Infant support device

An infant holding device, including an infant holding portion, including a ductile sheet covered with infant-compatible material and a stand portion, adapted to support the infant holding portion in a vertically diagonal position, so that the infant holding portion thereby has a top and a bottom. In one preferred embodiment the ductile sheet is made of aluminum. In an additional preferred embodiment the infant holding portion is separable from the stand portion.

BACKGROUND

Correct infant positioning is an important adjunct to the care of a premature infant. Although supporting and positioning the infant is recognized as a high priority, health care professionals have mostly used found objects to do the job, such as blankets, pillows, towels. Many positioning aids have been developed, but they have been primarily aimed at restraining movement in two-dimensions, helping to keep the baby from twisting or rolling around on the bed, for example. A simpler approach is the use of pillows or other objects to elevate the head. To accommodate wires and tubes, these devices can be deformed or the user can place several devices around the baby with spaces between them. Unfortunately, when the infant requires respiratory support this big, soft mass of positioning devices gets in the way of the tubing. Another approach, involving the use of small, spaced devices, reduces stability and complicates readjustment. Finally these materials often lose their shape over time, thereby requiring constant monitoring and adjustment.

There are a number of problems with these methods. First, they tend to use solid blocks, rolls, etc. that do not naturally accommodate tubing and wires. This makes it more difficult to attach tubing and wires to the baby without potentially injuring him/her by pushing, pulling, lifting or twisting. Second, they are not adapted to hold the baby above the surface of the bed which would provide a space between the baby and the bed through which wires could be extended; nor does it permit placing the baby at a specific, beneficial position in three dimensions and holding him/her there securely.

In addition, although it is known that a premature infant may be sensitive to the exact position into which he/she is placed, currently available infant support devices do not permit quick and accurate readjustment of infant position. As a consequence, valuable neonatal intensive care unit staff time may be spent readjusting pillows. At the same time, the needs of the infant are ill met, as a position adjustment takes longer and is made less precisely than would be desirable if possible.

SUMMARY

In a first separate aspect the present invention may take the form of an infant holding device, including an infant holding portion, including a ductile sheet covered with infant-compatible material and a stand portion, adapted to support the infant holding portion in a vertically diagonal position, which thereby has a top and a bottom.

In one embodiment, the infant holding portion and the stand portion are formed from a single ductile sheet. In another embodiment the infant holding portion and the stand portion are separable, the stand portion being capable of supporting the infant holding portion by means of stand engagement elements located at the head and foot ends of the infant holding portion.

In a second separate aspect the present invention may take the form of a method of supporting an infant that uses an infant holding device including a ductile sheet covered with infant-compatible material. The infant holding device is bent into a shape adapted to retain the infant and the infant is placed into the infant holding device. In some embodiments, the position of the infant holding device is adjusted with respect to pitch angle or roll angle in order to hold the infant in a desired position.In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent by reference to the drawings and by study of the following detailed descriptions.

DEFINITIONS

Ductile sheet: In the context of this application the term “ductile sheet” should be taken to mean a sheet of material that can be bent into a new shape by human hands and that then retains the new shape until bent again with at least an equal amount of force.

Human hands: In the above definition “human hands” means a pair of human hands having the amount of strength present in 95% of people between the ages of 15 and 75 years.

Sheet: In the above definition the word “sheet” encompasses both a solid or porous sheet of material such as metal or polymer and a thin mat of tightly woven, composite or layered material.

Infant-compatible: In the context of this application, “infant-compatible” means a material that can contact an infant without causing damage to the infant's skin. Accordingly, such a material is non-abrasive, smooth and hypo-allergenic.

Detailed Description of the Preferred Embodiments

Referring toFIGS. 1 and 2, a preferred embodiment of an infant support assembly10is made of a stand12, and a moveable element14. Moveable element14includes an infant holding portion16, to which is attached a head end stand engagement element18and a foot end stand engagement element20. The stand, in turn, has two engagement element holders22, supported by a stand body23, each retaining one engagement element,18and20, by a friction and tension fit. Each engagement element18and20, is made of resilient material and is held in mild compression by an engagement element holder22. Accordingly, the urge to expand of elements18and20keeps each in place in a holder22, but is not so strong as to make it difficult to rotate elements18and20in holders22. Accordingly, moveable element14, and if in use, infant25, stays in place between readjustments, but can also be easily rotated to a new position. A pair of long legs24and a pair of short legs26are all hinged onto the rest of stand12, so that they may be placed into a flat position, as shown inFIG. 1, or a locked upright position, as shown inFIG. 2. With legs24and26upright, the moveable element14defines about a 30° angle with the surface, supporting infant support assembly10.

Referring toFIG. 1A, infant holding portion16is made from a material having a center ductile sheet30covered with an infant-side layer32of infant compatible soft, foam material, and an outside layer34of a flexible foam material. Preferably, the center ductile sheet30is made of nearly pure aluminum such as an Aluminum Association Type 1XXX aluminum, and preferably Type 1145 aluminum sheet material (99.45% pure) having a thickness in the range of 0.2 mm (0.008 inch) to 2 mm (0.079 inch), and preferably having a thickness of about 1.29 mm. (0.0508 inch). Preferably, the metal is annealed to a dead soft or “O” temper. Bending the center ductile sheet30during the process of adjusting the support10to conform to a desired shape increases the rigidity (i.e. stiffness) of the support. Although aluminum is a natural candidate for the ductile core sheet30, other ductile materials could be used. Other metals, such as iron and nickel are malleable and it is possible that a sheet of stainless steel having a thickness of less than a millimeter, could possess the required bending and shape-holding to meet the definition of “ductile material” set forth in this application. Other materials, such as a tightly-woven fiberglass or carbon-fiber mat or various composites and foams, may also be able to meet this definition.

The infant-side layer32of padding material has a thickness of about 6 mm (¼ in), although other thicknesses may be used. Layer32should also be somewhat resiliently compressible and porous and is therefore made of open-cell polymeric foam, such as a polyurethane foam, with an applied layer of flexible pressure sensitive adhesive. An acceptable density for such foam material is 0.5-4.0 lbs. per cubic foot, with 0.75 lbs.-3.0 lbs. per cubic foot being preferred. An indentation load deflection of about 25 is preferred, but any value up to 40 is acceptable, to provide sufficient firmness yet be comfortable. The open-cell construction of the infant-side layer32of padding material allows sufficient circulation of air, to cool and to dissipate any moisture from the skin of an infant using the support10, to provide comfort and safe conditions for the infant. One acceptable material for the infant-side layer32is available from Foamex, of Compton, Calif., as its Foam Grade F 145 44 F.6 FA 44145-304.

In an alternative preferred embodiment, support10includes a fabric covering made of a soft and absorbent or moisture-wicking fabric with a significant amount of elasticity to accommodate differing bending transformations of support10. For example, a brushed terrycloth or boucle fleece of 65 percent polyester and 35 percent rayon fiber of 100 denier yarn, available from Eclat Textile Co. Ltd. of City of Industry, Calif., as its product number 1206D performs well for absorbing moisture and exudate from an infant's skin. Preferably, such a cloth is a low loop, tightly knitted material, brushed to provide a soft and slightly matted surface which is absorbent and not abrasive, so that support10can be used comfortably in direct contact with the infant's skin. In one preferred embodiment, the fabric covering around support10is shaped to fit snugly around fingers40, like a glove. In an alternative preferred embodiment, the fabric covering around support10is shaped to span the gaps between fingers40, like a mitten.

The outside layer34of padding material has a thickness preferably in the range of 2 mm inch to 7 mm. The layer34of padding material should be of a somewhat resiliently compressible or elastomeric material, and may be of a polymeric foam such as a closed cell microcellular low density expanded polyethylene available from Voltek Division of Sakisui American Corporation, as Volara Type A foam. Such foam material used as layer34preferably has a density of at least about 1.0 lbs. per cubic foot and preferably at least 2.0 lbs. per cubic foot. In an alternative preferred embodiment, outside layer34is a infant-compatible polymeric sheet, as opposed to a foam. Skilled persons will be familiar with a wide range of infant compatible polymers. In a further alternative embodiment, center ductile sheet30is a polymeric sheet with layers32and34sealed together about the sheet. In yet another preferred embodiment, an outer seal of silicone or other adhesive is provided.

In one preferred embodiment, engagement elements18and20are made of the same material as is infant holding portion16, but in an alternative preferred embodiment, elements18and20are made of a more highly resilient material coated with a higher friction substance, to better engage holders22. In one preferred embodiment, holders22include ears (not shown) that contact elements18and22over a larger surface area, for greater friction resistance, in order to help element14stay in place once positioned.

Infant holding portion16, further includes an infant platform38, and a set of fingers40extending outwardly and upwardly from infant platform38. Fingers40can be curled up around infant25to affirmatively secure the infant. Although inFIGS. 1 and 2moveable element14is shown at approximately a 30° upward tilt, in one preferred embodiment, legs24and26may be placed into a variety of positions, resulting in different tilts for element14.

In one preferred embodiment, the spaces between fingers40can vary in width, becoming narrower further down toward infant platform38. This embodiment permits the support of tubes and lines of varying thickness.

An infant support tab42is formed by a cut in infant platform38.FIG. 2shows tab42in use as intended, supporting an infant from sliding down the diagonally oriented infant platform38. In an alternative preferred embodiment, a tab, like tab42, is formed by attaching a small sheet of material to platform38. Alternatively, tab42could be omitted with the function of supporting the baby provided by a finger that is bent inwardly to the correct supporting position.

Considering assembly10, many advantages should now be apparent. One difficulty in the care of prematurely born, fragile infants, is the need to extend wires and tubing to different places on the infant. It is desirable, however, to keep these tubes and wires separated from the infant, except for in the place where they attach to the infant or to some other element that is attached to the infant. But when the infant is supported by cushions or padding, this can be difficult to do. Also, in some situations it may be difficult to access a wire or tube, in order to make an adjustment when a portion of a wire or tube is covered by a cushion.

