SECUREMENT DEVICE FOR INFANTS

Description

BACKGROUND

The present invention generally relates to a securement device for infants. More specifically, the present invention relates to a securement device for infants born prematurely and/or requiring medical intervention including but not limited to phototherapy, intubation and intravenous line access.

Generally, a premature infant is one who is born before thirty-seven weeks of pregnancy. Each year, about one in ten infants in the United States is born prematurely. Depending on how premature the infant is born, the premature baby may not be fully developed at birth and may have more health problems than infants born at term.

The earlier in pregnancy an infant is born, the more likely he or she is to have health issues. Infants born preterm (before thirty-six weeks of pregnancy) are most likely to have health issues. Infants born between thirty-four and thirty-seven weeks of pregnancy are also at increased risk of having health issues related to premature birth. Some premature infants will spend extended time in a hospital's neonatal intensive care unit (also called NICU).

Some infants need NICU care for weeks or months until they can breathe on their own, eat by mouth and maintain their body temperature and body weight. While in NICU, hospital and even at home, premature infants often require medical equipment being attached to infants' various organs, such as apnea monitor, arterial line, bililights, blood pressure monitor, cardiopulmonary monitor, intravenous line, endotracheal tube, and others.

While a premature infant is treated, it is desirable that the infant is comfortable and secure. Swaddling (wrapping) the infant such that the infant's arms are secured along or across his or her body is a preferred and developmentally appropriate method to secure the infant. Swaddling inhibits the infant's arms from their natural, involuntarily and uncontrolled movement that tends to prevent an infant from falling asleep and startle him or her from sleep. The pressure from the swaddle around an infant's chest is believed to further calm the infant, which results in less crying and longer periods of uninterrupted sleep. The ability of this device to only partially swaddle the infant allows for the comfort of the infant while simultaneously allowing for the required treatments such as phototherapy, line placement and thermoregulation all while not interrupting visual assessments of the infants.

Moreover, it is desirable that a device that is used for swaddling also allows phototherapy that is often used to treat premature infants and full-term infants, for example, for jaundice.

Finally, such devices should be made of material that does not irritate infant's skin, and preferably provides additional comfort to the infant due to its increased softness.

There is, therefore, a need for a securement device for an infant, for example, prematurely born infant, that is configured to secure the infant during treatments, allows access for medical equipment to the infant and phototherapy.

SUMMARY

In one aspect, the present invention provides a securement device for infants made from a material. The securement device has a middle portion, two sleeves positioned opposite from each other in relation to the middle portion and extending laterally outwards from the middle portion and tails extended from the sleeves to facilitate tight securement of infant's arm during swaddling. The securement device also includes a plurality of openings that are configured to allow the infant's arms to be placed through the openings for access to the infant's arms and/or back while the sleeves are wrapped across the infant's chest area to secure the infant in a desirable position.

In another aspect, the present invention provides a securement device for infants made from a material that is 50% to 90% transparent to light to enable phototherapy through the material. The securement device has a middle portion, two sleeves positioned opposite from each other in relation to the middle portion and extending laterally outwards from the middle portion and tails extended from the sleeves to facilitate tight securement of infant's arm during swaddling. The securement device also includes a plurality of openings that are configured to allow the infant's arms to be placed through the openings for access to the infant's arms and/or back while the sleeves are wrapped across the infant's chest area to secure the infant in a desirable position,

BRIEF DESCRIPTION OF THE DRAWINGS

In order for the invention to be readily understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, aspects of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings.

FIG. 1 depicts a diagram of a securement device for securing and positioning an infant according to embodiments of the invention;

FIG. 2A depicts a diagram of a rear view of the securement device according to embodiments of the invention where a plurality of openings is shown in accordance with embodiments of the invention;

FIG. 2B depicts a diagram of a rear view of the securement device according to embodiments of the invention where no openings are shown in accordance with embodiments of the invention;

FIG. 3A. depicts a diagram of the securement device being used to secure an infant who is placed in the supine position in accordance with embodiments of the invention; and

FIG. 3B depicts a diagram of the securement device being used to secure an infant who is placed in the prone position in accordance with embodiments of the invention.

