Abstract:
A hybrid mounting card is disclosed that includes one or more receptacles form fit for respective portions of a medical device in order to receive and secure the respective portions of the medical device therein and a mounting card adapted to receive and secure the one or more receptacles. The one or more receptacles are configured on the mounting card to secure the medical device to the mounting card in a defined configuration. The use of the receptacles increases the types of medical devices that can be secured to mounting cards. The use of mounting cards enables medical devices to be stored in sterile barrier packaging systems that do not require custom thermoforming of an entire medical tray, such as medical pouches and standard blank medical trays.

Description:
BACKGROUND 
     Numerous types of devices are enclosed in packaging of one kind or another. The packaging might range in its purpose and characteristics (e.g., circuit board wrapped in static resistant film, glass vase enveloped in bubble wrap, stereo receiver enclosed in a box). Each of these packaging systems has a desired goal with respect to the package contents. In some cases the packaging is oriented in a certain way so as to display the contents more openly. In other cases the packaging will be primarily to provide protection to the contents. 
     Some industries have very precise guidelines concerning the types of packaging that can be used to store certain types of goods. Sometimes these packaging systems are very costly to use as tooling cost and materials may require a significant outlay by the manufacturer or packaging producer. Further, changes in product configuration or packaging guidelines may mean that existing packaging may no longer meet the required specifications. The medical device industry requires sterile barrier packaging solutions for single-use Class II and Class III medical devices (or components). The two main types of sterile barrier packaging solutions are medical pouches (pouches) and custom thermoformed medical trays (trays). 
       FIG. 1  illustrates an example medical pouch  100 . The pouch  100  includes two layers secured together with a seal  110  along a majority of the edges and an opening  120  for placing a medical device therein. The seal  110  may be such that any compromises therein are evident to a user so the device can be deposed of if the seal  110  was compromised. One of the two layers may be a clear material that enables a medical device contained therein to be seen. The other material may be a material that enables sterilization to occur (e.g., enables ethylene oxide to pass therethrough). After the medical device is inserted, the opening  120  in the pouch  100  may be sealed using bar sealing equipment and the pouch  100  may be sterilized using any number of known techniques. To remove the medical device from the pouch  100  a user simply pulls the layers of the pouch  100  apart. 
     The pouches  100  can be designed and produced at a relatively low cost and in a relatively short time frame. The operations required to seal the pouches  100  after the medical device has been inserted therein are relatively easy and low cost. Accordingly, the pouches  100  provide for a cost and operational effective means for providing sterile packaging of medical devices. Furthermore, the space required to store pouch inventory and equipment (bar sealing equipment) as well as the space required for operations (sealing) is relatively small. 
     However, the use of the pouches  100  is typically limited to certain types of medical devices, including devices and components that are lightweight by design and/or long catheter-type devices. The pouches may not be suitable for medical devices that, for example, have sharp edges that may puncture the pouch if the medical device shifts during transport or need a higher level of structural support. 
       FIG. 2  illustrates a custom thermoformed medical tray  200 . The tray  200  provides a formed fit receptacle  210  within a main body  220  to hold a specific medical device  230 . The main body  220  also provides structural support to protect the medical device  230  contained therein. The device  230  securely fits within the receptacle  210  and then a lid (not illustrated) is placed over the tray  200  and sealed thereon using sealing equipment. The lid may be sealed to the tray  200  along the edges  240  of the tray  200 . To remove the device  230 , the lid is removed from the tray  200  and the device is extracted from the receptacle  210 . The design and production of the trays  200  may be relatively expensive and time consuming as it may require extensive prototyping, may require a relatively large amount of material (e.g., plastic) that needs to be tooled, and may require a user to implement a more costly batch production assembly method as changes in product mix may require different trays and tooling for continued packaging operations. 
     Furthermore, sealing the lids on the trays  200  may be relatively complex and time consuming (more complex and time consuming then the process for sealing pouches). For example, during the lid sealing procedure the lids may be prone to misplacement or having the device stuck in the seal areas. The additional complexity in the sealing process for the trays  200  may result in a relatively large amount of maintenance (more maintenance then for the pouches  100 ). Moreover, the space required to store the tray inventory and equipment (sealing equipment) as well as the space required for operations (sealing) may be relatively large (more space required then for pouches). 
