Embodiments of the present invention relate to non-contact biosensor design, specifically a biosensor with a circuit designed to compensate for the motion of the sensor to reduce signal noise in the sensor output.
Non-contact sensors generally suffer from signal degradation from motion (defined as changes in proximity between the sensor and the skin). When motion occurs, the gain of the amplifier changes, and unwanted currents are injected at the input of the amplifier that can cause large, unwanted voltage swings at the output.
Accordingly, the present invention is directed to an active biosensing electrode and method that obviates one or more of the problems due to limitations and disadvantages of the related art.
An electrode device is disclosed that can provide non-invasive non-contact measurements of biological signals such as from the heart, muscles, or brain (ECG, EMG, EEG) from a subject. The exemplary electrode device is a non-contact sensor that does not make an ohmic/galvanic connection to the skin but rather acquires the signal by forming a capacitor with the skin at the sensing site. The exemplary electrode device is configured with a feedback path that is defined based on, or as a function, of proximity. Thus, in response to motion, unwanted currents are cancelled, and the gain does not change.
In accordance with the purpose(s) of this invention, as embodied and broadly described herein, this invention, in one aspect, relates to a sensor device according to principles described herein may include an amplifier having a first input terminal, a second input terminal, and an output; a dielectric body; a capacitive sensor disposed on the dielectric body and having an output coupled to the first input terminal of the amplifier; a feedback capacitor having a first capacitive plate coupled to the output of the capacitive sensor and the first input terminal of the amplifier and having a second capacitive plate coupled to the output of the amplifier.
In another aspect, the invention relates to a biosensor according to principles described herein may include a flexible substrate; a first feedback capacitive plate on the flexible substrate; a second feedback capacitive plate on the flexible substrate; a sensor capacitive plate on the flexible substrate; and a biasing circuit connected between the second feedback capacitive plate, and the first feedback capacitive plate, wherein the first feedback capacitive plate is coupled to the sensor capacitive plate.
Additional advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description or may be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and is not restrictive of the invention, as claimed.
Further embodiments, features, and advantages of the active sensor device as well as the structure and operation of the various embodiments of the active sensor device, are described in detail below with reference to the accompanying drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
The accompanying figures, which are incorporated herein and form part of the specification, illustrate a sensor circuit Together with the description, the figures further serve to explain the principles of the sensor circuit described herein and thereby enable a person skilled in the pertinent art to make and use the sensor circuit.
Reference will now be made in detail to embodiments of the active sensor design with reference to the accompanying figures. The same reference numbers in different drawings may identify the same or similar elements.
An exemplary circuit design is disclosed for non-invasive non-contact measurements of biological signals (“biosignals”) such as from the heart, muscles, or brain (ECG, EMG, EEG) from a subject. The exemplary device is a non-contact sensor that does not make an ohmic/galvanic connection to the skin, but rather acquires the signal by forming a capacitor with the skin at the sensing site. The exemplary device is configured with a feedback path that is defined based on, or as a function, of proximity. Thus, in response to motion, unwanted currents are cancelled, and the gain does not change/is stabilized.
Because of its capacitive sensing mechanism, the exemplary device can be configured to be worn and provide robust measurements for extended periods, e.g., through clothing or in helmets. In contrast, in typical bio-measurement applications, electrodes are placed with security to avoid motion corruption (for example, with adhesive or an electrolyte gel). This can make the installation of such devices uncomfortable and render long-term measurements infeasible for patients. In addition, because the intrinsic structure of the exemplary electrode device can cancel motion corruption or artifacts, the exemplary electrode device can be employed with ultra-low-power sensor systems that do not require extensive digital signal processing or post-processing for artifact removal.
A prototype has been developed and tested with success. In the prototype system, the amplifier 112 is configured to be actively biasing the feedback capacitor 108 with a negative potential to substantiate an equal but opposite charge to the input plate 114 of the feedback plate connected to the input of the amplifier 112. To this end, when the electrode moves, the changes in capacitance allows these charges to be released from the plates resulting in an unwanted current. But, there are equal and opposite amounts of charge at this node 120, and because both the feedback and sensing capacitors 104 and 108 both change with movement, this movement of charge-resulting cancels intrinsically. If the feedback capacitor 108 was fixed, only the charge would move from the sensing capacitor 104, and the output voltage Vout at node 124 of the amplifier would change to cancel this (presenting a large motion artifact). The exemplary electrode device does not require this change in voltage, and thus no motion artifact is induced at the output.
In the example shown in
The structure can include a circuit that biases the feedback capacitor with a voltage proportional and inverted to the patient body voltage biasing the sensing capacitor. When a capacitor is biased by a voltage, and the proximity between the plates of the capacitor are modulated, a current is induced defined by i=dC/dt V. Because the circuit is continuously adapting the feedback capacitor bias voltage, and because the proximity of the sensing capacitor and the feedback capacitor are modulated by the same amount—the currents induced on each capacitor at “the first terminal” intrinsically cancel each other.
Referring to
. The gain can be determined as Cs/Cf, which, when substituted by the capacitance equation, provides a gain determined by Areasense/Areafeedback.
The example device of
Indeed, the exemplary electrode device is intrinsically resilient to motion artifacts, consuming no extra computing or analog circuitry to implement as compared to typical pre-amplifier implementations. The exemplary electrode device can be particularly useful in being employed in new sensing environments that are highly noisy while providing low power performance (as well as non-noisy and conventionally used environments). It can facilitate long-term-wearable biosensing applications and can be manufactured with over-the-counter parts or custom (but cheap) circuit board designs, in contrast to the current state of the art, which requires specially designed and fabricated integrated circuits (or use as disposable or short-term applications and/or using expensive and complex circuitries).
Table 1 shows a comparison of the performance of the exemplary electrode device to other contact sensor designs.
The following describes an example implementation of a standard non-contact biosensor. While motion is a significant concern, low coupling factor biosensors can still find use in applications with excellent patient adhesion. Applications for this style of biosensor could be in tightly bound mechanical wearables, such as watches or headbands.
Since the operating point is defined by exploiting the anti-parallel diodes between the amplifier inputs, the DC-level is not well defined due to component variation. To combat this, the buffer pre-amplifier is high-pass filtered (sub-1 Hz corner) and fed to the second amplifier in the package to drive the cable. The MAX40077 has an input capacitance of 7 pF. In this design, a minimally acceptable coupling factor of 0.5 was used as a design target. Thus, the sensing plate is sized to be 7 pF at 1 mm.
To minimize parasitics, the board-level design was implemented on a four-layer stack-up 701, as illustrated in
As previously presented, the coupling factor of previous cap-mode biosensors degrades dramatically with motion. Similarly, in preamplifier designs with gain [7][8], where the gain is defined as a function of the feedback capacitor and the input (sense) capacitor, the performance may degrade because of motion. One could implement a system where an out-of-band signal is driven to the body and then picked off from the signal chain, with the goal of deriving the sense capacitance in real time. However, this adds complexity to the system and relies on a known good connection somewhere on the body.
However, these capacitive-type amplifier configurations, according to the principles described herein, hold an exciting characteristic. Their in-band gain is given by:
The sense capacitor is fabricated in process as a PCB thin foil layer fill coupled to the patient body. While the design is intrinsically weakened by the mechanical reality of the use case, this also provides the designer with the opportunity to control aspects of the design. Using rigid-flex polyimide fabrication processes, one can not only create the sensing capacitor in the fabrication process, but also the feedback capacitor. This is illustrated in
In mechanically constrained wearables, such as helmets, it is standard to have compressible pads, typically made from foam, to act as cushions for comfort. The described electrode can be integrated within pads, reducing motion artifact since displacement currents induced at the sense interface cancel each other out. Schematically, the simple circuit structure is shown in
The exemplary electrode device can be configured with an active guard circuitry and shields, e.g., to degradation of the gain at large distances, e.g., from fringe capacitance that may be formed between the input and output of the amplifier.
A sensor device, according to principles described herein, may include an amplifier having a first input terminal, a second input terminal, and an output; a dielectric body; a capacitive sensor disposed on the dielectric body and having an output coupled to the first input terminal of the amplifier; a feedback capacitor having a first capacitive plate coupled to the output of the capacitive sensor and the first input terminal of the amplifier and having a second capacitive plate coupled to the output of the amplifier.
The dielectric body may include a compressible material, such as compressible foam. The dielectric body may include an adhesive.
The second input terminal of the amplifier may be tied to ground when using a bipolar supply. The second input terminal of the amplifier may be connected to a mid supply when using a unipolar supply.
The amplifier may actively bias the feedback capacitor with a negative potential to substantiate an equal but opposite charge to the first capacitive plate of the feedback capacitor connected to the input of the amplifier.
The feedback capacitor may be a variable capacitor.
The capacitive sensor may be formed by a first capacitive plate configured to comprise a sensing capacitor in combination with the dielectric body when in proximity with a body acting as a second capacitive plate.
The output of the amplifier may have a constant gain defined by capacitance Cs of the capacitive sensor and capacitance Cf of the feedback capacitor. The gain may be defined as Cs/Cf. Capacitance Cs of the capacitive sensor and capacitance Cf of the feedback capacitor may track together with the proximity of the capacitive sensor to a body acting as a second capacitive plate of the capacitive sensor.
The body may be skin. The skin may be human skin.
The first input terminal of the amplifier may be an inverting terminal, and the second input terminal of the amplifier may be a non-inverting terminal.
The sensor may further include a guard circuit protecting the capacitive sensor from fringe capacitance.
The sensor may be wearable. The sensor device is incorporated into a wearable device.
The sensor device may be employed for ECG, EMG or EEG measurements.
A biosensor according to principles described herein may include a flexible substrate; a first feedback capacitive plate on the flexible substrate; a second feedback capacitive plate on the flexible substrate; a sensor capacitive plate on the flexible substrate; and a biasing circuit connected between the second feedback capacitive plate, and the first feedback capacitive plate, wherein the first feedback capacitive plate is coupled to the sensor capacitive plate.
The biasing circuit may be an amplifier.
In an aspect, the flexible substrate may have a first side and a second side, with the first feedback capacitive plate on the first side of the flexible substrate; the second feedback capacitive plate is on the second side of the flexible substrate, and the sensor capacitive plate on the first side of the flexible substrate.
The flexible substrate may have a first side and a second side with the first feedback capacitive plate, the second feedback capacitive, and the sensor capacitive plate on the first side of the flexible substrate.
The biosensor may be wearable. The biosensor may be incorporated into a wearable device. The biosensor may include an adhesive on the flexible substrate.
The biosensor may be employed for ECG, EMG, or EEG measurements.
The flexible substrate may be made of polyimide.
The biosensor may include a foam dielectric on the sensor capacitive plate on a side opposite the flexible substrate.
Throughout this application, various publications may have been referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains. While it is reported in journal/conference papers of the use and design of non-contact designs, they do not address the issue of motion artifact, capacitor divider degradation, and other aforementioned technical implementation issues discussed herein.
An early non-contact design has been described in [1′]. Ref. [2′] describes a non-contact electrode that operates with an instrumentation amplifier. Ref. [3′] discloses a non-contact electrode that operates with discrete components with a custom guard circuit.
A more recent design employs a custom silicon pre-amp with input capacitance cancellation [4′], [5′]. While strapping input capacitance can help with a gain drop-off, it may not help in addressing injected current from changes in the sensing capacitor, as can be provided by the exemplary electrode design.
Refs. [6′]-[9′] discloses a non-contact electrode sensor with input bias current compensation. This is a mixed-domain data correction technique that can use immense amounts of power and is very large.
In contrast, the exemplary electrode device is configured with a structure that can intrinsically cancel unwanted induced currents, e.g., from motion, and maintains amplifier gain across a wide range of distances.
Some references, which may include various patents, patent applications, and publications, are cited in a reference list and discussed in the disclosure provided herein. The citation and/or discussion of such references is provided merely to clarify the description of the present disclosure and is not an admission that any such reference is “prior art” to any aspects of the present disclosure described herein. In terms of notation, “[n]” corresponds to the nth reference in the list. All references cited and discussed in this specification are incorporated herein by reference in their entireties and to the same extent as if each reference was individually incorporated by reference.
Although example embodiments of the present disclosure are explained in some instances in detail herein, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the present disclosure be limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.
It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “5 approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and/or to the other particular value.
By “comprising” or “containing” or “including” is meant that at least the name compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.
In describing example embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Steps of a method may be performed in a different order than those described herein without departing from the scope of the present disclosure. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.
As discussed herein, a “subject” may be any applicable human, animal, or other organism, living or dead, or other biological or molecular structure or chemical environment, and may relate to particular components of the subject, for instance, specific tissues or fluids of a subject (e.g., human tissue in a particular area of the body of a living subject), which may be in a particular location of the subject, referred to herein as an “area of interest” or a “region of interest.”
The term “about,” as used herein, means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value by a variance of 10%. In one aspect, the term “about” means plus or minus 10% of the numerical value of the number with which it is being used. Therefore, about 50% means in the range of 45%-55%. Numerical ranges recited herein by endpoints include all numbers and fractions subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.90, 4, 4.24, and 5).
Similarly, numerical ranges recited herein by endpoints include subranges subsumed within that range (e.g., 1 to 5 includes 1-1.5, 1.5-2, 2-2.75, 2.75-3, 3-3.90, 3.90-4, 4-4.24, 4.24-5, 2-5, 3-5, 1-4, and 2-4). It is also to be understood that all numbers and fractions thereof are presumed to be modified by the term “about.”
The following patents, applications and publications as listed below and throughout this document are hereby incorporated by reference in their entirety herein.
It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
Throughout this application, various publications may have been referenced. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains.
The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.
While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the present invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.
This application claims the priority benefit of U.S. Provisional Patent Application Ser. No. 63/305,364, filed Feb. 1, 2022, entitled “Active Biosensing Electrode Design,” which application is hereby incorporated by this reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2023/012088 | 2/1/2023 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63305364 | Feb 2022 | US |