Enhanced therapeutic stimulus for non-nutritive suck entrainment system

ES 2 811 100 T3

DESCRIPTION

Enhanced therapeutic stimulus for a non-nutritive suction entrainment system

Research or development sponsored by the federal government

The subject matter discussed in the present patent application was supported in part by US Grant No. R01-DC003311 from the National Institutes of Health (NIH). The government may have certain rights on the subject matter of this report.

Field of the invention

The invention relates generally to a software system and processing apparatus or devices incorporating the software system for assessing the organization of a non-nutritive sucking pattern (NNS) of a patient and for entailing an organized NNS pattern in the patient. . More specifically, the present invention relates to a software system that receives data from an orofacial stimulation apparatus to assess the patient's natural NNS pattern and generates a tactile stimulus through the orofacial stimulation apparatus to convey an organized NNS pattern.

Background of the invention

Preterm birth puts babies at increased risk for learning disabilities, delayed development of speech, language, and motor skills, and mortality. The premature baby often has difficulties with breathing and feeding and therefore may stay in the hospital for long periods of time. Non-nutritive sucking (NNS) is a motor behavior that can be observed and used to make inference about brain development and organization in this young population.

Oral stimulation therapy is a common practice, in which feeding therapists manually apply stimulation using the fingertip. However, the manual application of stimulation has a number of drawbacks. One of these drawbacks includes variation and limitation in the amount of movement (amplitude) and rhythm (frequency) from one therapist to another, or even the same individual. As a result, extensive and expensive training and experience is required for a therapist to be proficient in providing manual stimulation and assessment.

Additionally, manual stimulation is delivered essentially blind, as patients may respond by producing a variety of undesirable motor actions, including but not limited to clenching the jaw, squeezing the tongue, thrusting the tongue, or other reactions that may be confused. with NNS events. As such, it can be difficult to determine whether manual stimulation is beneficial to the patient.

Therefore, there is a need for an automated system and procedure to assess a patient's natural NNS pattern and provide an accurate and beneficial tactile stimulus to correct and organize the patient's NNS pattern.

Poore M., Zimmerman E., Barlow SM, Wang J. and Gu F .. 2008. Patterned orocutaneous therapy improves sucking and oral feeding in preterm infants. Acta Paediatrica 97: 920-927 relates to a study of orocutaneous therapy with patterns in premature infants and studies their non-nutritive sucking and / or the success of oral feeding.

Finan DS and Barlow SM 1996. The Actifier: A Device for Neurophysiological Studies of Orofacial Control in Human Infants. Journal of Speech and Hearing Research, Volume 39: 833-838 describes a device for stimulation of intraoral tissues in human infants, used to investigate the responsiveness of the central sucking pattern generator in human infants to mechanical disturbance.

Summary of the invention

The present invention relates to a system for assessing and displaying a non-nutritive sucking pattern (NNS) in a patient. In one aspect, the system is executable by a processor to stimulate a central pattern generator and trigeminal nerve in a human brain, where such stimulation influences brain development or response, including repair, control of respiration, the control of NNS, chewing and their combinations, in a human brain. The system includes an assessment module for recording a pressure signal received from a pressure transducer in an orofacial stimulator apparatus and generating a display signal for displaying assessment data based on the received pressure signal. The system also includes a feature extraction module to identify one or more components of the patient's non-nutritive suction pattern in the pressure signal, determine a symmetry of the patient's non-nutritive suction pattern, determine a repetition of the non-nutritive suction pattern. nourishing the patient, and assigning a spatiotemporal index value to the patient's non-nutritive sucking pattern, the value of the spatiotemporal index indicates an overall rating of the patient's non-nutritive sucking pattern.

The system further includes a therapy module for generating 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 in contact. by the lip and mouth of the patient. Pulses

ES 2 811 100 T3 are delivered 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 therapy module also generates 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 apparatus.

In various respects, the base frequency is between 1.5 Hz and 5 Hz and the two or more pressure pulses cause a surface movement of between approximately 260 microns and 300 microns, with a maximum transition interval of 20 milliseconds to 50 milliseconds. . The therapeutic pressure profile can include at least 6 pressure pulses in succession in contact with the patient for at least two minutes, at least twice a day. Furthermore, each of the two or more pressure pulses is composed of higher order harmonics of the base frequency and each pressure pulse has a square wave peak.

In other aspects, the amplitude of the higher-order harmonic decay is greatest at the beginning of each pressure pulse and the higher-order harmonic decay for the two or more pressure pulses varies in amplitude and frequency. Furthermore, in one aspect, the higher order harmonic decay for the two or more pressure pulses are identical in amplitude and frequency. Each of the two or more pressure pulses may have a first-order damped overshoot square wave profile, in which the damped overshoot square wave profile of the two or more pressure pulses has a Q factor greater than or equal to to ½. The pressure transducer generates an analog pressure signal in response to the pressure applied to the orofacial stimulator device.

In one aspect, the display signal contains waveform data, wherein the waveform data indicates at least one event in the pressure signal. Also, the signal can contain at least one event. An event can be a pressure spike, a non-nutritive sucking event, a gust, a bite, or combinations thereof. The NNS values ​​assigned to the waveform data can be based on a suction symmetry, a suction amount, a suction magnitude, and a burst time of the patient's non-nutritive suction pattern. A spatiotemporal index value can be calculated that relates to the regularity of the repetitive burst of suction. For example, the value of the spatiotemporal index can measure the similarity in up to five repetitive bursts of sucking detected within a titration as a measure of the reproducibility of the baby's sucking.

In one aspect, the system further includes a calibration module for calibrating the orofacial stimulator apparatus. The orofacial stimulator apparatus is calibrated prior to receiving pressure signals in the assessment module, generating the therapeutic pressure pulse signal, or both. Alternatively, the orofacial stimulator apparatus can be calibrated after receiving pressure signals in the assessment module, generating the therapeutic pressure pulse signal, or both. In addition, the orofacial stimulator apparatus can be calibrated before and after receiving pressure signals in the evaluation module, generating the therapeutic pressure pulse signal, or both. For example, the calibration module can verify the expansion characteristics of the pacifier. Verification is done by measuring the frequency and amplitude of changes in the pacifier using a laser micrometer in communication with the system. The system can digitize and record the frequency and amplitude of changes in pacifier shape to verify that the desired therapy pulse is being delivered. In various other aspects, the system further includes a review module for reviewing at least one of the assessment data, the generated therapeutic pressure profile, or both.

In various other embodiments, the system can be encoded on a non-transient computer-readable medium that is further encoded with instructions for operating a non-nutritive system to generate non-nutritive stimuli for a patient. The instructions are executable by a processor in communication with memory. Related objects and advantages of the present invention will be apparent from the following description.

Description of figures

Figure 1 is a block diagram of a non-nutritive suction titration and entraining system in accordance with one aspect.

Figure 2 is a block diagram of the computing environment in accordance with one aspect of the non-nutritive suction titration and entraining system.

Figure 3 is a block diagram of the data source in accordance with one aspect of the non-nutritive suction titration and entraining system.

FIG. 4 is a block diagram of a non-nutritive suction entrainment application in accordance with one aspect of the non-nutritive suction entrainment and titration system.

Figure 5 is a block diagram of a system module in accordance with one aspect of the non-nutritive suction titration and entraining system.

Figure 6 is a block diagram of a titration module in accordance with one aspect of the titration system and involving non-nutritive suction.

ES 2 811 100 T3

Figure 7 is a block diagram of a therapy module in accordance with one aspect of the non-nutritive suction titration and entrainment system.

Figure 8 is a block diagram of a therapeutic pulse generation system in accordance with one aspect of the non-nutritive suction assessment and entrainment system.

Figure 9 is a block diagram of an orofacial stimulator apparatus in accordance with one aspect of the non-nutritive suction assessment and entrainment system.

Figure 10 illustrates a procedure for rating a non-nutritive suction pattern in accordance with one aspect of the non-nutritive suction rating and entrainment system.

Figure 11 illustrates a procedure for stimulating a patient to engage in a non-nutritive sucking pattern organized in accordance with one aspect of the non-nutritive sucking assessment and entrainment system.

Figures 12-31 are screen shots of various graphical user interface displays according to aspects of the titration system and involving non-nutritive suction.

Detailed description of the invention

The present invention relates to a processing system for the assessment and neural involvement of a non-nutritive sucking pattern (NNS) in a patient as defined in claim 1 attached hereto. Typically, the patient is a premature baby; however, the system can also be used for patients who are unable to suck or swallow properly to receive food, including, but not limited to, full-term infants, young children, adolescents, and adults. For example, the system can be used in the treatment of those who have been weakened by strokes, hemorrhages, or other conditions that are correlated with an impairment in neurological development or function.

A patient's NNS pattern is generated by the Patient Central Suction Pattern Generator (sCPG). A central pattern generator (CPG) is a neural circuit or a combination of neural circuits located in the cerebral cortex, brainstem, and / or spinal cord of the patient that drives rhythmic motor behaviors such as sucking, breathing, chewing and locomotion. The patterns generated by CPGs can be modulated by a variety of external stimuli. As such, the most beneficial therapeutic results manifest when therapy consistently mimics the intrinsic frequency of sCPG.

It is often difficult for therapists to model the fine temporal structure of an organized NNS burst pattern, involving a frequency modulated (FM) burst structure, using manual stimulation. The FM burst structure is characterized by a series of suction 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 generally 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 repeating pattern even by the most experienced therapist.

The present invention relates to the identification of particular characteristics of the FM burst structure and provides criteria or descriptions of characteristics of the NNS pattern that can be used as diagnostic indicators to measure the development of oromotor control among patients. In addition, the identified characteristics are useful to configure a tactile stimulus that can be applied to patients to modify or correct a poor NNS pattern.

Figure 1 is a block diagram of a non-nutritive sucking (NNS) titration and entrainment system 100 (NNS system) to assess a patient's natural NNS pattern and to provide a tactile stimulus that will stimulate the central pattern generator. suction (sCPG) and the trigeminal nerve of a human brain to embody a proper NNS pattern. In addition, the 100 NNS system can be used to assess and monitor brain activity to control breathing, chewing, or combinations thereof. The NNS system 100 includes a computing device 102 for processing data and running one or more applications, a data source 104 for storing data, a pulse generation system 106 for generating pneumatic pulses in response to input signals, and an apparatus 108 Orofacial stimulator to transfer pneumatic pulses to a patient as a tactile stimulus.

According to one aspect, computing device 102 includes memory 200 and at least one processor 202 for executing a NNS therapy and assessment 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 apparatus 108, and data input by a user of the 100 NNS system. Display 206 also displays one or more graphical user interface (GUI) input forms or displays, generated by NNS application 204, as shown in Figures 12-31. The GUI input forms and displays allow a user of the 100 NNS system to log in, view and / or interact with the various modules of the system. The GUI input forms and viewers also allow the user to enter, view, and / or interact with patient data, NNS assessment data, NNS therapy data, and / or other data.

ES 2 811 100 T3 related to the assessment and therapeutic stimulation of the patient. In addition, the GUI input forms and displays allow the user to configure and interact with the pulse generator system 106 and the orofacial stimulator apparatus 108.

The computing device 102 may also include an input device 208, such as a keyboard or pointing device (eg, a mouse, trackball, pen, or touch screen) to enter data or configure a feature of the NNS system 100 using the GUI input forms and viewers. The computing device 102 may further include, or at least be in communication with, the data source 104.

The data source 104 may be a database stored on a local hard disk (HDD) incorporated in the computing device 102. Alternatively, data source 104 may be a database or other data structure stored remotely from computing device 102. For example, computing device 102 may be in communication with data source 104 over a network, including but not limited to the Internet. As shown in Figure 7, the data source can store a variety of data. For example, data source 104 may store user data 700 including profiles and login information, such as passwords, for users of the NNS system 100. Data source 104 may also contain patient data 702, including patient records and historical assessment and therapy session data 704 and 706, respectively. The data source 104 also stores data for therapy pulse profiles 708 that can be used to target a variety of patients, as well as other data 710 collected from experiments or research trials conducted using the 100 NNS system.

In accordance with one aspect, as shown in Figure 3, the NNS therapy and assessment application 204 includes a number of instructions, applets, modules 300-308, and sub-modules for receiving, processing, and generating data and / or signals for the assessment of a NNS pattern and the therapeutic stimulation of a patient's mouth and lips to imply an adequate NNS pattern. The NNS therapy and assessment application modules 204 include an NNS application system module 300, an assessment module 302, a therapy module 304, a leak detection module 306, and an investigation module 308.

The NNS application system module 300 includes various sub-modules 400-406 to provide access to various features and functionality of the NNS therapy and assessment application 204. For example, the NNS application system module 300 includes a user login sub-module 400 that allows a user of the NNS system 100 to log into the NNS application 204. In one aspect, the NNS application system module 300 generates the GUI input forms 1200 and 1202, as shown in Figures 12-13, where the user can select a user account and log into the NNS application 204 afterwards. to enter a valid password for the selected user.

The NNS application system module 300 includes a user configuration sub-module 402 that allows users of the NNS system 100 with sufficient privileges to add, edit, or delete user accounts. By way of example and without limitation, an administrator can enter data into GUI input forms 1204 and 1206, as shown in Figures 14-15, to create, modify, or delete a user profile to grant or restrict access to the 204 NNS app.

Similarly, the NNS application system module 300 includes a patient configuration sub-module 404 that allows users of the NNS system 100 with sufficient privileges to add, edit, or delete patients. By way of example and without limitation, an administrator may enter data into input forms 1208 and 1210, as shown in Figures 16-17, to create, modify, or delete a profile for a patient who may receive an assessment or therapy. NNS using the 100 NNS system. The NNS application system module 300 also includes a session selection sub-module 406 that allows users of the NNS system 100 to select whether the NNS system will be used to assess the NNS pattern naturally generated by a patient or to provide a therapeutic stimulus. to the patient. As such, session selection sub-module 406 sends requests to assessment module 302 and therapy module 404 in response to the type of session selected by the user.

When a rating request is generated, the NNS application system module 300 generates a primary rating input form 1212 to allow the user to enter data and interact with the NNS application 204 during the rating session. By way of example, and not limitation, one embodiment of the primary valuation entry form 1212 is shown in Figure 18. In one aspect, the primary assessment entry form 1212 includes one or more control buttons 1214 for accessing a list of all patients actively associated with the NNS application 204. When a patient is selected, the primary assessment input form 1212 displays a history 1216 of assessments for the selected patient, and is capable of displaying waveforms of the previous assessments in a waveform frame 1218. In one aspect, previous waveforms and assessment histories 1216 may be stored as assessment session data 704 in data source 104.

The primary assessment input form 1212 also includes a control button 1220 to allow a user to view a patient's medical history 1294, an example of which is shown in Figure 31. In addition, the control button 1220 allows the user to add or edit patient data, while the control button 1222 allows the user to add notes to the patient assessment data. In addition, the user can select button 1224

ES 2 811 100 T3 to start a new assessment session for the selected patient or select the control button 1226 to directly switch to a therapy session for the selected patient.

In one aspect, an assessment session consists of recording and displaying a signal received in the computing device 102 from a pressure transducer 902 of the orofacial stimulator apparatus 108, as shown in Figure 9. The transducer 902 translates the pressure changes caused by the suction and mouth movements of the patient into an analog signal that tracks the pressure applied to a pacifier 904 as a function of time. The analog pressure signal is converted to a digital signal in an analog-to-digital converter 802 of the pulse generator system 106. The analog-to-digital converter 802 is incorporated into a real-time controller 800, which receives and modifies the received and / or generated pressure signals in real time. The digital pressure signal is received, recorded, and displayed by the evaluation module 302.

In one aspect, the titration module 302 includes a number of sub-modules 500-508, including, but not limited to, a titration configuration sub-module 500, a titration calibration sub-module 502, a titration capture module 504, a sub-module 506 feature extraction and a 508 post-appraisal review module. The various sub-modules 500-58 generate and display one or more GUI input forms as shown in Figures 19-26 that allow the user to configure, initiate, and review an assessment session.

Valuation configuration submodule 500, for example, generates a valuation configuration input form 1228. The titration setup gUi input form 1228 includes one or more controls 12301242 and data fields 1244-1248 for entering data related to a total titration time 1246, an intermediate titration indicator 1244, a pacifier type and setting 1236 904, and optionally, the weight 1248 of the patient. As a patient's behavior and mood are often unpredictable, it is difficult for the user to know in advance how long the assessment session may take. Therefore, the intermediate score indicator is selected as a 'best estimate' for the actual time it may take to capture enough activity from the NNS pattern to score the patient. As such, the total valuation time allows the user to continue collecting data, if desired, after an intermediate valuation indicator. In one aspect, the rating collection sub-module 504 stops capturing rating data at the intermediate rating indicator.

The titration calibration submodule 502 generates a titration calibration GUI input form 1250. In one aspect, the calibration input form 1250 allows the user to communicate with and configure the pulse generator system 106 and the orofacial stimulator 108 to verify the desired function and calibration for the components of the pulse generator system and the stimulator apparatus. orofacial before the start of an assessment session.

The titration capture sub-module 504 receives the digital pressure signal from the pulse generation system 106. In one aspect, the titration capture sub-module 504 records and displays the patient's NNS pattern activity as a waveform 1252. In other aspects, the titration capture sub-module 504 can receive and store the digital pressure signal without displaying the activity of the NNS pattern. In another aspect, the titration capture sub-module 504 may display the activity of the NNS pattern in another form, such as a chart, chart, or table.

The titration capture sub-module 504 may further generate a number of displays during the titration capture session. For example, Figures 22-25 are display screens showing the progress of the assessment session at the beginning of session 1254, at intermediate indicator interval 1256, at user input duration time 1258, and at the end of the 1260 valuation session. In other aspects, a smaller or larger number of displays 1254-1260 may be provided during the assessment session.

In one aspect, the titration data capture session may be initiated by input received through a start control button 1262 displayed on display 206. Alternatively, the titration data capture session may be initiated by a switch on a handpiece 900 of orofacial stimulator apparatus 108.

During or after a titration session, feature extraction sub-module 506 analyzes the digital pressure signal received by titration capture sub-module 504. In particular, feature extraction sub-module 506 identifies various components of the patient-generated NNS pattern. For example, in waveform 1252 of Figure 21, feature extraction sub-module 506 identifies pressure spikes 1264, individual suction events 1266, as well as bursts 1268, which are defined as two or more pressure events. suction in less than about 1.2 seconds. In addition, feature extraction sub-module 506 also identifies a number of non-NNS events 1270, such as biting movements made by the patient. In one aspect, feature extraction submodule 506 may provide annotations, including color coding, to identify the various 1264-1268 NNS events.

In one aspect, feature extraction sub-module 506 quantifies the overall performance of the patient-generated NNS pattern by assigning a space-time index (STI) value to the pattern. For example, the STI value can be obtained by calculating the similarity of up to five individual suction bursts. The value of STI

ES 2 811 100 T3 measures the symmetry and repetition of the NNS burst pattern generated by the patient by integrating the symmetry and number of 1264-1268 NNS events selected into the patient's NNS pattern.

In another aspect, feature extraction sub-module 506 automatically determines a number of parameters that are desirable to evaluate the patient-generated NNS pattern and determine the best course of therapy in treating the patient. For example, the evaluation parameters can 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 number total events per minute. In other examples, a smaller or larger number of parameters, as well as different parameters may be considered when evaluating the NNS pattern generated by the patient.

The evaluation parameters can be determined using a portion or subset of the collected evaluation data. For example, a more active two-minute window that has the highest number of NNS events is identified by feature extraction submodule 506. The most active window is generally indicated by a bar 1272 in the displayed waveform 1252. When calculating the six evaluation parameters, the feature extraction submodule 506 can ignore any NNS activity outside the most active window.

After capturing the patient-generated NNS pattern and determining the assessment parameters, the post-assessment review module 508 generates a post-session GUI input form 1274 where the user can confirm the identification of the patient who underwent. to the assessment session and write notes regarding the assessment session. By way of example and without limitation, the user may indicate the alertness of the patient, entering terms such as alert, crying, drowsy, drowsy, or any other term that identifies the alertness level of the patient during the assessment session. The user can further quantify the patient's alertness as active or silent, as the patient's STI value may fluctuate between assessment sessions due to the patient falling asleep during the capture period.

Once a patient has been diagnosed or characterized as having a disorganized NNS pattern, it is often desirable that the patient undergo a therapy session to involve the patient's sCPG to produce an organized NNS pattern. Typically, a therapy session involves applying an external stimulus to or near the lips and mouth of the patient to modify the NNS pattern generated by the sCPG. The orofacial stimulator apparatus 108 contacts the patient at or near the lips and mouth to deliver therapeutic stimulation, provided by the movement of the pacifier caused by pressure pulses, to the patient's orofacial nerves through regulated changes in the diameter of the mouth. the surface of the pacifier 904. Pressure pulses carried by orofacial stimulator apparatus 108 are activated in pulse generator system 104 in response to a therapy pulse profile generated by therapy module 304.

When a therapy session is to be conducted, the NNS application system module 300 generates a main therapy GUI input form 1276, as shown in Figure 27. The main therapy GUI input form 1276 includes a control button 1278 to allow a user to begin a new therapy session. The main therapy GUI input form 1276 also includes a control button for viewing previous therapy session data 706 stored in data source 104, therapy session data 706 includes summaries and detailed information for therapy sessions. previous.

In one aspect, the therapy module 304 includes a number of sub-modules 600-606, including but not limited to a therapy setup sub-module 600, a therapy calibration sub-module 602, a therapy execution sub-module 604, and a post-therapy review sub-module 606. The various 600-606 sub-modules generate one or more GUI input forms for viewing that allow the user to set up, run, and review a therapy session.

The therapy setup sub-module 600, for example, generates a therapy setup input form 1280. The assessment setup GUI input form 1280 includes a number of controls 12821286 related to the therapy session and the pacifier 904 of the orofacial stimulator 108 apparatus. The input form 1280 of the titration setup GUI also includes a control button 1288 that allows the user to select or modify one or more therapy pulse profiles.

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 904. The surface displacements of the pacifier 904 provide a tactile stimulus to or near the lips and mouth (eg, intraoral tissues, anterior lingual depressors, dorsum of anterior tongue) of the patient to engage the patient's sCPG to naturally produce an NNS pattern that mimics the waveforms of the generated therapy.

Preferably, the therapy waveform consists of one or more prominent therapeutic bursts and each burst contains two or more square wave pulses. Typically, the bursts are separated by a configurable and variable delay interval.

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 100 NNS system. Preferably, each pulse in a therapeutic burst is a square wave pulse having the same configurable amplitude. Also, the period of each pulse

ES 2 811 100 T3 increases sequentially, causing the frequency of the waveform to decrease from the start of the therapeutic burst to the end of the therapeutic burst. A desirable deceleration sequence pulse sequence has periods of approximately 510 ± 3 ms, 526 ± 3 ms, 551 ± 3 ms, 580 ± 3ms, 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 a periodic interval of approximately 626 ms.

Preferably, each square wave pulse period is shaped to minimize positive and negative rise / fall times. For example, the transition intervals of the leading or trailing edges of each pulse between each pulse can be adjusted 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. The therapy waveform is desired to have minimal noise or wave at the peaks of square waves, to be perceived as clean square waves. As therapy pulse profiles can be modified in the amplitude and frequency domains, a power spectrum analysis shows that the preferred therapy waveform generates pacifier shift 904 at a fundamental frequency of approximately 1.7 Hz and higher. . This fundamental frequency is preferred to engage the patient's nervous system through skin signal detection. Also, the preferred therapy waveform has a Q factor greater than or equal to 1/2. As such, the relatively high frequency of the rising and falling edges of the therapy pulse helps to achieve prominence of the stimulus in the patient.

In all respects, the user can configure 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 to account for variability in patients. For example, the age, stamina, and / or fitness of patients may vary, requiring the user to select or modify a therapy pulse profile through the therapy setup sub-module 600.

Therapy Calibration Submodule 604 functions similarly to the Titration Calibration Submodule 502 and generates a Therapy Calibration GUI input form 1250 similar to the Titration Calibration GUI input form. 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 apparatus 108 to verify the intended function and calibration of the instruments prior to the start of the test session therapy.

In one aspect, the expansion characteristics of the therapy pulses delivered by the expansion of the pacifier are verified using a laser micrometer (not shown) in communication with the therapy calibration sub-module 604. The laser micrometer data regarding the frequency and amplitude components of the therapy pulse in the pacifier 904 can be digitized, recorded and analyzed by the NNS application 204.

The therapy execution sub-module 604 captures and displays the patient's NNS pattern activity during a therapy session. The therapy execution sub-module 604 may generate a 1290 display, as shown in Figure 29, showing the progress of the therapy session at the beginning of the session, during the therapy session, at a rest interval, and at the end. of the therapy session, respectively. In other aspects, fewer or more displays may be provided during the therapy session.

Similar to an assessment session, the therapy session can be initiated by input received through the start control button 1278 of the GUI input form 1276. Alternatively, the therapy session can be initiated by a switch on a handpiece 900 of the orofacial stimulator apparatus 108.

After a therapy session, the post-therapy review sub-module 606 generates a post-session GUI input form similar to the post-assessment session GUI input form 1274 where the user enters notes regarding the therapy session. The user can indicate the patient's alert status, such as alert, crying, drowsy, or drowsy.

The NNS application 204 further includes a leak detection module 306. The leak detection module 306 continuously monitors the performance of the pneumatic subsystems within the pulse generator system 104 and the pneumatic lines and connections of the orofacial stimulator 108 to detect air leaks.

In one aspect, the leak detection module 306 determines that there may be an air leak by identifying reduced pulse amplitudes, increased pulse reductions, and / or the need for a longer stroke length in an air pump or pulse generator 804. tire to generate the requested pressure. Additionally, the leak detection module 306 can identify air leaks caused by disconnected air lines and poorly seated receiver tubes or pacifiers. Module 306 will display a warning 1292, as shown in Figure 30, requiring the user to address the leak. The Leak Detection Module 306 can automatically and continuously monitor the 100 NNS during assessment and therapy sessions.

The NNS application 204 also includes the research module 308 that allows a user of the NNS system 100 to perform various research protocols and experiments. In particular, the investigation module 308 receives and transmits data to an input / output (I / O) port of the computing device 102 or to the real-time controller 800 of the pulse generation system 106. The I / O port, in turn, can be in communication with any of a variety of external instruments for investigation.

ES 2 811 100 T3

In various other aspects, the NNS therapy and assessment application 204 may include additional modules for other functions, including those typically associated with medical or rehabilitation facilities. By way of example and without limitation, the NNS application 204 may also include a billing module to interface with an existing billing system or a printing module to print various data, medical records, or reports.

Figure 10 illustrates a procedure for conducting an assessment session to capture and analyze the NNS pattern of a patient in accordance with one aspect of the NNS system 100. In step 1000, a user of the NNS system 100 selects a patient from a displayed list of patients. Next, the user selects a control button to enter the NNS application 204 assessment mode at step 1002 and selects the initiate reassessment control button 1224 at step 1004. The assessment session is configured as desired in step 1006 based on the patient's age, injuries, or other patient data 702, and optionally data 704 regarding the patient's assessment history. The orofacial stimulator apparatus 108 is calibrated in step 1008, while the patient is positioned to encourage a rooting response to the orofacial stimulator apparatus in step 1010. At step 1012, the assessment session is initiated, while the orofacial stimulator apparatus is brought into contact with the patient's lips and mouth in step 1014. In other aspects, the orofacial stimulator apparatus 108 is inserted into the patient's mouth. at step 1014. Similarly, in other respects, steps 1012 and 1014 can be reversed.

Once the assessment session is complete, the r orofacial stimulator 108 is removed from the patient in step 1016. After the feature extraction sub-module 406 analyzes the collected assessment data, using the input form 1274 generated by post-assessment review module 508 After the assessment session, the user can initiate another assessment session for the same patient or a different patient. Alternatively, the user may exit the NNS application 204.

FIG. 11 illustrates a procedure for conducting a therapy session to involve a patient's sCPG to generate an NNS pattern organized in accordance with one aspect of the NNS system 100. In step 1110, a user of the NNS 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 in step 1102 and then selects a control button 1278 to initiate new therapy in step 1104. The therapy pulse profile to be generated during the therapy session is selected from the therapy pulse profile data 708 in step 1106 and in step 1108, the therapy pulse profile is configured as desired based on patient age, injury or other patient data 702 and any of the patient NNS assessment data 704. The orofacial stimulator device 108 is calibrated in step 1110, while the patient is positioned to encourage a rooting response to the orofacial stimulator device in step 1112. In step 1114, the therapy session is initiated, while the orofacial stimulator device it is brought into contact with the patient's lips and mouth in step 1116. In other aspects, the orofacial stimulator apparatus 108 is inserted into the patient's mouth in step 1116. Similarly, in other respects, steps 1114 and 1116 can be reversed. During the therapy session, the user can try to keep the patient as still as possible.

Once the therapy session is complete, the orofacial stimulator apparatus 108 is removed from the patient at step 1118. The user can provide summary comments regarding the therapy session at step 1120 using the generated GUI input form 1274. by post-therapy review module 606. After the therapy session, the user can start another therapy session for the same patient or a different patient. Alternatively, the user may instead exit the NNS application 204.

It will be appreciated that the device of the present invention can be incorporated in the form of a variety of embodiments, only a few of which have been illustrated and described above.