Abstract:
Biological fluid collection. At least some of the illustrative embodiments are systems including a sleeve of elastomeric material and a receptacle coupled to the sleeve. The sleeve may include: first and second ends, each end comprising respectively a first and a second orifice; and a passage extending between the first and second orifices. The receptacle may include: a side wall and a bottom that define an interior volume and a height; and an entrance portion that defines an internal diameter, wherein the height of receptacle is at least half the internal diameter. The receptacle may mechanically couple to the sleeve such that the interior volume is fluidly coupled to the passage of the sleeve.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims the benefit of U.S. Provisional Patent Application No. 61/612,347 filed Mar. 18, 2012 by Steven A. Shubin Sr., titled “Biological Fluid Collection System,” which is incorporated herein by reference as if reproduced in its entirety. 
     
    
     BACKGROUND 
       [0002]    A variety of biological fluid collection devices and systems have been developed to assist with or otherwise aid in the production and collection of biological fluids. Included are systems and devices that aid in the stimulation and therefore production of seminal fluid such as masturbation sleeves and other such systems. Examples of such devices are disclosed in: U.S. Pat. No. 5,782,818, issued Jul. 21, 1998, titled “Device for Discreet Sperm Collection”; U.S. Pat. No. 5,806,523, issued Sep. 15, 1998, titled “Prophylactic and Prosthetic Device”; U.S. Pat. No. 5,807,360, issued Sep. 15, 1998, titled “Device for Discreet Sperm Collection”; and U.S. Pat. No. 5,466,235, issued Nov. 14, 1995, titled “Female Functional Mannequin”; all to Steven A. Shubin, Sr. and all of which are incorporated herein by reference in their entirety. 
         [0003]    The collection of seminal fluid, whether in humans or animals, can be problematic and difficult. Whether, as is the case with human males collection can be an embarrassing and awkward experience, or as can be the case with male animals, collection can be problematic when attempting to obtain the sample. Further, and in the cases of large animals such as horses and the like, the collection can be dangerous due to the size, unpredictability, and un-cooperation of the animal. 
         [0004]    With respect to humans, the procedure is still quite archaic and comprises the individual masturbating into a specimen receptacle, which can lead to discomfort. That is, the erect male penis is generally upwardly oriented, while the collection device must be held or situated lower or downwardly thereto. As such, the donor must force the erect penis downwardly in order for the ejaculate to be received in the specimen container. Forcing the erect penis downwardly not only can be difficult and uncomfortable, but in some cases can also be painful. Further, conflict between the position of the specimen container with respect to the erect penis can then lead to loss of ejaculate and/or inadvertent loss of more sperm rich ejaculate due to improper timing of the onset and/or ejaculation of the male. Whether due to discomfort that may occur during use or the difficulty in the simultaneous angulation and alignment of the specimen container and the penis, improvements are desired. 
         [0005]    Yet further, the specimen containers that are used in today&#39;s facilities are designed for utilitarian purposes rather than comfort. For example, the specimen container itself functions strictly as a receptacle and offers nothing in the way of comfort, ease of use, or other assistance to and/or for the donor. Still further, the size, shape, rough edges and screw threads of today&#39;s specimen containers can actually cause the donor discomfort and even pain if contact with the genitalia is made. 
         [0006]    Yet further, the collection of seminal fluid in animals is also problematic and difficult. For these specimens, collection can pose physical dangers to personnel engaged in the collection. As such, devices, systems, and methods that reduce the unpredictability and increase the cooperation of the animal are desired. Further, as the acquired semen specimens are not only used in the diagnoses and treatment of the animal, but may also be sold to breeders and the like, such specimens can be profitable and thus, the owners of these animals seek to have the specimen fully captured with the least amount of waste. 
         [0007]    Moreover, doctors say prostate health may benefit from the stimulation of the production of seminal fluid and thus systems that facilitate the process while mitigating the disadvantages previously described are desired. Recent studies have found that prostate health in human males may be related to frequency of ejaculation. In particular, infrequent ejaculation can lead to swelling of the prostate, known as congestive prostatitis, and may also increase the cancer risk in human males. Some medical sources suggest an ejaculation frequency of three to four times per week to ensure good prostate health. One study found a 14% lower lifetime prostate cancer rate for men who ejaculate between 13 and 20 times per month, and a upwards of 33% lower lifetime prostate cancer risk for men who ejaculate 21 times or more each month. Devices for stimulation and collection of seminal fluids may aid achieving higher ejaculations rates among men, particularly the unmarried and long-married. 
