Devices and methods for supporting and containing premature babies and small-for-age infants

Abstract

Infant support devices and containment devices are described for use with premature and small-for-age infants, and in particular premature babies two kilograms or less, and even babies of one kilograms or less. The devices can be used separately or in combination (whereupon both support and containment are achieved together).

Claims

1. A method for supporting a premature infant, comprising: a) providing a bed comprising i) a bottom enclosure comprising a bottom surface and a shape-adjustable fabric surface, said bottom surface joined with said shape-adjustable fabric surface so as to comprise a defined region and a surrounding region, said surrounding region comprising discrete compressible materials retained therein with, said defined region lacking discrete compressible materials and surrounded by said surrounding region, ii) a top enclosure attached to said bottom enclosure, said top enclosure comprising a fabric contact surface and a flap for closing the top enclosure, iii) a layer of foam material positioned inside the bed between said contact surface of said top enclosure and said shape-adjustable surface of said bottom enclosure, said layer comprising a concave head cavity, said head cavity aligned above said defined region; b) placing a premature infant into said bed, such that said infant's torso contacts said fabric contact surface above said surrounding region and said infant's head contacts said fabric contact surface above said head cavity; and c) moving said discrete compressible materials to adjust the shape of said shape-adjustable surface so as to create a boundary around at least a portion of said infant.

2. The method of claim 1, wherein said boundary conforms to the dimensions of at least said portion of said infant.

3. The method of claim 1, wherein said boundary conforms to the dimensions of at least a portion of said foam layer.

4. The method of claim 1, wherein said premature infant weighs 1 kilogram or less.

5. The method of claim 1, wherein said discrete compressible materials comprise compressible beads.

6. The method of claim 1, wherein said bottom enclosure has no openings and said compressible beads are contained in said surrounding region.

7. The method of claim 5, wherein said beads comprise elastomeric polymer.

8. The method of claim 5, wherein said beads comprise thermoplastic elastomeric polymer.

9. The method of claim 1, wherein said defined region is circular in shape.

10. The method of claim 1, wherein said top enclosure is joined to said bottom enclosure on three sides, with an opening on a fourth side for inserting said foam layer.

11. The method of claim 10, wherein said boundary of step c) is internal to at least one of said four sides.

12. The method of claim 1, wherein the boundary of step c) is positioned around said infant's head.

13. The method of claim 1, wherein the boundary of step c) is positioned around said infant's torso.

14. The method of claim 1, wherein said boundary of step c) rises at least one half inch above the remainder of the surrounding region of said contact surface.

15. The method of claim 1, wherein said bed is warmed prior to step b).

16. The method of claim 15, wherein said bed is warmed with a warming light.

17. The method of claim 1, wherein said premature infant is placed into said bed in step b) face up.

18. The method of claim 1, further comprising the steps of d) lifting said infant off of said contact surface, e) removing said foam layer from inside the bed, and f) inserting a new foam layer into said bed, wherein said new foam layer has a larger head cavity.

19. The method of claim 18, further comprising g) placing said infant back on said contact surface of said bed.

20. An infant support device comprising i) a bottom enclosure comprising a bottom surface and a shape-adjustable fabric surface, said bottom surface joined with said shape-adjustable surface so as to comprise a defined region and a surrounding region, said surrounding region comprising discrete compressible materials retained therein with, said defined region lacking discrete compressible materials and surrounded by said surrounding region, ii) a top enclosure attached to said bottom enclosure, said top enclosure comprising a fabric contact surface and a flap for closing the top enclosure, and iii) a layer of foam material positioned inside the infant support device between said contact surface of said top enclosure and said shape-adjustable surface of said bottom enclosure, said layer comprising a concave head cavity aligned above said defined region.

21. The device of claim 20, wherein said discrete compressible materials comprise compressible beads.

22. The device of claim 21, wherein said beads comprise elastomeric polymer.

23. The device of claim 21, wherein said beads comprise thermoplastic elastomeric polymer.

24. The device of claim 20, wherein said defined region is circular in shape.

25. The device of claim 20, wherein said bottom enclosure is joined to said contact surface of said top enclosure on three sides, with an opening on a fourth side for inserting said foam layer.

