Abstract:
A method of self-sampling and analyzing a semen sample without visiting a doctor&#39;s office, utilizing a kit including an insulated box containing an ice brick, a sample bottle, and a preservative solution, including the steps of:  
     1) Ordering a kit by telephone or on the Internet;  
     2) Receiving and placing the kit in a freezer until ready for use;  
     3) Placing a semen sample into the sample bottle and adding the preservative solution to the sample bottle;  
     4) Placing the sample bottle into the kit next to the ice brick in the insulated box;  
     5) Shipping the kit and the sample bottle to a diagnostic laboratory for analysis of the semen sample;  
     6) Analyzing the semen sample on a semen analyzer at the diagnostic laboratory;  
     7) Transmitting a confidential analysis report to the patient setting forth analysis of the semen sample;  
     8) Consultation service for the patient; and  
     9) Referral service for the patient.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention relates to a method of self-sampling and analyzing a semen sample. More particularly, this at-home semen analysis kit is an easy method in which to have access to an infertility medical laboratory without the user actually having to go to the laboratory in person. The at-home semen analysis kit provides the user the necessary equipment, preservative chemicals, paraphernalia, shipping boxes (return mailer) and instructions for the self-sampling of the user&#39;s semen at the privacy of the user&#39;s home, whereby the user will receive his results by mail within 48 hours of the semen sample being analyzed at the infertility medical laboratory.  
         BACKGROUND OF THE INVENTION  
         [0002]    Medical statistics have shown that in couples unable to conceive, approximately one-half of the time a male factor is involved. The sole cause is with the male alone 40% of the time, and 10% being combined male and female causes. Fifty percent of the time the factors can be attributed to the female partner only.  
           [0003]    In addition, males with a known history of sexually transmitted disease, history of exposure to chemical, environmental, or other workplace hazards, may have an increased risk of an abnormal semen analysis.  
           [0004]    Other factors associated with an abnormal semen analysis are: a history of surgery for undescended testes and inguinal hernias, excessive exposure to hot tubs and prolonged use of tight briefs. Anabolic steroids are definitely a cause of low sperm counts. Trauma to the groin area also my be a factor.  
           [0005]    There remains a need for an easy way to have access to an infertility medical practice without actually having to go there in person by the user. Medical research has shown that sperm can survive for days in a preservative solution, this analysis can be accomplished without wasting hours going to and from a medical infertility laboratory as you can get the same information through the use of an overnight at-home semen and collection kit.  
         DESCRIPTION OF THE PRIOR ART  
         [0006]    Methods for transporting medical samples, such as semen, blood, bone marrow, skin tissue and the like by conventional overnight delivery/mail services have been disclosed in the prior art. For example, U.S. Pat. No. 5,983,661 to Wiesman discloses a container arrangement and method for transporting equine semen. This container allows for transporting samples of equine semen over long distance while at the same time maintaining the motility and fertility of the transported spermatorozoa for at least 48 hours without the sperm being inactivated. This prior art patent does not teach or disclose a method of self-sampling and collection for analysis of a semen sample being an at-home semen collection and analysis kit of the present invention.  
           [0007]    U.S. Pat. No. 6,018,713 to Coli et al discloses an integrated system and method for ordering and retrieving the cumulative results/reporting of medical tests. Further, this invention relates to an improved system and method for on-line ordering of medical tests in a health care network, an improved system and method for uniformly recording and reporting test results, and an improved system and method for collecting and statistically analyzing test results. This prior art patent does not teach or disclose a method of self-sampling and collection for analysis of a semen sample being an at-home semen collection and analysis kit of the present invention.  
           [0008]    None of the prior art patents disclose or teach a method for self-sampling and collection of human semen sample for analysis through the use of an at-home semen collection and analysis kit as shown in the present invention.  
           [0009]    Accordingly, it is an object of the present invention to provide an at-home semen collection and analysis kit that gives the user an easy way in which to have access to a medical infertility laboratory without the user actually having to go to the laboratory in person.  
