FLUID MONITORING DEVICE INCLUDING IMPEDANCE SENSING ELEMENT
20220022768 · 2022-01-27
Inventors
- Myungchan Kang (Woodbury, MN, US)
- Jaewon Kim (Woodbury, MN, US)
- Jung-ju Suh (Seoul, KR)
- Chekhua Chua (Shanghai, CN)
Cpc classification
A61B2562/18
HUMAN NECESSITIES
A61B5/053
HUMAN NECESSITIES
A61M5/14
HUMAN NECESSITIES
A61M5/002
HUMAN NECESSITIES
A61B2562/164
HUMAN NECESSITIES
International classification
A61B5/053
HUMAN NECESSITIES
A61B5/00
HUMAN NECESSITIES
A61M5/00
HUMAN NECESSITIES
Abstract
Fluid monitoring devices (100,200,700) including an impedance sensing element (110,210,410,510,610,710,61,62,63) are provided. The impedance sensing element (110,210,410,510,610,710,61,62,63) includes a calibration portion (212, 412, 512, 612, 712) and a measurement portion (214,414,514,614,714), and the fluid monitoring devices (100,200,700) can be self-calibrated in real time based on calibration data from the calibration portion (212,412,512,612,712).
Claims
1. A flexible sensor for fluid monitoring comprising: a flexible substrate having a first side and a second side opposite the first side; an impedance sensing element disposed on the first side of the flexible substrate; and a circuit unit functionally connected to the sensing element to receive data related to an impedance of the impedance sensing element from the impedance sensing element and process the data, wherein the impedance sensing element includes a calibration portion and a measurement portion electrically connected to the calibration portion, the calibration portion configured to generate calibration data, and the measurement portion configured to generate measurement data, and wherein the circuit unit is configured to calibrate the measurement data based on the calibration data.
2. The sensor of claim 1, further comprising an adhesive layer disposed on the first side of the flexible substrate.
3. The sensor of claim 2, further comprising a shielding layer disposed on the second side of the flexible substrate.
4. The sensor of claim 1, wherein the impedance sensing element includes an array of interdigitated electrodes.
5. The sensor of claim 4, wherein the calibration portion includes a first portion of the interdigitated electrodes, and the measurement portion includes a second portion of the interdigitated electrodes.
6. The sensor of claim 5, wherein the first and second portions are oriented substantially orthogonal with respect to each other.
7. The sensor of claim 5, wherein the first and second portions have different configurations.
8. The sensor of claim 1, wherein the calibration portion and the measurement portion have different configurations to generate the respective adjacent first and second segments of impedance-related property versus fluid level, the first and second segments having different slopes.
9. The sensor of claim 8, wherein the slope of the first segment of the calibration portion is greater than that of the second segment of the measurement portion.
10. The sensor of claim 1, wherein the impedance sensing element further includes a third portion configured to generate warning data, the third portion having a configuration different from the measurement portion.
11. The sensor of claim 1, wherein the impedance sensing element has a rotational symmetric configuration such that the generated data are substantially independent from an orientation of the impedance sensing element.
12. An intravenous (IV) injection package comprising: a fluid container to contain fluid; and the flexible sensor of claim 1 attached to an outer side of the fluid container.
13. A method of monitoring fluid, the method comprising: providing an impedance sensing element including a calibration portion and a measurement portion electrically connected to the calibration portion; disposing the impedance sensing element adjacent to a volume of fluid to be monitored; varying the fluid volume such that a fluid level thereof continuously runs across the calibration portion and the measurement portion of the sensor in sequence; and measuring an impedance-related property of the impedance sensing element when varying the fluid volume to obtain a plot of impedance-related property versus fluid level, wherein the plot has a calibration segment corresponding to the calibration portion of the sensor and a measurement segment corresponding to the measurement portion of the impedance sensing element, the calibration segment and the measurement segment are connected at a transitional point.
14. The method of claim 13, further comprising calibrating, via a circuit unit, the impedance sensing element based on the calibration segment of the plot.
15. The method of claim 14, further comprising determining, via the circuit unit, the fluid level based on the measurement segment of the plot after the calibration.
16. The method of claim 13, further comprising integrating the impedance sensing element to a flexible sensor including an adhesive layer on a first side of the flexible sensor to cover the impedance sensing element.
17. The method of claim 16, further comprising providing a shielding layer disposed on a second side of the flexible sensor opposite the first side.
18. The method of claim 13, wherein the calibration segment and the measurement segment have different slopes adjacent the transitional point.
19. The method of claim 13, wherein the slope of the calibration segment is greater than that of the measurement segment.
20. The method of claim 13, wherein the impedance sensing element has a rotational symmetric configuration such that the measured impedance-related property is substantially independent from an orientation of impedance sensing element with respect to the fluid level.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The disclosure may be more completely understood in consideration of the following detailed description of various embodiments of the disclosure in connection with the accompanying figures, in which:
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[0029] In the drawings, like reference numerals indicate like elements. While the above-identified drawing, which may not be drawn to scale, sets forth various embodiments of the present disclosure, other embodiments are also contemplated, as noted in the Detailed Description. In all cases, this disclosure describes the presently disclosed disclosure by way of representation of exemplary embodiments and not by express limitations. It should be understood that numerous other modifications and embodiments can be devised by those skilled in the art, which fall within the scope and spirit of this disclosure.
DETAILED DESCRIPTION
[0030] The present disclosure provides fluid monitoring devices including impedance sensing elements, and methods of making and using the devices.
[0031]
[0032] The fluid monitoring device 100 further includes an adhesive layer 130 on the first side 122 of the flexible substrate 120, configured to attach the device 100 to a fluid container 2 such as, for example, an intravenous (IV) bag. In some embodiments, an optional encapsulating layer can be provided between the adhesive layer 130 and the flexible substrate 120 to protect the impedance sensing element 110 and/or other circuitries on the flexible substrate 120. The optional encapsulating layer can be, for example, a polymeric layer or other suitable coating layers to prevent direct moisture contact to the impedance sensing element 110. A releasable liner can be used to protect the adhesive surface of the adhesive layer 130 before use. In some embodiments, the fluid monitoring device 100 includes an optional shielding layer 140 on the second side 124 of the flexible substrate 120, configured to shield electromagnetic interference (EMI) from the impedance sensing element 110. The shielding layer 140 may be made of any electrically conductive materials such as, for example, copper, transparent conductors, etc.
[0033] In the depicted embodiment of
[0034] It is to be understood that an impedance sensing element described herein can be any suitable impedance sensing element other than an interdigitated capacitor as long as it can monitor the adjacent fluid by measuring its impedance-related property. For example, in some embodiments, the impedance sensing element may include one or more parallel-plates capacitors or other suitable types of capacitors.
[0035] The device 100 further includes a circuit unit 150 functionally connected to the sensing element 110 to receive data related to an impedance of the impedance sensing element 110 from the impedance sensing element 110 and process the data to obtain fluid-volume-related information. In some embodiments, the circuit unit 150 may include a microprocessor to process the data. In some embodiments, the circuit unit 150 may include a wireless component such as, for example, a Bluetooth Low Energy (BLE) component. It is to be understood that a fluid monitoring device described herein can integrate with any suitable functional circuitry to make use of an impedance sensing element thereof.
[0036] When the fluid monitoring device 100 is attached to the outside 21 of the fluid container 2, the impedance sensing element 110 is oriented with its elongation direction 3 substantially parallel to a vertical direction 5, substantially perpendicular to a fluid level B of the fluid inside the container 2, as shown in
[0037] The measured plots may vary, for example, depending on the dielectric property of the fluid contained in the fluid container. As shown in
[0038]
[0039] When the fluid monitoring device 200 is attached to an outside of a fluid container containing fluid, the impedance sensing element 210 is oriented such that the calibration portion 212 is substantially along a horizontal direction and the calibration portion 214 is substantially along a vertical direction. The calibration portion 212 and the measurement portion 214 form an up-side-down “L” shape. Along the vertical direction 5, the calibration portion 212 extends between positions B1 and B2 with a vertical length D1, and the measurement portion 214 extends between positions B2 and B3 with a vertical length D2. In some embodiments, the ratio of the vertical length D1 over the vertical length D2 may be in the range, for example, 0.01 to 1. A relatively short vertical length D1 can help to quickly calibrate the sensing element, while a relatively long vertical length D2 can provide an elongated window to quantitively monitor the fluid level.
[0040] An impedance-related property (e.g., impedance, admittance, capacitance, conductance, etc.) of the impedance sensing element 210 can be measured upon the variation of the fluid level B along the vertical direction 5.
[0041] For a given fluid to be measured, the slopes S1 and S2 of the segments 201 and 202 can be determined by the configurations of the respective portions 212 and 214. In the depicted embodiment, the portions 212 and 214 have different orientations and produce segments having different slopes S1 and S2, where the position B2 is a transitional point connecting the calibration portion 212 and the measurement portion 214, and the slope changes from S1 to S2 across the transitional point. In some embodiments, S1 can be greater than S2, and the ratio of S1/S2 can be in the range of, for example, about 1 to about 10.
[0042] The fluid level or volume in the fluid container can be determined in real time based on the measured impedance-related property (e.g., impedance, admittance, capacitance, conductance, etc.) versus fluid level plot having a calibration segment and a measurement segment such as, for example, the plot of
[0043] The fluid monitoring device 200 can be used to determine a fluid level or volume of an unknown fluid in the fluid container.
[0044]
[0045] At 320, the impedance sensing element is disposed adjacent to a fluid to be monitored. In some embodiments, the impedance sensing element can be disposed on an outside of a fluid container, for example, an infusion line or a fluid bag of an intravenous (IV) therapy. The process 300 then proceeds to 330.
[0046] At 330, an impedance-related property of the impedance sensing element is measured when a fluid level runs across the calibration portion to obtain calibration data. In the depicted embodiment of
[0047] At 340, when the fluid level runs across the measurement portion, the impedance sensing element continues to measure the impedance-related property to obtain measurement data. In the depicted embodiment of
[0048] At 350, the impedance sensing element is calibrated, via a circuit unit or a microprocessor, based on the calibration data. In some embodiments, the slopes of a calibration segment (e.g., S1 of segment 201 in
[0049] At 360, the fluid level of the fluid to be monitored is determined, via the circuit unit, based on the measurement data with the calibration at 350. It is to be understood that the impedance-related property of the sensing element may linearly or non-linearly vary with the fluid level (or fluid volume). Such a linear or non-linearly relationship can be used to calibrate the measurement data and determine various fluid properties (e.g., a fluid volume, a fluid level, a fluid flow rate, etc.) based on the calibrated measurement data.
[0050] The impedance sensing elements described herein may have various configurations and can be utilized to implement a self-calibration process such as the method 300 to determine various fluid properties (e.g., a fluid volume, a fluid level, a fluid flow rate, etc.) of an unknown fluid.
[0051] In the embodiment of
[0052] In the embodiment of
[0053] In the embodiment of
[0054] While
[0055]
[0056] An impedance-related property (e.g., impedance, admittance, capacitance, conductance, etc.) of the sensing element 710 can be measured upon the variation of fluid level B along the vertical direction 5.
[0057] For a given fluid to be measured, the respective slopes S1, S2 and S3 of the segments 701, 702 and 703 may be determined by the configurations of the respective portions 712, 714 and 716. In the depicted embodiment, the portions 712 and 716 have the same orientations and produce segments having substantially the same slopes (e.g., S1=S3); the portions 712/716 and 714 have different orientations and produce segments having different slopes (e.g., S1 or S3 greater than S2).
[0058] The fluid level or volume in the fluid container can be determined in real time based on a plot of impedance-related property (e.g., impedance, admittance, capacitance, conductance, etc.) versus fluid level, where the plot has a calibration segment and a measurement segment such as, for example, the plot of
[0059] When the fluid level reaches the position B3, a transitional point between the measurement portion 714 and the bottom portion 716, and runs across the bottom portion 716, the fluid monitoring device can detect the change of slopes from S2 to S3 and generate desired signals such as, for example, a warning signal.
[0060] In some embodiments, an impedance sensing element described herein may have a symmetric configuration. In the embodiment depicted in
[0061] In the embodiment depicted in
[0062] In the embodiment depicted in
[0063] An impedance sensing element with a symmetric configuration can exhibit certain orientation-independency. For example, its impedance measurement can be independent from its orientation with respective to its center point (e.g., 61c, 62c, or 63c in
[0064] It is to be understood that an impedance sensing element can have any suitable symmetric configuration as long as the corresponding plots of impedance (admittance capacitance, conductance, etc.) versus fluid level can exhibit at least one transitional position (e.g., B2 in
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[0066] Unless otherwise indicated, all numbers expressing quantities or ingredients, measurement of properties and so forth used in the specification and embodiments are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached listing of embodiments can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings of the present disclosure. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claimed embodiments, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
[0067] Exemplary embodiments of the present disclosure may take on various modifications and alterations without departing from the spirit and scope of the present disclosure. Accordingly, it is to be understood that the embodiments of the present disclosure are not to be limited to the following described exemplary embodiments, but is to be controlled by the limitations set forth in the claims and any equivalents thereof.
[0068] Listing of Exemplary Embodiments
[0069] Exemplary embodiments are listed below. It is to be understood that any one of embodiments 1-12 and 13-20 can be combined.
Embodiment 1 is a flexible sensor for fluid monitoring comprising:
[0070] a flexible substrate having a first side and a second side opposite the first side;
[0071] an impedance sensing element disposed on the first side of the flexible substrate; and
[0072] a circuit unit functionally connected to the sensing element to receive data related to an impedance of the impedance sensing element from the impedance sensing element and process the data,
[0073] wherein the impedance sensing element includes a calibration portion and a measurement portion electrically connected to the calibration portion, the calibration portion configured to generate calibration data, and the measurement portion configured to generate measurement data, and
[0074] wherein the circuit unit is configured to calibrate the measurement data based on the calibration data.
Embodiment 2 is the sensor of embodiment 1, further comprising an optional encapsulating layer and an adhesive layer disposed on the first side of the flexible substrate.
Embodiment 3 is the sensor of embodiment 2, further comprising a shielding layer disposed on the second side of the flexible substrate.
Embodiment 4 is the sensor of any one of embodiments 1-3, wherein the impedance sensing element includes an array of interdigitated electrodes.
Embodiment 5 is the sensor of embodiment 4, wherein the calibration portion includes a first portion of the interdigitated electrodes, and the measurement portion includes a second portion of the interdigitated electrodes.
Embodiment 6 is the sensor of embodiment 5, wherein the first and second portions are oriented substantially orthogonal with respect to each other.
Embodiment 7 is the sensor of embodiment 5 or 6, wherein the first and second portions have different configurations.
Embodiment 8 is the sensor of any one of embodiments 1-7, wherein the calibration portion and the measurement portion have different configurations to generate the respective adjacent segments of impedance-related property versus fluid level, the segments having different slopes.
Embodiment 9 is the sensor of embodiment 8, wherein the slope of a calibration segment is greater than that of a measurement segment.
Embodiment 10 is the sensor of any one of embodiments 1-9, wherein the impedance sensing element further includes a third portion configured to generate warning data, the third portion having a configuration different from the measurement portion.
Embodiment 11 is the sensor of any one of embodiments 1-10, wherein the impedance sensing element has a rotational symmetric configuration such that the generated data are substantially independent from an orientation of the impedance sensing element.
Embodiment 12 is an intravenous (IV) injection package comprising:
[0075] a fluid container to contain fluid; and
[0076] the flexible sensor of any one of embodiments 1-11 attached to an outer side of the fluid container.
Embodiment 13 is a method of monitoring fluid, the method comprising:
[0077] providing an impedance sensing element including a calibration portion and a measurement portion electrically connected to the calibration portion;
[0078] disposing the impedance sensing element adjacent to a volume of fluid to be monitored;
[0079] varying the fluid volume such that a fluid level thereof continuously runs across the calibration portion and the measurement portion of the sensor in sequence; and
[0080] measuring an impedance-related property of the impedance sensing element when varying the fluid volume to obtain a plot of impedance-related property versus fluid level, [0081] wherein the plot has a calibration segment corresponding to the calibration portion of the sensor and a measurement segment corresponding to the measurement portion of the impedance sensing element, the calibration segment and the measurement segment are connected at a transitional point.
Embodiment 14 is the method of embodiment 13, further comprising calibrating, via a circuit unit, the impedance sensing element based on the calibration segment of the plot.
Embodiment 15 is the method of embodiment 14, further comprising determining, via the circuit unit, the fluid level based on the measurement segment of the plot after the calibration.
Embodiment 16 is the method of any one of embodiments 13-15, further comprising integrating the impedance sensing element to a flexible sensor including an adhesive layer on a first side of the flexible sensor to cover the impedance sensing element.
Embodiment 17 is the method of embodiment 16, further comprising providing a shielding layer disposed on a second side of the flexible sensor opposite the first side.
Embodiment 18 is the method of any one of embodiments 13-17, wherein the calibration segment and the measurement segment have different slopes adjacent the transitional point.
Embodiment 19 is the method of any one of embodiments 13-18, wherein the slope of the calibration segment is greater than that of the measurement segment.
Embodiment 20 is the method of any one of embodiments 13-19, wherein the impedance sensing element has a rotational symmetric configuration such that the measured impedance-related property is substantially independent from an orientation of impedance sensing element with respect to the fluid level.
[0082] Reference throughout this specification to “one embodiment,” “certain embodiments,” “one or more embodiments,” or “an embodiment,” whether or not including the term “exemplary” preceding the term “embodiment,” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the certain exemplary embodiments of the present disclosure. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in one embodiment,” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the certain exemplary embodiments of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.
[0083] While the specification has described in detail certain exemplary embodiments, it will be appreciated that those skilled in the art, upon attaining an understanding of the foregoing, may readily conceive of alterations to, variations of, and equivalents to these embodiments. Accordingly, it should be understood that this disclosure is not to be unduly limited to the illustrative embodiments set forth hereinabove. In particular, as used herein, the recitation of numerical ranges by endpoints is intended to include all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). In addition, all numbers used herein are assumed to be modified by the term “about.”
[0084] Furthermore, various exemplary embodiments have been described. These and other embodiments are within the scope of the following claims.