CN204501617U - A kind of device for catget embedding onto acupuncture points for double blind - Google Patents

Abstract

An acupoint thread embedding device for double-blind clinical trials. The front end of the needle tube is provided with a needle body for guiding the thread embedding into the human body. The needle tube is provided with a pushing device for pushing the thread embedding into the human body. The front end of the base is provided with a needle core. The front end of the needle is inserted into the needle body; the side of the base is provided with an elastic pressing piece, and the locking protrusion on the elastic pressing piece cooperates with the locking opening on the needle tube to compress the spring between the locking base and the inner bottom surface of the needle tube, and There is also a switch on the needle tube to make the locking protrusion detach from the locking opening; the inner wall of the front section of the needle tube is provided with a limit card slot that cooperates with the elastic pressure piece to limit the retraction of the pushing device; the embedding is located far away from the needle port The bottom of the needle body, and the inner diameter of the needle body matches the diameter of the embedding thread, so as to avoid the embedding thread slipping from the needle port, and the needle port is equipped with a sealing plug; the distance between the limit card slot and the card opening is greater than that of the needle port The distance from the short side to the embedding thread, so that the front end of the needle core exceeds the short side of the needle port after the embedding thread is ejected.

Description

An acupoint catgut embedding device used in double-blind clinical trials

technical field

The utility model relates to an acupoint catgut embedding device for double-blind clinical trials.

Background technique

Acupoint catgut embedding therapy is developed on the basis of acupoint acupuncture. It embeds medical catgut, surgical thread, and umbilical cord on the acupoint or in the tissue, so as to stimulate the acupoint or regulate it through the body's absorption process. The purpose of meridian qi and blood. Acupoint catgut embedding stimulates acupoints for a long time, with long-lasting effect and continuous effect. It can significantly reduce the number of acupuncture and reduce the pain of patients. Medicated thread can also be used to achieve special therapeutic purposes. It is more and more widely used in clinical practice. For the problems in its clinical promotion, various improved technical solutions have been proposed, including "disposable aseptic minimally invasive thread needle syringe", "disposable catgut embedding acupuncture syringe", "a rapid acupuncture point Thread Embedding Device", "Acupoint Thread Embedding Device", "A Special Device for Thread Embedding" and other Chinese patent applications. It is safer, or to save costs, etc., but there is no acupoint catgut embedding device designed for double-blind clinical trials at present.

The main purpose of double-blind clinical trials is to prevent the research results from being affected by the placebo effect (placebo effect) or observer bias (observer bias). During double-blind control, neither the operator nor the subjects of the experiment know the content and purpose of the experiment. Both the experimenter and the research participants do not know which subjects accept which experimental conditions, which can avoid the extra variables caused by the subjective expectations of both the subject and the subjects, and make the test results more objective, accurate and scientific, convincing and easy to be judged. recognized.

At present, the clinical trials of acupoint catgut embedding published in international journals have fewer blind trials, among which almost single-blind (such as German K Streitberger, J Kleinhenz published an article "" on the Lancet] in 1998 "Research Report on Comfort Needles", the needle design is unique, blunt, imitating the degree of real acupuncture without piercing the skin (placebo needle method), occasionally double-blind clinical trials can be seen, but the devices used in double-blind trials It is an ordinary acupoint thread embedding device, which has no targeted design to deal with the blind method, and the thread embedding inside the needle is easy to leak out. The operator can easily find the difference between the experimental group and the control group by observing the needle opening and comparing the feel of the thread embedding. The probability of blind-breaking is high, the concealment is strong, it is difficult to detect, the cost of blind-breaking is low, it is difficult to supervise, and the requirements for operator self-discipline are high. At the same time, this blind method has low recognition and credibility.

In addition, on the basis of the German K Streitberger's needles, two "double-blind" acupuncture clinical trial needles were derived. One is a placebo needle invented by Japanese Nobuari Takakura in 2007, and the other is an intradermal placebo needle invented by Korean Sungchul Kim in 2008.

