Abstract:
A container system for medical instruments comprising a molded plastic reticulated tray composed of a continuous rib that forms a tray rim and a plurality of intersecting ribs defining large openings therebetween. The intersecting ribs are dished and have opposite ends connected to the continuous ribs at spaced apart locations therealong. The plurality of intersecting ribs also have rounded surfaces so that a washing or cleaning fluid directed at the plurality of intersecting ribs from the outside, upon flowing through said openings will follow and intimately contact those rounded surfaces so that those surfaces are cleaned thoroughly. A preferred embodiment of the system also includes a reticulated cover releasably connected to the tray and various brackets for fixating instruments in the tray.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     This invention relates to a system for holding selected medical instruments and devices during sterilization and storage prior to use and to facilitate their cleaning and storage following such use.  
         [0003]     Different surgical procedures require the use of different sets of instruments or devices, the number of tools in the set depending upon the complexity of the procedure. Thus, prior to a particular procedure, the surgeon determines or knows from experience which instruments will be required. Those instruments are gathered together as a set, placed in a container which is packaged in a plastic package and sterilized in an autoclave. The packed instruments are then stored in that sterile condition until ready for use. When the surgeon is ready to perform the procedure, the container is brought to the operating room and opened, exposing the still sterile instruments therein. Following use, the instruments are usually returned to the container and sent to a cleaning facility where the containers and instruments therein are placed in a washing machine which directs jets of water/detergent cleaning fluid at the containers and their contents to clean them prior to resterilization.  
         [0004]     To improve the circulation of cleaning fluid throughout the container, the container walls are usually formed with a multiplicity of vent holes which may be used to anchor the various brackets which support and fixate the various instruments within the container. Examples of such containers are disclosed in U.S. Pat. Nos. 5,424,048; 5,681,539; 6,193,932 and 6,331,280.  
         [0005]     Heretofore, the various containers and trays used for the above purposes have been structures whose walls are more closed than open. In other words, the containers have planar walls with a multiplicity of vent holes therein leaving relatively wide webs of plastic extending between the vent holes, the total area of the webs invariably being much larger than the total area of the vent holes in order to maintain the structural integrity and rigidity of the container. As a result, when water/detergent or other cleaning fluid impinges upon the container during the cleaning process, the fluid may not come into intimate contact with all the inside surfaces of the webs with the result that those surfaces will not be cleaned to the extent that they should be. That is, as the cleaning fluid is directed into the container through the vent holes, turbulent flow occurs causing the fluid to flow past portions of the flat interior surfaces between the holes resulting in a shadow effect thereon and insufficient cleaning of the flat surface portions within those shadows.  
         [0006]     In order to obtain a better circulation of cleaning fluid through the container during washing, it has been contemplated to use a more open structure for the container, i.e. one composed of intersecting ribs wherein the total area of the openings into the container between the ribs totals much more than that of the ribs bounding the openings. Thus it has been contemplated to form a tray or container of metal wire coated with a plastic material, i.e. similar to a dish washer rack. Although such an open structure composed of intersecting ribs allows maximum circulation of fluid through the container with minimal shadow effect, it is not particularly suitable for medical applications. This is because during normal usage over time, the plastic coating can be scratched or otherwise damaged exposing the underlying metal wire which will oxidize and provide sites for the buildup of bacteria. Also when such a wire structure is deformed, it will tend to remain so with the result that it may not inter-fit properly with other components of the container system. For example, if a wire tray is deformed, its cover may not fit properly on the tray.  
         [0007]     Of course, the above problems can be avoided by molding the container or tray entirely of plastic as has been done for clothes baskets, soap dishes and the like. However, such molded plastic open structures are invariably constituted of intersecting webs or ribs which are thin and have a rectangular cross section. Resultantly, the containers of this type are not rigid enough to protect sensitive medical instruments. Also, since the inner and outer surfaces of those ribs are flat, they suffer the same shadow effect discussed above in connection with perforated plastic trays, albeit to a lesser extent. While the former problem can perhaps be alleviated by thickening the ribs, the latter problem cannot.  
         [0008]     Thus it would be very advantageous if there existed a container for holding medical instruments during washing and cleaning processes which has the advantages of plastic coated metal wire baskets in terms of strength and rigidity and none of the aforesaid disadvantages thereof.  
       SUMMARY OF THE INVENTION  
       [0009]     Accordingly, this invention aims to provide a medical instrument container system capable of protectively enclosing medical instruments while maximizing the exposure of the container interior to a cleaning fluid.  
         [0010]     Another object of the invention is to provide such a system which includes a strong rigid instrument container in the form of a basket or cage molded entirely of a plastic able to withstand sterilization and cleaning processes.  
