CN111920683B - Two-purpose device for placebo electric needle and common placebo needle - Google Patents

Abstract

The invention discloses a dual-purpose device for a placebo electric needle and a common placebo needle, which comprises a needle component used for penetrating into human body acupoints to perform real acupuncture treatment, and a placebo needle component used for not penetrating into the human body acupoints in a control experiment of the acupuncture treatment, and a needle base used for fixing the needle component and the placebo needle component at the human body acupoints; the pair of the puncture needle bases respectively correspond to the puncture needle assembly and the placebo needle assembly; the puncture needle base comprises a foam layer, an insulating adhesive layer and a release paper layer which are sequentially arranged from top to bottom; the needle head of the placebo needle assembly is a blunt head which can not puncture the insulating adhesive layer, and the needle head of the needle assembly is a pointed head which can puncture the insulating adhesive layer; the placebo needle component and the needle component are made of conductive metal, can be connected with an external electric acupuncture instrument, and respectively input pulse current to the needle component and the placebo needle component. The needle and the placebo needle of the invention are identical in appearance during the needle retention treatment, thus ensuring the implementation of double-blind test.

Description

Two-purpose device for placebo electric needle and common placebo needle

Technical Field

The invention belongs to the field of clinical medicine, in particular to a placebo needle device used for a double-blind test in acupuncture clinical scientific research.

Background

In order to advance the modernization of traditional Chinese medicine and provide a evidence-based position for acupuncture and traditional Chinese medicine in the health care system with dominant modern medicine, clinical researchers of traditional Chinese medicine are urgently required to carry out strict test design and curative effect detection on clinical tests by using clinical practice experience and biomedical knowledge so as to meet scientific standards necessary for obtaining international acceptance and acceptance.

Double blind testing is a more rigorous clinical test method internationally accepted and accepted, and is used when the subject is a human, with the aim of eliminating subjective deviations and personal preferences among subjects or researchers' consciousness that may occur to influence the test results. In the double-blind test, the subjects participating in the test, researchers, medical staff participating in the evaluation of curative effect and safety, inspectors, data administrators and statistical analysis staff do not know the treatment distribution program, do not know which subjects belong to the control group and which subjects belong to the experimental group, so that unconscious implications can be well avoided, subjective bias affecting test results is reduced, and the obtained test results are more rigorous and accurate.

In clinical trials of acupuncture, double blind tests are required to reach very high scientific stringency. The subjects were randomly assigned to either a control group or a test group, with both subjects selecting the same point, but the subjects of the control group received placebo needle treatment and the subjects of the test group received acupuncture needle treatment. Currently, a Streitberger device, a Park device and the like are generally used as a placebo needle of a control group internationally, but the telescopic device is inconvenient to use, has a complex structure, needs auxiliary tools for fixing (such as double faced adhesive tape, plastic rings and the like), and is limited in the research of special needling parts such as heads, fingers, toes and the like and different needling techniques; the empty sense generated by the retraction of the needle body cannot realize the blind method of an operator in the clinical test of needling, and the needle tip of the device contacts with the skin to cause slight treatment effect, especially, the electric needle therapy is generally used for treating diseases clinically at present, when the device is operated as a placebo needle of a control group in the electric needle clinical test, the weak current generated by the contact of the needle tip with the skin can generate certain stimulation effect on the body, so that potential treatment effect can exist, thereby interfering with the accuracy of the test result.

None of the current placebo needled devices is a very ideal needle placebo method, especially unsuitable as an electroneedle placebo method, and none of the current placebo needled devices is suitable for all needling studies in clinical research.

Disclosure of Invention

The invention aims to: aiming at the defects of the prior art, the invention provides a dual-purpose device for a placebo electric needle and a common placebo needle, which is used for double-blind experiments in clinical scientific research of acupuncture, has exquisite structure and convenient operation, and is suitable for all acupuncture clinical researches.

