Artificial Teat

Abstract

The present invention resides in the soothing of infants, particularly soothing from persistent crying in distressed but healthy infants using an artificial teat having a neck and a head, wherein the head is solid. The teat has particular use for the normalisation of cranial rhythmic impulses in such infants.

Claims

1. An artificial teat for use as a pacifier, the teat being a single unit having a neck and a head, wherein the head is solid.

2. An artificial teat according to claim 1, wherein the neck and head are flexible relative to each other.

3. An artificial teat according to claim 1, wherein the teat includes a waist, or narrowing, in its width and/or depth where the neck joins the head.

4. An artificial teat according to claim 1, wherein the neck includes a cavity.

5. An artificial teat according to claim 1, wherein the neck has a length that is less than about 30% of the total length of the teat, or optionally the neck has a length that is between about 20% to 30% of the total length of the teat.

6. (canceled)

7. An artificial teat according to claim 1, wherein the head has a Shore hardness for medical grade silicone rubber of between about 10 and 30, or optionally the head has a Shore hardness for medical grade silicone rubber of between about 18 and 25.

8. (canceled)

9. An artificial teat according to claim 1, wherein the head is angled upwards from a transverse (horizontal) plane.

10. An artificial teat according to claim 1, wherein the head has a width of between about 15 and 20 mm, and/or the head has a length of the head of between about 20 and 30 mm.

11. (canceled)

12. An artificial teat according to claim 1, wherein the head includes a convex upper surface, and/or the head includes a concave lower surface.

13. (canceled)

14. An artificial teat according to claim 1, wherein the teat is made from natural latex or polyethylene terephthalate (PET).

15. An artificial teat according to claim 1, wherein the teat includes a textured surface, and/or wherein the teat includes a micro-textured outer surface.

16. (canceled)

17. An artificial teat according to claim 1, wherein the teat is attached to a shield.

18. An artificial teat according to claim 16, wherein the shield includes one or more vent hole, and/or wherein the one or more vent hole comprises between about 30%-45% of the shield.

19. (canceled)

20. An artificial teat according to claim 16, wherein the shield includes a textured surface on the face that, in use, contacts a user, and/or wherein the textured surface includes a micro-texture.

21. (canceled)

22. An artificial teat according to claim 16, wherein the shield includes a grip on a face opposite the teat.

23. An artificial teat according to claim 22, wherein the grip includes a recess.

24. An artificial teat as claimed in claim 1 for treating or soothing discomfort, or normalizing cranial rhythmic impulses in an infant.

25. An artificial teat as claimed in claim 24, wherein the infant has abnormal or disrupted cranial rhythmic impulses.

26. (canceled)

27. An artificial teat as claimed in claim 24, wherein the infant is healthy.

28. An artificial teat as claimed in claim 24, wherein the infant is from new born up to about 2 years of age.

Description

[0051] The present invention will now be described in further detail with reference to non-limiting examples shown in the figures, in which:

[0052] FIG. 1 is a view from above of a pacifier including a teat of the present invention;

[0053] FIG. 2 is a perspective view from the end of the teat of the present invention, towards a pacifier shield;

[0054] FIG. 3 is a perspective cross section view from one side of a pacifier including the teat of the present invention; and

[0055] FIG. 4 is a view of the one end of a pacifier, illustrating the shield and grip.

[0056] FIG. 1 shows a pacifier 1 including a teat 10, a shield 20 and a grip 30. The teat 10 has a head 12, a waist 14 and a neck 16.

[0057] When viewed from above, the head 12 has a substantially rectangle shape with a rounded or curved tip 12a, straight side edges 12b and shoulders 12c that slope inwards from the side edges 12b. The base of the head 12, i.e. the point at which the head 12 is at its narrowest, forms the waist 14 on the teat 10.

[0058] The neck 16 widens in width from the narrowest part of the shoulders 12c on the head 12 towards the shield 20, with the narrowest part of the neck 16 forming the waist 14 of the teat 10.

[0059] The shield 20 has a curvature that substantially mirrors the curvature on the front of an infant's face across the width of the mouth. Although not shown, the end of the neck 16 away from the waist 14 of the teat 10 is a free end that is embedded within the structure of the shield 20.

[0060] Grip 30 extends outwards from the middle of the shield 20, away from the teat 10.

