Urination device

Abstract

Aspects of the present invention relate to an apparatus and method for channelling urine away from a body. In particular, but not exclusively, the present invention relates to a non-invasive device for channelling the flow of urine away from a vaginal urethral orifice of a user, reducing or preventing the contact of urine with vaginal or perineal wounds. Certain embodiments of the present invention may provide improved vaginal and perineal wound management and reduced pain during urination after gynaecological surgery, including during postpartum urination. Certain embodiments of the present invention allow for improved ease of collection of urine samples.

Description

[0001] URINATION DEVICE

[0002] Aspects of the present invention relate to an apparatus and method for channelling urine away from a body. In particular, but not exclusively, the present invention relates to a non-invasive device for channelling the flow of urine away from a vaginal urethral orifice of a user, reducing or preventing the contact of urine with vaginal or perineal wounds. Certain embodiments of the present invention may provide improved vaginal and perineal wound management and reduced pain during urination after gynaecological surgery, including during postpartum urination. Certain embodiments of the present invention allow for improved ease of collection of urine samples.

[0003] Childbirth related perineal trauma, damage to the skin and muscles of the perineum as a result of childbirth, occurs in 90% of vaginal births. Childbirth related perineal trauma occurs due spontaneous laceration or tearing to the perineum during childbirth, or due to medical procedures such as episiotomies. Perineal tears are classified by severity from first to fourth degree. Approximately 5% of primiparous women experience third or fourth degree tearing during childbirth. Third and fourth degree tearing involves laceration to the vaginal mucosa, perineal body and anal sphincter. Second to fourth degree perineal tears require stitches and can take at least 4 weeks to heal.

[0004] Childbirth related perineal trauma can make urination in the weeks post childbirth painful. A painful stinging sensation is caused when urine contacts a wounded area. Painful postnatal urination may result in deliberate dehydration and urine retention in patients, which can cause low milk production in breastfeeding mothers and bladder or kidney infections. Additionally, urine may contain infectious agents, therefore repeated contact of urine with an injury site can impede wound healing and increase risk of soft tissue infection.

[0005] There is a long unmet need for an accessible solution to reduce or prevent pain during urination in patients who have undergone gynaecological surgery. 130 million women give birth each year, therefore, a solution is particularly important for mothers who have experienced childbirth related perineal trauma. Current medical guidance for painful postpartum urination is to pour water over the vaginal area during and / or after urination, or to sit in water while urinating. This practice is unhygienic. While the urine is diluted by the water, it is not completely prevented from contacting the wounded area. Therefore, this practice does not prevent the risk of soft tissue infection. Additionally, this medical guidance is not practical or hygienic where clean running water is not available.

[0006] The medical guidance is also not realistic for urination outside the home, for example in public toilets. This can result in a lack of mobility and social isolation for new mothers. An alternative solution is required to prevent or reduce painful postpartum urination and to improve perineal wound management.

[0007] Individuals may also have perineal or vaginal wounds as a result of cosmetic procedures, cancer treatment, feminization or other gynaecological surgeries. Prevention of urine contacting wounds to avoid painful urination and reduce the chance of soft tissue infection is also required after such procedures.

[0008] Painful urination resulting from perineal or vaginal wounds can also make collection of urine samples for medical tests more difficult. Urine tests are generally part of postnatal medical checks. There is therefore a requirement for the provision of a device which reduces the difficulty of collection of urine samples in individuals who have childbirth related perineal trauma.

[0009] It is an aim of the present invention to at least partly mitigate one or more of the above-mentioned problems.

[0010] It is an aim of certain embodiments of the present invention to channel the flow of urine away from a vulval external urethral orifice, preventing or reducing contact of urine with the perineum and vulva.

[0011] It is an aim of certain embodiments of the present invention to provide apparatus for reducing or preventing the contact of urine with vaginal or perineal wounds such that said wounds are kept clean and dry.

[0012] It is an aim of certain embodiments of the present invention to provide apparatus for reducing or preventing pain during urination after gynaecological surgery, in particular during postpartum urination.

[0013] It is an aim of certain embodiments of the present invention to provide apparatus for reducing or preventing the risk of soft tissue infection after gynaecological surgery. It is an aim of certain embodiments of the present invention to provide apparatus for improved ease of urine sample collection.

