WO2007141490A1

WO2007141490A1 - Neonatal swaddler

Info

Publication number: WO2007141490A1
Application number: PCT/GB2007/002021
Authority: WO
Inventors: Christine Freya Pearson; William Yonge
Original assignee: Individual
Current assignee: Individual
Priority date: 2006-06-09
Filing date: 2007-06-01
Publication date: 2007-12-13
Anticipated expiration: 2008-12-09
Also published as: GB2438821A; GB0822800D0; GB2452001A; GB0611410D0

Abstract

A neonatal swaddler (10) comprises front and rear flexible panels (18, 12) arranged as a bag or sleeve into which a newborn baby's torso and limbs can be inserted so that the baby's head (46) projects from the mouth of the bag or one end (64) of the sleeve and the front and rear panels cover the front and rear, respectively, of the baby's torso and limbs. The front panel is formed with perforations (74) or the like to facilitate access to the baby in the region of its umbilical stump, and/or the bag or sleeve is formed adjacent each of its sides with perforations (76) or the like to facilitate access to the baby's arms. Access can therefore be obtained to the baby's umbilical stump and arms without substantially weakening the remainder of the swaddler, and with reduced risk of injury to the baby.

Description

TITLE

Neonatal swaddler

DESCRIPTION

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 37⁰C. Immediately after birth, the baby is subjected to the cooling effect of its new, lower temperature surroundings, for example at a room temperature of 2O⁰C, 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.

To assist in maintaining a newborn baby's body temperature, a neonatal wrap has been proposed in patent document US3739399. 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 US3739399 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 further 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. If access is required to the baby, for example to its umbilical stump to inject a drug or take a blood sample, one of the flaps can be folded back after its fastener has been undone, but a relatively large expanse of the baby's skin is then exposed.

A swaddler has also been proposed in patent document US3636566. 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 US3739399, a major problem with the swaddler of US3636566 is that, being made from bubble-wrap material, it obscures the baby to some extent. It is said in US3636566 that the material of the swaddler is rupturable and relatively easily torn 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 torn 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.

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.

In accordance with a first aspect of the present invention, there is provided a neonatal swaddler that, like the swaddler of US3636566, comprises front and rear flexible panels arranged as a bag into which a newborn baby's torso and limbs can be inserted so that the baby's head projects from the mouth of the bag or one end of the sleeve and the front and rear panels cover the front and rear, respectively, of the baby's torso and limbs. Alternatively, the panels may form a sleeve into which the newborn baby's torso and limbs can be inserted so that the baby's head projects from one end of the sleeve. By contrast to the swaddler of US3636566, the swaddler of the present invention is characterised in that the front panel is formed with means to facilitate access to the baby in the region of its umbilical stump, and/or the bag or sleeve is formed adjacent each of its sides with means to facilitate access to the baby's arms. By providing a specific means to facilitate access to the baby's umbilical stump and arms, access can be obtained without substantially weakening the remainder of the swaddler, and with reduced risk of injury to the baby.

The front panel is preferably substantially transparent over at least the majority of its area, and, unlike the swaddler of US3636566, the front panel is preferably provided by a single layer of material over at least the majority of its area, so that the baby's body can be seen clearly through the front panel.

In one embodiment, the means to facilitate access to the baby in the region of its umbilical stump is provided by the front panel being formed as two side-by-side portions that are releasably joined at their adjacent sides, for example by a band of adhesive, a hook-and-loop fastening such as Velcro^® or a zip-fastener.

In other embodiments, the means to facilitate access to the baby in the region of its umbilical stump is provided at least one line of weakness (for example formed by perforations) in the front panel along which the front panel can readily be torn. For simplicity of manufacture, a redundant line of weakness is preferably also formed in the rear panel in register with the, or each such line of weakness in the front panel.

In one such embodiment, a plurality of such umbilical lines of weakness are provided, each forming a generally closed loop. A clinician can then choose which loop to tear around in order to obtain the most convenient access to the baby's umbilical stump, depending on the relative sizes of the baby and the swaddler. In practice, it is unnecessary for the clinician to tear all the way along the loop so that a portion of the front panel becomes detached. Instead, the clinician can tear part way along the loop so that a flap is formed which can subsequently be folded back down over the baby. The or each loop has an area preferably not exceeding about 10 cm², and more preferably about equal to about 4 cm², so that only a relatively small portion of the baby's skin is exposed.