DETAILED DESCRIPTION

Reference to “a specific embodiment” or a similar expression in the specification means that specific features, structures, or characteristics described in the specific embodiments are included in at least one specific embodiment of the present invention. Hence, the wording “in a specific embodiment” or a similar expression in this specification does not necessarily refer to the same specific embodiment.

Hereinafter, various embodiments of the present invention will be described in more detail with reference to the accompanying drawings. Nevertheless, it should be understood that the present invention could be modified by those skilled in the art in accordance with the following description to achieve the excellent results of the present invention. Therefore, the following description shall be considered as a pervasive and explanatory description related to the present invention for those skilled in the art, not intended to limit the claims of the present invention.

Reference to “an embodiment,” “a certain embodiment” or a similar expression in the specification means that related features, structures, or characteristics described in the embodiment are included in at least one embodiment of the present invention. Hence, the wording “in an embodiment,” “in a certain embodiment” or a similar expression in this specification does not necessarily refer to the same specific embodiment.

A securement device for infants that are born prematurely and/or require accessibility to the infants for various equipment to be attached to the infant's body while the infant is secured (swaddled) is provided. The securement device also allows phototherapy for delivering light to the front and back of the infant.

Generally, a premature infant is one who is born before thirty-seven weeks of pregnancy. Health care providers describe birth terms as follows:

• • Late preterm: infant is born between thirty-four and thirty-six completed weeks of pregnancy.
  • Moderately preterm: infant is born between thirty-two and thirty-four weeks of pregnancy.
  • Very preterm: infant is born at less than thirty-two weeks of pregnancy.
  • Extremely preterm: infant is born at or before twenty-five weeks of pregnancy.

Premature infants are born before optimal fetal musculoskeletal and neurologic maturation has completed, and as such, are initially cared for in a neonatal intensive care unit (NICU). Infants that are born with illness or suffered certain birth defects are also usually cared for in the NICU.

In NICU premature or ill infants require various medical attention and treatments, that in turn, often require different equipment. At the same time, the infants need to be restrained and positioned to allow access to the infant for diapering and maintenance of medical connections such as apnea monitor, arterial line, bililights, blood pressure monitor, cardiopulmonary monitor, intravenous line, endotracheal tube, tracheostomy tube, and others.

Repositioning and access to the infant must be done with minimal disruption to the infant. It is generally preferred that access is allowed while the infant is in the three typical positions: 1) “supine” (i.e., infant on his/her back), 2) “prone” (i.e., infant on his/her belly), and 3) “side-lying” (i.e., infant on one of his/her sides.).

Moreover, while a premature infant is treated, it is desirable that the infant is comfortable. Wrapping the infant such that infant's arms are secured along or across his or her body inhibits the arms from their natural, involuntarily and uncontrolled movement that tends to prevent a baby from falling asleep and startle an infant from sleep. The pressure from the swaddle around an infant's chest further calms the infant, which results in less crying and longer periods of uninterrupted sleep.

Often premature infants develop jaundice that is treated by phototherapy and exposing the infant's skin to light. Phototherapy for skin conditions is generally considered safe. However, side effects can include redness, dry or itchy skin. It is, therefore, preferred that the material touching the infant's body that is treated by phototherapy provides additional comfort to the infant due to its increased softness.

FIG. 1 illustrates a securement device 10 that secures the infant's arms across his or her body inhibiting the arms from their natural, involuntarily and uncontrolled movement. At the same time, the securement device 10 induces calmness and allows access for various equipment to be attached to the infant's body while the infant is secured (swaddled).

As shown in FIGS. 1, 2A and 2B, the securement device 10 has a middle portion 12 and sleeves 14, 16 positioned opposite from each other in relation to the middle portion 12. The securement device 10 can also include tails 26 that extend from the sleeves 14,16. The middle portion 12 is configured to receive the infant's upper back and body so that the sleeves 14,16 correspond with infant's arms. The tails 26 extend from the sleeves 14, 16 and facilitate tight securement of infant's arm during swaddling.

The sleeves 14,16 extend laterally outward from the middle portion 12. Sleeves 14,16 can have the same or different length and width, and can be asymmetrical or symmetrical.

According to embodiments of the present invention, the middle portion 12 can have length of 3.1 inches to 9.1 inches and width of 2 inches to 4 inches. The sleeves 14,16 can have length of 3.1 inches to 9.1 inches and width of 2 inches to 4 inches in width. Tails 26 can have length of 6.1 inches to 18.1 inches and width of 2 inches to 4 inches in width. The length and width of the middle portion 12, the sleeves 14,16, and tails 26 varies depending on the birth term, e.g., late preterm, moderately preterm, very preterm or extremely preterm. It is understood by a person skilled in the art that securement device 10 can be sized to accommodate larger infants, including term and postdate infants, and this invention is not limited to infants born prematurely.

Each tail 26 includes fastening ends 20. Fastening ends 20 can include securing mechanism 31, such as Velcrow®, hook and loop, buttons, ties, snaps or other mechanism suitable for securely fastening the fastening ends 20.

As shown in FIGS. 1 and 2A, sleeves 14, 16 have openings 24. Openings 24 are configured to allow the infant's arms to be placed through the openings to allow access to the infant's arms and/or back while the sleeves 14,16 are wrapped across the infant's chest area to secure the infant in a desirable position, e.g., supine, prone or side-lying positions. In other words, the device 10 is configured to accommodate different sizes of babies and adaptability by to staff to accommodate medical devices. According to preferred embodiments, each sleeve 14,16 can include [6 to 8 opening 24]. The number of openings can also be determined based on the pre-term of the infant and medical equipment that is needed to the access the infant. The openings 24 can be of various size and form, such as oval, rectangular and so forth.

In addition to the openings 24, secondary openings 25 can be provided for providing access by medical tubes to certain parts of the infant's body. The secondary openings 25 can be smaller in size to accommodate medical tubing rather that infants'arms as in case of the openings 24.

As shown in FIG. 1, according to embodiments of the present invention, the securement device 10 can include two layers 35,36 of a material 40 sewn or fused together and on top of each other.

As illustrated in FIGS. 1 and 2A, openings 24 can be constructed to pass through both layers 35,36, thereby exposing the infant's skin when the infant is placed on his/her stomach or side (prone and side-lying positions). This configuration allows for access to the infant for connecting medical equipment such as apnea monitor, arterial line, bililights, blood pressure monitor, cardiopulmonary monitor, intravenous line, tracheostomy tube, and others.

In another embodiment, openings 24 can be constructed through a first layer 35 only, as shown in FIG. 2B, thereby providing no access to the infant's arms from the back of the securement device 10. This configuration, provides additional comfort to the infant when he/she is in the supine position (i.e., infant on his/her back) by providing a barrier of the material between the infant and the surface, while at the same time securing the infant's arms.

FIG. 3A illustrates the securement device 10 being used to secure the infant who is placed in the supine position where the openings 24 allow access to the infant's arms and body, while the infant remains secure and tightly swaddled.

FIG. 3B illustrates the securement device 10 being used to secure the infant who is placed in the prone position. The openings 24 allow access to the back of infant's arms and body while the infant remains secure and tightly swaddled.

According to embodiments of the present invention, the material 40 allows light transmission. Phototherapy that uses light is often used to treat neonatal jaundice and other conditions. The phototherapy can be delivered by way of an overhead bank of lights or via a pad that contains phototherapy lights that is placed under the infant. To allow the light transmission from a light emitting device (not shown) to reach the infant, while the infant is scurred as shown in FIGS. 3A and 3B through the material 40, the material 40 can be 50% to 90% transparent to light having a wavelength of 430 nm to 490 nm.

The material 40 can include a 2-ounce organic cotton stretchable material with increased softness to provide additional comfort for the infant. Additional fabrics can include bamboo or muslin and be net-like. The material 40 can also include spandex in an amount from about 2 wt % to about 98 wt %. More preferably, the material 40 is a four-way stretch fabric of 92 wt % to 94 wt % organic cotton and from about 5% to 8% wt % spandex. While the material 40 can be any non-flexible or flexible elasticized material selected from the group consisting of: nylon, rayon, polyester, cotton, linen, canvas, plastic, wool, heat conductive fabrics, porous light-permeable fabrics, antimicrobial fabrics, and combinations or blends thereof, it is understood that cotton/spandex blended retractable fabrics are especially preferred.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, element components, and/or groups thereof.

The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form described. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated.