Abstract:
The invention relates primarily to the field of packaging sterile articles for use in the medical device field. In an embodiment, the invention includes a package for a repetitive volume sectionally separable medical device. The package can include support material for receiving and retaining a repetitive volume sectionally separable medical device. The support material can have a plurality of sealable portions suitable for sealing after placement of the medical device in contact with the support material. The package can also include indicia placed on said sealable portions of the support material. Other embodiments are included herein.

Description:
[0001]    This application claims the benefit of U.S. Provisional Application No. 60/848,260, filed Sep. 30, 2006, the content of which is herein incorporated by reference. 
     
     FIELD OF THE INVENTION 
       [0002]    The invention relates primarily to the field of packaging sterile articles for use in the medical device field. The invention also relates to products for human or animal consumption requiring special handling. 
       BACKGROUND OF THE INVENTION 
       [0003]    Within the field of medical devices there exists stringent requirements for device sterility and other precautions. These requirements are designed to ensure consistent and safe products within the safe functional parameters described and offered to benefit end users of the products. Typically, the highest standards of sterility and purity are reserved for in vivo uses of medical devices, but there is also an increasing demand on manufacturers to maintain similar protections for ex vivo devices or other intermediate applications. Such high standards relate to products for both human and animal use. 
         [0004]    The field of medical device packaging is known to have primary and secondary packaging levels, such as devices sealed within one time use trays that are then placed within pouches. These pouches may then be placed within cartons and larger assemblies of cartons placed within shippers. In one example, such shippers or similar configurations are processed in sterilization chambers or devices using gamma radiation, E-beam, ethylene oxide, or other means according to compatibility or vulnerability of constituents of the device or pharmaceuticals in the device. Following this sterilization process, the medical devices are typically placed in commerce, either directly or via intermediate inspection and logistics processes. Commercial applications for the designated product uses may include either diagnostic or therapeutic uses. In one example, after sterilization, a medical device may be shipped to a hospital and placed near a medical surgical unit. The device secondary packaging may be opened to prepare for the primary package opening within or proximate to the surgical field. As each primary packaging is opened, the packaging and the medical device within essentially lose any prior sterile certification. This is due to the importance of maintaining the sterile boundaries for the medical devices in order to maintain high quality patient care. 
       SUMMARY OF THE INVENTION 
       [0005]    The invention comprises material for sterile packaging of products useful for mammalian medical or ingestive requirements having improved construction to enable efficient use of a selective volume of product while maintaining sterility of remaining product. 
         [0006]    In an embodiment, the invention includes a package for a repetitive volume sectionally separable medical device. The package can include support material for receiving and retaining a repetitive volume sectionally separable medical device. The support material can have a plurality of sealable portions suitable for sealing after placement of the medical device in contact with the support material, said sealable portions having a length and a width. The package can also include indicia placed on said sealable portions of the support material to guide the user of the package to a separation location where the user may separate portions of the repetitive volume sectionally separable medical device while maintaining an adjacent portion of the repetitive volume sectionally separable medical device in a sealed configuration. 
         [0007]    In an embodiment, the invention includes a packaged sterile medical device. The packaged sterile medical device can include a support material defining a plurality of enclosed volumes, each enclosed volume separated from adjacent enclosed volumes by a sealed region of the support material. The packaged sterile medical device can also include a plurality of high volume components, the high volume components disposed within the enclosed volumes and a plurality of low volume components, the low volume components disposed between adjacent high volume components, wherein one or more of the low volume components pass between adjacent enclosed volumes through the sealed region. 
         [0008]    In an embodiment, the invention includes a method of packaging a medical device. The method can include disposing the medical device within a support material, the medical device comprising a plurality of high volume components and a plurality of low volume components, the low volume components disposed between adjacent high volume components. The method can also include forming sealed regions with the support material, the sealed regions separating a plurality of enclosed volumes from each other, each sealed region coincident with a low volume component. 
         [0009]    This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope of the present invention is defined by the appended claims and their legal equivalents. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The invention may be more completely understood in connection with the following drawings, in which: 
           [0011]      FIG. 1  is a side elevation view of a spool-shaped assemblage of material configured with products placed within the material. 
           [0012]      FIG. 2  is a plan section view of material and product therein according to an embodiment of the invention. 
           [0013]      FIG. 3  is a side sectional view of material and product therein according to an embodiment of the invention. 
           [0014]      FIG. 4  is an end sectional view of material and product therein according to an embodiment of the invention. 
           [0015]      FIG. 5  is an end sectional view of material and product therein according to an embodiment of the invention. 
           [0016]      FIG. 6  is a top plan section view of product suitable for use according to an embodiment of the invention. 
           [0017]      FIG. 7  is a top plan section view of product suitable for use according to an embodiment of the invention. 
           [0018]      FIG. 8  is a top plan section view of product suitable for use according to an embodiment of the invention. 
           [0019]      FIG. 9  is a top plan section view of material and product according to an embodiment of the invention. 
           [0020]      FIG. 10  is a perspective elevation sectional view of a dispensing container for use with one or more assemblages and products according to an embodiment of the invention. 
