Surgery – Isolation treatment chambers – Incubators
Reexamination Certificate
1998-04-01
2001-04-03
Peffley, Michael (Department: 3739)
Surgery
Isolation treatment chambers
Incubators
C600S021000
Reexamination Certificate
active
06210320
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of Invention
This invention relates generally to the treatment of extremely premature infants, and more specifically to an improved thermal barrier and its use for providing a neutral thermal environment.
2. Description of the Relevant Art
Maintenance of body temperature in premature infants is of critical importance to their health and survivability. At the present time, there are many infant warmers in use for the treatment and maintenance of babies. Such infant warmers typically include an overhead infrared heater, which is the source of the warmth for an infant placed in the warmer. Such devices usually offer an efficient means for rewarming infants who have been cold stressed, while allowing access to the infant for emergency resuscitation, diagnostic, and therapeutic procedures, and further enabling uninterrupted heat delivery for maintenance of body temperature during routine nursing and medical care.
While radiant warmers perform adequately in providing for the environmental needs of premature infants (30-36 weeks gestational age) or full-term infants (36 weeks and above gestational age), the needs of the extremely premature neonate are not sufficiently met. An extremely premature neonate, which has a gestational age of between 24 and 28 weeks, and/or a birth weight of less than 1,000 grams (1-2 lbs.), is subject to a degree of cold stress that a less premature or full-term infant does not experience. One of the most challenging aspects in caring for an extremely premature neonate is body temperature maintenance. The extremely premature neonate has very little ability to maintain its own body temperature. The extremely premature neonate is therefore extremely sensitive to environmental temperature changes. When an extremely premature neonate is subject to a volatile temperature environment, causing a decrease in body temperature, a spiraling coarse of reactions occur. Body metabolism rates increase in an attempt to raise body temperature. The metabolic increase, in turn, leads to increased oxygen consumption, which can be devastating to an extremely premature neonate who is already in a state of respiratory compromise due to its inherent lung prematurity. Caloric consumption is also increased, which is a critical factor to the well being of an already weight compromised infant (less than 1000 gm). Moreover, it is typical for an extremely premature neonate to have a very underdeveloped skin system. Because of the thin, gelatinous nature of the extremely premature neonate's skin, the neonate is at risk for significant insensible water loss which can effect every body system and can lead to dehydration with significant electrolyte and fluid imbalances and further weight loss.
To prevent these life threatening events from occurring, it is desirable that significant variation in the extremely premature neonate's environment be reduced to the extent possible. A neutral thermal environment with a constant temperature and humidity level is sought so that the extremely premature neonate's body systems are not in a constant struggle to adapt. The environment must occupy a relatively small volume, since even incubator volumes are relatively large and contain variations in temperatures and humidity that are considered too low and too variable. The environment must be maintained even when the patient is undergoing procedures or examination. In the past, various makeshift techniques have been used in an attempt to cover an extremely premature neonate exposed on a warmer bed, including enclosing the warmer bed in plastic wrap. However, the neutral thermal environment is continuously disturbed when frequent access to the patient is required. In the care of an extremely premature neonate, the acuity level of the neonate requires that the clinician have almost constant access.
In light of the above identified problems with the need to maintain a neutral thermal environment and a consistent humidity level for extremely premature infants, a device is needed that will create a thermal barrier around the patient which creates this consistent neutral environment. Moreover, the device must be designed such that access to the patient is made practical with minimal change to the humidity provided and the neutral thermal environment.
SUMMARY OF THE INVENTION
The present invention provides a moisture and thermal barrier for the maintenance of an improved neutral thermal and humidified environment when used with a specialized heating and humidifying apparatus. The device can surround an extremely premature neonate (less than 1000 gm and 24 to 28 weeks gestational age) to provide an environment with substantially constant temperature and humidity levels. Maintenance of the neutral thermal and humidified environment reduces insensible water loss in the infant and reduces excessive oxygen consumption. The thermal barrier may have covered flexible openings for manual access to the patient for conducting medical procedures. By eliminating the need for removing the barrier for patient access, air exchange and loss of heat, moisture, warmth, and humidity are substantially eliminated during almost the entire course of patient care. Advantageously, the barrier may be made from a clear, medium-weight, plastic-like material, to provide for complete and constant visualization of the patient. Moreover, the thermal barrier is suitable for use with X-ray and other visualization equipment.
In one aspect, a thermal and moisture barrier device for use with a specialized heating and humidifying apparatus in the care of extremely premature neonatal infants is provided. The barrier comprises a collapsible and substantially flexible cover which defines an enclosed volume, large enough to accommodate an extremely premature neonatal infant. Also provided is at least one flexible opening, located on a portion of the cover which communicates with the enclosed volume. Advantageously, a diaphragm provides closure of the flexible openings. The diaphragm is a resiliently flexible sheet extending across the opening and has slits.
In another aspect of the invention, the thermal and moisture barrier is used in conjunction with an incubator or similar device. The barrier can be a free-standing tetrahedral or right circular cylinder enclosure. An edge portion of the barrier can have an edge portion that creates a seal with a bed or other surface, when the device is placed over an extremely premature infant. A further understanding of the nature and advantages of the present invention may be realized by reference to the remaining portions of the specification and the drawings.
REFERENCES:
patent: 4885000 (1989-12-01), Hogan
Rogone Mary S.
Webber, II Austin J.
Kearney R.
Lopez Theodore P.
Peffley Michael
Skjerven Morrill & MacPherson LLP
Small Beginnings, Inc.
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