Abstract:
The invention relates to a phonation assistance device for a tracheotomy patient, including: an exhalation circuit connected to a tracheotomy cannula inserted in the trachea of the patient, the exhalation circuit including an outlet opening for the passage of the air exhaled by the patient; and a valve for opening/closing the outlet opening for normally assuming, when the patient inhales, a position for closing the outlet opening and, when the patient exhales, a position for closing the outlet opening. It also includes means for the positive priority control of the valve for selectively moving the valve into the closed position when the patient exhales.

Description:
CROSS REFERENCE TO PRIOR APPLICATIONS 
       [0001]    This application is a U.S. National Phase application under 35 U.S.C. §371 of International Application No. PCT/FR2010/050858, filed on May 5, 2010 and claims benefit of priority to French Patent Application No. 0953058, filed on May 7, 2009. The International Application was published in French on Nov. 11, 2010 as WO 2010/128250 A1 under PCT Article 21 (2). All of these applications are herein incorporated by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    The present invention relates to a phonation assistance device for a tracheotomy patient, of the type comprising:
       an exhalation circuit connected to a tracheotomy cannula inserted in the trachea of the patient, the exhalation circuit including an outlet opening for the passage of the air exhaled by the patient; and   a valve for opening/closing the outlet opening for normally assuming, when the patient inhales, a position for closing the outlet opening and, when the patient exhales, a position for opening the outlet opening.       
 
       BACKGROUND 
       [0005]    In certain medical situations where a patient encounters difficulties in breathing, it is necessary to perform a tracheotomy, which is an operation in which an incision is made in the patient&#39;s neck so as to establish communication with the inside of the trachea. 
         [0006]    A cannula, called tracheotomy cannula and through which outside air can penetrate, is then inserted through the incision in the trachea, thereby making it possible to ensure spontaneous or mechanical pulmonary ventilation of the patient without going through the upper respiratory paths. 
         [0007]    However, the implantation of a tracheotomy cannula in a patient&#39;s trachea generally does not allow the passage of the exhaled air toward the upper respiratory paths, which are responsible for ensuring the operation of the vocal cords to allow the patient to produce phonemes. 
         [0008]    Devices of the aforementioned type are known making it possible to mechanically ventilate the patient using a ventilator while allowing him to keep the possibility of producing phonemes. In such devices, a check valve is positioned on the tracheotomy cannula, allowing the inhaled flow of aft to penetrate the trachea through that valve, while the exhaled air can only exit toward the patient&#39;s vocal cords if there is sufficient space between the cannula and the trachea, thereby allowing him to preserve the use of speech. 
         [0009]    However, as long as the check valve is present on the tracheotomy cannula, the patient is required to breathe through his mouth, leading to dehydration of the respiratory paths. Furthermore, in most cases, the valve cannot be removed by the patient alone, and removing the valve requires disconnecting, then reconnecting the ventilator, which can be dangerous for the patient, in particular when the patient is at home and not in a medical setting. Furthermore, if the exhalation through the mouth is not complete due to an excessive resistance between the cannula and the trachea and/or an overly short exhalation time imposed by the ventilator, there is a risk of pulmonary hyperinflation. 
         [0010]    The invention aims to propose a simple device that makes it possible to facilitate the breathing and speech of a patient having undergone a tracheotomy, while preventing or at least reducing both the dehydration of the patient&#39;s respiratory paths and the risk of pulmonary hyperinflation. 
       SUMMARY 
       [0011]    To that end, the invention relates to a device of the aforementioned type, characterized in that it also comprises priority positive control means of the valve, adapted to selectively bring the valve into the closing position when the patient exhales. 
         [0012]    The device according to the invention can include one or more of the following features:
       the priority positive control means comprises a first solenoid valve for controlling the valve, and a control switch for the first solenoid valve;   the valve comprises a housing in which the exhalation circuit emerges and comprising an air outlet opening, and a member steered by the pressure housed in the housing and adapted to assume a closed position in which it closes the outlet opening, and an open position in which it opens the outlet opening;   the priority positive control means comprises a pressure generator selectively connected, via the first solenoid valve, to the member controlled by the pressure;   the pressure generator is a continuous fan turbine;   the device comprises an inhalation circuit permanently connected to the cannula and comprising an inlet opening allowing the passage of air inhaled by the patient;   the device comprises a ventilator whereof the discharge is connected to the inhalation circuit;   the ventilator comprises a second solenoid valve and is selectively connected to the valve via the second solenoid valve;   the first solenoid valve is selectively controlled by the switch and b the ventilator; and   the device comprises a tracheotomy cannula intended to be inserted into the trachea of the patient and connected to the exhalation circuit.       
 
         [0022]    BRIEF DESCRIPTION OF THE DRAWINGS 
         [0023]    The invention will be better understood upon reading the following description, provided solely as an example and done in reference to the appended drawings, in which: 
         [0024]      FIG. 1  is a cross-sectional profile view of the upper respiratory paths of a human being; 
         [0025]      FIG. 2  is a diagrammatic view illustrating the operating principle of a device according to a first embodiment of the invention during an inhalation phase; 
         [0026]      FIGS. 3 and 4  are views similar to that of  FIG. 2  during first and second exhalation phases, respectively; 
         [0027]      FIG. 5  is a view diagrammatically illustrating the device of  FIG. 2  during a first inhalation phase; 
         [0028]      FIG. 6  is a perspective view of the valve of the device of  FIG. 5 ; 
         [0029]      FIGS. 7 ,  8  and  9  are views similar to that of  FIG. 5  during a first exhalation phase, a second inhalation phase, and a second exhalation phase, respectively; and 
         [0030]      FIGS. 10 ,  11 ,  12  and  13  are views diagrammatically illustrating a device according to second, third, fourth, and fifth embodiments of the invention, respectively. 
     
    
     DETAILED DESCRIPTION 
       [0031]    In order to better understand the following description, several reminders about human anatomy are provided in reference to  FIG. 1 , in which the upper respiratory paths  10  of a human being  12  are shown. 
         [0032]    The respiratory paths, also called airways, are channels that allow air to pass from the nose  14  and the mouth  16  to the lungs and alveoli during ventilation, also called respiration. The term upper respiratory paths  10  designates the part of the respiratory paths situated above the larynx  18 , and lower respiratory paths designates the part of the respiratory paths situated below the larynx  18 . 
         [0033]    The larynx  18  is an organ situated at the throat and containing the vocal cords  20 , the vibration of which allows phonation, i.e. the production of vocal sounds. The larynx  18  is extended toward the lower respiratory paths by the trachea  22 . 
         [0034]    The trachea  22  is a conduction zone making it possible, during inhalation, to convey air from the larynx  18  into the bronchi, and to make the carbon dioxide-rich air exit during exhalation. 
         [0035]    When a patient needs continuous mechanical ventilation, which makes it possible to supply spontaneous ventilation using a device called a ventilator, or respirator, a tracheotomy may be necessary to ensure the most reliable and effective interface possible between the ventilator and the patient. 
         [0036]      FIG. 2  diagrammatically illustrates the operating principle of a device  24  according to a first embodiment of the invention, and which is a phonation assistance device for a patient  12  having undergone a tracheotomy. 
         [0037]    The device  24  comprises a tracheotomy cannula  26  inserted into the trachea  22  of a patient  12 , an inhalation circuit  28  and an exhalation circuit  30  connected to the cannula  26 . 
         [0038]    The inhalation circuit  28  is formed by a tube  32  continuously connected to the cannula  26  and including an inlet opening  34  allowing the passage of air inhaled by the patient  12 . 
         [0039]    The device  24  also comprises a ventilator  36  whereof the discharge is connected to the inlet opening  34  of the inhalation circuit  28 . The ventilator  36  operates discontinuously, so as to generate a flow of air only during the inhalation phases. 
         [0040]    The inhalation circuit  28  is thus delimited on one side by the ventilator  36 , and on the other side by the cannula  26 . 
         [0041]    The exhalation circuit  30  is formed by a distal segment  37  of the tube  32  and comprises a tubular outlet  38  injected on the tube  32 , allowing the passage of air exhaled by the patient  12 , and an opening/closing valve  40  of the outlet opening  38 . 
         [0042]    The exhalation circuit  30  is thus delimited on one side by the bleed of the outlet opening  38  on the tube  32 , and on the other side by the cannula  26 . 
         [0043]    The inhalation circuit  28  is therefore formed by the entire tube  32  while the exhalation it  30  is formed by part of the tube  32 . 
         [0044]    As will be detailed later, the valve  40  can be moved under the effect of the patient&#39;s breathing, between a closed position of the outlet opening  38  when the patient  12  inhales, and an open position of the outlet opening  38  when the patient  12  exhales. 
         [0045]    As illustrated in  FIG. 2 , during the inhalation phase, the valve  40  is in the closed position of the outlet opening  38 . 
         [0046]    The ventilator  36  then delivers a flow of air, shown by the arrows F 1 , which penetrates through the inlet opening  34  and inside the inhalation circuit  28 , as far as into the cannula  26  to emerge in the trachea  22  of the patient  12  toward the latter&#39;s lungs. 
         [0047]    In reference to  FIG. 3 , during the exhalation phase, the valve  40  is in the open position of the outlet opening  38 . 
         [0048]    The air previously inhaled is then exhaled (arrows F 2 ) and rises in the trachea  22  toward the cannula  26 . The exhaled flow of air F 2  next penetrates the cannula  26  as far as the exhalation circuit  30  to emerge outside the device  24  through the outlet opening  38 . 
         [0049]    During this exhalation phase, the exhaled flow of air F 2  passing in the cannula  26 , the patient  12  does not have the ability to speak. 
         [0050]    In order to allow him to express himself when he wishes, the device  24  comprises a means M for controlling the valve  40  that can be actuated by the patient  12 , as will be explained in more detail later, to selectively bring the valve  40  into the closed position of the outlet opening  38  when he exhales. 
         [0051]    As shown in  FIG. 4 , when the patient  12  actuates the control means M, the valve  40  is closed and blocks the exhaled air. All of the exhaled air is then evacuated through the upper respiratory paths  10 . The patient  12  can thus use this flow of air F 3  to vibrate his vocal cords  20  and produce phonemes. 
         [0052]      FIG. 5  diagrammatically illustrates the first embodiment of the device  24 . 
         [0053]    In reference to  FIG. 6 , the valve  40  comprises a housing  42  in which the exhalation circuit  30  emerges through the outlet opening  38 . 
         [0054]    The housing  42  is mounted on the end  44  of the exhalation circuit  30 , forming a plug covering that end  44 , and comprises a side air outlet opening  46 . 
         [0055]    The valve  40  also comprises a membrane  48  housed in the housing  42  and positioned on the outlet opening  38 , and a tip  50  housed in the housing  42  and positioned on the membrane  48 . 
         [0056]    The membrane  48  is made from a flexible plastic material so as to assume, under the effect of an outside overpressure, a closed position of the outlet opening  38 , and without pressure or with an internal overpressure, an open position of the outlet opening  38 . 
         [0057]    The tip  50  comprises a connecting member  52  protruding toward the outside of the housing  42  through a hole  54  formed in a bottom wall  55  of the housing  42 . The connecting member  52  is connected to a pressure source, as will be explained in more detail hereafter. 
         [0058]    As illustrated in  FIG. 5 , the means M for controlling the valve  40  comprises a first solenoid valve  56  for controlling the valve  40 , a switch  58  for controlling the first solenoid valve  56 , and a pressure generator  60 . 
         [0059]    The pressure generator  60  is selectively connected, via the first solenoid valve  56 , to the outer surface of the membrane  48  of the valve  40  by a tube  62  connected to the member  52  ( FIG. 6 ) of the tip  50 . 
         [0060]    In the considered example, the pressure generator  60  is formed by a continuous fan turbine, delivering an overpressure from 4 to 20 mbar. 
         [0061]    The ventilator  36  comprises a bellows  64  controlled by a motor  67  and an air intake conduit  65  connected to the bellows  64  and emerging on the outside of the ventilator  36 . The discharge of the bellows  64  is connected to the inlet opening  34  of the inhalation circuit  28 . 
         [0062]    The ventilator  36  also comprises two check valves  66 , a first valve  66 A being positioned in the conduit  65 , allowing the entry of outside air into the bellows  64  and preventing the air confined in the bellows  64  from exiting outside the ventilator  36 . The second valve  66 B is positioned in the discharge of the bellows  64 , allowing the air confined in the bellows  64  to penetrate the inhalation circuit  28  and preventing that air from again penetrating the bellows  64 . 
         [0063]    The ventilator  36  also comprises a second solenoid valve  68  and a means M′ for controlling the second solenoid valve  68 . The control means M′ makes it possible, through the second solenoid valve  68 , to selectively connect the bellows  64  to the outer surface of the membrane  48  of the valve  40  by a tube  70  connected to the tube  62  and therefore to the member  52  ( FIG. 6 ) of the tip  50 . 
         [0064]    The tubes  62  and  70  thus come together to form a single branch  72  connected to the tip  50 . 
         [0065]    The control means M′ is also connected to the motor  67  of the bellows  64  so as to synchronize the blowing with the opening of the second solenoid valve  68  on the tube  70  and therefore with the closing of the valve  40 . 
         [0066]    During a first inhalation phase shown in  FIG. 5 , the switch  58  is not actuated so that the pressure generator  60  is not connected to the valve  40 , while the means M′ automatically control the second solenoid valve  68  so as to connect the bellows  64  to the valve  40 , the bellows  64  initially containing a volume of air. 
         [0067]    To generate blowing during the inhalation, the bellows  64  then delivers a flow of air F 1 , part of which passes through the tubes  70 ,  72  to penetrate inside the housing  42  of the valve  40  through the tip  50 . This flow of air F 1  generates a pressure that presses the membrane  48  against the outlet opening  38 , covering the latter sealably. 
         [0068]    The other part of the flow of air F 1  passes along the inhalation circuit  28  as far as the tracheotomy cannula  26  to emerge in the trachea  22  of the patient  12  as far as into the latter&#39;s lower respiratory paths. 
         [0069]    At the end of this first inhalation phase, the bellows  64  is emptied of all or some of its air, and its volume is reduced. 
         [0070]    During a first exhalation phase illustrated in  FIG. 7 , the switch  58  is still not actuated, so that the pressure generator  60  is still not connected to the valve  40 , while the means M′ automatically control the second solenoid valve  68  so as to no longer connect the bellows  64  to the valve  40 . 
         [0071]    No more pressure is then applied on the membrane  48 , which thus opens the outlet opening  38 . 
         [0072]    The flow of air F 2  exhaled by the patient  12  rises through the trachea  22 , penetrates the cannula  26 , and emerges toward the outside through the outlet opening  38  and the outlet opening  46  of the housing  42 . 
         [0073]    Windows  74  ( FIG. 6 ) are formed at the end  44  of the exhalation circuit  30 , around the outlet opening  38 , so as to allow the exit of the exhaled air flow F 2 . 
         [0074]    During this first exhalation phase, the outside air is “aspirated” in the air intake conduit  65  toward the bellows  64 , which “inflates” again using the motor  67 . 
         [0075]    During this first exhalation phase, the patient  12  cannot speak. 
         [0076]    When the patient  12  wishes to express himself, he actuates the switch  58 , which allows the first solenoid valve  56  to connect the pressure generator  60  to the valve  40 . 
         [0077]    Thus, during a second inhalation phase shown in  FIG. 8 , the pressure generator  60  delivers a flow of air F 1 ′ that is added to the flow of air F 1  delivered by the ventilator  36  so as to cover the outlet opening  38  while allowing the flow of air F 1  to circulate through the inhalation circuit  28  as far as the trachea  22  of the patient  12 . 
         [0078]    During a second exhalation phase illustrated in  FIG. 9 , the switch  58  is still actuated so as to close the outlet opening  38  by the flow of air F 1 ′, thereby forming an obstacle to the passage of the flow of air F 3  exhaled by the patient  12  through the exhalation circuit  30 . 
         [0079]    The patient  12  can thus use the exhaled flow of air F 3 , which escapes exclusively between the trachea  22  and the tracheotomy cannula  26 , so as to vibrate his vocal cords  20  and therefore speak. 
         [0080]    By closing the exhalation circuit  30 , the exhalation can only be done through the upper respiratory paths, and the patient can regain a normal exhalation phonation. 
         [0081]    If the patient  12  no longer wishes to speak or if he feels a pulmonary hyperinflation, he need only release the switch  58 . 
         [0082]    According to a second embodiment of the invention shown in  FIG. 10 , the inhalation  28  and exhalation  30  circuits are separate from one another and are each formed by a respective tube  76 ,  78 . 
         [0083]    The tubes  76 ,  78  come together to form a single tube  79  connected to the tracheotomy cannula  26 . 
         [0084]    The end portion of the exhalation circuit  30  comprising the valve  40  and the pressure generator  60  are integrated inside the ventilator  36 . 
         [0085]    A single solenoid valve  80  connected to the valve  40  is incorporated in the ventilator  36  so as to be under the dual control of the ventilator  36  by the control means M′, and the patient  12  by the switch  58 . To that end, the solenoid valve  80  is connected selectively to the bellows  64  by the control means M′ and to the pressure generator  60  by the switch  58 , for example using a jack  82 . 
         [0086]    A third embodiment of the invention is illustrated in  FIG. 11  and differs from the second embodiment of  FIG. 10  in that the solenoid valve  80  is under the control of the ventilator  36  by the control means M′, which in turn are under the control of the patient  12  by the switch  58 . 
         [0087]    The control means M′ generally comprise a CPU (Central Processing Unit) card, flow rate and pressure sensors, and a control card of the motor  67 . 
         [0088]    The switch  58  can assume any form adapted to the patient  12 , for example a push button or a manual contactor adapted for patients having a motor handicap. 
         [0089]    The valve  40  previously described comprises a membrane  48 , but it is entirely possible to replace the membrane with a cuff adapted to inflate/deflate under the effect of pressure so as to cover/free the outlet opening  38 . 
         [0090]    Alternatively, the valve  40  is formed by a non-pneumatic electromechanical system adapted to close/free the outlet opening  38 . In that case, the solenoid valve  80  is eliminated and the electromechanical system is directly connected to the control means M′. 
         [0091]    The ventilator  36  can be of any type, for example a type operating with a turbine in place of the bellows  64  and the motor  67 , as shown in  FIGS. 12 and 13 . 
         [0092]      FIG. 12  illustrates a fourth embodiment of the invention that differs from the third embodiment of  FIG. 11  in that the bellows  64  and the motor  67  are replaced by a continuous turbine  84 . 
         [0093]    In that case, the valve  66 A is also eliminated. 
         [0094]    During the inhalation phase, the turbine  84  delivers a flow of air to the patient  12  with a pressure Pi at the outlet of the turbine  84 , while the means M′ automatically control the solenoid valve  80  so as to connect the turbine  84  to the valve  40  and thereby cover the outlet opening  38  with a pressure corresponding to Pi. 
         [0095]    During the exhalation phase, the turbine  84  still delivers a flow of air, but that flow of air is deflected relative to the inhalation circuit  28  by bypass means (not shown) of the turbine  84 . The inhalation circuit  28  is therefore no longer supplied. 
         [0096]    Still during the exhalation phase, the solenoid valve  80 , under the control of the control means M′, allows the pressure generator  60  to power the valve  40  at a predetermined pressure Pe that can vary from 0 to a value equal to or greater than Pi. In this way, the valve  40  can only open and free the outlet opening  38  when the patient  12  creates an overpressure in the exhalation circuit  30  greater than Pe. 
         [0097]    As long as the pressure generated by the patient  12  in the exhalation circuit  30  is below Pe, the air exhaled by the patient  12  cannot emerge toward the outside through the outlet opening  38  and the patient  12  can use all of the exhaled air to speak. 
         [0098]    When the pressure generated by the patient  12  in the exhalation circuit  30  is greater than or equal to Pe, the air exhaled by the patient  12  can emerge partially toward the outside through the outlet opening  38 , and thus, part of the air exhaled by the patient  12  is not usable for phonation. 
         [0099]    When Pe is null, phonation is not possible because the valve  40  is open and practically all of the flow of air exhaled by the patient  12  emerges to the outside through the outlet opening  38 . This adjustment to a null Pe is generally used in the case where the patient  12  suffers from neuromuscular pathologies, since it makes it possible, with constant mechanical ventilation, to deliver a flow of air to the patient  12  with a relatively low pressure Pi that is therefore better tolerated by the patient  12 . 
         [0100]    When the patient  12  wishes to speak, he actuates the switch  58 , which allows the control means M′ to automatically adjust the pressure supplied by the pressure generator  60  to a value Pe&#39; greater than Pe. The value of Pe&#39; is predefined optimally so as to keep the outlet opening  38  hermetic during the exhalation phase and to thereby ensure the best phonation possible. If Pe is null, the phonation that was not possible during the exhalation phase becomes possible. 
         [0101]    Thus, during the exhalation phase and when he actuates the switch  58 , the patient  12  can generate an exhaled flow of air with a higher exhalation pressure than when he does not actuate the switch  58 , with a maximum threshold corresponding to the pressure Pe′ supplied by the pressure generator  60 , without creating leaks toward the outlet opening  38 . The patient  12  can then speak with greater intensity. 
         [0102]    A fifth embodiment of the invention is shown in  FIG. 13  and differs from the fourth embodiment of  FIG. 12  in that the pressure generator  60  and the bypass means of the turbine  84  are eliminated. 
         [0103]    During the inhalation phase, the turbine  84  delivers a flow of air to the patient  12  with a pressure Pi at the outlet of the turbine  84 , while the means M′ automatically control the solenoid valve  80  so as to connect the turbine  84  to the valve  40  and thereby cover the outlet opening  38  with a pressure corresponding to Pi. 
         [0104]    During the exhalation phase, the turbine  84  is still connected to the valve  40  and delivers, both to the patient  12  and the valve  40 , a pressure Pe lower than or equal to the pressure Pi. In fact, unlike the embodiment of  FIG. 12 , the inhalation circuit  28  is continuously powered and the turbine  84  can maintain a minimum pressure in the inhalation  28  and exhalation  30  circuits at a value corresponding to the pressure Pe in the valve  40 , to within the pressure losses in the inhalation and exhalation circuits  28 ,  30 . 
         [0105]    If, during the exhalation phase, the patient  12  does not add any overpressure to the pressure generated by the turbine  84 , overpressure that would make it possible to have an exhalation pressure greater than the pressure Pe in the valve  40 , then the air produced both by the turbine  84  and the patient  12  during the exhalation phase escapes solely between the trachea  22  and the cannula  26  and can therefore be completely used for phonation. 
         [0106]    If the patient  12 , while exhaling, makes it possible to have an exhalation pressure greater than Pe, part of the air exhaled by the patient  12  then emerges toward the outside through an outlet opening  38  and is not used for phonation. 
         [0107]    If the pressure Pe adjusted by a prescriber on the turbine  84  is null, phonation is not possible because the valve  40  is open and practically all of the flow of air exhaled by the patient  12  emerges to the outside through the outlet opening  38 . This adjustment to a null Pe is generally used in the case where the patient  12  suffers from neuromuscular pathologies as it makes it possible, with constant mechanical ventilation, to deliver a flow of air to the patient  12  with a relatively low pressure Pi that is therefore better tolerated by the patient  12 . 
         [0108]    When the patient  12  wishes to speak, he actuates the switch  58 , which allows the control means M′ to adjust the pressure applied by the turbine  84  to the valve  40  to a value Pe&#39; greater than Pe. The value of Pe′ is predetermined optimally, at most equal to Pi, so as to keep the outlet opening  38  hermetic during the exhalation phase and to thereby ensure the best possible phonation. In this way, the patient  12  can speak. 
         [0109]    The invention therefore proposes a simple device that makes it possible to facilitate the respiration and speech upon exhalation of a ventilated tracheotomy patient by increasing the pressure level necessary to open the exhalation circuit selectively using a switch, thereby making it possible to increase the intensity of the voice. 
         [0110]    In fact, the device forms both an inhalation/exhalation circuit when the patient does not wish to speak, and only an inhalation circuit to restore phonation, preventing or at least reducing the dehydration of his respiratory paths. 
         [0111]    The patient can therefore simply and easily, without assistance from a third party, go from an exhalation situation through the upper respiratory paths when he wishes to speak, to an exhalation situation through the tracheotomy cannula when he does not wish to speak. 
         [0112]    The device according to the invention thus gives the patient more autonomy, which is an advantage in particular for ventilated tracheotomy patients at home.