Abstract:
An infant thermoregulation and monitoring support device is configured for thermoregulation support of infants, particularly premature and/or low birthweight infants. The device includes an enfolding mechanism, a carrying mechanism and a temperature stabilizing device. The carrying mechanism and the temperature stabilizing device are coupled to the enfolding mechanism. The temperature stabilizing device is configured to detect and/or modify the temperature of the enfolding mechanism.

Description:
[0001]    This application claims priority to U.S. provisional patent application No. 62/232,618, filed on 25 Sep. 2015, the disclosure of which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF DISCLOSURE 
     Background 
       [0002]    The present disclosure relates generally to a device for thermoregulation and monitoring support of infants, particularly premature and/or low birthweight infants. 
         [0003]    Each year, 15 million babies are born too soon or too small, and even in tropical settings, virtually all these premature and/or low birthweight babies are compromised in their ability to maintain a normal body temperature. As a result, scores of babies face grave danger from newborn hypothermia (low body temperature). For all newborns, but especially small babies, even a slight drop in body temperature below 36.5° C. can profoundly increase the risk for breathing problems, feeding difficulties, and infection, all of which are leading causes of global newborn death. Due to its estimated prevalence, hypothermia is thought to underlie virtually all of global newborn mortality. Unfortunately, despite the staggering magnitude of the problem, there is currently a paucity of safe, effective, feasible, culturally-acceptable, and affordable technical interventions to address neonatal hypothermia in resource-limited settings, where 99% of all global newborn deaths occur. 
         [0004]    In high-income countries, current solutions to prevent and/or manage hypothermia include incubators, radiant warmers, gel mattresses, and warming blankets. These market products are often ill-suited for resource-limited settings; incubators and radiant warmers, in particular, are often prohibitively expensive to acquire, challenging to maintain, require infrastructure that is often scarce in low- and middle-income countries (e.g., reliable electricity), and need skilled personnel who are trained to safely operate, maintain, and repair the machinery. 
         [0005]    Incubator care is not necessary for all small babies. At present, the preferred option to prevent hypothermia in resource-limited settings among medically stable, so-called “small, well babies” is Kangaroo Mother Care (KMC)/“skin-to-skin” care (STS). KMC/STS is an intervention in which the baby and caregiver lay on each other&#39;s bare skin; this “no tech solution” for newborn thermal regulation is well-suited and highly efficacious in many resource-limited settings. KMC/STS is targeted for scale-up by leading global health partners as an affordable, high-impact intervention. Despite the demonstrated benefits, relatively low-cost, and seeming simplicity of KMC/STS, in the 30 years since KMC was introduced to the world, wide-scale implementation and scalability have been hampered. Barriers to KMC/STS include the perceived complexity of training for health workers, implementation costs for health facilities (construction of KMC wards), and burden on caregivers (continuous KMC requires STS contact 20+ hours per day). 
         [0006]    Accordingly, an easy-to-use, low cost device for supporting infant thermoregulation and monitoring is still needed both in resource-limited geographies as well as in developed geographies. 
       SUMMARY 
       [0007]    In various embodiments, an infant thermoregulation and monitoring support device may include an enfolding mechanism, a carrying mechanism, and a temperature stabilizing device configured to maintain the temperature and monitor vital signs of the infant carried in the enfolding and/or carrying mechanisms. 
         [0008]    Additional features and advantages of the present invention will become apparent to those skilled in the art upon consideration of the following detailed description of the illustrative embodiment exemplifying the best mode of carrying out the invention as presently perceived. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    The foregoing aspects and many of the intended advantages of this invention will become more readily appreciated as the same becomes better understood by reference to the following detailed description when taken in conjunction with the accompanying drawings. 
