CA2170936C - Flushable midstream urine collector - Google Patents
Flushable midstream urine collector Download PDFInfo
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- CA2170936C CA2170936C CA 2170936 CA2170936A CA2170936C CA 2170936 C CA2170936 C CA 2170936C CA 2170936 CA2170936 CA 2170936 CA 2170936 A CA2170936 A CA 2170936A CA 2170936 C CA2170936 C CA 2170936C
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/007—Devices for taking samples of body liquids for taking urine samples
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Abstract
A flushable midstream urine collector which is discardable, dissolvable, and flushable in the water of a common flush toilet without obstructing or damaging the water discharge lines of the waste water system is disclosed. The collector includes an open-ended tubular body which defines a flow passage and a cup member which is mounted in the flow passage. The cup member by-passes the initial and terminal portions of the urine stream when a patient voids into the collector, but the cup member collects a midstream sample which may be easily transferred from the cup member to a collection tube. The primary structural components of the tubular body and cup member are formed from a water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl. However, thin protective layers of water-insoluble material line the interior of the tubular body and cup member for preventing urine passing through the device from initiating premature dissolution of the primary components of the collector. When discarded in the water of a toilet bowl, the water in the bowl envelopes the collector, initiates dissolution of the primary components of the device, and the protective layers of the device, which are relatively weak, collapse or disperse once the primary layers of the device lose their structural integrity. Thereafter, the entire device can be flushed through the water discharge lines without obstructing or damaging the waste water system.
Description
~~~a~~s FLUSHABLE MIDSTREAM
URINE COLLECTOR
BACKGROUND AND SUMMARY
Conventional urine sample collectors generally take the form of a simple cup which includes a closable lid. Typically, the patient voids into the cup, closes the lid, and then returns it to a nurse who must wear gloves to pick up, label, and place the cup in a plastic zip-lock bag for transport to a laboratory for analysis. The sample container must then be disposed of through a certified medical waste disposal company which follows stringent and expensive disposal standards. Handling of the sample container must be carefully conducted throughout the entire process since diseases such as AIDS or hepatitis can be transmitted by improper handling of urine specimens.
Conventional sample cups also present problems with respect to the sample being contaminated by the initial portion of the urine stream. The importance of collecting a "midstream"
sample for urine analysis is well known. A particularly advantageous device for collecting a midstream sample is disclosed in my Patent No. 4,557,274. Briefly, the device includes a tubular body through which a patient voids and a cup member is positioned in the flow passage of the tubular body which by-passes the initial and terminal portions of the urine stream but collects a midstream sample. The sample can then be simply transferred from the cup member to a conventional air-evacuated collection tube or conventional syringe. While this device presents an effective way of collecting a midstream urine sample, there still exists a need in the industry for a device which overcomes the complexity and cost of handling and disposal of urine sample collection devices.
An important aspect of this invention therefore lies in providing an uncomplicated low-cost midstream urine collector which is adapted for one time use and which is discardable in a common toilet bowl and waste water system without obstructing or 2~70~3G
damaging the water discharge lines. More specifically, the collector automatically by-passes the contaminated initial portion of the stream and then collects a sterile or at least relatively uncontaminated midstream sample which is quickly and easily transferred to a sterile collection tube. The collector is primarily composed of a water-soluble material which gives the device its structural integrity and, when the device is discarded in the water of a toilet bowl, it readily dissolves or disperses so that it may be flushed through the water discharge lines of a waste water system without obstructing or damaging the system.
Protective layers of water-insoluble material line or coat the majority of the surfaces of the device which are exposed to urine when a patient voids into the device. However, the protective layers are thin and relatively weak so that they will break-up or disperse once the primary water-soluble components of the collector dissolve. Such a construction is low-cost in design and is suitable for manufacturing and marketing as a disposable item for one-time use and subsequent disposal in a flush toilet.
In brief, the flushable midstream urine collector includes a tubular body which defines a flow passage and a cup member which is disposed in the flow passage. Cover means are provided for effectively sealing the mouth of the cup member in a first operative state so that the initial portion of the urine stream is deflected and for exposing the mouth of the cup member in a second operative state so that the mouth of the cup member is exposed to receive an uncontaminated subsequent midstream portion. The tubular body and cup member are composed of primary layers of water-soluble material which provide the structural components of the device and which will dissolve or disperse when disposed in the water of a toilet bowl. Thin protective, but relatively weak, layers of water-insoluble material line the inner surfaces of the tubular body and cup member to prevent premature dissolution of the primary layers when a patient voids into the collector. When the device is disposed in the water of a toilet bowl, the primary layers of the tubular body and cup 21~093~
member dissolve or disperse so that the device loses its structural integrity and the relatively weak protective layers collapse and disperse so that the entire collector is readily flushable. The primary layers of the tubular body and the cup member may be composed of a relatively rigid water-soluble polymer such as polyvinyl alcohol. The protective layers of water-soluble material may be composed of wax, polyvinyliodine, or other thin water-insoluble materials which are relatively weak and which will break-up or disperse upon dissolution of the primary layers.
The inner surface of the sup member is provided with a protective layer of water-insoluble material to contain the midstream sample. However, the outer water-soluble surface of the cup member must be left exposed to the flow passage;
otherwise, if both the inner and outer surfaces of the cup member were protected by water-insoluble material, the cup member would not dissolve or disperse when disposed in the water of a toilet bowl. Accordingly, urine passing through the passage will contact the water-soluble outer surface of the cup member.
However, it is believed that the contact between the urine and primary layer occurs only randomly and that the fluid does not directly contact the primary layer for a sufficient amount of time to compromise the structural integrity of the cup member.
For example, a patient will typically void into the collector for a period of approximately 30-60 seconds whereas the primary layer requires generally at least 2 minutes of direct and constant exposure to fluid, preferably 2-5 minutes, in order to completely dissolve or disperse.
The collector may also include urine-deflection means positioned around the mouth of the cup member for deflecting urine passing through the passage away from the outer surface of the cup member to minimize contact between the urine and the unprotected water-soluble outer surface of the cup member. The construction of the urine-deflection means differs depending upon ' ' the type of cover means which is disposed over the upwardly-directed mouth of the cup member.
In one embodiment, the cover means include a water-soluble membrane which extends over the mouth of the cup member and which is capable of disintegrating within a few seconds upon direct exposure to a stream of urine. Attachment means are provided for securing the water-soluble membrane over the mouth of the cup member, and the attachment means may take the form of an annular collar. The collar may also form the urine-deflection means by being secured to the cup member so that it projects outward from the cup member and beyond its outer surface to deflect urine passing through the passage away from the cup member's exposed outer surface. The collar may also include an upper surface which extends downwardly along an inclined plane away from the cup member to direct urine flowing through the passage away from the outer surface of the cup member.
In another embodiment, the cover means include a cover plate which is formed of a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material. The cover plate is supported in a first position upon the cup member so that it covers the mouth of the cup member and the protective water-insoluble layer is exposed to the passageway for protecting the primary water-soluble layer from fluids flowing through the passage. The cover plate is supported upon the cup member for movement between a first position in which it covers the mouth of, and deflects urine away from, the cup member, and a second position in which it is displaced from the mouth to allow a midstream sample to enter the cup. The cover may be urged into the second position by a spring, gravity, or other suitable means. Preferably, when the cover plate is in its second position, the water-soluble primary layer of the cover plate is exposed to fluids passing through the passage to initiate dissolution of the cover plate while the sample is being 217Q~~~
collected. In this embodiment, the urine-deflection means for protecting the outer surface of the cup member may take the form of the cover plate which includes a peripheral portion which projects outward beyond the outer surface of the cup member for shielding the outer surface of the cup member when the cover plate is in the first position. While the urine-deflection means will be displaced or inoperative when the cover plate is in the second position, it is believed that providing such a urine-deflection means, although only for a short interval, is advantageous since it protects the exposed outer surface of the cup member from the initial surge of the urine stream.
