Abstract:
A veterinary instrument for use in animal husbandry that includes an inner member with a swab or similar element attached at one end, located inside a second inner member meant to protect the innermost member and attached swab, and an outermost member that surrounds both inner members and has a closed mold manufactured protective cap on one end. The instrument has one or two safety pins which ensure that the instrument cannot be used until they are removed.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The present invention relates to a novel veterinary device or instrument useful in medication, antiseptic, culture collection, and artificial insemination processes utilized in animal husbandry. More particularly, the present invention relates to a veterinary instrument and sealed holder having improvements to the cap and the holding tube that make the device function more effectively and lower the cost and time of manufacturing.  
         [0003]     2. Discussion of the Related Art  
         [0004]     U.S. Pat. No. 4,586,604 to Alter and entitled “Culture Collection Instrument and Sealed Swab Holder Therefor” discloses one device in the prior art. U.S. Pat. No. 4,457,313 to Alter entitled “Shield Protector for Artificial Insemination and Culture Collection Instruments” discloses another. The disclosure of each of these patents in its entirety is hereby expressly incorporated by reference into the present application for the purposes of indicating the background of the present invention and illustrating the state of the art.  
         [0005]     As is known to those skilled in the art, the collection of a sample from the cervix of animal requires that the culture collection device must first pass through the vulva and/or cervical canal of the animal. Of course, these are not sterile and generally contain bacteria or diseased germs, such as vaginal or uterine infections or microplasa. Thus, previously recognized problems have been that when the instrument is inserted into the animal the culture collection instrument can transport infectious contaminants from the vulva and/or cervical canal into the cervix of the animal, or the element that will ultimately collect the sample can be prematurely contaminated before reaching the area that is the actual subject of the culture collection. Needless to say, it is worthwhile to have a culture collection instrument that reduces the contamination of both the cervix of the animal and the culture collection element while the instrument is being inserted into the animal. The same can be said for artificial insemination instrumentation.  
         [0006]     Despite past improvements in the art, prior designs did not completely eliminate the contamination problems associated with collecting a culture of insemination. While some devices did solve the problem of how to protect the element delegated to take the culture, they left room for material improvement in mitigating the threat of contamination of the cervix by the transportation of contaminants from outer parts of the animal&#39;s reproductive tract. Specifically in some prior art devices, the protective cap or tip on the end of the device was scored on the outside surface so as to allow the protected and sterile inner members to break through the protective cap once the instrument had reached the area where the sample was to be taken from. The scoring on the outside of the cap provided groves or channels that, in effect, acted as areas of entrapment for foreign material that could entrap material during both insertion and before the device was used. The scoring of the protective cap had been necessarily located on the outside of the cap because of the method of manufacture. The cap was produced by hand utilizing a repetitive dipping process and then later hand scoring the cap on the outside with a razor or similar instrument. The method of manufacturer of this cap resulted in a further disadvantage in that the hand made nature of the process was costly, time consuming, and unable to be automated, which all led to increased costs for the final culture collection device product.  
         [0007]     These prior methods of production also led to a further undesired characteristic of the instruments in that the force required to push the inner members through the protective cap varied substantially among individual devices. This situation was a direct result of the fact that the method of manufacture of the hand produced caps led to variations in material thickness and depth of scoring among the caps. The inconsistent force required to employ the sample taking element frustrated ease of use because product purchasers could never become familiar with a consistent method of use.  
         [0008]     What is needed, therefore, is a protective cap that does not have areas of entrapment of foreign material on the outside of cap and that has a consistent thickness and depth of scoring or perforation. Achieving these desired cap characteristics requires a new method of cap manufacturing that is consistent and that would ideally be cheaper, less time intensive, and compatible with automation.  
         [0009]     An additional limitation of the prior art is that the devices could be prematurely deployed. For example, the inner members could break through the protective cap during transportation or handling prior to being inserted into an animal to collect a culture. When this occurs, the device is effectively useless because the sample collecting element is not sufficiently protected from contamination once the protected cap is breached.  
         [0010]     Therefore, what is further needed is a method to prevent the inner elements from breaching the protective cap until that time as when the device user is ready to deploy the device to collect a sample.  
       SUMMARY AND OBJECTS OF THE INVENTION  
       [0011]     A primary object of the invention is to provide an improved culture collection device or insemination instrument that isolates and protects the inner portion of the device upon its insertion into or removal from the interior of the body or cervix of an animal and to sealingly retain this element for subsequent handling and transport to the analysis laboratory. Another objective of the invention is to incorporate a manufactured cap in the instrument that lessens the chance of contamination to the sample or tube and inner areas of the animal by eliminating areas of entrapment of foreign material on the device&#39;s protective cap and also makes collection of a sample easier by providing a protective cap medium that requires a consistent force to be breached when the swab is being applied to the sample area inside the animal. Another object of the invention is to make manufacture of such devices cheaper and more efficient by use of incorporating the manufactured cap into the device. A further object of the invention is to make transport, handling, and storage of the device safer by including at least one safety pin in the device, which prevents premature deployment of the sample taking members.  
         [0012]     In one embodiment of the invention a first inner member, comprised of a swab at the first end attached to an elongated tube or rod, is inside a second inner member. The second inner member is further inside an outer member that is sealed at the first end with a protective cap perforated on the inside. The perforations are predetermined thin sections, such as in the shape of an “X”, incorporated into the piece with all slits or indentations located on the inside surface of the cap. Consequently, the outside of the cap is a smooth, continuous surface lacking any areas of entrapment that could possibly collect foreign matter before or while the instrument is inserted past the vulva lining and through the cervical canal and then transport it to the cervix or other sample area. To deploy the device and take the sample, the second inner member with the first inner member&#39;s swab end inside, is pushed forward so that the first end of the second inner member breaches the cap of the outer member. The first inner member is then pushed forward through the open first end of the second inner member so that the swab extends past the first end of the second inner member, thereby being introduced to the environment to be sampled.  
         [0013]     Once the sample is taken, the swab is retracted back into the second inner member and the second inner member, with the first inner member inside, is retracted back to its original position inside the outer member. After the swab and second inner member are again isolated inside the outer member, the entire device is removed from the animal. The swab, now containing the sample, is then preserved for testing by removing the second inner member and the enclosed first inner member from the outer tube and then capping the open first end of the second inner member, which is no longer enclosed by the outer member. The second inner member, which protects the swab of the first inner member, has a scored section, located bellow the point where the swab inside is positioned, that completely circumvents the second inner member and allows for the second inner member to be easily and cleanly broken at the scored section. The enclosed elongated tube or rod of the first inner member also has a scored section that is aligned with the scored section of the second inner member while the device is in its retracted position, and this scored section allows the first inner member to break contemporaneously with, and at the same point, as the second inner member when second inner member is broken. The broken end of the second inner member is then capped on the broken end so that it is now capped on both ends and contains the broken off end of the first inner member and its swab element inside. The user now has a sealed and sanitary holder for the swab element that prevents contamination of the sample and facilitates transportation and storage for later testing.  
         [0014]     Additionally, a preferred embodiment also can have one or more safety pins that prevent the first inner member, second inner member, and outer member from moving longitudinally in relation to each other before the safety pins are removed. These pins are meant to protect from the inner members shifting in a manner that would permit the second inner member, and enclosed first inner member, to breach the outer member&#39;s protective cap before the user is ready to deploy the device to collect a sample. The use of these safety pins makes shipping and handling of the items safer and ensures the device cannot be employed until the pins are removed. This feature is important as the device is only good for one use, and the device must be discarded if the protective cap is breached while the instrument is outside of the animal.  
         [0015]     In another embodiment of the invention, the device may be used as an artificial insemination instrument. In this embodiment the swab element of the first inner member is not present and the first inner member is simply a tube or solid rod, which is substantially the same size as the inner diameter of the second inner member. The semen sample is placed inside the second inner member in the cavity which exists between the end of the first inner member and the end of the second inner member. Once the device is fully inserted into the animal and the second inner member breaks through the protective cap, the first inner member is pushed forward to at least the end of the second inner member, thereby discharging the semen sample into the cervix of the animal. The device is then withdrawn from the animal and discarded.  
         [0016]     In another embodiment of the invention, the cap on the end of the outer member is a molded plastic cap manufactured in a mold process, such as an injection molding process, with predetermined perforations, such as in the shape of an “X”, incorporated into the cap. The mold is designed so that any slits or indentations of the perforations are molded onto the inside surface of the cap, thereby leaving the outer surface of the cap a smooth, continuous surface. The cap can be manufactured in a reproducible process that assures consistent thickness of the normal and the perforated sections of the cap. The precise manufacturing method of the protective cap, and the uniform perforations that result, ensure that the force required to push the second inner member through the cap is consistent between different devices.  
         [0017]     In another embodiment of the invention, the one or two safety pins consist of a loop sufficient in size to accommodate a human finger and a pin like projection extending from that ring. Preferably, the first inner member, second inner member, and outer member all have a pair of identical holes that are oriented perpendicular to the axis of the members and are located in such a manner that on each member each hole directly opposes its paired hole. When the instrument is in its predeployed state all three pairs of the holes align collinearly so that the pin&#39;s projection, which is longer than the diameter of the outer member, can pass through all three pairs of holes, thereby physically preventing the members from shifting longitudinally in relation to each other. To enable the instrument for use the user must remove the pin or pins by first removing the pin tab, located near the end of pin projection, that prevents the pin from being removed and then grab hold of or slip his finger into the pin ring and pull the safety pin away from the instrument until it is removed.  
         [0018]     In another embodiment of the invention, the ring of the first safety pin is connected to the projection of the safety pin so that the plane of the ring is at about a forty-five degree angle in relation to the projection. This configuration allows the operator of the device to grip and use the device like a syringe when pushing the second inner member through the protective cap. The user puts his thumb through the pin ring and then puts his index and middle fingers on the first flange so that the device is between the two fingers. By bringing his thumb and index and middle fingers together as if using a syringe, the operator can more easily force the second inner member to break through the protective end cap while deploying the device. This embodiment is especially useful when the device is for artificial insemination.  
         [0019]     In one method of using the device, the device must be removed from a gas sterilized package before it is employed.  
         [0020]     In another method of using the device, the device is first unwrapped from a gas sterilized package and then the safety pin or pins are removed. Subsequently the instrument is inserted into the cervical canal of a mare and when the device is in the desired spot the second inner member is pushed through the cap perforated with an “X”. The swab element is then pushed about two inches beyond the first end of the second inner member to collect the sample. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0021]      FIG. 1  is a perspective view of a culture collection instrument in accordance with the present invention;  
         [0022]      FIG. 2  is a longitudinal cross-sectional view of the culture collection device of  FIG. 1  in accordance with the present invention during insertion of the device into the cervical canal of an animal and before inner members have breached the protective cap;  
         [0023]      FIG. 3  is a fractional longitudinal view of the culture collection device in accordance with the present invention showing the device fully deployed to take a sample while in the cervix of the animal with a protective cap breached by the first and second inner members and with a swab element extended beyond a first end of a second inner member so as to contact the sample target;  
         [0024]      FIG. 4  is a fractional longitudinal view of the second inner member, after extraction from the animal and removal of an outer member, with the swab element retracted back inside the second inner member having successfully collected a sample and showing the subsequent breaking off of the first and second inner members along the aligned scored sections of the first and second inner members;  
         [0025]      FIG. 5  is a longitudinal view of the broken off end of the second inner member capped on both ends so as to create a protective sealed environment for the broken off end of the first inner member, with the sample contained on the swab end of the first inner member;  
         [0026]      FIG. 6  is a longitudinal cross-section view of a protective cap showing the smooth outer surface and perforated inner surface;  
         [0027]      FIG. 7  is an axial rear view of the protective cap showing molded “X” perforations on an inside surface of the cap;  
         [0028]      FIG. 8  is an axial front view of the protective cap showing the smooth outer surface and molded “X” perforations on the inside surface;  
         [0029]      FIG. 9  is a side view of a safety pin for the culture collection device showing the pin like projection with associated tab and a ring shaped finger hold;  
         [0030]      FIG. 10  is a longitudinal side view showing two safety pins inserted into the culture collection device.  
