Patent Publication Number: US-2020299048-A1

Title: Device for Protecting an Inner Container

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     This application claims priority to and the benefit of U.S. provisional application No. 62/503,219, filed on May 8, 2017 in its entirety. This application is the national stage application from international application number PCT/US2018/031704, having an international filing date of May 8, 2018 and which claims priority to U.S. provisional application No. 62/503,219. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates to health care equipment and devices for protecting inner containers. More specifically, the present disclosure relates to devices for protecting containers capable of holding fluid specimens for storage, analysis, or processing in medical, pharmaceutical, clinical, forensic, dental, industrial, agricultural, environmental, and veterinary applications. 
     BACKGROUND OF THE DISCLOSURE 
     In the biomedical science and health care industries in particular, blood is drawn for various tests to assess an animal&#39;s health. Test tubes or storing, transporting, and processing blood may have an additive for either promoting or inhibiting clotting, depending on the intended application. From the blood sample, the intended application may require the testing or processing of serum or plasma. To accomplish this, the blood is disposed in a test tube with an additive. 
     Modern blood collection tubes and test tubes are made from plastic, requiring treatment with an additive, especially in applications requiring centrifugation to obtain a serum or plasma supernatant. Plastic is almost exclusively used due to the risks that glass test and blood collection tubes pose: breakage, contamination of the sample, contamination of the laboratory, contamination and injury of the personnel handling the sample, and the spread of blood-borne pathogens and diseases. The test and blood collection tube materials, additives, and specifications are therefore regulated by governing agencies such as the U.S. Food and Drug Administration which generally requires the use of plastic test and blood collection tubes. 
     Traditionally, blood collection tubes were made out of glass, particularly in the mid 1900&#39;s. Glass tubes did not require a clotting additive because the silica in glass already promoted clotting. The blood cells and platelets would coagulate, and during centrifugation would fall to the bottom of the tube, leaving a supernatant of serum or plasma. 
     Glass test tubes and blood collection tubes are ideal for biomedical and health care applications requiring the retrieval of plasma or serum. Newer regenerative treatments with platelet-rich plasma and platelet-rich fibrin for example require drawing a person&#39;s blood, spinning the sample down in a centrifuge, retrieving a supernatant, and treating the person with the supernatant that may or may not be further processed. These applications are distinguished from drawing blood merely for in vitro health screenings because part of the sample (the supernatant containing plasma or serum that is platelet rich) is returned to the person&#39;s body. 
     In a particular example, platelet-rich fibrin applications in dental procedures is becoming increasingly popular due to expedited healing. Other applications include hair loss, wrinkle and antiaging, and orthopedic treatments. These treatments typically require multiple sessions. Multiple sessions also means greater exposure to additives from plastic tubes. 
     Plastic test tubes are generally treated with silicones and silicas. Inhalation and internal exposure to silicas can result in fibroids and subsequently cancer. Exposure to the additives likely poses an industrial occupational hazard for those in the manufacturing sector. People receiving treatments with their own serum or plasma are exposed to additive residue, sometimes directly into the bloodstream if the serum or plasma is injected or topically applied to an open wound or suture. Furthermore, hormone disruptors such as bisphenol A can leach from the plastic in to the sample and supernatant to be used in treatment. 
     Accordingly, sample exposure to additives as inherently occurring with plastic tubes should be avoided or eliminated while still conforming to government regulations. 
     SUMMARY OF THE DISCLOSURE 
     What is needed is a cost-effective durable device to be used in connection with a breakable inner container at least partially filled with a sample. A device generally comprises an inner container housed in the cavity of an outer protective body. The outer protective body may be fixably or removably attached to the inner container. 
     The inner container is capable of holding a sample which may be a bodily fluid such as blood or serum, a soil or water sample, a pharmaceutical preparation, or a nutritional product. The inner container is configured to fit inside an internal cavity defined by the outer protective body. 
     A lid prevents contamination or expulsion of a sample disposed within the inner container. The lid is configured to be securable upon the upper end of the outer protective body while providing a vacuum seal as well as positional stabilization for the inner container. The lid is configured to be frictionally secured over the upper end of the outer protective body. The frictional security provides enhanced stability and contamination prevention for the device for protecting an inner container. 
     The outer protective body has a ledge disposed at an upper end thereof. The ledge is configured to securely receive the lid thereon. This embodiment provides an efficient manner of holding the lid on the device for protecting an inner container and sample. A strap can be implemented to secure an inner container with its own lid or cap where the outer protective body does not receive the lid or cap thereon. 
     The device may be presented in a sterile pack for single or multi use after autoclaving. Multiple devices may be presented in a single sterile pack and may be configured according to the intended application. For example, specialized packs may be configured for platelet-rich fibrin applications in dental and oral surgical procedures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, that are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure. 
         FIG. 1  shows an exploded view of an exemplary device for protecting an inner container. 
         FIG. 2  shows a perspective view of an exemplary device for protecting an inner container. 
         FIG. 3  shows a side sectional view of an exemplary device for protecting an inner container. 
         FIG. 4  shows an additional side sectional view of an exemplary device for protecting an inner container. 
         FIG. 5  shows an enlarged side sectional view of an open end of an exemplary device for protecting an inner container. 
         FIG. 6  shows a perspective view of an exemplary device for protecting an inner container in a sterile pack. 
         FIG. 7  shows a side sectional view of an exemplary device for protecting an inner container. 
         FIG. 8  shows an exploded view of an exemplary device for protecting an inner container with a strap. 
     
    
    
     REFERENCE NUMERALS OF THE DRAWINGS 
     
         
         
           
               10  device 
               11  inner container 
               12  outer protective body 
               13  housing 
               14  internal cavity 
               15  open end 
               16  rim 
               17  elongated tubular housing 
               18  open upper end 
               19  lip 
               20  ledge 
               21  wall 
               22  lid 
               23  base 
               24  receptacle 
               25  cap 
               26  first seal 
               27  second seal 
               28  strap 
               29  ridge 
               30  connection point 
               32  fastener 
               33  sterilized housing 
               34  void 
               40  strap 
               41  fastener 
               42  closed end 
           
         
       
    
     DETAILED DESCRIPTION 
     The present disclosure provides generally for a device for protecting an inner container, especially for use in industries such as biomedical science, health care, dentistry, agriculture, industrial, and veterinary health and wellness. 
     According to the present disclosure, a device generally comprises an inner container housed in the cavity of an outer protective body. The outer protective body may be fixably or removably attached to the inner container. The inner container is capable of holding a sample which may be bodily fluid such as blood or serum, a soil or water sample, a pharmaceutical preparation, or a nutritional product. 
     In preferred embodiments, the inner container is made of a glass such as borosilicate for example, and the outer protective body is made out of a molded or extruded plastic such as polyethylene terephthalate (“PET”). In preferred embodiments, the outer protective body is translucent or transparent to allow visibility of the sample in the inner container. The glass inner container provides compatibility with the sample for storage and processing while the plastic outer protective body prevents breakage of the inner container and destruction and contamination of the sample. 
     In preferred embodiments, the outer protective body may be removed and autoclaved for interchangeable or recycled use. However, in some embodiments, the outer protective body may be fixably attached to an inner container for single use. The protective body is preferably configured to fit in standard centrifuges and test tube holders. 
     In preferred embodiments and under sterile conditions, a lid and/or a cap applied will create a vacuum seal yet provide penetration of a needle into the inner container to retrieve a sample. The sample may then be further processed, applied to or within an animal&#39;s body, or used for in vitro experimentation. 
     Specialized sterile packs may be customized according to the intended application. For example, dental and oral surgery procedures using platelet-rich fibrin may require one to six devices in a sterile pack for single use whereas environmental applications may require a pack of twelve tubes for various sample sites. 
     Preferably, the device should be treated like any other collection or test tube with safety precautions such as placing the device in a holder when not in use or when placing an inner container, cap, lid, or strap on or into the device&#39;s outer container. 
     A sample may comprise a solid, liquid, or gas. A sample may be deposited into the inner container before or after the inner container is inserted into the outer container or protective body if the outer protective body is removably attached. 
     In the following sections, detailed descriptions of examples and methods of the disclosure will be given. The description of both preferred and alternative examples are exemplary only, and it is understood that to those skilled in the art that variations, modifications, and alterations may be apparent. It is therefore to be understood that the examples do not limit the broadness of the aspects of the underlying disclosure as defined by the claims. 
     Referring to  FIG. 1 , an exploded view of an exemplary device for protecting an inner container is shown. The device for protecting an inner container  10  (“the device”) comprises an inner container  11  and an outer protective body  12 . In the shown embodiment, the inner container  11  comprises an elongated tubular housing  13  defining an internal cavity  14  therein with an open end  15  disposed oppositely a closed lower end. The lower end is of any suitable shape. Additionally, in the illustrated embodiment, the closed lower end is rounded. The open upper end  15  is defined by a rim  16 . 
     Furthermore, the inner container  11  is configured to receive a biological, medical, fluids, food or chemical sample therein. The inner container  11  is made of a non-contaminating material. In one embodiment, the inner container  11  is made of glass. When using glass, blood coagulation is promoted in the cavity  14  wherein the biological, medical or chemical sample is a blood sample. 
     In another embodiment, the inner container  11  further comprises at least one additive, such as an SFS coating, a gel, a clot activator, a separator or an anticoagulant compound. In another embodiment, the inner container  11  is vacuum-sealed by a cap  25  which may secure a lid  22  or be independent therefrom depending on the type of inner container used such as a standard tube or a vacuum sealed tube. The inner container  11  may be any container configured to receive a sample therein. 
     In one embodiment, the inner container is configured to be processed in a centrifuge when assembled with the outer protective body  12 . In another embodiment, the inner container is configured to be used in the manufacture of platelet rich fibrin (PRF). In yet another embodiment, the inner container is configured to be used in In Vitro Diagnostic (IVD) tests. In another embodiment, the outer protective body  12  comprises an elongated tubular housing  17  defining a cavity therein with an open upper end  18 . The open upper end  18  is defined by a lip  19 . 
     The outer protective body  12  is configured to house the inner container  11  therein. The outer protective body  12  is configured to prevent breakage of the inner container  11 . The outer protective body  12  is made of a shatter-resistant material, such as polyethylene terephthalate (PET), plastic, latex, ceramic, fiberglass, metal, flexi-glass, rubber, melamine, tempered glass, polypropylene, carton, glazed stoneware, metallic glass, or a combination of the above materials. The outer protective body  12  is further configured to be shock-resistant, meaning that the outer protective body  12  can sustain an impact without damage to an internal component, such as the inner container  11  or the biological, medical or chemical sample disposed therein, and liquids and food or other consumable sample. In one embodiment, the inner container  11  is longer in length, from the rim to the bottom, than the outer protective body  12 , such that a portion of the inner container  11  extends above the lip  19  of the outer protective body  12 . The lip  19  defines a ledge  20  with a wall  21  extending upward therefrom. When the device for protecting a sample  10  is placed in a vertical position, the ledge  20  is oriented on a horizontal axis and the wall  21  is oriented on a vertical axis. The outer protective body  12  is sized to receive the inner container  11  in the cavity thereof 
     For example, the outer protective body may be 15 centimeters long and the inner container may be 10 or 12 centimeters long. In another example, the outer protective body and the inner container may be the same length. Conventional sizes and shapes may be implemented. 
     Referring to  FIG. 2 , a perspective view of an exemplary device for protecting an inner container is shown. The device for protecting an inner container  10  is configured to be arranged in a containment position and an open position. The containment position is defined where the inner container is removably disposed within the outer protective body  12 . Furthermore, in the containment position, the lid  22  is engaged upon the outer protective body  12 , such as to ensure that the biological, medical or chemical sample will not leak in the unlikely yet possible event the inner container breaks. 
     Referring to  FIG. 3 , a side sectional view of an exemplary device for protecting an inner container is shown. The outer protective body  12  comprises an interface configured to receive a cap  25 . Under the shown embodiment, the cap  25 , or alternatively a lid  22  depending on configuration, may attach to the outer protective body  12  and aligns with the lip  19  disposed on an upper portion of the outer protective body  12 . This embodiment ensures that fluid will not escape from the cavity of the inner container  1  as a first seal  26  is formed between the inner container  11  and an internal side of the base  23  of the lid  25 . Additionally, a second seal  27  is formed between the outer protective body  12  and the cap  25  or lid  22  at the lip  19 . 
