Maintaining the body temperature of patients at a suitable level to prevent hypothermia and other conditions is important in a many areas of medical care, and is particularly in pediatric care. Infants and young children have diminished ability to conserve body heat as a result of a number of anatomic and physiologic factors including thin dermis, a paucity of subcutaneous fat, diminished body fat stores, immaturity of hypothalamic function and hormonal secretion, and a disproportionately large head to body surface area. Hypothermia may be associated with profound adverse pathophysiologic effects including coagulopathy, impaired enzymatic function, changes in cerebral blood flow, increased oxygen consumption and decreased oxygen transport to vital organs as well as patient discomfort.
There are numerous methods for maintaining normal core body temperature (normothermia) in pediatric patients in the controlled environment of an intensive care unit or operating room. Radiant heaters, thermostatically controlled patient rooms, warmed intravenous fluids, forced-air warmers, heated blankets, isolettes (neonates only) and a variety of other devices are in common use. However, pediatric and other patients are susceptible to hypothermia when transported from a temperature-controlled environment to other areas of a hospital such as imaging suites and operating rooms, or when transported from one medical facility to another by ground or air. During these periods in uncontrolled environments, there are limited means currently available for maintaining patients in a normothermic state.
Complicating the need to maintain body temperature during transport, patients are often connected to devices for infusion of medications and intravenous fluids, or have tubes inserted into the trachea, stomach, bladder and other body cavities. In addition, leads are routinely attached to the skin for monitoring of body temperature, heart rate and rhythm, respirations, oxygen saturation and blood pressure. Should any of these numerous connections become dislodged, the results could be catastrophic. Therefore, direct visualization of the patient's chest, abdomen and extremities is critical not only to ensure intact connections, but also to observe chest excursion, skin perfusion, and other aspects that ensure patient safety.
The present disclosure addresses a need for a portable warming device to prevent hypothermia through radiant and convective heat loss, and a need for a portable blanket that permits continuous observation of the thorax and extremities during transport, both for patient observation and to assure that tubes and monitoring leads do not become dislodged during transport.
In one aspect of the invention, a transparent warming blanket is provided which includes at least one flexible transparent layer, a plurality of resistive wires integrated with the transparent layer, and a battery electrically connected to the resistive wires so as to provide sufficient power to induce heat from the resistive wires, wherein heat produced from the wires is sufficient to achieve and maintain a steady state temperature of about 40 degrees Celsius beneath a substantial portion of the blanket.
In another aspect of the invention, the warming blanket is configured to provide a steady state temperature of about 40 degrees within an environment having an ambient temperature of about 23 degrees Celsius or less. In one embodiment, the steady state temperature can be achieved, for example, within a time period of about 14 minutes. In another embodiment, the steady state temperature can be achieved within a time period of about 2 minutes.
In an embodiment, the plurality of resistive wires comprises nichrome. The at least one flexible transparent layer can comprises a polyvinyl chloride (PVC). In another embodiment, the at least one flexible transparent layer can comprise two transparent layers. The resistive wires can be disposed between the layers.
The warming device can include a digital controller to regulate the power output of the resistive wires. In an embodiment, the blanket further includes a multichannel MOSFET electrically connected to the resistive wires and the controller, the controller and MOSFET configured to produce a duty cycle limiting the maximum power output to limit a surface temperature output to directly adjacent skin of about 37 degrees Celsius or less.
In one embodiment of the invention, the battery provides a power output of about 12 Volts. In another embodiment, the battery can provide a power output of about 24 Volts.
In an embodiment, the blanket is fully portable, such as for use in transporting a patient under the blanket to or within a medical facility while being warmed. The battery can, for example, weigh about 1.5 Kg or less.
In an embodiment, the at least one transparent layer is sufficiently sized to cover at least an infant. In another embodiment, the at least one transparent layer is sufficiently sized to cover at least an adult. To accommodate the size of the blanket, the battery may be appropriately powered and scaled to in order to warm it according to embodiments herein.
