Abstract:
A collector-analyzer apparatus for urine has a urine collecting tube joined with a urine receiving canister. Suction is produced in the collecting tube to join the tube with a penis or to the exterior surface of a female urethra orifice. Once suction is achieved the collecting tube stays in place by suction action. When urine flows into the urine collecting tube a sensor triggers a vacuum pump to produce a higher level of suction to flush the urine into the canister where a level sensor determines the quantity of urine received or resident within the canister. Various sensors in the canister determine levels of non-urine partials such as occult blood, drugs, salt, and other substances. When urine is no longer detected within the urine tube, the vacuum pump is turned off and a low-level vacuum remains to assure interconnection between the urine tube and the urethra.

Description:
CROSS-REFERENCE TO RELATED PATENT APPLICATION 
       [0001]    This application claims priority from prior U.S. provisional patent application Ser. No. 62/297,096 filed Feb. 18, 2016, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    Field of the Invention 
         [0003]    The present invention relates to external incontinence devices and, more particularly, to external urinary incontinence devices configured for the human anatomy and to related analytics. 
         [0004]    Brief Discussion of the Related Art 
         [0005]    Male urinary incontinence is a common medical problem that is managed in the prior art with absorbent diapers, indwelling urinary catheters and/or external, non-invasive urine collection devices. Diapers are associated with a high rate of skin breakdown and decubitis ulcer formation while indwelling urinary catheters are a leading cause of urinary tract infections. Accordingly, there has been a great demand for non-invasive external incontinence devices for collecting human urine without exposing the body to continuous urine contact. To avoid leakage, prior art external, non-invasive devices for collecting urine, as exemplified by U.S. Pat. No. 5,263,947 to Kay, U.S. Pat. No. 5,827,247 to Kay and U.S. Pat. No. 5,830,932 to Kay, have incorporated a para-metal seal formed of a ring or annular arrangement of leaves or petals carried by a urine drainage housing and adapted to be adhesively secured to the end of the penis to produce a seal preventing leakage of urine. To enhance the seal, additional sealing layers have been proposed; however, such sealing layers are frequently applied incorrectly when the application requires that the individual applying the device independently establishes an optimal accurate application of the additional sealing layer(s). Application of the additional sealing layer(s) is commonly inaccurate, with the additional sealing layer(s) being applied too proximal or too distal to other sealing layer(s) or with inadequate alignment to achieve an optimal bilaminar seal. Each additional sealing layer must be applied in a specific spatial orientation with respect to previously applied sealing layers, to optimize the leak free duration of each device application. Therefore, there is a need for an external incontinence device which can be applied with a consistent spatial orientation to allow leak-free use especially for females. Furthermore, there is a need for a collection device with analytic capabilities. 
         [0006]    Brief discussion of related analytics: These devices are known in applications for sensing protein, screening for diseases, detection of Nanocantilevers point mutations, blood glucose monitoring, detection of chemical and biological warfare agents, and have been used in nanoelectromechanical systems. Molecules adsorbed on a microcantilever cause vibrational frequency changes and deflection. Viscosity, density, and flow rate can be measured by detecting these physical changes. This development has increased the sensitivity limit to the extent that researchers can now visualize the counting of molecules. With the ability of high throughput analysis of analytes and ultra-sensitive detection, this technology holds promise for the next generation of miniaturized and highly sensitive sensors. Molecular diagnostic devices are getting smaller with the advancement of miniaturization techniques. There is increasing interest in the field of bio sensor research on miniaturized platforms. Miniaturization is essential for in-vivo physiological monitoring, multiple specificity sensor arrays, sensor portability and minimized sample volumes. Conventional biosensors need extensive packaging, complex electronic interfacing and regular maintenance. These new micro-sensors have advantages over conventional analytical techniques in terms of high sensitivity, low cost, simple procedure, low analyte requirement, non-hazardous procedures and quick response. 
         [0007]    Sodium Chloride: A poly-silicon nanowire is used to sense and measure sodium chloride concentration in solution. The Department of Communications Engineering, at Yuan Ze University, Taiwan, has developed a NaCl concentration; ion sensitive field-effect transistor; using poly-silicon nanowires. This sensor was fabricated by top-down technique for sodium chloride concentration measurement. The results showed that the smallest threshold voltage and the best resolution were 1.65 V and 0.41 μM, respectively. This sensor is able to be reused more than 50 times while maintaining acceptable performance and showed good linearity of calibration within a wide range of concentrations. Based on these results, the proposed sensor has potential to be used for measuring complicated samples with suitable modification on the surface of nanowires. 
         [0008]    Moisture: In yet another development, Professor Alan Lakso of Cornell University has engineered a micro-chip which is able to hold water in a small cavity and exchange moisture from that cavity with moisture in its environment via a nano-porous membrane. The chip measures any changes in the pressure within the cavity that result from water entering or being drawn out. In order to relay the data it gathers, the chip may be wired to a Wi-Fi card, a data logger, or other device for gathering and transmitting information. The chip can last outdoors for at least a few years, although freezing temperatures may cause failure. 
         [0009]    Liquid Level: For liquid level sensing, optical infrared devices are commercially available and can be used to replace mechanical type float switches while providing high precision level control. These devices have compact construction with no moving parts so as to provide high reliability. They meet or exceed all common safety standard and are RoHS compliant. Alternately, ITV plc of the UK produces a water level sensor part number 6336 commonly used for this intended purpose. 
         [0010]    Occult Blood: For occult blood detection, optical sensors are available, as for example from Sonotec Products, EU. to detect the smallest amounts of blood in dialysates on transparent tubes non-invasively. As the wavelength is adapted to the transmittance of blood, the international standard IEC 60601-2-16:2008 for medical electrical devices is fulfilled reliably. Hence, these sensors are able to detect as small as 0.04% of blood in an isotonic saline solution. For instance, one such commercially available detector meets high safety standards and features a serial interface. With simple commands, this sensor can be tested and sensitivity level adjusted. Such a device is suitable for all tasks that require the optical detection of transmission differences of liquids in transparent tubes. Due to the high sensitivity of these sensors it is even possible to detect when a tube filled with a clear fluid runs empty. 
         [0011]    Drugs: The Amedicheck Panel Urine Drug Testing Cup is available through TransMed Co. LLC, Cumming, Ga. This device is used to determine the presence of the following substances: Marijuana (THC), Opiates (OPI), Methamphetamines (METH), Cocaine (COC), Phencyclidine (PCP), Amphetamines (AMP), Oxycodone (OXY), Barbiturates (BAR), Benzodiazepine (BZO), Methadone (MTD), Tricyclic Antidepressants (TCA), and Ecstasy (MDMA). 
         [0012]    Proteins: Recently, numerous biosensors for detecting specific biomolecules such as DNA, proteins and antibody-antigen have been studied for a clinical and industrial demand with the progress of life science. There has been considerable attention directed to protein molecules since the occurrence of disease is well known at this level. Even though several techniques for the detection of proteins such as optical, mass spectrometry, and electrochemical measurement are in existence, field effect transistor based biosensors, which are fabricated by semiconductor integrated circuit techniques, have lately attracted attention because of its various advantages in miniaturization, standardization, mass-production and especially suitable configuration for an on-chip integration of both the sensor and measurement system. A gate field effect transistor biosensor for the detection of streptavidin-biotin protein complexes in a silicon micro-fluidic channel has been developed. The connection between this device and a micro-fluidic system could be achieved offering merits of isolation between the device and solution, compatibility with integrated circuit technology and applicability to the micro total analysis system. Such a device was fabricated combining semiconductor integrated circuit and micro-electro-mechanical system techniques. 
       SUMMARY OF THE INVENTION 
       [0013]    The presently described and claimed collector-analyzer apparatus includes an interface portion and a receiver portion. These two portions are joined by a flexible interconnection tube so that they may be set some feet apart. The interface portion is adapted for joining with the human urethra, either male or female, and as such, enables reception of discharged urine. The receiver portion includes a suction generator and a urine flask. Suction of about 5 inches of HG is produced within the flask, the interconnection tube, and the interface portion. This suction enables the temporary joining between the interface portion and the urethra. The interface portion remains external to the body and may be released at any time by simply breaking suction. The apparatus is worn at times when urination is expected or desired and may be disconnected and removed from, and reconnected to, an individual at any time. The interface portion of the apparatus has a soft plastic urine tube which terminates with an open tube end that receives the penis within it and is sealed by suction. Once sealed, the suction source may be released while leaving a light vacuum within the urine tube thereby maintaining the seal. The open tube end for the female is flared and elastically conforming when pressed against the labium minora centered on the opening which is the female urethra outlet. Again, a light suction is applied which joins the end of the urine tube to the area of the labium minora that surrounds the urethra outlet, and once established the source of suction may be released leaving the tube and female urethra joined by a vacuum condition within the urine tube. In both the male and female approach, suction within the tube may be released at any time by opening a hand valve or by pulling the tube away from the area where vacuum is attaching it. However, while suction is present urination will produce a liquid stream that flows into the urine tube and then into the interconnection tube terminating in the urine flask which will fill and be manually emptied as necessary. A liquid sensor is located within the urine tube and a signal wire carries an electrical voltage to an analog-to-digital (A/D) converter within a digital processor. Wireless operation is also possible. The computer reacts by applying a current to a relay to apply power for turning on the vacuum generator. This produces a higher suction level within the urine tube, the interconnection tube and the flask thereby drawing the urine into the flask and assuring that all urine that has entered the urine tube is deposited into the flask. When the liquid sensor no longer senses the presence of liquid, the electrical voltage drops to zero and the vacuum generator closes down while leaving a low-level suction for maintaining urine tube-urethra interconnection. Sensory elements within the flask are able to detect characteristics of the urine. For instance, using known sensors and analytic techniques: salt (NaCl), occult blood, proteins, glucose, drugs, and various chemical compositions are able to be detected qualitatively and in some cases quantitatively. Such detections produce signals which are directed to the digital processor for data logging and analysis including plotting values against time, determination of values relationship to standard values, and identification of pathogen growth. This information is able to be wirelessly transmitted to medical personnel for review and to take remedial action if required. Therefore, it is an object of the described invention to maintain a tube-to-urethra joint external to the body. It is another object to provide a means for allowing urination to occur without interrupting a person&#39;s sleep. It is a further object to continuously monitor a patient&#39;s biological signs through urine sampling and analysis. It is a still further object to collect urine in a system that is low cost, easily, operated and portable to be useful by paramedics in the field. These and other aspects of embodiments herein described will be better appreciated when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Changes and modifications may be made within the scope of the embodiments herein presented without departing from the spirit thereof. Unless otherwise indicated expressions of singularity shall include plurality and vice-versa, while expressions of the alternative shall be considered nonexclusive. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    Illustrations in the drawing sheets presented herein are examples only and should not be taken as limiting. The same reference numeral refers to the same element as it may appear in multiple figures and drawing sheets. 
           [0015]      FIG. 1  is a proximal perspective view of an interface portion of a described apparatus showing a urine tube extending proximally from an enclosure; 
           [0016]      FIG. 2  is a section view thereof taken along cutting plane line  2 - 2  in  FIG. 1  and showing a penis interface with a urine tube; 
           [0017]      FIG. 3  is a vertical section view of a typical female abdomen with a peritoneum area showing a urethral interface with a urine tube of the apparatus; 
           [0018]      FIG. 4  is a perspective view of a garment interface with the urine tube; 
           [0019]      FIG. 5  is a side elevation view of an enclosure of the apparatus; 
           [0020]      FIG. 6  is a perspective view of an open top thereof showing components of a receiver portion of the apparatus; 
           [0021]      FIG. 7  is a side view of a canister of the apparatus; 
           [0022]      FIG. 8  is a front view of a vacuum gauge of the apparatus; and 
           [0023]      FIG. 9  is a schematic diagram of the apparatus defining interconnections. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    As shown in the attached drawing figures, a collector-analyzer apparatus includes an interface portion  110  ( FIGS. 1 and 2 ) and a receiver portion  120  ( FIGS. 5 and 6 ). These two portions are joined by a flexible interconnection tube  20  so that they may be conveniently set some distance apart during operation. 
         [0025]    As shown in  FIGS. 1 and 2 , interface portion  110  is adapted for joining with the urethra, either male or female, and as such, enables reception of discharged urine; see the arrow labeled “fluid” in  FIG. 2 .  FIGS. 1 and 2  illustrate penis  5  which is inserted into proximal open end  12  of urine tube  10 . Tube  10  may be of a transparent soft elastomeric material such as a silicone gel. Internal ribs  16  within tube  10  are shown and it is pointed out that they provide an improved griping of tube  10  around penis  5  so that penis  5  is secured within tube  10  by suction action with little if any leakage as will be described. Shown also, are a spherical enclosure  30 , vent holes  36  to allow air to enter enclosure  30 , and proximal entry  32  in enclosure  30  which tightly grips tube  10 . 
         [0026]      FIG. 2  illustrates further the character of interface portion  110  including rigid disc  50  shown edgewise, which may be a circular flat object secured within distal end  14  of urine tube  10 . It is pointed out that urine tube  10 , being of an elastomeric material, is able to stretched around disc  50  to hold it in place axially relative to urine tube  10 . Disc  50  has a central hole  14  which accepts proximal end  22  of interconnection tube  20  securing it in place. Fluid sensor  62  may be mounted on disc  50  as shown and as described below is functional in the process of generating suction when urine is present within urine tube  10 . It is suction that draws urine from tube  10  to tube  20 . One or more electrical vent valves  40  are contained within enclosure  30  and mounted through holes in disc  50  which secures valves  40  in place. Valves  40 , when open, provide air flow into urine tube  10  but close to prevent fluid from entering the interior of enclosure  30 . Valves  40  are of such size as to allow some air to enter tube  10 , and while suction overcomes the tendency of pressure rising due to this air inflow, to maintain a negative pressure within tube  10  suction is increased to compensate. Fluid sensor  62  may also have a companion sensor to monitor air pressure (suction) at that point. Connector  70  is used to allow separation of interconnection tube  20  to allow a more comfortable management of the joining of urine tube  10  with the penis  5  or the urethra and to allow a user to move about freely when the apparatus is not being used. Electrical wires will also be disconnected at that time. An o-ring  72  is used to seal connector  70 . 
         [0027]      FIG. 3  illustrates the joining of urine tube  10  with the female urethra  3  at the urethral orifice which is adjacent to the tissue surface of the vestibule. As shown, urine tube  10  may be flared or forced into a flared condition thereby conforming opening  12  as a suction-cup type joint for improved suction attachment. 
         [0028]      FIG. 4  shows an enablement wherein urine tube  10  is engaged with an undergarment  80  such as an underwear, under-pant, panty, diaper or similar item worn by an individual when using apparatus  100 . As shown, urine tube  10  may be inserted through an opening or a slit, fold, etc.  82  in undergarment  80 , wherein opening  82  may have a strong elastic edge or closure capable of helping to hold urine tube  10  in place so that axial movement between urine tube  10  and undergarment  80  is minimized. In this case urine tube  10  is secured in place by both garment  80  as well as by suction as previously described. 
         [0029]    In  FIG. 5  case  200  may include a hinged cover  205  as shown. Cover  205  may have a digital processor system  208  mounted within. System  208  may be a Seetec model W759 digital processor with seven-inch LCD monitor resistive touch panel and WIFI, Bluetooth, and GPS communication capability or any equivalent as will be known to those of skill in the art. 
         [0030]    In  FIG. 6 , as shown, case  200  may enclose graduated canister  210  with its attached lid  215 . Case  200  may also house motor driven vacuum pump  220  with its attached shut-off valve  230  and vacuum gauge  240 . Suction tube  250 , may interconnect shut-off valve  230  with canister lid  215  and may include filter  260  which may be used to prevent vacuum pump oil from traveling upstream into canister  210  and also may prevent bacteria from traveling downstream to reach pump  220  and be exhausted to the environment. Vacuum pump  220  may be powered by AC current via power cord  270  as shown, or alternately may be powered by a DC battery pack with inverter (not shown). Suction (low pressure) in canister  210  is developed in interconnection tube  20  and urine tube  10  for application at penis  5  or urethra  3  as previously described. Urine, when present, is therefore sucked through urine tube  10 , interconnection tube  20 , and into canister  210 . 
         [0031]      FIG. 7  illustrates graduated canister  210  with its lid  215 . As described, urine is delivered into canister  210  via interconnection tube  20  which is fitted to inlet  217  of lid  215 . Suction is applied at fitting  218  of lid  215 . Sensors  280   a,    280   b,  and  280   c  are representative of a wide variety of sensors that may be utilized in characterizing collected samples of urine. Such sensors may be mounted, as shown, in strips on the interior side surface of canister  210  as shown or may have another form and may be mounted in other ways. Such sensors may be able to detect liquid level, trace chemicals, biological agents, occult blood, and other features of urine as described in the foregoing Brief Discussion of Related Analytics. 
         [0032]      FIG. 8  illustrates vacuum gauge  240  capable of reading vacuum in mm Hg on the inner scale and inches of Hg on the outer scale with higher vacuum, or stronger suction (lower pressure) increasing in a counter-clockwise movement of the gauge&#39;s indicator. Suction of about 5 inches (145 mm) Hg is controlled as a maximum set point by gauge  240  so that valve  230  is automatically closed when vacuum level attempts to exceed this value thereby preventing damage to the penis sheath or to the tissues of the labia minora/vestibule. Vacuum operations include two modes: Standby and Active. In Standby mode a low level of suction is created after which vacuum pump  220  is shut down. This low level of suction maintains attachment of urine tube  10  to penis or urethral aperture. During standby mode valves  40  and  240  are held closed to preserve suction. Standby mode may be held throughout the night, but if urine enters tube  10  while the system is in Standby mode, urine sensor  62  immediately triggers Active mode operation through computer  208 . Sensor  62  signals computer  208  which causes pump  220  to turn on and valves  40  and  240  to open. Suction is generated at urine tube  10  which overcomes air inflow through valves  40  to maintain suction and driving urine through tubes  10  and  20  and into canister  210 . When sensor  62  no longer detects the presence of urine, the reverse occurs so that apparatus  100  resumes the standby mode. In an alternate mode of operation, vacuum pump  220  may be on during standby to assure that enough suction is produced to hold attachment of urine tube  10  as described above. 
         [0033]      FIG. 9  shows how several interconnections between components of the described system are joined. Computer  208  controls operations. Urine tube  10  is joined to the urethra by suction during Standby mode. When urine enters urine tube  10  urine sensor  62  detects this substance and signals computer  208  which, in turn, signals vacuum gage  240 . Gage  240  opens vacuum valve  230  and turns on vacuum pump  220 . Computer  208  signals inlet valves  40  thereby opening them. With vacuum pump  220  now operating and with vacuum valve  230  open suction is applied through vacuum tube  250  and canister  210  and interconnection tube  20  and urine tube  10  which flushes the urine into canister  210 . When urine sensor  62  no longer senses urine in urine tube  10  the signal to computer  208  is extinguished and signals are sent to inlet valves  40  and, through vacuum gauge  240  to close vacuum valve  230  and close-down vacuum pump  220 . In the alternative, standby mode may be entered with vacuum valve  230  and/or vacuum pump  220  throttled to achieve a low suction level as monitored by vacuum gauge  230 . When urine is present in canister  210  sensors  280  determine the presence of, and quantitative characteristic of several partials within the urine such as: proteins, drugs, occult Blood, sodium chloride (NaCl), and other elements, compounds, and substances. Such partials may be determined to micro levels using one or more of the techniques described in the foregoing Brief Discussion of Related Analytics. It is within the skill level of those experienced in the computer arts to define an algorithm or software program to carry out the processes described in  FIG. 9 . It is within the skill level of those experienced in systems engineering to define a means for interconnecting the components of apparatus  100  as shown in  FIG. 9 . 
         [0034]    It should be recognized that the described system may be adapted for use with animals other than humans. For instance, there is a need for taking and analyzing urine samples of farm animals such horses, mules, cows, and also non-farm animals and other mammals. 
         [0035]    In this description, embodiments are described as a plurality of individual parts, and methods as a plurality of individual steps and this is solely for the sake of illustration. Accordingly, it is contemplated that some additional parts or steps may be added, some parts or steps may be changed or omitted, and the order of the parts or steps may be re-arranged, while maintaining the sense and understanding of the apparatus and methods as claimed.