         [0008]    Beyond assisting with respect to prostate health effects of ejaculation, devices for stimulation and collection of seminal fluids through ejaculation may also assist in reversing desensitization issues. That is, repeated masturbatory stimulation of the penis using the hand or rough cloth can lead to desensitization of the penis, particularly in the absence of lubrication in some form. Desensitization can then result in erectile dysfunction during copulation. Use of properly lubricated devices designed specifically for the stimulation and collection of seminal fluid may help reverse the desensitization issues, and thus reduce the occurrence of erective dysfunction related to the desensitization issue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    For a detailed description of exemplary embodiments, reference will now be made to the accompanying drawings in which: 
           [0010]      FIG. 1  is a disassembled exploded perspective view of an embodiment of the system of the disclosure; 
           [0011]      FIG. 2  is a disassembled exploded perspective view of another embodiment of the system of the disclosure; 
           [0012]      FIG. 3  is a side sectional view of an assembled embodiment of the system of  FIG. 1 ; 
           [0013]      FIG. 4  is a side view of an angled receptacle according to one embodiment of the disclosure; 
           [0014]      FIGS. 5A and 5B  illustrate multiple views of an adapter according to one embodiment of the disclosure; 
           [0015]      FIG. 6A  illustrates a perspective view of an adapter according to one embodiment of the disclosure; 
           [0016]      FIG. 6B  illustrates a perspective view of an adapter according to one embodiment of the disclosure; 
           [0017]      FIG. 6C  illustrates a perspective view of an adapter according to one embodiment of the disclosure; 
           [0018]      FIG. 6D  illustrates a perspective view of an adapter according to one embodiment of the disclosure; 
           [0019]      FIG. 6E  illustrates a perspective view of an adapter according to one embodiment of the disclosure; 
           [0020]      FIG. 7A  illustrates a disassembled exploded perspective view of the system of  FIG. 2 ; 
           [0021]      FIG. 7B  illustrates a disassembled exploded perspective view of the system of  FIG. 2 ; and 
           [0022]      FIGS. 8A and 8B  illustrate a flowchart of a method in accordance with an embodiment of the disclosure. 
       
    
    
     NOTATION AND NOMENCLATURE 
       [0023]    Certain terms are used throughout the following description and claims to refer to particular system components. As one skilled in the art will appreciate, different companies may refer to a component by different names. This document does not intend to distinguish between components that differ in name but not function. 
         [0024]    In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . .” Also, the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection or through an indirect connection via other devices and connections. Further such connection may be a communicative connection, including but not limited to fluid or other mechanical communication, signal communication or the like, and may, but need not mean physically attached so as to form a single unit when so coupled. 
         [0025]    Where specific dimensional and material specifications have been included or omitted from the specification or the claims, or both, it is to be understood that the same are not to be incorporated into the claims, unless so claimed. 
         [0026]    For purposes of description herein, the terms “upper”, “lower”, “above”, “below”, “right”, “left”, “rear”, “front”, “vertical”, “horizontal”, and derivatives thereof, shall relate to the orientation of the device as shown in  FIG. 3 . 
         [0027]    The same reference numerals may be used throughout the drawings to refer to the same or like parts. Further like features between the various embodiments may utilize similar numerical designations. Where appropriate, the corresponding alphabetic designator has been changed. Further, the dimensions illustrated in the drawings (if provided) are included for purposes of example only and are not intended to limit the scope of the present invention. 
         [0028]    “Fluid” is used and defined in a broad, general, and ordinary sense, and the terminology is meant to apply to, inter alia, urine, seminal, and other biological fluids. 
         [0029]    Further, the purpose of the Abstract is to enable the United States Patent and Trademark Office, the public, and especially the scientists, engineers, and practitioners in the art who are not familiar with the patent or legal terms of phraseology, to learn quickly, from a cursory inspection, the nature of the technical disclosure of the application. Accordingly, the Abstract is intended to define neither the invention nor the application, which is only measured by the claims, nor is it intended to be limiting as to the scope of the claims in any manner. 
       DETAILED DESCRIPTION 
       [0030]    The following discussion is directed to various embodiments. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment. 
         [0031]    The various example embodiments discussed below were developed in the context of collection of human sperm and seminal fluids, and thus the discussion that follows is based on the developmental context; however, the embodiments disclosed herein are not meant to be limited to just collection of human sperm and seminal fluids (unless claimed as such), and the systems, devices, and methods disclosed herein may be utilized with any biological fluid (e.g., urine), as well as the collection of such fluids in non-human animals (e.g., horses). 
         [0032]    The collection of biological fluid from male animals can be problematic. In the case with human males, collection can be embarrassing and awkward. In the cases of large animals such as horses, the collection of specimens can pose physical dangers, and thus devices, systems, and methods that reduce the unpredictability and increase the cooperation of the animal are also desired. 
         [0033]    The disadvantages and drawbacks of the related-art are addressed, at least in part, through the example system  10  disclosed and described herein. Referring now to  FIG. 1 , there is shown a fluid collection system  10  which comprises a device  20  including a shell  22  and a sleeve  40 , an adapter  60  (which may be equivalently referred to as a connector or elbow), and a receptacle  80  (which may be equivalently referred to as a reservoir or vessel), along with caps  24  and  86  (which may be equivalently referred to as lids or covers). 
         [0034]    Device  20  may include shell  22  and sleeve  40 . As illustrated in  FIGS. 1 and 2 , shell  22  may comprise a single-piece ( FIG. 1 ) or multiple-piece ( FIG. 2 ) embodiment. The multiple-piece embodiment may be referred to as a “clam-shell” structure. The embodiment of  FIG. 2  is illustrated in the open configuration to display the interior features of the shell  22 . The multiple-piece embodiment in  FIG. 2 , when closed, may appear substantially the same as the single-piece embodiment of  FIG. 1  with respect to the exterior features thereof. Conversely, the interior features of the single-piece embodiment of  FIG. 1  may be substantially the same as the multiple-piece embodiment of  FIG. 2 . Shell  22  may form a first opening  32  and a second opening  34  with a central passage  33  and corresponding first and second ends  32 A and  34 A. Referring again to  FIG. 1 , in the embodiment illustrated, an outside surface of the shell  38  also includes features  39  to assist with gripping the shell. 
         [0035]    In at least some embodiments, shell  22  retains the sleeve. Further, the sleeve may be removably disposed within the shell or an integral part thereof. Yet further ( FIG. 2 ), shell  22  may be bifurcated into a first  112  and second  114  portion and hingedly  116  connected. The multiple-piece shell embodiment of system  10  will be further described on conjunction with  FIG. 7  below. 
         [0036]    Still referring to  FIGS. 1 and 2 , in at least some embodiments at least one of shell  22  and sleeve  40  is configured to retain the other such that the sleeve and the shell are constrained from substantially sliding longitudinally in either direction (i.e., reciprocatively) with respect to the other as along an axis x-x ( FIG. 2 ). For example, shell  22  may comprise one or more features which mateably connect, couple, or otherwise act to keep sleeve  40  from substantially longitudinally moving therein. In the illustrated embodiment in  FIG. 2 , a ring  36  is provided to be received within an annular groove  56  forming a recession in sleeve  40 , however other features, protrusions or similar devices may be used. When mateably received therein, the sleeve and the shell are substantially constrained from reciprocatively sliding longitudinally with respect to one another during use. 
         [0037]    Shell  22  may be designed and constructed to mate with removable covers or caps  24  and  86 . Cap  24  may be configured to threadably mate with end  32  of shell  22 . Other connections may be equivalently used, such as telescoping connections, as well as partial-turn positive locking systems. Cap  86  ( FIG. 1 ) may be designed and constructed to threadably mate with end  34  of shell  22 , as, for example, when system  10  is stored while not in use. Yet further, the shell may be configured in appearance in any manner, from and including sexually suggestive, to inconspicuous. 
         [0038]    In the illustrative examples of  FIG. 1  and  FIG. 2 , the shell  22 , adapter  60 , and receptacle  80  comprise mateable threads such that the adapter removably connects the shell  22  to the receptacle  80 . Other connecting fittings or fixtures may be used (e.g., a bayonet fitting), and such fixtures would fall within the spirit and scope of the present inventive principles. 
         [0039]      FIG. 3  shows a cross-sectional elevation view of the system  10 . In particular,  FIG. 3  shows an elongate, flexible, polymeric, and compressible sleeve  40  (e.g., an insert) comprising first end  42  and second end  44 . First end  42  defines a first orifice  48 , and second end  44  defines a second orifice  50 . Sleeve  40  defines an elongate channel  46  between the first orifice  48  and second orifice  50 . In the example system shown, the elongate channel  46  is defined along a central axis of the sleeve  40 , with central axis being perpendicular to planes defined by the outer-most features of the first and second orifices  48  and  50 . However, the elongate channel need not reside along the central axis of the sleeve  40 . 
