Artificial nipple head
阅读说明：本技术 人造奶嘴头部 (Artificial nipple head ) 是由 妮可拉·贝特曼 于 2019-02-22 设计创作，主要内容包括：本发明在于婴儿的抚慰,特别是在使用人造奶嘴头部的痛苦但健康的婴儿持续啼哭的抚慰,该人造奶嘴头部具有颈部和头部,其中头部为实心的。奶嘴头部特别用于使此类婴儿的颅律冲动正常化。(The present invention resides in the soothing of infants, particularly the soothing of a painful but healthy infant who continues to cry on an artificial nipple head having a neck and a head, wherein the head is solid. The pacifier head is particularly useful for normalizing cranial rhythm impulses in such infants.)
1. An artificial nipple head for use as a soother, the nipple head being a single unit having a neck and a head, wherein the head is solid.
2. The artificial nipple head of claim 1, wherein the neck and head are flexible relative to one another.
3. An artificial teat head according to claim 1 or claim 2 wherein the teat head comprises a waist or narrowing in width and/or depth where the neck joins the head.
4. An artificial nipple head according to any one of claims 1 to 3, wherein the neck includes a chamber.
5. An artificial nipple head according to any one of claims 1 to 4, wherein the length of the neck is less than about 30% of the total length of the nipple head.
6. An artificial nipple head according to claim 5, wherein the length of the neck is about 20% to 30% of the total length of the nipple head.
7. An artificial nipple head according to any one of claims 1 to 6, wherein the head has a Shore hardness of medical grade silicone rubber of about 10 to 30.
8. The artificial nipple head of claim 7, wherein the head has a shore hardness of about 18 to 25.
9. An artificial nipple head according to any one of claims 1 to 8, wherein the head is angled upwardly from a transverse (horizontal) plane.
10. An artificial nipple head according to any one of claims 1 to 9, wherein the head has a width of about 15 to 20 mm.
11. An artificial nipple head according to any one of claims 1 to 10, wherein the head length of the head is about 20 to 30 mm.
12. An artificial teat head according to any one of claims 1 to 11 wherein the head comprises a convex upper surface.
13. An artificial nipple head according to any one of claims 1 to 12, wherein the head includes a concave lower surface.
14. An artificial nipple head according to any one of claims 1 to 13, wherein the nipple head is made of natural latex or polyethylene terephthalate (PET).
15. An artificial nipple head according to any one of claims 1 to 14, wherein the nipple head includes a textured surface.
16. An artificial nipple head according to any one of claim 15, wherein the nipple head includes a microtextured outer surface.
17. An artificial nipple head according to any one of claims 1 to 16, wherein the nipple head is attached to a shield.
18. The artificial nipple head of claim 17, wherein the shield includes one or more vent holes.
19. The artificial nipple head of claim 18, wherein said one or more vents comprise about 30% to 45% of said shield.
20. An artificial teat head according to any one of claims 17 to 19 wherein the shield comprises a textured surface on the face which is in contact with a user in use.
21. The artificial nipple head of claim 20, wherein said textured surface comprises a micro-texture.
22. An artificial nipple head according to any one of claims 17 to 21, wherein the shield includes a handle on a face opposite the nipple head.
23. The artificial nipple head of claim 22, wherein said handle includes a notch.
24. An artificial nipple head according to any one of claims 1 to 23, for use in treating or alleviating discomfort in an infant.
25. The artificial nipple head of claim 24, wherein the infant has abnormal or disturbed cranial rhythm impulses.
26. An artificial nipple head according to any one of claims 1 to 23, for use in normalising cranial rhythm impulses in infants.
27. An artificial nipple head according to any one of claims 24 to 26, wherein the infant is healthy.
28. An artificial nipple head according to any one of claims 24 to 27, wherein the infant is newborn up to an age of about 2 years.
Technical Field
The present invention resides in the soothing of infants, particularly the constant crying of painful but healthy infants on the head of an artificial nipple.
Background
Orthopedists believe that the process of delivery results in intracranial dysfunction, which may be manifested as somatic symptoms, one of which is excessive crying of the infant. Unexplained sustained crying behavior occurs in 10-30% of infants under three months and often leads to the primary care givers seeking medical advice (Douglas and Hill (2011) BMJ,15:343, d 7772; Morris et al (2001) Arch. Dis. child.84: 15-19; Lucassen (2010) Clinical Evidence,2: 309; Mcrrry et al (2010) J. am. Board fam. Med.23: 315-322). One option is to provide intracranial osteopathy.
