Pacifier system for studying and stimulating the human orofacial system

The present subject matter is suited for evaluating biomechanics and electrophysiology of an infant's orofacial system during sucking. The present subject matter includes at least one orofacial sensor and a processor. In various examples, the present subject matter additionally includes one or a combination of: a pacifier having a baglet, a receiver assembly, a stimulation device, a memory, a display, and data acquisition and analysis software. Advantageously, the present subject may non-invasively sample and analyze suck and may stimulate nerve endings in the face of an infant.

TECHNICAL FIELD

This patent application pertains generally to system and methods for evaluating animals, and more particularly, to systems and method for studying and stimulating a human orofacial system.

BACKGROUND

The developing brain of a typical human fetus adds thousands of neurons per minute. During fetal development and at birth, neural cells link to specific neurological functions. It follows that a newborn infant's brain develops neuron-neurological function connections in light of post birth experiences.

In premature birth, the premature infant loses opportunities for safe neurological development in utero. This loss can be compounded by medical complications associated with premature birth, such as strokes or hemorrhages. Further, medical complications often are treated with painful procedures which correlate with impairment in neurological development. Each of these stresses can affect a premature infant's ability to suck, swallow, or breathe on their own. Such impairments can affect the development of intelligence and speech.

This problem affects several hundred thousand babies annually in the United States. Many of these babies suffer with a partially developed nervous system, respiratory system, and/or other anatomy. Fortunately, since the brain continues to develop throughout life, damaged neurological networks can be overcome by early detection and treatment. However, many of these neurological impairments and developmental disabilities are not discovered using available diagnostic tools. What are needed are new tools to identify problems earlier.

SUMMARY

Various embodiments of the present subject matter include a system for testing suck capabilities and the mechanically evoked trigeminal-facial reflex in premature babies, newborns, and infants. In various embodiments, the system includes at least one orofacial sensor and at least one processor.

Various embodiments of the present subject matter apparatus and methods for analyzing subject's suck using a force-feedback sensing approach.

In one embodiment, the present subject matter provides a system for use with a subject having a mouth, the system comprising: a baglet, adapted for non-nutritive sucking on by the subject; a plurality of orofacial sensors, adapted to sense at least one non-nutritive suck signal and at least one facial musculature signal, the plurality of orofacial sensors including a plurality of electrodes configured to sense the at least one facial musculature signal; a processor, adapted to receive the at least one non-nutritive suck signal and the at least one facial musculature signal; and a stimulus device configured to apply a mechanical stimulus on tissue of the subject outside of the subject's mouth, the stimulus device using at least one sensor for operating the stimulus device under force-feedback, such that the stimulus device is programmed to follow movement of at least a portion of the tissue outside of the subject's mouth to impart stimulus delivery, wherein the processor is configured to automatically compute a non-nutritive suck profile indication using one or both of: the at least one non-nutritive suck signal and the at least one facial musculature signal, and to compute a suck deficiency indication using, at least in part, the non-nutritive suck profile indication and a predetermined suck profile, and the stimulus device provides the stimulus based, at least in part, on the suck deficiency indication.

In one embodiment, the present subject matter provides a system for evaluating an orofacial system of a subject having a mouth, the system comprising: a plurality of orofacial sensors including a plurality of electrodes configured to sense at least one facial musculature signal from the subject; a processor, adapted to receive each facial musculature signal; and a stimulation device, coupled to the processor and configured to impart a stimulus to the orofacial system of the subject adjacent to the subject's mouth, the stimulation device operated using a force-feedback configuration, such that the stimulation device is programmed to follow movement of at least a portion of the orofacial system adjacent to the subject's mouth to impart stimulus delivery, wherein the processor is adapted to compute a non-nutritive suck profile indication using the at least one facial musculature signal and to compute a suck deficiency indication using, at least in part, the non-nutritive suck profile indication and a predetermined suck profile.

In one embodiment, the present subject matter provides a system for evaluating an orofacial system of a subject having a mouth, the system including a baglet, adapted for non-nutritive sucking on by the subject; a plurality of orofacial sensors, adapted to sense at least one non-nutritive suck signal and at least one facial musculature signal; a processor, adapted to receive each non-nutritive suck signal and each facial musculature signal; a stimulation device, coupled to the processor and adapted to impart a stimulus to the orofacial system of the subject near the subject's mouth, the stimulation device operated in a force-feedback configuration, such that the stimulation device is programmed to follow movement of at least a portion of the orofacial system adjacent to the subject's mouth to provide stimulus delivery; and a display device, coupled to the processor, wherein at least one orofacial sensor comprises a plurality of electrodes, and wherein the processor is adapted to compute a non-nutritive suck profile indication using one or both of: the at least one non-nutritive suck signal and the at least one facial musculature signal and to compute a suck deficiency indication using, at least in part, the non-nutritive suck profile indication and a predetermined suck profile.

In one embodiment, the present subject matter provides a method comprising: sensing a non-nutritive suck signal from a subject; sensing electrical potential information of the subject's perioral musculature; computing a non-nutritive suck profile indication using one or both of: the non-nutritive suck signal and the electrical potential information; comparing the non-nutritive suck profile indication to a predetermined suck profile; and providing a stimulus to the subject's tissue adjacent to the subject's mouth, the stimulus based, at least in part, on comparing the non-nutritive suck profile indication to the predetermined suck profile, the stimulus applied using a force-feedback approach programmed to follow movement of at least a portion of the tissue adjacent to the subject's mouth to provide stimulus delivery.

In one embodiment, the present subject matter provides a method including coupling a plurality of orofacial sensors to a processor; coupling a stimulation device to the processor, the stimulation device configured to produce a physical force on a subject's orofacial system adjacent to the subject's mouth and to operate under force-feedback, such that the stimulation device is programmed to follow movement of the subject's orofacial system adjacent to the subject's mouth to impart effective stimulus delivery; and mounting the plurality of orofacial sensors, the processor, and the stimulation device in a device adapted to interface with orofacial tissue, wherein at least one orofacial sensor is adapted to sense a non-nutritive suck signal, wherein at least one orofacial sensor is adapted to sense electrical potential information from orofacial tissue, and wherein the processor is adapted to compute a suck profile indication using one or both of: the non-nutritive suck signal and the electrical potential information, and to compute a suck deficiency indication using, at least in part, the non-nutritive suck profile indication and a predetermined suck profile.

The present subject matter in various embodiments may allow for the non-invasive, objective, and rapid performance of an electrophysiologic assessment of the trigeminal-facial function and suck biomechanics in infants at risk for neurological impairments and developmental disabilities.

This Summary is an overview of some of the teachings of the present application and not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details about the present subject matter are found in the detailed description and appended claims. The following detailed description and drawings that form a part thereof provide some examples of the present subject matter and are not to be taken in a limiting or exclusive sense. The scope of the present invention is defined by the appended claims and their legal equivalents.

The present subject matter may allow for the non-invasive, objective, and rapid performance of an electrophysiologic assessment of the trigeminal-facial function and suck biomechanics in infants at risk for neurological impairments and developmental disabilities.

DETAILED DESCRIPTION

FIG. 1is a partial side view, having a cut-away, and illustrating a system having a first portion500and a second portion600for interacting with a patient, according to one embodiment of the present subject matter. In various embodiments, the system is adapted for studying the biomechanics and electrophysiology of an infant's orofacial system during non-nutritive sucking. The present subject matter, however, additionally is adapted for study of other biomechanics and electrophysiology. In various embodiments, a system100includes a housing102to accommodate, among other things, a motor104and a receiver assembly106. Attached to the motor104may be a stimulus applicator134, in various embodiments. In some examples, an adjustable size relation may exist between the stimulus applicator134and the receiver assembly106. For example, some embodiments use larger stimulus applicators134paired with smaller receiver assemblies106. Additional embodiments pair smaller stimulus applicators134with larger receiver assemblies106.

In various examples, the receiver assembly106is instrumented with an orofacial sensor, such as a suck sensor, to sense a suck signal from an infant. In various examples, the receiver assembly106is adapted for detachable coupling of a pacifier110via a ring-groove configuration. In one example, the pacifier110used in system100is a medical grade silicon pacifier, such as a SOOTHIE pacifier. SOOTHIE is a registered trademark of Children's Medical Ventures, Inc., which is incorporated in Delaware. Other pacifier makes and models additionally fall within the scope of the present subject matter. Various embodiments use pacifiers available in at least three sizes: micro-premature infants, premature infants, and term infants.

In some examples, the pacifier110includes a baglet112having a baglet opening114and a baglet base116. In some example, the pacifier110further includes a baglet cavity118. In some examples, the suck sensor is pneumatically coupled to the baglet opening114to sense the suck signal from the infant when the pacifier is inserted into the infant's mouth. Various examples of suck sensors are discussed herein. In various examples, the system100includes one or more orofacial sensors, such as facial musculature sensors, to sense one or more facial musculature signals from the infant. In some examples, the one or more sensors each include an electrode that is positioned at or near the baglet base116. Various examples of facial musculature sensors are discussed herein.

Various examples of the present subject matter include a processor122, which may co-exist with a timing circuit. In one example, the processor122is electrically coupled to the suck sensor108to receive the suck signal, and is further electrically coupled to each facial musculature sensor120to receive the one or more facial musculature signals. In some examples, both the suck signal and the facial musculature signals are first received by a sense detection circuit124before being communicated to the processor122. In various examples, the processor122uses the suck signal and the facial musculature signals to execute instructions to compute a suck profile indication. In some examples, the processor122uses only the facial musculature signals to execute instructions to compute the suck profile indication.

The suck profile indication provides a summary of the infant's suck capabilities, which may be compared with a predetermined suck profile, in various embodiments. In some embodiments, sensed suck and facial musculature signals are included in the suck profile indication. Various embodiments provide a suck profile indication of one or more similarly-aged neurologically intact infants. For example, some embodiments provide a suck profile indication for infants not suffering from neurological impairments or developmental disabilities.

In addition to computing the suck profile indication, the processor122, in various examples, also executes instructions to compute a suck deficiency indication. In some examples, the suck deficiency indication is computed using the suck profile indication and one or more predetermined suck profiles. In various examples, the one or more predetermined suck profiles are stored in a memory126of the processor122. In some examples, the one or more predetermined suck profiles are communicated to the memory126by way of an external user interface128. The external user interface128provides an input device for a user and is communicatively coupled to the processor122, in various embodiments.

In various examples, the processor122is electrically coupled to a stimulus control module130. The stimulus control module130, in various embodiments, is configured to adjust or initiate a stimulus based on the suck deficiency indication computed by the processor122. Some embodiments include a punctuate mechanical stimulus. The stimulus control module130adjusts or initiates a stimulus by generating a stimulus control signal. In various embodiments, stimulus control module130communicates a stimulus control signal to an output circuit132. Upon receiving the stimulus control signal, the output circuit132may in turn activate the motor104, in various examples. In various examples, the motor104receives electrical communication from the output circuit132and transduces such communication into a mechanical action. In one example, the motor104is a linear motor which transposes the electrical communication to one or more linear displacements. In some examples, a stimulus applicator134is mechanically coupled to the motor104and imports the mechanical action to the infant's face. One type of mechanical action is displacement, but others additionally fall within the present scope.

In various embodiments, the motor104includes at least one stimulation device sensor to sense information related to the stimulus applicator's134impact against the subject. In various embodiments, the sensor measures impact against the subject's face. Additional sensors sense the stimulus applicator's position relative to the housing102. The sense circuit124, in various embodiments, is capable of receiving sense information from the at least one stimulation device sensor. Various embodiments provide sense information to the processor122. The processor122is adapted to analyze the sense information and compare it to available stored data. Various embodiments use this sense information to improve patient satisfaction, by reducing harmful force subjected to the face. In one embodiment, this is accomplished by the processor122through computation of a signal directing movement of motor104. In some examples, such signal is communicated to the motor104by way of the output circuit132.

Various embodiments include one or more displays136, to project data sensed by a suck sensor, data sensed by the facial musculature sensors120, and/or the at least one stimulation device sensor. In various embodiments, the display additionally projects data analyzed by the processor122. In various embodiments, the display projects data entered via the external user interface128. In some embodiments, data displayed on one or more displays136is visible in real time.

In various examples, the memory126is configured to one or more predetermined suck profiles. Memory126, in various examples, is additionally configured to store a history of one or a combination of the suck signal, the facial musculature signals, the suck profile indication, the suck deficiency indication, the stimulus control signal, the force information (e.g., force signal), and/or the displacement information (e.g., displacement signal).

FIG. 2is a schematic diagram illustrating a patient measurement system100having a first portion500and a second portion600, according to one embodiment of the present subject matter. In various embodiments, the system100is capable of studying the biomechanics and electrophysiology of an infant's orofacial system during non-nutritive sucking. In various embodiments, the system includes an orofacial sensor, such as a suck sensor108; a motor104; numerous stimulation device sensors144,146; numerous orofacial sensors, such as facial musculature sensors120; and/or a processor122. In some examples, system100is powered by plugging an integrated cord into an electrical outlet. In another example, the system100is powered by one or more batteries which may provide for greater mobility. Other power sources may also be employed without departing from the scope of the present subject matter.

In one example, the suck sensor108senses a suck signal from an infant and communicates the signal to the electrically coupled processor122. In one example, the suck sensor108is pneumatically coupled to a pacifier110having a baglet112. In various embodiments the suck sensor108generates a suck signal when the baglet112is inserted into the infant's mouth and sucked on by the infant. In various embodiments, the suck signal is amplified by a suck amplifier140to provide an amplified suck signal. The amplified suck signal may be used by a suck comparator142and converted from an analog signal to a digital signal. The suck comparator142is adapted to compare the amplified suck signal sensed from the infant to one or more predetermined suck profiles. As discussed above, the one or more predetermined suck profiles are based on observations from similarly-aged infants who are neurologically intact. In various examples, the one or more predetermined suck profiles are stored in a memory126. After comparing the amplified suck signal to one or more predetermined suck profiles, the suck comparator142can compute a suck deficiency indication.

Based on the suck deficiency indication, in various embodiments, the processor122may execute instructions to compute a stimulus control signal to activate the motor104, which may be adapted to stimulate the infant. In various examples, the stimulus control signal is sent to a motor comparator148. In additional embodiments, the stimulus control signal is amplified by a motor amplifier150to provide an amplified stimulus control signal. The amplified stimulus control signal, in some examples, moves motor104, which causes movement of a stimulus applicator relative to an infant's face. In various embodiments, movement depends on signals provided to the processor122by at least one stimulation device sensor. In one example, the motor104is a linear motor coupled to a stimulus probe. In an additional example, the stimulus probe acts as the stimulus applicator.

In some embodiments, the motor is adapted to allow for up to 8 mm of tracking displacement. In additional embodiments, the motor is adapted to allow for up to 15 mm of tracking displacement. Other tracking displacements are additionally within the scope of the present subject matter. Varying embodiments of the present subject matter allow for tracking displacement under forced feedback conditions.

In some examples of the present subject matter, the motor104may be integrated with numerous stimulation device sensors, such as a load cell144and a differential variable reluctance transducer (DVRT)146. The load cell144provides force information (e.g., via a force signal) of the motor104by transposing force into an electrical signal, in various embodiments. In one example, the force signal is amplified by a force amplifier152and is used by the motor comparator148and converted from an analog signal to a digital signal. The motor comparator148compares the amplified force signal to a predetermined, preprogrammed force threshold to ensure the stimulus applicator134does not harm the infant's face, in various embodiments. In some examples, the DVRT146provides position information of the motor104by transposing motor displacement into an electrical signal. In one embodiment, position information is based on a displacement signal. In one example, the displacement signal is amplified by a displacement amplifier154and converted from an analog signal to a digital signal.

The instrumentation of the load cell144and the DVRT146with the motor104allows the stimulus applicator134(FIG. 1) to operate under force-feedback for stimulus delivery and real time force tracking, in various embodiments. Force-feedback signifies that the stimulation device may be programmed to closely follow the infant's face to accurately import one or more stimuli to the same. In one example, the stimulus applicator may follow the infant's face in real time. Such real time tracking allows the stimulus applicator to import accurate, effective stimulus delivery whether or not the infant's face is moving.

In one example, numerous facial musculature sensors120each include an electrode. In one example, the electrodes non-invasively sense and provide to the electrically coupled processor122one or more facial musculature signals. In one example, eight electrodes are divided into four channels of signals. The facial musculature signals are amplified, in various embodiments, by numerous facial musculature sensor amplifiers138and are converted from analog signals to digital signals by way of one or more signal conditioners. In one example, the facial musculature signals are amplified by GRASS P511 Bioamplifiers, which are manufactured by Grass Telefactor, a division of AstroMed of 600 East Greenwich Avenue, West Warwick, R.I. 02893. In one example, the facial musculature signals are converted from analog to digital signals by a 16-bit front end analog-to-digital card manufactured by National Instruments, Inc., of 11500 N Mopac Expressway, Austin, Tex. 78759-3504. Other amplifiers and signal conditioners are also possible without departing from the scope of the present subject matter. As will be discussed in greater detail below, the facial musculature sensors120may be used to sense activity the infant's brain is sending to the infant's face during sucking.

