Field of the invention

This invention relates generally to baby-care products, and more particularly to a blanket enabled for autonomous controlled warming using which a neonate can be wrapped and kept warm safely over an extended period of time.

Definitions and interpretations

Before undertaking the detailed description of the invention below, it may be advantageous to set forth definitions of certain words or phrases used throughout this patent document: the terms “include” and “comprise,” as well as derivatives thereof, mean inclusion without limitation; the term “or” is inclusive, meaning and/or; the phrases “associated with” and “associated therewith,” as well as derivatives thereof, may mean to include, be included within, interconnect, with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like; and the term “SMMS” refers a composite fabric consisting of two layers spunbond and two layers meltblown material which is soft, delicate and skin-friendly; the term “NeoWarm Blanket” is the name presently allocated by the present Applicant to the self-warming blanket proposed herein, and as such the name is used synonymously with the description “self-warming blanket” in this document; the term “infant” is generally used to denote neonatal, preterm, or hypothermic babies; the term “neonate” refers a newborn baby of age under twenty eight days of birth, but also refers alternatively to any baby in need of due care / intervention for hypothermia.

Background of the invention and Description of related art

Neonatal hypothermia is defined as an abnormal thermal state in which the newborn’s body temperature drops below 36.5 °C (97.7 °F). Progressive reduction in body temperature leads to adverse clinical effects ranging from mild metabolic stress to death. In 1997, the World Health Organization categorized hypothermia into 3 stages based on core temperature, prognosis and action required - a) Cold stress 36.0 to 36.4 °C (96.8 to 97.5 °F); cause for concern, where remedial measures must be aimed to warm the baby and seek to identify cause(s); b) Moderate hypothermia: 32.0 to 35.9 °C (89.6 to 96.6 °F); danger where remedial measures must be aimed for immediate warming of the baby is needed; and c) Severe hypothermia: <32.0 °C (<89.6 °F); outlook is grave where remedial measures via skilled care are urgently needed.

Traditionally, blankets are used for swaddling neonates to thereby provide comfort, emotional security, and conserve bodily warmth. Conventional blankets perform fine except for neonates and premature babies who often do not have precise control of body temperature. In this case, there is a pressing need for some means that can introduce and maintain necessary warmth for said neonates having hypothermia. In a conservative estimate, roughly twenty million premature and low-birth-weight babies are born around the world each year. Pre-term babies are often susceptible to hypothermia and those taking birth in the remote areas (either at home or limited-equipped PHCs) require immediate transportation to the closest well-equipped (higher) nearest medical center with incubators and/or radiant warmers to keep the babies warm and save their lives

Mortality rate in pre-term babies is high, especially in developing countries which have a scarcity of warming tables / incubators / carriers for care of such neonates. Besides being overwhelmingly outweighed by demand, these warming tables / incubators / carriers tend to be expensive, complex to use as well as difficult to maintain or repair and hence unfortunately remain largely out of reach. Also, the requirement for warmers becomes even more significant for intra as well as inter hospital transfer including up to few hundred kilometers. Often the babies are transported in used sarees and towels at home that neither provide adequate insulation nor act as a source of warmth there by resulting in further loss of body temperature. Most of the ambulances used to transport babies from suburban/rural areas to nearest SNCU/higher center are not climate controlled and are not equipped with auxiliary power to use warmers. Hypothermia itself may not be life threatening however if not addressed in time, further complications make the neonate vulnerable and even death can occur in babies that are severely hypothermic for longer duration. Therefore, there is a pressing need for a truly “ready” to use, non-electric, and portable warmer for serving a large population of new born children that can introduce and maintain necessary warmth for neonates which is essentially inexpensive and easy to use, besides being easily scalable for large scale production to meet existing demand for the same.

