The disclosed embodiment relates to the collection of a human urine-specimen, the storage of said urine-specimen and the primary testing or analysis of said urine-specimen.
A Video Urodynamic Ultrasound test is a diagnostic procedure, which involves monitoring a female patient voiding her full bladder while a vaginal ultrasound transducer probe is inserted within her vagina in order to visually monitor and record the contracting bladder from a full condition to an empty condition. It should be obvious that the patient, the doctor and or medical technicians might experience a fair amount of stress, discomfort and embarrassment as the free-flowing urine is expelled all over the ultrasound transducer probe, the doctor's hands holding the ultrasound transducer probe, over the patient herself and the examination table, floor, etc. Embarrassment and discomfort aside, there are some very serious urine contamination and other hygienic issues to consider in addition to the time, effort, and cost involved in cleaning up and decontamination each and every time such a procedure is performed.
Referring to
A second negative factor related to the conventional Video Urodynamic Ultrasound Test is that because there is no control over the urine stream 32, there are no other diagnostic tests that may be performed simultaneously such as an Uroflowmetry test. Under current medical procedures, getting additional diagnostic urodynamic data such as urine flow rate, urine flow duration, urine flow intervals, urine stream pressure, urine volume, etc. is normally and currently gathered through one or more separate Uroflowmetry test procedures during one or more separate visits to the Urologist's clinic. By combining the two and possibly three of the most commonly performed female urodynamic tests into one procedure, both clinic and urologist time and costs can be significantly reduced. By having the data from each test procedure correlated and synchronized at one central collection point for review, the data gathered becomes significantly more informative and valuable. Additionally, the time saved in both cleanup and decontamination efforts after a Video Urodynamic Ultrasound test also becomes a major time and cost saving consideration.
The foregoing aspects and other features of the disclosed embodiment are explained in the following description, taken in connection with the accompanying drawings, wherein:
The instant invention resolves the above noted deficiencies of conventional systems and methods by combining the ultrasound transducer probe and coupling one or more appropriate data collection sensors to a device having similar urine collecting features as the FUD devices described in U.S. patent application Ser. No. 14/557,791 filed on Dec. 2, 2014 and U.S. patent application Ser. No. 15/644,296 filed Jul. 7, 2017, the disclosures of which are incorporated herein by reference in their entireties, to form a new self-contained Uroflowmetry device, which is designed to cooperate with the conventional ultrasound transducer probe. This new Uroflowmetry device would have significant advantages over existing Uroflowmetry devices in that it would allow various types of diagnostic data to be collected at or near the actual source of the urine stream, that being the urethral opening itself as opposed to current Uroflowmetry devices which attempt to gather and interpret limited information related to urine flow at some distance from the source. New and significantly more accurate and informative data may now be collected such as but not limited to urine-stream temperature, urine stream force/pressure at the source along with urine flow rate, urine flow duration, urine flow intermittent stoppages and voided urine volume.
Referring to
Such a diagnostic device offers certain advantages reported herein arising from urine stream collection to specimen containers such as shown in
Second: by virtue of the over-all design of said check-valve (3), accidental spillage of the contents of said urine-specimen-container (1) is also eliminated.
Third: through the implementation of a separate attachable urine-collection (6, 7, 12, 17) device designed to co-operate with said check-valve (3), said urine-specimen-container (1) is kept some distance away from the urine-stream during urine collection thereby significantly reducing the risk of urine coming into contact with either the urine-specimen-container's exterior or with the patient's hand holding the urine-specimen-container (1).
Fourth: through the implementation of a separate attachable urine test-strip-container device (12) designed to co-operate with said check-valve (3), any test-strips or reagents exposed to the urine specimen are at all times safely enclosed and isolated away from human contact within said test-strip container device (17).
Fifth: as the test-strips and reagents are at all times contained within said test-strip container device (17) and because the test-strip container (12) remains attached to the urine-specimen-container (1) until after the test-strip is analyzed, the potential issue of a test-strip being miss-matched to another patient's urine-specimen-container is eliminated.
Sixth: (The aforementioned BD VACUTAINER™ system includes a semi-exposed hypodermic needle attached to the lid of the specimen-cup container. Although there is a prominent warning label referring to this needle, medical staff commonly feels the need to warn patients of the danger of this needle while providing a urine-specimen. The aspects of the disclosed embodiment are designed to be able to co-operate with the BD VACUTAINER™ system is such a way as to limit potential exposure to the needle to trained medical staff only, thus making the system substantially safer for patients.
At no time during the whole process of urine-specimen collection through urine-specimen analysis is the urine-specimen exposed to human contact while properly implementing the aspects of the disclosed embodiment.
According to one aspect of the disclosed embodiment, a urine-specimen-container (1) includes a flat exterior bottom surface and an opposing upper access portal incorporating a check-valve device (3) having a normal closed condition. Said check-valve (3) is designed to co-operate with any number of interchangeable system attachments (6, 7, 12, 17), that in one aspect may be considered a set, each of which can cause said check-valve to have an open condition when properly attached to said urine-specimen-container (1).
