Abstract:
This invention relates to the collection and handling of biological or chemical specimens. The invention provides a device and a method for collecting and preparing patient samples, such as sputum, to be used in downstream diagnostics tests. The invention reduces the handling and exposure of healthcare workers to the sample by the use of a bag in which hermetic seals are utilized to separate sample aliquots.

Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    This U.S. Application is related to PCT Application Serial No. PCT/US2010/______, and U.S. application Ser. No. 12/______, both filed May 14, 2010, to Viljoen et al., and entitled SAMPLE PROCESSING CASSETTE, SYSTEM, AND METHOD; and is related to PCT Application Serial No. 12/______, filed May 14, 2010, to Viljoen et al., and entitled SPECIMEN CONTAINER, SYSTEM, AND METHOD, the entirety of the contents of these applications being incorporated by reference herein for all purposes. 
       CLAIM OF PRIORITY 
       [0002]    This application claims the benefit of the filing date of U.S. Provisional Application Ser. No. 61/216,225, filed on May 14, 2009, entitled SAMPLE SEPARATION DEVICE, SYSTEM AND METHOD, to Viljoen et al.; and U.S. Provisional Application Ser. No. 61/216,360, filed on May 15, 2009, entitled SAMPLE PROCESSING CASSETTE, SYSTEM, AND METHOD, to Viljoen et al.; the entirety of the contents of the applications being incorporated by reference herein for all purposes. 
     
    
     FIELD 
       [0003]    This present disclosure relates to a sample or specimen container for use in collecting, processing and analyzing source materials, such as a biological or chemical specimen. 
       BACKGROUND 
       [0004]    The collection and analysis of a source material, such as a biological fluid specimen, may be done for a variety of reasons from diagnosis of diseases to the detection of drugs or other substances. Generally, the collection and analysis of a source material such as blood or urine is typically initiated by collecting the specimen in a hard container typically made of a glass or plastic material. The collection and testing of a source material presents a number of challenges, especially in locations without sufficient health and laboratory facilities. Even in highly developed communities, the fragile or hazardous nature of many types of source materials require that the materials are either tested immediately or preserved until arrival at an adequate laboratory facility. Various clinical situations require a sample of a collected specimen to be isolated for use. For example, specimens are routinely collected at a point-of-care clinic where patients are suspected to have communicable disease. Often multiple tests are performed on the collected specimen. As a result, the collected specimen must be divided into multiple samples for the different tests as well as for storage for future tests or shipping to a centralized lab. Thus, when a source material cannot be immediately tested, there is a considerable amount of time between source material collection and eventual diagnosis, where an individual may be unknowingly transmitting a disease to others. 
         [0005]    Separation of the collected specimen into different portions may generally pose an exposure risk to the health-care worker who handles the collected specimen. In many instances, the specimen may be collected in a cup or bag, and then the health-care worker must fully open the cup or bag and pour, pipette, or scoop out portion(s) of the sample for analysis. Further, this current practice may have a risk of contamination. It is desirable to reduce or eliminate such risks of exposure and contamination. 
         [0006]    An example of where the present invention according to the disclosure is particularly useful is in the collection of specimens from a population where the patients are suspected of having tuberculosis. Typically, sputum is collected from the patient in a collection bag, and the health-care worker must be exposed to an open bag filled with potentially hazardous tuberculosis bacilli to conduct analysis of the specimen. In the present invention, multiple portions of the specimen may be separated into compartments for immediate testing or preservation while reducing the exposure during this step. For example, multiple compartments could be specified for use in typical diagnostics tests and optimized (e.g. for handling and sample volume) given consideration to the downstream tests to be performed. In one known alternative (U.S. Pat. No. 5,423,792) there is disclosed a fluid specimen plastic container for holding a biological fluid specimen wherein the container has a port opening for receipt of the specimen, means for mechanically sealing the container including a sealable cap, a heat seal, or a plug, with the specimen therein, and wherein the seal is effected after receipt of the specimen and can include formation of more than one sealed compartments for subsequent separation and analysis and at least one of the sealed compartments having a rigid or semi rigid element therein protruding from a hole in the compartment to dispense the specimen contained therein, and the container also has an identification element capable of inscription thereon. 