[0014] It is an aim of certain embodiments of the present invention to provide a method for improved ease of urine sample collection.

[0015] Summary of the Invention

[0016] In a first aspect of the present invention, there is provided a urination device for directing a flow of fluid away from an orifice of a body of a user, the urination device comprising

[0017] a tubular component, wherein the tubular component further comprises

[0018] a first end portion, wherein the first end portion comprises a first opening configured to be locatable over the orifice;

[0019] a further end portion, wherein the further end portion comprises a further opening; and

[0020] an element for directing fluid flow, said fluid flow directing element being located on an internal surface of the tubular component and being configured to direct flow of fluid away from the orifice.

[0021] In certain embodiments, the fluid flow directing element comprises a first raised portion provided in a helical pattern on an internal surface of the tubular component.

[0022] In certain embodiments, the first and further openings each comprise a rim portion.

[0023] In certain embodiments, a first end of the raised portion is located adjacent to the rim portion of the first opening, and a further end of the raised portion is located adjacent to a rim portion of the further opening. In certain embodiments, between the first end of the raised portion and the further end of the raised portion, the helical pattern of the raised portion undergoes one revolution.

[0024] In certain embodiments, the first end of the raised portion further comprises a chamfer.

[0025] In certain embodiments, the tube has a longitudinal axis and the helix comprises a helix angle of between 5 and 50 degrees relative to the longitudinal axis of the tube. In certain embodiments, the helix comprises a helix angle of between 5 and 45 degrees relative to the longitudinal axis of the tube, e.g. 5 and 40 degrees, 5 to 35 degrees, 5 and 30 degrees, 5 and 25 degrees.

[0026] In certain embodiments, the raised portion is configured to promote a laminar flow of fluid through the tubular component.

[0027] In certain embodiments, the fluid flow directing element comprises a further raised portion provided in a helical pattern on an internal surface of the tubular component, wherein the raised portion and further raised portion are configured as a double helix.

[0028] In certain embodiments, a first end of the further raised portion is located adjacent to the rim of the first opening and disposed opposite the first end of the raised portion, and a further end of the further raised portion is located adjacent to the rim of the further opening disposed opposite the further end of the raised portion.

[0029] In certain embodiments, between the first end of the further raised portion and the further end of the further raised portion, the helix of the further raised portion undergoes one revolution.

[0030] In certain embodiments, the first end portion is slanted, optionally wherein the first end portion is slanted at an angle of between about 0 to 40 degrees e.g. about 0 to 30 degrees, about 5 to 35 degrees, about 10 to 30 degrees, e.g. about 30 degrees.

[0031] In certain embodiments, the first end portion is slanted at an angle of about 25-30 degrees. In certain embodiments, the first end portion is slanted at an angle of about 30 degrees.

[0032] In certain embodiments, the first end portion is not slanted.

[0033] In certain embodiments, the rim of the first opening comprises a rounded lip portion. Aptly, the rounded lip is configured to form a seal against the body of the user in use.

[0034] In certain embodiments, the tubular component further comprises one or more indents located on an external surface. Aptly, the one or more indents is configured to allow one or more fingers of the user to grip the device. In certain embodiments, the device comprises a sample collection chamber, wherein the sample collection chamber comprises a hollow container and an aperture sized to fit over the further end portion. Aptly, the sample collection chamber is configured to be releasably connectable to the further end portion such that the tubular component and sample collection chamber are fluidically connectable.

[0035] In certain embodiments, the further end portion comprises a connector element and the sample collection chamber comprises a corresponding connector element, wherein the connector element and corresponding connector element are releasably connectable.

[0036] In certain embodiments, the sample collection chamber further comprises a lid such that the sample collection chamber can be sealed.

[0037] In certain embodiments, the device in use is configured to be positioned in a generally vertical orientation.

[0038] In certain embodiments, the device in use is configured to be positioned at an angle of between about 10 and 40 degrees.

[0039] In a second aspect of the present invention, there is provided a method for collecting a sample, the method comprising:

[0040] a) assembling a urination device according to the first aspect of the present invention, wherein said assembling comprises attaching a further end portion of a tubular component of the urination device to a sample collection chamber;

[0041] b) locating a first opening of a first end portion of the tubular component over an orifice of a user such that a seal if formed between a rim of the opening and the body of the user around the orifice;

[0042] c) collecting fluid sample released from the orifice within the sample collection chamber;

[0043] d) removing the urination device away from the body of the user; and

[0044] e) detaching the further end portion from the sample collection chamber.

[0045] In certain embodiments, the method comprises, prior to step a) removing a lid from the sample collection chamber. In certain embodiments, the method comprises, after step e) closing the sample collection chamber using the lid.

[0046] Certain embodiments of the present invention provide a urination device for channelling the flow of urine away from a female external urethral orifice such that no or little urine contacts tissue surrounding the external urethral orifice e.g. the perineum or vulva.

[0047] Certain embodiments of the present invention provide a urination device comprising a fluid flow director.

[0048] Certain embodiments of the present invention provide a method for improving the ease of collection of a urine sample.

[0049] Embodiments of the present invention will now be described hereinafter, by way of example only, with reference to the accompanying drawings in which:

[0050] Figure 1 illustrates a tube portion of a urination device;

[0051] Figure 2A illustrates a side view of the tube portion of the urination device;

[0052] Figure 2B illustrates a cross section of the tube portion of the urination device;

[0053] Figure 3A illustrates an alternative side view of the tube portion of the urination device;

[0054] Figure 3B illustrates an alternative cross section of the tube portion of the urination device;

[0055] Figure 4 illustrates a view of a further opening of the tube portion of the urination device;

[0056] Figure 5 illustrates the tube potion and a sample bottle of the urination device; and

[0057] Figure 6 illustrates an alternative embodiment of the urination device.

[0058] In the drawings like reference numerals refer to like parts. Urination Device

[0059] Certain embodiments of the present invention provide a non-invasive urination device for channelling the flow of urine from a vulval external urethral orifice away from the body of a user. Aptly, the user is female. In certain embodiments the user may be a post-surgical transgender male. The term ‘non-invasive’ as used herein refers to a device which is not inserted into an internal body cavity. In particular, the device of certain embodiments is for channelling the flow of urine from a vulval external urethral orifice away from the body of a user such that there is no or minimal contact of urine with vaginal or perineal skin of a user. In certain embodiments, the device prevents urine exiting the external urethral orifice from contacting wounds in the perineal and / or vaginal area. Aptly the urination device comprises a hollow open-ended tube, wherein the tube is generally cylindrical. Aptly, the urination device has a consistent diameter along its length. Aptly, the tube comprises a substantially circular horizontal cross section. Aptly, the device comprises an element for directing fluid flow, wherein said fluid flow directing element is located on an internal surface of the tube. The fluid flow directing element can guide flow of urine along an inner surface of the tube, away from the body of the user such that urine has minimal or no contact with the vulva and perineum of the user.

[0060] In certain embodiments, the device comprises a first opening located at a first or proximal end of the tube. In certain embodiments, the device comprises a lip portion surrounding the first opening. Aptly, in use the first opening is positioned over the vulval external urethral orifice of the user such that the lip portion is located adjacent to and in contact with the skin of the user and encircles the vulval external urethral orifice. The device may be positioned such that the tube is located in a generally vertical position in use. Alternatively, the device may be positioned such that the tube is located at an angle relative to a vertical axis of a user e.g. 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees or 35 degrees with respect to the vertical axis of the user.

[0061] A further opening located at a further or distal end of the tube is located distally away from the body of the user, and, for example aimed toward the bowl of a toilet. Urine enters the tube through the first opening from the vulval external urethral orifice where it is channelled through the interior of the tube and out of the further opening, away from the body of the user, by the fluid flow director. The urine can therefore be efficiently channelled away from the body and has minimal or no contact with the skin of the vulva and perineum of the user. In certain embodiments of the present invention the fluid flow directing element comprises at least one raised portion located in a helical pattern on the internal surface of the tube. Aptly, the at least one raised portion forms a ridge that coils around the inner surface of the tube.

