Electric heating – Heating devices – With power supply and voltage or current regulation or...
Reexamination Certificate
1999-10-26
2001-07-10
Paschall, Mark (Department: 3742)
Electric heating
Heating devices
With power supply and voltage or current regulation or...
C219S497000, C219S494000, C392S456000, C604S114000
Reexamination Certificate
active
06259074
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to temperature regulating devices, and particularly a temperature regulating device for physiological fluids and a connector assembly integrated thereto for interconnecting a fluid conduit to the device so that a fluid of a desired temperature can be provided via the fluid conduit to a patient.
BACKGROUND OF THE INVENTION
Devices for warming physiological fluids, such as for example whole blood and packed cells, to a desired temperature before providing the warmed physiological fluids to a patient are well known. Once such prior art device is the HOTLINE® system made by the assignee of the instant invention. Such a device uses a heater and hardwired control for heating a fluid such as for example water to a desire temperature, so that the water can in turn warm the infusate to be provided to the patient via a fluid conduit. Inasmuch as the feedback for such system is hardwired, its feedback response is somewhat limited. Moreover, given the limitation of the display mechanism in the prior art HOTLINE® device, no meaningful interfacing between the device and the user is achieved.
So, too, given that the first generation HOTLINE® device is hardwired, in order to determine the integrity of its temperature sensing components, a technician has to physically open up the device, and then test each one of the individual components. This need for disassembling the machine in order to test the integrity of its sensors and other components, needless to say, is time consuming and expensive. Furthermore, the hardwired control circuit for the prior art device does not provide the flexibility or capacity to enable the adding or modification of data that a clinician may want, but which had not been hardwired into the system.
SUMMARY OF THE PRESENT INVENTION
The device of the instant invention for regulating the temperature of a fluid is divided into three main sections, namely a controller section, a temperature regulator section and a user interface section. In the temperature regulation section, there is a reservoir wherein a fluid that is to be temperature regulated is stored. Such fluid may be for example water. The fluid is driven by a pump to a heater, or cooler, so that the temperature of the fluid may be warmed or cooled to a desired temperature. The regulated temperature of the fluid is then sensed by thermistors, which provide a feedback to a processor at the controller section. The sensed temperature is compared with a preset temperature for maintaining the temperature of the fluid to the desired temperature.
The thus temperature regulated fluid is provided to bidirectional ports, which are coupled to a connector assembly that effects an interface between the device and a disposable fluid conduit. The temperature regulated fluid warms/cools an infusate that is also being carried along the fluid conduit and provided to a patient. A couple of sensors or switches are located proximate to the connector assembly for ensuring that the fluid conduit is positively connected to the connector assembly and that there has not been any tampering with the connector assembly. In the case that tampering is detected, a signal may be provided to the processor to shut down the system, so that the device could not work without the user having to first return it to the factory for repair. Such repair may require the replacement of a ROM chip which algorithm is either destroyed or erased when the sensor senses that the connector assembly has been tampered with.
The connector assembly is designed in such a way that the circulation of fluid through the fluid conduit occurs only if the fluid conduit is correctly mated to the connector assembly. To test the integrity of the temperature regulating section, the fluid conduit can be replaced by a temperature calibration or checking device, Once the temperature checking device correctly fits to the connector assembly, a test takes place for determining the calibration and integrity of the various temperature sensing components in the temperature regulating section, to therefore ensure that the device is operating properly.
The controller section of the device of the instant invention has as its main component the controller processor, which may be a conventional microprocessor. There are a number of functions performed by the processor. These include monitoring the current being used by the pump motor by means of a current sensor. The thus sensed motor current of the pump is then used by the processor as a feedback to determine the load being placed on the pump and whether the pump is operating within an acceptable range. The temperature of the temperature regulated fluid is continuously monitored by a pair of thermistors, and fed back to the processor, which then uses the feedback temperature to determine if the operation of the device should continue. This is done by the processor determining whether there is a difference between the respective temperatures sensed by the thermistors and/or whether either one of the thermistors has sensed an overheated temperature for the fluid.
The processor further monitors the sensors that are positioned proximate to the connector assembly so as to continuously monitor whether the fluid conduit is correctly mounted to the connector assembly and whether a temperature calibration device has been fitted to the connector assembly in place of the fluid conduit. If a temperature calibration device is sensed, calibration and testing of the functionality of the thermistors and a fail-safe thermostat would take place. As was discussed before, any tampering with the connector assembly may be sensed by the processor, which then could output an instruction to inhibit, destroy or erase an algorithm in a particular memory store such as for example a ROM so as to shut down the system.
The controller also interacts with the user interface section. There, a display, preferably in the form of a LCD display, is provided so that instructions in any one of a plurality of languages stored in the controller section of the device can be displayed to the user. To operate the machine, either a touch sensitive screen or input keys placed on the front of the user interface section are used. Different lights at the user interface section provide the user with a constant indication of the operational status of the device of the instant invention.
Insofar as the temperature regulation device of the instant invention is processor controlled, the various functions that the device performs can therefore be controlled by software, as compared to the prior art devices which require hardwired operations. Accordingly, the functions of the device of the instant invention are readily changeable, checked and controlled.
It is therefore an objective of the present invention to provide a device that regulates the temperature of a fluid by continuous feedback.
It is another objective of the device of the instant invention to have the ability for self testing the integrity of its various components in its temperature regulation section on each power on.
It is yet another objective of the present invention to provide an interface that is adaptable to be used by people using different languages.
It is still yet another objective of the present invention to provide a temperature regulating device that has functions that are readily upgradable, without any need to disassemble the device.
REFERENCES:
patent: 3383085 (1968-05-01), Vielmo
patent: 3891817 (1975-06-01), Brown
patent: 4700888 (1987-10-01), Samulak
patent: 4759749 (1988-07-01), Verkaart
patent: 4874359 (1989-10-01), White et al.
patent: 5266778 (1993-11-01), Bailey
patent: 6118099 (2000-09-01), Lake et al.
Brunner Charles
Kyn Pavel
Waldron Vicent
Zarkhin Eugene B.
Paschall Mark
SIMS Level 1, Inc.
Woo Louis
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