In an embodiment, the warming blanket can alternatively be powered from an indefinitely dedicated power source. For example, the blanket could be plugged into and powered from a traditional wall socket in order to initially or indefinitely warm the blanket, then unplugged and switched to battery power while the blanket and person thereunder is transported or moved.
These and other features and advantages of the present invention will become apparent upon reading the following detailed description when taken in conjunction with the drawings.
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The linear approximation for radiation can be used and the equivalent radiative heat transfer coefficient (hr) assuming large enclosure can be expressed as
hr=4σTm3
in which σ is the Stefan-Boltzmann constant, and Tm is the average temperature of the two surfaces. This approximation introduces an error below 0.1% in this case and allows modeling the system as a thermal resistance network and solving for temperatures and heat fluxes. Natural convection coefficient for the head (hnh) is estimated with the correlation for the Nusselt number of a sphere
in which Dh is the diameter of the head, ka is the thermal conductivity of air, Pr is the Prandtl number of air, and RaD is the Rayleigh number based on the head diameter. The natural convection coefficient for the outer surface of the blanket 18 is estimated with the correlation for a flat plate with heated surface facing up
in which W is the width of the heating region, and Raw is the Rayleigh number based on this width. Conduction resistances are defined in
The temperature of the middle plane of the blanket 40 (Trh) as a function of the known heat transferred to the body 44 (Qb) needed to keep the head warm is defined as:
From the middle plane temperature, the heat transfer to the environment (Qenv) can be calculated by
Finally the power requirement to obtain the desired temperature is calculated as the sum of the heat fluxes to the environment and to the body. A correction is added for about 5 L/min hot air leaving the region under the blanket. Power requirement results for a particular embodiment constructed to maintain a temperature of about thirty-seven degrees C. for pediatric patients are discussed below, with reference to table 1.
The minimum time required to reach the desired temperature can be estimated by the time it takes to heat the blanket 18, assuming only one side is exposed to the environment and the other is perfectly insulated. Assuming a lumped capacitance for the blanket, an energy balance per unit area yields
in which ρi and ci are the density and heat capacity of the insulator, and Li is the total thickness of the blanket (Loi+Lii). Assuming the blanket to be initially at environment temperature, this equation can be solved to get the minimum time it takes to reach the desired temperature (Td):
As described above, the temperature distribution can be evaluated to assure safe temperatures, particularly adjacent the heating wires 16. To calculate the temperature distribution across the blanket 18, the blanket 18 can be approximated as a fin, except in the region near the wire 16. Heat generation of the wire 16 is replaced by a uniform volumetric heating that has the same width as the thickness of the blanket 18, since isotherms in the wire region are approximately circular. Referring now to
in which x1 is the distance from the center to the edge of the first section that includes heating, and T1 is the temperature of the blanket 18 as a function of x1. This equation can be rewritten using an effective convection coefficient (heff), and an effective environment temperature (T∞):
Introducing the fin parameter (m2=2heff/kiLi), the equations for the two sections can be written with their boundary conditions, considering that heff and T∞ are the same for the second section but there is no heat generation:
The first two boundary conditions result from the symmetry conditions and the two others from the continuity of temperature and heat flux at the junction between the two sections. This set of equations is solved to get the temperature distribution. The complete equation is omitted here, but the results were compared to a finite element analysis simulation and showed close correlation. The simulation results show that the approximation of the circular temperature distribution around the wire is adequate and the choice of area for volumetric heat generation is correct.
The maximum increase of temperature due to the wire 16 compared to the average temperature found in the steady state model can be determined from this calculation. With this information it is possible to assure that when the average temperature is at the required level to maintain the selected body temperature, and that the regions directly over wires are not too hot. The maximum temperature difference (ΔTm) from the average temperature is given by
The relation between the maximum increase in temperature compared to average temperature due to the spacing is shown in
As discussed above, the 1D model can be used to assure maximum temperature is sufficiently low to prevent burning of the skin after prolonged exposure. Here, the inner surface is assumed to be in contact with the skin or, at least, near the skin. For some parts of the blanket 18 that are far from the patient 32, the temperature nay exceed this maximum temperature, because the air is insulating the inner surface. The limiting criterion for those areas is that the temperature should decrease to an acceptable level upon contact with the skin. The instantaneous surface temperature (Tc) for two solids brought into contact, in this case the flexible material comprising the blanket and skin at temperatures before contact Tpvc and Tskin, is given by
in which the product (kpc)skin is a measured value for skin, and the product (kpc)pvc is a measured value for the blanket material. A specific example is discussed below.
Using the equations set forth above, warming devices can be constructed for different selected temperatures, designed specifically for infant, child, adult, or other categories of patients or patient needs. In one embodiment, for example, a warming device 10 was advantageously constructed for use to maintain the body of an infant between three and twelve months of age at a temperature of about thirty-seven degrees C., for a duration of about forty-five minutes. Here, to prevent overheating or burning, the blanket 18 is preferably maintained at a temperature below forty-three degrees C. To assure portability, the warming device 10 is designed to be lightweight and transparent, and therefore to enable a medical practitioner to view both the patient 32 and any connections made between the patient and monitoring or other equipment, particularly during transport. Here, the warming device 10 was designed to weigh 4.5 kg or less.
To meet these objectives, the warming device 10 was constructed as a flexible transparent blanket 18 comprising a thermoplastic material, such as polyvinylchloride (PVC). As described above with reference to
As described above, the heating element 12 can comprise wires 16 extending between corresponding bus bars 14. Here, the wires 16 were selected to be constructed from nichrome, which is well suited for use in a portable, transparent device. Conductive wires 16 constructed of nichrome are small, lightweight, and provide a high degree of accuracy for resistive heating. The wires 16 are thin, here 0.08 mm, with a resistance rating of 2.5 Ω/cm. The wires 16 are 600 mm in length, providing a series resistance of about 150Ω.
Referring again to
To generate an effective resistance of 3Ω such resistances were added in parallel with 6.35 mm spacing. The bus bars 14 are constructed of copper, and 6.35 mm in width. The 1D model, described above, shows that the spacing should not exceed the current 6.35 mm for the thickness of 1.5 mm, to assure the maximum temperature of the inner surface of the blanket in contact with the skin remains within a safe limit of 43° C.
The nichrome wires 16 can be easily bonded to the thermoplastic layers 36 and 38 through melting. PVC, for example, experiences decomposition at 140 degrees C., and begins to melt at around 160 degrees C. By applying the correct amount of power through the wires 16, a localized melting radius develops and provides welding of the wire 16 to the PVC layers 36 and 38. Experimental results indicated that this result could be achieved by applying a power per unit length of 0.44 W/cm for 20 seconds.
The controller 19 was designed to include low voltage battery 20, such as a 12 V DC supply, which can be pulse width modulated to provide power to the heating element 12, as described above. To meet the requirement of portability, the controller 19 was designed to have a battery capacity sufficient for two full 45 min cycles at full power. The controller was also designed to be lightweight (1.4 kg) and to be small enough to fit on the patient's bed (15 cm×10 cm×9 cm). The digital controller 24 can be programmed to provide a timer, which can be set to a pre-determined time frame, such as 45 minutes, or which can be selectively established by the user accessing the controller 24 through, for example, the display 26. Other user input devices such as keyboards and touch pads can also be provided. The heating is preferably limited to 45 minutes, and the capacity of battery 20 can be limited to below 90 minutes.
The digital controller 24 can also be programmed to address electrical risks and risk of hyperthermia. To ensure electrical safety, the resistance of the blanket 18 is verified on startup. A significant change in the resistance of the blanket 18 can indicate broken wires 16. For example, the controller 24 may be programmed to take corrective action when the resistance increased by 50% or more. The digital controller 24 can also be programmed to address the risk of hyperthermia, which can arise if the power controller 19 is disconnected from the heating element 12 of the blanket 18, or if the voltage of battery 20 drops. The controller 24 can either issue an alert to the user, turn off the power to the heating element 12 of the blanket 18, or both if the resistance of the blanket increases substantially
Power requirements for this embodiment, as determined using the equations described above are shown in table 1 below, where the thermal conductivity of the insulator for the selected material is 0.16 W/m2K. Assuming an ambient temperature of about twenty two degrees C., the power controller 19 needs to deliver about 50 W of power.
Referring now to
When a warming device 10 as described above was operated in steady state tests at different power levels including 12 V, 16 V, 24 V, and 31 V, the time to reach a temperature of 40° C. took respectively 14 min, 5 min, 2.5 min and 2 min. Indeed it was found during the steady state testing that the device should operate close to 12 V to deliver the required power which would mean a pre-heating time of 14 min. A heating cycle of 2.5 min at 200 W (24 V) will reach the desired steady-state temperature more quickly.
The warming device described above can be easily constructed using the following steps: (1) cut two layers 36 and 38 of PVC to the selected size, (2) place the first layer 36 on a tooling board providing appropriate spacing for the bus bars and wires, (3) position copper bus bars 14 on the layer 36, (4) wrap nichrome wires 16 to create the resistive heating element 12, (5) position the second layer 38 of PVC to form the blanket 18, (6) connect the power controller 19 to the heating element 12, and (6) apply adhesive to the outer edges. In one specific embodiment, tooling can be fabricated using CNC, and ¼″ spring pins can be applied to a plywood board to align the nichrome wires 16.
The disclosure therefore describes a transparent portable warmer device, which can be advantageously applied to insure patient normothermia during medical transport, which can be advantageously applied to infants and other pediatric applications. The device can be constructed as a blanket 18 made from two thin layers 36, 38 of flexible transparent PVC bonded together by heating nichrome wires 16 placed between the layer. A power controller 19 can be applied to keep the patient warm, and can include batteries 20 capable of providing the desired power during a 90 min period.
A minimum heating power of 50 W was determined by heat transfer analysis to provide steady state operation to maintain a target temperature of thirty seven degrees C. A 1D model for the blanket 18 was used to determine that the spacing between the wires should be about 6.35 mm for a selected thickness of 1.5 mm, and that this selected thickness and spacing would establish a maximum temperature at the inner surface of the blanket 18 in contact with the skin to be about 43° C.
For this embodiment, the instantaneous surface temperature Tc can be calculated using the equation above, where (kpc)skin is measured to be 1.3×106 J/m4sK and (kpc)pvc is 2.8×105 J/m4sK. Far from the skin, assuming the inner surface to be perfectly insulated, the maximum temperature of the blanket can reach 47° C., for the heat flux needed in steady state. Assuming the infant skin temperature to be 37° C., the instantaneous contact temperature is 40° C., which is safe for an infant.
Experiments show the great transparency of the device and the adequate flexibility, and confirm the heat transfer analysis results. Steady state power, tested with an aluminum U-shape extrusion, is in good agreement with the model. Time to heat the blanket exceeds the predicted one, but shows the same trend. Temperature distribution measured with a thermal camera showed a difference below 0.5° C. from the 1D model. Preliminary testing shows that the temperature of the blanket drops to an acceptable level when brought in contact with the skin, even if the temperature before contact exceed 43° C. The system was operated experimentally during 70 min period using a 1.5 kg battery, satisfying the portability requirement.
While present inventive concepts have been described with reference to particular embodiments, those of ordinary skill in the art will appreciate that various substitutions and/or other alterations may be made to the embodiments without departing from the spirit of present inventive concepts. For example, although a PVC material is described, silicone rubber, vinyl, and PET (Polyethylene Terephtalate) flexible materials can also be used. Further, although nichrome wires are described above, various types of metal and other resistive current-carrying materials can be applied as part of the heating element. Accordingly, the description herein is meant to be exemplary, and does not limit the scope of present inventive concepts. A number of examples have been described herein. Nevertheless, it should be understood that various modifications may be made. For example, suitable results may be achieved if the described techniques are performed in a different order and/or if components in a described system, architecture, device, or circuit are combined in a different manner and/or replaced or supplemented by other components or their equivalents. Accordingly, other implementations are within the scope of the present inventive concepts.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/774,181 filed on Mar. 7, 2013, which is incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2014/021739 | 3/7/2014 | WO | 00 |
Number | Date | Country | |
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61774181 | Mar 2013 | US |