     In the illustrated embodiment, the lid  22  is vertically lower than the periphery of the cap  25  disposed around the lid  22 . Under this embodiment, the indent is easier to locate and is easier to penetrate with a needle. Alternatively and depending on the configuration of the inner container, the cap  25  may be vertically lower than the lid  22 . Clearances may be by 0.2 mm to 2 cm for example. 
     Referring to  FIG. 4 , an additional side sectional view of an exemplary device for protecting an inner container is shown. Under the shown embodiment, the lid is frictionally secured to the device for protecting a sample. A first seal  26  is frictionally formed between the inner container  11  and the base  23  of the lid  22 . Additionally, a second seal  27  is frictionally formed between the outer protective body  12  and an overlapping portion  40  of the receptacle  24  of the lid  22 . 
     Referring to  FIG. 5 , an enlarged side sectional view of an open end of an exemplary device for protecting an inner container is shown. In one embodiment, the device for protecting a sample comprises a fastener  32  disposed between the connection point  30  of the lid  22  and the outer protective body  12 . 
     In the illustrated embodiment, the fastener comprises a ridge  29  and a ledge  20 . The ridge  29  is disposed on the internal surface of the outer protective body  12 . The ledge  20  is disposed on the external surface of the receptacle  24 . When the device for protecting a sample is placed into a locked position, the ledge  20  will pass under the ridge  29 , such that the lid will be frictionally secured to the outer protective body  12 . 
     Referring to  FIG. 6 , a perspective view of an exemplary device for protecting an inner container in a sterile pack is shown. In one embodiment, the sterilized housing  33  is configured to receive the inner container, the outer protective body and the lid therein. By packaging the device for protecting a sample  10  in the sterilized housing  33 , it is ensured that the device for protecting a sample will be sterile when used. In the illustrated embodiment, the sterilized housing  33  is transparent. The sterilized housing  33  is made of any suitable material, such as plastic. 
     Referring to  FIG. 7 , a side sectional view of an exemplary device for protecting an inner container is shown. In one embodiment, a void  34  is defined between the inner container  11  and the outer protective body  12 . The void  34  may be of any desired size. In one embodiment, the space  34  extends entirely between the inner container  11  and the outer protective body  12 . In another embodiment, the void  34  is at least partially filled with a solid, a liquid or a gas. 
     Referring to  FIG. 8  an exploded view of an exemplary device for protecting an inner container with a strap is shown. Under the shown embodiment, the outer protective body  12  comprises a strap  40  disposed on an end thereof, preferably opposite a closed end  42 . The strap  40  is configured to interact with a fastener  41 , such that the inner container  11  can be secured in the outer protective body  12  by the strap. This configuration allows for a greater variety of inner containers to be used with the device. The device&#39;s outer body may be made from a material selected from the group consisting of polyethylene terephthalate, plastic, latex, ceramic, fiberglass, metal and any breakage-resistant material. 
     The device may be used with inner containers made from glass, ceramic, porcelain, plastics and may also have additives such as SFS, a coating, a gel, a clot activator, a surfactant, a separator, or an anticoagulant compound. 
     A number of embodiments of the present disclosure have been described. While this specification contains many specific implementation details, there should not be construed as limitations on the scope of any disclosures or of what may be claimed, but rather as descriptions of features specific to particular embodiments of the present disclosure. 
     Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in combination in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a sub-combination. 
     Thus, particular embodiments of the subject matter have been described. Other embodiments are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the claimed disclosure.