Semen sample collection kits and devices

Abstract

A support 1 for holding a semen sample collection receptacle such as a condom 17 or sheath comprises a flexible, four-sided flat planar support structure 2 such as cardboard, two opposite edges 5,6 of

Description

FIELD The present invention relates to semen sample collection kits and devices. The present invention more particularly relates to a device for supporting a condom containing a semen sample. BACKGROUND Semen analysis is the cornerstone of the laboratory evaluation of male fertility, providing essential information on sperm count, semen volume, sperm concentration, motility, and morphology. Abnormalities in one or more of these parameters are associated with male factor infertility. The current gold standard is that semen specimens are collected in a sterile sample cup at an in-person clinic or, if collected at home, should be examined by the clinic within one hour of production. Although obtaining a semen sample is relatively straightforward in theory, an unknown but likely considerable number of people experience significant barriers to obtaining fertility testing. Amongst the myriad of personal reasons that make semen analysis challenging or prohibitive, people may find the collection process in a clinic to be stressful, or the conditions make it difficult to become aroused. For religious or medical reasons, it is also not possible for some people to collect a sample via masturbation into a collection cup. Mail-in semen testing utilises so-called ‘delayed testing’ techniques and is emerging as a new, alternative option to the in-person clinic experience. Patients are typically sent a testing kit and produce a sperm sample at home in a sterile collection cup. The patient then mixes their sperm sample with a provided preservative fluid from a vial. The preservative fluid extends the longevity / viability of the semen sample for testing far beyond the standard one-hour window since production to enable the semen sample to be transported to a laboratory in the collection cup for semen analysis. Samples are usually still viable for testing between 24-72 hours after ejaculation, depending on the exact process and fluid used. To date, all existing testing companies provide a sterile collection cup as a semen sample collection receptacle. However, no existing testing company attempts to address the problems associated with the use of collection cups and semen sample collection that are described above. There is a need for semen sample collection kits and devices which seek to alleviate at least some of the problems described herein. BRIEF DESCRIPTION OF THE INVENTION The present invention provides a semen sample collection receptacle support device as claimed in claim 1 and a semen sample collection kit as claimed in claim 14. The present invention also provides preferred embodiments as claimed in the dependent claims. BRIEF DESCRIPTION OF THE FIGURES In order that the present disclosure maybe more readily understood, preferable embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, in which: Figure 1 is a schematic diagram of a device of an example of this disclosure, with the device in a planar configuration, Figure 2 is a perspective view of the device of figure 1 in a support configuration, Figure 3 is a perspective view showing a condom being inserted into the device of figure 2, Figure 4 is a perspective view showing a condom supported by the device of figure 2, Figure 5 is a perspective view corresponding to figure 4 showing a preservative liquid being added to the condom, Figure 6 is a view corresponding to figure 4 showing the condom being removed from the device, Figure 7 is a diagrammatic view of a flexible support structure of another example of this disclosure in a planar configuration, and Figure 8 is a diagrammatic view of packaging of a kit of an example of this disclosure. DETAILED DESCRIPTION OF THE DISCLOSURE Using a semen sample collection receptacle, such as a condom, will give many people a more comfortable and preferable option for collecting their semen sample at home. Unlike when using a collection cup, wearing a non-spermicidal condom means the user can achieve ejaculation via penetrative sex with a partner as well as via masturbation. There is also a higher likelihood that all the semen (ejaculate) will be captured within the condom versus into a collection cup. Consequently, using a semen sample collection receptacle, such as a condom, with devices and kits of some examples of this disclosure maximises the volume of semen collected, which increases the accuracy of semen analysis compared with a potentially lower volume of semen that is typically collected using a collection cup. The devices and kits of some examples of this disclosure use a condom or another type of flexible bag, container or sheath as a semen sample collection receptacle and thereby provide a convenient solution for patients to collect a semen sample at home. This also provides a practical solution for use within the scientific requirements of mail-in semen analysis processes. Referring initially to figure 1 of the accompanying drawings, a semen sample collection receptacle support device 1 comprises a flexible support structure 2. In this and other examples, the flexible support structure 2 is a planar or substantially planar flexible sheet. In some examples, the flexible support structure is of cardboard. In other examples, the flexible support structure comprises at least one aperture (not shown), each of which may be open or at least partly closed by a respective transparent element. In further examples, the flexible support structure is at least partly of plastic. The flexible support structure 2 is provided initially in a flat or planar configuration, as shown in figure 1. The flexible support structure 2 is configured to be deformed manually by a user to enable the user to change the shape of the flexible support structure from the planar configuration to a support configuration. The flexible support structure 2 comprises a first edge 3 and a second edge 4 that are spaced apart from one another. In this example, the first edge 3 and the second edge 4 are arcuate and the length of the second edge 4 is greater than the length