WO2019005740A1 - Baby bottle device - Google Patents

Baby bottle device Download PDF

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Publication number
WO2019005740A1
WO2019005740A1 PCT/US2018/039417 US2018039417W WO2019005740A1 WO 2019005740 A1 WO2019005740 A1 WO 2019005740A1 US 2018039417 W US2018039417 W US 2018039417W WO 2019005740 A1 WO2019005740 A1 WO 2019005740A1
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Prior art keywords
bottle
baby bottle
sensor assembly
baby
recited
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PCT/US2018/039417
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French (fr)
Inventor
Michael R. DETMER
Rebekah R. GOSSOM
Douglas Jackson
Saliya KIRIGEEGANAGE
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University Of Louisville Research Foundation, Inc.
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Publication of WO2019005740A1 publication Critical patent/WO2019005740A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J9/00Feeding-bottles in general
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/60ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to nutrition control, e.g. diets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/70Device provided with specific sensor or indicating means

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Primary Health Care (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A baby bottle device for use with a baby bottle comprises: a software program installed and running on an external device; a bottle sensor assembly that is configured to fit inside of or on an external surface of a baby bottle, the bottle sensor assembly including one or more sensors for determining when the bottle is being used and a transceiver for communicating data or instructions to the software program. Upon receipt of data or instructions from the bottle sensor assembly, the software program initiates an action, such as the playback, of a sound recording.

Description

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
International Patent Application
for
BABY BOTTLE DEVICE
CROSS-REFERENCE TO .RELATED APPLICATIONS
|0 I0 j The present invention claims priority to U.S. Patent Application Serial No, 62/524,982 filed on June 26, 2017 d U.S. Patent Applieation Serk! No. 62/548,123 led August.21„ 2017, the entire disclosures of which are i ncorporated herei n by reference.
i STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
|0§02 j This invention was made with government support under U0 I HL127518 awarded by the National Institutes of Health. The government has certain rights in the invention..
BACKGROUND OF THE INVENTION
j :0003] The present invention relates to a baby bottle device and providing reinforcement or biofeedback to the infant in direct response to the infant's use of a baby bottle.
[0004]' Parents of children world wide are concerned about feeding problems. Fi fty percen t of mothers claim at least one of their children eat poorly (Keraier, 2013), Feedin is one of the most complex and important activities in the first months of life. It requires the successful integration of many interrelated bodily functions, including sensory integration, physiologic maturity, coordination of the suck-swallow-breathe reflex, and oral motor skills. Most premature infants demonstrate functional oral feeding fay thirty-six gestaiionai weeks (Sundseth Ross, 2013), and most term infants demonstrate this skill on the first day of life. If the
nenrodevelopniental milestone of successful oral feeding ability is missed, acquisition of feeding skills at a later time is more' difficult, or impossible (Rommel, 2003),
10005] Feeding problems are seen in up- to 45% of typically developing children and up to 80% of those with developmental delays (Boyle, 201. 1; Capilouto, 2016; Lmscheid, 2003;
Phalen, 2013), accounting for approximately 57% of all children, or 2.26 million children per year (Martin. 2016), In a national random sample of 3,022 infants, 1 % of caregivers with infants between 4- months reported feeding issues, with an increase to 50% at 1 -24 month (Cairath, 2004), Earlier studies revealed 25-30% of infants presented with feeding issues within the first 4-6 months (Forsyth, 1 85; Lindberg, 1991), with more than 10% having ongoing problems (Lindberg, 1 1 ), The most frequent isolated oral feeding problems have been linked to socking (23%) and were sensory-related (20%) (Rommel, 2003). Of note, nipple feeding via breast or bottle is the most common and recommended practice during the first six months (American Academy of Pediatrics, 2012).
(Ό0Ο6] Feeding problems are most commonly attributed to the difficult transition from breast-feeding to bottle-feeding, prematurity or a history of prematurity, developmental disorders, and structural issues. One in three infants with feeding problems exhibit milk refusal from the bottle when they are transitioning from breast to bottle-feeding due to the mother needing to return to work or if her milk supply is not meeting the mitritionai requirements of the infan (Levine, 2011). This m y be due to learned aversions to an artificial nipple, disinterest in. a novel nipple, or decreased respiratory stability during bottle-feeding as it is less paced than breastfeeding (Ross, 2015), Oftentimes, underlying issues can go unnoticed durin
breastfeeding, but become much more apparent and problematic when transitioning to the bottle.
[0007j Additionally, 10-1 1 % of international live births, which is approximately 15 million children per year, are premature births (Belizan, 2013; Centers for Disease Control and
Prevention, 2016). These children, compared to their counterparts, are almost four times more likely to have feeding problems (Samara, 2009), with earlier birth correlated with a higher prevalence of feeding difficulty (Sundseth Ross, 2013). .Alarmingly, neonatal intensi ve care unit graduates with respiratory or gastrointestinal diagnoses, primarily feeding disorders, account for one in four of all hospital readmissions within the first year of life, which are among the most expensive hospital readmissions ranging from $4153 - $904 (Underwood, 2007), Furthermore, approximately 30% of premature infants continue to be underweight across the early childhood years (Sundseth Ross, 2013), and infants bom prematurely with a history of feeding difficulty are more likely to have a language delay at 18 months adjusted age (Adams-Chapman, 2013),
('0008] Infants with, structural issues such as tongue-ties, which are found in 4-10% of newborns (O'Shea, 2014), commonly have feeding problems, and infants who do not undergo division - a surgical procedure to correct the tongue-tie - show no improvement following traditional support, from a. lactation consultant (Hogan, 2005). Children with disabilities, such as cerebral palsy, down syndrome, or autism spectrum disorder, also commonly exhibit feeding problems (Pineda, 2016). n tact. Sharp and colleague's (2013) meta-analysis revealed children with autism spectrum disorder experienced significantly more feeding problems than their typically developing peers.
(OOOSfJ' Finally,, hospitalized infants who are discharged home to receive tube feedings, either gavage or gastrostomy, which is over 25% of infants born prematurely (Jadcherla, 2010), demonstrate feeding problems when transitioning to oral feeding (Mason, 2005).
(0010] Successful oral feeding is a neorodevelopmental progression thai must occur to: (a) provide sufficient nutrient intake, which is critical to optimize the brain's capacity; (b) develop motor function; (c) optimize sensory processing; and (d) motivate social prowess. Hemmi and colleague's (201 ) meta-analysis revealed children with.a-history of feeding issues show more behavioral problems including anxiety, depression, ADHD, and aggression. Furthermore, those wi th a histor of feedin g problems , not including premature infants or those with a histor y of anatomical, structural, or developmental disorders., are almost four times more likely to have a language .impairment (Malas, 2017). While it is known that early and adequate management of feeding problems is critical to avoid adverse developmental delays, feeding-related concerns in preschool children are among the most common issues seen by primary healthcare professionals (Arvedson, 2008).
('0011] Feeding problems are primarily addressed by parents using trial and error with different nipple types and recommendations from other parents, or from medical professionals. Persistent or severe problems may be treated in an outpatient setting by pediatric speech.- language pathologists or occupational therapists after a referral from, a pediatrician. Traditional methods to address bottle refusal include, but are not limited to, behavioral 'modifications, positioning techniques, thickening of liquids, desensitizarion exercises, diet modifications, and changes in the nipple/flow of the bottle; however, the evidence for these interventions is limited (Miller, 201 1 ), Some clinicians use therapeutic aids such as the Z-Vibe® or an electrical stimulation device called the Vita.lSt.im©. (Z-Vibe© is a registered trademark of ARK
Therapeutic Services, inc. of Columbia, 'South Carolina, and VkalStim© is a registered trademark of DJD, LLC of Vista, California.) Another commercially available product for use with premature infants is the fa t® Feeding Solution, which includes an. apparatus attached to a bottle to detect sucking behavior and provides objective data to help clinicians guide premature infants to a safe and healthy transition to independent oral feeding, (nfant© is a registered trademark of Nfant Labs, L LC of A tlanta, Georgia .) However, these products can only be used to collect data, develop oral motor strength, or decrease oral aversion; they cannot be used to provide operant conditioning during bottle feeding.
|0i!12| Music is a highly engaging, attention-sustaining., and reinforcing stimuli for infants (Standley & Walworth, 2010). Music is believed to be the only stimuli that can diffusely activate the brai and may enhance learning of .new behavior due to its ability to stimulate dopaminergic regions of the brain, which s related to motivation and reward-seeking behavior (Stegemoller, 2014). The use of music as a contingency is strongly supported by research to teach infants new behaviors (Larson, 1 90; Standley, 1996; Robertson, 2017) including those related to feeding (Chotna, Slaughter, Wang, Stark, & Maitre, 2014); a meta-analysis of 98 contingent music studies demonstrated that the benefits of contingent music are almost three standard deviations greater tha control baseline conditions, with an extremel large effect size of 2.90 (Standby, 1996), in addition, Standley ( 1996) found that music is more effective than other contingent non-music stimuli and more effective than music played continuously. Standley, Walworth, Hillmer, Strutzel, & Robertson (20.13) played contingent music as a reward for spontaneous breaths with premature infants who were dependent on ventilator assistance for three 30-mtnute sessions d uring their first week of ventilation and revealed a 40% reduction (14.5 days) in length of ventilation infants born at 28 weeks gestation or less, Robertson (2017) also found mothers who used contingent lullaby singing compared to control mothers were able to significantly reduce the duration of their fu!l-temi newborn's cryin 'and improve positive parent-infant interaction behaviors during the first six weeks of life. Chorna et. a.l. (2014) found that the mother's singing voice as a contingency for sucking on a pacifier resulted in
significantiy increased oral feeding rates, oral volume intake, oral feeds/day, and faster time to fell oral feeds.
[0013 j Furthermore, the mother's voice is an important component for successful behavior modification when using contingent music techniques with infants., By 40 weeks gesta ion, infants demonstrate a strong preference for what they like to hear, with their mother's voice being their favorite, especially in a higher-pitched, sing-song style (Milford, 2010). Doe to this preference, the mother's singing as reinforcement is the optimal reward, infants respond best to sung lullabies as they are repetitive, predictable, relatively unchanging, and contain inherent music elements, including falling melodic lines, major keys, and a steady riiythmic pulse, that allow the infant to maintain a calm state (Detmer & Whelan, 2017; Standley, 201 ),
('0014] Additionally, parents who use music with their child show improved bonding, attachment, and positive social behaviors (Edwards, 2011; Robertson, 2017; Walworth, 2009). Infants who receive contingent parental singing during feedings are expected to exhibit improved secure-attachment and positive social behaviors with parents.
10015} Finally, exposure to the lullaby singing, particularly the mother's voice, is important for speech and language development (Mc ahon, Winteraiark, & Lahav, 2012; McMullen & Saffran, 2004), Infants who listen to their mother's singing voice frequently, such as with each feeding, are expected to demonstrate improved long-term speech and language skills.
