Abstract:
A device for the non-invasive measurement of the core temperature of a patient that includes a tympanic thermometer with a means for measuring the temperature of the patient is described. The device includes a flexible tube capable of being inserted into an external auditory meatus and including an end to which a sensor is connected; a housing including a shell to which a display for displaying the measured temperature is attached; a first blocking means for blocking the external auditory meatus; and a second blocking means for isolating the external auditory meatus from the ambient environment. According to the invention, the measuring means, the housing and the first and second blocking means are sealed and washable.

Description:
BACKGROUND 
       [0001]    The invention relates to a tympanic thermometer. 
         [0002]    The present invention relates to the field of medical thermometers. In particular, it is aimed at the tympanic thermometers intended to measure the temperature of a body, for example of a human body, accurately, notably in difficult climatic conditions and environments. 
         [0003]    It is known practice to measure the temperature of a human body, for example, at the tympanum, because it substantially agrees with the real “core” internal temperature of a body compared with the temperatures read in other, conventional bodily areas (armpit, oral cavity, etc.). 
         [0004]    A tympanic thermometer is known for example from the document EP 0,461,068 that is designed for emergency rescues, for example, in cold, in mountains, at sea, in order to diagnose possible hypothermia. This thermometer comprises a tympanic probe provided with a foam ring and a support limiting its penetration into the external auditory meatus. A flexible cord links the probe to a housing comprising a shell equipped on its first face with means for displaying the measured temperature and with an ear insulating foam fixed onto its second face. Furthermore, a band is used to tighten the housing, covering the ear, on the head of a patient. 
         [0005]    However, it is not possible to decontaminate and disinfect this tympanic thermometer which comprises parts made of foam in contact with bodily areas of a patient, in particular with the external auditory meatus and the auricle of the ear, which can transfer microorganisms from one patient to another, infecting them. Furthermore, the thermal insulation of the external auditory meatus from the ambient environment that this foam offers is insufficient, which can adversely affect the quality of the measurements. In practice, the foam fixed onto the shell is an open-cell foam resulting in the absorption of liquid and the penetration of micro-organisms. To this is added the fact that this thermometer is not sealed, does not withstand the fluids used in medical environments and has numerous constraints on its use. 
         [0006]    The objective of the invention is notably to mitigate all or some of the drawbacks of the prior art. 
         [0007]    More specifically, one object of the invention is to provide a tympanic thermometer that is easy to clean and decontaminate. 
       SUMMARY 
       [0008]    These objectives are achieved by virtue of a device for measuring the internal temperature of a patient, the device comprising a tympanic thermometer comprising: 
         [0009]    a means for measuring the temperature of a patient consisting of a flexible tube capable of being introduced into an external auditory meatus and comprising an end to which a sensor is fixed; 
         [0010]    a housing comprising a shell to which means for displaying the measured temperature are fixed; 
         [0011]    a first blocking means for blocking the external auditory meatus; 
         [0012]    a second blocking means for insulating the external auditory meatus from the ambient environment. 
         [0013]    The invention is noteworthy in that the measurement means, the housing and the first and second blocking means are sealed and can be cleaned. 
         [0014]    Thus, the tympanic thermometer can be cleaned, disinfected and decontaminated by means as used for example in the medical services to avoid the transfer of microorganisms such as bacteria, viruses or fungi that can infect the patients. 
         [0015]    According to a particular embodiment, the second blocking means is a separate element from the housing of the tympanic thermometer. 
         [0016]    This makes it possible for the measurement device to be manipulated easily and in particular for the reading of the displayed measured temperature to be easily accessible. Obviously, the separation of the two elements means that the second blocking means can easily be cleaned and decontaminated. 
         [0017]    According to a second embodiment, the second blocking means is fixed to the housing, forming a sealed assembly. Such an arrangement will have the advantage of avoiding use of the thermometer without the second blocking means. 
         [0018]    Advantageously, the second blocking means comprises a thermally insulating foam formed in a sealed, impermeable and removable jacket. 
         [0019]    This means that the foam used to insulate the external auditory meatus of an ear from the ambient environment is not in contact with some of the bodily areas of the patient, or with other contaminable elements, which avoids the spread of infections. The sealed, impermeable and removable jacket is an inexpensive and reliable solution, and facilitates the replacement of the foam. 
         [0020]    According to an important feature, the second blocking means has a covering surface area of between 400 mm 2  and 5000 mm 2 . 
         [0021]    This means that the second blocking means can be adapted to all categories of patients and makes it possible to insulate the inside of the ear but also beyond the auricle of the ear. 
         [0022]    Provision is made for the jacket to have a height of between 10 and 70 mm so as to contain any thickness, in particular thermally insulating foams that have a great thickness for a better insulation of the external auditory meatus. 
         [0023]    According to another embodiment, the first blocking means comprises at least a part which substantially forms an angle of between 35 and 90° with an axis, this axis being wholly or partly concentric with a wall of this part to block the external auditory meatus and limit the penetration of the tube into said meatus. 
         [0024]    According to a preferred aspect, the tympanic thermometer and/or the second blocking means are made of polymer materials in order to withstand the hostile environments and improve the seal-tightness. 
         [0025]    To increase the thermal insulation capability, the foam is made of a closed-cell polymer material. 
         [0026]    Advantageously, provision is made for the measurement device to exhibit a positive buoyancy in a fluid depending on the materials and its dimensions to avoid the risk of it sinking for example, in an intervention at sea for example. 
         [0027]    For reasons of hygiene or adaptability of the measurement means to different patients, provision is made for the measurement means to be removable. 
         [0028]    Advantageously, the housing can comprise at least one unit for storing the measured temperature. That should allow for the different temperatures read to be tracked. 
         [0029]    Provision is also made for the link between the housing and the measurement means to be of wireless type. This arrangement avoids the bulk of the measurement device and favors the ergonomics, handleability and convenience in data exchange. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0030]    Other innovative features and advantages will emerge from the following description, given by way of indication and without limitation, with reference to the attached drawings, in which: 
           [0031]      FIG. 1  is a perspective view of a measurement device according to a first embodiment of the invention; 
           [0032]      FIG. 2  is a side view of another embodiment of the measurement device in a situation of use on a patient; 
           [0033]      FIG. 3  is a perspective view of another embodiment of the measurement device with the second blocking means fixed onto the housing of the tympanic thermometer; 
           [0034]      FIG. 4  represents a perspective and front view of the measurement device according to  FIG. 3 ; 
           [0035]      FIG. 5  is a perspective view of a thermally insulating foam formed in a jacket; 
           [0036]      FIG. 6  is a detailed view of an embodiment of the first blocking means according to the invention; 
           [0037]      FIG. 7  illustrates a measurement means in the ear of a patient; 
           [0038]      FIG. 8  illustrates another embodiment of the invention with the removable measurement means; 
           [0039]      FIG. 9  is a block diagram of the measurement device; 
           [0040]      FIG. 10  is a view of another embodiment of the invention; 
           [0041]      FIG. 11  is a perspective view of another embodiment of the measurement device according to the invention; and 
           [0042]      FIG. 12  is a side view of the measurement device according to  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION 
       [0043]    The device  1  for measuring the internal temperature of a patient according to the invention is designed for medical personnel to take a measurement of the tympanic temperature of the patient. This temperature measurement device is particularly suited to a hostile environment, such as mountains, sea, etc. 
         [0044]      FIG. 1  illustrates, in a perspective view, an embodiment of the invention in which the device  1  for measuring the internal temperature of the patient comprises a tympanic  2  or auricular thermometer. 
         [0045]    The tympanic thermometer  2  comprises a measurement means  3 . The latter can consist of a flexible tube  4  capable of being introduced into the external auditory meatus C of the patient and comprising an end  5  to which a sensor  6  is fixed. The sensor  6 , well known to those skilled in the art, is intended to pick up the heat radiated by the tympanum. A first blocking means  7 , which is in contact with a bodily area of the patient, in particular with the elastic cartilage of the ear O, is mounted at the other end  5 ′ of the flexible tube  4 . The first blocking means  7  is for blocking the external auditory meatus C of the ear O. The flexible tube  4  has a diameter of between 2 and 15 mm. It can have a length of between 4 and 20 mm. 
         [0046]    The tympanic thermometer  2  also comprises a housing  8  provided with a shell  9  to which means  10  for displaying the temperature measured by the sensor  6  are fixed. More specifically, the display means  10  are fixed onto a front face  11  of the shell  9 . The display means  10  can comprise a frame  13  supporting, for example, an LCD (Liquid Crystal Display) screen. Control or indication buttons  14  (on/off, battery readout, etc.) can be provided, for example, on the frame  13  or the shell  9  of the housing  8  (see  FIGS. 4 ,  11  and  12 ). The shell  9  also has a rear face  12  in which a housing can be formed, intended to receive at least one battery (not represented). The housing will be closed by a removable cover (also not represented). The housing  8  can be linked with the measurement means  3  by a flexible cord  23 . The housing  8  can have a height H of between, for example, 5 and 20 mm. 
         [0047]    The tympanic thermometer  2  also comprises a second blocking means  15  which is in contact with a bodily area of the patient, in particular with the auricle O. The second blocking means  15  makes it possible to insulate the external auditory meatus of the ear of the patient from the ambient environment as illustrated in  FIG. 2 . 
         [0048]    According to the invention, the measurement means  3 , the housing  8 , the first  7  and second  15  means for blocking the external auditory meatus C of the patient are sealed and can be cleaned. 
         [0049]    In the context of the present invention, the term “sealed” should be understood to mean that no fluid is allowed to pass and that it is capable of being cleaned, disinfected, decontaminated by a disinfectant liquid solution, such as, but not limited to, the solutions used for medical devices. 
         [0050]    As can be seen in  FIGS. 1 and 2 , the second blocking means  15  is a separate element from the housing  8  of the tympanic thermometer  2 . Each of the separate elements is sealed. 
         [0051]    In  FIG. 3 , it can be seen that the second blocking means  15  is fixed to the housing  8 . In this case, the housing  8  and the second blocking means  15  form a sealed assembly. To perfect the seal-tightness and the fixing, a plate  16  can be interposed between the second blocking means  15  and the housing  8  of the tympanic thermometer  2 . The fixing can be carried out by gluing, welding or another sealed element. 
         [0052]    A strap  17  for holding the second blocking means  15  pressed onto the ear O of the patient can be provided. The strap  17  can be secured to the plate  16  which is provided with two openings  18  for this purpose ( FIGS. 3 and 4 ). The strap  17  can also be fixed to the second insulating means  15  ( FIG. 1 ). The strap  17  can comprise tightening loops  19  and/or closure loops  20 . However, it is possible to envisage having the second blocking means  15  mounted on an arc in the configuration of an audio headset for example, or similar. Similarly, an elastic band (not represented) may be sufficient to press the second blocking means  15  onto the ear O of the patient. 
         [0053]    As illustrated in  FIG. 5 , the second blocking means  15  is made of a thermally insulating foam  21  which is formed in a sealed and impermeable jacket  22 . The jacket  22  can also be removable. 
         [0054]    Advantageously, the tympanic thermometer  2  and/or the second blocking means  15  are made of polymer materials. 
         [0055]    To make the measurement device as sealed as possible, a transparent sealing film can be provided, either mounted on the front face  11  and/or on the rear face  12  of the housing  8 . The sealing film can be made of polyethylene for example. It can be fixed by gluing or welding, seal-tight fixing screws or other means. 
         [0056]    The thermally insulating foam  21  can be made of a closed-cell polymer material. Preferably, the foam  21  is made of polyurethane. Other materials can of course be used. The thickness of the foam  21  can be between 20 and 60 mm. It also has a density of between 20 and 45 kg/m 3 . Through its composition and its thickness, the foam  21  allows for an excellent insulation of the external auditory meatus from the ambient environment. 
         [0057]    The jacket  22  can be made of a flexible polymer. Preferably, the jacket  22  can be made of silicone or polyurethane. It can have a height of between 10 and 70 mm so that it matches the thickness of the insulating foam  21 . The jacket  22  can be provided with a sealed closure  24  of slider type making it possible to open or close the jacket  22  in order to introduce the foam  21  therein or remove it therefrom. However, the jacket  22  can be completely closed for example by welding or gluing. 
         [0058]    The second blocking means  15  can have any shape, circular, rectangular or other. Provision is made for the second blocking means  15  to have a covering surface area  25  of between 400 mm 2  and 5000 mm 2 . 
         [0059]    The first blocking means  7  represented in  FIG. 6  can be fixed or overmolded or mounted removably on the flexible tube  4 . More specifically, the first blocking means  7  comprises at least a part  26  which substantially forms an angle a of between 35 and 90° with an axis A. This axis A is wholly or partly concentric with the wall presented by the part  26  of the first blocking means  7 . The wall of the part  26  can be in the form of a collar or substantially circular. Preferably, this angle a is substantially 90°. This configuration makes it possible on the one hand to block the external auditory meatus and on the other hand to limit the penetration of the measurement means  3 , notably the flexible tube  4 , into this duct, and limit the heat losses. Also, the sensor  6  and/or flexible tube  4  has a rounded end to avoid any risk of pain in the event of contact with the wall of the auditory meatus or with the tympanum. The first blocking means  7  can take the form of an (intra-auricular) earflap or of an earphone. 
         [0060]    According to an advantageous feature, the measurement device  1  exhibits a positive buoyancy in a fluid depending on the material and on its dimensions. More specifically, the seal-tightness of the tympanic thermometer  2  and of the second blocking means prevents, on the one hand, any ingress of liquid. On the other hand, the material used, in this case polyurethane for the foam  21  and/or the jacket  2 , is a highly buoyant material. The measurement device  1  has a weight of between 60 and 500 g, the weight of the measurement device  1  being less than the buoyancy which corresponds to the density of the fluid multiplied by the volume of the fluid. The measurement device  1  can thus float in sea or river water for example. 
         [0061]    Provision can be made for the measurement means  3  to be removable ( FIG. 7 ), in particular, for example, from the flexible cord  23  or from the first blocking means  7 . The flexible tube  4  can be disconnected at its other end  5 ′ (situated before or after the first blocking means  7 ) from the flexile cord  23  or from the first blocking means  7 . The flexible cord  23  can comprise, at one of its ends  27 , a female-type connection plug  28  making it possible to connect the second end  5 ′ of the flexible tube  4  comprising a male connection plug  28 ′ for example. Obviously, any type of connection means can be considered. This configuration makes it possible for the measurement means  3  to be unique and disposable, or makes it possible for the measurement means  3  to be interchangeable for the latter to be adapted to different patients, such as new-born babies, children and adults. 
         [0062]    According to a feature that can be envisaged (see  FIG. 10 ), the link between the housing  8  and the measurement means  3  is of wireless type. The housing  8  and the measurement means can each be equipped with a transmitter and a receiver (not represented) to ensure the transmission T of the information from the housing  8  or from the measurement means  3 . The wireless link can use Wi-Fi, infrared, and other such systems. Preferably, the wireless system uses the Bluetooth® configuration according to the well-known standards IEEE 802.15.1 to IEEE 802.15.4. The housing  8  can also communicate wirelessly with other terminals containing a medical file of the patient for example. 
         [0063]    According to another feature that can be envisaged, the housing  8  can comprise at least one unit  31  for storing the measured temperature. In  FIG. 9  representing a block diagram of the measurement device  1 , the latter can comprise a CPU processing unit  29 . This processing unit  29  is connected to a temperature measurement unit  30 , a storage unit  31  for storing the measurements read and other program data, a unit  32  for displaying the information processed by the processing unit  29  and a communication interface unit  33 . The storage unit  31  is intended to receive data in analog and/or digital format. Preferably, the storage unit  31  can comprise an electronic integrated circuit mounted on a printed circuit which is housed in the housing of the tympanic thermometer  2 . The memory can be of RAM and/or ROM and/or EPROM type. 
         [0064]    The measurement device I is used as follows: a user introduces the measurement means  3  comprising the flexible tube  4  and the sensor  6  into the external auditory meatus C of the ear O of the patient or of the accident victim. The first blocking means  7  blocks the external auditory meatus by means of a part  26  of this first blocking means  7  which abuts with the entry of the auditory meatus for a first insulation. The user presses the second insulation means  15  onto the auricle so as to hold, on the one hand, the measurement means  3  inside the auditory meatus, and, on the other hand, totally insulate said meatus from the ambient environment. A small volume of air located inside the meatus then reaches the temperature of the blood in the internal carotid artery. The user can then view the temperature by virtue of the display means  10 . The user can then grip the head of the patient on which the second blocking means  15  is placed. The user can keep the housing  8  between the hands or position it on the head of the patient by means of the strap  17 . The thermometer does not need to be calibrated. Reliable measurements concerning the core temperature of the patient can thus be obtained, non-invasively.