The core premise of intracranial osteopathy was originally described by Sutherland more than 70 years ago: the major respiratory mechanisms (The Cranial bowl, Mankato, Minn: Free Press Co; 1939, reissue, 1986). The five components of The major respiratory mechanisms are intrinsic fluctuations of cerebrospinal fluid, motility of The central nervous system, motility of The tensile membrane of each other, motility of The skull, involuntary motility of The ilium of The pelvis (kern. m., Wisdom In The Body (2001), Thorsons). The main respiratory mechanism is said to act in an oscillatory manner during the inspiration (flexion, external rotation) and expiration (relaxation, internal rotation) phases. When touching the head, the primary respiratory mechanism is called Cranial Rhythm Impulse (CRI).
The term "cranial rhythm impulse" describes the slow pulsatile motion exhibited by the body. Many low frequency oscillations in the range of 6 to 9cpm (0.1-0.15 Hz) are found in humans, such as blood pressure, blood flow velocity (Traube-hering (th) oscillations), variability in heart rate (R to R intervals), sympathetic tone in muscle, and intracranial fluid oscillations. These phenomena can be linked directly or indirectly to the oscillations of the autonomic nervous system, in particular of the sympathetic nervous system. The reported CRI with frequency range of 4 to 14cpm (0.06-0.23Hz) shares a spectral band with the above-mentioned physiological oscillations. CRI has been shown to correspond to the low frequency TH in blood flow velocity (Nelsonet al (2001) J.am.osteopath.Assoc.101: 163-173). In addition, manual intracranial techniques have been shown to affect TH (Sergueef et al (2004) Alternative therapeutics in Health and medicine.8: 74-76; Nelson et al (2004) am. acad. osteopath.J.14:15-17) and similar low frequency oscillations in intracranial fluid (Moskalenko & Kravchenko (2004) am. acad. osteopath.J.14: 29-40).
In 2009, Kotzampatiris et al investigated whether CRI abnormalities were associated with excessive crying in infants (J. alternative and Complementary Medicine (2009),15(4): 341-. 139 full-term infants were evaluated for excessive crying. In the samples, 41.7% of the infants showed excessive crying. Excessive crying is associated with abnormal CRI at 2 weeks, but not at birth. In fact, infants with abnormal CRI had a 6.8 times higher likelihood of excessive crying at 2 weeks than infants with normal CRI, suggesting that cranial rhythm reduction is a factor in excessive crying in infants.
The development of anatomy, behaviourology and science also describes that the Autonomic Nervous System (ANS) is not only an autonomous and sympathic response, but also has a third important component, the "social nervous system". Collectively referred to as the three-in-one nervous system. Aspects of the social nervous system enable infants to develop important social behaviors, such as connections with mothers. This is a neurophysiologic phenomenon whereby an infant, for example, orients, communicates with, finds her breast, eats milk, coordinates sucking, breathes, and swallows with her mother. All parts of the ANS are interrelated.
Continuous crying in infants indicates three-dimensional nervous system damage and injury (Porges. S., psychophysiology (1995) 32; Porges. S., int. J. psychophysiology (2001)42: 123. 146; Porges. S., Biological Psychology (2007)74(2): 116. 143; Porges. S., The Polyvagal theory (2012) in Sills. F. Foundations in Cranio Biological dynamics (2012) Vol2. th normals boilers).
Newborn and premature infants are subjected to post-traumatic stress of delivery, especially after medical assistance with obstetric forceps, suction, or caesarean section. Even for infants born after natural non-failure delivery, their cranium will be squeezed to pass through the birth canal and the cranium will need to rebalance and relieve the strain pattern. Infants naturally have a sucking reflex which helps the rebalancing and relieving process.
It has been noted that infants, and in particular infants born after medical intervention, are particularly beneficial to suck the little finger of a parent, nurse or midwife, reaching with the finger to the top of the mouth or to the hard jaw.
The portion of the skull immediately above the area of the mouth comprises the jawbone and the maxilla, which have two sutures: medial bone suture jaws and lateral jaws. These sutures affect the sphenoids that cover the jawbone and maxilla structures and extend to both sides of the mouth. It is believed that the benefit obtained by sucking the fingers is because the balance of the structure, including the jawbone, maxilla and sphenoid, is critical to the mechanics of the skull, especially because the structure is located in the center of the head.