('0016]' One commercially available music -based device sed to address feeding "skills in premature infants is the Pacifier Activated Lullaby, which is sold and distributed by Powers Medical Devices, LLC of Boca Raton, Florida. This device is. specifically designed to improve non-nutritive sucking (i.e., using a pacifier, not a bottle) to improve nipple feeding in preterm infants in the neonatal intensive care unit, but this device cannot be used to provide contingent music in response to feeding from bottle. It can only be used with a pacifier, and it is only approved b the FDA to be used with infants with an adjusted gestation age of up to two months
[0017} Applicant is unaware of any commercially available products that can be used during bottle feeding to provide .reinforcement or biofeedback to the infant in direct 'response to he infant's use of a baby bottle, and, more particularly, in response the infant's sucking behavior. SUMMARY OF THE INTENTION
[001S] The present invention is a baby bottle device, which provides reinforcement or biofeedback to the infant in direct response to the infant' s use of a baby bottle, and, more particularly, in response to the infant's sucking behavior. In other words, the baby bottle device of th present invention is used to improve motivation and compiiance with botiie-feeding in infants and to improve parent -infant attachment and speech and language skills. The baby bottle device is based on. operant conditioning of sucking ors the nipple of a bottle using positive reinforcement via an action, such as the playback of a sound recording with the voice of a caregiver (e.g., mother) singing a song. Other possible actions for providing such positive reinforcement include, but are not limited to; initiating the playback of a video recording;
illuminating ne' or more lights; triggering an audio or visual alarm; or initiating a mechanical action (such as vibration).
[0019} The playback of the sound recording or other action is contingent and, in response to the infant's sucking, will enhance, reinforce, and encourage nutritive sucking to improve the infant's bottle-feeding skills or interest in bottle-feeding.
[0020] An exemplary baby bottle device made in accordance with the present invention generally includes: a bottle sensor assembly that is configured, to fit inside of or on an external surface of a baby bottle; and a software program in the form of computer-readable instructions installed and running on an external device, such, as a srnartphone, tablet, speaker, or toy.
f0021j lu some embodiments, the bottle sensor assembly incl udes a pressure sensor that detects pressure variations wi thin the baby bottle to determine when the bottle is being used, i.e. , when the infant is sucking on the nipple of the bottle. [6022] In some embodiments, the bottle sensor assembly also includes a motion sensor (such as an aeceleronieter or reed switch) that can detect motion if and when the bottle is being bandied.
[0023] in some embodiments, the bottle sensor assembly also includes a temperature sensor that can be used to detect the sudden change of temperature that will occur when the baby bottle is tipped down.
[0024] The output signals from each sensor are communicated to and received by a microcontroller. Based on the signals received from the sensors, the microcontroller makes a determination as to whether the baby bottle is being used (i.e., whether the infant is sucking on the nipple of the bottle) and then initiates transmission of data about usage of the bottle and/or instructions for initiating an action to the software program via a transceiver.
[0025] in response to receiving data or instructions from the bottle sensor assembly, the software program initiates pl ayback of a sound recording or another action. With respect to the playback of a sound recording, one preferred sound recording would be the voice of a caregive (e.g., mother) singing a song. Other forms of sound recordings could i nclude, but are not limited to; music, another singer's voice, humming, speech, tones, sound effects, radio broadcasts, or white noise.
[0026] In some embodiments, a capsule is configured to house the bottle sensor assembly. The capsule has a generall cylindrical shape and includes an upper flange, so that the capsule can be inserted into the opening of a baby bottle, with the upper flange resting an and engaging the rim of the opening of the baby bottle. In this position, the capsule does not occupy any significant portion of the useable volume of the baby bottle, nor does it interfere with the mating of a nippl e retainer (or collar) to the opening. The capsule defines an interior ca ity that is sized and confi ured to house the bottle sensor assembly, and the pressure sensor is preferably positioned near the top of the capsule just below the nipple. The capsule also defines a channel for liquid to flow from the bottle through the capsule and to the nipple.
DESCRIPTION OF THE DRAWINGS
[0027] FIG, 1 is a schematic view of an exemplary' baby bottle device made in accordance with the present i vention;
[0028] FIG. 2 is a schematic view of another exemplary baby bottle device made in accordance with the present invention;
[0029] FIG. 3 is a plan view of an exemplary bottle sensor assembl y;
[0030]' FIG; 4 is a plan view of an opposite side of the exemplary bottle sensor assembly of FIG. 3;
[0031} FIG. 5 is a perspective view of a capsule that i configured to house the exemplary bottle sensor assembly of FIGS. 3 and 4;
[0032] FIG. 6 is a side-sectional view of the capsule taken along line 6-6 of F G. 5, illustrating the position ing of the exemplary bottle sensor assembly inside of the capsule;
[0033) FIG, 7 is a perspective view of the capsule of FIG. 5 as inserted into the opening of a baby bottle;
[0034] FIG. 8. is a perspective view of the capsule of FSXl, 5 wi th an adapter ring for engaging the opening of a baby bottle with. wider mouth;
[0035] FIGS. 9A and 9B are schematic views of a baby bottle that includes a magnetic element that moves or slides in response to manipulation of the bottle and the force of gravity; and (0036] FIG, 10 is a schematic view of another exemplary baby bottle device made in accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
037 The present invention is a baby bottle device, which provides reinforcement or biofeedback to the infant m direct response to the infant's use of a baby bottle, and, more particularly, in response to the infant's sacking behavior. In other words, the baby bottle device of the present invention is used to improve motivation and compliance with bottle-feeding in infants and to improve parent-infant attachment and speech and language skills. The baby bottle device is based on operant conditioning of sucking on the nipple of a bottle using positive reinforcement via an action, such as the playback of a sound recording with the voice of a caregiver (e.g., mother) singing a song. Other possible actions for providing such positive reinforcement include, but are not limited to: initiating the playback of a video recording;
illuminating one or more lights; triggering an audio or visual alarm; or initiating a mechanical action (such as vibration),
100381 The playback of the sound recording or other action is contingent and, in response to the infant's sucking, will enhance, reinforce, and encourage nutritive sucking to improve the infant's bottle-feeding skills or interest in bottle-feeding, along with improving parent-infant bonding and speech and language development in th infant., The baby bottle devic can be: used by parents or caregi vers in the home en vironment or daycare when the infant is having difficulty transitioning to a voluntary suck patter or transitio ing from breastfeeding or tube feedings, either gavage or gastrostomy, to bottle feeding. It may also be used to promote parent-infant bonding and improved speech and language skills. It may also be used by pediatric speech therapists, occupational therapists, or other healthcare staff in an inpatient or outpatient setting to address feeding motivation or oral aversion in infants. It may also be used by feeding therapists to address oral aversion or other feeding problems in infants.
