Sample collections devices

Abstract

A sample collector 700 for a bodily cavity comprises an open-ended receptacle 702 and an elongate actuating member 716 that extends through the receptacle’s base 706 in a sealed manner and connects to

Description

[002] Sample collection from the human body, and particularly collection of samples from bodily cavities can be unreliable, difficult, unhygienic, and / or painful. There is a specific need for an improved sample collection device for the collection of menstrual blood, tissue samples, or other vaginal discharge. While a conventional menstrual cup can be used to collect such samples, this can have disadvantages, which include but are not limited to potential sample contamination, potential exposure of collected samples, accidental spillage or sample loss, and painful removal. Therefore, it will be understood that it is desirable to provide improvements to sample collection devices. SUMMARY

[003] Accordingto a first aspect, there is provided a sample collection device for a bodily cavity. The sample collection device may comprise a receptacle for sample collection comprising an open end, a base, and a wall extending between the base and the open end. The sample collection device may comprise an elongate actuating member comprising a proximal end and a distal end. The open end may comprise a rim and the base comprises an aperture. The wall may comprise a line of weakness. The line of weakness may define at least a portion of the perimeter of a deformable segment of the wall. The elongate actuating member may be configured to extend through the aperture such that a seal is formed between the elongate actuating member and the aperture to prevent leakage of the sample from the receptacle through the aperture and such that the distal end extends away from the receptacle. The proximal end of the elongate actuating member may be connected to the deformable segment such that when a user applies a pulling force to the distal end, the elongate actuating element is configured to deform the deformable segment so as to at least partially close the open end of the receptacle.

[004] The deformable segment may make sealing contact with a further portion of the receptacle, so as to seal the open end of the receptacle.

[005] The line of weakness may form a peripheral edge of the deformable segment. The wall may comprise a non-deforming portion on a first side of the line of weakness and the deformable segment on a second side of the line of weakness.

[006] The line of weakness may be curved or may have a curved profile. The line of weakness may have an arcuate shape. The peripheral edge of the or each deformable section may comprise the line of weakness and a portion of the rim. The line of weakness may or may not connect to the rim.

[007] The term “line” in line of weakness should be understood as including a band or strip of weakness having a width. In functional terms, the line of weakness should be understood as an elongate structure extending on or in the wall, which defines a boundary at which the wall is predisposed to deform.

[008] The curved profile may define the depth or length of the deformable segment. The radius of the curved profile may vary around the circumference of the receptacle such that the deformable segments have non-identical sizes. The line of weakness may not connect to the rim of the receptacle. The line of weakness of adjacent deformable segments may be connected to form a continuous line of weakness extending around the receptacle. The continuous line of weakness may extend around an entire circumference of the receptacle.

[009] The elongate actuating member may be a flexible string-like element configured to be pulled under tension. Tension applied to the elongate actuating member may be transferred to the deformable segment so as to deform the deformable segment. Tension applied to the elongate actuating member may be operable to remove the sample collection device from a bodily cavity.

[0010] The deformable segment or segments may be adjacent to the open end of the receptacle.

[0011] The sample collection device mayfurther comprise a stop elementformed on the elongate actuating member. The stop element may be configured to prevent movement of the elongate actuating member beyond the stop element.

[0012] The stop element may be configured to so as to limit or prevent further or over deformation of the deformable segment. The stop element may be configured to transfer a pulling force applied to the elongate actuating member to the base, such that the pulling force acts to remove the sample collection device from the bodily cavity in which it is located.

[0013] The sample collection device may further comprise a locking mechanism configured to lock the deformable segment in sealing contact with the further portion of the receptacle.

[0014] The locking mechanism may comprise a locking feature formed on the elongate actuating member. The locking feature may be configured to pass through the aperture in a first direction but prevented from passing through the aperture in a second direction opposite to the first direction.

[0015] The first direction is from the interior of the receptacle to the exterior, and the second direction is from the exterior of the receptacle to the interior. Movement in the first direction may be movement caused by application of a pulling force to the distal end of the elongate actuating member. The locking feature may be a notch, barb, or protrusion formed on the elongate actuating member.

[0016] The locking mechanism may comprise a sliding lock.

[0017] A sliding lock may be a locking part which is slidably movable relative to the elongate actuating element in a first direction and prevents sliding movement relative to the elongate actuating element in a second direction opposite to the first direction. A sliding lock may use a barb-like arrangement or a ratchet-like arrangement. A sliding lock may be a locking feature which engages the elongate actuating element and resists movement relative to the elongate actuating element unless a threshold force is overcome.

[0018] The locking mechanism may be releasable so as to selectively permit unlocking of the locking mechanism. The locking mechanism may be a deformable valve or slot, such as a ‘bite valve’ mechanism. The locking mechanism may be releasable by applying a squeezing force to the locking mechanism so as to deform an opening of the locking mechanism to allow reverse movement of a locking feature of the elongate actuating member.

