Acupuncture needle and method of manufacturing the same

Abstract

To provide an acupuncture needle having a thin coating film and high insulation of the coating film, and to provide a method of manufacturing the acupuncture needle.SOLUTION: An acupuncture needle 1 capable of being energized is made of metal and constituted of a needle body 2 and a needle handle 5, a tip part 4 of the needle body 2 is conical, and the outer surface other than the tip part 4 of the needle body is covered with a polyparaxylylene film 3. The manufacturing method according to the present invention includes a deposition step of thermally decomposing a paraxylylene dimer to deposit polyparaxylylene on the surface of a metal rod, and a polishing step of polishing the tip of the metal rod on which the polyparaxylylene is deposited into a conical shape.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to an acupuncture needle for use in acupuncture treatment and a method for manufacturing the same.

Background Art

[0002] Conventionally, in acupuncture treatment of traditional Chinese medicine, a stainless steel filiform needle with a diameter of about 0.2 mm and a length of several tens of mm of the needle body is inserted into the acupoints of the human body (so-called "acupoints") from several mm to several tens of mm, and various treatments are performed to normally restore physical discomfort such as pain and stiffness by needle stimulation. Furthermore, in recent years, depending on the symptoms, a minute current is passed through the filiform needle inserted into the body, and electroacupuncture treatment is also performed in which the effects of the stimulation by the current and the needle stimulation are expected. Patent Document 1 proposes attaching and curing a urethane resin, a silicone resin, etc. to the needle body by dipping. Patent Document 2 proposes forming a resin film and a ceramic film on the needle body in this order.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, the acupuncture needles of the prior art have problems in that the film thickness of the coating is thick and the insulation of the coating is low.

[0005] In order to solve the above conventional problems, the present invention provides an acupuncture needle with a thin coating film thickness and high insulation of the coating film and a method for manufacturing the same.

Means for Solving the Problems

[0006] One embodiment of the present invention is an electrically conductive acupuncture needle. The acupuncture needle is made of metal and is composed of a needle body and a needle handle. The tip of the needle body is conical, and the outer surface of the needle body except for the tip is covered with a polyparylene film.

[0007] One embodiment of the manufacturing method of the present invention relates to a method for manufacturing an acupuncture needle, which includes a vapor deposition step of thermally decomposing a parylene-based dimer and vapor-depositing polyparylene on the surface of a metal rod, and a polishing step of polishing the tip of the metal rod on which the polyparylene is vapor-deposited into a conical shape.

Advantages of the Invention

[0008] The acupuncture needle of the present invention is electrically conductive, composed of a metal needle body and a needle handle. The tip of the needle body is conical, and the outer surface of the needle body except for the tip is covered with a polyparylene film. As a result, an acupuncture needle with a thin film thickness and high insulation of the film can be provided. Polyparylene has a linear structure, high crystallinity, high dielectric strength, and is a pinhole-free and uniform coating film. Therefore, even if the film thickness of the film is thin, it has high insulation and can be energized only to the target muscle part, providing an acupuncture needle with a high therapeutic effect. In addition, polyparylene has good biocompatibility, high safety for the living body, and low resistance during penetration.

Brief Description of the Drawings

[0009]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Embodiments for Carrying Out the Invention

[0010] The acupuncture needle of the present invention is made of metal and is composed of a needle body and a needle handle. The tip of the needle body is conical, and the outer surface of the needle body except for the tip is covered with a polyparylene film. With this structure, electricity can be conducted from the needle handle and discharged from the tip of the needle body. Since the outer surface of the needle body except for the tip is covered with a polyparylene film, discharge from this part is less likely to occur. Also, the tip of the needle body is conical, and the current spreads radially from the conical surface. Therefore, discharge can occur only from the tip of the needle body, and electrotherapy can be performed efficiently. The needle body is also referred to as the needle shaft.