26. The device of claim 25, wherein said contact surface of said top enclosure is joined to said shape-adjustable surface of said bottom enclosure by sewing, stitching or knitting.

27. A system comprising an infant containment device positioned on top of an infant support device, said infant support device comprising i) a bottom enclosure comprising a bottom surface and a shape-adjustable fabric surface, said bottom surface joined with said shape-adjustable surface so as to comprise a defined region and a surrounding region, said surrounding region comprising discrete compressible materials retained therein with, said defined region lacking discrete compressible materials and surrounded by said surrounding region, ii) a top enclosure attached to said bottom enclosure, said top enclosure comprising a fabric contact surface and a flap for closing the top enclosure, and iii) a layer of foam material positioned inside the infant support device between said contact surface of said top enclosure and said shape-adjustable surface of said bottom enclosure, said layer comprising a concave head cavity aligned above said defined region; said infant containment device positioned on said contact surface and comprising a) first and second individually moveable outer arms connected through a middle piece, b) first and second individually moveable inner arms connected to said middle piece at first and second junctions, said first and second junctions separated by a space equal to at least half the width of said first or second inner arms, wherein said inner and outer arms comprise compressible material covered in fabric.

Description

DESCRIPTION OF THE FIGURES

(1) FIG. 1A is a (top view) photograph of one embodiment of a support device comprising a contact surface, with the foam insert (comprising a head cavity) positioned inside the device so as to provide firmness for the infant. FIG. 1B is a (side view) photograph of the support device embodiment, showing the seam where the top enclosure is attached to the bottom enclosure.

(2) FIG. 2 shows a close-up photograph of the embodiment shown in FIG. 1 to highlight the fact that a boundary can be raised (internal to the edge) using the moveable materials.

(3) FIG. 3A is a photograph of the bottom surface of the bottom enclosure of the embodiment shown in FIG. 1 highlighting the defined region (containing no moveable materials) and the folded edge which facilitates the insertion of the foam layer. FIG. 3B is a close up view of the defined region (16) (containing no moveable materials).

(4) FIG. 4 is a close-up photograph of the top portion of a foam insert (5), comprising a head cavity (4) with perforations (3).

(5) FIG. 5A is a (end view) photograph of one embodiment of a support device, showing the folded edge (or flap) of the top enclosure (7) when opened in preparation for the insertion of a foam insert (not shown). In this position, the opening reveals the shape-adjustable surface of the bottom enclosure (6), along with a compartmentalizing seam or stitch (2) (which allows for substantially equal amounts of moveable material in the two halves of the bottom enclosure). FIG. 5B is a (side view) photograph where the foam insert (12) is shown positioned through the opening caused by the flap (14) for insertion into the device. FIG. 5C shows the insertion of a single layer of foam through the edge of the embodiment shown in FIG. 1, highlighting the ease by which such layers can be inserted and removed using the folded edge.

(6) FIG. 6 is photograph of one embodiment of an infant containment device comprising interconnected outer arms and inner arms.

(7) FIG. 7 is a photograph showing the use of both an infant containment device and an infant support device, wherein the containment device is positioned on top of the support device, with the two inner arms crossed and the two outer arms establishing a boundary.

(8) FIG. 8A is a close-up photograph of one arm of one embodiment of an infant containment device, showing a compartmentalizing seam. FIG. 8B shows how beads can me moved beyond the compartmentalizing seam so as to load one end of the arm with extra beads. FIG. 8C shows how beads can be moved back through the compartmentalizing seam so as to deplete one end of the arm of beads (relative to other portions of the arm). FIG. 8D is a close-up photograph of the end of the arm that has been depleted of beads (relative to the adjacent portion of the arm).

(9) FIG. 9A is a schematic drawing showing a side cutaway revealing the beads retained in bottom enclosure, along with the seam where the top enclosure is attached to the bottom enclosure. The top enclosure shows the depression in the contact surface for the infant's head, along with the flap in a closed position (folded over for closure). FIG. 9B is a top view schematic drawing of one embodiment of a bladder containing compressible materials (in the shaded area), the bladder fitting around the enclosure (i.e. the defined region lacking compressible materials) where the infant's head will contact the device. In one embodiment, the edges of two portions of the bladder meet, but are not sewn together, allowing it to be easily inserted and removed from the covering. FIG. 9C is a side view schematic drawing showing the opening for the foam insert as well as an opening for inserting and removing the bladder from the bottom enclosure.

(10) FIG. 10A is side view of one embodiment of an infant containment device showing the four arms as well as the diamond shaped attachment. FIG. 10B is a close-up view of the diamond shaped attachment.

DESCRIPTION OF PREFERRED EMBODIMENTS

(11) The present invention contemplates infant support devices and containment devices for use with premature and small-for-age infants, and in particular premature babies two kilograms or less, and even babies of one kilograms or less. While not limited to any single application, certain embodiments of the infant support devices are particularly suited for use in the Neonatal Intensive Care Unit (NICU). The support devices are contemplated for smaller, premature babies or small-for age infants as a bed, pad, support or mattress.

(12) FIG. 1A shows a photograph of fabric shape-adjustable contact surface (10A) of one embodiment of an infant support device (11) with the polymer insert (comprising a head cavity) positioned inside the device (the outline of which (9A) can be seen in the Figure) so as to provide firmness for the infant. The fabric contact surface (10B) above said head cavity is shown as a soft depression. FIG. 1B is a (side view) photograph of the support device embodiment, showing the seam (8) where the top enclosure (7) is attached to the bottom enclosure (6). FIG. 1B shows the insert outline (9A) surrounded by a positioning seam (9B), which keeps the insert in place. As shown in FIGS. 1A, 1B and 2, the preferred embodiment lacks a hard base substrate. Instead of a hard plastic base with the foam layers on top, a softer substrate (e.g. fabric, textile or cloth substrate) more of the nature of a pillow (i.e. permitting pressure distortion) is employed. In a preferred embodiment, firmness comes from a solid foam insert (that permits less pressure distortion).

(13) FIG. 5A is a (end view) photograph of one embodiment of a support device, showing the folded edge (or flap) (14) of the top enclosure (7) when opened in preparation for the insertion of a foam insert (not shown). In this position, the opening reveals the shape-adjustable surface of the bottom enclosure (6), along with a compartmentalizing seam (2) in the shape-adjustable surface (note that this surface serves as the floor of the top enclosure). FIG. 5B is a (side view) photograph where the foam insert (12) is positioned through the opening caused by the flap (14) for insertion into the device. FIG. 5C is a (end view) photograph showing the insertion of a single layer of polymer foam (12) through the side (13) of the embodiment shown in FIG. 1, highlighting the ease by which such layers can be inserted and removed using the folded edge (14).

(14) The folded edge (14) is also highlighted in FIG. 3A. FIG. 3A is a photograph of the bottom surface (15) of the bottom enclosure of the embodiment shown in FIG. 1 highlighting the defined region (16) (containing no moveable materials), the surrounding region (17) (containing discrete compressible materials) and the folded edge (14) which facilitates the insertion of the foam layer (when opened) and containment of the foam layer (when closed). FIG. 3B is a close up view of the defined region (16) (containing no moveable materials).

(15) The contact surface (10A) is shown as well as the fabric contact surface (10B) above said head cavity, in an enlarged view (FIG. 2). The discrete moveable materials inside the fabric allow one to form a raised boundary (18), which can be conforming and customized to the dimensions of at least a portion of the edges of the foam insert and/or said infant (the infant is not shown). In a preferred embodiment, this raised boundary (18), which is shown next to the positioning seam (9B), will remain raised until adjusted (by hand) again.

(16) In one embodiment, the present invention contemplates stitches that compartmentalize the compressible materials (e.g. beads) so as to maintain a generally even distribution of these materials. Such compartmentalizing stitches only prevent easy movement; that is to say, beads can be forced around such stitches as illustrated in FIG. 8A-D. More specifically, FIG. 8A is a close-up photograph of one arm (40) of one embodiment of an infant containment device (with a design on the fabric), showing a compartmentalizing stitch (41). FIG. 8B shows how beads can me moved beyond the compartmentalizing stitch (41) so as to load one end of the arm (40) with extra beads. FIG. 8C shows how beads can be moved back around the compartmentalizing stitch (41) so as to deplete one end of the arm of beads (relative to other portions of the arm). FIG. 8D is a close-up photograph of the end of the arm that has been depleted of beads (relative to the adjacent portion of the arm).