In a preferred aspect, said check-valve (3) has a one-piece construction design and is made of a flexible resilient synthetic material, that is, the material has an innate propensity to return to its original manufactured shape after being manually deformed or flexed. In a preferred aspect, said check-valve (3) may have a shape and form not dissimilar to a common infant's feeding bottle nipple; said nipple having a short slit (4) and (5) cleanly cut across the lower end of said nipple allowing for a small tubular object to pass through said slit.
According to another aspect of the disclosed embodiment, said urine-specimen-container (1) may co-operate with a temporarily attached urine-collection device having the sole function of facilitating the collection of urine from a flowing urine-stream. Said urine-collection device (7) may have a funnel shaped reservoir (8) at its top end and a hollow exit-tube (6) at its lower end; said hollow-tube (6) designed to co-operate with said check-valve (3) causing said check-valve (3) to have an open-condition when said hollow-tube (6) is manually passed through said check-valve (3). After a sufficient amount of urine has flowed into said urine-storage-container, said urine-collection device (7) is intended to be detached from said urine-specimen-container (1) and properly disposed of. Detaching said urine-collection device from said urine-storage-container causes said check-valve (3) to automatically resume its original closed condition thereby safely sealing the collected urine specimen within said urine-storage-container.
As the disposable urine-collection device (7) effectively separates the co-operating urine-storage-container by some distance from the urine-stream itself, both the exterior of said urine-storage-container and the patient's hand holding said urine-collection-container are substantially isolated from potential exposure to and contamination by the flowing urine-stream.
According to still another aspect of the disclosed embodiment, said urine-storage-container may co-operate with a temporarily attached urine test-strip-container device (12) having one function of isolating a generic urine test-strip from user contact both before and after said test-strip has been exposed to a urine-specimen and another function of keeping said test-strip physically related to the original urine-specimen-container thereby avoiding potential miss-matching of test-strip data to the wrong patient.
Said test-strip-container device (12) may be a simple transparent hollow-tube of sufficient internal diameter to accept a generic urine test-strip within said hollow-tube. Included is a separate slender rod or straw (14) with a means at one end of attaching a generic urine-test-strip; said straw (14) being able to move freely within said hollow-tube and being of a length preferably an inch or two longer then said hollow tube. In a preferred aspect, said straw (14) is indeed a simple common drinking straw of sufficient diameter to allow the non-reagent end of a generic test-strip to be securely lodged a short distance into one end of said straw. Of course, any other efficient means of securing the test-strip to the end of the straw may be employed.
Said test-strip-container device (12) may have an exterior flange (13) located close to its lower end regulating the depth said test-strip-container can be inserted into said urine-storage-container; said test-strip container device (12) is designed to co-operate with said check-valve (3) causing said check-valve (3) to have an open-condition when said test-strip container device (12) is manually passed through said check-valve (3).
With said test-strip-container device (12) properly attached to said urine-specimen-container, said combined rod or straw (14) and test-strip may be pushed downwards into said urine-specimen-container sufficient for the reagent-end of said test-strip to make full contact with the urine-sample collected within said urine-storage-container and immediately withdrawn up into said hollow tube only to a level where said test-strip is still contained within said transparent hollow-tube. After the prescribed waiting period for said generic test-strip, said test-strip may be safely viewed through said transparent hollow-tube and analyzed by comparison to a control-strip according to normal clinic procedure.
After said test-strip-container (12) has served its intended function, said device is intended to be detached from said urine-storage-container and properly disposed of. Detaching said test-strip-container device (12) from said urine-storage-container causes said check-valve to automatically resume its original closed condition thereby safely sealing the original collected urine specimen within said urine-storage-container ready for future testing or proper disposal.
Said test-strip, after making contact with the urine-sample has never been exposed to contact with the medical staff or any work surfaces and the original urine-sample remains at all times securely contained within said urine-storage-container safe from accidental spillage or unwanted contamination.
According to another aspect of the disclosed embodiment, said urine-storage-container may co-operate with an alternative temporarily attached test-strip or reagent container device (17); said alternative design intended to facilitate the testing of generic multi-panel urine test devices. Said alternative design being a hollow-tube designed to co-operate with said check-valve (3) causing said check-valve (3) to have an open condition when said hollow-tube (20) is passed through said check-valve (3). Said hollow tube may incorporate a transparent reservoir (18) at the top end of said hollow-tube (20), said reservoir sufficient in size and shape to contain one of a variety of commonly used generic multi-panel urine test devices. Said multi-panel test device container may also have a tapered exterior section (19) just below said reservoir designed to co-operate with said access portal (2) of said urine-storage-container forming an airtight seal between said tapered section (19) and said urine-specimen-container (1).
With said multi-panel test device container (17) properly attached to said urine-specimen-container (1) and a multi-panel test device (21) in place within said reservoir (18), said urine-specimen-container (1) may be manually squeezed sufficient to cause the urine sample contained within to flow upwards into said multi-panel container reservoir and just sufficient to temporarily make contact with the lower end of said generic multi-panel test device. Once the multi-panel test-device has been properly exposed to the urine sample, manual pressure is removed from the urine-storage-container thereby causing the urine sample to return to the interior of the urine-storage-container, leaving said urine-test-device container reservoir empty of urine.
After the prescribed waiting period, the multi-panel test device may be read through the transparent walls of said reservoir after which the test-device container device itself may be detached from the urine-storage-container, causing said check-valve to resume its normal closed condition. Said test-device and test device container may now be properly disposed of leaving the original urine-sample safely contained within said urine-storage-container for future testing or proper disposal.
Alternatively, the urine-specimen-container (1) may be coupled to a discharge opening 2900 of the female urinary diagnostic device 2300 illustrated in, e.g.,
In one aspect the urine specimen container or fluid sample collection device includes at least one fluid conduit penetrator (6, 7, 12, 17) as described herein, and a container and penetration fitment (see, e.g., the combination of container (1), check-valve (3) which includes slit (4, 5) with a valved opening penetration into the container, the valved opening penetration being configured to seal the container (1) and includes a valve, such as check-valve (3) configured to accept through the valve the at least one fluid conduit penetrator to effect a transfer of fluid into and out of the container (1). As described herein the at least one fluid conduit penetrator (6, 7, 12, 17) and the container and penetration fitment are configured for urine specimen collection. In one aspect the at least one fluid conduit penetrator (6, 7, 12, 17) is provided as a set of interchangeable fluid conduit penetrators.
Check-valve (3) may be constructed of any flexible synthetic material, which reliably returns to its original shape and form after being manually deformed or flexed. In other words, the check-valve (3) is resiliently closable where the check-valve automatically opens from an insertion of the at least one fluid conduit penetrator (6, 7, 12, 17) through the check-valve (3). In one aspect, as described herein the check-valve (3) includes a resilient membrane having a slit (4) and (5) where the resilient membrane comprises a bulb having a convex surface extending into the container (1) where the slit (4) and (5) is located on the convex surface so as to be resilient to fluid pressure. The proven and preferred check-valve (3) design shown is very similar to a common infant's feeding-bottle nipple in both material and form with the addition of a slit (4) and (5) added to the end of the nipple. Of course, any other check-valve design with a normal closed condition could also function. An alternative functional design might comprise a flexible membrane with a centrally located pin-sized piercing, which could be manually forced to expand radially to cause an open condition, which automatically returns to a closed condition when said manually applied force is removed.
Urine-collection attachment (7) may be constructed of any material, which will not contaminate the urine sample. There may be multiple alternative external shapes given to the urine-collection attachment (7) to be determined by such possible factors as the patient's gender, physical size, health condition or possibly even whether the patient is standing or reclining while the urine-specimen is being collected; all the while maintaining the primary function of collecting urine from a flowing urine-stream and simultaneously transferring the urine into said urine-specimen-container.
The final step of the total procedure is the detachment and sanitary disposal of the urine test-strip-container assembly (A) leaving the original urine sample (10) safely and securely sealed within the urine-specimen-container (1) as it is seen back in
At no time from the point of urine collection to final disposal of all components of the disclosed embodiment has the urine sample been exposed to contact by either the patient or the medical staff involved in the procedure.
The final step of the total procedure being the detachment and sanitary disposal of the urine test-panel-container (17) leaving the original urine sample safely and securely sealed within the urine-specimen-container (1) with check-valve (3) having automatically returned to its normal closed and sealed condition. Urine-specimen-container (1) may now be stored for future testing or properly disposed of.
At no time from the point of urine collection to final disposal of all the used components of the disclosed embodiment have the urine-sample or the activated urine test-panel been exposed to contact by either the patient or the medical staff involved in the procedure.
Referring again to
The probe guide passage 2305 is configured for interior engagement with a vaginal opening 35 for placement of the stream collection opening 2400 relative to the urethra opening 37. The probe guide passage 2305 is shaped and sized so as to conform to the shape of the ultrasound transducer probe 2399 allowing the ultrasound transducer probe 2399 to easily move in either direction within the probe guide passage 2305. For example, the probe guide passage 2305 defines a sounding probe guide surface 2320 that positions the ultrasound transducer probe 2399 within the vagina opening 35. The sounding probe guide surface 2320 is configured for positioning the stream collection opening 2400 over the urethral opening 37 and as a passageway and guide for the ultrasound transducer probe 2399. At least part of the probe guide passage 2305 and an edge 2401 of the stream collection opening 2400 of the urine stream collection container 2301 form an integrated interface 2450 configured for placement of the stream collection opening 2400 relative to the urethra opening 37 and substantially simultaneous interior engagement of the probe guide passage 2305 with the vaginal opening 35 for placement of the ultrasound transducer probe 2399 in a predetermined position within the vagina.
In one aspect, the internal baffle 2310 forms at least a portion of the probe guide passage 2305 and defines a sounding probe guide surface 2320 that positions the ultrasound transducer probe 2399 within the vaginal opening 35 against a wall in the vagina. The internal baffle 2310 defines an interior wall of the urine stream collection container 2301 that provides a spillway from the stream collection opening 2400 to the discharge opening 2900. The discharge opening 2900 may cooperate with the urine specimen container 1 (
Referring also to
In one aspect, the female urinary diagnostic device 2300 further includes air vent 2340 and/or optional observation cover or lid 2350. The air vent 2340 serves to prevent an airlock within the urine stream collection container 2301 which might impede the smooth flow of urine exiting the discharge opening 2900 thereby resulting in inaccurate urine flow data. The lid 2350 may be configured to pivot about a hinge 2360 so as to provide visual ingress into the urine stream collection container 2301 via a viewing aperture. In one aspect, the viewing aperture is configured such that placement of the stream collection opening 2400 relative to the urethra opening 37 is observed through the viewing aperture.
Referring now to
In this aspect, the female urinary diagnostic device 2300′ further includes a coupling 2905 connected to the discharge opening 2900′ configured for coupling one or more sensors 2390 to the female urinary diagnostic device 2300′. In another aspect, the discharge opening 2900′ is configured so as to define a coupling sized and shaped so as to conformally couple an entry port of the sensor 2390 to the female urinary diagnostic device 2300′, so that the sensor 2390 is dependent from the diagnostic device, and the female urinary diagnostic device 2300′ and sensor 2390 form an assembled unit. Providing the Uroflowmetry device 2390 attached directly to the female urinary diagnostic device 2300′ allows gathering urine-flow data closer to the source of the urine stream 32 (i.e., the urethral opening itself) so that a more varied and possibly more accurate data such as true urine-flow rate, bladder pressure, or even urine temperature, for example, rather than the relatively limited data that is gathered from the sensor 2390 several feet away from the source of the urine stream 32. Because the female urinary diagnostic device 2300′ creates a stable platform between the female urinary diagnostic device 2300′ and the urethral opening, any category of sensor desired could now be positioned within millimeters of the urethral opening 37 allowing for very accurate and consistent data of whatever type to be collected regarding the urine stream 32 at its very source. This ability could possibly provide similar data currently only available during a Cystometric Urodynamic procedure, which is an invasive procedure requiring two internal catheters and anesthetics, a separate clinic visit and unfortunately commonly results in Urinary Tract Infections.
The pathway of the urine-stream 32 as it enters the stream collection opening 2400′ of female urinary diagnostic device 2300′ and exits via the discharge opening 2900′ entering the sensor 2390 within which liquid flow-data is gathered before exiting the sensor 2390 and continuing into a urine collection tank.
Temporarily deactivating the locking Mechanism 2370 allows the ultrasound transducer probe 2399 to move fore and aft while searching for the best video image of the bladder 42. Once the best position is achieved, the locking Mechanism 2370 is re-activated so that gentle forward pressure now ensures a proper seal of the stream collection opening 2400′ over the urethral opening 37. Once the act of urination (bladder contraction) begins, data being gathered from both the ultrasound transducer probe 2399 and from the sensor 2390 is being sent to a common data gathering point for future review and analysis.
Referring to
Because the aspects of the present embodiment allow for urine stream pressure/force, flow rate and volume to be measured at the urethral opening itself, another Urodynamic test known as a Cystometric test which is physically invasive in that it requires the insertion of two catheters and the use of anesthetics could possibly be avoided in many cases. As a Cystometric test measures internal bladder pressure over time and therefore also records changes in bladder pressure caused by involuntary spasms etc., similar data could be also be recorded and interpreted by measuring changes in urine stream pressure/force as the urine exits the urethral opening. If the urine flow is temporarily blocked at a point just past the sensor 2390, then the pressure within the bladder and the pressure within the urine stream collection container 2301, 2301′ will equalize, in other words, pressure data gathered from within the female urinary diagnostic device 2300, 2300′ and sensor 2390 would be the same as pressure data gathered from within the bladder itself thus avoiding the need for an invasive internal Cystometric test as currently performed. An advantage of collecting pressure data at the urethral opening as opposed to within the bladder itself via an internal catheter is that the catheter technically replaces the urethra and therefore should there be any negative conditions or anomalies related to the urethra itself, then these conditions will not be accounted for in the results of the diagnosis. If the Urologist finds the data gathered from a urine pressure/force sensor located at the urethral opening sufficiently informative to avoid an invasive Cystometric test, then the female urinary diagnostic device 2300 would provide data currently requiring three separate procedures performed on three separate clinic visits into data gathered during one single non-invasive procedure requiring only one clinic visit.
Measuring urine stream temperature accurately at the source could prove significant as a temperature above normal could indicate a condition such as a bladder or kidney infection and therefore have a direct correlation or impact on the results relating to the other data that was simultaneously collected.
Additionally, negative pressure could be introduced within the collection tank which would be located past the sensor 2390 (in a closed air-tight system) and the resulting suction would help draw the stream collection opening 2400 more tightly against the vulva forming an even more secure seal against urine leakage than physical hand pressure alone. Also, in order to further inhibit any urine leakage at the stream collection opening 2400, the urine stream collection container 2301 could be divided into two chambers separated by a one-way valve designed to allow urine to flow towards the sensor 2390 but not back out the stream collection opening 2400. Such a valve could be of a common Duckbill design. The second chamber in this embodiment could be flexible or expandable in nature (balloon-like) which would also decrease the likelihood of urine back-flow resulting in possible urine leakage at the stream collection opening 2400.
Reviewing the test results on, e.g., a computer monitor, the urologist will not only see the ultrasound video but will also see displayed one or more other graphs or other forms of data that were simultaneously gathered during the same bladder voiding event. So now, if the video is paused at a specific point where the urologist viewed, for example, an involuntary bladder spasm or any other notable anomaly, the urologist could now accurately confirm this occurrence by viewing the Uroflowmetry graph which would confirm that at that very point in time, an increase in urine stream pressure/force did indeed occur and by how much. By employing the aspects of the disclosed embodiment, the urologist now has significantly more accurate, more informative and more varied data with which to form a significantly more informed diagnosis regarding the patient than previously possible.
Referring now to
In one aspect, the urine stream collection passage 1210P includes a stream collection opening 1211 (i.e., a FUD urine entrance port) and a discharge opening 1212 (i.e., a FUD urine/menstrual fluid exit port) similar to the description above with respect to at least device 2300. The stream collection opening 1211 is formed by a collector portion of the body 1210, and is shaped and sized so as to contact tissue of the vulva substantially proximate the urethral opening 37 forming a seal to surround and isolate the urethral opening 37 (
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Still referring to
In one aspect, the tip 1234 of the expansion actuator 1233 is shaped with a lobed, cam, angled tip, surface facing distal end and disposed to engage and leverage an engagement surface 1236A-n (arranged as a cam or ramp in unexpanded configuration where the cam has first position (see, e.g.,
Still referring to
Still referring to
While the drawings are illustrated as utilizing a mechanical design having fins, in other aspects, the at least one expanding member(s) 1232A-n may be any suitable anchoring device to seat the FUD 1200 in any suitable way, and anchor the FUD 1200. For example, any method of converting a relatively small diameter vaginal probe into a larger diameter generally funnel or tapering shaped component that anchors itself against and within the walls of the vagina is intended to fall within the scope of the invention as various alternative and modifications can be derived by those skilled in the art without departing from the disclosed embodiment. For example, in one aspect, the placement probe is resilient so that as the expansion actuator 1233 is retracted out of the FUD 1200, the at least one expanding member(s) 1232A-n automatically contracts or resiles, returning back to the unexpanded condition (i.e., the closed configuration 1235) or the expanded condition (i.e., the open configuration 1238). For example, in one aspect, at least one of the expanding members is resilient to spring back automatically to the unexpanded position. In this aspect, the placement probe 1230 may include a funnel/cup component made of a collapsible elastic material, which is inserted into the vagina in a collapsed or folded condition. Upon insertion into the vagina, the funnel/cup component automatically expands back from the collapsed state the funnel/cup state, once fully inserted, and collapses again during removal. As such, the FUD 1200 forms a vaginal probe of a relatively small diameter for ease of insertion and is designed to expand to a larger diameter once fully inserted within the vagina. In other aspects, the expansion actuator 1233 and the at least one expanding member(s) 1232A-n may be formed as a one-piece unit. In another example, the placement probe 1230 may include a thin synthetic elastic sleeve or sheath 1241, which encapsulates the fins 1232A-n. The elastic sleeve 1241 may provide an elastic collapse force, which assists in closing the fins 1232A-n into the closed configuration 1235 after disengaging the expansion actuator 1233.
Referring now to
Referring now To
In accordance with one or more aspects of the disclosed embodiment a female urinary device is provided. The female urinary device includes a urine stream collection passage having a stream collection opening and a discharge opening, the stream collection opening being sized and shaped so as to contact the tissue of the vulva substantially proximate the urethral opening forming a seal to surround and isolate a urethral opening; and a placement probe connected to urine stream collection passage and being sized and shaped for interior engagement with a vaginal opening, wherein a distal end of the placement probe is configured to expand between a closed configuration, for insertion into the vaginal opening, and an open configuration, for anchoring the placement probe within the vagina and seating the stream collection opening relative to the urethral opening.
In accordance with one or more aspects of the disclosed embodiment the distal end includes at least one tine configured to expand between an open configuration and a closed configuration for anchoring the placement probe within the vagina.
In accordance with one or more aspects of the disclosed embodiment the at least one tine is resilient.
In accordance with one or more aspects of the disclosed embodiment the distal end includes a thin synthetic elastic sleeve configured to effect a bias for closing the placement probe.
In accordance with one or more aspects of the disclosed embodiment the distal end of the placement probe is a collapsible elastic material.
In accordance with one or more aspects of the disclosed embodiment the female urinary device further includes an expansion actuator effecting expansion of the distal end of the placement probe.
In accordance with one or more aspects of the disclosed embodiment the expansion actuator forms at least a portion of a menstrual fluid passage, wherein a tip of the expansion actuator includes an opening which forms a menstrual discharge opening for collection of menstrual fluid.
In accordance with one or more aspects of the disclosed embodiment the female urinary device provides substantially simultaneous passage through the menstrual fluid passage and urine stream collection chamber to effect discharge of the menstrual fluid from the menstrual fluid passage through a menstrual fluid discharge opening and discharge of urine from the urine stream collection chamber through one or more of the urine discharge opening and a spillway.
In accordance with one or more aspects of the disclosed embodiment a female urinary device is provided. The female urinary device includes a urine stream collection chamber having a stream collection opening and a discharge opening, the stream collection opening being sized and shaped so as to contact the tissue of the vulva substantially proximate the urethral opening forming a seal to surround and isolate a urethral opening; and a menstrual fluid passage coupled to the urine stream collection chamber, the menstrual fluid passage having a menstrual fluid discharge opening and a menstrual fluid collection opening, the menstrual fluid passage being isolated from the urine stream collection chamber, wherein a distal end of the menstrual fluid passage is configured to expand between a closed configuration, for insertion into the vaginal opening, and an open configuration, for collection of the menstrual fluid and to effect alignment of the stream collection opening relative to the urethral opening.
In accordance with one or more aspects of the disclosed embodiment the distal end includes at least one tine configured to expand between an open configuration and a closed configuration for anchoring the menstrual fluid passage within the vagina.
In accordance with one or more aspects of the disclosed embodiment the at least one tine is resilient.
In accordance with one or more aspects of the disclosed embodiment the distal end includes a thin synthetic elastic sleeve configured to effect a bias for closing the menstrual fluid passage.
In accordance with one or more aspects of the disclosed embodiment the distal end of the menstrual fluid passage is a collapsible elastic material.
In accordance with one or more aspects of the disclosed embodiment the female urinary device further includes an expansion actuator effecting expansion of the distal end of the menstrual fluid passage.
In accordance with one or more aspects of the disclosed embodiment the expansion actuator forms at least a portion of the menstrual fluid passage, wherein a tip of the expansion actuator includes an opening which forms a menstrual discharge opening for collection of menstrual fluid.
In accordance with one or more aspects of the disclosed embodiment the female urinary device provides substantially simultaneous passage through the menstrual fluid passage and urine stream collection chamber to effect discharge of the menstrual fluid from the menstrual fluid passage through a menstrual fluid discharge opening and discharge of urine from the urine stream collection chamber through one or more of the urine discharge opening and a spillway.
In accordance with one or more aspects of the disclosed embodiment a method of collecting urine with a female urinary device is provided. The method includes providing a urine stream collection passage having a stream collection opening and a discharge opening, the stream collection opening being sized and shaped so as to contact the tissue of the vulva substantially proximate the urethral opening forming a seal to surround and isolate a urethral opening; and effecting anchoring within the vagina with a placement probe configured for interior engagement with a vaginal opening, wherein a distal end of the placement probe is configured to expand between a closed configuration, for insertion into the vaginal opening, and an open configuration, seating the stream collection opening relative to the urethral opening.
In accordance with one or more aspects of the disclosed embodiment the method further includes providing at least one tine at the distal end configured to expand between the open configuration and the closed configuration for anchoring the placement probe within the vagina.
In accordance with one or more aspects of the disclosed embodiment the method further includes providing collapsible elastic material at the distal end configured to expand between the open configuration and the closed configuration for anchoring the placement probe within the vagina.
In accordance with one or more aspects of the disclosed embodiment the method further includes effecting expansion of the distal end of the placement probe with an expansion actuator.
In accordance with one or more aspects of the disclosed embodiment a female urinary diagnostic device is provided. The female urinary diagnostic device including a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening, a probe guide passage configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethral opening, and an internal baffle that defines an interior wall of the urine stream collection container that provides a spillway from the stream collection opening to the discharge opening and cooperates with at least a urine sensing device, where the spillway provides urine passage to the urine sensing device and a collection tank, wherein the internal baffle forms at least a portion of the probe guide passage and defines a sounding probe guide surface that positions a sounding probe within the vaginal opening.
In accordance with one or more aspects of the disclosed embodiment the sounding probe guide surface positions the sounding probe against a wall of the vaginal opening.
In accordance with one or more aspects of the disclosed embodiment the interior wall has an anterior surface forming the spillway, and a posterior surface, opposite the anterior surface that forms the sounding probe guide surface within the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the interior wall substantially surrounds at least part of the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the interior wall is disposed around the probe guide passage so that the stream collection opening and the discharge opening of the urine stream collection container are on opposite sides of the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the discharge opening is located below the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the urine stream collection container has a viewing aperture through which placement of the stream collection opening relative to the urethral opening is observed.
In accordance with one or more aspects of the disclosed embodiment at least part of the probe guide passage and an edge of the stream collection opening of the urine stream collection container form an integrated interface configured for placement of the stream collection opening relative to the urethral opening and substantially simultaneous interior engagement of the probe guide passage with the vaginal opening for placement of the sounding probe in a predetermined position.
In accordance with one or more aspects of the disclosed embodiment a method of performing a vaginal diagnostic procedure and discharging urine with a female urinary diagnostic device is provided. The method including providing a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening, effecting placement of the stream collection opening relative to the urethral opening with a probe guide passage configured for interior engagement with a vaginal opening, providing an internal baffle that defines an interior wall of the urine stream collection container, the internal baffle forming at least a portion of the probe guide passage, the internal baffle providing a spillway from the stream collection opening to the discharge opening, the spillway cooperating with at least a urine sensing device to provide urine passage to the urine sensing device and a collection tank, and positioning a sounding probe within the vaginal opening via a sounding probe guide surface defined by the internal baffle forming at least a portion of the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the method further including positioning, with the sounding probe guide surface, the sounding probe against a wall of the vaginal opening.
In accordance with one or more aspects of the disclosed embodiment the interior wall has an anterior surface forming the spillway, and a posterior surface, opposite the anterior surface that forms the sounding probe guide surface within the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the interior wall substantially surrounds at least part of the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the interior wall is disposed around the probe guide passage so that the stream collection opening and the discharge opening of the urine stream collection container are on opposite sides of the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the discharge opening is located below the probe guide passage.
In accordance with one or more aspects of the disclosed embodiment the urine stream collection container has a viewing aperture through which placement of the stream collection opening relative to the urethral opening is observed.
In accordance with one or more aspects of the disclosed embodiment at least part of the probe guide passage and an edge of the stream collection opening of the urine stream collection container form an integrated interface, the method further comprising positioning, with the integrated interface, the stream collection opening relative to the urethral opening and substantially simultaneous engaging an interior of the vaginal opening with the probe guide passage for placement of the sounding probe in a predetermined position.
In accordance with one or more aspects of the disclosed embodiment a female urinary diagnostic device is provided. The female urinary diagnostic device including a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening, a probe guide passage configured for interior engagement with a vaginal opening for placement of the stream collection opening relative to the urethral opening, and a common wall, joining the probe guide passage and the urine stream collection container and isolating the probe guide passage from the urine stream collection container, wherein the common wall provides a spillway from the stream collection opening to the discharge opening and cooperates with at least a urine sensing device coupled to the urine stream collection container to sense flow from the discharge opening, wherein the common wall forms at least part of the probe guide passage, and wherein the probe guide passage is configured so as to receive a sounding probe through the probe guide passage and position the sounding probe in a predetermined position relative to a wall of the vagina.
In accordance with one or more aspects of the disclosed embodiment the common wall forms at least part of the probe guide passage so that the at least part of the probe guide passage is defined by the urine stream collection container.
In accordance with one or more aspects of the disclosed embodiment at least part of the probe guide passage and an edge of the stream collection opening of the urine stream collection container form an integrated interface configured for placement of the stream collection opening relative to the urethral opening and substantially simultaneous interior engagement of the probe guide passage with the vaginal opening for placement of the sounding probe in the predetermined position.
In accordance with one or more aspects of the disclosed embodiment the common wall forms part of the edge of the stream collection opening.
In accordance with one or more aspects of the disclosed embodiment at least part of the probe guide passage and an edge of the stream collection opening of the urine stream collection container form an integrated interface configured for placement of the stream collection opening relative to the urethral opening and interior engagement of the probe guide passage with the vaginal opening to provide substantially simultaneous isolated passages respectively for passing a urine stream via the spillway to the urine sensing device in one of the isolated passages, and for positioning the sounding probe in the predetermined position through another of the isolated passages.
In accordance with one or more aspects of the disclosed embodiment the isolated passages provided by the integrated interface are disposed so as to substantially simultaneously direct passage of urine stream past the urine sensing device via the spillway in the one of the isolated passages and position the sounding probe in the predetermined position through the other isolated passage to sound a predetermined anatomical region coincident with passage of the urine stream.
In accordance with one or more aspects of the disclosed embodiment the female urinary diagnostic device further including a coupling connected to the discharge opening configured for coupling the urine sensing device to the discharge opening.
In accordance with one or more aspects of the disclosed embodiment the discharge opening is configured so as to define a coupling sized and shaped so as to conformally couple an entry port of the urine sensing device to the female urinary diagnostic device, so that the urine sensing device is dependent from the female urinary diagnostic device, and the female urinary diagnostic device and urine sensing device form an assembled unit.
In accordance with one or more aspects of the disclosed embodiment the probe guide passage comprises a coupling configured so as to engage the sounding probe disposed in the probe guide passage and clamp the sounding probe to the diagnostic device so that the diagnostic device and sounding probe form an assembled unit.
In accordance with one or more aspects of the disclosed embodiment a method of performing a vaginal diagnostic procedure and discharging urine with a female urinary diagnostic device is provided. The method including providing a urine stream collection container having a discharge opening and a stream collection opening, the stream collection opening being configured to surround and isolate a urethral opening, positioning, with a probe guide passage configured for interior engagement with a vaginal opening, the stream collection opening relative to the urethral opening, providing a common wall, joining the probe guide passage and the urine stream collection container and isolating the probe guide passage from the urine stream collection container, the common wall providing a spillway from the stream collection opening to the discharge opening, wherein the common wall forms at least part of the probe guide passage and cooperates with at least a urine sensing device coupled to the urine stream collection container, positioning, a sounding probe, through the probe guide passage, in a predetermined position relative to a wall of the vagina and sensing, with the urine sensing device or sounding probe, urine flow.
In accordance with one or more aspects of the disclosed embodiment the common wall forms at least part of the probe guide passage so that the at least part of the probe guide passage is defined by the urine stream collection container.
In accordance with one or more aspects of the disclosed embodiment at least part of the probe guide passage and an edge of the stream collection opening of the urine stream collection container form an integrated interface, the method further comprising positioning, with the integrated interface, the stream collection opening relative to the urethral opening and substantially simultaneous engaging an interior of the vaginal opening with the probe guide passage for placement of the sounding probe in the predetermined position.
In accordance with one or more aspects of the disclosed embodiment the common wall forms part of the edge of the stream collection opening.
In accordance with one or more aspects of the disclosed embodiment at least part of the probe guide passage and an edge of the stream collection opening of the urine stream collection container form an integrated interface, the method further comprising positioning, with the integrated interface, the stream collection opening relative to the urethral opening and engaging an interior of the vaginal opening with the probe guide passage to provide substantially simultaneous isolated passages respectively for passing a urine stream via the spillway to the urine sensing device in one of the isolated passages, and for positioning the sounding probe in the predetermined position through another of the isolated passages.
In accordance with one or more aspects of the disclosed embodiment the method further including substantially simultaneously directing passage of urine stream past the urine sensing device via the spillway in the one of the isolated passages and positioning the sounding probe in the predetermined position through the other isolated passage to sound a predetermined anatomical region coincident with passage of the urine stream.
In accordance with one or more aspects of the disclosed embodiment the method further including a coupling connected to the discharge opening configured for coupling the urine sensing device to the discharge opening.
In accordance with one or more aspects of the disclosed embodiment the discharge opening is configured so as to define a coupling sized and shaped so as to conformally couple an entry port of the urine sensing device to the female urinary diagnostic device, so that the urine sensing device is dependent from the female urinary diagnostic device, and the female urinary diagnostic device and urine sensing device form an assembled unit.
In accordance with one or more aspects of the disclosed embodiment the method further including engaging the sounding probe with a coupling disposed in the probe guide passage and clamping the sounding probe to the diagnostic device so that the diagnostic device and sounding probe form an assembled unit.
It should be understood that the foregoing description is only illustrative of the aspects of the disclosed embodiment. Various alternatives and modifications can be devised by those skilled in the art without departing from the aspects of the disclosed embodiment. Accordingly, the aspects of the disclosed embodiment are intended to embrace all such alternatives, modifications and variances that fall within the scope of the appended claims. Further, the mere fact that different features are recited in mutually different dependent or independent claims does not indicate that a combination of these features cannot be advantageously used, such a combination remaining within the scope of the aspects of the disclosed embodiment.
This application is a continuation-in-part of U.S. Non-Provisional patent application Ser. No. 16/857,489 filed on Apr. 24, 2020, which claims priority from and the benefit of U.S. Provisional Patent Application No. 62/980,610 filed on Feb. 24, 2020, the disclosures of which are incorporated by reference herein in their entireties.
Number | Date | Country | |
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62980610 | Feb 2020 | US |
Number | Date | Country | |
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Parent | 16857489 | Apr 2020 | US |
Child | 18191496 | US |