[0019] The locking mechanism may be provided by adhesive or similar, which maintains the deformable segment in sealing contact with another portion of the device.

[0020] The deformable segment may have a thickness less than a thickness of the wall on an opposing side of the line of weakness.

[0021] The thickness of the wall on the opposing side of the line of weakness may be between 1 mm and 2mm, or more specifically between 1.2mm to 1.5mm. The thickness of the deformable segment may be between 0.5mm and 1.5mm, or more specifically between 0.8 to 1.0mm. The thickness of the deformable segment may be up to 50%, 60%, 66%, 75%, or 83% of the thickness of the wall on the opposing side of the line of weakness.

[0022] The thickness of the deformable segment may be centred with respect to the thickness of the wall on the opposing side of the line of weakness. In other examples, the thickness of the deformable segment may be offset with respect to the thickness of the wall on the opposing side of the line of weakness. The offset may be toward the exterior surface of the wall or towards the interior surface of the wall.

[0023] The sample collection device may further comprise a stem connected to the base of the receptacle wherein the aperture extends through the stem. The stem may extend outwardly from the base. A locking mechanism, if provided as set out above, may be located in the stem.

[0024] The line of weakness may comprise a stepped or tapered change in thickness of the wall. The line of weakness may comprise a living hinge. The living hinge may be an area or line of localised thinning of the wall.

[0025] A wall material on a first side of the line of weakness may be different to a segment material forming the deformable segment, such that the line of weakness is formed at the intersection between the wall material and the segment material. Additionally or alternatively, the line of weakness may be formed by a line or strip of hinge material different to a wall material and different to a segment material. In examples where the line of weakness is formed by a line or strip of hinge material, the segment material may or may not be the same as the wall material.

[0026] The wall material may be medical grade silicone, thermoplastic elastomer or natural rubber. The segment material may be medical grade silicone, thermoplastic elastomer or natural rubber. The hinge material may be medical grade silicone, thermoplastic elastomer or natural rubber.

[0027] The receptacle may be bell-shaped or conical. The diameter of the receptacle may be largest at the rim of the open end. The diameter of the receptacle may be smallest at the base. The diameter of the receptacle may decrease between the rim and the base.

[0028] The rim may have a thickness which is greater than or equal to a thickness of the wall adjacent to the open end of the receptacle.

[0029] The sample collection device may comprise a plurality of deformable segments. The deformable segments may be spaced about the circumference of the receptacle. The deformable segments may be substantially equally spaced. The elongate actuating member may comprise a plurality of connecting portions at the proximal end. Each connecting portion may be configured to connect to a respective one of the plurality of deformable segments.

[0030] The elongate actuating member may be configured such that a pulling force applied to the distal end is transferred to the connecting portions, such that the connecting portions apply a respective pulling force to their respective deformable segment.

[0031] Each deformable segment may have at least one connecting portion. Each deformable segment may be connected to more than one connecting portion. There may be an equal number of connecting portions and deformable segments.

[0032] The connecting portions of the elongate actuating member may have nonidentical lengths. Connecting portions of different lengths may provide different actuation characteristics, so as to control the deformation and / or movement of their respective deformable segment. The connecting portions may connect to a respective one of the plurality of deformable segments at different points of the segment.

[0033] A plurality of deformable segments may be provided. At least two of the deformable segments may have non-identical sizes.

[0034] The elongate actuating member may be over moulded or co-moulded such that it forms a part of the receptacle, and may be integral to the material of the receptacle. The elongate actuating member may be a separate part, such as a string, around which the receptacle is moulded. The elongate actuating member may be connected to the receptacle in other ways, such as welding or gluing or via a fastening loop pre-moulded into the receptacle.

[0035] Co-moulding may involve a single moulding process comprising simultaneous injection of material forming the receptacle and the elongate actuating member into a single mould.

[0036] Over moulding may involve two separate moulding processes comprising first, moulding the receptacle to form a substrate material and second, moulding the elongate actuating member to the substrate material to form a bond between the receptacle and the elongate actuating member.

[0037] The moulding process may be injection moulding. The device may be formed by additive manufacture, such as 3D printing.

[0038] The sample collection device may further comprise a pad and sheath. The pad and / or the sheath may act as a sealing means.

[0039] The sample collection device may further comprise a cap or lid for sealing of the receptacle.

[0040] The elongate actuating member may comprise a different material to the receptacle.

[0041] The sample collection device may be a menstrual cup.

[0042] The features and / or limitations referred to above may be combined with respect to any of the other aspects, features or limitations described above, except combinations of such features as are mutually exclusive. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Embodiments of the invention will now be described, by way of example, with reference to the accompanying drawings, in which:

[0044] Figures 1 a-g show an exemplary sample collection device;

[0045] Figures 2a-b show an exemplary sample collection device;

[0046] Figures 3a-c show an exemplary sample collection device;

[0047] Figures 4a-d show an exemplary sample collection device;

[0048] Figures 5a-c show an exemplary sample collection device;

[0049] Figures 6a-c show an exemplary sample collection device; and

[0050] Figures 7a-d show an exemplary sample collection device; and

[0051] Figures 8a-8b show an exemplary sample collection device. DETAILED DESCRIPTION OF THE DRAWINGS

[0052] With reference to Figure 1, an exemplary sample collection device 100 is shown. The sample collection device 100 is for insertion into a bodily cavity, such as the vaginal canal or rectum to collect samples. Where the sample collection device 100 is for insertion into the vagina to collect samples of menstrual blood, tissue samples, or other discharge, it may be referred to as a menstrual cup. It should be appreciated that the sample collection device may be suitable for collecting a range of different samples from the human body by insertion into a bodily cavity.

[0053] Figure 1a shows a sideviewof thesample collection device 100, Figure 1b shows a top view of the sample collection device 100, Figure 1c shows a cross sectional side view of the sample collection device 100, and Figure 1d shows a perspective wireframe view of the sample collection device 100. In each of these Figures 1 a-d, the sample collection device 100 is shown in an open configuration, which may be the naturally occurring or stable configuration of the sample collection device 100.

[0054] As will be appreciated, the sample collection device 100 comprises a receptacle 102 for sample collection. The receptacle may also be referred to in this detailed description as a cup for brevity. The receptacle 102 comprises an open end 104, a base 106, and a wall 108 extending between the base 106 and the open end 104. At the open end 104, the receptacle 102 has a rim 110.

[0055] In this example, the receptacle 102 is generally bell-shaped, as the diameter of the receptacle may be largest at the rim 110 of the open end 104 and smallest at the base 106. The diameter of the receptacle 102 generally decreases between the rim 110 and the base 106. In some examples, the receptacle may be conical, hemispherical, or dish-like in shape. It should be understood that the precise shape of the receptacle, as defined by the wall, may vary and generally the receptacle forms a cup for receiving and containing a sample under gravity.

[0056] The rim 110 is thickened compared to the thickness of the wall adjacent the open end 104 of the receptacle 102.

[0057] The sample collection device 100 in this example further comprises a stem 112 connected to the base 106 of the receptacle 102. The stem 112 is formed integrally with the receptacle 102 and extends outwardly from the base 106 at the centre of the base 106. The stem 112 generally extends downwardly when the device 100 is upright (i.e., with the open end 104 upwards).

[0058] The base 106 of the receptacle 102 comprises an aperture 114. The aperture extends though the wall 108 at the base 106, and connects the inside of the receptacle 102 to the outside of the receptacle 102. In this example where a stem 112 is provided, the aperture 114 extends through the stem 112.

[0059] The sample collection device 100 comprises an elongate actuating member 116, which has a proximal end 116a and a distal end 116b. The elongate actuating member 116 is a flexible string-like element configured to be pulled by a user to apply tension to the member 116. As can be appreciated in Figure 1 c, the elongate actuating member 116 is configured to extend through the aperture 114 and extend downwardly from the stem 112 and the base 106 away from the receptacle 102. The distal end 116b of the elongate actuating member 116 therefore extends from the base 106 of the device 100 analogously to a tampon string. The distal end 116b of the elongate actuating member 116 may have some features to improve or assist gripping the distal end, such as ridges, dots or other texture.

[0060] In this example, a stop element 120 is provided to limit movement of the elongate actuating member 116. Specifically, the stop element 120 is a protrusion formed on the elongate actuating member 116 near the proximal end 116a. The stop element 120 is sized such that it may not pass through the aperture 114 and so the elongate actuating member 116 may not be pulled through the aperture 114 past the stop element 120. Once the stop element 120 contacts the base 106, it acts to transfer the pulling force applied to the elongate actuating member 116 to the base 106, such that the pulling force then acts on the device 100 as a whole to remove the sample collection device 100 from the bodily cavity in which it is located, again analogously to a tampon string. Of course, it should be understood that not all examples of sample collection devices in keeping with this disclosure may have a stop element.

[0061] In this example, the sample collection device 100 also comprises a locking mechanism 122 configured to lock the elongate actuating member 116 in a ‘pulled’ position, and for other reasons which will be set out further below. In the example of Figures 1 a-f, the locking mechanism 122 comprises a locking feature 122a formed on the elongate actuating member 116 at a point between the proximal and distal ends. The locking feature is a protrusion that is sized and shaped so that it may pass relatively easily into and through the aperture 114 from the inside to the outside, but is prevented from passing back through the aperture 114 in the other direction. In this example, the locking feature 122a is arrowheadshaped, with the arrowhead pointing towards the distal end 116b, so that it can easily pass into and through aperture in one direction but not the other. The locking feature 122a might alternatively be described as a barb. It should be appreciated that othertypes of locking mechanism are useable, and indeed other locking mechanisms are described below. It is also possible that a locking mechanism could be provided by adhesive or similar, which sticks to, and therefore maintains the deformable segment in sealing contact with, another portion of the device.

[0062] Furthermore, some examples of sample collection devices in accordance with this disclosure may not have locking mechanisms.

[0063] As can be appreciated in Figures 1 a and 1 d, the sample collection device 100 comprises at least one deformable segment 124, and specifically four deformable segments 124. The four deformable segments 124 are formed as a part of the wall 108, and are evenly spaced about the circumference of the receptacle 102 adjacent the open end 104.

[0064] Each deformable segment 124 defined by a line of weakness 126 formed on the wall 108. The line of weakness 126 forms a portion of the peripheral edge 124a of the deformable segment 124. The wall 108 can be considered to comprise a non-deforming portion 128 on a first side of the line of weakness 126 and the deformable segment 124 on a second side of the line of weakness 126. Each deformable segment 124 is configured to be deformed orfolded inwardly towards the centre of the receptacle 102 much more easily than the rest of the wall 108, as will be described in more detail below.

[0065] In this example, each line of weakness 126 has a curved profile which starts at a position near the open end 104 of the receptacle 102, curves downwardly towards the base 106 and then back upwards towards the open end 104. The deformable segment 124 is formed on the open end side of the line of weakness 126, and has a petal-like shape. As the deformable segments 124 are formed between the line of weakness 126 and the rim 110, the rim 110 notionally forms a further portion of the peripheral edge 124a of each deformable segment 124. In this example, the line of weakness 126 does not connect to the rim 110. It will be appreciated that the curved profile of the line of weakness 126 defines the depth or length of the deformable segment 124. In this example, the line of weakness 126 of the adjacent deformable segments 124 connected to form a continuous line of weakness extending around the entire circumference of the receptacle 102.

[0066] The nature of the line of weakness 126 itself will now be discussed. In this example, the line of weakness 126 is formed as an abrupt change in the thickness of the wall 108. As can be observed in Figure 1c, the deformable segments 124 have a thickness T1 which is substantially less than a thickness T2 of the wall 108 on the opposing side of the line of weakness 126. In this way, the line of weakness 126 is the location of this change in thickness. It should be understood that the line of weakness 126 could be achieved in many other ways. In this example, the line of weakness 126 is a stepped change in thickness, but equally in other examples, the line of weakness could be formed as a tapered change in thickness of the wall. In other examples, the line of weakness may be formed as living hinge, such as an area or line of localised thinning of the wall. More generally, it should be understood that the line of weakness may not be a precise line per se and should be understood as a feature of the receptacle wall which encourages localised folding or deformation in that particular region in preference to other regions.

[0067] In yet further examples, the line of weakness could be formed by a change in material. For example, a wall material on a first side of the line of weakness may be differentto a segment materialformingthe deformable segment, such thatthe line of weakness is formed at the intersection between the wall material and the segment material. Or, the line of weakness could be a thin strip of hinge material different to the material of the wall and / or the deformable segment.

[0068] Referring to Figures 1 a, 1 c and 1 d, it can be observed that the thickness T1 of the deformable segment is not centred with respect to the thickness of the wall on the opposing side of the line of weakness 126. Specifically, the deformable segment 124 is offset inwardly, so that the line of weakness 126 is visible on the exterior of the receptacle 102, while the internal surface of the wall 108 is smooth. In other examples, the thickness of the deformable segment may be centred with respect to the thickness of the wall on the opposing side of the line of weakness, or could be offset outwardly, like the example of Figures 7a-d described in more detail below.

[0069] The functionality of the sample collection device 100 will now be described in more detail with additional reference to Figures 1e and 1f, which show the device 100 in an alternate sealed configuration, and Figure 1g, which shows the device in an intermediate state, between Figure 1 d and 1 e.

[0070] The proximal end 116a of the elongate actuating member 116 is connected to each deformable segment 124. In the sample collection device 100, this is achieved by a plurality of connecting portions 116c formed at the proximal end 116a of the elongate actuating member 116. Each connecting portion 116c connects the elongate actuating member 116 to a respective one of the plurality of deformable segments 124. In this example there are four deformable segments 124, and so there are four connecting portions 116c. The connecting portions 116c are effectively four subdivisions of the elongate actuating member 116. It should be understood that the elongate actuating member 116 is generally configured such that a pulling force applied to the distal end 116b is transferred to the connecting portions 116c, so that the connecting portions 116c apply a respective pulling force to their respective deformable segment 124. Therefore, tension applied to the elongate actuating member 116 will be transferred to the deformable segments 124 so as to deform / fold the deformable segment 124.

[0071] The elongate actuating member 116 is therefore configured such that, when a user applies a pulling force to the distal end, as illustrated by the arrow F in Figure 1 f, the elongate actuating member 116 applies a force to deform each of the deformable segments 124 inwardly and downwardly to the position shown in Figures 1 e and 1f. In this deformed or folded position, the deformable segments 124 may come together and make sealing contact between one another at a central position, so as to close the open end 104 of the receptacle 102.

[0072] As shown in Figure 1f, when the distal end 116b of the elongate actuating member 116 is pulled through the aperture 114 until the stop element 120 contacts the base 106, the locking feature 122a enters the aperture 114 and is prevented from reverse movement. This locks the elongate actuating member 116 in this position. This in turn holds the deformable segments 124 in their folded / deformed position, and secures the sample collection device 100 in a sealed configuration in which the contents of the receptacle 102 are sealed inside. A sealing lip 118 is provided at the base 106 to form a seal between the elongate actuating member 116 and the aperture 114, so as to prevent leakage of the sample from the receptacle 102 through the aperture 114. The device 100 in Figure 1f further comprises a cap or lid 134 to provide a means of sealing of the receptacle.

[0073] Now that the structure of the device 100 is understood, use of the device 100 will be briefly described. The device 100 is initially configured in its open state, as shown in Figures 1a-d. It is then inserted with the open end 104 first into the bodily cavity, so that the open end 104 of the receptacle is able to receive and collect a sample, such as menstrual blood or other tissue samples or discharge, much like a conventional menstrual cup. As with menstrual cups and other internally-located collection devices, the device 100 may require some folding of the receptacle to provide easier insertion.

[0074] When removal of the device 100 is required, such as when the receptacle 102 is sufficiently filled with a sample, the user or a medical professional grips the distal end 116b of the elongate actuating member 116, and applies a pulling force F. The pulling force F acts predominantly to pull the elongate actuating member 116 through the aperture 114 and to thereby deform the deformable segments 124. In other words, the elongate actuating member 116 slides relative to the base 106 of the receptacle and extends by an increasing distance from the base 106. Figure 1g shows the device 100 in an intermediate stage during its closure (i.e., between the states shown in Figures 1d and 1e) to aid understanding of the deformation of the deformable segments 124 that occurs when the elongate actuating member 116 is pulled.

[0075] The lengths of the connecting portions 116c and the location of the stop element 120 are configured such that the deformable segments 124 are urged firmly into contact before the stop element 120 contacts the base 106. Generally, it will be understood that the period of pulling between the initiation of the pulling force and the moment the stop element 120 contacts the base is a first phase of pulling, which may be described as a closing phase, during which the open end 104 of the device 100 is closed and sealed by the deformable segments 124.

[0076] A secondary effect of the deformation of the deformable segments 124 is that a seal formed between the rim 110 of the device 100 and a wall of the bodily cavity may be broken, and therefore suction resistance to the removal of the device 100 from the cavity may be reduced or alleviated.

[0077] Once the stop element 120 contacts the base 106, the pulling action enters a second phase, which may be described as the removal phase. Continued pulling on the distal end 116b of the elongate actuating member 116 no longer translates or slides the member 116 through the aperture 114 and, instead, acts directly on the base 106 of the receptacle 102 and, more generally on the device 100 as a whole. Continued pulling therefore acts to move the device 100 relative to the walls of the bodily cavity in which it is inserted and, ultimately, remove the device 100 from the cavity.

[0078] In this example, the locking mechanism 122 maintains the device 100 in its sealed configuration even after the pulling force on the elongate actuating member 116 is released. Therefore, the device 100 can form a secure, sealed container for the collected sample without requiring transfer of the sample to another container. If a locking mechanism is not provided on another example device, then tension can simply be maintained on the elongate actuating member 116 by pulling. Versions without a locking mechanism may be more appropriate if, for example, the sample does not require long-distance transport. Such versions may provide clean and sanitary transfer of a sample to another nearby location for testing or into an alternative container for transport, without exposing the sample to the ambient environment.

[0079] Various alternative examples of sample collection devices will now be described. To avoid extensive duplication of description, where a feature of a further example device is functionally equivalent to a feature of the device 100, a reference numeral will be used with the same tens and units digits (and, if appropriate, letter) as the feature in device 100. For example, device 200 described below has a receptacle 202 which is functionally equivalent to the receptacle 102 of the device 100, and connecting portions 216c which are functionally equivalent to the connecting portions 116c of the device 100. The following description will therefore focus exclusively on the differences between device 100 and the example devices of Figures 2a to 7d.

[0080] Figures 2a and 2b show a sample collection device 200 that is mostly identical to device 100 described above. However, sample collection device 200 has an alternative locking mechanism 222 comprising a sliding lock 222b.

[0081] Aslidinglock222b is a locking part which is slidably movable relative to the elongate actuating member 216. In some examples, the sliding lock 222b may be movable in either direction along the elongate actuating member 116, but may grip the elongate actuating member 116 with a significant force that must be overcome to allow movement, such as a sliding clasp. Such a sliding lock may be particularly suitable if the device 200 is to be reusable. On other examples, the sliding lock 222b may be unidirectional. Specifically, the sliding lock 222b may be movable in a direction towards the proximal end, but is not permitted to slide relative to the elongate actuating member 116 in the opposing direction (i.e., towards the distal end). The sliding lock 222b can use a barb-like arrangement or a ratchet-like arrangement. In this example, the sliding lock 222b is separate to the receptacle 202 and the stem 212, but in other examples, it may be formed integrally to the base 206 or the stem 212, so that all movement of the elongate actuating member 216 through the aperture 214 is irreversible. In order to open the device 200 to release a sample, the sliding lock 222b may be selectively releasable. Alternatively, the sample could be released by severing the elongate actuating member 116, which might be appropriate if the device 200 is a singleuse device. Additionally, device 200 does not feature a stop element.

[0082] Figures 3a, 3b, and 3c show a further alternative sample collection device 300. In this example, there is effectively a single deformable segment 324. The elongate actuating member 316 extends through a loop 330 formed on the internal surface of the wall 308 proximate the open end 304, and the proximal end 316a if connected to the deformable segment 324 which is formed on a directly opposing side of the receptacle 302. It will be appreciated that a pulling force applied to the distal end 316b of the elongate actuating member 316 will deform / fold the single deformable segment 324 across the receptacle 302 to seal against the opposing side of the receptacle 302. Additionally, device 300 does not feature a stop element.

[0083] Figures 4a, 4b, 4c, and 4d show a yet further alternative sample collection device 400, which has two opposing deformable segments 424, with two respective connecting portions 416c. The device 400 has two curved lines of weakness which define the two deformable segments 424. In use, pulling the elongate actuating member 416 urges the two deformable segments directly towards one another to close the open end 404 of the device 400, where in this example they meet and seal at a central line extending across the device. The device 400 does not have a stem or locking mechanism.

[0084] Figures 5a, 5b, and 5c show a further alternative sample collection device 500. The device 500 has two major distinctions from device 100 described above.

[0085] Firstly, the locking mechanism 522 of sample collection device 500 is releasable so as to selectively permit unlocking of the locking mechanism 522. In this example, a locking feature 522a is a spherical protrusion on the elongate actuating member 516. The locking mechanism 522 also comprises a deformable valve 522b, which comprises a slot. More colloquially, the deformable valve 522b takes the form of a ‘bite valve’. When the elongate actuating member 516 is pulled, the locking feature 522a passes through the aperture 514 and a slot of the deformable valve 522b, and is unable to return through the slot. However, when a squeezing force S is applied to the stem 512, this deforms the valve 522b and opens the slot of the valve 522b, thereby allowing the locking feature 522a to pass back through the aperture 514 to permit release of the deformable segments 524 back to their natural position.

[0086] A second distinguishing feature of the sample collection device 500 in comparison to device 100 is that the connecting portions 516c of the elongate actuating member have non-identical lengths. Upon application of a pullingforce on the elongate actuating member 516, the shortest connecting portion 516c’will come under tension first, and thereby transfer to its respective deformable segment 524’ before the other deformable segments. The next shortest connecting portion 516c” may then come under tension and apply force to its respective deformable segment 524”, and so on, until the pulling force is applied to deformable segment 524”” which is associated with the longest connecting portion 516c””. In this way, the deformable segments 524 will be actuated in sequence and therefore form sealing contact by stacking upon one another rather than meeting simultaneously as would be the case for device 100. It will be appreciated that providing connecting portions of different lengths in this and other configurations can provide different actuation characteristics to the deformable segments, so as to control the timing and extent of their movement.