(17) FIG. 9A is a schematic drawing showing a side cutaway revealing the beads (1) retained in the bottom enclosure (of course, the beads are not normally exposed), along with the seam (8) where the top enclosure is attached. Also shown is the fabric contact surface (10B) above the head cavity and the flap (14) in a closed position at the foot of the device.

(18) In one embodiment, the filled and washed device measures approximately 17 inches in length and 12.5 inches in width. The device size will vary slightly due to shrinkage during routine washing and from movement as the filler can shift in one direction or the other. The device fits easily into any model isolette or crib used in Neonatal Intensive Care Units. This embodiment of the device is made of fabric, batting, and pellet filler. The device weighs approximately 5 lbs. The outer cover is made of 90% cotton, 10% spandex (soft, stretchy) fabric. The selected fabric withstands washing in warm water temperatures and bleaching. The first pocket (FIG. 5A shows this enclosure in the open position) accommodates the molded foam insert (e.g. one of three different sized inserts available from Boston Brace, Avon, Mass.) that are inserted into the device, one layer at a time. Border stitching keeps the insert in place when the device is moved or infant movement occurs. The foam insert facilitates normalized head shape development and maintains the infant in a neutral position when lying supine or semi side-lying. The second pocket (FIG. 3A shows the bottom surface of the bottom enclosure) has a 2 and inch circular stitched area, centrally positioned areaapproximately 4 inches from the top of the deviceto accommodate the depression of the foam insert (when in place). Approximately 0.25 inch batting is enclosed within the circular stitching that provides comfort when the infant is in a prone position. The remainder of the second pocket is filled with compressible pellets (FIG. 9 shows this in a schematic drawing). The pellets serve several purposes. They form a comfortable soft nest or boundary around the infant. They also add weight to keep the device stationary. A stationary device is important as to not cause movement or dislodgement of lifesaving medical devices (such as IV tubing or ventilator tubing) often used in the care of sick infants. They also provide a comfortable place to rest when the infant is positioned prone. A double-layer of fabric covers the backside of the device. The innermost layer is made with a sturdy cotton fabric with limited stretch providing extra durability or structure.

(19) The present invention also contemplates infant containment devices. FIG. 6 is photograph of one embodiment of an infant containment device (21) comprising interconnected outer arms (19A and 19B) and inner arms (20A and 20B). The device (21) comprises first and second (19A and 19B) individually moveable outer arms connected through a middle piece (22), as well as) first and second (20A and 20B) individually moveable inner arms connected to said middle piece (22) at first (23A) and second (23B) junctions, said first and second junctions separated by a space or gap (24) equal to at least half the width (and up to the full width, double width or greater) of either said first or second inner arms, wherein said inner and outer arms comprise compressible material covered in fabric, textile or cloth.

(20) While a four (4) arm embodiment is shown in FIG. 6, other embodiments can have fewer (e.g. three) or greater (e.g. 5 or even 6) numbers of arms. All of the arms need not be connected (although this provides a single convenient unit when all of the arms are connected). The arms are designed to envelope the infant. The two outer arms (19A and 19B) are configured to lie alongside the infant, while the inner (or middle) arms are configured to lay across, on top of the infant to provide containment.

(21) As noted above, the infant support devices described herein can be used alone or in combination with the infant containment devices described herein. FIG. 7 is a photograph showing the use, in combination, of an infant containment device (30) and an infant support device (31), wherein the containment device is positioned on top of the support device, with the two inner arms crossed (29) and the two outer arms establishing a boundary (28). The first and second inner arms can be used to secure the baby from large movement (e.g. in order to perform a procedure, such as putting in an intravenous (IV) line). The outer arms can be used to create a boundary to reduce the chance of the baby sliding or migrating out of or off of an infant support device (e.g. bed, pad, pillow or mattress). At the top of the support device (33) the arms can be around the head (but preferably not over the face or under the head), such as alongside the head or even along the top of the head.

(22) It is not intended that the present invention be limited to only particular dimensions for the containment device. The arms or extensions may measure up to 50 inches in length, but more preferably are approximately 40 inches in length. The circumference of each arm or length may measure up to 10 inches, but more preferably 9 inches. In one embodiment, there is a diamond shaped insert (see element 34 of FIGS. 10A and 10B) at the bifurcation of the arms or extensions (19A-B and 20A-B), in order to provide more strength and durability with movement, tugging, and washing. The diamond shaped fabric attachment (34) makes it less likely that the device will come apart during normal use.

(23) The containment device is made of washable material with the moveable materials (compressible beads or pellets) inside the fabric, textile or cloth. In a preferred embodiment, a double layer of fabric is used to ensure durability. The weight of the arms can be controlled by the amount of moveable materials added. For example, in one embodiment, the outer arms comprise more compressible material (e.g. more pellets or beads) than the inner arms. The inner arms can have fewer pellets or beads, so that the weight on the infant is not too great. Each of the four arms, in one embodiment, have compartmentalizing stitches located a third of the way down to prevent constant, non-purposeful shifting of the beads. It was found that the fill (e.g. pellets) was not mobile with the middle two extensions sewn in. For this reason, a different design is preferred.

Example 1

(24) It is not intended that the present invention be limited to a polymer foam insert of a particular type of firmness. In one embodiment, the present invention contemplates Volara type EO foams. Volara type EO foams are flexible, soft to the touch, closed cell EVA copolymer based materials. Type EO foams are ideally suited for use in medical devices and in applications designed for skin and food contact. The conformability and softness of type EO combined with the strength and toughness of a crosslinked EVA copolymer, has made this grade of foam well-suited to the inserts of the present invention. The density range of the product is: 2 to 4 to 6 pounds per square foot (pcf). To evaluate a foam product for potential use with the infant support device of the present invention, it is useful to take into consideration tensile strength and compression strength over the density range of the product. This is shown below in table form:

(25) TABLE-US-00001 2 pcf 4 pcf 6 pcf Compression Strength/(ASTM D3575) (lb/sq-in) @ 25% compression 5 8 10 (lb/sq-in) @ 50% compression 13 18 24 Tensile Strength/(ASTM D3575) (lb/sq-in) Machine Direction 66 141 217 (lb/sq-in) Cross-Machine Direction 46 106 167

(26) This measurement rates the firmness and feel of foam by evaluating its ability to support weight and pressure. These values help categorize materials by placing them along a numerically categorized spectrum.

Example 2

(27) A first prototype was designed with four layers and two separate pockets attached in the middle, with the first pocket for the foam insert and the second pocket for the pellet filler. The device with two layers in the center was bulky.

(28) A second prototype was assembled. It still comprised four layers and two pockets but it was changed so that there is only one middle layer (shown in FIG. 5A as having a compartmentalizing seam, which is optional), with two layers of fabric on the backside (which result in a smoothly finished product. Pocket 1 (the top enclosure) holds the foam insert (see FIGS. 5B and 5C). The inner layer on the backside of pocket 2 (the bottom enclosure) is made of a less stretchy fabric to add durability, especially when being washed. The pellets are sewn permanently into the second pocket (which is fully enclosed), along with a small amount of batting in the round circular area at the head of the device (not shown). This design change allows the pellets to move more freely within the device, decreases bulkiness of the device, allows full benefit (soft bedding for the infant) of compressible (squishy) soft pellets, while still enabling placement and removal of the foam insert.

(29) The foam insert can be held in place with a simple envelope style closure. During the design development, the envelope closure or flap (see FIG. 5A, element 14) was lengthened. If it is too short and shrinks (e.g. during washing), the closure could become non-effective. This device originally measured 15 inches in length and was only 10 inches in width. In the preferred embodiment, the size of the device is increased in both length and width to allow for shrinkage (17.5 inches long and 12.5 inches wide). The preferred overlap for the envelope style closure or flap is stitched on the sides and folds over on to itself, allowing for an unobstructed opening for inserting and removing the foam insert.

(30) Optionally, darts (not shown) could be placed on both sides of the head depression so that the fabric would lay smoothly in the depression of the foam insert. However, given the shallow depression, such bullets are not necessary.