CN111920683A

CN111920683A - Dual-purpose device for placebo electric needle and common placebo needle

Info

Publication number: CN111920683A
Application number: CN202010951932.XA
Authority: CN
Inventors: 孙建华; 裴丽霞; 陈璐; 刘芊言; 吴晓亮
Original assignee: Jiangsu Provincial Hospital of Chinese Medicine
Current assignee: Jiangsu Provincial Hospital of Chinese Medicine
Priority date: 2020-09-11
Filing date: 2020-09-11
Publication date: 2020-11-13

Abstract

The invention discloses a consolation electric needle and common consolation needle dual-purpose device, which comprises an acupuncture needle component used for puncturing human acupuncture points to carry out real acupuncture treatment, a consolation needle component used for not puncturing the human acupuncture points in a control experiment of the acupuncture treatment, and an acupuncture needle base used for fixing the acupuncture needle component and the consolation needle component at the human acupuncture points; the pair of the pricking needle bases respectively correspond to the pricking needle assembly and the comforting needle assembly; the felting needle base comprises a foam layer, an insulating glue 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 cannot puncture the insulating adhesive layer, and the needle head of the acupuncture needle assembly is a pointed head which can puncture the insulating adhesive layer; the consolation needle component and the acupuncture needle component are both made of conductive metal materials and can be connected with an external electric acupuncture apparatus, and pulse current is respectively input to the acupuncture needle component and the consolation needle component. The appearance of the needle-punching needle is consistent with that of the placebo blunt needle in the process of needle-remaining treatment, thereby ensuring the implementation of the double-blind test.

Description

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

Technical Field

The invention belongs to the field of clinical medicine, in particular to acupuncture clinical equipment, and particularly relates to a comfort needle device used in a double-blind test in acupuncture clinical scientific research.

Background

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

Double blind trials are an internationally recognized and accepted method of more rigorous clinical trials, used when the subjects are human, and aimed at eliminating subjective deviations and personal preferences in the mind of the subjects or researchers that may be present to affect the outcome of the trial. In the double-blind test, subjects, researchers, medical staff, inspectors, data managers and statistical analysis staff who participate in the test do not know the treatment distribution program, and do not know which subjects belong to a control group and which subjects belong to an experimental group, so that unconscious suggestion can be well avoided, the subjective bias influencing the test result is reduced, and the obtained test result is more rigorous and accurate.

In clinical trials of acupuncture, double-blind trials are required to achieve a very high degree of scientific stringency. The subjects were randomly assigned to the control group or the test group, and the acupoints of both groups were the same, but the subjects in the control group received the placebo needle treatment and the subjects in the test group received the acupuncture needle treatment. At present, the Streitberger device, Park device and the like are generally used internationally as a placebo needle of a control group, but the telescopic device is inconvenient to use and complex in structure, needs auxiliary tools for fixing (such as double-sided adhesive tape, plastic rings and the like), and is limited to research on special acupuncture parts such as heads, fingers, toes and the like and different acupuncture techniques; the empty feeling generated by retraction of the needle body can not realize the blind method of an operator in the acupuncture clinical test, and the needle point of the device can cause slight treatment effect when contacting the skin, especially the current clinical application generally uses the electric needle therapy to treat diseases.

None of the current placebo acupuncture devices is a very ideal acupuncture placebo, and is particularly unsuitable as an electric acupuncture placebo, and none of the current placebo acupuncture devices is suitable for all acupuncture studies in clinical research.

Disclosure of Invention

The purpose of the invention is as follows: the invention aims to solve the technical problem of the prior art, provides a double-purpose device of a consolation electric needle and a common consolation needle for double-blind experiments in acupuncture clinical scientific researches, has exquisite structure and convenient operation, and is suitable for all acupuncture clinical researches.

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

a dual placebo electrical needle and plain placebo needle device comprising:

an acupuncture needle assembly for puncturing the acupoints of human body to perform real acupuncture treatment;

a placebo needle assembly for acupuncture treatment which did not penetrate the acupuncture points of the human body in the control experiment;

the puncture needle base is used for fixing the puncture needle assembly and the comfort needle assembly at the acupuncture points of the human body;

the pair of the pricking needle bases respectively correspond to the pricking needle assembly and the comforting needle assembly; the felting needle base comprises a foam layer, an insulating glue 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 cannot puncture the insulating adhesive layer, and the needle head of the acupuncture needle assembly is a pointed head which can puncture the insulating adhesive layer;

the consolation needle component and the acupuncture needle component are both made of conductive metal materials and can be connected with an external electric acupuncture apparatus, and pulse current is respectively input to the acupuncture needle component and the consolation needle component.

Specifically, the acupuncture needle assembly comprises an acupuncture needle body handle, an acupuncture needle body and an acupuncture needle head; the handle of the needle body is wrapped at the rear end of the needle body; the acupuncture needle head is a pointed end and is positioned at the head part of the acupuncture needle body.

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

Preferably, the acupuncture needle body and the comfort needle body are both made of stainless steel materials, the diameter of the acupuncture needle body is 0.18-0.60 mm, and the length of the acupuncture needle body is 13-75 mm; placebo needles were 0.40mm in diameter and 13mm in length.

Preferably, the lance body handle and the placebo handle are both conductive metal wires and are respectively wrapped at the rear end of the lance body in a winding manner.

Preferably, the insulating adhesive layer is a polyisobutylene type plaster, and the thickness of the insulating adhesive layer is 0.2-0.5 mm. The polyisobutylene type plaster is safe, non-toxic, non-conductive, hypoallergenic, strongly viscous and easily tearable, and is subjected to aseptic processing.

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

Furthermore, the side surface of the base of the puncture needle is coated with the insulating paper layer so as to enhance the effect of cutting off the current, prevent the current from diffusing to the skin outside the acupuncture point and generate possible treatment effect.

Preferably, the acupuncture needle body handle and the placebo needle handle are the same in length and are both made of red copper.

Has the advantages that:

1. the needle-punching needle and the comfort blunt needle in the assembly are completely consistent in material, the needle part of the comfort needle is passivated in appearance, after the needle is inserted, a control group subject has needle touch feeling, but real and false needles cannot be distinguished, and the needle-punching method cannot be seen from the appearance in the needle-remaining treatment period to have any difference, so that the implementation of a double-blind test is ensured; compared with the prior art, the placebo electric needle and common placebo needle dual-purpose device provided by the invention can effectively cut off the pulse current output by the electric needle instrument in clinical scientific research and use, so that the potential treatment effect of the electric needle does not exist in a control group subject, the accuracy of a test result is ensured, the placebo electric needle is an ideal placebo method for the electric needle, and the placebo electric needle can be used as a common placebo needle when the electric needle instrument is not connected.

2. The invention has ingenious design, the foam layer of the pricking pin base can well support the needle body, and the invention is suitable for the acupuncture research of various needle insertion depths, such as shallow acupuncture; the base of the needle is small and exquisite in appearance, is suitable for special acupuncture parts such as the head, fingers, toes and the like, is convenient for acupuncture operation, and is suitable for acupuncture techniques with different angles and directions, such as oblique acupuncture, flat acupuncture and other special acupuncture techniques.

3. The polyisobutylene type plaster which is safe, non-toxic, non-conductive, low in allergy, strong in adhesion, easy to tear and sterile-processed is used in the pricking pin base, so that the lancet is safe and insulated, is provided with the adhesive tape, and does not need an additional auxiliary fixing tool; the whole device has simple structure, easy acquisition and convenient operation, and is suitable for batch production for use in clinical acupuncture and moxibustion research.

Drawings

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

FIG. 1 is a block diagram of the device for both placebo electrical needles and conventional placebo needles.

FIG. 2 is a first usage state diagram of the device for both placebo electrical acupuncture and general placebo acupuncture.

FIG. 3 is a second view showing the state of use of the device for both the placebo electric needle and the general placebo needle.

Wherein each reference numeral represents:

1, needling a needle assembly; 11 a lance body handle; 12 needle-pricking bodies; 13 pricking a needle head; 2 comforting the needle assembly; 21 a placebo handle; 22 placebo needles; 23 placebo needle; 3 a felting needle base; 30 insulating paper layers; 31 a foam layer; 32 insulating glue layers; 33 release paper layer.

Detailed Description

The invention will be better understood from the following examples.

The structures, proportions, and dimensions shown in the drawings and described in the specification are for understanding and reading the present disclosure, and are not intended to limit the scope of the present disclosure, which is defined in the claims, and are not essential to the skilled in the art. In addition, the terms "upper", "lower", "front", "rear" and "middle" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the relative positions may be changed or adjusted without substantial technical changes.

As shown in fig. 1, the dual-purpose device of the placebo electric needle and the ordinary placebo needle mainly comprises a needle puncture needle assembly 1, a placebo needle assembly 2 and a pair of needle puncture needle bases 3.

Wherein, the acupuncture needle assembly 1 is used for puncturing the human body part to carry out real acupuncture treatment. The acupuncture needle assembly 1 comprises an acupuncture needle body handle 11, an acupuncture needle body 12 and an acupuncture needle head 13; the handle 11 of the needle body is wrapped at the rear end of the needle body 12; the acupuncture needle head 13 is a pointed end and is positioned at the head part of the acupuncture needle body 12.

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

The puncture needle base 3 is used for fixing the puncture needle assembly 1 and the comfort needle assembly 2 at the position of the needle insertion of a human body. Each lancet base 3 comprises a foam layer 31, an insulating glue layer 32, a release paper layer 33 and an insulating paper layer 30 which is covered on the side surface in sequence from top to bottom. The insulating adhesive layer 32 is a polyisobutylene type plaster which is safe, non-toxic, non-conductive, low in allergy, strong in adhesion and easy to tear, is subjected to sterile treatment, and has the thickness of 0.2 mm. The release paper layer 33 is attached to the bottom of the insulating adhesive layer 32, prevents the insulating adhesive layer from being contaminated, and is easy to peel. The pricking pin base 3 is integrally cylindrical, the diameter is 10mm, and the height is 5 mm.

The handle of acupuncture needle subassembly 1 and consolation needle subassembly 2 all forms through the wire winding of red copper material at the rear end of needle body, and diameter, length, material, colour appearance characteristic are identical completely, can be used to connect outside electric acupuncture appearance, inputs impulse current to the needle body. The needle body materials and the thickness of the acupuncture needle assembly 1 and the comfort needle assembly 2 are the same. The acupuncture needle assembly 1 can select different specifications with the length of 13-75 mm and the diameter of 0.18-0.60 mm, and the acupuncture needle assembly 2 has the needle body with the length of 13mm and the diameter of 0.40 mm. The needle of the needle assembly 1 is sharpened to form the needle 13, and the needle of the placebo needle assembly 2 is blunted to form a placebo needle 23 having a diameter equal to that of the needle. The acupuncture needle head 13 can easily penetrate through the insulating adhesive layer 32 to penetrate into a human body, the comfort needle head 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 remaining period without the finger force action of a doctor, and the compact adhesive layer is filled in a small needle hole, so that the effect of isolating current can be fully achieved.

When acupuncture clinical scientific research is tested, acupuncture points to be acupunctured are determined, acupuncture needles with corresponding body positions and proper specifications are selected, the skin is disinfected conventionally, and the acupuncture needle base 3 is stuck to the acupuncture points after the release paper is torn off. The treatment method of the test subjects is that the needle body 12 penetrates through the needle base 3 to penetrate into the subcutaneous position of the acupuncture point to a proper depth; the control subjects were treated by piercing the placebo needles 22 into the foam layer 31 and onto the insulation layer 32, and the patients had a needle touch, and the procedure was completed. Since the needle gauge of the needle assembly 1 is selected based on the insertion depth of the selected acupoint, the length of the needle body above the foam pad is comparable to the height above the placebo body 22 after the needle stick body 12 has penetrated the acupoint. As shown in fig. 2 and 3, the base of the needle is suitable for special acupuncture parts such as head, fingers, toes and the like, is convenient for acupuncture operation, and is suitable for various acupuncture techniques with different angles and directions, such as oblique acupuncture, flat acupuncture and other special acupuncture techniques.

If the needle is used for the electric needle clinical test, after the operations are finished, the electric needle instrument is connected to the corresponding acupuncture needle handle 11 and the placebo needle handle 21, the proper electric needle waveform, frequency, current intensity and electric needle duration are selected, and the pulse current is input. After the needle body is connected with the electric acupuncture instrument, the insulating glue layer 32 and the insulating paper layer 30 can effectively cut off the pulse current output by the electric acupuncture instrument, so that the potential treatment effect of the electric acupuncture does not exist in a test subject of a control group, and the accuracy of a test result is ensured.

The invention provides a way and a method for a device for both a placebo electric needle and a common placebo needle, and a plurality of methods and ways for realizing the technical scheme, and the above description is only a preferred embodiment of the invention, and it should be noted that, for a person skilled in the art, a plurality of improvements and decorations can be made without departing from the principle of the invention, and the improvements and decorations should be regarded as the protection scope of the invention. All the components not specified in the present embodiment can be realized by the prior art.

Claims

1. A dual use device for a placebo electrical needle and a plain placebo needle, comprising:

an acupuncture needle assembly (1) for puncturing the acupoints of a human body to perform real acupuncture treatment;

a comfort needle assembly (2) for acupuncture treatment in a control experiment without penetrating the acupuncture points of the human body;

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

the pricking needle bases (3) are a pair and respectively correspond to the pricking needle assembly (1) and the comforting needle assembly (2); the puncture needle base (3) comprises a foam layer (31), an insulating glue layer (32) and a release paper layer (33) which are arranged from top to bottom in sequence;

the needle head of the consolation needle assembly (2) is a blunt head which cannot puncture the insulating glue layer (32), and the needle head of the acupuncture needle assembly (1) is a pointed head which can puncture the insulating glue layer (32);

the comfort needle assembly (2) and the acupuncture needle assembly (1) are both made of conductive metal materials and can be connected with an external electric acupuncture apparatus, and pulse current is respectively input to the acupuncture needle assembly (1) and the comfort needle assembly (2).

2. The dual-purpose device for placebo electrical needles and general placebo needles according to claim 1, wherein:

the acupuncture needle assembly (1) comprises an acupuncture needle body handle (11), an acupuncture needle body (12) and an acupuncture needle head (13); the needle-pricking body handle (11) is wrapped at the rear end of the needle-pricking body (12); the acupuncture needle head (13) is a pointed end and is positioned at the head part of the acupuncture needle body (12).

3. The dual-purpose device for placebo electrical needles and general placebo needles according to claim 1, wherein:

the placebo needle assembly (2) comprises a placebo handle (21), a placebo 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 at the head of the placebo needle body (22).

4. The device for both the placebo electro-acupuncture and the general placebo needle according to claim 2 or 3, wherein the acupuncture needle body (12) and the placebo needle body (22) are both made of stainless steel, the diameter of the acupuncture needle body (12) is 0.18-0.60 mm, and the length is 13-75 mm; the placebo needle (22) has a diameter of 0.40mm and a length of 13 mm.

5. The device according to claim 2 or 3, wherein the needle body handle (11) and the needle body handle (21) are both conductive wires and are wrapped around the rear end of the needle body by winding.

6. The device according to claim 4, wherein the layer of adhesive (32) is a polyisobutylene-type patch having a thickness of 0.2-0.5 mm.

7. The device of claim 4, wherein the foam layer (31) of the lancet base (3) has a height of 5-8 mm.

8. Device according to claim 1, characterized in that the lancet base (3) is coated on its side with an insulating paper layer (30).

9. The device according to claim 5, characterized in that the needle-stick body handle (11) and the placebo handle (21) are of the same length and are made of red copper.