[0087] Figures 6a, 6b, and 6c show a yet further example of a sample collection device 600. A top view of the device 600 is not shown, but it would appear substantially identical to the top view of device 100 in Figure 1 b. Device 600 does not comprise a stem. The main distinguishing features of device 600 are that it comprises deformable segments 624 with non-identical sizes and shapes. Specifically, the shape of the line of weakness 626 of each deformable segment 624 is different, so as to impart different characteristics to the deformable segments 624. Figure 6a shows one of the deformable segments 624’ and its respective line of weakness 626’. As can be observed, the curved profile of the line of weakness 626’ has a first end a short distance D1 away from the rim 610, then curves downwardly and back upwardly, having its second end a greater distance D2 from the rim 610 compared to its first end. The line of weakness 626’ is therefore asymmetric, which imparts asymmetry to the deformable segment 624’. The adjacent deformable segment 624” has a line of weakness 626” which has its first end coincident with the second end of the line of weakness 626’ (i.e., a distance D2 away from the rim 610) and has a curved profile with its second end being the same distance D1 away from the rim 610 as the first end of the line of weakness 626’. Therefore, deformable segment 624” and line of weakness 626” are also asymmetric, and effectively form a mirror image of deformable segment 624’ and line of weakness 626”. The other two deformable segments formed on the opposing side of the device 600 are identicalto segments 624’ and 624” in this example. Therefore, the deformable segments 624 may come together and seal in a more predictable manner with less interference. However, in other examples, each of the segments 624 could have a unique profile, which could cause them to be, for example, actuated in sequence and form sealing contact by stacking upon one another in a similar manner to device 500. Changes in the shape and / or size of the deformable segments may be achieved by adjusting the radius or other characteristics of the line of weakness 626 of the deformable segments 624 arranged around the circumference of the receptacle 602.

[0088] Another example of a sample collection device 700 is shown in Figures 7a, 7b, 7c, and 7d. The sample collection device 700 differs from device 100 described above predominantly in that the deformable segments 724 are formed with a reduced thickness compared to the portion of the wall 708 below the line of weakness 726 which is offset towards the outer surface of the wall 708. Therefore, the outer surface of the receptacle 702 is smooth and continuous, while the abrupt change in thickness defining the line of weakness 726 is formed on the internal surface of the wall 708, which is inside the receptacle 702. This may provide a more comfortable sample collection device, as the outer surface of the receptacle 702, which is in contact with the wall of the bodily cavity, is smooth and less likely to catch on the cavity wall or cause rubbing or other irritation.

[0089] Another example of a sample collection device 800 is shown in Figures 8a and 8b. The sample collection device 800 differs from device 100 described above predominantly in that it further comprises a sheath 830 and pad 832. The sheath 830 and pad 832 may take the form as described in GB2585339B. The sheath 830 is attached to the base 806 of the receptacle 802. In Figure 8a, the receptacle 802 is open and the sheath extends away from the base 802 around the elongate actuating member 816. In Figure 8b, when the receptacle 802 is in a deformed or folded position, the pad 832 may be moved over the rim 810 of the receptacle 802 such that the sheath 830 extends around the receptacle 802 to act as a sealing means.

[0090] Further features that may apply to any of the sample collection devices 100, 200, 300, 400, 500, 600,700 and 800 will now be described.

[0091] The elongate actuating member may be over moulded or co-moulded such that it forms an integral part of the receptacle. The elongate actuating member may therefore be integral to the material of the receptacle. In other examples, the elongate actuating member may be a separate part, such as a string, cord, or wire, around which the receptacle is moulded. The elongate actuating member may comprise a different material to the receptacle.

[0092] Co-moulding could involve a single moulding process comprising simultaneous injection of material forming the receptacle and the elongate actuating member into a single mould. Over moulding may involve two separate moulding processes comprising first, moulding the receptacle to form a substrate material and second, moulding the elongate actuating member to the substrate material to form a bond between the receptacle and the elongate actuating member. The moulding process may be injection moulding, compression moulding or transfer moulding. The devices or parts thereof may be manufactured by additive manufacture, such as 3D printing.

[0093] In yet further examples, the elongate actuating member may be connected to the receptacle in other ways, such as welding or gluing or via a pre-moulded fastening loop.

[0094] It will be appreciated that the material of the device, and especially of the receptacle and / or its deformable segments may require some flexibility or resilient deformability. Furthermore, the material of the device may be non-toxic or body-safe. Suitable materials for the device or parts thereof may be medical grade silicone, thermoplastic elastomer, natural rubber, medical grade polyethylene or alternative flexible plastics.

[0095] It will be appreciated that the example devices described above have various different features. For example, the devices described and illustrated have varying numbers of deformable segments, and specific examples described and illustrated with one, two, and four deformable segments. It should be appreciated that other numbers of deformable segments (and respective connecting portions) can be achieved while adhering to the principles of the present disclosure, for example, sample collection devices having three, five, six, eight, or more deformable segments can be envisaged.

[0096] Generally, the sample collection devices disclosed herein may improve sample collection by achieving one or more of: ease of use, reliability of collection, and / or user comfort. The sample collection devices disclosed herein may also provide improvements in safety and hygiene. For example, the disclosed device may provide more reliable and clean removal, transport, transfer, storage and / or handling of a sample. The devices may be reusable following sterilisation, in which case they may be constructed more durably with appropriate material thickness for reuse. Reusable sample collection devices could use either no locking mechanism or a releasable locking mechanism. Alternatively, sample collection devices according to this disclosure may be designed for single-use, which might include more permanent locking mechanisms which require destruction to release, and the materials used may be thinner, less durable, or more readily recycled or disposed of.

[0097] It will also be appreciated that the sample collection devices disclosed herein, and particularly the exemplary sample collection devices 100, 200, 300, 400,500,600,700, and 800, may have or not have certain features, such as stems, locking mechanisms, stop elements, connecting portions, differing numbers of deformable segments, different forms of line of weakness, and different receptacle shapes. It should be appreciated that sample collections devices disclosed herein may be provided or not provided with various features depending upon their exact use case, and that these features may be somewhat independent such that they can be combined in various permutations so as to achieve different functionality and effects.

Claims

1. A sample collection device for a bodily cavity comprising:a receptacle for sample collection comprising an open end, a base, and a wall extending between the base and the open end; andan elongate actuating member comprising a proximal end and a distal end;wherein the open end comprises a rim and the base comprises an aperture;wherein the wall comprises a line of weakness defining at least a portion of the perimeter of a deformable segment of the wall;wherein the elongate actuating member is configured to extend through the aperture such that a seal is formed between the elongate actuating member and the aperture to prevent leakage of the sample from the receptacle through the aperture and such that the distal end extends away from the receptacle; andwherein the proximal end of the elongate actuating member is connected to the deformable segment such that when a user applies a pulling force to the distal end, the elongate actuating element is configured to deform the deformable segment so as to at least partially close the open end of the receptacle.

2. A sample collection device as claimed in claim 1, wherein the deformable segment makes sealing contact with a further portion of the receptacle, so as to seal the open end of the receptacle.

3. A sample collection device as claimed in claim 1 or 2, wherein the deformable segment is adjacent the open end of the receptacle.

4. A sample collection device as claimed in any one of the preceding claims, further comprising a stop element formed on the elongate actuating member, the stop element configured to prevent movement of the elongate actuating member beyond the stop element.

5. A sample collection device as claimed in any one of the preceding claims, further comprising a locking mechanism configured to lock the deformable segment in sealing contact with the further portion of the receptacle.

6. A sample collection device as claimed in claim 5, wherein the locking mechanism comprises a locking feature formed on the elongate actuatingmember, wherein the locking feature is configured to pass through the aperture in a first direction but prevented from passing through the aperture in a second direction opposite to the first direction.

7. A sample collection device as claimed in claim 5, wherein the locking mechanism comprises a sliding lock.

8. A sample collection device as claimed in claim 5, wherein the locking mechanism is releasable so as to selectively permit unlocking of the locking mechanism.

9. A sample collection device as claimed in any one of the preceding claims, wherein the deformable segment has a thickness less than a thickness of the wall on an opposing side of the line of weakness.

10. A sample collection device as claimed in any one of the preceding claims, further comprising a stem connected to the base of the receptacle wherein the aperture extends through the stem.

11. A sample collection device as claimed in claim 10, further comprising a locking mechanism, wherein the locking mechanism is located in the stem.

12. A sample collection device as claimed in any one of the preceding claims, wherein the line of weakness comprises a stepped or tapered change in thickness of the wall.

13. A sample collection device as claimed in any one of claims 1 to 11, wherein the line of weakness comprises a living hinge.

14. A sample collection device as claimed in any one of claims 1 to 11, wherein: i) a wall material on a first side of the line of weakness is different to a segment materialformingthe deformable segment, such that the line of weakness is formed at the intersection between the wall material and the segment material; and / orii) the line of weakness is formed by a line or strip of hinge material different to a wall material.

15. A sample collection device as claimed in any one of the preceding claims, wherein the receptacle is bell-shaped or conical and the diameter of the receptacle is largest at the rim of the open end.

16. A sample collection device as claimed in any one of the preceding claims, comprising a plurality of deformable segments, and wherein the elongate actuating member comprises a plurality of connecting portions at the proximal end, wherein each connecting portion is configured to connect to a respective one of the plurality of deformable segments.

17. A sample collection device as claimed in claim 16, wherein the connecting portions of the elongate actuating member have non-identical lengths.

18. A sample collection device as claimed in any one of the preceding claims, wherein as plurality of deformable segments are provided and wherein at least two of the deformable segments have non-identical sizes.

19. A sample collection device as claimed in any one of the preceding claims, wherein the elongate actuating member is over moulded or co-moulded such that it forms part of the receptacle.

20. A sample collection device as claimed in any one of the preceding claims, wherein the receptacle comprises a pre-moulded fastening loop to secure the elongate actuating member to the device.

21. A sample collection device as claimed in any one of the preceding claims, further comprising a pad and sheath.

22. A sample collection device as claimed in any one of the preceding claims, further comprising a cap or lid for sealing of the receptacle.

23. A sample collection device as claimed in any one of the preceding claims, wherein the sample collection device is a menstrual cup.s

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