In terms of shape, Nobuari Takakura's skin-broken "true acupuncture" needle is indistinguishable from the "comfort needle" with a blunt flat-headed needle that does not break the skin and does not touch the skin. The inventor hopes to use this To achieve the purpose of obscuring the judgment of the operator. The intradermal needle invented by Sungchul Kim has the same needle tip design. It is expected that the intradermal needle is so small that it is difficult to detect the difference between its sharpness and bluntness, so as to obscure the judgment of the operator. However, Nobuari Takakura’s comfort needles are comparable to those of Nobuari Takakura in terms of astringent feeling during needle insertion, needle insertion resistance, needle withdrawal resistance, resilience after loosening the needle, needle sliding or displacement relative to the skin, transparency, bleeding, and skin deformation after needle withdrawal. The real skin-breaking acupuncture is very different, and it can be a factor that easily breaks the blindness. According to Takakura's research, there is about 67% (160/240) chance that the operator will guess the type of acupuncture equipment. According to Kim's research, 55.8-56.7% of the operators and 60-66.7% of the subjects can identify whether it is a placebo needle or not. In general, the shape of the Takakur placebo needle is well shielded, but the shielding during operation is insufficient, and it is not competent for many tasks. Acupuncture study. The shape of Kim's comfort needle is not enough to cover, and careful observation is easy to break the blindness, but the cover is better during operation, and it is suitable for multi-acupoint research.

In general, the double-blind design has been explored by the two comfort needles, but there are many possible blind-breaking factors, and it is difficult to cover the operator’s intentional blind-breaking. With repeated and long-term use, and experience accumulation, the blind-breaking rate will increase. It increases accordingly, so its application is rare in the world, and it is difficult to popularize.

While acupuncture and moxibustion therapy is going international, the authenticity and reliability of acupuncture and moxibustion effects continue to be debated. Therefore, if we want to provide strong evidence for the effectiveness of acupuncture and moxibustion therapy, and even make acupuncture and moxibustion therapy widely recognized at home and abroad, it is extremely important to use double-blind design method and placebo-acupuncture control method in acupuncture research. At present, there are certain difficulties in the implementation of acupuncture and moxibustion clinics and experiments, and it is a key scientific and technological problem that has long been urgently needed to be solved in the traditional medical field of the motherland. The establishment of methods and techniques for double-blind clinical trials of acupoint catgut embedding is conducive to objectively assisting high-quality clinical research on acupoint catgut embedding applied to various diseases, and can provide a basis for the authenticity and reliability of acupuncture effects that rely on acupoint stimulation. Strong evidence provides high-quality evidence-based medical support for the objective evaluation of acupuncture efficacy and the promotion and application of treatment-adapted diseases, which has profound significance and social value.

Contents of the invention

In order to overcome the shortcoming that there is no special acupoint catgut embedding device in the existing double-blind clinical trials, the utility model provides an acupoint catgut embedding device for double-blind clinical trials that can increase operation standardization and reliability.

The technical scheme that the utility model adopts is:

An acupoint thread embedding device for double-blind clinical trials, comprising a needle tube, the front end of the needle tube is provided with a needle body for guiding the thread embedding into the human body, and the needle tube is provided with a pushing device for pushing the thread embedding into the human body, It is characterized by:

The pushing device includes a base, the front end of the base is provided with a needle core that can penetrate the needle body to eject the embedding thread, the front end of the needle core is inserted into the needle body; the end of the base is fixedly connected with the spring, and the base There is an elastic pressing piece on the side of the elastic pressing piece, and the locking protrusion on the elastic pressing piece matches the locking opening on the needle tube to compress the spring between the base and the inner bottom surface of the needle tube, and the needle tube is also provided with There is a switch to make the card position protrusion out of the card position opening;

The inner wall surface of the front section of the needle tube is provided with a limit card slot matched with the elastic pressure piece to limit the retraction of the push device;

The embedding thread is located at the bottom of the needle body away from the needle port, and the inner diameter of the needle body is adapted to the diameter of the embedding thread to prevent the embedding thread from slipping from the needle port, and the needle port is equipped with a seal plug;

The distance between the limiting slot and the locking opening is greater than the distance from the short side of the needle opening to the embedding thread, so that the front end of the needle core exceeds the short side of the needle opening after the embedding thread is pushed out.

Further, one end of the locking opening has an upper abutment surface, and the other end has a lower abutment surface; one side of the locking protrusion has an abutting surface; the upper abutting surface and the upper surface of the locking protrusion Conflict with each other to limit the upward movement of the elastic pressing piece, and the lower abutting surface is in conflict with the abutting surface to limit the downward movement of the elastic pressing piece.

