Patent Application
20190105212
The following relates generally to supporting and holding a neonate, and to related arts such as the neonate incubator arts. However, it is to be understood that it also finds application in other usage scenarios and is not necessarily limited to the aforementioned application.
Prematurely born neonates do not have the capability to position themselves in a comfortable position due to their underdeveloped proprioception and muscle strength. When neonates experience distress, they reflexively stretch their back and spread their arms, thereby adding to their discomfort. Once in this stressful position, the neonates are unable to reposition themselves back into a comfortable position.
Furthermore, neonates find containment to add to their comfort (i.e., by mimicking a womb) and such containment provides continuous pressure against their limbs to help muscle and bone formation. On the other hand, as many neonates have underdeveloped lungs and can depend on mechanical ventilation, it is important that their lungs inflate and deflate properly, and so the containment should not adversely impact neonate respiration.
Proper lung inflation, as well as comfortable lying and containment all start with proper positioning. Currently, neonates are properly positioned in a fetal posture, in which the hands are close to the face, the elbows are touching each other, the back is rounded, and the knees are lifted towards the chin. This posture should be emulated in side, prone, and supine positions.
The following provides new and improved methods and systems which overcome the above-referenced problems and others.
It is recognized that known systems and methods of positioning a neonate have deficiencies. Conventionally, neonates in an incubator are contained and cushioned by suitably arranged pillow-type supports. However, movement of the neonate can move these supports out of position, leaving the neonate uncomfortable. Additionally, it has been found that relatively close containment of the neonate is beneficial as it simulates womb conditions and tends to comfort the neonate. On the other hand, since many neonates have underdeveloped lungs, sufficient room must be provided for respiration. Similar considerations arise in the context of carrier for transporting the neonate outside of the incubator.
Various improvements are disclosed herein.
In some illustrative embodiments, a disclosed neonate positioning device can employ a backbone made of a material that is sufficiently stiff to provide support and resist movements of the neonate, yet also sufficiently pliable to enable a user (i.e., a nurse) to adjust the backbone to conform with the specific neonate.
In some embodiments, the backbone is contemplated to be made of an elastomeric material that has the requisite balance between stiffness and flexibility. In other embodiments, the backbone is made of a material that becomes flexible upon application of slight heating. Some disclosed materials with this property comprise aliphatic compounds, especially those with melting points around 37-42° C. or so. Such compounds become soft upon application of slight warmth, such as that generated by a nurse holding the backbone. In such cases, the backbone may be shapeable by hand, even while in contact with the neonate. In other disclosed embodiments, an aliphatic compound with a higher melting point (e.g., 46-65° C.) may be used. In this case, it may not be possible to shape the backbone while contacting the neonate, but the shaping could be performed after heating with a hairdryer or other moderate source of warmth.
Aliphatic compounds with suitably low melting temperatures may have properties that are undesirable in a neonate support backbone, such as being in the form of an oil or fatty substance. To address this, structures have been developed in which the backbone has a containment bag, bladder, liner, or the like (for example, made of silicone and/or polyethylene) which is filled with cotton or another filler material providing desirable cushioning and into which an aliphatic oil is dispersed by soaking and/or capillary action. The resulting backbone is relatively pliable like a pillow, but has the desired stiffness at room temperature due to the aliphatic compound while being shapeable upon application of sufficient warmth.
In accordance with one aspect, a support for supporting a neonate is provided. The support includes a body portion including a shapeable material. The body portion is configured for adjustment during use. A silicone layer surrounds the body portion. The body portion is (i) sufficiently pliable to enable adjustment thereof to conform to a shape of the neonate upon application of a stimulus to the body portion, and (ii) sufficiently stiff to provide support for, and resist movements of, the neonate in the absence of the stimulus.
In accordance with another aspect, a method for making a support for supporting a neonate is provided. A bottom portion of a silicone layer is molded into a container-like shape. A body portion is placed into the container-like shape of the silicone layer. A heated aliphatic layer is poured over the body portion. The aliphatic layer is cooled. A top portion of the silicone layer is added over the body portion to seal the support.
In accordance with another aspect, a support for supporting a neonate is provided. The support includes a body portion that includes a shapeable material. The body portion is configured for adjustment during use. An aliphatic layer is disposed on at least a portion of the body portion. A silicone layer is disposed over the aliphatic layer. The body portion is: (i) sufficiently pliable to enable adjustment thereof to conform to a shape of the neonate upon application of thermal energy to at least one of the body portion and the aliphatic layer; and (ii) sufficiently stiff to provide support for, and resist movements of, the neonate in the absence of the thermal energy.
One advantage resides in providing a support for a neonate that is made from a single unit.
Another advantage resides in providing a support for a neonate that can be manipulated with an external stimulus applied to the support.
Another advantage resides in providing a support for a neonate that encourages healthy neonate bone and muscle growth.