         [0040]    In one embodiment, the passage  46  is sized so to accommodate the human penis. The first orifice  48  receives the penis, and the passage  46  sized (e.g., diameter) being smaller than the girth of the penis so as to contact, circumferentially, and stimulate the penis. Further, the sleeve or insert  40  may be formed from any suitable material which simulates human flesh (i.e., of the type forming sexually receptive orifices). For example, the sleeve  40  may be made of thermoplastic elastomer (TPE) gel, silicon, polyvinyl chloride (PVC), or elastomeric rubber, to name a few. Suitable elastomeric gels have been described in the above-referenced U.S. Pat. No. 5,782,818. Sleeve  40  may be removably placed inside chamber of the shell  22  upon removal of the cap  24 . In another embodiment, the passage  46  is sized so to accommodate a non-human penis (e.g., a horse, dog). 
         [0041]    As illustrated by  FIG. 3 , a receptacle  80  for holding, capturing, receiving and/or storing collected seminal or other fluid is coupled to adapter  60  (such as by a threaded connection), and the adapter  60  is coupled to the sleeve  40 . In the example system, the adapter couples to the sleeve  40  by way of shell  22 , but in other cases a shell  22  need not be used and thus the adapter  60  may couple directly to the sleeve  40 . The receptacle  80  defines an interior volume  83 , and when coupled as shown in  FIG. 3 , the passage  46  is fluidly coupled to the interior volume  83 . 
         [0042]    Adapter  60  in the illustrated embodiment forms an angle as measured from a first end  62  to a second end  64 . The adapter  60  may be angled (shown as a in  FIG. 3 ), from 100 degrees to 170 degrees in one embodiment, from 110 degrees to 160 degrees in another embodiment, and from 120 degrees to 150 degrees in a third embodiment. Thus, when receptacle  80  is coupled to device  20 , receptacle  80  is disposed at an angle to and extends below, or away from, a central axis of passage  46 . The angle α may be measured at any suitable location, such as in reference to a side of the adapter  60  as shown. In other cases, the angle α may be measured as the angle between a central axis formed by a first end of the adapter  60  (e.g., the end that couples to the shell  22 ) to a central axis formed by a second end (e.g., the end that couples to the receptacle  80 ). 
         [0043]      FIG. 4  shows a side elevation view of a receptacle  81  in accordance with another embodiment. In particular, receptacle  81  defines a first open end  82  and an interior volume  83 . In the example embodiment of  FIG. 4 , the adapter  60  may be omitted, and the receptacle  81  coupled to directly or indirectly to the sleeve  40 . Thus, in the embodiment of  FIG. 4 , the receptacle  81  itself defines a transition region  85  such that the receptacle is angled from the first end  82  to a second end  84 . The transition region  85  may be angled (shown as A in  FIG. 4 ) from 100 degrees to 170 degrees in one embodiment, from 110 degrees to 160 degrees in another embodiment, and from 120 degrees to 150 degrees in a third embodiment. In at least some embodiments, the angle, A, may be defined between a first central axis, 1-1″ perpendicular to a plane defined by the outermost feature of end  82  and a second central axis 2-2″ perpendicular to a plane defined by the outermost feature of end  84 . 
         [0044]    In example systems, the receptacle is further configured to removably accommodate a cap  87 . Cap  87  may include threads or other fittings suitable to mate with the threads or other fittings provided with receptacle  81  to mateably couple to shell  22 . In at least some embodiments of receptacle  81 , the threads (e.g., threads  89 ) or other fittings are disposed on an exterior surface of the adapter. Thus, cap  87 , when in place on receptacle  81  after use isolates interior volume  83  thereof and secures the contents against loss or contamination. Although cap  87  has been described in conjunction with receptacle  81 , cap  87  may equally be configured to removably mate with an embodiment in accordance with receptacle  80  wherein cap  87  includes threads or other fittings suitable to mate with the threads or other fittings provided with receptacle  80  to mateably couple to adapter  60 . 
         [0045]      FIGS. 5A and 5B  depict various perspective views of adapter  60  in accordance with example systems. In particular,  FIGS. 5A and 5B  show that in some embodiments, the adapter  60  defines a first end  62  which is configured to couple to the system  20 , such as by threads  63 . The adapter  60  further comprises a second end  64  which is configured to couple to a receptacle  80  (not shown in  FIGS. 5A and 5B ) such as by threads  65 . In some cases, the diameter of the aperture defined in the first end  62  is larger than the diameter of the aperture defined in the second end  64 , but in the other cases the relative size may be the same, or the aperture defined in the second end  64  may be larger. Again, threaded connections are examples, and other connection types may be used. 
