Patent Application
20200299048
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.
In the biomedical science and health care industries in particular, blood is drawn for various tests to assess an animal'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'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'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'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.
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.
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.
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'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'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
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.
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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
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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.
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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.
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.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2018/031704 | 5/8/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62503219 | May 2017 | US |
