Apparel – Body garments – Shirts
Reexamination Certificate
1998-01-15
2001-07-03
Vanatta, Amy B. (Department: 3765)
Apparel
Body garments
Shirts
C002S069500, C002S111000, C005S494000, C128S872000, C128S873000
Reexamination Certificate
active
06253380
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed generally to the treatment of neonatal hyperbilirubinemia and, more particularly, to an improved apparatus and method for treating neonatal hyperbilirubinemia.
Excessive levels of serum-bilirubin in newborn infants causes a condition called neonatal hyperbilirubinemia. Hyperbilirubinemia is treated by irradiating the affected infants with therapeutic levels of light within a given wavelength range (e.g., within the blue light range of the light spectrum). For best results, the blue light radiation should be evenly distributed over the entire surface of the affected infants' bodies.
One conventional treatment method requires placing blue light sources above the affected infants' hospital cribs and irradiating the infants from above. While this “overhead” phototherapy treatment has provided satisfactory results, the infants must be rolled over (from their fronts to their backs, and vice-versa) during treatment to insure even distribution of the blue light radiation. In addition, the use of overhead light sources results in less free space being available in typically cramped hospital rooms.
A second conventional treatment for hyperbilirubinemia includes a self-contained therapy apparatus for supporting and irradiating the affected infants. The apparatus includes a circular phototherapy hood having an array of blue light sources. The affected infants are placed on a sling-type support frame that is slidably received within the circular hood. The blue light sources are arrayed to provide a near-uniform distribution of radiation along practically the entire surface of the infants' bodies. While this “all around” treatment method has its advantages over the “overhead” treatment method described above in that it practically eliminates the need for rolling the infants over during treatment, the apparatus is expensive, is not adaptable for use with regular hospital cribs and, because it is a self-contained unit, is not readily portable.
In addition, because the blue light radiation should be evenly distributed over the infants' bodies for best results, conventional treatments have used active arm and/or leg restraints to keep the infants from rolling over or otherwise moving during treatment. As can be imagined, these active restraints have caused the newborn infants to become uncomfortable and restive during treatment.
SUMMARY OF THE INVENTION
The present invention provides an apparatus for treating hyperbilirubinemia that is portable and useable with regular hospital cribs or cots. In addition; the apparatus provides a passive restraint system that is designed to hold the affected infants in a relatively comfortable and unrestrictive manner during treatment. In a preferred embodiment of the present invention, the apparatus includes a transparent cot-like structure for supporting an infant above a blue light irradiation unit.
According to a first aspect of the present invention, an apparatus for irradiating an infant includes a frame for supporting the infant, and a source of radiation positioned below the frame and the infant. The frame includes a fully transparent section for allowing the radiation to pass therethrough to the infant.
According to a second aspect of the present invention, an apparatus for irradiating an infant includes an irradiation unit insertable in a cot in place of a mattress, and a frame operable to support the infant above the irradiation unit. The irradiation unit includes a source of radiation and a transparent upper surface disposed above the source of radiation. In addition, the frame includes a transparent foil positioned above the irradiation unit. In a dependent aspect, the apparatus further includes a therapy blanket detachably connected to the frame to cover the infant. The therapy blanket includes a transparent section through which radiation can pass to the infant. In a preferred aspect, the therapy blanket defines a pouch having a pair of sleeves for passively restricting the infant to be treated.
According to a third aspect of the present invention, a cot for supporting an infant for phototherapy treatment is provided. The cot includes a frame having a pair of opposed side members, and a transparent sheet material connected to the pair of opposed side members. At least one of the opposed side members is hingedly attached to the frame. In a preferred aspect, each of the side members defines a groove through which the ends of the transparent sheet material are pulled to attach the sheet material to the frame.
According to a fourth aspect of the present invention, a method for treating hyperbilirubinemia is provided, which comprises the following steps: providing a source of radiation in place of a mattress of a cot; providing a frame for supporting an infant to be treated, the frame including a transparent material; placing the frame above the source of radiation; placing the infant on the transparent material of the frame; and irradiating the infant. In a preferred aspect, the infant is passively restrained within a pouch defined in a blanket detachably connected to the frame.
The present invention provides an apparatus for treating hyperbilirubinemia that saves space, is easy to use, and is less expensive than other conventional apparatuses. Moreover, because the present invention can be used with a regular hospital crib, the infant may be treated in close proximity to its mother, which makes the infant feel comfortable and aids in mother/infant bonding. In addition, the treatment apparatus provides light that is precisely directed a minimum distance to the affected infant, which results in superb therapeutic performance.
These and other features and advantages of the present invention will be further understood upon consideration of the following detailed description of the present invention, taken in conjunction with the accompanying drawings.
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“Cradle 360”, Médipréma.
“Ohmeda Biliblanket™ Phototherapy System”, © 1990 The BOC Group, Inc.
“Fiberoptic Phototherapy Device” Literature, Fiberoptic Medical Products, Inc.
“The Wallaby Phototherapy System®”, Fiberoptic Medical Products, Inc.
Kunzler Hans R.
Larsson Michael
Baniak Pine & Gannon
Medela Holding AG
Vanatta Amy B.
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