Patent Publication Number: US-9901488-B1

Title: Undergarment wearable patient monitor

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
     The present application is a Continuation-In-Part of prior filed application Ser. No. 15/278,950 filed Sep. 28, 2016, now U.S. Pat. No. 9,675,497. 
     BACKGROUND OF THE INVENTION 
     Urinary incontinence, the loss of bladder control, is a very common condition in elderly patients. The severity of urinary incontinence ranges from occasionally leaking urine to having an uncontrollable urge to urinate before reaching a toilet in time. Of the approximately 1.7 million patients in convalescent hospitals and nursing homes in the United States at the present time, half of such patients are deemed to be incontinent. 
     The present routine in most nursing homes in the United States is to check all patients every two hours around the clock for urinary leakage and to change a patient to a dry undergarment when wetness is discovered. Although this method of treatment of urinary incontinence helps to maintain the dryness of undergarments of patients, patients may be unnecessarily disturbed when they are dry and, conversely, may become wet again shortly after being changed. In the latter case, the patient would remain in a wet condition for as much as two hours. 
     Another frequently encountered problem in nursing homes is the development of a decubitus ulcer, also known as a pressure ulcer, a pressure sore, or a bed sore. The development of decubitus ulcers is due to the infrequent turning or change of position in bed by elderly patients. Rounds commonly made every two hours by caregiver to assure timely turning of a patient may be insufficient for noting patient movement. The situation is especially prevalent in lean or cachectic subjects who are especially liable for developing decubitus ulcers. It should also be noted that decubitus ulcers develop through pressure, shearing, and moisture, the latter commonly deriving from incontinence. 
     In the past, many systems of detecting incontinence and other patient conditions have been proposed. For example, U.S. Pat. Nos. 4,106,001, 5,266,928, 5,469,145, 6,603,403, 7,394,391, 7,477,156, and 8,299,317 disclose employing one or more conductive elements which are in direct contact with moisture expelled by a patient to produce an electrical signal which triggers an alarm indicating the presence of urinary moisture. 
     U.S. Pat. No. 8,772,568 shows an incontinence detection system which employs a disposable sensor that is attached to a diaper-like assembly worn around the waist of the of the patient. 
     U.S. Pat. Nos. 6,573,837, 7,053,781, and United States Patent Publication 2012/0268278 describe incontinence monitoring systems that employ a metallic element sensor in combination with adhesive and layered pads that lie between the metallic sensors and the skin of the patient. 
     U.S. Pat. Nos. 8,111,165 and 8,416,088 show a patient sensor system that utilizes an incontinence or moisture detector in direct contact with the skin of the patient in combination with a pressure sensor to detect contact of the patient&#39;s skin with a support. 
     An incontinence detector having reusable elements in combination with a tilt sensor to avoid the development of decubitus ulcers would be a notable advance in the medical arts. 
     SUMMARY OF THE INVENTION 
     In accordance with the present application, a novel and useful bed patient monitor apparatus is herein provided. 
     The apparatus of the present application includes a base member that has a first surface and an opposite second surface. The present apparatus is intended for use with a conventional undergarment or diaper normally worn patients suffering from incontinence. The second surface of the base member is intended to lie against such undergarment. 
     A moisture sensor is also employed in the present invention and a portion is positioned under the first surface of the base member case. The moisture sensor is configured to generate a signal, preferably a radio signal, upon the detection of moisture by the use of metallic conductors that react to increase in conductivity between the conductors due to moisture such as urine. A porous sheet is positioned over the first surface and is intended to contact the skin of the patient and to isolate the metallic elements of the sensor from the skin of the patient. The porous sheet may take the form of a mesh fabric that has a memory and is fastened to the base member to allow rotation or separation relative to the base member. The porous sheet is of sufficient durability to be reused after cleaning and to return itself to its original position against the moisture sensor through the memory possessed by the porous sheet, which may take the form of a plastic material. 
     In addition, the apparatus of the present invention possesses a tilt sensor. The tilt sensor is mounted to the base and is configured to generate a signal, preferably a radio signal, indicating the absence of turning of the patient during a selected time period. In this manner, caregivers are alerted to the possibility of the development of decubitus ulcers because of a patient remaining against a surface, such as a bed, for prolonged periods of time. 
