Abstract:
The present invention provides a device for collection of biological material from the preputial region of a male animal. The basic principles for collection of the biological material are using a collection tip configured for filling the preputial space and scraping the mucosal walls when the device is pulled from the fornix of the prepuce. In one embodiment, the device includes a collection tip, configured for scrapping the mucosal lining of the prepuce, operably connected to an applicator rod.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention is directed generally to collection of biological samples and more particularly, collection of biological samples from the male reproductive tracts. 
       BACKGROUND OF THE INVENTION 
       [0002]    Central to the diagnosis of diseases of the reproductive organs in cattle is collection of the inciting organism. In the diagnosis of Trichomoniasis and Vibriosis in cattle there are generally no outward signs of the disease until producers begin seeing higher than normal abortion rates. The diagnosis of Trichomoniasis and Vibriosis is best accomplished by a testing program which requires collection of biologic material from the male reproductive tract. Currently, the diagnosis of Trichomoniasis and Vibriosis in the male requires multiple collections, even in infected animals, due to the difficulty in retrieving the inciting organisms. The need to repeatedly collect these animals is both expensive and labor intensive. 
         [0003]    Thus, there is a need to provide a more accurate means of collecting biologic samples from the male reproductive tract. 
       SUMMARY OF THE INVENTION 
       [0004]    Accordingly, an embodiment of the present invention is directed to a biological sample collection device, said device including a collection tip configured for scraping a mucosal surface and collecting a biological sample while being retrieved from the fornix of the prepuce; an applicator, wherein the applicator is a rod operably coupled to the collection tip and configured for directing the collection tip to the fornix of the prepuce through a pushing action and to retrieve same by a opposite pulling action. 
         [0005]    It is to be understood that both the foregoing general description and the following detailed description are exemplary only and are not necessarily restrictive of the invention as claimed. The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate an embodiment of the invention and together with the general description, serve to explain the principles of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0006]    The numerous advantages of the present invention may be better understood by those skilled in the art by reference to the accompanying figures in which: 
           [0007]      FIG. 1  is an enlarged view of a biological sample device in accordance with an embodiment of the present invention: 
           [0008]      FIG. 2  is an enlarged view of a biological sample device, including a protective sleeve, a speculum, and an applicator guide in accordance with an embodiment of the present invention; 
           [0009]      FIG. 3  is an enlarged view of a biological sample device, including a protective sleeve, a speculum, and an applicator guide in accordance with an embodiment of the present invention; 
           [0010]      FIG. 4  is a sectioned view of a male animal penis and prepuce, including an inserted biological sample device in accordance with an embodiment of the present invention; 
           [0011]      FIG. 5A  is an enlarged view of a biological sample device with cupping fins in accordance with an embodiment of the present invention; 
           [0012]      FIG. 5B  is a end-on view of a biological sample device with cupping fins in accordance with an embodiment of the present invention; and 
           [0013]      FIG. 6  is a flowchart illustrating a method of for using a biological sample device in accordance with an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0014]    Reference will now be made in detail to the presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. 
         [0015]    Referring generally to  FIGS. 1-4 , a biological sample collection device in accordance with an exemplary embodiment of the present invention is shown. The device  100  may include a collection tip  102 . The collection tip  102  may be a cup and a vial. The collection tip  102  is configured to collect a biological sample. The collection tip  102  is configured for scraping the mucosal wall  404  of the penis  404  and the mucosal wall of the prepuce  408  when removed from the collection point. For example, to aid in the collection of a biological sample the collection tip rim  106  may be flared with a beveled edge or alternatively the collection tip  102  may include cupping fins  502 , or side cut outs/openings of the collection tip. The collection tip  102  of the present invention is conical in shape in order to assist in the ease of placement when inserting the device  100  into the prepuce. The device  100  further includes an applicator  104 . The applicator  104  is a rod with a length of between 18 and 21 inches. Alternatively, the applicator  104  may be a pipette. 
         [0016]    The applicator  104  is operably coupled  108  to the collection tip  102 . For example, the applicator  104  may be operably coupled  108  to the collection tip  102  by a collar connection as shown in  FIG. 1 . However, the applicator  104  may operably coupled  108  to the collection tip  102  via a suction connection, a rivet connection, a threaded connection, a snap connection and a molded or welded connection. Additionally, the collection tip  102  may be removed from the applicator  104  in order to facilitate the placement of the collection tip  102  into a suitabte media container. The removal of the collection tip  102  from the applicator  104  may be via a reversal of any of the operable coupled  108  techniques including but not limited to breaking of a score line  114  on the applicator  104 . 
         [0017]    In a further embodiment of the present invention the device  100  may include a speculum  204 . The speculum  204  is a tubular structure configured for providing luminal access. The speculum  204  has a first end  206  and a second end  208 . The first end  206  is configured with a rounded edge to aid with insertion. When device  100  is used with the speculum  204  the speculum  204  is placed into the opening of the prepuce and the device  100  is advanced into the prepuce without the added risk of contamination from the external edges of the prepuce. The device  100  is advanced through the second end  208  and enters the prepuce at the first end  206 . The device is advanced to the fornix  404  of the prepuce. 
         [0018]    In a further embodiment of the present invention, the device  100  may include a protective sleeve  202 . The protective sleeve  202  may be made of paper or plastic. The protective sleeve  202  is configured for aseptically containing the device  100 . For example, the protective sleeve  202  may be a package configured for holding the device  100  including the collection tip  102 , the application  104 , the speculum  204 , and the applicator guide  216 . The protective sleeve  202  may further be configured for sterilizing. For example, the protective sleeve  202  may be suitable for gas, radiation, or heat sterilization. Further, the protective sleeve  202  is configured for opening and aseptically presenting the device  100  for use. For example, the protective sleeve  202  may include a tear strip  214 , a pressure zipper, an adhesive seal, and a folded end cap. 
         [0019]    In a further embodiment of the present invention, the device may include an applicator guide  216 . The applicator guide  216  is a tubular structure with a first end  218  and a second end  220 . The applicator guide  216  interior is sized to support linear displacement of the applicator  104  when the applicator  104  is advanced through the applicator guide  216 . The outer diameter is sized to sealingly fit within the speculum  204  interior. Further, the applicator guide  216  is sealingly retained between the first end  206  and the second end  208  of the speculum. Further, the first end  218  of the applicator guide  216  is recessed from the first end of the speculum  204 . 
         [0020]    Referring generally to  FIG. 6 , a method for collecting biological samples is illustrated in accordance with an embodiment of the present invention. The method  600  includes the step of selecting a male animal  602 . In a further embodiment of the present invention the step of selecting a biological sample device  604 . The step of selecting a biological sample device  604  is generally dependent on the breed, age, and size of the male animal. For example, an older bull with have deeper mucosal folds thereby requiring the use of a device  100  of a larger collection tips  102  size. Further, the method  600  includes the step of introducing the biological sample collection device  606  into the prepuce of a male animal. The step  606  requires restraining the male animal for the procedure and to clean the area of the prepuce where entry will be made. The step  606  then requires the stabilization of the prepuce by placing a hand externally on the wall of the prepuce and inserting the speculum  204  into the prepuce. Step  606  then includes inserting the collection tip  102  through the speculum  204  in a manner as to exit the first end  206  of the speculum  204  and enter into the prepuce; by pushing towards the animal with the applicator  104 , advancing the collection tip  102  to the full length of the fornix  404  located at the full depth of the prepuce. Further, the method  600  includes the step of collecting a biological sample from the prepuce of the male animal  608 . The step of collecting a biological sample from the prepuce of a male animal  608  includes a pulling on the applicator  104  whereby the collection tip  102  retreats from the fornix  404  of the male animal. The retreat engages the collection tip rim  106  with the mucosal walls  406  of the prepuce and the penis  402  of the male animal. The engagement permits the collection tip rim  106  to reach deep into the mucosal folds and to scrape the smegma material from the mucosa. Alternatively, the collection tip  102  may include cupping fins  502  as illustrated in  FIGS. 5A and 5B  to aid in collection of smegma material from the recess of the fornix  404 . 
         [0021]    Further, the method  600  includes the step of preparing the biological sample for testing  610 . The step  610  may include removing the sample from the collection tip  102  and place on a microscope or into a container with media suitable for transferring the specific biologic sample. For example, the present invention may provide for the removal of the applicator  104  when the entire collection tip  102  is inserter into a media filled vial suitable for seating and transporting. 
         [0022]    It is understood that the specific order or hierarchy of steps in the foregoing disclosed methods are examples of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the method can be rearranged while remaining within the scope of the present invention. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented. 
         [0023]    It is further understood that the collection of biological material is not limited to the male species. The accompanying drawings are for illustration of the biological collection device  100  with the male species referenced for clarity, however collection of biological material from the female of the species may be accomplished with use of the biological collection device  100 . 
         [0024]    It is believed that the present invention and many of its attendant advantages are to be understood by the foregoing description, and it is apparent that various changes may be made in the form, construction and arrangement of the components thereof without departing from the scope and spirit of the invention or without sacrificing all of its material advantages. The form herein before described being merely an explanatory embodiment thereof, it is the intention of the following claims to encompass and include such changes.