[0039} FIG. 1 is a schematic view of an exemplary baby bottle device made in accordance with the present invention. As shown, the baby bottle device generally includes: a bottle sensor assembly 10 that is configured to fit inside of o on an external surface of a baby bottle, as further described below; and an external devic 60 tunning software program 62 in the form of computer-readable instructions, to some cases, the external device 60 is a mobile computing device, such as a smartphone or tablet, in which case the software program 62 is in the form of a "mobile app" running on the mobile computing device. In other cases, the external device 60 is a speaker, toy, or similar device that includes a microprocessor with a memory component for storing and executing the software program 62.
[0040] Referring still to FIG. 1 , in this exemplary embodiment, the bottle sensor assembly 10 includes pressure sensor 20 that detects pressure variations within the baby bottle to determine when the bottle is being used, i.e., when the infant is sucking on the nipple of the bottle. In this exemplary embodiment, the bottle sensor assembly 10 also includes a motion sensor 22 (such as an accelerometer) that can detect motion if and when the bottle is being handled, along with the orientation of the bottle .
| 0©4i | Referring stil l to FIG . i , the output si gnals from each of the pressure sensor 20 and the motion sensor 22 are communicated to and received by a microcontroller -30, which includes memory 32 and is powered b a power source 40, such as a battery. Based on the signals received from the sensors 20, 22, the microcontroller 30 makes a determination as to whether the baby bottle is being used ( i .e., whether the infant is sucking on the nipple of the bottle) and then initiates transmission of data abou usage of the bottle and/or instructions for initiating an action to the software program 62 via a transceiver 50.
('0042] In this regard, the motion sensor (accelerometer) may be used to augment the pressure data or may be used as a method to control when and how pressure data is polled. For example, in one exemplary implementation, the motion sensor (accelerometer) 22 detects if a baby bottle is ready for feeding as a result of motion and/or orientation of the bottle. After detecting such movement and/or orientation, the microcontroller 30 polls data- from the press tire sensor 20 to determine whether the infant is sucking on the nipple of the bottle, In other words, the microcontroller 30 determines whether the change in pressure exceeds a predetermined threshold indicative of the infant sucking on the nipple of the bottle, or whether the pressure pattern is indicative of the infant sucking on the nipple of the bottle.
[ΘΘ43] in response to receiving data or instructions from the bottle sensor assembly- 10, the software program 62 initiates playback of a sound recording or another ac tion. With respect to the playback of a sound recording, one preferred sound recording would he the voice of a caregiver (e.g. , mother) sin.¾in¾ a song. Other forms of sound recordings could include, but are not limited to: music, another singer's voice, humming, speech, tones, sound effects, radio broadcasts, or white noise,
[0044] With respect to such initiation of the playback of the sound recording or other action, it is -contemplated and preferred that such action would only be initiated when the pressure- data indicates that the infant is generating enough suck strength to initiate flow of milk through the nipple, and the action will only continue for a predetermined time period (e.g., six seconds, which is a typical pause time between suck bursts), after which the action would cease unless the infant triggers it again via another appropriate suck. (ΘΘ45] As alluded to above, with respect to the playback of a sound recording, music is the preferred form of sound recording. When music is used as the sound recording, it is preferably an acapeila, age-appropriate song at a tempo of about sixty beats per minute, as this rate correlates to a typical infant's nutriti ve suck rate of one suck per second (Wolff, 1968). Playing music at the same optimal rate of the suck causes the infant to coordinate sucking with the music due to the principle of tmtrainrnent. hi essence, entrainnieiit is a process in physics where two oscilla tors lock into phase with one another (Bradt, 2009). In the 'body, it commonly occurs when an autonomic mechanism synchronizes with a strong, external auditory stimuli, such as music (Hart, 201 ). Music entraimnent has been demonstrated to improve a variety of body functions across the lifespan, including speech, gait, motor functions, and respiratory and heart rates. The phenomenon of entrapment is present very early in life, as evidenced by preterm infants who demonstrated significant changes in heart rate and sucking behavior in response to entrained sounds (Loewy, 2013), and a shorter period on ventilator assistance (eight days) when the .tempo of music was matched to infants' respiratory rate and systematically decreased to reach the desired rate of sixty respirations/minute (Standley, Walworth, Hillmer, Strutzel, & Robenson, 2013). Music set to the tempo of an age-appropriate song and played contingently in response to the infant's sucking on a bottle nipple will encourage the infant to suck in a rhythmic and paced manner, an essential skill for effective feeding.
