Comfort needle auxiliary device for Qishi-Huang needle double-blind experiment and use method of comfort needle auxiliary device

Abstract

The invention relates to the technical field of double-blind experiments, in particular to a placebo needle auxiliary device for a Qishi-Huang needle double-blind experiment and a using method thereof.The device comprises experiment needles, the Qishi-Huang needle and the placebo needle are included, the Qishi-Huang needle is used for conducting acupuncture operation on a human body, and the placebo needle is used for simulating acupuncture to conduct a contrast experiment; the auxiliary device comprises a sleeve, and the auxiliary device comprises a Qishi needle auxiliary device and a placebo needle auxiliary device; the same operation process as a real Qishi needle is strictly followed, the condition that a needle body pierces a human body is simulated through a telescopic structure of the placebo needle, and when a needle head of the placebo needle penetrates through a first fixing film layer and touches a skin simulation layer, the magnitude of needle applying pressure is detected through a pressure sensor, so that the magnitude of current of an electrode plate is controlled, and the operation process is simplified. At the moment, the current control module dynamically adjusts output, the air feeling of real acupuncture after needle insertion is simulated, and therefore the problem that a user is prone to being broken by the traditional comforting acupuncture method is effectively solved.

Description

Technical Field

[0001] The present invention relates to the technical field of double-blind experiments, and in particular to a placebo needle auxiliary device for a Qihuang acupuncture double-blind experiment and a method of using the device. Background Art

[0002] The double-blind experiment of Qihuang acupuncture is an important method in the field of traditional Chinese medicine acupuncture research. Its core is to ensure that neither the subjects nor the operators can distinguish the difference between real acupuncture and placebo acupuncture, so as to objectively evaluate the clinical efficacy of Qihuang acupuncture.

[0003] The placebo acupuncture method in traditional double-blind experiments has obvious limitations, which seriously affects the reliability of the experiment and the credibility of the results. Traditional placebo acupuncture mostly uses non-penetrating simulation, but subjects can detect the authenticity through touch or differences in the operator's technique, resulting in the failure of the blind method.

[0004] Therefore, in order to address the problem that the above-mentioned traditional placebo acupuncture method is easily detected, the present invention proposes a placebo acupuncture auxiliary device for double-blind experiments with Qihuang acupuncture and a method of use thereof. The device strictly follows the same operating procedures as the real Qihuang acupuncture, and only the acupuncture depth and stimulation intensity are regulated by the internal mechanism of the device, thereby ensuring the rigor of the double-blind experiment. Summary of the Invention

[0005] In order to overcome the problem that traditional placebo acupuncture methods are easily detected, the present invention proposes a placebo acupuncture auxiliary device for double-blind experiments of Qihuang acupuncture and a method of using the device.

[0006] The technical solution of the present invention is: a placebo needle auxiliary device for double-blind experiments of Qihuang acupuncture, comprising:

[0007] The experimental needle includes a Qihuang needle and a placebo needle, wherein the Qihuang needle is used for acupuncture on the human body, and the placebo needle is used for simulating acupuncture for a control experiment, wherein the placebo needle includes a placebo needle handle and a placebo needle body, wherein the placebo needle body is arranged at the lower end of the placebo needle handle, and the Qihuang needle includes a Qihuang needle handle and a Qihuang needle body, wherein the Qihuang needle body is fixedly connected to the lower end of the Qihuang needle handle;

[0008] The auxiliary device includes a sleeve, and the auxiliary device includes a Qihuang needle auxiliary device and a placebo needle auxiliary device. The Qihuang needle auxiliary device and the placebo needle auxiliary device have the same appearance.

[0009] Preferably, a sliding groove is provided at the lower end of the placebo needle handle, a spring is fixedly connected in the sliding groove of the placebo needle handle, a placebo needle body is slidably connected in the sliding groove of the placebo needle handle, and the placebo needle body is fixedly connected to the spring.

[0010] Preferably, the outer surface material and diameter of the placebo needle are consistent with those of the real Qihuang needle, the needle tip of the placebo needle is blunt, and the needle tip of the Qihuang needle is pointed.

[0011] Preferably, a limiting block 1 is fixedly connected to the interior of the sleeve of the placebo needle auxiliary device, a battery is provided inside the limiting block 1, and a pinhole 1 is penetrated through the middle of the upper end of the limiting block 1.

[0012] Preferably, the lower end of the limit block 1 is fixedly connected to the sleeve with a fixed membrane layer 1, the lower end of the fixed membrane layer 1 is fixedly connected to the sleeve with a skin simulation layer, the lower end of the skin simulation layer is fixedly connected to the sleeve with a connecting layer, the fixed membrane layer 1 is a medical-grade polyurethane film, the skin simulation layer is a silicone-gelatin composite material, which is used to simulate the elastic modulus of the human dermis, and the placebo auxiliary device is also equipped with a current control module and a pressure sensor.

[0013] Preferably, the sleeve of the Qihuang needle auxiliary device is fixedly connected to a limiting block 2, a needle hole 2 is opened through the middle of the upper end of the limiting block 2, and the lower end of the limiting block 2 and the sleeve are fixedly connected to a fixed film layer 2, and the fixed film layer 2 is a medical grade polyurethane film.

[0014] Preferably, a plurality of rectangular grooves are provided on the upper end of the placebo needle body, and a slip ring is provided on the surface of the placebo needle body.

[0015] Preferably, the battery of the placebo needle auxiliary device is electrically connected to the skin simulation layer and the electrode sheet.

[0016] Preferably, the method for using the placebo needle auxiliary device for the Qihuang acupuncture double-blind experiment includes the following steps:

[0017] S1, disinfection of auxiliary devices followed by location of acupuncture points;

[0018] S2, the control group placed the Qihuang needle assisting device on the located acupoints, and the experimental group placed the placebo needle assisting device on the located acupoints;

[0019] S3, disinfect the acupuncture sites of Qihuang needles and placebo needles;

[0020] S4, holding the handle of the placebo needle and inserting the handle of the placebo needle into the placebo needle auxiliary device, the needle tip of the placebo needle passes through the fixed membrane layer 1 and touches the skin simulation layer, at this time, the pressure sensor detects the acupuncture pressure value in real time, and dynamically adjusts the output current of the electrode sheet (14) through the current control module, accurately simulating the nerve stimulation signal of real acupuncture, realizing tactile deception, and the current range is 0.05-0.3mA; holding the handle of the Qihuang needle and inserting the Qihuang needle body into the Qihuang needle auxiliary device, the needle tip of the Qihuang needle passes through the fixed membrane layer 2 and is inserted into the human body;

[0021] S5: After the acupuncture is completed, the needle is removed immediately by the acupuncturist without leaving it in place.

[0022] The operation process of the placebo needle is completely consistent with that of the real Qihuang needle, including disinfection, needle holding and insertion angle.

[0023] Preferably, in step S4, when the placebo needle touches the skin simulation layer, the blunt needle cannot penetrate. At this time, the placebo needle body compresses the spring and moves inside the placebo needle handle to simulate the needle body being inserted into the human body. A micro sensor is provided in the connecting layer to adjust the current of the electrode sheet according to the acupuncture pressure of the placebo needle.

[0024] Beneficial effects of the present invention:

[0025] The present invention strictly follows the same operating procedures as the real Qihuang needle, including positioning, disinfection, needle insertion and other steps. The telescopic structure of the placebo needle simulates the situation of the needle body entering the human body. When the needle tip of the placebo needle passes through the fixed membrane layer and touches the skin simulation layer, the pressure sensor detects the needle pressure value in real time, and the current control module dynamically adjusts the output current of the electrode sheet to accurately simulate the nerve stimulation signal of real acupuncture, realize tactile deception, and effectively solve the problem that traditional placebo acupuncture methods are easily detected. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 What is shown is a schematic diagram of the overall three-dimensional structure of the present invention;

[0027] Figure 2 Shown is a schematic diagram of the cross-sectional structure of the placebo needle auxiliary device of the present invention;

[0028] Figure 3 Shown is a schematic diagram of the cross-sectional structure of the Qihuang acupuncture auxiliary device of the present invention;

[0029] Figure 4 Shown is a schematic diagram of the internal structure of the needle handle of the placebo needle of the present invention;

[0030] Figure 5 Shown is a schematic diagram of the experimental process of the present invention.

