric support  78 . The tubes  88  and the needle holder  94  can be enclosed safely by telescoping inner cover  96  over tubes  88  and needle holder  94  and by nesting the bottom edge of top  96  in upwardly open peripheral groove  82 , as shown most clearly in  FIGS. 5 and 6 . Shielded needle assemblies  114  then can be engaged releasably in upwardly open receptacles  108  and  110 . 
   A health care worker can use safety transport box  10  by carrying box  10  to a patient who requires blood or other bodily fluids to be collected and tested by a laboratory. The technician places bottom wall  18  of outer base  16  on a table or other supporting surface. Latches  46 ,  48 ,  60  and  62  are manipulated to permit front and rear shells  28  and  30  to be rotated away from one another and into the orientation shown in FIG.  3 . The health care technician then grips inner cover  96  and pulls upwardly to separate inner cover  96  from open peripheral channel  82  in elastomeric support  78  of inner base  64 . The open bottom edges of inner cover  96  then can be supported on a table or other planar surface near outer enclosure  12 . The health care worker then removes needle holder  94  from cylindrical projection  92  and removes the shielded needle assembly  114  from one of the receptacles  108  and  110  in inner cover  96 . Needle assembly  114  then is engaged with needle holder  94  in the conventional manner. This typically requires removing a proximal cap from a proximal needle on needle assembly  114  and engaging a hub of needle assembly  114  in a mounting aperture of needle holder  94 . A distal cap on needle assembly  114  then may be removed and the health care worker may position the distal tip of the needle cannula into a targeted blood vessel of the patient. The health care worker then sequentially removes evacuated blood collection tubes  88  from inner base  64  merely by pulling tubes  88  upwardly with sufficient force to separate tubes  88  from apertures  86  in top wall  84  of elastomeric support  78 . A selected volume of blood or other bodily fluid is collected in each of a plurality of tubes  88 , and tubes  88  are sequentially redeposited into apertures  86  of elastomeric support  78 . After a sufficient number of tubes  88  have been collected for the required tests, needle holder  94  and needle assembly  114  are withdrawn from the patient. Needle assembly  114  is safely shielded and then may be separated from needle holder  94  or may be re-deposited attached with the holder in an upright position over cylindrical projection  92 . When separated from the needle assembly  114 , needle holder  94  may be positioned again on cylindrical projection  92  in inner base and the shielded needle assembly can be discarded in a safe manner. Inner cover  96  then can be secured over inner base  64  by telescoping inner cover  96  over tubes  88  and needle holder  94  or needle/holder assembly with safety feature engaged and telescoping inner cover the bottom edges of inner cover  96  into upwardly open channel  82  in elastomeric support  78  of inner base  64 . The health care worker then merely rotates front and rear shells  28  and  30  toward one another and into the closed condition shown in  FIGS. 2 and 5 . The safety transport box then can be transported safely to a laboratory for analysis of the collected specimens and for needle/holder assembly elimination. 
   The illustrated embodiment shows the safety transport box  10  adapted for storing and transporting equipment to collect samples of blood. However, the safety transport box  10  can be used for collecting other bodily fluids, such as urine, saliva and such. These optional embodiments do not require the inner enclosure to be adapted for storing a needle holder or needle assembly.