Abstract:
A method for collecting and analyzing urine at the time it is released uses a urine collecting tube joined with a 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. 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 with the urine tube.

Description:
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS 
       [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. 
         [0002]    This application is a continuation-in-part of prior U.S. non-provisional patent application Ser. No. 15/412,049 filed Jan. 22, 2017, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0003]    Field of the Invention 
         [0004]    The present invention relates to the collection of body fluids, particularly urine, and to a method of automated collection and analysis 
         [0005]    Brief Discussion of the Related Art 
         [0006]    Male urinary collection and analysis is common for medical reasons. This 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. 
       BRIEF DISCUSSION OF RELATED ANALYTICS 
       [0007]    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. 
         [0008]    Sodium Chloride: 
         [0009]    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. 
         [0010]    Moisture: 
         [0011]    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. 
         [0012]    Liquid Level: 
         [0013]    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. 
         [0014]    Occult Blood: 
         [0015]    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. 
         [0016]    Drugs: 
         [0017]    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). 
         [0018]    Proteins: 
         [0019]    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 
       [0020]    The presently described apparatus includes a urine tube and a canister. The urine tube is adapted for joining with the human urethra, either male or female, and as such, enables reception of urine discharges. Suction of about 5 inches Hg is produced within the apparatus. This suction enables the temporary joining between the interface portion and the urethra. 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 will. The urine tube is adapted by size for receiving an individual&#39;s penis or with a flared end to engage a female urethra where in both cases suction is used for engagement. Once sealed, the suction source may be released while leaving a light vacuum within the urine tube thereby maintaining the seal. In both the male and female approach, suction within the tube may be released at any time by releasing suction. However, suction is present during urination which will send urine into the urine canister. A liquid sensor signals when urine is present. This produces a higher suction level within the urine tube, drawing the urine into the canister. When the liquid sensor no longer senses the presence of liquid, the vacuum generator closes-down while leaving a low-level suction for maintaining connection of the urine tube to the urethra. Sensors within the canister are able to detect substances within the urine. For instance, using known sensors and analytic techniques: Quantitative analysis of occult blood, proteins, glucose, drugs, and various chemical compositions can be determined. This information is delivered to a digital processor for data logging and analysis including plotting values against time. Comparison of measured values relative to standards, enables prediction of medical conditions including illness. Therefore, it is an object of the invention to maintain a tube at a urethra outlet. It is another object to provide a means for allowing urination to occur without interrupting a person&#39;s sleep or activities. 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 
         [0021]    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. 
           [0022]      FIG. 1  is a proximal perspective view of an interface portion of a described apparatus showing a urine tube extending proximally from an enclosure; 
           [0023]      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; 
           [0024]      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; 
           [0025]      FIG. 4  is a perspective view of a garment interface with the urine tube; 
           [0026]      FIG. 5  is a side elevation view of an enclosure of the apparatus; 
           [0027]      FIG. 6  is a perspective view of an open top thereof showing components of a receiver portion of the apparatus; 
           [0028]      FIG. 7  is a side view of a canister of the apparatus; 
           [0029]      FIG. 8  is a front view of a vacuum gauge of the apparatus; 
           [0030]      FIG. 9  is a schematic diagram of the apparatus defining interconnections; and 
           [0031]      FIG. 10  is a logic flow diagram illustrating the described method. 
       
    
    
     DETAILED DESCRIPTION 
       [0032]    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. 
         [0033]    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 . These figures 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 gripping of tube  10  around penis  5  so that penis  5  is secured within tube  10  by suction action with no leakage. Shown also, are a spherical enclosure  30 , vent holes  36  to allow air to enter enclosure  30 , and proximal entry  32  in enclosure  30  holds tube  10  securely in place. 
         [0034]      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, may be stretched around the periphery of 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 with a tight fit. Fluid sensor  62  may be mounted on disc  50  as shown and as will be described may be 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 electromechanical 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 prevents fluid from passing outward (one-way valve). 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). 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 (see  FIG. 9 ) will also be disconnected at that time. An o-ring  72  is used to seal connector  70 . 
         [0035]      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 holding. 
         [0036]      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 the apparatus. 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 and loss of suction attachment is also minimized. In this case urine tube  10  is secured in place by both garment  80  as well as by suction as previously described. 
         [0037]    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. 
         [0038]    In  FIG. 6 , as shown, case  200  may enclose graduated canister  210  with its attached, sealed 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  where it would 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  where it can be analyzed. In like manner, other fluids may be suctioned into canister  210  for analysis. 
         [0039]      FIG. 7  illustrates graduated canister  210  with 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 sensor and sensory materials that may be utilized in characterizing collected samples of urine or other fluids. 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 used to detect liquid level, trace chemicals, biological agents, occult blood, and other foreign agents or components of collected urine as described in the foregoing Brief Discussion of Related Analytics. 
         [0040]      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 (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 the proximal end  12  of urine tube  10  to penis or urethral aperture. During standby mode valves  40  and  240  are held closed to preserve suction for the maintenance of attachment of urine tube  10 . 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 which forces 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 the apparatus 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.  FIG. 10  shows the above operation in detail. 
         [0041]      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 it and signals computer  208  which, in turn, signals vacuum gage  240  and opens vacuum valve  230  and also 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 species within the urine such as: proteins, drugs, occult Blood, sodium chloride (NaCl), and other elements, compounds, and substances. Such content may be determined down 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 such as defined in  FIG. 10  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 the apparatus as shown in  FIG. 9 . 
         [0042]    It should be recognized that the described apparatus 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 non-farm animals and other mammals. 
         [0043]    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.