The tubular member includes a support means for supporting a collection tube for removal of the urine sample and evacuation passage means are provided between the cup member and the support means. The collection tube may take the form of an air-evacuated collection tube having a pierceable stopper that is slidably supported by the support means adjacent to a hollow spike communicating with the evacuation passage means. After the patient has finished voiding, the collector is simply placed upon an unyielding support surface and the evacuator tube is urged axially to cause piercing of the stopper and the flow of at least a portion of the midstream sample into the sterile tube. The support means is composed entirely of a water-soluble material so that it will dissolve or disperse when disposed in the water of a toilet bowl. Likewise, the evacuation passage means are primarily composed of a water-soluble material except for a thin protective layer of water-insoluble material which lines the interior passage which extends in communication between the cup member and support means. The hollow spike may be composed of a water-insoluble material such as a rigid plastic or metal.
However, the spike is preferably constructed to have a relatively short length of approximately 0.5 to 1.5 inches, preferably about 1 inch, so that it may be flushed in a common flush toilet without obstructing the water discharge lines. Once a nurse has extracted a urine sample from the collector with a collection tube, the collector is discarded in the water of a toilet bowl.
After a sufficient interval has elapsed so that the primary layers of the tubular body and cup member, as well as the support means and evacuation passage means, dissolve and disperse, the toilet can then be flushed for permanent disposal of the collector.
Other features, aspects, and advantages of the invention will become apparent from the specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a flushable midstream urine collector embodying the present invention.
FIG. 2 is an exploded fragmentary perspective view illustrating a portion of the cup member and one embodiment of the cover means.
FIG. 3 is a fragmentary vertical sectional view illustrating the construction of the water-soluble and water-insoluble layers of the device and depicting operation of the device at the beginning of a sample-collecting procedure.
FIG. 4 is a sectional view similar to FIG. 3 but illustrating the device after the cover member has started to disintegrate and a midstream sample has begun to enter the cup member.
FIG. 5 is a sectional view similar to FIGS. 3 and 4 but illustrating the further step of transferring_the midstream sample from the cup member to an evacuated collection tube.
FIG. 6 is a fragmentary vertical sectional view of a midstream collector constituting another embodiment of the invention.
FIG. 7 is a fragmentary vertical sectional view illustrating another embodiment of the invention.
FIG. 8 is a fragmentary vertical sectional view illustrating the embodiment shown in FIG. 7 with the cover plate in a second position.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to the drawings, the numeral 10 generally designates a flushable midstream urine collector which includes a tubular body 11 having an upper inlet 12, a lower outlet 13, and a flow passage 14 extending therebetween. The body is funnel-shaped, the lower section lla of the body being generally cylindrical and the upper section llb being frusto-conical in configuration. The lower section 11a is provided with a plurality of outwardly projecting legs 15 so that the collector may be placed in an upstanding position upon a tabletop or other support surface. A particularly advantageous construction of a midstream urine collector, although non-flushable, is disclosed in my U.S. 4,557,274 patent.
The tubular body 11 includes inner and outer surfaces 16 and 17 and inner surface 16 defines flow passage 14. The tubular body is composed of a primary outer layer 18 of a water-soluble polymeric material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin inner protective layer 19 of a water-insoluble material which lines inner surface 16 of the body and prevents urine flowing through the passage from contacting the water-soluble primary layer of the body. Outer layer 18 forms the structural component of the tubular body and may be formed from water-soluble polymers which are capable of being formed into rigid or semi-rigid articles.
One particularly suitable water-soluble material is polyvinyl alcohol which is commercially available in pelletized form and which may be injection molded at low temperatures to form the tubular body. However, it will. be understood that other water-soluble polymeric materials may be effective, such as polyethylene oxide or carboxymethyl cellulose. In any event, it is believed preferable if the water-soluble material requires at least about 2 minutes of direct exposure to a fluid in order to significantly dissolve or disperse. Preferably, the water-soluble material is constructed so that it will dissolve or _g_ 217~93~
disperse in a period of about 2-5 minutes after it is discarded in the water of a toilet bowl. However, water-soluble materials which may require up to a period of about 10 minutes to dissolve are still believed to be suitable as leaving the collector in the toilet bowl for such a time period is usually not inconvenient in a typical situation in which a patient is providing a urine sample.
Unlike the primary layer of the tubular body, the inner protective layer 19 is relatively thin and weak and serves primarily as a protective coating to prevent direct exposure of the primary layer to fluids flowing through the passage of the tubular body. The inner protective layer lacks sufficient strength to maintain its structural integrity when the primary layer of the tubular body dissolves or disperses and will readily collapse and disperse upon dissolution of the primary layer. The protective layer may be formed from water-insoluble polymeric materials such as polyvinyl chloride or polyvinyliodine, or other suitable water-insoluble materials known in the art. One particularly suitable water-insoluble material is wax which may be easily applied by spray coating a thin layer of wax onto the inner surface of the tubular body.
Within the flow passage 14 of body 11 is a cup member 20. The cup member includes an outer surface 20a which is exposed to the flow passage and an inner surface 20b which defines an interior chamber 21 positioned below an upwardly-directed mouth 22. The cup member is preferably mounted within the upper portion of the body's lower section 11a, and bridging means in the form of struts 23 support the cup member within the flow passage. The cup member is substantially smaller than the body and, in particular, has an outer diameter smaller than the inside diameter of body 11. Consequently, fluid entering the inlet of the funnel-shaped body may flow downwardly through passage 14 past cup member 20 and may be discharged through outlet 13.
The cup member is composed of a primary layer 24 of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and the primary layer of the cup member may have the same, or a similar, construction as the primary layer of the tubular body. The cup member also includes a thin protective, but relatively weak, layer 25 of water-insoluble material which lines the inner surface 20b of the cup member and prevents fluid collected in chamber 21 from contacting the primary layer 24 of the cup member. Protective layer 25 may have the same, or a similar, construction as the protective layer which lines the inner surface of the tubular body.
The struts 23 which support cup member 20 in the flow passage are primarily composed of a water-soluble material except for a thin layer 23a of water-insoluble material which faces inlet 12 and deflects fluid entering and flowing through the passage away from the primary water-soluble component of the struts. It will be understood that at least a portion of the water-soluble component of the struts should remain exposed to the passage so that, when the collector is discarded in the water of a toilet bowl, the water will contact and initiate dissolution of the primary component of the struts.
It will also be noted that outer surface 20a of cup member 20 is formed from water-soluble primary layer 24 which is exposed to fluids flowing through the passage; otherwise, if the outer and inner surfaces of the cup member were coated with a water-insoluble material, the cup member would be completely insulated and would not dissolve or disperse in the water of a toilet bowl. Although the water-soluble outer surface of the cup member is exposed to the fluid passage, it is believed that fluids passing through the passage will not cause significant disintegration or dissolution of the cup member. This is because fluids passing through the passage only randomly contact the outer surface of the cup member, and such contact only occurs during the limited period of time that the patient voids into the . ~1'~0~3G
collector, which is typically a period of about 30 to 60 seconds.
In contrast, the primary layer of the cup member, as well as the primary layer of the tubular body, are preferably constructed of a water-soluble material which requires at least about 2 minutes of direct exposure to a fluid in order to significantly dissolve or disperse. When a the collector is discarded in the water of a toilet bowl, the water in the bowl envelopes the collector and initiates dissolution of the exposed primary layer 18 of the tubular body and the exposed. primary layer 20a of the cup member so that within approximately 2-10 minutes, preferably 2-5 minutes, the primary layers of the collector lose their structural integrity. The relatively weak protective layers then collapse or disintegrate so that the entire collector is readily flushable through a common flush toilet without obstructing or otherwise damaging the discharge lines of the water disposal system.
Cover means 26 extend over the mouth 22 of cup member 20. In the embodiment shown in FIGS. 1-5, the cover is formed entirely, or substantially so, of a non-contaminating water-soluble material capable of rapidly disintegrating upon direct exposure to an aqueous fluid (urine). The cover is shown to be dome-shaped; however, other configurations might be suitable such as, for example, a conical configuration or a sloping planar configuration. In any event, it is important that the imperforate cover 26 present an upwardly-facing outer surface capable of deflecting fluid entering the flow passage of the body and preventing the fluid from initially entering cup member 20.
To maintain the cover in a dome condition, cup member 20 may be provided with a framework of arched supporting struts 27. The struts are primarily formed from a non-contaminating water-soluble polymeric material which may be the same, or similar to, the primary layers of the tubular body and cup member. However, the uppermost portion or upwardly-directed surfaces 27a of the struts which support the cover are provided with a thin protective layer of water-insoluble material to prevent the ~~7~~3s struts from significantly disintegrating when a patient voids into the collector. While the unprotected surfaces of the struts will come into random contact with the urine stream, it is believed that the thin protective layer 27a of water-insoluble material is sufficient to deflect the stream and prevent prolonged direct contact between the stream and the structural components of the struts so that only a minimal portion of the struts may dissolve during use and flow into the cup member.
However, like the cover itself, the struts are formed of a non-contaminating water-soluble polymeric material which will not effect the sample that is collected.
Attaching means are provided for securing the cover over the mouth of the cup member. The attachment means may take the form of a circumferential beaded portion 28 provided on the cover so that the cover may be locked into place upon the cup member by a resilient collar 29 disposed about the cover, between the bead 28 and the annular flange or rim 30 about the mouth of the cup member, in the manner depicted most clearly in FIG. 3.
Collar 29 is preferably composed primarily of a water-soluble material which may be the same as or similar to the primary layers of the tubular body and cup member. However, collar 29 includes a thin protective layer 29a of water-insoluble material on its uppermost surfaces which face inlet 12 of the tubular body for preventing the primary water-soluble component of collar 29 from prematurely dissolving when a patient voids into the device.
Operation of the cover means between a first operable state in which it seals the mouth of the cup member and deflects the initial portion of urine stream and a second operative state is which it exposes the mouth of the cup member for collection of a subsequent midstream sample will now be described. As stated, cover 26 consists essentially of a thin membrane formed of water-soluble polymeric material, and such material should not contaminate the fluid that contacts and dissolves it. The term "non-contaminating" is used here to mean any material that when dissolved in a fluid sample will not have any significant effect on the results of tests that may subsequently be performed on that sample. A particularly effective material for such purposes has been found to be a polyvinyl alcohol film of the type marketed by Polymer Films, Inc., Rockville, Connecticut, under the trade-mark PVOH 17-35-1; however, other water-soluble non-contaminating polymeric materials might be used such as, for example, methyl cellulose and derivatives thereof. The thickness of the film or membrane may be varied depending on the material used but, in any event, the composition and thickness of the membrane should be such that disintegration of the cover commences within a period of about 2 to 15 seconds when the cover is directly exposed to a stream of urine. Preferably, such disintegration should commence within about 3 to 8 seconds.
Consequently, when a patient voids into the sterile tubular collector, the initial contaminated portion of the stream (contaminated by the labia in the female and the foreskin and distal urethra in the male) is deflected by the cover and bypasses cup member 20. Such deflected bypassing flow is represented by arrows 31 in FIG. 3. After a few seconds, the membrane cover 26 begins to disintegrate, allowing a midstream portion of the flow to enter the cup member (FIG. 4). Complete bypassing of the cup member again occurs after that member has become completely filled with the relatively uncontaminated midstream portion of the flow of urine. Once urination is completed, the midstream portion remains collected in the cup member, with the beginning and terminal portions of the stream having been passed through the funnel-shaped body and into the toilet bowl.
Means are provided for extracting a sample from the cup member and transferring such sample to a sterile collection tube.
More specifically, support means 32 are provided as part of the tubular body 11 and an evacuation passage means 33 defines an interior passage 34 which extends in communication between the support means and the cup member. The support means and evacuation passage means are formed almost entirely, or substantially so, of a water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl.
Preferably, the support means and evacuation passage means are formed from the same material as the primary layers of the tubular body and cup member. As mentioned, pelletized water-soluble polymers such as polyvinyl alcohol may be injection molded at low temperatures to form the unitary device.
Consequently, all of the substantial components of the collector are formed from a water-soluble polymer which will dissolve or disperse in the water of a toilet bowl and the remainder of the device is formed from thin protective, but relatively weak, layers of water-insoluble material which lack sufficient strength to maintain their structural integrity upon dissolution of the primary components of the collector. Interior passage 34 includes a thin protective layer 34a of water-insoluble material so that collected fluid will not prematurely initiate dissolution of the evacuation passage means. A tubular spike 35 projects upwardly and outwardly from the wall on the lower body section 11a and its lumen constitutes an extension of the evacuation passage means 33. As shown most clearly in FIGS. 3 and 5, the spike is provided with a pointed upper end 36 spaced slightly below the stopper 37 of a conventional air-evacuated collection tube 38. The spike may be formed from a rigid plastic or metal and will typically be constructed of a water-insoluble material.
Preferably, the spike has a length of approximately 0.5 to 1.5 inches, preferably about 1 inch, so that the tubular spike may be flushed with the device in a common flush toilet without obstructing the water discharge lines.
The collection tube may be of the same type commonly used with double-pointed needles for the collection of blood samples, such as, for example, the collection tubes sold under the "Vacutainer" trade-mark by Becton, Dickinson & Company, Rutherford, New Jersey. The collection tube 38 is snugly but slidably supported within the support means 32 that extends alongside body 11. Normally, the tube 38 is supported above the 2~.7~9~G
tip of spike 35 as shown in FIG. 3. After a midstream sample has been collected within cup 20, the collection tube 38 is urged axially downward in the direction represented by arrow 39 in FIG.
to cause the tip 36 of spike 35 to pierce the membrane of stopper 37. Since the tube 38 is supplied in evacuated condition, piercing of the membrane causes liquid to flow from cup 20 into the collection tube (FIG. 5). The stopper 37 is self-sealing, which is well known in the art; hence, upon removal of the collection tube from the collector 10, stopper 37 automatically shields and protects the collection sample from contamination. In this manner, the device automatically extracts the relatively uncontaminated midstream portion, allowing the initial and terminal portions of the stream to pass through the device and into the toilet. Following urination, the collector is simply placed upon a stable support surface, and the patient, nurse or other person urges the air-evacuated collection tube 38 axially downward to cause the collection sample to be transferred from the cup member to the tube. Thereafter, the device may be discarded in the water of a toilet bowl so that the primary layers of the tubular body and the cup member, as well as the support means and the evacuation passage means, dissolve or disperse and the protective inner layers sufficiently disintegrate so that the entire collector, including the short tubular spike, may be safely flushed through the water discharge lines of a waste water treatment system.
The embodiment of FIGS. 6-8 is substantially the same in structure and operation as the embodiment of FIGS. 1-5 except for the cup 20' and the cover means 26'. Cup 20' is similar to cup 20 and includes a primary layer 24' of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and an inner protective layer 25' of water-insoluble material which lines the interior of cup 20' and prevents fluids contained therein from initiating dissolution of primary layer 24'. Primary layer 24' and protective layer 25' may have the same, or a similar composition, as the primary and protective layers 24 and 25, respectively, of cup 20. It will be noted that primary layer 24' of water-soluble material is left exposed to the passage just like the primary layer 24 of cup 20.
Cover means 26' includes a cover plate 100 which is composed of a first primary layer 101 of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective layer 102 of water-insoluble material. The cover plate extends over the mouth 103 of the cup 20' so that the water-insoluble protective layer 102 is exposed to the flow passage, and the cover plate normally prevents fluid falling downwardly through the passage from entering the cup.
Means are provided for urging cover plate 100 into a second position displaced from the mouth of the cup member to collect the midstream sample.
In the illustrations given in Figures 7 and 8, the urging means takes the form of a spring element 104 which has one end secured to the disk-shaped cover plate 100 and its opposite end joined to cup 20'. The spring element exerts a force on the cover plate tending to pivot that plate from the first or closed position shown in FIG. 7 to the second or open position depicted in FIG. 8. However, the action of the spring is resisted by a water-soluble second cover portion 105 of the cover means which is secured to both the cup and plate 100 and holds the plate in its closed position. Cover portion 105 is formed of a film of polyvinyl alcohol or any other non-contaminating water-soluble polymeric material capable of dissolving within a period of about 2-15 seconds (preferably about 3-8 seconds) upon direct exposure to urine flowing downwardly through tubular body 11. When the water-soluble cover portion 105 dissolves, the spring element exerts a force on the cover plate which pivots it to the second position shown in Figure 8 which exposes the mouth of the cup member to fluids passing through the passage. When the cover plate 100 is in the second position, the primary water-soluble layer 101 of the cover plate is exposed to fluid passing through 21'~093~
the tubular body and that fluid may initiate partial dissolution of that member prior to disposal in the water of a toilet bowl.
In the embodiment shown in FIG. 6, the disk-shaped cover plate is shifted from its first (closed) position to its second (open) position by means of gravity. More specifically, the cover plate 100 is normally held in position by the connecting portion 105, thereby sealing the mouth of cup 20' as depicted by the broken lines in FIG. 6. The connecting portion 105 is composed of the same material as a water-soluble non-contaminating cover portion as the previous embodiments (for example, polyvinyl alcohol), with the result that urine entering the body of the collector will initially be deflected by the sloping cover portion and then, as connecting portion 105 disintegrates, cover plate 100 will slide away from the mouth of the cup 20', dropping into the lowered position shown in FIG. 6.
The relatively uncontaminated midstream portion of the flow of urine may then enter the cup member, and the collected sample may be transferred to an evacuated collection tube 38 in the same manner described in connection with the prior embodiments. Since gravity is primarily responsible for shifting the cover plate 100 into its second position, the mouth of the cup member 20' must extend along a sloping plane having a sufficient incline to cause the cover plate to slide out of position when the connecting portion 105 is dissolved. In general, the angle of inclination should be at least 30° measured from the horizontal, with angles in the range of 45° to 60° being preferred. When the cover plate 100 is in the lowered or second position, the water-soluble component (layer 101) of the plate is exposed to fluids passing through the device which will initiate some dissolution of the cover plate prior to disposal of the device in the toilet bowl.
In such a construction, an annular ring 23' may be provided instead of stretch 23 for mounting cup member 20' within the tubular body. Like struts 23, ring 23' is preferably formed from a water-soluble material but includes a thin protective layer 23a' of water-insoluble material disposed upon its uppermost . 21~0.~36 surface and facing inlet 12 for protecting the ring from prematurely dissolving.
It has been noted that the outer surface 20a of the cup member is formed from the water-soluble primary layer but is left exposed to fluid passing through flow passage 14. While it is believed that fluid flowing through the passage only randomly contacts the outer surface for a limited period of time, it may be desirable in some applications to provide means for protecting the outer surface from at least the initial surge of the urine stream. Urine deflection means may therefore be provided around the mouth of the cup member for deflecting urine passing through the passage away from the exposed outer surface of the cup member.
In the embodiment illustrated in FIGS. 1-5, the urine deflection means may take the form of collar 29 which projects outward from cup member 20 and beyond the cup member's outer surface 20a so that fluid passing through the passage will impinge upon the collar and be directed outward away from the outer surface of the cup member as most clearly illustrated in FIG. 4 by arrow 40. Collar 29 may include a sloped surface 29b which forms the upper-most part of the collar and which extends along an inclined plane away from the cup member for directing fluids flowing through the passage in an outward direction away from the exposed outer surface of the cup member.
In the embodiments illustrated in FIGS. 6-8, the urine deflection means may take the form of the cover plate 100 which includes a peripheral portion 106 which extends outward from the cup member and beyond the cup member's outer surface for shielding the exposed outer surface of the cup member, which is positioned below and inward from the peripheral portion of the cover plate, from fluids flowing through the passage. While it will be understood that the cover plate is displaced from the mouth of the cup member in the second position, the peripheral portion of the cover plate is still advantageous since it deflects urine away from the outer surface of the cup member 2~7~93~
while in the first position and protects the outer surface of the cup member from the initial surge of the urine stream.
While in the foregoing I have disclosed embodiments of the invention in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.
URINE COLLECTOR
BACKGROUND AND SUMMARY
Conventional urine sample collectors generally take the form of a simple cup which includes a closable lid. Typically, the patient voids into the cup, closes the lid, and then returns it to a nurse who must wear gloves to pick up, label, and place the cup in a plastic zip-lock bag for transport to a laboratory for analysis. The sample container must then be disposed of through a certified medical waste disposal company which follows stringent and expensive disposal standards. Handling of the sample container must be carefully conducted throughout the entire process since diseases such as AIDS or hepatitis can be transmitted by improper handling of urine specimens.
Conventional sample cups also present problems with respect to the sample being contaminated by the initial portion of the urine stream. The importance of collecting a "midstream"
sample for urine analysis is well known. A particularly advantageous device for collecting a midstream sample is disclosed in my Patent No. 4,557,274. Briefly, the device includes a tubular body through which a patient voids and a cup member is positioned in the flow passage of the tubular body which by-passes the initial and terminal portions of the urine stream but collects a midstream sample. The sample can then be simply transferred from the cup member to a conventional air-evacuated collection tube or conventional syringe. While this device presents an effective way of collecting a midstream urine sample, there still exists a need in the industry for a device which overcomes the complexity and cost of handling and disposal of urine sample collection devices.
An important aspect of this invention therefore lies in providing an uncomplicated low-cost midstream urine collector which is adapted for one time use and which is discardable in a common toilet bowl and waste water system without obstructing or 2~70~3G
damaging the water discharge lines. More specifically, the collector automatically by-passes the contaminated initial portion of the stream and then collects a sterile or at least relatively uncontaminated midstream sample which is quickly and easily transferred to a sterile collection tube. The collector is primarily composed of a water-soluble material which gives the device its structural integrity and, when the device is discarded in the water of a toilet bowl, it readily dissolves or disperses so that it may be flushed through the water discharge lines of a waste water system without obstructing or damaging the system.
Protective layers of water-insoluble material line or coat the majority of the surfaces of the device which are exposed to urine when a patient voids into the device. However, the protective layers are thin and relatively weak so that they will break-up or disperse once the primary water-soluble components of the collector dissolve. Such a construction is low-cost in design and is suitable for manufacturing and marketing as a disposable item for one-time use and subsequent disposal in a flush toilet.
In brief, the flushable midstream urine collector includes a tubular body which defines a flow passage and a cup member which is disposed in the flow passage. Cover means are provided for effectively sealing the mouth of the cup member in a first operative state so that the initial portion of the urine stream is deflected and for exposing the mouth of the cup member in a second operative state so that the mouth of the cup member is exposed to receive an uncontaminated subsequent midstream portion. The tubular body and cup member are composed of primary layers of water-soluble material which provide the structural components of the device and which will dissolve or disperse when disposed in the water of a toilet bowl. Thin protective, but relatively weak, layers of water-insoluble material line the inner surfaces of the tubular body and cup member to prevent premature dissolution of the primary layers when a patient voids into the collector. When the device is disposed in the water of a toilet bowl, the primary layers of the tubular body and cup 21~093~
member dissolve or disperse so that the device loses its structural integrity and the relatively weak protective layers collapse and disperse so that the entire collector is readily flushable. The primary layers of the tubular body and the cup member may be composed of a relatively rigid water-soluble polymer such as polyvinyl alcohol. The protective layers of water-soluble material may be composed of wax, polyvinyliodine, or other thin water-insoluble materials which are relatively weak and which will break-up or disperse upon dissolution of the primary layers.
The inner surface of the sup member is provided with a protective layer of water-insoluble material to contain the midstream sample. However, the outer water-soluble surface of the cup member must be left exposed to the flow passage;
otherwise, if both the inner and outer surfaces of the cup member were protected by water-insoluble material, the cup member would not dissolve or disperse when disposed in the water of a toilet bowl. Accordingly, urine passing through the passage will contact the water-soluble outer surface of the cup member.
However, it is believed that the contact between the urine and primary layer occurs only randomly and that the fluid does not directly contact the primary layer for a sufficient amount of time to compromise the structural integrity of the cup member.
For example, a patient will typically void into the collector for a period of approximately 30-60 seconds whereas the primary layer requires generally at least 2 minutes of direct and constant exposure to fluid, preferably 2-5 minutes, in order to completely dissolve or disperse.
The collector may also include urine-deflection means positioned around the mouth of the cup member for deflecting urine passing through the passage away from the outer surface of the cup member to minimize contact between the urine and the unprotected water-soluble outer surface of the cup member. The construction of the urine-deflection means differs depending upon ' ' the type of cover means which is disposed over the upwardly-directed mouth of the cup member.
In one embodiment, the cover means include a water-soluble membrane which extends over the mouth of the cup member and which is capable of disintegrating within a few seconds upon direct exposure to a stream of urine. Attachment means are provided for securing the water-soluble membrane over the mouth of the cup member, and the attachment means may take the form of an annular collar. The collar may also form the urine-deflection means by being secured to the cup member so that it projects outward from the cup member and beyond its outer surface to deflect urine passing through the passage away from the cup member's exposed outer surface. The collar may also include an upper surface which extends downwardly along an inclined plane away from the cup member to direct urine flowing through the passage away from the outer surface of the cup member.
In another embodiment, the cover means include a cover plate which is formed of a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material. The cover plate is supported in a first position upon the cup member so that it covers the mouth of the cup member and the protective water-insoluble layer is exposed to the passageway for protecting the primary water-soluble layer from fluids flowing through the passage. The cover plate is supported upon the cup member for movement between a first position in which it covers the mouth of, and deflects urine away from, the cup member, and a second position in which it is displaced from the mouth to allow a midstream sample to enter the cup. The cover may be urged into the second position by a spring, gravity, or other suitable means. Preferably, when the cover plate is in its second position, the water-soluble primary layer of the cover plate is exposed to fluids passing through the passage to initiate dissolution of the cover plate while the sample is being 217Q~~~
collected. In this embodiment, the urine-deflection means for protecting the outer surface of the cup member may take the form of the cover plate which includes a peripheral portion which projects outward beyond the outer surface of the cup member for shielding the outer surface of the cup member when the cover plate is in the first position. While the urine-deflection means will be displaced or inoperative when the cover plate is in the second position, it is believed that providing such a urine-deflection means, although only for a short interval, is advantageous since it protects the exposed outer surface of the cup member from the initial surge of the urine stream.
The tubular member includes a support means for supporting a collection tube for removal of the urine sample and evacuation passage means are provided between the cup member and the support means. The collection tube may take the form of an air-evacuated collection tube having a pierceable stopper that is slidably supported by the support means adjacent to a hollow spike communicating with the evacuation passage means. After the patient has finished voiding, the collector is simply placed upon an unyielding support surface and the evacuator tube is urged axially to cause piercing of the stopper and the flow of at least a portion of the midstream sample into the sterile tube. The support means is composed entirely of a water-soluble material so that it will dissolve or disperse when disposed in the water of a toilet bowl. Likewise, the evacuation passage means are primarily composed of a water-soluble material except for a thin protective layer of water-insoluble material which lines the interior passage which extends in communication between the cup member and support means. The hollow spike may be composed of a water-insoluble material such as a rigid plastic or metal.
However, the spike is preferably constructed to have a relatively short length of approximately 0.5 to 1.5 inches, preferably about 1 inch, so that it may be flushed in a common flush toilet without obstructing the water discharge lines. Once a nurse has extracted a urine sample from the collector with a collection tube, the collector is discarded in the water of a toilet bowl.
After a sufficient interval has elapsed so that the primary layers of the tubular body and cup member, as well as the support means and evacuation passage means, dissolve and disperse, the toilet can then be flushed for permanent disposal of the collector.
Other features, aspects, and advantages of the invention will become apparent from the specification and drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a flushable midstream urine collector embodying the present invention.
FIG. 2 is an exploded fragmentary perspective view illustrating a portion of the cup member and one embodiment of the cover means.
FIG. 3 is a fragmentary vertical sectional view illustrating the construction of the water-soluble and water-insoluble layers of the device and depicting operation of the device at the beginning of a sample-collecting procedure.
FIG. 4 is a sectional view similar to FIG. 3 but illustrating the device after the cover member has started to disintegrate and a midstream sample has begun to enter the cup member.
FIG. 5 is a sectional view similar to FIGS. 3 and 4 but illustrating the further step of transferring_the midstream sample from the cup member to an evacuated collection tube.
FIG. 6 is a fragmentary vertical sectional view of a midstream collector constituting another embodiment of the invention.
FIG. 7 is a fragmentary vertical sectional view illustrating another embodiment of the invention.
FIG. 8 is a fragmentary vertical sectional view illustrating the embodiment shown in FIG. 7 with the cover plate in a second position.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to the drawings, the numeral 10 generally designates a flushable midstream urine collector which includes a tubular body 11 having an upper inlet 12, a lower outlet 13, and a flow passage 14 extending therebetween. The body is funnel-shaped, the lower section lla of the body being generally cylindrical and the upper section llb being frusto-conical in configuration. The lower section 11a is provided with a plurality of outwardly projecting legs 15 so that the collector may be placed in an upstanding position upon a tabletop or other support surface. A particularly advantageous construction of a midstream urine collector, although non-flushable, is disclosed in my U.S. 4,557,274 patent.
The tubular body 11 includes inner and outer surfaces 16 and 17 and inner surface 16 defines flow passage 14. The tubular body is composed of a primary outer layer 18 of a water-soluble polymeric material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin inner protective layer 19 of a water-insoluble material which lines inner surface 16 of the body and prevents urine flowing through the passage from contacting the water-soluble primary layer of the body. Outer layer 18 forms the structural component of the tubular body and may be formed from water-soluble polymers which are capable of being formed into rigid or semi-rigid articles.
One particularly suitable water-soluble material is polyvinyl alcohol which is commercially available in pelletized form and which may be injection molded at low temperatures to form the tubular body. However, it will. be understood that other water-soluble polymeric materials may be effective, such as polyethylene oxide or carboxymethyl cellulose. In any event, it is believed preferable if the water-soluble material requires at least about 2 minutes of direct exposure to a fluid in order to significantly dissolve or disperse. Preferably, the water-soluble material is constructed so that it will dissolve or _g_ 217~93~
disperse in a period of about 2-5 minutes after it is discarded in the water of a toilet bowl. However, water-soluble materials which may require up to a period of about 10 minutes to dissolve are still believed to be suitable as leaving the collector in the toilet bowl for such a time period is usually not inconvenient in a typical situation in which a patient is providing a urine sample.
Unlike the primary layer of the tubular body, the inner protective layer 19 is relatively thin and weak and serves primarily as a protective coating to prevent direct exposure of the primary layer to fluids flowing through the passage of the tubular body. The inner protective layer lacks sufficient strength to maintain its structural integrity when the primary layer of the tubular body dissolves or disperses and will readily collapse and disperse upon dissolution of the primary layer. The protective layer may be formed from water-insoluble polymeric materials such as polyvinyl chloride or polyvinyliodine, or other suitable water-insoluble materials known in the art. One particularly suitable water-insoluble material is wax which may be easily applied by spray coating a thin layer of wax onto the inner surface of the tubular body.
Within the flow passage 14 of body 11 is a cup member 20. The cup member includes an outer surface 20a which is exposed to the flow passage and an inner surface 20b which defines an interior chamber 21 positioned below an upwardly-directed mouth 22. The cup member is preferably mounted within the upper portion of the body's lower section 11a, and bridging means in the form of struts 23 support the cup member within the flow passage. The cup member is substantially smaller than the body and, in particular, has an outer diameter smaller than the inside diameter of body 11. Consequently, fluid entering the inlet of the funnel-shaped body may flow downwardly through passage 14 past cup member 20 and may be discharged through outlet 13.
The cup member is composed of a primary layer 24 of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and the primary layer of the cup member may have the same, or a similar, construction as the primary layer of the tubular body. The cup member also includes a thin protective, but relatively weak, layer 25 of water-insoluble material which lines the inner surface 20b of the cup member and prevents fluid collected in chamber 21 from contacting the primary layer 24 of the cup member. Protective layer 25 may have the same, or a similar, construction as the protective layer which lines the inner surface of the tubular body.
The struts 23 which support cup member 20 in the flow passage are primarily composed of a water-soluble material except for a thin layer 23a of water-insoluble material which faces inlet 12 and deflects fluid entering and flowing through the passage away from the primary water-soluble component of the struts. It will be understood that at least a portion of the water-soluble component of the struts should remain exposed to the passage so that, when the collector is discarded in the water of a toilet bowl, the water will contact and initiate dissolution of the primary component of the struts.
It will also be noted that outer surface 20a of cup member 20 is formed from water-soluble primary layer 24 which is exposed to fluids flowing through the passage; otherwise, if the outer and inner surfaces of the cup member were coated with a water-insoluble material, the cup member would be completely insulated and would not dissolve or disperse in the water of a toilet bowl. Although the water-soluble outer surface of the cup member is exposed to the fluid passage, it is believed that fluids passing through the passage will not cause significant disintegration or dissolution of the cup member. This is because fluids passing through the passage only randomly contact the outer surface of the cup member, and such contact only occurs during the limited period of time that the patient voids into the . ~1'~0~3G
collector, which is typically a period of about 30 to 60 seconds.
In contrast, the primary layer of the cup member, as well as the primary layer of the tubular body, are preferably constructed of a water-soluble material which requires at least about 2 minutes of direct exposure to a fluid in order to significantly dissolve or disperse. When a the collector is discarded in the water of a toilet bowl, the water in the bowl envelopes the collector and initiates dissolution of the exposed primary layer 18 of the tubular body and the exposed. primary layer 20a of the cup member so that within approximately 2-10 minutes, preferably 2-5 minutes, the primary layers of the collector lose their structural integrity. The relatively weak protective layers then collapse or disintegrate so that the entire collector is readily flushable through a common flush toilet without obstructing or otherwise damaging the discharge lines of the water disposal system.
Cover means 26 extend over the mouth 22 of cup member 20. In the embodiment shown in FIGS. 1-5, the cover is formed entirely, or substantially so, of a non-contaminating water-soluble material capable of rapidly disintegrating upon direct exposure to an aqueous fluid (urine). The cover is shown to be dome-shaped; however, other configurations might be suitable such as, for example, a conical configuration or a sloping planar configuration. In any event, it is important that the imperforate cover 26 present an upwardly-facing outer surface capable of deflecting fluid entering the flow passage of the body and preventing the fluid from initially entering cup member 20.
To maintain the cover in a dome condition, cup member 20 may be provided with a framework of arched supporting struts 27. The struts are primarily formed from a non-contaminating water-soluble polymeric material which may be the same, or similar to, the primary layers of the tubular body and cup member. However, the uppermost portion or upwardly-directed surfaces 27a of the struts which support the cover are provided with a thin protective layer of water-insoluble material to prevent the ~~7~~3s struts from significantly disintegrating when a patient voids into the collector. While the unprotected surfaces of the struts will come into random contact with the urine stream, it is believed that the thin protective layer 27a of water-insoluble material is sufficient to deflect the stream and prevent prolonged direct contact between the stream and the structural components of the struts so that only a minimal portion of the struts may dissolve during use and flow into the cup member.
However, like the cover itself, the struts are formed of a non-contaminating water-soluble polymeric material which will not effect the sample that is collected.
Attaching means are provided for securing the cover over the mouth of the cup member. The attachment means may take the form of a circumferential beaded portion 28 provided on the cover so that the cover may be locked into place upon the cup member by a resilient collar 29 disposed about the cover, between the bead 28 and the annular flange or rim 30 about the mouth of the cup member, in the manner depicted most clearly in FIG. 3.
Collar 29 is preferably composed primarily of a water-soluble material which may be the same as or similar to the primary layers of the tubular body and cup member. However, collar 29 includes a thin protective layer 29a of water-insoluble material on its uppermost surfaces which face inlet 12 of the tubular body for preventing the primary water-soluble component of collar 29 from prematurely dissolving when a patient voids into the device.
Operation of the cover means between a first operable state in which it seals the mouth of the cup member and deflects the initial portion of urine stream and a second operative state is which it exposes the mouth of the cup member for collection of a subsequent midstream sample will now be described. As stated, cover 26 consists essentially of a thin membrane formed of water-soluble polymeric material, and such material should not contaminate the fluid that contacts and dissolves it. The term "non-contaminating" is used here to mean any material that when dissolved in a fluid sample will not have any significant effect on the results of tests that may subsequently be performed on that sample. A particularly effective material for such purposes has been found to be a polyvinyl alcohol film of the type marketed by Polymer Films, Inc., Rockville, Connecticut, under the trade-mark PVOH 17-35-1; however, other water-soluble non-contaminating polymeric materials might be used such as, for example, methyl cellulose and derivatives thereof. The thickness of the film or membrane may be varied depending on the material used but, in any event, the composition and thickness of the membrane should be such that disintegration of the cover commences within a period of about 2 to 15 seconds when the cover is directly exposed to a stream of urine. Preferably, such disintegration should commence within about 3 to 8 seconds.
Consequently, when a patient voids into the sterile tubular collector, the initial contaminated portion of the stream (contaminated by the labia in the female and the foreskin and distal urethra in the male) is deflected by the cover and bypasses cup member 20. Such deflected bypassing flow is represented by arrows 31 in FIG. 3. After a few seconds, the membrane cover 26 begins to disintegrate, allowing a midstream portion of the flow to enter the cup member (FIG. 4). Complete bypassing of the cup member again occurs after that member has become completely filled with the relatively uncontaminated midstream portion of the flow of urine. Once urination is completed, the midstream portion remains collected in the cup member, with the beginning and terminal portions of the stream having been passed through the funnel-shaped body and into the toilet bowl.
Means are provided for extracting a sample from the cup member and transferring such sample to a sterile collection tube.
More specifically, support means 32 are provided as part of the tubular body 11 and an evacuation passage means 33 defines an interior passage 34 which extends in communication between the support means and the cup member. The support means and evacuation passage means are formed almost entirely, or substantially so, of a water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl.
Preferably, the support means and evacuation passage means are formed from the same material as the primary layers of the tubular body and cup member. As mentioned, pelletized water-soluble polymers such as polyvinyl alcohol may be injection molded at low temperatures to form the unitary device.
Consequently, all of the substantial components of the collector are formed from a water-soluble polymer which will dissolve or disperse in the water of a toilet bowl and the remainder of the device is formed from thin protective, but relatively weak, layers of water-insoluble material which lack sufficient strength to maintain their structural integrity upon dissolution of the primary components of the collector. Interior passage 34 includes a thin protective layer 34a of water-insoluble material so that collected fluid will not prematurely initiate dissolution of the evacuation passage means. A tubular spike 35 projects upwardly and outwardly from the wall on the lower body section 11a and its lumen constitutes an extension of the evacuation passage means 33. As shown most clearly in FIGS. 3 and 5, the spike is provided with a pointed upper end 36 spaced slightly below the stopper 37 of a conventional air-evacuated collection tube 38. The spike may be formed from a rigid plastic or metal and will typically be constructed of a water-insoluble material.
Preferably, the spike has a length of approximately 0.5 to 1.5 inches, preferably about 1 inch, so that the tubular spike may be flushed with the device in a common flush toilet without obstructing the water discharge lines.
The collection tube may be of the same type commonly used with double-pointed needles for the collection of blood samples, such as, for example, the collection tubes sold under the "Vacutainer" trade-mark by Becton, Dickinson & Company, Rutherford, New Jersey. The collection tube 38 is snugly but slidably supported within the support means 32 that extends alongside body 11. Normally, the tube 38 is supported above the 2~.7~9~G
tip of spike 35 as shown in FIG. 3. After a midstream sample has been collected within cup 20, the collection tube 38 is urged axially downward in the direction represented by arrow 39 in FIG.
to cause the tip 36 of spike 35 to pierce the membrane of stopper 37. Since the tube 38 is supplied in evacuated condition, piercing of the membrane causes liquid to flow from cup 20 into the collection tube (FIG. 5). The stopper 37 is self-sealing, which is well known in the art; hence, upon removal of the collection tube from the collector 10, stopper 37 automatically shields and protects the collection sample from contamination. In this manner, the device automatically extracts the relatively uncontaminated midstream portion, allowing the initial and terminal portions of the stream to pass through the device and into the toilet. Following urination, the collector is simply placed upon a stable support surface, and the patient, nurse or other person urges the air-evacuated collection tube 38 axially downward to cause the collection sample to be transferred from the cup member to the tube. Thereafter, the device may be discarded in the water of a toilet bowl so that the primary layers of the tubular body and the cup member, as well as the support means and the evacuation passage means, dissolve or disperse and the protective inner layers sufficiently disintegrate so that the entire collector, including the short tubular spike, may be safely flushed through the water discharge lines of a waste water treatment system.
The embodiment of FIGS. 6-8 is substantially the same in structure and operation as the embodiment of FIGS. 1-5 except for the cup 20' and the cover means 26'. Cup 20' is similar to cup 20 and includes a primary layer 24' of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and an inner protective layer 25' of water-insoluble material which lines the interior of cup 20' and prevents fluids contained therein from initiating dissolution of primary layer 24'. Primary layer 24' and protective layer 25' may have the same, or a similar composition, as the primary and protective layers 24 and 25, respectively, of cup 20. It will be noted that primary layer 24' of water-soluble material is left exposed to the passage just like the primary layer 24 of cup 20.
Cover means 26' includes a cover plate 100 which is composed of a first primary layer 101 of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective layer 102 of water-insoluble material. The cover plate extends over the mouth 103 of the cup 20' so that the water-insoluble protective layer 102 is exposed to the flow passage, and the cover plate normally prevents fluid falling downwardly through the passage from entering the cup.
Means are provided for urging cover plate 100 into a second position displaced from the mouth of the cup member to collect the midstream sample.
In the illustrations given in Figures 7 and 8, the urging means takes the form of a spring element 104 which has one end secured to the disk-shaped cover plate 100 and its opposite end joined to cup 20'. The spring element exerts a force on the cover plate tending to pivot that plate from the first or closed position shown in FIG. 7 to the second or open position depicted in FIG. 8. However, the action of the spring is resisted by a water-soluble second cover portion 105 of the cover means which is secured to both the cup and plate 100 and holds the plate in its closed position. Cover portion 105 is formed of a film of polyvinyl alcohol or any other non-contaminating water-soluble polymeric material capable of dissolving within a period of about 2-15 seconds (preferably about 3-8 seconds) upon direct exposure to urine flowing downwardly through tubular body 11. When the water-soluble cover portion 105 dissolves, the spring element exerts a force on the cover plate which pivots it to the second position shown in Figure 8 which exposes the mouth of the cup member to fluids passing through the passage. When the cover plate 100 is in the second position, the primary water-soluble layer 101 of the cover plate is exposed to fluid passing through 21'~093~
the tubular body and that fluid may initiate partial dissolution of that member prior to disposal in the water of a toilet bowl.
In the embodiment shown in FIG. 6, the disk-shaped cover plate is shifted from its first (closed) position to its second (open) position by means of gravity. More specifically, the cover plate 100 is normally held in position by the connecting portion 105, thereby sealing the mouth of cup 20' as depicted by the broken lines in FIG. 6. The connecting portion 105 is composed of the same material as a water-soluble non-contaminating cover portion as the previous embodiments (for example, polyvinyl alcohol), with the result that urine entering the body of the collector will initially be deflected by the sloping cover portion and then, as connecting portion 105 disintegrates, cover plate 100 will slide away from the mouth of the cup 20', dropping into the lowered position shown in FIG. 6.
The relatively uncontaminated midstream portion of the flow of urine may then enter the cup member, and the collected sample may be transferred to an evacuated collection tube 38 in the same manner described in connection with the prior embodiments. Since gravity is primarily responsible for shifting the cover plate 100 into its second position, the mouth of the cup member 20' must extend along a sloping plane having a sufficient incline to cause the cover plate to slide out of position when the connecting portion 105 is dissolved. In general, the angle of inclination should be at least 30° measured from the horizontal, with angles in the range of 45° to 60° being preferred. When the cover plate 100 is in the lowered or second position, the water-soluble component (layer 101) of the plate is exposed to fluids passing through the device which will initiate some dissolution of the cover plate prior to disposal of the device in the toilet bowl.
In such a construction, an annular ring 23' may be provided instead of stretch 23 for mounting cup member 20' within the tubular body. Like struts 23, ring 23' is preferably formed from a water-soluble material but includes a thin protective layer 23a' of water-insoluble material disposed upon its uppermost . 21~0.~36 surface and facing inlet 12 for protecting the ring from prematurely dissolving.
It has been noted that the outer surface 20a of the cup member is formed from the water-soluble primary layer but is left exposed to fluid passing through flow passage 14. While it is believed that fluid flowing through the passage only randomly contacts the outer surface for a limited period of time, it may be desirable in some applications to provide means for protecting the outer surface from at least the initial surge of the urine stream. Urine deflection means may therefore be provided around the mouth of the cup member for deflecting urine passing through the passage away from the exposed outer surface of the cup member.
In the embodiment illustrated in FIGS. 1-5, the urine deflection means may take the form of collar 29 which projects outward from cup member 20 and beyond the cup member's outer surface 20a so that fluid passing through the passage will impinge upon the collar and be directed outward away from the outer surface of the cup member as most clearly illustrated in FIG. 4 by arrow 40. Collar 29 may include a sloped surface 29b which forms the upper-most part of the collar and which extends along an inclined plane away from the cup member for directing fluids flowing through the passage in an outward direction away from the exposed outer surface of the cup member.
In the embodiments illustrated in FIGS. 6-8, the urine deflection means may take the form of the cover plate 100 which includes a peripheral portion 106 which extends outward from the cup member and beyond the cup member's outer surface for shielding the exposed outer surface of the cup member, which is positioned below and inward from the peripheral portion of the cover plate, from fluids flowing through the passage. While it will be understood that the cover plate is displaced from the mouth of the cup member in the second position, the peripheral portion of the cover plate is still advantageous since it deflects urine away from the outer surface of the cup member 2~7~93~
while in the first position and protects the outer surface of the cup member from the initial surge of the urine stream.
While in the foregoing I have disclosed embodiments of the invention in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.
Claims (22)
1. A flushable midstream urine collector comprising:
a tubular body having an upper inlet, a lower outlet, inner and outer surfaces, and a flow passage extending between said inlet and outlet along said inner surface;
said tubular body being composed of a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said tubular body and prevents urine passing through said flow passage from contacting said primary layer;
a cup member mounted within said passage below said inlet and being substantially smaller than said passage to permit flow of urine through said passage past said cup member;
said cup member having an outer surface which is exposed to said flow passage and an inner surface which defines an interior chamber below an upwardly-directed mouth, said cup member being composed of a primary layer of water-soluble material which forms the outer surface of the cup member and which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said chamber;
cover means disposed over said upwardly-directed mouth of said cup member and having at least a portion thereof formed of a non-contaminated water-soluble polymeric material capable of disintegrating within a short interval upon direct exposure to a stream of urine;
said cover means having a first operative state wherein said portion is intact and effectively seals said mouth of said cup member and a second operative state wherein said portion of said cover means is dissolved by exposure to an initial portion of a stream of urine and the mouth of said cup member is exposed to receive an uncontaminated subsequent portion of said stream in said chamber.
a tubular body having an upper inlet, a lower outlet, inner and outer surfaces, and a flow passage extending between said inlet and outlet along said inner surface;
said tubular body being composed of a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said tubular body and prevents urine passing through said flow passage from contacting said primary layer;
a cup member mounted within said passage below said inlet and being substantially smaller than said passage to permit flow of urine through said passage past said cup member;
said cup member having an outer surface which is exposed to said flow passage and an inner surface which defines an interior chamber below an upwardly-directed mouth, said cup member being composed of a primary layer of water-soluble material which forms the outer surface of the cup member and which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said chamber;
cover means disposed over said upwardly-directed mouth of said cup member and having at least a portion thereof formed of a non-contaminated water-soluble polymeric material capable of disintegrating within a short interval upon direct exposure to a stream of urine;
said cover means having a first operative state wherein said portion is intact and effectively seals said mouth of said cup member and a second operative state wherein said portion of said cover means is dissolved by exposure to an initial portion of a stream of urine and the mouth of said cup member is exposed to receive an uncontaminated subsequent portion of said stream in said chamber.
2. The collector of claim 1 in which urine-deflection means are positioned around said mouth of said cup member for deflecting urine passing through said passage away from said exposed outer surface of said cup member.
3. The collector of claim 1 in which said water-soluble portion of said cover means extends over the mouth of said cup member when said cover means is in said first operative state; said water-soluble portion being dissolvable to expose the mouth of said cup member when said cover means is in said second operative state; said collector including attachment means for securing said water-soluble portion over said mouth of said cup member and urine-deflection means positioned around said mouth of said cup member for deflecting urine passing through said passage away from said outer surface of said cup member.
4. The collector of claim 3 in which said attachment means and said urine-deflection means comprise a collar which secures said water-soluble portion of said cover means over the mouth of said cup member and which projects outward from the cup member and beyond the outer surface of said cup member.
5. The collector of claim 4 in which said collar forms an annular ring which includes an upper surface which extends downwardly along an inclined plane away from the cup member.
6. The collector of claim 3 in which said water-soluble portion of said cover is generally dome-shaped and a framework of struts are provided for supporting said water-soluble portion of said cover means; said framework being composed of water-soluble material adapted to dissolve or disperse when disposed in the water of a toilet bowl; said framework including upper surfaces which support said water-soluble portion of said cover and which include a thin protective layer of water-insoluble material disposed thereon.
7. The collector of claim 1 in which said cover means includes a cover plate composed of a primary layer of water-soluble material capable of dissolving or dispersing when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material, said cover plate being normally disposed in a first position extending over the mouth of said cup member with said protective layer exposed to said flow passage when said cover means is in said first operative state; said collector including means for urging said cover plate into a second position displaced from the mouth of said cup member when said cover means is in its second operative state; said water-soluble portion of said cover means normally holding said cover plate in its first position but allowing said cover plate to shift into said second position when said water-soluble portion is dissolved; said primary water-soluble layer of said cover plate being exposed to said flow passage when in said second position so that urine passing through said passage will initiate dissolution of said cover plate.
8. The collector of claim 7 in which said means for urging said cover plate to shift into said second position comprises a spring element having one end secured to said cover plate and having another end immobilized with respect to said cup member.
9. The collector of claim 7 in which said means for urging said cover plate of said cover means into its second position comprises the mouth of said cup member extending along an inclined plane, said cover plate being slidable away from the mouth of said cup member under the influence of gravity when said water-soluble portion of said cover means is dissolved; said primary water-soluble layer of said cover plate being exposed to said flow passage when in said second position.
10. The collector of claim 8 in which said cover means further includes urine-deflection means positioned around said mouth of said cup member for deflecting at least a portion of urine passing through said passage away from said outer surface of said cup member; said urine-deflection means comprising said cover plate which includes a peripheral portion which projects outward from the cup member and beyond said outer surface of said cup member when said cover plate is in said first position.
11. The collector of claim 1 in which said cup member is supported within said passage by a plurality of struts which are each formed from a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material, said protective layer facing said inlet of said passage and said primary layer including at least a portion which is exposed to the flow passage.
12. The collector of claim 1 in which said primary layer of said tubular body and said primary layer of said cup member are composed of water-soluble polyvinyl alcohol.
13. The collector of claim 1 in which said protective layer of said tubular body and said protective layer of said cup member are composed of a thin layer of wax.
14. The collector of claim 1 in which said protective layer of said tubular body and said protective layer of said cup member are composed of a thin layer of polyvinyliodine.
15. A flushable midstream urine collector comprising:
a tubular body having an upper inlet, a lower outlet, inner and outer surfaces, and a flow passage extending between said inlet and outlet along said inner surface;
said tubular body being composed of a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said tubular body and prevents urine passing through said flow passage from contacting said primary layer;
a cup member mounted within said passage below said inlet and being substantially smaller than said passage to permit flow of urine through said passage past said cup member;
said cup member having an outer surface which is exposed to said flow passage and an inner surface which defines an interior chamber below an upwardly-directed mouth, said cup member being composed of a primary layer of water-soluble material which forms the outer surface of the cup member and which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said chamber;
cover means disposed over said upwardly-directed mouth of said cup member and having at least a portion thereof formed of a non-contaminated water-soluble polymeric material capable of disintegrating within a short interval upon direct exposure to a stream of urine;
said cover means having a first operative state wherein said portion is intact and effectively seals said mouth of said cup member and a second operative state wherein said portion of said cover means is dissolved by exposure to an initial portion of a stream of urine and the mouth of said cup member is exposed to receive an uncontaminated subsequent portion of said stream in said chamber;
support means provided by said tubular body for supporting a removable container, said support means being comprised of water-soluble material capable of dissolving or dispersing when disposed in the water of a toilet bowl; and evacuation passage means defining an interior passage extending between said chamber of said cup member and said support means, said evacuation passage means being composed of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said interior passage.
a tubular body having an upper inlet, a lower outlet, inner and outer surfaces, and a flow passage extending between said inlet and outlet along said inner surface;
said tubular body being composed of a primary layer of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said tubular body and prevents urine passing through said flow passage from contacting said primary layer;
a cup member mounted within said passage below said inlet and being substantially smaller than said passage to permit flow of urine through said passage past said cup member;
said cup member having an outer surface which is exposed to said flow passage and an inner surface which defines an interior chamber below an upwardly-directed mouth, said cup member being composed of a primary layer of water-soluble material which forms the outer surface of the cup member and which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said inner surface of said chamber;
cover means disposed over said upwardly-directed mouth of said cup member and having at least a portion thereof formed of a non-contaminated water-soluble polymeric material capable of disintegrating within a short interval upon direct exposure to a stream of urine;
said cover means having a first operative state wherein said portion is intact and effectively seals said mouth of said cup member and a second operative state wherein said portion of said cover means is dissolved by exposure to an initial portion of a stream of urine and the mouth of said cup member is exposed to receive an uncontaminated subsequent portion of said stream in said chamber;
support means provided by said tubular body for supporting a removable container, said support means being comprised of water-soluble material capable of dissolving or dispersing when disposed in the water of a toilet bowl; and evacuation passage means defining an interior passage extending between said chamber of said cup member and said support means, said evacuation passage means being composed of water-soluble material which will dissolve or disperse when disposed in the water of a toilet bowl and a thin protective, but relatively weak, layer of water-insoluble material which lines said interior passage.
16. The collector of claims 15 in which said evacuation passage means communicates with said cup member at a lower end thereof.
17. The collector of claim 15 in which said evacuation passage means includes a tubular spike having a pointed end adapted to penetrate a membrane of a collection tube when a collection tube is inserted into said support means.
18. The collector of claim 17 in which said support means comprises a guideway for slidably supporting a collection tube adjacent said spike.
19. The collector of claim 18 in which a collection tube is slidably supported within said guideway and has a membrane oriented for engagement with said spike for the piercing of said membrane and the withdrawal of urine from said cup member into said collection tube when the membrane of said collection tube is pierced by said spike.
20. The collector of claim 17 in which a collection tube in the form of a syringe is removably supported by said support means; said syringe having a tip equipped with a resilient self-sealing stopper into which said spike projects.
21. The collector of claim 17, 18, 19 or 20 in which said spike has a length of less than one inch.
22. The collector of claim 17, 18, 19 or 20 in which said spike has a length of about 0.5 to 1.5 inches.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US39907195A | 1995-03-08 | 1995-03-08 | |
| US399,071 | 1995-03-08 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2170936A1 CA2170936A1 (en) | 1996-09-09 |
| CA2170936C true CA2170936C (en) | 2002-05-28 |
Family
ID=23578011
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2170936 Expired - Fee Related CA2170936C (en) | 1995-03-08 | 1996-03-04 | Flushable midstream urine collector |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2170936C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014135856A1 (en) * | 2013-03-04 | 2014-09-12 | Forte Medical Limited | Urine collection device |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2440842B (en) | 2006-09-30 | 2008-08-20 | Funnelly Enough Ltd | Urine collection device |
| DK180052B1 (en) * | 2018-06-18 | 2020-02-05 | Anders Geert Holding Aps | A device for collecting midstream urine from a human individual |
| CN110279437B (en) * | 2019-06-14 | 2021-11-30 | 中国人民解放军陆军军医大学第一附属医院 | Urine sampler |
-
1996
- 1996-03-04 CA CA 2170936 patent/CA2170936C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014135856A1 (en) * | 2013-03-04 | 2014-09-12 | Forte Medical Limited | Urine collection device |
| EP3701879A1 (en) * | 2013-03-04 | 2020-09-02 | Forte Medical Limited | Urine collection device |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2170936A1 (en) | 1996-09-09 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |