Double-blind acupuncture placebo needle for clinical test

Abstract

The utility model discloses a double-blind acupuncture placebo needle for clinical tests, which relates to the technical field of medical experimental instruments and is characterized in that one end of a needle body is a passivated needle tip (skin contact end), the other end of the needle body is a sharpened needle tip (connected with a needle handle) capable of puncturing artificial skin gel, and the sharpened end of the needle tip is nested in a hollow needle handle. The needle body can slide in the needle body containing hole channel of the needle handle when being subjected to external force, the needle body containing hole channel is filled with the gel artificial skin capable of simulating the acupuncture hand feeling, the needle point can pierce the gel artificial skin when being subjected to external force, and therefore the hand feeling during acupuncture is simulated, and a needle applicator is covered. The technical problem that double blindness cannot be completed due to the fact that an existing placebo needle cannot simulate the real needle inserting hand feeling is solved; and the passivated needle head can be used for stabbing without stabbing into a subject, so that the subject feels painful, and whether the subject is a comforting needle or not cannot be distinguished, and therefore, double-blind operation can be smoothly completed.

Description

Technical Field

[0001] The utility model relates to the technical field of medical experimental instruments, in particular to a double-blind acupuncture placebo needle for clinical trials. Background Art

[0002] Acupuncture is a technique guided by Traditional Chinese Medicine (TCM) theory that involves inserting needles into specific areas of the body, combined with specific manipulation techniques, to stimulate acupuncture points and meridians to achieve the desired therapeutic effect. As a distinct intangible cultural heritage of my country, acupuncture has not only benefited the Chinese people but has also garnered widespread attention worldwide in recent years, with its popularity only growing. However, further high-quality research is needed to further validate acupuncture's effectiveness, and randomized controlled trials are currently the gold standard for evaluating the effectiveness of medical interventions.

[0003] In order to isolate the specific effects of the intervention being observed, randomized controlled trials need to randomly assign subjects to treatment and control groups, where the treatment group receives a specific treatment and the control group receives a placebo treatment. All aspects except the treatment remain the same between the two groups, providing a benchmark for comparing the effects of the intervention. In addition, to reduce the influence of subjective bias and expectation effects on the trial results, a blind method must be used during the experiment, that is, the participants and / or researchers do not know whether the subjects are receiving the actual treatment or the control. In acupuncture randomized controlled trials, the placebo acupuncture needles are special needles set up for the establishment of the placebo control group and the implementation of the blind method. Currently, the most commonly used placebo acupuncture needles include the Streitberger device, the Park device, the Akakura device, etc. The characteristics of these devices can be summarized as follows: (1) using a blunt needle to simulate the feeling of an acupuncture needle piercing the skin without piercing the skin, so that the subjects believe that they are receiving acupuncture treatment; (2) the part where the needle contacts the body surface is covered with a cannula to achieve the effect of blinding. (3) the part where the needle contacts the body surface is fixed with auxiliary tools such as a rubber pad. However, these devices generally have the following problems: (1) Because experimental acupuncture operations require experienced acupuncturists to perform, existing placebo needles cannot simulate the feel of real needle insertion. For experienced acupuncturists, it is easy to distinguish whether it is a placebo needle, and double-blind testing cannot be completed; (2) The difference between the appearance of placebo needles and real acupuncture is too large, which can easily cause suspicion in the subjects and lead to breaking the blind; (3) The operation is cumbersome and is not very applicable in real clinical trials; (4) The structure is complex and the production cost is high, which is not suitable for mass production. Utility Model Content

[0004] In view of the above problems in the prior art, the present invention provides a double-blind acupuncture placebo needle for clinical trials to solve the technical problem that the existing placebo needle cannot complete the double-blind test because it cannot simulate the real needle insertion feel.

[0005] The technical solutions adopted in this utility model are as follows:

[0006] A double-blind acupuncture placebo needle for clinical trials comprises a needle body and a needle handle, wherein one end of the needle body is provided with a blunted needle tip and the other end is provided with a needle tip, and the blunted needle tip of the needle body is the end that contacts the skin; the needle handle is provided with a needle body accommodating channel, and the needle tip of the needle body is embedded in the needle body accommodating channel of the needle handle, and artificial skin gels for fixing the needle body and blocking the needle tip are respectively provided in the needle body accommodating channel, and the artificial skin gel for fixing the needle body is located outside the needle body accommodating channel.

[0007] In the utility model, the needle body can slide in the needle body accommodating channel of the needle handle when subjected to external force. The needle body accommodating channel is filled with gel artificial skin that can simulate the feeling of acupuncture. In addition to the blunt needle head, the other end of the needle body connected to the needle handle is designed as a needle tip, which can pierce the gel artificial skin, thereby simulating the feeling of acupuncture and deceiving the acupuncturist, thereby solving the technical problem that the existing placebo needle cannot simulate the real needle insertion feeling and cannot complete the double-blind operation; the blunt needle head can prick the subject without piercing the subject, making the subject feel pain and unable to distinguish whether it is a placebo needle, thereby successfully completing the double-blind operation.