[0031] Explanation of the accompanying symbols: 1. Placement needle handle; 2. Sliding groove; 3. Spring; 4. Placement needle body; 5. Qihuang needle handle; 6. Qihuang needle body; 7. Sleeve; 8. Limit block one; 9. Battery; 10. Needle hole one; 11. Fixed film layer one; 12. Skin simulation layer; 13. Connecting layer; 14. Electrode sheet; 15. Limit block two; 16. Needle hole two; 17. Fixed film layer two. DETAILED DESCRIPTION

[0032] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are some but not all of the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative efforts belong to the scope of the present application.

[0033] Please refer to Figure 1-Figure 4 The present application provides an embodiment: a comfort needle auxiliary device for double-blind experiment of Zhizhong needle, including experiment needle, including Zhizhong needle and comfort needle, the Zhizhong needle is used for acupuncture operation on human body, the comfort needle is used for simulation acupuncture for control experiment, the comfort needle includes comfort needle handle 1 and comfort needle body 4, the comfort needle body 4 is arranged at the lower end of the comfort needle handle 1, the Zhizhong needle includes Zhizhong needle handle 5 and Zhizhong needle body 6, the Zhizhong needle body 6 is fixedly connected to the lower end of the Zhizhong needle handle 5.

[0034] The auxiliary device includes sleeve 7, the auxiliary device includes Zhizhong needle auxiliary device and comfort needle auxiliary device, the Zhizhong needle auxiliary device and the comfort needle auxiliary device are consistent in appearance.

[0035] In the double-blind experiment, the comfort needle is combined with the comfort needle auxiliary device, and the Zhizhong needle is combined with the Zhizhong needle auxiliary device for control experiment.

[0036] The lower end of the placebo needle handle 1 is provided with a sliding groove 2, and a spring 3 is fixedly connected in the sliding groove 2 of the placebo needle handle 1. The sliding groove 2 of the placebo needle handle 1 is slidably connected with a placebo needle body 4, and the placebo needle body 4 is fixedly connected to the spring 3. When performing acupuncture, hold the placebo needle handle 1 to press the placebo needle. At this time, the placebo needle body 4 will squeeze the spring 3 to move toward the upper end of the placebo needle handle 1, thereby simulating the situation where the needle body pierces the human body. The outer surface material and diameter of the placebo needle are consistent with those of the real Qihuang needle. The needle head of the placebo needle is blunt, and the needle head of the Qihuang needle is pointed. This design can prevent the acupuncturist and the subject from noticing the placebo needle through appearance. The sleeve 7 of the placebo needle auxiliary device is fixedly connected to a limiting block 8, and a battery 9 is provided inside the limiting block 8. The middle part of the upper end of the limiting block 8 is penetrated by a Needle hole 10. After the placebo needle body 4 is placed in the device, the needle hole 10 in the limit block 8 can prevent the acupuncturist from observing the situation of the placebo needle body 4 during acupuncture, and the needle hole 10 also has the function of fixed limitation. The lower end of the limit block 8 is fixedly connected to the sleeve 7 with a fixed film layer 11. The fixed film layer 11 and the lower end of the fixed film layer 11 are fixedly connected to the sleeve 7 with a skin simulation layer 12. The lower end of the skin simulation layer 12 is fixedly connected to the sleeve 7 with a connecting layer 13. When the placebo needle body 4 is controlled to apply downward pressure, the placebo needle body 4 first penetrates the fixed film layer 11. The fixed film layer 11 is used to fix the placebo needle body 4. When the placebo needle body 4 pierces the placebo needle body 4 and touches the skin simulation layer 12, the blunt head of the placebo needle body 4 cannot penetrate the skin simulation layer 12.

