Thermal suit for a premature baby

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators

Reexamination Certificate

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C607S104000, C002S069000

Reexamination Certificate

active

06228106

ABSTRACT:

BACKGROUND OF THE INVENTION
This invention relates to a suit for an infant, in particular, a newborn infant.
In particular with premature infants it is often necessary to protect them from the free atmosphere with regard to temperature, humidity and oxygen content and to provide an artificial atmosphere which makes the survival of the infant easier and aids the maturing process. Such an atmosphere is nowadays attempted to be produced in incubators. Such incubators are generally manufactured of transparent material. With regard to size they are dimensioned such that they may not only accommodate the infant as such, but the infant may also be handled within the case, and for this appropriate handling openings are provided. In order to keep the atmosphere within this formation within predetermined limits with regard to temperature, humidity and oxygen content, these being particularly required for the development of the infant, appropriate supply units with controls and likewise are provided. Such systems are known in numerous embodiments and are for example described in DE 36 16 359 A1.
A disadvantage with these comparatively large spacial formations is that an exact heat balancing is not possible. It is, however, desirable since the premature infant may only direct all energy into its growth in a thermoneutral maintaining environment. Furthermore, it is seen as disadvantageous that a rapid temperature control, as is desirable from a therapeutic point of view be it for reducing or increasing the body temperature, is hardly possible due to the large masses of air.
Even more difficult is the balancing of fluid economy which with incubators at present is not possible at all. It is however important to know how much water the infant needs in order to replace as completely as possible the loss of fluid via the skin, the excretions and in the breath. Since the balancing of the fluid economy of the infant in the incubator is at present not possible, one has already gone over to increasing the air dampness in the incubator up to the saturation limit in order to minimize fluid loss via the skin and breath. This however brings with it considerable disadvantages, with regard to the water supply as well as removal. The water vapor condenses on the walls of the incubator, which on the one hand leads to the view into the incubator no longer being possible or at least being much hindered, and on the other hand leads to there forming locations at which water collects, this not able to be removed or only with difficulty. Since the dampness in combination with the heat produces good conditions for the formation of germs, exacting in this region with high air humidity, there arises problems during operation as well as cleaning.
Although in the meantime there are transportable incubators on the market, the infant however for the purpose of transport must always be transferred to another incubator, which brings with it irritations. Moreover the transportable incubators too are very bulky, such that the infant also therein can only be transported in a limited manner.
Also small heating beds are also know, these being provided with mattress heating and/or with a heat irradiator from above. As a complementary measure, a sheet cover is known from U.S. Pat. No. 4,712,263.
One conventional approach to controlling the infant's body temperature is the use of the incubator. Some of the downfalls of incubators are that opening the incubator causes the temperature and water vapor to fall for a certain period of time. An increase of humidity to above 80% sometimes results in condensation and invisibility of the infant. Although incubators are mobile to some extent, infants have to be taken out for a ride in a transport incubator, for radial logic investigations, like magnetic resonance imaging (MRI).
Another problem with incubators is that neither radiologic nor surgical interventions are possible under a constant, homogeneous, humid environment. The incubator with its large gas capacity in the matters with its large heat sink prevent rapid and proportional regulation of environment. Also, incubators offer no means to assess water loss to guide fluid intake and replacement.
There is scientific evidence that has proven that mild brain hyperthermia, for example, 2°-3° higher than normal, aggravates morbidity and neuronal damage. In contrast, mild hypothermia, lowering the temperature for example 2-3° C. below normal, has been shown to protect against neuronal damage in case of ischemic-hypoxic insults to the brain. It has been found that lowering of brain temperature of levels which are protective for neuronal damage facilitates improving the neurological and thus psycho-motor developmental outcome. Thus, it has been suggested that a thermal environment which fosters not only healthy growth, but also protects against squele of brain injury is desired.
Moreover, incubators provide the same environment for the head and its brain as well as for the rest of the body. Since the brain temperature provides a decisive roll for neural damages after hypoxic insults, differentiated regulation of head temperatures and protective hypothermia is a protective, therapeutic goal which cannot be achieved by the incubator as such. High temperature in incubators and, in particular, heated mattresses might even be dangerous to a hypoxic brain.
In the past, plastic foils or polyurethane patches, covering the infant, have been employed to minimize the water loss. Heated mattresses have been provided, but they provide heat homogeneously. Unfortunately, none of the aforementioned devices have offered a satisfying solution to selectively and independently controlling an infant's head temperature versus body temperature so that, for example, the head temperature can be lowered while the body temperature is kept at a normal temperature.
There is, therefore, a need to provide a system and method for independently and selectively controlling an infant's head temperature and body temperature.
SUMMARY OF THE INVENTION
Against this state of the art, is the object of the present invention to remedy the disadvantages outlined above or at least to reduce them, and this being with technically simple means.
According to the invention, for this a suit for an infant, in particular a newborn infant is put forward, which comprises the features specified in claim
1
. Advantageous further formations are indicated in the dependent claims as well as in the following description.
The invention envisages a suit which at least encloses the body rump of the infant and on the inner side consists of non-irritant material. The suit is impermeable to water vapor at least from the inside to the outside, in order to reduce fluid loss via the skin to a large extent. Furthermore the suit is designed to be thermally regulated, and where a body location or body part remains free and the suit would comprise an opening to the atmosphere, is sealed with respect to the body by way of a sealing connection in order to reliably separate the inner and outer atmosphere of the suit.
The suit according to the invention is applied in conventional incubators, but may also be applied outside of the incubator, for example for the purpose of transport but also for the purpose of examination. Thus a multitude of radiological examinations, such as for example nuclear spintomography, but also other diagnostic methods may be applied, without having to remove the infant from the suit. The infant thus always remains in its protective atmosphere which is ensured by the suit.
Preferably the suit is designed such that it leaves free the face of the infant and only this region, so that he mouth and nose remain accessible for the purpose of breathing and intake of food, and so that the condition of the infant may be ascertained at all times by way of observing the face. Where appropriate for this facial region there may be provided a protective shield which additionally also protects the face from heat loss and in particular may serve to prepare an increased oxygen concentration of

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