[0011] Polyparylene has a chemical structure represented by the following (Chemical Formula 1), has a linear structure, has high crystallinity, high dielectric strength, and is a pinhole-free and uniform coating film. Therefore, even if the film thickness of the coating is thin, an acupuncture needle with high insulation can be provided. Being a pinhole-free and uniform coating film means it is a vacuum deposition film. By the polymerization (polymerization) of molecular-level dimers, it becomes a dense film, the film thickness becomes uniform, and the resistance during penetration is low. Also, polyparylene has good biocompatibility and high safety for the living body. This is also clear from the fact that it is described in the Biomaterials Compendium of the US Food and Drug Administration (FDA).

[0012] Polyparylene preferably has a chemical structure represented by the following (Chemical Formula 1).

Chemical Formula

[0013] The average thickness of the polyparylene film is preferably 0.5 to 50 μm, more preferably 1 to 45 μm, and even more preferably 2 to 40 μm. Thereby, the insulating property of the coated portion can be enhanced.

[0014] The acupuncture needle is preferably made of stainless steel. If it is made of stainless steel, the cost can be low and it can be a disposable needle, having rust prevention property and high safety.

[0015] The method for manufacturing the acupuncture needle of the present invention includes a vapor deposition step of thermally decomposing a parylene-based dimer and vapor-depositing polyparylene on the surface of a metal rod, and a polishing step of polishing the tip of the metal rod on which the polyparylene is vapor-deposited into a conical shape.

[0016] (1) Vapor Deposition Step The formation of a film made of polyparylene is performed by forming a thin film of polyparylene on the outer surface of a metal rod by chemical vapor deposition (CVD method) using a parylene dimer. As examples of the parylene dimer, the following Chemical Formulas (6) to (8) are given. [Chemical Formula] [Chemical Formula] [Chemical formula] When the dimer of the above (Chemical formula 6) is subjected to chemical vapor deposition, the polymer of (Chemical formula 2) is obtained. When the dimer of the above (Chemical formula 7) is subjected to chemical vapor deposition, the polymer of (Chemical formula 3) is obtained. When the dimer of the above (Chemical formula 8) is subjected to chemical vapor deposition, the polymer of (Chemical formula 4) is obtained. When the dimer in which CH2 of the above (Chemical formula 6) is replaced by CF2 is subjected to chemical vapor deposition, the polymer of (Chemical formula 5) is obtained.

[0017] As a poly(p-xylylene) film forming apparatus, an apparatus equipped with a p-xylylene dimer vaporization chamber, a p-xylylene dimer pyrolysis chamber, a poly(p-xylylene) deposition chamber, and a cooling chamber is used. For example, in the film formation of a poly(p-xylylene) film, a metal rod as a raw material for a needle is placed in the deposition chamber, the pressure inside the apparatus is reduced to 5 to 50 mTorr, preferably 10 to 30 mTorr, and the p-xylylene dimer as a raw material is vaporized at 100 to 200 °C in the vaporization chamber. Next, the p-xylylene dimer is pyrolyzed into p-xylylene monomer by heating at 650 to 700 °C in the pyrolysis chamber and introduced into the deposition chamber. When the monomer contacts the metal rod, polymerization occurs at the interface, and a poly(p-xylylene) film is formed. The poly(p-xylylene) film thus obtained is excellent in chemical resistance and gas barrier properties, is formed uniformly and continuously, and does not generate pinholes. In addition, the thickness of the poly(p-xylylene) layer can be controlled by the degree of vacuum, the temperature of the vaporization chamber, and the deposition time.

[0018] (2) Polishing process In this process, the tip of the metal rod on which poly(p-xylylene) is deposited is polished into a conical shape using a grinder or the like. Then, the needle handle is attached.

[0019] The acupuncture needle of the present invention is used by inserting the needle body to a predetermined position on the living body, energizing from the needle handle, and discharging from the conical surface at the tip of the needle body. By energization, continuous electrical stimulation can be performed. For energization into the living body, it is preferable to supply a low-frequency AC power source of 0.1 to 100 Hz and 0.1 to 10 mA for 15 minutes or more as an example. Thereby, pain can be suppressed by signals from the brain, or treatment can be performed by improving blood flow.

