Abstract:
A dynamically configurable medical device and information container is disclosed. The container includes ergonomic features that enable ease of handling and unloading of the contents of the container. Specifically, a configurable section serves as an ergonomic gripping section and a containment section. The container also includes tamper-proof strips that are visible indications of prior opening or tampering with the container. Furthermore, vent holes are implemented to release sterilization gas residues to limit the sterilization gas content of the container.

Description:
FIELD OF THE INVENTION  
       [0001]     The invention relates to specialized containers adapted to hold and contain a medical device and related information.  
       BACKGROUND OF THE INVENTION  
       [0002]     Containers designed for storing and transporting medical devices and surgical equipment are well known in the art. Generally, these types of containers include a container and a cover with sufficient volume to hold medical devices and components securely. Various types of attachments such as, for example, hinges, snap-on grooves or other structures are used to securely place the cover on the container.  
         [0003]     One of the general performance requirements for medical device containers is the need to maintain a protection for a sterilized package from the point of packaging, storage to delivery. Specifically, the primary features of most sterilized medical implant packages are to provide protection of the implants during shipping and enable sterile delivery to the operating room. However, there are several limitations in most of these packages and containers. Primarily, most medical device containers are cumbersome and require various operations to package, deliver and handle. Further, current medical device containers do not appear to provide ergonomic features that are compatible with the handling and delivery of implantable medical devices.  
         [0004]     There is, therefore, a need to provide a container for sterile delivery of implantable medical devices, with features and structures that enhance packaging efficiency on the manufacturing floor, promote ease of handling and complement implant procedure efficiency in the operating room.  
       SUMMARY OF THE INVENTION  
       [0005]     The invention is directed to a container for a medical device and related information that is tailored to house, cradle, support and protect the medical device in a sterile environment. Specifically, the container in accordance with the present invention, is dynamically configurable to enable an efficient high volume assembly, packaging, shipping and delivery operation while further enabling safe handling and unpacking of the contents of the container in an orientation suitable for a quick access and removal to implant in a patient.  
         [0006]     Among many of the novel features, the invention includes a container with a partial segment that remains closed while allowing access to the medical device when the container is opened. Further, the container includes vent holes to enable a gradual but continuous release of sterilization gas residues such as ethylene oxide or hydrogen peroxide that would otherwise accumulate in the box and may render the package unacceptable in certain jurisdictions with strict emission standards.  
         [0007]     In yet another aspect of the invention, the container includes ergonomic features that promote a simple and efficient handling of the container while enabling a secure hand-off to a surgeon in an operating room. The container also provides a tamper-proof indicator that includes a breakaway strip which breaks away when the cover of the container is opened for the first time, thus providing visible proof if the container was ever tampered with or in anyway compromised.  
         [0008]     While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description which shows and describes illustrative embodiments of the invention.  
         [0009]     As will be realized, the invention is capable of modification in various obvious aspects, all without departing from the scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]      FIG. 1  is a perspective drawing of the container in accordance with the present invention.  
         [0011]      FIG. 2  is a perspective drawing showing cooperative elements of the present invention.  
         [0012]      FIGS. 3A  shows a prior art container and  FIG. 3B  provides the ergonomic aspects of the present invention in comparison thereof.  
         [0013]      FIG. 4A  depicts the ergonomic and ease of handling aspects of the present invention.  
         [0014]      FIG. 4B  is a depiction of the ease of handling provided by the present invention.  
         [0015]      FIG. 5  illustrates the use of a tray adapted for placement in the container.  
         [0016]      FIGS. 6A-6D  are cross-sectional views of the container in accordance with the present invention, depicting various elements and details thereof.  
         [0017]      FIG. 7A  is a side view of the container in a fully open position to accept medical devices in a medical device packaging operation.  
         [0018]      FIG. 7B  is a plan view showing the internal structures and cooperative elements in accordance with the present invention.  
         [0019]      FIGS. 8A and 8B  are perspective drawings of an alternate embodiment of the invention.  
         [0020]      FIG. 9  is a perspective drawing showing a CD mount.  
         [0021]      FIG. 10  is a perspective drawing showing sectional views A-A and B-B.  
         [0022]      FIGS. 11A and 1B  are sectional views showing support structures for the grip area in accordance with the invention.  
         [0023]      FIGS. 12A and 12B  are alternate sectional views showing support structures for the grip area in accordance with the invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0024]     Referring to  FIG. 1 , container  10  includes bottom shell  12  with flange  14  around the perimeter thereof. Similarly, top shell  16  includes a flange  18  around its perimeter. Bottom shell  12  and top shell  16  are adapted to fit at the flanges to form a containment volume therebetween.  
         [0025]     Specifically, bottom shell  12  and top shell  16  are hingeably connected at hinge  22  to enable pivotable separation to thereby maintain container  10  in an open position to accept the medical device. Further, top shell  16  includes living hinge  24  to enable a section of top shell  16  to pivotally open about living hinge  24 . Handle grip  26  provides a sure-grip surface for handling container  10 . Grip  26  may be selected from various friction surfaces including indentations to fit the fingers, raised strips or regions, shaped depressions, non-skid sinewy surfaces or equivalent.  
         [0026]     Referring to  FIG. 2 , container  10  is dynamically configurable to enable full separation between top shell  16  and bottom shell  12  to load a device in container  10 . Specifically, hinge  22  enables a full exposure of the storage and containment region in which the medical device will be stored. After placement of the medical device in container  10 , a portion of top shell  16  is secured by means of a plurality of snap-on plugs  32 . Plugs  32  provide secure fixation of section  38  by providing a mating between portions of flange  14  and flange  18 .  
         [0027]     Some elements of the present invention are shown in  FIG. 3B  for comparison with the prior art container structure of  FIG. 3A . Among several innovative aspects, the present invention provides significant ergonomic features in sharp contrast to the prior art. For example, the secure grip area/fixable section  38  of the present invention, enables the hand to grip at the thinnest dimension of the box  FIG. 3B  as compared to the prior art that would require the hand to span across the bottom of container  10  thus making the handling unstable and cumbersome. Further, this innovative feature enables container  10  to be opened in such a way that the orientation of the implantable device remains in a position suitable for a quick inspection and implant.  
         [0028]     Referring to  FIG. 4A , container  10  is depicted in its normal closed position with the hand placed in grip area/fixable section  38 .  FIG. 4B  illustrates unlocking latching mechanism/snap-on lock  34  which releases a section of top shell  16  from the closed position to pivot about living hinge  24 . This section of top shell  16  is operable while maintaining a grip on the secure grip area  38 . This permits the presentation of the device in a sterile condition while providing stability from dislodgement partly because of the support provided in fixable section  38 . More specifically, fixable section  38  provides an enclosed pocket in which a portion of the contents of container  10  are sheltered and supported. This arrangement is likely to protect the contents from damage in the event container  10  is dropped or otherwise mishandled while top shell  16  is open.  
         [0029]     Further, fixable section  38  provides dynamic configurability to container  10 . Specifically, before fixable section  38  is fixed, container  10  is fully open. In this position, contents are placed in container  10 . Thereafter, fixable section  38  is anchored yielding a different configuration displaying less than a full volume of container  10 .  
         [0030]      FIG. 5  depicts an embodiment of a self-supporting tray  36  in which the implantable medical device may be stored. Tray  36  is sterile and may be made from foam or plastic material, including a hollow central interior portion with a flange extending thereabout for placing the medical device and other information therein.  
         [0031]     Referring to  FIGS. 6A-6D , various details, including vent  28  and the cooperation of living hinge/opening hinge  24 , are shown. Specifically, referring to  FIG. 6D , at least one breakaway strip  44  is shown in opposition to hinge  24 . Breakaway strip  44  operates as a tamper-proof indicator. When latch mechanism  34  is unlocked and opening hinge  24  angulates upward a tensile force is exerted on breakaway strip  44  which ultimately breaks to allow hinge  24  to flex while opening container  10 . A broken strip serves as visible proof that container  10  has been opened and/or tampered with thus enabling the end user to reject the package.  
         [0032]      FIGS. 7A and 7B  depict various features of container  10 . Snap-on plug structure  32  permanently locks fixable section  38  in place.  FIG. 7A  shows, the bottom half of container  12  that could be loaded when hinge  22  is fully open. Thereafter, the device and information is placed in bottom shell  12  and hinge  22  is actuated, snap on plug structure  32  locks together to permanently fix grip area/fixable section  38  as described hereinabove.  
         [0033]     Referring to  FIG. 7B , an alternate embodiment of vent  28  is shown, including latching mechanism  34  having engageable parts attached both at the bottom shell  12  and top shell  16 .  
         [0034]     Referring to  FIG. 8A , another embodiment of container  10  is shown. Specifically, fix grip area  46  is a cantilevered section with hinge  22   a  fixed across the extent of grip area  46 .  
         [0035]     With reference to  FIG. 8B , when latching mechanism  34  is released to biasingly pop up top shell  16 , fix grip area  46  remains fixed in relation to top shell  16 . Top shell  16  is pivotally connected at hinges  50 . This arrangement enables the pivoting movement of top shell  16  while maintaining grip area  46  in a fixed position.  
         [0036]      FIG. 9  is a representative of yet another embodiment where CD retainer hub  52  is formed on the inner side of top shell  16 . Retainer hub  52  is sized and shaped to receive and retain CD  54 .  
         [0037]     Referring to  FIG. 10  in connection with  FIGS. 11A and 11B , a cross-section view of container  10  is shown. Specifically, friction fit  56  is formed from mating extrusions to provide support to grip area  46  and retain it fixed in a cantilevered position.  
         [0038]     Similarly,  FIGS. 12A and 12B  depict another embodiment in which slidable section  58  frictionally engages side wall  14  to provide support to fix grip area  46 . Other forms of cantilever connections that support grip area  46  include pegs, posts and other equivalent structures on which grip area  46  may be mounted.  
         [0039]     While some selected and representative embodiments have been shown in accordance with the present invention, it should be clear to those skilled in the art that further embodiments may be made without departing from the scope of the present invention.