WO2016206632A1

WO2016206632A1 - Rapid measurement device based on bioimpedance technique and method thereof

Info

Publication number: WO2016206632A1
Application number: PCT/CN2016/087088
Authority: WO
Inventors: 徐现红; 戴涛; 高松
Original assignee: 思澜科技（成都）有限公司
Priority date: 2015-06-25
Filing date: 2016-06-24
Publication date: 2016-12-29
Also published as: CN105286863A

Abstract

A rapid measurement device based on a bioimpedance technique for a tissue and method thereof. The measurement device comprises an array probe (100), a switch unit (200), a signal excitation unit (300), a signal acquisition unit (400) and an analysis processing unit (500). The array probe (100) is respectively connected to the signal excitation unit (300) and the signal acquisition unit (400) via the switch unit (200). The array probe (100) comprises a substrate (101) and an electrode array (102) embedded in the substrate. The electrode array (102) has N × M electrodes arranged in an array and forming multiple testing regions to perform bioimpedance measurement with two or four electrodes as a unit. The method realizes testing of a biological tissue to be tested at different depths and surfaces by increasing testing regions and reducing the number of repeating selection operation, thus achieving comprehensiveness and preventing omissions in a test.

Description

Rapid measuring device based on bioimpedance technology and method thereof

Technical field

The invention belongs to the field of bioimpedance measurement, and in particular relates to a rapid measuring device based on bioimpedance technology and a method thereof.

Background technique

At present, in the clinical biopsy process of hospitals, frozen biopsy or paraffin biopsy is usually used. The test results of the two have great requirements on the individual identification ability of the inspectors, so they are very subjective. Scientific research shows that different tissues have different impedance spectrum characteristics, so the bio-impedance spectrum characteristics of the target can be accurately identified, but in the actual operation process, the tissue to be detected is different, especially the size of the abnormal lesion. Different, and may exist in any part of the measured tissue, resulting in the measurement results can not effectively reflect the characteristics of the tissue. If the impedance characteristics of the diseased tissue are to be accurately measured, the coverage of the impedance detection electrode is required to be small enough, but when the impedance is detected After the electrode coverage is small enough, it is necessary to repeatedly perform multiple detections on the measured tissue, and it is easy to cause missed detection, resulting in low detection efficiency, thereby reducing measurement effectiveness.

Summary of the invention

In view of the deficiencies of the prior art described above, it is an object of the present invention to provide a rapid measurement device based on bioimpedance technology and a method thereof that are accurate, efficient, and avoiding missed detection.

In order to achieve the above object, the technical solution adopted by the present invention is as follows:

A rapid measuring device based on bioimpedance technology, the measuring device comprises an array probe, a switching unit, a signal excitation unit, a signal acquisition unit and an analysis processing unit, wherein the electrode array of the probe is respectively connected to the signal excitation unit by a switching unit Connected to the signal acquisition unit, wherein the array probe comprises a substrate and an electrode array embedded on the substrate, the electrode array is arranged by N×M electrodes and formed in two or four The electrodes are a plurality of detection areas for bioimpedance measurement of the unit.

Preferably, the analysis processing unit outputs the excitation signal generated by the signal excitation unit to the designated two electrodes through the switching unit, and connects the two electrodes in the switching unit selection electrode array to the signal acquisition unit, and detects the excitation. The signal and the acquisition signal calculate impedance characteristics of the tissue covered by the excitation electrode and the acquisition electrode.

Preferably, the detection area includes a minimum detection area and a combined detection area.

Further preferably, the minimum detection area is any two adjacent electrodes detecting the area covered by the biological tissue to be tested.

Further preferably, the combined detection area detects the area covered by the biological tissue to be tested by any two non-adjacent electrodes overlapping the minimum detection area.

In order to achieve the above object, another technical solution adopted by the present invention is as follows:

A rapid measurement method based on bioimpedance technology, the specific steps of which are as follows:

Switching control of any two adjacent electrodes one by one to detect a first impedance spectrum of a plurality of minimum detection regions of a region covered by the biological tissue to be tested, and obtaining a first impedance spectral characteristic parameter set X(i), where i=1, 2 ,...n;

Then, the second impedance spectrum of the plurality of combined detection regions of the area covered by the biological tissue to be tested is detected by switching any two non-adjacent electrodes of the overlap detection minimum detection area one by one, and the second impedance spectrum characteristic parameter set Y(j) is obtained. , where j=1, 2, . . . n.

