Head mold device for in-vitro test

By designing a head model device that includes a bionic brain and a signal generation module, the problem of existing devices being unable to accurately verify the effectiveness of human brain medical devices has been solved, achieving a more efficient verification effect.

CN223808145UActive Publication Date: 2026-01-16SHANGHAI MEDICAL DEVICE INSPECTION & RES INST
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Patent Information

Application Number
CN202522649272.0
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2025-12-15
Publication Date
2026-01-16
Estimated Expiration
2035-12-15

AI Technical Summary

Technical Problem

Existing in vitro testing devices cannot accurately verify the effectiveness of medical testing devices that act on the human brain.

Method used

A head model device for in vitro testing was designed, comprising a head model body, a bionic brain, a signal generation module, and transmission wires. The bionic brain has the same outer contour as the human brain and is conductive. It is connected to the signal generation module through the transmission wires to generate multiple modulated test signals to simulate the signal scene in the human brain.

Benefits of technology

This improves the accuracy of validating the device under test in the human brain environment, enabling testing to more closely resemble the real human brain environment.

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Abstract

The utility model provides a head mold device for an in-vitro test, and relates to the technical field of instrument detection. The head mold device for in-vitro testing is suitable for testing an instrument to be tested, the instrument to be tested comprises at least one detection electrode, the head mold device comprises a head mold body, the head mold body is provided with a first cavity, a first lower opening and at least one first through hole, and the first lower opening and the first through hole are connected with the first cavity; the bionic brain is placed in the first cavity, the bionic brain has the same outer contour as the human brain, the bionic brain has electrical conductivity, and the at least one detection electrode is suitable for penetrating through the at least one first through hole and is connected with the bionic brain; the signal generation module is suitable for generating a plurality of modulation test signals; the first ends of the multiple transmission wires are connected with the signal generation module, and the second ends of the multiple transmission wires penetrate through the first lower opening and are connected with the bionic brain. The head mold device can improve the verification reliability of the effectiveness of the to-be-tested instrument.
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Description

TECHNICAL FIELD

[0001] The present application mainly relates to the technical field of instrument detection, and particularly relates to a head mold device for in-vitro test. BACKGROUND

[0002] Before a medical instrument is used for a patient, in-vitro test needs to be carried out to verify the safety, effectiveness and the like of the medical instrument. In particular, for a medical detection instrument acting on the human brain, due to the complexity of the human brain, the existing device in the in-vitro test cannot accurately verify the effectiveness of the medical detection instrument.

[0003] Therefore, there is an urgent need for a head mold device for in-vitro test which can be used to verify the effectiveness of a to-be-tested instrument. CONTENT OF THE INVENTION

[0004] The technical problem to be solved by the present application is to provide a head mold device for in-vitro test, so as to improve the reliability of verifying the effectiveness of a to-be-tested instrument.

[0005] To solve the above technical problem, the present application provides a head mold device for in-vitro test, which is suitable for testing a to-be-tested instrument, the to-be-tested instrument comprising at least one detection electrode, the head mold device comprising: a head mold body, the head mold body having a first cavity and a first lower opening and at least one first through hole connected with the first cavity respectively; a bionic brain, the bionic brain being placed in the first cavity, the bionic brain having the same outer contour as a human brain, and the bionic brain having electrical conductivity, wherein the at least one detection electrode is adapted to pass through the at least one first through hole and be connected with the bionic brain; a signal generation module, the signal generation module being adapted to generate a plurality of modulated test signals; and a plurality of transmission leads, first ends of the plurality of transmission leads being connected with the signal generation module respectively, and second ends of the plurality of transmission leads passing through the first lower opening and being connected with the bionic brain respectively.

[0006] Optionally, the signal generation module comprises: a signal source, the signal source being adapted to generate a plurality of different test signals; and a signal modulation unit, the signal modulation unit being adapted to be connected with the signal source, and the signal modulation unit being adapted to generate a plurality of corresponding modulated test signals according to the input plurality of different test signals.