[0020] This will be described with reference to the following drawings. In the following drawings, the same reference numerals indicate the same objects. FIG. 1 is a schematic cross-sectional view of an acupuncture needle 1 in an embodiment of the present invention. This acupuncture needle 1 is composed of a needle body (needle shaft) 2 and a needle handle 5, and the outer surface of the needle body 2 other than the conical portion 4 at the tip is covered with a polyparaxylylene film 3. As an example, the diameter of the needle body is 0.3 mm, the length is 90 mm, the thickness of the polyparaxylylene film is 15 μm, the outer diameter of the needle handle is 1.2 mm, and the length is 20 mm.

[0021] FIG. 2 is a schematic cross-sectional view of an acupuncture needle product 9 in an embodiment of the present invention. In this acupuncture needle product 9, the acupuncture needle 1 is housed inside the needle tube 10. The stopper 11 is removed, the needle tube 10 on the tip side of the acupuncture needle 1 is applied to the human skin, and the acupuncture needle 1 is inserted into the skin in this state. The presence of the needle tube 10 enables the acupuncture needle 1 to be accurately inserted into the target position.

[0022] FIG. 3 is a schematic explanatory view showing acupuncture treatment using the acupuncture needles 1a and 1b in an embodiment of the present invention. Current is sent from the current supply device 6 to the clips via the lead wires 7a and 7b, and the human body is energized from the acupuncture needles 1a and 1b.

[0023] FIG. 4 is a schematic explanatory view showing electrical stimulation using the acupuncture needles of an embodiment of the present invention and a comparative example. The right side is an example of the acupuncture needle 1 of an embodiment of the present invention, and since there is an insulating film, energization can be performed only on the target muscle. The left side is an example of the acupuncture needle 8 of the comparative example, and since there is no insulating film, energization occurs not only on the target muscle but also on other muscles.

[0024] FIG. 5 is a schematic explanatory view showing a vapor deposition apparatus 12 for forming a polyparaxylylene film on a stainless steel bar according to an embodiment of the present invention. This vapor deposition apparatus 12 is composed of a vaporization chamber 13, a pyrolysis chamber 15, a vapor deposition chamber 16, a cooling chamber 18, and a vacuum pump 19, and the total volume is 25 liters. As an example, it is operated under the following conditions. (1) The inside of the vapor deposition apparatus 12 is adjusted to a vacuum degree of about 30 mTorr by the vacuum pump 19. (2) In the vaporization chamber 13, it is heated to 150 to 170 °C to sublime the paraxylylene dimer 14 in the vaporization chamber. (3) In the pyrolysis chamber 15, the dimer 14 is pyrolyzed into a paraxylylene monomer at a temperature of 650 to 690 °C. (4) In the vapor deposition chamber 16, it is treated at room temperature to about 35 °C for 25 minutes, and a film of polyparaxylylene obtained by polymerizing the monomer is vapor-deposited on a plurality of stainless steel bars installed in the tumbler 17. The exhaust gas is cooled to -​​70 °C in the cooling chamber 18 and sent to the vacuum pump 19. (5) Thereafter, the stainless steel bar on which the polyparaxylylene film is vapor-deposited is taken out. (6) Finally, the tip of one end of the stainless steel bar with a polyparaxylylene film is polished into a conical shape using a grinder, the needle handle attachment portion of the stainless steel bar is polished, the needle handle is attached as shown in FIG. 1, and then it is housed in a cylinder as shown in FIG. 2.

Example

[0025] The following will be described using examples. The present invention is not limited to the examples. (Example 1) A stainless steel rod with a diameter of 0.3 mm and a length of 90 mm was placed in the vapor deposition apparatus 12 shown in FIG. 5, and a polyparaxylylene film was deposited on the outer surface of the stainless steel rod using a chemical vapor deposition apparatus composed of a vaporization chamber, a pyrolysis furnace, and a vapor deposition chamber with a paraxylene dimer. Specifically, the paraxylene dimer was introduced into the vaporization chamber, and the inside of the apparatus was adjusted to a vacuum degree of 30 mTorr. Next, it was heated to 150 - 170 °C to sublime the dimer in the vaporization chamber, and then the dimer was passed through a pyrolysis chamber at 650 - 690 °C to be pyrolyzed into monomers. The monomers were introduced into a vapor deposition chamber (room temperature) equipped with a tumbler containing 500 stainless steel rods, and the treatment was carried out for 25 minutes to deposit a polyparaxylylene film. The tumbler was rotated at 2 rpm. When 30 stainless steel rods were arbitrarily selected and the thickness of the polyparaxylylene coating was measured, the average thickness was about 5 μm. The tip of one end of the stainless steel rod with the polyparaxylylene coating was polished into a conical shape using a grinder. Then, the handle attachment part of the stainless steel rod was polished, a handle was attached as shown in FIG. 1, and then it was housed in a cylinder as shown in FIG. 2. When the obtained acupuncture needle was inserted into the human body and a low-frequency alternating current power supply with a current of 2.7 mA and a frequency of 10 Hz was supplied, vibration was observed only at the target muscle part, and no muscle vibration was observed in the polyparaxylylene coating part. FIG. 6B is a photograph of the acupuncture needle of this Example 1 inserted into the intermediate vastus muscle of the human body and electrically stimulated. Contraction was observed only in the intermediate vastus muscle.

[0026] (Comparative Example 1) When an acupuncture needle without a polyparaxylylene coating was inserted into the human body and a low-frequency alternating current power supply with a current of 2.7 mA and a frequency of 10 Hz was supplied, vibration of the muscle in contact with the needle body was observed, and it was confirmed that the energization to the target muscle was diluted. FIG. 6A is a photograph of the acupuncture needle of this Comparative Example 2 inserted into the intermediate vastus muscle of the human body and electrically stimulated. Contraction of both the rectus femoris and the intermediate vastus muscles was observed, and it was confirmed that the current was scattered from the entire needle body.

Industrial Applicability

[0027] The acupuncture needle of the present invention is useful as an acupuncture needle for electrotherapy.

Explanation of Signs

[0028] 1, 1a, 1b, 8 Acupuncture needles 2 Needle body (shaft) 3 Polyparaxylylene film 4 Needle tip conical part 5 Needle handle 6 Current supply device 7a, 7b Lead wires 9 Acupuncture needle product 10 Needle tube 11 Stopcock 12 Evaporation device 13 Vaporization chamber 14 Paraxylylene dimer 15 Pyrolysis chamber 16 Deposition chamber 17 Tumbler 18 Cooling chamber 19 Vacuum pump

Claims

1. An electrically conductive acupuncture needle, wherein the acupuncture needle is made of metal and is composed of a needle body and a needle handle, the tip of the needle body is conical, and the outer surface of the needle body except for the tip is covered with a polyparaxylylene film. The acupuncture needle is characterized by this.

2. The acupuncture needle according to Claim 1, wherein the polyparaxylylene has a chemical structure represented by the following (Chemical Formula 1). 【化1】 However, X: H or Cl, Y: H or F, and n represents the repeating unit of the polymer.

3. The acupuncture needle according to Claim 1, wherein the average thickness of the polyparaxylylene film is 0.5 to 50 μm.

4. The acupuncture needle according to Claim 1, wherein the acupuncture needle is made of stainless steel.

5. The acupuncture needle according to Claim 1, wherein the acupuncture needle is energized from the needle handle and can discharge from the conical surface of the tip of the needle body.

6. A method for manufacturing the acupuncture needle according to any one of Claims 1 to 5, comprising a vapor deposition step of thermally decomposing a paraxylylene-based dimer and vapor-depositing polyparaxylylene on the surface of a metal rod, and a polishing step of polishing the tip of the metal rod on which the polyparaxylylene is vapor-deposited into a conical shape. The method for manufacturing an acupuncture needle is characterized by this.

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