Still further advantages of the present disclosure will be appreciated to those of ordinary skill in the art upon reading and understanding the following detailed description.
The present disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the present disclosure.
Ideally, positioning of a neonate should be done with one support that can solve numerous positioning needs. For example, the support should be able to take on various shapes according to the size and needs of the neonate. The support should provide resistance to deformation, caused by motion (e.g. kicking hands and feet, and the like) of the neonate. In some illustrative embodiments, the support is made from one or more materials that can be shaped in an easy way and then frozen in a desired shape during use, suiting the needs of the neonate. A support body suitably has a skeleton made of such material. An outside layer may be cotton or another skin-friendly material.
Supports disclosed herein are shapeable upon application of a stimulus thereto. With reference to
In some example embodiments, the body portion 12 is made from a shapeable material 16. In some embodiments, the shapeable material includes an aliphatic compound (also known as a non-aromatic compound). As understood by one of skill in the art, aliphatic compounds are organic compounds that do not include aromatic rings. In an aliphatic compound, the carbon atoms usually form straight or branched chains, or “looser” ring structures as compared with aromatic rings. Thus, aliphatic solids tend to be shapeable, and typically exhibit relatively low melting points. Some illustrative relatively soft aliphatic solids include certain elastomers, resins, waxes, fats, and emulsifiers. Elastomers provide elasticity or bounce for the body portion 12, and can be a natural latex, such as couma macrocarpa (i.e., leche caspi or sorva latex), loquat (i.e., nispero), tunu, jelutong, chicle, or a synthetic rubber (e.g. styrene-butadiene rubber, butyl rubber, polyisobutylene). Resins may be incorporated to provide a cohesive body or strength for the body portion 12. Some suitable resins include glycerol esters of gum, terpene resins, and/or polyvinyl acetate. The body portion 12 may further include a wax, which acts as a softening agent for the body portion 12. Some suitable waxes include paraffin or microcrystalline wax. A fat material may be included—fats behave as plasticizers for the body portion 12, and can be hydrogenated vegetable oils. An emulsifier may be added to aid with hydration for the body portion 12, and can be lecithin or glycerol monostearate. Various combinations of one or more of an elastomer, resin, wax, fat, or emulsifier may be used to provide a composite with desired properties. Fillers may also be provided to impart texture for the body portion 12, and can for example be calcium carbonate or talc. The shapeable material 16 of the body portion 12 is designed to be: (i) sufficiently pliable to enable adjustment thereof to conform to a shape of the neonate upon application of a stimulus to the body portion 12; and (ii) sufficiently stiff to provide support for, and resist movements of, the neonate in the absence of the stimulus. In addition, the body portion 12 has a stiffness to provide pressure against the neonate, thereby facilitating bone and muscle growth of the neonate.
In some embodiments, the silicone layer 14 partially surrounds a portion of the body portion 12. In other examples, the silicone layer 14 is a container that completely surrounds the body portion 12. In some embodiments, the silicone layer 14 is a container that encapsulates the body portion 12 to prevent leakage of the (typically soft, or semi-solid) shapeable material 16. To do so, the silicone layer 14 is made from a silicone material (e.g., medical grade silicone, hydroxyl-terminated silicone cured with boric acid, and the like) that is has a low degree of hardness (e.g., 0-10 Shore hardness). Stated another way, the silicone layer 14 is soft. The silicone layer 14 is transparent or translucent so as to reveal an interior thereof. In some instances, the silicone layer 14 includes a top portion 14′ and a bottom portion 14″. For example, the bottom portion 14″ can be formed to a container-like shape (e.g., a box-like shape, a bowl-like shape, and the like). The body portion 12 is inserted into the container-like shape of the bottom portion 14″, and the top portion 14′ is positioned over the body portion 12 to “close off the container” and seal the support 10. Once the silicone layer 14 is positioned about the body portion 12, the support 10 is cured. The degree of curing determines the rigidity of the silicone layer 14.
In some embodiments, a barrier layer 15 is disposed between the shapeable material 16 and the silicone layer 14. The barrier layer 15 is provided to prevent diffusion of the shapeable material 16 to the silicone layer 14. The barrier 15 is composed of a suitable packaging material, such as polyethyleneterephthalate (PET). In some examples, a bag of polyethyleneterephthalate can be used to make the barrier layer 15. This bag can be filled with the shapeable material 16 and sealed. The resulting bag is immersed in the silicone layer 14, which is held in place in a mold followed be curing of the silicone layer 14.
With reference to
The aliphatic layer 18 is made from an aliphatic compound 20. As known to one of skill in the art, aliphatic compounds become shapeable when a force or stimulus is applied thereto (e.g., warmth). Thus, the aliphatic compound 20 can be warmed, shaped into a desired shape, and then cooled to maintain the desired shape. In some embodiments, the aliphatic compound 20 is selected from a group of compounds including nonadecane, icosane, heneicosane, docosane, tricosane, pentacosane, and triacontane. Table 1 provides the chemical formula and melting temperature of each of these illustrative aliphatic compounds 20. These are merely illustrative examples, and other aliphatic compounds, or other materials with desired shapeability properties, are also contemplated.