[0007] Optionally, the head mold device further comprises: a base comprising a second cavity, the second cavity having a second upper opening corresponding to the first lower opening, the base being connected with the head mold body, wherein the signal modulation unit is placed in the second cavity, and the plurality of transmission leads further pass through the second upper opening.

[0008] Optionally, the signal modulation unit comprises: a first modulation subunit, the first modulation subunit being adapted to adjust the frequency of the input test signal.

[0009] Optionally, the signal modulation unit comprises a second modulation subunit, the second modulation subunit being adapted to adjust the amplitude of the input test signal.

[0010] Optionally, the head mold device further comprises a support plate, the support plate being located in the first cavity and fixedly connected with the head mold body, the support plate having a plurality of second through holes, the second through holes being adapted to allow the plurality of transmission wires to pass through, and the bionic brain being adapted to be placed on the support plate.

[0011] Optionally, the head mold device further comprises a support plate, the support plate being located in the first cavity and integrally formed with the head mold body, the support plate having a plurality of second through holes, the second through holes being adapted to allow the plurality of transmission wires to pass through, and the bionic brain being adapted to be placed on the support plate.

[0012] Optionally, the plurality of modulated test signals comprise eye movement electrical signals, electromyographic signals, neural signals and interference signals.

[0013] Optionally, the end of the second end has a waterproof joint, and the plurality of transmission wires are connected with the bionic brain through the waterproof joint.

[0014] Optionally, the diameter of the first through hole is 1.6cm-2.4cm.

[0015] Compared with the prior art, the present application has the following advantages: by placing a bionic brain with the same outer contour as the human brain in the head mold body, and the bionic brain being conductive, the device under test can be in contact with the bionic brain according to the actual use mode. On this basis, by connecting the signal generation module and the bionic brain through the plurality of transmission wires, the plurality of modulated test signals can be input into the bionic brain to simulate the scenario in which a plurality of different signals in the human brain are mixed with each other, thereby facilitating the verification of the ability of the device under test to effectively acquire specified information in the above scenario, i.e. improving the verification accuracy of the effectiveness of the device under test. BRIEF DESCRIPTION OF DRAWINGS

[0016] The accompanying drawings are included to provide a further understanding of the present application, and are incorporated and constitute a part of this application, illustrate embodiments of the present application, and together with the description serve to explain the principles of the present application. In the drawings:

[0017] Figure 1 is a schematic view of a head mold device and a device under test according to an embodiment of the present application; and

[0018] Figure 2 is Figure 1 is a side sectional view of the head mold device in DETAILED DESCRIPTION

[0019] In order to illustrate the technical solutions of the embodiments of the present application more clearly, the drawings needed in the embodiment description will be briefly introduced. Obviously, the drawings in the following description only show some examples or embodiments of the present application, and those skilled in the art can further apply the present application to other similar situations without any creative effort, based on the drawings. The same reference signs in the drawings represent the same structure or operation, unless otherwise clear from the context or otherwise indicated.

[0020] As shown in the present application and claims, unless the context clearly indicates otherwise, the words "one", "an", "a", and / or "the" do not mean "only one", but can include a plurality or "one or more" unless the context clearly indicates otherwise. Generally, the terms "comprising" and "including" only indicate that the elements explicitly listed are included, and these elements do not constitute an exclusive list, and the device can further include other elements.

[0021] Unless specifically stated otherwise, the relative arrangement of components and steps, numerical expressions, and numerical values set forth in the various examples herein are not limiting. Also, it should be understood that the various parts shown in the drawings are not necessarily drawn to scale in order to emphasize certain features of the examples. Techniques, methods, and devices known to those of ordinary skill in the art can not be discussed in detail, but should be considered as part of the description, where appropriate. In all examples shown and discussed herein, any specific values should be interpreted as merely illustrative and not as a limitation on the scope of the example. Thus, other examples of the example embodiments can have different values. It is noted that like reference numerals and letters in the following drawings represent like items, and thus once an item is defined in one drawing, it need not be discussed further in subsequent drawings.

[0022] In the description of the present application, it should be understood that the orientation words such as "front, back, up, down, left, right", "horizontal, vertical, perpendicular, horizontal", and "top, bottom" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the indicated device or element must have a particular orientation or be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the scope of protection of the present application; the orientation words "inner, outer" refer to the inner and outer relative to the contour of the components themselves.

[0023] For purposes of the description hereinafter, spatial

[0024] In addition, it is to be appreciated that the use of "first", "second", etc. terminology can connote the nature, particular order, or hierarchy of objects, but not necessarily the order, unless specifically stated otherwise. A first object recited in the claims can be termed a second object, and similarly, a second object can be termed a first object, without departing from the scope of the claims, unless otherwise indicated. Furthermore, the foregoing description for the illustrative aspects of the disclosure has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Many modifications and variations are possible in light of the above teaching. Any or all steps can be performed in reverse or skipped. It is intended that the scope of the claims be limited not with the foregoing description, but rather determined by the claims themselves as interpreted by the skilled person. Likewise, a variety of inventive processes can be identified from the description, which can be employed in conjunction with other like processes not expressly described, without departing from the scope of the claims. Accordingly, the claims are not intended to be limited to the processes specifically disclosed, but rather have the scope defined by the claims and their full scope of equivalents.

[0025] It will be understood that when a component, is referred to as being "on", "connected to", "coupled with" or "in contact with" another component, it can be directly on, connected, coupled with or in contact the other component, or one or more intervening components can also be present. In contrast, when a component is referred to as being "directly on", "directly connected to", "directly coupled with", or "directly in contact with" another component, there are no intervening components present. By the same token, when a first component is referred to as being "electrically in contact with" or "electrically coupled with" a second component, there is an electrical path between the first component and the second component that allows current to flow. The electrical path can include capacitors, coupled inductors, and / or other components that allow current to flow, even if there is no direct contact between conductive components.

[0026] Reference Figure 1 and Figure 2An embodiment of the present application provides a head model device 100 (hereinafter referred to as the head model device 100) for in-vitro testing, which is suitable for testing a to-be-tested instrument 200. The to-be-tested instrument 200 comprises two detection electrodes 21. It should be noted that the present application does not limit the number of the detection electrodes 21 in the to-be-tested instrument 200, and in some embodiments, the to-be-tested instrument 200 comprises one detection electrode 21. In addition, in the present embodiment, when the to-be-tested instrument 200 acts on a human body, the detection electrodes 21 are inserted into the skull and contact the human brain, so as to obtain the electrical signals in the human brain, and then the to-be-tested instrument 200 generates a corresponding detection result by analyzing the collected electrical signals.

[0027] With reference to the foregoing Figure 1 and Figure 2 continuously, the head model device 100 comprises a head model body 11, a support plate 12, a bionic brain (not shown in the figure), a signal generation module 13, a plurality of transmission wires 14 and a base 15. Specifically, the head model body 11 has a first cavity 111, a first lower opening 112 and a plurality of first through holes 113 connected with the first cavity 111 respectively. The diameter of the first through hole 113 is 1.6 cm-2.4 cm. In the present embodiment, the plurality of first through holes 113 are distributed on the top of the head model body 11, and the distribution range of the plurality of first through holes 113 covers the area range in which the detection electrodes 21 are actually inserted into the skull, so that the possible insertion positions of the detection electrodes 21 on the skull can be simulated. It can be understood that in some embodiments, the to-be-tested instrument 200 is inserted into the skull in a region other than the top of the skull, and in these embodiments, the first through hole 113 is arranged at the corresponding position of the head model body 11, so that the head model device 100 can adapt to the use mode of the to-be-tested instrument 200. It should be further noted that the present application also does not limit the number of the first through holes 113, and in some embodiments, the head model body 11 comprises only one first through hole 113.

