Artificial Breast

Breastfeeding of babies by their mothers is known to confer a range of benefits to baby and mother (and indeed others) when compared to, for example, bottle feeding. These include physical, psychological and emotional benefits to health and wellbeing.

There are however many circumstances when breastfeeding is not preferred or practicable for one or more short or long periods of time and feeding is performed in another manner by the mother or some other person or people. In these circumstances fluids (including water), solutions, mixtures, suspensions and emulsions, including milk (and often the mother's own, expressed milk) are often fed to the baby using a bottle or other container equipped with a device to control the flow to the baby, often in a demand-responsive manner. This is usually a teat. Such "bottle feeding" is also often used without prior and/or subsequent breastfeeding or attempts to breastfeed.

A number of problems can arise when a baby is bottle-fed. For example, the material fed may not be appropriately nutritious; it may be contaminated; or the temperature may be inappropriately high or low for the baby.

There can also be difficulty in getting the baby to bottle feed and more frequently it may be difficult subsequently to get the baby to feed from the mother's breast. The prospect that breastfeeding may be difficult after the baby has experienced one or more other forms of feeding, and the reality (if then starting to breastfeed is difficult, or if continuing to breastfeed is difficult after a change) is often a matter of great concern to many, especially the mother. Jhe health of the baby and/or the mother, and many complex relationships, can be detrimentally affected.

There are many characteristics and signals that may influence the ease with which a baby will feed from its mother's breast. These include the baby's natural desire and ability to latch onto the nipple, to remain there and to suck productively. Among the characteristics that may influence this are the shape, feel, flexibility, texture and appearance of the mother's breast and nipple, while the baby is latching onto the nipple, and while it is sucking or simply attached; the ease with which milk is obtained; the smell of the mother's breast and milk, the sounds such as her breathing and her heart beating, the temperature in that region, the manner in which the baby is held, and so on.

Differences in one or more of these and other characteristics may make it difficult to swap from bottle-feeding to breast-feeding (or vice versa) and achieve or maintain successful latching (attachment), sucking and feeding by the baby. Swapping from one system to the other may result in difficulties termed nipple confusion.

Manufacturers of feeding systems, most commonly including teats, have developed many improvements in recent years, in part to reduce nipple confusion. Teats can be obtained in a range of shapes, sizes, textures, colours and materials, and deliver fluids and mixtures, especially as a response to sucking, with differing ease and at different rates. They sometimes address potential problems such as colic. Nevertheless, the difficulty to get a baby to breastfeed after it has experienced other feeding methods such as bottle feeding e.g. with these teats remains a major concern and reality.

A problem that contributes to difficulties in bottle-feeding and breastfeeding, and the change from one to the other, is that although some teats are more similar to any

particular mother's nipple and breast than other teats, none actually mimics the particular mother's nipple and breast in its characteristics prior to and during feeding.

A solution to the problem of getting a baby to begin to breastfeed or revert to breastfeeding after alternative methods, including bottle-feeding, is to ensure that the alternative feeding experience is very similar to that of breastfeeding. Thus, for example, the size, shape, structure, flexibility, consistency, texture, colour and smell of the teat of a bottle should be as similar as possible to those characteristics of the baby's own mother's breast in the suckling region. This is the nipple and may include the areolar region and sometimes the region close by. Processes such as latching, sucking and other oral motor skills will then be performed as similarly as possible to those developed, used and experienced in breastfeeding. Ideally the characteristics of the teat will be similar to those of the baby's own mother's breast when not being sucked, and will change in characteristics on sucking in the same ways as does the baby's own mother's nipple and the region close by.

As can be seen in Figure 1 , in its resting state a mother's breast 11 near the nipple has an areolar region 12 and nipple 13 that may change in shape during suckling (Figure 2). As shown in Figure 3 for a teat under suction by the baby, problems of nipple confusion can be overcome if the teat 20 of a feeding bottle has a portion 21 near the bottle that closely mimics the characteristics of the baby's own mother's breast 11, another portion 22 is similar to the areolar region 12, and a portion 23 is closely analogous to the nipple 13 of the baby's own mother.

In some situations it may be impracticable to make the teat mimic the baby's own mother's nipple and breast both prior to and during suckling, in which case a partial improvement will be achieved by mimicking it well prior to suckling, and a greater improvement if mimicked during suckling.

The more similar the teat can be to its own mother's nipple and breast, the more the teat will stimulate and reinforce the correct oral motor skills that are needed for breast feeding; and reduce nipple confusion. The baby is then likely to be able to use very similar mouth, lip and tongue positions when using the bottle teat as it does when feeding directly from its own mother's breast.

The teat will be functional and in most respects be similar to teats that are generally available, e.g. have a lip at its base to permit attachment to a bottle, and a slit, hole or other means through which the baby can suck fluid; and e.g. may have one or more slits, holes, permeable areas or tubes to avoid the baby ingesting unacceptable amounts of air, and other detail on inner surfaces to minimise e.g. colic.