of the first edge 3. The flexible support structure 2 comprises a first end 5 and a second end 6 that are spaced apart from one another. The first edge 3 and the second edge 4 each extend between the first end 5 and the second end 6. Referring now to figure 2 of the accompanying drawings, the flexible support structure 2 is configured to be deformed into a support configuration, as shown in figure 2, in which part of the first end 5 is proximate part of the second end 6. This deformation of the flexible support structure 2 transforms the device from a planar or substantially planar configuration to a three-dimensional support configuration. When the flexible support structure 2 is in the support configuration, the first edge 3 defines at least part of an edge 7 of an opening 8. The purpose of this opening 8 will be described in more detail below. Referring again to figure 1 of the accompanying drawings, the device 1 comprises an attachment arrangement to retain the flexible support structure 2 in the support configuration. In some examples, the attachment arrangement comprises at least one connector 9 provided at the first end 5 of the flexible support structure 2. In this example each connector 9 is an angular tab or protrusion which protrudes from the first end 5 of the flexible support structure 2. In this example, there are two connectors 9, but in other examples there may be only one connector or more than two connectors. In other examples, each connector 9 may be a differently shaped tab or portion, such as a rectangular. The attachment arrangement further comprises at least one slot 10 provided at the second end 6 of the flexible support structure 2. Each slot 10 is configured to receive and retain a respective connector 9 to retain the flexible support structure 2 in the support configuration. In this example, the plurality of connectors 9 are spaced apart from one another along part of the first end 5 of the flexible support structure 2. In this example, the plurality of slots 10 are spaced apart from one another along part of the second end 6 of the flexible support structure 2. In some examples, the attachment arrangement comprises at least one row 11 of slots 10 spaced apart from one another in a direction substantially away from the second end 6 of the flexible support structure 2. In this example, the attachment arrangement comprises a further row 12 of slots spaced apart from one another in a direction substantially away from the second end 6 of the flexible support structure 2. In these examples, each slot 10 of the row of slots 11, 12 is spaced from an adjacent slot 10 of the row of slots 10 by 1 -2 mm. In other examples, the attachment arrangement comprises a different attachment mechanism. For example, in some examples, the attachment arrangement comprises a hook and loop (e.g. Velcro™) attachment, or an interference fit attachment. The flexible support structure 2 is configured to be deformed by a user into a frustoconical or substantially frustoconical shape, as shown in figure 2. The user attaches the first end 5 to the second end 6 releasably by inserting the connectors 9 into corresponding slots 10 to retain the device in the support configuration. The rows 11,12 of slots 10 enable a user to select the distance over which the first end 5 overlaps the second end 6. The selected overlap also determines the diameter of the opening 8. A user can therefore configure the device 1 so that the opening 8 has a diameter that is appropriate forthe user’s requirements. In some examples, when the flexible support structure 2 is in the support configuration, the opening 8 has a diameter of 20-75 mm. In other examples, the device 1 is configured to provide an opening 8 having a diameter of 32-36 mm. In further examples, the device 1 is configured to provide an opening 8 having a diameter of 20-69 mm or 45-69 mm. In this example, the opening 8 is circular but in other examples the opening 8 is a different shape, for instance oval, or a straight-sided shape, such as square, rectangular, or quadrilateral. In each of these examples, the largest dimension of the opening 8 is within the diameter range described above. When the flexible support structure 2 is in the support configuration, as shown in figure 2, the second edge 4 defines at least part of an edge 13 of a further opening 14. In some examples, the further opening 14 has a diameter that is greater than the diameter of the opening 8 and the flexible support structure 2 is a substantially frustoconical shape when in the support configuration. The edge 13 of the further opening 14 rests on a surface when the flexible support structure 2 is being carried by the surface. The enlarged lower end and frustoconical shape provides stability to the device 1 when in use, as described below. In some examples, the flexible support structure 2 is provided with at least one weight element that is positioned at or proximate the second edge 4 to increase the weight of the device 1 in the vicinity of the edge 13 of the further opening 14. The increased weight lowers the centre of gravity and further stabilises the device 1 when the device 1 is resting on the edge 13. In some examples, each weight element is a separate element that is attached to the flexible support structure 2. In other examples, each weight element is a portion of the flexible support structure 2 having increased thickness, such as an enlarged lip, along at least part of the second edge 4 of the flexible support structure 2. In other examples, the device 1 has a different shape to frustoconical when the device 1 is in the support configuration. In other examples, the flexible support structure 2 may be deformed into any shape to provide a support structure having an opening with a diameter of 20-75 mm or preferably 32-36 mm. Referring now to figures 3 and 4 of the accompanying drawings, in use, a user assembles the device 1 by deforming the flexible support structure 2 into the support configuration as described above. The user 15 then produces a semen sample 16 in a semen sample collection receptacle in the form of a condom 17. For simplicity, the description below will refer to the semen sample collection receptacle as a condom. The diameter of the opening 8 can be easily adjusted to the size and circumference of standard condoms, for example smallest to largest standard widths ranging from 30-69 mm, and covering an average width of 52-54 mm. The adjustable nature of the device 1 enables a user to adjust and secure a selected size for the opening 8 and this minimises the possibility of the user accidentally dropping their used condom through an opening that is too large. The user 15 then inserts the condom 17 containing the semen sample 16 through the opening 8, as indicated generally by the arrow 18 in figure 3. The flexible support structure 2 supports the condom 17 by carrying a first portion 19 of the condom 17 on the edge 7 of the opening 8 when a second portion 20 of the condom 17 extends through the opening 8. When the condom 17 is supported by the device 1, the opening in the first portion 19 of the condom 17 is held open by the edge 7 of the opening 8 in the device 1 while the second portion 20 of the condom 17 hangs down within the device 1. In this examples, the cone-based shape helps to distribute the weight of the condom, semen sample and additive / preservative liquid evenly, making it unlikely to cause the sides of the device 1 to give way or destabilise. The angles and stability provided by the base of the cone-shaped device 1 are such that even a hit or accidental knock to the device 1 by a user would likely prevent the condom 17 from slipping off the device 1 or causing the device 1 and condom 17 to fall over. The shape also helps to ensure that the device 1 does not move around when it is being used. In examples where the flexible support structure 2 comprises at least one aperture, the user 15 is able to view the second portion 20 of the condom 17 through each aperture when the condom 17 is supported by the device 1. In examples where the at least one aperture is open, the user 15 is able to access the second portion 20 of the condom 17 through each aperture when the condom 17 is supported by the device 1. In some examples, the flexible support structure 2 is provided with notches, indents or protrusions proximate the first edge 3 to help secure and stabilise the condom 17 around the opening 8. In further examples, an elastic / rubber band or clip may be used to secure the condom 17 to the sides of the opening 8. Referring now to figure 5 of the accompanying drawings, while the condom 17 is supported by the device 1, the condom 17 is held in a stable and secure manner by the device 1 so that the user 15 can pour an additive liquid 21, such as a preservative, from a container 22 into the condom 17. The user 15 can therefore add a preservative liquid (e.g. approximately 10 ml) easily with minimal risk of spillage. Once the preservative liquid has been added to the condom 17 the preservative liquid mixes with the semen sample to preserve the semen sample for many hours to allow for storage and transport prior to testing. The device 1 of some examples has an advantage over conventional solutions since the device 1 ensures that the user does not have to awkwardly hold a used condom in their hand(s) whilst attempting to add anything to it simultaneously. Adding anything, especially a vial of liquid, to a used condom is difficult. It would be particularly challenging for patients to do in an at-home setting without some assistance. The device 1 of examples of this disclosure helps to make the process as easy as possible for users to add the preservative fluid to the used condom on their own. The device 1 minimises possible spillage and makes the action quicker, more likely to be successful and less cumbersome to complete than it would otherwise be without using the device 1. Referring now to figure 6 of the accompanying drawings, afterthe preservative liquid or other additive liquid has been added to the condom 17, the user lifts the condom 17 out through the opening 8, as indicated generally by arrow 23 in figure 6. The user 15 then seals the opening in the condom 17 using a clip or other clamping device or by tying a knot in the condom. Once sealed, the condom 17 may be placed into a leak-proof bag for transportation. The condom 17 can then be sent, for instance by mail, to a laboratory for semen analysis. The use of the condom maximises the amount of semen that is collected and retained for analysis. The total volume of sperm produced by a user is critical to know as a semen analysis metric, and the use of the condom 17 and the device 1 ensures that the ejaculate can be entirely contained. In some examples, a user adds other preservative liquid to the semen sample in the condom 17 to preserve the semen sample for cryogenic freezing. In some examples, a kit comprises a preservative liquid for use when cryogenic freezing a semen sample. Referring now to figure 7 of the accompanying drawings, while the flexible support structure 2 of the examples described above has a frustoconical or substantially frustoconical shape when in the support configuration, in other examples, the flexible support structure has a different shape when in the support configuration. In another example, the flexible support structure 2 is rectangular or substantially rectangular and the first edge 3 and the second edge 4 are straight instead of arcuate. In this example, when the flexible support structure 2 is deformed and the first end 5 is attached to the second end 6, the device 1 has a cylindrical or generally cylindrical shape. However, it is to be appreciated that the opening 8 defined by the flexible support structure 2 in this example has a diameter that is within the same range as the opening 8 of the examples described above. In this example the attachment arrangement comprises only one connector 9 and one slot 10. However, it is to be appreciated that in other examples, the device 1 may comprise a greater number of connectors 9 and / or slots 10. In further examples of this disclosure, a semen sample collection kit is provided which incorporates the device 1 described above and a condom 17. The kit is provided to a user, potentially also with a container containing a preservative fluid or other additive, and a clip so that a user can produce a semen sample at home easily. Referring to figure 8 of the accompanying drawings, in some examples, the kit comprises packaging 24 which, in this example, is in the form of a rectangular box. The packaging 24 contains the condom 17 and the device 1 when the device 1 is in a substantially planar configuration. The device 1 is therefore designed to be flat-pack to be delivered in the packaging 24 by mail and assembled by the user. In some examples, the packaging 24 has a width W that is less than 254 mm and a height H that is less than 38 mm to enable the package to be delivered through a standard United Kingdom letterbox. A user can therefore receive the kit through the mail, produce the semen sample at home and return the semen sample in the packaging 24 by mail to a laboratory for semen analysis. When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components. The invention may also broadly consist in the parts, elements, steps, examples and / or features referred to or indicated in the specification individually or collectively in any and all combinations of two or more said parts, elements, steps, examples and / or features. In particular, one or more features in any of the embodiments described herein may be combined with one or more features from any other embodiment(s) described herein. Protection may be sought for any features disclosed in any one or more published documents referenced herein in combination with the present disclosure. Although certain example embodiments of the invention have been described, the scope of the appended claims is not intended to be limited solely to these embodiments. The claims are to be construed literally, purposively, and / or to encompass equivalents. REPRESENTATIVE FEATURES Representative features are set out in the following clauses, which stand alone or may be combined, in any combination, with one or more features disclosed in the text and / or drawings of the specification. 1. A semen sample collection receptacle support device comprising: a flexible support structure comprising: a first edge and a second edge that are spaced apart from one another, and a first end and a second end that are spaced apart from one another, wherein the first edge and the second edge each extend between the first end and the second end, and wherein the flexible support structure is configured to be deformed into a support configuration in which part of the first end is proximate part of the second end and the first edge defines at least part of an edge of an opening, wherein the device comprises: an attachment arrangement configured to retain the flexible support structure in the support configuration so that the flexible support structure can support a semen sample collection receptacle by carrying a first portion of the semen sample collection receptacle on the edge of the opening when a second portion the semen sample collection receptacle extends through the opening. 2. The device of clause 1, wherein the attachment arrangement comprises at least one connector provided at the first end of the flexible support structure, and at least one slot provided at the second end of the flexible support structure, wherein each slot is configured to receive and retain a respective connector to retain the flexible support structure in the support configuration. 3. The device of clause 2, wherein the attachment arrangement comprises a plurality of connectors spaced apart from one another along part of the first end of the flexible support structure, and a plurality of slots spaced apart from one another along part of the second end of the flexible support structure. 4. The device of clause 2 or clause 3, wherein the attachment arrangement comprises at least one row of slots spaced apart from one another in a direction substantially away from the second end of the flexible support structure. 5. The device of clause 4, wherein each slot of the row of slots is spaced from an adjacent slot of the row of slots by 1-2 mm. 6. The device of any one of the preceding clauses, wherein when the flexible support structure is in a substantially planar configuration, the first edge and the second edge are arcuate and the length of the second edge is greater than the length of the first edge. 7. The device of any one of the preceding clauses, wherein when the flexible support structure is in the support configuration the opening has a diameter of 20-75 mm. 8. The device of any one of the preceding clauses, wherein when the flexible support structure is in the support configuration the second edge defines at least part of an edge of a further opening, wherein the edge of the further opening rests on a surface when the flexible support structure is being carried by the surface. 9. The device of clause 8 as dependent on clause 7, wherein the further opening has a diameter that is greater than the diameter of the opening and the flexible support structure is a substantially frustoconical shape when the flexible support structure is in the support configuration. 10. The device of any one of the preceding clauses, wherein flexible support structure is of cardboard. 11. The device of any one of the preceding clauses, wherein flexible support structure comprises an aperture to allow a user to view the second portion the semen sample collection receptacle when the semen sample collection receptacle is being supported by the device. 12. The device of any one of the preceding clauses, wherein the flexible support structure is provided with at least one weight element that is positioned at or proximate the second edge. 13. The device of clause 12, wherein the at least one weight element is a portion of the flexible support structure having increased thickness 14. A semen sample collection kit comprising: the device of any one of the preceding clauses; and a semen sample collection receptacle, wherein the semen sample collection receptacle is a condom. 15. The kit of clause 14, wherein the kit comprises: packaging containing the condom and the device when the device is in a substantially planar configuration, the packaging having a width that is less than 254 mm and a height that is less than 38 mm. 16. The kit of clause 14 or clause 15, wherein the kit comprises: a container containing a preservative fluid which, when mixed with a semen sample, extends the longevity of the semen sample fortesting.

Claims

1. A semen sample collection receptacle support device comprising:a flexible support structure comprising:a first edge and a second edge that are spaced apart from one another, anda first end and a second end that are spaced apart from one another, wherein the first edge and the second edge each extend between the first end and the second end, and wherein the flexible support structure is configured to be deformed into a support configuration in which part of the first end is proximate part of the second end and the first edge defines at least part of an edge of an opening, wherein the device comprises:an attachment arrangement configured to retain the flexible support structure in the support configuration so that the flexible support structure can support a semen sample collection receptacle by carrying a first portion of the semen sample collection receptacle on the edge of the opening when a second portion the semen sample collection receptacle extends through the opening.

2. The device of claim 1, wherein the attachment arrangement comprises at least one connector provided at the first end of the flexible support structure, and at least one slot provided at the second end of the flexible support structure, wherein each slot is configured to receive and retain a respective connector to retain the flexible support structure in the support configuration.

3. The device of claim 2, wherein the attachment arrangement comprises a plurality of connectors spaced apart from one another along part of the first end of the flexible support structure, and a plurality of slots spaced apart from one another along part of the second end of the flexible support structure.

4. The device of claim 2 or claim 3, wherein the attachment arrangement comprises at least one row of slots spaced apart from one another in a direction substantially away from the second end of the flexible support structure.

5. The device of claim 4, wherein each slot of the row of slots is spaced from an adjacent slot of the row of slots by 1-2 mm.

6. The device of any one of the preceding claims, wherein when the flexible support structure is in a substantially planar configuration, the first edge and the second edge are arcuate and the length of the second edge is greater than the length of the first edge.

7. The device of any one of the preceding claims, wherein when the flexible support structure is in the support configuration the opening has a diameter of 20-75 mm.

8. The device of any one of the preceding claims, wherein when the flexible support structure is in the support configuration the second edge defines at least part of an edge of a further opening, wherein the edge of the further opening rests on a surface when the flexible support structure is being carried by the surface.

9. The device of claim 8 as dependent on claim 7, wherein the further opening has a diameter that is greater than the diameter of the opening and the flexible support structure is a substantially frustoconical shape when the flexible support structure is in the support configuration.

10. The device of any one of the preceding claims, wherein flexible support structure is of cardboard.

11. The device of any one of the preceding claims, wherein flexible support structure comprises an aperture to allow a user to view the second portion the semen sample collection receptacle when the semen sample collection receptacle is being supported by the device.

12. The device of any one of the preceding claims, wherein the flexible support structure is provided with at least one weight element that is positioned at or proximate the second edge.

13. The device of claim 12, wherein the at least one weight element is a portion of the flexible support structure having increased thickness14. A semen sample collection kit comprising:the device of any one of the preceding claims; anda semen sample collection receptacle, wherein the semen sample collection receptacle is a condom.

15. The kit of claim 14, wherein the kit comprises:packaging containing the condom and the device when the device is in a substantially planar configuration, the packaging having a width that is less than 254 mm and a height that is less than 38 mm.

16. The kit of claim 14 or claim 15, wherein the kit comprises:a container containing a preservative fluid which, when mixed with a semen sample, extends the longevity of the semen sample fortesting.13

Images