     Accordingly, there is a tradeoff between the cost and logistical advantages of the pouches  100  and the structural advantages of the trays  200 . Some devices require trays  200  such as devices that are heavier or have a higher profile. However, there are devices that utilize the trays simply because they cannot be used with the pouch  100  and there is no real alternative other that the tray  200 . 
       FIG. 3  illustrates a block diagram of current medical device packaging spectrum  300 . On one end of the spectrum  300  there are medical devices typically packaged within pouches  310 . On the other end of the spectrum there are those devices that need to be packaged in the trays  330 . In the middle of the spectrum are devices that utilize the trays but do not require the trays  320 . Devices included in this part of the spectrum include cannula, trocar, catheter and many other devices. 
     Alternative packaging systems are needed for the devices within the middle of the spectrum  320 . The alternative packaging systems should provide a sterile barrier solution with at least some of the cost and logistical advantages of the pouches  100  and at least some of the structural advantages of the trays  200 . 
     SUMMARY 
     Mounting cards may be used to secure a medical device thereto where the mounting card may be larger then the device and have various tabs and/or folds formed therein to hold the medical device to the card. The mounting card may secure the medical devices such that the device may not damage the pouch. This enables the device to be packaged in medical pouches and thus provide a low cost option for sterile packaging of these devices. The types of devices that can be secured within the tabs and/or folds may be limiting and may require some level of skill to mount the devices. 
     A hybrid mounting card may replace the tabs and/or folds with one or more receptacles (e.g., thermoformed pieces that will accept a portion of the device) where the mounting card is adapted to receive the one or more receptacles. The hybrid-mounting card may be designed, prototyped, tested, and produced for much less expense and have a much quicker turn-around time then conventional medical trays. The hybrid-mounting card may provide the cost and logistical advantages of the pouches and the structural advantages of the trays. The hybrid-mounting card combines the snug fit advantages of tray solutions with the low cost of mounting cards. The hybrid mounting card solution significantly improves the ease of loading and unloading the medical device onto a mounting card. The hybrid mounting card solutions may be inserted into pouches and extend the types of devices that pouches can be used for. 
     Neither the mounting card nor the hybrid mounting cards utilized within the pouch provides a packaging solution having the side strength provided by custom trays. Utilizing the mounting cards with blank trays having certain defined sizes (Universal trays) may provide the side support of a custom tray without the cost. The mounting cards utilized in Universal trays may provide the benefits of the “snug fit” and side-strength of a custom thermoformed tray with the low tooling cost advantage of a non-tray solution. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The features and advantages of the various embodiments will become apparent from the following detailed description in which: 
         FIG. 1  illustrates an example medical pouch; 
         FIG. 2  illustrates an example custom thermoformed medical tray; 
         FIG. 3  illustrates a block diagram of current medical device packaging spectrum; 
         FIGS. 4A-C  illustrate several views of an example hybrid mounting card used to secure a medical device thereto, according to one embodiment; 
         FIGS. 4D-E  illustrate several views of an example hybrid mounting card used to secure a medical device thereto, according to one embodiment; 
         FIGS. 5A-B  illustrate comparison perspective views of an example medical device mounted to hybrid mounting card being inserted in a medical pouch and the same example medical device inserted in a custom thermoformed tray, according to one embodiment; 
         FIGS. 6A-C  illustrate various view of example receptacles, according to one embodiment; and 
         FIGS. 7A-B  illustrate several views of a Universal tray packaging system, according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Certain medical devices are packaged in custom thermoformed trays because pouches are not an option because if the devices shifted in transport the device could damage the pouch. These devices could possibly be packaged in a pouch if the device was secured in some fashion so that the device could not damage the pouch. For example, if a medical device having a sharp point was secured to a mounting card so that sharp point was not near an edge of the card. The mounting card, with device attached thereto, could then be installed in a pouch. 
     The mounting card may be larger then the device and have various tabs and/or folds formed therein to hold the medical device to the card. The mounting card may be made of a moldable material (e.g., high-density polyethylene). The mounting card may be prototyped by cutting the moldable material to the appropriate size and then cutting and/or folding the material to achieve the desired configuration of the mounting card and the desired hold. The cutting and/or folding of the prototype may be done manually or a prototype design may be generated in software and the software may instruct, for example, a die cutter to make the appropriate cuts and/or crease the material at the appropriate points to form the folds. Once a prototype design is finalized, the mounting cards may be produced in appropriate quantities by, for example, using a die cutter to cut large pieces of material into a plurality of mounting cards. 
     The cost of the material that the mounting card are made of may be relatively inexpensive. The design of the tabs and/or folds may be relatively easy and fast, as it does not require any molds to be created. The fabrication of the custom mounting cards may be relatively easy, cheap and fast. The installation of the medical device onto the mounting card using the tabs and/or folds may require some level of mechanical ability to configure the tabs/folds and secure the device thereto. The mounting card and device can be inserted into the pouch. The use of the mounting card can extend the types of medical devices that may be inserted in pouches. However, the types of medical devices that can be mounted to the mounting cards may be limited. That is, it may be difficult to design tabs and/or folds to secure large, heavy, or awkward shaped medical devices. 
     To increase the types of medical devices that can be secured to mounting cards, small thermoformed pieces may be designed to receive the medical device at various locations and the mounting cards may be designed to secure the small thermoformed pieces thereto. The combination of the mounting card and small thermoformed pieces (hybrid mounting card) may then be capable of securing a wider variety of medical devices. 
       FIGS. 4A-C  illustrate several views of an example hybrid mounting card  400  used to secure a medical device  430  thereto.  FIG. 4A  illustrates an exploded view of the hybrid mounting card  400 . The hybrid mounting card  400  may include one or more small thermoformed pieces  420  (receptacles, mini-formers) and a mounting card  410  adapted to receive the one or more receptacles  420  (one illustrated). The receptacles  420  may be used to accept and secure portions of the device. The number and size of the receptacles  420  may be determined based on the device to be mounted to the card  400 . The receptacles  420  may include a recessed portion (channel)  422  that the device (or portion thereof) fits within. The size, shape and depth of the channels  422  may be based on the parameters of the device. The receptacles  420  may be made of a flexible material so that sidewalls  424  of the channel  422  flex out when pressure is applied to insert the device in the channel  422 . When the device is within the channel  422  the sidewalls  424  may flex back and provide pressure on the device to secure the device therein. When pressure is applied to remove the device the sidewalls  424  may flex out to enable removal of the device. 
     The mounting card  410  may include openings  412  to receive the receptacles  420 . The location of the openings  412  may be based on how the device is to be configured on the hybrid-mounting card  400  and where the device is to be secured (where the pressure points are). The receptacles  420  may include a lip  426  formed along a lower edge. Indents  428  may be formed in the receptacles  420  above the lip  426  (or possibly be formed in the lip  426 ). The openings  412  may have tabs  414  formed therein that are in alignment with the indents  428 . The receptacles  420  may be secured to the mounting card  410  by passing an upper portion of the receptacle  420  through the opening  412  and having the lip  426  abut a lower surface of the mounting card  410 . The tabs  414  may enter the indents  428  to secure the receptacle  420  to the mounting card  410 . The tabs  414  may flex up as an upper portion of the receptacle  420  passes therethough until the indents  428  are reached at which point the tabs  414  may enter thereinto. 
     In an alternative embodiment, where the indent  428  are formed in the lip  426 , the receptacle  420  may be adjusted within the opening  412  so that the tabs  414  can be pushed below the lip  426  at the indents  428 . The receptacle  420  may then be adjusted within the opening  412  so that the tabs  414  push up against the indents  428  from below to hold the lip  426  against the lower surface and secure the receptacle  420  to the mounting card  410 . 
       FIG. 4B  illustrates a perspective view of the top of the example hybrid mounting card  400  ready to receive the medical device  430 . The receptacle  420  is inserted in the opening  412  in the mounting card  410  and the tabs  414  entered the indents  428  to secure the receptacle  420  to the mounting card  410 . The medical device  430  may be inserted into the receptacle  420  such that the receptacle  420  holds the appropriate portion of the medical device  430  and the medical device  430  is contained on the card  410 . 
       FIG. 4C  illustrates a perspective view of the bottom of the example hybrid mounting card  400  (alternative embodiment where the indents  428  are formed in the lip  426 ). The receptacle  420  has been passed through the opening  412  in the mounting card  410  so that the lip  426  is resting against the lower surface of the mounting card  410 . The tabs  414  may be below the lip  426  and pushing up on the indents  428  from below to hold the lip  426  against the lower surface and secure the receptacle  420  to the mounting card  410 . 
     It should be noted that affixing the receptacle  420  within the opening  412  is not limited to the use the tabs  414  and indents  428  as illustrated in  FIGS. 4A-C . Rather any means for securing the receptacle  420  within the opening  412  is within the current scope. For example, the opening  412  may have indents formed therein, the lip  426  may have tabs, and the tabs may pass through the indents and then push down on the mounting card  410  to hold the mounting card  410  to the lip  426 . By way of another example, there may be no tabs or indents in the lip  426  or opening  412  used to secure the lip  426  to the lower surface of the mounting card  410 . Rather, some type of adhesive, and/or connectors may be used secure the lip  426  to the lower surface of the mounting card  410 . 
     It should be noted that affixing the receptacle  420  to the mounting card  410  is not limited to the use of the opening  412 . Rather any means for securing the receptacle  420  to the mounting card  410  is within the current scope. For example, the mounting card  410  may include slits or grooves formed therein for receiving the lip of the receptacle  420 . 
       FIGS. 4D-E  illustrate several views of an example hybrid mounting card  450  used to secure a medical device  430  thereto.  FIG. 4D  illustrates an exploded view of the hybrid mounting card  450 . The hybrid mounting card  450  may include or more small thermoformed pieces  470  (receptacles, mini-formers) and a mounting card  460  adapted to receive the one or more receptacles  470  (one illustrated). The receptacles  470  may be similar to the receptacles  420  and include a recessed portion (channel)  472  that the device (or portion thereof)  430  fits within, and a lip  476  formed along a lower edge. The mounting card  460  may include slots  462  formed therein for receiving the lip  476  of the receptacle  470 . 
       FIG. 4E  illustrates a perspective view of the top of the example hybrid mounting card  450  ready to receive the medical device  430 . The receptacle  470  is placed on top of the mounting card  460  and the lip  476  is inserted into the slots  462  to secure the receptacle  470  to the mounting card  460 . The medical device  430  may be inserted into the receptacle  470  such that the receptacle  470  holds the appropriate portion of the medical device  430  and the medical device  430  is contained on the card  460 . 
     It should be noted that affixing the receptacle  470  to the mounting card  460  is not limited to the use the slots  462  and lip  476  as illustrated in  FIGS. 4D-E . Rather any means for securing the receptacle  470  to the mounting card  460  is within the current scope. For example, some type of adhesive, and/or connectors may be used secure the lip  476  to the upper surface of the mounting card  460 . 
     The receptacles  420 ,  470  may be designed using computer aided design (CAD) software. Since the designs are relatively small, molds may be fabricated for the receptacles with a much lower cost than larger molds for custom medical trays, and in a relatively quicker time frame. The mold may be used to check the design or the mold may be used to fabricate prototype receptacles (e.g., by thermoforming using the mold) and the prototype receptacles may be used to check the design. The prototype receptacle may be tested to ensure that it provides the desired snug fit for the device  430 . The prototype receptacle may also be tested to ensure that it can be secured to the mounting card correctly. 
     The mounting cards  410 ,  460  may be designed using CAD software and a prototype may be created utilizing, for example, a die cutter to cut card stock to the appropriate size and to include the appropriate means to receive the receptacles (e.g., openings, slits) based on the CAD design. The prototype mounting cards may be made in a relatively short time frame and for a relatively low cost. The prototype mounting cards may be tested to ensure that the prototype receptacle fits securely therein. 
     The prototype receptacles and prototype mounting cards may be configured to create the prototype hybrid-mounting card to ensure that the overall design layout effectively supports the device. Once the prototype hybrid-mounting card has been validated and the design is finalized, the receptacles  420 ,  470  and the mounting cards  410 ,  460  may be produced. To produce the receptacles  420 ,  470  a plurality of production molds (either for the same receptacle or different receptacles) may be made so that a plurality of receptacles can be thermoformed from a single sheet of material. 
     The hybrid-mounting card  400 ,  450  combines the snug fit advantages of tray solutions with the low cost of mounting cards while improving the ease of loading and unloading the medical device onto a mounting card. The hybrid mounting cards can be designed, prototyped, tested, and produced for much less expense and have a much quicker turn-around then conventional trays. The hybrid mounting cards may be inserted into pouches and extend the types of devices that pouches can be used for. 
       FIG. 5A  illustrates a perspective view of the example hybrid mounting card  400  being installed in a pouch  100 . By using the hybrid mounting card  400  to secure the device  430 , the device  430  that typically would not be installed within the pouch  100  because, for example, the possibility of damaging the pouch  100  may be installed within the pouch  100 . 
     For comparison purposes,  FIG. 5B  illustrates a perspective view of the device  430  inserted in a thermoformed tray  300 . The tray  300  includes much more material and much more customization to secure the device  430 . Additionally, as previously noted sealing the lid to the tray  300  is more complicated then sealing the pouch  100 . 
     The size and type of receptacles that can be designed to secure devices is virtually limitless. Rather than designing a large receptacle to secure a device (e.g., like a tray), small receptacles may be designed to secure the device at various pressure points. The receptacles may be oriented on the mounting card to provide the receptacles (pressure points) at the appropriate locations based on the configuration of the device. 
       FIGS. 6A-C  illustrate various view of example receptacles.  FIG. 6A  illustrates various views on an example receptacle  600  that includes a groove  602  (e.g., rather large) formed all the way through the receptacle  600 . This type of receptacle  600  may be used for supporting the middle portion of a device (the device extends from both sides of the receptacle  600 ). As illustrated the receptacle  600  includes a lip  604  formed along a lower edge and the lip  604  has indents  606  formed therein. 
       FIG. 6B  illustrates various views on an example receptacle  610  that includes a trough  612  formed therein. The trough  612  may include a first end that is wider and deeper  614  and a second end that is narrower and shallower  616 . The first end  614  may be closed while the second end  616  may be open to enable a device to extend therefrom. The receptacle  610  may include a lip  618  formed along a lower edge and the lip  618  may have indents  619  formed therein. This type of receptacle  610  may be used for supporting an end of a device where the very end includes a larger and wider section. 
       FIG. 6C  illustrates various views on an example receptacle  620  that includes a channel  622  formed therethrough. The receptacle  620  also includes a strap  624  that extends therefrom that includes a snap  626  near the end and the body includes an insert  628  to receive the snap  626 . The use of the strap  624  enables the device to be further secured therein. This type of receptacle  620  may be used when the channel  622  does not provide pressure on the device at that point. For example, if the device included a portion that was looped around this type of receptacle  620  could be utilized to secure the portion. 
     While the mounting cards enable pouches to be utilized for devices that they normally would not be able to, the pouches still may not be used for devices that require the side support provided by the trays. However, some devices that require the side support provided by trays do not need to be packaged in custom trays. 
     The mounting cards  400 ,  450  could be utilized in blank trays (no special fabrication to house components, simply the shell) where the mounting cards provide the support for the device and the standard trays provide the side support. The blank trays could come in standard sizes (Universal trays) and the mounting cards could be configured to fit with the various standard sizes. The mounting cards may include sidewalls to keep the mounting card, and the device secured thereto, from shifting around within the tray. The mounting card may be placed within the tray so that the bottom of the mounting card abuts the top of the tray and the device faces the opening in the tray. The tray may then be sealed so the device is not visible prior to opening the Universal tray. 
     According to one embodiment, the device will be inserted within the Universal tray so that the device can be seen from the front of the tray (provide a nice presentation). As the mounting card would likely block a substantial portion of the opening in the Universal tray the mounting card may need to be fabricated in such a fashion as to enable sterilization to occur. This may include providing openings on the sidewalls or the main body of the mounting cards. 
       FIGS. 7A-B  illustrate several views of a Universal tray packaging system  700 .  FIG. 7A  illustrates an exploded view of the Universal tray packaging system  700 . The system  700  includes a Universal tray  720  and a hybrid-mounting card  710  (e.g.,  400 ,  450 ) having sidewalls  712 . The device  730  is mounted to the card  710  between the sidewalls  712 .  FIG. 7B  illustrates a perspective view of the system  700  assembled. The device  730  is mounted to the mounting card  710  and the universal tray  720  is secured over the mounting card  710  and device  730 . 
     Although the disclosure has been illustrated by reference to specific embodiments, it will be apparent that the disclosure is not limited thereto as various changes and modifications may be made thereto without departing from the scope. Reference to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described therein is included in at least one embodiment. Thus, the appearances of the phrase “in one embodiment” or “in an embodiment” appearing in various places throughout the specification are not necessarily all referring to the same embodiment. 
     The various embodiments are intended to be protected broadly within the spirit and scope of the appended claims.