Further, the inner wall of the needle tube is recessed outward to form the limit card slot, and the limit card slot has a side abutment surface, and the side abutment surface is in conflict with the rear side of the locking protrusion, so as to limit the retraction of the spring.

Further, the switch is an elastic bead, the fixed end of the switch is arranged on the outer bottom surface of the needle tube, and the free end of the switch is provided with a pressing protrusion corresponding to the opening of the locking position, so as to push the locking protrusion downward. out of the locking opening, and the lower abutting surface of the locking opening is an inclined surface, so as to guide the locking protrusion to escape from the locking opening.

Further, the upper surface of the locking protrusion is a smooth arc surface, and the inner wall of the needle tube is provided with a groove between the locking opening and the limiting slot to guide the sliding of the elastic pressing piece.

Further, the front end of the needle core is a blunt opening that cannot penetrate into the human body.

Further, the blunt mouth is a flat mouth, a round mouth or a square mouth.

Further, the sealing plug has a sealing column that can be inserted into the needle body, the end of the sealing column has a plug, and the plug and the sealing column form an inclined stepped surface, and the stepped surface and the sealing column The end faces of the needle port are parallel to each other so that the stepped surface fits the needle port.

The beneficial effects of the utility model are reflected in:

First, reduce the possibility of "breaking the blind" and reduce the possibility of identifying the authenticity of the appliance: 1. This appliance uses the design of embedding/gut away from the needle mouth, so that the two can keep a certain distance to avoid The operator found the buried thread/gut through the needle port and lighting equipment to break the blind. 2. Use the embedding/gut sealing plug. It is stipulated in the operating procedures that the sealing plug can only be removed before acupuncture, which can avoid "breaking the blind" caused by the slipping of the embedding/gut due to handling or shaking. It can avoid the possibility of the operator violating the regulations to observe the embedding/gut through the needle eye. 3. Consider the diameter of the embedding/gut, so that the tension and friction in the needle tube are greater than or equal to gravity, so as to avoid "breaking the blind" caused by the slipping of the embedding/gut out of the needle port. 4. The push device with spring force as the driving force is designed to push the embedding/gut, the needle core is hidden in the needle tube, and manual operation of the needle core is prohibited, avoiding the risk of embedding/gut due to manual operation of the needle core The possibility of "breaking blindness" brought about by the difference in blocking feeling and hand feeling.

Second, increase the identifiability and exposure rate after the "blind breaking" occurs, reduce the concealment of the operator's "blind breaking", and then reversely achieve the standard blind operation process, reduce the probability of the operator breaking the blind, and improve reliability Purpose: 1. Apply the design of the locking position after the needle core is ejected, and the limit card slot matched with the elastic pressure sheet, prohibiting the retraction of the needle core. Once the needle core is ejected, the embedding/gut is exposed outside the needle body , the utility model promptly can not be reused. 2. After the embedding thread is ejected, the front end of the needle core exceeds the short side of the needle port, and the needle core is blunt and cannot penetrate into the skin tissue. Once the needle core is ejected, the embedding/gut is exposed to the needle. In addition, the utility model can no longer penetrate the human body, and can be detected by inspectors and noticed by the subjects, so as to prevent the operator from hiding after "breaking the blind", thereby increasing the standardization and reliability of the operation; if the operator When the switch is activated to detect the authenticity of the device, the embedding thread is ejected, causing blindness, but the front end of the needle core is exposed outside the needle tip, so that the needle body cannot be inserted into the human body again; the switch cannot be activated again if the push device is restricted to retract; these two points It can prevent the operator from hiding after breaking the blind, making it easy for the blinding monitor and the subjects to find the breaking of the blind, and achieve the purpose of quality control of the blinding method.

Thirdly, the utility model can also be used as a universal disposable acupoint catgut embedding device, which has the advantages of sterility, convenience and speed.

Description of drawings

Fig. 1 is a schematic diagram of the overall structure of the utility model.

Fig. 2 is an enlarged view of the structure of the circled part in Fig. 1 .

