Patent Application
20220183479
Each year approximately 3,853,472 babies are born in the United States. Of those babies, approximately 380,000 are born prematurely (<37 weeks gestation). In addition, each year approximately ˜2700 babies are transported to a higher level of care via ambulances and helicopters in the United States and Canada. Transportation of these premature babies born prematurely causes additional stresses to the babies, further impacting in their development and ability to thrive. The stresses to the baby during transport are extraordinary and cause challenges in providing optimal developmental care. The primary goal is to improve neonatal transport processes and outcomes by minimizing stressors.
Providing neonatal developmental care is challenging in the Neonatal Intensive Care Unit (NICU), but is particularly challenging during transport. The stresses to the baby and the challenges to developmental care for babies during transport are extraordinary. Transportation of babies is required when babies are born and require increased medical support including admission to the NICU. This occurs with babies born in a hospital, needing transport to an in-house NICU or born in an outlying hospital requiring ground transport via ambulance or by air on a helicopter to a higher level NICU. The inventive embodiments described herein result in improvement in neonatal transport processes and outcomes by decreasing sound and vibration to the most vulnerable patients during both ground and air transport as well as reducing stress to infants on neonatal transport both outside and within the hospital, for example, from the delivery room to the NICU.
Providing optimal care for premature babies requires providing safe transportation for these babies. Oftentimes these babies must be transported by ambulance or by helicopter, resulting in additional sensory impact. The goals of the inventive embodiments described herein include minimizing those negative sensory impacts as well as providing optimal conditions for the transportation of premature babies. Numerous challenges arise in manipulating premature babies in preparation for or during transportation, including proper positioning of the baby to avoid injury or negative sensory impact to the baby. Premature babies are disproportionately impacted by very minor stressors that would not affect full term babies. For example, sound and vibration are major stressors for both ground and air transports, and these stressors disproportionately impact premature babies and can cause long term affects in their development. Light and positioning have also been identified as common stressors during neonatal transport.
A more particular description briefly stated above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments and are not therefore to be considered to be limiting of its scope, the embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
For the purposes of promoting an understanding of the principles and operation of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to those skilled in the art to which the invention pertains.
Studies have shown that reducing sound and vibration and movement of an infant enhances their development and reduces stress to their developing systems. Transportation often causes excessive vibration to newborn infants. This is particularly detrimental to premature or sick newborn babies. Statistics show that the overall incidence of IVH is greater during transport as compared to inborn (local hospital), wherein transport accounts for approximately 27.4% of IVH cases, and inborn accounts for 13.42% of IVH cases. Severe IVH is higher in transport compared to inborn, wherein transport accounts for 44.1% of severe IVH cases, as compared to 32.9% for inborn cases.
Additionally, controlling or inhibiting sound impacts to these newborn infants is particularly difficult, but particularly important. Most known hearing protection devices are large and bulky, and ineffective against low frequency noise.
Consequently, embodiments provided herein address both the reduction or elimination of movement or vibration and/or the reduction or elimination of sound (in one example by providing ear protection) for babies, particularly during transportation. Combining these solutions as well as supporting correct positioning of the baby during transport is crucial in facilitating safe and healthy transport by reducing risk factors.
In at least one embodiment described herein, there is provided an infant transport support device including a first side, a second side, a top side, a bottom side, a first end and a second end. The device may include at least one protrusion extending from said top side of the device for supporting a neck of an infant during transport. The protrusion may extend from the top surface of the top side and may partially, or fully extend from the first side to the second side of the device. The protrusion provides sufficient support to the head and neck of the baby placed on the device, to support the head and neck in neutral position. The protrusion is configured to contact and support a neck of the baby. In some non-limiting embodiments, the protrusion may be removable from the device and/or adjustable in position and size relative to the device to allow for various sizes of babies to be placed thereon. For example, depending on the anatomy of the particular baby to be supported by the infant transport support device, the protrusion may be placed closer to a first end of the device or to a second end of the device such that the protrusion supports a neck of a baby. In embodiments wherein a second protrusion is included, the second protrusion may support the gluteus or feet of the baby to reduce downward movement (i.e., movement toward the second end 114) of the device 100 further maintaining position of the baby during transport on the device 100. In one example, the protrusion 122 may include an inflatable device attachable to or extending from the top surface of the top side of the device 100. The inflatability allows for adjustability of the size and depth of the protrusion to increase or decrease the distance between the top of the protrusion 122 and the top surface 118 of the top side 110, accounting for babies of different sizes and characteristics. Proper support of the head and neck provides effective intubation procedures while maintaining neuroprotection positioning. The device embodiments described herein prevent cervical rotation, cervical flexion and cervical hyperextension, which are the main causes of IVH. The elevation of the device may vary, or the device may be provided in multiple sizes and elevations. In at least one embodiment, the device may include an elevation of between 16-30 degrees. In one example, the top side and bottom side may extend from the second end at at least 10 degrees, in another example, the top side and bottom side may extend from the second end at at least 15 degrees. In yet another example the top side and bottom side may extend from the second end at a 16-30 degree angle. During transport, there are space restraints that must be considered due to the size and dimensions of the isolettes and transport isolettes. For an in-house incubator, a 30-degree elevation is recommended. Increasing the elevation of the first side of the device between 15-45 degrees decreases the incidence of intraventricular hemorrhage for babies born between 22-32 weeks gestation (or less than 1500 grams birth weight). In one non-limiting embodiment, an angle (θ) created between the top side and bottom side of the device may include between a 16-30 degree angle or the other angels discussed herein (at least 10 degrees, at least 15 degrees, etc.). In one specific non-limiting embodiment shown in
The device may further include a first and/or a second lateral border 130, 132 as shown in the top plan view of
When long tern positioning persists (even when it is medically imperative), the effects can be far reaching and have greater, long lasting effects on daily function during these critical hours of early development.
At least a second protrusion may be provided in another embodiment, which may extend from the top side of the device, and as with the first protrusion, may be removable from the device or adjustable thereon, or may be permanently fixed relative to the device. The second protrusion prevents downward movement of the infant, preventing the infant from sliding down on the mattress and further securing its position. Moreover, this second protrusion may be provided to facilitate pelvic tilt with trunk and hip flexion to the midline.
A notch 134may be formed in the top surface of the device 100, in a non-limiting example, to provide infant head stabilization. This may be formed by a dip or molding into the device on the top surface 118 of the top side of the device, in one example. Head stabilization may also be provided by the lateral borders 130, 132 described above. The amount of support within the device 100 may be adjustable in some non-limiting embodiments, wherein it may be filled or wherein the support may be removed from the inside of the device 100. In one example, the device 100 may include a zipper or button or other closure to provide access to the internal portion of the device 100. The adjustability may be advantageous for a baby that requires more prone positioning, wherein additional internal filler material may be inserted into the internal portion of the device 100 to provide such positioning.
The device may be formed, at least part, of memory foam and/or springs to reduce vibration and provide supportive comfort to an infant placed thereon, in non-limiting embodiments. The effects of vibration on infants, particularly premature infants can be detrimental.
The device may be provided for single patient use to enhance infection control, in some non-limiting embodiments. For example, a removable, disposable covering may surround the device for use. The cover may be non-permeable, but breathable for comfort, and for maintaining patient temperature, and can be removed from the device for cleaning or disposal to allow re-use of the device. The device may allow for unobstructed x-ray procedures to reduce disturbances to the infant which are caused by removing and replacing the infant onto the device between scans.
Embodiments of the device may further include a shade device 140 shown in
The device may ideally be adjustable to accommodate various sizes of babies, including Low Birth Weight babies (LBW) which weigh less than 2500 g, very low birthweight babies (VLBW), weighing less than 1500 g, and extremely low birth weight babies (ELBW), weighing less than 1000 g. In some examples, the lower portion of the device may be adjustable to increase or decrease pelvic support. Adjustable lateral head and trunk supports may be removable from and attachable to the device or built into the device for providing additional support to various sizes of infants.
The structural characteristics of the device embodiments described herein reduce the need for straps and attachments to the baby. From a sensory perspective, all points of physical contact on a baby send messages to the brain. The brain registers and interprets the response. At first the baby may go into fight mode; however, when the sensation persists (i.e.—strapping, tape) the baby's sensory system goes into a flight mode and often times shuts down. Both of these physiological responses have devastating short and long-term impacts on the baby's sensory system (ability to interpret stimuli in the environment) as well as its endocrine (stress response) system.
In some embodiments, the device may include accessory support including support structures to secure respiratory tubing and devices, for example. The device may include a material to provide security for plastic tubes, and other accessories, to prevent slipping through for airway, (endotracheal tubes, CPAP, nasal cannula) extending therefrom to prevent pulling the baby into position, or on the nose and face. The type of material that could be utilized would be of one that would maintain a tube or other accessory in place and prevent slipping. These features would decrease the need to continue moving the infant to accommodate tubes slipping out of the holder, which occurs often without the device embodiments described herein. The intubation tubing is necessary when indicated, but considerations for direction of pull should be always be made. Once there is this high arch in the palate usually caused by long-term intubation, a baby is at a disadvantage from baseline and will need to work harder to maintain suck on a pacifier as well as demonstrate oral motor coordination for safe and efficient extraction of milk from nipple for adequate weight gain. A baby with a high palate will have to work harder to get milk from breast or bottle due to this shift on oral motor anatomy. Feeding implication and effects reach far beyond days spent in the NICU. For example, the endotracheal tube is left in the mid-line position for a long period of time the infant's palate will start to surround the tube thus creating a high palate. The endotracheal tube must be moved from side to side of the infant's mouth. Furthermore, the tension on the infant's mouth due to the endotracheal tube pulling needs to eliminated. Securing the tube with a securement device that does not slip, as described herein prevents these issues.
It is to be noted that the terms “first,” “second,” and the like as used herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The terms “a” and “an” do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Furthermore, to the extent that the terms “including,” “includes,” “having,” “has,” “with,” or variants thereof are used in either the detailed description and/or the claims, such terms are intended to be inclusive in a manner similar to the term “comprising.” The modifier “about” used in connection with a quantity is inclusive of the stated value and has the meaning dictated by the context (e.g., includes the degree of error associated with measurement of the particular quantity). It is to be noted that all ranges disclosed within this specification are inclusive and are independently combinable.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. 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 these terms do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced item. Furthermore, to the extent that the terms “including,” “includes,” “having,” “has,” “with,” or variants thereof are used in either the detailed description and/or the claims, such terms are intended to be inclusive in a manner similar to the term “comprising.” Moreover, unless specifically stated, any use of the terms first, second, etc., does not denote any order, quantity or importance, but rather the terms first, second, etc., are used to distinguish one element from another.
Notwithstanding that the numerical ranges and parameters setting forth the broad scope are approximations, the numerical values set forth in specific non-limiting examples are reported as precisely as possible. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, all ranges disclosed herein are to be understood to encompass any and all sub-ranges subsumed therein. As a non-limiting example, a range of “less than 10” can include any and all sub-ranges between (and including) the minimum value of zero and the maximum value of 10, that is, any and all sub-ranges having a minimum value of equal to or greater than zero and a maximum value of equal to or less than 10, e.g., 1 to 7.
This application claims the benefit of U.S. Provisional Application No. 63/199,150 filed Dec. 10, 2020, and is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63199150 | Dec 2020 | US |