[0061] FIG. 2 shows the head 12 of the teat 10 being angled upwards away from the horizontal plane as the teat 10 extends away from the shield 20.

[0062] The shield 20 is a substantially rectangular frame with rounded corners. The frame resembles a pair of ears having a left and a right, with the centre of each ear being empty of material to provide vent holes 22. The two ears are bisected by a central pillar 24 to which the base of the neck 16 of the teat 10 is attached. The central pillar 24 also adds structural stability to the shield 20. There is a dip 26 in the shaping of the shield 20 at the point at which the upper end of the central pillar 24 joins the shield 20 when in use. This dip 26 provides clearance for the nose so the shield 20 does not impede breathing.

[0063] FIG. 3 illustrates the shaping of the teat 10. As can be seen, the head 12 of the teat 10 is angled upwards from the horizontal plane of the pacifier 1. The upper surface 12e of the head 12 has a convex profile, with a shallow rise from the waist 14 towards the apex of the curve. The profile the descends quickly to tip 12a which is semi-circular in profile. The lower surface 12e of the head 12 has a shallow convex profile from the tip 12a to the waist 14 and between sides 12b.

[0064] FIG. 3 also shows the cavity 18 in the neck 16 that extends from the waist 14 of the teat 10 to the shield 20. The shape of the cavity mirrors the external shape of the neck 16 so the thickness of the wall of the neck 16 is the same around the circumference of the neck 16.

[0065] FIG. 3 shows how the pacifier 1 is assembled. The free, open end of the neck 16 includes a collar 19 that describes the circumference of the base of the neck 16. The collar 19 sits on the inside surface of a shoulder on the face of the shield 20 that faces the teat 10.

[0066] In the middle of shield 20, a wall 32 extends away from the teat 10, perpendicular to the shield 20, forming the side wall of the grip 30. The front face 34 of the grip 30 is a shaped plate that is a click-fit over the open end of wall 32. The front face 34 also includes a recess 36, to which is attached an internal protrusion that locates inside collar 19 of the teat 10 when the pacifier 1 is assembled.

[0067] FIG. 4 illustrates the shield 20 and grip 30. The grip 30 has a substantially rectangular shape with rounded or arcuate corners. Indeed, the shape of the grip in the embodiment shown is the same, scaled-down shape as the shield 20. The grip 30 has front face 34 with an outer circumference that is shaped and sized to co-operate with walls 32 shown in FIG. 3. The grip 30 has a depth that forms a recess 36 that is sized to fit an adult fingertip.

[0068] Osteopaths and cranial-sacral therapists are trained to be able to feel and assess for the motion of the skull bones, tissues and circulation with their hands. Infants using a pacifier including the teat of the present invention were assessed before and whilst using the pacifier. It was found that the pacifier stimulated and normalised cranial rhythms. The same infants were also assessed using an ordinary pacifier and, although soothing for an infant, the ordinary pacifier did not affect cranial rhythms. Hands-on cranial tests demonstrated physiological benefits, improved soothing response and a reduction in persistent crying in distressed but healthy infants. In the sample (n=22), 82% (n=18) accepted the pacifier described herein.

[0069] Eighteen infants aged between 1-12 weeks old were involved in a non-randomised intervention feasibility study to test the soother described here. All participants received the soother described herein in addition to regular treatment and questionnaires at baseline, 2 and 4 weeks follow-up. All participants were invited to participate in a 30 minute semi-structured interview after 4 weeks follow-up to find out about their experience using the soother.

[0070] Parent/s and infant with unexplained infant crying who meet the inclusion criteria were recruited from online support platforms, groups and paediatric chiropractor clinics.

[0071] Detailed feedback in the form of qualitative interviews was forthcoming from nine parents. Chiropractors involved with the study fed back experiences from a further three parents and six parents did not volunteer feedback.

[0072] The infants presented in four Chiropractic clinics with a wide range of symptoms and diagnoses. Common ones were distress, excessive day and night time crying, not sleeping, constipation, unable to lie comfortably on their backs, colic and reflux. On examination, it was found that these infants had a wide range of cranial imbalances such as tension in the jaw, facial irregularities, palette compression, mild plagiocephaly and other structural patterns. Interestingly, the structural findings reflect those identified by Waddington et al (supra). Waddington et al found that, out of one hundred new-borns examined, 99% of them had at least one sphenobasilar synchondrosis strain pattern, with other cranial restrictions.

[0073] The majority of parents of infants in the present study had already sought help and advice from other medical professionals such as midwives or GPs. Several were on prescription medication for colic such as Infracol and, some were using non-standard milk formulas if not breast fed. Where possible, the infants were offered the use of the soother prior to receiving chiropractic, cranial or cranial-sacral therapy as a way to test for acceptability before a further intervention was offered.

[0074] Most of the infants had already tried standard commercially available soothers and some of them could use one and some parents expressed a reluctance or distrust in using a standard soother. The infants were difficult to settle using normal parenting soothing methods, including standard soothers, and for many mothers, their infants only appeared to find relief when on the breast, even when not hungry, which was stressful for those mothers, and in some cases, led to Mastitis and difficulties with feeding. This also created tension and anxiety that they were not being a good parent (including fathers/other caregiver) through not knowing how to successfully comfort and soothe their infant.

[0075] The average length of time the soother was needed and regularly used by an infant varied but, overall, was approximately 2-3+ weeks. It is possible that the soother described herein is working more effectively and faster than anticipated.

[0076] The key findings are: [0077] babies as young as 7 days old up to 12 weeks old could successfully use the soother. Sixteen out of eighteen infants in the group used the soother. [0078] eight out of nine parents interviewed by an independent researcher or through questionnaire feedback said they had found between some and much benefit from using the soother for their baby. [0079] chiropractors fed back that the soother appeared to be really helpful and useful to very distressed infants. One reported that, for some infants, using the soother was helpful in addition to and over and above the standard treatment given by the chiropractor. [0080] a common reported benefit for parents was the relief they felt from using the soother because, up until the soother was offered, the baby would not settle even though not hungry or when they were distressed and nothing else would settle them including having tried standard commercially available soothers. Parents reported that the soother really soothed their baby and in particular helped them to move into and stay in a deep sleep. This meant that both infants and parents could get some rest, as well as extending and establishing better sleeping patterns in these infants. [0081] use of the soother appeared not to inhibit or affect feeding methods. Infants were successfully able to use the soother whether breast or bottle fed. The use of this soother in young infants did not affect, compromise or reduce breast feeding. The use of the soother allowed three mothers with sore nipples and mastitis to recover. Instead of constant cluster feeding (feeding in frequent short bursts) on the breast by a distressed infant for non-nutritive purposes, this soother was a good acceptable substitute. As an unexpected outcome, it led to these mothers being able to continue with breast feeding rather than giving up through on-going discomfort. The use of the soother reduced discomfort generally for all mothers who were breast feeding and helped them to identify when an infant had a need to suck or chew rather than being hungry. The outcome of being able to pace breastfeeding or bottle feeding helped to reduce colic and reflux symptoms by giving infants more time to digest and absorb a previous feed. [0082] both chiropractors and parents noted that the soother stimulated deeper and stronger natural sucking by infants. This means that an infant is not only exercising and actively mobilising their tongue muscles but also improving co-ordination resulting in more effective faster feeding. A problem with short feeding episodes can be that an infant is unable to fill themselves up with the highly nutritious fat enriched hind milk within the rear of the breast. Access to the hind milk requires an effective tongue and co-ordinated sucking reflex. [0083] in one case, once the soother was used by an infant, the parent was able to stop using all prescribed medication for colic. [0084] it was noted that the earlier this soother was introduced for an infant (ideally between 1-4 weeks), there was a greater overall impact reported by parents about an infant's wellbeing. In addition, the soother was generally more easily accepted and used by an infant. This also resulted in improved confidence and contentment within mothers, particularly for first time mothers.

[0085] This was a preliminary evaluation of the use of the soother described herein with distressed infants and their parents. There were limitations in terms of the methodology and in collecting the data, not least because undertaking research on a highly sensitive subject involving very young infants and stressed parents is difficult. Parents found that the soother helped their infants when nothing else had, including having already tried a variety of commercially available soothers.

[0086] The soother as described herein assists in relieving somatic dysfunction within a healthy infant by providing active relief, reducing symptoms in distressed babies and better soothing. This relief is possible for an infant to enjoy up to 12+ weeks old.