In the literature of osteopathy and craniosacral, the skull base and Sphenoid Base Junction (SBJ) is referred to as the natural fulcrum about which skeletal motion occurs. It is also the highest pole of the embryonic notochord. The major cranial nerve passes through or across the base of the skull. Thus, the impact or pressure of this area can affect the overall nerve function. It has been noted that areas causing respiratory and digestive problems in infants where imbalances affect The autonomic nuclear and neuroendocrine immune systems (Sills f., The sentent Embryo, tissue intellgence and Trauma Resolution (2012) concerns in microbiological biology, Vol2, North Atlantic Books).
The infant's skull has immature sutures at birth, large open haloes that typically remain open and flexible until 15 months of age to allow rapid growth of human brain size during this period. The sphenoid bone is divided into three parts at birth, and the occipital bone is divided into four parts. Both bones form the basis of the skull and are specifically oriented together as the sphenoid-base junction (SBJ).
Strain patterns can occur in the head and spine during pregnancy and/or birth, and plagiocephaly can result due to the presence of flexibility in the skull. These strain patterns may also continue or occur after birth following guidelines for always placing the infant on his back to avoid crib death syndrome.
If left uncorrected, strain patterns and plagiocephaly can lead to other physical and emotional challenges in childhood, including reading disorders, Attention Deficit Hyperactivity Disorder (ADHD), headaches, abdominal cramps, irregular head shapes, fidget in children, reflux, poor sleep patterns, emotional problems, and lack of growth. Medical interventions such as intracranial adjustments and spinal massage treatments may lead to significant improvements. Studies have shown that when the infant's skull and body are rebalanced, the child relaxes, falls asleep, and begins to grow awkwardly. However, as the infant grows, the strain patterns of the head, such as the valleys and ridges, may be re-established, thus requiring further or continued intervention. However, as mentioned above, such intervention requires an experienced professional and success or failure depends largely on the competence of the professional.
Another approach is to take advantage of the baby's natural sucking reflex forces and provide a dummy pacifier or pacifier designed to exert the appropriate force, contact force and/or motivating stimulus on the hard jaw. Pacifiers typically have a hollow, flexible nipple head. As a result, such pacifiers cannot or are not designed to exert the proper force on the hard jaw, not least because the nipple head is compressed and the three dimensional shape collapses upon sucking. Infants requiring such rebalancing often reject such pacifiers because they do not provide the relief sought by the infant.
May use, for exampleA pacifier is sold having an upwardly angled nipple head shaped to rest against a hard jaw. Such pacifiers are sold to have benefits in the development of the mandible and palate. However, again, such pacifiers are hollow and therefore have the same disadvantages as conventional pacifiers.
WO 2012/101409 describes a pacifier having a straight, substantially unformed nipple head which in use angles upwardly to bear against a hard jaw. The nipple head is a solid object having a strong inner core and a softer outer layer. A disadvantage of such pacifiers is that the outer layer may tear and separate from the core, possibly resulting in a choking risk.
Disclosure of Invention
The present invention results from the following findings: infants sucking on a person's fingers generally get better relief and soothing than using a common commercially available hollow nipple head, especially when some infants refuse to use many commercially available soothers, but all infants can and will suck on a person's fingers. Accordingly, the present invention resides in a teat head of a soother which overcomes the disadvantages of existing soothers and provides relief obtained by sucking a person's fingers.
In particular, the invention resides in an artificial nipple head for use as a soother, the nipple head being a single unit having a neck and a head, wherein the head is solid. It is believed that such a pacifier head may stimulate time-sequenced pulses of the superficial temporal artery of the head (located in front of the ear), which indicates an increase in blood flow. The pacifier head also stimulates cranial rhythm impulses in the nervous system, which improves health. In particular, the nipple head increases the suck reflex, which helps stimulate oxytocin production. In small infants, oxytocin is a natural pain relief after birth and reduces the fight/flight hormone symptoms, thereby making the infant more relaxed.
In one embodiment, the neck and head of the artificial nipple head are flexible relative to each other. It will be appreciated that flexibility may be imparted by any suitable means, for example different shore hardnesses of the head and neck, or a suitably narrowed neck in width, depth and/or height to give flexibility to the teat head as a whole and/or the head relative to the neck.
In one embodiment, flexibility may be achieved by including a waist or narrowing of the teat head at its width and/or depth where the neck meets the head or tip. The inclusion of a waist or narrowing profile may impart flexibility to the pacifier so that the angle of the head or end of the pacifier in the mouth may be controlled by changing the position and shape of the tongue. This flexibility allows the user to move the nipple head within the mouth, thereby maximizing the soothing and soothing effects. The waist also allows the nipple head to be supported internally by the lips, helping to keep the nipple head within the mouth rather than falling out due to its own weight.
Alternatively or additionally, the neck may comprise a chamber. A chamber in the neck of the teat head where the teat head emerges from the shield at the front plane of the teat head to about the middle of the teat head and towards the front extremity of the teat head gives the teat head more flexibility. This allows the solid head of the teat head to be easily moved within the mouth.
Although the length of the neck of the teat head extending from the mask towards the head or end of the teat will depend on the age of the user and the size of the user, it is desirable that this length is less than about 30%, for example about 20% to 30% of the total length of the teat head. In one embodiment, the length of the neck is 25% of the total length of the nipple head. In another embodiment, the length of the neck is 21% of the total length of the nipple head.
The head of the teat head is solid, which means that it is always made of the same material and does not contain a chamber. The head is sold to provide a firm and stable shape that will exert pressure on the top of the mouth when sucked. Applying pressure to the top of the mouth (the hard jaw) stimulates and moves the skull and soft tissue that forms the bottom of the skull.
Preferably, the solid head has a shore hardness of about 10 to 30 of medical grade silicone rubber. A shore hardness of about 18 to 25, for example 20, has been found to be particularly suitable for use in the head of the teat head of the invention. The shore hardness is a measure of the resistance of a material to indentation, the lower the shore hardness, the more flexible the material. A solid nipple head is necessary to transmit pressure from the middle position of the nipple head to the front tip to the top of the mouth in order to stimulate the top of the mouth. It will be appreciated that the shore hardness and hence the density of the teat head may vary according to the age, severity of discomfort and length of time the teat head of the present invention is used, depending on the requirements of the infant.
A nipple head with a shore hardness of about 40 is usually rejected almost immediately by the baby, presumably because the hardness does not provide effective comfort and may cause discomfort. While a nipple head with a shore hardness of about 7 is generally acceptable for infants, the hardness makes no significant difference in improving or stimulating cranial rhythm, and thus a nipple head with a shore hardness of about 7 is considered ineffective as a pacifier in infants whose CRI is disturbed.
The head of the teat head is angled upwardly from the transverse (horizontal) plane so that, in use, the upper surface of the head aligns with and follows the shape of the roof of the mouth. This makes the pressure transfer from the nipple head to the top of the mouth more efficient. The centre line of the head of the teat head is offset from the transverse (in use horizontal) plane by an angle of from about 15 to about 25 degrees, preferably about 20 degrees.
The shape of the head of the teat head is important to the comfort and effectiveness of the teat head. In particular, the head may be shaped to bear against the hard jaw to mobilize soft tissue and suture connections and stimulate more positive motion in the infant's mouth to release their tongue muscles. It is suggested that this positive movement stimulates positive endocrine activity and the rebalancing of hormonal benefits (such as oxytocin production) to mimic sucking the breast. This, in turn, provides a more effective soothing response.
The head of the teat head may have a generally rectangular shape when viewed from above or below, the shape having an outwardly flared shoulder, with the width of the teat head expanding from the neck to the head. The straight side of the head is arranged into an arc-shaped end. The width of the head may be about 15 to 20mm, and the length of the head may be about 20 to 30 mm. It will be appreciated that the length and width of the head will depend on the age and weight of the infant. For example, preterm and low birth weight infants may require a smaller nipple head than a full term average weight infant.
The upper surface of the head in use has a convex profile, when viewed from the side, which mimics the concave shape of a hard jaw. In this way, the head fits the shape of the roof of the mouth from the waist of the neck to the tip or end of the head, and therefore the pressure transfer is more uniform. The contour rises more gradually from the waist to the highest point of the curve than it falls from the highest point to the end. In particular, the contour rises from the horizontal plane from the waist towards the end of the head at an angle of about 25 to 30 degrees, such as 28 degrees. The curve reaches the upper horizontal plateau and then descends at an angle of 40 to 50 degrees (about 45 degrees) toward the tip of the head. The highest point of the upper surface of the head is horizontal and the furthest extent of the tip of the teat head is substantially perpendicular to the horizontal. The upper surface of the head in use has a generally semi-circular profile when viewed from the distal end towards the neck.
The lower surface of the head in use has a concave profile from the neck to the tip and across the width of the head. The contour has a curvature less than the upper surface and provides a shape to fit the tongue to provide comfort and increased control over the solid head.
It should be appreciated that the nipple head may be made of any suitable pharmaceutical grade silicone or rubber. However, a material with better dispersion of saliva on its surface (a more "wettable" material) has better adherence in the mouth. In order for the surface to become wet, the surface free energy of the material must be higher than the surface tension of saliva.
For the purposes of this application, materials such as natural latex and polyethylene terephthalate (PET) are considered particularly suitable because of their high surface free energy.
Surface tension in saliva provides less adhesion, but enhanced or increased adhesion may be achieved by adding microstructures (surface roughness on the order of microns). However, in order for the microstructure adhesion to be effective, the microstructure must be used in combination with a wettable surface. Thus, the outer surface of the teat head may have a textured surface, for example a microtexture. This texture aids in wetting and improves adhesion when in contact with saliva, thereby improving retention of the nipple head in the mouth.
In a preferred embodiment, the nipple head is attached to a shield to prevent the infant from swallowing the nipple head. It will be appreciated that any suitable shield for a pacifier or pacifier may be used.
Ideally, the protective cover is rigid and made of copolymer or homopolymer polypropylene suitable for food contact to maintain hygiene.
When testing the nipple head of the present invention, it was found that the nipple head and shield (referred to herein as a "pacifier" when combined) tended to fall without assistance and needed to be held in place by the infant. The weight of the shield is determined to be important.
Thus, in one embodiment, the hood is a generally rectangular frame having a curvature shaped to generally reflect the shape of the face around the infant's mouth. The frame of the hood or its perimeter may include curved corners and notches or recesses in its shape. It will be appreciated that when the pacifier is used, a recess is provided in the top edge of the frame so that the shield does not obstruct or interfere with the nose, does not impair breathing and the correct orientation of the nipple head is easily identified.
If the shield is a solid plate, it is preferred that the plate includes one or more apertures to allow the underlying skin to breathe and perspire when the pacifier is used. Ideally, such an aperture is maximised to reduce the weight of the pacifier. For example, the holes may comprise about 30% -45% of the shield. In a particular example, the area of the shield may be about 1628mm2And may include a thickness of about 552mm2The area of the holes. This arrangement provides about 34% porosity to the shield. For the weight savings of this particular example, the volume of the protective cover without holes may be about 4448mm3And the volume of the protective cover with the hole can be about 3119mm3. In this particular example, the weight is reduced by about 29%. In other words, the holes remove about 29% of the weight. Thus, the holes may reduce the weight of the shield by about 20% to 40%.
The reduction in weight of the shield also helps to shift the center of mass of the pacifier within the mouth which in turn improves the retention of the nipple head in the mouth without the aid of the hand.
Indeed, the position of the centre of mass of the pacifier is important for the retention of the nipple head within the mouth. In particular, force analysis shows that tongue pressure increases the reaction force of the upper jaw when not sucking. This reaction has the effect of drawing the pacifier out of the mouth. Also, the location of the center of mass may cause the pacifier to rotate, which may result in ejection of the pacifier. Thus, ideally, the center of mass should be located at the lips and gums.
The shield also forms part of the contact perimeter, the size of which has an effect on the adhesion. Thus, the surface of the protective mask that is in contact with the face may include texture in the form of microtexture.
In one embodiment, the shield includes a knob or button that projects away from the nipple head and, in use, protrudes from the face of the infant. Such a protrusion provides a grip allowing the pacifier to be held for insertion, movement within the mouth and removal.
It will be appreciated that the knob or handle adds weight to the shield and therefore consideration needs to be given to its design to ensure that the additional weight added does not make the teat head easily pop or fall under the weight of the shield. The handle is preferably moulded from the same material as the shield and is therefore rigid and made of a copolymer or homopolymer polypropylene suitable for food contact.
The surface of the handle facing away from the infant in use may include a recess. Ideally, such a recess is sized to fit the adult's fingertips so that the pacifier may be supported and manipulated by a caregiver when in use.
The invention also includes the use of a teat head as described herein in the treatment or soothing of discomforts in infants or a method of treatment or soothing of discomforts in infants. Ideally, the infant is healthy, but may have abnormal or interrupted cranial rhythm impulses. In other words, the invention resides in the use of a pacifier head to normalize intracranial impulses and/or to treat abnormal intracranial impulses in infants. The nipple head of the present invention may also be used to rebalance or ameliorate the bodily dysfunction of an infant. Somatic dysfunction may be defined as a functional impairment or alteration of the relevant constituents of the somatic system, including skeletal, articular and myofascial structures and associated vascular, lymphatic and neuronal structures. For example, pacifiers are believed to help address compressive or inertial forces experienced at the sphenoid-base interface (SBJ) due to pregnancy, the process of childbirth, and postpartum events/experiences. The sphenoids are ladder structures or gear levers in the skull (kern. m.2001(supra), sills. f.2012 (supra)). If not balanced, the autonomic nervous system is under stress and the CRI decreases. In fact, Waddington et al (J.Am. osteopath asoc.2015Nov; 115(11):654-65) found that most healthy newborns suffer from somatic dysfunction with at least one sphenoid strain pattern. The more stress patterns an infant is, the less unpleasant the infant, which can cause colic and other symptoms, such as persistent crying.
Without wishing to be bound by theory, it is believed that the pacifier of the present invention may exert its effects on the palate, suture connections, soft tissue and tongue muscles. In particular, it is believed that the pacifier transmits a combination of reactive forces to help normalize the natural motion of the SBJ or to help self-repair the natural motion of the SBJ. It also helps to normalize the composition of the main respiratory mechanisms. This is achieved by suction, tongue movement and the pacifier in the configurations described herein.
The baby can look healthy. Also, the infant may be vomiting, suffering from a disease or disorder, or unhealthy. Infants are defined as the age from birth to about 2 years old. This definition includes premature infants.
Although described with reference to the use of the teat head of the invention in calming healthy but painful infants, it will be appreciated that the teat head use of the invention may also include soothing and stimulating the suck reflex of infants who are unable or unable to breastfeed. The nipple head of the present invention may also be suitable for infants who face medical challenges such as cleft javas or down syndrome.
It will be appreciated that such uses include methods of treatment.
Drawings
The invention will now be described in more detail with reference to non-limiting embodiments shown in the accompanying drawings, in which:
FIG. 1 is a top view of a pacifier comprising a nipple head of the present invention;
FIG. 2 is a perspective view from the end of the nipple head of the present invention looking toward the pacifier shield;
FIG. 3 is a perspective cut-away view from one side of a pacifier comprising a nipple head of the present invention; and
fig. 4 is a view of one end of a pacifier showing a shield and handle.
Detailed Description
Fig. 1 shows a pacifier 1 comprising a nipple head 10, a
The
The width of the
The curvature of the
A handle 30 extends outwardly from the middle of the
Fig. 2 shows that when nipple head 10 is extended away from
The
Fig. 3 shows the formation of the teat head 10. It can be seen that the
Fig. 3 also shows a
Fig. 3 shows the assembly of the pacifier 1. The free open end of the
In the middle of the
Fig. 4 shows the
Trained osteopathic and cranio-sacral therapists are able to sense and assess the movement of the skull, tissue and circulation with their hands. Infants using a pacifier comprising a nipple head of the invention were evaluated before and when using the pacifier. It has been found that pacifiers stimulate and normalize cranial rhythm. The same infant was also evaluated using a conventional pacifier which, although soothing to the infant, did not affect cranial rhythm. Manual intracranial testing showed that in strained but healthy infants, physiology was beneficial, improving the placebo response, and reducing persistent crying. Of the samples (n-22), 82% (n-18) received the pacifiers described herein. 18 infants aged 1-12 weeks participated in a non-randomized intervention feasibility study to test the pacifiers described herein. All participants received the pacifier described herein, except for the conventional treatment and questionnaire, at completed week 2 and 4 follow-up visits. After a 4 week follow-up, all participants were invited to a 30 minute semi-structured interview to understand their experience with the pacifier.
Parents meeting inclusion criteria and/or infants with unexplained infant crying were recruited from online support platforms, groups and pediatric spine medical clinics.
Nine parents will provide detailed feedback in the form of a qualitative interview. The spine physician participating in the study fed back the experience of three other parents, while six parents did not voluntarily feed back.
These infants are seen in four chiropractic clinics, which have a wide range of symptoms and diagnosis. The common types are painful, excessive crying during the day and night, drowsiness, constipation, inability to lie comfortably on the back, colic and regurgitation. Upon examination, these infants were found to have a wide range of intracranial disorders such as mandibular tone, facial irregularities, jaw compression, mild plagiocephaly, and other structural patterns. Interestingly, the structural findings reflected the results of the Waddington et al (supra) determination. Waddington et al found that 99% of the 100 neonates examined had at least one cartilage strain pattern with other intracranial limitations.
In this study, most parents of infants have sought assistance and advice from other medical professionals (e.g., midwives or general practitioners). Some people are taking prescription drugs for abdominal pain, e.g. InfracolTMStill others use non-standard milk formulas if not breast fed. The infant is allowed, where possible, to use a pacifier prior to receiving a spinal massage, intracranial or craniosacral treatment as a way to test acceptability before receiving further intervention.
Most infants have tried standard commercial pacifiers, some of which may use one, and some parents who expressed a reluctance to use or distrust using a standard pacifier. These infants are difficult to soothe using normal nursing comforting methods including standard pacifiers, and for many mothers their infants appear to only feel relieved when they eat milk, which puts stress on the mothers, if not hungry, and in some cases, causes mastitis and feeding difficulties. This also results in their inability to become good parents (including father/other caregivers) and create stress and anxiety by not knowing how to successfully soothe and soothe the infant.
The average length of time that an infant needs and uses a pacifier on a regular basis varies, but is generally about 2-3 weeks or more. The pacifiers described herein may operate more efficiently and faster than desired.
The key findings are:
infants 7 days to 12 weeks old can successfully use the pacifier. 16 of the 18 infants in this group used pacifiers.
Of the 9 parents who received independent investigator visits or feedback through questionnaires, 8 indicated that they found that the use of the pacifier provided "some benefits" and "many benefits" to their infants.
The pacifier seems "indeed very helpful and useful to very painful infants" in spinal feedback. A report reports that for some infants, the use of a pacifier "helped" in addition to the standard treatment provided by the spiner.
The benefit generally accepted by parents is that they feel relaxed from using the pacifier because the infant cannot settle, if not hungry, until the pacifier is provided, or when they feel painful, including attempting to use a standard commercial pacifier. Parents report that pacifiers do soothe their infants, particularly helping their infants enter and remain in deep sleep. This means that both the baby and the parent can get some rest and prolong and establish the sleep pattern of these babies.
Use of a pacifier does not appear to inhibit or affect the feeding method. Infants can successfully use the pacifier whether breast-feeding or bottle-feeding. The use of such a pacifier in a small baby does not affect, impair or reduce breast feeding. Three mothers with painful nipples and mastitis can recover by using the rubber nipple. The pacifier of the present invention is a good acceptable alternative to the continuous intensive feeding (frequent short term feeding) of a painful infant on the breast for non-nutritional purposes. The unexpected result is that these mothers are able to continue breastfeeding without giving up because of continued discomfort. The use of a pacifier can generally alleviate the discomfort of all breastfeeding mothers and help them determine when the baby needs to suck or chew rather than hunger. The result of being able to do breast or bottle feeding helps to alleviate colic and reflux symptoms by giving the infant more time to digest and absorb previous food.
The pacifier encourages the infant to suck deeper and more naturally, as noted by both the spine doctor and the parents. This means that the infant can not only exercise and actively mobilize the muscles of the tongue, but can also improve coordination and thus more effectively and more quickly feed. A problem with short term feeding may be that the infant cannot eat the fat rich after milk that is highly nutritious behind the breasts. Post-consumption milk requires an effective tongue and a coordinated sucking reflex.
In one case, once the baby has used the pacifier, the parent can stop using all of the prescribed medications for colic.
Notably, the earlier an infant uses such a pacifier (ideally 1-4 weeks), the greater the overall impact parents report on the health of the infant. In addition, pacifiers are generally more acceptable and usable by infants. This also improves the confidence and satisfaction of the mother, especially the newborn mother.
This is a preliminary assessment of the use of the pacifiers described herein by the distressed infant and its parents. There are limitations in methodology and data collection, especially because of the difficulty in studying highly sensitive subjects involving very small infants and stressful parents. Parents find the pacifier of the present invention to be helpful to the infant in the absence of other things, including the various commercially available pacifiers that have been tried.
The pacifiers described herein may help alleviate the somatic dysfunction of a healthy infant by providing active relief, alleviating the symptoms of a distressed infant, and better soothing. Such relief may allow the infant to enjoy an age of up to 12 weeks or more.
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