• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    specimen collection container having a fluid separation chamber. a specimen collection container having a separation chamber includes a first chamber; a second chamber and a valve located between the first chamber and the second chamber. in an open position, the valve allows fluid communication between the first chamber and the second chamber. in a closed position, the valve maintains fluid isolation between the first chamber and the second chamber. fluid flow passes from the first chamber to the second chamber through the valve allowing a predetermined volume of fluid to pass from the first chamber to the second chamber. when the predetermined volume of fluid passes to the second chamber, the valve changes from the open position to the closed position so that additional fluid from the fluid flow received by the first chamber is held in the first chamber in fluid isolation from the predetermined volume of fluid contained in the second chamber.
    公开号:BR112015018173B1
    申请号:R112015018173-2
    申请日:2013-01-30
    公开日:2021-06-22
    发明作者:Bradley M. Wilkinson；Robert Ellis；Keith A. Moskowitz；Craig A. Gelfand；Raymond Wasek；Jean-Bernard Alla；Kenneth Louis Lee
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    BACKGROUND OF THE INVENTION Field of Invention
    [001] The present invention is directed to a specimen collection container and, more particularly, a specimen collection container having two chambers separated by a valve to separate an initially emptied patient urine from the mid-flow portion of the sample of urine. Description of Related Art
    [002] When obtaining a urine sample for an outpatient, it is generally preferable to collect the sample from the mid-flow portion of the urine stream. It is important to reject the “first jet” of urine from samples because the first volumes of emptied urine carry a disproportionately higher level of bacteria. The bacteria are often collected from the outer skin/tissue and possibly also from the urethra volume. The elevated bacterial level of the first stream of urine or first stream may lead to false-positive results due to the presence of bacteria, and could falsely suggest urinary tract infection, leading to unnecessary treatment or medication and inappropriate patient management. Since surface bacteria are always present, the chance of contamination of a urine sample is universal. As a result, urine samples are typically ordered as “clean collection” or “medium flow”. Such requirements require the patient or caregiver to use antiseptic wipes to disinfect the external tissue. Additionally, patients are instructed to allow the first urine to fall into the toilet bowl before filling the sample collection cup. It is believed that the first stream of urine not only contains high levels of tissue surface bacteria, but actually "washes" the outer surfaces, such that there is little or no stray surface bacteria captured in later mid-flow urine volumes. .
    [003] The state of the art for medium flow urine collection is essentially a manual process that relies entirely on the user or patient to perform the collection correctly. Typical instructions for medium-flow urine collection may require a user to empty into the toilet, then stop the flow of urine, move the collection cup into position, empty into the cup until full, stop the flow of urine and move the full body away, and finish emptying into the toilet. In general a user will be instructed to clean the surrounding skin/external tissue with an antiseptic wipe prior to emptying. The process is complicated, with a user's hands being close to the urine stream and often exposing the user's skin to urine.
    [004] Confusion and discomfort are not the only drawbacks of having a process dependent on the user manual. In addition, patients need to be provided with proper instructions placing an additional requirement and burden on the patient and caregiver. Often, such as in situations where privacy is impossible (for example, in the middle of a busy emergency room), caregivers do not provide any instructions. In addition, patients may not understand or choose not to follow instructions even when they are given, particularly if the patient is already nervous, scared, or agitated. For example, there is significant circumstantial evidence of people not using the antiseptic wipes, either because they burn or are uncomfortable or because patients confuse the antiseptic wipes with hand wipes to be used after providing the sample. In fact, there is no way of knowing, without actually looking at the patient to provide the urine sample, if any of the instructions are actually followed.
    [005] There are also physiological complications that can contribute to high bacterial contamination. Some evidence indicates that intentionally interrupting the urine flow can lead to the reintroduction of bacteria, essentially creating a new “first jet” of urine from the restarted urine stream. The restarted urine may not flow over the same skin/tissue as the first stream, and as a result, it may pick up bacteria from the previously unwetted skin. Another possibility is that interrupted urine flow can actually dislodge bacteria, dead cells, or other potential contaminants that would not have been available to contaminate urine during an otherwise normal voiding event. Thus, the manual start-stop-start again process to collect midflow urine may contribute to some bacterial contamination.
    [006] The frequency of bacterial contamination of plant samples varies from 10-40%, depending on the nature of the tests and the institution where the studies are carried out. Such statistics indicate that the problem is widespread and quite common. This likely contributes to significant waste, in increased cost and time associated with poor sample handling or running and tests that provide ambiguous or potentially useless data. Retesting may be appropriate in some circumstances; however, especially in an outpatient setting, the patient may not be available to provide a second sample. Consequently, a new test is never performed or simply not required.
    [007] Therefore, in view of the difficulties in obtaining a correct urine sample using commonly available methods, there is a need for a collection apparatus that makes the collection process easier and reduces the risk of exposing the patient to the urine stream. The instrument must be intuitive to use and must be designed to promote the proper use and handling of the collected specimen at all points before, during and after emptying the urine. Additionally, the device must increase patient comfort and convenience by effectively selecting mid-flow urine so that the user does not have to consciously force stop and then initiate emptying. Not requiring the patient to start-stop-start emptying urine stream reduces the risk of natural physiological contamination from flow interruption. Similarly, the device should only require minimal manipulation by one patient in order to collect urine. Furthermore, the device should eliminate the need for patients to be directly exposed to the stream of urine. Finally, to ensure the safe and easy transfer of the urine sample from the collection container to a specimen collection tube for testing, the device must not include one or more access holes allowing direct flow of the collected sample from the container into a tube. of test. SUMMARY OF THE INVENTION
    [008] Provided herein is a specimen/sample collection container having a fluid separation chamber for receiving a fluid flow and for separating an initial volume of the fluid flow from an average flow portion of the fluid flow. The specimen collection container further includes an orifice for accessing and removing the medium flow portion of the fluid from the container and for transferring the medium flow portion to a sample collection tube. A method for collecting a fluid sample using a specimen collection vessel having a fluid separation chamber is also described.
    [009] According to an embodiment of the present invention, a specimen collection container includes a first chamber having an open top, a side wall, and a bottom; a second chamber having an upper part, a closed lower part, and a side wall; and a valve disposed between the first chamber and the second chamber. The valve changes from an open position which allows fluid communication between the first chamber and the second chamber to a closed position which maintains fluid isolation between the first chamber and the second chamber. In the open position, a predetermined volume of fluid, received in the first chamber, can pass from the first chamber to the second chamber. When the predetermined volume of fluid passes to the second chamber, the valve changes from the open position to the closed position so that additional fluid received within the first chamber is held in the first chamber in fluid isolation from the predetermined volume of fluid contained. in the second chamber.
    [010] In certain configurations, the specimen collection container valve includes a channel extending between the first chamber and the second chamber and an expandable absorbent material. The expandable absorbent material absorbs the predetermined volume of fluid and expands to engage the channel thereby shifting the valve to the closed position. In certain alternative configurations, the container further comprises a gasket so that expansion of the expandable absorbent material positions the gasket for valve change. The expandable absorbent material can be a sponge.
    [011] In certain alternative configurations, the valve includes a channel, extending between the first chamber and the second chamber, and a floating float. When the second chamber receives the predetermined fluid volume, the floating float engages the channel by a buoyancy force exerted on the float by the predetermined fluid volume to shift the float from open to closed position. Optionally, a portion of the floating float initially seals the channel. Fluid passing from the first chamber to the second chamber disengages the float from the channel placing the valve in the temporarily open position.
    [012] In certain configurations, the specimen collection container further includes an orifice for accessing and removing a fluid sample from the first chamber. The orifice may include a nozzle defining a channel between the first chamber and an exterior of the specimen collection container; and a membrane covering the channel that changes from a closed position to an open position to allow removal of the fluid sample therefrom. The hole may be disposed within the side wall of the first chamber. The orifice may also include a needle having an outer tip, an inner tip adjacent to the first chamber, and a needle cannula extending therebetween, wherein fluid access to the first chamber is established through the needle cannula. Optionally, the outer tip of the needle is recessed with respect to an outer surface of the collection container to safely handle the device.
    [013] According to a further embodiment of the present invention, a specimen collection container includes an interior chamber having a bottom, a side wall, and an open top; and an absorbent disposed within the inner chamber that absorbs a predetermined volume of fluid. When a fluid flow enters the chamber through the open top, the absorbent absorbs the predetermined volume. Additional fluid from the fluid flow is held in the inner chamber in fluid isolation from the fluid absorbed by the absorbent. Optionally, the absorbent includes bentonite, diatomaceous earth, pelites, zeolites, chitosan, alginates, starch-based powders, and/or sodium polyacrylate. The absorbent can include a powder. Alternatively, the absorbent may include a pouch enclosing an absorbent material.
    [014] In certain embodiments, the inner chamber includes a screen separating the inner chamber into a first chamber and a second chamber with the absorbent held therein. The screen allows fluid to pass from the first chamber to the second chamber, but prevents the absorbent from passing from the second chamber to the first chamber.
    [015] According to a further embodiment of the present invention, a specimen collection container includes a first chamber having an open top portion, a side wall, and a bottom portion; a second chamber having an upper part, a closed lower part, and a side wall; and a valve disposed between the first chamber and the second chamber. The valve changes from a first closed position where the first chamber and second chamber are in fluid isolation, to an open position which allows fluid communication between the first chamber and the second chamber, to a second closed position where the fluid isolation between the first chamber and the second chamber is restored. The valve may include a spring acting reed valve.
    [016] In certain configurations, a fluid entering the first chamber changes the valve from the first closed position to the open position and the presence of a predetermined volume of fluid within the second chamber changes the valve from the open position to the second closed position. Optionally, the valve includes a reed valve that changes from the first closed position to the open position when fluid contacts the surface of the reed adjacent to the first chamber. The valve also subsequently changes from the open position to the second closed position when a predetermined volume of fluid received within the second chamber contacts the surface of the vane adjacent to the second chamber. BRIEF DESCRIPTION OF THE DRAWINGS
    [017] The following description is provided to enable those skilled in the art to make and use the described modalities considered to carry out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all modifications, variations, equivalents and alternatives are within the spirit and scope of the present invention.
    [018] Figure 1A is a cross-sectional front view of a specimen collection container with a valve in the open position according to an embodiment of the present invention.
    [019] Figure 1B is a front cross-sectional view of the container of Figure 1A with the valve in the closed position according to an embodiment of the present invention.
    [020] Figure 2A is a cross-sectional front view of a specimen collection container with a valve in the open position according to an embodiment of the present invention.
    [021] Figure 2B is a cross-sectional front view of the container of Figure 2A with the valve in the closed position according to an embodiment of the present invention.
    [022] Figure 3A is a cross-sectional front view of a specimen collection container with a valve in the open position according to an embodiment of the present invention.
    [023] Figure 3B is a front cross-sectional view of the container of Figure 3A with the valve in the closed position according to an embodiment of the present invention.
    [024] Figure 4 is a perspective view of a specimen collection container having an absorbent bag in accordance with an embodiment of the present invention.
    [025] Figure 5 is a perspective view of the absorbent bag of Figure 4, according to an embodiment of the present invention, with a partial cut-away part to reveal the inside of the bag.
    [026] Figure 6 is a perspective view of a specimen collection container having an absorbent material according to an embodiment of the present invention.
    [027] Figure 7 is a front cross-sectional view of a specimen collection container, having an outflow port, according to an embodiment of the present invention.
    [028] Figure 8 is a front cross-sectional view of a specimen collection container, according to an embodiment of the present invention having an elastomeric orifice free of sharp material.
    [029] Figure 9 is a front cross-sectional view of the specimen collection container of Figure 8 engaged with a sample collection tube for removing a sample from the container, in accordance with an embodiment of the present invention.
    [030] Figure 10 is a front cross-sectional view of a sample collection tube, according to an embodiment of the present invention.
    [031] Figure 11A is a top view of an absorbent material for use in a specimen collection container, according to an embodiment of the present invention.
    [032] Figure 11B is a top view of an absorbent material for use in a specimen collection container, according to an embodiment of the present invention.
    [033] Figure 11C is a top view of an absorbent material for use in a specimen collection container, according to an embodiment of the present invention.
    [034] Figure 11D is a top view of an absorbent material for use in a specimen collection container, according to an embodiment of the present invention.
    [035] Figure 11E is a perspective view of an absorbent material for use in a specimen collection container, according to an embodiment of the present invention. DESCRIPTION OF PREFERRED MODALITIES
    [036] For the purpose of facilitating the understanding of the invention, the attached drawings and description illustrate preferred embodiments thereof, from which the invention, various embodiments of its structures, construction and method of operation, and many advantages can be understood and appreciated.
    [037] For purposes of the following description, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal ”, and derivatives thereof must relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume alternative variations and sequences of steps, except where expressly specified otherwise. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following report, are simply exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics related to the modalities described here should not be considered as limiting.
    [038] Referring to Figures 1A-3B, a specimen collection container 10 includes a first chamber 12 in fluid communication with a second chamber 14 through a valve 16. The specimen collection container 10 is adapted to receive and separate a fluid flow in an initial or empty volume and an average or sample flow volume. The medium or sample flow volume can be removed from the specimen collection container 10 by biological testing. Container 10 is formed from any relatively inert medical grade polymer such as high density polyethylene or polystyrene. Alternatively, container 10 can be formed from glass, paper, or cellulose based products.
    [039] The specimen collection container 10 includes a first chamber 12 having an open top 18, a side wall 20, and a closed bottom 22. As shown in Figures 3A-3B, the side wall 20 can be slanted to the lower part 22 of the first chamber 12 giving a funnel shape to the first chamber 12 such that the diameter A of the open upper part 18 is greater than the diameter B of the closed lower part 22. In this configuration, the fluid is introduced into the chamber. funnel-shaped slides more easily down to the bottom of the container.
    [040] The first chamber 12 may include a fluid volume indicator 33 to show the amount of fluid contained therein. The first chamber 12 may be covered by a removable lid 24 which can be placed over the open top 18 of the first chamber 12 after the fluid sample is introduced into the chamber 12. The lid 24 prevents the fluid sample from leaking from the container. 10 and prevents the sample from being contaminated.
    [041] The first chamber 12 is in fluid communication with the second chamber 14. The second chamber 14 includes a closed top 26, side wall 20 and closed bottom 28. In a non-limiting mode, the second chamber 14 is positioned below the first chamber 12 such that the lower part 22 of the first chamber 12 also forms the closed upper part 26 of the second chamber 14. In one embodiment, the second chamber 14 has a volume of about 12 ml to 15 ml which may be less than the first chamber volume 12.
    [042] The fluid communication between the first chamber 12 and the second chamber 14 is established through the valve 16. The valve 16 changes from a first position, in which the fluid communication between the first chamber 12 and the second chamber 14 is established, to the second position, in which the first chamber 12 and the second chamber 14 are held in fluid isolation. In one embodiment, valve 16 includes a channel 32 that connects first chamber 12 with second chamber 14. When valve 16 is in the closed position, channel 32 is blocked to prevent fluid in first chamber 12 from flowing into the second. chamber 14. Similarly, valve 16 prevents fluid contained in second chamber 14 from passing back to first chamber 12. When valve 16 is in the closed position, fluid follows fluid flow path L2. In the open position, fluid flow L1 is allowed between the first chamber 12 and the second chamber 14 through the channel 32.
    [043] Referring to Figures 1A and 1B, in a non-limiting embodiment of the present invention, the valve 16 includes an expandable absorbent material 34, such as a compressed sponge, contained within the second chamber 14. The absorbent material 34 can be glued in the closed lower portion 28 of the second chamber 14. In an exemplary embodiment, the absorbent material 34 has a diameter of 4.32 cm and an expanded height of about 1.58 cm. In comparison, the height of the second chamber 14 is about 1.27 cm. Consequently, when expanded the absorbent material 34 occupies an entire volume of the second chamber 14. When wetted, the absorbent material 34 expands upwardly towards the closed top 26 to engage the channel 32. The absorbent material 34 can be formed in any configuration that allows for rapid fluid absorption and expansion in size. Some configurations increase the rate of absorption by increasing the surface area of the absorbent material 34. Referring to Figures 11A-11E, possible shapes of the absorbent material 34 include, but are not limited to, a cylinder, a cylindrical shaped object with perforated holes , a cylindrical shape with bits removed, a donut shape, and several separate thinner cylinders.
    [044] Referring again to Figures 3A and 3B, according to a non-limiting embodiment, the second chamber 14 includes a ribbed base 36. The absorbent material 34 is placed on the ribbed base 36 or similar support structure. The support structure elevates the absorbent material 34 allowing the collection of fluid in the space 38 below the absorbent material 34 and allowing fluid to be absorbed by a lower surface of the absorbent material 34. Exposing an additional surface of the absorbent material 34 to fluid increases the absorption rate.
    [045] According to an additional non-limiting embodiment, valve 16 further includes a gasket 40 to create a waterproof seal in channel 32, as shown in Figures 1A-1B. Gasket 40 is secured to an upper portion of absorbent material 34. Gasket 40 can be, for example, a polymeric foam disk. It is noted that the gasket 40 effectively blocks a portion of the absorbent material 34 from absorbing liquid. Consequently, it is important that other surfaces of the absorbent material are accessible to the fluid flow L1 so that the absorbent material 34 expands as quickly as possible. When wet absorbent material 34 expands and rises in an upward direction, gasket 40 engages channel 32, thereby sealing channel 32 and effectively shifting valve 16 to the closed position. Once gasket 40 is in place and engaged with channel 32, first chamber 12 and second chamber 14 are in fluid isolation from each other. Consequently, any additional fluid that enters the first chamber 12 through the open top 18 is held in the first chamber 12. This fluid held in the first chamber 12 is the medium flow urine sample.
    [046] In a further non-limiting embodiment, the valve 16 consists of a floating float 142 which is forced in an upward direction into channel 32 when the fluid level of the second chamber 14 rises. In one embodiment, floating float 142 includes gasket 40 to form a seal between float 142 and channel 32.
    [047] Co, referring to Figures 2A and 2B, in a further embodiment of the invention, the valve 16 is a "reed valve". In the reed valve, a portion 144 of the float 142 is secured to the closed upper portion 26 of the second chamber 14 forming a hinge 146. In one embodiment, the hinge 146 is a live hinge. In another embodiment, the reed valve includes a mechanical spring. The float 142 is held in close proximity to the channel 32 such that, initially, the float 142 covers the channel 32. The force exerted on the float 142 of the fluid flow L1 entering the first chamber 12 pushes the float 142 away from the channel 32 allowing fluid to pass directly through channel 32 from first chamber 12 to second chamber 14. As the fluid level from second chamber 14 increases, the range of motion for float 142 is reduced, until finally float 142 is held in place against the top 26 of the second chamber 14 and the channel 32. Once the float 142 is in place against the channel 32, fluid flow L2 from the first chamber 12 to the second chamber 14 is blocked. Therefore, additional fluid introduced into the first chamber 12 is collected and held in the first chamber 12. The fluid collected within the first chamber 12 is the mid-flow portion of the urine flow.
    [048] Referring again to Figures 3A and 3B, the valve 16 of the specimen collection container 10 may also include a float 142 and expandable absorbent material 34. When wetted, the absorbent material 34 increases in size eventually contacting the float 142 of the reed valve 16 and eventually forcing float 142 toward channel 32 to form a seal. When expanded, the absorbent material 34 maintains the float 142 in the closed position, thereby ensuring that the first chamber 12 and second chamber 14 remain in fluid isolation even when the specimen container is pushed or moved.
    [049] Referring to Figures 4 and 5, according to a further embodiment of the present invention, an absorbent bag 234 is included within the sample collection container 10. The bag 234 may be a non-woven filter paper bag 236 enclosing a microabsorbent powder 238. Fluid enters the container in accordance with fluid flow L. Bag 234 absorbs a first predetermined volume of fluid. The absorbed part corresponds with the initial jet or empty urine which is kept in isolation in the second chamber in the embodiments of the invention described above. In the present embodiment, once the pouch 234 reaches a saturation point, indicating that it has absorbed the predetermined amount of fluid, any additional fluid introduced into container 10 is held in container 10 in liquid form.
    [050] In one embodiment, the container 10 includes a screen 240 separating the first chamber 12 from the second chamber 14. The screen 240 effectively secures the bag 234 within the second chamber 14 and prevents the bag from floating to the top of the container when the fluid level increases. Screen 240 could be formed from a wire mesh or a disc having a number of holes drilled.
    [051] Referring to Figure 6, according to a further embodiment of the present invention, the first chamber 12 and the second chamber 14 are separated by a piece of filter paper 340. The second chamber 14 contains an absorbent powder 334. absorbent powder 334 can be a mineral based compound or a synthetic compound. Examples of mineral-based absorbent compounds include bentonite and diatomaceous earth. Bentonite is an aluminum phyllosilicate formed from impure clay. Diatomaceous earth is a compound formed from absorbent silica particles. Other natural absorbent materials include: pelites, zeolites and chitosan. Organic absorbent powders are commercially available from a number of sources including: Sigma-Aldrich, LLC, MedTrade Products Ltd, and Haliburton. Absorbent alginates or starch-based powders can also be used within the scope of the invention, more synthetic absorbent powders are formed from sodium polyacrylate. A commercially available sodium polyacrylate powder is "Insta-Snow" manufactured by Steve Spangler, Inc. of Englewood, Colorado.
    [052] When wetted, the absorbent powder forms a solid structure that will not pass through the filter paper 340, thereby separating the first chamber 12 from the second chamber 14. The powder 334 holds a predetermined initial volume of fluid. Once powder 334 is saturated, any additional fluid introduced into container 10 is held in container 10 in liquid form. As with previous modalities written above, the unabsorbed liquid portion constitutes the mid-flow urine sample. Alternatively, fiber papers are known in the art which are impregnated with sodium polyacrylate particles. Absorbent paper of this type is made by Safetec of America, Inc., located in Buffalo, NY. One or more pieces of the absorbent paper are placed in the second chamber 14 of the container 10. The absorbent paper is used to absorb a first jet of fluid in the same way as the absorbent powder.
    [053] Referring to Figure 7, in accordance with a non-limiting embodiment, the invention further includes an outflow port 50 for removing the sample (e.g., mid-flow urine) from the sample container 10. In a In one embodiment, the outflow port 50 comprises a needle 52 having a needle cannula 59 for accessing the sample contained in the first chamber 12. The needle 52 may be located in a cutaway portion 56 of the sidewall 20 or cap 24 so that a proximal end 83 of needle 52 is recessed from surfaces of container 10. Needle 52 is in contact with an access tube 58 which extends into first chamber 12 of container 10. Fluid passes through access tube. 58 before entering the needle cannula 54 for removal from container 10.
    [054] Referring to Figures 7 and 10, to extract a sample from container 10, a user places a sample collection tube 510 (eg, a test tube) over needle 52. In general, tube 510 includes an open end 512 covered by a plug 514 having a pierceable membrane 516. Needle 52 pierces membrane 516 accessing an inner portion 518 of tube 510 and creating a fluid connection between first chamber 12 and tube 510 through needle cannula 54 In one configuration, the sample collection tube 510 may be evacuated so that upon engagement with the container 10, fluid is drawn from the interior of the container into the sample collection tube by vacuum extraction. In another configuration, the entire container assembly may be inverted allowing fluid (eg, the mid-flow urine sample) to flow from collection container 10 to specimen collection tube 510.
    [055] Referring to Figure 8, according to an alternative embodiment, a sharps-free orifice 70 extends from the side wall 20 or cover 24 of the first chamber 12. The sharps-free orifice 70 includes a nozzle 72 extending from container 10 or cap 24. A channel 74 is defined through mouthpiece 72 allowing access to first chamber 12. An elastomeric seal 76 covers channel 74 preventing fluid from leaking from orifice 70 until user is prepared. to collect fluid in a specimen collection tube 410, as shown in Figure 9. Referring to Figure 9, the specimen collection tube 410 has an open top 412 covered by a cap or an inversion cap closure 414 Reverse cap closure 414 includes an access tube 418. Access tube 418 fits into channel 74 of mouthpiece 72 and pushes elastomeric seal 76 out of the way to establish a fluid connection between the first chamber. 12 and the sample collection tube 410. Once the fluid connection is established, the container 10 is inverted allowing the fluid sample to flow, along the flow path L3, from the first chamber 12 to the tube. collection 410 by gravity. The inversion cap closure 414 may further include a vent 420 that allows air displaced by the fluid sample to escape from the enclosed tube 410.
    [056] The presently claimed sample collection container 10 is used to collect a medium flow urine sample for testing. In use, a patient directs a stream of urine down the sidewall 20 towards the channel 32 and the valve 16. In one embodiment, the first chamber 12 is funnel-shaped having a sloped sidewall 20. The sidewall The slanted 20 allows fluid to flow more easily downwardly towards the bottom 22 of the first chamber 12. The funnel-shaped first chamber 12 also ensures that the entire first stream or first stream of urine will pass through the first chamber 12 and will enter the second chamber 14. For containers having straight sides and straight angled corners, a portion of the first jet may gather in the first chamber 12, potentially contaminating the fluid sample.
    [057] Fluid flow passes through channel 32 and valve 16 and collects in second chamber 14. When the fluid level in second chamber 14 increases to a predetermined level, valve 16 changes from an open to a closed position. The predetermined volume for the second chamber 14 can be between about 12 ml and 15 ml. Valve 16 should not change to the closed position until the predetermined volume of fluid passes to the second chamber 14. If valve 16 closes too early, a portion of the initial stream of urine will be captured in the first chamber 12 contaminating the urine sample of medium flow. If valve 16 closes too slowly, some of the first stream of urine, which initially passed to the second chamber 14, will flow back to the first chamber 12 contaminating the urine sample contained in the first chamber 12.
    [058] Once the required amount of mid-flow urine is collected in the first chamber 12, the specimen collection container 10 is removed from the urine stream. Alternatively, the patient may consciously stop the flow of urine to prevent overflowing from container 10. Container 10 may include a fluid level indicator line 44 to inform the patient when the required amount of fluid has been collected. The lid 24 is then collected over the open top 18 of the first chamber 12 to prevent fluid from leaking out of the container 10 or from being contaminated. The medium flow urine sample is then removed from the first chamber 12 through the outflow port 50 or from the sharps-free port 70 using any of the extraction procedures described above.
    权利要求:
    Claims (20)
    [0001]
    1. Specimen Collection Container, CHARACTERIZED in that it comprises: a first chamber configured to hold a fluid, the first chamber having an open top, a sidewall, and a bottom; a second chamber having an upper part, a closed lower part, and a side wall; and a valve disposed between the first chamber and the second chamber, and changeable from an open position, which allows fluid communication between the first chamber and the second chamber, to a closed position which maintains fluid isolation between the first chamber and the second chamber. chamber, wherein, in the open position, a predetermined volume of fluid received in the first chamber can pass from the first chamber to the second chamber, and wherein when the predetermined volume of fluid passes to the second chamber, the valve changes from the open position to the closed position, so that additional fluid received within the first chamber is held in the first chamber in fluid isolation from the predetermined volume of fluid contained in the second chamber; an expandable material disposed within the second chamber, the expandable material being expandable to change the valve from the open position to the closed position; and an orifice having a closed position and an open position, wherein the orifice is configured to provide access to a fluid sample of the first chamber fluid through the orifice when the orifice is in the open position; and wherein additional fluid is held in the first chamber when the valve is in the closed position and the orifice is in the closed position and the fluid is inaccessible from the first chamber through the orifice or through the valve when the valve is in the position closed and the hole is in the closed position.
    [0002]
    2. Specimen collection container, according to claim 1, CHARACTERIZED by the fact that the valve comprises: a channel extending between the first chamber and the second chamber, in which the expandable material is an absorbent expandable material, and the expandable material absorbs the predetermined volume of fluid and expands to engage the channel thereby shifting the valve to the closed position.
    [0003]
    3. Specimen collection container, according to claim 2, CHARACTERIZED by the fact that it further comprises a gasket so that the expansion of the absorbent expandable material positions the gasket for valve change.
    [0004]
    4. Specimen collection container, according to claim 2, CHARACTERIZED by the fact that the expandable absorbent material is a sponge.
    [0005]
    5. Specimen collection container, according to claim 1, CHARACTERIZED by the fact that the valve comprises: a channel, extending between the first chamber and the second chamber; and a floating float that engages the channel when the valve is changed from an open to a closed position.
    [0006]
    6. Specimen collection container, according to claim 5, CHARACTERIZED by the fact that a part of the floating buoy initially seals the channel, and in that the fluid passing from the first chamber to the second chamber disengages the floating buoy from the channel placing the valve in the open position.
    [0007]
    7. Specimen collection container, according to claim 1, CHARACTERIZED by the fact that the orifice comprises: a mouthpiece defining a channel between the first chamber and an exterior of the specimen collection container; and a membrane covering the channel that changes from a closed position to an open position to allow removal of the fluid sample from the first chamber.
    [0008]
    8. Specimen collection container, according to claim 1, CHARACTERIZED by the fact that the orifice is arranged inside the side wall of the first chamber.
    [0009]
    9. Specimen collection container, according to claim 1, CHARACTERIZED by the fact that the orifice is disposed within a removable cover adapted to cover the open top of the first chamber.
    [0010]
    10. Specimen collection container according to claim 1, CHARACTERIZED by the fact that the orifice comprises a needle having an outer tip, an inner tip adjacent to the first chamber, and a needle cannula extending between them, wherein fluid access to the first chamber is established through the needle cannula.
    [0011]
    11. Specimen collection container, according to claim 10, CHARACTERIZED by the fact that the outer tip of the needle is recessed with respect to an outer surface of the collection container.
    [0012]
    12. Specimen Collection Container, CHARACTERIZED by the fact that it comprises: an interior chamber having a bottom, a sidewall, and an open top; and an absorbent disposed within the inner chamber that absorbs a predetermined volume of fluid, wherein when a fluid flow enters the chamber through the open top, the absorbent absorbs the predetermined volume, and additional fluid of the fluid flow is maintained in the chamber. internal in fluid isolation from the fluid absorbed by the absorbent; and an orifice for accessing and removing additional fluid from the inner chamber.
    [0013]
    13. Specimen collection container, according to claim 12, CHARACTERIZED by the fact that the absorbent comprises bentonite, diatomaceous earth, pelites, zeolites, chitosan, alginates, starch-based powders, and/or sodium polyacrylate.
    [0014]
    14. Specimen collection container according to claim 12, CHARACTERIZED by the fact that the inner chamber comprises a screen separating the inner chamber into a first chamber and a second chamber with the absorbent maintained therein, and in which the screen allows fluid to pass from the first chamber to the second chamber but prevents the absorbent from passing from the second chamber to the first chamber.
    [0015]
    15. Specimen collection container, according to claim 12, CHARACTERIZED by the fact that the absorbent comprises a powder.
    [0016]
    16. Specimen collection container, according to claim 12, CHARACTERIZED by the fact that the absorbent comprises a pouch enclosing an absorbent material.
    [0017]
    17. Specimen Collection Container, CHARACTERIZED by the fact that it comprises: a first chamber having an open top part, a side wall, and a bottom part; a second chamber having an upper part, a closed lower part, and a side wall; and a valve disposed between the first chamber and the second chamber, and changeable from a closed first position in which the first chamber and second chamber are in fluid isolation, to an open position which allows fluid communication between the first chamber and the second chamber. chamber, to a second closed position where fluid insulation between the first chamber and the second chamber is restored; and an expandable, expandable material for moving the valve from the open position to the second closed position.
    [0018]
    18. Specimen collection container, according to claim 17, CHARACTERIZED by the fact that the valve comprises a spring acting vane valve.
    [0019]
    19. Specimen collection container, according to claim 17, CHARACTERIZED by the fact that a fluid entering the first chamber changes the valve from the first closed position to the open position.
    [0020]
    20. Specimen collection container, according to claim 17, CHARACTERIZED by the fact that the valve comprises a reed valve that changes from the first closed position to the open position where the fluid contacts the surface of the reed valve adjacent to the first chamber, and subsequently changeable from the open position to the second closed position when a predetermined volume of fluid received within the second chamber contacts the expandable material.
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    同族专利:
    公开号 | 公开日
    AU2013377104B2|2017-01-19|
    MX370078B|2019-11-29|
    CA2898731A1|2014-08-07|
    US20180161017A1|2018-06-14|
    CN104955402A|2015-09-30|
    US11246572B2|2022-02-15|
    EP2950719A1|2015-12-09|
    CA3024248A1|2014-08-07|
    CA2898731C|2019-01-15|
    US9913627B2|2018-03-13|
    JP2016505156A|2016-02-18|
    AU2013377104A1|2015-08-13|
    MX2015009285A|2016-04-04|
    CN104955402B|2018-04-13|
    CN108652677A|2018-10-16|
    EP2950719B1|2019-05-29|
    US20180168557A1|2018-06-21|
    JP6169728B2|2017-07-26|
    ES2740475T3|2020-02-05|
    US20140213934A1|2014-07-31|
    EP3574843A2|2019-12-04|
    WO2014120133A1|2014-08-07|
    EP3574843A3|2020-03-25|
    BR112015018173A2|2017-07-18|
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    法律状态:
    2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-11-26| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-04-13| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-22| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/01/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/752,590|US9913627B2|2013-01-29|2013-01-29|Specimen collection container having a fluid separation chamber|
    US13/752,590|2013-01-29|
    PCT/US2013/023707|WO2014120133A1|2013-01-29|2013-01-30|Specimen collection container having a fluid separation chamber|
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