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:

a placebo electric needle and plain placebo needle dual purpose device comprising:

a needling needle assembly for penetrating into the acupoints of human body to perform real acupuncture treatment;

placebo needle assembly for acupuncture treatment in control experiments without penetrating human acupoints;

A lancet base for securing the lancet assembly and the comfort needle assembly at the body's acupuncture point;

the pair of the puncture needle bases respectively correspond to the puncture needle assembly and the placebo needle assembly; the puncture needle base comprises a foam layer, an insulating adhesive layer and a release paper layer which are sequentially arranged from top to bottom;

The needle head of the placebo needle assembly is a blunt head which can not puncture the insulating adhesive layer, and the needle head of the needle assembly is a pointed head which can puncture the insulating adhesive layer;

The placebo needle component and the needle component are made of conductive metal, can be connected with an external electric acupuncture instrument, and respectively input pulse current to the needle component and the placebo needle component.

Specifically, the lancet assembly includes a lancet body handle, a lancet body, and a lancet tip; the needle body handle is wrapped at the rear end of the needle body; the needling needle head is a pointed head and is positioned at the head of the needling needle body.

Specifically, the placebo needle assembly comprises a placebo needle handle, a placebo needle body and a placebo needle head; the placebo needle handle is wrapped at the rear end of the placebo needle body; the placebo needle is a blunt tip and is positioned at the head of the placebo needle body.

Preferably, the needling needle body and the placebo needle body are made of stainless steel, the diameter of the needling needle body is 0.18-0.60 mm, and the length is 13-75 mm; the placebo needle had a diameter of 0.40mm and a length of 13mm.

Preferably, the needle body handle and the comfort needle handle are conductive metal wires, and are wrapped at the rear end of the needle body in a winding mode.

Preferably, the insulating adhesive layer is polyisobutene type emplastrum with the thickness of 0.2-0.5 mm. The polyisobutene type plaster is safe, nontoxic, non-conductive, low in allergy, strong in adhesion, easy to tear and subjected to aseptic treatment.

Preferably, the height of the foam layer of the puncture needle base is 5-8 mm.

Further, the side surface of the puncture needle base is coated with an insulating paper layer so as to enhance the blocking effect on the current, prevent the current from diffusing to the skin outside the acupuncture points and generate possible treatment effect.

Preferably, the length of the needle body handle is the same as that of the comfort needle handle, and the needle body handle and the comfort needle handle are made of red copper.

The beneficial effects are that:

1. The needle pricking needle and the placebo needle in the component are completely consistent in material, the needle head part of the placebo needle is passivated in appearance, a subject in a control group has a needle head supporting sense after needle insertion, but true and false needle pricks cannot be distinguished, and the needle pricking methods are not different in appearance during needle retention treatment, so that the implementation of a double-blind test is ensured; compared with the prior art, the dual-purpose device for the placebo electric needle and the common placebo electric needle can effectively cut off the pulse current output by the electric needle instrument in clinical scientific research use, so that the potential treatment effect of the electric needle does not exist for a subject in a control group, the accuracy of a test result is ensured, and the dual-purpose device is an ideal electric needle placebo method and can be used as the common placebo electric needle when the electric needle instrument is not connected.

2. The invention has ingenious design, the foam layer of the puncture needle base can well support the needle body, and the invention is suitable for the needling study of various needle insertion depths, such as shallow needling; the needle base has a compact appearance, is suitable for special needling positions such as head, fingers, toes and the like, is convenient to perform needling operation, and is suitable for needling techniques such as oblique needling, flat needling and the like with different angles and directions.

3. The polyisobutene type plaster which is safe, nontoxic, non-conductive, low in anaphylaxis, strong in adhesion, easy to tear and sterile in treatment is used in the puncture needle base, so that the polyisobutene type plaster is safe and insulating, is provided with the plaster, and does not need an additional auxiliary fixing tool; the whole device has simple structure, easy acquisition and convenient operation, and is suitable for mass production for clinical scientific research of acupuncture.

Drawings

The foregoing and/or other advantages of the invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying drawings and detailed description.

FIG. 1 is a block diagram of the placebo electric needle and conventional placebo needle dual purpose device.

Fig. 2 is a diagram of the use of the placebo electric needle and normal placebo needle dual purpose device.

Fig. 3 is a second view of the use of the placebo electric needle and normal placebo needle dual purpose device.