[0028] With reference to the foregoing Figure 1 and Figure 2In the embodiment, the support plate 12 is located in the first cavity 111 and fixedly connected with the head mold body 11. In the embodiment, the bionic brain is placed in the first cavity 111, and further, the bionic brain is adapted to be placed on the support plate 12, so as to simulate the position of the human brain in the skull. In the embodiment, the bionic brain has the same external contour as the human brain, and the bionic brain has conductivity, so as to provide a more realistic in-vitro test environment for the instrument 200 to be tested. In some embodiments, the bionic brain further includes a plurality of simulated brain partitions, and each simulated brain partition corresponds to a plurality of real brain partitions of the human brain, so that the head mold device 100 has better simulation effect. In addition, in order to realize the conductivity of the bionic brain, the material of the bionic brain in the embodiment is conductive silica gel, but the application does not limit the range of materials that make the bionic brain have conductivity. In some embodiments, the material of the bionic brain is nickel-carbon conductive silica gel, in some embodiments, the material of the bionic brain is silver-copper conductive silica gel, and in some embodiments, the material of the bionic brain is polyvinyl alcohol-sodium borate gel embedded with silver microflakes and gallium-based liquid metal microdroplets.

[0029] With reference to Figure 1 and Figure 2 , it should be noted that in some embodiments, the external contour of the head mold body 11 corresponds to the external contour of the human skull, so as to improve the authenticity of the head mold device 100 simulating the human skull and achieve better simulation test effect. In an example, the external contour of the head mold body 11 is made according to the external contour of the human head one-to-one, wherein the external contour of the head mold body 11 corresponds to the external contour of the head above the human neck. In some embodiments, the support plate 12 is integrally formed with the head mold body 11, so as to improve the overall firmness. It should be further noted that in some embodiments, in order to facilitate replacement of the bionic brain, the head mold body 11 is cut in a direction parallel to the plane in which the support plate 12 is located above the support plate 12, so as to be divided into an upper part and a lower part, and then the bionic brain can be conveniently placed on the support plate 12 by removing the upper part after the locking relationship between the upper part and the lower part is released, and then the bionic brain is located in the first cavity 111 by locking the upper part and the lower part again.

[0030] With reference to 1 and Figure 2The signal generation module 13 is adapted to generate a plurality of modulated test signals. The plurality of modulated test signals includes an electro-oculogram signal, an electromyogram signal, a neural signal, and an interference signal. The signal generation module 13 includes a signal source 131 and a signal modulation unit 132. Specifically, the signal source 131 is adapted to generate a plurality of different test signals, and the signal modulation unit 132 is adapted to be connected to the signal source 131 and to generate a plurality of corresponding modulated test signals according to the plurality of different test signals inputted. Further, the signal modulation unit 132 includes a first modulation sub-unit 1321 and a second modulation sub-unit 1322. The first modulation sub-unit 1321 is adapted to adjust the frequency of the test signal inputted, and the second modulation sub-unit 1322 is adapted to adjust the amplitude of the test signal inputted.

[0031] Specifically, in the embodiment, the signal source 131, the first modulation sub-unit 1321, and the second modulation sub-unit 1322 are connected in sequence, so that the tester controls the signal source 131 to generate a specific test signal, and then the first modulation sub-unit 1321 and the second modulation sub-unit 1322 adjust the frequency and the amplitude of the test signal in sequence to obtain a modulated test signal corresponding to the test signal. It can be understood that the test signal with a standard amplitude and a standard frequency generated by the signal source 131 can generate a more random and irregular modulated test signal through the processing of the signal modulation unit 132, so as to be more in line with the characteristics of the electrical signal in the real human brain. In addition, in the embodiment, the first modulation sub-unit 1321 and the second modulation sub-unit 1322 respectively include corresponding PCB cards, so that the PCB cards realize the functions of corresponding frequency adjustment and amplitude adjustment. It should be noted that such PCB cards and the signal source 131 can be directly purchased.

