A probe and device for bioimpedance testing

Abstract

The present invention provides a bio-impedance test probe, which includes an insulating base and an electrode array composed of multiple electrodes. Among them, the insulating base is provided with a concave surface, and the electrode array is located on the concave surface. At the same time, a bio-impedance test device is also provided, which includes the above-mentioned bio-impedance test probe and a base used in cooperation with the bio-impedance test probe; the bio-impedance test probe further includes a contact point provided on the insulating base, the contact point is electrically connected to the electrode, and is provided on the outer surface of the insulating base outside the concave surface; the base includes a groove for accommodating the insulating base, and a contact member is provided on the surface of the groove. When the insulating base is placed in the groove, the contact point is correspondingly connected to the contact member.

Description

Technical Field

[0001] The present invention relates to the field of bioimpedance testing, and particularly to a probe for bioimpedance testing. Background Art

[0002] Bioelectrical impedance, as a basic physical parameter of biological tissues, has received extensive attention for a long time. Bioelectrical impedance measurement, or simply bioimpedance technology, is a detection technology that uses the electrical properties of biological tissues and organs and their variation laws to extract biomedical information related to the physiological and pathological conditions of the human body. It usually sends a small alternating measurement current or voltage to the detection object through an electrode system placed on the surface of the measured biological tissue, detects the corresponding impedance and its variation, and then obtains relevant physiological and pathological information according to different application purposes.

[0003] Existing bioimpedance test probes usually consist of an insulating plane and test electrodes embedded in the insulating plane. However, in actual bioimpedance testing, the contact surface between the measured biological tissue and the electrode is actually not a plane. As a result, during the testing process, the contact between the electrode and the measured biological tissue will exert a contact pressure on the measured biological tissue to ensure good contact. However, the contact pressure will cause the measured biological tissue to deform, and at the same time, the dense parts inside will slide, resulting in measurement failure or deviation of the measurement results at the electrode contact part. The dense parts are usually diseased tissues. In addition, existing test probes need to be operated by hand, but it is easy for the operator to cause inconsistent contact pressure due to hand tremors during the operation, resulting in inconsistent test results. Summary of the Invention

[0004] To solve the above problems, the present invention provides a bioimpedance test probe, including an insulating base with a concave surface and an electrode array, wherein the electrode array is disposed on the concave surface.

[0005] The concave surface constitutes the contact surface between the insulating base and the measured biological tissue. The concave surface can be any one of common surfaces, which is concave inward on the insulating base, that is, a receiving cavity is formed on the insulating base.

[0006] Furthermore, the concave surface can be a cylindrical surface. Preferably, the directrix of the cylindrical surface is an arc; the concave surface can be a spherical crown. Preferably, it is a hemisphere; the concave surface can be a part of a fan-shaped ring surface. Specifically, it is the outer arc surface of the fan-shaped ring surface; the concave surface can also be a paraboloid, etc. The specific shape of the concave surface is selected according to the shape of the measured biological tissue.

[0007] The contact surface of each electrode constituting the electrode array with the measured biological tissue is preferably flush with the concave surface or not more than 2 mm from the concave surface. That is to say, the electrode contact surface is arranged along the radian of the concave surface to avoid the situation that the measured biological tissue cannot fit well with the concave surface due to too long protrusion of the electrode, thus increasing the test difficulty; meanwhile, the contact area between the electrode and the measured biological tissue is increased. The other end of the electrode is hidden in the insulating base and is also connected to an external control unit or a power supply unit through a wire. Further, the electrode array covers the concave surface, and the electrodes are evenly distributed on the concave surface.

[0008] When using the probe for bioimpedance testing, the accommodating cavity formed by the concave surface can directly hold the measured biological tissue and lift the biological tissue.

[0009] Another usage mode is that the measured biological sample is placed on the stage, and the concave surface covers the measured biological tissue.

[0010] Further, the bioimpedance test probe further includes a cutting member, which is arranged along the edge of the concave surface in a circle. The cutting member is used to cut off the redundant part adhered to the outer edge of the measured biological tissue. The cutting member can be selected as a blade, and the sharp side of the blade is arranged in the opposite direction to the concave surface, so as to make the volume of the excised tissue sample consistent each time and improve the measurement accuracy.

[0011] Furthermore, the bioimpedance test probe further includes a negative pressure hole for sucking the tissue fluid on the surface of the measured biological tissue. The tissue fluid will cause deviation in the bioimpedance test result. The negative pressure hole is arranged in the insulating base and communicated with the concave surface, and is arranged out of alignment with the electrode.

[0012] Through the bioimpedance test probe provided by the present invention, it is possible to avoid the phenomenon that the internal structure of the measured biological tissue is misaligned and slides due to the extrusion of the flat contact surface during the test process; it also avoids the phenomenon that the test is unstable and the impedance test results are inconsistent due to the shaking of the hand-held probe during the operation process. In addition, when the measured biological tissue is placed in the accommodating cavity formed by the concave surface, the electrode arranged along the radian of the concave surface has the advantage of increasing the contact area between the electrode and the measured biological tissue compared with the electrode arranged on a plane, so as to ensure stable contact between the electrode and the biological tissue and smooth progress of the test. In summary, using the bioimpedance probe provided by the present invention can further improve the consistency and stability of the bioimpedance test results.

[0013] The present invention also provides a bio-impedance testing device, which includes any one of the above bio-impedance testing probes and a base used in cooperation with the probe. The base is provided with a groove for accommodating the insulating base of the probe. The base and the probe are electrically connected through a connector. A contact is provided on the insulating base of the probe, and a contact member corresponding to the contact is provided at a corresponding position in the groove of the base. At the same time, the present invention also provides a method for using the bio-impedance testing device: assemble the bio-impedance probe and the base to ensure that the contacts are electrically connected to the corresponding contact members; place the measured biological tissue in the concave curved surface of the bio-impedance probe to make the biological tissue contact the electrode array, and then the bio-impedance test can be started. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 Schematic diagram of the impedance measurement probe provided in Embodiment 1;

[0015] Figure 2 For Figure 1 bottom view of;

[0016] Figure 3 For Figure 1 left view of;

[0017] Figure 4 For Figure 3 cross-sectional view taken along A-A' in;

[0018] Figure 5 Front view of the impedance measurement probe provided in Embodiment 2;

[0019] Figure 6 Top view of the impedance measurement probe provided in Embodiment 2;

[0020] Figure 7 For Figure 5 cross-sectional view taken along B-B' in;

[0021] Figure 8 Schematic diagram of the impedance measurement probe provided in Embodiment 3;

[0022] Figure 9 For Figure 8 front view of;

[0023] Figure 10 For Figure 9 cross-sectional view taken along C-C' in;

[0024] Figure 11 Schematic diagram of the impedance measurement probe provided in Embodiment 4;

[0025] Figure 12 For Figure 11 top view of;

[0026] Figure 13 For Figure 12middle D-D' cross section;

[0027] Figure 14 A schematic diagram of an impedance measurement probe provided in Example 5;

[0028] Figure 15 A schematic diagram of the probe base provided in Example 5;

[0029] Figure 16 A schematic diagram of an impedance measurement device provided in Example 5;

[0030] Figure 17 A structural block diagram of the impedance measurement device provided in Example 5;

[0031] Figure 18 A schematic flow chart of a bioimpedance testing method provided in Example 6. DETAILED DESCRIPTION

[0032] Example 1

[0033] like Figure 1 As shown, a probe 100 for bioimpedance testing includes an insulating base 110 and an electrode array 120 disposed thereon. Specifically, the insulating base 110 is bowl-shaped, comprising a hollow hemisphere 112 and a base 113. The base 113 is fixed to the outer surface of the hollow hemisphere 112 and is located at the top of the hollow hemisphere 112. The inner surface of the hollow hemisphere 112 is a concave surface 111, on which the electrode array 120 is arranged.

[0034] Figure 2 FIG1 is a bottom view of the probe 100. In this embodiment, the electrode array 120 is composed of four sheet electrodes 121 arranged at equal intervals, and the electrode array 120 is located in the central area of the concave surface 110. In other embodiments, the electrode array may use any type of electrode and electrode arrangement, such as a rectangular four-electrode array or a concentric circular electrode array.

[0035] Figure 3 is a front view of the probe 100, Figure 4 for Figure 3 The cross-sectional view at A-A' is shown in FIG. Obviously, the curvature of the concave surface 111 is different from that of the hollow hemisphere 112. The hollow hemisphere 112 is not a thin shell, but has a thickness, including a layer between the concave surface 111 and the outer surface.

[0036] The electrode 121 is embedded in the hollow hemisphere 112, specifically, in the interlayer of the hollow hemisphere 112. The portion of the electrode 121 that contacts the biological tissue being tested slightly protrudes or is flush with the concave surface 111. The four electrodes 121 are distributed along the arc of the concave surface 111, that is, the portion of the four electrodes located on the concave surface 111 isFigure 4 The connecting line in the cross-sectional view is not a straight line, but rather forms an arc that aligns with the concave surface 111. The base 113 is a cavity that provides space for the tails of the four electrodes 121. Therefore, its width is greater than the width of the electrodes 121, its length is greater than the length of the electrode array 120, and its height is consistent with the height of the electrodes 121. Not shown in the figure, the base 113 is provided with an opening through which wires can be passed to connect the tails of the electrodes 121 to an external control unit or power supply unit.

[0037] When the probe 100 performs a bioimpedance test on the biological tissue to be tested, the bowl-shaped insulating base 110 is covered on the biological tissue to be tested, and the electrode array 120 contacts the biological tissue to be tested and performs a bioelectrical impedance test. The contact surface between the biological tissue and the electrode is not completely planar. Therefore, if an existing planar test probe is used, during the test, the contact pressure applied by the electrode measuring surface will cause the dense structure in the biological tissue to be tested to slide, thereby causing deviations in the test results. However, when the probe 100 is used for testing, the biological tissue to be tested is in close contact with the electrode array 120. Even if compression occurs, the curved surface shape of the concave surface 111 completely wraps the biological tissue to be tested, and the force on the biological tissue to be tested is balanced. The dense structure inside the tissue will not slide or dislocate, thereby improving the accuracy of the test results.

[0038] According to the structure provided in the first embodiment, a variety of concave surfaces with small curvatures can be designed. During testing, the probe 100 including a concave surface with a suitable curvature can be selected according to the shape characteristics of the biological tissue being tested.

[0039] Example 2

[0040] Figures 5 to 7 The probe 200 provided in the second embodiment of the present invention is shown. The probe 200 includes an insulating base 210 , an electrode array 220 and a support 230 .

[0041] The shape of the insulating base 210 is an arc groove, that is, from the front view of the probe 200, the insulating base 210 is an arc; from the cross-sectional view at BB', the insulating base 210 is still an arc. Accordingly, the inner surface of the insulating base 210 is a concave surface 211. Figure 5 still Figure 7 They are all arc-shaped, thereby providing accommodation space for the biological tissue being tested.

[0042] An electrode array 220 is provided on the concave surface 211. In the second embodiment, the electrode array 220 is composed of a plurality of electrodes 221 arranged at equal intervals along the axial direction. Figure 6 It can be seen that the electrode 221 is strip-shaped at the top exposed on the concave surface 211, and the electrode array 220 occupies most of the central area of the concave surface 211.Figure 5 As shown, the vertical heights of the electrodes 221 are not the same, and the top connection lines of the electrodes 221 form an arc line with a curvature approximately the same as that of the concave surface 211. In Figure 7 , the electrodes 221 are embedded on the insulating base 210. The top of the electrode 211 is a concave surface, and its curvature is consistent with that of the concave surface 211. What is not shown in the figure is that the bottom of the electrode 221 is fixed to a PCB board embedded inside the insulating base 210, and an opening is provided on the insulating base 210. The PCB is connected to an external control unit or a power supply unit through the opening part.

[0043] In this embodiment, the support 230 is a hollow base with a flat bottom surface, which is fixedly connected to the bottom of the insulating base, and its function is to support the insulating base 210 so that the concave surface 211 faces upward. In other embodiments, the support 230 can be any structure that can stand up the probe 200, such as a bracket form can also be adopted.

[0044] ? When the measured biological tissue is a small strip and its surface is uneven, if the existing planar contact surface probe is used for testing, it is not easy to find the measurement surface of the measured biological tissue, and when measuring in contact with the measurement electrode, the contact pressure applied by the electrode measurement surface will cause the measured biological tissue to deform or the dense structure inside it to slide, etc. The arc-shaped groove insulating base 210 and its concave surface 211 provided in the second embodiment can effectively avoid such problems. During bioimpedance measurement, the probe 200 is placed as Figure 5 shown, with the concave surface 211 facing upward. The measured biological tissue is placed on the concave surface 211. Under the action of gravity, it contacts the electrode array 220 on the concave surface 211, and thus bioimpedance testing can be performed. The electrode array 220 occupies most of the central area of the concave surface 211. The electrodes 221 are concave surfaces on the exposed part of the concave surface 211. Compared with the contact formed by the planar electrode and the strip-shaped measured object, which is only a contact point, the contact between the concave electrode 221 and the strip-shaped measured object can form a contact surface with the same width as the electrode. Thus, the contact area with the measured biological tissue is increased, and it will not be extruded by external forces.

[0045] The probe 100 provided in the first embodiment can also be used in the impedance testing method in the second embodiment by directly placing the measured biological tissue inside its insulating base 110. The measured biological tissue targeted in the first embodiment is preferably spherical, while the measured biological tissue in the second embodiment is preferably strip-shaped biological tissue taken by a puncture needle or a biopsy forceps. Based on the probe 200 provided in the second embodiment, the width and cross-sectional curvature of the concave surface 211 can be designed according to the shape and size of the actual puncture needle or biopsy forceps used; or the concave surface provided in the second embodiment and the electrode array thereon can be directly integrated with the puncture needle or biopsy forceps.

[0046] Embodiment Three

[0047] Figures 8 to 10 A bioimpedance measurement probe 300 is provided, comprising an insulating base 310 , an electrode array 320 and a base 330 , wherein the insulating base 310 is a hollow semi-cylinder comprising two semi-circular plates 313 and a concave surface 311 .

[0048] The electrode array 320 is distributed on the concave surface 311 and is composed of a plurality of point electrodes 321. In this embodiment, the point electrodes 321 form an m*n rectangular array, wherein Figure 9 From the perspective of the provided view, all electrodes in the nth row are at the same height. All electrodes in the mth column are arranged according to the curvature of the concave surface 311, such as Figure 11 As shown, the distribution of the four electrodes 121 is the same as that in the first embodiment. The structure of the base 330 is also the same as the base 113 in the first embodiment.

[0049] Probe 300 is designed for ex vivo biological tissue. Cutting edges 312 are located on the two semicircular plates 313 and the straight edges of the concave surface 311. In other words, probe 300 includes a rectangular ring of cutting edges 312. Before the bioimpedance test begins, the open end of probe 300 is placed over the ex vivo biological tissue. Because the ex vivo tissue is too large to be completely covered by probe 300, the surface of the tested area does not completely align with the concave surface 311. Cutting edges 312 are used to trim the tissue, ensuring a consistent volume for each measurement and improving test accuracy.

[0050] Example 4

[0051] Figures 11 to 13 The probe 400 for bioimpedance testing provided in the fourth embodiment includes an insulating base 410, a concave curved surface 411, and an electrode array 420. The insulating base 410 is a cylindrical body with a concave curved surface 411 on its top surface, and the arrangement of the electrode array 420 is roughly the same as the arrangement of the electrode array of the probe 100 provided in the first embodiment. In addition, the probe 400 is further provided with negative pressure holes 412 that pass through the insulating base 410. The number of negative pressure holes 412 is set as needed, and they are staggered with the electrodes 421, and are preferably set at the center of the concave curved surface 411 and around the center, as shown in FIG. Figure 15 The insulating base 410 not only accommodates the tail of the electrode 421 and provides support for the insulating base 410 , but also provides a channel for the negative pressure hole 412 .

[0052] The function of the negative pressure hole 412 is that when the probe 400 performs impedance testing according to the biological impedance testing method provided in the second embodiment, that is, when the measured biological tissue is placed in the insulating base 410, it is in close contact with the electrode array 420 under the action of the gravity of the measured biological tissue itself and impedance testing is carried out. However, during this process, the tissue fluid of the measured biological tissue itself will also flow towards the concave surface 411 under the action of gravity, especially accumulating at its bottom. Tissue fluid is a good conductor of electricity, which will cause the impedance result of the measured biological tissue to be on the small side. The function of the negative pressure hole 413 is to suck the accumulated tissue fluid on the surface of the concave surface 411 and the tissue fluid on the contact surface between the measured biological tissue and the concave surface 411, thereby improving the accuracy of biological impedance testing.

[0053] Embodiment Five

[0054] To avoid cross-infection in biological impedance testing, the probe can be used as a disposable item. The present invention also provides a biological impedance measurement device 10. Figures 14 to 17 Figure 8 shows a biological impedance measurement device 10 and its components: a probe 500 and a base 20.

[0055] The probe 500 is similar in structure to the aforementioned probe, including an insulating base 510, a concave surface 511 provided on the insulating base 510, and electrodes 521 arranged at equal intervals on the concave surface 511. In this embodiment, the concave surface 511 is a cylindrical surface, the insulating base 510 is a cuboid shape with one surface being the concave surface 511, and the electrodes 521 are selected as sheet electrodes with the same bending radian as the concave surface 511. A contact 513 is provided on the outer surface of a plane of the insulating base 510, and the contact 513 and the electrodes 521 are electrically connected in a one-to-one correspondence.

[0056] However, in other applications, any probe that conforms to the intention of the present invention can be selected, such as those provided in Embodiment One to Embodiment Four.

[0057] The base 20 is a cuboid shape including a groove 21. The shape of the groove 21 is adapted to the insulating base 510 of the probe. The shape of the groove 21 is a cuboid, and its length and width are equal to the length of the insulating base 510, and its height is less than or equal to the height of the insulating base 510. Contact members 22 with the same number as the contacts 513 are provided on the surface of the groove 21 for contacting the contacts 513 and conducting electricity and communication. The specific positions of the contact members 22 are determined according to the positions of the contacts 513. When the contacts 513 are located on a vertical side surface of the insulating base 510, the contact members 22 are located on the vertical surface of the groove 21, and the distance from the contact members 22 to the horizontal plane of the groove 21 is equal to the distance from the contacts 513 to the horizontal plane of the insulating base 510. That is, the groove 21 can just accommodate the probe 500, the insulating base 510 of the probe 500 is engaged with the groove 21, and after the engagement, the contact members 22 and the contacts 513 are in close contact in a one-to-one correspondence.

[0058] Inside the base 20, a switching unit 24 is provided. The switching unit 24 is electrically connected to the external contact 22. The contact 22 for power-on is selected through the switching unit 24 to select the working electrode. A multi-selection switch can be used for the switching unit 24. In addition, inside the base 20, there is also an excitation unit 25 for signal excitation and a storage unit 26 for storing the test results of bio-impedance.

[0059] When a bio-impedance measurement device 10 is in use, it can also be connected to a human-computer interaction system 30 for use. The base 20 is communicatively connected to the human-computer interaction system through a wire 23. The human-computer interaction system 30 can be used to input information to control the switching unit 24 and can also be used to display the test results of bio-impedance.

[0060] Embodiment Six

[0061] As Figure 18 shown, a method for testing bio-impedance includes:

[0062] S1. Assemble the bio-impedance probe with the base to ensure that the contacts are electrically connected to the corresponding contacts.

[0063] S2. Place the measured biological tissue in the concave curved surface of the bio-impedance probe to ensure good contact between the biological tissue and the electrode array.

[0064] S3. After S2 is completed, the bio-impedance test can be carried out.

[0065] Between S2 and S3, an operation of S21 can also be included, and the electrode for bio-impedance test is selected through the switching unit of the base.

[0066] After a bio-impedance test is completed, that is, after S3, the operation of S4 can be carried out. Disassemble the used bio-impedance probe, select a new bio-impedance probe and the measured biological tissue, and then repeat the above steps.

[0067] Through the above method, the bio-impedance test can be carried out conveniently and quickly, while cross-infection between different biological tissues is eliminated, and accurate test results can be obtained.

[0068] The above embodiments only describe and present the present invention. The present invention is not limited to the scope of the above disclosed embodiments, and any modification covered by the scope of the claims or equivalent belongs to the protection scope of the present invention.

Claims

1. A bioimpedance test probe, comprising an insulating base and an electrode array consisting of a plurality of electrodes, wherein: The insulating base is provided with a concave surface, the electrode array is located on the concave surface, and the contact surface of each electrode constituting the electrode array and contacting the biological tissue to be measured is flush with the concave surface or protrudes from the concave surface and does not exceed 2 mm from the concave surface; the bioimpedance testing probe also includes a cutting piece, which is arranged along the edge of the concave surface. When the biological tissue to be measured is an in vitro biological tissue and at least part of it is located outside the edge of the concave surface, the cutting piece is configured to cut off the part of the biological tissue to be measured that is located outside the edge of the concave surface to ensure that the surface of the biological tissue to be measured facing the concave surface can be completely in contact with the concave surface.

2. The bioimpedance test probe according to claim 1, characterized in that: The concave surface is one of a cylinder, a spherical cap, a parabola, and an outer arc of a sector torus.

3. The bioimpedance test probe according to claim 1, characterized in that: The concave surface can be used to hold the biological tissue to be tested.

4. The bioimpedance test probe according to claim 1, wherein: The concave surface can be used to cover the biological tissue to be tested.

5. The bioimpedance test probe according to claim 1, characterized in that: The bioimpedance test probe further includes a negative pressure hole, which is arranged on the concave surface and staggered with the electrode.

6. A bioimpedance testing device, comprising the bioimpedance testing probe according to any one of claims 1 to 5, and a base for use with the bioimpedance testing probe; The bioimpedance test probe further includes a contact provided on the insulating base, the contact being electrically connected to the electrode and provided on the outer surface of the insulating base outside the concave curved surface; The base includes a groove for accommodating an insulating base, and a contact piece is provided on the surface of the groove. When the insulating base is placed in the groove, the contact points are connected to the contact piece accordingly.

7. The bioimpedance testing device according to claim 6, characterized in that: The base further includes a switching unit, which selects electrodes for bioimpedance testing by switching the contact members.

8. The bioimpedance testing device according to claim 6, characterized in that: The base and the bioimpedance test probe are detachably assembled.

9. A bioimpedance testing method, comprising: Assembling the bioimpedance test probe according to any one of claims 1 to 5 with a base, so that the contacts of the bioimpedance test probe are correspondingly connected to the contact members on the base; Placing the biological tissue to be measured in the bioimpedance probe so that it is in contact with the concave surface of the bioimpedance probe and in contact with the electrode array; Perform a bioimpedance test.

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