Patent Application
20180364109
The invention relates to a heat-flow sensor, a method of measuring the temperature of a subject using a heat-flow sensor, and a temperature sensing arrangement.
Core body temperature (CBT) is an important vital sign in medical environments. A patient under anaesthetic is unable to regulate his/her body temperature, and operating rooms are generally cooled to a low level. Hypothermia occurs when the body core temperature drops below 36° C. to a potentially dangerous level. Surgical patients are often hypothermic upon leaving the operating room. Hypothermic patients run the risk of heart complications, especially during the first 24 hours after surgery, since hypothermia acts as a shock to the system. Other problems associated with hypothermia are increased risk of infection and bleeding. For these reasons, the CBT is generally closely monitored during medical procedures, or during long-term monitoring of a recovering patient. Conventional methods can involve intrusive probes (oesophageal, rectal, urethral) or active heat-flow sensors that require heating elements and control loops to control the heating elements.
Passive heat-flow sensors that do not require heating elements have the advantage that they are less hazardous to the patient, and consume relatively little power. A conventional heat-flow sensor can only measure heat flow in the outward direction, e.g. outward relative to the surface of the skin to which the sensor is applied. However, core body heat flows in all directions, not just outward from the body. Therefore, a conventional passive heat-flow sensor generally cannot measure core body temperature to the necessary degree of precision unless the sensors are well insulated (which increases the size of the sensor due to the surrounding insulation). Another problem is that the contact area between body and sensor is rarely thermally uniform, particularly since the contact area of the sensor generally needs to be quite large. For example, the temperature profile over a patient's head can exhibit significant differences on account of the positions of the arteries below the skin. A passive heat-flow sensor of the conventional type using two or more vertical thermistor arrangements can provide inaccurate temperature measurements due to poor adhesion of the sensor to the skin, or due to an air pocket between sensor and skin. Such a situation may arise in the case of a wearable sensor worn by a patient while moving around. Furthermore, a conventional heat-flow sensor is quite sensitive to ambient temperature changes.
Therefore, it is an object of the invention to provide an improved heat-flow sensor for measuring the temperature of a subject.
The object of the invention is achieved by the passive heat-flow sensor of claim 1; by the method of claim 7 of measuring the temperature of a subject using such a passive heat-flow sensor; and by the temperature sensing arrangement of claim 11.
A heat-flow sensor comprises a contact face for placement on a subject during a temperature monitoring procedure. According to the invention, the heat-flow sensor comprises a plurality of combined thermistor arrangements, each comprising an inner thermistor (arranged at an inner face of the sensor) and an upper thermistor (arranged at the upper surface of the sensor) and arranged relative to the inner thermistor to measure a vertical heat flow outward from the subject, i.e. to measure heat flow between the inner thermistor and the upper thermistor; and also a lateral thermistor arranged relative to the inner thermistor to measure a horizontal heat flow along the contact face, i.e. to also measure heat flow between the inner thermistor and the lateral thermistor.
The geometrical terms used in the claims relate to an assumed horizontal plane representing the outer surface of the subject and serve only to define a reference space. A “horizontal heat flow” is therefore any heat flow along the surface of the subject, and a “vertical heat flow” is any heat flow outward from the surface of the subject. It shall be understood that, in reality, a heat-flow sensor can assume any orientation when attached for example to the skin of a patient.
In the context of the invention, the arrangement of one thermistor relative to another is to be understood to mean that these two thermistors are essentially aligned in the direction along which a heat flow is to be measured. Here also, the geometrical terms “upper”, “inner” and “outer” are used in the context of the reference space. Therefore, it will be understood that an inner thermistor is arranged at an inner face of the sensor, and an upper thermistor is arranged towards an outer surface of the sensor, such that an upper thermistor is vertically in line with an inner thermistor to measure a heat flow outward from the subject. The outward heat flow is in a direction from an inner thermistor to an upper thermistor when the subject is warmer than the sensor; when the subject is cooler than the sensor the heat flow direction is in reverse. Similarly, it will be understood that a lateral thermistor is arranged in line with an inner thermistor to measure a heat flow along the surface of the subject, for example along the patient's skin. The lateral heat flow is in a direction between the inner thermistor and the lateral thermistor and serves to detect any difference in temperature between the inner sensor region and the side of the sensor containing the lateral thermistor.
An advantage of the heat-flow sensor according to the invention is that the combination of a lateral heat flow monitor with the usual vertical heat flow monitor allows a much more precise temperature measurement, particularly since the lateral heat flow is explicitly measured, instead of only being estimated (as is the case for some conventional heat-flow sensors). The core body temperature of the subject for example a patient during and after surgery can be determined to a much greater degree of precision, so that critical situations such as hypothermia can be detected and dealt with in a timely manner.
According to the invention, the method of measuring the temperature of a subject using such a passive heat-flow sensor comprises the steps of placing the contact face of the heat-flow sensor on the subject during a temperature monitoring procedure; receiving temperature measurements collected by at least one combined thermistor arrangement of the heat-flow sensor; and calculating the temperature of the subject from the temperature measurements.
The inventive method can deliver favorably precise results on account of the additional information provided by the lateral heat flow monitor of the combined thermistor arrangement in the inventive heat-flow sensor. This can be very advantageous in situations for which a precise temperature monitoring is required, for example to provide medical personnel with precise information regarding a patient's core body temperature, for example in an emergency situation requiring rapid decision-making.
According to the invention, the temperature sensing arrangement comprises such a heat-flow sensor and an evaluation unit arranged to receive temperature measurement values from the thermistors and to calculate the temperature of the subject on the basis of the temperature measurement values.
The dependent claims and the following description disclose particularly advantageous embodiments and features of the invention. Features of the embodiments may be combined as appropriate. Features described in the context of one claim category can apply equally to another claim category.
In the context of the invention, the term “subject” can relate to any living being. Critical thermal conditions generally arise in the context of operative situations, emergency medical situations, etc. in which a human patient may enter a state of hypothermia or hyperthermia. Therefore, without restricting the invention in any way, the terms “subject” and “patient” may be regarded as synonymous in the following. The term “heat-flow sensor” as used in the following in the context of the invention may be assumed to refer to a passive heat-flow sensor. Preferably, the passive heat-flow sensor is made of a foam material, and the outer surface of the inventive heat-flow sensor is uniformly exposed to the ambient surroundings. In a further preferred embodiment, a uniform layer of a suitable material in place over the sensor may be used to protect the sensor from damage. However, it should be understood that any thermal influence of such a protective layer will apply in equal measure to each upper thermistor. In other words, the upper thermistors of the inventive passive heat-flow sensor are arranged to be influenced uniformly by the ambient surroundings.
A thermistor is a device whose electrical resistivity changes in response to a change in temperature, and can be embedded in the material of a heat-flow sensor. A thermistor can be realized as a component with two electrical connectors so that it can be included in an appropriate circuit. A temperature change is registered as a change in current or voltage, depending on the circuit realization. A thermistor component can also be realized as a compact integrated circuit (IC) device.
As indicated in the introduction, passive heat-flow sensors using one or more vertical arrangements of thermistor pairs are known from the prior art. The inventive heat flow sensor extends the sensitivity of the temperature measurement by also detecting and measuring a lateral heat flow along the surface of the patient, and the patient's temperature is deduced from the vertical heat flow and lateral heat flow measurements. The inventive heat-flow sensor may be referred to simply as an enhanced heat-flow sensor in the following. In the following, the terms “combined thermistor arrangement” and “enhanced thermistor arrangement” may therefore be used interchangeably. Similarly, the terms “thermistor arrangement” and “thermistor configuration” may be used interchangeably. The term “temperature measurement value” is to be understood as the quantity reported by a thermistor to an evaluation unit, while the term “temperature measurement” relates to the sensed temperature of the subject, i.e. the temperature reported by the evaluation unit of a heat-flow sensor or by the evaluation unit of a temperature sensing arrangement.
The thermal resistivity of the intervening path between two thermistors (inner thermistor and upper thermistor; inner thermistor and lateral thermistor) is determined by structural properties of the temperature monitor such as the material of the sensor and the thickness of the sensor. The thermal resistivity can be measured and can be a known quantity.
For accurate temperature sensing, any inner thermistor of the inventive heat-flow sensor is preferably close to or coincident with the contact face of the sensor. Similarly, any lateral thermistor of an enhanced thermistor configuration is preferably positioned towards an outer region of the sensor and also close to or coincident with the contact face of the sensor. Any upper thermistor is preferably close to the “uppermost” surface of the sensor, i.e. its outside surface when attached to the subject.
In one preferred embodiment of the invention, the thermistors can be connected via wire connections to an evaluation unit. For example, temperature measurement values can be received by an evaluation unit connected to the sensor by a cable connection. In another preferred embodiment of the invention, the sensor can be equipped with an interface for transmitting the temperature measurement values wirelessly to the evaluation module. The sensor may also incorporate an analog-to-digital converter to convert analogue measurement values into digital values for data transmission. The heat-flow sensor of the inventive temperature sensing arrangement can preferably be realized as a wearable device, i.e. a patient can wear the heat-flow sensor for a long-term temperature monitoring interval. An evaluation unit of the inventive temperature sensing arrangement can preferably be realized as a portable device. For example, the patient or any medical personnel can use a hand-held device with a display such as a tablet computer or smart-phone to observe temperature development. In a wearable realization, results of temperature monitoring can be shown on the display of a smart watch or similar device. In a further preferred embodiment of the invention, the temperature sensing arrangement can be incorporated in a patient support device such as an operating table in a surgical operating theatre, a mattress of a hospital bed, an, infant sleeping bag or incubator of a neonatal ward, etc.
In a relatively straightforward embodiment of the inventive heat-flow sensor, a single inner thermistor is used, and this is connected to an upper thermistor and also to a lateral thermistor to achieve the favorable side compensation for accurate estimation of deep body temperature. During a temperature monitoring interval, the temperatures of the three thermistors are observed. The deep body temperature Tdb (core body temperature) can be expressed as:
where T1 is the temperature at the inner thermistor; T2 is the temperature at the upper thermistor; T3 is the temperature at the lateral thermistor; RV is the “vertical” thermal resistivity between inner thermistor and upper thermistor; and RH is the “horizontal” thermal resistivity of the electrical connection between inner thermistor and lateral thermistor. RB is the thermal resistivity of the body to which the sensor is applied, for example skin thermal resistivity. The thermal resistivity of a patient's skin can be estimated, or an already established value can be used by default.
An inner thermistor, common to both vertical and lateral thermistor pairs of an enhanced thermistor configuration, can be located near the center of the sensor, preferably as close as possible to the contact surface. This arrangement may be preferred for a straightforward realization of the inventive heat flow sensor that comprises only a single enhanced thermistor configuration. Such an “enhanced single heat-flow sensor” can provide temperature measurements relating to the outward heat flow from the patient, enhanced or augmented by temperature measurements in one lateral direction along the patient's skin. This configuration already enables a relatively accurate estimation of the patient's core body temperature.
The inventive heat-flow sensor can comprise only such enhanced thermistor arrangements. These can be separate and distinct from each other. Equally, the inventive heat-flow sensor can comprise multiple vertical thermistor pairs, giving a configuration of enhanced thermistor arrangements, each comprising a vertical thermistor pair and the lower thermistor of a neighboring pair. In an alternative embodiment of the invention, the enhanced thermistor arrangements share a single inner thermistor and a single upper thermistor. This enhanced single heat-flow sensor measures heat flow in one vertical direction through the inner and upper thermistors, and augments the vertical heat flow information by additional information obtained by measuring heat flow in several sideways or lateral directions, whereby each lateral direction effectively passes through the inner thermistor and one lateral thermistor. By incorporating more than one lateral thermistor, it is possible to monitor heat flow in more than one lateral direction, allowing a better estimation of the thermal behavior of the area under the sensor contact surface. The lateral thermistor of a combined thermistor arrangement can be a solitary thermistor arranged at the contact face; alternatively the lateral thermistor of a combined thermistor arrangement can be the inner thermistor of a vertical thermistor pair.
In another preferred embodiment, in addition to its enhanced thermistor arrangement(s), the inventive heat-flow sensor comprises a separate vertical thermistor arrangement with a further inner thermistor and a further upper thermistor arranged relative to that inner thermistor to measure a further vertical heat flow outward from the subject. This additional vertical thermistor arrangement is functionally independent of any combined thermistor arrangement, and such an embodiment may be referred to as an enhanced dual heat-flow sensor. Preferably, the vertical thermistor arrangement is positioned centrally in the heat-flow sensor. A centrally positioned and independent vertical thermistor arrangement can be flanked by a plurality of equidistantly arranged enhanced thermistor configurations, for example.
In an embodiment comprising a vertical thermistor arrangement and one enhanced thermistor arrangement, it is not necessary to know the thermal resistivity of the skin, since this term cancels out of the equation for deep body temperature Tdb, which is now expressed as:
where TV1 is the temperature at the inner thermistor of the vertical thermistor arrangement and TV2 is the temperature at the upper thermistor of the vertical thermistor arrangement; T1 is the temperature at the inner thermistor of the enhanced heat-flow thermistor arrangement, T2 is the temperature at the upper thermistor of the enhanced thermistor arrangement, and T3 is the temperature at the outer or lateral thermistor of the enhanced thermistor arrangement. K and L are scalar values. The value K is expressed as:
The scalar value L is a ratio and can be expressed as:
where RV2 is the thermal resistivity between inner and upper thermistors of the vertical thermistor arrangement; and RH is the thermal resistivity between inner and lateral thermistors of the enhanced thermistor arrangement.
In one exemplary embodiment, for which the vertical thermal resistivity RV of the enhanced thermistor arrangement is twice the horizontal thermal resistivity RH, equation (4) reduces to:
This allows equation (2) to be solved for the value of deep body temperature Tdb.
In a particularly preferred embodiment of the invention, the heat-flow sensor comprises multiple enhanced thermistor arrangements. Similar equations on the basis of equations (2)-(5) above can be developed for embodiments of the inventive enhanced heat-flow sensors that two or more enhanced thermistor arrangements. The evaluation unit can comprise a microprocessor or functional equivalent, realized to execute one or more algorithms, based on the above equations that process the temperature measurement values delivered by the thermistors in order to compute a deep body or core temperature of the subject.
An advantage of measuring heat flow in more than one lateral direction is that it allows a precise temperature measurement even if the heat-flow sensor is not ideally or optimally in position. It can often be difficult to exactly determine a correct or ideal sensor placement, for example when a sensor is to be placed over the carotid artery. A slightly “off-center” placement could result in significant errors in temperature measurements when a prior art heat-flow sensor is used. An inventive heat-flow sensor with several enhanced thermistor configurations provides several candidate temperature measurement values, from which a more precise core body temperature can be deduced. For example, in a preferred embodiment of the invention, temperature measurements are received from a plurality of combined thermistor arrangements, and the temperature measurements are averaged before calculating the temperature of the subject. Equally, the maximum temperature value reported by a thermistor may be used for the calculation of lateral and vertical flows. For example, the temperature measurement values received from the sensor can be examined to identify the pair of inner and outer thermistors that shows the maximum vertical heat flow. This vertical thermistor pair will generally be characterized by the inner thermistor that has the greatest temperature measurement value, for example. Then, the vertical thermistor pairs (or the lateral thermistors) that neighbor that “maximum vertical flow” thermistor pair are identified. Their temperature measurement values are then used to establish a lateral heat flow outward from the “maximum vertical flow” thermistor pair.
Another advantage of using several enhanced thermistor configurations is given by the ability to identify an enhanced thermistor configuration that is sub-optimally placed to measure temperature. The inventive method preferably comprises the steps of comparing temperature measurements from a plurality of enhanced thermistor configurations; identifying an enhanced thermistor configuration that is providing unreliable temperature measurement values; and discarding those temperature measurement values.
For example, a situation might arise in which the sensor is not ideally attached to the skin of the patient. In a heat-flow sensor with three or more equidistantly arranged enhanced thermistor configurations, any significant difference between the values delivered by the enhanced thermistor configurations can be identified. If one of the enhanced thermistor configurations delivers vales that are significantly different from the values delivered by the other enhanced thermistor configurations, and if the values delivered by the other enhanced thermistor configurations are relatively similar, this would indicate that the sensor is not adequately attached to the skin. Any thermistor delivering outlier or non-conformant values is preferably disregarded so that its data does not falsify computation of the core body temperature.
In both sensors when using the side thermometer the estimated CBT is less sensitive to environmental changes and gives good results, whereas the basic single and dual heat-flow CBT sensors without a side thermometer are sensitive to the environmental changes. Including a side thermistor improves the estimated CBT during a variation of the core body temperature as well as during a variation of environmental changes.
Other objects and features of the present invention will become apparent from the following detailed descriptions considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed solely for the purposes of illustration and not as a definition of the limits of the invention.
In the drawings, like numbers refer to like objects throughout. Objects in the diagrams are not necessarily drawn to scale.
Obtaining a temperature measurement at any one point in time using the sensor 1 involves collecting the temperature measurement values T1, T2, T3 from the thermistors S1, S2, S3 respectively (i.e. thermistor S1 delivers temperature measurement value T1, thermistor S2 delivers temperature measurement value T2 etc.) and calculating a sensed temperature using knowledge of the heat flux through the sensor 1. To compute the sensed temperature using the enhanced single heat-flow sensor 1, it is also necessary to determine or estimate the thermal resistivity RB of the skin, which may vary from patient to patient. The sensed body temperature Tdb may be calculated using equation (1) as already described above. To this end, the measurement values collected by the thermistors S1, S2, S3 are sent to an evaluation unit 2 of the temperature monitoring arrangement 10, for example over a cable connection or wirelessly. A microprocessor 3 of the evaluation unit 2 performs the necessary computations to arrive at the body temperature. A display 4 can show core body temperature development as time progresses. While the diagram only indicates one lateral thermistor for the sake of simplicity, any number of lateral thermistors S3 and vertical thermistor pairs S1, S2 can be implemented by such an enhanced single heat-flow sensor.
The final estimated core body temperature depends to a large extent on the geometry and thermal conductivity of the sensor. Experimental results have shown that even during sub-optimal conditions, the enhanced sensor performs very well. When applied to a reference body that is gradually heated, the temperature sensed using data provided by an inventive enhanced single heat-flow sensor is a much closer match than the temperature sensed using data provided by the conventional single heat-flow sensor. Similarly, the temperature sensed by an enhanced dual heat-flow sensor according to the invention has been observed to be more precise than a comparable conventional dual sensor, which although considered to be quite accurate can report sensed temperatures that are off by about 0.4° C. This is considered to be a significant discrepancy regarding core body temperature, particularly when it is necessary to identify a tendency towards hypothermia or hyperthermia so that preventive measures can be taken to avoid a critical situation.
The improvement in accuracy of the inventive enhanced heat-flow sensor is because it considers lateral heat flow also, and is therefore significantly less sensitive to variations in ambient temperature. The improvement in accuracy has been observed for a reference body with a constant temperature at 37.5° C. and a variation in the ambient or outside temperature from 0° C. to 30° C. The body temperature as measured by the inventive enhanced heat-flow sensor remains essentially constant for all values of ambient temperature, whereas a comparable conventional heat-flow sensor exhibits relatively poor performance particularly at the lower temperatures, The enhanced heat-flow sensor according to the invention performs significantly better than its conventional counterpart which does not.
Although the present invention has been disclosed in the form of preferred embodiments and variations thereon, it will be understood that numerous additional modifications and variations could be made thereto without departing from the scope of the invention. For example, any suitable sensor shape may be used. Equally, different numbers of vertical and lateral thermistors can be incorporated in various embodiments of the inventive enhanced heat-flow sensor. As described above, calculation of core temperature can be performed on the sensor or can be performed remotely. Results can be displayed locally (on a screen) or remotely on a smart watch, mobile phone or the display of any other suitable device. Furthermore, the principle of the invention can be used in an active sensor realization, for example by controlling a heating element to bring the sensor to a zero heat-flux state.
For the sake of clarity, it is to be understood that the use of “a” or “an” throughout this application does not exclude a plurality, and “comprising” does not exclude other steps or elements. The mention of a “unit” or a “module” does not preclude the use of more than one unit or module.
| Number | Date | Country | Kind |
|---|---|---|---|
| 15201450.2 | Dec 2015 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2016/082200 | 12/21/2016 | WO | 00 |
