Abstract:
The present application provides a system for measuring and storing data in an external device including a collection unit transferring fluid, a sensing unit connected to the collection unit for sensing the pressure of the fluid and converting the pressure into data, a housing assembly for housing the sensing unit, and a communication unit connected to the housing assembly receiving the data from the sensing unit and transmitting the data to the external device. The system provides a communication device for transmitting a signal to the external device having a plurality of buttons, each button corresponding to a condition, a light indicating operation of a button, and an electronic circuitry detecting the operation of the button, identifying the operation of the button as the signal, and transmitting the signal to an external device. The present application further provides a method for measuring data using the above-described system.

Description:
FIELD OF THE INVENTION 
       [0001]    This invention generally relates to a measuring device for medical applications. More particularly, the invention is related to a measuring device and method for measuring data of a patient and storing the data in an external device. The invention is also related to monitoring a clinical state of a patient using a communication device of the measuring system. 
       BACKGROUND OF THE INVENTION 
       [0002]    Medical devices capable of measuring various patient related data (e.g., fluid flow rates) are known in the medical field. One such device is disclosed in WO 02/07595, which provides a disposable catheter tube including at least one channel for receiving a liquid, a pressure sensor for placing in contact with the liquid, and a pressure chamber for measuring the pressure of the liquid provided with at least two ports connecting the channel and the pressure sensor. The catheter fits into a recess on a connector unit, which holds the pressure sensor enabling the catheter to contact the pressure sensor. When the catheter is used, the catheter tube is flushed and filled with water. The catheter tube is then introduced into the patient, for instance in the urinary bladder, and water is introduced into the bladder via a channel present for this purpose in the catheter tube. At this time, the pressure sensor measures the pressure of the liquid in the patient. 
         [0003]    One advantage of such devices using a disposable catheter is increased hygiene. The disposable catheter can be supplied in a sterile state. The disposable catheters are also inexpensive. However, the conventional medical device requires a peripheral computing device, such as a computer or personal digital assistant (PDA) to transmit the measured data. Additionally, electrical wiring connects the connector unit of the conventional medical device to the peripheral equipment. Unfortunately, electrical wiring is bulky. This configuration prevents mobility of the patient. Another disadvantage of this system is that the connector unit does not have wireless capability to communicate with the doctor&#39;s computer. Thus, the patient must stay in the room near the computer. 
         [0004]    As described in WO 04/006761, the catheter devices integrate the catheters, pressure chambers, and pressure sensors into a single cassette.  FIG. 1  is a top view of a conventional measuring medical device. The measuring device  1  includes a cassette  2 , which is received in a cassette holder  3 . The catheters  4  transfer a liquid to pressure chambers (not shown) in the cassette  2 . The measuring means of the device of  FIG. 1  include three catheters  4 , which are provided with three ports, i.e. a first port  5   a ,  5   b , and  5   c  for connection of a catheter tube (not shown), a first venting port  7 , and a second venting port  8 . The catheters  4  are provided with a two-way tap  9  and a non-return valve  10  for opening and closing the catheter tube, respectively. 
         [0005]    The catheters  4  of the conventional medical device  1  are integrated into the cassette  2 . The holder  3  including the cassette  2  can be attached to the patient for ambulatory use. However, the transmitter  11  housed inside the holder  3  of the conventional medical device  1  is not part of the cassette  2 . The cassette  2  is releasably connected to the holder  3  by means of a connector  13 . 
         [0006]    Recently, catheter devices have been developed to include a wireless transmitter in the connector unit. The connector unit has a plurality of recesses to receive the pressure chamber of a catheter. The absence of wires in the connector unit increases the freedom of movement of the patient to a significant degree as described in WO 04/006761. With the use of wireless communication, the patient and the peripheral equipment do not have to be located in the same room. However, the transmitter of WO 04/006761 does not provide local storage for the measured data. 
         [0007]    The device of WO 04/006761 integrated the pressure chambers, pressure sensors, and catheters into a single cassette, which connects to the transmitter. An advantage of this system is that during ambulatory use, the measuring system is enclosed in the holder and can be worn under the patient&#39;s clothing. When the catheters are inserted inside the cassette, the cassette can be exposed to bodily fluids of the patient. A disadvantage of this system is the transmitter is housed in a separate holder, which increases the size of the measuring system. 
         [0008]    A catheter device has been developed to include the transmitter enclosed inside the cassette during measurements. In WO 05/025415, the cassette acts as a shield for the transmitter. To ensure sterilization after the transmitter is inserted into the cassette, the cassette can be closed off to avoid contact between the bodily fluids being measured by the catheters housed in the cassette and the transmitter. The cassette may be disposable to increase sterilization. 
         [0009]      FIG. 2  illustrates an exploded view of another conventional medical device shown and described in WO 05/025415, which includes the transmitter (not shown) enclosed inside the cassette  2  during measurements. The cassette  2  is shown in  FIG. 2  having four pressure chambers  6 , each of which can receive a catheter  4 . Each pressure chamber  6  includes an opening into the cavity of the cassette  2 , in or under which opening a pressure sensor  13  can be attached, such that the pressure sensor can measure the pressure of the bodily fluids within the pressure chamber  6 . The catheters  4  and pressure sensors  13  are placed in the cassette  2  such that the cassette  2  is liquid-tight. In this case, it is possible to seal the cassette  2  off to avoid contact between the bodily fluids measured by the catheters  4  and the transmitter, connecting plate  14 , and first connector  15  housed in the cassette  2 . The catheters  4  are fixed to the cassette  2  and are not exchangeable. 
         [0010]    Additionally, a chip  16  is provided inside the cassette  2  that is connected to the cassette holder  2  and to the power source to form a chip and cassette assembly. The chip  16  includes an electronic circuit with a counter or timer. The counter of the chip  16  is activated and starts timing a preset period during the operation of the medical device, for example, receiving and transmitting data obtained with the pressure sensors  13 . When the pressure sensors  13  contact the pressure chamber  6 , the contents of the chip  16  are read by the transmitter through the connector  15  after insertion into the cassette  2 . The chip  16  performs a verification cycle to determine whether the chip and cassette assembly are compatible with transmitter. If the results of this verification cycle are compatible with the transmitter, the transmitter can read the pressure sensors  13  to obtain the desired data. After the preset period elapses, the chip  16  will stop the device and prevent reuse of the cassette  2 . The chip  16  shown in  FIG. 2  can also be provided with memory means in which data is stored to identify the doctor or hospital, the type of catheters connected to the cassette, and the like. This prevents unauthorized or improper use. However, the conventional medical device shown in  FIG. 2  is not equipped to store the patient&#39;s data. 
         [0011]    The cassette of WO 05/025415 is also equipped with an electronic circuit or chip to store information regarding whether the cassette has been used to measure data from the pressure sensor. The chip in the cassette is designed to allow only one use of the cassette. This prevents re-use of the cassette and possible cross-infection. However, the chip provided in WO 05/025415 does not provide local storage for the measured data. 
         [0012]    Accordingly, there is continued interest in the development of new devices and methods for measuring medical related data of a given patient, which allows for storage of the patient&#39;s data inside the medical device. Increased wireless capability is also desired between the components of the medical device. The use of catheters having a pressure sensor housing connected to each catheter allows for easier and efficient exchange. Of particular interest would be the use of a communication device, which allows the patient to enter their clinical or urological state without using a computer or requiring assistance from medical personnel. 
         [0013]    It is an object of the present application to solve the foregoing needs. 
       SUMMARY OF INVENTION 
       [0014]    Devices, systems, and methods are provided for measuring data of a patient using collection units, sensing units, and communication units. The collection unit or catheter transfers bodily fluids, such as blood or urine. The sensing unit or pressure sensor senses the pressure of the bodily fluids and converts this measurement into a data signal. An embodiment of the present application includes the catheter and the corresponding pressure sensor housed in its own housing. The connection between the housing and the catheters is detachable. Each housing is connected to the transmitter with a connector. 
         [0015]    In accordance with an alternative embodiment of the present application, the transmitter can send the measurement data wirelessly to the doctor&#39;s computer or to a PDA. The computer or PDA will record, analyze, and store the measurement data. Additionally, the transmitter includes a memory card or chip inside for local storage of the measurement data. This memory card can be utilized for long term or short-term storage. For example, the memory card can be used for storage when there is no connection between the transmitter and the computer. Additionally, the memory card can also be used to input additional data into the external computer. This data can include the types of catheters used, and data specific to the patient, such as, identification, age, sex, and medical history. This feature allows the memory card to be programmed for a specific patient or a type of use. This function directs the software of the doctor&#39;s computer to perform in a custom manner depending on the specific patient or type of use stored in the programmed memory card. The memory card can also store data when the patient is ambulatory. Thus, the measurement data of the patient can be monitored during the ambulatory mode. 
         [0016]    The system of the present application also includes a communication device that communicates with the transmitter and the computer. The communication device allows the patient to enter markers of their clinical state during their treatment. The communication device has a plurality of buttons, each button corresponding to a condition of a patient. The patient may depress a button when for example, they are feeling pain or need to urinate. Once a button is depressed, a signal is sent to the transmitter and the transmitter stores this signal locally in the memory card. The transmitter can also send the signal to the computer collecting the data. When the signal is received by the transmitter, the transmitter sends a signal back to the communication device, which displays a light to indicate that the signal has been received. The communication device can also be used to activate other devices, such as a flowmeter, for example. 
         [0017]    Previously, the conventional device required the patient to communicate their clinical state to a medical assistant or use a PDA to enter their clinical state. The communication device of the present application allows the patient to move freely and efficiently record their clinical state. The use of the communication device also eliminates the need for a medical assistant during measurement. The communication device is a compact device, such as a remote control, unlike a PDA. Another advantage of the present application over conventional systems is that the communication device is a cheaper and simpler solution. 
         [0018]    Another embodiment of the present application is that the wireless capability of the transmitter is extended to allow increased communication between the devices of the system. In the present application, the transmitter can talk to other wireless devices, such as the flowmeter. Therefore, the measurement data collected by the flowmeter is sent directly to the transmitter via wireless communication. After the measurement data is sent, the transmitter can store the data locally or send the data to the computing device. The patient can also press a button on the communication device to establish a connection between the transmitter and the flowmeter. This allows the patient to send measurement data at a predefined interval or when the patient experiences a change in their clinical state. The transmitter sends this data to the computer for further analysis and/or storage. 
         [0019]    According to another embodiment of the present application, the catheter and pressure sensor assembly have wireless capability. Once the catheter and the pressure sensor assembly collect data from the patient, the measurement data can be sent to the transmitter. Because a wireless connection has been established between the catheter and pressure sensor assembly with the transmitter, the catheter and pressure sensor assembly do not need to be attached to the transmitter. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  illustrates a conventional medical device for measuring data of a patient; 
           [0021]      FIG. 2  illustrates an exploded view of the cassette of another conventional medical device; 
           [0022]      FIG. 3  is a view of the system for measuring data of a patient, according to an embodiment of the present application; 
           [0023]      FIG. 4  is a view of the communication device, transmitter, and pressure sensor housings of the present application; 
           [0024]      FIG. 5  illustrates a front view of the transmitter and pressure sensor housings, according to an embodiment of the present application; 
           [0025]      FIG. 6  illustrates a back view of the transmitter and the pressure sensor housings, according to an embodiment of the present application; 
           [0026]      FIG. 7  illustrates a back view of the transmitter and the connection, according to an embodiment of the present application; 
           [0027]      FIG. 8  illustrates an enlarged view for the pressure sensor housing, according to an embodiment of the present application; 
           [0028]      FIG. 9  illustrates an exploded view for the pressure sensor housing, according to an embodiment of the present application; 
           [0029]      FIG. 10  illustrates the communication device in accordance with an embodiment of the present application; and 
           [0030]      FIG. 11  illustrates a system diagram, according to an embodiment of the present application. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0031]    Reference will now be made in detail to the present preferred embodiments of the present application, examples of which are illustrated in the accompanying drawings, wherein like reference numerals refer to the like elements throughout. The embodiments are described below in order to explain the present invention by referring to the figures. 
         [0032]      FIG. 3  is a system for measuring data of a patient, according to an exemplary embodiment of the present application. Referring to  FIG. 3 , in the given embodiment, the system includes at least one catheter transferring fluid of a patient, at least one pressure sensor connected to the at least one catheter for detecting pressure of the fluid and converting the pressure of the fluid into data, at least one pressure sensor housing assembly housing the at least one pressure sensor, and a transmitter releasably connected to the pressure sensor housing assembly for receiving the data from the pressure sensor and transmitting the data to an external device, such as a computer. The catheter is releasably connected to the pressure sensor housing. 
         [0033]    Unlike conventional systems for measuring data of a patient, the transmitter  51  includes a memory card  53 , which allows the transmitter  51  to compute with peripheral devices, such as the doctor&#39;s computer. The memory card  53  stores the measurement data received from the pressure sensor  59 . The transmitter  51  has wireless capability to communicate with peripheral devices and transmit stored data. 
         [0034]    Further, as shown in  FIG. 3 , each catheter  55  is connected to its own pressure sensor housing  57 . The pressure sensor is installed inside the pressure sensor housing  57 . Each pressure sensor housing  57  is connected to the transmitter  51  via a connector  61 . The connectors  61  are easily attached and removed from the connections  63  found in the back of the transmitter  51  as shown in  FIGS. 6 and 7 . Thus, the catheters and pressure sensor housings can be replaced easily or interchanged in the present application. Another advantage of the separate pressure sensor housings is that the pressure sensor housings can be removed from the transmitter  51  after measurement. This allows the doctor or nurse to remove any pressure sensor housing individually upon completion of the measurement of the data. 
         [0035]    The system of the present application also includes a communication device  65  releasably connected to the transmitter  51  as shown in  FIG. 4 .  FIGS. 4 ,  10 , and  11  show an exemplary remote control unit as the communication device  65 . However, the communication device  65  is not limited to an embodiment including a remote control. The communication device  65  is carried by the patient or inserted into their pants or jacket pocket during the ambulatory stage. The doctor or nurse can affix the transmitter  51  to the patient&#39;s underbelly using the fixation adapter  69 . The fixation adapter  69  includes a self-adhesive panel on the bottom side  67  of the transmitter  51  and hooks on both sides of the transmitter  51 . The fixation adapter  69  is disposable in order to maintain hygiene. 
         [0036]    As shown in  FIG. 5 , in the given example, a pressure sensor housing  57  for a rectal catheter  71  and a pressure sensor housing  57  for a bladder catheter  73  are connected to the transmitter  51 . The respective catheters  71  and  73  are color-coded with a blue ring or red ring, for example, to distinguish the types of catheters. Apart from the ring color, the connector for each type of housing is different. The rectal or balloon catheter connects to a housing with a 6-pole connector. The bladder catheter connects to a housing with an 8-pole connector. Both connector types are standard modular connectors, such as, for example, the ones used for telephones and computers. However, it should be understood that the catheters may be multi-lumen catheters in order to accompany both a bladder pressure part and an urethra pressure part. A pressure sensor housing for multi-lumen catheters are compatible with the connection  63  of the transmitter  51  of the present application. 
         [0037]      FIG. 6  illustrates the back view of the transmitter  51  of the given embodiment showing two pressure sensor housings  57  connected to the transmitter  51 .  FIG. 7  shows the back view of the transmitter  51 , which in the given embodiment includes connections for electrodes, a bladder catheter  73 , a rectal catheter  71 , and the communication device  65 . The communication device  65  can interface with the transmitter via wireless communication technology, such as, but not limited to radio transmission signals. Importantly, the pressure sensor housing of the present application allows the doctor or nurse to detach or attach catheters individually. The transmitter and the pressure sensor housing are more compact and lighter than conventional devices. The transmitter does not contact any bodily fluid from the catheter because the pressure sensor housing transmits the measured data from the pressure sensor to the transmitter over the cable and connector assembly  77 . In so doing, the cable and connector assembly increases the sterility of the system. The catheter is disposable in order to decrease the possibility of infection of the patient. 
         [0038]      FIG. 8  is a view of an exemplary pressure sensor housing  57  of the present application after assembly.  FIG. 9  is an exploded view of the pressure sensor housing  57  of  FIG. 8 . In each pressure sensor housing  57 , there are three parts including the top cover sensor housing  75   a , the bottom cover sensor housing  75   b , and the cable and connector assembly  77 . The wires of the cable and connector assembly  77  are connected (e.g., by soldering) to the pressure sensor  59 , which allows the pressure sensor  59  to communicate with the transmitter when the cable and connector assembly  77  is inserted in a connection  63  found on the back of the transmitter. The pressure sensor  59  is then secured (e.g., glued) to an inside surface of the top cover sensor housing  75   a . However, connecting of the pressure sensor housing  57  to the cable and connector assembly  77  could follow the step of the pressure sensor  59  being secured to the top cover sensor housing  75   a . The checkvalve  79  is secured into the top cover sensor housing  75   a . The cable and connector assembly  77  slides into the top cover sensor housing  75   a . Optionally, the cable and connector assembly  77  could be fastened (e.g., glued) to the inside surface of the top cover sensor housing  75   a . The bottom cover sensor housing  75   b  clicks onto the bottom of the top cover sensor housing  75   a . This connection between the bottom cover sensor housing  75   b  and the top cover sensor housing  75   a  could be secured or made permanent with glue. The lock ring  81  has a female luer connector, which is on an end of the catheter, locking with a male luer connector, which is part of the pressure sensor housing. The lock ring  81  snaps onto the rear of the top cover sensor housing  75   a  and the cap  83  is screwed on the checkvalve  79 . Because the catheter handling the bodily fluids is enclosed in the pressure sensor housing and the catheter does not contact the transmitter, the pressure sensor housing of the present application improves hygiene. 
         [0039]    As noted above, another important aspect of the present application is the communication device  65  shown, for example, in  FIG. 10 . The communication device can be used when the patient is ambulatory. As shown in  FIG. 10 , the communication device  65  has a plurality of buttons. Each button  85  of the communication device corresponds to a predefined marker of the patient&#39;s condition, such as their clinical or urological state. For example, the buttons can be programmed to indicate that the patient is thirsty or that the patient needs to urinate. Once the patient pushes a button  85  on the communication device  65 , a data signal indicative of the button pressed is sent to the transmitter  51 . In the given embodiment, a light  87  on the communication device  65  is activated when the transmitter  51  receives the data signal from the communication device  65 . Once the transmitter  51  receives the signal, the transmitter  51  stores the data signal in its memory chip  53  or sends the data signal to the doctor&#39;s computer. Thus, the communication device allows the patient to send predefined markers to the transmitter or computer. The communication device activates the wireless connection between the transmitter and other wireless devices, such as the flowmeter. 
         [0040]    The communication device allows the doctor to monitor the patient and their clinical state in real-time. This feature also allows the doctor or nurse to monitor the patient in another location. The communication device of the present application also allows the patient to use the measuring device privately. The communication device decreases the need for a nurse or medical assistant to monitor the patient, which reduces cost. Another advantage of the communication device of the present application is that it allows the patient to record their current conditions during measurement when they occur. 
         [0041]    In the given embodiment, the communication device  65  also includes a button  89  for flowmeter activation. A flowmeter (not shown) is a machine that measures urine flow collected when voiding the bladder. It is possible for the patient to turn the flowmeter on and off using this button  89  on the communication device  65 . Specifically when the patient presses button  89 , the connection to the flowmeter is activated. When the patient presses button  89  on the communication device  65  again, the connection to the flowmeter is terminated. Therefore, the patient can use the communication device to turn the flowmeter on and off. 
         [0042]    If the flowmeter is equipped with a Bluetooth™ or a wireless connection, the transmitter  51  can set up a connection directly with the flowmeter. The transmitter can forward the data to the doctor&#39;s computer. The transmitter  51  can also store the data if equipped with a memory card. The communication device of the present application can also be configured to have buttons correspond to other wireless devices. By pressing a button on the communication device, the communication device can communicate with other wireless devices. This allows the patient to use the communication device to send measurement data and predefined markers to the transmitter, which has the capability to communicate wirelessly with other devices. Thus, the doctor or nurse can monitor the patient&#39;s condition without using a computer located in the patient&#39;s room. If wireless communication is used, the patient and doctor do not have to be located in the same location. 
         [0043]      FIG. 11  illustrates an exemplary system diagram according to an embodiment of the present application. The transmitter  51  is a central device for receiving, transmitting, and storing measurement data from the sensors  91  and predefined markers for the communication device  65 . The transmitter is a re-usable device, which does not contact the bodily fluids of the patient. The sensors  91 , for example, include EMG electrodes  93 , which are self-adhesive electrodes that register electrical signals from the muscles where they are applied to the patient. The EMG electrodes  93  transmit the electrical signals over cables to the transmitter  51 . The cables of the EMG electrodes  93  are connected to the transmitter  51  in the connection  63  for electrodes shown in  FIG. 7 . The EMG electrodes are disposable and designed for a single use. 
         [0044]    In an embodiment of the present application, the sensors  91  can include a pressure sensor for a single catheter or multiple catheters, such as a multi-lumen catheter. The types of catheters shown in  FIG. 11  include an urethral catheter  95  and a balloon catheter  97 . All of the catheters can be disposable and are intended for use in a single application. However, the catheters are not limited to the embodiment including urethral catheters and balloon catheters. The flowmeter  99  is also shown in  FIG. 11 . All of the sensors are connected directly to the transmitter in the present application. 
         [0045]    The communication device  65  is connected directly to the transmitter  51 . In another embodiment of the present application, the communication device communicates with the transmitter wirelessly. The memory card  53  in the transmitter  51  can store the measurement data during ambulatory use. The memory card can also be used to input additional data into the external computer. When the memory card is programmed for a specific patient or a type of use, the doctor&#39;s computer performs in a custom manner depending on the programmed memory card. The transmitter  51  collects data from the various sensors  91  and the communication device  65  and sends the data to a PDA or the doctor&#39;s computer. If the transmitter has wireless capability, the transmitter  51  transmits the measurement data wirelessly to the doctor&#39;s computer or PDA for display and analysis. 
         [0046]    As is apparent from the above description, the present invention provides a communication device for a measuring device for medical applications. The communication device allows the patient to send indicators of their clinical state directly to the transmitter. The communication device can also activate the flowmeter connection. The communication device is less expensive than previous computing devices, which required nurses or medical assistants to manually enter the clinical data of a patient when a patient was using a catheter. 
         [0047]    The transmitter can locally store the indicators of the patient in a memory chip or wirelessly communicate the indicators to an external computer, such as a PDA. If the catheter and the pressure sensor assembly have wireless capability, the catheter can transfer the fluid having a pressure, the pressure sensor can convert the pressure of the fluid into data, and the wireless pressure sensor assembly can send the data to the transmitter. Thus, the pressure sensor assembly does not need a connector to communicate with the transmitter. 
         [0048]    Although a few embodiments of the present application have been shown and described, it would be appreciated by those skilled in the art that changes may be made in this embodiment without departing from the principles and spirit of the invention, the scope of which is defined in the claims and their equivalents.