[0062] In certain embodiments the fluid flow directing element comprises a first raised portion which forms a helix on the internal surface of the tube. Aptly, a start point of the helix is located on the internal surface of the tube adjacent to the lip of the first opening, and further aptly an end point of the helix is located on the internal surface of the tube adjacent to the further opening. The start point and the end point of the first raised portion may be provided in the same vertical axis. In an embodiment, the tube has a longitudinal axis and the helix comprises a helix angle of between 5 and 50 degrees relative to the longitudinal axis of the tube. In certain embodiments, the helix comprises a helix angle of between 5 and 45 degrees relative to the longitudinal axis of the tube, e.g. 5 and 40 degrees, 5 to 35 degrees, 5 and 30 degrees, 5 and 25 degrees.

[0063] In certain embodiments, the helix comprises a helix angle of between 10 and 40 degrees, e.g. 10 and 35 degrees, 10 and 30 degrees, 10 and 25 degrees.

[0064] In certain embodiments, the helix comprises a helix angle of between 15 and 40 degrees, e.g. 15 and 35 degrees, 15 and 30 degrees, 15 and 25 degrees.

[0065] Aptly the helix undergoes approximately one revolution between the start point and the endpoint.

[0066] In certain embodiments the helix is configured as a right-handed helix. In certain embodiments the helix is configured as a left-handed helix.

[0067] In certain embodiments, the first raised portion has a substantially constant pitch across substantially its whole length.

[0068] In certain embodiments the fluid flow directing element comprises a further raised portion. Thus, in certain embodiments, the fluid flow directing element a first and a further raised portion, each raised portion being located in helical pattern on the internal surface of the tube. In certain embodiments, the fluid flow directing element comprises two helices located on the internal surface of the tube, where the helices are raised from the internal surface of the tube, each of the two helices forming a respective ridge coiled around the internal surface of the tube. Aptly the helices may be configured as a double helix. Aptly a start point of a first helix is located on the internal surface of the tube adjacent to the lip of the first opening, and an end point of the first helix is located on the internal surface of the tube adjacent to the further opening. Aptly a start point of a further helix is located on the internal surface of the tube adjacent to the lip of the first opening and on the opposite side of the first opening to the start point of the first helix, and an end point of the further helix is located on the internal surface of the tube adjacent to the further opening and on the opposite side of the further opening to the end point of the first helix. In certain embodiments the helices are configured as a right-handed double helix. In certain embodiments the helices are configured as a left-handed double helix.

[0069] In certain embodiments, the further raised portion has a substantially constant pitch across substantially its whole length. The start point and the end point of the further raised portion may be provided in the same vertical axis. In an embodiment, the tube has a longitudinal axis and the helix of the further raised portion comprises a helix angle of between 5 and 50 degrees relative to the longitudinal axis of the tube. In certain embodiments, the helix of the further raised portion comprises a helix angle of between 5 and 45 degrees relative to the longitudinal axis of the tube, e.g. 5 and 40 degrees, 5 to 35 degrees, 5 and 30 degrees, 5 and 25 degrees.

[0070] In certain embodiments, the helix of the further raised portion comprises a helix angle of between 10 and 40 degrees, e.g. 10 and 35 degrees, 10 and 30 degrees, 10 and 25 degrees.

[0071] In certain embodiments, the helix the further raised portion comprises a helix angle of between 15 and 40 degrees, e.g. 15 and 35 degrees, 15 and 30 degrees or 15 and 25 degrees.

[0072] The fluid flow directing element promotes the flow of fluid through the tube and out of the further opening of the tube in a single constant stream. The flow directing element may promote the laminar flow of fluid. This allows for fluid, such as urine, to flow quickly away from the vulval external urethral orifice through the tube and prevents the fluid from splashing back upwards towards the user once it has exited the tube. The configuration of the fluid flow directing element therefore prevents contact of the fluid with the skin of the user.

[0073] Sample Collection

[0074] In certain embodiments, the urination device further comprises a sample collection chamber for collecting a urine sample. In certain embodiments the sample collection chamber is a sample collection bottle. Aptly the sample collection bottle comprises a hollow chamber and an opening. Aptly the sample collection bottle is connectable to the further (distal) end of the tube such that the tube and the sample collection bottle are in fluidic connection. Aptly urine exiting the tube via the further opening enters the sample collection chamber where it can be collected.

[0075] In certain embodiments the opening of the sample collection bottle fits over the further end of the tube such that the tube and sample collection bottle are in fluidic connection. In certain embodiments the opening of the sample collection bottle fits over the further end of the tube such that the bottle and the tube are connected by friction fit. In certain embodiments the further end of the tube comprises one or more connector elements and the rim of the opening of the sample collection bottle comprises one or more corresponding connector elements such that the bottle and the tube are connectable.

[0076] In certain embodiments the sample collection bottle is sealable such that the sample within the bottle can be transported easily without spillage. For example, the sample collection bottle may further comprise a lid which can be fitted over the opening, once removed from the tube, to prevent the sample spilling from the bottle.

[0077] Materials

[0078] In certain embodiments the urination device is composed of medical grade plastic. In certain embodiments the urination device is composed of biomedical resin. Aptly, where the urination device is composed of medical grade plastics or biomedical resin, the urination device can be sterilised after use and reused multiple times. In certain embodiments where the urination device is composed of medical grade plastics or biomedical resin, the urination device may further comprise the sample collection bottle composed of medical grade plastics or biomedical resin respectively. In certain embodiments the urination device is composed of cardboard. Aptly the cardboard comprises a waxy and / or plastic type coating. Aptly if composed of cardboard, the urination device may be single use, in that it is used once and thrown away after use.

[0079] Turning to the Figures, a first embodiment is shown in Figure 1.

[0080] Figure 1 illustrates an embodiment of a non-invasive urination device 100 for channelling the flow of urine from a vulval external urethral orifice away from the body of a user. In particular, the device is for channelling the flow of urine from a vulval external urethral orifice away from vaginal or perineal wounds of a user such that there is minimal or no contact of urine with the vulva or perineum.

[0081] As illustrated in Figure 1 the urination device comprises a hollow tube 105. Aptly, the tube 105 is cylindrical and comprises a wall 110. Aptly, the tube has the same diameter along its length. The wall defines an inner surface 112 and an outer surface 114 of the tube 105. The tube 105 further comprises a first opening 115 at a first end portion of the tube 120 and a further opening 125 at a further end portion of the tube 130. Aptly, the first end portion is a proximal end portion of the tube. Aptly, the further end portion is a distal end portion. The horizontal cross section of the tube 105 is circular in the illustrated embodiment.

[0082] The first end portion of the tube 120 comprises a rounded lip portion 135, the rounded lip portion 135 forming a ring around a rim of the first opening 140. The surface of the lip 135 is smooth such that it is comfortable for the user to hold or push the lip against the skin of the vulva. The lip portion 135 is further configured to form a seal with the skin of the user, such that when the lip portion 135 is held against the skin around the vulval external urethral orifice of the user, urine exiting the vulval external urethral cannot flow in between the lip 135 of the tube and the skin of the user but is instead directed into the first opening 115 of the tube.

[0083] The first end portion of the tube 120 is angled or slanted. A first reference point 145 on the lip portion, is positioned higher than a second reference point 150 on the lip portion, where the second reference point 150 is on an opposing side of the lip portion 135 to the first reference point 145. The slanted configuration of the first end portion provides a close fit and allows for greater ease of positioning the first opening over the vulval external urethral orifice of the user. The further end portion of the tube 130 is not slanted, such that a rim of the further opening 155 is positioned on a single plane.

[0084] As illustrated in Figure 1 the tube comprises a fluid flow directing element located on the internal surface 112 of the tube. Aptly the fluid flow directing element is a raised portion configured as a first helix 160, and a further helix 165. The first and further helices 160, 165 are raised from the internal surface 112 of the tube forming respective ridges coiled around the internal surface 112. The first and further helices 160,165 may be configured as a right-handed double helix. Aptly, a first end of the first helix 162 is located on the internal surface 112 of the tube adjacent to the rim of the first opening 140 and a further end of the first helix 163 is located on the internal surface first helix undergoes one revolution between the first end 162 and further end 163 of the first helix. A first end of the further helix 166 is located on the internal surface 112 of the tube adjacent to the rim of the first opening 140 and on the opposite side of the rim to the first end point of the first helix 162. A further end of the further helix 167 is located on the internal surface 112 of the tube adjacent to the rim of the further opening 155 and on the opposite side of the further opening to the further end of the first helix 163. The further helix undergoes one revolution between the first end 166 and further end 167 of the further helix.