|ΘΘ46| With respect to the use of the voice of a caregiver (e.g., mother) singing a song, it. is contemplated that, when initially setting up the device., the software program 62 will allow the mother to sing along to prerecorded and pre-loaded songs as guides to create the sound recording of the caregiver. In other words, the caregiver would select a song, which would preferably be in either a "low" or "high" key: A and D, respectively, from the a library of recorded music and then record their own live singing over the selected song. Then, during playback, the infant would only hear the caregiver's recording, not the pre-loaded guide song. Alternatively, the caregiver would choose an original song and record to a metronome set at sixty beats per minute, which, as described above, is the optimal suck rate of infants. In this regard, it is farther contemplated' that the software program 62 would provide a flashing image on the screen and/or cause a vibratory pulse of the external device 60 to set to the tempo of the music at sixty beats per minute during the recording session. The resultant sound .recording would then be stored in the library for future use. Finally, it should also be recognized that the caregiver could always choose to use one of the pre-loaded guide songs as the music reinforcement, rather than creating an original recording,
10047] As a farther refinement, the software program 62· can also collect feedi data for the parent, caregiver, or medical professional, including, for example, a number of initiations of the sound recording, a number of times the sound recording stopped, a. umber of sticks per burst, a length of pause time between sucks, a length of a feeding session, a percentage of time spent, actively sucking during the feeding session, and a length of a feeding session. Such feeding data would then allow the user to track, for example, feeding rates, suck rates, and feeding volumes over time.
[Θ048] FIG. 2 is a schematic view of another exemplary baby bottle device made in accordance with the present invention. As shown, the baby bottle device again generally includes : a bottle sensor assembl 110 that is configured to fit inside of or on an external surface of a baby bottle, as further described below ; and a software program 62 in the form of computer- readable instructions installed and running on an external device 60, such as a smartphone or tablet, or even a toy. (8649] Referring still to FIG. 2, in this exemplary embodiment, t e bottle sensor assembly 110 again includes a pressor© sensor 120 that detects pressure variations within the baby bottle to determine when the bottle is being used, i.e., when the infant is sucking on the nipple of the bottle, in this exemplary embodiment, the bottle sensor assembly Ϊ 10 also includes a motion sensor ! 22 (such as an aceelerometer) that can detect motion if and when the bottle is being handled, along with the orientation of the bottle.
[0056] Referring still to FIG. 2, in this exemplary embodiment, the bottle sensor assembly 110 also includes a temperature sensor 124 that can be used to detect the sudden change of temperature that will occur when the baby bottle is tipped down.
[0051 J Referring still to FIG. 2, in this exemplary embodiment, the bottle sensor assembly 1 also includes a reed switch 126, whic can sense the presence of a nearby magnetic component. Thus, the reed switch 126 can sense if the bottle sensor assembl 110 has been remo ved from a storage case containing a magnetic component, thus providing a means for power management. The reed switch 126 can also be used as a means to functionally disconnect the power source, thus effectively serving as a power switch. The reed switch .126 can also sense the position of a moveable element, such as a float that contains a magnet in order to detect movement aftd or orientation, as further described below.
[0052] Referring still to FIG. 2, the output signals f om each of these sensors 120, 122, 124 and the reed switch 126 are communicated to and received by a microcontrolle 130, which includes a memory 132 and is powered, by a power source 140, such as a battery. Based on the signals received from the sensors 120, 122, 124 and the reed switch 126. the microcontroller 130 makes a determination as to whether the baby bottle is being used (i.e. , whether the infant is socking on the nipple of the bottle) and the ini tiates transmission of data about usage of the bottle and/or instructions for initiating an action to die software program 62 via a transceiver 150.
('0053] in this regard, the motion sensor (accelerometer) 122, the temperature sensor 124, and/or the reed switch 126 may be used to augment the pressure data or ma he used as a method to control when and how pressure dat is polled. For example, in one exemplar
implementation, the motion sensor {accelerometer) 122 and/or the reed switch 126 detects if bab bottle is being handled as a result of the motion of the bottle or the liquid contained therefrom, or the temperature sensor 124 detects the sudden change of temperature that occurs when the bottle, which is filled with warm liquid, is tipped down. After detecting such movement, the microcontroller 130 polls data from the pressore sensor 120 to determine whether the infant is sucking on. the nipple of the bottle, in other words, the microcontrolle 130 determines whether the change in pressure exceeds a predetermined threshold indicative of the infant sticking on the nipple of the bottle.
(0054] In response to receiving data or instructions from the bottle sensor assembly 11 , the software program 62 initiates playback of a sound recording or another action. Again, with respec t to the playback of a sound recording, one preferred sound recording would be the voice of a caregi ver (e.g., mother) singing a song. Other sound recordings could include, but are not limited to: music, another singer's voice, humming, speech, tones, sound effects, radio broadcasts, or white noise..
10055] FIG. 3 is a plan view of an exemplary bottle sensor assembly 210, which., in this case, includes a printed circuit board 212. A pressure sensor 220 is mounted to the circuit board 212 to detect pressure variations. One preferred pressure sensor for use in the bottk sensor assembly 210 is a piezoresistive absolute pressure sensor. Model No. LPS33HW, as manufactured and distributed by STMicroelectronics International N.V. of Scliipliol. Netherlands. When an infant socks on the nipple of the bottle , there is a pressure drop that can be sensed by thi s particular sensor, which, as further described below, is positioned in the bottle just below the nipple.
[0056} Referring still to FIG. 3, an acceleronieter 222 is also mounted to the circuit board 212 to detect motion and/or orientation. One preferred aceeierometer for use in the bottle sensor assembly 210 is a low-power, 3-axis aoceierometer. Model No. LISDH3, manufactured and. distributed by STMicroelectronies International N. V. of Schiphol, Netherlands. As described above, the aoceierometer 222 is intended to detect motion and/or orientation, and thus may be used as a method to control when and how pressure data is polled. For example, in one
exemplary implementation, the motion sensor (accelerometer) 222 and/or the reed switch 226 detects if a baby bottle is ready for feeding as a result' of motion and/or orientation of the bottle; A fter detectin such movement and/or orientation, the microcontroller 230 polls data from the pressure sensor 220 to determine w hether the infant is sucking on the nipple of the bottie . In othe words, the microcontroller 230 determines whether the change in. pressure exceeds a predetermined threshold indicative of the infant sucking on the nipple of the bottle, or whether the pressure pattern is indicative of the infant sucking on the nipple of the bottle.