       
    
    
       [0021]    While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the invention is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the invention. 
       DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0022]    It is well known that sterile primary packaging of medical devices, soft goods, human consumption products or pharmaceuticals is preferably a single or unitary package having a set amount (often just one) of devices therein. However, this requirement may be unnecessarily wasteful or inefficient. Such inefficiencies increase the cost of healthcare and reduce productivity and profitability in this field. In one example, such excessive costs are tolerated in view of the paramount importance of maintaining a safe, sterile, and known quality product. In a second example, such costs create disincentives and impediments to using the best products and devices. Packaging improvements are needed to facilitate efficiencies and to accommodate unique product requirements. 
         [0023]    Within the field of medical devices and other products for either ingestion or critical exposure to mammals, such devices and products must be handled with a heightened standard of care. In particular, some products may require advanced and comprehensive sterilization protocols prior to being introduced into the stream of commerce or even into settings of experimental uses. These types of products are also typically subject to comprehensive regulatory schemes which add higher costs to the overall design and manufacturing of these products. Accordingly, any means of reducing the costs of these products is of particular value to the manufacturer as well as the end user. Clearly, competitive advantage accrues to the manufacturer and distributor in such circumstances. Indeed, preferred end user costs may also be an advantage. 
         [0024]    Further examples of possible savings by use of this invention include continuous process manufacturing, high volume discount purchasing, reduced unit costs of shipping and handling, and selective volume utilization by users. Other attributes and advantages will become apparent from the following descriptions of the invention and its various embodiments.  FIG. 1  illustrates a packaging configured as a primary packaging post-processed roll or assemblage  10  of multiple products or devices  13  suitable for integrated processing, shipment, and end-use configuration for selective volume utilization. In one example, roll or assemblage  10  is a primary packaging assemblage of individual medical devices  13  (or related wound care products such as bandages, wipes, applicators, and the like) configured for selective volume utilization as will be shown and described in relation to  FIGS. 2-10 . In some embodiments, the products or devices can be referred to as a repetitive volume sectionally separable medical device. 
         [0025]      FIG. 2  depicts in plan view a portion of assemblage  10  having a plurality of seal locations  16  (sealed regions) which enable cutting adjacent the seal locations by a user to obtain use of products  13  while maintaining the remaining products  13  in a sterile configuration ready for future use. The sealed regions can be of various sizes and can extend across the width of the support material  22 . In some embodiments, the sealed regions can be at least three millimeters in length. In this example, the spool or assemblage  10  of products  13  is dispensed in the direction of arrow A. The user would cut the support material  22  surrounding and protecting products  13  generally to the left of the area of the seal locations at cut lines C-C when the products to the left of such cut lines were needed for use. This action can result in separating the package into a first usable package section and a second storable package section, each section having a portion of the products  13  therein. In the embodiment shown in  FIG. 2 , the seal locations  16  are generally delineated by a narrowed portion of support material  22 , although other indicia or methodology may be utilized to assist the user. It is noted that the products  13  in  FIG. 2  are depicted as a bead chain device such as a wound spacer or a dispenser of bioactive agents having both high volume components  26 , shown as beads (such as geometrically or spherically shaped beads) or capsules, and low volume components  31 , shown here as flexible linking material or flexible linking elements. In some embodiments, such flexible linking elements may be integral with one another so as to form a substantially continuous element. Products  13  may be of consistent or varied length within sterile sections of assemblage  10 , with such sections  17  (or enclosed volumes) being defined as those regions formed between a plurality of sterile seal locations. The enclosed volumes can be sterile and/or hermetically sealed. In some embodiments, a plurality of high volume components  26  can be disposed within a single enclosed volume. By way of example, in some embodiments, between one and one hundred high volume components can be disposed within a single enclosed volume. Products  13  may also comprise only one type of component or many types. Depending on the product material configuration, products  13  may be attached to a portion of support material  22  or not. For a continuous length device it may be useful and efficient to meter the seal locations of the support material  22  coincident with a portion of the flexible low volume component  28 , as shown in  FIG. 2 . As such, in some embodiments, one or more flexible low volume components  28  can pass between adjacent enclosed volumes through the seal locations of the support material  22 . 
         [0026]    Support material  22  may be selected from a range of known and acceptable packaging materials, including, for example, spunbonded high density polyethylene fiber material known and sold under the brand name TYVEK (commercially available from DuPont, Wilmington, Del.). Support material  22  can also include, but is not limited to, polytetrafluoroethylene, polyethylene terephthalate, other polyethylenes, polyamides, polyimides, polystyrene, polypropylene, polyvinyl chloride, and the like. In some embodiments, support material  22  can also include cellulosic materials, such as cellulosic fiber webs, and foils, such as metallic foils. In some embodiments, support material  22  can include a combination of materials such as a cellulosic material bonded to a polymer. In some embodiments, support material  22  can be substantially transparent. In other embodiments, support material  22  can be substantially opaque. 
