Modular, deformable, cushioned, resistive infant positioning system and method

11517488 · 2022-12-06

    Inventors

    Cpc classification

    International classification

    Abstract

    A modular, deformable, repositionable, cushioned gentle cushioned, resistive infant positioning system and method for use with infants is provided that includes first and second tubular pillows each having two longitudinally-elongated chambers adjoined at a first and second pillow lateral flexure-enabling element, respectively. The second tubular pillow is preferably wider than the first tubular pillow and includes two straps. Methods of using the pillows of the cushioned, resistive infant positioning system are presented that provide positioning, calming, and/or the prevention and/or the correction of head shape deformations.

    Claims

    1. A method of using an infant positioning system (100) to position an infant, comprising: obtaining a first tubular pillow (20) fashioned from fabric formed into a tubular shape extending from a left distal end (21) to a right distal end (29); said first tubular pillow (20) being filled with a first pre-determined amount of a manipulatable resilient cushioning material (35); said first tubular pillow (20) comprising a first pillow left chamber (22); a first pillow right chamber (28); and a first flexure-enabling element (25) disposed at a midpoint of said tubular shape that enables flexing of said first pillow left chamber (22) with respect to said first pillow right chamber (28) at said first flexure-enabling element (25); placing the infant in a supine position; manipulating said first pre-determined amount of said manipulatable resilient cushioning material (35) within said first tubular pillow (20); flexing said first tubular pillow (20) at said first flexure-enabling element (25); positioning said first tubular pillow (20) with inward-facing portions of said first pillow left chamber (22) snuggly touching a left top of the infant's head and a left upper side of the infant's head; positioning said first tubular pillow (20) with inward-facing portions of said first pillow right chamber (28) snuggly touching a right top of the infant's head and a right upper side of the infant's head; obtaining a second tubular pillow (40) fashioned from fabric formed into a second tubular outer shell extending from a left distal end (41) to a right distal end (49); said second tubular pillow (40) being filled with a second pre-determined amount of said manipulatable resilient cushioning material (35); said second tubular pillow (40) comprising a second pillow left chamber (42); a second pillow right chamber (48); and a second flexure-enabling element (45) disposed at a midpoint of said tubular shape that enables flexing of said second pillow left chamber (42) with respect to said second pillow right chamber (48) at said second flexure-enabling element (45); manipulating said second pre-determined amount of said manipulatable resilient cushioning material (35) within said second tubular pillow (40); flexing said second tubular pillow (40) at said second flexure-enabling element (45) to form a U-shape; positioning said second tubular pillow (40) with inward-facing portions of said second pillow left chamber (42) snuggly touching an outer left side of the infant's legs and an outer left side of the infant's trunk to create a left lower boundary; positioning said second tubular pillow (40) with inward-facing portions snuggly touching the infant's feet to create a lower boundary; and positioning said second tubular pillow (40) with inward-facing portions of said second tubular pillow right chamber (48) snuggly touching an outer right side of the infant's legs and an outer right side of the infant's trunk to create a right lower boundary.

    2. The method of using an infant positioning system (100) to position an infant, as recited in claim 1, further comprising resting a portion of said second tubular pillow (40) upon the infant to provide calming.

    3. The method of using an infant positioning system (100) to position an infant, as recited in claim 1, further comprising providing diagrams of alternate positions into which the infant can be positioned by utilizing said first tubular pillow (20) and said second tubular pillow (40).

    4. The method of using an infant positioning system (100) to position an infant, as recited in claim 1, wherein said second tubular pillow (40) further comprises a left and right strap (50) each of which comprises a distal and proximal end; said method further comprising: manually moving said left strap (50) distal end across the infant's body; tucking said left strap (50) distal end under said second pillow right chamber (48); manually moving said right strap (50) distal end across said left strap and across the infant's body; and tucking said right strap (50) distal end under said second pillow left chamber (42).

    5. The method of using an infant positioning system (100) as recited in claim 1, wherein said first tubular pillow (20) comprises a first outer shell (24) and said second tubular pillow (40) comprises a second outer shell (44); and wherein said first outer shell (24) and said second outer shell (44) are formed of a hypoallergenic fabric.

    6. The method of using an infant positioning system (100) as recited in claim 1, wherein said manipulatable resilient cushioning material (35) comprises polypropylene pellets.

    7. The method of using an infant positioning system (100) as recited in claim 1, wherein said manipulatable resilient cushioning material (35) comprises a gel.

    8. The method of using an infant positioning system (100) as recited in claim 1, further comprising: repositioning said first tubular pillow (20) with said first pillow left chamber (22) placed onto a surface; repositioning the infant from said supine position to a prone position by placing the infant onto said first pillow left chamber (22); bending said first tubular pillow (20) at said first flexure-enabling element (25) to situate said first pillow right chamber (28) to rest upon the infant's back; and repositioning said second tubular pillow (40) to snuggly touch the infant's legs to create a lower boundary.

    9. The method of using an infant positioning system (100) as recited in claim 8, wherein said second tubular pillow (40) further comprises left and right straps (50); said method further comprising: manually crossing one of said left and right straps (50) across the other one of said left and right straps (50); tucking said left strap (50) under said second pillow right chamber (48); and tucking said right strap (50) under said second pillow left chamber (42).

    10. The method of using an infant positioning system (100) as recited in claim 1, further comprising: positioning said said left distal end (21) and said right distal end (29) of said first pillow (20) to be adjacent to said left distal end (41) and to said right distal end (49) of said second tubular pillow (40); repositioning said first pillow (20) by moving said left distal end (21) and said right distal end (29) outwardly away from said second tubular pillow (40); and curving said left distal end (21) and said right distal end (29) of said first pillow (20) upward.

    11. The method of using an infant positioning system (100) as recited in claim 10, wherein said second tubular pillow (40) further comprises left and right straps (50); said method further comprising: repositioning said first tubular pillow (20) with said first pillow left chamber (22) placed onto a surface; repositioning the infant from said supine position to a prone position by placing the infant onto said first pillow left chamber (22); bending said first tubular pillow (20) at said first flexure-enabling element (25) to situate said first pillow right chamber (28) to rest upon the infant's back; and repositioning said second tubular pillow (40) to snuggly touch the infant's legs to create a lower boundary.

    12. The method of using an infant positioning system (100) to position an infant, as recited in claim 11, further comprising: repositioning said second tubular pillow (40) with inward-facing portions of said second pillow left chamber (42) snuggly touching the outer left side of the infant's head and shoulders to create a left upper boundary; repositioning said second tubular pillow (40) with inward-facing portions of said second tubular pillow right chamber (48) snuggly touching the outer right side of the infant's head and shoulder to create a right upper boundary; repositioning said first tubular pillow (20) with inward-facing portions of said first pillow left chamber (22) snuggly touching the outer left side of the infant's legs and trunk to create a left lower boundary; and repositioning said first tubular pillow (20) with inward-facing portions of said first pillow right chamber (28) snuggly touching the outer right side of the infant's legs and trunk to create a right lower boundary.

    13. The method of using an infant positioning system (100) as recited in claim 12, further comprising: manually crossing one of said left and right straps (50) across the other one of said left and right straps (50); tucking said left strap (50) under said first pillow right chamber (28); and tucking said right strap (50) under said first pillow left chamber (22).

    14. The method of using an infant positioning system (100) to position an infant, as recited in claim 1, further comprising: repositioning said second tubular pillow (40) with inward-facing portions of said second pillow left chamber (42) snuggly touching the outer left side of the infant's head and shoulders to create a left upper boundary; repositioning said second tubular pillow (40) with inward-facing portions of said second tubular pillow right chamber (48) snuggly touching the outer right side of the infant's head and shoulder to create a right upper boundary; repositioning said first tubular pillow (20) with inward-facing portions of said first pillow left chamber (22) snuggly touching the outer left side of the infant's legs and trunk to create a left lower boundary; and repositioning said first tubular pillow (20) with inward-facing portions of said first pillow right chamber (28) snuggly touching the outer right side of the infant's legs and trunk to create a right lower boundary.

    15. The method of using an infant positioning system (100) as recited in claim 14, wherein said second tubular pillow (40) further comprises left and right straps (50); said method further comprising: manually crossing one of said left and right straps (50) across the other one of said left and right straps (50); tucking said left strap (50) under said first pillow right chamber (28); and tucking said right strap (50) under said first pillow left chamber (22).

    Description

    BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

    (1) The preferred embodiments of the invention will hereinafter be described in conjunction with the appended drawings, provided to illustrate and not to limit the invention, where like designations denote like elements.

    (2) FIG. 1 is a top view of the three pillows of a first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention.

    (3) FIG. 2 is a top view of the first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a supine position in an isolette.

    (4) FIG. 3 is a top view of the first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a side-lying position in an isolette.

    (5) FIG. 4 is a top view of the first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a prone position in an isolette.

    (6) FIG. 5 is a side view of the first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a prone position in an isolette.

    (7) FIG. 6 is a top view of the first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a supine position in a crib.

    (8) FIG. 7 is a front view of an embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a seated position, such as in an infant car seat or swing.

    (9) FIG. 8 is a diagrammatic view of the first embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention.

    (10) FIG. 9 is a diagrammatic view of an exemplary placement of three pillows in the first embodiment of the present invention for receiving an infant in the supine position, such as in an isolette.

    (11) FIG. 10 is a diagrammatic view of an exemplary placement of three pillows in the first embodiment of the present invention with an infant in the supine position, such as in an isolette.

    (12) FIG. 11 is a diagrammatic view of an exemplary placement of three pillows in the first embodiment of the present invention with an infant in the side-lying position, such as in an isolette.