         [0007]    Without sufficient laboratory capabilities, disease diagnosis is generally facilitated by obtaining a biological or chemical specimen from a patient at a point-of-care facility and then sending the specimen to a centralized laboratory for testing. During transfer, specimen samples, may degrade or be damaged which jeopardizes or compromises the integrity of the diagnostic results. Even if a specimen is received in an acceptable condition, days or even months may pass before a patient receives the results of the laboratory test of the specimen. In remote developing areas, it may be difficult, or even impossible, to locate and notify the patient of a positive diagnosis, only adding to the difficulty of controlling the spread of communicable diseases in these areas, particularly diseases that are more easily spread through human to human contact or interaction. 
         [0008]    Despite the significant advances made in many developed countries to control and even eradicate certain diseases, controlling the spread of certain diseases remains a serious issue. One particular concern is the troubling high rates of tuberculosis that remain in many areas. The spread of tuberculosis in some regions continues as a serious issue given the ease with which the disease is transmitted and the vast number of individuals who are carriers of the disease but are asymptomatic. Tuberculosis is generally an airborne bacterium that is easily spread through close contact, making effective prevention of the spread of the disease nearly impossible. 
         [0009]    As an added difficulty, the standard tests for tuberculosis diagnosis in many areas include smear microscopy and mycobacterial culture. While sensitive, culture typically requires six weeks or more to obtain growth and identification of the mycobacteria. While relatively inexpensive, smear microscopy is reported to identify only half the cases of tuberculosis (even less for HIV/AIDS co-infection) and is also unable to identify if a strain is drug-resistant. Thus, the current systems for tuberculosis diagnosis lead to low rates of disease identification in a timely and accurate manner, thereby limiting patient follow-up and proper treatment. These consequences perpetuate not only spread of the disease, but also the development of drug-resistant strains of tuberculosis. 
         [0010]    Existing polymerase chain reaction (PCR) technology has also been used for the diagnosis of tuberculosis, but has been hindered by its highly complex preparative steps and long amplification times in the range of hours. In many clinical settings, typical diagnostic methods (including PCR) are comprised of a considerable number of steps and a considerable number of lab devices to prepare and analyze the sample to obtain an actual diagnostic result. While there have been advances in the sample collection to results process (typically by consolidating and automating certain steps), the fact remains that molecular diagnostics are typically confined to high-complexity labs. Even where PCR testing has been shown somewhat effective, most health care facilities cannot support the funding or staffing needs for an operational PCR lab. Additionally, the expense and complexity of conventional PCR technology has prohibited it from being widely applied for diagnosis in areas where tuberculosis is most prevalent. The cost requirements for a high complexity laboratory simply cannot be met in many remote, underdeveloped or economically struggling areas. 
         [0011]    In response, there has been a push for point-of-care diagnostic devices that will accurately diagnose tuberculosis while substantially reducing the time required for diagnosis. However, point-of-care diagnostics of tuberculosis pose additional challenges. The risk of infection for any health care worker or lab technician becomes potentially extremely high with tuberculosis samples. Most laboratories that regularly handle infected tuberculosis samples are equipped with fume hoods, biohazard safety cabinets, air sanitation systems or isolated rooms so that anyone in contact with the samples is at least reasonably protected from infection. Health facilities in developing countries that would serve as point-of-care testing locations are simply not equipped with this safety equipment, further increasing the infection risk of health-care workers. Further, current PCR diagnostics requires expensive machinery and/or has slow processing times making existing PCR technology unsuitable for point-of-care use in some areas. Thus, any point-of-care device should also minimize the need for high-technology equipment and technicians. 