Preferably, whether the impedance spectrum characteristics of the biological tissue to be tested covered by the detected first impedance spectral characteristic parameter set X(i) or the second impedance spectral characteristic parameter set Y(j) conform to relevant organizations in the clinical bioimpedance database Characteristics.

Preferably, the area of the combined detection area does not exceed 100 times the area of the minimum detection area.

Switching control of any four adjacent electrodes one by one to detect a first impedance spectrum of a plurality of minimum detection regions of a region covered by the biological tissue to be tested, and obtaining a first impedance spectral feature parameter set X(i), where i=1, 2 ,...n;

And then switching the second impedance spectrum of the plurality of combined detection regions of the area covered by the biological tissue to be tested by any four non-adjacent electrodes that control the overlapping minimum detection area one by one, and obtaining the second impedance spectrum characteristic parameter set Y(j) , where j=1, 2, . . . n.

Preferably, whether the impedance spectrum characteristics of the biological tissue to be tested covered by the first impedance spectral characteristic parameter set X(i) or the second impedance spectral characteristic parameter set Y(j) detected are in accordance with relevant organizations in the clinical bioimpedance database feature.

After adopting the above technical solution, the advantages of the present invention compared with the prior art are:

1. In the prior art, a four-electrode impedance or a two-electrode impedance measurement scheme using a fixed electrode tip size, the electrode size and the arrangement manner are fixed, and are sensitive only to detection targets within a specific size and depth, and the resolution is limited; The automatic switching control detects the impedance spectrum of the minimum detection area and the impedance spectrum of the combined detection area, and mutually verifies the impedance spectrum of the combined detection area of the minimum detection area and the detection area of the minimum detection area to improve the measurement accuracy;

2. The prior art needs to select points on the target to be measured and measure multiple times, which not only has low measurement efficiency, but also is easy to miss detection; the invention can measure the microscopic and different scales (change the measurement electrode spacing) of the measured object through Increasing the number of detection electrodes can ensure the sensitivity of the minimum detection area, that is, by increasing the detection area, reducing the number of repeated selection points measurement, and reducing the probability of missed detection;

3. The present invention is advantageous for quickly locating the position of a tissue in a biological tissue to be tested compared to the prior art.

DRAWINGS

The present invention is further described below in conjunction with the accompanying drawings and embodiments:

1 is a schematic structural view of a measuring device according to Embodiment 1 of the present invention;

2 is a schematic view showing the arrangement and arrangement of the electrode arrays according to the first embodiment of the present invention;

3 is a schematic diagram of a switching state of a switching unit according to Embodiment 1 of the present invention;

4 is a schematic flow chart of a measurement method according to Embodiment 2 of the present invention;

Figure 5 is a schematic diagram 1 showing the distribution of tissue P in the biological tissue to be tested;

6 is a schematic diagram of a specific operation of the measurement method according to Embodiment 2 of the present invention;

7 is a schematic flow chart of a measurement method according to Embodiment 3 of the present invention;

Figure 8 is a schematic diagram showing the distribution of tissue P in the biological tissue to be tested.

9 is a first schematic diagram 1 of a measurement method according to Embodiment 3 of the present invention;

FIG. 10 is a second schematic diagram of a specific operation of the measurement method according to Embodiment 3 of the present invention.

Reference mark:

100-electrode array, 101-substrate, 102-electrode array, 200-switching unit, 300-signal excitation unit, 400-signal acquisition unit, 500-analytical processing unit, 600-tissue sample, 700-tissue P.

detailed description

A four-electrode impedance or two-electrode impedance measurement scheme with a fixed electrode tip size is commonly used. However, the prior art solution has a fixed electrode size and arrangement, and is sensitive only to detection targets within a specific size and depth, and has limited resolution; and it is also required to select points on the biological tissue to be tested and measure multiple times, resulting in measurement. Inefficient, and easy to miss or misdetect. To this end, the present invention proposes a rapid measuring device based on bioimpedance technology and a method thereof. Rather, the invention is only a preferred embodiment of the invention and is not intended to limit the scope of the invention.

