Electric heating – Heating devices – With power supply and voltage or current regulation or...
Reexamination Certificate
2002-04-17
2003-11-25
Jeffery, John A. (Department: 3742)
Electric heating
Heating devices
With power supply and voltage or current regulation or...
C392S418000, C392S382000, C600S022000, C219S217000
Reexamination Certificate
active
06653605
ABSTRACT:
FIELD OF THE INVENTION
The invention relates generally to infant care units such as incubators and infant warmers and relates more particularly to a system, method and apparatus for monitoring the status of an infant being warmed or treated and controlling operation of the incubator or infant warmer.
BACKGROUND OF THE INVENTION
Infant incubators and infant warmers are used to provide heat support to premature infants who cannot maintain their own body temperature. Temperature control is provided by various different processes. In many incubators and infant warmers the temperature control process is selectable by the user.
Both the control and monitoring of infant warmers and incubators can be provided using various different sensing and control systems. So-called manual mode may be used wherein information is provided as to the temperature in the incubator or the infant space of the infant warmer and the heater output may be set manually. This type of system is an open loop system. Typically some type of alarm is provided to indicate heater power termination if this is not confirmed by the caregiver. Monitoring and control referred to as air control is often used where the user sets the desired air temperature of the incubator or baby warmer space. The system provides for measurement of the actual temperature inside the infant's compartment or infant space and regulates a heater to supply adequate heat to reach the desired air temperature. An air temperature deviation alarm can be selected by the user, for example between 1.5 and 2.5° C. or some similar setting.
Skin control of an infant warmer or incubator is based on a desired skin temperature for the patient and based on a sensing of the actual skin temperature of the patient. A skin temperature sensor is attached to the infant (for example at the abdomen or lower back or head). The incubator or warmer measures the infant's skin temperature via the skin sensor and regulates a heater to supply adequate heat to reach the desired skin temperature. A skin temperature deviation alarm can be selected for example from 0.3 to 1.0° C. An alarm can be triggered if the actual skin temperature falls outside the alarm limits. So called skin control monitoring and control has advantages and is considered a preferred mode of operation for incubators and infant warmers.
U.S. Pat. No. 6,048,304 discloses a process for controlling the operating parameters of an incubator. The process uses skin control concepts and in particular provides multiple sensors such as a first sensor for measuring the infant patients core temperature (such as for measuring the skin temperature at the head or abdomen) and a peripheral skin temperature sensor. Additionally an air temperature sensor measures the actual air temperature in the incubator. The process sets the air temperature in the incubator as a function of both the core temperature and the peripheral temperature of the infant patient. The actual core temperature and peripheral temperature are calculated based on sensed values. The use of both a sensing to determine the core temperature and peripheral temperature is proven to be useful. It has been noted that undercooling can be recognized in the case of highly premature or full-term newborn babies from an intense cooling of the periphery, while the core of the body is still in the normal range. This is based on the body's attempt to maintain the core temperature by throttling the blood flow to the periphery, thus reducing the heat loss to the environment at the periphery. An increasing fever can be recognized from a decrease in the peripheral temperature with rising core temperature of the body. The body has centralized the blood flow to the core in this case in order to heat to a higher temperature, and it throttles the blood flow to the periphery in order to save heat and to use it to heat the central organs. A subsiding fever can be recognized from the high core temperature of the body with a simultaneously high peripheral temperature. The body uses the large surface of the periphery to cool the core of the body by a corresponding release of heat. The process of U.S. Pat. No. 6,048,304 provides a solution of the problem that temperatures measured at the patient are measured at the skin surface and are therefore distorted by external effects such as air flows. This determination of core and peripheral temperatures based on calculations using sensed values allows operating conditions of the incubator to be set correctly. U.S. Pat. No. 6,048,304 is hereby incorporated by reference.
Recently clinical studies have shown that co-bedding of premature twins in the same warming device can be beneficial to the development of the infants. However, currently available warming devices do not provide the same control methods as discussed above for twins. The problem relates to the fact that two patients are occupying the space. Since one of the twins would have to be selected to be the “supplier” of the skin temperature measured via the skin temperature sensor, this could result in a problem since the heat requirements of the two infants could be different. If skin temperature information from only one infant is used, resulting in one infant being comfortable, the other infant could be too warm or too cold.
As such, infant care devices (incubators/warmers) used for co-bedding of premature twins are operated in air or manual mode respectively, thereby avoiding the selection of a “control infant.” The user has to manually check both infant temperatures and then adjust the air temperature setting to a value agreeable for both infants. Even if sensors are connected to each of the infants for taking skin temperature readings, hence avoiding the manual taking of temperatures, it is still necessary to operate the device in air/manual mode with the air temperature set and adjusted by the caregiver at regular intervals.
This has the disadvantages of requiring a great deal of time so as to be time intensive for the caregiver. The result may be inconsistent and may depend on the individual caregiver's attention and thoroughness. Frequent interruptions of the infant's create “down time,” since the incubator needs to be opened and the infants will be manipulated during the process of taking the temperature of each infant.
SUMMARY OF THE INVENTION
The primary object of the invention is to allow the user to operate the incubator in substantially the same manner regardless of the number of infant occupants—single or double, triple, quadruple, etc. and/or to provide a monitoring and control system and method than monitors and controls based on the patient's temperature regardless of the number of occupants—single or double, triple, quadruple, etc.
According to the invention, a system for controlling the heating and temperature monitoring of infant incubators and infant warmers is provided with an incubator or infant warmer space, a heater for heating the space as well as a first temperature sensor and a second temperature sensor. An input device for input of one or more control setting works in conjunction with a control device connected to the heater and to the first temperature sensor and the second temperature sensor. The control device forms a control temperature from an input first skin temperature target control setting for a first patient and an input of a second skin temperature target control setting for a second patient and further patients if present and controls the heater based on a difference between the control temperature and an actual temperature value based on a first actual temperature sensed by the first temperature sensor and a second actual temperature sensed by the second temperature sensor.
The control device preferably calculates the control temperature as the average of the input first skin temperature target for the first patient and the input of the second skin temperature target for a second patient. The actual sensed temperature value may be the average of the first actual temperature sensed by the first temperature sens
Dräger Medical AG & Co. KGAA
Jeffery John A.
McGlew and Tuttle , P.C.
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