KR102458419B1 - Sham acupuncture with bond capsule and the using method thereof - Google Patents

Abstract

The present invention relates to a false needle equipped with a bond capsule and a method of using the same.
To this end, the chimpan; a bond capsule provided inside the needle tube and accommodating the bond therein; and a needle member provided in the needle tube, wherein an inclined portion narrowing downward is formed inside the lower portion of the needle tube.
According to the present invention, since the false needle is stably fixed to the recipient's skin, the recipient cannot distinguish whether the acupuncture he or she is receiving is real or false acupuncture, thereby providing perfect blinding in a randomized control experiment. .

Description

SHAM ACUPUNCTURE WITH BOND CAPSULE AND THE USING METHOD THEREOF

The present invention relates to a sham acupuncture and a method of using the same, and more particularly, to a sham acupuncture used together with a real acupuncture needle in order to objectively prove the effect of the acupuncture needle and equipped with a bond capsule, and a method of using the same.

Acupuncture is a treatment that has been practiced for more than two thousand years in East Asia such as Korea, Japan, and China, and as interest in and use of acupuncture for clinical effects increases, attempts to scientifically interpret its mode of action and mechanism are also increasing.

Therefore, the need for objective evidence for the effectiveness of acupuncture is being emphasized, and as a result, evidence-based clinical trials of acupuncture treatment based on randomized controlled studies to verify the effectiveness of acupuncture have begun to increase.

In the initial clinical study of acupuncture treatment, when a control group was established, the conventional treatment or no treatment group for each disease was used and compared with the acupuncture treatment group. However, various types of false acupuncture began to be used as a control group as it was argued that the placebo phenomenon should be excluded when verifying the effectiveness of acupuncture treatment.

However, the existing false acupuncture did not properly blind the recipient, so there were many cases in which the recipient could recognize whether the acupuncture was fake or real, making it difficult to conduct a proper randomized control experiment.

Korean Intellectual Property Office Application No. 10-2015-0189382

The present invention has been devised to solve the above problems, and to provide a false needle equipped with a bond capsule, and a method of using the same, which makes it impossible for an operator and a recipient to distinguish whether the needle is a real needle or a false needle with the naked eye. will be.

In addition, the present invention provides a false needle equipped with a bond capsule so as to be firmly supported on the skin, and a method of using the same.

In order to solve the above problems, the present invention provides a false needle consisting of the following configuration.

needle tube;

a bond capsule provided inside the needle tube; and

It includes a needle member provided in the needle tube,

A false needle, characterized in that the inclined portion narrowing downward is formed inside the lower portion of the needle tube.

In this case, the bond capsule has a conical shape and is provided on an inclined portion inside the needle tube.

According to the present invention false needle having such a configuration, when the operator presses the needle member, the needle member descends in the needle tube, penetrates the upper and lower portions of the bond capsule, and comes into contact with the skin. At this time, the bond in the bond capsule flows out of the destroyed capsule and flows downward from the inside of the needle tube by gravity and is applied to the skin of the recipient. At this time, since the bond capsule has a conical shape and the conical bottom surface is disposed in the needle tube, the bond is discharged at a high speed by the same principle as a funnel.

The bond may be applied to the skin by flowing down the inner surface of the needle tube and the lower needle member or falling down in the space between the inner surface of the needle tube and the lower needle member.

On the other hand, it is more preferable that the lower end of the inclined portion is formed with a reverse inclined portion that widens downward. By such a reverse slope, the outgoing bond can be applied to the skin quickly and widely when flowing downward through the inside of the needle tube.

It is advantageous that the needle member has a sharp tip in order to break the bond capsule, but in that case, there is a possibility that it may be inserted into the skin, which may cause a problem in its function as a false needle.

In consideration of this point, in another embodiment of the present invention, a lower needle member in contact with the skin is further provided separately from the needle member for breaking the bond capsule.

Specifically, the lower end of the needle member for breaking the bond capsule is sharply formed so that the upper and lower portions of the bond capsule can be quickly and easily pierced. Separately, it may further include a lower needle member attached to the lower surface of the bond capsule and functioning as a blunt-tipped false needle.

By applying an adhesive to either or both of the upper surface of the lower needle member and the lower surface of the bond capsule, the lower needle member remains attached to the lower surface of the bond capsule when false needles are not used.

During the procedure, the needle member penetrates the upper and lower portions of the bond capsule and then comes into contact with the upper surface of the lower needle member to press the lower needle member. As a result, the lower needle member is separated from the bond capsule and moves downward to come into contact with the skin. The bond flows out of the ruptured capsule and flows through the needle tube and is applied to the skin.

In this case, if a groove is formed in the upper portion of the lower needle member, the needle member may press the lower needle member more stably.

Meanwhile, the false needle of the present invention may further include a pressing member formed on the upper end of the needle member.

In addition, a friction support member may be further provided at the upper end of the needle tube. The friction support member is preferably formed of expanded polystyrene or rubber.

The bond in the bond capsule is cyanoacrylate, fibrin glue, protein-based glue, polyethylene glycol glue, polyurethane glue, methylidine malonic ( methylidene malonate) is preferably prepared including any one or more of acids.

It is preferable that aromatic oil is added to the bond. As the aroma oil, lavender, patchouli, tangerine, and various other oils can be used. As aroma oil is included in the bond, skin irritation can be calmed, and the body and mind of the recipient can be stabilized according to the direction. Above all, it is possible to increase the accuracy of the double-blind test by distracting the subject's attention by the scent of the aroma oil.

The outer shell of the bond capsule is preferably made of an elastic material that can be destroyed by the pressure of the needle member while maintaining the internal bond from leaking out, and may be formed of, for example, gelatin.

On the other hand, it is provided between the pressing member and the needle tube, so as to prevent the pressing member from being pressed toward the needle tube, it may further include a safety ring (ring) of an open side type.

In addition, the present invention provides a method of using a false needle equipped with a bond capsule, comprising the following steps.

descending the pressing member in the direction of the needle tube;

descending with the needle member as the pressing member descends;

passing the needle member through the bond capsule;

A step in which the bond flows out from the bond capsule and adheres to the skin.

The needle member penetrating the bond capsule is in contact with the skin of the recipient.

In this case, the needle member passing through the bond capsule may press the upper portion of the lower needle member and the lower needle member may be in contact with the skin of the recipient.

In addition, before the step of lowering the pressing member in the needle tube direction, the step of removing the safety ring sandwiched between the pressing member and the needle tube may be further included.

According to the false needle provided with the bond capsule of the present invention and a method of using the same, the following effects are obtained.

First, since it is impossible for the recipient to distinguish whether the acupuncture he or she is receiving is real or false acupuncture, it is possible to provide perfect blinding in a randomized controlled trial.

Second, the existing false acupuncture needle is detached from the skin after the procedure, so that the recipient can easily recognize whether the acupuncture he or she is receiving is a false acupuncture or a real needle. Therefore, the recipient does not recognize the type of acupuncture. Moreover, even the operator cannot know whether the acupuncture he or she is treating is a false needle, so it is possible to provide an accurate double-blind trial environment.

Third, there is an effect of providing more accurate evidence for the verification of the acupuncture treatment effect by providing the same pain sensation as the real acupuncture to the recipient without the use of false acupuncture when performing false acupuncture. In other words, it can provide accurate evidence on whether or not the effect of acupuncture is due to the placebo effect.

Fourth, since the safety ring is sandwiched between the needle tube and the pressure member during storage, it can be safely stored, and at the same time, only the safety ring needs to be removed and used. have.

1 is a perspective view of a conventional false needle viewed from the side.
2 is a perspective view showing a state when real acupuncture is performed using a conventional false acupuncture support.
3 is a perspective view showing a state when a false acupuncture is performed using a conventional false acupuncture support.
4 is a view showing the outside of the false needle according to the first embodiment of the present invention.
5 is a front cross-sectional view of a part of a false needle according to the first embodiment of the present invention;
6 is a cross-sectional view showing a state in which false acupuncture is performed according to the first embodiment of the present invention.
7 is a front cross-sectional view showing the inside of a false needle according to a second embodiment of the present invention.
8 is a cross-sectional view showing a state in which false acupuncture is performed according to a second embodiment of the present invention.
9 is a front cross-sectional view showing the inside of a false needle according to a third embodiment of the present invention.
10 is a cross-sectional view illustrating a state in which false acupuncture is performed according to a third embodiment of the present invention.
11 is a front cross-sectional view of a part of a false needle according to a fourth embodiment of the present invention.
12 is a cross-sectional view showing a state in which false acupuncture is performed according to a fourth embodiment of the present invention.
13 is a front view of a false needle to which a friction member is coupled according to a fifth embodiment of the present invention, wherein (a) and (b) are views before and after pressing the needle member, respectively.
14 is a view showing a state in which the safety ring is coupled when storing the false needle according to the sixth embodiment of the present invention.
15 is an enlarged perspective view of the safety ring of FIG. 14 .
16 is a flowchart showing a method of using a needle according to the present invention.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

The present invention can make various changes and can have various forms, and specific embodiments are not intended to limit the present invention, and include all changes, equivalents and substitutes included in the spirit and scope of the present invention. should be understood as

1 to 3 are views showing a state of one of the conventional false needles.

First, Figure 1 is a side view of a conventional false needle.

Existing false needles consist of acupuncture (1), acupuncture (2), and acupuncture (3), and in order to support these false needles, a vinyl tape (9) with a cover required for skin adhesion is coated. It was composed of an acupuncture support including an attachment part 7 to which the skin contact surface 8 is coupled and a needle guide tube 6 that penetrates the attachment part 7 and serves to induce a false needle.

2 is a perspective view showing a state when real acupuncture is performed using a conventional false acupuncture support.

For a double-blind trial, the real needle and the false acupuncture should be recognized as the same by the recipient, providing a perfect blinding effect. For this purpose, in the conventional double-blind test using a false acupuncture, the real needle was inserted into the needle guide tube 6 of the conventional false acupuncture supporter even when the real acupuncture was administered to the recipient.

3 is a perspective view showing a state when a false acupuncture is performed using a conventional false acupuncture support.

After the real needle is inserted into the experimental group as shown in FIG. 2, as shown in FIG. 3 in the control group, a false needle is inserted into the needle guide tube 6 of the acupuncture support and the treated person is treated. Unlike real needles, false needles do not penetrate through the skin of the recipient because the acupuncture point 3 is blunt.

That is, in the conventional false acupuncture, real or false acupuncture was applied through a needle support attached to the skin in order to provide a perfect blinding effect to the recipients of the experimental group and the control group.

However, since these conventional false needles are attached to the patient using a vinyl tape, the adhesion is not good, so there are many cases in which they fall off the skin or separate from the treated part through the movement of the patient. And, by recognizing the detached needle, the recipient can recognize whether the acupuncture is real or false, so there is a problem in that it is not possible to provide a perfect blinding to the patient. In addition, there was the inconvenience of having to remove the vinyl tape (9) one by one during the procedure.

4 is a view showing the outside of the false needle according to the first embodiment of the present invention.

The false needle 100 of acupuncture according to the first embodiment of the present invention is configured to include a pressing member 110 , a needle member 120 , a needle tube 130 , and a bond capsule 140 . In the drawing, when viewed from the outside, only the pressing member 110 , the needle tube 130 , and the needle member 120 exposed between the pressing member 110 and the needle tube 130 are recognized as the false needle 100 .

Therefore, before being used in a randomized control trial, the recipient cannot determine which is the real needle and which is a false needle (100) based on appearance alone.

5 is a front sectional view of a part of a false needle of a needle according to the first embodiment of the present invention;

In the drawing, an inclined portion 132 is formed below the inside of the needle tube 130 of the false needle 100 . The inclined portion 132 has a narrow inner diameter as it goes down.

A bond capsule 140 is placed on the inclined portion 132 . The bond capsule 140 is formed in a conical shape, and includes a bond therein. The bond is leaked when the bond capsule 140 is destroyed and is attached to the skin, thereby strengthening the skin fixation of the false needle 100 .

The material of the bond is preferably a medical bond used for wound closure instead of a suture or stapler. More specifically, cyanoacrylate, fibrin glue, protein-based glue, polyethylene glycol glue, polyurethane glue, methylidinmalonic ( methylidene malonate) may be prepared including any one or more of acids.

Meanwhile, aromatic oil may be added to the bond. As the aroma oil, lavender, patchouli, tangerine, and various other oils can be used.

As aroma oil is included in the bond, skin irritation can be calmed, and the body and mind of the recipient can be stabilized according to the aroma effect. In addition, the accuracy of the double-blind test can be improved by dispersing the subject's attention by the scent of the aroma oil.

As described above, by using the medical bond, it is possible to minimize concerns about side effects due to the bond and skin contact.

In addition to the above materials, if the bond capsule 140 is ruptured, it can be used as long as it is a liquid material that quickly flows out and dries quickly after coming into contact with the skin.

In addition, the outer shell of the bond capsule 140 is good to maintain the strength to accommodate the liquid bond inside. The liquid bond accommodated in the bond capsule 140 is preferably filled with a high pressure. Accordingly, when inserted into the needle, it can be rapidly destroyed and applied to the surrounding skin area while spreading. Specifically, the outer shell of the bond capsule 140 may use an elastic material such as gelatin.

6 is a cross-sectional view showing a state in which false acupuncture of acupuncture according to the first embodiment of the present invention is performed.

When the user presses the pressing member 110 of FIG. 4 , the pressing member 110 and the needle member 120 descend from the inside of the needle tube 130 , and the needle member 120 moves to the inclined portion 132 of the needle tube 130 . When reaching to the upper surface of the bond capsule 140 located in the contact, the bond capsule 140 is burst. The end of the needle member 120 is blunt so as not to be inserted into the skin, but since the needle itself has a small diameter, sufficient force can be applied to burst the bond capsule 140 .

As the bond capsule 140 is destroyed, the bond descends through the inner wall of the needle tube 130 , the surface of the needle member 120 or the space between the needle tube 130 and the needle member 120 to be applied to the skin.

At this time, in the drawing, the needle member 120 ruptures the bond capsule 140 so that the liquid bond of the bond capsule 140 leaks out and flows out to the skin, but the needle member 120 is not inserted into the skin. have. That is, the needle member 120 descends and bursts the bond capsule 140 , in contact with the skin to provide a feeling of pain, but is not actually inserted. In this state, the false needle 100 flows from the bond capsule 140 . It is applied on the 'A' area and fixed on the skin by the fixed bond.

That is, the needle member 120 is not inserted into the skin, but the needle tube 130 is fixed to the skin by the bond flowing out from the bond capsule 140 , so that the test subject in the control group can distinguish whether the needle they have been treated is a false needle or a real needle. can't do it

According to the acupuncture according to the first embodiment of the present invention, according to the acupuncture according to the first embodiment of the present invention, whether the treated person set as the control group in the randomized control experiment or the recipient set as the experimental group received the acupuncture treatment before or after receiving the acupuncture treatment whether the acupuncture was real or false. It can provide a perfect blinding effect that is indistinguishable.

In addition, the false needle 100 is not inserted into the skin, but since it is in the form of a needle having a very small diameter, it provides a sensation similar to that of the real needle to the person undergoing the procedure. Therefore, there is an effect that can fundamentally block the controversy about whether the effect of acupuncture is a placebo effect in a randomized control trial.

In addition, even the operator cannot check whether false needles exist, providing more perfect experimental conditions.

7 is a front cross-sectional view of a part of a false needle according to a second embodiment of the present invention.

In the second embodiment, the reverse inclined portion 134 is formed at the most distal end of the needle tube 130 , that is, at the portion in contact with the skin during the procedure.

8 is a cross-sectional view showing a state in which false acupuncture is performed according to a second embodiment of the present invention.

The inside of the needle tube 130 has a larger diameter at the portion in contact with the skin by the reverse inclined portion 134 . Therefore, the outflowing bond flows downward through the inside of the needle tube 134 and spreads widely when applied to the 'A' area of the skin, so that it can be applied to the skin quickly.

On the other hand, the needle member 120 is advantageous to have a sharp tip in order to destroy the bond capsule 140, but in that case, there is a possibility that the needle member 120 may be inserted into the skin, which may cause a problem in its function as a false needle.

In consideration of this point, in the third embodiment of the present invention, a lower needle member 122 in contact with the skin is further provided separately from the needle member 120 for breaking the bond capsule 140 .

9 is a front cross-sectional view of a part of a false needle according to a third embodiment of the present invention.

In the third embodiment, the lower needle member 122 is attached to the lower surface of the bond capsule 140 . Bonding of the bond capsule 140 and the lower needle member 122 may be accomplished by applying an adhesive to the bonding surface of the bond capsule 140 and the lower needle member 122 or the outer skin of the bond capsule 140 has viscosity. have. At this time, since the lower needle member 122 has to be separated from the bond capsule 140 during the procedure as will be described later, it is preferable that the adhesion is not too strong.

The needle point of the lower needle member 122 is made blunt. And, unlike this, the needle member 120 is sharply formed so that it is possible to quickly and easily penetrate the upper and lower portions of the bond capsule 140 .

10 is a cross-sectional view showing a state in which false acupuncture is performed according to a third embodiment of the present invention.

In the drawing, during the procedure, the needle member 120 penetrates the upper and lower portions of the bond capsule 140 and then contacts the upper surface of the lower needle member 122 to press the lower needle member 122 . As a result, the lower needle member 122 is separated from the bond capsule 140 and moves downward to come into contact with the skin. And the bond flows out from the destroyed capsule and flows into the needle tube and is applied to the 'A' area of the skin.

On the other hand, in another embodiment of the present invention, the needle member 120 is provided with a configuration that allows the lower needle member 122 to be pressed more stably.

11 is a front sectional view of a part of a false needle according to a fourth embodiment of the present invention.

In the drawing, a groove 124 is formed in the upper portion of the lower needle member 122 . When the needle member 120 is lowered, its needle tip is inserted into the groove 124 of the lower needle member 122 as shown in FIG. 12 . Accordingly, the needle member 120 may press the lower needle member 122 more stably.

Meanwhile, the present invention provides additional various configurations for the operation and storage of the false needle 100 .

13 shows a case in which a friction member is coupled according to a fifth embodiment of the present invention, and (a) and (b) are views before and after the needle member is pressed, respectively.

In the fifth embodiment, a configuration is provided so that the needle member 120 is not easily inserted into the needle tube 130 against the user's intention. To this end, a friction support member 150 bonded to the upper portion of the needle tube 130 is provided to provide an appropriate friction force to resist the lowering of the needle tube 130 . The friction support member 150 is formed of an elastic material such as polystyrene or rubber. According to this configuration, when the operator presses the needle member 120 in the state as shown in (a) in the drawing, the needle member 120 passes through the friction support member 150 and the needle tube 130 as shown in (b) of the drawing. ) because it moves while overcoming the resistance of the elastic material when inserted into the interior, it is possible to prevent the phenomenon of being lowered only by pressing by the user's very small force. In addition, the friction support member 150 also serves to limit the depth at which the needle member 120 is pressed, thereby preventing the needle member 120 from being treated with excessively strong pressure on the skin.

Meanwhile, FIG. 14 is a view showing a state in which a safety ring is coupled when storing a false needle according to a sixth embodiment of the present invention.

In the sixth embodiment, in order to prevent the pressing member 110 from being pressed by an external impact when the false needles according to various embodiments of the present invention are transported or stored, a safety between the pressing member 110 and the needle tube 130 is provided. A ring 170 is provided.

15 is an enlarged perspective view of the safety ring of FIG. 14 .

In the drawing, the safety ring 170 is formed in a circular ring shape with an opening (B) formed on one side. The safety ring 170 is made of an elastic material, and therefore, when the needle is separated from the safety ring 170, the opening may be widened and taken out.

Therefore, if the user of the needle simply removes and uses the safety ring 170 fitted to the false needle 100 after opening the box in which the false needle 100 is accommodated, the needle is prevented from being pressed unintentionally when not in use. .

On the other hand, FIG. 14 shows a state in which the safety ring 170 is coupled in the absence of the friction support member, the friction support member may be coupled and the safety ring 170 may be coupled thereon. In this case, it is preferable that the diameter of the friction support member is smaller than that of the needle tube 130 so that the safety ring 170 can be fitted thereinto.

16 is a flowchart showing a method of using a needle according to the present invention.

First, in order to use the false needle 100 according to the present invention, a process in which the safety ring 170 is removed is performed (S100). Next, a process in which the pressing member 110 descends in the needle tube 130 direction is performed (S200), and as the pressing member 110 descends, one side of the needle member 120 is fixed to the pressing member 110. also descends together (S300).

As the needle member 120 descends in this way, the needle member 120 ruptures the bond capsule 140 (S400).

When the bond capsule 140 is ruptured, the bond leaks out and adheres to the skin of the recipient (S500), and as a result, the false needle 100 remains fixed on the skin.

At this time, the needle member 120 penetrating the bond capsule 140 may press the upper portion of the lower needle member 122 and the lower needle member 122 may contact the skin of the recipient.

Therefore, according to the method of using acupuncture according to an embodiment of the present invention, it is possible to provide a perfect blinding effect to the recipient and at the same time provide a similar sensation to receiving real acupuncture in the control group, thereby objectively demonstrating the effect of acupuncture. In a randomized control experiment to do this, the experimenter can set the desired control group and experimental group.

As described above, although described with reference to preferred embodiments of the present invention, those skilled in the art can variously modify the present invention without departing from the spirit and scope of the present invention as set forth in the claims below. and may be changed.

1: bed 2: bed
3: needle point 6: needle guide tube
7: attachment part 8: skin contact surface
9: vinyl tape 100: false spit
110: pressing member 120: needle member
122: lower needle member 124: groove
130: needle tube 132: inclined portion
134: reverse slope 140: bond capsule
150: friction support member 170: safety ring

Claims (5)

needle tube;
a bond capsule provided inside the needle tube and accommodating the bond therein; and
It includes a needle member provided in the needle tube,
An inclined portion that narrows downward and a reverse inclined portion that is located under the inclined portion and widens downward are formed in the lower portion of the needle tube,
The bond capsule is made in the shape of a cone,
Further comprising a pressing member formed on the upper end of the needle member,
It is provided on the upper end of the needle tube and further comprises a friction support member formed of expanded polystyrene or rubber,
In the bond capsule, cyanoacrylate, fibrin glue, protein-based glue, polyethylene glycol glue, polyurethane glue, methylidinmalonic (methylidene malonate) includes a bond formed by including any one or more of the acid,
A false needle with a bond capsule, characterized in that the bond contains aromatic oil. delete delete delete delete

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