[0085] In certain embodiment, the tube 105 further comprises one or more circular or ovular shallow indents 170 located on the outer surface 114 of the wall 110 and configured such that the fingertips of a user can be fitted into the indents. In the illustrated embodiment the tube comprises a first indent OA, a second indent 170B, and a third indent 170C. The first and second indents 170A,170B are located adjacent to each other, the first indent 170A located closer to the first end of the tube 120 than, and positioned above, the second indent 170B. The first and second indents 170A, 170B are configured such that the index finger and middle finger of the user can be placed over the first and second indents 170A,170B respectively to allow ease of holding the tube 105. The tube 105 comprises a third indent 170C located on the opposite side of the outer surface of the tube 114 to the first indent 170A and configured such that a thumb of a user may be located therein. The first and second indents 170A, 170B are located on the outer surface of the tube 114 and located below or aligned in a vertical plane with the first point 145 and the third indent 170C is located on the outer surface of the tube 114 and located below or aligned in a vertical plane with the further point 150. Therefore, when the tube is held by the user such that the lip 135 is placed around the vulval external urethral orifice, the first point 145 faces ventrally and the further point 150 faces dorsally such that the angled first end of the tube 120 fits comfortably over the vulval external urethral orifice of the user.

[0086] The tube additionally comprises connection elements 175A.175B located on the outer surface 114 of the wall 110 at the further end of the tube 130. The connection elements 175A.175B are for connecting the further end of the tube 130 to a sample collection bottle (not shown in Figure 1).

[0087] Figure 2A illustrates a side view of the tube 105 of the urination device 100. Figure 2A illustrates the angled first end 120 in more detail. The angle 200 between the first point 145 and the second point 150 on the lip may be between 0 and 30 degrees. Optionally the angle may be between 20 and 30 degrees. The length of the tube 205 between the first point 145 on the lip and the rim of the further opening 155 may be between 90mm and 120mm. For example, the length of the tube 205 is 100mm The length of the tube 105 is such that when a user is seated on a toilet and the first end portion of the tube is located over the vulval external urethral orifice of the user, the further end portion does not make contact with the toilet bowl or toilet water. The tube is also sized such that it can easily be held in one hand of a user and sized such that it is portable, for example the user can easily transport the device with them such as in a bag.

[0088] Figure 2B illustrates a cross section of the tube 105 along the axis A-A’ of figure 2A. Figure 3B illustrates a cross section of the tube 105 along the axis B-B’ of figure 3A. Figures 2B and 3B illustrate the first helix 160 and further helix 165 in more detail. The first and further helices 160,165, not shown in their entirety in Figure 2B or Figure 3B as a cross section of the tube 105 is illustrated. The first and further helices 160,165 comprise a square, or optionally rectangular, cross section 210. The ridge around the internal surface 112 formed by the first and further helices 160,165 therefore comprises flat surfaces. The hight and width of the cross section 210 of each of the helices may be between 1.5-2.5mm. The first end of the first helix 162 and the first end of the further helix (not shown) further comprises a respective chamfer 215. Each chamfer 215 may be at a 45 degree angle. Each chamfer ensures the first end of the first helix and first end of the further helix do not have a sharp edge, the chamfer therefore prevents the scratching of the body of the user when the urination device is in use.

[0089] As illustrated in Figures 2B and 3B the wall 110 of the tube defines an inner surface 112 and outer surface 114 of the tube. The wall may be between 1mm and 3mm thick. The further opening 125 may have a diameter 220 between about 24mm and 26mm, the diameter of the further opening 125 defined between opposite sides on the inner surface 112 of the wall 110.

[0090] Figure 4 illustrates a view of the further end of the tube 130. Figure 4 illustrates the connection elements 175A, 175B in more detail. The connection elements allow the further end of the tube 130 to be connected to a sample collection bottle (not shown). A first connection element 175A and a further connection element 175B are respectively located on the outer surface 114 of the wall 110. The first and further connection elements 175A.175B are located on opposite sides of the wall 110 at the further end of the tube 130. Each connection element 175A, 175B protrudes from the outer surface 114 of the wall 110. The first and further connection elements 175A, 175B each comprise a respective cylindrical neck 400,405 extending perpendicular to the wall 110, and respective a cylindrical knob 410, 415 located at the end of each neck 400,405. The diameter of each cylindrical knob 410, 415 is wider than a respective cylindrical neck 400, 405. The diameter of each cylindrical knob 410, 415 is greater than its length. The length of each neck 400,405 may be 1.75mm, the length of each cylindrical knob 410, 415 may be 2.00mm. The connection elements 175A, 175B are male connection elements and are configured to be connectable to corresponding female connection elements located on the rim of the sample collection bottle such that the further opening 130 is fluidically connectable to the sample collection bottle.

[0091] As illustrated in figure 5, the urination device 100 may further comprises a sample collection bottle 500. The sample collection bottle of the illustrated embodiment is a cylindrical bottle comprising a hollow cylinder 505 which comprises a wall 507, an opening 510 at a first end 515 and a closed base 520 at a further end 525. The sample collection bottle 500 may comprise a capacity of between 100ml to 200ml. The sample bottle further comprises a first and further corresponding or female connector element 530, 535 located on the inside of the rim 540 of the sample collection bottle. Each corresponding connector element 530, 535 is connectable to a respective connection element of the tube 175A, 175B. Each corresponding connector element 530, 530 comprises a groove located around a portion of the inside of the rim 540 of the sample collection bottle in which the cylindrical knob 410, 415 of each the connector element can be located and where each groove grips the neck 400,405 of each respective connector element.

[0092] The opening 510 of the sample collection bottle is configured to fit over the further end of the tube 130, such that the respective connection element 175A, 175B is connected to a respective corresponding connector element 530, 535. When the sample collection bottle 500 and tube 105 are connected the further opening of the tube 125 and the opening of the sample collection bottle 510 are fluidically connected. Urine exiting the tube 105 through the further opening 125 enters the sample collection bottle 500 through the opening of the bottle 510, such that urine is collected in the sample collection bottle 500.

[0093] In an alternative embodiment (not shown) the sample collection bottle may further comprise a lid which can fit over the opening of the bottle, such that any urine in the bottle does not leak out of the bottle. This configuration allows urine to be easily transported within the sample collection bottle.

[0094] A method of collecting a urine sample using the urination device as illustrated in Figure 5 comprises: a) connecting the tube 105 to the sample collection bottle 500 by connecting the connector elements 175A, 175B located on the further end of the tube 130 to respective corresponding connector elements 530,535 located on the inside of the rim 540 of the sample collection bottle;

[0095] b) locating the first opening of the tube 115 over a vulval external urethral orifice of the user such that the first point 145 on the lip 135 of the tube faces ventrally and the further point 150 on the lip 135 of the tube faces dorsally and such that a seal is formed between the lip 135 and the skin of the user around the vulval external urethral orifice;

[0096] c) directing the flow of urine expelled from the vulval external urethral orifice away from the body of the user in the tube 105 using the fluid flow director elements 160,165 such that there is no or minimal contact of urine with the perineum or vulva of the user and collecting urine released within the sample collection bottle 500;

[0097] d) removing the urination device 100 away from the body of the user; and

[0098] e) detaching the sample collection bottle 500 from the tube 105.

[0099] Optionally, after step e) a lid may be placed over the opening 510 of the sample collection bottle.

[0100] In an alternative method of use of the urination device, step a) and e) are omitted such that a urine sample is not collected, the method comprises:

[0101] a) locating the first opening of the tube 115 over a vulval external urethral orifice of the user such that the first point 145 on the lip 135 of the tube faces ventrally and the further point 150 on the lip 135 of the tube faces dorsally and such that a seal if formed between the lip 135 and the skin of the user around the vulval external urethral orifice;

[0102] b) aiming the further end of the tube 130 towards a suitable receptacle such as the bowl of a toilet,

[0103] c) directing the flow of urine expelled from the vulval external urethral orifice away from the body of the user in the tube 105 using the fluid flow director elements 160,165 such that there is no or minimal contact of urine with the perineum or vulva of the user; and d) removing the urination device 100 away from the body of the user.

[0104] Figure 6 illustrates an alternative embodiment of a non-invasive urination device 600 for channelling the flow of urine from a vulval external urethral orifice. The urination device 600 of the present embodiment comprises a tube 605 identical to the embodiment previously described in figures 1 to 5, apart from the tube 605 does not comprise connection elements. Throughout the description and claims of this specification, the words “comprise” and “contain” and variations of them mean “including but not limited to” and they are not intended to (and do not) exclude other moieties, additives, components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

[0105] Features, integers, characteristics or groups described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of the features and / or steps are mutually exclusive. The invention is not restricted to any details of any foregoing embodiments. The invention extends to any novel one, or novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

[0106] The reader’s attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

Claims

CLAIMS:

1. A urination device for directing a flow of fluid away from an orifice of a body of a user, the urination device comprisinga tubular component, wherein the tubular component further comprises a first end portion, wherein the first end portion comprises a first opening configured to be locatable over the orifice;a further end portion, wherein the further end portion comprises a further opening; andan element for directing fluid flow, said fluid flow directing element being located on an internal surface of the tubular component and being configured to direct flow of fluid away from the orifice,wherein the first and further openings each comprise a rim portion, wherein the fluid flow directing element comprises a first raised portion provided in a helical pattern on an internal surface of the tubular component, further wherein a first end of the raised portion is located adjacent to the rim portion of the first opening, and a further end of the raised portion is located adjacent to a rim portion of the further opening, andwherein the helical pattern of the raised portion undergoes one revolution.

2. The urination device according to claim 1, wherein the first end of the raised portion further comprises a chamfer.

3. The urination device according to any of claims 1 to 2, wherein the tube has a longitudinal axis and the first raised portion comprises a helix angle of between 5 and 50 degrees relative to the longitudinal axis of the tube, wherein optionally the helix angle is between 5 and 45 degrees relative to the longitudinal axis of the tube, e.g. 5 and 40 degrees, 5 to 35 degrees, 5 and 30 degrees or 5 and 25 degrees.

4. The urination device according to any one of claims 1 to 3, wherein the raised portion is configured to promote a laminar flow of fluid through the tubular component.

5. The urination device according to any one of claims 1 to 4, wherein the fluid flow directing element comprises a further raised portion provided in a helical pattern onan internal surface of the tubular component, wherein the raised portion and further raised portion are configured as a double helix.

6. The urination device according to claim 5, wherein a first end of the further raised portion is located adjacent to the rim of the first opening and disposed opposite the first end of the raised portion, and a further end of the further raised portion is located adjacent to the rim of the further opening disposed opposite the further end of the raised portion.

7. The urination device according to claim 6, wherein between the first end of the further raised portion and the further end of the further raised portion the helix of the further raised portion undergoes one revolution.

8. The urination device according to any preceding claim, wherein the first end portion is slanted, optionally wherein the first end portion is slanted at an angle of between 0 to 40 degrees e.g. 0 to 30 degrees, 5 to 35 degrees, 10 to 30 degrees, about 30 degrees.

9. The urination device according to any preceding claim, wherein the rim of the first opening comprises a rounded lip portion, optionally wherein the rounded lip is configured to form a seal against the body of the user.

10. The urination device according to any preceding claim, wherein the tubular component further comprises one or more indents located on an external surface, wherein the one or more indents is configured to allow one or more fingers of the user to grip the device.

11. The urination device according to any preceding claim, further comprising a sample collection chamber, wherein the sample collection chamber comprises a hollow container and an aperture sized to fit over the further end portion, wherein the sample collection chamber is configured to be releasably connectable to the further end portion such that the tubular component and sample collection chamber are fluidically connectable.

12. The urination device according to claim 11, wherein the further end portion comprises a connector element and the sample collection chamber comprises a corresponding connector element, wherein the connector element and corresponding connector element are releasably connectable.

13. The urination device according to claim 11 or 12, wherein the sample collection chamber further comprises a lid such that the sample collection chamber can be sealed.

14. The urination device according to any preceding claim, which in use is configured to positioned in a generally vertical orientation.

15. A method for collecting a sample, the method comprising:a) assembling a urination device according to any preceding claim, comprising attaching a further end portion of a tubular component of the urination device to a sample collection chamber;b) locating a first opening of a first end portion of the tubular component over an orifice of a user such that a seal if formed between a rim of the opening and the body of the user around the orifice;c) collecting fluid sample released from the orifice within the sample collection chamber;d) removing the urination device away from the body of the user; ande) detaching the further end portion from the sample collection chamber; optionally, prior to step a) removing a lid from the sample collection chamber and / or after step e) closing the sample collection chamber using the lid.

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