As can be discerned from Table 1, the melting temperature of the aliphatic compound 20 typically increases as the length of the molecule increases. In one example, icosane has a melting point of 37° C., thereby allowing a user to warm the icosane aliphatic layer 18 by hand (i.e., ambient body heat) and shape the body portion 12 into a desired shape to hold the neonate, even while the neonate is positioned on the support 10. In another example, docosane has a higher melting point of 42° C., thereby allowing a user to warm the aliphatic layer 18 with a small, easily-available heating unit (e.g., a blow dryer, a space heater, and the like) and shape the body portion 12 into a desired shape to hold the neonate, even while the neonate is positioned on the support 10. More generally, in some embodiments the aliphatic compound has a melting point in the range 30° C.-70° C. inclusive, so that holds its shape at room temperature (suitably defined as 20° C.-27° C. inclusive, and more typically 20° C.-25° C.) and becomes shapeable upon application of thermal energy. It should be noted that the applied thermal energy does not necessarily need to heat the aliphatic compound above its melting point, as the aliphatic compound may become soft and deformable at a temperature close to, but still below, its melting point.
The aliphatic compound 20 may have properties that are undesirable, such as being in the form of an oil or fatty substance. To address this, the silicone layer 14 is configured as a containment bag, bladder, liner, or the like. The aliphatic layer 18 is embedded within or contained inside the silicone layer 14. Stated another way, the silicone layer 14 is disposed over (i.e., surrounds) the aliphatic layer 18. In some embodiments, the body portion 12 is configured to absorb oily/fatty byproducts of the aliphatic layer 18 (e.g., by soaking, capillary action, and the like).
In some embodiments, a potting material layer 22 can be inserted into a portion of the support 10. As shown in
Advantageously, the support 10 is shaped into a desired shape upon application of an external stimulus 24 thereto. Examples of the stimulus 24 can be: mechanical energy (i.e., movement), thermal energy (e.g., crystallization, melting phenomena, and the like), light, and electrical energy. The type of stimulus 24 used depends on a variety of factors. For example, the selected type of stimulus 24 depends on: (1) the material(s) chosen to produce the support 10; (2) access to an incubator in which the neonate is held; (3) any presence of electrical cables or tubes; (4) absence of metals because of use of x-ray machines; or (5) complexity in general.
In some examples, a mechanical external stimulus 24 is applied to the support 10. In this example, the shapeable material 16 and the aliphatic layer 18 are deformed with limited effort, but still exhibit enough rigidity to withstand neonatal weight and neonatal movements. In other examples, a thermal (hereinafter, “warmth”) external stimulus 24 is applied to the support 10. For example, the shapeable material 16 can be coated with the aliphatic layer 18, shaped into a desired shape with warmth (e.g., from body heat or an external heat source) until the aliphatic layer 18 is slightly below, at, or above the melting point of the aliphatic compound 20, and then left in room temperature to “freeze” (i.e., cooled below the melting point of the aliphatic compound 20), thereby allowing the body portion 12 to settle into the desired shape.
In other embodiments, one or more holes 26 can be formed into the body portion 12. Advantageously, the holes 26 bridge a top portion (i.e., a top surface) of the silicone layer 14 and a bottom portion (i.e., a bottom surface) of the silicone layer 14, thereby allowing the aliphatic layer 18 to penetrate into the body portion 12. To separate the top and bottom portions of the silicone layer 14, one or more separation members 28 are placed into the holes 26. The separation members 28 contact each of the top and bottom portions of the silicone layer 14 to provide a separation therebetween. In some examples, the separation members 28 can be rods; however, it will be appreciated that the separation members 28 can have any suitable configuration to separate the top and bottom portions of the silicone layer 14. Advantageously, the separation members 28 limit access of the aliphatic layer 18 to the bottom portion of the silicone layer 14.
With reference to
It is to be appreciated that the foregoing are merely illustrative examples, and numerous variants are contemplated. The container may be made of another flexible material other than silicone, such another curable polymer. Various meshes, granulated materials, or so forth can be employed as the body portion, or in some embodiments the body portion is omitted entirely. While the illustrative example is a disk-shaped generally planar support, in other embodiments the support may be otherwise shaped. It is contemplated to add an outer cloth jacket or other suitable outer layer to improve comfort at contact with the neonate. While in the illustrative fabrication process the container is sealed by potting the top portion 14′, other approaches are contemplated, such as providing a pre-molded top portion that is attached to the bottom portion by adhesive, heat-tacking or the like.
The invention has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be constructed as including all such modifications and alterations as they come within the scope of the appended claims or the equivalents thereof.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2016/050905 | 2/19/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62135349 | Mar 2015 | US |