Fig. 3 is a schematic diagram of the utility model using process, wherein:

Fig. 3a is a schematic diagram when the needle body is aligned with an acupuncture point;

Fig. 3b is a schematic diagram when the needle body is pierced into the skin or tissue of the subject or patient;

Figure 3c is a schematic diagram when the needle body is withdrawn slightly upward;

Figure 3d is a schematic diagram of pushing down the switch to push the embedding thread into the skin or tissue of the subject or patient;

Fig. 3e is a schematic diagram when the elastic pressing piece is inserted into the acupoint in the limiting slot and the catgut embedding is successful;

Fig. 3f is a schematic diagram when the needle body is pulled out upwards.

Fig. 4 is a schematic diagram of the structure of the sealing plug.

Detailed ways

Referring to the accompanying drawings, an acupoint catgut embedding device for double-blind clinical trials includes a needle tube 5, the front end of the needle tube 5 is provided with a needle body 1 for guiding the embedding thread 2 into the human body, and a pusher is provided inside the needle tube 5 The above-mentioned embedding thread 2 enters the pushing device of the human body,

The pushing device includes a base 11, the front end of the base 11 is provided with a needle core 3 that can penetrate the needle body 1 to eject the embedding thread 2, and the front end of the needle core 3 is inserted into the needle body 1; The end is fixedly connected with the spring 8, and the side of the base 11 is provided with an elastic pressing piece 10, and the locking protrusion 9 on the elastic pressing piece 10 is matched with the locking opening on the needle tube 5, so that the spring 8 Compressed between the base 11 and the inner bottom surface of the needle tube 5, and the needle tube 5 is also provided with a switch 7 for disengaging the locking protrusion 9 from the locking opening;

The inner wall surface of the front section of the needle tube 5 is provided with a limit card slot 4 that cooperates with the elastic pressure piece 10 to limit the retraction of the push device;

The embedding thread 2 is located at the bottom of the needle body 1 away from the needle mouth, and the inner diameter of the needle body 1 is adapted to the diameter of the embedding thread 2 to prevent the embedding thread 2 from slipping from the needle mouth, and the The needle port is equipped with a sealing plug 16;

The distance between the limiting slot 4 and the locking opening is greater than the distance from the short side of the needle opening to the embedding thread 2, so that the front end of the needle core 3 exceeds the needle opening after the embedding thread 2 is pushed out the short side.

One end of the clamp opening has an upper abutment surface 12, and the other end has a lower abutment surface 11; one side of the clamp protrusion 9 has an abutment surface 13; the upper abutment surface 12 and the clamp protrusion The upper surface 14 of 9 is in conflict with each other to limit the upward movement of the elastic pressing piece 10 , and the lower abutting surface 11 is in conflict with the abutting surface 13 to limit the downward movement of the elastic pressing piece 10 .

The inner wall of the needle tube 5 is recessed outwards to form the limit card slot 4, the limit card slot 4 has a side abutment surface 15, and the side abutment surface 15 is in conflict with the rear side of the locking projection 9 to limit the spring 8. retract.

The switch 7 is an elastic bead, the fixed end of the switch 7 is arranged on the outer bottom surface of the needle tube 5, and the free end of the switch 7 is provided with a pressing protrusion 6 at the position corresponding to the opening of the locking position, so that the locking position is raised 9 pushes out the locking opening downward, and the lower abutment surface 11 of the locking opening is an inclined plane, so as to guide the locking protrusion 9 to escape from the locking opening.

The upper surface of the locking protrusion 9 is a smooth arc surface, and the inner wall of the needle tube 5 is provided with a groove between the locking opening and the limiting slot 4 to guide the sliding of the elastic pressing piece 10 .

The front end of the needle core 3 is a blunt opening that cannot penetrate into the human body.

The blunt mouth is flat, round or square.

The sealing plug 16 has a sealing column 161 that can be inserted into the needle body 1 , the end of the sealing column 161 has a plug 162 , and the plug 162 and the sealing column 161 form an inclined step surface 1621 , the step surface 1621 is parallel to the end surface of the needle port, so that the step surface 1621 fits the needle port.

Before implementing the blind acupuncture point catgut embedding operation, the sealing plug 16 will not be removed during the operation process to reduce the blind breaking rate. The catgut embedding/gut is placed at the bottom of the needle body 1 (the catgut embedding group at sham acupoints is not placed in the blind control group), and the spring 8 is kept in the state of energy storage and ready to go. Pressing the switch 7 activates the pushing needle core 3 to move toward the needle body 1, and pushes the embedding thread 2 to the outside of the needle body.

The distance between the limiting slot 4 and the locking opening is greater than the distance from the short side of the needle opening to the embedding thread 2, so that the front end of the needle core 3 exceeds the needle opening after the embedding thread 2 is pushed out the short side. Since the needle mouth is an inclined plane, it has a short side and a long side, and the short side of the needle mouth refers to the side closer to the end of the needle body.

The use process of the present utility model is:

(1) The operator pulls out the plug sealing plug 16 under the supervision of the supervisor;

(2) Aim the needle body 1 at the acupuncture point, as shown in Figure 3a;

(3) downward force, and puncture the needle body 1 into the skin or tissue of the subject or patient, as shown in Figure 3b;

(4) After the needle body 1 penetrates into the skin or tissue of the subject or patient, the needle body 1 is slightly withdrawn upward for a distance of about 5mm-1cm (the specific distance depends on the length of the embedding thread), as shown in Figure 3c;

(5) Press the switch 7 downwards, press the protrusion 6 to push the locking protrusion 9 downwards out of the opening of the locking position, the potential energy of the spring 8 is released, and the needle core 3 is previously pushed, and the needle core 3 pushes the needle body The embedding thread 2 in 1 is pushed into the skin or tissue of the subject or patient, as shown in Figure 3d;

(6) The pushing device moves toward the needle body 1 until the elastic pressing piece 10 snaps into the limiting slot 4 and makes a sound of "clicking", indicating that the acupuncture point embedding is successful. At this time, the side contact surface 15 Contradicting with the rear side of the locking protrusion 9, the pushing device cannot be retracted, and the utility model cannot be used continuously, as shown in Figure 3e;

(7) Pull out the needle body 1 upwards, and the needle core 3 with a flat mouth is exposed outside the needle mouth, and the utility model cannot be reused, as shown in Fig. 3f.

The utility model reduces the concealment of the operator "breaking the blind" by reducing the possibility of "breaking the blind" and increasing the recognizability and exposure rate after the "breaking the blind", and then increases the standardization and reliability of the operation. Thus applicable to double-blind clinical trials:

First, reduce the possibility of "breaking the blind" and reduce the possibility of identifying the authenticity of the appliance:

1. This device uses the design that the embedding/gut is far away from the needle port to keep a certain distance between the two, so as to prevent the operator from finding the embedding/gut through the needle port and lighting equipment and causing blindness.

2. Use the embedding/gut sealing plug. It is stipulated in the operating procedures that the sealing plug can only be removed before acupuncture, which can avoid "breaking the blind" caused by the slipping of the embedding/gut due to handling or shaking. It can avoid the possibility of the operator violating the regulations to observe the embedding/gut through the needle eye.

3. Consider the diameter of the embedding/gut, so that the tension and friction in the needle tube are greater than or equal to gravity, so as to avoid "breaking the blind" caused by the slipping of the embedding/gut out of the needle port.

4. The push device with spring force as the driving force is designed to push the embedding/gut, the needle core is hidden in the needle tube, and manual operation of the needle core is prohibited, avoiding the risk of embedding/gut due to manual operation of the needle core The possibility of "breaking blindness" brought about by the difference in blocking feeling and hand feeling.

Second, increase the identifiability and exposure rate after the "blind breaking" occurs, reduce the concealment of the operator's "blind breaking", and then reversely achieve the standard blind operation process, reduce the probability of the operator breaking the blind, and improve reliability the goal of:

1. Apply the locking position design after the needle core is ejected, and the limit card slot matched with the elastic pressure sheet, prohibiting the needle core from retracting. Once the needle core is ejected, the embedding/gut is exposed outside the needle body. New models are no longer usable.

2. After the embedding thread is ejected, the front end of the needle core exceeds the short side of the needle port, and the needle core is blunt and cannot penetrate into the skin tissue. Once the needle core is ejected, the embedding/gut is exposed to the needle. In addition, the utility model can no longer penetrate the human body, and can be detected by inspectors and noticed by the subjects, so as to prevent the operator from hiding after "breaking the blind", thereby increasing the standardization and reliability of the operation; if the operator When the switch is activated to detect the authenticity of the device, the embedding thread is ejected, causing blindness, but the front end of the needle core is exposed outside the needle tip, so that the needle body cannot be inserted into the human body again; the switch cannot be activated again if the push device is restricted to retract; these two points It can prevent the operator from hiding after breaking the blind, making it easy for the blinding monitor and the subjects to find the breaking of the blind, and achieve the purpose of quality control of the blinding method.

The content described in the embodiment of this specification is only an example of the realization form of the utility model concept, and the protection scope of the utility model should not be regarded as being limited to the specific form stated in the embodiment, and the protection scope of the utility model also extends to Equivalent technical means that those skilled in the art can think of according to the concept of the utility model.

Claims (8)

1. A point thread embedding device for double-blind clinical trials, comprising a needle tube, the front end of the needle tube is provided with a needle body that guides the thread embedding into the human body, and the needle tube is provided with a pusher that pushes the thread embedding into the human body device, characterized in that: The pushing device includes a base, the front end of the base is provided with a needle core that can penetrate the needle body to eject the embedding thread, the front end of the needle core is inserted into the needle body; the end of the base is fixedly connected with the spring, and the base There is an elastic pressing piece on the side of the elastic pressing piece, and the locking protrusion on the elastic pressing piece matches the locking opening on the needle tube to compress the spring between the base and the inner bottom surface of the needle tube, and the needle tube is also provided with There is a switch to make the card position protrusion out of the card position opening; The inner wall surface of the front section of the needle tube is provided with a limit card slot matched with the elastic pressure piece to limit the retraction of the push device; The embedding thread is located at the bottom of the needle body away from the needle port, and the inner diameter of the needle body is adapted to the diameter of the embedding thread to prevent the embedding thread from slipping from the needle port, and the needle port is equipped with a seal plug; The distance between the limiting slot and the locking opening is greater than the distance from the short side of the needle opening to the embedding thread, so that the front end of the needle core exceeds the short side of the needle opening after the embedding thread is pushed out. 2. The acupoint catgut embedding device for double-blind clinical trials as claimed in claim 1, wherein one end of the clamping opening has an upper abutment surface, and the other end has a lower abutment surface; One side of the protrusion has an abutment surface; the upper abutment surface is in conflict with the upper surface of the locking protrusion to limit the upward movement of the elastic pressing piece, and the lower abutment surface is in conflict with the abutment surface , to limit the downward movement of the elastic pressing piece. 3. The acupoint catgut embedding device for double-blind clinical trials as claimed in claim 2, characterized in that: the inner wall of the needle tube is recessed outwards to form the limiting slot, and the limiting slot has a side abutment surface, so The side abutting surface is in conflict with the rear side of the locking protrusion, so as to limit the retraction of the spring. 4. A kind of acupoint catgut embedding device for double-blind clinical trials as claimed in claim 3, characterized in that: the switch is an elastic pressure bar, the fixed end of the switch is arranged on the outer bottom surface of the needle tube, and the switch is free. The end is provided with a pressing protrusion corresponding to the card position opening to push the card position protrusion downward out of the card position opening, and the lower contact surface of the card position opening is a slope to guide the card position. The position protrusion is disengaged from the card position opening. 5. The acupoint catgut embedding device for double-blind clinical trials as claimed in claim 4, characterized in that: the upper surface of the locking protrusion is a smooth arc surface, and the inner wall of the needle tube is on the A groove guiding the sliding of the elastic pressing piece is provided between the locking opening and the limiting slot. 6. An acupoint catgut embedding device for double-blind clinical trials according to claim 5, characterized in that: the front end of the needle core is a blunt opening that cannot penetrate into the human body. 7. An acupoint catgut embedding device for double-blind clinical trials according to claim 6, wherein the blunt opening is flat, round or square. 8. A kind of acupoint catgut embedding device for double-blind clinical trials as claimed in claim 7, characterized in that: the sealing plug has a sealing column that can be inserted into the needle body, and the end of the sealing column has a A plug, the plug and the sealing column form an inclined step surface, the step surface is parallel to the end surface of the needle port, so that the step surface fits the needle port.