Abstract:
A container for storing a histological sample comprises a container housing having an open top end and a bottom end defining a container interior. The container interior is configured to hold a fluid and receive the sample. A removable lid encloses the open top end. A container insert engages the container housing so as to substantially inhibit leaking of the fluid from the container. The insert includes an aperture configured to permit a sample holder containing the sample passage therethrough so as to enable depositing of the sample within the fluid in the container.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Patent Application No. 62/024,196 filed on Jul. 14, 2014. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to specimen containers for holding specimens in preparation for biopsy, and more particularly relates to a specimen container having an insert through which a medical instrument holding a specimen may be passed to deposit the specimen in the container. The insert is self-sealing such that liquid in the container (e.g., a fixative agent such as formaldehyde) does not spill out of the container either prior to or after withdrawal of the medical instrument. 
     BACKGROUND 
     Ideally, medical sample collection should be conducted so that any collected specimens are preserved as quickly as possible. Thus, in hospital, clinical or nursing home environments, sample collection is optimally conducted at a patient&#39;s bedside wherein a collected histological specimen is immediately placed within a sample container filled with a fixative agent. However, fixative agents are generally caustic or toxic chemicals and care should be taken to avoid unwanted contact. Furthermore, many fixative agents include volatile chemicals which may irritate the eyes, nose and/or throat upon exposure. 
     Currently, medical specimen containers may be either filled with fixative agent fluids immediately prior to use or may come pre-charged with a fixative solution. In either case, loading of the histological specimen requires a nurse or other medical technician to open the sample container to allow deposition of the tissue sample within the fluid in the container. Upon opening of the container, volatile gases within the headspace of the container may be released into the room, possibly into the face of the nurse, technician, physician and/or patient. Further, depositing the sample within the container may lead to splashing of the fixative fluid thereby increasing the chance of unwanted exposure to the hazardous fluid. An additional hazard arises should the container lid be improperly sealed to the sample container. An improperly sealed lid may lead to leaking of the fluid, and beyond the potential contact with the fixative fluid, may lead to contact with any potentially bio-hazardous material collected and stored within the container. 
     Thus, there is a need for a sample container which collects and stores histological samples, particularly when the container is pre-charged with a fixative fluid wherein exposure to the fixative fluid and its vapor is minimized. The present invention addresses these and other needs. 
     BRIEF SUMMARY 
     In general, an embodiment of the present invention is directed to a container for storing a histological sample. The container comprises a container housing having an open top end and a bottom end defining a container interior. The container interior is configured to hold a fluid and receive the sample. A removable lid encloses the open top end. A container insert engages the container housing so as to substantially inhibit leaking of the fluid from the container. The insert includes an aperture configured to permit a sample holder containing the sample passage therethrough so as to enable depositing of the sample within the fluid in the container. 
     In accordance with a further embodiment of the present invention, the container insert is further configured to include a resealable septum layer bonded to the top face of the container insert. The container is configured to hold a water layer between the resealable septum layer and the open top end of the container. 
     Additional objects, advantages and novel features of the present invention will be set forth in part in the description which follows, and will in part become apparent to those in the practice of the invention, when considered with the attached figures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings form a part of this specification and are to be read in conjunction therewith, wherein like reference numerals are employed to indicate like parts in the various views, and wherein: 
         FIG. 1  is a perspective view of a specimen container in accordance with an embodiment of the invention; 
         FIG. 2  is a plan view of the container insert seen in  FIG. 1 ; and 
         FIG. 3  is a perspective view of an embodiment of the container insert; and 
         FIG. 4  is a perspective view of a specimen container in accordance with a further embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION 
     With reference to  FIG. 1 , an embodiment of a medical specimen container in accordance with the present invention is generally indicated by reference numeral  10 . As can be seen in  FIG. 1 , container  10  includes a container housing  20  having an open top end  21  and a bottom end  22  defining a container interior. Container  10  is configured to hold a fluid  40 , such as a fixative solution comprising formalin, formaldehyde, glutar aldehyde, Bouin&#39;s fixative, ethyl alcohol or the like as is commonly practiced in the art. A lid  24  is removably secured to housing  20  so as to enclose open top end  21 . In accordance with an embodiment of the present invention, lid  24  is threadably matable with housing  20 . Open top end  21  may further be sealed via a seal layer  26 . Seal layer  26  may be comprised of any suitable seal material commonly used within container sealing applications, including polymeric materials, foil, or laminated combinations thereof. Seal layer  26  may be configured to be a puncturable layer or may be peelably removable as indicated generally by arrow  25  so as to selectively enable access to the container interior. In accordance with an aspect of the present invention, lid  24  and/or seal layer  26  may maintain the container interior in a sterile state until the container is opened to deposit a biological sample  60 . 
     With continued reference to  FIG. 1  and with attention further directed to  FIG. 2 , container housing  20  is adapted to carry a container insert  30 . In accordance with an embodiment of the present invention, insert  30  is proportioned so as to fit snuggly within container housing  20 . In one possible embodiment, insert  30  is constrained within housing  20  through a friction fit. In an alternative embodiment, insert  30  may further include a fastening engagement such as an adhesive between the outer surface of the insert  30  and the inner wall of the housing  20 . In accordance with an aspect of the present invention, container insert  30  is supported by housing  20  so as to be located above the level of fluid  40  while substantially inhibiting leaking of fluid  40  from the container. As used herein, the phrase “substantially inhibiting” is to be interpreted to mean that, at most, only a minimal amount of fluid  40  bypasses insert  30  should the container be vigorously jostled or inverted. Alternatively, the level of fluid  40  may coincide with the bottom surface  33  of insert  30 . In no event should fluid  40  fill the container so as to have a fluid level above the top surface  31  of insert  30 . Insert  30  may be constructed of any suitable resilient yet compressible material such as, but not limited to an open- or closed-pore foam of polyethylene, polyurethane, polystyrene, silicone, nylon and combinations thereof. 
     Container housing  20  may further include a label portion  37  onto which may be written, affixed or displayed indicia  38 . Indicia  38  may include any desired information, such as patient name, birth date, date of procedure, location of procedure, sample number or the like. In accordance with an aspect of the present invention, label portion  37  is located on the outer surface of container housing  20  above bottom surface  33  of insert  30 . In this manner, neither label portion  37  nor indicia  38  overlap or otherwise obscure the portion of container  10  containing fluid  40  and, when deposited, sample  60 . In this manner, medical personnel can visually inspect container  10  prior to deposition of a sample to ensure that the container has not been previously used. 
     As can best be seen in  FIG. 2 , insert  30  is configured to define an aperture  32  through which a sample holder  50  containing a sample  60  may be passed. By way of example, sample holder  50  may be biopsy forceps used to extract a tissue sample from a patient. As shown in  FIG. 2 , aperture  32  is formed by at least one slit extending the longitudinal length of insert  30  (i.e. from a top face  31  to bottom face  33  as shown in  FIG. 1 ). Opposing faces of the slit and arranged to be held within touching contact with one another so as to create a friction seal and thereby inhibit or prevent unwanted passage of fluid  40  through the aperture  32 . In accordance with an aspect of the present invention, aperture  32  is formed by two slits, with first slit  32   a  being generally perpendicular to second slit  32   b . In this manner, sample holder  50  may penetrate insert  30  by displacing and compressing the foam material of the insert. Passage of sample holder  50  through the body of insert  30  allows deposition of sample  60  within fluid  40  within container housing  20  (see  FIG. 1 ). In accordance with an aspect of the present invention, insert  30  may compress so as to snuggly envelop sample holder  50  as the sample holder resides within the insert. In this manner unwanted escape of fluid  40  from the container may be minimized or prevented while sample  60  is being deposited. Upon withdrawal of sample holder  50 , insert  30  decompresses and reseals aperture  32  to, once again, substantially inhibit leakage of fluid  40  from container  10 . 
     Turning now to  FIG. 3 , an alternative embodiment of a container insert  30 ′ is configured to include an aperture  32 ′ comprised of a pair of indentations  32   a ′/ 32   b ′ depending, respectively, from opposing top face  31 ′ and bottom face  33 ′ of insert  30 ′. In accordance with a further embodiment of the present invention, aperture  32 ′ may include a single indentation depending from either the top face or bottom face. As seen in  FIG. 3 , there remains at least some sealable portion  34 ′ of aperture  32 ′ so as to prevent passage of fluid  40  through the aperture  32 ′. Indentations  32   a ′/ 32   b ′ are configured to reduce friction between sample holder  50  and insert  30 ′ by reducing the amount of insert  30 ′ engaged by sample holder  50  when the sample holder is slidably inserted into and withdrawn from container  10 . However, sealable portion  34 ′ is proportioned to maintain a sufficient seal so as to substantially inhibit leaking of the fluid  40  from container housing  20  before, during and after the deposition of sample  60 . 
     Turning now to  FIG. 4 , an alternative embodiment of a medical specimen container n accordance with the present invention is generally indicated by reference numeral  100 . Medical specimen container  100  is similar to medical specimen container  10  of  FIG. 1  except for the provision of a water layer  70  situated above the container insert (such as container insert  130  which will be discussed in more detail below). Water layer  70  allows sample holder  50  to be rinsed following passage through insert  30 / 130  and deposition of sample  60  within fluid  40 . In this manner, any hazardous fluid, such as a fixative solution comprising fluid  40 , is removed from sample holder  50  before the sample holder is extracted from container  100 . This rinsing reduces the potential for inadvertent contact with the fixative solution. Water layer  70  also serves to create a gas barrier between fluid  40  and top end  21  of container  100 . As a result of this gas barrier, any volatilization of fluid  40  is isolated to the headspace located between the top of fluid  40  and the bottom of container insert  30 / 130  such that a nurse, technician, physician and/or patient does not come into contact with or otherwise inhale potentially harmful fluid  40  fumes upon opening of container  100 . 
     In accordance with an aspect of embodiment  100  of the present invention, the comingling of water  70  and fluid  40  is minimized, and in a further aspect, is prevented such as by way of container insert  130 . Container insert  130  is similar to container insert  30  describe above with regard to embodiment  10  but has been adapted to include a resealable septum layer  131  bonded to top surface  31  of container insert  30 . Resealable septum layer  131  is configured to provide a watertight barrier between water  70  and fluid  40  while also being puncturable to permit selective insertion and withdrawal of sample holder  50 . Resealable septum layer  131  may be further configured to sealingly engage sample holder  50  while the sample holder penetrates the septum material. In this manner, the watertight barrier is maintained while sample  60  is being deposited. Resealable septum layer  131  is still further configured to reseal upon withdrawal of sample holder  50  from septum layer following deposition of sample  60  within fluid  40 . 
     In accordance with an aspect of the present invention, resealable septum layer  131  may be comprised of any suitable material, such as but not limited to natural and synthetic rubber, silicone, thermoplastic elastomers and combinations thereof. Resealable septum layer  131  may have any suitable thickness so long as the material thickness provides the requisite sealing, puncturability and resealability properties as described above. 
     In accordance with an aspect of the present invention, insert  30 / 30 ′, including that portion  30  of insert  130 , may be impregnated with an anti-microbial agent so as to assist in maintaining a sterile field within container housing  20 . Alternatively and/or additionally, insert  30 / 30 ′ and its respective aperture  32 / 32 ′ may be surface coated with an anti-microbial agent. 
     Although the present invention has been described in considerable detail with reference to certain aspects thereof, other versions are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the aspects contained herein. 
     All features disclosed in the specification, including the claims, abstract, and drawings, and all the steps in any method or process disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. Each feature disclosed in the specification, including the claims, abstract, and drawings, can be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.