Patent Application
20100137906
This application is related to pacifiers and more particularly to texture nipples for non-nutritive suck entrainment therapy.
Sucking is a precocial motor behavior in humans. However, premature infants often demonstrate oromotor dyscoordination and are unable to suck or feed orally. This inability to feed can delay discharge from neonatal intensive care units and hinder development of coordinated oromotor behavior.
Infants' readiness to feed is often evaluated by their display of non-nutritive sucking (NNS). Typically, NNS begins between 28 and 33 weeks gestational age (GA) and is remarkably stable by 34 weeks.
The brain of a typically developing fetus includes an organized set of neurons in the brainstem and cortex that are involved in the production of centrally patterned rhythmic motor behaviors. These neural circuits are known as central pattern generators or simply “CPG's”. One such rhythmic behavior that is controlled by a CPG is the suck. Under normal circumstances, the human infant is precocial for suck, which means it is a motor behavior that is established in utero and functional at birth. An infant's ability to suck at birth is important for, among other things, getting nourishment and stimulating the infant's developing brain.
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. As a result of the impairment in neurological development, the premature infant may possess grossly disorganized CPG's and therefore exhibit grossly disorganized suck, which itself can lead to other medical complications and a failure to thrive and develop. Other ramifications of disorganized suck may include: ramifications relating to the infant's overall sensorimotor development, perceptual capacity, and even delays in higher cognitive function including speech, language, and other processing skills. There is a need in the art for devices to assist development of organized suck patterns in patients exhibiting disorganized suck
This application provides apparatus including a nipple comprising a bulbous portion, a tubular portion having a central axis and a first end of the tubular portion connected to the bulbous portion, wherein the tubular portion includes a micro-topology texture band about an exterior surface, and a flange connected to a second end of the tubular portion. In various embodiments, a nipple includes a radio frequency identification (RFID) chip.
This Summary is an overview of some of the teachings of the present application and is 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 the appended claims. The scope of the present invention is defined by the appended claims and their equivalents.
The following detailed description of the present subject matter relates to the accompanying drawings which show, by way of illustration, specific aspects and embodiments in which the present subject matter may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present subject matter. References to “an”, “one”, or “various” embodiments in this disclosure are not necessarily to the same embodiment, and such references contemplate more than one embodiment. The following detailed description is, therefore, not to be taken in a tactile spatial resolution limiting sense, and the scope is defined only by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.
In various embodiments, height of the apex of each node 217 from the base is about 0.005 inches, or 125 microns. In various embodiments, the distance between closely neighboring nodes is about 0.008 inches, or 200 microns. A second textured portion 218 includes surface feature ribs 219 extending parallel to the central axis 216 of the tubular portion and equally spaced about the circumference. In various embodiments, the ribs 219 are spaced about 0.008 inches, or 200 microns, from each other. In the illustrated embodiment, the ribs have a triangular cross section. It is understood that ribs with other cross section shapes, spacing and heights are possible without departing from the present subject matter. In various embodiments, nominal uniform height of surface features range from about 0.125 mm (0.005 in.) to about 0.500 mm (0.020 in.) and nominal spacing of surface features range from about 0.200 mm (0.008 in.) to about 0.500 mm (0.020 in.).
The nipple 210 includes a bulbous end. In some embodiments, the diameter of the bulbous end 211 is greater than the diameter of the tubular portion 212 of the nipple. In various embodiments, the diameter of the tubular portion 212 is about 12 mm. and the diameter of the bulbous end 211 is about 13 mm. It is understood that other diameters and combination of diameters for the bulbous end and tubular portion of the nipple are possible without departing from the scope of the present subject matter.
The texture of the bulbous end includes a pattern of surface features about the exterior surface. The pattern is formed from rows of individual surface feature nodes extending from the distal end of the bulbous end of the nipple toward the tubular portion of the nipple. In various embodiments, the rows of nodes define a helical pattern where the rows extend about the circumference of the bulbous portion while also extending to the tubular portion. It is understood that other texture patterns and shaped texture areas are possible without departing from the scope of the present subject matter. In various embodiments, surface features are arranged such that the space between the apex of each neighboring surface feature forms a pattern of surface features to reinforce interactions with mechanoreceptors and second- and third-order neural receptor networks present in trigeminal pathways. In various embodiments, surface features within a pattern have a uniform nominal height in a range from about 0.125 mm (0.005 in.) to about 0.500 mm (0.020 in.) and uniform nominal spacing in arrange from about 0.200 mm (0.008 in.) to about 0.500 mm (0.020 in.).
In various embodiments, the RFID chip 444 is programmed with information, such as a unique code, to identify the nipple and information related to the nipple 440. For example, information related to the nipple may include, but is not limited to, the nipple manufacturer, the model of the nipple, nipple dimensions, texture patterns on the nipple, one or more unique identification codes for identifying the nipple, a patient assigned to the nipple, or combinations thereof. An example of a RFID chip for use with a nipple according to various embodiments of the present subject matter is the “μ-Chip” made by Hitachi measuring 0.05 mm×0.05 mm×5 μm thick. It is understood that nipples with other RFID chips are possible without departing from the scope of the present subject matter.
Nipples according to various embodiments of the present subject matter may be used as part of a system to sense, diagnose and/or treat non-nutritive suck (NNS). In one example, a device 446 designed for sensing, diagnosing and treating NNS includes a RFID reader to wirelessly 445 read the RFID chip 444 and collect information related to the nipple 440. The information related to the nipple may be used for a number of operational and security purposes including, but not limited to, setting operational parameters of the non-nutritive suck device, preventing improper or unauthorized use of a nipple with a NNS device or combinations thereof. For example, in various embodiments, a nipple with a RFID chip includes texture, such as discussed above, for stimulating orofacial nerves in a patient's lips and mouth during NNS entrainment therapy. Information related to the texture and to the patient is identified using a code read from the RFID chip 444. The identified information may be used to set operational parameters of a NNS device 446 related to the particular nipple and the patient's particular NNS stimulation therapy.
This application is intended to cover adaptations and variations of the present subject matter. It is to be understood that the above description is intended to be illustrative, and not restrictive. The scope of the present subject matter should be determined with reference to the appended claim, along with the full scope of equivalents to which the claims are entitled.