     It may be apparent that a novel and useful patient monitor apparatus has been heretofore described. 
     It is therefore an object of the present application to provide a bed patient monitor apparatus that includes a device which detects wetness in an undergarment due to a patient&#39;s incontinence. 
     Another object of the present application is to provide a patient monitor apparatus that is relatively small and wearable, being compatible with undergarments found in the prior art. 
     Another object of the present application is to provide a bed patient monitor apparatus which may be used with a moisture detection sensor in combination with a tilt sensor to provide information which allows caregivers to remove a wet undergarment and substitute a dry one therefor, as well as to turn a patient to prevent the development of decubitus ulcers due to excessive pressure and/or moisture against the skin of the patient. 
     Another object of the present application is to provide a bed patient monitor apparatus that includes a moisture sensor isolated from the skin of the patient by a porous sheet which is separable from the moisture sensor base and returns to its position against the moisture sensor base due to the memory characteristic of the porous sheet. 
     Another object of the present application is to provide a bed patient monitor apparatus that is capable of obtaining a signal and transmitting said signal to a caregiver to provide information such as identity of the patient, patient&#39;s room, the bed number of the patient, and the like. 
     Another object of the present application is to provide a bed patient monitor apparatus that reliably generates a signal to indicate to a caregiver the amount of motion of the patient as well as the positional change of the patient during a certain period and transmitting a signal representative of the same to a display accessible to the caregiver. 
     Yet another object of the present application is to provide a bed patient monitor apparatus which is accurate and not subject to the generation of false signals indicating incontinence of the patient. 
     The application possesses other objects and advantages especially as concerns particular characteristics and features thereof which will become apparent as the specification continues. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  is a top plan view of the apparatus of the present application in its assembled condition. 
         FIG. 2  is a sectional view taken along line  2 - 2  of  FIG. 1  indicating the memory and bending characteristic of the porous mesh attached to the sensor base, such mesh being depicted with an exaggerated thickness for the sake of clarity. 
         FIG. 3  is a front, left side, bottom, perspective view of the component case prior to integration into the apparatus depicted in  FIG. 4 . 
         FIG. 4  is a front, left side, bottom isometric view of the apparatus of the present invention prior to connection of the sensor and porous sheet to the case, as shown in  FIG. 2 , and with the cover removed from the case. 
         FIG. 5  is a perspective view of another embodiment of the apparatus of the present application depicting a variation of the moisture sensor, absent the porous sheet, having cutout areas for the egress of urine. 
         FIG. 6  is a perspective view of an undergarment showing the apparatus of the present invention in place therewithin in dashed line format. 
         FIG. 7  is a front, top, left side perspective view of a programming unit which is used with the apparatus of the present application depicted in  FIGS. 1-5 . 
         FIG. 8  is a front, left side, bottom perspective view of a hand held monitor which may be employed by a caretaker in conjunction with the apparatus of the present application depicted in  FIGS. 1-5 . 
     
    
    
     For a better understanding of the invention, reference is made to the following detailed description of the preferred embodiments thereof which should be referenced to the prior described drawings. 
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION 
     Various aspects of the present invention will evolve from the following detailed description of the preferred embodiments thereof which should be referenced to the prior delineated drawings. 
     The wearable apparatus sought for patenting as a whole is identified in the drawings by reference character  10 . Apparatus  10  includes as one of its elements a base member  12 , best shown in  FIGS. 1 and 2 . Base member  12  includes a first surface  14 , which is intended to lie against a patient&#39;s skin, and an opposite second surface  16 . Second surface  16  is intended to lie against an undergarment, which will be described in greater detail as the specification continues. Base member  12  may be formed of any suitable rigid or semi rigid material, typically a plastic material. As depicted in the drawings, a moisture sensor  22  on base member  12  is made from a flexible material and is tapered from a top portion  18  to a rounded bottom portion  20 ,  FIG. 1 . For example, base member  12  is approximately 20 cm. long, 8 cm. across top portion  18 , and 5 cm. across bottom portion  20 . Needless to say, apparatus  10  having base member  12  is relatively compact in size. 