    (13) FIG. 12 is a diagrammatic view of an exemplary placement of three pillows in the first embodiment of the present invention with an infant in the prone position, such as in an isolette.

    (14) FIG. 13 is a diagrammatic view of an exemplary placement of three pillows in the first embodiment of the present invention with an infant in the supine position, such as in a crib.

    (15) FIG. 14 is a cross-sectional view of a first aspect of the first tubular pillow of the present invention.

    (16) FIG. 15 is a cross-sectional view of a second aspect of the first tubular pillow of the present invention.

    (17) FIG. 16 is a cross-sectional view of a first aspect of the second tubular pillow of the present invention.

    (18) FIG. 17 is a cross-sectional view of a second aspect of the second tubular pillow of the present invention.

    (19) FIG. 18 is a cross-sectional view of a first aspect of the compact pillow of the first embodiment of the present invention.

    (20) FIG. 19 is a cross-sectional view of a second aspect of the compact pillow of the first embodiment of the present invention.

    (21) FIG. 20 is a diagrammatic view of measurements taken to determine head deformities.

    (22) FIG. 21 is a flowchart illustrating the method of determining the degree of head deformity.

    (23) FIG. 22 is a chart illustrating the degrees of head deformity.

    (24) FIG. 23 is a flowchart illustrating a generalized method of use of the modular, deformable, cushioned, resistive infant positioning system of the present invention.

    (25) FIG. 24 is a top view of the two pillows of the second embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention.

    (26) FIG. 25 is a top view of the second embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a supine position in an isolette.

    (27) FIG. 26 is a top view of the second embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a side-lying position in an isolette.

    (28) FIG. 27 is a top view of the second embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a prone position in an isolette.

    (29) FIG. 28 is a side view of the second embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a prone position in an isolette.

    (30) FIG. 29 is a top view of the second embodiment of the modular, deformable, cushioned, resistive infant positioning system and method of the present invention in the environment of use with the infant in a supine position in a crib.

    (31) Like reference numerals refer to like parts throughout the several views of the drawings.

    DETAILED DESCRIPTION OF THE INVENTION

    (32) Shown throughout the figures, the present invention is directed toward a modular, deformable, cushioned, resistive infant positioning system and, additionally, to a method of use of the disclosed system. Two exemplary embodiments are provided. In the first embodiment of FIGS. 1-6, three pillows are utilized. In the second embodiment of FIGS. 24-29, two pillows are utilized.

    (33) The method of use includes using the cushioned, resistive infant positioning system for positioning an infant while providing support with boundaries, for facilitating calming and stress relief, and/or for prevention or correction of positional head deformities both in and out of the isolette (incubator).

    (34) Referring now to FIG. 1, a cushioned, resistive infant positioning system, shown generally as reference number 100, is illustrated in accordance with a first embodiment of the present invention. As shown, the first embodiment of the cushioned, resistive infant positioning system 100 comprises a first tubular pillow 20, a second tubular pillow 40, and a compact pillow 60. Each of the pillows 20, 40, 60 can be independently, manually located by clinicians to support, comfort and position a portion of the infant's body. Also, each of the pillows 20, 40, 60 are manually shapeable and deformable, due to a manually manipulatable resilient cushioning material 35 (FIGS. 14-19) contained within the pillows 20, 40, 60. For convenience of discussion, the designations “left” and “right” will refer to the orientation of pillows 20, 40, 60 as shown in FIG. 1, not to the orientation of the right and left sides of an illustrated infant 90.

    (35) The first tubular pillow 20 is a longitudinally-elongated tubular filled pillow having an outer shell 24 that encloses and contains an amount of a resilient cushioning material 35 (seen in the cut views of FIGS. 14-15). The first tubular pillow 20 extends from a left distal end 21 to a right distal end 29, with a first medial portion 26 in a central area of the tubular shape disposed between the left distal end 21 and the right distal end 29. Disposed within the first medial portion 26 is a first pillow lateral flexure-enabling element 25 that at least substantially, and preferably wholly, divides the first tubular pillow 20 into two chambers—a longitudinally-elongated first pillow left chamber 22 and a longitudinally-elongated first pillow right chamber 28. The first pillow lateral flexure-enabling element 25 is configured to facilitate the manual bending of the first tubular pillow 20, such as illustrated in FIG. 2 in which the first pillow left chamber 22 is arranged snuggly alongside the right side of the head and upper body of the infant while the first pillow right chamber 28 is arranged snuggly alongside the left side of the head and upper body of the infant 90.

    (36) The first tubular pillow 20 may be between 2 inches and 6 inches in width and is preferably between 2.5 and 3.5 inches in width. The first tubular pillow 20 may be between 18 and 32 inches in length and is preferably between 22 and 26 inches in length. The tubular pillow 20 may weigh between 0.4 and 2 pounds and is preferably between 0.5 and 1.5 pounds. Experimentation has shown that a preferred size of the first tubular pillow 20 is 24 inches in length, 3 inches in width, and weighs 1 pound.