In various embodiments, the processor122can be configured to store, in real time, a history of one or a combination of the suck signal, the facial musculature signals, the suck deficiency indication, the stimulus control signal, and/or the force and displacement signals. Further, in various examples, the processor122is programmed to analyze and display, in real time, one or a combination of the suck signal, the facial musculature signals, the suck deficiency indication, the stimulus control signal, and/or the force and displacement signals. The real time storing, analyzing, and displaying of data, which is present in various examples of the system100, may be achieved by one or more software programs communicated to the processor122, in various embodiments. In some examples, a first software program is used for data acquisition purposes while a second software program is used to analyze and display the data in real time. In some examples, a single software program is used for data acquisition, analysis, and/or display purposes.

In one example, a software program is capable of real time multi-channel data acquisition, waveform display, and analysis of an infant's sucks biomechanics. One example automatically calculates and displays, in histogram for, suck “burst” periods, suck amplitude, and suck pause periods. In various embodiments, one or more of these data are displayed in real time. Additionally, in various embodiments, the software program is capable of performing frequency domain analysis (e.g., Fourier transforms) of suck burst events. In one example, the software program acquires data in 30 second time periods, with the number of data collection periods only limited by the PC-system's hard drive resources. Time periods of other amounts are also within the scope of the present subject matter. The software program of this example is capable of simultaneously sampling facial musculature from the infant's perioral muscles, including bilateral sampling of orbicularis oris superior and orbicularis oris inferior skin sites.

In various embodiments, a software program is capable of real time multi-channel data acquisition and graphical display of one or a combination of: stimulus control signals, force signals, displacement signals, suck signals, and/or facial musculature signals. The multi-channel data acquisition of some embodiments includes 8 channels, 16-bit, 100 microsecond dwell acquisition. In various embodiments, a software program performs pre-trigger (e.g., 50 milliseconds) and post-trigger (e.g., 100 milliseconds) data acquisition to capture a reflex activation and modulation of the trigeminal-facial reflex response during non-nutritive suck of infants. The software program, in various embodiments, ensures that mechanical stimulation to the infant's face evokes the trigeminal-facial reflex. Additionally, in various embodiments, a software program controls the stimulation in both time and location respects according to a reference to the infant's suck cycle. In one example, the software program is capable of simultaneously sampling facial musculature from the infant's perioral muscles, including bilateral sampling of orbicularis oris superior and orbicularis oris inferior skin sites (e.g., the sphincter muscle around the mouth, forming much of the tissue of the lips). In further examples, the software program of this example is capable of performing digital signal processing including: demeaning, rectifying, integration, and/or signal averaging of facial musculature signals in reference to a mechanical stimulus event.

FIG. 3Ais a perspective view of a first portion500of a system for monitoring a patient, according to one embodiment of the present subject matter. In various embodiments, the system is for studying biomechanics and electrophysiology of an infant's orofacial system during non-nutritive sucking. The present subject matter, however, additionally is adapted for study of other biomechanics and electrophysiology. In various embodiments, the first portion500of the system100includes a housing102to accommodate a motor104and a receiver assembly. Attached to the motor104may be a stimulus applicator134, in various embodiments. In some examples, an adjustable size relation may exist between the stimulus applicator134and the receiver assembly. The receiver assembly, in various examples, is adapted for detachable coupling of a pacifier110via a ring-groove configuration. In one example, the pacifier110includes a baglet112having a baglet opening114and a baglet base116. The baglet112is adapted for sucking on by an infant, in various embodiments.

The first portion500further includes one or more orofacial sensors, such as facial musculature sensors120, in various embodiments. In some examples, each facial musculature sensor120may include an electrode. As discussed above, the facial musculature sensors120may be used to non-invasively sense and provide at least one facial musculature signal from the infant to a processor122. The eight facial musculature sensors120illustrated each include an electrode, in various embodiments. In one example, the eight electrodes are located at the baglet base116and are arranged annularly to mate with a curvature of the infant's face. In one example, the eight electrodes may be 4 mm diameter discs, which are spaced 4.5 mm apart from one another. In another example, the electrodes aligning with the corners of the infant's mouth may include a 2 mm vertical offset. Such spacing and offset may allow each electrode to establish effective communication with the infant's face, and thus, may ensure accurate facial musculature signals are sensed, in various embodiments. In some examples, the facial musculature sensors120are electrically connected to a measurement system by a quick-connect connection155providing for rapid assembly and disassembly.