         [0012]    Notwithstanding the above, there long remains a need for point-of care diagnostic equipment that reduces the risk of infection to healthcare workers, improves the accuracy and speed of diagnostic testing and results, and does so with relatively simplified and lower cost equipment. There is a further remaining need for diagnostic tools that aid in accurate diagnosis while a patient is still at the point-of-care facility so that infected individuals can be treated immediately to help reduce the risk of infecting others. There also remains a need that the diagnoses also provide data regarding drug-resistant strains of a disease so that patients are not treated with a medication that they are resistant to, which will also reduce the risk of transmission to others. There also long remains a need for diagnostic equipment that provides a closed system so healthcare workers will have no direct contact with any specimen. There also long remains a need for diagnostic equipment having low-cost, simplified components so that the equipment can be easily repaired in developing areas. 
       SUMMARY 
       [0013]    The present disclosure provides for a point-of-care specimen collection device that is useful as part of a method to provide quick and accurate disease diagnosis as part of a closed system having low cost and simplified components. The present disclosure further provides for the collection, treatment and analysis of a sample material in the form of a biological or chemical specimen wherein the specimen is collected and sealed in a specimen container for testing for a disease or other characteristic. 
         [0014]    In one exemplary embodiment, the present disclosure provides a specimen container that may be used virtually anywhere including for use at a medical point-of-care facility, wherein the specimen container can receive a source material and can then enable the transfer of some of the source material to a processing device while substantially reducing exposure risks to the health care worker. In particular, the specimen container will receive a source material, in particular a sputum sample, from an individual. The specimen container includes a containing portion having a flexible wall and at least one opening. 
         [0015]    The present disclosure also contemplates a processing device for detection of a disease, the processing device including a body configured to include a processing well, a fluid transport path, at least one heating element, a temperature sensing device and a covering. The processing well may be adapted to receive a device for mixing and pumping a source material. The fluid transport path may include a valve. The at least one heating element may be disposed proximate the processing well. The temperature sensing device may be disposed proximate the processing well. The covering may be placed over the processing well so that the contents of the processing well remain within the body. 
         [0016]    The present invention provides a device and method for collection of a patient sample and separating the sample into various portions for further testing. The specimen container includes a containing portion having a flexible wall and at least one opening that may be sealed after specimen collection. In addition to the main body, the container may be comprised of at least one additional compartment in which some of the sample may be transferred internally and contained. More particularly, at least one compartment of the bag with some specimen may be isolated by forming at least one interior seal of the bag. 
         [0017]    Without needing to re-open the bag, the compartmentalized aliquot(s) of the specimen may be physically separated from the main body. The compartmentalization is achieved through a variety of means, such as a mechanical interlock, heat sealing, pressure sensitive adhesive, or any combination thereof. The compartments may be pre-formed during the manufacturing of the collection bag, or formed subsequent to sample collection. 
         [0018]    In a preferred embodiment, a port is present on a portion of the bag which can be sealingly attached to a processing device to transfer an aliquot of the specimen thereto for example diagnostic processing. Additionally, inclusion of ID tags to both to the main bag and the compartment may aid in sample tracking. 
         [0019]    The invention herein contemplates a device and method for the collection, treatment and analysis of a source material wherein all collection, treatment and analysis steps may take place at one point-of-care medical facility. The diagnostic equipment disclosed herein may allow for the collection of the source material to be performed in a closed system with minimal transfer of source material and minimal technician participation so that risk of infection to health care workers is minimized. Collection of source material may occur so that the source material is sealed within a specimen container. The collection system may further allow for multiple sealed specimen compartments within a specimen container. All collection, treatment, and analysis may occur in a shortened time frame so that patients can provide a sample and receive a diagnosis in one trip to a health care facility. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  is a graphical, plan view of a specimen container according to an exemplary embodiment; 
           [0021]      FIG. 2  is a graphical, plan view of the specimen container of  FIG. 1  including a plurality of specimen sample compartments (ID tags) according to an exemplary embodiment; 
           [0022]      FIG. 3A  is a partial, graphical view of the specimen container of  FIG. 2  detailing the specimen sample compartment of the sample container according to one exemplary embodiment; 
           [0023]      FIG. 3B  is a partial, graphical view of the specimen container of  FIG. 2  detailing a alternate exemplary embodiment of the specimen sample compartment; 
           [0024]      FIG. 4  is a graphical, plan view of a specimen container according to another exemplary embodiment; 
           [0025]      FIG. 5  is a graphical, plan view of the specimen container of  FIG. 4  showing a specimen sample compartments sealed and separated from the specimen container; 
           [0026]      FIG. 6  is a graphical, plan view of a specimen container according to yet another exemplary embodiment; 
           [0027]      FIG. 7  is a graphical, plan view of a specimen container having a plurality of specimen sample compartments according to yet another exemplary embodiment; 
           [0028]      FIG. 8  is a graphical, plan view of a specimen container according to yet another exemplary embodiment having a specimen sample compartment sealed and separated using perforations; 
           [0029]      FIG. 9  is a graphical, plan view of a specimen container according to yet another exemplary embodiment wherein the specimen sample compartment includes a port opening for transferring the specimen; and 
           [0030]      FIG. 10  is a graphical, plan view of a specimen container according to yet another exemplary embodiment including an injection port. 