[0032] Continuing to refer to Figure 1 and Figure 2 , in the embodiment, the base 15 includes a second cavity 151. The second cavity 151 has a second upper opening 1511 corresponding to the first lower opening 112, and the base 15 is connected to the head model body 11. Further, in the embodiment, the signal modulation unit 132 is placed in the second cavity 151, so as to play a protective role on the signal modulation unit 132, and also to increase the overall stability of the head model device 100 through the base 15. It should be noted that the base 15 has a third through hole 152 connected to the second cavity 151, so that the signal source 131 located outside the base 15 can be connected to the signal modulation unit 132 in the second cavity 151 through the third through hole 152. It can be understood that the head model device 100 can generate different test signals by replacing the signal source 131, so it is helpful to replace the signal source 131 conveniently by setting the signal source 131 in the base 15.

[0033] Continuing to refer toFigure 1 and Figure 2 In this embodiment, the support plate 12 has a plurality of second through holes 121, and the second through holes 121 are adapted to pass a plurality of transmission wires 14. In this embodiment, the first ends 141 of the plurality of transmission wires 14 are respectively connected to the signal generation module 13, and the second ends 142 of the plurality of transmission wires 14 are respectively passed through the first lower opening 112 and connected to the bionic brain. Specifically, in this embodiment, the first ends 141 of the transmission wires 14 are connected to the second modulation sub-unit 1322, the transmission wires 14 are sequentially passed through the second upper opening 1511 and the first lower opening 112 to enter the first cavity 111, and continue to pass through the second through hole 121 to be connected to the bionic brain on the support plate 12, thereby inputting a plurality of modulation test signals into the bionic brain, and realizing the simulation of the transmission of complex electrical signals in the human brain. In some embodiments, the end of the second end 142 has a waterproof joint, and the plurality of transmission wires 14 are connected to the bionic brain through the waterproof joint, so that in the case that the bionic brain has a certain humidity, the problem that the transmission wires 14 are leaked and the modulation test signals cannot be effectively transmitted to the bionic brain can be effectively avoided.

[0034] It should be noted that the plurality of second through holes 121 are distributed on the support plate 12, so that each transmission wire 14 can be connected to a specific area of the bionic brain through the corresponding second through hole 121, thereby inputting the corresponding modulation test signal of each transmission wire 14 to the specific area, and then simulating the generation of different signals in different brain areas of the human brain, which is beneficial to verify the performance of the to-be-tested device 200. It can be understood that when a plurality of different modulation test signals are transmitted to the bionic brain, the to-be-tested device 200 needs to acquire a specific modulation test signal under the interference of a plurality of modulation test signals. This way is closer to the real signal transmission scene of the human brain, so as to better verify the effectiveness of the to-be-tested device 200.

[0035] The structure of the head mold device 100 has been described above, and the process of using the head mold device 100 to test the to-be-tested device 200 in vitro will be further described through an example. First, the detection electrode 21 of the to-be-tested device 200 is passed through the first through hole 113 and connected to the bionic brain. Second, the signal source 131 corresponding to the to-be-tested device 200 is selected, and the signal source 131 is connected to the signal modulation unit 132. Then, the transmission wire 14 is passed through the second through hole 121 and connected to the specific area of the bionic brain. Subsequently, the signal source 131 and the to-be-tested device 200 are turned on. Finally, the generated record of the to-be-tested device 200 is analyzed to evaluate the effectiveness of the to-be-tested device 200.

[0036] Having described the basic concepts, it is obvious that the above-described application disclosure is merely an example for the skilled person in the art and does not limit the application. Although not explicitly described herein, the skilled person can make various modifications, improvements and modifications to the application. Such modifications, improvements and modifications are suggested in the application and still fall within the spirit and scope of the exemplary embodiments of the application.

[0037] Meanwhile, specific words are used in the application to describe the embodiments of the application. As "one embodiment", "an embodiment", and / or "some embodiments" means a certain feature, structure or characteristic related to at least one embodiment of the application. Therefore, it should be emphasized and noted that the "an embodiment" or "one embodiment" or "an alternative embodiment" mentioned in different places in the specification does not necessarily refer to the same embodiment. In addition, certain features, structures or characteristics in one or more embodiments of the application can be properly combined.

[0038] Similarly, it should be noted that, in order to simplify the description of the application and to help understand one or more embodiments of the application, sometimes multiple features are combined into one embodiment, figure or description thereof in the foregoing description of the embodiments of the application. However, this method of disclosure does not mean that the features required by the application are more than those mentioned in the claims. In fact, the features of the embodiments are less than all the features disclosed in the foregoing single embodiment.

[0039] Some embodiments use numbers to describe components, attributes, etc. It should be understood that such numbers used in the description of the embodiments are, in some examples, modified by the adjectives "about", "approximately" or "generally". Unless otherwise stated, "about", "approximately" or "generally" indicates that the number allows for a ±20% variation. Accordingly, in some embodiments, the numerical parameters in the description and claims are approximations that can vary depending on the desired characteristics of the individual embodiments. In some embodiments, numerical parameters should be considered in the context of the number of significant digits and errors inherent to measurement of such parameters. Although the numerical ranges and parameters in some embodiments of the application are approximations, in specific embodiments, these numerical values are set to be as precise as possible.

[0040] Although the application has been described with reference to the current specific embodiments, those skilled in the art will realize that the above-described embodiments are only used to illustrate the application, and various equivalent changes or replacements can be made without departing from the spirit of the application, therefore, any changes, modifications to the above-described embodiments within the scope of the spirit of the application will fall within the scope of the claims of the application.

Claims

1. A headform device for use in in-vitro testing, characterised in that, The head model device is suitable for testing a to-be-tested instrument, the to-be-tested instrument comprising at least one detection electrode, the head model device comprising: a head model body having a first cavity and a first lower opening and at least one first through hole connected with the first cavity respectively; a bionic brain placed in the first cavity, the bionic brain having the same outer contour as a human brain and having conductivity, wherein the at least one detection electrode is adapted to pass through the at least one first through hole and be connected with the bionic brain; a signal generation module adapted to generate a plurality of modulated test signals; and a plurality of transmission leads, first ends of the plurality of transmission leads being connected with the signal generation module respectively, second ends of the plurality of transmission leads passing through the first lower opening and being connected with the bionic brain respectively.

2. The headform apparatus for in-vitro testing of claim 1, wherein, The signal generation module comprises: a signal source adapted to generate a plurality of different test signals; and a signal modulation unit adapted to be connected with the signal source, the signal modulation unit being adapted to generate the corresponding plurality of modulated test signals according to the input plurality of different test signals.

3. The headform apparatus for in-vitro testing of claim 2, wherein, The head model device further comprises: a base comprising a second cavity having a second upper opening corresponding to the first lower opening, the base being connected with the head model body, wherein the signal modulation unit is placed in the second cavity, and the plurality of transmission leads further pass through the second upper opening.

4. The headform apparatus for in-vitro testing of claim 2, wherein, The signal modulation unit comprises: a first modulation sub-unit adapted to adjust the frequency of the input test signal.

5. The headform apparatus for in-vitro testing of claim 2, wherein, The signal modulation unit comprises: a second modulation sub-unit adapted to adjust the amplitude of the input test signal.

6. The headform apparatus for use in in-vitro testing of claim 1, wherein, The head model device further comprises: a support plate located in the first cavity and fixedly connected with the head model body, the support plate having a plurality of second through holes adapted to allow the plurality of transmission leads to pass through, wherein the bionic brain is adapted to be placed on the support plate.

7. The headform apparatus for use in in-vitro testing of claim 1, wherein, The head model device further comprises: a support plate located in the first cavity and integrally formed with the head model body, the support plate having a plurality of second through holes adapted to allow the plurality of transmission leads to pass through, wherein the bionic brain is adapted to be placed on the support plate.

8. The headform apparatus for use in in-vitro testing of claim 1, wherein, The plurality of modulated test signals comprise an electro-oculogram signal, an electromyogram signal, a neural signal and an interference signal.

9. The headform apparatus for use in in-vitro testing of claim 1, wherein, End portions of the second ends have waterproof joints, and the plurality of transmission leads are connected with the bionic brain through the waterproof joints.

10. The headform apparatus for use in in-vitro testing of claim 1, wherein, The first through hole has a diameter of 1.6 cm to 2.4 cm.