           [0010]      FIG. 1  is a view of an infant thermoregulation and monitoring support device with both an enfolding mechanism and a carrying mechanism in an open position; 
           [0011]      FIG. 2  is a view of a backside of a user while transforming a carrying mechanism from an open position to a closed position by the user; 
           [0012]      FIG. 3  is a view of a backside of a user wearing a carrying mechanism in a closed position with at least one strap being adjusted; 
           [0013]      FIG. 4  is a view of a support panel of a carrying mechanism; 
           [0014]      FIG. 5  is a is a view of the outward facing surface of an infant thermoregulation and monitoring support device with the device being placed on a user; 
           [0015]      FIG. 6  is a view an infant thermoregulation and monitoring support device worn by a user; 
           [0016]      FIG. 7  is a view of an infant thermoregulation and monitoring support device worn by a user with a neck support engaged; 
           [0017]      FIG. 8  a view of an enfolding mechanism in an open position; 
           [0018]      FIG. 9  is a view of an infant positioned on an enfolding mechanism in an open position; 
           [0019]      FIG. 10  is a view of an infant in an enfolding mechanism with a middle fold in a closed position; 
           [0020]      FIG. 11  is a view of an infant in an enfolding mechanism with a middle fold and a left fold in closed positions; 
           [0021]      FIG. 12  is a view of an infant in an enfolding mechanism in a closed position with a middle fold, a left fold and a right fold all in closed positions; 
           [0022]      FIG. 13  is a view of an infant in an enfolding mechanism with a middle fold and a right fold in the closed position and a left fold in a partially open position allowing access to the infant&#39;s right arm; 
           [0023]      FIG. 14  is a view of an infant in an enfolding mechanism with a middle fold and a left fold in the closed position and a right fold in a partially open position allowing access to the infant&#39;s left arm; 
           [0024]      FIG. 15  is a view of an infant within an enfolding mechanism with a middle fold, a left fold and a right fold in the closed position while allowing access to the infant&#39;s right leg; 
           [0025]      FIG. 16  is a view of an infant within an enfolding mechanism with a middle fold and a right fold in the closed position and a left fold in a partially open position allowing access to the infant&#39;s left leg; 
           [0026]      FIG. 17  is a view of a circuit design for a temperature stabilizing device; and 
           [0027]      FIG. 18  is a flowchart for an algorithm for a microcontroller within a temperature stabilizing device. 
       
    
    
       [0028]    Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of various features and components according to the present disclosure, the drawings are not necessarily to scale and certain features may be exaggerated in order to better illustrate and explain the present disclosure. The exemplification set out herein illustrates embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner. 
       DETAILED DESCRIPTION 
       [0029]    For the purposes of promoting an understanding of the principals of the invention, reference will now be made to the embodiments illustrated in the drawings, which are described below. The embodiments disclosed below are not intended to be exhaustive or limit the invention to the precise form disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may utilize their teachings. It will be understood that no limitation of the scope of the invention is thereby intended. The invention includes any alterations and further modifications in the illustrative devices and described methods and further applications of the principles of the invention which would normally occur to one skilled in the art to which the invention relates. 
         [0030]    Referring to  FIG. 1 , an infant thermoregulation and monitoring support device  10  generally includes a carrying mechanism  12 , an enfolding mechanism  14  and a temperature stabilizing device  36  ( FIG. 6 ). 
         [0031]    In more detail, and still referring to  FIG. 1 , carrying mechanism  12  generally includes a waistband  16 , a support panel  18 , and at least one strap  20 ,  22 . Additionally, carrying mechanism  12  may be in an open position ( FIG. 1 ) or a closed position ( FIGS. 3 and 6 ). In general, carrying mechanism  12  is in a closed position when being worn by a user with straps  20 ,  22  over the user&#39;s shoulders, waistband  16  around the user&#39;s waist and support panel  18  across the user&#39;s chest and/or torso. Carrying mechanism  12  is in an open position generally when not being worn by a user and waistband  16  ends  16   a ,  16   b  are not joined. Common users for the device may include caregivers and/or parents. Carrying mechanism  12  may be sized to fit any range of adults or young adolescences. 
         [0032]    Further, in various embodiments, carrying mechanism  12  may be formed of a comfortable, easily cleaned fabric. The fabric may also express anti-microbial properties, UV resistant characteristics, abrasion resistant characteristics and breathability properties. Additionally, the fabric may be easily cleaned with a dilute bleach solution. In one exemplary embodiment, carrying mechanism  12  may be formed using WeatherMax 65® fabric. 
         [0033]    With reference now to  FIG. 2 , waistband  16  may include a first end  16   a  and a second end  16   b . First end  16   a  and second end  16   b  may be joined to transform waistband  16  from an open position to a closed position via at least one hook and loop closure, a snap, a button and/or other similar closure mechanisms. First end  16   a  and second end  16   b  may come together at varied distances to allow waistband  16  to fit various sized users around the waist. Thus, in one exemplary embodiment, first end  16   a  may include a long strip of a hook or loop side of a hook and loop closure, while second end  16   b  may include a long strip of the other side of a hook and loop closure. Further, first end  16   a  and second end  16   b  may substantially overlap when brought together to form waistband  16 . Additionally, in various embodiments, first end  16   a  and second end  16   b  may come together at the front or side of user  2 , while in other embodiments, ends  16   a  and  16   b  may come together at the rear of user  2 . Also, in various embodiments, foam may be used within waistband  16  for additional support for device  10 . 
         [0034]    Referring to  FIG. 3 , straps  20 ,  22  may include at least one adjuster  52 . Adjuster  52  allows for straps  20 ,  22  to be adjusted so that device  10  may fit a variety of users&#39; torsos. In one exemplary embodiment, adjuster  52  may be a buckle. Further, adjuster  52  may be located along straps  20 ,  22  such that it is adjustable from the front or the back of user  2 . Additionally, in various embodiments, straps  20 ,  22  may include foam inserts to help support device  10 . 
         [0035]    Referring now to  FIG. 4 , support panel  18  includes at least one section. In various embodiments, support panel  18  may include three sections. More particularly, the three sections may be a rectangular section  66  and two triangular sections  68 ,  70 , one attached to each side of rectangular section  66 . Additionally, in various embodiments, triangular sections  68 ,  70  may be attached by stitching or other similar methods to the sides of rectangular section  66 . Support panel  18  may spread across most of a user&#39;s chest and/or torso. 
         [0036]    With reference now to  FIGS. 5 and 6 , carrying mechanism  12  may further include a pocket  34 . Pocket  34  may be sewn onto the outward facing surface of carrying mechanism  12 . Further, pocket  34  may be used to secure temperature stabilizing device  36  to device  10  or to hold other items needed while caring for a child or generally. Pocket  34  may be made of mesh, similar fabric to that used for carrying mechanism  12  or any other fabric capable of containing items. In various embodiments, waistband  16  may be wide enough such that temperature stabilizing device  36  may be secured solely to waistband  16 . Also, carrying mechanism  12  may be configured to include a perforation or grommet  38 . In various embodiments, enfolding mechanism  14  may be in electrical communication with a temperature stabilizing device  36  via perforation or grommet  38  ( FIG. 1 ). 
         [0037]    Still referring to  FIG. 6 , device  10  may be securely worn by user  2  such that infant  1  ( FIG. 7 ) may be placed between device  10  and the chest of user  2 . In various embodiments, when device  10  is worn by user  2 , enfolding mechanism  14  may be in the open position and carrying mechanism  12  may be in the closed position. 
         [0038]    With reference to  FIG. 7 , support panel  18  allows infant  1  to be secured to the chest of user  2  in the appropriate position. The appropriate position of infant  1  may include the legs of infant  1  in a frog-like position, the head of infant  1  turned to the side and the head and neck of infant  1  supported by neck support  32 . In addition, neck support  32  may be engaged when infant thermoregulation and monitoring support device  10  is worn by user  2 . In various embodiments, neck support  32  may be engaged by folding neck support  32  down or over to allow more support for the infant&#39;s neck. 
         [0039]    With reference now to  FIGS. 1 and 8 , enfolding mechanism  14  generally includes a back panel  24 , a left fold  26 , a right fold  28 , a middle fold  30 , and a neck support  32 . Enfolding mechanism  14  may be made in many different sizes. For instance, in various embodiments, enfolding device  14  may be suitable for babies that are less than 1500 grams, while in other embodiments enfolding device  14  may be suitable for babies that are greater than 1500 grams. Additionally, in one exemplary embodiment, enfolding device  14  may be configured to be self-warming. 
         [0040]    Further, in various embodiments, enfolding device  14  may be formed of a flexible material that can house lightweight heating elements. The material may be waterproof, breathable and/or windproof. Further, in various embodiments, the heating elements may be woven into the flexible material. In one exemplary embodiment, enfolding device  14  may also be formed by sandwiching an insulated material, such as Insul-Brite, between at least two layers of a conductive, woven material, such as rip stop, or more specifically, Super Waterproof Breathable Tex 3-ply Ripstop. 
         [0041]    Referring now to  FIGS. 8-12 , enfolding mechanism  14  may be in an open position ( FIGS. 1, 8 and 9 ) or a closed position ( FIG. 12 ). In various embodiments, enfolding mechanism  14  may be in an open position when infant thermoregulation and monitoring support device  10  is being worn by a user or in a closed position when device  10  is not being worn by a user. This allows the infant to be in contact with the user when the device is being worn, but wrapped in enfolding mechanism  14  when the user is unavailable. With reference to  FIG. 9 , an infant  1  is properly positioned on back panel  24  of enfolding mechanism  14  in an open position with the infant&#39;s head resting upon neck support  32 . Referring to  FIGS. 9-12 , enfolding mechanism  14  may be transitioned from an open position ( FIG. 9 ) to a closed position ( FIG. 12 ). Middle fold  30 , left fold  26 , and right fold  28  may be securely closed by use of at least one of a hook and loop closure, a zipper, a button, a snap and/or a similar mechanism. 
         [0042]    Referring to  FIG. 10 , generally, the first step in transitioning enfolding mechanism  14  to the closed position is for middle fold  30  to be in a closed position by folding the flap up and over the infant&#39;s legs and chest while left fold  26  and right fold  28  are in the open position or still unfolded. Subsequently, with reference to  FIG. 11 , middle fold  30  remains closed while right fold  28  may be transitioned into a closed position by folding the flap over onto middle fold  30 . Left fold  26  may remain in an open position. This may also be done such that left fold  26  and middle fold  30  may be in a closed position while right fold  28  may be in an open position. 
         [0043]    Then, referring to  FIG. 12 , enfolding mechanism  14  is in the closed position when middle fold  30 , right fold  28 , and left fold  26  are all in the closed position. Left fold  26  may be transitioned into a closed position by folding the flap over onto middle fold  30  and right fold  28 . In various embodiments, folds  26 ,  28  and  30  may be closed by engaging snaps, buttons, hook and loop closures or similar closure mechanisms. In an exemplary embodiment, the closure is a snap  40 . Additionally, referring to  FIGS. 13-16 , enfolding mechanism  14  may allow for access to the limbs of an infant  1  while the rest of infant  1  is still within enfolding mechanism  14 . Thus, referring to  FIG. 13 , a right arm  44  of infant  1  may be accessible by allowing right fold  28  to be partially open by opening at least one closure mechanism. Further, with reference to  FIG. 14 , a left arm  46  of infant  1  may be accessible by left fold  26  being partially open. Additionally,  FIGS. 15 and 16  show legs  48 ,  50  of infant  1  being accessible by left fold  26  being partially open ( FIG. 15 ) or right fold  28  being partially open ( FIG. 16 ). 
         [0044]    Referring now to  FIG. 17 , a temperature stabilizing device may include a circuit that includes at least one of a heat source  52 , a temperature sensor  56 , a microcontroller  58 , at least one audible signal  60 , at least one visual signal  62 , and/or a power source  64 . In various embodiments, temperature stabilizing device  36  may further include electrical housing that encompasses at least one of heat source  52 , temperature sensor  56 , microcontroller  58 , audible signal  60 , visual signal  62 , and/or power source  64 . Additionally, the electrical housing may be created through the use of a 3D printer. In various embodiments, the electrical housing may be of a rectangular prism geometry. Further, the electrical housing may include a lid and a main box. Additionally, in various embodiments, a rubber gasket may be sandwiched between a lid and a main box of the electrical housing to provide necessary waterproofing. Also, stainless steel nuts and bolts may be used to clamp the lid in place. 
         [0045]    In alternative embodiments, a temperature stabilizing device may further include one or a plurality of sensors. The sensor(s) may monitor the infant&#39;s body temperature, respiration rate, heart rate, apnea, oxygen saturation, blood sugar, bilirubin, and/or body weight (including daily changes in body weight). 
         [0046]    In addition, temperature sensor  56  and/or any other provided sensor may be linked to a transmitter. The transmitter may transmit sensor data to an external display or device (i.e., smart phone) via a hardwire connection or a wireless connection. In an exemplary embodiment, the connection is via Bluetooth®. Further, the display or device may also contain an algorithm such that the display or device may produce an alert (visual or audible) when sensor data is out of designated ranges. 
         [0047]    Still referring to  FIG. 17 , in various embodiments, microcontroller  58  may be in circuit with temperature sensor  56 , power source  64 , heat source  52 , visual signals  62  and audible signal  60  such that according to an algorithm (flow chart for algorithm— FIG. 18 ), microcontroller  58  may instruct power source  64  and heat source  52  to provide an even warmth to enfolding mechanism  14  when temperature sensor  56  indicates to microcontroller  58  that infant  1  is too cold. In an exemplary embodiment, audible signal  60  may be a piezo electric speaker, visual signals  62  may be an LED light and power source  64  may be a battery and/or solar panel. Alternatively, heat for warming the device may be produced by a chemical pack, a heat absorbing pack, heating elements, exposure to boiling or a microwave, or direct exposure to maternal or solar heat sources. 
         [0048]    In various embodiments, audible signal  60  may be activated when the temperature of infant  1  as determined by temperature sensor  56  is above 37.7° C. or below 36.4° C. Additionally, in various embodiments, temperature stabilizing device  36  may include at least three visual signals  62 . Further, each of the at least three visual signals may signal different temperature ranges. For instance, in various embodiments, one visual signal may be activated when the temperature of infant  1  is determined by the temperature sensor  56  to be less than 36.4° C., while another is activated when the temperature is determined to be at or between 36.4° C. and 37.7° C., while yet another is activated when the temperature is determined to be above 37.7° C. Additionally, in various embodiments, the at least three visual signals may be of different colors such as blue for temperatures below 36.4° C., white for temperatures between 36.4° C. and 37.7° C. and red for temperatures above 37.7° C. 
         [0049]    While this disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains. 
         [0050]    Furthermore, the scope is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “on and only one” unless explicitly so stated, but rather “one or more.” Moreover, where a phrase similar to “at least one of A, B, or C” is used in the claims, it is intended that the phrase be interpreted to mean that A alone may be present in an embodiment, B alone may be present in an embodiment, C alone may be present in an embodiment, or that any combination of the elements A, B or C may be present in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. 
         [0051]    In the detailed description herein, references to “one embodiment,” “an embodiment,” “an example embodiment,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art with the benefit of the present disclosure to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments. 
         [0052]    Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element herein is to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase “means for.” As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.