Patent Application
20060047215
This invention relates to the field of patient vital signs monitoring, and in particular to a combined sensor assembly that integrates at least one electrical sensor capable of measuring electrical signals representative of a physiological parameter of a patient with at least one acoustic sensor, such as a microphone.
A number of known sensor assemblies have been made available in the field of remote monitoring, particularly the field of vital signs monitoring, in order to measure certain physiological parameters of a patient, such as, for example, electrical signals from a patient in the form of ECG (electrocardiogram) signals. To that end, a conventional sensor assembly 10 that is used for this purpose, such as depicted in
Applicants are presently aware of U.S. Patent Applications U.S. 2003/0176800A1 and U.S. 2003/0176801A1, each of which describe a combination assemblage that includes both an ECG electrode, as well as an acoustic microphone, that are arranged coaxially relative to one another. As is shown in FIG. 1 of the '800 publication, the microphone is disposed within the assemblage at the apex of a conically or bell-shaped collection volume that is formed above the ECG electrode portion thereof. The purpose of the collection volume according to the teachings of the patent is to focus and isolate the reception of audio sounds, such as respiration or heart-related sounds, by the acoustic transducer of the microphone, as is typically done for microphones of this type. The above reference further observes that the use of an electrically conductive gel used with the ECG electrode portion of the assembly assists in sealing the collection volume and further assists to prevent against inside/outside air flow relative to the collection volume.
It is therefore a primary object of the present invention to improve the overall efficiency and design of vital signs monitoring systems.
It is another primary object of the present invention to provide an improved sensor assembly in order to provide improved ease in patient examination, increased efficiency and/or increased accuracy.
It is another primary object of the present invention to provide a low cost, reliable sensor that is suitable for attachment, for example, to the body of a patient.
It is another primary object of the present invention to provide improved acoustic performance for a sensor assembly, the assembly being insensitive to acoustic noise and preferably having a low-profile configuration.
Therefore and according to a preferred aspect of the present invention, there is provided a combined sensor assembly comprising:
According to one embodiment of the present invention, the at least one acoustic sensor and the at least one electrical sensor are each coupled to the patient using the same conductive gel material, wherein the conductive gel material provides transmission characteristics so as to provide an effective acoustic impedance match to the skin in addition to providing electrical conductivity for the electrical sensor. Preferably, the at least one acoustic sensor comprises a microphone having an acoustic transducer that is directly coupled with the conductive gel material substantially without an intermediate air buffer, such as that described and required in the field, for example, in the preceding '800 publication.
The combined sensor assembly can be designed with the two sensors (electrical, acoustic) arranged either coaxially or laterally with respect to one another.
The herein described combined sensor assembly can include literally any form of physiological sensor that detects electrical activity of a patient (e.g., ECG, EEG, EMG, etc.) but can further include additional physiologic sensors in addition to the at least one electrical sensor, such as those capable of measuring, for example, body temperature, blood pressure, heart rate, blood glucose, blood oxygen saturation, and the like, these additional sensors not necessarily relying upon an electrical signal generated from the patient. Preferably, the combined sensor assembly can be configured for use in either a hard-wired or tethered version in order to transmit the generated signals from the contained sensors to a bedside monitor or to a hospital network. Alternatively, a miniature radio transceiver antenna, and embedded microprocessor can be added to the overall sensor assembly in order to permit wireless transmission of ECG and other physiological parametric data to a remote location. As such, the herein described sensor assembly can be used to monitor numerous patient vital signs, physical diagnoses, and/or molecular diagnoses, in which representative detected signals can be transmitted from the combined sensor assembly by either a wired or a wireless connection to a remote monitoring station or other site.
One advantage provided is that the combined sensor assembly of the present invention is fairly simple in design and is easily manufactured. The sensor assembly can be used in a conventional manner as to attachment to a patient, therefore no new training is required.
Another advantage provided by the present combined sensor assembly is that use of a conductive gel material with an integrated microphone or other form of acoustic sensor permits respiratory and heart-related sounds to be picked up more readily than known assemblies for this purpose and without requiring multiple and separate assemblies with good immunity to extraneous acoustic noise, such as that produced by chest hair. Another advantage is that a combined sensor assembly as described can be made cheaper than those previously known. A further advantage is that only a single gel can be required to effectively couple the assembly to the patient, the assembly thereby being easy to apply and use.
These and other objects, features and advantages will become readily apparent from the following Detailed Description that should be read in conjunction with the accompanying drawings.
FIGS. 8(a) and 8(b) are partial perspective views of an acoustic sensor used for purposes of testing; and
The following description relates to a combined sensor assembly for use in monitoring a patient, the assembly comprising at least one electrical sensor capable of measuring an electrical signal representative of a physiological parameter of a patient and at least one integrated acoustic sensor that is made in accordance with certain preferred embodiments of the present invention. Throughout the discussion that follows, certain terms such as “top”, “bottom”, “lateral”, and the like are used to relate a frame of reference with regard to the accompanying drawings. These terms, however, should not viewed as overly limiting of the present invention, except where specifically indicated. In addition, the electrical sensor portion of the combined sensor assembly described herein is an ECG sensor assembly for detecting electrical signals from the heart of a patient. It will be readily apparent, however, that the herein described combined sensor assembly can be used in connection with literally any physiological parameter sensor that is capable of detecting an electrical signal relating to a patient, such as for example, EEG, EMG, and the like. From the following discussion it will also be readily apparent to those of sufficient skill in the field that additional physiological parameter sensors, whether electrical, acoustic, or other, can also be integrated into the present sensor assembly in combination with those discussed above for measurement of other patient vital signs such as body temperature, blood glucose, respiration rate, heart rate, pulse rate, and blood pressure, among others.
For purposes of background in understanding the problems solved according to the present invention, reference is first made to
Still referring to
With the preceding background being provided and referring now to
The top portion 88 of the enclosure 84 of the herein described combined sensor assembly 80 retains a number of retained components. These components include a wireless radio transceiver 114 as well as a portable power supply (such as at least one integrated miniature battery, although the battery can be separately provided), an acoustic sensor 118 (in this instance, an acoustic microphone), and at least one electrical sensor 122 (in this instance, an ECG electrode).
Additional electronic circuitry may be added to the above noted structure 114 as known to those skilled in the art. This circuitry would amplify the signals detected by sensors 122 and 118, digitize them through appropriate A/D converters, manipulate them into usable data information (such as, but not limited to, heart rate and breath rate) via low power microprocessors, and connect the resulting signal and data to the radio transceiver 114. Such microprocessors may also control radio communication links as well. Alternatively, the microprocessors may communicate to an external bedside monitor or system, with wires through connectors 154 (
For purposes of this embodiment and for reasons of clarity, only a single electrical sensor/electrode is illustrated. As shown in
In operation, the peelable strip (not shown) of the bottom portion 92 of the combined sensor assembly 80 is removed and the rubber periphery 96 of the combined sensor assembly 80 is attached via the adhesive face 100 directly to the skin of the patient. In this instance, the combined sensor assembly 80 is mounted onto the chest of the patient. An adhesive material may be imbedded in the gel material to improve contact and coupling between the skin and electrical sensors 122 and acoustic sensor 118. The gel material 110 is selected not only to provide an effective electrical contact between the skin of the patient and the electrical sensor 122, but also to provide an effective acoustic impedance match between the flat piezoelectric transducer of the acoustic microphone (acoustic sensor 118) and the skin of the patient. Moreover and based on the design of the sensor assembly 80, there is substantially no air buffer layer provided between the gel material 110 and the flat piezoelectric transducer of the acoustic sensor 118. Other sensor designs can be contemplated wherein the gel material can be either directly added onto the skin of the patient or alternatively, the gel material can also be included within the covering itself at the sensor interface to provide the necessary interconnection, both electrically and acoustically.
The electrical sensor (ECG electrode) 122 operates to detect electrical signals from the heart of the patient and to transmit these signals to a contained miniature microprocessor having sufficient memory for storage. In addition, the miniature microprocessor can further include logic for initially processing the signals. An A/D converter is used to convert the analog sensor signals into a digital format for transmission by the wireless transceiver 114, the transceiver including an antenna. Alternatively, the signals can be transmitted by means of a wired connection to a monitor or other device, wither for processing or for display thereof.
The acoustic portion of the herein described sensor assembly 80 involves vibration of the transducer's piezoelectric material in response to sounds that are produced by the heart, lungs, or vocal cords. This vibration generates voltage across the piezoelectric material and, thereby, an electrical signal representing the sound(s) is also generated. The gel material 110 acts as an acoustic impedance matching (acoustically conductive) medium, thereby providing good transmission of the patient's heart and lung sounds to the piezoelectric material. The acoustic signals are then also either transmitted to the contained microprocessor for storage and/or processing or for transmission using the wireless transceiver 114 to a separate site after converting the signals from an analog to a digital form. According to a preferred embodiment, the herein described sensor assembly 80 can include a multiplexor for incorporating the individual signals, using frequency hopping or other means, into a transmission data packet for transmission using an industry standards-based protocol such as WiFi, 802.11(a,b,g), Ultra Wide Band, Bluetooth, 802.15.1, Zigbee, 802.15.4, or other forms of wireless link. Alternatively, the signals can be transmitted by a wired connection to a separate monitoring device, such as an ECG or other form of monitor, a display, a remote monitoring station or other site.
A myriad of other embodiments are possible within the inventive scope of the invention that has already been already described herein. The following pertains to examples of these embodiments.
Referring to
Referring to
Referring to
In operation, the bottom side of the combined sensor assembly 160 is attached to the skin of the patient and the conductive gel material 180 on the bottom facing side thereof provides both electrical connectivity between the electrical sensor 168 and the skin as well as an acoustic impedance match between the skin and the transducer of the acoustic sensor 172. As in the preceding, there is no intermediate air buffer layer between the transducer of the acoustic sensor 172 and the gel layer 180.
Referring to FIGS. 8(a) and 8(b), there is shown an exemplary acoustic sensor 190 used for purposes of testing. The tests were conducted using a custom designed stethoscope test machine. This test machine comprises a vertically oriented actuator whose output oscillates sinusoidally; an elastomeric pad on the actuator output that simulates the acoustic characteristics of the chest tissue; and a computer that controls the actuator, reads the output signal, and displays and stores the measured signal from the sensor. In operation, the tested sensor 190 is loaded against the elastomeric pad and the frequency of the actuator is swept from 20 Hz to 2000 Hz. The sensor 190 used for purposes of this test is manufactured by Andromed in accordance with previously incorporated U.S. Pat. No. 6,661,161B1 and includes a thin piezoelectric film or membrane 194 provided on the exterior (patient facing side) of the sensor, the interior including a printed circuit board (PCB) (not shown). Electrical contact is established between the exterior of the acoustic sensor 190 and the printed circuit board (not shown) in the interior of the acoustic sensor by means of electrical coatings 200, 202 provided on opposite sides of the piezoelectric film or membrane 194, as shown in
Referring to
FIGS. 11 (no gel) and 12 (with gel) provide similar representations at 0.3 kg with the comparative results, indicating that the signal difference between the two plots averages approximately 7 dB over much of the curve. This increase represents a factor of nearly 5 increase in signal energy for this load.
Finally, FIGS. 13 (no gel) and 14 (with gel) represent air/gel curves, respectively, taken at 0.1 kg. The results at this load indicate a signal difference of nearly 12 dB associated with adding gel to the sensor/tester interface or a factor increase of about 16 in signal energy. As a result, it appears the results of using conductive gel are more profound with decreased or minimal loads though an increase was demonstrated at each load.
It will be readily apparent from the foregoing discussion, that numerous modifications and variations are possible to one of adequate skill in the field that will embody the inventive concepts capturing the scope of the invention, as now posited by the following claims.
