Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Reexamination Certificate
2000-01-14
2002-01-29
Dvorak, Linda C. M. (Department: 3739)
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
C600S334000
Reexamination Certificate
active
06343223
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to oximeter sensors, and in particular oximeter sensors with a heating element to improve perfusion.
Pulse oximetry is typically used to measure various blood characteristics including, but not limited to, the blood-oxygen saturation of hemoglobin in arterial blood, and the rate of blood pulsations corresponding to a heart rate of a patient. Measurement of these characteristics has been accomplished by use of a non-invasive sensor which passes light through a portion of the patient's tissue where blood perfuses the tissue, and photoelectrically senses the absorption of light in such tissue. The amount of light absorbed is then used to calculate the amount of blood constituent being measured.
The light passed through the tissue is selected to be of one or more wavelengths that are absorbed by the blood in an amount representative of the amount of the blood constituent present in the blood. The amount of transmitted or reflected light passed through the tissue will vary in accordance with the changing amount of blood constituent in the tissue and the related light absorption. For measuring blood oxygen level, such sensors have been provided with light sources and photodetectors that are adapted to operate at two different wavelengths, in accordance with known techniques for measuring blood oxygen saturation.
Heaters have been used in sensors to improve the perfusion, or amount of blood, adjacent the sensor. This will thus improve the measurement since the light will encounter a larger volume of blood, giving a better signal-to-noise ratio for the oximeter reading.
U.S. Pat. No. 4,926,867 shows a piece of metal used as a heater in an oximeter sensor. A separate thermistor is used to measure the amount of heat so that the heater can be controlled to avoid burning the patient.
U.S. Pat. Nos. 5,299,570 and 4,890,619 both show ultrasonic elements being used for perfusion enhancement.
Because the normal human body core temperature is approximately 37° C., and burning of tissue could take place for temperatures above approximately 42-43° C., a tight range of control of the heating element is required. Another challenge is the heat gradient and delay time between the heating element and the temperature measuring element.
Pulse oximeter sensors are often attached to a digit, or ear. These sites on a patient provide an adequate level of blood perfusion for measuring the oxygenation of the blood hemoglobin. In addition, the distance across these appendages is sufficiently short to allow the detection of transmitted red or infrared light.
One type of sensor is a clothespin-type clip which attaches across the earlobe, with the emitter and detector opposite each other. Such conventional sensors sometime suffer from poor sensitivity and poor calibration or accuracy. This type of sensor often applies pressure which exsanguinates the tissue and alters the blood present leading to accuracy errors.
One type of oximeter sensor will add a diffusing optic to diffuse the light emitted from the light-emitting diodes (LEDs) to cause it to pass through more tissue, and thus more blood. An example of a pulse oximeter sensor using such a diffusing element is shown in U.S. Pat. No. 4,407,290.
One technique for limiting the exsanguination effect is to separate the light emitters and detector from the portion of the sensor which holds it to the appendage and applies the pressure. Examples of sensors where the light emitters and detector avoid the point of pressure are set forth in U.S. Pat. Nos. 5,413,101 and 5,551,422.
Another type of clip-on sensor is marketed by Nonin Medical, Inc. for attaching to an ear. Instead of using a transmission sensor where light is transmitted from an emitter on one side of the ear through the ear to a detector on the other side, a reflectance sensor is used with both the emitter and detector on the same side of the ear. The Nonin medical sensor has spacing between the emitter and the detector of approximately 4 mm, which is similar to the thickness of a typical earlobe. On the opposite side of the ear a reflective surface is provided to reflect the light from the emitter back to the detector.
The typical distance of a standard, bandaid-type reflectance sensor which can attach to the forehead or other part of the body is 6-10 mm. Traditionally, a spacing of this magnitude was felt to be appropriate to ensure that a measurable amount of light could be detected with sufficient pulsatile signal components.
SUMMARY OF THE INVENTION
The present invention provides a method and apparatus for improving blood perfusion by both heating a patient's skin and providing emitters and a detector which are offset from each other. Since the emitters and detector are not directly opposite each other, the light is forced to pass through more blood perfused tissue (with blood perfusion enhanced by heating) to pass from the emitters to the detector. This causes the light emitted by the emitters to pass through more blood-perfused tissue to reach the detector than it would on the direct path through the appendage if the emitters and detector were opposite each other.
In one embodiment, the heater is a thermistor. The thermistor generates controlled heat, and is not just used for sensing the temperature. In an oximetry sensor, the thermistor is located in the vicinity of the light emitter and photodetector to warm the optically-probed tissue region. As heat is dissipated, temperature changes are sensed as resistance changes according to Ohm's law. Active thermal regulation by varying the amount of thermistor current and power can safeguard against burning the tissue while maximizing perfusion. The combination of heating and offset increase the amount of blood that the light from the emitters passes through.
It has been shown recently that general warming of the tissue region increases the amount of blood perfused in the tissue. This increased perfusion substantially strengthens the pulse oximetry signal. Benefits include quick signal acquisition, increased accuracy, and greater tolerance to motion artifact.
In one embodiment, the thermistor is a positive temperature coefficient (PTC) thermistor rather than the more common, negative temperature coefficient (NTC) thermistor. The PTC provides a highly desirable safety feature as poor connections yield a perceived, higher-than-normal resistance indication. As a result, the actual thermistor temperature is regulated at a lower-than-expected temperature, avoiding the chance of burns.
Another advantage of the same thermistor being used for both generating heat and temperature measurement is that there is no thermal gradient between the heating element and the sensing element as in the prior art. This allows for a faster response time, which is critical for maintaining a tight temperature range.
The thermistor's resistance can be conventionally determined either by a two-wire or a four-wire method. The four-wire method is typically used when the connections used in the two-wire method would have resistances that could significantly affect the measurement. In the four-wire method, one pair of wires is used to inject a known current through the thermistor, while the other pair is used to sense the voltage across the thermistor. This enables a highly accurate determination of the thermistor's temperature.
In an alternate embodiment, a simple bridge circuit with a setpoint resistor may be used to automatically bias the thermistor at a particular resistance/temperature. Once the thermistor's desired operating resistance is known from the factory, the appropriate value of the setpoint resistor can be employed in the circuit. This simple circuit could be integrated into the sensor itself or in the remote monitor.
In one offset, the sensor includes at least one reflecting surface for redirecting light back to the blood-perfused tissue in the region of the offset between the emitters and detector. Preferably, the offset distance is at least greater than, and more preferably at leas
Chin Rodney
Hobbs Steven
Dvorak Linda C. M.
Mallinckrodt Inc.
Ruddy David M.
Townsend & Townsend & Crew LLP
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