1. Field of the Invention
This invention relates to a neonatal swaddler and method of manufacture thereof.
Immediately before a baby is born, it is wet and its temperature throughout is generally equal to its mother's core temperature, i.e. blood heat, about 37° C. Immediately after birth, the baby is subjected to the cooling effect of its new, lower temperature surroundings, for example at a room temperature of 20° C., by convection, conduction and radiation. Also, if the baby is left naked and wet, it is subjected to a significant cooling effect as its skin dries due to the latent heat of evaporation. The cooling effects of convection and evaporation are accentuated if the baby is in a draught. A newborn baby's temperature regulation system may be underdeveloped, especially if it is born prematurely. Cold stress can harm a newborn baby, in that energy requirements can cause low blood sugar, acidosis and reduced production of lung surfactant, leading to poor adaptation from intra-uterine to extra-uterine life and a worse long-term developmental outcome especially, but not solely, for premature babies. It is therefore important to keep the baby warm.
In a hospital, once a premature baby has been delivered, it is typically immediately transferred to a resuscitaire where it is stabilised for a period of time. The baby may then be transferred to a neonatal unit on the resuscitaire or in a transport incubator, where the baby is then placed into a permanent incubator. It is critical to keep the baby warm over the period of time from delivery until the baby has been placed in the permanent incubator and the temperatures of the incubator and baby have stabilised. Other times when a new born baby may be exposed to the cold are if it is being transferred to hospital, for example after a home birth, or if it is being transferred between different hospitals or neonatal units.
2. Description of the Prior Art
To assist in maintaining a newborn baby's body temperature, a neonatal wrap has been proposed in patent document U.S. Pat. No. 3,739,399. That wrap comprises a specially-shaped sheet of plastics bubble-wrap material that has slits cut in it so that it has a central area from which a number of flaps extend. In use, as soon as possible after birth the baby is placed supine on the central area of the sheet, and the flaps are then folded over the baby and held in place by Velcro® fasteners. Once all of the flaps have been folded over and attached, the wrap is intended to cocoon the baby's torso and limbs and forms a hood for the baby's head. The baby can be kept in the neonatal wrap while it is being taken to an incubator, and for its first few hours in the incubator while the baby's temperature regulating system stabilises. However, a problem with the neonatal wrap of U.S. Pat. No. 3,739,399 is that, if a wrap that is sized to accommodate a large baby is instead used for a relatively small baby, significant gaps are likely to be formed between adjacent flaps so that the baby is not so well protected as might be. A farther problem with that wrap is that, being made from bubble-wrap material, it does obscure the baby to some extent, which is a major disadvantage. A further disadvantage of that wrap is that a large number of fasteners needs to be done up in order to cocoon the baby in the wrap, and need to be undone when the wrap is no longer required.
A swaddler has also been proposed in patent document U.S. Pat. No. 3,636,566. That swaddler comprises an envelope of plastics bubble-wrap material that has an open end through which a newborn baby's torso and limbs can be inserted into the envelope, and a flap extending from the open end of the envelope so that the flap forms, or can be formed into, a hood for the baby's head. Like the wrap of U.S. Pat. No. 3,739,399, a major problem with the swaddler of U.S. Pat. No. 3,636,566 is that, being made from bubble-wrap material, it obscures the baby to some extent. It is said in U.S. Pat. No. 3,636,566 that the material of the swaddler is rupturable and relatively easily tom to enable ready access to any portion of the baby's body. However, it should be noted that a sheet of bubble wrap is formed by two layers, each of which must be sufficiently strong to maintain its integrity, but that both layers would need to be tom in order to penetrate the sheet. It is therefore expected that if the material is made sufficiently strong to maintain its integrity, it would be difficult to tear it and that there would be a risk of hurting the baby in the process.
Another swaddler is known from patent document U.S. Pat. No. 4,083,064. That swaddler is generally of the form of a transparent shirt having sleeves with closed ends. The front of the shirt has left and right panels which overlap slightly (over about 8% of the width body part of the shirt) and can be held together by sticky tape. A problem with using sticky tape is that is has an uncanny knack of sticking to places where it is not intended and of not sticking to places where it is intended for example because of wetness. A further disadvantage is that the sticky tape obscures the transparency of the front panels. The bottom of the shirt can also be closed with sticky tape. Apart from the front opening between the left and right front panels, the swaddler of U.S. Pat. No. 4,083,064 is not specially adapted to provide access to, for example, the baby's arms. However, the document does mention that the material of the shirt arms can be slit.
An aim of the present invention, or at least of specific embodiments of it, is to provide an improved neonatal wrap or swaddler that provides sufficient protection to the newborn baby, that can accommodate babies of different sizes satisfactorily, that is easy to fit to the baby, that enables ready access to the baby's umbilical stump and other parts of the baby's body, that enables the baby's body to be seen clearly, and that is relatively easy and inexpensive to manufacture.