     Moisture sensor unit  22  carries a plurality of metallic traces or strips  26  disposed on top surface  14  of base member  12  in a looped, generally parallel configuration,  FIGS. 1 and 2 . It should be apparent that any urine disposed on sensor  22  between any of a pair of plurality of traces  26  will allow conduction of electrical current therebetween and will generate a signal sent to electronic components  28  within case  30  of base member  12 , shown in  FIG. 3 . Again, such signal generation may include a radio signal and is of conventional configuration. 
     Referring now to  FIG. 3 , it may be observed that a case  30  is depicted that includes a perimeter wall  32  and an interior partition  34 . Bottom  36  of case  30  supports electronic components  28 , depicted in  FIG. 4 . Base member case  30  possesses a first or upper compartment  41  and a second or lower compartment  43 . A shelf  38  is formed by interior partition  34  against bottom  36 . Looking again at  FIG. 4 , it may be seen that a pair of wires  40  attached to metal traces  26  pass through transverse holes  42  and to a circuit board  44  on bottom  36  of case  30 . Among the specific components of plurality of components  28  is a battery  46  and a tilt sensor  48 , the importance of which will be described hereinafter. A pair of wires  50  link battery  46  to circuit board  44 . Cover  51  encloses case  30  as depicted in  FIG. 1 . 
     With further reference to  FIGS. 1, 2, and 4 , it is illustrated therein that a porous sheet  52  is positioned over or on top of sensor  22 . Again, porous sheet  52  is intended to contact the skin of the user of apparatus  10  and to prevent a false signal being generating by moisture sensor  22  through natural body moisture of a patient. Porous sheet  52  is shown in the form of a mesh fabric sheet that is illustrated in  FIGS. 1 and 4  as allowing the viewing of first surface  14  and metal traces  26  of sensor  22 , thereupon. Specifically, porous sheet  52  may take the form of a polypropylene mesh, product number XN4411 distributed by Industrial Netting Corporation of Minneapolis, Minn. Mesh sheet  52  may possess a thickness of about 0.10 cm. (0.04 in.), having hole sizes that are approximately 0.15 cm. (0.06 in.) and possessing an open area of about 80%. Of course, other suitable porous sheets may be employed with apparatus  10  of the present invention. Most importantly, porous sheet  52  is semi-flexible and possesses a memory, the significance of which follows hereinafter.  FIG. 2  indicates that porous sheet  52  and moisture sensor  22  lie above shelf  38  of case  30 . End  54  of moisture sensor  22  and a portion of porous sheet  52 , shown as the upper ends on  FIG. 4 , are held to shelf  38  by an adhesive  56  which may be a potting compound,  FIG. 2 . Consequently, porous sheet  52  may be separated, rotated, or lifted relative to base member  12  according to directional arrows  58  and  60 . Since porous sheet  52  possesses a memory, movement of porous sheet  52  into the position depicted in  FIG. 2  allows porous sheet  52  to be cleaned and dried. Upon release of porous sheet  52  by a user, porous sheet  52  will return itself to a position over moisture sensor  22 , as indicated by directional arrow  60 . 
     Apparatus  10  also includes as one of its elements a tilt sensor  48  which lies within case  30 . Tilt sensor may take the form of a 3-axis orientation/motion detection sensor, model number MMA7660FC manufactured by Freescale Semiconductor, Inc. of Austin Texas. Tilt sensor  48  tracks a patient&#39;s turning motion relative to the head to foot axis of the patient. Upon such motion, a radio signal is generated in a conventional manner by the activation of tilt sensor  48  and, eventually, notifies a care provider when a positional change has taken place in the patient wearing apparatus  10 . More specifically, the radio signal generated by tilt sensor  48  may be programmed to inform a caregiver when a patient wearing device  10  has had insufficient turning movement during a selected time period. Should this occur, the care provider would visit a particular patient and turn the patient in order to avoid the possibility of the patient developing decubitus ulcers. For example, a signal may be generated by tilt sensor  48  when a turning motion of at least  30  degrees in the head to foot axis of the patient has not occurred during selected time periods such as 30 minutes, 60 minutes, 90 minutes, or 120 minutes as the case may be. 
     The moisture sensor  22  depicted in  FIGS. 1-4  is typical of sensors used in many devices for the treatment of childhood enuresis. The configuration of sensor  22  of apparatus  10  is less than satisfactory, however, when used as part of an alert system for adult incontinence. In the care of adult patients, it is desirable, if possible, to avoid frequent changes of bed clothes. Since the sensor unit  22 , shown in  FIGS. 1, 2, and 4 , is solid, urine cannot penetrate through sensor unit  22  for absorption by the disposable cotton undergarment  66 . As a result, urine tends to puddle around the leg holes of the undergarment  66  and may leak onto patient&#39;s bed clothes,  FIG. 6 . 
     The alternate embodiment of apparatus  10 A, shown in  FIG. 5 , largely prevents this problem by allowing urine to go through multiple openings  33  in the sensor unit  49  to reach the absorbent pad in the undergarment  66 . Three such openings  35 ,  37 , and  39  are shown in  FIG. 5 . Multiple openings  33  in the sensor unit  49 , as shown in  FIG. 5 , are about 80% of its surface area. Reaction time to wetness is not slowed down as compared to sensor  22  of  FIGS. 1, 2, and 4 . 
     In this regard, sensor unit  49  includes metallic traces formed into three pair of parallel electrodes  51 ,  53 , and  55 , being oriented vertically atop a Mylar sheet  12 ,  FIG. 5 . Solder pads  61 ,  63 , and  65  allow the left hand traces on  FIG. 5  of each pair of electrodes  51 ,  53 , and  55  to be connected to each other, preferably with a strip of adherent copper foil tape  73 . Tape  73  is available from the ULINE Corporation of Pleasant Prairie, Wis. Epoxy masks  77  and  79  permit the right hand traces of pairs of electrodes  51 ,  53 , and  55  to cross copper foil tape  73 , without electrical connection, and to reach electrical leg  57 . Electrical leg  57  terminates in solder pad  67 . Solder pads  65  and  67  connect to wires  40  which carry the wire conduction signal to electronic components  28 , in the same manner as shown in  FIG. 4 . Again, multiple rectangular cutouts  33  in the sensor unit  49 , three of which are shown as  35 ,  37 , and  39 , allow urine to flow through the sensor unit  49  and to reach the absorbent pad of the undergarment  66 . Porous mesh  52  of  FIG. 4 . (not shown in  FIG. 5 ), covers sensor unit  49  to prevent spurious alarms. 
     In operation,  FIG. 6 , apparatus  10  or  10 A has been placed in a disposable, padded, cotton undergarment  66  such that second surface  16  of base member  12  lies against the fabric of undergarment  66 , while first surface  14 , overlain by porous sheet  52 , presses against the body of the patient within undergarment  66 . In this manner, device  10  is able to detect flow of urine of the patient wearing undergarment  66  via moisture sensor unit  22  or  49  as well as to detect inadequate turning or movement of the patient during selected time periods via the signals generated by tilt sensor  48 . By using the programming unit  68 ,  FIG. 7 , having a display  70  and a keypad  72 , the caregiver may enter the name, room, and bed number, as well as the desired time interval during which a patient must turn at least 30 degrees in the head-foot axis. The wearable moisture position sensor apparatus  10  has a radio receiver and the programming unit  68  has a short range radio transmitter. Previous data is automatically removed and new data entered when keypad  72  is used with programming unit  68  next to the apparatus  10 . 
     Monitor  74 ,  FIG. 8 , held by the caregiver is capable through display  76  of revealing the name, room, and bed number of patients needing attention. For example, patient locations may be displayed in rotation, one at a time, and remain on display  60  for a period of 5 seconds along with the terms “wet” and/or “turn” being displayed. Once a situation has been corrected by the caregiver, the display will remove this information. In addition, a beeper  78  will initiate an audio alert prior to displaying the information on display  76 . Such audio alert will be repeated if the condition causing the alert is not corrected after a certain time, say five minutes. LED  80  indicates a low battery condition as well as a charging status for monitor  74 . Keypad  82  may be used to limit items appearing on display  76 . Namely, such items may be restricted to a selected nursing station or to a subsection of such nursing station, as the case may be. 
     While in the forgoing embodiments of the present invention have been set forth in considerable detail for the purposes of making a complete disclosure of the invention, it may be apparent to those skilled in the art that numerous changes may be made in such details without departing from the spirit and principles of the invention.