The aforementioned want is attempted to be resolved by some solutions from around the world. Notable examples include-

1) Embrace: This is a medical device that acts like an incubator. This device is in form of a sleeping bag which can be wrapped around a neonate. Heat is introduced by means of a pouch containing a phase-change material which can be ‘recharged’ by submerging it in boiling water for a few minutes. (Ref: https://www.embraceinnovations.com/)

2) IncuBlanket by Warmilu: This is a non-electric warming device based on inclusion of warming packs in a baby-sized sleeping bag. The warmer packs can be recharged non- electrically through boiling. (Ref: http://warmilu.com/)

3) Ready-heat: These are disposable self-warming blankets that contain a chemical premix that serves as a heating element. Said heating element is activated by oxygen in the atmosphere and generates heat without the need of an external power source. (Ref: https://www.jbmedicalsupplies.com.au/our-products/ready-heat ) Some further references can be observed in US5956766A (issued to Jeanette Roberta Benway) which discloses a blanket for warming a child seated in a stroller. Another example is CN101217925B (issued to Smith Medical Asd) which discloses a restricted regulated airflow blanket. Yet another example is EP0527738A1 (issued to William C. Mccormack) which discloses a heating blanket for infants.

Above solutions, though targeting the same wants voiced here above, are still far away from the specialized care needed for neonates and premature babies, especially for longer holding times. Therefore, to the limited extent presently surveyed, prior art does not list a single effective solution embracing all considerations mentioned hereinabove, thus preserving an acute necessity-to-invent for the present inventors who, as result of their focused research, have come up with a novel solution for resolving all needs of the art once and for all.

It shall be understood that work of the presently named inventors, specifically directed against the technical problems recited hereinabove and currently part of the public domain including earlier filed patent applications, and publicly worked inventions are neither expressly nor impliedly admitted as prior art against the present disclosures. A better understanding of underlying principles of the present invention will be obtained from the following narration which sets forth an illustrative yet-preferred embodiment.

Objectives of the present invention

The present invention is identified in addressing at least all major deficiencies of art discussed in the foregoing section by effectively addressing the objectives stated under, of which:

It is a primary objective to provide a self-warming device having autonomous controlled warming capabilities in which a baby can be wrapped and kept warm over an extended period of time

It is another objective further to the aforesaid objective(s) that temperature of the heating element responsible for autonomous controlled warming does not go beyond 60°C at any time.

It is another objective further to the aforesaid objective(s) that components of the self-warming device are washable, reusable and / or capable of being easily and inexpensively replenished.

It is another objective further to the aforesaid objective(s) that temperature experienced by the neonate when ensconced within the self-warming blanket does not go beyond 37.5 °C at any time.

It is another objective further to the aforesaid objective(s) that the self-warming device is small, light weight, has no moving parts, and is comfortable for securely holding a neonate inside it. It is another objective further to the aforesaid objective(s) that working of the heating element responsible for autonomous controlled warming does not involve any external source of power, cause pollution, or otherwise be hazardous to the environment.

It is another objective further to the aforesaid objective(s) that usage of the self-warming device is simple, and within ambit of even a layman.

It is another objective further to the aforesaid objective(s) that the self-warming device is cost-effective and does not involve expensive procurement / operational costs and / or costs of consumables.

The manner in which the above objectives are achieved, together with other objects and advantages which will become subsequently apparent, reside in the detailed description set forth below in reference to the accompanying drawings and furthermore specifically outlined in the independent claim 1. Other advantageous embodiments of the invention are specified in the dependent claims.

Brief description of drawings

The present invention is explained herein under with reference to the following drawings, in which:

Figure 1A is a schematic illustration of the self-warming device of the present invention in a blanket type embodiment.

Figure 1B is a schematic representation of the manner in which a neonate is ensconced in the selfwarming device of Figure 1 A.

Figure 1C is a front view of the holder (01) of the present invention in its closed form, as used in experimental validations recited herein.

Figure 1D is a front view of the holder (01) shown in Figure 1C in its open form.

Figure 1E is a rear view of the holder (01) shown in Figure 1C showing the heating pocket closed.

Figure 1F is a rear view of the holder (01) shown in Figure 1C showing the heating pocket open.

Figure 2Ais a schematic illustration of the holder (01) in a box type embodiment.

Figure 2Bis a front view of the holder (01) in its box type embodiment, wherein the heating element is placed under the mattress.

Figure 2C is a front view of the holder (01) of Figure 2B, with mattress removed showing the heating element inside. Figure 2D is a rear view of the holder (01) of Figure 2B.

Figure 2E is a front view of the holder (01) in its box type embodiment, wherein the heating element is placed in a slot / pocket provided on the rear side of the holder.

Figure 2F is a front view of the holder (01) of Figure 2E, with mattress removed.

Figure 2G is a rear view of the holder (01) of Figure 2E, showing pocket / slot for receiving the heating element.

Figure 3 is a schematic exploded view illustrating the layering of materials comprising the holder (01) as per the present invention.

Figure 4 is a schematic cross-sectional view illustrating the functioning of layered materials comprising the holder (01) as per the present invention.

Figure 5 is a graph of day-wise repeatability of precise and controlled warming function exhibited while using the holder (01) of the present invention.

Figure 6 is another graph of day-wise repeatability of precise and controlled warming function exhibited while using the holder (01) of the present invention.

Figure 7 is a graph illustrating operation of the holder (01) of the present invention in comparison to next-comparable devices commercially available in the market.

Figure8A is a photograph comparing the thermal imagery of the heating element (02) at 15 minutes and 9 hours from activation.

Figure 8B is a photograph comparing the thermal imagery of the self-warming device (blanket)and phantom (water bottle mimicking a neonate), both at 9 hours from activation.

Figure 9A is a schematic representation of an alternative embodiment of the holder (01) of the present invention having an in-built window for observation of the neonate ensconced therein.

Figure 9B is a schematic representation of yet alternative embodiment of the holder (01) of the present invention having an in-built window for observation of the neonate ensconced therein and a thermochromic indicator for monitoring suitability of temperature for the neonate to be ensconced therein. Figure 10A is a chart showing month wise distribution of number of neonates supported in the validation experiments.

Figure 10B is a chart showing gender wise distribution of number of neonates supported in the validation experiments.

Figure 11A is a chart showing sampled temperature profile of a male subject neonate enrolled in the validation experiments.

Figure 11 B is a chart showing sampled temperature profile of a female subject neonate enrolled in the validation experiments.

Figure 12 (A to F) showcases an exemplary step-wise protocol of implementing the self-warming device of the present invention.

Figure 13A showcases provisions for securing the self-warming device of the present invention to a bed / cradle / platform.

Figure 13B showcases the manner in which the self-warming device of the present invention is secured within a cradle.

Figure 13C showcases the manner in which the self-warming device of the present invention is secured on a bed / platform.

Figure 13D showcases the manner in which the self-warming device of the present invention is secured within a vehicle (ambulance) for safe transportation of the neonate.

The above drawings are illustrative of particular examples of the present invention but are not intended to limit the scope thereof. The drawings are not to scale (unless so stated) and are intended for use solely in conjunction with their explanations in the following detailed description. In above drawings, wherever possible, the same references and symbols have been used throughout to refer to the same or similar parts. Though numbering has been introduced to demarcate reference to specific components in relation to such references being made in different sections of this specification, all components are not shown or numbered in each drawing to avoid obscuring the invention proposed.

Attention of the reader is now requested to the detailed description to follow which narrates a preferred embodiment of the present invention and such other ways in which principles of the invention may be employed without parting from the essence of the invention claimed herein. Statement / Summary

In alignment with the objectives mentioned hereinabove, the present invention seeks to establish an instantly-usable, portable, non-electric self-warming device to fulfill the gap of warm transportation of neonatal, preterm, or hypothermic babies, which is based on air-activated warming technology that intelligently packages simple, eco-friendly ingredients that manifest a controlled exothermic reaction to create an instant and easy-to-use life-saving self-warming device which comprises two essential components - a holder in either blanket or box configurations to ensconce a neonate, and a heating element receivable within a pocket provided in the holder, which heating element does not require any external source of energy or heat for activation. This self-warming device is truly instant and a breakthrough in neonatal careunlike other products proposed in the past, as the warmth can be felt upon exposure of the heating element to air and the blanket is ready for use within 15 to 20 minutes after activation that lasts for up to 8 hours per instance of the heating element being consumed for use. The duration of warmth can be increased by simply replacing subsequent instances of the heating element. Use of the blanket, disposal of the heating element are all eco-friendly and within ambit of even a layman.

Detailed description

Principally, general purpose of the present invention is to assess disabilities and shortcomings inherent to known systems comprising state of the art and develop new systems incorporating all available advantages of known art and none of its disadvantages. Accordingly, the disclosures herein are directed towards a neonatal care product, being a self-warming device in either between blanket or box configurations which is enabled for autonomous controlled warming and using which a neonate can be ensconced and kept warm over an extended period of time as may be required in clinical settings or transport of neonates to / between medical facilities.

The self-warming device to allow a user to care for a neonate susceptible to hypothermia proposed herein comprises two essential components - a holder to ensconce a neonate (within which the neonate is received at a central position), and a heating element admeasuring 26 cm X 16 cm (LxB) receivable within a pocket admeasuring 30 cm X 20 cmprovided in the holder, to thereby heat the holder holding the neonate for keeping the neonate warm as required over an extended period of time.

Herein, it is contemplated that the holder (01) to be designed as a conventional wrap / swaddling blanket illustrated in the accompanying Figures 1 (A to F) or alternatively in a box type design illustrated in the accompanying Figures 2 (A to G). As commonly seen in these drawings, the selfwarming device for neonate care as per the present invention comprises a holder (01) and a heating element (02) provided as individual separate components. The heating element (02) is a consumable to be used when required by being received in a pre-activated form in a slot / pocket integral to the holder (02) and / or replaced with a new instance when its service life (heating effect) is exhausted and yet continued warming of the neonate is required. As for the box type design, two additional embodiments are intended, wherein the slot / pocket integral to the holder (02) is either designed to be under the mattress provided within the box as shown in Figures 2 (B to D) or at the rear side of the box as shown in the Figures 2 (E to G).

The blanket for the box type embodiment admeasures between14" X 7.5" X 3" to 26" X 18 " X 4", while that for the blanket type embodiment admeasures between 14" X 7.5" X 3" to 26" X 18 " X 4" (all measurements in length x width x height format). The blanket type embodiment allows the user to wrap peripheral sides of said blanket around the neonate to thereby ensconce comfortably and securely the neonate therewithin.

It shall be appreciated however that design of heating element (02) is common to either blanket-type or box-type designs of the holder (01). Among these two embodiments, the blanket type embodiment is the preferred mode of the present invention. With reference to the accompanying Figures 1 (A to F) and Figures 2 (A to G), it can be seen that the holder (01) is designed to cozily ensconce there-within a neonate, and in such position be subjected to even, autonomous, controlled warming over an extended period by means of the heating element (02).

According to a related aspect hereof explained with reference to the accompanying Figures 3 and 4, the holder (01) is made of a plurality of layers, the sequence of which intelligently retains and disperses heat in a manner to allow the heat generated by the heating element to sustain desired temperature uniformly about the neonate ensconced within the holder (01). Accordingly the composite structure comprises soft insulating fabric and contact surfaces for comfort / ease of handling of the neonate, as well as layers of functional elements such as a SMMS sterile cloth (for maintaining hygiene), a 1” foam mattress for cushioning the neonate, a7 ply corrugation board layer for rigidity, and microfiber / Cotton / Velvet clothlayers around the foam mattress and corrugated cardboard for moisture-absorption and cleanliness of the neonate held therewithin. These layers are affixed to one another via common art means.

In the construction elaborated above, it shall be noted that the composite reached is reusable, washable, sterilizable, and that the choice and order of addition and mixing the individual materials forming the fundamental chemistry of the blanket may be varied as per different degrees of softness and conformity to the heating element. These variations are intended to be covered by ambit of the present invention.

According to another related aspect hereof, the heating element (02) is a pouch containing an assortment of chemicals to be detailed in the later part of this document. Said pouch is provided in an air impermeable packaging made of multiple layered metalized film to avoid accidental / unintended activation. The pouch itself, on the other hand, is made of multilayered, laser perforated polypropylene or polyethylene. The laser perforations are of size 60 to 300 microns or less with an average density of 2 to 5 perforations per sq cm. These perforations are to allow controlled specific exposure to air when the pouch is brought out of the air impermeable packaging, to thereby initiate the exothermic reaction. It shall be understood here, that such controlled permeation of air is a critical factor to slow manifestation of the exothermic reaction and hence continued warming across extended period of time.

According to another aspect hereof, the heating element (02) is made to face away from the neonate / baby ensconced within the holder (01). Here, the heating element (02) is made to face towards the underbelly of the holder (01) or towards the surface (bed / table / lap) on which the neonate / baby is placed for being ensconced within the holder (01).

According to another related aspect of the present invention, the heating element (02) contains ingredients, which when activated, manifest an exothermic reaction involving oxidation of iron in the presence of air and water along with a heat conductor to thereby generate heat. This heat is distributed uniformly and retained within the holder (01) for as much as 10 hours due to the insulated multi-layered construction of said the holder (01) elaborated above.

Chemical ingredients in the heating element (02) are packaged at a total weight of 180 g to 220 g in each pouch, and comprise majorly the following species- a) Primary reactant - Iron in powdered form / filing / dust taken at a range between1/3 to 5/7 fraction of total weight b) Carbon source - Activated carbon (incompletely burnt wood / coal) taken at a range between 1/7 to 2/7 fraction of total weight c) Initiator (A source of H+ and OH- ions, such as water) - Water / glycol-water mixture in proportion defined by stoichiometry of the probable reactions d) Catalyst (An alkali or alkaline earth metal chloride or other compound) - Any Grp I or Grp II halide salts; KCI taken at a range between 1/20 to 1/5 fraction of the total weight e) Dielectric Material - Any mineral silicate, silica, diatomaceous earth, vermiculites taken at a range between 1/20 to 1/5 fraction of total weight f) Porous absorbent material - Silica-based absorbent materials, glues, deliquescent materials taken at 1/10 to 1/5 fraction of total weight

Chemical reactions designed to occur via ingredients within the heating element as under-

Fe _(S) + H ₂ 0 _(|) ® Fe ₂ 0 ₃ +H ₂₍₉₎ . (1)

AG° ₂₉₈ = -14.26kJ/mol, AS° ₂₉₈ = +94.16J/(Mol*K)

Fe _(S) + 2H ₂ 0 _(|) ® Fe ₂ (OH) _2(s) +H ₂₍₉₎ . (2)

AG° ₂₉₈ = -15.72kJ/mol, AS° ₂₉₈ = +51 36J/(Mol*K) 2Fe(OH) ₍ s ₎ ® Fe ₃ 0 _4(S) + 2H20 _(|) + H2 _(g) . (5)

AG°298 = -19.68kJ/mol, AS° ₂₉₈ = +152.15J/(Mol ^* K)

2Fe(011) : _(S) ® Fe ₂ 0 _3(S) + 3H ₂ 0 _(I) . (6)

AG°298 = -43.62kJ/mol, AS ⁰ ₂₉₈ = +88.05J/(Mol ^* K)

Thermodynamics of oxidation of Fe ²⁺ ions with 0 ₂ in aqueous phase:

Fe ²⁺ _(aq) + 0 _2(aq) + H+ _(aq) ® Fe ³ + _(aq) + H0 _2(aq) . (7)

AG°298 = +86.95kJ/mol

2Fe ²⁺ ₍ a _q) + 0 ₂₍ a _q) + 2H ⁺ _(aq) ® 2Fe ³⁺ _(aq) + H ₂ 0 _2(aq) . (8)

AG°298 = +12.8kJ/mol

7Fe ²⁺ ₍ a _q) + 0 ₂₍ a _q) + 4H+ _(aq) ® 4Fe ³⁺ _(aq) + 2H ₂ 0 ₍ a _q) . (9)

AG°298 = -177.40kJ/mol

Reaction of pure iron with ferric cations Fe ³⁺ in aqueous phase:

Fe _(S) + 2Fe ³⁺ _(aq) ® 3Fe ²⁺ _(aq) . (10)

AG°298 = -233.5kJ/mol, AS ⁰ ₂₉₈ = +273J/(Mol ^* K)

It shall be understood that neonates / babies are particularly sensitive to heat, and hence composition and mass of the heating element (02) is maintained so that the temperature of the heating element does not go beyond 60°C at any time. At the same time, layers of the holder (01) are designed so that the temperature experienced by the neonate / baby does not go beyond 37.5 °C. Figure 8A is a photograph comparing the thermal imagery of the heating element (02) at 15 minutes and 9 hours from activation of a heating element, which shows uniformity in elevated temperature maintained across time. And Figure 8B is a photograph comparing the thermal imagery of the self-warming device (blanket) and phantom (water bottle mimicking a neonate), both at 9 hours from activation of a heating element which are indicative of maintenance of a neonate safely at required temperature across an extended period. These analyses show perfect compliance to the objectives stated herein before.

The present invention has been reduced to practice by the inventors named herein. In independent trials, the self-warming blanket of the present invention has been observed to showcase high repeatability of precise and controlled warming function as well as enhanced results surpassing comparable devices available in the market. Observations of these trials are showcased in the accompanying Figures 5, 6 and 7 respectively, which showcase that the exhibits excellent day-wise repeatability of precise and controlled warming, which well scores over in comparison to next- comparable devices commercially available in the market.

The present invention is typified in having a very simple protocol of use. First, a user may remove the heating element (02) from its air impermeable packaging by tearing open said packaging. As the heating element (02) gets exposed to air, the ingredients inside get activated instantly, releasing heat / warmth in few seconds. The user may then place the heating element (02) in the slot provided in the holder (01). A neonate / baby may be then swaddled in the holder (01) as said holder (01) gets warned up uniformly and sufficiently (in under 20 minutes). Once activated and wrapped, the holder (01) keeps the neonate / baby warm for up to 8 hours.

After 8hours, the user is directed to remove the neonate from the holder (01), therein also removing and disposing the heating element (02) which is by then, a dry waste.

According to alternative embodiments hereof, the self-warming blanket of the present invention is intended to encompass certain add-on / optional elements. As shown in Figure 9A, the holder (01) is intended to have an in-built window (04) of transparent material such as plastic for observation of the neonate ensconced therein. Figure 9B shows yet alternative embodiment wherein said in-built window is additionally provided with a thermochromic indicator (05) chosen among state of art thermochromic materials for ascertaining / monitoring suitability of temperature for the neonate to be ensconced therein.

Experimental validation

The self-warming blanket of the present invention has been validated in independent studies undertaken by the applicant named herein for a target population comprising pre-term low birth weight neonates having hypothermia. Trials were undertaken with appropriate ethics approvals andinvolved 182 neonates within hospital settings. Accordingly, a multisite observational study was implemented by the applicant named herein in phase wise manner in various clinical trial settings in different states of India.

Aim of trials undertaken was to confirm the performance of the holder (01) and analyze results thereof to enable large scale pilot trials especially designed to account for transport of neonates.

Subjects for trials: Any newborn with gestational age between 31-38 weeks and birth weight between 1 kg to 2.5 kg having hypothermia were included in the trials conducted. Neonates having severe Hypothermia / Requiring CPAP/lncubation / Newborn with Hemodynamic instability / Newborn with congenital anomalies were excluded from the trials undertaken.

Experimental protocol: Data collection was done at the labor room and post natal wards of these clinical settings. Neonates who met the inclusion criteria were wrapped with pre-activated warm blanket of the present invention and continuous temperature monitoring was done at regular intervals with the help of Forehead thermometer till the baby reach normothermia and maintained it for 6-8 hrs. Then the heating element was removed and discarded in regular solid waste.

A first experiment was undertaken for confirming whether or not the temperature of the heating element responsible for autonomous controlled warming does not go beyond 60°C at any time. An experiment was designed for assessing the temperature profiling and temperature management of the self-warming blanket of the present invention. In this experiment, a bottle filled with water was used to mimic a baby. Accordingly, a test protocol was defined to include the following sequence of steps-

1) A data acquisition system (NiDAQ + bundled software) capable of assessing temperatures using an array of thermocouples is switched on. The reference temperature was set at 26°C, and the system was allowed to stabilize till room temperature was in the range between 25°C to 26°C.

2) The thermocouples connected to the NiDAQ data acquisition system were attached at various positions of the self-warming blanket to thereby monitor temperatures at corresponding locations as per the scheme outlined in table 1 below-

Table 1

3) The heating element (02)was accessed by tearing off its packaging via the ‘V’ cut provided and said heating element (02) was activated by gently shaking the same three to four times.

4) The activated heating element (02) was kept outside the self-warming blanket for about 10 minutes, to allow stable elevated temperature to be attained uniformly across the heating element (02);

5) The water bottle was heated in a water bath to a temperature of 36°C, and once this temperature was attained, the heating element (02) was kept inside the pocket provided within the holder (01);

6) the water bottle was wrapped in non-woven material such as polypropylene SMMS wrap (spunbond + meltblown + meltblown + spunbond) and kept in contact with the self-warming blanket with attached thermocouples;

7) Flap of the self-warming blanket is closed around the bottle, which is secured in place using the buckle adjustment(likewise, provisions for securing the self-warming device of the present invention to a bed / cradle / platform were provisioned by selecting among common art modalities of affixation including Velcro straps, buckled belts, their combinations and so on, as visible in Figure 13A, Figure 13B, Figure 13C and Figure 13D to help the neonate being comfortably and securely ensconced within the holder (01) while being on a bed, platform, in a cradle and alternatively in vehicular transit) 8) SOP of NiDAQ is followed for obtaining results of the experimental setup.

The activated heating element (02) allowed to stabilize at step 4) above was subjected to Thermal Imaging (FLIR Systems). Images shown at Figure 12 (B and B) indicate that the temperature of the heating element responsible for autonomous controlled warming, at any position on it, does not go beyond 40°C at any time.

It shall be noted that choice of water based phantom / bag is based on thermo physical properties (reference: https://pubmed.ncbi.nlm.nih.gov/10598948/). Specific heat, thermal conductivity and density are closer to some of the tissue related phantoms used in the literature for neonate related thermal measurements. Figures 5 and 6are graphs of day-wise repeatability of precise and controlled warming function exhibited while using the self-warming blanket of the present invention which was proven to to be significantly better than that possible using next-comparable devices commercially available in the market as shown in the Figure 7.

Furthermore, an experimental trail design was employed to test the self-warming blanket with neonate subjects. Figure 12 (A to F) showcases an exemplary step-wise protocol of implementing the selfwarming device of the present invention which is in conformity with the protocol stated hereinabove. The test populations and observations are summarized in the tables below.

Table 2

Table 3

Table 4

Table 5

Table 6

Table 7

Table 8

Table 9

The studies elaborated above have shown statistically significant results in clinical trials at various trial facilities that the warm blanket subject hereof is performing well, similar to the standard of care provided by radiant warmers or incubators in preventing hypothermia.

The impact of warm blanket at various clinical settings was varied as it was dependent on multiple factors such as birth temperature of the baby, geographical area the hospital is located, climatic variations in different clinical settings and seasonal variations. Number of babies successfully supported at various clinical settings are enlisted in Table 10 below.

Table 10

Month wise distribution of number of neonates supported is provided in Figure 14A. Gender wise distribution of neonates supported is provided in Figure 14B.

Observations of each of the trial settings is enlisted in the tables 11 to 14 below.

Table 11 - Trial setting 1 ()

Mean temp before IN = 35.965°C Mean temp after OUT = 37.557°C

Average residency of neonate in the warmer subject hereof = 303.125 minutes

Table 12 - Trial setting 2

Mean temp before IN = 36.131°C Mean temp after OUT = 37.669°C

Average residency of neonate in the warmer subject hereof = 292.796 minutes

Table 13 - Trial setting 3

Mean temp before IN = 36.786°C Mean temp after OUT = 37.057°C

Average residency of neonate in the warmer subject hereof = 393.571 minutes

Table 14 - Trial setting 4

Mean temp before IN = 37°C Mean temp after OUT = 37.433°C

Average residency of neonate in the warmer subject hereof = 540 minutes In above experimental studies, it was concluded that- a) body temperature of 154 neonates was successfully regulated during the studyacross all ages (in months), taking into account the month wise distribution of number of neonates reflected in the accompanying Figure 10A. b) implementation of the warmer product subject hereof is gender insensitive as both the genders are supported for hypothermia in trial settings, taking into account the gender wise distribution of subject neonates reflected in the accompanying Figure 10B and the sample temperature profiles for male and female subjects reflected in the accompanying Figures 11 A and 11 B respectively c) the average duration the neonates were supported in all clinical settings where the clinical trials were conducted was 6.4 hours d) neonates can be supported with warm blanket continuously for up to 8 h (at least till the time tested) while maintaining normothermia during the time of support e) use of the self-warming device proposed herein has a typical temperature profile of infants under treatment in incubators (doi: 10.1371/journal. pone.0164817. g002), thus in a comparable, but although in a significantly improved implementation, ease, costs as compared thereto.

It shall be noted for the test data above, that neonate placement may be or may not be strictly continuous in the self-warming device, for the period of 8 hours or more, as the neonates may be removed intermittently for feeding, bathing, medical intervention etc. Yet, through the results of clinical trials, it is confirmed that the self-warming blanket proposed herein is effective in preventing hypothermia in neonates with gestational age between 31-37 & birth weight between 1- 2.5 kg having hypothermia.

The self-warming blanket proposed hereinwas proven effective in preventing hypothermia among low birth weight neonates by increasing the temperature of the neonate and maintained it for up to 8 hours. Based on the necessity, the duration of warmth can be increased by simply replacing the heating element in the blanket. Furthermore, due to the aforesaid selection and use of materials said self-warming blanket costs 1/5 ^th the cost of lowest product available in the market. From the aforesaid experimental data, it is evident that the self-warming blanket proposed herein effectively achieves the intended objectives, and hence an able technology for introducing and maintaining necessary warmth for neonates / babies is thus provided in form of a self-warming device which essentially scores over prior art which is furthermore identified in having the following salient features-

1) Small and light design which is comfortable for infants / babies

2) Comfortable to both baby and the person carrying the baby + blanket

3) Easy and inexpensive to manufacture, to use, to store

4) Has safely regulated warmth with real-time temperature indicator as optional feature, which makes it safe for neonates / babies and intuitive to use, without needing any special skills

5) Has no moving parts, and is operable without electricity, battery or other fuels

6) Has reusable, durable construction, no moving parts and extremely portable

7) Plug-and-play utility in clinical settings and transporting neonates / babies

8) Zero possibility of neonate hypothermia, infection, or risk of suffocation or strangulation for neonates / babies.

9) Long-lasting thermal management up to 8 hours of use

10) Environment friendly to dispose off

11) Allows easy access to neonate for monitoring / diaper change etc while keeping moisture at bay.

As will be realized further, the present invention is capable of various other embodiments and that its several components and related details are capable of various alterations, all without departing from the basic concept of the present invention. Accordingly, the foregoing description will be regarded as illustrative in nature and not as restrictive in any form whatsoever. Modifications and variations of the system and apparatus described herein will be obvious to those skilled in the art. Such modifications and variations are intended to come within ambit of the present invention, which is limited only by the appended claims.