         [0046]      FIGS. 6A-6E  shows various perspective views of adapter  60  in accordance with another example embodiment. In the embodiment depicted in  FIG. 6A-6E , adapter  60  may structurally be similar to the adapter of  FIGS. 5A and 5B , but may further comprise a vent in the form of an aperture  66  through a sidewall of the adapter  60 . The aperture  66  enables pressure equalization between an interior volume of the system  10  and atmospheric pressure. In order to prevent loss of bodily fluids, in most cases the aperture  66  is disposed on an upper surface  67  of the adapter; however, alternate configurations and locations for aperture  66  are also possible as long as the aperture provides for and enables for the release of entrained air. Further, a user can regulate the rate at which the pressure equalizes by obstructing or partially obstructing the aperture using, for example, a finger or thumb. In this way, a partial vacuum may be produced within system  10 , and the suction created thereby can aid in the expulsion of seminal fluid. Vacuum control may aid in the collection of a specimen from a patient whose ejaculation is weak, for example. Alternatively, in another embodiment, a plug (not shown) having a hole or aperture therein may be provided, wherein the plug may be inserted in vent  66 , and wherein the aperture is sized such that the flow of air between the interior volume of system  10  and the exterior is controlled to maintain the partial vacuum in the interior volume. In this way, the plug plays the role of the user&#39;s finger or thumb. Further, the plug may be provided with a snap fitting or fixture or similar structure to retain the plug in the vent during use of system  10 . 
         [0047]    In  FIG. 6A  the angled aspect of adapter  60  is shown in further detail. In at least some embodiments, the angle, α as described above in conjunction with  FIG. 3 , may be defined between a first central axis, 1-1″ perpendicular to a plane defined by the outermost feature of end  62  and a second central axis 2-2′ perpendicular to a plane defined by the outermost feature of end  64 . 
         [0048]      FIGS. 7A and 7B  show two exploded perspective views of the system  10  in accordance with example clam-shell embodiments. In particular, sleeve  40  is disposed within shell  22 , which shell  22  is comprised of two portions, portion  112  and portion  114  connected via hinge  116 . Adapter  60  removably couples receptacle  80  to shell  22  via threads  73 ,  63 ,  65  and  79 . The embodiment of adapter  60  shown in  FIG. 7  includes vent  66 . 
         [0049]      FIGS. 8A and 8B  illustrate a flowchart of a method in accordance with an embodiment of the disclosure. Referring first to  FIG. 8A , the method, collecting seminal fluid from a mammalian male, starts at block  800 . In block  802 , the mammalian male is stimulated to ejaculation. The seminal fluid is received within a passage of an elastomeric sleeve, block  804 . The elastomeric sleeve is oriented such that the seminal fluid is gravity fed to a receptacle, block  806 . In block  808 , the receptacle is removed from coupling with the elastomeric sleeve, and, in block  810  a cap is placed on the receptacle. The method ends at block  812 . 
         [0050]    Referring now to  FIG. 8B , illustrated therein is the method of block  802  in further detail. The mammalian male is stimulated in block  801 . During at least a portion of the stimulation, the interior volume of the receptacle is vented to atmospheric pressure, block  803 , such as through aperture  66 . However, during ejaculation, pressure within the interior volume is reduced, block  805 . Reduction of pressure (e.g., creating a pressure less than atmospheric pressure) may involve blocking the aperture  66  at the point the penis is inserted into the sleeve, and then partially retracting the penis from the sleeve while holding the aperture  66  in a blocked configuration. The increased volume defined between the penis and receptacle  80 , without the introduction of airflow in the aperture  66 , results in creation of pressure in the interior volume which is less than atmospheric. The lowered pressure may act to force greater seminal fluid flow, and greater sperm flow, (compared a vented system) than the situation where the seminal fluid is ejaculated to an atmospheric pressure receptacle  80 . 
         [0051]    In use, if not assembled, the system  10  is assembled by inserting the sleeve  40  into the shell  22 . Further, in embodiments having a clam-shell design, by assembling or closing the shell to form the openings  32  and  34  at respective ends  32 A and  34 A. The first end  62  of the adapter  60  can then be connected to the second end  34 A of the shell  22 ; and the second end  64  of the adapter  60  can be coupled to the first end  82  of the receptacle  80 . This configuration then enables the fluid communication from the first orifice  48  to the interior  83  of receptacle  80 . The penis is then inserted into the sleeve  40  and mechanically manipulated until ejaculation, wherein the specimen flows into and is collected in receptacle  80 . Receptacle  80  can then be detached from the adapter  60  and covered with the cap  87  for analysis, use, sale, and/or distribution. The system can then be cleaned and either a new or reused receptacle  80  can be used for repeated usage of system  10 . 
         [0052]    The above discussion is meant to be illustrative of the principles and various embodiments of the present invention. Numerous variations and modifications will become apparent to those skilled in the art once the above disclosure is fully appreciated. For example, end caps are not essential to the use of the system. It is intended that the following claims be interpreted to embrace all such variations and modifications.