Embodiment 1

As shown in FIG. 1 and FIG. 2, an embodiment of the present invention provides a rapid measurement system based on a biological tissue impedance technique, and the measurement device includes an array probe 100, a switching unit 200, a signal excitation unit 300, a signal acquisition unit 400, and An analysis processing unit 500 is connected to the signal excitation unit 300 and the signal acquisition unit 400 by a switching unit 200, wherein the array probe 100 includes a substrate 101 and is embedded on the substrate 101. The electrode array 102 is an array of N x M electrode arrays and forms a plurality of detection regions for bioimpedance measurement in units of two or four electrodes.

In the embodiment of the present invention, the analysis processing unit 500 outputs the excitation signal generated by the signal excitation unit 300 to the designated two electrodes through the switching unit 200, and selects two electrodes in the electrode array 100 through the switching unit 200. Connected to the signal acquisition unit 400, the impedance characteristics of the tissue covered by the excitation electrode and the acquisition electrode are calculated by detecting the excitation signal and the acquisition signal.

The detection area includes a minimum detection area and a combined detection area, wherein the minimum detection area is any two or four adjacent electrodes detecting a coverage area of the biological tissue to be tested; and the combined detection area is an arbitrary overlap detection area Two or four non-adjacent electrodes detect the area covered by the biological tissue to be tested. In the embodiment of the present invention, four electrodes are mainly taken as an example.

As shown in FIG. 3, in the embodiment of the present invention, any four electrodes of each detection area have any two adjacent electrodes as excitation electrode pairs, and any adjacent two electrodes are collection electrode pairs, wherein the excitation electrode pairs Applying an excitation positive and negative signal, the collection electrode pair is responsible for collecting a voltage signal or a current signal on the excited target (the biological tissue to be tested); and the switching electrode control is performed to cover each set of adjacent electrodes through the switch switching control and respectively performing signal acquisition Bioimpedance measurement to achieve a full range of bioimpedance measurements of the biological tissue being tested. The switching unit 200 in the embodiment of the present invention is a switch array composed of multiple switches or multiple switches.

In the embodiment of the present invention, the electrode array arrangement and the switching control electrode signal excitation and signal acquisition are used to change the actual detection coverage of the biological tissue to be tested. In the embodiment of the present invention, the excitation electrode and the collection electrode coverage area are any four adjacent electrodes detecting the coverage area of the biological tissue to be tested (minimum detection area) or the detection of any four non-adjacent electrodes overlapping the minimum detection area. The area covered by the biological tissue to be tested (combined detection area). In addition, the excitation electrode and the collection electrode coverage area may be any two adjacent electrodes detecting the area covered by the biological tissue to be tested (minimum detection area) or any two non-adjacent electrodes overlapping the minimum detection area. The area covered by the biological tissue (combined detection area).

Therefore, the embodiment of the invention can realize all-round dead angle detection of different depths and areas of the biological tissue to be tested, thereby effectively avoiding missed detection or misdetection; and also facilitating assisting one of the measured impedance characteristic parameters of the biological tissue to be tested. The location of the organization. It is especially suitable for large-scale microscopic and macroscopic analysis of large biological tissues to be tested.

In order to facilitate the understanding of the measurement method of the embodiment of the present invention, the following is an example of an electrode array regularly distributed by 3×3 electrodes, and the above is only a preferred embodiment of the present invention, and thus does not limit the protection of the present invention. range.

Embodiment 2

As shown in FIG. 4, FIG. 5 and FIG. 6, the embodiment of the present invention provides a rapid measurement method based on bioimpedance technology, which contacts the probe 10 with the biological tissue to be tested; the specific steps of the measurement method are as follows:

Switching control of any two adjacent electrodes one by one to detect a first impedance spectrum of a plurality of minimum detection regions D1, D2, D3 of a region covered by the biological tissue to be tested, and obtaining a first impedance spectral characteristic parameter set X(i)X ( i) ∈{X(1), X(2), X(3)};

And then switching the second impedance spectra of the plurality of combined detection regions E1, E2, and E3 of the coverage area of the biological tissue to be tested by any two non-adjacent electrodes that control the overlapping minimum detection regions D1, D2, and D3 one by one, and obtain the first The two impedance spectrum characteristic parameter set Y(j) ∈ {Y(1), Y(2), Y(3)}.

In order to ensure that the impedance spectrum characteristics detected by the present invention are accurate, the method of the embodiment of the present invention further includes comparing the detected first impedance spectrum characteristic parameter set X(i)X(i)∈{X(1), X(2). ), X(3)} or the impedance spectrum characteristics of the tissue samples covered by the second impedance spectral characteristic parameter set Y(j)∈{Y(1), Y(2), Y(3)} conform to the clinical bioimpedance Relevant organizational characteristics in the database. The clinical biological tissue impedance database is a database for acquiring impedance spectral characteristic parameters of biological tissues according to clinical experiments.

The detected first impedance spectral characteristic parameter set X(i)X(i)∈{X(1), X(2), X(3)} and the clinical biological tissue impedance database verify that each minimum detection is obtained. Whether the impedance spectrum characteristic parameters of the biological tissue to be tested corresponding to the regions D1, D2, and D3 are consistent. The detected second impedance spectral characteristic parameter set Y(j) ∈{Y(1), Y(2), Y(3)} and the clinical biological tissue impedance database verify that each combined detection area E1, E2 Whether the impedance spectrum characteristic parameters of the biological tissue to be tested corresponding to E3 are consistent.

Since the impedance frequency characteristic parameters of each of the minimum detection area and the combined detection area are detected, it is compared with the impedance frequency characteristic parameter of the tissue related to the clinical bioimpedance database to determine whether it is consistent; and the research shows that the smaller the detection area, the detected tissue area and depth The smaller the analysis, the analysis of different detection areas can be used to analyze the tissue characteristics of different depths and regions of the biological tissue. In an embodiment of the invention, the combined detection area does not exceed 100 times the area of the minimum detection area. Therefore, the embodiment of the invention can realize all-round and no-angle impedance measurement of different depths and surfaces of the tissue sample, thereby avoiding missed detection.

In addition, the method described in the embodiments of the present invention is useful for assisting in locating the location of a certain tissue in the biological tissue to be tested. The specific brief description is as follows: switching the control of any two adjacent electrodes one by one to detect the first impedance spectrum of the minimum detection areas D1, D2, D3 of the area covered by the biological tissue to be tested, and obtain the first impedance spectrum characteristic parameter set X ( i) ∈{X(1), X(2), X(3)}; the detected first impedance spectral characteristic parameter set X(i) ∈ {X(1), X(2), X(3 Whether the comparison is performed with the clinical biological tissue impedance database, wherein the clinical biological tissue impedance database establishes a database for acquiring impedance spectral characteristic parameters of the relevant tissue according to clinical experiments; and then switching the control of the overlapping minimum detection region D3 one by one. Two non-adjacent electrodes detect a second impedance spectrum of the combined detection regions E1, E2, E3 of the area covered by the biological tissue to be tested, and obtain a second impedance spectrum characteristic parameter set Y(j) ∈ {Y(1), Y(2), Y(3)}; performing the detected second impedance spectral characteristic parameter set Y(j) ∈{Y(1), Y(2), Y(3)} and the clinical biological tissue impedance database The alignment analysis is consistent. Since the intersection of the minimum detection area D3 and the combination area E3 is D3, the impedance characteristic of the tissue P700 in the biological tissue to be tested corresponding to the detection detection area D3 is located, so that the tissue is located in the biological tissue area covered by the detection area D3. It also allows the user to move the probe position for better measurement.

Embodiment 3

As shown in FIG. 7, FIG. 8, FIG. 9, and FIG. 10, the embodiment of the present invention provides a rapid measurement method based on bioimpedance technology, which contacts the probe 10 with the biological tissue to be tested; the specific steps of the measurement method are as follows:

Switching one by one to control the first impedance spectrum of the plurality of minimum detection areas A1, A2, A3, and A4 of the area covered by the biological tissue to be tested, and obtaining the first impedance spectrum characteristic parameter set X(i) ∈{X(1), X(2), X(3), X(4)};

And then switching the plurality of combined detection areas B1, B2, B3, B4, B5, B6, B7 of the area covered by the biological tissue to be tested by any four non-adjacent electrodes of the overlapping minimum detection areas A1, A2, A3, and A4. , the second impedance spectrum of B8, and obtain the second impedance spectrum characteristic parameter set Y(j) ∈ {Y(1), Y(2), Y(3), Y(4), Y(5), Y (6), Y(7), Y(8)}.

In order to ensure that the impedance spectrum features detected by the present invention are accurate, the method in the embodiment of the present invention further includes Including the first impedance spectral characteristic parameter set X(i) ∈ {X(1), X(2), X(3), X(4)} or the second impedance spectral characteristic parameter set Y(j) detected by the comparison. Impedance spectrum of tissue samples covered by ∈{Y(1), Y(2), Y(3), Y(4), Y(5), Y(6), Y(7), Y(8)} Whether the features meet the relevant organizational characteristics in the clinical bioimpedance database. The clinical biological tissue impedance database is a database for acquiring impedance spectral characteristic parameters of biological tissues according to clinical experiments.

The detected first impedance spectral characteristic parameter set X(i) ∈ {X(1), X(2), X(3), X(4)} and the clinical biological tissue impedance database verify that each minimum is obtained. Whether the relevant tissue impedance spectrum characteristic parameters of the biological tissue to be tested corresponding to the detection areas A1, A2, A3, and A4 are consistent. The detected second impedance spectrum characteristic parameter set Y(j) ∈ {Y(1), Y(2), Y(3), Y(4), Y(5), Y(6), Y(( 7), Y(8)} and the clinical biological tissue impedance database verify that the relevant tissue impedance spectrum characteristics of the biological tissues to be tested corresponding to each combined detection area B1, B2, B3, B4, B5, B6, B7, B8 Whether the parameters are consistent.

In addition, the method described in the embodiments of the present invention is useful for assisting in locating the location of a certain tissue in the biological tissue to be tested. As shown in FIG. 9, the nine electrodes are respectively controlled to form four minimum detection areas A1, A2, A3, and A4, and the output unit and the acquisition input are sequentially excited by the switching unit, and the output is switched to the minimum detection area according to the four-electrode measurement mode. On the four electrodes, and calculate the first impedance frequency characteristic parameter set X(i) ∈{X(1), X(2), X(3), X(4)} of the region by bioimpedance; Whether the detected first impedance spectral characteristic parameter set X(i)∈{X(1), X(2), X(3), X(4)} is consistent with the clinical biological tissue impedance database; Switching the second impedance of the combined detection areas B1 and B2 of the area covered by the biological tissue to be tested by detecting the four non-adjacent electrodes of the randomly overlapping minimum detection area A1 one by one. Spectrum, and obtain a second impedance spectrum characteristic parameter set Y(j) ∈ {Y(1), Y(2)}; and then the detected second impedance spectral characteristic parameter set Y(j) ∈ {Y(1 ), Y(2)} is consistent with the clinical biological tissue impedance database for comparison analysis. Since the intersection of the minimum detection area A1 and the combination area B1, B2 is A1, the impedance characteristic of the tissue P700 in the biological tissue to be tested corresponding to the detection detection area A1 is located, so that the tissue is located in the biological tissue to be tested covered by the detection area A1. The area also allows the user to move the probe position for better measurement.

As shown in FIG. 10, the nine electrodes are respectively controlled to form four minimum detection areas A1, A2, A3, and A4, and the output unit and the acquisition input are sequentially excited by the switching unit, and the output is switched to the minimum detection area according to the four-electrode measurement mode. On the four electrodes, and calculate the X(i) ∈{X(1), X(2), X(3), X(4)} of the region by bioimpedance; the first impedance spectrum to be detected The characteristic parameter set X(i)∈{X(1), X(2), X(3), X(4)} is consistent with the clinical biological tissue impedance database for consistency analysis; The four non-adjacent electrodes of the area A1 detect the second impedance spectrum of the combined detection areas C1 and C2 of the area covered by the biological tissue to be tested, and obtain the second impedance spectrum characteristic parameter set Y(j) ∈ {Y(1) , Y(2)}; and then compare the detected second impedance spectral characteristic parameter set Y(j) ∈{Y(1), Y(2)} with the clinical biological tissue impedance database for consistency; The intersection of the detection area A1 and the combination area C1 and C2 is A1, and the impedance characteristic of the tissue P700 in the biological tissue to be tested corresponding to the detection detection area A1 is located. Therefore, the tissue P700 is located in the biological tissue area covered by the detection area A1, and can also allow the user to appropriately move the probe position for better measurement.

The method of the invention firstly performs impedance spectrum scanning on the tissue samples one by one using the minimum detection area (focusing on the impedance detection of the surface of the biological tissue to be tested), and then adopting a combination of the minimum detection areas corresponding to the abnormal tissue existing in the biological tissue to be tested. The detection area scans the tissue samples one by one by impedance spectrum (focusing on the impedance detection of different depths of the biological tissue to be measured), and finally synthesizes the signal of the minimum detection area and the combined detection area covering the minimum detection area according to the area where the suspected lesion tissue is detected. Analysis, reconfirmation of suspected diseased tissue.

The above is only a preferred embodiment of the present invention, and those skilled in the art will have any changes in the specific embodiments and application scope according to the idea of the present invention. It should be understood that the invention is limited.

Claims

A rapid measuring device based on bioimpedance technology, the measuring device comprises an array probe, a switching unit, a signal excitation unit, a signal acquisition unit and an analysis processing unit, wherein the electrode array of the probe is respectively connected to the signal excitation unit by a switching unit Connected to the signal acquisition unit, wherein the array probe comprises a substrate and an electrode array embedded on the substrate, the electrode array is arranged by N×M electrodes and formed in two or four The electrodes are a plurality of detection areas for bioimpedance measurement of the unit.
The rapid measurement device based on bioimpedance technology according to claim 1, wherein the analysis processing unit outputs the excitation signal generated by the signal excitation unit to the designated two electrodes through the switching unit, and passes through the switching unit. The two electrodes in the electrode array are connected to the signal acquisition unit, and the impedance characteristics of the tissue covered by the excitation electrode and the acquisition electrode are calculated by detecting the excitation signal and the acquisition signal.
The rapid measurement device based on bioimpedance technology according to claim 1, wherein the detection area comprises a minimum detection area and a combined detection area.
The rapid measurement device based on bioimpedance technology according to claim 3, wherein the minimum detection area is any two adjacent electrodes detecting the area covered by the biological tissue to be tested.
The rapid measurement device based on bioimpedance technology according to claim 3, wherein the combined detection area is an area covered by the biological tissue to be tested by any two non-adjacent electrodes overlapping the minimum detection area.
A rapid measurement method based on bioimpedance technology, the specific steps of which are as follows:

Switching control of any two adjacent electrodes one by one to detect a first impedance spectrum of a plurality of minimum detection regions of a region covered by the biological tissue to be tested, and obtaining a first impedance spectral characteristic parameter set X(i), where i=1, 2 ,...n;

And then switching the second impedance spectrum of the plurality of combined detection regions of the area covered by the biological tissue to be tested by any two non-adjacent electrodes that control the overlap detection minimum area one by one, and obtaining the second impedance spectrum feature Parameter set Y(j), where j=1, 2, . . . n.
The rapid measurement method based on bioimpedance technology according to claim 6, wherein the detected first impedance spectral characteristic parameter set X(i) or the second impedance spectral characteristic parameter set Y(j) is covered Whether the impedance spectrum characteristics of the biological tissue to be tested conform to the relevant tissue characteristics in the clinical bioimpedance database.
The rapid measurement method based on bioimpedance technology according to claim 6, wherein the combined detection area does not exceed 100 times the area of the minimum detection area.
A rapid measurement method based on bioimpedance technology, the specific steps of which are as follows:

Switching control of any four adjacent electrodes one by one to detect a first impedance spectrum of a plurality of minimum detection regions of a region covered by the biological tissue to be tested, and obtaining a first impedance spectral feature parameter set X(i), where i=1, 2 ,...n;

And then switching the second impedance spectrum of the plurality of combined detection regions of the area covered by the biological tissue to be tested by any four non-adjacent electrodes that control the overlapping minimum detection area one by one, and obtaining the second impedance spectrum characteristic parameter set Y(j) , where j=1, 2, . . . n.
The rapid measurement method based on bioimpedance technology according to claim 8, wherein the detected first impedance spectral characteristic parameter set X(i) or the second impedance spectral characteristic parameter set Y(j) is covered Whether the impedance spectrum characteristics of the biological tissue to be tested conform to the relevant tissue characteristics in the clinical bioimpedance database.
The rapid measurement method based on bioimpedance technology according to claim 10, wherein the combined detection area does not exceed 100 times the area of the minimum detection area.