Fecal collection apparatus, fecal collection attachment device, and methods of using same

Abstract

The stool collection device includes a body having an insertion end and a removal end opposite the insertion end, the body forming a body space between the insertion end and the removal end, a sample collection member positionable within the body space through the insertion end, the sample collection member having a stool contact portion for holding a stool sample and a handle portion spaced from the stool contact portion, and a plug provided at the removal end of the body, the plug positionable from a closed position to an open position for restricting fluid from passing from the body space through the removal end.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of co-pending U.S. Provisional Patent Application No. 63 / 411,670, filed September 30, 2022, co-pending U.S. Provisional Patent Application No. 63 / 476,664, filed December 22, 2022, and co-pending U.S. Patent Application No. 18 / 476,618, filed September 28, 2023, which are incorporated by reference in their entirety, including any drawings.

[0002] FIELD OF THE INVENTION This disclosure relates generally to sample collection devices and methods of using same, and more particularly to a stool collection device for collecting a stool sample and mixing the stool sample with an emulsifying buffer for testing. [Background technology]

[0003] To perform an antigen test on a stool sample, a user may collect the stool sample for shipping to a testing facility. This requires the testing facility to handle the stool sample to be tested, which may result in contamination or sample spoilage. In certain instances, the stool sample can be collected for testing and inserted into a syringe, eliminating the need to handle the stool sample. However, the amount of stool sample collected is not controlled, which may result in inaccurate results.

[0004] Therefore, there is a need for an improved sample collection device for collecting fecal samples and enabling antigen testing of fecal samples while reducing handling of the fecal sample during testing. Summary of the Invention [Means for solving the problem]

[0005] In one embodiment, the stool collection device includes a body including an insertion end and a removal end opposite the insertion end, the body forming a body space between the insertion end and the removal end; a sample collection member positionable within the body space through the insertion end, the sample collection member including a stool contacting portion for holding a stool sample and a handle portion spaced from the stool contacting portion; and a plug provided at the removal end of the body, the plug positionable from a closed position to an open position to restrict fluid passage from the body space through the removal end.

[0006] In another embodiment, a stool collection device includes a body having an insertion end and a removal end, a plunger at least partially disposed within the body, a sample collection member positionable within the body through the insertion end, the sample collection member having a stool contacting portion for retaining a stool sample, and a guide cap disposed at the insertion end of the body, the plunger being movable between a locked state and an unlocked state relative to the guide cap, the plunger being prevented from moving axially in a direction corresponding to a longitudinal axis extending from the insertion end to the removal end of the body when the plunger is in the locked state, and the plunger being movable axially when the plunger is in the unlocked state.

[0007] In yet another embodiment, the fecal collection attachment device is positionable on a syringe, the fecal collection attachment device including: a guide cap positionable on the syringe, the guide cap having a rail; a plunger having a slotted portion, the plunger being rotatable relative to the guide cap to position the rail of the guide cap within the slotted portion of the plunger; and a sample collection member positionable through the plunger, the sample collection member having a fecal contact portion that retains a fecal sample, wherein when the rail of the guide cap is positioned within the slotted portion of the plunger, the plunger is prevented from moving axially relative to the guide cap; and when the rail of the guide cap is not positioned within the slotted portion of the plunger, the plunger is allowed to move axially.

[0008] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description taken in conjunction with the drawings. [Brief explanation of the drawings]

[0009] The embodiments set forth in the drawings are illustrative and exemplary in nature and are not intended to limit the subject matter defined by the claims. The following detailed description of exemplary embodiments can be understood when read in conjunction with the following drawings, in which like structure is indicated with like reference numerals and in which:

[0010] [Figure 1] 1 is a schematic top perspective view of a feces collection device according to one or more embodiments shown and described herein; FIG.

[0011] [Figure 2] 2 is a schematic bottom perspective view of the fecal collection device of FIG. 1 according to one or more embodiments shown and described herein.

[0012] [Figure 3] 2 is a schematic exploded view of the brush, body, and plug of the fecal collection device of FIG. 1 according to one or more embodiments shown and described herein.

[0013] [Figure 4] 2 is a schematic exploded view of the sample collection member, plunger, and guide cap of the stool collection device of FIG. 1 according to one or more embodiments shown and described herein. FIG.

[0014] [Figure 5] 5 is a schematic cross-sectional view of a stool collection device taken along line 5-5 of FIG. 1 according to one or more embodiments shown and described herein.

[0015] [Figure 6] 2 is a schematic plan view of the stool collection device of FIG. 1 in a locked state, according to one or more embodiments shown and described herein.

[0016] [Figure 7] 2 is a schematic plan view of the stool collection device of FIG. 1 in an unlocked state, according to one or more embodiments shown and described herein.

[0017] [Figure 8] 2 is a schematic perspective view of the stool collection device of FIG. 1 in an unlocked and raised position, according to one or more embodiments shown and described herein.

[0018] [Figure 9] 2 is a schematic perspective view of the stool collection device of FIG. 1 in an unlocked and lowered position, according to one or more embodiments shown and described herein.

[0019] [Figure 10] 1 is a schematic exploded cross-sectional view of a stool collection device including a sample collection member and a body according to one or more embodiments shown and described herein.

[0020] [Figure 11] 11 is a schematic cross-sectional view of the stool collection device of FIG. 10 including a sample collection member partially inserted within the body according to one or more embodiments shown and described herein.

[0021] [Figure 12] 11 is a schematic cross-sectional view of the sample collection member of the stool collection device of FIG. 10 in a depressed position, according to one or more embodiments shown and described herein.

[0022] [Figure 13] 11 is a schematic cross-sectional view of the sample collection member of the stool collection device of FIG. 10 engaging the buffer valve in a closed position, according to one or more embodiments shown and described herein.

[0023] [Figure 14]11 is a schematic cross-sectional view of the sample collection member of the stool collection device of FIG. 10 engaging the buffer valve in an open position, according to one or more embodiments shown and described herein.

[0024] [Figure 15] 11 is a schematic cross-sectional view of the buffer reservoir of the feces collection device of FIG. 10 in a depressed position, according to one or more embodiments shown and described herein.

[0025] [Figure 16] 11 is a schematic perspective view of the stool collection device of FIG. 10 with the buffer reservoir in a depressed position and the plug removed from the body of the stool collection device, according to one or more embodiments shown and described herein. FIG.

[0026] [Figure 17] 1 is a schematic top perspective view of a feces collection device according to one or more embodiments shown and described herein; FIG.

[0027] [Figure 18] 18 is a schematic bottom perspective view of the fecal collection device of FIG. 17 according to one or more embodiments shown and described herein.

[0028] [Figure 19] 18 is a schematic exploded view of the brush, body, plug, and filter of the fecal collection device of FIG. 17 according to one or more embodiments shown and described herein.

[0029] [Figure 20] 2 is a schematic exploded view of the sample collection member, plunger, sealing member, and guide cap of the stool collection device of FIG. 1 according to one or more embodiments shown and described herein. FIG.

[0030] [Figure 21] 21 is a schematic cross-sectional view of a stool collection device taken along line 21-21 of FIG. 17 according to one or more embodiments shown and described herein.

[0031] [Figure 22] 18 is a schematic partial plan view of the stool collection device of FIG. 17 in a locked state, according to one or more embodiments shown and described herein.

[0032] [Figure 23] 18 is a schematic partial plan view of the stool collection device of FIG. 17 in an unlocked state, according to one or more embodiments shown and described herein.

[0033] [Figure 24] 18 is a schematic perspective view of the stool collection device of FIG. 17 in an unlocked and lowered position, according to one or more embodiments shown and described herein. DETAILED DESCRIPTION OF THE INVENTION

[0034] Embodiments described herein relate to a fecal collection device that includes a body, a sample collection member positionable within the body, and a plug releasably coupled to a removal end of the body that restricts fluid from passing from the removal end through the body. The sample collection member includes a fecal contacting portion that facilitates collection of a predetermined amount of fecal material that will be mixed with an emulsifying buffer within the body. Various embodiments of the fecal collection device and the operation of the fecal collection device are described in more detail herein. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or similar parts.

[0035] Directional terms used herein, such as up, down, right, left, front, back, top, and bottom, are defined solely with reference to the figures depicted and are not intended to imply absolute orientations.

[0036] Unless expressly stated otherwise, it is in no way intended that any method described herein be construed as requiring that its steps be performed in a particular order, or that any apparatus require a particular orientation. Thus, where a method claim does not actually recite the order in which its steps are to be followed, or any apparatus claim does not actually recite an order or orientation with respect to individual components, no order or orientation is intended to be inferred. This is true, for example, but not limited to, from matters of logic regarding the arrangement of steps, operational flow, component order, or component orientation, the plain meaning derived from grammatical construction or punctuation, and any possible implicit basis for interpretation of the number or type of embodiments described herein.

[0037] As used herein, the singular forms "a," "an," and "the" include one or more referents unless the context clearly dictates otherwise. Thus, for example, reference to "a" element includes aspects having a single element or multiple elements, unless the context clearly dictates otherwise.

[0038] As will be appreciated, the stool collection devices disclosed herein allow a user to collect a stool sample and store it in a body, such as a syringe, which can be used to mix the stool sample with an emulsifying buffer and dispense a specific amount of the mixture, thereby eliminating the need to transfer the stool sample to a separate dispensing mechanism, which may result in contamination of the stool sample.

[0039] 1 and 2, a fecal collection device 100 is shown according to one or more embodiments described herein. In embodiments, the fecal collection device 100 generally includes a body 102, a sample collection member 104 that collects a fecal sample and is positionable within the body 102, and a plug 106 that is releasably coupled to the removal end 108 of the body 102. It should be understood that an emulsifying buffer, agent, or solution may be initially provided within the body 102, with the plug 106 preventing the emulsifying buffer from being dispensed from the removal end 108 of the body 102. In some embodiments, a brush 110 is provided within the body 102 to facilitate scraping of the sample collection member 104 to remove the fecal sample from the sample collection member 104 and mix the fecal sample with the emulsifying buffer.

[0040] In embodiments, the stool collection device 100 includes a plunger 112 at least partially disposed within the body 102 through an insertion end 114 of the body 102 opposite the removal end 108. The sample collection member 104 is insertable into the body 102 through the plunger 112. In some embodiments, the stool collection device 100 includes a guide cap 116 disposed at the insertion end 114 of the body 102. The guide cap 116, in embodiments, engages with the plunger 112. As described in more detail herein, in embodiments, the guide cap 116 is rotatably secured to the body 102. In embodiments, the plunger 112 is rotatable relative to the guide cap 116 to allow the plunger 112 to be positionable between an unlocked state and a locked state. In the unlocked state, as shown in FIG. 1 , the sample collection member 104 and plunger 112 can be further inserted into the body 102 by the application of force. In the locked state, as shown in FIG. 2 , the sample collection member 104 and plunger 112 are prevented from being further inserted into the body 102 by the application of force. When the plug 106 is removed from the removal end 108 of the body 102 and the plunger 112 is positioned in the unlocked state, further movement of the sample collection member 104 into the body 102 forces the plunger 112 further into the body 102. As the plunger 112 moves into the body, the emulsifying buffer mixed with the fecal sample exits the body 102 through the removal end 108. In some embodiments, the body 102 is a syringe, more specifically, a syringe body. Furthermore, the guide cap 116, the plunger 112, and the sample collection member 104 can form a fecal collection attachment device that can be retrofitted to a syringe body, such as the body 102.

[0041] 3, an exploded view of the body 102, plug 106, and brush 110 is shown in greater detail. As described herein, the plug 106 can be positioned at the removal end 108 of the body 102 to prevent emulsifying buffer from flowing out of the removal end 108 of the body 102. The brush 110 (shown in an extended or deployed position in FIG. 3) can be positioned within the body 102.

[0042] With respect to the body 102, the body 102 includes a body wall 118 that defines a body space 120. The body wall 118 includes a removal end 108 located at the lowest point of the body 102 and an insertion end 114 located at the highest point of the body 102 opposite the removal end 108. The body 102 further includes a longitudinal axis L that extends in the + / -Z direction of the coordinate axes shown in the drawings.

[0043] In an embodiment, the body 102 includes an upper body portion 122 including the insertion end 114 and a lower body portion 124 including the removal end 108. In an embodiment (not shown), the outer diameter of the lower body portion 124 is equal to or greater than the outer diameter of the upper body portion 122. In other embodiments, as shown, the outer diameter of the lower body portion 124 is smaller than the outer diameter of the upper body portion 122. In embodiments in which the outer diameter of the lower body portion 124 is smaller than the outer diameter of the upper body portion 122, an arcuate or tapered wall portion 126 may be provided extending from the upper body portion 122 to the lower body portion 124. In an embodiment, the lower body portion 124 includes a base wall 128, an inner vertical wall 130 extending from the base wall 128, and an outer vertical wall 132 extending from the base wall 128 and spaced apart from the inner vertical wall 130. The outer vertical wall 132 has an inner diameter larger than the outer diameter of the inner vertical wall 130 such that a recess 134 is formed between the outer vertical wall 132 and the inner vertical wall 130. The recess is closed at its end opposite the removal end 108 by a base wall 128. A conduit 136 is formed through the base wall 128, extending to place the inner vertical wall 130 in fluid communication with the body space 120. Thus, emulsifying buffer can flow from the body space 120 of the upper body portion 122 through the conduit 136 formed in the inner vertical wall 130 of the lower body portion 124 and out the removal end 108 of the body 102.

[0044] In some embodiments, the body 102 includes a flange 138 disposed at its insertion end 114 and extending radially relative to the longitudinal axis L of the body 102. That is, the flange 138 extends in a direction substantially perpendicular to the longitudinal axis L of the body 102. In embodiments, the flange 138 is disposed at the insertion end 114 of the body 102 and includes a first flange portion 140 extending from the insertion end 114 of the body 102 in a first radial direction relative to the longitudinal axis L, and a second flange portion 142 extending from the insertion end 114 of the body 102 in a second radial direction. In embodiments, the first flange portion 140 and the second flange portion 142 are diametrically opposed to each other and extend in opposite radial directions, although this is by way of example only. While the flange 138 illustrated herein includes a pair of flange portions 140, 142, it should be understood that any number of flange portions may be provided. For example, the flange 138 may include a single flange portion or three or more flange portions. In embodiments in which three or more flange portions are provided, the flange portions may be spaced apart from one another in any suitable arrangement, such as, for example, being circumferentially equidistant from one another.

[0045] Continuing to refer to Figure 3, the plug 106 is shown removed from the body 102. In the embodiment shown in Figure 3, the plug 106 includes a gripping portion 144 and an extension 146 extending from the gripping portion 144. The extension 146, in an embodiment, defines a space 148 therein that extends toward the gripping portion 144.

[0046] In some embodiments, plug 106 includes external threads 152 formed on the end of extension 146 that threadably mate with internal threads formed on outer longitudinal wall 132 of lower body portion 124 to retain plug 106 within lower body portion 124. In some embodiments, plug 106 may include internal threads formed on the end of extension 146 that threadably mate with external threads formed on inner longitudinal wall 130 of lower body portion 124 to retain plug 106 within lower body portion 124.

[0047] 3, the plug 106 is shown as a component that can be threaded with the lower body portion 125 of the body 102, but it should be understood that this is by way of example only. For example, in some embodiments, the plug 106 can be coupled to the lower body portion 125 of the body 102 via a frangible seal. For example, the body 102 and the plug 106 can, in embodiments, be a single, monolithic structure, and the plug 106 can be removed from the body 102 by applying a force in a direction away from the removal end 108 of the body 102.

[0048] In some embodiments, the plug 106 may be press-fit into the removal end 108 of the body 102. Regardless of the particular physical implementation of the connection, it should be understood that the plug 106 is removable from the lower body portion 124 of the body 102 by applying a force against the plug 106.

[0049] With further reference to FIG. 3 , the brush 110 is shown separate from the body 102. The brush 110 is positionable between an expanded position when not disposed within the body 102, as shown in FIG. 3 , and a folded position when disposed within the body 102, as shown in FIGS. 1 and 2 . The brush 110 has a base 154 and a cleaning member 156 disposed on the base 154. However, it should be understood that the cleaning member 156 may extend from the base 154 as a unitary, monolithic structure, as opposed to being a separate structure disposed on the base 154. An opening 158 extends through the brush 110 to allow a mixture of emulsified buffer and fecal sample to pass through the brush 110 when the cleaning member 156 is disposed within the body 102. The cleaning member 156 includes one or more cleaning portions 160 that extend radially from the base 154 when the cleaning member 156 is in the expanded position. In embodiments, the cleaning portion 160 may include an opening that allows fluid to pass therethrough.

[0050] As shown in FIG. 3 , the cleaning member 156 includes three cleaning portions 160 extending outward from the base 154 when the cleaning member 156 is in the deployed position. The cleaning portions 160 may be equidistantly spaced apart circumferentially relative to the base 154, but this is by way of example only. While the embodiment shown in FIG. 3 depicts three cleaning portions 160, it should be understood that the cleaning member 156 may include any suitable number of cleaning portions 160, such as one, two, or four or more cleaning portions 160. Each cleaning portion 160 has an inner surface 162 and an outer surface 164 opposite the inner surface 162. In the deployed position, the outer surface 164 faces outward toward the base 154, and the inner surface 163 faces inward. In embodiments, the inner surface 162 of each cleaning portion 160 includes a plurality of bristles 166 extending away from the base 154 in the deployed position. The bristles 166 may be provided in any suitable arrangement along the inner surface 162 of the cleaning portion 160. For example, the bristles 166 may be arranged in one or more rows. In embodiments, the cleaning portion 160 may be a deformable or flexible member, formed of a flexible plastic, rubber, or the like, to allow the cleaning portion 160 of the cleaning member 156 to fold relative to the base 154 and place the brush 110 in the folded position. In other embodiments, one or more hinge portions may be provided joining the cleaning portion 160 to the cleaning member 156 adjacent the opening 158 formed in the brush 110 to allow the cleaning portion 160 to flex relative to the base 154, such as a living hinge formed at the intersection of the cleaning portion 160 with the base 154. In embodiments where one or more hinge portions are provided, the cleaning portion 160 may be formed from a rigid or substantially rigid material while still allowing the brush 110 to fold between the unfolded and folded positions. In embodiments, the bristles 166 are formed from a flexible material that provides brushing and cleaning capabilities.

[0051] 4, an exploded view of the sample collection member 104, plunger 112, and guide cap 116 is shown in greater detail. As described in detail herein, the sample collection member 104, plunger 112, and guide cap 116 are disposed at the insertion end 114 of the body 102.

[0052] With respect to the sample collection member 104, the sample collection member 104 comprises a feces contacting portion 168 that collects and retains a feces sample, and a handle portion 170 spaced from the feces contacting portion 168. In an embodiment, the sample collection member 104 includes an elongate member 172 having a feces contacting end 174 and a handle end 176 opposite the feces contacting end 174. The feces contacting portion 168 is provided at the feces contacting end 174 of the elongate member 172, and the handle portion 170 is provided at the handle end 176 of the elongate member 172. In an embodiment, the feces contacting portion 168, the handle portion 170, and the elongate member 172 are formed as a single, monolithic structure. In embodiments, elongate member 172 includes a first elongate member portion 178 proximate feces-contacting portion 168, a second elongate member portion 180 proximate handle portion 170, and a tapered portion 182 extending between first elongate member portion 178 and second elongate member portion 180. Specifically, tapered portion 182 extends from second elongate member portion 180 to first elongate member portion 178 such that the diameter of first elongate member portion 178 is smaller than the diameter of second elongate member portion 180. In some embodiments, a groove 184 is formed in elongate member 172 proximate handle end 176 of elongate member 172. In embodiments, a sealing member 186, such as an O-ring, is provided in groove 184 to provide a fluid-tight seal with plunger 112.

[0053] The feces contacting portion 168 is deformable between an uncompressed position and a compressed position. The feces contacting portion 168 includes one or more pincers 188 extending from the feces contacting end 174 of the elongate member 172. As shown in FIG. 4 , the feces contacting portion 168 includes two pincers 188 spaced apart from one another. However, it should be understood that the feces contacting portion 168 may include any suitable number of pincers 188 between which a fecal sample is collected. For example, the feces contacting portion 168 may include one pincer 188 for collecting a fecal sample. In other embodiments, the feces contacting portion 168 may include three or more pincers 188. Each pincer 188 includes a proximal end 190 extending from the elongate member 172, a distal end 192 opposite the proximal end 190, an inner surface 194, and an outer surface 196 opposite the inner surface 194. In embodiments, the pincers 188 may be spaced apart to form a receptacle 200 in which a fecal sample is retained. In embodiments, each pincer 188 may have an arcuate shape such that the distance between opposing pincers 188 decreases along the length of the pincer 188 in a direction away from the elongate member 172 (i.e., in the −Z direction as shown). In this embodiment, each pincer 188 includes a widening point 198 formed at a location substantially midway between the proximal end 190 and the distal end 192 of the pincer 188. Thus, the receptacle 200 formed by the pincer 188 may have a substantially oval shape extending from the proximal end 190 and the distal end 192 of the pincer 188. The fecal contact portion 168 may be formed from a deformable or flexible material, such as a flexible plastic, rubber, or the like, to allow the pincers 188 to compress toward each other when a force is applied in a direction from the outer surface 196 of the pincer 188 toward the receptacle 200. In other embodiments, the feces contacting portion 168 may be formed from a substantially rigid material, but may be flexibly joined to the elongate member 172 to allow the pincers 188, and more specifically the distal ends 192 of the pincers 188, to compress toward each other when force is applied.

[0054] With fecal contacting portion 168 in the uncompressed position, fecal contacting portion 168 defines an outer uncompressed sample collection diameter between outer surfaces 196 of each pincer 188 at widened point 198 of each pincer 188. When fecal contacting portion 168 is in the compressed position, such as when fecal contacting portion 168 is being inserted through plunger 112, fecal contacting portion 168 defines an outer compressed sample collection diameter between outer surfaces 196 of each pincer 188 at widened point 198 of each pincer 188 that is smaller than the outer uncompressed sample collection diameter when fecal contacting portion 168 is in the uncompressed position.

[0055] The handle portion 170 is provided at a handle end 176 of the elongated member 172 opposite the feces contacting portion 168. The handle portion 170 includes a base plate 202 provided at the handle end 176 of the elongated member 172 and a tab 204 extending from the base plate 202 in a direction opposite the elongated member 172. In the embodiment shown, the base plate 202 has a circular shape. However, it should be understood that the base plate 202 may have any suitable shape.

[0056] 4 , the plunger 112 includes a plunger body 206 and a plunger guide 208. The plunger body 206 has an upper end 210, a lower end 212 opposite the upper end 210, an inner surface 214, and an outer surface 216 opposite the inner surface 214 and extending between the upper end 210 and the lower end 212. In an embodiment, the inner surface 214 and the outer surface 216 each taper from the upper end 210 to the lower end 212. The inner surface 214 of the plunger body 206 forms an open-ended channel 218, and the end of the channel 218 opposite the plunger guide 208 includes a sample collection opening 220. The sample collection opening 220 defines an opening inner diameter. In an embodiment, a groove 222 is formed in the outer surface 216 of the plunger body 206 adjacent the lower end 212 of the plunger body 206, and a sealing member 224, such as an O-ring or gasket, is provided in the groove 222 to provide a fluid-tight seal between the outer surface 216 of the plunger body 206 and the body 102.

[0057] Continuing to refer to FIG. 4 , the plunger guide 208 is provided at the upper end 210 of the plunger body 206. The plunger guide 208 includes a first finger 226 extending outward from the outer surface 216 of the plunger body 206. In the embodiment shown, the plunger guide 208 includes the first finger 226 and a second finger 228 extending outward from the outer surface 216 of the plunger body 206. In the embodiment shown, the first finger 226 and the second finger 228 are diametrically opposed to each other such that the first finger 226 and the second finger 228 are disposed on opposite sides of the plunger body 206, although it should be understood that this is by way of example only. While the plunger guide 208 is shown as including the first finger 226 and the second finger 228, it should be understood that the plunger guide 208 may include any number of fingers, such as one finger or three or more fingers.

[0058] With respect to the first finger 226, the first finger 226 includes a lower finger portion 230 and an upright finger portion 232 extending from the lower finger portion 230. The lower finger portion 230 includes an extending portion 234 extending in a direction away from the plunger body 206 from the point where the upright finger portion 232 extends from the lower finger portion 230. Similarly, the second finger 228 includes a lower finger portion 236 and an upright finger portion 238 extending from the lower finger portion. The lower finger portion 236 of the second finger 228 similarly includes an extending portion 240 extending from the point where the upright finger portion 238 extends from the lower finger portion 236. As shown in FIG. 4 , the upright finger portion 238 of the second finger 228 includes a tapered portion 242. The tapered portion 242 forms a recess 244 with the lower finger portion 236 such that the length of the extension portion 240 of the second finger 228 extending from the upright finger portion 238 of the second finger 228 is greater than the length of the extension portion 234 of the first finger 226 extending from the upright finger portion 232 of the first finger 226.

[0059] Continuing to refer to FIG. 4 , the guide cap 116 includes an outer wall 246 including an upper end 248 and a lower end 250. The lower end 250 of the outer wall 246 is provided with a bottom wall 252 having a notch 254 formed therein. As described in more detail herein, the notch 254 enables the guide cap 116 to be positioned on the body 102 ( FIG. 3 ) at the insertion end 114 by allowing the flange 138 ( FIG. 3 ) of the body 102 to extend through the notch 254 and be received within the guide cap 116. The guide cap 116 includes a blocking wall 256 extending from the outer wall 246 toward the center of the guide cap 116. While only one blocking wall 256 is shown, it should be understood that a blocking wall 256 may extend from both sides of the outer wall 246 of the guide cap 116. A lower retention groove 258 is formed by the overlap between the bottom wall 252 and the blocking wall 256. As described in more detail herein, the flange 138 (FIG. 3) of the body 102 is insertable through a notch 254 formed in the bottom wall 252 and is positionable within the lower retention groove 258 when the guide cap 116 is rotated relative to the body 102 to inhibit movement of the body 102 independent of the guide cap 116 along the longitudinal axis L, thereby retaining the guide cap 116 on the insertion end 114 of the body 102.

[0060] 1, 2, and 4, the guide cap 116 includes an upper retention groove 260 formed in the outer wall 246. The upper retention groove 260 is defined by a lower recess wall 262 and an upper recess wall 264 formed in the outer wall 246 of the guide cap 116. More specifically, the upper retention groove 260 comprises a first groove portion 266 formed between the upper recess wall 264 and the upper end 248 of the guide cap 116, and a second groove portion 268 formed between the lower recess wall 262 and the upper end 248 of the guide cap 116. As best shown in FIG. 2, the first groove portion 266 has a height defined by the distance between the upper end 248 of the guide cap 116 and the upper recess wall 264, which is greater than the height of the second groove portion 268 defined by the distance between the upper end 248 of the guide cap 116 and the lower recess wall 262. It should be appreciated that the height of the first groove 266 is only slightly greater than the thickness of the lower finger portion 230 of the first finger 226 to prevent substantial movement of the plunger 112 along the longitudinal axis L. In embodiments, the height of the first groove 266 is 5% to 50% greater than the thickness of the lower finger portion 230. In embodiments, the height of the first groove 266 is 5% to 20% greater than the thickness of the lower finger portion 230. As described in more detail herein, the upper retention groove 260 partially receives the first finger 226 of the plunger 112; more specifically, the first finger 226 is positionable between the first groove 266 or the second groove 268 based on rotation of the plunger 112 relative to the guide cap 116 when the guide cap 116 is disposed on the body 102. 2 and 4, the guide cap 116 includes a pair of upper retention grooves 260 formed therein such that each upper retention groove 260 receives a corresponding one of the first finger 226 or the second finger 228. In embodiments, as shown in FIG. 2, a protrusion 270 extends from the upper end 248 of the outer wall 246 within the upper retention grooves 260 toward the upper recess wall 264. In some embodiments, the protrusion 270 extends from the upper end 248 of the outer wall 246 within each upper retention groove 260. In other embodiments, the protrusion 270 extends from the upper recess wall 264 to the upper end 248 of the outer wall 246.In other embodiments, protrusions 270 are provided on both the upper recess wall 264 and the upper end 248 of the outer wall 246 within each upper retaining groove 260 .

[0061] Referring now to FIG. 5 , a cross-sectional view of the fecal collection device 100 is shown in an assembled state. As shown, in the assembled state, the plug 106 is disposed at the removal end 108 of the body 102. In the embodiment shown in FIG. 5 , the extension 146 of the plug 106 is received within a recess 134 formed between the inner and outer longitudinal walls 130, 132 of the body 102. Furthermore, the inner longitudinal wall 130 of the body 102 is received within a space 148 formed in the extension 146 of the plug 106. As described herein, the plug 106 may be press-fit into the removal end 108 of the body 102, may be integrally formed with the body 102 as a unitary, monolithic structure and separable from the body 102 with a frangible seal, or may be threadedly coupled to the body 102 by external threads 152. With extension 146 of plug 106 inserted into recess 134 of lower body portion 124, gripping portion 144 remains disposed outside lower body portion 124, such that gripping portion 144 remains accessible by a user and plug 106 can be removed from body 102 when force is applied. As shown, emulsifying buffer 272 is provided within body space 120 and retained therein by plug 106, thereby preventing emulsifying buffer 272 from exiting body 102 through conduit 136 of lower body portion 124.

[0062] As shown in Figure 5, the brush 110 is positioned within the body cavity 120. In the embodiment shown in Figure 5, the brush 110 is positioned proximate the removal end 108 of the body 102. The brush 110 is shown in a folded position within the body cavity 120 such that the cleaning portion 160 extends substantially along the longitudinal axis L of the body 102 with the bristles 166 facing inward. Additionally, in the configuration shown in Figure 5, the brush 110 is positioned such that the opening 158 extending through the base 154 of the brush 110 is coaxially aligned with the conduit 136 formed in the lower body portion 124 of the body 102.

[0063] In embodiments, a filter 274 may be disposed within the body space 120 between the base 154 of the brush 110 and the base wall 128 of the lower body portion 124. The filter 274 may be formed from a porous material and may have a plurality of channels formed therein to allow particles mixed with the emulsifying buffer 272 having a diameter equal to or less than a predetermined diameter to pass through the filter 274 toward the removal end 108 of the body 102. Thus, particles having a diameter greater than the predetermined diameter defined by the filter 274 remain on the same side of the filter 274 as the brush 110.

[0064] In use, the guide cap 116 is placed onto the insertion end 114 of the body 102 by inserting the insertion end 114, and in particular the flange 138 of the body 102, through the notch 254 in the bottom wall 252 of the guide cap 116 and rotating the guide cap 116 relative to the body 102 so that the flange 138 is retained within the lower retention groove 258 of the guide cap 116. Specifically, when the guide cap 116 is rotated relative to the body 102, the first flange portion 140 and the second flange portion 142 are each positioned within the respective lower retention groove 258 formed between the blocking wall 256 and the bottom wall 252 of the guide cap 116. Thus, the guide cap 116 is prohibited from moving along the longitudinal axis L of the body 102.

[0065] 5 , the plunger 112 is shown inserted into the insertion end 114 of the body 102 and engaged with the guide cap 116. In embodiments, the plunger 112 may be first placed into the guide cap 116, which may then be attached to the body 102. However, it should be understood that in embodiments, it may be possible to place the plunger 112 into the insertion end 114 of the body 102 and engage with the guide cap 116 after the guide cap 116 is already secured onto the insertion end 114 of the body 102. In some embodiments, the guide cap 116 may be formed as a unitary, monolithic structure with the body 102 to eliminate the need to bond the guide cap 116 onto the body 102.

[0066] 5 , the first finger 226 and the second finger 228 of the plunger 112 are positioned to extend through the upper retention groove 260 of the guide cap 116. With the plunger body 206 disposed within the body space 120, the sealing member 224 circumscribing the outer surface 196 of the plunger body 206 adjacent the lower end 212 of the plunger body 206 provides a fluid-tight seal between the outer surface 196 of the plunger body 206 and the body wall 118 of the body 102. Initially, as shown, the first finger 226 and the second finger 228 are each positioned within the corresponding first groove portion 266 of the upper retention groove 260 such that the plunger 112 is in the locked state. As described herein, when the plunger 112 is in the locked state, the plunger 112 is restricted from moving along the longitudinal axis L of the body 102 in a direction toward the insertion end 114 of the body 102.

[0067] The sample collection member 104 may then be utilized to collect a fecal sample, such as by inserting the fecal contacting portion 168 into the fecal material and collecting the fecal sample in the receptacle 200 between the pincers 188. The sample collection member 104 may then be inserted into the body 102 through a sample collection opening 220 formed in the plunger body 206 and inserted into the body space 120 through the insertion end 114 of the body 102. Prior to inserting the sample collection member 104 into the plunger 112, the fecal contacting portion 168 is in an uncompressed position with the pincers 188 spaced apart, defining an uncompressed sample collection outer diameter. As described herein, the uncompressed sample collection outer diameter of the plunger body 206 is larger than the opening inner diameter of the sample collection opening 220. Thus, when the feces contacting portion 168 is inserted into the plunger 112 and contacts the inner surface 214 of the plunger body 206 at the sample collection opening 220, the inner surface 214 of the plunger body 206 compresses the pincers 188 of the feces contacting portion 168, placing the feces contacting portion 168 in a compressed position. As described herein, when the feces contacting portion 168 is in the compressed position, the feces contacting portion 168 has a compressed sample collection outer diameter that is smaller than the opening inner diameter. Thus, the feces contacting portion 168 is able to pass through the sample collection opening 220. In this way, excess fecal sample adhering to the exterior of the feces contacting portion 168 is retained within the plunger 112, rather than being inserted further into the body space 120 and mixed with the emulsification buffer 272. This ensures that only a controlled amount of fecal material is able to mix with the emulsification buffer 272 within the body space 120. As shown, when the sample collection member 104 is fully inserted into the body 102, the sealing member 186 on the elongated member 172 of the sample collection member 104 forms a fluid-tight seal between the elongated member 172 of the sample collection member 104 and the inner surface 214 of the plunger body 206. This prevents the emulsifying buffer 272 from flowing out the insertion end 114 of the body 102 through the channel 218 formed in the plunger 112.

[0068] To mix the fecal sample with the emulsifying buffer 272, the sample collection member 104 is moved and rotated in opposite directions throughout the body space 120 along the longitudinal axis L of the body 102. In this manner, the bristles 166 of the brush 110 scrape the fecal sample from the fecal contacting portion 168 of the sample collection member 104 so that the fecal sample mixes with the emulsifying buffer 272.

[0069] 6 and 7, the plunger 112 is shown in a locked and unlocked state, respectively. When in the locked state, as shown in FIG. 6, the first finger 226 and the second finger 228 of the plunger 112 are disposed within the first groove portion 266 of the corresponding upper retention groove 260. More specifically, when the plunger 112 is in the locked state, the first finger 226 and the second finger 228 are disposed between the upper end 248 of the outer wall 246 and the upper recess wall 264 of the corresponding upper retention groove 260. A protrusion 270 extends from the upper end 248 of the outer wall 246 above the upper recess wall 264, thereby preventing the plunger 112 from being inadvertently moved from the locked state to the unlocked state. Specifically, when plunger 112 is in the locked state, protrusion 270 applies a predetermined amount of resistance to plunger 112 rotating toward the unlocked state as protrusion 270 abuts first finger 226. The particular amount of resistance corresponds to the size of protrusion 270 extending into upper retention groove 260. When a predetermined force is applied to rotate plunger 112 from the locked state to the unlocked state, first finger 226 can pass protrusion 270 and be positioned within second groove 268. Similarly, when a predetermined force is applied to rotate plunger 112 from the locked state back to the unlocked state, first finger 226 passes back past protrusion 270 and is positioned within first groove 266.

[0070] 7 , the first finger 226 and the second finger 228 of the plunger 112 are disposed within the second groove portion 268 of the corresponding upper retention groove 260. More specifically, when the plunger 112 is in the locked state, the first finger 226 and the second finger 228 are disposed between the upper end 248 of the outer wall 246 and the lower recess wall 262 of the corresponding upper retention groove 260. Because the height of the second groove portion 268 extending between the upper end 248 of the outer wall 246 and the lower recess wall 262 is significantly greater than the thickness of the first finger 226 and the second finger 228, the plunger 112 is able to move along the longitudinal axis L of the body 102 toward the removal end of the body 102 to the point where the first finger 226 and the second finger 228 abut the lower recess wall 262.

[0071] In embodiments, indicia may be provided on the upper end 248 of the outer wall 246 of the guide cap 116 to provide a visual indication of the position or state of the plunger 112. The indicia may include a lock symbol 276 to indicate that the plunger 112 is in a locked state and an unlock symbol 278 to indicate that the plunger 112 is in an unlocked state. For example, when the plunger 112 is in the locked state, the first finger 226 is disposed within the first groove portion 266 of the upper retention groove 260 and is positioned adjacent to the lock symbol 276, as shown in FIG. 6. Alternatively, when the plunger 112 is in the unlocked state, the first finger 226 is disposed within the second groove portion 268 of the upper retention groove 260 and is positioned adjacent to the unlock symbol 278, as shown in FIG. 7.

[0072] 8, the plunger 112 is shown in an unlocked state with the first finger 226 disposed within the second groove portion 268 of the upper retaining groove 260. More specifically, the plunger 112 is shown in a raised position abutting the upper end 248 of the outer wall 246 of the plunger 112. It should be understood that when in the raised position, the mixture of emulsifying buffer 272 (FIG. 5) and fecal sample is not dispensed from the body 102. To dispense the mixture of emulsifying buffer 272 and fecal sample from the removal end 108 of the body 102, the sample collection member 104 is pushed in a direction toward the removal end 108 of the body 102 along the longitudinal axis L such that the handle portion 170 of the sample collection member 104 presses against the plunger 112, causing the plunger 112 to move along the longitudinal axis L toward the removal end 108 of the body 102. 9, the plunger 112 is shown in a lowered position such that the plunger 112 has traveled a predetermined stroke and the first finger 226 abuts the lower recess wall 262. In use, the sample collection member 104 and plunger 112 alternate between the raised and lowered positions to dispense additional supplies of the mixture of emulsifying buffer 272 and fecal sample.

[0073] 10-16, another embodiment of a fecal collection device 300 is shown according to one or more embodiments described herein. It should be understood that the fecal collection device 300 may include features of the fecal collection device 100 (FIGS. 1-9) described herein, such as the brush 110, plunger 112, and guide cap 116, without departing from the scope of the present disclosure. In an embodiment, the fecal collection device 300 generally includes a body 302, a sample collection member 304 for collecting a fecal sample and positionable within the body 302, and a plug 306 releasably coupled to the body 302.

[0074] 10 , body 302 includes an insertion end 308 and a removal end 310 opposite insertion end 308. Body 302 defines a body space 312 between insertion end 308 and removal end 310. More specifically, body 302 includes a body wall 314 that defines body space 312. Body wall 314 includes removal end 310 at the lowest point of body 302 and insertion end 308 at the highest point of body 302 opposite removal end 310. It should be understood that body 302 may include a structure similar to that of body 102 described above.

[0075] The body 302, in an embodiment, includes a buffer reservoir 316 disposed within the body space 312. The buffer reservoir 316 includes a reservoir body 318 including one or more sidewalls 320 that define a reservoir space 322. The reservoir space 322 has a first end 324 facing the removal end 310 of the body 302 and a second end 326 facing the insertion end 308 of the body 302 opposite the first end 324. The first end 324 of the reservoir body 318 is a closed end, and the second end 326 of the reservoir body 318 is an open end, allowing the sample acquisition member 304 to be inserted into the reservoir space 322. The reservoir body 318 further includes one or more openings 328 in the one or more sidewalls 320 of the reservoir body 318 proximate the second end 326 of the reservoir body 318. In some embodiments, the one or more openings 328 are elongated in a direction extending from the first end 324 of the reservoir body 318 to the second end 326 of the reservoir body 318 and are spaced apart from one another around the circumference of the reservoir body 318.

[0076] In embodiments, the emulsifying buffer 330 is provided within the reservoir space 322 and retained therein by a buffer plunger 332 provided at the second end 326 of the reservoir body 318. In some embodiments, the buffer plunger 332 engages with one of the side walls 320 of the reservoir body 318. In embodiments, the buffer plunger 332 includes a plunger seal 334 provided at the second end 326 of the reservoir body 318. The buffer plunger 332, in embodiments, secures the reservoir body 318 within the body space 312. In embodiments, the plunger seal 334 is an elastomeric gasket or the like, at least partially disposed between the side wall 320 and the body wall 314 of the reservoir body 318 to provide a friction fit between the reservoir body 318 and the body wall 314. The plunger seal 334 includes an opening 336 that allows the sample acquisition member 304 to extend through the plunger seal 334 and enter the reservoir space 322. As described in more detail herein, the reservoir body 318 is movable between a retracted position and a depressed position within the body space 312. When moving from the retracted position to the depressed position, the reservoir body 318 moves in a direction toward the removal end 310 of the body 302 when a force is applied by the sample acquisition member 304 against the first end 324 of the reservoir body 318.

[0077] The buffer plunger 332, in embodiments, includes a buffer valve 338 that allows the emulsification buffer 330 to be dispensed from the reservoir space 322 through one or more openings 328 in the sidewall 320 of the reservoir body 318 upon application of force by the sample collection member 304, which actuates the buffer valve 338. As best shown in FIGS. 13 and 14 , the buffer valve 338 includes a fixed portion 340 and a releasable portion 342 movable relative to the fixed portion 340 and is operably positionable between a closed position and an open position. When a force exceeding a first threshold is applied to the releasable portion 342 by the sample collection member 304, the releasable portion 342 moves relative to the fixed portion 340, positioning the buffer valve 338 from the closed position to an open position. In the open position, a space 344 is formed between the releasable portion 342 and the fixed portion 340. As described in more detail herein, the emulsifying buffer 330 can exit the reservoir space 322 through the opening 328, either around or through the sample collection member 304, through a space 344 formed between the releasable portion 342 and the fixed portion 340. Additionally, the buffer valve 338 is movable within the reservoir space 322 upon application of a force exceeding a second threshold, the second threshold being greater than the first threshold, by the feces-contacting portion of the sample collection member, as described herein.

[0078] 10 , in some embodiments, a filter 346 is disposed within the body space 312 between the first end 324 of the buffer reservoir 316 and the removal end 310 of the body 302. The filter 346 may be formed from a porous material and may have a plurality of channels formed therein to allow particles mixed with the emulsified buffer 330 having a diameter equal to or less than a predetermined diameter to pass through the filter 346 toward the removal end 310 of the body 302. Thus, particles having a diameter greater than the predetermined diameter defined by the filter 346 remain on the same side of the filter 346 as the buffer reservoir 316.

[0079] 10 , the plug 306 is releasably coupled to the removal end 310 of the body 302, and the plug 306 is positionable from a closed position, in which the plug 306 restricts fluid from passing from the body cavity 312 through the removal end 310, to an open position. Thus, when the plug 306 is coupled to the removal end 310 of the body 302 and in the closed position, the plug 306 prevents the emulsification buffer 330 from being dispensed from the removal end 310 of the body 302. It should be understood that the plug 306 may be similar to the plug 106 described herein. Thus, in embodiments, the plug 306 may be threadably coupled to the body 302 as described herein. In some embodiments, the plug 306 may be coupled to the body 302 via a frangible seal. For example, the body 302 and the plug 306, in embodiments, are a unitary, monolithic structure, and the plug 306 may be detachable from the body 302 by applying a force in a direction away from the removal end 310 of the body 302.

[0080] The sample collection member 304 is positionable within the body 302 via an insertion end 308. The sample collection member 304 may be similar to the sample collection member 104 described above. More specifically, the sample collection member 304 includes a fecal contacting portion 348 that collects and retains a fecal sample, and an elongated member 350 extending from the fecal contacting portion 348. The elongated member 350 includes a fecal contacting end 352 and a handle end 354 opposite the fecal contacting end 352. The fecal contacting portion 348 is disposed at the fecal contacting end 352 of the elongated member 350. The fecal contacting portion 348 may be similar to the fecal contacting portion 168 described above.

[0081] In embodiments, the sample collection member 304 may include a handle portion 356 slidably positionable along the elongated member 350. The handle portion 356 may be positionable between an extended position and a retracted position to adjust the overall length of the sample collection member 304. With the handle portion 356 in the extended position, the handle portion 356 extends from the elongated member 350 in a direction opposite the fecal contacting portion 348, allowing a fecal sample to be collected by the fecal contacting portion 348 while maintaining an increased distance between the user and the sample itself. In embodiments, the handle portion 356 may include a cap 358 provided at the end of the handle portion 356 facing the fecal contacting portion 348 and adjacent the handle end 354 of the elongated member 350 when in the extended position.

[0082] Once the elongate member 350 is inserted into the body 302, the handle portion 356 can be unlocked, such as by rotating the handle portion 356 relative to the elongate member 350 from a locked position and sliding the handle portion 356 along the elongate member 350 from an extended position to a depressed position, thereby shortening the overall length of the sample acquisition member 304. Once in the depressed position, the handle portion 356 can again be rotated such that the cap 358 engages the insertion end 308 of the body 302 to seal the body 302. In embodiments, the cap 358 can lock into engagement with the insertion end 308 of the body 302 either upon contact or rotation of the handle portion 356, locking the sample acquisition member 304 to the body 302.

[0083] 10-16 illustrate various stages in which the fecal collection device 300 is used. Accordingly, the operation of the fecal collection device 300 will now be described. As shown in FIG. 10, the sample collection member 304 is first utilized to collect a sample within the fecal contacting portion 348. As described herein, the handle portion 356 may be initially provided in an extended position to increase the overall length of the sample collection member 304 to facilitate sample collection by the operator. Additionally, the reservoir body 318 is initially in a retracted position, and the buffer valve 338 is initially in a closed position, such that the emulsifying buffer 330 is contained within the reservoir space 322. Furthermore, the plug 306 is provided at the removal end 310 of the body 302 to prevent fluid from entering or exiting the body 302.

[0084] 11 , the sample collection member 304 is shown partially inserted into the body 302 through the insertion end 308. Specifically, the feces-contacting portion 348 is inserted into the body 302 and extends through the plunger seal 334. It should be understood that the inner diameter of the opening 336 in the plunger seal 334 corresponds to the outer diameter of the feces-contacting portion 348 of the sample collection member 304. Thus, the plunger seal 334 ensures that a predetermined amount of the collected sample is able to enter the buffer reservoir 316. Specifically, the plunger seal 334 scrapes excess sample from the feces-contacting portion 348, allowing the excess sample to enter the buffer reservoir 316.

[0085] 12 , the handle portion 356 is rotated to lock and disengage the elongate member 350, allowing the handle portion 356 to move from the extended position to the pushed-in position. Once the handle portion 356 is in the pushed-in position, the handle portion 356 can again be rotated relative to the elongate member 350 to lock the cap 358 of the handle portion 356 to the body 302 and seal the insertion end 308 of the body 302. It should be appreciated that the handle portion 356 can selectively disengage the cap 358 such that the sample collection member 304 can be further inserted into the body 302 without the cap 358 inhibiting movement of the sample collection member 304.

[0086] 13 , the feces contacting portion 348 is shown inserted further into the reservoir space 322 and engaging the releasable portion 342 of the buffer valve 338, which is shown in the closed position. As shown, the releasable portion 342 may be insertable into the end of the feces contacting portion 348. With the feces contacting portion 348 inserted further into the reservoir space 322, the elongated member 350 extends through the plunger seal 334 to maintain a seal with the second end 326 of the reservoir body 318.

[0087] 14 , the sample collection member 304 is shown inserted further into the body 302 such that the fecal contacting portion 348 pushes the releasable portion 342 toward the first end 324 of the reservoir body 318, placing the buffer valve 338 in an open position. As described herein, with the buffer valve 338 in the open position, a space 344 is formed between the releasable portion 342 and the fixed portion 340, allowing the emulsifying buffer 330 to flow therebetween toward the second end 326 of the reservoir body 318.

[0088] 15 , the sample collection member 304 is shown inserted further into the reservoir space 322 such that the sample collection member 304 is pushed further into the body 302 toward the removal end 310. In doing so, the buffer valve 338 is moved toward the first end 324 of the reservoir body 318, displacing the emulsifying buffer 330 toward the second end 326 of the reservoir body 318. More specifically, the emulsifying buffer 330 is directed through a space 344 formed in the buffer valve 338, around the feces-contacting portion 348 and elongate member 350 of the sample collection member 304, and out of the reservoir space 322 through one or more openings 328 in the sidewall 320 of the reservoir body 318. As the emulsifying buffer 330 moves around the feces contacting portion 348, the emulsifying buffer 330 mixes with the sample collected by the feces contacting portion 348 to form a mixture of emulsifying buffer 330 and the collected sample, which is stored in the body space 312 between the body wall 314 and the reservoir body 318, and therefore outside the reservoir space 322.

[0089] 16 , the mixture of emulsifying buffer 330 and collected sample is displaced from reservoir space 322 and provided between body wall 314 and reservoir body 318. It should be appreciated that plunger seal 334 maintains a fluid-tight seal between reservoir body 318 and body wall 314 to prevent the mixture of emulsifying buffer 330 and collected sample from flowing out of body space 312 toward insertion end 308 of body 302. Plunger seal 334 also creates a vacuum within body 302 between body wall 314 and reservoir body 318.

[0090] To expel the mixture of emulsifying buffer 330 and sample mixture from stool collection device 300, plug 306 is removed from removal end 310 of body 302, for example, by rotating plug 306 if threaded, or by separating plug 306 from body 302 if a frangible seal is provided. Sample collection member 304 is then pushed further into body 302 toward removal end 310, directing the mixture through filter 346 located at removal end 310. As the mixture passes through filter 346, particulates larger than a predetermined diameter are prevented from passing through filter 346, and the remaining mixture is expelled from body 302 through removal end 310.

[0091] 17 and 18 , a fecal collection device 400 is shown according to one or more embodiments described herein. In embodiments, the fecal collection device 400 generally includes a body 402, a sample collection member 404 that collects a fecal sample and is positionable within the body 402, and a plug 406 that is releasably coupled to a removal end 408 of the body 402. It should be appreciated that an emulsifying buffer, agent, or solution may be initially provided within the body 402, with the plug 406 preventing the emulsifying buffer from being dispensed from the removal end 408 of the body 402. In some embodiments, a brush 410 is provided within the body 402 to facilitate scraping of the sample collection member 404 to remove the fecal sample from the sample collection member 404 and mix the fecal sample with the emulsifying buffer.

[0092] In embodiments, the fecal collection device 400 includes a plunger 412 disposed at least partially within the body 402 through an insertion end 414 of the body 402 opposite the removal end 408. The sample collection member 404 is insertable into the body 402 through the plunger 412. In some embodiments, the fecal collection device 400 includes a guide cap 416 disposed at the insertion end 414 of the body 402. The guide cap 416, in embodiments, engages with the plunger 412. As described in more detail herein, in embodiments, the guide cap 416 is rotatably secured to the body 402. In embodiments, the plunger 412 is rotatable relative to the guide cap 416 to allow the plunger 412 to be positionable between an unlocked state and a locked state. In the unlocked state, the plunger 412 can be further inserted into the body 402 by the application of force. In the locked state, the plunger 412 is prevented from being further inserted into the body 402 by the application of force. With plug 406 removed from removal end 408 of body 402 and plunger 412 positioned in the unlocked state, movement of plunger 412 causes the emulsifying buffer mixed with the fecal sample to be expelled from body 402 through removal end 408. In some embodiments, body 402 is a syringe, more specifically a syringe body. Furthermore, guide cap 416, plunger 412, and sample collection member 404 can form a fecal collection attachment device that can be retrofitted onto a syringe body, such as body 402.

[0093] 19, an exploded view of the body 402, plug 406, and brush 410, and filter 574 is shown in greater detail. As described herein, the plug 406 can be positioned at the removal end 408 of the body 402 on top of the filter 574 to prevent emulsified buffer from flowing out the removal end 408 of the body 402. The brush 410 (shown in an extended or deployed position in FIG. 19) can be positioned within the body 402.

[0094] With respect to the body 402, the body 402 includes a body wall 418 that defines a body space 420. The body wall 418 includes a removal end 408 at the lowest point of the body 402 and an insertion end 414 at the highest point of the body 402 opposite the removal end 408. The body 402 further includes a longitudinal axis L that extends in the + / -Z direction of the coordinate axes shown in the drawings.

[0095] 19 and 21 , the body 402 includes an upper body portion 422 including the insertion end 414 and a lower body portion 424 including the removal end 408. In an embodiment (not shown), the outer diameter of the lower body portion 424 is equal to or greater than the outer diameter of the upper body portion 422. In another embodiment, as shown, the outer diameter of the lower body portion 424 is smaller than the outer diameter of the upper body portion 422. In an embodiment, the upper body portion 422 includes a base wall 428, and the lower body portion 424 is formed by a vertical wall 430 extending from the base wall 428. The vertical wall 430 of the lower body portion 424 includes a conduit 436 extending through the base wall 428 to fluidly connect the lower body portion 424 to the body cavity 420 of the upper body portion 422. Thus, the emulsifying buffer can flow from the body space 420 of the upper body portion 422 through the conduit 436 formed by the vertical wall 430 of the lower body portion 424 and out the removal end 408 of the body 402 .

[0096] In some embodiments, the body 402 includes a flange 438 disposed at its insertion end 414 and extending radially relative to the longitudinal axis L of the body 402. That is, the flange 438 extends in a direction substantially perpendicular to the longitudinal axis L of the body 402. In embodiments, the flange 438 is disposed at the insertion end 414 of the body 402 and includes a first flange portion 440 extending from the insertion end 414 of the body 402 in a first radial direction relative to the longitudinal axis L, and a second flange portion 442 extending from the insertion end 414 of the body 402 in a second radial direction. In embodiments, the first flange portion 440 and the second flange portion 442 are diametrically opposed to each other and extend in opposite radial directions, although this is by way of example only. While the flange 438 shown herein includes a pair of flange portions 440, 442, it should be understood that any number of flange portions may be provided. For example, the flange 438 may include a single flange portion or three or more flange portions. In embodiments in which three or more flange portions are provided, the flange portions may be spaced apart from one another in any suitable arrangement, such as, for example, being circumferentially equidistant from one another.

[0097] 19 and 21, there is shown a plug 406 attached to the body 402. In the embodiment shown in Figures 19 and 21, the plug 406 includes a gripping portion 444 and an extension portion 446 extending from the gripping portion 444.

[0098] In embodiments, the plug 406 may be integrally formed as a unitary monolithic structure with the body 402 at the removal end 408 of the body 402. Thus, the frangible seal 450 may be formed in either the plug 406 or the body 402 where the plug 406 and body 402 meet. The frangible seal 450 may include, for example, perforated edges, multiple cuts, etc., to allow the plug 406 to be easily removed from the body 402, such as by applying a force away from the removal end 408 of the body 402.

[0099] In other embodiments, the plug 406 may be press-fit into or threadedly engage with the removal end 408 of the body 402, as described in other embodiments shown herein. Regardless of the specific physical implementation of the connection, it should be understood that the plug 406 is removable from the lower body portion 424 of the body 402 by applying a force against the plug 406.

[0100] 19, the brush 410 is shown separate from the body 402. The brush 410 is positionable between an expanded position when not disposed within the body 402, as shown in FIG. 19, and a collapsed position when disposed within the body 402, as shown in FIGS. 17 and 18. The brush 410 includes a brush body 456 having a first surface 462 and a second surface 464 opposite the first surface 462. The brush body 456 also includes one or more bristles 466 extending from the first surface 462 in a direction perpendicular to the plane of the body 402. Thus, when the brush 410 is in the collapsed position, the bristles 466 each extend radially toward one another. The bristles 466 may be provided in any suitable arrangement along the first surface 462 of the brush body 456. For example, the bristles 466 may be arranged in one or more rows. In embodiments, the brush body 456 and bristles 466 may each be formed from a flexible plastic, rubber, or the like to allow the brush body 456 to be folded into a collapsed position.

[0101] A filter 574 may be disposed within the body space 420 between the brush 410 and the base wall 428 of the lower body portion 424. The filter 574 may be formed from a porous material or may have a plurality of channels formed therein to allow particles having a diameter equal to or less than a predetermined diameter, mixed with the emulsifying buffer, to pass through the filter 574 toward the removal end 408 of the body 402. Thus, in use, particles having a diameter greater than the predetermined diameter defined by the filter 574 remain on the same side of the filter 574 as the brush 410.

[0102] 20 , an exploded view of the sample collection member 404, plunger 412, and guide cap 416 is shown in greater detail. As described in detail herein, the sample collection member 404, plunger 412, and guide cap 416 are disposed at the insertion end 414 of the body 402.

[0103] With respect to the sample collection member 404, the sample collection member 404 comprises a fecal contacting portion 468 for collecting and retaining a fecal sample and a handle portion 470 spaced from the fecal contacting portion 468. In an embodiment, the sample collection member 404 includes an elongate member 472 having a fecal contacting end 474 and a handle end 476 opposite the fecal contacting end 474. The fecal contacting portion 468 is provided at the fecal contacting end 474 of the elongate member 472, and the handle portion 470 is provided at the handle end 476 of the elongate member 472. In an embodiment, the fecal contacting portion 468, the handle portion 470, and the elongate member 472 are formed as a single, monolithic structure. In an embodiment, the elongate member 472 has a tapered portion located substantially in the middle of the elongate member 472, as described in other embodiments herein. In some embodiments, as described in other embodiments herein, a groove is formed in the elongated member 472 adjacent the handle end 476 of the elongated member 472, and a sealing member such as an O-ring is provided in the groove to provide a fluid-tight seal with the plunger 412.

[0104] The feces contacting portion 468 is deformable between an uncompressed position and a compressed position. The feces contacting portion 468 includes one or more pincers 488 extending from the feces contacting end 474 of the elongate member 472. As shown in FIG. 20 , the feces contacting portion 468 includes two pincers 488 spaced apart from one another. However, it should be understood that the feces contacting portion 468 may include any suitable number of pincers 488 between which a fecal sample is collected. For example, the feces contacting portion 468 may include one pincer 488 for collecting a fecal sample. In other embodiments, the feces contacting portion 468 may include three or more pincers 488. Each pincer 488 includes a proximal end 490 extending from the elongate member 472, a distal end 492 opposite the proximal end 490, an inner surface 494, and an outer surface 496 opposite the inner surface 494. In embodiments, the pincers 480 may be spaced apart to form a receptacle 500 in which a fecal sample is retained. In embodiments, each pincer 488 may have an arcuate shape such that the distance between opposing pincers 488 decreases along the length of the pincer 488 in a direction away from the elongate member 472 (i.e., in the −Z direction as shown). In this embodiment, each pincer 488 includes a widening point 498 formed at a location substantially midway between the proximal end 490 and the distal end 492 of the pincer 488. Thus, the receptacle 500 formed by the pincer 488 may have a substantially oval shape extending from the proximal end 490 and the distal end 492 of the pincer 488. The fecal contact portion 468 may be formed from a deformable or flexible material, such as a flexible plastic, rubber, or the like, to allow the pincers 488 to compress toward each other when a force is applied in a direction from the outer surface 496 of the pincer 488 toward the receptacle 500. In other embodiments, feces contacting portion 468 may be formed from a substantially rigid material, but may be flexibly joined to elongate member 472 to allow pincers 488, and more specifically, distal ends 492 of pincers 488, to compress toward each other when force is applied.

[0105] With feces contacting portion 468 in the uncompressed position, feces contacting portion 468 defines an outer uncompressed sample collection diameter between outer surfaces 496 of each pincer 488 at widened point 498 of each pincer 488. When feces contacting portion 468 is in the compressed position, such as when feces contacting portion 468 is being inserted through plunger 412, feces contacting portion 468 defines an outer compressed sample collection diameter between outer surfaces 496 of each pincer 488 at widened point 498 of each pincer 488 that is smaller than the outer uncompressed sample collection diameter when feces contacting portion 468 is in the uncompressed position.

[0106] Handle portion 470 is provided at a handle end 476 of elongated member 472 opposite feces contacting portion 468. Handle portion 470 includes a tab 504 extending in a direction opposite elongated member 472. In the illustrated embodiment, tab 504 has a concave surface that conforms to the shape of a user's thumb or finger. However, it should be understood that tab 504 may have any suitable shape.

[0107] 20 , the plunger 412 includes a plunger body 506 and a plunger guide 508. The plunger body 506 has an upper end 510, a lower end 512 opposite the upper end 510, an inner surface 514, and an outer surface 516 opposite the inner surface 514 and extending between the upper end 510 and the lower end 512. In an embodiment, the inner surface 514 and the outer surface 516 each taper from the upper end 510 to the lower end 512. The inner surface 514 of the plunger body 506 forms an open-ended channel 518, and the end of the channel 518 opposite the lower end 512 of the plunger body 506 includes a sample collection opening 520. The sample collection opening 520 defines an opening inner diameter. In an embodiment, a groove 522 is formed in the outer surface 516 of the plunger body 506 adjacent the lower end 512 of the plunger body 506, and a sealing member 524, such as an O-ring, gasket, or the like, is provided in the groove 522 to provide a fluid-tight seal between the outer surface 516 of the plunger body 506 and the body 402.

[0108] In embodiments, a first flange 526 and a second flange 528 are provided on the upper end 510 of the plunger body 506 and thus extend radially. As shown, the first flange 526 extends in a first radial direction, and the second flange 528 extends in a second radial direction opposite the first radial direction. Thus, in embodiments, the first flange 526 and the second flange 528 are diametrically opposed to each other and extend in opposite radial directions, but this is by way of example only. While a pair of flanges 526, 528 is shown herein, it should be understood that any number of flanges may be provided. For example, the plunger body 506 may include a single flange or three or more flanges. In embodiments where three or more flanges are provided, the flanges may be spaced apart in any suitable arrangement, such as, for example, equidistant from each other in the circumferential direction.

[0109] 20 , the plunger guide 508 is formed on the outer surface 516 of the plunger body 506 proximate the lower end 512 of the plunger body 506, i.e., near the lower end 512 and the upper end 510, and spaced from the groove 522. However, it should be understood that the plunger guide 508 may be located anywhere along the plunger body 506. The plunger guide 508 has at least one slotted portion. As shown, the plunger guide 508 includes a first slotted portion 530 on one side of the outer surface 516 of the plunger body 506 and a second slotted portion 532 on the opposite side of the outer surface 516 of the plunger body 506. The first slotted portion 530 includes a first upper wall 534 and a first lower wall 536 that form a first slot 538. Similarly, the second slotted portion 532 includes a second upper wall 540 and a second lower wall 542 that form a second slot 544. Although the plunger guide 508 is shown as including a first slotted portion 530 and a second slotted portion 532, it should be understood that the plunger guide 508 may include any number of slotted portions, such as one slotted portion or three or more slotted portions.

[0110] 20 , the guide cap 416 includes an outer wall 546 having an upper end 548, a lower end 550, and an inner surface 552. An opening 554 is formed by the outer wall 546, and a plurality of teeth 556 extend radially inward from the inner surface 552 of the outer wall 546 into the opening 554. As described in more detail herein, the opening 554 allows the guide cap 416 to be positioned on the body 402 ( FIG. 19 ) at the insertion end 414, and the flange 438 ( FIG. 19 ) of the body 402 extends into the opening 554 of the guide cap 416 to engage the plurality of teeth 556 of the guide cap 416 and retain the guide cap 416 on the insertion end 414 of the body 402. The guide cap 416 further includes a first rail 558 and a second rail 560 formed on the inner surface 552 of the outer wall 546 of the guide cap 416. A first rail 558 and a second rail 560 are formed on opposite sides of the inner surface 552 of the outer wall 546 of the guide cap 416. As described in more detail herein, the first rail 558 and the second rail 560 correspond to the first slotted portion 530 and the second slotted portion 532, respectively. Thus, the number and position of the first rails 558 and the second rails 560 correspond to the number and position of the first slotted portion 530 and the second slotted portion 532. In an embodiment, a first stopper 562 is provided at an end of the first rail 558, and a second stopper 564 is provided at an end of the second rail 560. The first stopper 562 has an axially extending thickness and / or a radially extending width that is greater than the corresponding thickness and width of the first rail 558. Similarly, the second stop 564 has an axially extending thickness and / or a radially extending width that is greater than the corresponding thickness and width of the second rail 560. Although the first slotted portion 530 and the second slotted portion 532 are described herein as being provided on the plunger guide 508 and the first rail 558 and the second rail 560 are described herein as being provided on the guide cap 416, it should be understood that the reverse may also be true. For example, the first slotted portion 530 and the second slotted portion 532 may be formed on the guide cap 416, and the first rail 558 and the second rail 560 may be formed on the plunger guide 508.

[0111] 21 , a cross-sectional view of the fecal collection device 400 is shown in an assembled state. As shown, in the assembled state, the plug 406 is disposed at the removal end 408 of the body 402. As described herein, the plug 406 may be press-fit into the removal end 408 of the body 402, may be integrally formed with the body 402 as a one-piece monolithic structure and separable from the body 402 at a frangible seal 450, or may be threadedly engaged with the body 402. Application of force at the frangible seal 450 allows the plug 406 to be removed from the body 402. As shown, an emulsifying buffer 572 is provided within the body space 420 and is retained therein by the plug 406, thereby preventing the emulsifying buffer 572 from exiting the body 402 through the conduit 436 in the lower body portion 424.

[0112] As shown in Figure 21, the brush 410 is positioned within the body space 420. In the embodiment shown in Figure 21, the brush 410 is positioned proximate the removal end 408 of the body 402. The brush 410 is shown in a folded position within the body space 420, with the bristles 466 facing inward.

[0113] In use, the guide cap 416 is placed over the insertion end 414 of the body 402 by inserting the insertion end 414, and in particular the flange 438 of the body 402, through the opening 554 of the guide cap 416. The guide cap 416 can be secured by rotating or press-fitting the guide cap 416 relative to the body 402 such that the flange 438 is captured within the teeth 556 of the guide cap 416. Once secured, the guide cap 416 is prohibited from rotating or moving along the longitudinal axis L of the body 402.

[0114] 21 , the plunger 412 is shown inserted into the insertion end 414 of the body 402. With the plunger body 506 disposed within the body space 420, a sealing member 524 circumscribing the outer surface 496 of the plunger body 506 adjacent the lower end 512 of the plunger body 506 provides a fluid-tight seal between the outer surface 496 of the plunger body 506 and the body wall 418 of the body 402. As described herein, when the plunger 412 is in the locked state, the plunger 412 is restricted from moving along the longitudinal axis L of the body 402 in a direction toward the insertion end 414 of the body 402.

[0115] The sample collection member 404 may then be utilized to collect a fecal sample, such as by inserting the fecal contacting portion 468 into the fecal material and collecting the fecal sample in the receptacle 500 between the pincers 488. The sample collection member 404 may then be inserted into the body 402 through a sample collection opening 520 formed in the plunger body 506 and inserted into the body space 420 through the insertion end 414 of the body 402. Prior to inserting the sample collection member 404 into the plunger 412, the fecal contacting portion 468 is in an uncompressed position with the pincers 488 spaced apart, defining an uncompressed sample collection outer diameter. As described herein, the uncompressed sample collection outer diameter of the plunger body 506 is larger than the opening inner diameter of the sample collection opening 520. Thus, when the feces contacting portion 468 is inserted into the plunger 412 and contacts the inner surface 514 of the plunger body 506 at the sample collection opening 520, the inner surface 514 of the plunger body 506 compresses the pincers 488 of the feces contacting portion 468, placing the feces contacting portion 468 in a compressed position. As described herein, when the feces contacting portion 468 is in the compressed position, the feces contacting portion 468 has a compressed sample collection outer diameter that is smaller than the opening inner diameter. Thus, the feces contacting portion 468 is able to pass through the sample collection opening 520. In this way, excess fecal sample adhering to the exterior of the feces contacting portion 468 is retained within the plunger 412, rather than being inserted further into the body space 420 and mixed with the emulsification buffer 572. This ensures that only a controlled amount of fecal material is able to mix with the emulsification buffer 572 within the body space 420. When the sample collection member 404 is inserted into the body 402, the elongated member 472 of the sample collection member 404 forms a fluid-tight seal with the inner surface 514 of the plunger body 506. This prevents the emulsifying buffer 572 from flowing out the insertion end 414 of the body 402 through the channel 518 formed in the plunger 412.

[0116] To mix the fecal sample with the emulsifying buffer 572, the sample collection member 404 is moved and rotated in opposite directions throughout the body space 420 along the longitudinal axis L of the body 402. In this manner, the bristles 466 of the brush 410 scrape the fecal sample from the fecal contacting portion 468 of the sample collection member 404 so that the fecal sample mixes with the emulsifying buffer 572.

[0117] 22 and 23, the plunger 412 is shown in a locked and unlocked state, respectively. When in the locked state, as shown in FIG. 22, the first rail 558 of the plunger 412 is received within the first slot 538 of the first slotted portion 530, and the second rail 560 is received within the second slot 544 of the second slotted portion 532. More specifically, when the plunger 412 is in the locked state, the first rail 558 is disposed between the first upper wall 534 and the first lower wall 536 of the first slotted portion 530, and the second rail 560 is disposed between the second upper wall 540 and the second lower wall 542 of the second slotted portion 532. In the locked state, the first upper wall 534 of the first slotted portion 530 abuts against the first stopper 562 and the second upper wall 540 of the second slotted portion 532 abuts against the second stopper 564, allowing the plunger 412 to rotate in only one direction.

[0118] 23 , the plunger 412 is rotated away from the first stopper 562 and the second stopper 564 such that the first rail 558 is moved out of the first slot 538 and the second rail 560 is moved out of the second slot 544. With the plunger 412 in the unlocked state, the sealing member 524 and / or the second end 512 of the plunger 412 contact the brush 410, or alternatively, the first flange 526 and the second flange 528 contact the top end 548 of the guide cap 416.

[0119] As described herein with respect to other embodiments, indicia may be provided on the outer wall 546 of the guide cap 416 to provide a visual indication of the position or state of the plunger 412. The indicia may include a locked symbol to indicate that the plunger 412 is in a locked state and an unlocked symbol to indicate that the plunger 412 is in an unlocked state.

[0120] To dispense the mixture of emulsifying buffer 572 and fecal sample from the removal end 408 of the body 402, the plunger 412 is rotated to an unlocked state and pushed along the longitudinal axis L toward the removal end 408 of the body 402. Accordingly, as shown in FIG. 24 , the plunger 412 is shown in a lowered position. In use, the sample collection member 404 can be further moved by twisting or moving it out of the body space 420 independently of the plunger 412 to facilitate the brush 410 removing the fecal sample from the sample collection member 404 and mixing it with the emulsifying buffer 572. Additionally, the plunger 412 can alternate between the raised and lowered positions to dispense an additional supply of the mixture of emulsifying buffer 572 and fecal sample. In embodiments, before moving the plunger 412 to the lowered position, the sample collection member 404 can be withdrawn from the body space 420, and a cap can be inserted into the plunger 412 to prevent the emulsifying buffer 572 from escaping from the body 402.

[0121] From the above, it should be understood that a stool collection device is defined herein as comprising a body, a sample collection member positionable within the body, and a plug at the removal end of the body that limits fluid passage from the removal end through the body. The sample collection member includes a stool contacting portion that facilitates collection of a predetermined amount of fecal material to be mixed with emulsification buffer within the body. As described herein, the stool collection device may include a plunger for controlling the dispensing of a predetermined amount of emulsification buffer from the body that is mixed with the collected stool sample. Additionally, a stool collection attachment device is disclosed that may be coupled to the body or the end of a syringe as a retrofit attachment.

[0122] Further aspects of the embodiments described herein are provided by the subject matter of the following clauses.

[0123] Clause 1. A stool collection device comprising: a body including an insertion end and a removal end opposite the insertion end, the body forming a body space between the insertion end and the removal end; a sample collection member positionable within the body space through the insertion end, the sample collection member having a stool contacting portion for holding a stool sample and a handle portion spaced from the stool contacting portion; and a plug releasably coupled to the removal end of the body, the plug positionable from a closed position to an open position to restrict fluid passage from the body space through the removal end.

[0124] Clause 2. The stool collection device of clause 1, further comprising a plunger disposed at least partially within the body space of the body.

[0125] Clause 3. The fecal collection device of clause 2, wherein the plunger comprises a sample collection opening defining an opening inner diameter, the sample collection member being insertable through the sample collection opening.

[0126] Clause 4. The stool collection device of clause 3, wherein the feces contacting portion is deformable between a compressed position and an uncompressed position, the feces contacting portion defining an uncompressed sample collection outer diameter that is greater than the opening inner diameter when in the uncompressed position, and defining a compressed sample collection outer diameter that is less than the uncompressed sample collection outer diameter when in the compressed position.

[0127] Clause 5. The stool collection device according to any one of clauses 2 to 4, further comprising a guide cap disposed at the insertion end of the main body.

[0128] Clause 6. The fecal collection device of clause 5, wherein the guide cap comprises a lower retaining groove and the body includes a flange extending from the insertion end, the flange of the body being insertable into the lower retaining groove to retain the guide cap on the body.

[0129] Clause 7. The fecal collection device of clause 5 or clause 6, wherein the guide cap comprises an upper retention groove comprising a first groove portion having a first height extending in an axial direction corresponding to a longitudinal axis extending from the insertion end to the removal end of the body, and a second groove portion having a second height extending in the axial direction, the second height being greater than the first height.

[0130] Clause 8. A fecal collection device as described in clause 7, wherein the plunger has radially extending fingers partially insertable into the upper retaining grooves, and the plunger is rotatable relative to the guide cap to move the fingers between the first groove portion and the second groove portion.

[0131] Clause 9. A stool collection device as described in clause 8, wherein the sample collection member and plunger are prevented from moving axially when the fingers are in the first groove, and the sample collection member and plunger are able to move axially when the fingers are in the second groove.

[0132] Clause 10. A stool collection device according to any one of clauses 1 to 9, further comprising a brush positioned within the body space of the body adjacent the removal end, the brush having a plurality of bristles that engage with the stool contact portion of the sample collection member.

[0133] Clause 11. The stool collection device according to any one of clauses 1 to 10, further comprising an emulsification buffer disposed in the main body space.

[0134] Clause 12. A stool collection device according to any one of clauses 1 to 11, wherein the plug is coupled to the body via a frangible seal.

[0135] Clause 13. A stool collection device according to any one of clauses 1 to 12, wherein the plug is monolithic with the body.

[0136] Clause 14. A stool collection device comprising: a body having an insertion end and a removal end; a plunger at least partially disposed within the body; a sample collection member positionable within the body through the insertion end, the sample collection member having a stool contact portion for retaining a stool sample; and a guide cap disposed at the insertion end of the body, wherein the plunger is movable between a locked state and an unlocked state relative to the guide cap, and wherein the plunger and sample collection member are prevented from moving axially in a direction corresponding to a longitudinal axis extending from the insertion end to the removal end of the body when the plunger is in the locked state, and the plunger and sample collection member are movable axially when the plunger is in the unlocked state.

[0137] Clause 15. A stool collection device according to clause 14, wherein the plunger comprises a sample collection opening defining an opening inner diameter.

[0138] Clause 16. A stool collection device according to clause 15, wherein the sample collection member comprises a handle portion and a stool contacting portion opposite the handle portion, the stool contacting portion being deformable between a compressed position and an uncompressed position, and the stool contacting portion defines an uncompressed sample collection outer diameter that is greater than the opening inner diameter when in the uncompressed position.

[0139] Clause 17. A fecal collection device according to any one of clauses 14 to 16, wherein the guide cap comprises a lower retaining groove, and the body includes a flange extending from the insertion end, the flange of the body being insertable into the lower retaining groove to retain the guide cap on the body.

[0140] Clause 18. A stool collection device according to any one of clauses 14 to 17, wherein the guide cap comprises an upper retaining groove comprising a first groove portion having a first height extending in an axial direction corresponding to a longitudinal axis extending from the insertion end to the removal end of the body, and a second groove portion having a second height extending in the axial direction, the second height being greater than the first height.

[0141] Clause 19. A fecal collection device according to claim 18, wherein the plunger comprises radially extending fingers partially insertable into the upper retaining grooves, and the plunger is rotatable relative to the guide cap to move the fingers into the first groove portion to a locked state and into the second groove portion to an unlocked state.

[0142] Clause 20. A stool collection device according to any one of clauses 14 to 19, further comprising a brush disposed within the body, the brush having a plurality of bristles that engage with the stool contact portion of the sample collection member.

[0143] Clause 21. A fecal collection attachment device positionable on a syringe, comprising: a guide cap positionable on the syringe, the guide cap including an upper retaining groove having a first groove portion and a second groove portion; a plunger including a finger partially insertable into the upper retaining groove, the plunger being rotatable relative to the guide cap to position the finger between the first groove portion and the second groove portion; and a sample collection member positionable through the plunger, the sample collection member including a fecal contact portion that retains a fecal sample, wherein when the finger is positioned in the first groove portion, the plunger and sample collection member are prevented from moving axially relative to the guide cap, and when the finger is positioned in the second groove portion, the sample collection member and plunger are able to move axially.

[0144] Clause 22. A fecal collection attachment device according to clause 21, wherein the plunger comprises a sample collection opening defining an opening inner diameter.

[0145] Clause 23. A fecal collection attachment device according to clause 22, wherein the sample collection member comprises a handle portion and a fecal contacting portion opposite the handle portion, the fecal contacting portion being deformable between a compressed position and an uncompressed position, and the collection end defines an uncompressed sample collection outer diameter that is greater than the opening inner diameter when in the uncompressed position.

[0146] Clause 24. A stool collection device comprising: a body including an insertion end and a removal end opposite the insertion end, the body forming a body space between the insertion end and the removal end; a sample collection member positionable within the body space through the insertion end, the sample collection member having a stool contacting portion for holding a stool sample and a handle portion spaced from the stool contacting portion; and a plug releasably coupled to the removal end of the body, the plug positionable from a closed position to an open position to restrict passage of fluid from the body space through the removal end.

[0147] Clause 25. The fecal collection device of clause 24, further comprising a buffer reservoir disposed within the body space, the buffer reservoir comprising one or more side walls.

[0148] Clause 26. A fecal collection device according to clause 25, further comprising a buffer plunger that engages one or more side walls of the buffer reservoir.

[0149] Clause 27. A fecal collection device according to clause 26, wherein the buffer plunger comprises a buffer valve, the buffer valve being positionable in a closed position in which the buffer valve restricts the flow of fluid through the buffer valve, and in an open position in which the buffer valve allows the flow of fluid through the buffer valve.

[0150] Clause 28. A stool collection device according to clause 27, wherein the buffer valve comprises a fixed portion and a releasable portion movable relative to the fixed portion when a force is applied by the stool contact portion of the sample collection member.

[0151] Clause 29. A stool collection device according to clause 27 or clause 28, wherein the buffer valve is movable within the buffer reservoir in a direction towards the removal end of the body when a force is applied by the stool contact portion of the sample collection member.

[0152] Clause 30. A stool collection device according to any one of clauses 25 to 29, wherein one or more side walls of the buffer reservoir comprise one or more openings.

[0153] Clause 31. A stool collection device according to any one of clauses 24 to 30, further comprising a filter disposed at the removal end of the body.

[0154] Clause 32. A stool collection device according to any one of clauses 25 to 31, further comprising a plunger seal disposed within the body space of the body at the end of the buffer reservoir.

[0155] Clause 33. A fecal collection device according to clause 32, wherein the plunger comprises a sample collection opening defining an opening inner diameter, and wherein the sample collection member is insertable through the sample collection opening.

[0156] Clause 34. A stool collection device according to clause 33, wherein the stool contacting portion is deformable between a compressed position and an uncompressed position, the stool contacting portion defining an uncompressed sample collection outer diameter that is greater than the opening inner diameter when in the uncompressed position, and defining a compressed sample collection outer diameter that is less than the uncompressed sample collection outer diameter when in the compressed position.

[0157] Clause 35. A stool collection device according to any one of clauses 24 to 34, wherein the plug is coupled to the body via a frangible seal.

[0158] Clause 36. A feces collection device according to any one of clauses 24 to 35, wherein the plug is monolithic with the body.

[0159] Clause 37. A stool collection device comprising: a body including an insertion end and a removal end opposite the insertion end, forming a body space between the insertion end and the removal end; a buffer reservoir disposed within the body space, the buffer reservoir comprising a reservoir body; a sample collection member positionable within the body space and the buffer reservoir through the insertion end, the sample collection member comprising a stool contact portion for retaining a stool sample; and a plug releasably coupled to the removal end of the body, wherein the buffer reservoir is movable in a direction towards the removal end of the body when force is applied by the sample collection member.

[0160] Clause 38. A fecal collection device according to clause 37, further comprising a buffer plunger engaging the buffer reservoir.

[0161] Clause 39. A fecal collection device according to clause 38, wherein the buffer plunger comprises a buffer valve, the buffer valve being positionable in a closed position in which the buffer valve restricts the flow of fluid through the buffer valve, and in an open position in which the buffer valve allows the flow of fluid through the buffer valve.

[0162] Clause 40. A stool collection device according to clause 39, wherein the buffer valve comprises a fixed portion and a releasable portion movable relative to the fixed portion.

[0163] Clause 41. A fecal collection device according to clause 39 or clause 40, wherein the buffer valve is movable within the buffer reservoir in a direction towards the removal end of the body.

[0164] Clause 42. A stool collection device according to any one of clauses 37 to 41, wherein a plurality of openings are formed in one or more side walls of the buffer reservoir.

[0165] Clause 43. A stool collection device according to any one of clauses 37 to 42, further comprising a filter disposed at the removal end of the body.

[0166] Clause 44. A stool collection device according to any one of clauses 37 to 43, further comprising a fluid stored in the buffer reservoir.

[0167] Clause 45. A stool collection device according to clause 44, wherein the fluid is an emulsifying buffer.

[0168] Clause 46. A stool collection device according to any one of clauses 37 to 45, further comprising a fluid stored in the buffer reservoir and capable of mixing with the stool sample when the buffer valve is in an open position.

[0169] It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments described herein without departing from the scope of the claimed subject matter. Thus, it is intended that the present specification cover modifications and variations of the various embodiments described herein, provided that such modifications and variations come within the scope of the appended claims and their equivalents.

Claims

1. A stool collection device comprising: a body including an insertion end and a removal end opposite the insertion end, the body defining a body space between the insertion end and the removal end; a sample collection member positionable within the body space through the insertion end, the sample collection member including a stool contact portion configured to hold a stool sample and a handle portion spaced from the stool contact portion; a plug disposed at the removal end of the body, the plug being positionable from a closed position to an open position to restrict passage of fluid from the body cavity through the removal end; A fecal collection device comprising:

2. The stool collection device of claim 1 , further comprising a plunger disposed at least partially within the body space of the body.

3. 3. The stool collection device of claim 2, wherein the plunger includes a sample collection opening defining an opening inner diameter, and the sample collection member is insertable through the sample collection opening.

4. 4. The stool collection device of claim 3, wherein the stool contacting portion is deformable between a compressed position and an uncompressed position, the stool contacting portion defining an uncompressed sample collection outer diameter that is larger than the opening inner diameter when in the uncompressed position, and defining a compressed sample collection outer diameter that is smaller than the uncompressed sample collection outer diameter when in the compressed position.

5. 3. The stool collection device of claim 2, further comprising a guide cap disposed at the insertion end of the body.

6. 6. The stool collection device according to claim 5, the guide cap comprises a plurality of teeth; the body including a flange extending from the insertion end; A feces collection device wherein the flange of the body engages the plurality of teeth of the guide cap to retain the guide cap on the body.

7. 6. The fecal collection device of claim 5, wherein the guide cap comprises a rail, the plunger comprises a slotted portion, and the plunger is rotatable relative to the guide cap to position the rail of the guide cap within the slotted portion of the plunger.

8. 8. The stool collection device of claim 7, wherein the plunger is prevented from moving axially when the rail of the guide cap is positioned within the slotted portion of the plunger, and the plunger is allowed to move axially when the rail of the guide cap is not positioned within the slotted portion of the plunger.

9. 10. The stool collection device of claim 1, further comprising a brush disposed within the body space of the body adjacent the removal end, the brush having a plurality of bristles that engage the stool contacting portion of the sample collection member.

10. The stool collection device of claim 1 , further comprising an emulsifying buffer disposed in the body cavity.

11. 10. The fecal collection device of claim 1, wherein the plug is coupled to the body via a frangible seal.

12. 10. The fecal collection device of claim 1, wherein the plug is monolithic with the body.

13. A stool collection device comprising: a body having an insertion end and a removal end; a plunger disposed at least partially within the body; a sample collection member positionable within the body through the insertion end, the sample collection member including a feces contacting portion for retaining a fecal sample; a guide cap disposed at the insertion end of the body; Equipped with the plunger is movable between a locked state and an unlocked state relative to the guide cap; the plunger is prevented from moving in an axial direction corresponding to a longitudinal axis extending from the insertion end to the removal end of the body when the plunger is in the locked state; A stool collection device, wherein the plunger is movable in the axial direction when the plunger is in the unlocked state.

14. 14. The stool collection device of claim 13, wherein the plunger includes a sample collection opening that defines an opening inner diameter.

15. 15. The stool collection device of claim 14, wherein the sample collection member comprises a handle portion and the stool contacting portion opposite the handle portion, the stool contacting portion being deformable between a compressed position and an uncompressed position, and the stool contacting portion defines an uncompressed sample collection outer diameter that is larger than the opening inner diameter when in the uncompressed position.

16. 14. The stool collection device of claim 13, the guide cap comprises a plurality of teeth; A fecal collection device, wherein the body includes a flange extending from the insertion end, the flange on the body engaging the plurality of teeth on the guide cap to retain the guide cap on the body.

17. 14. The fecal collection device of claim 13, wherein the guide cap comprises a rail, the plunger comprises a slotted portion, and the plunger is rotatable relative to the guide cap to position the rail of the guide cap within the slotted portion of the plunger.

18. 14. The stool collection device of claim 13, further comprising a brush disposed within the body, the brush having a plurality of bristles that engage the stool contacting portion of the sample collection member.

19. A stool collection attachment device positionable on a syringe, comprising: a guide cap positionable on the syringe, the guide cap comprising a rail; a plunger having a slotted portion, the plunger being rotatable relative to the guide cap to position the rail of the guide cap within the slotted portion of the plunger; a sample collection member positionable through the plunger, the sample collection member including a feces contact portion for retaining a fecal sample; Equipped with a stool collection attachment device, wherein when the rail of the guide cap is positioned within the slotted portion of the plunger, the plunger is prevented from moving axially relative to the guide cap, and when the rail of the guide cap is not positioned within the slotted portion of the plunger, the plunger is allowed to move axially.

20. 20. The fecal collection attachment device of claim 19, wherein the plunger comprises a sample collection opening defining an opening inner diameter, the sample collection member comprises a handle portion and the fecal contacting portion opposite the handle portion, the fecal contacting portion being deformable between a compressed position and an uncompressed position, and the collection end defines an uncompressed sample collection outer diameter that is larger than the opening inner diameter when in the uncompressed position.

Images