Double-blind test acupuncture device

Abstract

The utility model relates to the technical field of acupuncture clinical tests, in particular to a double-blind test acupuncture device which comprises a needle, a sleeve and a patch, an installation hole channel is formed in the sleeve, the patch is connected with the sleeve, the needle is arranged in the installation hole channel in a sleeved mode, and the installation hole channel is connected with the patch. The needling instrument comprises a first needling instrument with a pointed needle tip and a second needling instrument with a blunt needle tip; the sleeve comprises a first sleeve and a second sleeve; the mounting hole channel of the first sleeve is perpendicular to the bottom surface of the sleeve; the mounting hole channel of the second sleeve is inclined to the bottom surface of the sleeve. The double-blind test acupuncture device breaks through the limitation of an existing double-blind test acupuncture device on the acupuncture angle, meets the requirements of flat acupuncture, inclined acupuncture and straight acupuncture in clinical acupuncture, and further simplifies the structure of the device so as to reduce the production cost and the operation difficulty.

Description

Technical Field

[0001] This utility model relates to the technical field of acupuncture clinical trials, and more specifically, to a double-blind acupuncture device. Background Technology

[0002] The placebo effect refers to the phenomenon where patients experience symptom improvement or disease progression even after receiving a placebo that contains no actual therapeutic component. This phenomenon may occur because patients believe they are receiving effective treatment, leading to a positive psychological response that triggers physiological improvement. Alternatively, patients often receive more attention and care from researchers, and this social and emotional support can also contribute to symptom improvement. The placebo effect is prevalent in clinical practice; therefore, when evaluating the effectiveness of acupuncture, a placebo group is typically used as a control, and a double-blind method is employed. This ensures that neither patients nor researchers are aware of the trial group assignments, guaranteeing that the observed therapeutic effect is produced by the acupuncture itself, rather than by subjective factors.

[0003] To better conduct double-blind placebo-controlled acupuncture trials, a device is needed to ensure that the real acupuncture group and the placebo acupuncture group are as visually similar as possible, while guaranteeing that the placebo acupuncture group has little or no therapeutic effect. In existing technologies, such as the placebo needle disclosed in Chinese patent CN106361562A, a device for double-blind trials is provided. This device has two sets of acupuncture kits, one real and one dummy. Each kit includes a hollow tube and a needle inserted into the tube from the top. An adhesive patch made of opaque material is placed at the bottom of the tube to seal the bottom opening. The needle in the real acupuncture kit consists of a first needle handle and a first needle tip. The needle in the dummy acupuncture kit consists of a second needle handle, a second needle tip, and an intermediate connector. The second needle tip is a flat-headed tip. However, this device can only perform acupuncture from a straight angle, which cannot meet the needs of multiple acupuncture angles in clinical trials. Furthermore, the intermediate connector of the dummy acupuncture kit is complex, increasing the cost of clinical trials. Utility Model Content

[0004] This invention aims to address the limitations of existing acupuncture techniques, such as the single insertion angle and restricted needling techniques, by providing a double-blind acupuncture device. This device not only supports straight insertion but also allows for various insertion angles, including horizontal and oblique insertion, and supports needling techniques such as lifting, thrusting, and twisting, thus meeting the diverse needs of acupuncture clinical research. The device features a simple structure and convenient operation, reducing the difficulty of use for users.

[0005] To solve the above-mentioned technical problems, the technical solution adopted by this utility model is as follows:

[0006] A double-blind acupuncture device is provided, comprising a needle, a sleeve with an internal mounting channel, and a patch. The patch is connected to the sleeve, and the needle is fitted in the mounting channel. The needle includes a first needle with a pointed tip and a second needle with a blunt tip. The sleeve includes a first sleeve with the mounting channel axis perpendicular to the bottom surface of the sleeve and a second sleeve with the mounting channel axis obliquely intersecting the bottom surface of the sleeve.

[0007] Before use, the double-blind acupuncture device of this invention involves inserting both a pointed first needle and a blunt second needle into either a first or second sleeve, securing them in place within the mounting channels. The sleeve with the first needle serves as the actual acupuncture group, while the sleeve with the second needle serves as the placebo group. During acupuncture, the sleeve is selected based on the desired acupuncture location and angle. The first sleeve is used for direct insertion, while the second sleeve is used for horizontal or oblique insertion. Finally, the device is glued to the patient's skin using a film at the bottom of the sleeve, securing the entire device to the skin. The acupuncturist then performs the acupuncture. During this process, the pointed first needle pierces the skin, while the blunt second needle only applies slight pressure without piercing it, serving as the placebo group. This double-blind acupuncture device enables multi-angle acupuncture, meeting the needs of horizontal, oblique, and direct insertion in clinical acupuncture.

[0008] Furthermore, the angle between the axis of the mounting channel in the second sleeve and the bottom surface of the second sleeve is 45° or 15°. When the angle between the axis of the mounting channel in the second sleeve and the bottom surface is 45°, it corresponds to the oblique insertion operation in clinical acupuncture; when the angle between the axis of the mounting channel in the second sleeve and the bottom surface is 15°, it corresponds to the horizontal insertion operation in clinical acupuncture, thus expanding the research scope of the double-blind trial.

[0009] Furthermore, the cannula has an internal accommodating cavity communicating with the mounting channel. The accommodating cavity contains a filler material, through which both the first and second needles pass. The filler material within the cannula helps to fix the needles in place. When the first and second needles move up and down or rotate horizontally within the cannula, the filler material creates resistance, simulating the tightness felt during needle insertion in skin and muscle tissue. This reduces the difference in sensation between actual acupuncture and placebo acupuncture, improving the double-blind effect.

[0010] Furthermore, the first cannula includes a first sphere and a second sphere connected to each other. The diameter of the first sphere is smaller than the diameter of the second sphere. The first needle or the second needle enters through the first sphere and exits through the second sphere. The first sphere and the second sphere are connected to form a gourd-shaped cannula, which is convenient for the user to hold. At the same time, controlling the diameter of the first sphere to be smaller than the second sphere and positioning the first sphere close to the patient's skin makes the overall center of gravity of the device more stable during double-blind experiments, preventing the needle insertion position from shifting or the cannula from falling off.

[0011] Furthermore, both the first and second needles include a needle body connected to the needle tip, with the length of the first needle body being greater than that of the second needle body. Because the first needle body is longer than the second needle body, when pressed to the same depth, the first needle penetrates the skin while the second needle just touches the skin, maintaining a consistent appearance. The difference in their lengths represents the penetration depth.

[0012] Furthermore, an anti-slip part is provided on the upper part of the needle body, and the surface of the anti-slip part is threaded. The user controls the position of the first and second needles in the cannula by holding the anti-slip part. During operation, the threads on the surface of the anti-slip part can increase the roughness, thereby increasing the friction and facilitating operation.

[0013] Furthermore, the patch has an easy-tear protective sticker at its bottom, with an easy-tear portion extending outward from its circumference. One side of the patch is bonded to the sleeve, while the other side has the easy-tear protective sticker. During use, the acupuncturist can quickly tear the protective sticker off the patch using the easy-tear portion, facilitating the quick fixation of the acupuncture device onto the patient's skin.

[0014] Furthermore, the patch has a through hole inside, the shape of which is the same as the shape of the mounting channel. The through hole inside the patch facilitates the passage of the first or second needle through the patch, allowing acupuncturists to successfully complete multi-angle acupuncture tests without piercing the patch.

[0015] Furthermore, both the cannula and the patch are opaque. The opaque structure of the cannula and patch prevents acupuncturists from observing the needle tip shape during the procedure and from distinguishing between the visually identical real acupuncture group and the placebo acupuncture group, thus reducing the risk of unblinding.

[0016] Compared with the prior art, the beneficial effects of this utility model are:

[0017] 1. The first and second sleeves with different shapes break through the limitations of the existing double-blind acupuncture devices on the acupuncture angle, meet the requirements of horizontal, oblique and straight acupuncture in clinical acupuncture, and increase the application of the acupuncture device in various parts of the human body.

[0018] 2. The real acupuncture group and the placebo acupuncture group are consistent in appearance, and the internal filler simulates the tightness of acupuncture, which can reduce the sensory difference between patients and acupuncturists when performing real acupuncture and placebo acupuncture, and improve the double-blind effect.

[0019] 3. It is highly convenient to operate. The acupuncturist only needs to position the acupuncture point, peel off the protective sticker, stick it on the acupoint, and then push the needle all the way in to complete the operation. Attached Figure Description

[0020] Figure 1 A schematic diagram of the needle insertion device for a double-blind test with a straight insertion angle;

[0021] Figure 2 A schematic diagram of the needle-punching device for a double-blind test with a flat-punching angle;

[0022] Figure 3 This is a schematic diagram of the structure of the first needle;

[0023] Figure 4 This is a schematic diagram of the second needle.

[0024] Figure 5 This is a schematic diagram of the patch structure.

[0025] In the attached diagram: 110, first needle; 120, second needle; 130, needle body; 140, anti-slip part; 200, first sleeve; 210, mounting channel; 220, accommodating cavity; 230, filler; 240, first sphere; 250, second sphere; 300, patch; 310, easy-tear protective sticker; 320, easy-tear part; 330, through hole; 400, second sleeve. Detailed Implementation

[0026] The present invention will be further described below with reference to specific embodiments. The accompanying drawings are for illustrative purposes only, representing schematic diagrams rather than actual physical objects, and should not be construed as limiting the scope of this patent. To better illustrate the embodiments of the present invention, some components in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0027] In the accompanying drawings of this utility model, the same or similar reference numerals correspond to the same or similar components. In the description of this utility model, it should be understood that if terms such as "upper," "lower," "left," and "right" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting this patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0028] Example 1

[0029] This embodiment is a first embodiment of a double-blind acupuncture device, including a needle, a sleeve with an internal mounting channel 210, and a patch 300. The patch 300 is connected to the sleeve. The needle is fitted in the mounting channel 210. The needle includes a first needle 110 with a pointed tip and a second needle 120 with a blunt tip. The sleeve includes a first sleeve 200 with the axis of the mounting channel 210 perpendicular to the bottom surface of the sleeve and a second sleeve 400 with the axis of the mounting channel 210 obliquely intersecting the bottom surface of the sleeve.

[0030] like Figure 1 , Figure 2 As shown, before use, the double-blind acupuncture device in this embodiment is first inserted into either the first sleeve 200 or the second sleeve 400, with the first needle 110 having a pointed tip and the second needle 120 having a blunt tip. The needles are then fixed in the mounting channel 210. The sleeve with the first needle 110 is the actual acupuncture group, and the sleeve with the second needle 120 is the placebo group. During acupuncture, the sleeve is selected according to the different acupuncture positions and angles required for treatment. The first sleeve 200 is selected for acupuncture devices that need to be placed at the straight insertion point, while the second sleeve 400 is selected for acupuncture devices that need to be placed at the horizontal or oblique insertion points. Finally, the acupuncture device is fixed to the patient's skin by adhesive tape at the bottom of the sleeve. The acupuncturist then performs the acupuncture. During the acupuncture, the first needle 110 with a pointed tip pierces the skin, while the second needle 120 with a blunt tip only slightly presses on the skin and does not pierce it, serving as the placebo group.

[0031] like Figure 2 As shown, the angle between the axis of the mounting channel 210 in the second sleeve 400 and the bottom surface of the second sleeve 400 is 45° or 15°. When the angle between the axis of the mounting channel 210 in the second sleeve 400 and the bottom surface is 45°, it corresponds to the oblique insertion operation in clinical acupuncture; when the angle between the axis of the mounting channel 210 in the second sleeve 400 and the bottom surface is 15°, it corresponds to the horizontal insertion operation in clinical acupuncture, thus expanding the research scope of the double-blind trial.

[0032] The sleeve has an internal receiving cavity 220 that communicates with the installation channel. The receiving cavity 220 contains a filler 230, through which both the first needle 110 and the second needle 120 pass. For example... Figure 1 , Figure 2 As shown, the filler 230 can fix the needles in the cannula, and when the first needle 110 and the second needle 120 move up and down in the cannula, the filler 230 generates resistance to the needles, which can simulate the tightness of needle insertion in the skin and muscle tissue, reduce the difference in sensation between acupuncturists performing real acupuncture and comfort acupuncture, and improve the double-blind effect.

[0033] The first cannula 200 includes a first sphere 240 and a second sphere 250 connected to each other. The diameter of the first sphere 240 is smaller than the diameter of the second sphere 250. A first needle 110 or a second needle 120 enters through the first sphere 240 and exits through the second sphere 250. Figure 1 , Figure 2 As shown, the first sphere 240 and the second sphere 250 are connected to form a gourd-shaped sleeve, which is convenient for the user to hold. At the same time, the diameter of the first sphere 240 is smaller than that of the second sphere 250 and the second sphere 250 is positioned close to the patient's skin. During the double-blind experiment, this makes the overall center of gravity of the device more stable and prevents the needle insertion position from shifting or the sleeve from falling off.

[0034] Both the cannula and patch 300 are opaque. The opaque structure of the cannula and patch 300 prevents acupuncturists from observing the shape of the needle tip during the procedure and from distinguishing between the visually identical real acupuncture group and the placebo acupuncture group, thus reducing the risk of unblinding.

[0035] The working principle of the double-blind acupuncture device in this embodiment is as follows: First, the pointed first needle 110 and the blunt second needle 120 are both inserted into the first sleeve 200 or the second sleeve 400, keeping the needles fixed in the mounting channel 210. The sleeve with the first needle 110 is the actual acupuncture group, and the sleeve with the second needle 120 is the placebo acupuncture group. During acupuncture, the sleeve is selected according to the different acupuncture positions and angles required for treatment. The first sleeve 200 is selected for acupuncture devices that need to be placed at the straight insertion site, and the second sleeve 400 is selected for acupuncture devices that need to be placed at the horizontal or oblique insertion sites. Finally, the acupuncture device is fixed to the patient's skin by adhesive tape at the bottom of the sleeve. The acupuncturist performs the acupuncture operation. During the acupuncture, the pointed first needle 110 pierces the skin, while the blunt second needle 120 only slightly presses the skin and does not pierce it, serving as the placebo group.

[0036] Example 2

[0037] This embodiment is a second embodiment of the double-blind acupuncture device. This embodiment is similar to the first embodiment, except that both the first needle 110 and the second needle 120 include a needle body 130 connected to the needle tip, and the length of the needle body 130 of the first needle 110 is greater than the length of the needle body 130 of the second needle 120. For example... Figure 3 , Figure 4 As shown, the first needle 110 has a longer body 130 than the second needle 120, providing sufficient space for the placebo needle (which does not pierce the skin) to simulate acupuncture techniques such as vertical insertion and horizontal rotation, thus expanding the scope of the clinical trial protocol. During use, when inserting the first needle 110 and the second needle 120 into the cannula, it is important to ensure that the lengths of the needle bodies 130 protruding from the cannula are consistent. Because the lengths of the first needle 110 and the second needle 120 are different, the lengths they are submerged in the cannula are also different. Before acupuncture, the needle tips should not protrude from the cannula, ensuring that the acupuncture group and the placebo group appear identical, reducing the risk of blinding. During acupuncture, the needle tip of the first needle 110 must protrude from the cannula and pierce the skin.

[0038] like Figure 3 As shown, the needle body 130 is provided with an anti-slip part 140, and the surface of the anti-slip part 140 is provided with threads. The user controls the position of the first needle 110 and the second needle 120 in the cannula by holding the anti-slip part 140. During operation, the threads on the surface of the anti-slip part 140 can increase the roughness, thereby increasing the friction and facilitating operation.

[0039] The needle in this embodiment consists of three parts: the needle handle is located at the top, specifically the anti-slip part 140 of the needle, which is the hand-held part during acupuncture operation; the needle body 130 specifically refers to the smooth part below the handle; and the needle tip specifically refers to the tip below the body 130.

[0040] The working principle of the double-blind acupuncture device in this embodiment is as follows: When needles of different lengths are pressed to the same depth, the first needle 110 pierces the skin, while the second needle 120 just touches the skin. The two are consistent in appearance, and the difference in their lengths is the piercing depth. At the same time, it can give the placebo needle that does not pierce the skin a certain amount of room to move, so that it can simulate the needling techniques in the real acupuncture process, such as lifting and thrusting, horizontal rotation, etc., thus expanding the research scope of the clinical trial protocol.

[0041] Example 3

[0042] This embodiment is the third embodiment of the double-blind needle prick test device, including a patch 300 with an easy-tear protective sticker 310 at the bottom, and an easy-tear portion 320 extending outward from the circumferential surface of the easy-tear protective sticker 310. For example... Figure 5As shown, one side of the patch 300 is bonded to the sleeve, and the other side is provided with an easy-tear protective sticker 310. During use, the acupuncturist can quickly tear the easy-tear protective sticker 310 off the patch 300 through the easy-tear part 320, which makes it convenient for the acupuncturist to quickly fix the acupuncture device on the patient's skin.

[0043] The patch 300 has a through hole 330 inside, and the shape of the through hole 330 is the same as that of the mounting channel 210. The through hole 330 inside the patch 300 allows the first needle 110 or the second needle 120 to pass through the patch 300, so that the acupuncturist can successfully complete the multi-angle acupuncture test without puncturing the patch 300.

[0044] The working principle of the double-blind acupuncture device in this embodiment is as follows: one side of the patch 300 is bonded to the sleeve, and the other side is provided with an easy-tear protective sticker 310. During use, the acupuncturist can quickly tear the easy-tear protective sticker 310 off the patch 300 through the easy-tear part 320, so that the acupuncturist can quickly fix the acupuncture device on the patient's skin.

[0045] In the specific implementation of the above embodiments, the technical features can be combined in any non-contradictory way. For the sake of brevity, not all possible combinations of the above technical features are described. However, as long as the combination of these technical features is not contradictory, it should be considered to be within the scope of this specification.

[0046] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating this utility model, and are not intended to limit the implementation of this utility model. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.

Claims

1. A double-blind acupuncture device, characterized by, The device comprises a needle, a sleeve with an installation channel (210) and a patch (300), the patch (300) is connected with the sleeve, the needle is sleeved in the installation channel (210), the needle comprises a first needle (110) with a pointed needle tip and a second needle (120) with a blunt needle tip, the sleeve comprises a first sleeve (200) with the installation channel (210) axis perpendicular to the bottom surface of the sleeve and a second sleeve (400) with the installation channel (210) axis oblique to the bottom surface of the sleeve.

2. A double-blind needle injection device according to claim 1, characterized in that The angle between the installation channel (210) axis in the second sleeve (400) and the bottom surface of the second sleeve (400) is 45° or 15°.

3. The double-blind needle injection device of claim 1, wherein, The sleeve is internally provided with a containing cavity (220) in communication with the installation channel (210), the containing cavity (220) is internally provided with a filler (230), the first needle (110) and the second needle (120) both pass through the filler (230).

4. The double-blind needle injection device of claim 1, wherein, The first sleeve (200) comprises a first sphere (240) and a second sphere (250) connected with each other, the diameter of the first sphere (240) is smaller than the diameter of the second sphere (250), the first needle (110) or the second needle (120) passes in from the first sphere (240) and passes out from the second sphere (250).

5. A double-blind needle injection device according to any one of claims 1 to 4, characterized in that The first needle (110) and the second needle (120) both comprise a needle body (130) connected with the needle tip, the length of the needle body (130) of the first needle (110) is greater than the length of the needle body (130) of the second needle (120).

6. A double-blind needle injection device according to claim 5, wherein The needle body (130) is provided with an anti-skid part (140), the surface of the anti-skid part (140) is provided with a thread.

7. A double-blind needle injection device according to any one of claims 1 to 4, wherein The bottom of the patch (300) is provided with a tearable protective patch (310), the circumferential surface of the tearable protective patch (310) extends outwardly with a tearable part (320).

8. A double-blind needle injection device according to claim 7, wherein The inside of the patch (300) is provided with a through hole (330), the shape of the through hole (330) is the same as the shape of the installation channel (210).

9. A double-blind needle injection device according to any one of claims 1 to 4, wherein The sleeve and the patch (300) are both opaque structures.

Images