[0008] Preferably, an acupuncture base is further included, which is a round table made of non-transparent plastic material. A accommodating cavity for accommodating the needle body and needle handle is provided in the middle of the round table, and the accommodating cavity runs through the top and bottom of the round table. A magnet for magnetically attracting the needle body and passivating the needle tip is provided on the side wall at the bottom of the accommodating cavity. This technical solution can use its magnetism to attract the tip of the passivated needle when removing the needle to ensure normal needle removal.

[0009] More preferably, a sterile double-sided adhesive pad is affixed to the bottom surface of the acupuncture base, a release paper is affixed to the bottom surface of the sterile double-sided adhesive pad, and a through hole is provided at the corresponding position of the sterile double-sided adhesive pad that fits the truncated cone accommodating cavity for the needle body to move up and down for the blunt needle head. When using this technical solution, the release paper is torn off and the adhesive surface is affixed to the subject's skin to play a fixing role.

[0010] Preferably, the outer surface of the needle handle is provided with thread stripes to facilitate operation by the acupuncturist.

[0011] Preferably, the needle tip of the needle body is provided with a V-shaped barb at a position between the two pieces of artificial skin gel that fix the needle body and block the needle tip, the tip of the V-shaped barb faces the artificial skin gel that blocks the needle tip, and the open end of the V-shaped barb faces the artificial skin gel that fixes the needle body; this technical solution can ensure that the needle body will not slip out of the needle handle when the needle is removed, and will not affect the operation when the needle is inserted.

[0012] More preferably, the angle between the side wall of the V-shaped barb and the needle body is 5°, the V-shaped height is 1 mm, and the distance between the tip apex of the V-shaped barb and the apex of the needle tip is 1 mm.

[0013] Furthermore, the thickness of the two pieces of artificial skin gel for fixing the needle body and blocking the needle tip are both 2 mm, and the artificial skin gel for fixing the needle body is filled in the opening of the needle body accommodating channel.

[0014] In summary, compared with the prior art, the present invention has the following advantages and beneficial effects:

[0015] The utility model has a blunt needle tip at one end of the needle body (the end that contacts the skin) and a sharp needle tip that can pierce the artificial skin gel (the end that is connected to the needle handle). The sharpened needle tip is nested in the hollow needle handle. When the needle body is subjected to external force, it can slide in the needle body accommodating channel of the needle handle. The needle body accommodating channel is filled with gel artificial skin that can simulate the feeling of acupuncture. When the needle body is subjected to external force, the needle tip can pierce the gel artificial skin, thereby simulating the feeling of acupuncture and deceiving the acupuncturist, thereby solving the technical problem that the existing placebo needle cannot simulate the real feeling of needle insertion and cannot complete the double-blind operation. The blunt needle tip can prick the subject without piercing the subject, so that the subject feels pain and cannot distinguish whether it is a placebo needle, thereby successfully completing the double-blind operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 This is a schematic diagram of the overall structure of the double-blind acupuncture placebo needle (before acupuncture) provided in Example 1 of the present utility model;

[0017] Figure 2 A perspective view of a double-blind acupuncture placebo needle (after acupuncture) provided in Example 1 of the present utility model;

[0018] The markings in the figure are: 1. needle handle; 2. needle body; 3. artificial skin gel; 4. sterile double-sided adhesive pad; 5. acupuncture base; 6. magnet; 7. V-shaped barb; 8. release paper. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and various embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention. That is, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments.

[0020] Example 1

[0021] like Figure 1As shown in the figure, a double-blind acupuncture placebo needle for clinical trials provided in this embodiment comprises a needle handle 1, a needle body 2 and an acupuncture base 5. One end of the needle body 2 is provided with a blunt needle tip and the other end is provided with a sharp needle tip. The blunt needle tip of the needle body 2 is the end that contacts the skin. The needle handle 1 is provided with a needle body accommodating channel. The needle tip of the needle body 2 is embedded in the needle body accommodating channel of the needle handle 1. The needle body accommodating channel is provided with artificial skin gel 3 for fixing the needle body 2 and blocking the needle tip. The artificial skin gel 3 for fixing the needle body 2 is located outside the needle body accommodating channel. The specific parameters include: the thickness of the artificial skin gel 3 is 2mm, the artificial skin gel 3 for fixing the needle body 2 is filled at the opening of the needle body accommodating channel of the needle handle 1 to fix the needle body 2 in the needle body accommodating channel of the needle handle 1 (the needle body 2 passes through the artificial skin gel 3), and the artificial skin gel 3 for blocking the needle tip is filled 4mm away from the opening of the needle handle. When there is no external force, the needle tip of the needle body 2 does not contact it, but when it is subjected to external force, such as Figure 2 As shown, the needle tip of the needle body 2 pierces the artificial skin gel 3 that blocks the needle tip, thereby simulating the feel of acupuncture and deceiving the acupuncturist, thereby solving the technical problem that the existing placebo injection cannot achieve double-blindness because it cannot simulate the real feel of needle insertion.

[0022] In addition, the acupuncture base 5 is a truncated cone made of a non-transparent plastic material. A cavity for accommodating the needle body 2 and the needle handle 1 is provided in the middle of the truncated cone, and the cavity runs through the top and bottom of the truncated cone. A magnet 6 for magnetically attracting the needle body and passivating the needle tip is provided on the side wall at the bottom of the cavity. When removing the needle, the present technical solution can utilize the magnetic force of the magnet 6 to attract the passivated needle tip of the needle body 2 to ensure normal needle removal. In order to further facilitate fixation, a sterile double-sided adhesive pad 4 is affixed to the bottom surface of the acupuncture base 5, and a release paper 8 is affixed to the bottom surface of the sterile double-sided adhesive pad 4. The sterile double-sided adhesive pad 4 is affixed to the corresponding position of the truncated cone cavity with a through hole for the passivated needle tip of the needle body 2 to move up and down. When using the present technical solution, the release paper 8 is torn off and the adhesive surface of the sterile double-sided adhesive pad 4 is affixed to the subject's skin to play a fixing role, which is easy to operate.

[0023] In order to ensure that the needle body 2 does not slip out of the needle handle 1 when the needle is removed, and at the same time does not affect the operation when the needle is inserted, we have provided a V-shaped barb 7 with the opening facing downwards 1 mm away from the top of the sharpened needle tip (located in the inner part of the needle handle 1). The opening angle of the V-shaped barb 7 is 5° with the needle body, and the V height is set to 1 mm.

[0024] In order to ensure the smooth implementation of the double-blind experiment, in the specific implementation process, the double-blind acupuncture placebo needle provided in this embodiment is the same in appearance as the ordinary acupuncture needle, and is also provided with spiral stripes on the surface to prevent hand slippage and facilitate operation.

[0025] The above-described embodiments merely represent specific implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of protection of the present application. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the technical concept of the present application, and all such variations and improvements fall within the scope of protection of the present application.

Claims

1. A double-blind acupuncture placebo needle for clinical trials, comprising a needle body and a needle handle, characterized in that: One end of the needle body is configured as a blunt needle head and the other end is configured as a needle tip, and the blunt needle head of the needle body is the end that contacts the skin; the needle handle is provided with a needle body accommodating channel, and the needle tip of the needle body is embedded in the needle body accommodating channel of the needle handle, and the needle body accommodating channel is respectively provided with artificial skin gel for fixing the needle body and blocking the needle tip, and the artificial skin gel for fixing the needle body is located outside the needle body accommodating channel.

2. The double-blind acupuncture placebo needle for clinical trials according to claim 1, characterized in that: It also includes an acupuncture base, which is a round table made of non-transparent plastic material. A accommodating cavity for accommodating the needle body and needle handle is provided in the middle of the round table, and the accommodating cavity runs through the top and bottom of the round table. A magnet is provided on the side wall of the bottom of the accommodating cavity for magnetically attracting the needle body and passivating the needle tip.

3. The double-blind acupuncture placebo needle for clinical trials according to claim 2, characterized in that: The bottom surface of the acupuncture base is affixed with a sterile double-sided adhesive pad, the bottom surface of the sterile double-sided adhesive pad is affixed with release paper, and the sterile double-sided adhesive pad is affixed to the corresponding position of the truncated cone accommodating cavity with a through hole for the needle body blunt needle to move up and down.

4. The double-blind acupuncture placebo needle for clinical trials according to claim 1, characterized in that: The outer surface of the needle handle is provided with thread stripes.

5. The double-blind acupuncture placebo needle for clinical trials according to claim 1, characterized in that: The needle tip of the needle body is located between the two artificial skin gels that fix the needle body and block the needle tip and is provided with a V-shaped barb, the tip of the V-shaped barb faces the artificial skin gel that blocks the needle tip, and the open end of the V-shaped barb faces the artificial skin gel that fixes the needle body.

6. The double-blind acupuncture placebo needle for clinical trials according to claim 5, characterized in that: The angle between the side wall of the V-shaped barb and the needle body is 5°, the V-shaped height is 1 mm, and the distance between the tip apex of the V-shaped barb and the apex of the needle tip is 1 mm.

7. The double-blind acupuncture placebo needle for clinical trials according to claim 6, characterized in that: The thickness of the two pieces of artificial skin gel for fixing the needle body and blocking the needle tip are both 2 mm, and the artificial skin gel for fixing the needle body is filled in the opening of the needle body accommodating channel.

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