    (37) The second tubular pillow 40 is structurally similar to the first tubular pillow 20 having a longitudinally elongated form and having an outer shell 44 that encloses and contains an amount of a resilient cushioning material 35 (FIGS. 16-17) but is preferably further configured with two attached straps and preferably has a width that is greater than the width of the first tubular pillow 20. The second tubular pillow 40 extends from a left distal end 41 to a right distal end 49 with a central second medial portion 46 configured with a second pillow lateral flexure-enabling element 45, which substantially or wholly divides pillow 40 into two chambers—a longitudinally-elongated second pillow left chamber 42 and a longitudinally-elongated second pillow right chamber 48. The second pillow lateral flexure-enabling element 45 is configured to facilitate the manual bending of the second tubular pillow 40, such as illustrated in FIG. 2 in which the second pillow left chamber 42 and second pillow right chamber 48 are manually positioned adjacent to the right and left sides of the infant's lower body, respectively. The second tubular pillow 40 may be between 18 inches and 32 inches in length and is preferably between 22 and 26 inches in length. Though both tubular pillows 20, 40 may be the same width, preferably the width of the second tubular pillow 40 is greater than the width of the first tubular pillow. The second tubular pillow 40 may be between 2 inches and 7 inches in width and is preferably between 3.5 and 4.5 inches in width. Tubular pillow 40 may weigh between 1 and 3 pounds and is preferably between 1.0 and 2.0 pounds. Experimentation has shown that a preferred size is the second tubular pillow 40 is 24 inches in length and 4 inches in width with straps 50 that are 2 inches wide and 18 inches long.

    (38) The second tubular pillow 40 is preferably configured with two straps 50A, 50B (referred to generally as straps 50). The straps 50A, 50B are each formed of a thin, flat strip of material, which may be seamed or unseamed. The material of straps 50A, 50B may be the same fabric used to form the second tubular pillow 40 or may be of a different type of fabric. The straps 50A, 50B are attached at or near the left distal end 41 and at or near the right distal end 49 of pillow 40 at attachment points 51A and 51B, respectively. Straps 50A, 50B are preferably at least half the length of pillow 40 and not longer than the length of pillow 40. Each of straps 50A, 50B may be between 1.0 and 4.5 inches in width and between 14 and 24 inches in length and may preferably be between 1.5 and 2.5 inches in width and between 16 and 20 inches in length. An exemplary construction method to form each strap 50A, 50B is to procure a single piece of fabric having a length of the desired strap length plus two seam allowances and having a width of the desired strap width plus two seam allowances, folding the fabric piece in half, seaming along the long side of the folded fabric to form a tube, turning the tube to position the seam on the inside, seaming along the short distal end to close the distal end of tube, and sewing the proximal end of the strap in place (generally within the seam line 43) on the second tubular pillow 40. A second exemplary construction method to form the straps 50 is to utilize a piece of material with self-bound edges, such as a ribbon, braid, narrow knitted tube or band, self-edged tape, or other material which is constructed so as not to ravel along the edges, thus removing the necessity of seaming the outer edges.

    (39) The lateral flexure-enabling elements 25, 45 of tubular pillows 20, 40, respectively, are configured to allow the bending or flexing of the tubular pillows 20, 40 at a generally central location. The lateral flexure-enabling elements 25, 45 may be created in any of a variety of methods that facilitate the bending at a central location of the pillows 20, 40. For example, the lateral flexure-enabling elements 25, 45 may be formed by a seam, as shown in FIG. 1; may be formed by multiple seams, as shown in FIG. 3; may be formed by corresponding connectors; may be formed by an articulating joint; or may be formed in other known methods of construction to allow a first segment (left chamber 22, 42) to articulate with respect to a second segment (right chamber 28, 48).

    (40) The outer shells 24, 44, 64 (FIGS. 1, 14-19) of the first tubular pillow 20, second tubular pillow 40 and compact pillow 60 respectively, may be formed of fabric, which includes a single piece of fabric or multiple pieces of fabric joined to form fabric of the desired dimensions. In an exemplary construction method to form the tubular pillows 20, 40, the initial fabric piece 24, 44 may be folded in half and then sewn along one longitudinal peripheral edge along seam line 23, 43 (FIGS. 1, 14-17). The lateral flexure-enabling element 25, 45 may then be created by seaming along a single or multiple seam line or may be created by another disclosed means or means as is known in the art. Then a pre-determined amount of the cushioning material 35 is placed into the longitudinally-elongated first pillow and second pillow left chambers 22, 42 and the left distal ends 21, 41 are closed by sewing along seam line 37, 57, respectively. A second pre-determined amount of the cushioning material 35 is placed into the longitudinally-elongated right chambers 28, 48 and the right distal ends 29, 49 are closed by sewing along seam line 36, 56, respectively. Other construction methods as will be obvious to those skilled in the art are usable to construct one or more of the pillows 20, 40, 60. These variations include forming the pillow 20, 40, 60 from an upper and a lower panel of the same or of varying fabrics with peripheral seams 23, 43, 84 (FIGS. 14-19) and opposing peripheral seams 37, 53, 91 (FIGS. 15-16, 19) created along opposing long edges; forming the pillow 20, 40, 60 from multiple fabric pieces, such as with an upper terrycloth fabric panel sewn to a lower tightly woven smooth fabric; using one or multiple types of seams, such as plain, lapped, abutted, French, fabric welded, or bound seams; sewing the seams in different orders; and other sewing construction means, as are known in the art.

    (41) The third pillow, the compact pillow 60 of the first embodiment, extends from lateral peripheral edge 63 to opposing lateral peripheral edge 73 and from longitudinal peripheral edge 83 to opposing longitudinal peripheral edge 93. The compact pillow 60 includes an outer shell 64 (FIGS. 1, 18-19) that encloses and contains a pre-determined amount of a resilient cushioning material 35 (FIGS. 18-19). The compact pillow 60 is preferably square or rectangular with the lateral side width only slightly smaller than the longitudinal side length, but may alternatively be formed in other compact shapes, such as square, oval, circular, hexagonal, irregular, or the like. The compact pillow 60 is preferably under 12 inches in width and in length.

    (42) The outer shell 64 of the compact pillow 60, as shown in FIGS. 18-19, is formed of fabric, either a single piece of fabric or multiple joined pieces of fabric. In an exemplary single panel construction method, the compact pillow 60 may be formed by folding the fabric piece in half along the central, longitudinal fold line at lateral peripheral edge 63 and sewing along two of the three edges 73, 83, 93. Then an amount of the cushioning material 35 is placed into the pocket created, and the remaining open peripheral edge of the three edges 73, 83, 93 is sewn to enclose the cushioning material 35 and to close the outer shell 64 of the compact pillow 60.

    (43) A two panel construction method may be used with any of the three pillows 20, 40, 60. A first panel of a first fabric type, fabric weight, fabric structure or fabric material may be attached along a first seam line to a second panel of the same fabric or of a fabric having a different type, weight, structure or material. Thus, the first seam would substitute for the fold line described in the single panel construction methods described.

    (44) The outer shells 24, 44, 64 of the three pillows 20, 40, 60 are preferably formed of a soft, natural, hypoallergenic fabric, such as cotton, linen, bamboo, hemp, or silk fabric, but other natural or man-made materials can also be used, such as wool, lyocell, model, viscose, acetate, nylon, rayon, synthetics, and the like. The fabric may be formed of one type of fiber or of multiple types of fibers. The structure of the fabric may be woven, non-woven, fleece, flannel, terrycloth or the like. The type of fabric used to form the three outer shells 24, 44, 64 of the three pillows 20, 40, 60 may be identical or may vary between the different pillows 20, 40, 60. Most preferably, the outer fabric of outer shells 24, 44, 64 is pure cotton flannel. Preferably an inner casing 32, 52, 72 (FIGS. 14, 17, 18) is used inside the outer shells 24, 44, 64 to contain the cushioning material 35. Optionally, a removable exterior case 27, 47, 67 (FIGS. 14, 17, 18) may be provided to protect the outer shells 24, 44, 64. The exterior case 27, 47, 67 may be removed from the inner pillow for laundering. It may be formed with a zipper, complementary hook and loop closure mechanisms, or other closure means. The inner casing 32, 52, 72 and optional exterior case 27, 47, 67 may be formed in a similar manner to the construction method described for the outer shells 24, 44, 64.

    (45) The cushioning material 35 (FIGS. 14-19) comprises a filling-type material that is manipulatable, moveable and/or transferable by relocating, reorienting or displacing a portion of the cushioning material 35 via manual manipulation through the outer shell 24. Because the inner cushioning material 35 is able to be moved about inside the pillows 20, 40, 60, the clinician can manipulate the cushioning material 35 to distribute the weight of the pillow or to better position the infant's head or body. The cushioning material 35 may be particulate or gel. Particulate cushioning material includes polyurethane pellets/beads, polyester pellets, micro beads, polystyrene pellets, seeds or herbs (such as buckwheat, millet, flaxseed, lavender, hemp and the like) and similar known filling materials. Through experimentation, it has been found that the preferred particulate cushioning material 35 is clear, flat, oval polypropylene pellets of uniform shape and size weighing between 1.75 and 2.75 ounces per cup, and preferably 2.25 ounces per cup.

    (46) The tubular pillows 20, 40 of the second embodiment are constructed with the same materials and assembly as in the first embodiment. Additionally, the tubular pillows 20, 40 of the second embodiment are used with the same methods of manipulation, placement, and adjustment as in the first embodiment, but without the extra compact pillow 60. These methods of use are shown in FIGS. 24-29, which include methods used to position the infant in the supine, prone, and side-laying positions, as well as in the sitting position of FIG. 7. The second embodiment specifically illustrates that many of the advantages of the modular, deformable, cushioned, resistive infant positioning system 100 may be achieved without the use of the compact pillow 60.

    (47) Method of Use

    (48) The modular, deformable, cushioned, resistive infant positioning system 100 is usable for positioning and repositioning an infant while providing support with boundaries, calming and stress relief, and correction/prevention of head shape deformities in an isolette, in a crib and in other environments. Depending on the situation, need, and circumstances, the cushioned, resistive infant positioning system 100 may be used to meet aspects of all these objectives simultaneously or may be used to meet one (or more) of the objectives independently. For discussion purposes, each of these uses will be considered separately. FIGS. 2-7 illustrate methods of use of the first embodiment of the cushioned, resistive infant positioning system 100. FIGS. 25-29 illustrate methods of use of the second embodiment of the cushioned, resistive infant positioning system 100. FIG. 7 illustrates a method of use of the invention as applied to an infant in a sitting position, such as a car seat. The use of the cushioned, resistive infant positioning system 100 is also shown in a diagrammatic form in FIGS. 8-13.

    (49) Infants can be placed in prone, supine, side-lying, or sitting positions; different positions are appropriate for different situations. The goal in the NICU is to place the infant in any of a variety of positions that are appropriate for the particular infant at the particular time with the positions providing flexion, containment, alignment and comfort while allowing the infant some movement against boundaries. The cushioned, resistive infant positioning system 100 is designed to be situated and re-situated into advantageous configurations by the nursing staff to meet these positioning goals. In general, in the isolette the infant may be placed in prone, supine, or side-lying positions, while in the open crib the infant is placed on the back following the recommendation given in 1992 by the American Academy of Pediatrics (AAP) that infants be placed for sleep in a non-prone position. The infant would typically be kept in NICU in an isolette while weighing from less than 1 pound up to 4 pounds. At about 4 pounds in weight, the infant can generally maintain his or her body temperature, so is then moved to the open crib.

    (50) The utilization of the cushioned, resistive infant positioning system 100 to place the infant in various positions will be herein discussed without regard to the determination of which position is appropriate for which situation, which may be determined by nursing staff, doctors and other clinical experts. Though the positioning is herein discussed substantially in view of use in the NICU, some or all of the positioning discussed in that regard may al

    (51) so be appropriate for, and utilized in, the nursery, home or other childcare situations.

    (52) Broadly, referring to FIG. 23, to use the cushioned, resistive infant positioning system 100 of the first embodiment, the compact pillow 60 is chosen no and the inner cushioning material 35 is manipulated 101 as desired for the particular application. The compact pillow 60 is then shaped and positioned as desired 102. The compact pillow 60 may be used under the head for support, or, if not needed in that capacity, may be used in accessory uses, such as to protect an IV site, to support ventilator lines, to prop continuous positive airway pressure (CPAP) lines, to secure air lines, or the like.

    (53) Continuing to refer to FIG. 23, to use the cushioned, resistive infant positioning system 100 of the first or second embodiment, an upper tubular pillow (generally the first tubular pillow 20, but optionally the second tubular pillow 40) is selected 103, the inner cushioning material 35 is manually manipulated 104, and the upper pillow is placed adjacent to (near, around, over, or under) the infant's upper torso and head 105. Then, the lower tubular pillow (generally the second tubular pillow 40, but optionally the first tubular pillow 20)) is selected 106, the inner cushioning material 35 is manually manipulated 107, the pillow is shaped (generally in U-shaped configuration) and positioned 108 adjacent to (near, around, over, or under) the infant's lower body. The straps 50 are then adjusted to secure the pillows in the proper position 109, such as being crossed and tucked around the infant or with ends 59A, 59B (FIG. 1) under or over the opposing pillow.

    (54) A first exemplary use of the first embodiment of the cushioned, resistive infant positioning system 100 to position an infant in the supine position is shown in FIG. 2. If the infant can tolerate the supine position in the isolette, a clinician may use the inventive positioning system 100 to position the infant into the supine position. The clinician can use the compact pillow 60 for receiving the infant's head. Before use, the clinician can manipulate the cushioning material 35 of the compact pillow 60 as needed, such as to prevent a chin tuck, which can lead to apnea in premature infants. The clinician can then place the infant's head on the manipulated compact pillow 60.

    (55) The next steps continue the first exemplary use of the first embodiment of the infant positioning system 100 to position an infant in the supine position, as shown in FIG. 2, or begin the first exemplary use of the second embodiment (which lacks the compact pillow 60 of the first embodiment) of the infant positioning system 100 to position an infant in the supine position, as shown in FIG. 25. The clinician bends the first tubular pillow 20 at first pillow lateral flexure-enabling element 25 and places the inner edges of the longitudinally-elongated left and right chambers 22, 28 adjacent to the right and left sides of the infant's head, touching the sides of the top portion of the head. The distal ends 21, 29 can be placed on the infant's shoulders for calming, can be positioned outside of the second tubular pillow 40 or can be curved outward. By placing the infant's head directly in midline and by providing light pressure on the posterior of the skull, the infant's head “rounds out” and scaphocephaly is prevented. The second tubular pillow 40 can be bent at the second pillow lateral flexure-enabling element 45 and formed into a U-shape for placement around the legs and trunk of the infant, touching the outer sides of the legs and trunk to provide containment with some movement against boundaries. The second tubular pillow 40 also supports the infant and prevents the infant from slipping downward in the isolette. Straps 50 can be crossed and tucked under the opposing sides of second tubular pillow 40 to maintain pillow 40 adjacent to the infant.

    (56) FIG. 3 shows exemplary use of the first embodiment of the cushioned, resistive infant positioning system 100 to position an infant in the side-lying position. The clinician places a side of the infant's head upon the compact pillow 60 with the softness of the pillow 60 helping to prevent severe head shape deformities which can occur from lying on the firm mattress.

    (57) The next steps continue the side-lying exemplary use of the first embodiment, as shown in FIG. 3, or begin the exemplary use of the second embodiment of the infant positioning system 100 to position an infant in the supine position, as shown in FIG. 26. The first tubular pillow 20 is bowed at first pillow lateral flexure-enabling element 25 so that the inner portion of the center right chamber 22 can be placed alongside the top of the right side of the infant's head and with the left chamber 28 placed touching the opposite side of the head. The distal ends 21, 29 can be curved upward and outward. The second tubular pillow 40 is then bent at the second pillow lateral flexure-enabling element 45 to form a U-shape. It may then be situated against the legs of the infant to provide containment, to gain flexion, or to contribute to the infant's comfort. Or a portion of the second tubular pillow 40 may be rested on the infant for calming purposes. The straps 50 may be crossed and tucked under the body of the second tubular pillow 40 to secure it in the selected position.

    (58) An exemplary use of the embodiments of the cushioned, resistive infant positioning system 100 to position an infant in the prone position is shown in FIGS. 4-5 and is shown in FIGS. 27-28. In the prone position in the isolette the infant can be placed on one half of the first tubular pillow 20 to encourage flexion of the arms and legs. For example, the clinician places the longitudinal centerline of the first tubular pillow 20 generally along the longitudinal centerline of the flat, rectangular surface of the isolette, with, for example, the left distal end 21 at the top of the isolette. The head of the infant is placed on the left distal end 21 with the infant's body generally aligned with the centerline of the first tubular pillow 20. The first medial portion 26 of the first tubular pillow 20 is then brought upward between the legs (with the resilient cushioning material 35 manipulated, if needed, to create comfortable leg indentations). The remaining portion of the first tubular pillow 20, the first pillow right chamber 28 with right distal end 29, is then rested upon the back of the infant. The second tubular pillow 40 is then manually curved at the second pillow lateral flexure-enabling element 45 to form a U-shape, and is then placed around the infant's feet, touching the feet and sides of each leg for containment. The straps 50 may be crossed and wrapped around and under the opposing sides of the second tubular pillow 40 to maintain the infant in the prone position on the first tubular pillow 20 and to secure the second tubular pillow 40 close to the infant's torso. If provided, as in the first embodiment, the compact pillow 60 can be used in any accessory use, such as to direct or support lines or equipment within the isolette.

    (59) FIGS. 6, 29 shows an exemplary use of the cushioned, resistive infant positioning system 100 with an infant in an open crib. The infant is swaddled and lies on his back. The second tubular pillow 40 is shaped into a U-shape and placed directly around the head with the inner sides of pillow 40 touching the sides of the head. The first tubular pillow 20 is shaped into a U-shape and placed around the legs of the infant to prevent the infant from sliding down in the crib, which is often a problem because the head of the crib is generally elevated to reduce the possibility of reflux. Without support at the feet from first tubular pillow 20, the infant could easily slide down in the crib and away from the upper second tubular pillow 40. The straps 50 are crossed and tucked under the lower first pillow 20, thus securing the pillows 20, 40 around the infant in the selected placement. This positioning is useful for correcting a head shape deformity that has already occurred or preventing a deformity from occurring when the infant is still very small. If provided, as in the first embodiment, the compact pillow 60 can be used in any accessory use, such as by placing under the infant's head.

    (60) FIG. 7 shows an exemplary use of the cushioned, resistive infant positioning system 100 with a slightly older infant in a car seat, bouncy seat, baby swing or the like. If the infant is discharged but still needs correction of a head shape deformity (for example, scaphocephaly), a parent can be instructed on the use of the positioning system 100. For instance, the parent may be given the instructions to use the positioning system 100 for “x” number of hours per day. One of the tubular pillows 20, 40 is bent and placed adjacent to and around the head. If desired, the other one of the tubular pillows 20, 40 can be folded against itself and laid upon the lower torso of the infant for calming. If provided (as in the first embodiment), the compact pillow 60 can be used in any accessory use, such as by placing under the infant's head or supporting the infant's arms or feet.

    (61) FIGS. 8-13 show diagrammatically the positions discussed above. When the modular, deformable, cushioned, resistive infant positioning system 100 is in use within the NICU environment, the diagrammatic images may be displayed in any of various informative presentations to assist the clinicians in advantageously positioning the infant. For instance, the diagrams may be incorporated into support or instructional materials for presentation to clinicians, may be displayed on a poster near the area of use (for instance on an NICU wall), may be printed on sheets or bedding usable on the isolette mattress, may be printed on a laminated placard for attachment to an isolette, or may be used in other similar informative presentations.

    (62) FIGS. 14-15 illustrate that the first tubular pillow 20 may be formed of a single piece of fabric seamed at seam line 23, may be formed of multiple panels seamed at seam lines 23, 37, may be formed with or without a removable outer casing 27, and may be filled with various types of manipulatable resilient cushioning material 35, such as the beads of FIG. 14 or the gel of FIG. 15.

    (63) FIGS. 16-17 illustrate that the second tubular pillow 40 may likewise be formed of a single piece of fabric seamed at seam line 43, may be formed of multiple panels seamed at seam lines 43, 53, may be formed with or without a removable outer casing 47, and may be filled with various types of manipulatable resilient cushioning material 35, such as the beads of FIG. 16 or the gel of FIG. 17.

    (64) FIGS. 18-19 illustrate that the compact pillow 60 may also be formed of a single piece of fabric seamed at seam line 84, may be formed of multiple panels seamed at seam lines 84, 91, may be formed with or without a removable outer casing 67, and may be filled with various types of manipulatable resilient cushioning material 35, such as the beads of FIG. 18 or the gel of FIG. 19.

    (65) FIG. 20 shows three exemplary infant head proportions with lines to show the length and width measurements to be taken. The width (W) 75 is measured from the outer corner of the right eyelid to the outer corner of the left eyelid. The length (L) 70 is measured from the top of the forehead to the bottom of the chin. FIG. 21 shows the method used to determine the occurrence and/or severity of head shape deformity, using the measurements shown in FIG. 20. The diagram of infant A shows a head shape deformity of 26% and the diagram of infant B shows a head shape deformity of 19%, both of which indicate the need for the use of the cushioned, resistive infant positioning system 100. The diagram of infant C shows an infant with normal head proportions, such as after use of the cushioned, resistive infant positioning system 100. The normal head proportion for a newborn is L=1.34 (W).

    (66) The method to determine the degree of head deformity is presented in FIG. 21. In step 74 a width measurement (W) is taken by measuring from the outside of the right eyelid to the outside of the left eyelid of the infant's head. In step 75 a length measurement (L) is taken by measuring from the top of the forehead to the bottom of the chin. This width measurement (W) is divided by the length measurement (L) (step 76) with the result subtracted from 0.75 and multiplied by 100 to convert the fraction to a percentage (step 77). This results in the degree of deformity, which is then documented 78. For example, if an infant has a width measurement (W) of 6 cm and a length measurement (L) of 8 cm, then W/L=0.75=75%; therefore, this infant has an ideal measurement with no deformity. If an infant has a width measurement (W) of 6.75 cm and a length measurement (L) of 10.75 cm, then W/L=0.63=63%; therefore, this infant has a 12% (or moderate) deformity.

    (67) The degrees of head shape deformity are presented in FIG. 22. Using the method of FIG. 21, an infant with a (W/L=0.75=75%) has an ideal head proportion. Infants that have head proportions that result in 5-100% deformity have a mild deformity, while infants that have an 11-18% deformity result have a moderate deformity. Any deformity result over 18% is considered a severe deformity. The modular, deformable, cushioned, resistive infant positioning system 100 may be used to address any of these severities, in addition to being useful to prevent head shape deformities.

    (68) From the foregoing, it will be apparent that the modular, deformable, cushioned, resistive infant positioning system and method of use of the present invention can be used for improving infant positioning (including rotating an infant through multiple advantageous positions facilitating flexion, containment, alignment, movement against boundaries, encouraging more normal musculoskeletal and neuromotor development), promoting the calming an infant, and prevention or correction of positional head deformities.

    (69) While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible that are within the scope of this invention. In addition, the various features, elements and embodiments described herein may be claimed or combined in any combination or arrangement.