Mechanically coupled to the motor104is a stimulus applicator134, in various embodiments. In some examples, the stimulus applicator134is a stimulus probe. In one such example, the stimulus probe is 10 mm in diameter and is coupled to a Luer fitting for quick release. Other probe diameters and fittings may also be utilized without departing from the scope of the present invention. In various examples, the motor104receives a stimulus control signal from a processor, which the motor104transposes into a mechanical action, such as a linear motion. In some examples, the linear motion is imported, by way of the stimulus probe, to the infant's orofacial system. In one such example, the infant receives a facial indentation of approximately 600-900 microns during approximately a 10 millisecond time period. In various examples, the onset and timing of this mechanical stimulation is triggered in conjunction with the slope and pressure of the infant's suck. As discussed above, the mechanical stimulus is activated when the measurement system senses a suck pressure signal from the infant which, when compared to one or more predetermined suck profiles, is found to exhibit deficient characteristics. In response, a processor may synthesize a stimulus control signal that activates the motor104.

In various embodiments, by presenting a mechanical stimulus to the face of an infant, neuromuscular activity may be evoked via the trigeminal and facial cranial nerves. Specifically, when a stimulus is presented to the face of the infant, sensory nerve endings that are part of the trigeminal system may be activated. These are known as primary mechanosensory neurons. As a result, nerve fibers in the trigeminal system may be activated and enter the infant's brain stem where inter-neurons link the infant's sensory system to the infant's motor apparatus. Motor neurons have cell bodies in the infant's facial nucleus which “fire” (e.g., activate) upon receiving sensory signals from the sensory neurons. By using one or more orofacial sensors, such as facial musculature sensors120, at least one facial musculature signal (e.g., electromyographic (EMG) signal) may be recorded by the measurement system, in various embodiments. The significance of stimulating neuromuscular activity and measuring the infant's response, according to various embodiments of the present subject matter, is that such acts provide a strong developmental and diagnostic measurement of the infant's sucking capabilities. Additionally, various embodiments provide measurements which are quantitative, objective, and repeatable.

In some examples, the first portion500of the measurement system is adapted to be hand-held by a user. In additional embodiments, first portion500is adapted to be mountable to an external device. Other holding means that allow the measurement system100, or associated subcomponents, to sense one or a combination of: at least one suck signal and at least one facial musculature signal and further import a stimulus to the infant are also within the scope of the present subject matter.

FIG. 3Bis a frontal view of the illustration ofFIG. 3A. In various embodiments, the illustration demonstrates a tool capable of studying the biomechanics and electrophysiology of an infant's orofacial system during non-nutritive sucking. The present subject matter, however, additionally is adapted for study of other biomechanics and electrophysiology. First portion500includes a housing102to accommodate a motor104(FIG. 3A) and a receiver assembly, in various embodiments. In various examples, a pacifier110is detachably coupled to the receiver assembly. In one example, the pacifier110includes a baglet112having a baglet opening114.

In one example, the first portion500includes one or more orofacial sensors, such as facial musculature sensors120, and a stimulus applicator134. In one example, eight facial musculature sensors120, each including an electrode, are positioned annularly on an electrode PC-board156. In some examples, the sensors are positioned on a circuit board for a PC. Various sensor configurations are shaped to mate with a curvature of an infant's face. In one example, the eight facial musculature sensors120are electrically connected to the measurement system by a quick-connect connection155. In various examples, the stimulus applicator134may import a stimulus to the infant's face, such as a corner of the infant's mouth.

FIG. 3Cis a cross-sectional view taken along line3C-3C ofFIG. 3B. The illustration shows a receiver assembly106, a pacifier110, a suck sensor108, and numerous orofacial sensors, such as facial musculature sensors120, according to one embodiment of the present subject matter. It should be noted that other configurations within the scope of the present subject matter are adapted to use orofacial sensors besides suck sensor108. The receiver assembly106may be adapted for a detachable coupling of the pacifier110. Some embodiments of receiver assembly106include a ring-groove configuration. In one example, the detachable coupling is made possible via a receiver assembly106including a cannula105connecting a ball107. In various embodiments, the cannula is stainless steel. Additional embodiments incorporate a ball which includes DELRIN materials. DELRIN is a registered trademark of the E.I. DuPont de Nemours and Company Corporation, 101 West 10thSt., Wilmington, Del. 19898. The receiver assembly, in various examples, is ported for intra-(baglet) cavity118pressure transduction. In various embodiments, the ball107has a circumferential lip109which functions as a retainer for the pacifier110at or near a baglet base116. In one example, pacifier110includes a baglet112having a baglet opening114and the baglet base116. In one example, the pacifier110further includes a baglet cavity118.

In various embodiments, the suck sensor108may sense a suck signal from an infant and communicate such signal to a processor. In some examples, the suck sensor108is pneumatically coupled to the baglet opening114to sense the suck signal. In some examples, the suck signal includes an indication of one or a combination of: a suck intensity, a suck duration, and a suck frequency. In one example, the suck sensor108is positioned within baglet cavity118. In some examples, the suck sensor108is a pressure transducer, such as a pressure transducer manufactured by Honeywell International Inc., 101 Columbia Road, Morristown, N.J. 07962. In one example, the pressure transducer includes a bleed valve with Luer connections. Other pressure transducer makes and models may also be used without departing from the scope of the present subject matter. Similarly, other valves and connections may also be used without departing from the scope of the present subject matter.

Numerous facial musculature sensors120are adapted to non-invasively sense and communicate at least one facial musculature signal from the infant to a processor. In some examples, each facial musculature sensor120may include an electrode. In some examples, each of the numerous facial musculature sensors120is configured to sense at least one facial musculature signal. Additionally, in various embodiments, each of the facial musculature sensors120is configured to sense at least one suck signal. Various embodiments of the present subject matter do not include a suck sensor108.

FIG. 4is a perspective view illustrating orofacial sensors, according to one embodiment of the present subject matter. Various embodiments of the present subject matter use one or more orofacial sensors, such as facial musculature sensors120, capable of studying the electrophysiology of an infant's orofacial system during non-nutritive sucking. The present subject matter, however, additionally is adapted for study of other biomechanics and electrophysiology. In some examples, each facial musculature sensor120includes at least one electrode. In one example, the eight electrodes are arranged in four bipolar pairs providing four separate channels of information about an infant's orofacial system. For example, the spacing between any pair160A,160B,160C, . . . ,160N is constant. Further, in one example, the eight electrodes are arranged annularly to mate with a curvature of an infant's face by way of maintaining spacing160A,160B,160C, . . . ,160N. In one example, each such spacing measurement is 4.5 mm, while each electrode is a 4 mm diameter disc. In another example, the electrodes aligning with the corners of the infant's mouth may include a 2 mm vertical offset. In another example, at least one electrode is composed, at least in part, of gold. In yet another example, at least one electrode is composed, at least in part, of a material including silver/silver-chloride. Other electrode compositions may also be used without departing from the scope of the present subject matter. In a further example, each electrode is doped with CELLUVISC. CELLUVISC is a registered trademark of Allergan, Inc., Irvine, Calif. 92623. The present subject matter additionally includes other electrolyte solutions, to enhance the electrode's ability to sense EMG potentials from the infant's perioral musculature.

In various embodiments, a PC-board ring156accommodates the eight electrodes with spacing, as discussed above, to sense the infant's facial musculature signals. The spacing of the electrodes may be scalable to accommodate various face sizes of infants, in various embodiments. In one example, the PC-board ring156includes a quick-connect connection155, such as a gold plated socket connection to provide communication between the facial musculature sensors120and a plurality of facial musculature sensor amplifiers.

FIGS. 5A and 5Bare graphs illustrating performance of a force-feedback feature of a motor during live non-nutritive sucking in premature infants. Specifically,FIGS. 5A and 5Bgraphically illustrate a force signal provided by a load cell and a displacement signal provided by a DVRT, respectively. As discussed above, in some examples, the motor may be integrated with at least one stimulation device sensor, such as a load cell or a DVRT. As further discussed above, the load cell provides force information in the form of a force signal of the motor104, while the DVRT provides position information in the form of a displacement signal of the motor.

In some examples the suck signal may include information of one or a combination of: a suck intensity, a suck duration, and a suck frequency of an infant's suck.FIGS. 6A and 6Bare graphs illustrating analysis which may be performed by the processor upon receiving a suck signal from an infant during non-nutritive suck. Specifically,FIG. 6Agraphically illustrates one example of a real time pressure waveform indicative of the infant's suck intensity and suck duration.FIG. 6Bgraphically illustrates one example of a real time histogram indicative of the infant's suck frequency.

FIG. 7illustrates one example of a method to study the biomechanics and electrophysiology of an infant's orofacial system during sucking. The method includes sensing a suck signal162from an infant, sensing electrical potential information from perioral musculature164of the infant, computing a suck profile indication166of the infant, and comparing the suck profile indication168to a predetermined suck profile. In various examples, sensing the suck signal162includes inserting a baglet of a pacifier into the infant's mouth, such as before a scheduled feeding (e.g., 15 minutes prior to scheduled feeding). In some examples, sensing the suck signal162includes sensing one or a combination of: a suck intensity, a suck duration, and a suck frequency associated with the infant's suck. In some examples, sensing the electrical potential information164includes utilization of at least one electrode. In one example, one or more electrodes are gold electrodes. In another example, one or more electrodes are silver/silver-chloride electrodes.

In one example, the method includes applying a stimulus170to the infant. In various examples, the method further includes storing a history of one or a combination of: the suck signal, the electrical potential information, the suck profile indication, and the applied stimulus172. In various examples, the method further includes analyzing or displaying one or a combination of: the suck signal, the electrical potential information, the suck profile indication, and the applied stimulus to provide a real time indication of oral activity of the infant. In some examples, applying the stimulus170includes providing or adjusting a mechanical stimulus to the infant's face. In one example, the mechanical stimulus includes importing one or more linear displacements of approximately 600-900 microns in approximately a 10 millisecond time period to the infant's orofacial system.

The present subject matter includes a method of assembling a system. In one example, the method includes coupling an orofacial sensor, such as a suck sensor, with a processor and coupling one or more orofacial sensors, such as facial musculature sensors, with the processor. In some examples, the method further includes pneumatically coupling the suck sensor to a pacifier, such as a baglet of the pacifier. In some examples, the method further includes coupling the suck sensor to a receiver assembly. In some examples, the method further includes integrating each facial musculature sensor with an electrode.

In various embodiments, the method further includes coupling a stimulus control module with the processor. In various examples, the method further includes electrically coupling a stimulation device, such as a stimulus probe, to the stimulus control module. In some examples, the method further includes integrating the stimulation device with force-feedback capabilities. In one example, the stimulation device includes a motor, a stimulus applicator, and at least one stimulation device sensor. In some examples, the method includes mounting the plurality of orofacial sensors, the processor, and the stimulation device in a device, such as a housing, adapted to interface with orofacial tissue of the infant.

It is noted that it is preferable to sterilize all components of the system that come into contact with the infant. One way to sterilize, among many, is by the use of ethylene oxide.

The present subject matter allows for the non-invasive, objective, and rapid electrophysiologic assessment of trigeminal-facial function and suck biomechanics in infants, such as premature infants, at risk for neurological impairments and developmental disabilities. These neurological impairments and development disabilities may include pervasive developmental delays, sensory perception and integration disorders, sensorimotor dysfunction, cognitive impairments, literacy, language, and speech disorders, hemorrhage, respiratory distress syndrome, and oromotor dysfunction. By diagnosing neurological impairments and development disabilities early in an infant's life, the infant may be introduced to appropriate corrective action at an earlier time and as a result, reduce or eliminate the incidence or severity of the impairment or disability detected. Further, infants who use the system may develop higher IQs than their counterparts who were not introduced to the system.

Additionally, the present system may return information to a user regarding how well the infant's brain stem circuits and other parts of the brain are connected. The system may inform the user with information regarding how well the infant is responding when he/she is sucking, including the organization of his/her motor system, suck, duration and frequency, and muscle reflexes—all in real time on a display.

Study

Currently, studies of real time sampling of the biomechanics and electrophysiology associated with non-nutritive suck are underway for both normal term infants and clinical populations in a NICU.

The clinical populations in the NICU include infants experiencing respiratory distress syndrome, oromotor dysfunction, and brain infarcts. A total of 390 premature infants will participate in the study over a four year period concluding in the year 2007. The NICUs participating in the study include: Stormont-Vail Regional Health Center in Topeka, Kans. and Kansas University Medical Center in Kansas City, Kans.