         [0011]     A further object of the invention is to provide a system of this type which includes an instrument supporting basket or cage whose interior surfaces are shaped to minimize the shadow effect when a washing or cleaning fluid is incident on the basket or cage.  
         [0012]     Still another object of the invention is to provide a medical instrument container system which includes a container and cooperating brackets capable of holding variously shaped instruments and devices in a variety of configurations within the container.  
         [0013]     A further object of the invention is to provide a system of this type which can be made relatively inexpensively in quantity.  
         [0014]     Briefly, my container system for medical instruments comprises a tray which is reticulated and molded entirely of a plastic material able to withstand washing and sterilization. The tray has relatively large openings bounded by ribs having cross-sectional shapes that round-off substantially all of the interior and exterior surfaces of the tray. Resultantly, when a cleaning fluid is directed at the tray from the outside, the fluid follows the rounded streamlined surfaces of the ribs through the openings to the inside of the tray thereby eliminating the shadow effect and ensuring that all interior surfaces of the container are intimately contacted by that fluid.  
         [0015]     Each tray can be molded as a unitary part and thus can be made in quantity relatively inexpensively. The tray can be used by itself or fitted with a cover of similar reticulated construction. The cover may be releasably secured to the container to form a cage which protectively encloses the medical instruments without obstructing the free flow of cleaning fluid through the cage. As we shall see, my system may also include various instrument holders specially designed to be releasably secured to the ribs of the tray to fixate the instruments therein during handling prior to and following the cleaning process. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]     For a fuller understanding of the nature and objects of the invention, reference should be made to the following detailed description taken in connection with the accompanying drawings, in which:  
         [0017]      FIG. 1  is perspective view from above showing a medical instrument container system incorporating the invention;  
         [0018]      FIG. 2  is an exploded fragmentary perspective view on a larger scale showing the  FIG. 1  system including a matching cover;  
         [0019]      FIG. 3  is an end view of the  FIG. 2  system in a fully assembled condition;  
         [0020]      FIGS. 4A  to  4 E are perspective views showing various instrument holders that may be part of the  FIG. 1  system;  
         [0021]      FIG. 5A  is a view similar to  FIG. 1  of another container system embodiment, and  
         [0022]      FIG. 5B  is a perspective view of a cover that may be included in the  FIG. 5A  system.  
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0023]     Referring to  FIG. 1  of the drawings, my container system comprises a tray  10  which may contain one or more medical instruments or devices I. While the illustrated tray is rectangular, it could just as well have some other shape, e.g. round or oval. Preferably, each instrument I is supported within the tray by one or more holders  12  which fix the position of the instrument within the tray.  
         [0024]     As shown in  FIGS. 1 and 2 , tray  10  is a reticulated structure molded entirely of a rigid plastic able to withstand cleaning and sterilization processes, e.g. polyphenylsulphone, PTFE, etc. Thus, tray  10  is composed of plurality of spaced-apart ribs. These ribs include a rectangular rib  14   a  which forms a hoop at the rim of the tray, a plurality of spaced-apart, parallel, longitudinal ribs  14   b  which comprise the bottom wall of the tray and a multiplicity of spaced-apart, parallel, transverse ribs  14   c  which intersect ribs  14   b  at the bottom of the tray. The opposite end segments of ribs  14   b  and  14   c  are bent up and connect to rib  14   a  at the inboard face of that rib at spaced-apart locations therealong. These segments form the sides and ends of the tray. Preferably, the ribs  14   b  and  14   c  are spaced an appreciable distance from their neighboring parallel ribs, e.g. 0.75 inch or more, so that the openings O between the ribs are quite large compared to the ribs. In a preferred tray embodiment, the total area of the tray openings O should be at least twice the total longitudinal sectional area of the tray ribs  14   a,    14   b.  Also, the ribs are rounded, most preferably having circular cross-sections.  
         [0025]     For reasons to be described later, the rectangular rib  14   a  is formed with a plurality of outward bends or loops  16  which are spaced along the length of that rib at the sides of the tray. Also, short locating pins  18  extend up from rib  14   a  between the loops  16 .  
         [0026]     Attached to the ribs  14   a  to  14   c  at the opposite ends of container  10  is a pair of mirror image fixtures  22 . Preferably, each fixture is molded integrally with the continuous ribs  14   a  and perhaps also ribs  14   b  and  14   c.  However, the fixture may also be designed as a separate part which can snap onto those ribs. Each fixture  22  includes a pair laterally spaced-apart ears  22   a  formed with holes  24  forming journal bearings for loosely receiving the laterally extending axles  26   a  of a latch member  26 . As best seen in  FIGS. 2 and 3 , each latch member  26  is has a slit  26   b  between, and extending perpendicular to, its axles  26   a  so that the sides of the latch member may be pressed together to permit the insertion of the axles  26   a  into the holes  24  of the corresponding fixture  22  to facilitate the assembly of the latch members  26  to fixtures  22 . When assembled, each latch member  26  may be swung between an open or unlatched position shown in  FIGS. 1 and 2  wherein a latching surface  26   c  of the latch member  26  is spaced away from rib  14   a  of container  10  and a closed or latching position wherein the latching surface  26   c  is spaced above rib  14   a  a distance slightly less than the diameter of rib  14   a.    
         [0027]     Referring to  FIGS. 2 and 3 , preferably, but not necessarily, my container system also includes a mating molded plastic reticulated cover or lid  30 . While the cover and tray may have different depths to minimize molding costs, the illustrated cover is more or less identical to tray  10  when the two are side by side and a mirror image when the cover is inverted as shown. Thus cover  30  includes a rectangular rib  42   a  similar to rib  14   a  and which overlies rib  14   a  when the cover is positioned on the tray as shown in  FIG. 3 . Cover  30  also includes a plurality of longitudinal ribs  42   b  similar to ribs  14   b  as well as a multiplicity of transverse ribs  42   c  comparable to ribs  14   c  and which intersect ribs  42   b  thereby forming the top wall of the cover. Ribs  42   b  and  42   c  are turned down at their opposite ends so that they connect to rib  42   a  at spaced-apart locations along that rim at the inboard side thereof.  
         [0028]     As is the case with tray  10 , the rib  42   a  which forms the rim of cover  30  is formed with a series of outward bends or loops  44  at spaced-apart locations at the sides of cover  30 , as well as a series of locating pins  46  comparable to the pins  18  of tray  10 . The respective locating pins and loops on tray  10  and cover  30  are positioned so that when the cover  30  is inverted and positioned on the tray, the locating pins  18  of the tray project up into the loops  44  of the cover and the locating pins  46  of the cover extend down into the loops  16  of the tray thereby maintaining the tray and cover in perfect register.  
         [0029]     As best seen in  FIGS. 2 and 3 , cover  30  also includes integrally molded fixtures  48  at the opposite ends of the cover which are identical to the fixtures  22  of tray  10 . However, they do not form hinges for the latch members. Rather, the fixtures  48  function as keepers for the latch members  26  when cover  30  is positioned on tray  10  and secured thereto by latch members  26 . More particularly, each fixture  48  (as well as each fixture  22 ) is formed with a raised keeper surface  48   a.  When the corresponding latch member  26  is moved to its latching position shown in  FIG. 3 , the latching surface  26   c  of each latch member  26  resiliently engages and snaps over the keeper surface  48   a  of the corresponding fixture  48  thereby clamping cover  30  to tray  10 . When so clamped together, those parts only make line contact along the ribs  14   a  and  42   a,  minimizing the likelihood of bacterial build up where the cover meets the tray.  
         [0030]     It is obvious from the aforegoing that before assembly of the latch members  26  to tray  10 , the cover  30  is identical to the tray. Therefore, those two parts can be made using the very same mold. The locating loops  16 ,  44  and locating pins  18 ,  46  are all positioned so that when the cover  30  is inverted and its rib  32   a  brought into register with the tray rib  14   a,  the pins  18  of the tray will project up into the loops  44  of the cover and the pins  36  of the cover will project down through the loops  16  of the tray. Furthermore, this applies for both end-to-end registrations of the cover with the tray. In other words, if the cover  30  is turned 180° relative to the tray, the various locating loops and pins will still inter-fit to bring the cover and tray into register.  
         [0031]     As best seen in  FIG. 3 , to enable one to easily grasp the top of latch member  26  to pull the latch member away from the end of the cover to release the latch member from fixture  48 , that fixture is formed with a finger notch  48   b.  Of course, a comparable notch is present in fixture  22  since the two fixtures  22  and  48  are identical. Also, to provide clearance for each latch member  26  when that member is swung to its latching position, the rim-forming ribs  14   a  and  42   a  may be provided with flats  52  and  54 , respectively, which face the corresponding latch member as best seen in  FIG. 2 .  
         [0032]     It is a feature of this invention that the molded plastic reticulated tray and cover construction described herein provides a container system which is strong and rigid and well able to protect the instruments in the tray. Yet, the container system is still very open in that the total longitudinal sectional area of the ribs is a relatively small percentage of the total area of the openings in the tray/cover. That coupled with the fact that the surfaces of the ribs are rounded, assures that a cleaning fluid directed toward the tray or cover will pass easily into and through those container components, following the streamlined contours of the ribs so that there is minimal or no shadow effect at the interior surfaces of the container. This ensures that the entire container system and its contents will be thoroughly washed or otherwise cleaned in a minimal amount of time.  
         [0033]     Refer now to  FIG. 4A  which shows in greater detail one of the instrument holders  12  in  FIG. 1 . It is a molded plastic part consisting of a generally U-shaped base  62 . The opposite ends of base  62  are turned outward and downward to form a pair of spaced-apart vertical legs  64  which extend down below base  62  and are terminated by a pair of mirror image clips  66 . Each clip has one or more interior clamping surfaces  66   a  which are dimensioned to clamp to one or another of the tray ribs  14   b,    14   c.  Molded integrally to base  62  is a flexible resilient instrument holding pad or portion  68  formed with an opening or slot  68   a  for resiliently receiving a medical instrument I as shown in  FIG. 1 . Preferably, the holding pad  68  is molded integrally with base  62  in the manner described in my pending U.S. application Ser. No. 11/299,505, the entire contents of which are hereby incorporated by reference herein. As described in that application, the holding portion  68  is molded integrally with the base  62  so that there are no interstices or crevices or openings between those members which could be possible sites for bacterial infestation.  
         [0034]     As shown in  FIG. 1 , each holder  12  is clamped to the longitudinal ribs  14   b  at opposite sides of tray  10 . Accordingly, holder  12  must extend substantially the full width of tray  10  to secure the holder to those outboard ribs  14   b.  To anchor the holder to the tray, the clip  66  at the end of one of the legs  64  is engaged to one rib  14   b  and the legs  64  are spread apart sufficiently so that the clip  66  on the other leg can engage the rib at the other side of the tray. Leg  64  are sufficiently resilient that when released, they return to unstressed positions which securely clamp holder  12  to the tray and maintain the holder&#39;s transverse position in the tray. While the illustrated clips  66  are flat metal parts, they may have circular cross-sections at clamping surfaces  66   a  where they contact the ribs to minimize the contact areas therewith.  
         [0035]     Preferably also, the clips  66  are almost as wide as the distance between the transverse ribs  14   c  so that, when secured as aforesaid, holder  12  is also longitudinally fixed in tray  10 . Since the openings between the ribs  14   b,    14   c  at the bottom of the tray are square, each holder  12  could also be turned 90° and clamped to the transverse ribs  14   c  of tray  10  if that were necessary to retain a particular instrument or device within the tray.  
         [0036]     Of course the holder  12  need not extend the full width of tray  10 .  FIG. 4B  illustrates a holder  70  which is similar to holder  12  expect that it is narrower so that it spans only two openings in the tray bottom.  
         [0037]      FIG. 4C  shows another holder  72  which is similar to holder  70  expect that its base is formed with a pair of integral depending posts  74  which are spaced apart a distance substantially equal to the diameter of the ribs comprising tray  10 . When the holder  72  is clipped to tray  10  in a manner similar to that of holder  12  therein, the posts  74  will straddle a longitudinal rib  14   b  thereby positively fixing the lateral or transverse position of the holder within the tray even though the holder has resilient legs.  
         [0038]      FIG. 4D  illustrates a holder  76  with a pair of spaced-apart upstanding loops  76   a  for fixating a relatively wide instrument or device, while  FIG. 4E  illustrates a holder  78  having a single upstanding loop  78   a  which may be suitable, for example, to secure a scissor handle or other such instrument having an eye.  
         [0039]     Refer now to  FIGS. 5A and 5B  which illustrate, respectively, a molded plastic reticulated tray  80  and a cover  82  therefor with are much wider than tray  10  and cover  30  so that, using a variety of the instrument holders shown in  FIGS. 4A  to  4 E, a whole set of instruments or devices can be protectively enclosed for sterilization and handling. Being larger, the tray  80  and cover  82  are formed with two sets of fixtures similar to fixtures  22  which may accommodate two sets of latch members similar to members  26  in  FIG. 1 . Here also, the tray  80  and cover  82  may be identical molded plastic parts. However, the illustrated cover  82  is somewhat different from the tray in that it includes solid side straps  82   a  to prevent loose instrument I from sliding out of the tray. As in  FIG. 2 , the latch members are attached to the tray fixtures  22  but not to the cover fixtures, with the latter functioning as keepers for the tray latches. Of course in both system embodiments, the latch members could just as well be hinged to the cover fixtures with the tray fixtures functioning as keepers for those latch members.  
         [0040]     It is apparent from the foregoing that my container system has definite advantages in terms of protecting the instruments contained therein as well as facilitating efficient washing and sterilization of those instruments as well as the inside surfaces of the container. Yet being molded entirely of plastic, the system can be made in quantity relatively inexpensively. Therefore, it should prove to be very useful in hospital, clinics and other settings where medical instruments and devices have to be cleaned on a routine basis.  
         [0041]     It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained. Also, since certain changes may be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.  
         [0042]     It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention described herein.