           [0010]    Another object of the present invention is to provide an at-home semen collection and analysis kit that includes the necessary collection equipment, the preservative chemicals, an overnite return mailer and box, and instructions for the self-sampling of the user&#39;s semen at the privacy of the user&#39;s home, whereby the user will receive his confidential report by mail within 48 hours of the semen sample being analyzed at the infertility medical laboratory.  
           [0011]    Another object of the present invention is to provide an at-home semen collection and analysis kit, such that the user is not examined in a cold and impersonal medical facility, as well as having the mental anguish of sharing the user&#39;s most intimate medical information of his problems with an unknown medical staff.  
           [0012]    Another object of the present invention is to provide an at-home semen collection and analysis kit that is easy to use, durable in construction, and having simple packing instructions for shipment to the medical infertility laboratory.  
           [0013]    Another object of the present invention is to provide an at-home semen collection and analysis kit that maintains the integrity of the semen sample taken by the user prior to its analysis at the medical infertility laboratory, such that the sperm is in a viable state for proper analysis.  
           [0014]    Another object of the present invention is to provide an at-home semen collection and analysis kit that enables the economic transport of human semen, in a disposable, totally self-contained, passively cooled, inexpensive container that has essentially no moving parts, and that is not equipped with thermostatically controlled cooling arrangements or the like, for periods of time approximating at least 24 to 48 hours.  
           [0015]    A further object of the present invention is to provide an at-home semen collection and analysis kit that can be mass produced in an automated and economical manner and is readily affordable by the user.  
         SUMMARY OF THE INVENTION  
         [0016]    In accordance with the present invention, there is provided a method of self-sampling and analyzing a semen sample without visiting a doctor&#39;s office, utilizing a kit including a insulated box containing an ice brick, a sample bottle, and a preservative solution, including the steps of:  
           [0017]    1) Ordering a kit by telephone or on the Internet;  
           [0018]    2) Receiving and placing the kit in a freezer until ready for use;  
           [0019]    3) Placing a semen sample into the sample bottle and adding the preservative solution to the sample bottle;  
           [0020]    4) Placing the sample bottle into the kit next to the ice brick in the insulated box;  
           [0021]    5) Shipping the kit and the sample bottle to a diagnostic laboratory for analysis of the semen sample;  
           [0022]    6) Analyzing the semen sample on a semen analyzer at the diagnostic laboratory;  
           [0023]    7) Transmitting a confidential analysis report to the patient setting forth analysis of the semen sample;  
           [0024]    8) Allowing for a free consultation to discuss the results and referral to a specialist in their area if needed; and  
           [0025]    9) Establishing a referral system.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0026]    Further objects, features, and advantages of the present invention will become apparent upon the consideration of the following detailed description of the presently-preferred embodiment when taken in conjunction with the accompanying drawings, wherein:  
         [0027]    [0027]FIG. 1 is a schematic block diagram of the method of self-sampling and analyzing a semen sample of the preferred embodiment of the present invention showing all of the steps involved for the sampling, the shipping, the analysis and the reporting of results of a semen sample by the user&#39;s use of an at-home semen collection and analysis kit;  
         [0028]    [0028]FIG. 2 is a front perspective view of the at-home semen collection and analysis kit of the preferred embodiment of the present invention showing the major component parts within the kit;  
         [0029]    [0029]FIG. 3 is a top plan view of the at-home semen collection and analysis kit of the present invention showing the styrofoam retaining member, the foam insert having compartments therein, the semen collection bottle, the preservative chemical solution bottle and the ice brick;  
         [0030]    [0030]FIG. 4 is an exploded perspective view of the at-home semen collection and analysis kit of the present invention showing all of the component parts being used for the kit; and  
         [0031]    [0031]FIG. 5 is an exploded perspective view of the at-home semen collection and analysis kit of the present invention showing the kit, the outer shipping container and the overnite express lab pack envelope being prepared for shipment to the diagnostic laboratory for analysis. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0032]    The at-home semen collection and analysis kit  10  and its component parts of the preferred embodiment of the present invention are represented in detail by FIGS. 2 through 5 of the patent drawings. The method  200  of self-sampling and analyzing a semen sample  12  having various procedural and operational steps performed in this medical process is disclosed in the preferred embodiment of the present invention and is represented in detail by FIG. 1 of the patent drawings.  