Wherein each reference numeral represents:

1a needle assembly; 11a lancet body handle; a 12-needle lancet body; 13 needling a needle; 2 placebo needle assembly; 21 placebo needle handle; 22 placebo needle; 23 placebo needles; 3, a puncture needle base; 30 insulating paper layers; 31 foam layer; 32 insulating adhesive layers; 33 release paper layers.

Detailed Description

The invention will be better understood from the following examples.

The structures, proportions, sizes, etc. shown in the drawings are shown only in connection with the disclosure of the present invention, and are not intended to limit the scope of the invention, which is defined by the claims, but rather by the terms of modification, variation of proportions, or adjustment of sizes, without affecting the efficacy or achievement of the present invention, should be understood as falling within the scope of the present invention. Also, the terms such as "upper", "lower", "front", "rear", "middle", and the like are used herein for descriptive purposes only and are not intended to limit the scope of the invention for which the invention may be practiced or for which the relative relationships may be altered or modified without materially altering the technical context.

As shown in FIG. 1, the placebo electric needle and conventional placebo needle dual purpose device generally comprises a needle and lancet assembly 1, a placebo needle assembly 2, and a pair of lancet bases 3.

Wherein, the acupuncture needle assembly 1 is used for penetrating into the human body part to perform real acupuncture treatment. The needle assembly 1 comprises a needle body handle 11, a needle body 12, a needle tip 13; the needle body handle 11 is wrapped at the rear end of the needle body 12; the needle tip 13 is pointed and is located at the head of the needle body 12.

The placebo needle assembly 2 was used for the control experiment of acupuncture treatment without penetrating the human body. The placebo needle assembly 2 comprises a placebo needle handle 21, a placebo needle body 22 and a placebo needle head 23; the placebo needle handle 21 is wrapped at the rear end of the placebo needle body 22; the placebo needle 23 is blunt and is positioned on the head of the placebo needle body 22.

A needle base 3 for fixing the needle assembly 1 and the comfort needle assembly 2 to the body site. Each puncture needle base 3 comprises a foam layer 31, an insulating adhesive layer 32, a release paper layer 33 and insulating paper layers 30 coated on the side surfaces, which are sequentially arranged from top to bottom. The insulating adhesive layer 32 is a polyisobutylene type plaster which is safe, nontoxic, non-conductive, low in allergy, strong in adhesion and easy to tear, and is subjected to aseptic treatment, and the thickness of the plaster is 0.2mm. The release paper layer 33 is attached to the bottom of the insulation glue layer 32, prevents the insulation glue layer from being polluted, and is easy to peel. The lancet base 3 has a cylindrical shape as a whole, and has a diameter of 10mm and a height of 5mm.

The handles of the needle and placebo needle assemblies 1 and 2 are formed by winding metal wires made of red copper at the rear end of the needle body, and the diameters, the lengths, the materials and the color appearance characteristics are completely consistent, so that the needle and needle assembly can be used for connecting an external electric needle instrument to input pulse current to the needle body. The needle body materials and thicknesses of the needle puncture needle assembly 1 and the placebo needle assembly 2 are the same. The length of the needling needle assembly 1 can be 13-75 mm, the diameter of the needling needle assembly 2 can be 0.18-0.60 mm, and the length of the needle body of the needling needle assembly 2 is 13mm, and the diameter of the needling needle assembly is 0.40mm. The needle tip of the needle assembly 1 is sharpened to form a piercing needle tip 13 and the needle tip of the placebo needle assembly 2 is blunted to form a placebo needle tip 23 that is as thick as the needle body. The needle 13 can easily penetrate through the insulating adhesive layer 32 to penetrate into a human body, and the placebo needle 23 cannot puncture the insulating adhesive layer 32, even if the insulating adhesive layer 32 is accidentally punctured, the insulating adhesive layer 32 can rebound immediately during the needle retaining period without the finger force of a doctor, and the compact adhesive layer is filled in a tiny needle hole, so that the effect of isolating current can be fully achieved.

When the clinical scientific research test of acupuncture is carried out, the acupoints to be needled are firstly determined, the corresponding body positions and the needling needles with proper specifications are selected, the skin is conventionally disinfected, and the needling needle base 3 is stuck on the acupoints after the release paper is torn off. The test group subjects were treated by inserting the needle body 12 through the needle base 3 to a suitable depth subcutaneously into the acupoints; the treatment method of the subjects in the control group is that the placebo needle body 22 is penetrated into the foam layer 31 and reaches the insulating glue layer 32, and the patients have the contact feeling of the needle head, so that the operation is finished. Since the gauge of the needle assembly 1 is selected based on the depth of penetration of the selected acupoint, the length of the needle above the foam pad corresponds to the height above the comfort needle 22 after the needle 12 has penetrated the acupoint. As shown in fig. 2 and 3, the lancet base is suitable for special needling positions such as head, fingers, toes and the like, is convenient for needling operation, and is suitable for needling techniques such as oblique needling, flat needling and the like with different angles and directions.

In the case of an electric needle clinical trial, after the above operation is completed, an electric needle instrument is connected to the corresponding needle handle 11 and placebo needle handle 21, and a pulse current is input by selecting an appropriate electric needle waveform, frequency, current intensity and electric needle duration. After the needle body is connected with the electric needle instrument, the insulating adhesive layer 32 and the insulating paper layer 30 can effectively cut off the pulse current output by the electric needle instrument, so that potential treatment effect of the electric needle does not exist for a subject in a control group, and the accuracy of a test result is ensured.

The invention provides a concept and a method for realizing a dual-purpose device of a placebo needle and a common placebo needle, and the method and the way for realizing the technical scheme are a plurality of preferred embodiments of the invention, and it should be pointed out that a plurality of improvements and modifications can be made by those skilled in the art without departing from the principle of the invention, and the improvements and modifications are also considered as the protection scope of the invention. The components not explicitly described in this embodiment can be implemented by using the prior art.

Claims (3)

1. A placebo electric needle and conventional placebo needle dual purpose device comprising:

A needling needle assembly (1) for penetrating into the acupoints of human body to perform real acupuncture treatment;

A placebo needle assembly (2) for acupuncture treatment that does not penetrate the acupoints of human body in a control experiment;

a puncture needle base (3) for fixing the puncture needle assembly (1) and the placebo needle assembly (2) at the acupuncture points of the human body;

the pair of the needle bases (3) respectively correspond to the needle and needle assembly (1) and the placebo needle assembly (2); the puncture needle base (3) comprises a foam layer (31), an insulating adhesive layer (32) and a release paper layer (33) which are sequentially arranged from top to bottom;

The needle head of the placebo needle assembly (2) is a blunt head which can not puncture the insulating adhesive layer (32), and the needle head of the needle assembly (1) is a pointed head which can puncture the insulating adhesive layer (32);

The placebo needle component (2) and the needle component (1) are made of conductive metal and can be connected with an external electric acupuncture instrument, and pulse currents are respectively input to the needle component (1) and the placebo needle component (2);

the needling needle assembly (1) comprises a needle body handle (11), a needling needle body (12) and a needling needle head (13); the needle body handle (11) is wrapped at the rear end of the needle body (12); the needling needle head (13) is a pointed head and is positioned at the head of the needle body (12);

the placebo needle assembly (2) comprises a placebo needle handle (21), a placebo needle body (22) and a placebo needle head (23); the placebo needle handle (21) is wrapped at the rear end of the placebo needle body (22); the placebo needle (23) is a blunt end and is positioned at the head of the placebo needle body (22);

the needling needle body (12) and the placebo needle body (22) are made of stainless steel, the diameter of the needling needle body (12) is 0.18-0.60 mm, and the length is 13-75 mm; the diameter of the placebo needle body (22) is 0.40mm and the length is 13mm;

The insulating adhesive layer (32) is a polyisobutene type emplastrum with the thickness of 0.2-0.5 mm;

the height of the foam layer (31) of the puncture needle base (3) is 5-8 mm;

the side surface of the puncture needle base (3) is coated with an insulating paper layer (30).

2. The dual-purpose device for a placebo electric needle and a common placebo needle according to claim 1, wherein the needle body handle (11) and the placebo needle handle (21) are conductive wires, and are wrapped at the rear end of the needle body by winding respectively.

3. The dual-purpose device for a placebo electric needle and a common placebo needle according to claim 2, wherein the needle body handle (11) and the placebo needle handle (21) have the same length and are made of red copper.