The present invention relates to the field of equipment, means and arrangements employed for newborns, preferably for premature infants, and more particularly it refers to an arrangement for neuropostural and sensory suspension, hanging, pendant, of the premature newborn which, unlike conventional incubators, allows the newborn to be in a position similar to that in which it was inside the mother's uterus in order to promote the harmonious intrauterine development that newborns should receive prematurely.
In order to better understand the object and scope of the present invention, it is convenient to describe the current state of the art in reference to premature newborns and disadvantages that arise during the preventive care thereof.
Pathological newborns need a series of special care from birth and during their stay in the monitoring unit or neonatal intensive care unit. This is because they are very likely to present sequelae which are difficult to treat, such as blindness, deafness, cerebral palsy, which in many cases are prevented with adequate follow-up. To this end, parameters such as heart and respiratory rate, temperature, pulse oximetry, blood glucose or serum calcium levels, among other important parameters, should be controlled in the Monitoring Unit. However, despite the increasing internal efficiency of hospitals in their neonatal intensive care units, there a lack of external efficiency due to the lack of follow-up networks that may evolve all levels of health care, either from primary care in the first level to centers of high complexity to solve the most serious problems. This situation is responsible for the death of many children at risk.
Currently, one of the devices used for the treatment of pathological newborns is the incubator. This incubator works as an artificial uterus that recreates an optimal environment for the newborn, being a closed space well insulated thanks to the air filters that are in the ducts to the outside. These filters are able to retain dust and allergens which are in the environment, but also prevent outside bacteria or germs from coming into contact with the newborn. On the other hand, in order to control hydration, not only the temperature of the environment is important, but so is the degree of humidity, since a very dry environment favors dehydration even at low temperatures. The incubator has sensors that when they detect a sensible decrease of the relative humidity they cause the humidifiers of the environment to be activated. In addition, the incubator can include an electronic scale that keeps a continuous record of the weight of the newborn. Thanks to the provision of the scale, it is possible to keep a record of the evolution of the newborn without having to transfer it to other sectors for its respective analysis.
On the other hand, the newborn has on its body surface several electrodes capable of recording basic vital functions. These sensors include an electrocardiogram that records heart rate, an electroencephalogram that records brain activity, and respiratory rate sensors. All of them are adapted to both premature newborns and those who are not. Although the use of the incubator has helped to keep newborns under stable environmental conditions, there are still a number of drawbacks with regard to their posture within incubators.
Premature newborns often lack adequate muscle tone and are at risk of developing abnormal patterns of movement as well as skeletal deformities. Some of the difficulties are related to postural problems and incorrect body mechanics rather than neurological impairments. Hypotonic or decreased muscle tone has been observed in children born with between 28 and 30 weeks of gestation. Correct posture of premature newborns can promote normal motor development and minimize the development of abnormal movement patterns. The position of premature newborns is part of the basic neonatal nursing care and includes supine position, prone position, lateral decubitus position and inclined posture with raised head.
Prone posture has been shown to have many advantages for premature newborns. However, premature newborn is at risk of suffering from postural abnormalities and there is a strong association between prone position during sleeping and Sudden Infant Death Syndrome, with premature newborns representing between 10% and 20% of cases of Sudden Infant Death Syndrome and there is an increasing pressure to avoid this sleeping position in all newborns.
Given the current state-of-the-art available for premature newborns, it would be highly desirable to have a new arrangement that is constituted and built to address the aforementioned drawbacks and, in addition, to allow better conditions for newborns within incubators in order to promote a better development of their neuro-sensory functions.
It is therefore an object of the present invention to provide a novel arrangement for the neuropostural and sensory suspension of the newborn which provides better conditions within the incubator so that newborns can properly and appropriately develop in harmonic intrauterine form.
It is yet another object of the present invention to provide an arrangement which avoids the aforementioned drawbacks with respect to the prone and supine decubitus positions.
It is yet another object of the present invention to provide a supporting means which surround the newborn so that it may be in a position similar to that in the mother's uterus.
It is a further object of the present invention to provide actuating means which manage to keep the newborn suspended, surrounded and protected by the supporting means.
It is yet another object of the present invention to provide actuating means which may be robotic, electronic or manual to partially or completely change the position of the newborn.
It is another object of the present invention to provide a supporting means capable of maintaining the temperature of the newborn as well as improving the neurosensorial aspects thereof.
It is yet another object of the present invention to provide an arrangement for the neuropostural and sensory suspension of the premature newborn, which enhances proprioceptive, tactile, vestibular and auditive stimuli, among many others.
It is yet another object of the present invention to provide an arrangement for the neuropostural and sensory suspension of the premature newborn in incubators, wherein the incubators externally comprise a dome or cupola, doors, windows or access portholes, while inwardly comprise a horizontal partition which defines an upper part where the newborn rests and a lower part provided with measuring elements and thermoregulator means, wherein the arrangement comprising at least one supporting means provided at the upper part of the incubator and receiving the newborn, a plurality of tensioners passing through a pair of guide holes provided in the dome of the incubator, and actuating means arranged outside and above the dome or dome of the incubator, said supporting means being connected to the actuating means through the tensioners and suspended in the top of the incubator defining an intrauterine position in the newborn.
It is another object of the present invention to provide an arrangement for the neuropostural and sensory suspension of the premature newborn in incubators, the arrangement comprises at least one supporting means, inside the incubator, for receiving the newborn and keeping the newborn in an intrauterine position, a plurality of tensioners connected to the supporting means, and actuating means for actuating over the plurality of tensioners, said supporting means being suspended from said tensioners and the actuating means are capable of being actuated to move the tensioners and the suspended supporting means for emulating, when desired, any natural intrauterine movement.
For the sake of clarity and understanding of the object of the present invention, it has been illustrated in several figures, in which the invention has been represented in one of the preferred embodiments, all by way of example, in which:
Referring now to the figures, it is seen that the invention consists of a new arrangement for the neuropostural and sensorial suspension of the premature newborn in incubators, which allows improving its motor development in a correct and harmonic intrauterine manner. However, first and for exemplary purposes, a brief reference will be made to conventional incubators according to
On the other hand, said lower part 5 of the compartment 2 may be opaque or blind and houses respective measuring elements to carry out a control of parameters of the newborn and thermoregulator means which maintains the environment of compartment 2 in suitable climatic conditions. Generally, such measuring and thermoregulator elements may comprise elements such as scales, sensors, thermostat sensors, bacterial filters, fans or forcing elements, heaters, oxygen gauges, peltier plates, etc., which are well known in the field of art, furthermore not being part of the inventive object of the present invention, and therefore, we will not go into descriptive details about them. Referring again to the horizontal partition it provided with windows or end communication holes 10 which communicate with each other to the upper part 4 and the lower part 5. Said partition 3 is provided with a mattress 11 where the newborn rests in a prone position or supine position.
However, although previous art incubators have proved to be practical, according to studies of Latin American Network of Pediatrics and Neonatology, the following are physiological effects of the different postures (prone or supine position) that the newborn takes in the same.
In relation to heart rate, the prone position is associated with a reduced heart rate, except during sleep, when higher and less variable heart rates are observed in the prone position versus the supine position. No differences were observed in the incidence or duration of mild or clinically significant episodes of bradycardia or cardiac rhythm during the panning between the two positions.
As for oxygen saturation, three studies observed a significant difference in oxygen saturation between the prone and supine positions, whereas two studies found lower oxygen saturation in newborns in the supine position, although this is not reflected is the incidence of clinically significant desaturation. During apnea, a small decrease in mean oxygen saturation was observed both in the prone position and in the supine position.
Regarding lung function, there was no evidence that may suggest significant differences in lung function between the prone or supine positions, except for oxygen-dependent newborns, for whom minute volume and functional residual capacity were higher in the prone position. Respiratory muscle strength was higher in the supine position (with or without head tilt at 45°) than in the prone position.
Regarding pain, no significant differences were observed between groups of prone and supine position for pain response during the invasive procedure of the heel puncture for blood sampling. Newborns placed in the lateral decubitus position and with blanket wrapped by way of contention showed a statistically significant lower mean in pain scores than premature newborns not placed in that position.
On the other hand, cerebral hemodynamics, oxygenation of hemoglobin and cerebral blood volume increased significantly in newborns placed in the supine position compared to those placed is the prone position. After stabilization, prolonged placement in a posture with the head raised 30° to the body did not result in more significant changes in brain hemoglobin content.
Consequently, psychomotor and neurological exams showed a delay in the acquisition of muscular development in premature newborns placed in prone position, compared to newborns placed in supine or lateral position. Electrocortical activity was lower during sleep in newborns placed in prone position compared to those placed in the supine position. It was also observed that premature newborns in prone position lifted their heads much less frequently during sleep than term newborns, posing a risk of suffocation.
By virtue of the foregoing, the inventor of the present invention has developed a novel arrangement, whose neuromuscular result shows that the supine position has a significantly higher score of neuromuscular maturity than the prone position and a more relaxed state, expressed in a significantly lower heart and respiratory rate. In addition, the invention proposes to provide within the incubator sensory stimuli similar to those that the newborn would receive within the uterus of its mother, being this a very significant advantage compared to the conventional one developed so far.
Thus, according to
Likewise, said supporting means 12 may also comprise a double thermostated pouch 16 having at least three connecting points or ends 17 provided with respective holes or eyelets 18 connected to actuating means which will be described below. In addition, said double thermostated pouch 16 has at least one fluid trap 19 through which fluid flows between a fluid inlet port 20 and a fluid outlet port 21. Wherein said fluid is a liquid selected from group consisting of aqueous liquids, oily liquids or a combination thereof.
In this way, the double thermostated pouch 16 adopts and transfers the temperature of the recirculating medium by the action of a recirculated thermostated bath for aqueous or oily liquids as required. Preferably, but not limiting to the invention, the choice of oily liquids, i.e. with a viscosity greater than pure water, will be considered to decrease the effects of turbulence on the flow and evaporation into the environment.
On the other hand, and as mentioned above, the supporting means 12 is connected to actuating means 22 through tensioners 26, the actuating means 22 being outside and above the dome 6 and which can be electric, robotic, manual actuators or a combination thereof. In the case of the invention, but not limited thereto, electrical actuating means have been chosen, each comprising a motor connected to a reduction gear free from friction and pulses 24 which in turn is connected to another gear 41 which drives an auger 25 which operates or actuates a die 27 with pulley 29 which is threadedly displaced through the auger 25. A second guide pulley 30 is also provided through which a portion of the tensioner 26 slidably passes, with a connector 28 being also provided, such as an arm or bolt 28, to which one end of tensioner 26 is attached.
It pointed out that said motor 23 is in connection with said gear 24 by means of a shaft 43 and has a timer or “timing” which alternately activates anteroposterior, lateral and pendulum linear movements, the same being programmed according to the requirements of each patient. That is, the motors 23 may operate together or independently of one another to regulate the different heights of each connection point or end of the supporting means. This allows generating different positions in the newborn so that it can be in conditions similar to those under which it was in the uterus. In turn, the arrangement of the pulley 29 enables to reduce the load to lift the newborn as well as, it enables by means of its displacement, the shortening or stretching of the length of the tensioner in order to allow the raising or lowering of the respective end.
It should be noted that control of motors 23 is carried out by means of some known programmable arrangement, such as a CPU, a microcontroller, or a hybrid arrangement, in order to allow the coordination of each of the motors in synchronized form, obtaining as a result the objective movements of the invention. In addition to the programmable unit, a power unit or circuit may be provided which is responsible for transforming the control signal into a useful power value.
On the other hand, each of the tensioners 26 has, at the opposite end to that filed in the connector 28, such as arm or bolt 28, at least one hook 31 which is connected to the holes of the connecting points or ends of the supporting means. In turn, tensioners 26 are guided through guide holes 32 in the cupola or dome 6 of the incubator. In this way and in accordance with
With regard to the operation of the invention, starting from the position shown in
Once in the deployed position,
Once in the wrapping fold position, the height of each of the connecting points or ends of the supporting means can be varied or modified in order to obtain a correct intrauterine position or posture and similar to the position in which the newborn was inside the mother's uterus. This position may change over the time the newborn is in the incubator. The invented arrangement is able to emulate the mother's movements and positions.
According to
Said pivoting control arm 35 has a mounted guide separating plate 39 provided with respective holes 40 which are spaced apart in such a manner as to separate tensioners 26 passing therethrough. It should be noted that each of the ends of the tensioners 26, opposite to the end which is connected to the supporting means 12, will be held at one end of said pivoting control arm 35 through holes 36 and by adjusting the nut 36, as best shown in
In relation to the general movements that can be performed by the present invention,
Yet another type of movement may be that movement in the longitudinal axis of the supporting means 12, being an alternate rotation movement on an axis which is formed by drawing a longitudinal line between the center of the feet and the head of the newborn 33, similar to rotating on an own axis 47. Another type of movement can be that oscillatory movement of two alternating axes, achieving by this movement a sensation of being on a disc in which a point that rotates in its perimeter pushes the disc down, simulating an alternating descent and ascending rotation. Where, this type of movement is geometrically represented with two orthogonal axes which rotate towards both sides with harmonic senoidal and cosenoidal movements respectively. Although at least four types of movements have been described, this does not imply that the invention is limited thereto, but that other movements and combinations may be considered and carried out without any inconvenience.
According to some of the problems of prior art, a newborn who is born prematurely, is exposed to light, sound, proprioceptive and tactile stimuli that are not part of normal development; which are necessary to guarantee survival, but which nevertheless directly affect the CNS of that newborn child who is in the process of development. However, thanks to the use of the present invention, an early and timely intervention is performed in newborns, whose intrauterine development process was interrupted by promoting an effective approach and taking care of the safety of that being. In turn, an adequate neuropostural control is provided within the incubator, coupled with vestibular, proprioceptive and tactile stimuli, favoring an approximation to the intrauterine harmonic development that prematurely born infants should receive.
Among major stimuli which are improved by the invention, the following shall be found:
Alternatively, the arrangement of the present invention may include an audio system which allows the reproduction of recordings containing the sound of the mother's heartbeat, her voice and that of her direct relatives.
In this way, the arrangement for the neuropostural and sensory suspension of the premature newborn in incubators is constituted and built, which allows positioning the newborn in a position similar to that in which it was in the uterus is order to allow its harmonious intrauterine development. Also, the invention achieves potential benefits in the Prevention of Neurohortopic Disorders such as torticollis, kyphoscoliosis; Prevention of Neurosensory Disorders, whether tactile such as integration disorders and sensory processing such as oral defensiveness, tactile defense among others, or Visual disturbances such as strabismus; and in the Prevention of Vestibular Disorders such as poor or exaggerated equilibrium and straightening reactions, as well as hypo or hyperreactive Newborns, among other benefits.
Number | Date | Country | Kind |
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P160101793 | Jun 2016 | AR | national |
Number | Name | Date | Kind |
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5037375 | Gatts | Aug 1991 | A |
5385153 | Jamieson | Jan 1995 | A |
Number | Date | Country | |
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20170360638 A1 | Dec 2017 | US |