         [0033]    The at-home semen collection and analysis kit  10 , as shown in FIGS. 3 and 4, includes a styrofoam box or container  20  having a top cover member  22  and a retaining bottom member  32 , a foam insert  42  having a first circular opening  44  for receiving a semen sample collection bottle  50  therein and having a second circular opening  46  for receiving a preservation solution bottle  60  containing a chemical preservative solution  66  therein. Kit  10  further includes a formable, rectangularly-shaped ice brick or pack  70  for keeping the semen sample  12  within the semen sample collection bottle  50  at a cooled temperature in the range of 40° F. to 50° F. when stored in the styrofoam box  20 , a biohazard specimen plastic bag  72  having instructional indicia  82  thereon, a patient questionnaire medical response sheet  86 , an instruction sheet  88  for giving the method  200  of use for kit  10 , a return shipping container  90  and an overnite express lab pack envelope/return mailer  100 .  
         [0034]    The top cover member  22 , as shown in FIGS. 2 and 4, includes an exterior top wall surface  24 , an interior top wall surface  26  having interior lap-joint edging  28  and perimeter side walls  30   a  to  30   d.  The retaining bottom member  32  includes side walls  34   a,    34   b,    34   c  and  34   d  and a bottom wall  36  for forming an interior compartment  38 . Side walls  34   a  to  34   d  include perimeter lap-joint edging  40  for mating the retaining bottom member  32  with the interior lap-joint edging  28  of the top cover member  22  in order to close the styrofoam box  20  for shipping, as depicted in FIG. 5 of the drawings.  
         [0035]    The semen sample collection bottle  50  is made of light-weight plastic materials and includes a plastic screw-on cap  52  having an identification label  54  thereon, as depicted in FIG. 4 of the drawings. The preservation solution bottle  60  is also made of light-weight plastic materials and includes a plastic screw-on cap  62  with a metal seal  64  thereon. The preservation solution bottle  60  contains therein a chemical preservative solution  66  for preserving the semen sample  12  while in transit to the diagnostic laboratory for analysis. The preservation solution bottle  60  also includes an identification label  68  thereon.  
         [0036]    The biohazard plastic specimen bag  72 , as shown in FIGS. 3 and 4 of the drawings, includes a front wall  74 , a rear wall  76  for forming an interior compartment  78  therein and for receiving the semen sample collection bottle (with semen  12 ) therein, and a zip lock top section  80  for closing the specimen bag  72 . The biohazard plastic specimen bag  72  also includes a pocket compartment  84  located on the rear wall  76  for receiving the patient questionnaire medical response sheet  86  therein. Front wall  74  of specimen bag  72  includes instructional indicia  82  thereon for informing the user the use of the specimen bag  72 .  
         [0037]    The return shipping container  90  is made of light-weight corrugated cardboard material, as shown in FIG. 5, and includes an interior compartment  92  for receiving kit  10  therein and a side cover  94  for enclosing the entire kit  10  therein in preparation for final return shipment to the diagnostic laboratory for analysis.  
         [0038]    The overnite express lab pack envelopes/return mailer  100 , as shown in FIGS.  4  and of the drawings, includes a front wall  102  and a rear wall  104  for forming an interior compartment  106  therein and for receiving the (packed with kit  10 ) returner shipping container  90  therein; and a sealant top member  108  for closing the return mailer  100 . Front wall  102  includes an attached shipping bill and manifest  110  thereon for shipping the return mailer  100  to a designated diagnostic laboratory for having the semen sample  12  analyzed.  
       OPERATION OF THE PRESENT INVENTION  
       [0039]    The method  200  and operation of a self-sampling and analyzing kit  10  for analyzing a semen specimen  12  is represented by FIGS. 1, 4 and  5  of the patent drawings. The first step  210 , has the user ordering the kit  10  by telephone  212  or on the Internet  214  to the user&#39;s place of residence  216  for privacy.  
         [0040]    When the user receives the kit  10 , as shown in the second step  220 , the user places the entire styrofoam box  20  containing the cool pack/ice brick  70  and the preservation solution bottle  60  having a preservative solution  66  therein into the freezer  222 . The ice brick  70  is not frozen separately since it will reform into a different shape and then not fit inside the styrofoam box  20 .  
         [0041]    As shown in the third step  230 , when the user is ready to use the kit  10 , the user takes out the solution bottle B  60  containing the preservative solution  66  therein from the freezer  222  and places it in warm water for 10 minutes, allowing it to thaw and warm up. The semen sample  12  must be shipped the day it is collected. It is recommended that the user produce the semen sample  12  within 2-3 hours before the pick-up by the overnite delivery service  252 . If possible, the user should abstain from ejaculating for 2-3 days before providing the semen sample  12 ; this will ensure the highest possible sperm count. The user should not use spermicidal lubricants or any product containing spermicide which would effect the semen sample  12  when being analyzed at the diagnostic lab  254 . The user places as much of the semen specimen  12  as possible into the larger plastic bottle  50  labeled A (specimen), trying to get most of the ejaculation into the large bottle A  50 , as possible. The user then opens bottle B  60 , after it has thawed and warmed in warm water. The user then peels off the metal seal  64  and cap  62  carefully, so as not to cut the user&#39;s finger. The user then adds the contents of bottle B  60  (preservative solution  66 ) to bottle A  50 , which now contains the semen sample  12  and screws on cap  52  to seal bottle  50 . The user then gently shakes the semen collection bottle A  50  for 10 seconds to ensure adequate mixing. The user then discards the empty bottle B  60  into the user&#39;s household garbage.  
         [0042]    As shown in the fourth step  240 , the semen collection bottle A  50  is readied for shipment. To comply with federal postal regulations, a biohazard specimen bag  72  is provided in the kit  10 . After collection of the semen sample  12  in the large bottle labeled A  50 , the user then tightly seals bottle A  50  via cap  52 , such that the user firmly twists the cap  52  onto bottle A  50  to avoid leakage (in the plane under pressure), which now contains both the user&#39;s semen sample  12  and the preservative solution  66 . The user also fills out the patient questionnaire response sheet  86  for information needed by the diagnostic lab  254  for proper analysis  272  of the semen sample  12  sent by the user. The patient questionnaire response sheet  86  is folded and placed into the pocket compartment  84  of the biohazard specimen bag  72 . The user then now places bottle A  50  inside the biohazard bag  72 , seals it via the zip-lock top  80  and places it into the larger opening area  44  of the foam insert  42  inside the bottom retaining member  32  of box  20 . After sealing the biohazard specimen bag  72  the user then places it into the foam insert  42  of styrofoam box  20  next to the ice brick  70  for keeping the semen specimen  12  cooled in order to prevent the deterioration of the semen count or motility. The kit  10  is then closed tightly using the top cover member  22 , such that the interior lap-joint edging  28  of the top cover member  22  is matched and joined with the perimeter lap-joint edging  40  of the retaining member  32  of styrofoam box  20 . Kit  10  is then inserted into the interior compartment  92  of the return shipping container  90  and the side cover  94  is then closed to seal the kit  10  within the return shipping container  90 , as shown in FIG. 5 of the drawings.  
         [0043]    As shown in the fifth step  250 , the user simply follows the shipping instructions sheet  88  sent with the kit  10 . The specimen sample  12  must be shipped using an overnite delivery service  252 , such as Airborne Express or Federal Express, etc., using the air bill of laden  110  provided by the overnite delivery service  252 . The overnite delivery service  252  has already been pre-paid for by the diagnostic lab  254  to ensure the most reliable service. The user calls the overnite delivery service  252  to arrange for a pick-up at the user&#39;s home location  216 , Monday through Thursday only, shipments are not to be made on Fridays Saturdays or Sundays. The user then places the entire kit  10  and shipping container  90  inside interior compartment  106  of the overnite express lab pack envelope  100  and follows the mailing instructions as provided on the rear wall  104  of the lab pack envelope  108 . The user then puts his address on the pre-printed airbill manifest  110 , and places the airbill manifest  110  on the front wall  102  of the lab pack envelope  108 , where then the user seals the envelope  108  via the sealant top member  108 . The user is now ready to call the overnite delivery service  252  for his semen sample/kit  10  pick-up.  
         [0044]    As shown in the sixth step  260  of FIG. 1, the semen sample  12  from the user/patient is analyzed by a computer assisted semen analyzer (CASA)  262  at the medical infertility diagnostic laboratory  254 . A special microscope reads the semen sample  12  by time-exposure photomicrography and then the results are generated on the computer. This state of the art technology allows each semen specimen  12  to be read exactly in the same manner, eliminating human error or variation in reading the analysis  272  by different lab technicians. The analysis report  272  includes the standard details that any physician would want to know. These include the volume, sperm concentration per milliliter (sperm count) and motility. An accompanying explanation of the meaning of the results will be on the report. This will be sufficient to bring to any health professional for further evaluation and diagnosis. Definitions on the above include: Concentration—normal is over 20 million per milliliter. Motility—at least 50% should be motile. Volume—there should be 2-5 milliliters or cc&#39;s of fluid.  
         [0045]    As shown in the seventh step  270  of FIG. 1, a confidential analysis report statement  272  is generated via the semen analyzer  262 , and this analysis report statement  272  is then reported and transmitted to the patient setting forth the analysis  272  of the patient&#39;s semen sample  12 . The results are then mailed to the user by first-class mail from the U.S. Post Office within 48 hours of receipt of the semen specimen  12  by the lab  252 . The report statement  272  includes information as stated in the previous sixth step  260 .  
         [0046]    As depicted in the eighth step  280 , the user receives the lab analysis report  272  by the United States Postal Service within a few days after the receipt of the semen specimen  12 . The user then calls the lab  254  for free consultation to review results of the lab analysis report  272 .  
         [0047]    The final ninth step  290 , as shown in FIG. 1 of the drawings, the medical infertility diagnostic laboratory  254  establishes a referral system  292  with the patient for further problems, questions or needs with respect to infertility or other reproductive information needed by the patient.  
       ADVANTAGE OF THE PRESENT INVENTION  
       [0048]    Accordingly, an advantage of the present invention is that it provides for an at-home semen collection and analysis kit that gives the user an easy way in which to have access to a medical infertility laboratory without the user actually having to go to the laboratory in person.  
         [0049]    Another advantage of the present invention is that it provides for an at-home semen collection and analysis kit that includes the necessary collection equipment, the preservative chemicals, an overnite return mailer and box, and instructions for the self-sampling of the user&#39;s semen at the privacy of the user&#39;s home, whereby the user will receive his confidential report by mail within 48 hours of the semen sample being analyzed at the infertility medical laboratory.  
         [0050]    Another advantage of the present invention is that it provides for an at-home semen collection and analysis kit, such that the user is not examined in a cold and impersonal medical facility, as well as having the mental anguish of sharing the user&#39;s most intimate medical information of his problems with an unknown medical staff.  
         [0051]    Another advantage of the present invention is that it provides for an at-home semen collection and analysis kit that is easy to use, durable in construction, and having simple packing instructions for shipment to the medical infertility laboratory.  
         [0052]    Another advantage of the present invention is that it provides for an at-home semen collection and analysis kit that maintains the integrity of the semen sample taken by the user prior to its analysis at the medical infertility laboratory, such that the sperm is in a viable state for proper analysis.  
         [0053]    Another advantage of the present invention is that it provides for an at-home semen collection and analysis kit that enables the economic transport of human semen, in a disposable, totally self-contained, passively cooled, inexpensive container that has essentially no moving parts, and that is not equipped with thermostatically controlled cooling arrangements or the like, for periods of time approximating at least 24 to 48 hours.  
         [0054]    A further advantage of the present invention is that it provides for an at-home semen collection and analysis kit that can be mass produced in an automated and economical manner and is readily affordable by the user.  
         [0055]    A latitude of modification, change, and substitution is intended in the foregoing disclosure, and in some instances, some features of the invention will be employed without corresponding use of other features. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the spirit and scope of the invention herein.