However, in a preferred embodiment, the umbilical line of weakness extends longitudinally of the front panel, preferably from the top to the bottom of the front panel. In this - A -

case, means (such as a band or adhesive or a hook-and-loop fastening such as Velcro^®) are preferably provided for releasably rejoining the front panel after it has been torn along the umbilical line of weakness.

Each means to facilitate access to one of the baby's arms is preferably also provided by a line of weakness (for example formed by perforations) in the bag or sleeve adjacent the respective edge of the bag or sleeve. In this case, each line arm of weakness may be substantially inset from the respective edge of the bag or sleeve, and is preferably provided in the rear panel, so that after access has been obtained to the baby's arm, the opening will better seal itself. For simplicity of manufacture, each such line of weakness preferably has an associated redundant line of weakness formed in the front panel in register with the line of weakness in the rear panel. Each such line of weakness preferably extends along substantially the whole length of the respective side to facilitate removal of the baby from the swaddler once it is no longer required.

In the case where the front and rear panels are arranged as a bag having a closed bottom, a line of weakness (for example formed by perforations) is preferably formed in the bag extending along substantially the whole width of the closed bottom, to facilitate removal of the baby from the swaddler once it is no longer required.

In the case where the front and rear panels are arranged as a sleeve having an open bottom, said one end of the sleeve may be partly closed towards the sides of the sleeve, leaving a central opening for the baby's neck.

The swaddler may further include a flap extending from the rear panel beyond the mouth of the bag or said one end of the sleeve, so that the flap forms, or can be formed into, a hood for the baby's head.

A supply of neonatal swaddlers of the first aspect of the invention may be stored in hospital maternity ward, a baby care unit, a midwife's bag, a general practitioner's bag or a paramedic's bag. The neonatal swaddlers may, of course, be used anywhere that the delivery of a baby is expected, including for home births.

A second aspect of the present invention relates to the use of a neonatal swaddler of the first aspect of the invention to swaddle a neonatal human or animal immediately after birth to reduce heat loss. In accordance with a third aspect of the invention, there is provided a method of manufacture of neonatal swaddlers of one embodiment of the first aspect of the invention, the method including the steps of: extruding a tube of flexible material; flattening the extruded tube to form first and second substantially flat tube halves; perforating at least the first tube half along a longitudinal perforation line disposed generally centrally of the first tube half; perforating at least the second tube half along longitudinal perforation lines disposed adjacent the sides of the second tube half; welding the tube halves together along a series of transverse weld lines spaced apart along the tube; and perforating the tube halves, or cutting the tube, along a series of transverse perforation lines, or cut lines, each disposed adjacent a respective one of the weld lines.

For simplicity of manufacture, the perforations of the longitudinal perforation lines preferably perforate both tube halves.

Specific embodiments of the present invention will now be described, purely by way of example, with reference to the accompanying drawings, in which:

Figure 1 is a front view of a neonatal swaddler of a first embodiment of the invention;

Figure 2 is a front view of the swaddler of Figure 1 after a baby has been inserted, but before the hood has been fully formed;

Figure 3 is similar to Figure 2, but after the hood has been fully formed and a flap to provide access to the baby's umbilical stump has been produced;

Figure 4 is a front view of a neonatal swaddler of a second embodiment of the invention;

Figure 5 is a sectioned view of the swaddler of Figure 4, taken on the section tine V-V in

Figure 4, and with the film thickness of the swaddler exaggerated for clarity;

Figure 6 is a front view of the swaddler of Figures 4 and 5 after a baby has been inserted;

Figures IA-Il are schematic diagrams illustrating the steps in one example of a method of manufacture of a roll of swaddlers of Figures 4 to 6; and

Figure 8 shows a roll of swaddlers produced by the method of Figures 7A to 71. Referring to Figure 1, the neonatal swaddler 10 of the first embodiment of the invention is made from two films of flexible, optically-clear, plastics material, such as polyethylene, having a film thickness between about 25 μm and 35 μm. One of the films has a height Hl of about 380 mm and a width Wl of about 280 mm and forms a back panel 12 of an envelope 14 and a flap 16 for the envelope 14. The other film has a height H2 of about 270 mm and a width Wl of about 280 mm and forms a front panel 18 of the envelope 14. The films are welded along their bottom, left and right edges to form the envelope 14, such that the envelope 14 has an open end 20 and so that the flap 16 protrudes beyond the open end 20.

Bands 22 of adhesive are applied along the side margins of the flap 16 on the front surface of the flap 16 and are covered by peelable protective strips 24, part of the left strip 24 being shown peeled away in Figure 1.

One or both of the front and back panels 18,12 is formed with lines 26,28,30 of perforations along its or their left and right sides and their bottom where the front and back panels 18,12 overlap.

In the example shown in the drawings, six generally-square portions 32-37 of the front panel 18 are delineated by lines 40 of perforations. The portions 32-37 are arranged in an abutting sequence extending parallel to the side edges of the envelope 14 without reaching the top or bottom edge of the envelope 14. Each portion 32-37 has a width W2 and a height H3 each of about 20 mm, and therefore an area of about 4 cm².

Each perforation line 26,28,30,40 may be formed by a series of aligned slits through the plastics material, each slit having a length of about 2.5 mm, and the pitch of the slits being about 3 mm, so that there is a spacing of about 0.5 mm between adjacent slits. The slits serve to weaken the plastics material significantly so that it can be readily torn along the perforation lines 26,28,30,40. This effect can be demonstrated by taking a roll of polyethylene sandwich bags or freezer bags and comparing the tear strength of the material between two adjacent bags with the tear strength of the material part way along the side of a bag.

The swaddlers 10 may be supplied individually wrapped, for example in a polyethylene or paper wrapping. Alternatively, they may be supplied in a stack in a cardboard box, from which individual swaddlers 10 can be taken as required. Alternatively, they may be supplied in a cardboard box on a continuous roll with lines of perforations between adjacent swaddlers 10 that provide a significantly weaker connection than the perforation lines 30 at the bottoms of the swaddlers 10. The swaddlers 10 should be kept clean before use, but there is no need for them to be sterilised and kept sterile. However, they may be sterilised if required.

Referring to Figure 2, immediately after a baby has been born and the umbilical cord has been clamped and cut, and while the baby is still wet, the torso and limbs of the baby 42 are inserted feet-first through the opening 20 into the envelope 14 of the swaddler 10 so that the portions 32,34,36,38 extend down the front of the baby's body. One of the protective strips 24, say on the left, is then peeled away from its adhesive band 22, and the left corner 44 of the flap 16 is folded down so as to form half of a hood for the baby's head 46, and the adhesive band 22 is lightly pressed against the front panel 18 of the envelope 14 to hold that part of the flap 16 in position, as shown in Figure 2. The other protective strip 24 is then peeled away from its adhesive band 22, and the right corner 48 of the flap 16 is folded down so as to form the other half of the hood 50 for the baby's head 46, and that adhesive band 22 is lightly pressed against the front panel 18 of the envelope 14 to hold that part of the flap 16 in position. Consequently, as shown in Figure 3, the swaddler 10 covers the whole of the baby 42 except for its face. Accordingly, even though small gaps may remain between the hood 50 and the baby's head 46, the swaddler 10 significantly protects the baby 42 from the direct effect of draughts and significantly reduces the rate of evaporation of moisture from the baby's skin. Furthermore, because the front panel 18 is formed by a single film of optically-clear plastics material, the baby 42 can be clearly seen by an attending clinician, particularly changes in the baby's skin colour.

The clinician may need to perform a procedure using the baby's umbilical stump 52, such as the insertion of a large line or cannula into the umbilical artery or vein via the stump 50 to administer fluids, blood or drugs, to monitor blood pressure or central venous pressure, or to take blood samples. In this event, the procedure can be performed without removing the baby 42 from the swaddler 10. In particular, the clinician can choose that one of the six portions 32- 37 that is nearest to the stump 52 (portion 37 in the example of Figure 3), and tear the front panel 18 along three of the four lines 40 of perforation surrounding that portion 37 so that a flap 54 is formed which can be lifted to reveal an opening 56 providing access to the umbilical stump 52. After the procedure has been performed, the opening 56 can be closed by folding the flap 54 back. If desired, the flap 54 can then be stuck down by a handy piece of surgical adhesive tape.

hi the event that a clinician needs to perform a procedure using the baby's arm or leg (for example inserting or using an intravenous cannula), this can be performed again without removing the baby 42 from the swaddler 10. In particular, the clinician can select a portion 58,60 of the side perforation line 26,28 close to the arm of leg on which the procedure is to be performed, and tear that portion 58,60 of the edge perforation 26,28 so as to form an opening to gain access to the arm or leg. It is not intended that the envelope 14 should be a tight fit around the baby's torso and limbs, and, after the procedure has been performed, the opening may close up of its own accord. However, if desired, the tear can be repaired by a handy piece of surgical adhesive tape.

Once the baby's temperature is satisfactory and the baby is in an environment, such as an incubator, where its temperature can be maintained and the swaddler 10 is no longer required, the swaddler 10 can simply be removed by peeling back one of the hood-forming flap corners 44,48, and tearing the envelope 14 completely along the corresponding side perforation line 26,28 and completely along the bottom perforation line 30. The baby 42 can then be lifted from between the front and rear panels 18,12.

It will be appreciated that many modifications and developments may be made to the first embodiment of swaddler 10 described above. For example, different sizes and different numbers of the portions 32-37 may be used. Also, an adhesive area may be provided near the centre of the top edge of the flap 16 so that one or more darts may be formed in the hood 50 so that the hood more closely covers the top of the baby's head 46. Furthermore, the bottom edge of the envelope 14 may be gusseted.

Referring now to Figures 4 and 5 of the drawings, the neonatal swaddler 10 of the second embodiment of the invention is made from an extruded thin-film sleeve of flexible, optically-clear, plastics material, such as polyethylene, having a film thickness of about 60 μm, the sleeve being flattened so as to form integral front and back panels 18,12. The panels 18,12 have a height H4 of about 350 mm and a width W3 of about 300 mm. The bottom edge 62 of the sleeve is open. At the top edge 64 of the sleeve, the front and rear panels 18,12 are welded together along the line 66. The swaddler as described so far in this paragraph can therefore be made using standard plastics bag manufacturing techniques. After the top edge 64 has been welded, a semi-circular or semi-elliptical cutaway 70 is formed in the centre of the top edge 64 of the sleeve, and a number of cuts 72 (for example four) are made in each of the panels 18,12 radiating from the cutaway 70. The cutaway 70 and cuts 72 may be formed only in the front panel, but for simplicity of manufacture they may be formed in both panels 18,12. A line of perforations 74 extends centrally of the sleeve from the middle of the cutaway 70 to the middle of the bottom edge 62. The perforations 74 may be formed only in the front panel 18, but for simplicity of manufacture they may be formed in both panels 18,12. Also, lines of perforations 76 extend longitudinally of the sleeve adjacent the side edges 68. The perforations 76 are preferably formed in the rear panel 12, but they may alternatively be formed in the front panel 18, or, again, for simplicity of manufacture they may be formed in both panels 18,12. A band 78 of adhesive (see Figure 5) extends longitudinally of the front panel 18 to one side of the line of perforations 74 and is covered by a protective paper strip 80. The underside of the paper strip 80 has a release coating so that it can readily be peeled from the adhesive band 78. Alternatively, the protective strip 80 may be of polyethylene. The rear panel 12 bears a marking 82 of the torso and limbs of a baby.

As with the first embodiment, the swaddlers 10 of the second embodiment may be supplied individually wrapped, for example in a paper or polyethylene wrapping. Alternatively, they may be supplied in a stack in a cardboard box, from which individual swaddlers 10 can be taken as required. Alternatively, they may be supplied in a cardboard box on a continuous roll with lines of perforations between adjacent swaddlers 10. The swaddlers 10 should be kept clean before use, but there is no need for them to be sterilised and kept sterile. However, they may be sterilised if required.

Referring to Figure 6, immediately after a baby 42 has been born and the umbilical cord has been clamped and cut, and while the baby 42 is still wet, the baby 42 is inserted into the swaddler 10. This may be done by inserting the baby 42 head-first into the open, lower end 62 of the swaddler 10 so that the baby's head 46 projects through the opening formed by the cutaway 70 in the top end 64 of the swaddler 10, and so that the torso and limbs of the baby 42 are covered by the front and rear panels 18,12. Alternatively, the baby 42 may be inserted into the swaddler 10 by: (i) tearing the front panel 18 along the central line of perforations 74; (ii) opening out the resulting two halves 18L,18R of the front panel 18; (iii) laying the baby 42 on the rear panel 12; (iv) closing the front panel halves 18L,18R over the baby's torso and limbs; (v) peeling off the cover strip 80 from the adhesive band 78 on the left panel half 18L; and then (vi) placing the left edge of the right panel half 18R over the adhesive band 78 so as to join the panel halves 18L,18R together again, as shown in Figure 6.

Consequently, as shown in Figure 6, the swaddler 10 covers the whole of the baby 42 except for its head 46 and possibly part of its neck. (If desired, a separate bonnet may be placed on the baby's head 46.) The swaddler 10 therefore significantly protects the baby 42 from the direct effect of draughts and significantly reduces the rate of evaporation of moisture from the baby's skin. Furthermore, because the front panel 18 is formed by a single-layer film of optically-clear plasties material (except in the narrow region of the adhesive band 78), the baby 42 can be clearly seen by an attending clinician, particularly changes in the baby's skin colour. The flaps formed by the cuts 72 around the cutaway 70 enable the baby's shoulders and lower neck to be covered, while allowed some latitude in the positioning of the baby's neck relative to the cutaway 70 and allowing a single size of the swaddler 10 to satisfactorily accommodate a range of sizes of baby. Unlike the first embodiment, the lower end 62 of the swaddler 10 of the second embodiment is not welded closed. However, the height H4 of the swaddler 10 of the second embodiment is substantially greater than the length L, from neck to toe, of the longest baby 42 for which the swaddler 10 is intended, so that beyond the baby's feet the front panel 18 can lie flat on the rear panel 12 and provide a sufficiently effective seal.

The clinician may need to perform a procedure using the baby's umbilical stump, such as the insertion of 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. In this event, the procedure can be performed without removing the baby 42 from the swaddler 10. If the front panel 18 has not already been torn along the central line of perforations 74, the clinician: (i) tears the front panel 18 along the central line of perforations 74 to gain access to the baby's umbilical stump; (ii) performs the required clinical procedure; (iii) peels off the cover strip 80 from the adhesive band 78 on the left panel half 18L; and then (iv) places the left edge of the right panel half 18R over the adhesive band 78 so as to join the panel halves 18L, 18R together again, as shown in Figure 6. On the other hand, if front panel 18 has already been torn along the central line of perforations 74 and the left and right panel halves 18L,18R are already joined by the adhesive band 78, step "i" above is replaced by peeling the right panel half 18R from the adhesive band 78. It should be noted that the adhesive band 78 is arranged so that its bond strength to the left panel half 18L is greater than its bond strength to the right panel half 18R so that the right panel half 18R can reliably be peeled from the adhesive band 78 without destroying the bond between the adhesive band 78 and the left panel half 18L. Accordingly, access can repeatedly be gained to the baby's stump, and the panel halves 18L,18R can repeatedly be joined together afterwards.

In the event that a clinician needs to perform a procedure using the baby's arm (for example inserting or using an intravenous cannula), this can be performed again without removing the baby 42 from the swaddler 10. In particular, the clinician can select a portion 58 of the line of side perforations 76 close to the arm on which the procedure is to be performed, and tear that portion 58 of the side perforations 76 so as to form an opening to gain access to the arm. In the case where the perforations 76 are formed in both the front panel 18 and the rear panel 12, it is preferably only the perforations 76 in the rear panel 12 that are torn. The lines of side perforations 76 are a substantial distance from the baby when in its normal lying position, and after the procedure has been performed, the front and rear panels 18,12 are smoothed down flat so that the opening closes up. However, if desired, the tear can be repaired by a handy piece of surgical adhesive tape. In the event that a clinician needs to perform a procedure using the baby's leg, this can be performed similarly by selecting a portion 60 of the line of side perforations 76 close to the leg on which the procedure is to be performed and tearing that portion 60. Alternatively, the clinician can gain access to the baby's leg between the front and rear panels 18,12 at the open, lower end 62 of the swaddler 10.

Once the baby's temperature is satisfactory and the baby is in an environment, such as an incubator, where its temperature can be maintained and the swaddler 10 is no longer required, the swaddler 10 can simply be removed by peeling the right front panel half 18R from the adhesive strip 78 on the left front panel half 18L and lifting the baby 42 from the swaddler 10. If the baby 42 is to remain connected to tubes or wires which have been passed through openings in the lines of side perforations 76, it will also be required to extend the tear in the side perforations 76 to the lower end 76 of the swaddler 10.

An example of a method of manufacture of a roll 132 of swaddlers 10 as shown in Figures 4 to 6 will now be described with reference to Figures 7A to 71. As shown in Figure 7A, an extruding station 90 extrudes a circular, thin-walled tube 92 of plastics material which is fed to a flattening station 94, by which time a flattened tube 96 has been formed, and the flattening station creases the edges of the flattened tube 96. As shown in Figure 7B, a longitudinal perforating station 98 then forms three lines of perforations 100,102 in the flattened tube 96. The lines of perforations 100,102 will become the perforations 74,76 in the finished product. As shown in Figure 7C, a welding station 104 then forms a series of spaced-apart transverse welds 106 in the tube 96. Each transverse weld 106 will form the weld lines 66 in the finished product. As shown in Figure 7D, an adhesive-applying station 108 then applies a longitudinal band 110 of adhesive to one side of the central line of perforations 100. The adhesive band 110 will form the adhesive band 78 in the finished product. As shown in Figure 7E, a covering station 112 then applies a pre-printed strip 114 of paper over the band 110 of adhesive. The strip 114 will form the protective paper strip 80 in the finished product. As shown in Figure 7F, a cutting station 116 then cuts holes 118 and slits 120 in the flattened tube 106. The holes 118 and slits 120 will form the cutaways 70 and cuts 72 in the finished products. As shown in Figure 7G, a transverse perforating station 122 then forms a series of spaced-apart transverse lines of perforations 124 alongside the welds 106. The transverse lines of perforations 124 will enable individual swaddlers 10 to be torn of from the completed roll 130. As shown in Figure 7H, a printing station 126 then prints the markings 82 on the underside of the flatted tube 96, together with any other markings that may be desired. As shown in Figure 71, a winding and cutting station 128 then winds the flattened tube 96 onto a cylindrical cardboard core 130 and cuts the flattened tube 96 once a sufficient length has been wound, so as to produce the finished roll 132 of swaddlers 10.

As shown in Figure 8, individual swaddlers 10 can then be taken from the roll 132 by tearing along the lines of perforations 124.

Many modifications may be made to the method described with reference to Figures 7A to 8. For example, the functions of two or more of the processing stations 94,98,104,108,112,

116,122,126,128 may be combined, and the processing order may be altered. Also, the transverse perforating station 122 may be replaced by a cutting station, downstream of the printing station 126, that cuts the tube 96 along the lines 124 to separate the tube into individual swaddlers 10, and the winding and cutting station 128 may be replaced by a stacking and packing station.

Many modifications may be made to the swaddler of the second embodiment of the invention. For example a flap, similar to the flap 16 of the first embodiment, may be provided for forming a hood for the baby's head. Also, the swaddler 10 may be supplied with the front panel halves already separated along the line 74.

Other modifications may be made to either embodiment of the invention. For example, although it is preferred that the front panel 18 of the swaddler 10 be optically clear, the rear panel 12 and flap 16 of the swaddler 10 may be obscure or opaque. In that case, the rear panel 12 and flap 16 may be formed of, for example, bubble-wrap material or woven or matted fabric and/or may incorporate a metallic heat insulating film.

Although the invention was conceived as a swaddler 10 for neonatal humans, it may be modified as necessary so as to be of use with neonatal animals and to have an agricultural use.

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.

Claims

1. A neonatal swaddler (10) comprising front and rear flexible panels (18,12) arranged as a bag or sleeve into which a newborn baby's torso and limbs can be inserted so that the baby's head (46) projects from the mouth (20) of the bag or one end (64) of the sleeve and the front and rear panels cover the front and rear, respectively, of the baby's torso and limbs, characterised in that the front panel is formed with means (40; 74) to facilitate access to the baby in the region of its umbilical stump, and/or the bag or sleeve is formed adjacent each of its sides with means (26,28; 76) to facilitate access to the baby's arms.

2. A swaddler as claimed in claim 1, wherein the front panel is substantially transparent over at least the majority of its area.

3. A swaddler as claimed in claim 1 or 2, wherein the front panel is provided by a single layer of material over at least the majority of its area.

4. A swaddler as claimed in any preceding claim, wherein the means to facilitate access to the baby in the region of its umbilical stump is provided by the front panel being formed as two side-by-side portions that are releasably joined at their adjacent sides.

5. A swaddler as claimed in any one of claims 1 to 4, wherein the means to facilitate access to the baby in the region of its umbilical stump is provided at least one line (40; 74) of weakness in the front panel along which the front panel can readily be torn.

6. A swaddler as claimed in claim 5, wherein a redundant line of weakness is formed in the rear panel in register with the umbilical line of weakness in the front panel.

7. A swaddler as claimed in claim 5 or 6, wherein a plurality of such umbilical lines (40) of weakness are provided, each forming a generally closed loop.

8. A swaddler as claimed in claim 5, wherein the umbilical line (74) of weakness extends longitudinally of the front panel.

9. A swaddler as claimed in claim 8, wherein the umbilical line of weakness extends from the top to the bottom of the front panel.

10. A swaddler as claimed in claim 8 or 9, further including means (78) for releasably rejoining the front panel after it has been torn along the umbilical line of weakness.

11. A swaddler as claimed in any preceding claim, wherein each means to facilitate access to the baby's arm is provided by a line (26,28; 70) of weakness in the bag or sleeve adjacent the respective edge of the bag or sleeve.

12. A swaddler as claimed in claim 11, wherein each line arm of weakness is substantially inset from the respective edge of the bag or sleeve.

13. A swaddler as claimed in claim 11 or 12, wherein each arm line of weakness is provided in the rear panel.

14. A swaddler as claimed in claim 13, wherein each arm line of weakness has an associated redundant line of weakness formed in the front panel in register with the arm line of weakness in the rear panel.

15. A swaddler as claimed in any of claims 11 to 14, wherein each arm line of weakness extends along substantially the whole length of the respective side.

16. A swaddler as claimed in any preceding claim, wherein the front and rear panels are arranged as a bag having a closed bottom.

17. A swaddler as claimed in claim 16, wherein a line (30) of weakness is formed in the bag extending along substantially the whole width of the closed bottom.

18. A swaddler as claimed in any of claims 1 to 15, wherein the front and rear panels are arranged as a sleeve having an open bottom (62).

19. A swaddler as claimed in claim 18, wherein said one end of the sleeve is partly closed towards the sides of the sleeve, leaving a central opening (70) for the baby's neck.

20. A swaddler as claimed in claim 5, 11 or 17, or any claim when dependent thereon, wherein each line of weakness is provided by perforations.

21. A swaddler as claimed in any preceding claim, further including a flap (16) extending from the rear panel beyond the mouth of the bag or said one end of the sleeve, so that the flap forms, or can be formed into, a hood (50) for the baby's head.

22. A hospital maternity ward, a baby care unit, a midwife's bag, a general practitioner's bag, or a paramedic's bag containing a swaddler as claimed in any preceding claim.

23. The use of a neonatal swaddler as claimed in any of claims 1 to 21 to swaddle a neonatal human or animal immediately after birth to reduce heat loss.

24. A method of manufacture of neonatal swaddlers as claimed in claim 20 when dependent indirectly dependent on claims 9, 13 and 15, the method including the steps of: extruding a tube (92) of flexible material; flattening the extruded tube to form first and second substantially flat tube halves; perforating at least the first tube half along a longitudinal perforation line (100) disposed generally centrally of the first tube half; perforating at least the second tube half along longitudinal perforation lines (102) disposed adjacent the sides of the second tube half; welding the tube halves together along a series of transverse weld lines (106) spaced apart along the tube; and perforating the tube halves, or cutting the tube, along a series of transverse perforation lines

(124), or cut lines, each disposed adjacent a respective one of the weld lines.

25. A method as claimed in claim 24, wherein the perforations of the longitudinal perforation lines perforate both tube halves.