First and second aspects of the present invention relate to a neonatal swaddler formed from flexible sheet plastics material which is preferably transparent and single-ply. The material is folded along a pair of generally-parallel longitudinal fold-lines to form (i) a generally-rectangular back-panel of the swaddler between the lines, (ii) a generally-rectangular right front-panel beyond one of the fold-lines and (iii) a generally-rectangular left front-panel beyond the other fold-line. Each front-panel is connected to the back-panel along a respective transverse connection-line (such as a weld line) at one end of the swaddler The connection-lines are spaced apart so that when a newborn baby is placed between the front-panels and the rear-panel, the baby's neck can project from the swaddler between the connection-lines at said one end of the swaddler.
Third and fourth aspects of the invention relate to a method of manufacture of a neonatal swaddler The method involves folding flexible sheet plastics material along a pair of generally-parallel longitudinal fold-lines to form a generally-rectangular back-panel of the swaddler between the lines, a generally-rectangular right front-panel beyond one of the fold-lines and a generally-rectangular left front-panel beyond the other fold-line. The method furthermore involves connecting each front-panel to the back-panel (for example by welding) along a respective transverse connection-line at one end of the swaddler, the connection-lines being spaced apart so that when a newborn baby is placed between the front-panels and the rear-panel, the baby's neck can project from the swaddler between the connection-lines at said one end of the swaddler
In accordance with the first and third aspects of the present invention, when the swaddler is flat, the right and left front-panels overlap each other over at least 20% (and preferably over about 30%) of the width of the back-panel between the fold lines
In accordance with the second and fourth aspects of the invention, the overlap of the right and left front-panels, when the swaddler is flat, being between about 60% and 100% (and preferably between about 90% and 100%) of the spacing between the connection-lines.
Due to the amount of overlap, there is no need to provide any means for positively and releasably attaching the front panels to each other part way along the overlap, and preferably the swaddler is devoid of any such means. The lack of such attaching means simplifies manufacture and use of the swaddler and does not obscure the view of the baby through the front panels.
The front-panels are preferably connected to the back-panel along a common transverse connection-line (such as a weld line) at the opposite end of the swaddler. This assists in keeping the swaddler in shape and, as will be appreciated from the following detailed description of the drawings, need not require any additional manufacturing process steps.
A pair of side perforation-lines preferably extend between the ends of the swaddler each spaced from a respective one of the fold-lines. In use, the swaddler material can readily be torn along part of one of the perforation lines, without needing any cutting implement, in order to obtain access to the baby's arms or legs. Along each side perforation-line, the swaddler is preferably perforated through the back-panel and the respective front-panel.
A central perforation-line preferably extends between the ends of the swaddler. When the baby no longer has any use for the swaddler, the swaddler material can readily be torn along the central perforation line, without needing any cutting implement, in order to facilitate removal of the baby from the swaddler. Along the central perforation-line, the swaddler is preferably perforated through the back-panel but not through the front-panels so as not to weaken the front panels unnecessarily.
Referring to
The pieces 48 produced by the machine 10 each constitute a neonatal swaddler 60 as shown in
In use, the swaddler 60 is placed on a horizontal surface, and a new-born baby is placed in the swaddler 60 so that the baby lies face-up generally over the image 18 on the rear panel 62 and beneath the front panels 64R,64L, with the baby's head and neck projecting from the opening 66. The cutaway 52 and slits 54 prevent the material of the swaddler 60 digging into the baby's neck and allow the swaddler to conform more readily to the shape of the baby in the neck region so as to prevent significant draughts into or out of the swaddler in that region. However, the material of the swaddler 60 is sufficiently stiff that, in the event that part of the swaddler covers the baby's nose, it will not readily bend sufficiently to seal over the baby's nostrils. Nevertheless, the material of the swaddler 60 is sufficiently flexible, and the front panels 64R,64L overlap sufficiently, that the front panels 64R,64L conform to the general shape of the baby and therefore to each other so that they prevent significant draughts into or out of the swaddler 60 down the front of the swaddler 60. At least the front panels 64R,64L of the swaddler 60 are sufficiently optically-clear, even where the front panels 64R,64L overlap, that the colour and texture of the baby's skin is not obscured. In the event that a procedure needs to be carried out on the baby's torso (for example on the umbilical stump so as to insert a large line or cannula into the umbilical artery or vein via the stump to administer fluids, blood or drugs, to monitor blood pressure or central venous pressure, or to take blood samples), the front panels 64R,64L can be folded open to provide access, as shown in
A modified machine 10′ for manufacturing the swaddlers 60 is shown in
It will be appreciated that many modifications and developments may be made to the embodiments of the invention described above and the methods of manufacture. For example, the order of some of the stations shown in
It should be noted that the embodiments of the invention have been described above purely by way of example and that many other modifications and developments may be made thereto within the scope of the present invention.
Number | Date | Country | Kind |
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GB 0724053.4 | Dec 2007 | GB | national |