         [0031]      FIG. 11  is a longitudinal cross sectional view showing mold pieces of an injection molding process with an inner mold piece having an “X” shaped protrusion that will create the “X” shaped perforations on the resulting molded end cap.  
         [0032]      FIG. 12  is a fractional cross-sectional side view of a culture collection device with an alternative first safety pin where the pin ring is at about a 45 degree angle in relation to the pin projection.  
         [0033]      FIG. 13  is a fractional cross-sectional bottom view of the culture collection device with an alternative first safety pin where the pin ring is at a 45 degree angle in relation to the pin projection.  
         [0034]      FIG. 14  is a fractional cross-sectional side view of the veterinary device for use as an artificial insemination instrument wherein the swab element is not present and there is a semen sample inside the second inner member. 
     
    
       [0035]     In describing the preferred embodiment of the invention which is illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, it is not intended that the invention be limited to the specific terms so selected and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar purpose. For example, the word attached or terms similar thereto are often used. They are not limited to direct connection but include connection through other elements where such connection is recognized as being equivalent by those skilled in the art.  
       DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0036]     The present invention and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments described in detail in the following description.  
         [0037]     The construction of a culture collection device, such as disclosed in the present inventor&#39;s prior U.S. Pat. No. 4,586,604 and U.S. Pat. No. 4,457,313 is well-known to those skilled in the art and therefore a detailed description thereof is not necessary to fully understand the present invention, which is directed to novel improvements in the construction of the protective cap  16  and the addition of one or more elements, specifically on or more safety pins  30  and  31 .  
         [0038]     The invention is shown in  FIGS. 1 and 2  which depict a veterinary device or instrument  10  that is comprised of an outer member  11 , preferably a plastic tube, which has a protective cap or tip  16 , preferably a injection molded plastic cap, on its first end. When used as a collection device  100 , the device is further comprised of a first inner member  14  made up of a swab element  18  on the first end attached to an elongated rod or tube  19 , preferably made of plastic. The culture collection device  100  is further comprised of a second inner member  12 , preferably a plastic tube, which protects the first inner member  14 . The culture collection device  100  also contains one or more safety pins  30  and  31  running through the second inner member  12 , the first inner  14 , and possibly the outer member  11 .  
         [0039]     Preferably, the culture collection device  100  is approximately 30 inches long and with a diameter of 1 inch. In the preferred embodiment, the outer member  11  is approximately 22 inches in length, the second inner member  12  is approximately 25 inches in length, and the first inner member  14  is approximately 30 inches in length. Preferably, the plastic used for the first inner member  14 , second inner member  12 , and outer member  11  is a softer PVC plastic and the swab element  18  is a polystyrene cotton swab.  
         [0040]     As shown in  FIGS. 1, 2  and  3 , the cultural collection device  100  includes a second inner member  12  having a flange  46  at one end thereof, with the second inner member  12  adapted for movement relative to the outer member  11 . The first inner member  14  is slidably positioned within the second inner member  12  and adapted for relative movement with respect to the second inner member  12 . The first inner member  14  is constituted by a swab element  18 , which may or may not be contained in a medium  17 , located on the first end thereof and attached to an elongated rod or tube  19 . Importantly, as best shown in  FIGS. 2 and 4 , the second inner member  12  includes a scored section  26  which, when the device  100  is in its predeployed state, is located forward the flange  44  of the outer member  11  and before the swab element  18 , and further lines up with a scored section  28  on the elongated rod element  19 . Upon the flexing of the second inner member  12  and the first inner member  14 , the two scored sections  26  and  28  create a predetermined breaking point of the second inner member  12  that coincides with a predetermined breaking point of the first inner member  14 , respectively.  
         [0041]     To prepare for use of the device, the culture collection device  100  must first be removed from gas sterilized packaging (not shown). Next, the one or two safety pins  30  and  31  must be removed so that the first inner member  14 , the second inner member  12 , and the outer member  11  can all move longitudinally in relation to each other, as is required for the device to be deployed. The first pin  30  passes through the first inner member  14  and the second inner member  12  and is located forward of the flange  46  at the second end of the second inner member  12  and behind the flange  44  of the outer member  11 , as shown in  FIG. 10 . Before it is removed the first pin  30  passes through the two opposing holes  52  and  53  in first inner member  14  and the two opposing holes  54  and  55  in the second inner member  12 , with all four holes  52 ,  53 ,  54  and  55  being collinearly aligned. The second pin  31  passes through the first inner member  14 , second inner member  12 , and the outer member  11  and is located forward of the flange  44  at the second end of outer member  11  and behind the scored portion  26  of the second inner member  12 , as shown in  FIG. 10 . While inserted the second pin  31  passes through the two opposing holes  32  and  33  in the first inner member  14 , the two opposing holes  34  and  35  in the second inner member  12 , and the two opposing holes  36  and  37  in the outer member  11 , with all six holes  32 ,  33 ,  34 ,  35 ,  36  and  37  being collinearly aligned.  
         [0042]     The process to remove a pin is the same for the first pin  30  and the second pin  31 . To remove the first safety pin  30 , the pin tab  42 , located near the end of the pin projection  43  of the safety pin  30 , must first be broken off or otherwise removed. With the pin tab  42  removed, the user then grabs hold of the pin ring  38  and pulls the pin ring  38  away from the culture collection device  10  so that the pin projection  40  travels through the collinearly aligned holes  52 ,  53 ,  54 , and  55 . The first safety pin  30  is fully removed from the culture collection device  100  when the end of the pin projection  43  passes through hole  55 . Once pins  30  and  31  are removed, the culture collection device  11  is ready to be inserted into the animal in order to take a sample.  
         [0043]     In one embodiment of the invention, the ring  47  of an alternate version of the first safety pin  45  is connected to the projection  49  of the safety pin  45  so that the plane of the ring  47  is at a forty-five degree angle in relation to the projection  49 , as shown in  FIGS. 12 and 13 . This configuration allows the operator of the device to grip and use the device like a syringe when pushing the second inner member  12  through the protective cap  16 . The user puts his thumb through the pin ring  47  and then puts his index and middle fingers on the first flange  44  so that the outer member  11  is between the two fingers. By bringing his thumb and index and middle fingers together as if using a syringe, the operator can more easily force the second inner member  12  to break through the protective cap  16  in order to deploy the veterinary device  10 . This embodiment is especially useful when the device  10  is an artificial insemination instrument  110 , as shown in  FIG. 14 .  
         [0044]     When the cultural collection device  100  is fully inserted into the cervix of an animal (not shown), the first inner member  14  is moved forward to engage the protective cap  16 , which has an “X” shaped perforation  24  on the inner surface  20  of the cap  16 , that breaks open upon engagement by the first end  13  of the second inner member  12 , as shown in  FIG. 3 . The first inner member  14  is then pushed forward into the cervix of the animal, past the first end  13  of the second inner member  12  (or about 2 inches), so that the swab element  18  may either culture or apply medication to the animal, as desired, the position of final deployment as shown in  FIG. 3 .  
         [0045]     Referring to  FIGS. 3-5 , upon completion of the culturing or medication processes, the first inner member  14  and the attached swab element  18  are retracted back inside the first end  13  of the second inner member  12 . The first inner member  14  and the second inner member  12  are subsequently retracted together back inside the first end  15  of the outer member  11  so that the relative position of the three members  11 ,  12 , and  14  is the same as it was before deployment, with the significant difference being the protective cap  16  has been irreversibly breached. Now that the culture collection device  100  is in its fully retracted position, the entire culture collection device  100  is removed from the animal.  
         [0046]     The second inner member  12 , containing the first inner member  14 , is now withdrawn from the outer member  11 , the position as partially shown in  FIG. 4 . A first end cap  48  is inserted upon the first end  13  of the second inner member  12  to seal one end of the second inner member  12 .  
         [0047]     Upon the manual flexing of the second inner member  12 , the second inner member  12  readily and predeterminately breaks and separates at its scored section  26 . As the flexing force translates through to the first inner member  14 , the elongated rod element  19  of the first inner member  14  also readily and predeterminately breaks at its scored section  28 , as shown in  FIG. 4 . By scoring, it is meant that the second inner member  12  and the first inner member  14  may have a notch or indentation either partially or completely therearound, which will permit a complete and clean breaking and division of the second inner member  12  and first inner member  14  upon manual flexing of the two. Upon the predetermined breaking of the second inner member  12  and the first inner member  14 , a second end cap  50  is inserted upon the end of the swab protector element  12  opposite the first end  13  to provide a tubular sealed enclosure  68 , which provides a sealed and sanitary holder for the cultured swab element  18 . This tubular sealed enclosure  68  permits safe handling, storage, and transportation of the cultured swab element  18  prior to medical testing of the sample, as shown in  FIG. 5 .  
         [0048]     In the embodiment of the invention for use as an artificial insemination instrument, the swab element  18  of the first inner member  14  is not present and the first inner member  14  is simply the elongated rod  19 , which is substantially the same size as the inner diameter of the second inner member  12 , as shown in  FIG. 14 . The semen sample  29  is placed inside the second inner member  12  in the cavity  23  that exists between the end of the elongated rod  19  and the first end  13  of the second inner member  12 . Once the device  10  is fully inserted into the animal and the second inner member  12  breaks through the protective cap  16 , the first inner member  12  is pushed forward to at least the first end  13  of the second inner member  12 , thereby discharging the semen sample  29  into the cervix of the animal. The device is then withdrawn from the animal and discarded.  
         [0049]     A substantial, novel improvement of this invention over the prior art results from the superior method of manufacturing the protective cap  16 . Instead of being produced by hand in an open mold, as in the prior art, the culture collection device  10  of the present invention uses a manufactured protective cap  16  that is created in a closed molding process, such as an injection molding process. In the injection molding process, the mold  56  consists of a mold, made an outer shell  58  that defines the structure of the outer surface  22  of the cap  16  and a solid inner mold piece  62  that defines the structure of the inner surface  20  of the cap  16 , as best seen in  FIG. 11 . The outer shell  58  of the mold  56  is preferably made of two mirrored halves that come together during the molding process to form the outer shell  58 . The inner mold piece  62  has a “X” shaped protrusion  64  on the top end  66  of the inner mold piece  62  that results in the creation of the “X” shaped perforation  24  on the inner surface  20  of the protective cap  16  when the mold  56  is filled and the protective cap  16  is made. Preferably, the “X” shaped protrusion  64  on the inner mold piece  62  is situated such that the seams of the perforation  24  in the molded cap  16  will be offset from any seams created in the molded cap  16  by the transition between the two halves of the outer shell  58  of the mold  56 .  
         [0050]     The incorporation of the manufactured protective cap  16  results in superior performance of the culture collection device  100  for two reasons as discussed in the summary. First, the resulting smooth outer surface  22  of the cap  16  does not contain any slits or channels that can entrap foreign matter and then transport it into the cervix of the animal. Second, because of the precise nature of the molding process, the thickness of the cap  16  and the depth on the perforation  24  in the inner surface  20  of the cap  16  are uniform between devices, so that the user is required to apply the same force in order to breach the protective cap  16  with each use of a device, which promotes efficiency and ease of use. Further, the molding process for manufacturing the protective cap  16  is advantageous because it is cheaper than producing the protective cap in an open mold process and the closed mold process can be automated and easily reproduced, which further reduces the costs and time of manufacture and increases product performance  
         [0051]     The above-illustrated specific embodiments of the present invention are capable of variation and modification, and, therefore, the examples are intended merely to facilitate an understanding of ways in which the present invention may be practiced and to further enable those of skill in the art to practice the present invention. Accordingly, the examples should not be construed as limiting the scope of the present invention.