[0057J Referring still to FIG. 3, in this/exemplary embodiment, a reed switch 226 is also mounted to the circuit board 212, the use of which is former described, below. One preferred reed switch for use In the bottle sensor assembly 210 is the K.1.5-B-2-OE reed switch
mamifactared and distributed by Siandex Electronics of Cincinnati, Ohio. When such a reed switch 226 or similar sensor responsive to a magnetic field is part of the bottle sensor assembly, a magnetic element roust, be installed on or integrated into the baby bottle. For example, as shown in FIGS. 9A and 9B, a magnetic element 270 may be mounted on a shaft 272 on an exterior surface of a baby bottle, with the magnetic element 270 moving or sliding along the shaft 272 in response to manipulation of the bottle and the force of gravity. The reed switch 226, which is part of the bottle sensor assembly 210 inside of the bottle, is responsive to such
movement, with the reed switch 226 closing when the magnetic element 270 is in the vicinity of the reed switch 226.
[9058} Referring again to FIG, 3, the output signals from each of the sensors 220, 222 and the teed switch 226 are communicated to and received by a microcontroller 230, which is also mounted to the circuit board 212. One preferred microcontroller for use in the bottle sensor assembly 210 is an ATMEGA 328P microcontroller manufactured and distributed by Microchip Technology Inc. of Chandler, Arizona .
[0059} Re err ng still to FIG, 3, a transceiver 250 is also mounted to the circui t board 2:12. One preferred transceiver for use in the bottle sensor assembly 210 is a Bluetooth
communications module. (Bluetooth®' is a registered trademark of Bluetooth S1G, Inc. of Kirklarsd. Washington.) However, various other communications technologies or protocols could be used to facilitate such communication between the bottle sensor assembly 210 and the software program 62 (as shown in FIGS. 1 and 2) without departin from the spirit and scope of the present invention, including, for example, WiFi, RFID (described below)., near-field
communications (NFC), radio frequency communications (R.F), or wired connections,
[0060} Referring no to FIG. 4, in this exemplary embodiment, a battery 240 is mounted to the opposite side of the -circuit board 21 and serves as the power source for the microcontroller 230, the transceiver 250, and each of the sensors 220, 222 and the reed switch 226 (as shown in FIG. 3). However, various other forms of power could be used without departing from the spiri t and scope of the present invention, including, for example, inductively coupled, power or energy harvesting techniques,
('0061] Furthermore, with respect to the use of a battery, it is important to consider power management issues and conversation of battery life. The position or orientation of the baby bottle, as determined by the aceeleroineter 222 and/or the reed switch 226, can also be used to ensure that power is conserved if and until the bottle is in position for use. As mentioned, above, the reed switch 226 can also be used to 'functionally disconnect the battery during storage. This is accomplished by placing the bottie sensor assembly 210 near a magnetic element and causing the reed switch 226 to change states.
[0062] As described above with reference to FIGS. 1 and 2, based on the signals received from, the sensors■■■.220, 222, and the reed switch 226, the microcontroller 230 makes a
determination, as to whether the baby bottle is being used and then initiates transmission of data about usage of the bottle and/or instructions for initiating an actio via the transceiver 250 to the software program 62 that is installed and running on the external dev ce 60, such as a smartphone, tablet, speaker, or toy (as shown in FIGS, 1 and 2).
[0063] FIG. 5 is a perspective view of a capsule 280 that is configured to house the exemplary bottle sensor assembly 210 described above with respect to FIGS. 3 and 4, and FIG, 6 is a side-sectional view of the capsule 280 illustrating the positioning of the exemplary bottle sensor assembly 210 inside of the capsule 280. As sho n in FIGS. 5 and 6, the capsule 280 has a generally cylindrical shape and includes an upper flange 282. Accordingly, and referring now to FIG. 7, the capsule 280 can be inserted into the opening of a baby bottle 300, with the upper flange 282 resting on and engaging the rim 302 of the opening of the baby bottle 300. in this position, the capsule 280 does not occupy any significant portion of the useable volume of the baby bottle 300, nor does it interfere with the mating of a nipple retainer (or collar) to th opening.
('0064] Referring again to FIGS. 5 and 6, the capsule 280 defines an interior cavity 286 that is sized and configured to house the bottle sensor assembly 210. As shown, the pressure sensor 220 is positioned near the top of the capsule 280, and there is an opening 284 defined through the tipper surface of the capsule 280, Thus, in use, the pressure sensor 220 is positioned just below the nipple and is in fluid eomnn ucation with a ca vity that is defined between the nipple and the upper surface of the capsule 280. As such, the pressure sensor 220 can sense the pressure drop when an infant sucks on the nipple of the bottle. Since it is possible that liquid could enter the interior cavity 286 that houses the bottle sensor assembly 210, certain sealants may be applied to the bottle sensor assembly 210 and certain components thereof to protect them from, any potential damage.
[0065| Referring still to FIGS. 5 and 6, the capsule 280 als defines a channel 288: for liquid to flow from the bottle through the capsule 280 and to the nipple.
[0066] Since certain bottles are designed with a wider mouth, FIG. 8 illustrates that the baby bottle device of the present invention could also include an adapter ring 290, When needed, the bottle sensor assembl 210 would be seated in the adapter ring 290, which would, then rest on and engage the rim 302 of the opening of the baby bottle 300 (as shown in FIG. 7).
[0067} Again, in the above-described exemplary embodiments, a sound recording is preferably Initiated In response to detected usage of the baby bottl e. However, as mentioned above, other actions could also be ini tiated in response to usage of or interaction with the baby bottle, including, but not limited to: initiating the playback of a video recording; ill utninaii g one or more lights; triggering an audio or visual alarm; or initiating a mechanical action (such as vibration),
('0068] As a further refinement, although not shown in the Figures, other forms for sensors may also be incorporated into the bottle sensor assemblies 10, 110, 210 described above,
[0069] For example, if two or more electrodes are placed in the path of liquid, the resistance between electrodes can be used to sense the presence of a liquid. Measuring the presence of liquid could be used for detecting the position of the bottle or -the use of the bottle, especially- if combined with other mechanisms, such as a check valve. Again, the objective would be to determine if the infant is sucking on the nipple of the bottle, i.e., liquid is flowing.
[0070] For another example, capacitance between electrodes can be similarly used, to sense the presence of a liquid, -with th "objective again being to determin if the infant is sucking on the nipple of the bottle, i.e., liquid is flowing.
[00711 For another example,- -a moving element, such as a vane, impeller, float, or similar structure, could be positioned in the path of flow such that the element will move or deflect with flow. Such movement or deflection can be sensed using a wide variety of coils, hall effect sensors, optical sensors, strain sensors, or eapacitive sensors, in order to confirm flow. Again, the objective would be to determine if the infant is sucking on the nipple of the bottle, i.e., liquid is flowing.
(00-72} For another example, to the exten that -any -portion of the 'bottle or the nipple moves or deflects during use, that can be similarly sensed using a wide variety of sensors, with the objective again being to determine if the infant is sucking on the nipple of the bottle,
(0073] For additional examples, temperature sensors, ultrasonic/Doppler sensors, and optical sensors could also be used to detect flow of liquid through the nipple of the baby bottle. (6074] Also, in some exemplary embodiments, a switch could be incorporated in and/or used with the baby bottle device, such that the infant/child or the caregiver could manually initiate playback of a sound recording or another action using the switch.
(6075] Referring now to FIG. 10, in an alternate embodiment, rather than including a battery of similar power source as part of the sensor assembly inside of the baby bottle, a radio
frequency identification (RFID) or inductive coupling approach is used to power the sensors and facilitate data communications . Specifically, as shown in FIG. 10, the baby bottle device generally includes: a bottle sensor assembly 4.10 that includes a first portion 410a thai is configured to fit inside a baby bottle and a second portion 4 ! 0b that is external to the baby bottle; and a software program 62 in the form of computer-readable instructions installed and running on an external device 60, such as a smartphone, tablet, speaker, or toy.
(6076] Referring still to FIG. 10, in this exemplary embodiment the first portion 410 a of the bottle sensor assembly 410 includes, a pressure sensor 420 that detects pressure variations within the baby bottle to determine when the bottle is being used, i.e., when the infant is sucking on the nipple of the bottle, in this exemplary embodiment, the bottle sensor assembly 410 also includes a motion sensor 422 (such as an aeceierometer) thai can detect motion and/or orientation of the bottle,
(0077| Referring still to FIG. 10, the output signals from each of the pressure sensor 420 and the motion sensor 422 are communicated to and received by a microcontroller 430a, which includes a memory 432a, The microcontroller 430a is then connected to an RFID circuit 470a.
(0Θ78 j Referring still to FIG. 10, the second portion 10b of the bottle sensor assembl 10, which ma also be characterized as a "reader," is external, to the baby bottle. It also includes an Rf ID circuit 470b connected to a microcontroller 430b, which includes memory 432b.
Furthermore, the microcontroller 430b arid the RF1D circuit 470b is powered by a battery 440, j'0079] In use, an. AC current flowing in a primary coil of the RFID circuit 470b creates a magnetic field that induces energy in a secondary coil in the RFID circuit 470a when the two coils are i close proximity. Thus, the battery 440 that is part of the second portion 4i0b of the bottle sensor assembly 410 and is external to the bottle can be osed to power the components o the first portion 410a of the bottle sensor assembly- 410 that is inside of the bottle. Furthermore, this same link between the first portion 410a of the bottle sensor assembly 410 and the second portion 410b of the bottle sensor assembly 410 can be used as a commiraications channel. Thus, data from the pressure sensor 420 and the motion sensor 422 can be comm nicated from the first portion 410a of the bottle sensor assembly 410 to the second portion 4.10b of the .-bottle sensor assembly 410. This data could be the raw data from the respective sensors 420, 422, or the microcontroller 430a of the first portion 410a of the bottle sensor assembly 410 could make the determination as to whether the baby bottle is being used (i.e., whether the infant is sucking on the nipple of the bottl e) and communicate that data to the second portion 410b of the bottle sensor assembly 410,
f 0080] Once a detemiination is made as to whether the bab bottle is being used (i.e., whether the infant is sticking on the nipple of the bottle), the bottle sensor assembly 410 then initiates transmission of data about usage of the bottle and/or ins.hweti.ons for initiating an actio to the software program 62 via a transceiver 450. As described above, the software program 62 is in the form of computer-readable instructions installed and running on an external device 60, such as a smartphone, tablet, speaker, or toy. Furthermore, i this embodiment in which the second portion 410b of the bottle sensor assembly 4.10 is external to the bottle, the external device 60 may be effectively integrated with the second portion 410b of the bottle sensor assembly 410. in other words, the components for initiating playback of a sound recording or another action would be included in the same housing or physical enclosure as the second portion 410b of the bottle sensor assembly 10.
[0081 j In practi ce, the first portion 410a of the bottle sensor assembly 410 can be positioned inside of the baby bottle in the same manner as described above with respect to FIGS, 5-8. The second portion 41 Ob of the bottle sensor assembly 410 could then be slipped over the neck of the bottle or otherwise secured to an externa! surface of the bottle. In his regard,, for optimal energy transfer, the primary coil of the RFID circuit 470b of the second portion 410b of the bottle sensor assembly 410 should be coaxially aligned with the secondary coil of the RFID circo.it 470a of the .firstportion 410a f the 'bottle sensor assembly 410.
|Θ082} One of ordinary skill in the art wilt recognize that additional embodiments and implementations are also possible without departing from the teachings of the present invention. This detailed descript ion, and particularly the specific details of the exempl ary embodiments and implementations disclosed therein, is given primarily for clarity of understanding, and no unnecessary limitations are to be understood therefrom, for modifications will become obvious to those skilled in the art upon reading this disclosure and may be made without departing from the spirit or scope of the invention.
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Claims

What is claimed is:
L A baby bottle device for use wit a baby bottle, comprising;
a software program installed and running on an externa! device; a bottle sensor assembly that is configured to fit inside of or engage an external surface of the baby bottle, the bottle sensor assembly mcluditig one or more sensors for
determining when the baby bottle is being used and a transceiver for communicating data or instructions to the software program;
wherein, upon receipt of the data or instructions from the bottle sensor assembly, the software program initiates an action.
2. The baby bottle de vice as recited in claim 1, wherein the action is a play back of a sound recording.
3. The bab bottle device as recited in claim I, wherein the one or more sensors of the bottle sensor assembly includes:
a pressure sensor for detecting pressure variations with the baby bottle.
4. The baby bottle device as recited in claim 3, wherein the one o more sensors of the bottle sensor assembly further includes:
a motion sensor for detecting motion of the baby bottle. 5, The baby bottle device as recited in claim 4, whereifi the motion sensor is an accelerameter.
(i The baby bottle device as recited in claim 4, wherein the motion sensor is a teed switch.
7. The baby bottle device as recited in claim 4, wherein the bottle sensor assembly further includes:
a microcontroller, wherein the microcontroller receives output, signals from each of the pressure sensor and the motion sensor, determines whether the baby bottle is being used, and then initiates communication of the data or instructions to the software program vi the transceiver.
S, The baby bottl e de vice as recited in clai m 7, wherein the actio is a playback of a sound recording.
9, The baby bottle de vice as recited in claim 3 , wherein a first portion of the bottle sensor assembly, including the pressure sensor, is configured to fit inside of the baby bottle, and a second portion of the bottle sensor assembly is con figured to engage the exteraai surface of the baby bottle.
10. The baby bottle device as reci ted in claim in which the fi rst portion of the bottle sensor assembly incl udes a first RFED c ircuit, and the second portio of the bottl e sensor assembly includes a second RFID circuit, wherein the first RFID circuit and the second RFID circuit are operably connected to one another.
1.1, A baby bottle device for use wit a baby bottle, comprising;
a software program installed and running on an. external device;
a capsule having a generally cylindrical shape and including an upper flange, such that the capsule can be inserted into the opening of the baby bottle, with the upper flange resting on and engaging a rim of the opening of the baby bottle; and
a bottle sensor assembly housed within the capsule., the bottle sensor assembl including one or more sensors for det mining when the baby bottle is being used and a transceiver for communicating data or instructions to the software program:
wherein, upon receipt of the data or instructions fmm the bottle sensor assembly , the software program initiates an action.
12. The baby bottle device as recited in claim 1 1 , wherein the action is a playback; of a sound recording.
13. The baby bottle device as recited in claim I i , wherein the one or more sensors of the bottle sensor assembly includes:
a pressure sensor for detecting pressure variations with the baby bottle.
14, The baby bottle device as recited in claim 12, wherein the one or more sensors of the bottle sensor assembly further includes: a motion sensor for detecting motion of the baby bottle.
15. The baby bottle device as recited in claim 14, wherein the motion sensor is an aceeleronieter,
! Ci The baby bottle device as recited n claim 1 , wherein the motion sensor is a reed switch.
17. A baby bottle device for use with a baby bottle, comprising:
a software- program installed and running on an externa! device;
a capsule having a generally cylindrical shape and including an upper flange, such that the capsule, can be inserted into the opening of the baby bottle, with the upper flange resti ng on and engaging a rim of the opening of the bab bottle; and
a bottle sensor assembly housed within the capsule, the bottle sensor assembly including a pressure sensor for detecting pressure variations with the baby bottle and a transcei er for communicating data or instructions to the software program in response to the pressure variations;
wherein, upon receipt of the data or instructions from the bottle sensor assembly, the software program initiates an action.
18. The baby bottle device as recited in claim 17, wherein ihe action is a playback of a sound recording.
19. The baby bottle device as recited in claim 17, -and further comprising a motion sensor for detecting motion of the baby bottle..
20, The baby ottle device as recited in claim 19. and further comprising a
microcontroller, wherein the microcontroller receives output signals from each of the pressure sensor and the- motion sensor, determines whether the baby bottle is being used, and then initiates communication of the data or instructions to the software prograra via the transcei ver.
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WO2021174020A1 (en) * 2020-02-27 2021-09-02 Innovative Therapeutix, Inc. Infant feeding reinforcement system
EP4110262A4 (en) * 2020-02-27 2024-03-27 Innovative Therapeutix Inc Infant feeding reinforcement system
US11961412B2 (en) 2020-02-27 2024-04-16 Innovative Therapeutix, Inc. Infant feeding reinforcement system
GB2616420A (en) * 2022-03-06 2023-09-13 Sophia Francis Nadine Baby feeding bottle

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