[0037] The sleeve 7 of the Qihuang needle auxiliary device is fixedly connected to the limiting block 2 15, and the middle part of the upper end of the limiting block 2 15 is penetrated by a needle hole 2 16. The lower end of the limiting block 2 15 and the sleeve 7 are fixedly connected to a fixed film layer 2 17. After the Qihuang needle body 6 is placed in the device, the needle hole 2 16 in the limiting block 2 15 can prevent the acupuncturist from observing the condition of the Qihuang needle body 6 during acupuncture, and the needle hole 2 16 also has the function of fixing and limiting. The upper end of the comfort needle body 4 is provided with a plurality of rectangular grooves 18, and the surface of the comfort needle body 4 is provided with a slip ring 19. When the comfort needle body 4 is adjusted When pressure is applied, the placebo needle body 4 moves toward the upper end of the placebo needle handle 1, and the slip ring 19 also moves upward. When the acupuncture is completed, the placebo needle body 4 moves downward due to the force of the spring 3. At this time, the placebo needle body 4 is separated from the slip ring 19 on the surface. After separating from the slip ring 19, the upper end surface of the slip ring 19 expands outward, thereby being stuck in the placebo needle handle 1 to prevent rebound, thereby completely simulating the situation after the needle is inserted into the human body after acupuncture. The battery 9 of the placebo needle auxiliary device is electrically connected to the skin simulation layer 12 and the electrode sheet 14, and the battery 9 discharges the subject by supplying power to the electrode sheet 14.

[0038] See also Figure 5The present invention provides an embodiment of a method for using a placebo needle auxiliary device for a double-blind experiment of Qihuang acupuncture, comprising the following steps:

[0039] First, the auxiliary device is disinfected, and then the acupuncture points are located;

[0040] The control group placed the Qihuang needle-assisted device on the located acupoints, and the experimental group placed the placebo needle-assisted device on the located acupoints;

[0041] Disinfect the acupuncture sites of Qihuang needles and placebo needles;

[0042] Hold the placebo needle handle 1 and insert the placebo needle handle 1 into the placebo needle auxiliary device. When controlling the placebo needle body 4 to apply downward pressure, the placebo needle body 4 first penetrates the fixed membrane layer 11. The fixed membrane layer 11 is used to fix the placebo needle body 4. When the placebo needle body 4 penetrates the placebo needle body 4 and touches the skin simulation layer 12, the blunt head of the placebo needle body 4 cannot penetrate the skin simulation layer 12. At this time, the placebo needle body 4 will squeeze the spring 3 and move toward the upper end of the placebo needle handle 1, thereby simulating the situation where the needle body penetrates the human body. At the same time, the pressure sensor detects the acupuncture pressure value in real time, and the current control module dynamically adjusts the output current of the electrode sheet 14, thereby accurately simulating the nerve stimulation signal of real acupuncture and realizing tactile deception. The current range is 0.05-0.3mA.

[0043] Hold the Qihuang needle handle 5 and insert the Qihuang needle body 6 into the Qihuang needle auxiliary device. The Qihuang needle tip passes through the fixed membrane layer 2 17 and is inserted into the human body.

[0044] S5. After the acupuncture is completed, the needle is removed immediately by the acupuncturist without leaving it in place.

[0045] The above are merely preferred embodiments of the present invention and do not limit the present invention in any other form. Any technician familiar with the present invention may use the technical content disclosed above to change or modify it into an equivalent embodiment with equivalent changes and apply it to other fields. However, any simple modification, equivalent change and modification made to the above embodiment based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall still fall within the scope of protection of the technical solution of the present invention.

Claims

1. A placebo needle auxiliary device for double-blind Qihuang acupuncture experiments, characterized in that: Includes: The experimental needle comprises a Qihuang needle and a placebo needle, wherein the Qihuang needle is used for performing acupuncture on a human body, and the placebo needle is used for simulating acupuncture to perform a control experiment, wherein the placebo needle comprises a placebo needle handle (1) and a placebo needle body (4), wherein the placebo needle body (4) is arranged at the lower end of the placebo needle handle (1), and the Qihuang needle comprises a Qihuang needle handle (5) and a Qihuang needle body (6), wherein the Qihuang needle body (6) is fixedly connected to the lower end of the Qihuang needle handle (5); The auxiliary device includes a sleeve (7), and the auxiliary device includes a Qihuang needle auxiliary device and a placebo needle auxiliary device. The Qihuang needle auxiliary device and the placebo needle auxiliary device have the same appearance.

2. The placebo needle auxiliary device for double-blind Qihuang acupuncture experiments according to claim 1, characterized in that: A sliding groove (2) is provided at the lower end of the placebo needle handle (1), a spring (3) is fixedly connected in the sliding groove (2) of the placebo needle handle (1), a placebo needle body (4) is slidably connected in the sliding groove (2) of the placebo needle handle (1), and the placebo needle body (4) is fixedly connected to the spring (3).

3. The placebo needle auxiliary device for double-blind Qihuang acupuncture experiments according to claim 1, characterized in that: The outer surface material and diameter of the placebo needle are consistent with those of the real Qihuang needle. The needle tip of the placebo needle is blunt, while the needle tip of the Qihuang needle is pointed.

4. The placebo needle auxiliary device for double-blind Qihuang acupuncture experiments according to claim 1, characterized in that: A limiting block (8) is fixedly connected to the interior of the sleeve (7) of the placebo needle auxiliary device, a battery (9) is provided inside the limiting block (8), and a needle hole (10) is provided through the middle of the upper end of the limiting block (8).

5. The placebo needle auxiliary device for double-blind Qihuang acupuncture experiment according to claim 1, characterized in that: The lower end of the limit block 1 (8) and the sleeve (7) are fixedly connected to a fixed film layer 1 (11), the fixed film layer 1 (11), the lower end of the fixed film layer 1 (11) and the sleeve (7) are fixedly connected to a skin simulation layer (12), the lower end of the skin simulation layer (12) and the sleeve (7) are fixedly connected to a connecting layer (13), the fixed film layer 1 (11) is a medical-grade polyurethane film, the skin simulation layer (12) is a silicone-gelatin composite material, and is used to simulate the elastic modulus of the human dermis. The placebo needle auxiliary device is also equipped with a current control module and a pressure sensor.

6. The placebo needle auxiliary device for double-blind Qihuang acupuncture experiments according to claim 1, characterized in that: The sleeve (7) of the Qihuang needle auxiliary device is fixedly connected to the inner part of the limit block 2 (15), and the middle part of the upper end of the limit block 2 (15) is penetrated by a needle hole 2 (16). The lower end of the limit block 2 (15) and the sleeve (7) are fixedly connected to a fixed film layer 2 (17), and the fixed film layer 2 (17) is a medical grade polyurethane film.

7. The Qihuang acupuncture double-blind experimental placebo auxiliary device and its use method according to claim 1, characterized in that: The upper end of the comfort needle body (4) is provided with a plurality of rectangular grooves (18), and the surface of the comfort needle body (4) is provided with a slip ring (19).

8. The placebo needle auxiliary device for double-blind Qihuang acupuncture experiments according to claim 1, characterized in that: The battery (9) of the placebo needle auxiliary device is electrically connected to the skin simulation layer (12) and the electrode sheet (14).

9. A method for using a placebo needle auxiliary device for a double-blind experiment with Qihuang acupuncture, comprising using the placebo needle auxiliary device for a double-blind experiment with Qihuang acupuncture according to any one of claims 1 to 8, characterized in that: The following steps are included: S1, disinfection of auxiliary devices followed by location of acupuncture points; S2, the control group placed the Qihuang needle assisting device on the located acupoints, and the experimental group placed the placebo needle assisting device on the located acupoints; S3, disinfect the acupuncture sites of Qihuang needles and placebo needles; S4, hold the handle of the placebo needle (1) and insert the handle of the placebo needle (1) into the placebo needle auxiliary device, and the needle tip of the placebo needle passes through the fixed membrane layer 1 (11) and touches the skin simulation layer (12). At this time, the pressure sensor detects the acupuncture pressure value in real time, and dynamically adjusts the output current of the electrode sheet (14) through the current control module to accurately simulate the nerve stimulation signal of real acupuncture, realizing tactile deception, with a current range of 0.05-0.3mA; hold the handle of the Qihuang needle (5) and insert the Qihuang needle body (6) into the Qihuang needle auxiliary device, and the needle tip of the Qihuang needle passes through the fixed membrane layer 2 (17) and is inserted into the human body; S5: After the acupuncture is completed, the needle is removed immediately by the acupuncturist without leaving it in place. The operation process of the placebo needle is completely consistent with that of the real Qihuang needle, including disinfection, needle holding and insertion angle.

10. The method for using the Qihuang acupuncture double-blind experimental placebo needle auxiliary device according to claim 9, characterized in that: In step S4, when the placebo needle touches the skin simulation layer (12), the blunt needle cannot penetrate. At this time, the placebo needle body (4) compresses the spring (3) and moves inside the placebo needle handle (1), simulating the needle body being inserted into the human body.

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