Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Light application
Reexamination Certificate
2000-05-01
2002-10-15
Dvorak, Linda C. M. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Light application
C607S088000, C607S093000, C600S022000, C237S003000, C237S014000, C200S061000, CD24S163000
Reexamination Certificate
active
06464715
ABSTRACT:
This is the U.S. National Phase under 35 U.S.C. §371 of International Application PCT/BE98/00164, filed Oct. 30, 1998, which claims priority of Belgian application BE 9700872, filed Oct. 30, 1997.
SUBJECT OF THE INVENTION
The present invention relates to a so-called intensive multidirectional phototherapy device intended for treating a premature or full-term newborn suffering from severe icterus or liable to develop this.
TECHNOLOGICAL BACKGROUND AT THE BASIS OF THE INVENTION
The number of premature babies displaying serious icterus requiring exchange transfusion is on the increase. Since icterus can develop rapidly and exponentially, it is necessary to intervene very quickly if it is desired to prevent irreversible neurological damage. These premature babies must receive uninterrupted intensive care in incubators.
Until now, the treatment of icterus has consisted of an exchange transfusion making it possible to dissociate bilirubin which forms a poison before the transfusion of the newborn.
Given that most hyperbilirubinaemias are due to parental blood incompatibilities (incompatibilities with regard to rhesus factors, A, B, O, etc.), it is impossible to take blood from the parent in order to transfuse it to the newborn.
PRIOR ART
Neo-natal icterus has also been treated for many years in paediatric clinics by phototherapy of the skin of the newborns.
Document GB-A-2,216,012 describes an apparatus comprising an incubator made of a transparent material, provided in its upper part with a complex of fluorescent tubes placed parallel to one another beneath a reflecting surface so as to illuminate the newborn lying inside the incubator from above.
A support comprising such an incorporated reflecting surface is also described in Patent Application DE-A-3,910,238. This type of apparatus and of support requires the service personnel to turn the newborn frequently so as to irradiate his skin as uniformly as possible on all sides. This entails increasing the duration of the therapy and a certain amount of discomfort for the newborn, with the difficulty of obtaining truly uniform treatment over all parts of his skin.
Document FR-A-2,193,628 describes a particularly complex and bulky phototherapy apparatus comprising a compartment entirely made of a transparent material, including a bed on which the newborn is laid out and two groups of light sources placed respectively above and below the compartment. However, such an apparatus requires the use of large light tubes consuming a great deal of energy, given that the treated newborn is placed much too far from the light sources. However, the blue-light tubes normally used (Sansville et al., Journal of IES (January 1972)), which are effective in the treatment of icterus, are too long (possibly having a length of up to 520 mm for a 30 mm diameter) to create a device fitting in incubators. They require the use of ballasts and of on/off buttons to light them, these being liable to form a spark each time they are switched on. This is particularly dangerous during treatment in an incubator, which often requires oxygen concentrations exceeding 21% and possibly even up to 40 and 60%. As a result of the sparks generated, these apparatuses are excluded from being used for this purpose.
The desire of specialists is to have available a system which makes it possible to care for infants in serious distress having to undergo both intensive care, in an incubator or closed chamber, and effective intensive phototherapy that can be tailored according to the seriousness of the icterus they are developing, while still maintaining suitable monitoring of the treated newborn.
Aim of the Invention
The aim of the present invention is to provide a novel phototherapy apparatus or device which does not have the drawbacks of the devices of the prior art and which is of simple and modular design, so as to be able to be used for the safe treatment of a newborn that is liable to develop icterus or has icterus already, particularly in an incubator or closed chamber, so as to limit or avoid any traumatism in the newborn, particularly from exchange-transfusion operations.
Characteristic Elements of the Invention
The present invention relates to a so-called intensive phototherapy device making it possible to treat a newborn (either premature or full-term) suffering from serious icterus, in a maternity ward, in his mother's room and even in a closed environment such as an incubator or closed chamber, while limiting or avoiding exchange transfusion and guaranteeing optimum safety of the newborn being treated.
The phototherapy device of the invention is intended to comprise, advantageously fastened to the same frame, a light box which includes at least one light source (the said light source being designed in the light box to illuminate the said patient) and a support for the patient to be laid out on, the said support being at least partially (but essentially) transparent or tinted so as to let the light coming from the light box through.
In the phototherapy device of the invention, the support is placed above the light box so as to expose the patient (held on the support from below with respect to the direction of gravity), thus allowing better exposure of the areas having a high bilirubin concentration which are present in the patient's body and which tend to follow the direction of gravity.
According to the invention, the term “light box” should be understood to mean a hermetically sealed assembly capable of containing one or more light-emitting sources, such as tube lamps (or possibly other light sources connected to optical fibres), as well as all the components allowing these light sources to be modulated or turned off. The light box of the invention also incorporates various means ensuring that any excessive heating of fluids or gases which is caused by these light-emitting sources does not affect the patient to be treated and allows only the emission of light (which is preferably filtered, with no infrared and no ultraviolet) towards the newborn to be treated.
Furthermore, the light box of the invention includes external electrical connectors and air inlets/outlets making it possible to supply the various electrical, mechanical or electronic components of the device of the invention, particularly the light box, such as fans, air intake ducts and ducts for extracting air via suction cones, etc.
The thermal regulation system consists of an air extraction device comprising fans placed in the corners of the light box and allowing effective air flow towards the air suction and extraction cones.
The frame holding the light box and the support in an orientation allowing the patient to be exposed to the light is designed to allow the incorporation of the phototherapy device of the invention in an incubator or in a closed chamber.
For optimum safety, the light box is perfectly sealed and avoids any electrical or mechanical contact with components placed in the incubator or closed chamber. Such an arrangement prevents any spark or shock occurring which could have serious consequences for the patient.
According to the invention, the light sources are designed to generate light of greater than 3 mW per cm
2
of skin, preferably greater than 5 mW per cm
2
of skin, of the patient being treated. These light sources consist, for example, of lamps emitting blue or green light preferably having a spectrum of blue light mixed with green, these being tailored to any type of skin of a patient, including black or mulatto infants.
According to a preferred embodiment of the invention, use is made of light sources consisting of lamps whose spectral analysis reveals blue and green light in three bands (preferably of a wavelength ranging from 420 to 650 nm) and making it possible to deliver greater power of intense illumination than that in conventional tubes, with a broader available band and more rapid dissociation of bilirubin (particularly tube lamps of the {fraction (11/75)} D.Z.C type with a four-pin 2.G.7.4 cap and with a wavelength of 420 to 700 nm (such as those stipulated in
Gysens Lucien
Wauters Marie Yvonne
Dvorak Linda C. M.
Farah Ahmed
Knobbe Martens Olson & Bear LLP
Medestime S.A.
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