FIELD

The present disclosure relates to a resuscitation support apparatus and method, in particular to a resuscitation support apparatus and method for an infant.

BACKGROUND

Each year approximately 10 million babies worldwide do not spontaneously breathe at birth and thus require some form of neonatal resuscitation. In such circumstances, UK and US national guidelines, for example, recommend that positive pressure ventilation is initiated within the first minute of life. For effective ventilation to be achieved, the infant’s airway must also be patent, i.e. , there must be an open passageway to the baby’s lungs.

There remain, however, a number of significant challenges with existing techniques.

For example, improper head and neck positioning is identified as one of the most common problems in neonatal resuscitation and is believed to contribute to increased neonatal mortality, with subtle changes in the angle of the head of a newborn baby significantly impacting airway patency.

Moreover, many newborn babies have a prominent occiput, which causes the head to be in the flexion position when the baby is placed on their back on a flat surface.

SUMMARY

An aspect of the present disclosure relates to a resuscitation support apparatus for an infant, the resuscitation support apparatus comprising: a base component and a support member comprising a height adjustment mechanism. The base component may be configured for positioning an upper torso and head of an infant. The height of the support member may be adjustable to change the angle of the head relative to the upper torso so as to provide airway patency.

Beneficially, the resuscitation support apparatus may be used to ensure efficient and correct positioning of an infant’s head to provide airway patency and effective resuscitation. Having a support member comprising a height adjustment mechanism may allow for the apparatus to correctly angle the head relative to the torso regardless of the infant’s size. For example, a pre-term infant will be significantly smaller than a full term infant, and thus the degree of height adjustment required to achieve airway patency may be significantly smaller.

The apparatus may comprise a first configuration. In the first configuration of the apparatus, the base component and the support member may be planar or substantially planar. Beneficially, this facilitates the infant to be positioned flat on the base component when placed back-down on the apparatus. In the first configuration, the apparatus may take the form of planar sheet. This facilitates simple and efficient positioning of the infant for resuscitation. The provision of a planar surface may allow for the apparatus to be used for any size of infant, in comparison to, for example, an apparatus having supports of a pre-defined height which may not be suitable for all infants (for example, pre-term infants).

The apparatus may comprise a second configuration. In the second configuration, the base component may be planar or substantially planar and the support member may be configured to protrude from the base component. In the second configuration, the height adjustable support member may elevate the upper torso of an infant relative to the head. The second configuration may encompass any height of the height adjustable support member that is greater than the support member in the first configuration. Alternatively, in the second configuration, the height of the support member may correspond to a maximum height. The apparatus may also comprise a plurality of intermediate configurations in which the base component may be planar or substantially planar and the support member may be configured to protrude from the base component at a height that is no longer planar but less than the maximum height. The apparatus may comprise any number of intermediate configurations. Accordingly, the height of the support member may be adjusted to a desired height to angle the head relative to the upper torso as required to achieve airway patency. The desired height may be dependent upon the size and/or weight of the infant requiring resuscitation.

The height adjustment mechanism may be configured to facilitate manual adjustment. Beneficially, this allows for a user, for example a healthcare professional, to easily change the height of the support member as required depending upon the size of the infant. In this regard, the support member may be adjustable between a range of heights suitable for all infants, for example ranging from average pre-term sized babies to average plus-term babies.

The height adjustable mechanism may comprise an inflatable portion. For example, the support member may comprise an inflatable chamber. This may provide for the height of the support member to be varied quickly and across a wide variety of heights. The inflatable portion may be inflated or deflated to achieve the desired height. Beneficially, this will allow the user, for example a healthcare professional, to decide the degree of inflation required to achieve airway patency, as this will be dependent upon the size of the infant. The inflatable portion may be configured for deflation after use of the apparatus.

The support member may comprise a plurality of inflatable chambers. For example, the support member may comprise at least two inflatable chambers. The chambers may be fluidly connected. The provision of a plurality of fluidly connected chambers may provide for an even distribution of air throughout the support member. This may prevent the support member from flattening or deforming under the weight of the infant, ensuring that the optimum angle between the upper torso and head is maintained throughout the resuscitation procedure. Alternatively, the chambers may be independently inflatable. This may provide for a greater degree of variation in positioning the infant’s head relative to the upper torso and for adjusting the relative angle there between. For example, the distance between the head and upper torso of the infant to be resuscitated will vary according to the birth weight and length. For example, for pre-term or smaller infants, only a single chamber may be required to be inflated in order to achieve airway patency because of the size of the infant. Full term infants on the other hand may require more than one chamber to in inflated to achieve airway patency. Beneficially, the provision of multiple inflation chambers increases the flexibility of the resuscitation support apparatus for use regardless of the infant’s size and the user may decide the degree of inflation as required to achieve airway patency.

The apparatus may comprise a valve. The valve may communicate with the inflatable portion of the support member. This may facilitate attachment to an inflation arrangement configured to inflate the inflatable portion. The valve may be adjustable in size and/or shape, and/or configuration to allow for attachment to a variety of inflation arrangements. Beneficially, this may for example allow the apparatus to interface with off-the-shelf inflation apparatuses, for example an off-the-shelf pumping apparatus, or to interface with custom-made inflation apparatuses.

The apparatus may further comprise an inflation arrangement. The inflation arrangement may provide inflation, i.e. a supply a fluid e.g. liquid or gas, to the inflatable portion of the height adjustable support member. The apparatus further comprising the inflation arrangement may provide for a ready to use apparatus which does not require further assembly, saving time during time-critical resuscitation procedures. The inflation apparatus may be a manually operated inflation apparatus. The inflation apparatus may comprise, for example a pump arrangement. The pump arrangement may comprise, for example, a balloon pump or a piston pump, or the like.

The apparatus may be configured to be foldable in the first configuration. The base component may comprise a pliable material. The base component may comprise a pliable sheet of suitable material. This may allow the apparatus to be folded. For example, the apparatus may be configured to be folded for storage when the apparatus is not in use. This may be advantageous where storage space may be limited, for example in a hospital environment or within an ambulance. This may also increase the portability of the apparatus, which may be particularly relevant in a hospital environment or may allow for the resuscitation support apparatus to be packed and carried by, for example health professionals present at a birth outside of a hospital setting, such as a home birth. The apparatus may be configured to foldable in the second configuration. The apparatus being foldable in the second configuration may allow for the apparatus to be wrapped around the infant during resuscitation. Accordingly, the apparatus may provide warmth and security to the infant, and may minimise the risk of the infant developing hypothermia during the resuscitation procedure.

The apparatus may be shaped and sized appropriately for use with an infant. The base component may be shaped and sized appropriately for use with an infant. For example, the base component may be rectangular or substantially rectangular. For example, the base component may further comprise wings configured to swaddle an infant. In this regard, the resuscitation support apparatus may also act to help keep an infant warm and secure whilst being resuscitated.

The base component may further comprise a head portion for locating the head of the infant relative to the support member. Beneficially, this facilitates the correct orientation of the infant to allow for the support member to elevate the upper torso in preparation for resuscitation. The head portion may be located relative to the height adjustable support member so that the axial length between them is appropriate for infants. For example, the head portion may comprise a circular base upon which to lay an infant’s head. The head portion may allow the user to quickly lay the infant in an orientation relative to the support member which will allow the support member to correctly angle the head relative to the upper torso to achieve airway patency.

The base component may comprise a pliable material. For example, the base component may comprise a flexible polymer. The base component may comprise for example, any suitable flexible polymer which is approved for use in healthcare applications. For example, the base component may comprise, for example, at least one of flexible polyvinyl chloride (PVC), thermoplastic polyurethane (TPU), and ethylene vinyl acetate (EVA). The base component comprising a pliable material may provide for easy manipulation of the base component into the first configuration for use during a resuscitation procedure. Further, this may be allow for the aforementioned foldability of the apparatus for example, for storage, and/or transportation.

The apparatus may be configured for reuse/multiple operations. For example, the apparatus may be configured to be washable. In this respect, the apparatus may be configured to be reusable for multiple infants. The apparatus may be configured to be washable to allow for sterilisation. For example, the materials selected for use in the apparatus may be washable at temperatures up to for example, 90°C, or for example, 60°C to allow for sterilisation between uses. The apparatus materials may be any suitable material which has been approved for use in healthcare applications.

The apparatus may further comprise a layer of absorbent material. The layer of absorbent material may aid in reducing heat loss from the baby during the resuscitation procedure. The resuscitation procedure may occur within minutes of birth, and as such the infant may still be covered in amniotic fluid and other bodily fluids. These fluids may be absorbed by the layer of absorbent material. The absorbent material may comprise for example, microfiber, cotton towelling or the like.

The layer of absorbent material may be provided on a surface of the base component, wherein the layer of absorbent material is to be located between the base component and an infant, when the apparatus is in use. The layer of absorbent material may be provided on an upper surface of the base component. It will be understood that the term upper surface refers to the surface upon which the infant will rest during resuscitation.

The layer of absorbent material may be detachably coupled to the base component. For example, the base component comprises attachment means, for example a hook and loop arrangement, a zipper arrangement, or a button arrangement, and the layer of absorbent material may comprise a complementary attachment means. This may allow, for example, for washing or cleaning of the absorbent material in between uses, or for replacement of the absorbent material in between uses. The apparatus may be configured such that the layer of the absorbent material may be the only portion of the apparatus in contact with the infant and therefore, the absorbent material may be detached, and replaced with another layer of absorbent material to allow for a quick turnaround in use of the apparatus with different infants. This may simplify the cleaning process and/or minimise the risk of cross contamination between uses.

The layer of absorbent material may further comprise a hood portion configured for enveloping an infant’s head. This may further minimise heat loss from the infant during the resuscitation procedure. Providing a hood portion may further facilitate the correct placement of the infant on the apparatus during resuscitation.

The apparatus may further comprise a heating component. This may be provided to transfer heat to the infant, helping to maintain a desired body temperature during the resuscitation procedure. The heating component may be any suitable heating component. The heat component may comprise or take the form of an electrical heating component (for example a battery powered heating element). Alternatively, or additionally, the heating component may comprise a water based heating element, for example a hot water pouch, pocket or bottle. Alternatively or additionally, the heating component may comprise or take the form of a chemical heating component. The heating component may comprise an instant heat pack. For example, a reusable instant heat pack. For example, the reusable instant heat pack may comprise sodium acetate solution and a metal trigger disk. The instant heat pack may comprise a shape corresponding to the shape of the base component. The heat pack may comprise a trigger disk isolation portion for locating the trigger disk. This may allow for the trigger disk to be easily and quickly located when heating of the apparatus is required.

The apparatus may further comprise operational instructions on a portion of the apparatus. The operational instructions may be provided to be visible while the apparatus is in use. For example, the instructions for use may be printed on an upper surface of the base component. The instructions for use may be printed on the layer of absorbent material, where one is provided.

The apparatus may comprise outlined markings to ensure correct positioning of the infant for resuscitation. This may ensure that the height adjustable support member may correctly position the head relative to the torso to achieve airway patency. Outline markings may be easily visible allowing for efficient positioning during a time-critical procedure.

Another aspect of the present disclosure relates to a method of supporting an infant during resuscitation, the method comprising:

providing a resuscitation support apparatus according to the first aspect; positioning an infant back down on the base component of the resuscitation support apparatus; and

adjusting the height of the support member of the resuscitation support apparatus to change the angle between the infant’s head and upper torso to provide airway patency.

The method may further comprise arranging the apparatus of the resuscitation support apparatus into a first configuration which is planar or substantially planar and adjusting the support member to protrude from the base component. Adjusting the height of the support member may elevate the infant’s torso relative to the head to provide airway patency.

