Patent Document

CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation-in-part of U.S. patent application Ser. No. 12/390,142, entitled “Method and Apparatus for Measuring Non-Nutritive Suck Pattern Stability” filed on Feb. 20, 2009, which claims priority to U.S. Provisional Application No. 61/036,304 filed on Mar. 13, 2008 and U.S. Provisional Application No. 61/030,484 filed on Feb. 21, 2008, all of which are incorporated by reference in their entireties. 
     
    
     FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    The subject matter discussed in this patent application was funded in part by United States Grant No. R01-DC003311 from the National Institute of Health (NIH). The government may have certain rights to the subject matter discussed herein. 
     
    
     FIELD OF THE INVENTION 
       [0003]    The invention relates generally to methods and procedures using hardware and software systems, including any processing devices or appliances incorporating the software system to assess the organization of a non-nutritive suck (NNS) pattern of a patient and to entrain an organized NNS pattern in the patient. More specifically, the present invention relates to methods of monitoring and administering tactile stimuli to assess the patient&#39;s natural NNS pattern and to entrain an organized NNS pattern. 
       BACKGROUND OF THE INVENTION 
       [0004]    Premature birth places infants at increased risk for learning disabilities, delayed development of speech, language and motor skills, and mortality. The premature infant often has difficulties with respiration and feeding and therefore may remain in the hospital for prolonged periods of time. The non-nutritive suck (NNS) is a motor behavior that can be observed and used to make inference about brain development and organization in this young population. 
         [0005]    Oral stimulation therapy is a common practice, in which feeding therapists manually apply a stimulation using their fingertip. Manually applying stimulation, however, has a number of drawbacks. One such drawback includes the variance and limitation in the amount of motion (amplitude) and rhythm (frequency) from therapist to therapist, or even by the same individual. As a result, extensive and costly training and experience are required for a therapist to be proficient at providing manual stimulation and assessment. 
         [0006]    In addition, manual stimulation is given essentially blind, as patients can respond by producing a variety of undesirable motor actions, including but not limited to clenching the jaws, tongue compression, tongue thrusting, or other reactions that may be confused with desirable NNS events. As such, it can be difficult to determine if the manual stimulation is beneficial to the patient. 
         [0007]    Therefore, a need exists for an automated system and method of using the system to assess a patient&#39;s natural NNS pattern and to provide precise and beneficial tactile stimulus to correct and organize the patients NNS pattern. 
       SUMMARY OF THE INVENTION 
       [0008]    The present invention relates to a method of using a system having hardware, software, and appliance components for assessing and entraining a non-nutritive suck (NNS) pattern in a patient. In one aspect, a method is performed using a non-nutritive suck appliance assembly in communication with a non-nutritive suck application system to assess a non-nutritive suck pattern of patient. The method includes steps performed at a user interface generated for display on a display device of the non-nutritive suck application system. The steps include selecting the patient&#39;s name from a displayed list of patients generated by the non-nutritive suck application system, the non-nutritive suck application system having memory and executing a non-nutritive suck application on at least one processor. The steps also include selecting an assessment mode of the non-nutritive suck application, selecting a displayed “new assessment” control button, selecting an assessment to be performed at the user interface and configuring the assessment at the user interface. 
         [0009]    The method also includes steps for calibrating an orofacial stimulator appliance of the non-nutritive suck appliance assembly to perform the selected assessment procedure. The method further includes the steps of positioning the patient to encourage a rooting response to the orofacial stimulator appliance, starting the assessment, and inserting the orofacial stimulator appliance into the patient&#39;s mouth. The orofacial stimulator appliance is held to maintain contact with the patient&#39;s mouth during the assessment, and then removed from the patient&#39;s mouth at the conclusion of the assessment session. The method also includes providing summary remarks regarding the assessment at the user interface. 
         [0010]    In another aspect, a method is performed using a non-nutritive suck appliance assembly in communication with a non-nutritive suck application system to entrain a non-nutritive suck pattern of a patient. The method includes steps performed at a user interface generated for display on a display device of the non-nutritive suck application system. The steps include selecting the patient&#39;s name from a displayed list of patients generated by the non-nutritive suck application system, the non-nutritive suck application system having memory and executing a non-nutritive suck application on at least one processor. The steps also include selecting a therapy mode of the non-nutritive suck application, selecting a displayed “new therapy” control button, and, configuring a therapy protocol to be performed. 
         [0011]    The method also includes steps for calibrating an orofacial stimulator appliance of the non-nutritive suck appliance assembly to perform the selected therapy protocol. The method further includes the steps of positioning the patient to encourage a rooting response to the orofacial stimulator appliance, starting the selected therapy protocol, and inserting the orofacial stimulator appliance into the patient&#39;s mouth. The orofacial stimulator appliance is held to maintain contact with the patient&#39;s mouth during the therapy protocol, and then removed from the patient&#39;s mouth at the conclusion of the therapy protocol. The method also includes providing summary remarks regarding the therapy protocol at the user interface. 
         [0012]    In yet another aspect, a method is performed using a non-nutritive suck appliance assembly in communication with a non-nutritive suck application system to generate a productive non-nutritive suck pattern in a patient. The method includes assessing a current non-nutritive suck pattern of the patient, as described herein, reviewing an assessment waveform received by the non-nutritive suck application from the orofacial stimulator appliance, determining if a therapy protocol is necessary to generate the productive non-nutritive suck pattern, and providing a therapeutic stimulus to the patient, as described herein. 
         [0013]    In other aspects, the method further includes administering a therapy protocol by using the hardware, software, and appliance components to generate a therapeutic pressure pulse signal comprising a base frequency signal further comprising two or more pressure pulses, wherein each pulse period consists of a positive and negative displacement contacted by the lip and the mouth of the patient. Pulses are administered in a series of two or more pulses, and each of the two or more pressure pulses has a damped harmonic oscillating square wave profile and are separated by an interval between 500 milliseconds and 650 milliseconds in duration. The method may also include generating a therapeutic pressure profile signal comprising at least one of the therapeutic pressure pulse signals and transmits the therapeutic pressure pulse profile signal to the orofacial stimulator appliance. 
         [0014]    In various aspects, the base frequency is between 1.5 Hz and 5 Hz and the two or more pressure pulses causes surface motion of between about 260 microns and 300 microns, with a maximum transition interval of 20 milliseconds to 50 milliseconds. The therapeutic pressure profile may include at least six pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day. Further, each of the two or more pressure pulse is composed of higher order harmonics of the base frequency and each pressure pulse has a square wave peak. 
         [0015]    In various aspects, the methods further comprise calibrating the orofacial stimulator appliance by mounting a pacifier onto an end of the orofacial stimulator appliance or optionally, inserting a therapy insert into a receiver tube of the orofacial stimulator appliance. In addition, the calibration of the orofacial stimulator appliance, as well as the expansion characteristics of the pacifier may be verified prior to, during, or after use. Verification may be performed by measuring the frequency and amplitude of changes in the pacifier by a laser micrometer. In particular, the frequency and amplitude of the changes in the pacifier shape may be reviewed to verify that the desired therapy pulse is applied. 
         [0016]    In addition, various aspects of the methods include providing summary remarks that may include data regarding a state of alertness for the patient. 
         [0017]    The methods may also include steps for providing power to the non-nutritive suck application system, providing power to the non-nutritive suck appliance assembly, verifying a charge of a battery back-up unit, and logging in to the non-nutritive suck application. Further, the methods may have steps for adding a new patient to the displayed list of patients. Adding a new patient includes the steps of selecting an “add new patient” control button at the user interface, entering new patient data at the user interface, and, selecting a “save” control button to save the new patient data in the memory of the non-nutritive suck application. 
         [0018]    In addition, at least one of the assessment session or the therapy protocol may be started by selecting a “start assessment” control button or a “start therapy” control button, respectively, at the user interface. Alternately, at least one of the assessment or the therapy protocol may be started by depressing a button on the orofacial stimulator appliance. Related objects and advantages of the present invention will be apparent from the following description. 
     
    
     
       DESCRIPTION OF FIGURES 
         [0019]      FIG. 1  is a block diagram of a non-nutritive suck assessment and entrainment system according to one aspect. 
           [0020]      FIG. 2  is a block diagram of computing environment according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0021]      FIG. 3  is a block diagram of data source according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0022]      FIG. 4  is a block diagram of a non-nutritive suck entrainment application according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0023]      FIG. 5  is a block diagram of a system module according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0024]      FIG. 6  is a block diagram of an assessment module according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0025]      FIG. 7  is a block diagram of a therapy module according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0026]      FIG. 8A  is a block diagram of a therapeutic pulse generation system according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0027]      FIG. 8B  is a block diagram of an orofacial stimulator appliance according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0028]      FIG. 9  is a block diagram of a non-nutritive suck assessment and entrainment system according to one aspect. 
           [0029]      FIG. 10  illustrates a method for assessing a non-nutritive suck pattern according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0030]      FIG. 11  illustrates a method for stimulating a patient to entrain an organized non-nutritive suck pattern according to one aspect of the non-nutritive suck assessment and entrainment system. 
           [0031]      FIGS. 12-31  are screenshots of various graphic user interface displays according to aspects of the non-nutritive suck assessment and entrainment system. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]    The present invention relates to a system for assessing and the neural entrainment of a Non-Nutritive Suck (NNS) pattern in a patient. Typically, the patient is a premature infant; however, the system may also be used for patients unable to properly suck or swallow to receive nourishment, including but not limited to full-term infants, toddlers, adolescents, and adults. For example, the system may be used to treat those that have been debilitated by strokes, hemorrhages, or other conditions that correlate with an impairment in neurological development or function. 
         [0033]    The NNS pattern of a patient is generated by the patient&#39;s suck central pattern generator (sCPG). A central pattern generator (CPGs) is a neural circuit or combination of neural circuits located in the patient&#39;s cerebral cortex, brainstem, and/or spinal cord that drives rhythmic motor behaviors such as sucking, breathing, mastication, and locomotion. The patterns generated by the CPGs can be modulated by a variety of external stimuli. As such, the most beneficial therapeutic results are manifested when the therapy consistently mimics the intrinsic frequency of sCPG. 
         [0034]    It is often difficult for therapists to model the fine temporal structure of an organized NNS burst pattern, which involves a frequency-modulated (FM) burst structure, using manual stimulation. The FM burst structure is characterized by a series of suck cycles that successively decrease in frequency from the first compression cycle of the lips and mouth to the last compression cycle. The FM burst structure typically modulates between 1.5 Hz and 3 Hz. The structure of the FM burst is very difficult if not impossible to produce manually in a repeated pattern by even the most experienced therapist. 
         [0035]    The present invention relates to the identification of particular characteristics of the FM burst structure and provides criteria or descriptions of features of the NNS pattern that may be used as diagnostic indicators for gauging the development of oromotor control among patients. Further, the identified characteristics may be useful in configuring a tactile stimulus that may be applied to patients to modify or correct a deficient NNS pattern. 
       The Non-nutritive Suck (NNS) Application System (NNS Application System) 
       [0036]      FIG. 1  is a block diagram of a non-nutritive suck (NNS) assessment and entrainment application system (NNS application system)  100  for assessing a patient&#39;s natural NNS pattern and for providing a tactile stimulus that will stimulate the suck central pulse generator (sCPG) and trigeminal nerve of a human brain to entrain a proper NNS pattern. Further, the NNS application system  100  may be used to assess and entrain brain activity for controlling respiration, mastication, or combinations thereof. The NNS application system  100  includes a computing device  102  to process data and execute one or more applications, a data source  104  to store data, a pulse generation system  106  to generate pneumatic pulses in response to input signals, and an orofacial stimulator appliance  108  to transfer the pneumatic pulses to a patient as a tactile stimulus. 
         [0037]    According to one aspect, the computing device  102  includes memory  200  and at least one processor  202  to execute a NNS assessment and therapy application (NNS application)  204 , as shown in  FIG. 2 . The computing device  102  also includes a display  206 , such as a computer monitor, for displaying data stored in the data source  104 , data received from the pulse generation system  106  or the orofacial stimulator appliance  108 , and data input by a user of the NNS application system  100 . The display device  206  also displays one or more graphical user interfaces (GUIs) input forms or displays, generated by the NNS application  204 , as shown in  FIGS. 12-31 . The GUI input forms and displays enable a user of the NNS application system  100  to input, view, and/or interact with the various modules of the system. The GUI input forms and displays also allow a user to input, view, and/or interact with patient data, NNS assessment data, NNS therapy data, and/or other data related to the assessment and therapeutic stimulation of the patient. Further, the GUI input forms and displays permit a user to configure and interact with the pulse generation system  106  and the orofacial stimulator appliance  108 . 
         [0038]    The computing device  102  may also include an input device  208 , such as a keyboard or a pointing device (e.g., a mouse, trackball, pen, or touch screen) to enter data or configure a feature of the NNS application system  100  using the GUI input forms and displays. The computing device  102  may further include, or at least be in communication with, the data source  104 . 
         [0039]    The data source  104  may be a database stored on a local hard disk drive (HDD) incorporated into the computing device  102 . Alternately, the data source  104  may be a database or other data structure stored remotely from the computing device  102 . For example, the computing device  102  may be in communication with the data source  104  over a network, including but not limited to the Internet. As shown in  FIG. 7 , the data source may store a variety of data. For example, the data source  104  may store user data  700  that includes profiles and login information, such as passwords, for users of the NNS application system  100 . The data source  104  may also contain patient data  702  including patient charts and historical assessment and therapy session data  704  and  706 , respectively. The data source  104  also stores data for therapy protocols or therapy pulse profiles  708  that may be used to entrain a variety of patients, as well as, other data  710  gathered from experiments or research trials conducted using the NNS application system  100 . 
         [0040]    According to one aspect, as shown in  FIG. 3 , the NNS assessment and therapy application  204  includes a number of instructions, applets, modules  300 - 308 , and submodules to receive, process, and generate data and/or signals for the assessment of a NNS pattern and the therapeutic stimulation of a patient&#39;s mouth and lips to entrain a proper NNS pattern. The modules of the NNS assessment and therapy application  204  include an NNS application system module  300 , an assessment module  302 , a therapy module  304 , a leak detection module  306 , and a research module  308 . 
         [0041]    The NNS application system module  300  includes various submodules  400 - 406  to provide access to various the features and functionality of the NNS assessment and therapy application  204 . For example, the NNS application system module  300  includes a user login submodule  400  that allows a user of the NNS application system  100  to login into the NNS application  204 . In one aspect, the NNS application system module  300  generates GUI input forms  1200  and  1202 , as shown in  FIGS. 12-13 , where the user may select a user account and log in to the NNS application  204  after entering a valid password for the selected user. 
         [0042]    The NNS application system module  300  includes a user configuration submodule  402  that allows users of the NNS application system  100  with sufficient privileges to add, edit, or delete user accounts. By way of example and not limitation, an administrator may input data into GUI input forms  1204  and  1206 , as shown in  FIGS. 14-15  to create, modify, or delete a user profile to grant or restrict access to the NNS application  204 . 
         [0043]    Similarly, the NNS application system module  300  includes a patient configuration submodule  404  that allows users of the NNS application system  100  with sufficient privileges to add, edit, or delete patients. By way of example and not limitation, an administrator may input data into input forms  1208  and  1210 , as shown in  FIGS. 16-17 , to create, modify, or delete a profile for a patient that may receive an NNS assessment or therapy using the NNS application system  100 . The NNS application system module  300  also includes a session selection submodule  406  that allows users of the NNS application system  100  to select whether the NNS application system will be used to assess a patient&#39;s naturally generated NNS pattern or to provide therapeutic stimulus to the patient. As such, the session selection submodule  406  sends requests to the assessment module  302  and the therapy module  404  in response to type of session selected by the user. 
         [0044]    When an assessment request is generated, the NNS application system module  300  generates a main assessment input form  1212  to allow the user to input data and interact with the NNS application  204  during the assessment session. By way of example, and not limitation, an embodiment of the main assessment input form  1212  is shown in  FIG. 18 . In one aspect, the main assessment input form  1212  includes one or more control buttons  1214  to access a list of all the patients actively associated with the NNS application  204 . When a patient is selected, the main assessment input form  1212  displays a history  1216  of assessments for the selected patient, and is capable of displaying waveforms from the previous assessments in a waveform frame  1218 . In one aspect, the prior waveforms and assessment histories  1216  may be stored as assessment session data  704  in the data source  104 . 
         [0045]    The main assessment input form  1212  also includes a control button  1220  to permit a user to view a patient&#39;s medical chart  1294 , an example of which is shown in  FIG. 31 . In addition, the control button  1220  allows the user to add or edit patient data, while control button  1222  allows the user to add notes to the patient assessment data. In addition, the user may select control button  1224  to start a new assessment session for the selected patient or select control button  1226  to switch directly to a therapy session for the selected patient. 
         [0046]    In one aspect, the assessment module  302  includes a number of submodules  500 - 508 , including but not limited to an assessment configuration submodule  500 , an assessment calibration submodule  502 , an assessment capture module  504 , a feature extraction submodule  506 , and a post assessment review module  508 . The various submodules  500 - 508  generate and display one or more GUI input forms as shown in  FIGS. 19-26  that allow the user to configure, initiate, and review an assessment session. 
         [0047]    The assessment configuration submodule  500 , for example, generates an assessment configuration GUI input form  1228 . The assessment configuration GUI input form  1228  includes one or more controls  1230 - 1242  and data fields  1244 - 1248  to input data for selecting or configuring an assessment session. The input data may relate to a total assessment time  1246 , an intermediate assessment prompt  1244 , a type and configuration  1236  of the pacifier  810 , and optionally, the patient&#39;s weight  1248 . As the behavior and mood of a patient is often unpredictable, it is difficult for the user to know in advance how long the assessment session may take. Therefore, the intermediate assessment prompt is selected as a ‘best estimate’ for the actual time that it may take to capture enough NNS pattern activity to assess the patient. As such, the total assessment time permits the user to continue to collect data, if desired, after the intermediate assessment prompt. In one aspect, the assessment collection submodule  504  halts the capture of assessment data at the intermediate assessment prompt. 
         [0048]    The assessment calibration submodule  502  generates an assessment calibration GUI input form  1250 . In one aspect, the calibration input form  1250  allows the user to communicate with and configure the pulse generation system  106  and the orofacial stimulator appliance  108  to verify the intended function and calibration for the components of the pulse generation system and the orofacial stimulator appliance prior to the initiation of an assessment session. 
         [0049]    The assessment capture submodule  504  receives the digital pressure signal from the pulse generation system  106 . In one aspect, the assessment capture submodule  504  records and displays the patient&#39;s NNS pattern activity as a waveform  1252 . In other aspects, the assessment capture submodule  504  may receive and store the digital pressure signal without displaying the NNS pattern activity. In another aspect, the assessment capture submodule  504  may display the NNS pattern activity in another form, such as a chart, graph, or table. 
         [0050]    The assessment capture submodule  504  may further generate a number of displays during the assessment capture session. For example,  FIGS. 22-25  are screen displays that show the progress of the assessment session at the start of the session  1254 , at the intermediate prompt interval  1256 , at the user input duration time  1258 , and at the conclusion of the assessment session  1260 . In other aspects, fewer or a greater number of displays  1254 - 1260  may be provided during the assessment session. 
         [0051]    In one aspect, the assessment data capture session may be initiated by input received through a start control button  1262  shown on the display  206 . Alternately, the assessment data capture session may be initiated by a switch  816  on a handpiece  806  of the orofacial stimulator appliance  108 . 
         [0052]    During or subsequent to an assessment session, the feature extraction submodule  506  analyzes the digital pressure signal received by the assessment capture submodule  504 . In particular, the feature extraction submodule  506  identifies various components of the patient&#39;s generated NNS pattern. For example, in the waveform  1252  of  FIG. 21 , the feature extraction submodule  506  identifies pressure peaks  1264 , individual suck events  1266 , as well as bursts  1268 , which are defined as two or more suck events in less than about  1 . 2  seconds. In addition, the feature extraction submodule  506  also identifies a number of non-NNS events  1270 , such as chewing motions made by the patient. In one aspect, the feature extraction submodule  506  may provide annotations, including color-coding, to identify the various NNS events  1264 - 1268 . 
         [0053]    In one aspect, the feature extraction submodule  506  quantifies the overall performance of the patient&#39;s generated NNS pattern by assigning a Spatiotemporal Index (STI) value to the pattern. For example, the STI value may be derived by calculating the similarity of up to five individual suck bursts. The STI value measures the symmetrical and repetition of the patient&#39;s generated NNS burst pattern by integrating the symmetry and quantity of selected NNS events  1264 - 1268  in the patient&#39;s NNS pattern. 
         [0054]    In another aspect, the feature extraction submodule  506  automatically determines a number of parameters that are desirable for evaluating the patient&#39;s generated NNS pattern and determining the best course of therapy to treat the patient. For example, the evaluation parameters may include the STI value for the waveform, the number of bursts per minute, the number of events per burst, the number of NNS events per minute, an average peak pressure, as well as the total number of events per minute. In other examples, a fewer or greater number of parameters as well as different parameters may be considered when evaluating the patient&#39;s generated NNS pattern. 
         [0055]    The evaluation parameters may be determined using a portion or subset of the collected assessment data. For example, a “most active” two-minute window having the most number of NNS events is identified by the feature extraction submodule  506 . The most-active window is generally indicated by a bar  1272  on the displayed waveform  1252 . When calculating the six evaluation parameters, the feature extraction submodule  506  may ignore any NNS activity outside of the most-active window. 
         [0056]    After capturing the patient&#39;s generated NNS pattern and determining the evaluation parameters, the post assessment review module  508  generates a post-session GUI input form  1274  where the user may confirm the identify of the patient that underwent the assessment session and input notes regarding the assessment session. By way of example and not limitation, the user may indicate the state of alertness for the patient, by inputting terms such as alert, crying, drowsy, sleepy, or any other term that identifies the patient&#39;s level of alertness during the assessment session. The user may further quantify the patient&#39;s state of alertness as active or quiet, as the patient&#39;s STI value may fluctuate between assessment sessions due to the patient drifting off to sleep during the capture period. 
         [0057]    Once a patient has been diagnosed or characterized as having a disorganized NNS pattern, it is often desirable for the patient to undergo a therapy session to entrain the patient&#39;s sCPG to produce an organized NNS pattern. Typically, a therapy session consists of applying an external stimulus to or near the lips and mouth of the patient in order to modify the NNS pattern generated by the sCPG. The orofacial stimulator appliance  108  contacts the patient on or near the lips and mouth to deliver therapeutic stimulation, provided by the pacifier&#39;s motion as caused by the pressure pulses, to the patient&#39;s orofacial nerves via regulated changes in the surface diameter of a pacifier  810  that is a component of the orofacial stimulator appliance  104 , as shown in  FIGS. 8B and 9 . The pressure pulses conveyed by the orofacial stimulator appliance  108  are actuated at the pulse generator  104  system in response to a therapy pulse profile generated by the therapy module  304 . 
         [0058]    When a therapy session is to be performed, the NNS application system module  300  generates a main therapy GUI input form  1276 , as shown in  FIG. 27 . The main therapy GUI input form  1276  includes a control button  1278  to allow a user to start new therapy session. The main therapy GUI input form  1276  also includes a control button to display previous therapy session data  706  stored in the data source  104 , the therapy sessions data  706  includes summaries and detailed information for previous therapy sessions. 
         [0059]    In one aspect, the therapy module  304  includes a number of submodules  600 - 606 , including but not limited to a therapy configuration submodule  600 , a therapy calibration submodule  602 , a therapy execution submodule  604 , and a post-therapy review submodule  606 . The various submodules  600 - 606  generate one or more GUI input forms for display that allow the user to configure, execute, and review a therapy session. 
         [0060]    The therapy configuration submodule  600 , for example, generates a therapy configuration input form  1280 . The assessment configuration GUI input form  1280  includes a number controls  1282 - 1286  related to the therapy session and the pacifier  810  of the orofacial stimulator appliance  108 . The assessment configuration GUI input form  1280  also includes a control button  1288  that allows the user to select or modify one or more therapy pulse profiles. 
         [0061]    A therapy pulse profile consists of one or more therapeutic waveforms that result in variable but controlled radial displacements of the outer surface of the pacifier  810 . The surface displacements of the pacifier  810  provide a tactile stimulus to or near the lips and mouth (e.g., intraoral, anterior tongue tip, anterior tongue dorsum) of the patient to entrain the patient&#39;s sCPG to naturally produce an NNS pattern that mimics the generated therapy waveforms. Once configured, the therapy waveforms are actuated by the pulse generation system  106 , as shown in  FIGS. 8A and 9 . 
         [0062]    The therapy calibration submodule  604  functions similar to the assessment calibration submodule  502  and generates a therapy calibration GUI input form similar to the assessment calibration GUI input form  1250 . In one aspect, the calibration GUI input form allows the user to communicate with and configure the pulse generation system  106  and the orofacial stimulator appliance  108  to verify the intended function and calibration of the instruments prior to the start of the therapy session. 
         [0063]    In one aspect, the expansion characteristics of the therapy pulses as delivered by expansion of the pacifier are verified using a laser micrometer (not shown) in communication with the therapy calibration submodule  604 . The data from the laser micrometer regarding the frequency and amplitude components of the therapy pulse at the pacifier  810  may be digitized, recorded, and analyzed by the NNS application  204 . 
         [0064]    The therapy execution submodule  604  captures and displays the patient&#39;s NNS pattern activity during a therapy session. The therapy execution submodule  604  may generate a display  1290 , as shown in  FIG. 29 , that shows progress of the therapy session at the start of the session, during the therapy session, at a rest interval, and at the conclusion of the therapy session, respectively. In other aspects, fewer or a greater number of displays may be provided during the therapy session. 
         [0065]    Similar to an assessment session, the therapy session may be initiated by input received through the start control button  1278  of the GUI input form  1276 . Alternately, the therapy session may be initiated by the switch  816  on a handpiece  806  of the orofacial stimulator appliance  108 . 
         [0066]    After a therapy session, the post-therapy review submodule  606  generates a post-session GUI input form similar to the assessment post session GUI input form  1274  where the user inputs notes regarding the therapy session. The user may indicate the state of alertness for the patient, such as alert, crying, drowsy, or sleepy. 
         [0067]    The NNS application  204  further includes a leak detection module  306 . The leak detection module  306  continuously monitors the performance of pneumatic subsystems within the pulse generator system  104  and the pneumatic lines and connections of the orofacial stimulator appliance  108  to detect air leaks. 
         [0068]    In one aspect, the leak detection module  306  determines that there may be an air leak by identifying reduced pulse amplitudes, increased pulse roll-offs, and/or the need for a greater stroke length in an air pump or a pneumatic pulse generator  804  to generate the requested pressure. Further, the leak detection module  306  can identify air leaks caused by disconnected air lines, and poorly seated receiver tubes or pacifiers. The module  306  will display a warning  1292 , as shown in  FIG. 30 , requiring the user to address the leak. The leak detection module  306  may monitor the NNS application system  100  automatically and continuously during both assessment and therapy sessions. 
         [0069]    The NNS application  204  also includes the research module  308  that allows a user of NNS application system  100  to conduct various research experiments and protocols. In particular, the research module  308  receives and transmits data to an input/output (I/O) port of the computing device  102  or the real-time controller  800  of the pulse generation system  106 . The I/O port, in turn, may be in communication with any of a variety of external instruments for conducting research. 
         [0070]    In various other aspects, the NNS application  204  may include additional modules for other functions, including those typically associated with medical or rehabilitation facilities. By way of example and not limitation, the NNS application  204  may also include a billing module to interface with an existing billing system or a printing module for printing various data, charts, or reports. 
       The NNS Therapeutic Appliance Assembly 
       [0071]    Referring now to  FIGS. 1 ,  8 A-B, and  9 , the NNS Therapeutic appliance assembly includes the pulse generation system  106  and the orofacial stimulator appliance  108 . One or both of the pulse generation system  106  and the orofacial stimulator appliance  108  may be configured for each patient. By way of example, and not limitation, the size, shape, and/or type of pacifier  810  may be changed between patients. 
         [0072]    The orofacial stimulator appliance  108  includes the handpiece  806  and the pacifier  810  that are brought into contact with the patient to deliver the therapeutic stimuli. In one aspect, the handpiece  806  includes a receiver tube  812  in fluid communication with the interior of the baglet or pacifier  810 . The receiver tube  812  includes an interior void for receiving a volume of air from the pneumatic pulse generator  804  or from the pacifier  810 . Optionally, the handpiece  806  also includes a receiver tube insert  814 , that may be inserted in to the receiver tube  812  to limit the total volume of air in the interior void of receiver tube. The handpiece  806  may also include a mode valve  922  that is opened or closed depending on whether an assessment session or a therapy session is to be performed. 
         [0073]    During an assessment session, the computing device  102  may record and display a signal received from a pressure transducer  808  of the orofacial stimulator appliance  108 , as shown in  FIG. 8B . The transducer  808  translates pressure changes caused by sucking and mouthing movements of the patient into an analog signal that tracks the pressure applied to a pacifier  810  versus time. The analog pressure signal is converted to a digital signal at an analog-to-digital converter  802  of the pulse generation system  106 , as shown in  FIG. 8A . The analog-to-digital converter  802  is incorporated into a real-time controller  800 , that receives and modifies received and/or generated pressure signals in real-time. The digital pressure signal is then received, recorded, and displayed by the assessment module  302 . 
         [0074]    Similarly, in one aspect of a therapy session, the pulse generation system  106  receives amplitude data  900  and pulse duration data  902  for the desired waveforms. The amplitude data  900  and the pulse duration data are provided to the real-time controller  800  which may include an H-bridge (not shown) and a proportional—integral—derivative controller (PID controller)  904 . By way of example and not limitation, the PID controller  904  may be a CompactRIO controller. The PID controller  904  generates a signal  906  that is fed through a pulse-width modulation (PWM) component  908 . The modulated signal  910  is then provided to a motor  912  of the pneumatic pulse generator  804 . In one embodiment, the pneumatic pulse generator  804  consists of a linear motor  912  mechanically engaged to an air cylinder, such as but not limited to an Airpel airpot or other device having a piston fitted in a precision bore cylinder with position and pressure feedback sensors in communication with the PID controller  904 . The pulse generator  804  also includes a position feedback sensor  916  to monitor the position of the piston of the dashpot  914  and a pressure feedback sensor  918  to monitor the pressure with the dashpot  914 . The air displaced by the pneumatic pulse generator  804  is then transmitted to the handpiece  806 , through one or more pneumatic airlines, where the therapy waveform displaces the outer surface of the pacifier  810 . The pulse generator  804  may also include a vent valve  920  that is normally closed, however the valve may be opened and vented to atmosphere to ensure pressure equilibrium at the start of each assessment or therapy session. Optionally, the pulse generator  804  may also include another valve (not shown) that isolates the dashpot  914  from the handpiece  806  during a Power-On Self Test (POST). The optional valve therefore permits diagnostic testing of the application system  100 . 
       The Therapeutic Waveform 
       [0075]    Preferably, the therapy waveform consists of one or more salient therapeutic bursts and each burst contains two or more square wave pulses. Typically, the bursts are separated by a configurable and variable delay interval. 
         [0076]    According to one aspect, the nominal number of pulses in a desired therapeutic burst is six, while the actual number is configurable by users of the NNS application system  100 . Preferably, each pulse in a therapeutic burst is a square wave pulse having the same configurable amplitude. Further, the period of each pulse increases sequentially thereby, causing the waveform frequency to slow down from the start of the therapeutic burst to the end of the therapeutic burst. A desirable decelerating sequence pulse sequence has periods of approximately 510±3 ms, 526±3 ms, 551±3 ms, 580±3 ms, and 626±3 ms between therapeutic bursts. When more than five pulses are used in the therapeutic burst, the sixth and all subsequent pulses have an periodic interval of approximately 626 ms. 
         [0077]    Preferably, each square wave pulse period is shaped to minimize the positive and negative rise/fall times. For example, the transition intervals of each pulse&#39;s leading or trailing edges between each pulse may be tuned to create harmonics of 1.7±0.5 Hz, 5.5±0.5 Hz, 9.0±0.5 Hz, 12.5±0.5 Hz, and 16.5±0.5 Hz. It is desired that the therapy waveform have minimal ringing or flutter at the square wave peaks, in order to be perceived as a “clean” square waves. As the therapy pulse profiles may be modified in the amplitude and frequency domains, a power spectrum analysis shows that the preferred therapy waveform generates displacement of the pacifier  810  at a fundamental frequency of approximately 1.7 Hz and higher orders. This fundamental frequency is preferred to entrain the patient&#39;s nervous system through cutaneous signal detection. Further, the preferred therapy waveform has a Q factor greater than or equal to ½. As such, the relative high frequency of the rising and falling edges of the therapy pulse helps to achieve stimulus salience in the patient. 
         [0078]    In all aspects, the number of square wave pulses per therapeutic burst, the number of therapeutic bursts per therapy session, and the amplitude of the square wave pulses are configurable by the user to account for variability in the patients. For example, the age, endurance, and/or aptitude of the patients may vary, thereby requiring the user to select or modify a therapy pulse profile via the therapy configuration submodule  600 . 
       Methods of Using the Non-nutritive Suck Entrainment System (Entrainment System) 
       [0079]      FIG. 10  illustrates a method for performing an assessment session to capture and analyze a patient&#39;s NNS pattern in accordance with an aspect of the NNS system  100 . At step  1000 , a user of the NNS system  100  selects a patient from a displayed list of patients. The user then selects a control button to enter the assessment mode of the NNS application  204  at step  1002  and selects the “start new assessment” control button  1224  at step  1004 . The assessment session is configured as desired at step  1006  based upon the patient&#39;s age, injury, or other patient data  702  and optionally, data  704  regarding the patient&#39;s assessment history. The orofacial stimulator appliance  108  is calibrated at step  1008 , while the patient is positioned to encourage a rooting response to the orofacial stimulator appliance at step  1010 . At step  1012 , the assessment session is started, while the orofacial stimulator appliance is contacted with the patient&#39;s lips and mouth at step  1014 . In other aspects, the orofacial stimulator appliance  108  is inserted into the patient&#39;s mouth at step  1014 . Similarly, in other aspects, the steps  1012  and  1014  may be reversed. 
         [0080]    Once the assessment session is completed, the orofacial stimulator appliance  108  is removed from the patient at step  1016 . After the feature extraction submodule  406  analyzes the collected assessment data, using the input form  1274  generated by the post-assessment review module  508 . After the assessment session, the user may initiate another assessment session for the same patient or a different patient. Alternatively, the user may instead exit the NNS application  204 . 
         [0081]      FIG. 11  illustrates a method for performing a therapy session to entrain a patient&#39;s sCPG to generate an organized NNS pattern in accordance with an aspect of the NNS application system  100 . At step  1110 , a user of the NNS application system  100  selects a patient from a list of patients. The user then selects a control button to enter the therapy mode of the NNS application  204  at step  1102  and the selects a “start new therapy” control button  1278  at step  1104 . The therapy pulse profile to be generated during the therapy session is selected from the therapy pulse profile data  708  at step  1106  and at step  1108 , the therapy pulse profile is configured as desired based upon the patient&#39;s age, injury, or other patient data  702  and any of the patients NNS assessment data  704 . The orofacial stimulator appliance  108  is calibrated at step  1110 , while the patient is positioned to encourage a rooting response to the orofacial stimulator appliance at step  1112 . At step  1114 , the therapy session is started, while the orofacial stimulator appliance is contacted with the patient&#39;s lips and mouth at step  1116 . In other aspects, the orofacial stimulator appliance  108  is inserted into the patient&#39;s mouth at step  1116 . Similarly, in other aspects, the steps  1114  and  1116  may be reversed. During the therapy session, the user may attempt to hold the patient as still as possible. 
         [0082]    Once the therapy session is completed, the orofacial stimulator appliance  108  is removed from the patient at step  1118 . The user may provide summary remarks regarding the therapy session at step  1120  using the GUI input form  1274  generated by the post-therapy review module  606 . After the therapy session, the user may initiate another therapy session for the same patient or a different patient. Alternatively, the user may instead exit the NNS application  204 . 
         [0083]    Therapy sessions may be performed multiple times in the same day, week, or month. For example, a therapeutic session may consist of at least six pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day. In other examples, a greater or fewer number of pressure pulses may be applied in succession or periodically. 
         [0084]    It will be appreciated that the device and method of the present invention are capable of being incorporated in the form of a variety of embodiments, only a few of which have been illustrated and described above. The invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive and the scope of the invention is, therefore indicated by the appended claims rather than by the foregoing description. All changes, which come within the meaning and range of equivalency of the claims, are to be embraced within their scope.

Technology Category: a