       
    
    
     DETAILED DESCRIPTION 
       [0031]    In general, this disclosure contemplates a device and method for the collection, and later treatment and analysis of a source material such as a biological or chemical specimen. The specimen container disclosed herein allows for the improved collection of the source material as well as the subsequent treatment and analysis. The collection occurs so that the specimen is sealed within the specimen container. The specimen container is particularly useful as it provides a closed system for collecting source materials so that risk of infection to health care workers and others is reduced and preferably minimized. The specimen container and method are designed such that source material collection is particularly useful and analysis of specimen may occur in an improved manner and in a shortened time frame so that a patient can provide a biological sample and receive a diagnosis in one trip to a health care facility. The specimen container disclosed is particularly useful in the collection and subsequent treatment and analysis may take place at one point-of-care medical facility. 
         [0032]    Referring generally to the drawings and in particular to  FIGS. 1 through 3 , a specimen container (or collection bag)  10  is shown constructed in accordance with the present disclosure. Collection and analysis of a source material which may include blood, saliva, sputum, tissue, feces, urine, semen, vaginal secretions, hair, tears, biopsy material, cerebral fluid, spinal fluid, bone material, or any other biological sample that may be tested for disease presence. In addition to health care-related specimens, the present invention is useful for testing other specimens or source materials (which may include or be found in textiles, soil, food, water, and mold). The collection of the specimen is accomplished utilizing the illustrated specimen container  10 . The specimen container  10  is useful in the collection, analysis and determination of the presence of a particular disease (e.g., tuberculosis), or a particular substance in a person. In particular, the specimen container  10  is particularly useful to collect a specimen of sputum by having the person cough or expectorate into the opening  11 . The opening  11  is formed along one edge of the specimen container  10  and provides a relatively large opening  11  having a periphery that a person can put over their mouth and cough and/or expectorate into the specimen container  10  while limiting and/or preventing the sputum or expectorate from escaping or missing the specimen container  10 . Alternatively, the specimen container may include only one flexible wall onto which a source material is collected. The one flexible wall may then be folded upon itself and optionally sealed to contain the source material therein. This is particularly useful since the person is being tested for a disease, such as tuberculosis, and there is a very significant interest in avoiding further spread of the disease. In an alternate embodiment, the specimen container  10  is useful to collect other biological material including blood, saliva, sputum, tissue, feces, urine, semen, vaginal secretions, hair, tears, biopsy material, cerebral fluid, spinal fluid, bone material, or any other biological sample that may be tested for disease presence, which can also be deposited directly in the specimen container  10 . 
         [0033]    The opening  11  of the specimen container  10  is preferably located at or near a first side, edge or end  12  of the specimen container  10  to enable directly receiving the source material  35  within the specimen container  10  from the subject to be tested. The specimen container  10  further includes a second side, end or edge  16  and a third side, end or edge  17  that extend from the opening  11  and define a first portion  4 . While the specimen container  10  of  FIG. 1  is shown as having a relatively square shape that further includes the fourth side, end or edge  19 , it will be understood that the specimen container  10  may have any known or appropriate shape including round, elliptical, triangular, quadrilateral and so forth. Additional functional shapes allow for the analysis of any source material  35  located therein without the need to know the amount thereof or the use of other implements which may become infected with any disease present in the sample  35 . 
         [0034]    Collection of a material sample in the form of a source material  35  such as sputum from an individual is accomplished by having the individual either cough and/or expectorate into the opening  11  of the specimen container  10 . In one exemplary embodiment, as shown in  FIG. 1 , the specimen container  10  is preferably constructed of a flexible plastic material, such as a plastic bag having a seal  15  located proximal the opening  11 , similar to a sealable plastic, sandwich bag made of an appropriate, medical purpose material for use as a specimen collection and testing device. The seal  15  is constructed from any known or appropriate sealable structure (such as a plastic zipper-type or interlocking element structure) and provides a fluid-tight seal to the specimen container  10 . Alternative types of seal devices or methods, such as a heat seal or pressure sensitive adhesive seal, for sealing the specimen container  10  may also be used. Once the source material  35  is collected in the specimen container  10 , the seal  15  can be closed (i.e., sealed shut) by the patient providing the source material  35 . 
         [0035]    The specimen container  10  of the subject disclosure is intended to be a complete and closed system such that all features and functions are integral with the specimen container  10  and there is little or no need for manual tasks (such as a pouring, drawing or suctioning with a pipette, or scooping) to be performed with the seal  15  re-opened for sampling the source material  35  which further reduces the risks of exposure and contamination. Further, in one embodiment as best shown in  FIG. 2 , the specimen container  10  also includes areas for marking the specimen container  10  with unique identifier and/or patient information. 
         [0036]    To further avoid a need for an additional device, the specimen container has a flexible wall, bag-type structure which allows the collected source material  35  to be moved within the specimen container  10 . The source material  35  is moveable within the first and second portions of the specimen container  10  to prepare and/or subdivide (or apportion) the source material  35  into one or more specimen sample compartment  30 . The specimen container  10  further includes a second (or lower) portion  14  which is divided or segmented from the first portion  12  of the specimen container  10  by at least one separator, wall, divider or seal  18 . The first seal  18  extends laterally (as shown in  FIG. 1 ) from the side  16  to a central location. A second seal  18  extends vertically (as shown in  FIG. 1 ) from the side  19  in a direction toward the other seal  18 . A second separator, wall, divider or seal  20  extends diagonally (as shown in  FIG. 1 ) from the side  17  to the side  19  to define the specimen sample compartment  30 . 
         [0037]    Each separator, wall, divider or seal  18  and  20  may be made integral with the specimen container  10  similar to the seal  15  for closing the opening  11  or the seals  18  may alternatively be added or created at a later time, as desired. Each separator, wall, divider or seal  18  or  20  may include two appropriate sealable structures (such as a plastic zipper-type or interlocking element structure) that provide a fluid-tight seal on each side of the seal  18  and  20  locations. By sealing each portion of the specimen container  10 , there is an improved containment of the source material  35  and a reduced likelihood of exposure and risk of infection to a healthcare worker and others who handle the specimen container  10  and the portions  14 ,  24 . 
         [0038]    To improve the usability and function of the specimen container  10 , a tearable, removable or cutable structure, such as a line of etched or weakened spots or perforations  22  may be included between the sealable structures, as shown in  FIG. 1 , to make it easier to remove the portions  14  and  24  of the specimen container  10  for use in testing the part of the specimen  35  contained within each portion  14 ,  24 . It should be understood that the specimen container  10  can be designed to have any number of portions therein and segmented using a seal  18  similar to the portions  14  and  24 . 
         [0039]    The source material  35  is apportioned among the main bag portion  4  and bag portions  14  and  24 . While the specimen container  10  is designed so the opening  11  will properly and adequately receive the source material  35  in the portion  4 , the specimen container  10  preferably has a flexible wall portion or structure, such as a plastic bag, so the source material  35  can be moved within the specimen container  10  by applying pressure to the bag of the specimen container  10  to force the source material  35  to be distributed though out the extent of the interior of the specimen container  10 . It is possible to use any known or appropriate force generating mechanism to apply the pressure to move the source material  35 . In one embodiment, pressure may be applied by the patient or a healthcare work using her hands or using a device. In an exemplary embodiment the specimen container is placed on a surface and a roller or other similar structure is used for applying pressure to the bag and moving the specimen  35  within interior of the main portion  4  of the specimen container  10  and toward the portions  14  and  24 . 
         [0040]    Once an acceptable portion of the source material  35  is located within the portions  14  and  24 , the seals  18  and  20  can be completed. The specimen container  10  can be subdivided into a number of sealed and separated portions  14 ,  24  each of which contain at least a portion of the source material  35  for further testing and processing and the collecting or main portion  4  of the specimen container  10  can also be preserved or disposed in a more safe manner since it is also sealed by the seal  15  to limit and prevent others from contacting the portion of the source material  35  remaining therein. The disposable nature of all of the portions  4 ,  14 ,  24  of the specimen container  10  assists in improving the overall safety of the collection of the source material  35  as well as the related testing which reduces the risk of infection of healthcare workers and others that would traditionally come into contact with the patient during collection and testing for a disease. 
         [0041]    In one exemplary embodiment, the bag of the specimen container  10  can be sealed using a heat source applied at any of the seal locations, including at the opening  11  at the one edge to close the specimen container  10  and create a fluid-tight seal and thereby preserve the integrity of the source material  35  before apportioning the specimen in the various portions of the bag of the specimen container  10 . Alternative seal designs and means can be implemented by various known means such as heat or sonic staking or welding or pressure sensitive adhesive or mechanical interlock or other similar means or any combination thereof which may be automated or manually implemented. 
         [0042]    Further, the bag of the specimen container  10  may include any number of optional seals  18  located in any appropriate or alternative patterns disposed on the specimen container  10 . In one alternative exemplary embodiment as shown in  FIG. 2 , the specimen container  10  includes a plurality of sample compartments  30  in the form of specimen sub-containers  40  which extend or depend from the side  19  of the specimen container  10 . Each specimen sub-container  40  is coupled on one side to the specimen container  10 , similarly to the portions  14  and  24 , and includes a seal  48  in the form of a port  40  including a channel or passage  50  from the portion  4  of the specimen container  10 . In the present embodiment, a portion of the specimen  35  is moved into the specimen sub-container  40  and then the seal  48  is completed and the specimen sub-container  40  may then be removed from the portion  4  by tearing, cutting, or similar operation along the seal  48 . The seal  48  is sufficient so that after removal of the specimen sub-container  40 , the contents of both the specimen subcontainer  40  and the portion  4  remain hermetically contained. As shown, a plurality of specimen sub-containers  40  may be provided on a given specimen container  10  for any variety of uses such as testing for multiple diseases, conducting different tests for the same disease, for preservation, or cataloging purposes. For example, in the case of suspected tuberculosis, multiple specimen sub-containers  10  may be employed, each for typical tests such as culture, smear microscopy, or PCR-based molecular diagnostics. The volume and interface for each specimen sub-container  10  may be different, giving consideration for the specific test to be done on the specific specimen sub-container  10 . Each specimen sub-container  40  also preferably includes an identification (ID) tag portion, which allows for improved tracking and correct correlation of diagnostics results to the originating patient, especially in embodiments in which each specimen sub-container  40  is physically separated from the specimen container  10 . In a further exemplary embodiment as shown in  FIGS. 3A and 3B , the specimen sub-container  40  includes a threaded port  54 . The specimen sub-container  40  includes a seal  48  similar to that of the embodiment of  FIG. 2  so the specimen sub-container  40  can be separated from the portion  4  once a portion of the specimen  35  is located therein. Similarly, the seal  48  of specimen sub-container  40  of  3 B may include a perforation line  22  at location near the seal  48  where the specimen sub-container  40  may be separated from the portion  4  of the specimen container  10 . The port  54  of the specimen sub-container  40  is preferably sealingly interfaced with a container or processing device (not shown) prior to specimen collection. In this embodiment, the end of the port  54  is open and in fluid communication with the container or other processing device. In a further embodiment, the container or processing device may be integral to the specimen container  10 . In another embodiment, the port  54  may be similar to a port access of an intravenous line and may be a piercable port for use with a syringe or needle or other puncturing structure as may be part of a testing device (not shown) for withdrawing a portion of the specimen  35  located within the specimen sub-container  40  and subsequent processing and testing of the specimen  35 . In another alternative, the port  54  may be a positive pressure lock type port having a male or female connection for removably coupling to a female or male connection of another positive pressure lock type port for use in withdrawing the portion of the specimen  35  located in the specimen sub-container  40 . 
         [0043]    As noted above, the specimen container  10  may have shapes other than the rectangular shapes of the exemplary embodiments shown in the figures. In particular, the use of the sub-container  40  or the portions  14 ,  24  allow for a greater variety of alternative shapes for the specimen container  10  as well as allows for a variety of configurations useful for a greater variety of applications. For example, the specimen container  10  of  FIGS. 4 and 5  is a relatively basic, single sample compartment  30  design. The sample compartment  30  is defined by two seals  18  extending toward each other from the sides  17  and  19  located at one corner of the rectangular bag of the portion  4 . Once the specimen  35  is placed in the specimen container  10  through the opening  11 , the opening  11  is sealed. The specimen  35  is then moved (via application of a force) within the specimen container to force at least a portion of the specimen  35  to move around the seals  18  and enter the sample compartment  30 . Next, the space between the seals  18  is sealed closed and the sample compartment is then separated or detached from the main portion  4  of the specimen container  10  as best shown in  FIG. 5 . 
         [0044]    In the exemplary embodiment of  FIG. 6 , the sample compartment is defined by a single seal  18  extending diagonally from the side  17  to the side  19 . In the exemplary embodiment of  FIG. 7 , two sample compartments are formed in the corners of the specimen container  10  which has a rectangular shape. 
         [0045]    As best shown in  FIG. 10 , the specimen container  10  may also include additional components such as an insulating material to maintain heat within the specimen container  10  and a port  54  located within the portion  4  near the opening  11 . The port  55  may be useful for adding a material to the source material  35  to affect the source material  35  in some required and/or desirable manner prior to a portion of the source material  35  being separated with the sample compartment  30 . 
         [0046]    Though not necessarily drawn to scale, geometries, relative proportions and dimensions shown in the drawings are also part of the teachings herein, even if not explicitly recited. However, unless otherwise stated, nothing shall limit the teachings herein to the geometries, relative proportions and dimensions shown in the drawing. 
         [0047]    Unless stated otherwise, dimensions and geometries of the various structures depicted herein are not intended to be restrictive of the invention, and other dimensions or geometries are possible. Plural structural components can be provided by a single integrated structure. Alternatively, a single integrated structure might be divided into separate plural components. In addition, while a feature of the present invention may have been described in the context of only one of the illustrated embodiments, such feature may be combined with one or more other features of other embodiments, for any given application. It will also be appreciated from the above that the fabrication of the unique structures herein and the operation thereof also constitute methods in accordance with the present invention. 
         [0048]    The preferred embodiment of the present invention has been disclosed. A person of ordinary skill in the art would realize however, that certain modifications would come within the teachings of this invention. Therefore, the following claims should be studied to determine the true scope and content of the invention. 
         [0049]    The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the invention, its principles, and its practical application. Those skilled in the art may adapt and apply the invention in its numerous forms, as may be best suited to the requirements of a particular use. Accordingly, the specific embodiments of the present invention as set forth are not intended as being exhaustive or limiting of the invention. The scope of the invention should, therefore, be determined not with reference to the above description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. Other combinations are also possible as will be gleaned from the following claims, which are also hereby incorporated by reference into this written description.