The invention is defined by the appended claims. However, for the purposes of the present disclosure it will be understood that any of the features defined above or described below may be utilised in isolation or in combination. For example, features described above in relation to one of the above aspects or below in relation to the detailed description below may be utilised in any other aspect, or together form a new aspect.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 shows an isometric view of a resuscitation support apparatus according to the present disclosure;

Figure 2 shows a plan view of the base component of the resuscitation support apparatus of the present disclosure;

Figure 3 shows external covers which may be provided on the resuscitation support apparatus of the present disclosure;

Figure 4 shows an exploded view of the component parts of the resuscitation support apparatus of the present disclosure;

Figures 5A, 5B and 5C show the use of a resuscitation support apparatus according to the present disclosure with a full term infant;

Figures 6A and 6B show the use of a resuscitation support apparatus according to the present disclosure with a pre-term infant;

Figure 7 shows an exploded view of selected component parts of a resuscitation support apparatus according to the present disclosure; and

Figure 8 shows an isometric view of the apparatus of Figure 6 with the shoulder support inflated.

DETAILED DESCRIPTION OF THE DRAWINGS

A resuscitation support apparatus 10 for an infant is shown in Figure 1. The resuscitation support apparatus 10 comprises a base component 12 (shown in more detail in Figure 2) and a support member 14. The support member 14 is inflatable. Accordingly, when an infant is placed on the apparatus 10, the angle between an infant’s head and upper torso may be adjusted to provide airway patency. The angle of the head relative to the upper torso may be adjusted by changing the height of the support members 14, in this example by inflation or deflation.

The base component 12 may comprise a flexible polymer material, for example polyvinyl chloride, however any pliable material may be used if appropriate. In this example, the base component 12 comprises two polymer layers which are hermitically sealed forming a support member 14 comprising two inflatable chambers 14a, 14b. The inflatable chambers 14a, 14b in this example are fluidly connected. The base component 12, in this example, further defines an enclosure 13 for an instant heating element. The instant heating element comprising a solution of sodium acetate and a heat trigger disk 50. Accordingly, the base component 12 can be used to provide heating to an infant whilst the apparatus is in use, if required. The trigger disk 50 can be activated to crystallise the sodium acetate solution releasing heat in the process. The instant heating element may be reusable by re-setting the solution (for example, through exposure to heat).

The base component 12 comprises a heat disk isolation portion 52, within which the heat disk 50 is contained. This allows for the heat disk 50 to be easily accessible when heating is required.

The resuscitation support apparatus 10 further comprises covers 30 and 31. Covers 30 and 31 may comprise an absorbent material, for example a towelling material. The covers 30, 31 may comprise any suitable absorbent material for use in healthcare. For example, the cover may comprise a microfiber material, or a natural fibre material such as cotton. A cover 30, 31 can be provided on either side of the base component (Figures 3 and Figure 4). In this example, the cover 30 is provided with wings 36 which can be used to swaddle an infant after the infant has been positioned upon the apparatus. Swaddling the infant may reduce body heat loss during the resuscitation procedure and may also soothe the infant by making the infant feel secure. A hood 32 is also provided to envelope an infant’s head. As well as providing an indication of the correct orientation in which to lay the infant on the apparatus, the hood 32 may also prevent heat loss from the infant’s head during the resuscitation procedure.

The cover 30 is located upon an upper surface of the base component 12, such that an infant may be placed on top of the cover 30. As such, the cover 30 may absorb any amniotic fluid or other bodily fluids from the infant. The cover 30 is provided with printed operational instructions 34 so that the instructions will be visible to the user when using the resuscitation support apparatus 10. The cover 30 is also provided with an outline 38 marking the correct position and orientation of the baby in order to allow the support member 14 to adjust the angle of the head relative to the upper torso. The cover 30 further comprises a head portion 33. The head portion provides another clear indication of the required orientation of the infant’s head relative to the support member. A heat disk activation label 54 is also provided on the cover 30, allowing the user to quickly access the heat disk 50 when heating is required.

Another cover 31 may be provided on the bottom surface of the base component 12 and this cover may also comprise operational instructions 34. The operational instructions 34 may be located on wings 36 so that if the apparatus is used to swaddle an infant, the instructions 34 will remain visible to the user while the wings are folded over the infant.

In Figure 3, the covers 30 and 31 are the same shape. However, as shown in Figure 4, cover 31 may be shaped according to the dimensions of the base component 12.

The apparatus 10 is provided with a manually operated pump apparatus for inflating the support member 14. The balloon pump apparatus comprises a balloon 20, tubing 24, a release valve assembly 22 and an attachment 24 for attaching to the base component 12. The balloon pump apparatus 20 is connected by tubing to the inflatable chambers 14a, 14b allowing for one or both or the inflatable chambers to be inflated, thus adjusting the height of the support member 14. The manually operated pump apparatus may be configured to be easily accessible to the user, allowing for efficient inflation of the support member 14.

The resuscitation support apparatus 10 has a first configuration which is substantially planar (Figures 5A and 6A). An infant 60, 70 may be placed onto the apparatus in a neutral back-down position. The first configuration being substantially planar means that the apparatus 10 can be used with any size of infant, for example from a pre-term infant 70 to a full term infant 60. To open the infant’s airway, the resuscitation support apparatus 10 is adjusted into a second configuration in which the support member 14 protrudes from the base component. In Figure 5B, both inflatable chambers 14a, 14b have been inflated and the upper torso of infant 60 has been elevated. The angle between the upper torso and head has been decreased, and airway patency achieved. It will be appreciated that a single inflatable chamber may provide the same effect. In Figure 6B, the airway of a pre-term infant 70 has been opened by inflating the inflatable support member 14 to a lesser extent than that shown in Figure 5B, to elevate the upper torso relative to the head. Having two fluidly connected chambers 14a, 14b may ensure that regardless the extent of inflation, the air is evenly distributed across the support member 14. This may ensure that the support member does not deform (for example, flatten) under the weight of the infant and may ensure that the support member maintains the torso at a desired angle relative to the head throughout the resuscitation procedure. The provision of two inflatable chambers 14a, 14b may also increase the flexibility of the apparatus in terms of changing the angle of the head relative to the upper torso. This is particularly beneficial because of the range of sizes and weights of newborn infants.

After the resuscitation procedure has been completed, the support member 14 may be deflated using the release valve assembly 22 (Figure 5C). The pump apparatus may be detached and the base components along with covers 30 and 31 may be cleaned and/or sterilised in preparation for use with another infant. The resuscitation support apparatus 10 may be stored before and after use by folding the apparatus 10.

An alternative resuscitation support apparatus 100 is shown in Figures 7 and 8. Unless otherwise specified the features of the resuscitation support apparatus 100 which are the same as the previous example are denoted with the like reference numerals incremented by 100. In this example, base component 112 comprises two polymer layers that are hermitically sealed forming a support member 114 comprising two inflatable chambers 14a, 14b. The base component comprises attachment means 116, for example a hook and loop arrangement, or a zipper arrangement, or a button arrangement, to which a cover 130 comprising complementary attachment means 118 may be attached. Accordingly, cover 130 may be easily replaced, for example if the cover is damaged or contaminated. The cover 130 may be removed for cleaning and replaced with another identical cover for use with another infant, thus reducing the turnaround time for use of the apparatus with different infants. As such, the base component 112 may be wipe clean, for example meaning only the cover 130 would need replacing in between uses.

As with the first example, the resuscitation support apparatus comprises a first configuration which is substantially planar. An infant may be placed onto the apparatus and the support member 14 inflated to alter the angle of the upper torso relative to the head. The resuscitation support apparatus in the second configuration in which the support member protrudes from the base component is shown in Figure 8. The support member 14 is provided with two inflatable chambers as shown, although any number of chambers may be provided as required.

The resuscitation support apparatus 100 may be stored before and after use by folding the apparatus 100. In this example, the cover 130 may be removed before storage, with the base component forming a packaging around the cover 130. This may remove the need for additional packaging, for example a bag or wrapper.

It should be understood that the examples provided herein are merely exemplary of the present disclosure and that various modifications may be made thereto without departing from the scope defined by the claims.