In assembly10, a great deal of open space is provided to thread wires and tubes (collectively “lines”) and even to keep them separate, as there is space under the stand12, as well as space between stand12and moveable portion14, through which lines can be extended. It is even possible to extend lines through the open space defined by engagement elements18and20. Moreover, the spaces between fingers40provide access to the infant25. The position of infant25may be quickly changed, simply by rotating element14or by adjusting legs24and26.

Referring toFIGS. 3 and 4, in an alternative preferred embodiment of an infant holding assembly110, stand112includes legs126that are foldable sideways to move from a flat position (FIG. 3), to a vertically diagonal positionFIG. 4. A moveable portion114is the same as portion14of assembly10.

Referring now toFIGS. 5 and 6, in an alternative preferred embodiment of a fragile infant holding assembly210, a stand212supports a moveable portion214that has a a first end enlarged gear stand engagement element218, and a second end small round stand engagement element220. Stand212defines a high slot222and a low slot224, on opposite ends.

The roll angle can be changed by moving element218to a different engagement position, while the pitch can be changed by rotating moveable portion214by 180° and reengaging it so that element218mates with the lower slot, if it had previously engaged with the upper slot.

Referring now toFIGS. 7 and 8, an embodiment of a fragile infant holding device310is shown that includes a stand312made of two stand leg elements313and a stand crescent354, to which elements313selectively engage, to effect a fine gradation of pitch angles for a moveable portion314. In a preferred variant, moveable portion314engages with crescent354in the same way that portion14engages with stand12, for continuous roll angle adjustment.

Finally, referring toFIGS. 9-11, an infant support410, is made of a piece of soft material (discussed further below) that is transversely resiliently deformable, but is also capable of being bent into and holding a shape. A first412and a second end414of support410are opposed to each other. Referring toFIGS. 9 and 10, support410can be bent into a vertical triangle, with an infant holding portion416, proximal to first end412, being supported by vertical portion418. Portion416is connected to portion418by a medial portion420, which serves as a base, when support410is in use. Portion418is distinguished from base420by a bend419. Portion416includes an infant supporting platform421and a set of fingers422, which project outwardly from the sides of a lower portion of platform421. In use, fingers422are bent upwards to provide side-support to an infant424. When support410is in this deployed configuration infant holding portion416has a top that is coincident with the first end412of support410and a bottom426at its juncture with segment418.

Although inFIGS. 9 and 10platform421is shown at approximately a 30° upward tilt, bend419could be formed nearer to or further from end414to create a shallower or a steeper slope for platform421. In one configuration bend419is not formed and platform421is horizontal. Also, fingers422can be curled up around infant424to affirmatively secure the infant. An infant support tab428is formed by a cut in platform421.FIG. 9shows tab428in use as intended, supporting an infant from sliding down the diagonally oriented infant platform421. In an alternative preferred embodiment a tab, like tab428, is formed by attaching a small sheet of material to platform421. Alternatively, tab428could be omitted with the function of supporting the baby provided by a finger that is bent inwardly to the correct supporting position. A scallop429, for permitting tubes and insulated wires to pass under the neck of infant424, is formed between 4 and 7 cm from top412of platform421.

In an alternative preferred embodiment, medial segment420and vertical segment418are made of a different material from infant holding portion416. For example these portions could be provided with a90degree angle already in place between portion418and420, which could be made of a semi-rigid polymer sheet. In another preferred embodiment device410is provided already formed into a triangle, but with fingers422still extending to the side. In yet another preferred embodiment, fingers, similar to fingers422are attached to platform421. This alternative permits a different material, having different material properties, to be used for the fingers than for platform421.

It is most important that portion416be shaped into a form adapted to support a particular infant, although in some situations it will be important that the tilt of portion416be adjustable.

The above described embodiments of an infant holding assembly10,110,210,310and410answer all the issues noted in the Background section. Each design permits rapid repositioning of an infant in both pitch and roll. Assemblies10and110permit an infinitely fine gradation of roll angle adjustment, whereas assembly210permits many choices as to roll angle. Assembly310permits a fine granularity of pitch angle adjustment.

As for infant holder16, and the similar portions of assemblies110,210,310and410, it is shaped loosely like a human hand and can be deformed to cuddle and hold the baby in a wide variety of natural and developmentally correct poses. The design allows for elevating or lowering the baby's body; for inclining or declining it; even for rotating it axially. The fingers40or422can be wrapped around the baby, keeping it securely in one position. The fingers40or422have spaces between them, and can be further moved by the user, to accommodate tubes, wires and devices. Also, tubes and wires can be secured to the device creating a strain relief at that point. When it is necessary to adjust the baby's position, the tubing, wires and devices may remain attached to support10as the entire collection can be adjusted as a unit.