One way to provide a teat that is very similar to the baby's own mother's breast, especially nipple and areolar region, is to make an impression or cast of that area. This shape is specific to the baby's own mother but is also affected by conditions. The impression can be made in the resting state and/or after or during mild stimulation, e.g. sucking or simulated sucking, and may be taken e.g. at ambient pressure or under slightly diminished pressure to e.g. increase the length and modify the shape of the nipple, as is induced by the baby in the normal course of its feeding. One or more of these impressions can permit a teat to be designed that mimics the baby's own mother's breast prior to and when the baby latches, and when the baby is successfully feeding.

The teat produced may differ from the cast based on knowledge of the way that the baby's mouth will distort the sucked nipple.

Bespoke teats are sufficiently similar (in relevant characteristics) to the mother's nipple and the associated area that nipple confusion is generally less likely to arise, and if it does, is generally less severe, so that the baby feeds more readily from, or returns to and feeds more readily from, the mother's breast, after a period of feeding from the bespoke teats.

A close match to the mother's breast can be made in a variety of ways. For example, with or without the application of slight negative pressure, a negative impression of the nipple, the areolar region and if desired the region in close proximity to it, can be made with, for example, silicone. This (or these) can permit the fabrication of a wax positive (or positives), which can be grafted onto a base that is of a suitable shape for use in a baby's bottle. This whole can be used to generate a silicone negative mould, and thus a silicone positive. This silicone positive can then be used to construct a negative mould of a material (such as epoxy resin) that is sufficiently robust to allow the production of multiple (say, 20) bottle teats with shape, size and other characteristics that closely mimic the mother's own breast in the region of the nipple.

Teats of satisfactory quality can also be manufactured using a smaller number of steps, e.g. by omitting one pair of negative and positive moulds, e.g. the silicone negative and positive moulds.

Another way to provide a teat that is very similar to the baby's own mother's breast, especially the nipple and areolar region, is to generate a three-dimensional image so that, for example, a mould can be constructed based on that information or data set. This can have advantages such as permitting electronic transfer of the information to permit speedier remote fabrication. It may also allow reduction in the number of steps in fabrication.

The fabrication process can be shortened, and speeded, for example by the generation of a hologram. This can facilitate the production of a robust negative mould (from which multiple bespoke teats can be made directly) with a reduction in the number of process steps when compared with a more conventional fabrication process.

Rapid prototyping techniques including those incorporating computer aided design and computer aided manufacture can be particularly useful since a relatively small number of teats (or other devices, indicated below) will be required by any mother and her baby or babies.

While the overall shape can be determined e.g. by an imaging technique, the behaviour under a sucking action can be replicated based on measurements or observations, sometimes made during the application of pressure (or reduced pressure). The behaviour of the teat (or other device, below) when in the baby's mouth is of critical importance. For this reason it is necessary to construct the teat (or other device, below) from materials (normally polymers such as silicone) with the most appropriate flexibility and wall thickness (which may be varied within the device). The teat may have a single or multi-layered structure (and if multilayered the interstitial spaces may be filled with a non-toxic fluid of appropriate viscosity) such that the whole structure mimics the consistency of the nipple and breast very close to the nipple of the baby's own mother.

Although devices such as teats are best modeled on the baby's own mother's breast, it may still be beneficial to use similar procedures to generate a range of e.g. teats so that mothers can select the one most closely resembling their own nipples, based substantially on appearance or on more rigorous measurement of e.g. size, shape and flexibility.

Breastfeeding can be rendered difficult and/or uncomfortable if either or both of the mother's nipples are sore, sensitive or cracked. This can result from feeding by the baby. Devices to protect a nursing mother's nipples may also lead to nipple confusion. The protective device will not lead to nipple confusion if it is bespoke, and very similar in size, shape and other characteristics to the mother's nipple and nipple region. It will be clear to any skilled in the art that a bespoke nipple shield or protector can be fabricated using procedures similar to those exemplified for a bespoke teat. Indeed, if bespoke teats are being made, it is relatively simple to make bespoke nipple shields as well.

Babies are sometimes comforted by being given something, known as a soother, pacifier, comforter or dummy, to suck on. Such devices are often flexible and resemble a teat on a feeding bottle; but usually lack one or more openings such as holes or slits through which milk or other fluids would be delivered. They may lead to nipple confusion and thus difficulty in subsequently getting the baby to suckle from the mother. This will not occur, or certainly the tendency will be diminished, if they are bespoke, being based on and extremely similar to their own mother's nipple and breast near her nipple. They can be fabricated in a number of ways, including those exemplified for the bottle teat. Indeed, if bespoke bottle teats are being made, corresponding bespoke soothers may readily be made as well.

It may be appropriate in some instances, e.g. for the soother, to mimic the mother's nipple's shape and texture but modify one or more aspects of the fabricated structure, e.g. lengthen the portion analogous to the nipple somewhat so that the soother is less likely to fall from the baby's mouth.

Changes occur in the mother's breast close to the time of her baby's birth. The performance and value of bespoke teats, nipple shields, soothers and other devices is dependant on and enhanced by a close correspondence with the breast of the mother. Characteristics such as of the mother's nipple, and the area close by, may need therefore to be established close to the time when the baby might start to suckle. It must however be early enough to allow fabrication and supply of the devices in time for them to be useful.

It may also be useful to incorporate a close representation of a mother's nipple, areolar region or more of her breast, or indeed other parts of her, in feeding devices, rattles, teething aids, toys and other items, that will benefit the baby or child or mother or other carers, or their relationships.