         [0027]    In one embodiment, support material  22  may be manufactured to provide a generally rectangular plan view shape and an essentially flat side view shape. In this configuration, the products  13  would be placed on a bottom portion  36  and be covered by a top portion  39 , as shown generally in  FIG. 3 . Bottom portion  36  may be made to be more durable or to maintain its flat shape more than a flexible or conformable top portion  39 . Although various materials are available for the manufacture of support material  22 , it may be advisable to choose a material having sealable properties for the seal locations which may be achieved at a temperature or pressure, or by other means, which does not affect the function of any portion of product  13 , particularly that portion within the sealing locations. This can be a particularly critical design feature when the product  13  has a medical coating on it or requires important functional interactions to occur at the surface of the product when in use. 
         [0028]      FIG. 4  is a sectional end view of an alternate embodiment of support material  22  having a pre-shaped or curved bottom portion  46  and a generally planar yet conforming top portion  49 . This embodiment may be preferred in some packaging configurations in which the device is on a spool-shaped assemblage to enhance winding and dispensing of the products  13 . 
         [0029]    It is recognized that for greater protection of products  13 , a fully or substantially curved, or partially curved, unitary portion  56  of support material  22  may be formed around products  13  in a sleeve or hose-like configuration, as shown in  FIG. 5 . This figure also illustrates product  13  having a core composition  61  that is different than a surface composition  65 , such as a medical coating. This embodiment of product  13  may provide unique advantages for bioactive agent delivery due to controlled elution of more potent formularies of agent with less overall bioactive agent, and with less residual agent due to a core composition not containing any (or any significant amount of) agent. Also, such a configuration of product  13  may offer more protective features through use of a more durable outer coating to protect an intermediate or lower portion of such coating containing an elutable agent. This may be quite advantageous in extreme climates. This unique product  13  in combination with an embodiment of packaging material shown and discussed in relation to  FIGS. 1-5 , as well as  FIGS. 6-10  below, provide significant advantages and technical combinations of packaging advances for such products not previously recognized or achieved. Further improvements to support material  22  may also include light resistant material to prevent light activated depletion of bioactive agent potency or overall product shelf-life, as well as other types of preservative or functional characteristics able to be imparted to the support material  22  composition. 
         [0030]      FIGS. 6-8  depict various shapes and configurations of products  13  which are exemplary of the many more embodiments which are contemplated within the invention for use in mammals in combination with the sterile packaging concepts also disclosed herein.  FIG. 6  is a section of an assemblage  10  having polygonal shaped medical or ingested products  13  positioned on a liner  79  of either durable or degradable material. In a first durable embodiment, products  13  are removed or separated from liner  79  prior to use, whereas in a second degradable embodiment liner  79  and products  13  may both be placed in use in contact with the patient. Various materials are contemplated for liner  79 , such as conventional PLGA or PEG type of materials, as well as dextran, starch, or other polysaccharide type of specialized material having relatively benign byproducts of degradation.  FIG. 7  is a plan view of an alternative embodiment of a beaded product  13  connected by linking material.  FIG. 8  is yet another view of an alternative embodiment of a beaded product  13  connected by linking material. In all of the above products it is recognized that multiple efficacious features may be present—such as wound spacing and bioactive agent release, or other features relating to wound healing. 
         [0031]      FIG. 9  is a top plan view of a portion of assemblage  10  depicting multiple alternative embodiment configurations of seal locations  16 . Within each seal location exists indicia  82 , which may include perforations, markings, or labeling indicating to “CUT HERE” for guiding the user. This enables the volume of products  13  to the left of the cut or separation made by the user to be employed while maintaining the sterility and safety of the volume of products to the right of the cut or separation. It is recognized that various directional orientation of the assemblage may be used consistent with this invention. 
         [0032]    The sterile packaging concepts disclosed in this invention are particularly useful for products to treat trauma related injuries of patients. This is due to the fact of the highly varied wound structures of trauma, and the need for different volumes or quantities of product for each use. Accordingly, this type of packaging enables excellent selectivity of needed volume of products  13  by the user according to the procedure while simultaneously minimizing wasted product due to loss of sterility. This is also a highly conducive packaging for products which must be separated rather than packaged in one container, e.g. pills in a bottle, in order to maintain efficacy. It is even contemplated within this invention that every product or a series of products may be bounded by seal locations and therefore constitute sections for discreet use. In other instances this packaging is useful in very warm or very moist climates to maintain resistance against product deterioration or contamination before or after a first use. The relation of the mid-point of a seal location or area may be useful for designating a user cut or tear line. However, other embodiments of locating the separation of support material  22  may be used. 
         [0033]      FIG. 10  illustrates an exemplary dispensing container  90  for use with one or more assemblages  10  of products  13  configured for selective volume use. In this example, there is an assemblage similar to that shown in  FIG. 1  having a plurality of coiled or spooled linearly arranged products on support materials  22 , depicted by separately sized products on material sections  93 ,  95 . Either one or more simultaneous selective volume packaging lines of product having the same or different product sizes, volumes, bioactive means, or other feature may be simultaneously dispensed as shown in  FIG. 10  via one or more apertures defined by portions  98  of container  10 . 
         [0034]    It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
         [0035]    It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration to. The phrase “configured” can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like. 
         [0036]    The invention has been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention.