Abstract:
A swallowing stimulation system has a swallowing stimulator for use in triggering an act of swallowing in a patient. The swallowing system has an operating unit including operating elements for receiving user inputs, whereby the operating elements are allocated to different possible physical properties of a food, such that a user can allocate a particular food by means of the operating elements to at least one of at least two categories. The operating unit is designed to generate a control signal corresponding to a user input for the swallowing stimulator, and the swallowing stimulator is designed so that a stimulus for triggering an act of swallowing is formed in response to the control signal.

Description:
RELATED APPLICATION 
       [0001]    This patent application claims the benefit of U.S. Provisional Patent Application No. 61/264,854, filed on Nov. 30, 2009, which is hereby incorporated by reference in its entirety. 
     
    
     TECHNICAL FIELD 
       [0002]    The invention relates to the field of neuro-muscular stimulation, and in particular, to a swallowing stimulation system. 
       BACKGROUND 
       [0003]    Swallowing stimulation systems are known in principle. They help patients who have swallowing disorders in which the triggering of the swallowing reflex is disturbed, but the swallowing reflex itself is usually preserved. In a healthy person, the shaping of the so-called food bolus at the end of the chewing process triggers the swallowing reflex by pressure of the masticated food exerted by the tongue against the palate. In a swallowing stimulation system, a sensor unit may be provided to recognize the formation of the food bolus by the tongue and then send an output signal to a swallowing stimulator which triggers the patient&#39;s swallowing reflex through a corresponding stimulus. 
         [0004]    One difficulty that arises in practice is that the properties of the respective foods and accordingly the preparation of the foods in the mouth before swallowing differ greatly. For example, in a healthy person, a liquid such as a beverage flows quickly down the throat without any chewing action and the swallowing reflex is triggered. A piece of bread, however, is masticated in the mouth, softened and already predigested by a chewing action before the act of swallowing is triggered. Zwieback differs from a fresh piece of brown bread by its dry, mealy, crumbly consistency. This results in a different act of chewing and, in a healthy person, also a different act of swallowing. Thus, what is needed is a swallowing stimulation system that will take into account the variety of foods or beverages ingested. 
       SUMMARY 
       [0005]    A swallowing stimulation system includes a patient device in the form of an operating unit, having operating elements to receive user input, such that the operating elements are assigned to different possible physical properties or consistencies of a food, so that a user can assign a particular food to at least one of at least two categories, according to its consistency. The operating unit is used to generate a control signal corresponding to user input for a swallowing stimulator. The swallowing stimulator forms a stimulus for triggering the act of swallowing in response to the control signal. The swallowing stimulator may also be connected to a sensor unit designed to detect the formation of a food bolus by a patient&#39;s tongue and to send a corresponding output signal to the swallowing stimulator, such that the swallowing stimulator then forms a corresponding stimulus for triggering the act of swallowing. 
         [0006]    In the swallowing stimulator system, different parameter sets are preferably provided, optimally tailored to different foods, the particular preparation required in the patient&#39;s mouth and the triggering of the swallowing act and its optimization. The parameter sets preferably define different stimulation programs. Various parameter sets or stimulation programs need not be selected explicitly by the patient. The swallowing stimulator is instead designed to select a suitable parameter set or a suitable stimulation program as a function of the control signal generated by the operating unit. 
         [0007]    By using the operating elements, the patient need only make entries about the consistency of the particular foods ingested, and in this way the patient can easily select a particular stimulation program suitable for different foods via the operating unit and transmit this to the stimulator. Different stimulation programs are defined by parameter sets, and each parameter set is assigned to one operating element. 
         [0008]    A preferred swallowing stimulation system is one in which various parameter sets are stored in the operating unit, assigned to the operating elements, and in which the operating unit is designed to transmit a respective parameter set to the swallowing stimulator or the sensor unit or both after operation of an operating element by a user. Alternatively, the parameter sets may also be stored in the swallowing stimulator, and the operating unit may be designed to transmit only one control signal characterizing the user input to the swallowing stimulator, which then retrieves a control set stored in the swallowing stimulator. 
         [0009]    The operating unit preferably has a graphic display and is designed to display icons symbolizing a physical property of foods on the display screen. The display is preferably a touch screen. A section of the touch screen assigned to an icon shown on the display then forms a particular operating element, which is activated by touching the display screen in the corresponding section. It is advantageous if the operating unit is designed to interpret double-clicking on a section of the display that forms a particular operating element as activation of this operating element in order to avoid inadvertent operation. 
         [0010]    The present disclosure is also directed to a method for operating a swallowing stimulation system having a swallowing stimulator, which is designed for triggering an act of swallowing in a patient, whereby, the swallowing system has an operating unit with operating elements for receiving user inputs, whereby the operating elements are assigned to different possible physical properties of a food, such that a user can assign the particular food by means of the operating elements to at least one of at least two categories according to its consistency, the operating unit is designed to generate a control signal for the swallowing stimulator corresponding to the user input, and the swallowing stimulator is designed so that a stimulus for triggering an act of swallowing is triggered or formed as a function of the control signal. 
     
    
     
       DESCRIPTION OF THE DRAWINGS 
         [0011]    The present invention will now be explained in greater detail on the basis of exemplary embodiments with reference to the figures. In the figures: 
           [0012]      FIG. 1  shows a swallowing stimulation system having a swallowing stimulator and a patient device attached to the patient&#39;s wrist; 
           [0013]      FIG. 2  shows a patient device for a swallowing stimulator; 
           [0014]      FIG. 3  shows an example of a first variant of a user interface of the patient device; 
           [0015]      FIG. 4   a  shows pairs of properties describing the physical nature of food spanning a coordinate plane; 
           [0016]      FIG. 4   b  shows pairs of properties describing the physical nature of food as spanning a coordinate space; 
           [0017]      FIG. 5  shows an example of a second variant of a user interface of the patient device; 
           [0018]      FIG. 6  shows an example of a third variant of a user interface of the patient device; 
           [0019]      FIG. 7  shows an example of a fourth variant of a user interface of the patient device; 
           [0020]      FIG. 8  shows diagrams with parameters for a mode for drinking; and 
           [0021]      FIG. 9  shows diagrams with parameters for a mode for swallowing mashed food. 
       
    
    
     DETAILED DESCRIPTION 
       [0022]    With reference to  FIGS. 1 and 2 ,  FIG. 1  shows a swallowing stimulation system  35  having an implantable swallowing stimulator  40 , an implantable sensor unit  45 , which is wirelessly connected to the swallowing stimulator  40  and to an operating unit  50 , which may be worn as a patient device on a patient&#39;s wrist  52 . The operating unit  50  is able to communicate not only with the swallowing stimulator  40  but also with a remote service center  55  by way of a radio connection (e.g., mobile telephone). The sensor unit  45  serves as a triggering unit for the swallowing stimulator  40 , both of which may be accommodated jointly in one device and may receive or provide their information via suitably positioned electrodes. Sensor unit  45  and stimulator  40  may also be embodied as two separate units communicating wirelessly, or via hard-wired electrodes, as suggested in  FIG. 1 . The operating unit  50  for the swallowing stimulation system  35 , as shown in  FIG. 2 , contains a communication unit for the stimulator system  35  and a communication unit for communicating with the remote service center  55 . The operating unit  50  has a display screen  57 , preferably touch-sensitive, which at the same time represents the operating elements of the operating unit. Furthermore, the operating unit  50  may be provided with a wristband  58  so that operating unit  50 , may be worn on the patient&#39;s wrist  52  in the manner of a wristwatch. 
         [0023]    Different stimulation parameters may be used, depending on the foods to be ingested. Stimulation parameters for the swallowing stimulator  40 , for use in recognizing when the chewing procedure is concluded may include, for example:
       a threshold value to detect the pressure of the tongue against the palate,   the number of pressure cycles until triggering of the swallowing reflex should occur,   morphological properties of the pressure against the palate, e.g.,
           steepness of the rise and drop in pressure,   duration of the maximum pressure, and   time between chewing motions.   
           delay time between detection of formation of the food bolus and delivery of the stimulation pulse,   the stimulation pulse amplitude,   the stimulation pulse length,   number of pulses to be delivered,       
 
         [0034]    Type of pulse: current-controlled or voltage-controlled, 
         [0035]    Type of behavior if a stimulation pulse was not successful (non-capture):
       renewed delivery of a (stronger) stimulation pulse,   no renewed delivery of a stimulation pulse.
 
Parameter sets for particular sensing and stimulation patterns may be stored in one or more system components, namely operating unit  50 , sensor unit  45  and implantable swallowing stimulator  40 .
       
 
         [0038]    In a first variant of operating unit  50  shown in  FIG. 3 , a number of different operating elements are displayed on the touch display screen  57 , represented here by four exemplary icons  110 - 140 . Each icon symbolizes a certain food or its most important physical properties, with regard to chewing and swallowing, that preferably may be selected by touching the icon. For example, a first icon  110  symbolizes a beverage; a second icon  120  symbolizes a raw vegetable such as a carrot; a third icon  130  symbolizes meat, for example, a steak; and a fourth icon  140  symbolizes a soft food like ice cream. Coupled with each icon is a suitable parameter set for the swallowing stimulator  40 , which is either stored in the operating unit  50 , where it is assigned to a particular icon and is transmitted to the swallowing stimulator  40  when selected, or a command that is transmitted to the swallowing stimulator  40  and selects the respective parameter set stored in the stimulator  40 . The advantage of this variant is that it is simple to implement, and the display screen  57  needs only one key field per parameter set or icon, i.e., four fields are needed for the example shown in  FIG. 3 . 
         [0039]    To avoid inadvertent misadjustment of a particular selected program, suitable mechanisms, e.g., double-clicking, may be provided, i.e., the operating unit  50  may be designed to detect double-clicking on a corresponding icon and to interpret that as user input. Likewise, the control signals assigned to a user input are transmitted to the swallowing stimulator  40  using known security mechanisms, e.g., checksums. 
         [0040]      FIG. 4  shows an example of different physical properties of foods. If two pairs of food properties are plotted on orthogonal axes, it is possible to span a coordinate plane, and if three pairs of food properties are plotted on orthogonal axes it is possible to span a volumetric space. Two pairs may be displayed directly on the plane of the touch display screen  57 . Three or more pairs may be implemented by suitable interfacing, e.g., through multiple displays, additional buttons, slide bar controls, and the like. As the examples used here, SOLID and LIQUID may be mentioned here as a pair of food properties as well as BRITTLE and TOUGH/SMOOTH. Other pairs may include HOT and COLD. Other pairs of properties are also conceivable. 
         [0041]      FIG. 5  shows two of these pairs of food properties: a first pair  210 / 220 , and a second pair  230 / 240 , arranged in a two-dimensional coordinate space, on the touch display screen  57  of the operating unit  50 . Bi-directional arrows  250  indicate an operating element in the form of a continuum along each orthogonal axis of the coordinate space, which is spanned in a two-dimensional form. Combinations of properties may be selected by a cursor  260 . 
         [0042]    To further simplify user selection, certain icons representing foods may be placed directly on the coordinate plane according to their fundamental properties, as shown in  FIG. 6 . An advantage in comparison with the method of selection shown in  FIG. 3  is that the food properties on which the icons are based are immediately discernible and serve as landmarks to orient the user, as an improvement over the display shown in  FIG. 5 . Another advantage is that the user can immediately perform fine adjustments of the stimulation program. For example, the user may optimize the consumption of a vegetable soup by pressing not on the mug but instead at a point slightly more toward the center, to indicate a more solid, more brittle substance, depending on the ingredients of the soup. 
         [0043]    The swallowing stimulation system  35  disclosed herein thus offers a simple choice between suitable parameter sets which are optimally coordinated for different foods, the required preparation in the patient&#39;s mouth, and the triggering of the act of swallowing and its optimization. 
         [0044]    The patient may simply select a particular program suitable for different foods by way of the operating unit as an external device, and by transmitting this to the swallowing stimulator  40 . This allows a selection of stored parameter sets also in addition to “ad hoc” adjustments. 
         [0045]      FIG. 7  shows a further variant of the user interface shown in  FIG. 3 . Icons shown in  FIG. 7  represent physical properties of the food such as, for example, liquid  110 , mashed  150 , solid  130  and smooth  140 . The variant shown in  FIG. 7  will be used to describe exemplarily drinking and the swallowing of mashed food. The following table presents an overview of potentially relevant parameters and their range of values: 
         [0000]    
       
         
               
             
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Swallowing Stimulator Parameter Values 
               
               
                 Parameter Set needed for the Swallowing Stimulator 
               
             
          
           
               
                 Preset 
                 Preset 
                   
                 Possible 
                   
               
               
                 Parameters 
                 Value 
                 Dimension 
                 Values 
                 Comment 
               
               
                   
               
               
                 P_Min 
                  0.5-20 typical 
                 [N/cm 2 ] 
                 0 . . . n 
                 Minimal Pressure to start 
               
               
                   
                   
                   
                   
                 T_P_Min time window 
               
               
                 Chew_Count_Min 
                    1-20 typical 
                 — 
                 0 . . . n 
                 Number of chews to detect 
               
               
                   
                   
                   
                   
                 before swallowing is 
               
               
                   
                   
                   
                   
                 triggered by stimulation 
               
               
                   
                   
                   
                   
                 pulse 
               
               
                 T_P_Min 
                  50-1000 typical 
                 [ms] 
                 0 . . . n 
                 Minimal time where 
               
               
                   
                   
                   
                   
                 pressure must be above 
               
               
                   
                   
                   
                   
                 P_Min to count as a chew 
               
               
                 T_Chew_Max 
                    1-20 typical 
                 [ms] 
                 0 . . . n 
                 Maximum time between to 
               
               
                   
                   
                   
                   
                 chews 
               
               
                 T_Stim_Delay 
                  10-1000 typical 
                 [ms] 
                 0 . . . n 
                 Time between detection of 
               
               
                   
                   
                   
                   
                 Chew_Count_Min and 
               
               
                   
                   
                   
                   
                 stimulation pulse delivery 
               
               
                 Pulse_Type 
                 V or C 
                 — 
                 V, C 
                 V = Voltage_Control, C = 
               
               
                   
                   
                   
                   
                 Current_Control 
               
               
                 U_Stim 
                  0.5-20 typical 
                 [V] 
                 0 . . . n 
                 Voltage of Stimulation Pulse 
               
               
                   
                   
                   
                   
                 (when Pulse_Type = V) 
               
               
                 I_Stim 
                  0.01-20 typical 
                 [mA] 
                 0 . . . n 
                 Current of Stimulation Pulse 
               
               
                   
                   
                   
                   
                 (when Pulse_Type = C) 
               
               
                 T_Stim 
                 0.01-100 typical 
                 [ms] 
                 0 . . . n 
                 Length of stimulation pulse 
               
               
                 Count_Stim 
                    1-20 typical 
                 — 
                 0 . . . n 
                 Number of stimulation 
               
               
                   
                   
                   
                   
                 pulses to be delivered as a 
               
               
                   
                   
                   
                   
                 train 
               
               
                 T_Capture_Delay_Max 
                   1-500 typical 
                 [ms] 
                   
                 Maximum time after pulse 
               
               
                   
                   
                   
                   
                 delivery by which a capture 
               
               
                   
                   
                   
                   
                 must be detected. 
               
               
                 U_Capture_Detect_Min 
                  0.01-20 typical 
                 [mV] 
                   
                 Min EMG voltage measured 
               
               
                   
                   
                   
                   
                 by electrode to start 
               
               
                   
                   
                   
                   
                 T_Capture_Detect time 
               
               
                   
                   
                   
                   
                 window 
               
               
                 T_Capture_Detect_Min 
                    1-20 typical 
                 [ms] 
                   
                 Minimal time where 
               
               
                   
                   
                   
                   
                 U_EMG must be above 
               
               
                   
                   
                   
                   
                 U_Capture_Detect_Min to 
               
               
                   
                   
                   
                   
                 count as a successful 
               
               
                   
                   
                   
                   
                 stimulation 
               
               
                 T_Capture_Delay 
                  0.1-200 typical 
                 [ms] 
                   
                 Time after pulse delivery, 
               
               
                   
                   
                   
                   
                 waiting for 
               
               
                   
                   
                   
                   
                 Capture_Detected = TRUE 
               
               
                 Back_Up_Pulse 
                 On/Off 
                 — 
                 On/Off 
                 If first pulse was not 
               
               
                   
                   
                   
                   
                 successful, deliver another? 
               
               
                 U_Stim_BU 
                  0.5-20 typical 
                 [V] 
                 0 . . . n 
                 Voltage of Back-Up 
               
               
                   
                   
                   
                   
                 Stimulation Pulse Pulse 
               
               
                   
                   
                   
                   
                 (when Pulse_Type = V AND 
               
               
                   
                   
                   
                   
                 Back_Up_Pulse = On) 
               
               
                 I_Stim_BU 
                  0.01-20 typical 
                 [mA] 
                 0 . . . n 
                 Current of Back-Up 
               
               
                   
                   
                   
                   
                 Stimulation Pulse Pulse 
               
               
                   
                   
                   
                   
                 (when Pulse_Type = C AND 
               
               
                   
                   
                   
                   
                 Back_Up_Pulse = On) 
               
               
                 Use_Morphology 
                 On/Off 
                 On/Off 
                   
                 Use of P curve shape, e.g. 
               
               
                   
                   
                   
                   
                 speed of pressure rise/fall 
               
               
                 Vel_P_Rise_Min 
                  0.1-200 
                 [N/cm 2 s] 
                 0 . . . n 
                 Minimum speed with which 
               
               
                   
                   
                   
                   
                 pressure rises (when 
               
               
                   
                   
                   
                   
                 Use_Morphology = On) 
               
               
                 Vel_P_Fall_Min 
                  0.1-200 
                 [N/cm 2 s] 
                 0 . . . n 
                 Minimum speed with which 
               
               
                   
                   
                   
                   
                 pressure drops (when 
               
               
                   
                   
                   
                   
                 Use_Morphology = On) 
               
               
                   
               
             
          
         
       
     
         [0046]    Table 2 gives an overview of measured values and the sources from which they are derived: 
         [0000]    
       
         
               
             
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 Sources of swallowing stimulator parameter values 
               
             
          
           
               
                 Measured &amp; 
                   
                   
                   
                   
               
               
                 Derived 
                   
                   
                 Possible 
               
               
                 Parameters 
                   
                 Dimension 
                 Values 
                 Comment 
               
               
                   
               
               
                 P 
                 Measured 
                 [N/cm 2 ] 
                   
                 Pressure against palate 
               
               
                 T_P 
                 Measured 
                 [s] 
                   
                 Measured time with P &gt; 
               
               
                   
                   
                   
                   
                 P_min 
               
               
                 Vel_P_Rise 
                 Measured 
                 [N/cm 2 s] 
                 0 . . . n 
                 Speed with which pressure 
               
               
                   
                   
                   
                   
                 rises (when 
               
               
                   
                   
                   
                   
                 Use_Morphology = On) 
               
               
                 Vel_P_Fall 
                 Measured 
                 [N/cm 2 s] 
                 0 . . . n 
                 Speed with which pressure 
               
               
                   
                   
                   
                   
                 drops (when 
               
               
                   
                   
                   
                   
                 Use_Morphology = On) 
               
               
                 Chew_Detect 
                 Derived from 
                 — 
                 FALSE 
                 Chew has been detected 
               
               
                   
                 T_Chew_max, 
                   
                 or 
               
               
                   
                 P_Min, 
                   
                 TRUE 
               
               
                   
                 T_P_Min 
               
               
                 Chew_Count 
                 Derived from 
                 — 
                   
                 Increased by 1 when P &gt; 
               
               
                   
                 P and 
                   
                   
                 P_Min for more than 
               
               
                   
                 T_P_Min 
                   
                   
                 T_P_Min 
               
               
                 T_Chew 
                 Measured 
                 [s] 
                 0 . . . n 
                 Time between two increases 
               
               
                   
                   
                   
                   
                 of Chew_Count, must be &lt; 
               
               
                   
                   
                   
                   
                 T_Chew_max to count the 
               
               
                   
                   
                   
                   
                 chews as one action 
               
               
                 U_EMG 
                 Measured 
                 [mV] 
                   
                 Electrical recording of 
               
               
                   
                   
                   
                   
                 muscle activity at electrode 
               
               
                 Capture_Detected 
                 Derived from 
                 — 
                 FALSE 
                 Set when U_EMG &gt; 
               
               
                   
                 U_EMG 
                   
                 or 
                 U_Capture_Detect_Min for 
               
               
                   
                   
                   
                 TRUE 
                 more than 
               
               
                   
                   
                   
                   
                 T_Capture_Detect_Min 
               
               
                   
               
             
          
         
       
     
         [0047]      FIG. 8  shows diagrams for stimulating drinking. It should be mentioned that it is assumed that the swallowing behaviour for “dry swallowing” and drinking are the same. Therefore the following parameter set should be adequate for “dry swallowing,” clearance of saliva and drinking. Therefore the parameter P_Min, describing the minimum pressure of the tongue against sensor  45  to start the T_P_Min time window in which P_Min must be exceeded, shown in  FIG. 8  on the upper ordinate is set to a value of about 2 N/cm 2 . To trigger the swallowing the pressure P_Min has to exceed during the time window T_P_Min, which is true for  FIG. 8 . Due to the patient&#39;s choice of swallowing a liquid the Count_Chew_min parameter describing the minimum of chews before swallowing, is set to 1, while a chew is detected as described above by the pressure of the tongue to sensor  45  which exceeds P_Min for at least a time window T_P_Min. The stimulation of the swallowing process is delayed by the adjustable time T_Stim_Delay which is patient dependent and for example between 10 ms and 1000 ms, preferably about 0.6 s. 
         [0000]    The following parameters are examples to allow the stimulation of a swallowing process of a liquid: 
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 3 
               
             
             
               
                   
               
               
                 Parameter values for an exemplary “Drink” program of a swallowing 
               
               
                 stimulator 
               
               
                 Parameter Set for Mode DRINK (110) 
               
             
          
           
               
                   
                 Preset 
                   
                 Possible 
                   
               
               
                   
                 Value 
                 Dimension 
                 Values 
                 Comment 
               
               
                   
                   
               
             
          
           
               
                 Preset 
                   
                   
                   
                   
               
               
                 Parameters 
               
               
                 P_Min 
                 1.2 
                 [N/cm 2 ] 
                 0 . . . n 
                 Minimal Pressure to start 
               
               
                   
                   
                   
                   
                 T_P_Min time window 
               
               
                 Chew_Count_Min 
                 1 
                 — 
                 0 . . . n 
                 Number of chews to detect 
               
               
                   
                   
                   
                   
                 before swallowing is triggered 
               
               
                   
                   
                   
                   
                 by stimulation pulse 
               
               
                 T_P_Min 
                 0.2 
                 [s] 
                 0 . . . n 
                 Minimal time where pressure 
               
               
                   
                   
                   
                   
                 must be above P_Min to count 
               
               
                   
                   
                   
                   
                 as a chew 
               
               
                 T_Chew_Max 
                 2000 
                 [ms] 
                 0 . . . n 
                 Maximum time between to 
               
               
                   
                   
                   
                   
                 chews 
               
               
                 T_Stim_Delay 
                 0.6 
                 [s] 
                 0 . . . n 
                 Time between detection of 
               
               
                   
                   
                   
                   
                 Chew_Count_Min and 
               
               
                   
                   
                   
                   
                 stimulation pulse delivery 
               
               
                 Pulse_Type 
                 V 
                 — 
                 V, C 
                 V = Voltage_Control, C = 
               
               
                   
                   
                   
                   
                 Current_Control 
               
               
                 U_Stim 
                 5 
                 [V] 
                 0 . . . n 
                 Voltage of Stimulation Pulse 
               
               
                   
                   
                   
                   
                 (when Pulse_Type = V) 
               
               
                 I_Stim 
                 Not 
                 [mA] 
                 0 . . . n 
                 Current of Stimulation Pulse 
               
               
                   
                 applicable 
                   
                   
                 (when Pulse_Type = C) 
               
               
                   
                 here, 
               
               
                   
                 because 
               
               
                   
                 Pulse_Type = V 
               
               
                 T_Stim 
                 5 
                 [ms] 
                 0 . . . n 
                 Length of stimulation pulse 
               
               
                 Count_Stim 
                 1 
                 — 
                 0 . . . n 
                 Number of stimulation pulses to 
               
               
                   
                   
                   
                   
                 be delivered as a train 
               
               
                 T_Capture_Delay_Max 
                 10 
                 [ms] 
                   
                 Maximum time after pulse 
               
               
                   
                   
                   
                   
                 delivery by which a capture 
               
               
                   
                   
                   
                   
                 must be detected. 
               
               
                 U_Capture_Detect_Min 
                 3 
                 [mV] 
                   
                 Min EMG voltage measured by 
               
               
                   
                   
                   
                   
                 electrode to start 
               
               
                   
                   
                   
                   
                 T_Capture_Detect time window 
               
               
                 T_Capture_Detect_Min 
                 10 
                 [ms] 
                   
                 Minimal time where U_EMG 
               
               
                   
                   
                   
                   
                 must be above 
               
               
                   
                   
                   
                   
                 U_Capture_Detect_Min to count 
               
               
                   
                   
                   
                   
                 as a successful stimulation 
               
               
                 T_Capture_Delay 
                 10 
                 [ms] 
                   
                 Time after pulse delivery, 
               
               
                   
                   
                   
                   
                 waiting for Capture_Detected = 
               
               
                   
                   
                   
                   
                 TRUE 
               
               
                 Back_Up_Pulse 
                 On 
                 — 
                 On/Off 
                 If first pulse was not successful, 
               
               
                   
                   
                   
                   
                 deliver another? 
               
               
                 U_Stim_BU 
                 7 
                 [V] 
                 0 . . . n 
                 Voltage of Back-Up Stimulation 
               
               
                   
                   
                   
                   
                 Pulse Pulse (when Pulse_Type = 
               
               
                   
                   
                   
                   
                 V AND Back_Up_Pulse = On) 
               
               
                 I_Stim_BU 
                 Not 
                 [mA] 
                 0 . . . n 
                 Current of Back-Up Stimulation 
               
               
                   
                 applicable, 
                   
                   
                 Pulse Pulse (when Pulse_Type = 
               
               
                   
                 because 
                   
                   
                 C AND Back_Up_Pulse = On) 
               
               
                   
                 Pulse_Type = V 
               
               
                 Use_Morphology 
                 Off 
                 On/Off 
                   
                 Use of P curve shape, e.g. speed 
               
               
                   
                   
                   
                   
                 of pressure rise/fall 
               
               
                 Vel_P_Rise_Min 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Minimum speed with which 
               
               
                   
                 needed 
                   
                   
                 pressure rises (when 
               
               
                   
                 because 
                   
                   
                 Use_Morphology = On) 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Vel_P_Fall_Min 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Minimum speed with which 
               
               
                   
                 needed 
                   
                   
                 pressure drops (when 
               
               
                   
                 because 
                   
                   
                 Use_Morphology = On) 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Measured 
               
               
                 Derived 
               
               
                 Parameters 
               
               
                 P 
                 Measured 
                 [N/cm 2 ] 
                   
                 Pressure against palate 
               
               
                 T_P 
                 Measured 
                 [s] 
                   
                 Measured time with P &gt; P_min 
               
               
                 Vel_P_Rise 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Speed with which pressure rises 
               
               
                   
                 applicable, 
                   
                   
                 (when Use_Morphology = On) 
               
               
                   
                 because 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Vel_P_Fall 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Speed with which pressure drops 
               
               
                   
                 applicable, 
                   
                   
                 (when Use_Morphology = On) 
               
               
                   
                 because 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Chew_Detect 
                 Derived 
                 — 
                 FALSE 
                 Chew has been detected 
               
               
                   
                 from 
                   
                 or TRUE 
               
               
                   
                 T_Chew_max, 
               
               
                   
                 P_Min, 
               
               
                   
                 T_P_Min 
               
               
                 Chew_Count 
                 Derived 
                 — 
                   
                 Increased by 1 when P &gt; P_Min 
               
               
                   
                 from P 
                   
                   
                 for more than T_P_Min 
               
               
                   
                 and 
               
               
                   
                 T_P_Min 
               
               
                 T_Chew 
                 Measured 
                 [s] 
                 0 . . . n 
                 Time between two increases of 
               
               
                   
                   
                   
                   
                 Chew_Count, must be &lt; 
               
               
                   
                   
                   
                   
                 T_Chew_max to count the 
               
               
                   
                   
                   
                   
                 chews as one action 
               
               
                 U_EMG 
                 Measured 
                 [mV] 
                   
                 Electrical recording of muscle 
               
               
                   
                   
                   
                   
                 activity at electrode 
               
               
                 Capture_Detected 
                 Derived 
                 — 
                 FALSE 
                 Set when U_EMG &gt; 
               
               
                   
                 from 
                   
                 or TRUE 
                 U_Capture_Detect_Min for 
               
               
                   
                 U_EMG 
                   
                   
                 more than 
               
               
                   
                   
                   
                   
                 T_Capture_Detect_Min 
               
               
                   
               
             
          
         
       
     
         [0048]    If the user selects the program “Drink” by touching the corresponding beverage icon  110  on the touch display screen  57  of operating unit  50 , the above parameter set for “Drink”  110  is loaded and the stimulation program is started: 
         [0000]    The program waits to detect a chew by waiting for a minimum pressure P_Min to appear for at least the time T_P_Min at the site of the pressure sensor  45 . When that happens Chew_Count is increases from 0 to 1. 
         [0049]    A delay time T_Stim_Delay is given to allow the liquid to be moved into the throat. Then the stimulation pulse is delivered at the site of swallowing stimulator  40 . 
         [0000]    In this example the stimulation pulse is given to be successful, meaning that it stimulates the superior laryngeal nerve to activate the sphincter muscle. Activation of the sphincter muscle results in an increase of muscle activity which can be detected via electromyography recording EMG. The muscle activity is measured via the implantable sensor unit  45 . If the measured Voltage U_EMG is above U_Capture_Detect_Min for at least the time T_Capture_Detect_Min, a Capture, i.e. successful stimulation of the muscle is detected. Here the swallowing stimulation program terminates. The same or another program for swallowing can be triggered by selecting a food type displayed on the touch display screen  57  of operating unit  50 . 
         [0050]      FIG. 9  shows a diagram for stimulating a swallowing process for mashed food. Therefore the parameter P_Min, describing the minimum pressure of the tongue against sensor unit  45  to start the T_P_Min time window in which P_Min must be exceeded, shown in  FIG. 9  on the upper ordinate is set to a value of about 4 N/cm 2 . To trigger the swallowing the pressure P_Min has to exceed during the time window T_P_Min, which is true for  FIG. 9 . Due to the patients choice of swallowing mashed food the Count_Chew_min parameter describing the minimum of chews before swallowing, is set to 4, while a chew is detected as described above by the pressure of the tongue to sensor unit  45  which exceeds P_Min for at least a time window T_P_Min. The stimulation of the swallowing process is delayed by the adjustable time T_Stim_Delay which is patient dependent and for example between 10 ms and 1000 ms, preferably about 0.6 s. 
         [0051]    The following parameters are examples to allow the stimulation of a swallowing process of mashed food: 
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 4 
               
             
             
               
                   
               
               
                 Parameter values for an exemplary “Mashed Food” program of a 
               
               
                 swallowing stimulator 
               
               
                 Parameter Set for Mode MASHED FOOD (150) 
               
             
          
           
               
                   
                 Preset 
                   
                 Possible 
                   
               
               
                   
                 Value 
                 Dimension 
                 Values 
                 Comment 
               
               
                   
                   
               
             
          
           
               
                 Preset 
                   
                   
                   
                   
               
               
                 Parameters 
               
               
                 P_Min 
                 4 
                 [N/cm 2 ] 
                 0 . . . n 
                 Minimal Pressure to start 
               
               
                   
                   
                   
                   
                 T_P_Min time window 
               
               
                 Chew_Count_Min 
                 4 
                 — 
                 0 . . . n 
                 Number of chews to detect 
               
               
                   
                   
                   
                   
                 before swallowing is triggered 
               
               
                   
                   
                   
                   
                 by stimulation pulse 
               
               
                 T_P_Min 
                 0.2 
                 [s] 
                 0 . . . n 
                 Minimal time where pressure 
               
               
                   
                   
                   
                   
                 must be above P_Min to count 
               
               
                   
                   
                   
                   
                 as a chew 
               
               
                 T_Chew_Max 
                 2000 
                 [ms] 
                 0 . . . n 
                 Maximum time between to 
               
               
                   
                   
                   
                   
                 chews 
               
               
                 T_Stim_Delay 
                 0.6 
                 [s] 
                 0 . . . n 
                 Time between detection of 
               
               
                   
                   
                   
                   
                 Chew_Count_Min and 
               
               
                   
                   
                   
                   
                 stimulation pulse delivery 
               
               
                 Pulse_Type 
                 V 
                 — 
                 V, C 
                 V = Voltage_Control, C = 
               
               
                   
                   
                   
                   
                 Current_Control 
               
               
                 U_Stim 
                 5 
                 [V] 
                 0 . . . n 
                 Voltage of Stimulation Pulse 
               
               
                   
                   
                   
                   
                 (when Pulse_Type = V) 
               
               
                 I_Stim 
                 Not 
                 [mA] 
                 0 . . . n 
                 Current of Stimulation Pulse 
               
               
                   
                 applicable 
                   
                   
                 (when Pulse_Type = C) 
               
               
                   
                 here, 
               
               
                   
                 because 
               
               
                   
                 Pulse_Type = V 
               
               
                 T_Stim 
                 5 
                 [ms] 
                 0 . . . n 
                 Length of stimulation pulse 
               
               
                 Count_Stim 
                 1 
                 — 
                 0 . . . n 
                 Number of stimulation pulses to 
               
               
                   
                   
                   
                   
                 be delivered as a train 
               
               
                 T_Capture_Delay_Max 
                 10 
                 [ms] 
                   
                 Maximum time after pulse 
               
               
                   
                   
                   
                   
                 delivery by which a capture 
               
               
                   
                   
                   
                   
                 must be detected. 
               
               
                 U_Capture_Detect_Min 
                 3 
                 [mV] 
                   
                 Min EMG voltage measured by 
               
               
                   
                   
                   
                   
                 electrode to start 
               
               
                   
                   
                   
                   
                 T_Capture_Detect time window 
               
               
                 T_Capture_Detect_Min 
                 10 
                 [ms] 
                   
                 Minimal time where U_EMG 
               
               
                   
                   
                   
                   
                 must be above 
               
               
                   
                   
                   
                   
                 U_Capture_Detect_Min to count 
               
               
                   
                   
                   
                   
                 as a successful stimulation 
               
               
                 T_Capture_Delay 
                 10 
                 [ms] 
                   
                 Time after pulse delivery, 
               
               
                   
                   
                   
                   
                 waiting for Capture_Detected = 
               
               
                   
                   
                   
                   
                 TRUE 
               
               
                 Back_Up_Pulse 
                 On 
                 — 
                 On/Off 
                 If first pulse was not successful, 
               
               
                   
                   
                   
                   
                 deliver another? 
               
               
                 U_Stim_BU 
                 7 
                 [V] 
                 0 . . . n 
                 Voltage of Back-Up Stimulation 
               
               
                   
                   
                   
                   
                 Pulse Pulse (when Pulse_Type = 
               
               
                   
                   
                   
                   
                 V AND Back_Up_Pulse = On) 
               
               
                 I_Stim_BU 
                 Not 
                 [mA] 
                 0 . . . n 
                 Current of Back-Up Stimulation 
               
               
                   
                 applicable, 
                   
                   
                 Pulse Pulse (when Pulse_Type = 
               
               
                   
                 because 
                   
                   
                 C AND Back_Up_Pulse = On) 
               
               
                   
                 Pulse_Type = V 
               
               
                 Use_Morphology 
                 Off 
                 On/Off 
                   
                 Use of P curve shape, e.g. speed 
               
               
                   
                   
                   
                   
                 of pressure rise/fall 
               
               
                 Vel_P_Rise_Min 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Minimum speed with which 
               
               
                   
                 needed 
                   
                   
                 pressure rises (when 
               
               
                   
                 because 
                   
                   
                 Use_Morphology = On) 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Vel_P_Fall_Min 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Minimum speed with which 
               
               
                   
                 needed 
                   
                   
                 pressure drops (when 
               
               
                   
                 because 
                   
                   
                 Use_Morphology = On) 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Measured 
               
               
                 Derived 
               
               
                 Parameters 
               
               
                 P 
                 Measured 
                 [N/cm 2 ] 
                   
                 Pressure against palate 
               
               
                 T_P 
                 Measured 
                 [s] 
                   
                 Measured time with P &gt; P_min 
               
               
                 Vel_P_Rise 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Speed with which pressure rises 
               
               
                   
                 applicable, 
                   
                   
                 (when Use_Morphology = On) 
               
               
                   
                 because 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Vel_P_Fall 
                 Not 
                 [N/cm 2 s] 
                 0 . . . n 
                 Speed with which pressure drops 
               
               
                   
                 applicable, 
                   
                   
                 (when Use_Morphology = On) 
               
               
                   
                 because 
               
               
                   
                 Use_Morphology = 
               
               
                   
                 Off 
               
               
                 Chew_Detect 
                 Derived 
                 — 
                 FALSE 
                 Chew has been detected 
               
               
                   
                 from 
                   
                 or TRUE 
               
               
                   
                 T_Chew_max, 
               
               
                   
                 P_Min, 
               
               
                   
                 T_P_Min 
               
               
                 Chew_Count 
                 Derived 
                 — 
                   
                 Increased by 1 when P &gt; P_Min 
               
               
                   
                 from P 
                   
                   
                 for more than T_P_Min 
               
               
                   
                 and 
               
               
                   
                 T_P_Min 
               
               
                 T_Chew 
                 Measured 
                 [s] 
                 0 . . . n 
                 Time between two increases of 
               
               
                   
                   
                   
                   
                 Chew_Count, must be &lt; 
               
               
                   
                   
                   
                   
                 T_Chew_max to count the 
               
               
                   
                   
                   
                   
                 chews as one action 
               
               
                 U_EMG 
                 Measured 
                 [mV] 
                   
                 Electrical recording of muscle 
               
               
                   
                   
                   
                   
                 activity at electrode 
               
               
                 Capture_Detected 
                 Derived 
                 — 
                 FALSE 
                 Set when U_EMG &gt; 
               
               
                   
                 from 
                   
                 or TRUE 
                 U_Capture_Detect_Min for 
               
               
                   
                 U_EMG 
                   
                   
                 more than 
               
               
                   
                   
                   
                   
                 T_Capture_Detect_Min 
               
               
                   
               
             
          
         
       
     
         [0052]    To show the functionality of the back-up pulse in the example, the first stimulation pulse shall not be successful, so that the back-up pulse is triggered. The user selects the program “Mashed Food” by selecting the representative fourth icon  140  on the touch display screen  57  of operating unit  50 . The above parameter set for “Mashed Food” is loaded and the stimulation program is started: 
         [0053]    The program waits to detect a chew by waiting for a minimum pressure P_Min to appear for at least the time T_P_Min at the site of the pressure sensor unit  45 . When that happens Chew_Count increases from 0 to 1. The program then waits to detect further chews as described above until Chew_Count=Chew_Count Min, which, in this case, equals 4. 
         [0000]    A delay time T_Stim_Delay is given to allow the food to be moved into the throat.
 
Then a stimulation pulse is delivered via swallowing stimulator  40 .
 
         [0054]    In this example the stimulation pulse is given to be successful, meaning that it stimulates the superior laryngeal nerve to activate the sphincter muscle. Activation of the sphincter muscle results in an increase of muscle activity which can be detected via electromyography recording EMG. This is measured via the implantable sensor unit  45 . If the measured Voltage U_EMG is above U_Capture_Detect_Min for at least the time T_Capture_Detect_Min, a Capture, i.e., a successful stimulation of the muscle is detected. This is not the case in this example. Therefore a back-up stimulation pulse utilizing a higher voltage U_Stim_Bu is delivered. Again, U_EMG is measured and this time it remains above U_Capture_Detect_Min for the minimum time T_Capture_Detect_Min, so that a capture, i.e., successful stimulation of the muscle is detected. Here, the swallowing stimulation program terminates. The same or another program for swallowing may be triggered by selecting a food type displayed on the touch display screen  57  of operating unit  50 . 
       FURTHER EXEMPLARY EMBODIMENTS 
       [0055]    In general the following sequence is conceivable:
   1. The patient ingests food.   2. The patient selects the corresponding food on his patient device, operating unit  50 .   3. Swallowing stimulator  40  is programmed accordingly. The programming parameters are described above.   4. The patient ingests food, the stimulator  40  stimulates a corresponding act of swallowing.   5. If the same food is consumed again, renewed operation of the patient device, operating unit  50 , is not necessary.   6. If another food is ingested, the procedure is repeated starting with step 2.   
 
       Exemplary Embodiment 1 
     The Patient Drinks Hot Tea 
       [0000]    
       
         1. The food to be ingested is liquid. 
         2. The food to be ingested is (very) hot.
 
Exemplary embodiment 1 yields the following conclusions:
       Because the food is liquid, it need not be chewed.   If the liquid is ingested while very hot, it is cooled because of either the simultaneous intake of air (sipping) or because of the subsequent intake of air (drinking).   This food will not form a food bolus in swallowing but instead, it flows down the esophagus as liquid.   
     
       
     
         [0067]    The resulting changes in pressure in the mouth (e.g., a sudden increase in pressure when sipping) and the time for ingestion including cooling (typically 1-5 seconds in sipping, typically 2-5 seconds in the subsequent intake of air) are taken into account by the stimulator system  35 . Because the food is liquid, the pressure with which the tongue shapes the food bolus (not shapeable here) is not as high as it is with solid food. The trigger point for stimulation of the swallowing act is programmed so that stimulation of the esophagus typically occurs 1-5 seconds after the start of ingestion of food. 
       Exemplary Embodiment 2 
     The Patient Eats a Carrot 
       [0000]    
       
         1. The food to be ingested is solid and relatively brittle.
 
Exemplary embodiment 2 yields the following conclusions:
       The food must be chewed, here typically 10-20 times.   The chewed food is shaped by the tongue into a contact food bolus. The chewing operation will thus cause 10-20 pressure peaks on the palate. The stimulator  40  is programmed so that it counts the pressure peaks. Once the minimum number of chewing operations has been reached, the stimulation is “activated,” i.e., the shaping of the food bolus with the tongue and the shifting of the food bolus with the tongue in the direction of the throat trigger the act of swallowing by stimulation approximately 0.1-2 seconds later after detection of the operation.   
     
       
     
         [0071]    It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teaching. The disclosed examples and embodiments are presented for purposes of illustration only. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention.