Composite piezoelectric material acupuncture needle and preparation method and application thereof

Abstract

The invention discloses a composite piezoelectric material acupuncture needle and a preparation method and application thereof.The composite piezoelectric material acupuncture needle comprises an acupuncture needle body and a needle handle, a needle head is arranged at the front end of the acupuncture needle body, and a groove or a thread is formed in the bottom of the acupuncture needle body; the rear end of the acupuncture needle body is coated with a needle body insulating layer; one end of the needle handle is inserted into the groove or wound on the thread through the inner core made of the flexible composite piezoelectric material to be connected with the acupuncture needle body, and the outer surface of the extended inner core is coated with an insulated outer core and wound on the tail portion of the acupuncture needle body. The composite piezoelectric material is prepared through specific raw material proportioning, mixing and dispersing, a forming process and post-treatment, voltage and current are generated under the action of mechanical force, current output at the joint of the inner core of the needle handle and the acupuncture needle is conducted to the needle tip and acts on the skin, and the current is always controlled within the safety range of 0.01-0.5 mA. The insulating material on the outer layer of the needle handle can prevent current from being conducted to the hand, meanwhile, the needle holding hand feeling is guaranteed, and conversion from mechanical force to electric signals is not affected.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a composite piezoelectric material acupuncture needle, a preparation method and application thereof. BACKGROUND

[0002] Traditional disposable stainless steel acupuncture needles have a long history in clinical application, which regulate the meridian and blood of the human body by needling acupoints to achieve the purpose of treating diseases. However, the traditional acupuncture needle only relies on mechanical stimulation, and the treatment effect has certain limitations. In recent years, although the electro-acupuncture therapy provides electrical stimulation for the acupuncture needle through an external power supply, it enhances the treatment effect, but has problems such as complex equipment, inconvenient operation, high cost and the like, and needs additional power supply equipment and control module, which limits its application in some scenarios. Therefore, there is an urgent need for a new type of acupuncture needle which retains the advantages of traditional acupuncture and can simply realize electrical stimulation to enhance the treatment effect. SUMMARY

[0003] In view of the defects in the prior art, the present application provides a composite piezoelectric material acupuncture needle, a preparation method and application thereof, which is prepared by combining a piezoelectric material and a needle body of traditional acupuncture, uses the mechanical force of the operator on the needle handle to generate weak electrical stimulation, and then conducts the electrical stimulation to the acupoint of the body through the needle body to realize micro-electrical stimulation of the acupoint, thereby enhancing the effect of acupuncture stimulation. The structure is simpler, and the operation process is more accurate and safe.

[0004] The present application is realized by the following technical scheme: A composite piezoelectric material acupuncture needle comprises a needle body and a needle handle, the front end of the needle body is a needle head, and a groove or a thread is formed at the bottom of the needle body; an insulating layer is coated on the rear end of the needle body; one end of the needle handle is inserted into the groove or wound on the thread through the inner core of the flexible composite piezoelectric material and connected with the needle body, and the outer surface of the extended inner core is coated with an insulating outer core and wound on the tail of the needle body.

[0005] A preparation method of a composite piezoelectric material acupuncture needle comprises the following steps: (1) Preparation of the needle body: a needle body made of medical stainless steel is selected, a groove or thread structure is processed at the bottom of the needle body for packaging the needle handle made of flexible composite piezoelectric material; and an insulating coating is coated on the rear end of the needle body to form the needle body; (2) Flexible composite piezoelectric material preparation: Lead-free sodium bismuth titanate-barium titanate (BNT-7BT) piezoelectric ceramic powder and polyvinylidene fluoride (PVDF) material are mixed in a mass ratio of 5-7:3-5, ammonium polyacrylate is added as a dispersant, and N-methyl pyrrolidone (NMP) solvent is added for dissolution. After ultrasonic and mechanical stirring for 5-8 h, a uniform slurry is prepared. Then, the slurry is solidified and formed by molding process. Silver electrodes are plated on the surface of the solidified and formed flexible piezoelectric film, and electrode leads are left out for packaging. After polarization treatment, the domains of the piezoelectric ceramic particles are oriented uniformly, and the flexible composite piezoelectric material is obtained, which has piezoelectric properties. It is ready for use. (3) Needle handle manufacturing and integration: The flexible composite piezoelectric material obtained in step (2) is used as the inner core, and an insulating material is coated on the outer surface as the outer core. The protruding inner core at the front end is inserted into the groove at the bottom of the acupuncture needle body or wrapped around the threads and fixed to realize connection with the acupuncture needle body. The rear end part is wrapped around the rear end of the acupuncture needle body to form a needle handle.

[0006] Further, the needle body diameter in step (1) is 0.2-0.3 mm, and the length is 25-50 mm.

[0007] Further, the needle body insulating coating is applied to the 1 / 3-2 / 3 length of the acupuncture needle body extending forward.

[0008] Further, the amount of ammonium polyacrylate added is 1.0-1.5 wt%, and the amount of N-methyl pyrrolidone solvent added is 1.0-1.5 ml / g.

[0009] Further, the ultrasonic power is 200-400 W, and the stirring speed is 500-800 r / min.

[0010] Further, the molding process of step (3) uses flow casting or injection molding to make the slurry into a sheet or tubular flexible composite piezoelectric material blank.

[0011] Flow casting is a method of uniformly coating the slurry on a base film, controlling the height and moving speed of the scraper to form a uniform thickness of the blank layer. The height of the scraper is controlled to form a 0.4-0.5 mm thick blank layer, which is heated at 80-90°C for 1-2 h, and then solidified and formed after cooling. Injection molding method is to inject the slurry into the mold cavity, and solidify and form at a pressure of 15-20 MPa and a temperature of 150-160°C.

[0012] Further, the needle body insulating layer and the outer core of the needle handle use epoxy resin or silicone resin as the insulating material. The existing common dipping combined with thermal curing method or chemical vapor deposition method is used.

[0013] The needle handle of the present application is wound on the tail of the needle body to form a winding with a diameter of 2-3 mm, increasing the contact feeling of the hand.

[0014] In the present application, the tail of the needle body is a groove or a thread, and the prepared flexible composite piezoelectric material is inserted into the groove of the tail of the needle body or tightly wound on the thread structure, and is fixed by adhesive or hot pressing, ensuring that the mechanical force can be effectively transmitted to the flexible composite piezoelectric material, and the electrode of the composite material is connected to the tail of the needle, forming a conductive channel.

[0015] The working principle of the acupuncture needle of the composite piezoelectric material of the present application is as follows: The present application can produce 0.1-2V voltage and 0.01-0.5mA current by applying mechanical force (extrusion) to the needle handle made of flexible composite piezoelectric material, and can produce 1-50Hz pulse current when rotating, and the current is always controlled within the safe range of 0.01-1mA; the tail of the needle body is connected to the electrode of the flexible composite piezoelectric material of the needle handle, so that the connection between the needle handle and the needle body is the current output point, and the skin as the current loop is affected, so as to achieve the effect of stimulating the skin by voltage and current, and achieving the effect of electric stimulation of acupuncture. The user can produce different mechanical forces by pressing, rotating the needle handle or inserting / extracting the needle, so as to produce different stimulating voltage and current, and the intensity and frequency of electric stimulation can be adjusted by selecting different needle types and applying different mechanical forces.

[0016] Different mechanical forces are applied to the needle handle, which produces different stimulating voltage and current, specifically: when 1-5N radial pressure is applied to the needle handle, the needle handle of the flexible composite piezoelectric material produces corresponding current intensity, wherein 1N pressure corresponds to 0.05mA current, and 5N pressure corresponds to 0.3mA current; when the needle handle is rotated, the rotation speed is related to the pulse current frequency, 1 revolution / second corresponds to 5-10Hz pulse current, and 5 revolutions / second corresponds to 30-50Hz pulse current; during the process of inserting / extracting the needle, the needle handle produces 0.01-0.1mA weak baseline current under stress.

[0017] Compared with the prior art, the present application has the following advantages: 1. The present application converts mechanical force into electric output, thereby realizing electric stimulation, realizing self-power supply without external power supply, having simple structure, low cost, and convenient operation.

[0018] 2. The present application uses insulating material in the tail of the needle body to ensure that the output current accurately acts on the acupoint, avoids shunt, and improves the application effect. The outer core of the needle handle uses insulating material, which can prevent current conduction to the user's hand and ensure the feeling of holding the needle, and does not affect the conversion of mechanical force to electric signal.

[0019] 3. The present application can adjust the intensity and frequency of electric stimulation by adjusting the applied mechanical force, meet the needs of different electric stimulation, and significantly improve the application effect.

[0020] 4. The composite piezoelectric material acupuncture needle of the present invention is safer. Under normal use, the current generated by mechanical force is weak (0.01-0.5mA, voltage 0.1-2V, frequency 1-50Hz), which is far below the tissue damage threshold. Moreover, the output of the piezoelectric material is limited by the upper limit of mechanical force to avoid excessive stimulation. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the composite piezoelectric material acupuncture needle of Embodiment 1 of the present invention.

[0022] Figure 2 This is a schematic diagram of the composite piezoelectric material acupuncture needle of Embodiment 2 of the present invention.

[0023] Figure 3 This is a view of the composite piezoelectric material acupuncture needle of the present invention.

[0024] The component names corresponding to each number in the diagram are as follows: 1-Acupuncture needle body, 2-Needle tip, 3-Needle body insulation layer, 4-Groove, 5-Inner core, 6-Outer core, 7-Needle handle, 8-Thread. Detailed Implementation

[0025] The present invention will be further described in detail below through embodiments. These embodiments are only used to illustrate the present invention and do not limit the scope of protection of the present invention.

[0026] Example 1 A composite piezoelectric material acupuncture needle (such as...) Figure 1 As shown in the figure, it includes an acupuncture needle body 1 and a needle handle 7. The front end of the acupuncture needle body 1 is a needle tip 2, and a groove 4 is formed at the bottom of the acupuncture needle body 1; the rear end of the acupuncture needle body 1 is coated with a needle body insulation layer 3 extending forward from the bottom for 1 / 3 to 2 / 3 of its length; one end of the needle handle 7 is inserted into the groove 4 through a flexible composite piezoelectric material core 5 and connected to the acupuncture needle body 1, and the outer surface of the extended inner core 5 is coated with an insulating outer core 6 and wrapped around the tail of the acupuncture needle body 1.

[0027] Its preparation method includes the following steps: Preparation of the acupuncture needle body: A medical stainless steel needle body with a diameter of 0.2 mm and a length of 40 mm is selected. The front end is the needle tip. The lower half of the needle body, 15 mm to 25 mm long, is immersed in a prepared epoxy resin fluid for 2 to 20 seconds, then slowly lifted out and heated to cure, forming an insulating layer coated on the outer surface of the needle body. A groove with a depth of 0.25 mm is then machined at the bottom of the needle body to encapsulate the needle handle made of flexible composite piezoelectric material, thus forming the acupuncture needle body. (2) Flexible composite piezoelectric material preparation: Lead-free sodium bismuth titanate-barium titanate (BNT-7BT) piezoelectric ceramic powder and polyvinylidene fluoride (PVDF) material are mixed in a mass ratio of 6:4, 1.0wt% polyacrylamide is added as a dispersant, and 1.0ml / g of N-methyl pyrrolidone solvent is added for dissolution. A uniform slurry is prepared by ultrasonic stirring (speed 600r / min) for 8 hours at a power of 300W. Then the slurry is uniformly coated on the base film by using the flow casting method, and a 0.4mm thick and uniform green body layer is formed by controlling the height and moving speed of the scraper. After heating at 80℃ for 2h, it is cooled and solidified to form. Then silver electrode is plated on the surface of the solidified and formed flexible piezoelectric film, and then polarized at 25℃, 2kV / mm electric field, and then packaged with medical grade polyurethane film, leaving electrode leads, so that the domains of the piezoelectric ceramic particles are oriented uniformly, giving the flexible composite piezoelectric material piezoelectric properties, i.e. obtaining the flexible composite piezoelectric material, ready for use; (3) Needle handle manufacturing and integration: The flexible composite piezoelectric material obtained in step (2) is used as the inner core of the needle handle, and an insulating material epoxy resin is coated on the outer surface as the outer core. The protruding inner core at the front end is inserted into the groove at the bottom of the acupuncture needle body and fixed with epoxy resin adhesive to form a winding with a diameter of 2-3mm, increasing the hand contact feeling and realizing the connection with the acupuncture needle body. The rear end is wrapped around the rear end of the acupuncture needle body to form a needle handle.

[0028] Example 2 A composite piezoelectric material acupuncture needle (as shown in Figure 2 ) includes an acupuncture needle body 1 and a needle handle 7. The front end of the acupuncture needle body 1 is a needle head 2, and the bottom of the acupuncture needle body 1 is provided with a thread 8. The acupuncture needle body 1 rear end is coated with a needle body insulating layer 3 from the bottom to the front 1 / 3-2 / 3 length. One end of the needle handle 7 is wrapped around the thread 8 and connected to the acupuncture needle body 1 through the inner core 5 of the flexible composite piezoelectric material. The outer surface of the extended inner core 5 is coated with an insulating outer core 6 and wrapped around the tail of the acupuncture needle body 1.

[0029] The preparation method comprises the following steps: Acupuncture needle body preparation: A medical stainless steel needle body with a diameter of 0.25mm and a length of 35mm is selected. The front end is a needle head part. The lower half of the needle body is immersed in a prepared medical grade silicone resin fluid for 2-20s, then slowly lifted up, and then heated and cured to form a needle body insulating layer coated on the outer surface of the needle body. Then a thread structure is processed on the bottom of the needle body for winding and connecting the needle handle made of flexible composite piezoelectric material to form an acupuncture needle body; (2) Flexible composite piezoelectric material preparation: Lead-free sodium bismuth titanate-barium titanate (BNT-7BT) piezoelectric ceramic powder and polyvinylidene fluoride (PVDF) material are mixed in a mass ratio of 5:5, 1.4wt% ammonium polyacrylate is added as a dispersant, and 1.5ml / g of N-methyl pyrrolidone solvent is added for dissolution. A uniform slurry is prepared by ultrasonic stirring (rotational speed 700r / min) for 6h at a power of 400W. Then the slurry is injected into the mold cavity by injection molding method, and solidified and formed at a pressure of 15MPa and a temperature of 160℃. Then silver electrodes are plated on the surface of the solidified and formed flexible piezoelectric film, and then polarized at 25℃ and 2kV / mm electric field. Then a medical grade polyurethane film is used for packaging, leaving electrode leads, so that the domains of the piezoelectric ceramic particles are oriented uniformly, giving the flexible composite piezoelectric material piezoelectric properties, i.e. obtaining the flexible composite piezoelectric material, ready for use; (3) Needle handle manufacturing and integration: The flexible composite piezoelectric material obtained in step (2) is used as the inner core of the needle handle, and an insulating material epoxy resin is coated on the outer surface as the outer core. The exposed inner core at the front end is wrapped around the threads at the bottom of the acupuncture needle body, and fixed with an adhesive, forming a 2-3mm diameter winding, increasing the hand contact feeling, and realizing the connection with the acupuncture needle body; the rear end is wrapped around the rear end of the acupuncture needle body to form a needle handle.

[0030] Example 3 A composite piezoelectric material acupuncture needle includes an acupuncture needle body 1 and a needle handle 7. The front end of the acupuncture needle body 1 is a needle head 2, and a groove 4 is formed at the bottom of the acupuncture needle body 1. An insulating layer 3 is coated on the acupuncture needle body 1 at a length of 1 / 3-2 / 3 from the bottom to the front end. One end of the needle handle 7 is inserted into the groove 4 and connected to the acupuncture needle body 1 through the inner core 5 of the flexible composite piezoelectric material, and the extended inner core 5 is coated with an insulating outer core 6 and wrapped around the tail of the acupuncture needle body 1.

[0031] The preparation method comprises the following steps: Acupuncture needle body preparation: An acupuncture needle body is prepared by selecting a medical stainless steel needle body with a diameter of 0.3mm and a length of 50mm. The front end is a needle head part. The needle body is immersed in a prepared epoxy resin fluid for 2-20s at a length of 20-25mm from the bottom, then slowly lifted up, and then heated and solidified to form a needle body insulating layer coated on the outer surface of the needle body. A groove with a depth of 0.25mm is formed at the bottom of the needle body for packaging the needle handle made of flexible composite piezoelectric material to form an acupuncture needle body; (2) Preparation of flexible composite piezoelectric material: Lead-free sodium bismuth titanate-barium titanate (BNT-7BT) piezoelectric ceramic powder and polyvinylidene fluoride (PVDF) material were mixed at a mass ratio of 7:3. 1.5wt% of ammonium polyacrylate was added as a dispersant, and 1.5ml / g of N-methylpyrrolidone solvent was added for dissolution. The mixture was ultrasonically stirred at 350W (650r / min) for 8 h to prepare a uniform slurry. Then, the slurry was uniformly coated on the base film using the casting method. By controlling the height and speed of the scraper, a uniform 0.5 mm thick blank layer was formed. The blank was heated at 80℃ for 2 h and then cooled and solidified to form the final product. Next, silver electrodes are deposited on the surface of the cured flexible piezoelectric film, and then polarized under an electric field of 25℃ and 2kV / mm. Then, it is encapsulated with a medical-grade polyurethane film, with electrode leads reserved to ensure that the electric domain orientation of the piezoelectric ceramic particles is consistent, thus giving the flexible composite piezoelectric material piezoelectric properties, and the flexible composite piezoelectric material is obtained for later use. (3) Needle handle fabrication and integration: The flexible composite piezoelectric material obtained in step (2) is used as the inner core of the needle handle. The outer surface is coated with insulating epoxy resin as the outer core. The inner core protruding from the front end is inserted into the groove at the bottom of the acupuncture needle body and fixed with epoxy resin adhesive to form a winding with a diameter of 2-3 mm, which increases the tactile sensation of the hand and realizes the connection with the acupuncture needle body. The rear end part is wrapped around the rear end of the acupuncture needle body to form the needle handle.

[0032] Implementation and Application Application 1: The composite piezoelectric material acupuncture needles obtained in Example 1 were used in this application. For patients with neck pain caused by cervical spondylosis, acupoints such as Fengchi (GB20) and Dazhui (GV14) were selected for treatment. During needle insertion, the needle handle was subjected to force, generating a weak baseline current of 0.05 mA. After insertion, a radial pressure of 3 N was applied to the needle handle, generating a current of 0.15 mA. Simultaneously, the needle handle was rotated at a speed of 3 revolutions per second, generating a 15-20 Hz pulsed current, enhancing acupoint stimulation and effectively relieving neck pain.

[0033] Application 2: The composite piezoelectric material acupuncture needles obtained in Example 2 were used in this application. For patients with post-stroke hand dysfunction, acupoints such as Hegu (LI4) and Laogong (PC8) were selected. The doctor gently squeezed the needle handle, applying 1N of pressure to generate a 0.05mA current, and slowly rotated the needle handle (1 revolution / second) to generate a 5-10Hz pulsed current. This stimulated the acupoints to promote nerve repair and gradually restore the patient's hand function. Simultaneously, the needle type was adjusted according to the patient's recovery progress, selecting flexible composite piezoelectric material acupuncture needles of different thicknesses and densities to optimize the intensity and frequency of electrical stimulation. Application 3: The composite piezoelectric material obtained in Example 2 is used for acupuncture needles. For migraine patients, the acupuncture points such as the temple and the rate valley are selected. After the doctor deeply inserts the acupuncture needle, a radial pressure of 5N is applied to the needle handle, a current of 0.3mA is generated, the needle handle is rapidly rotated (5 revolutions / second), a pulse current of 30-50Hz is generated, and the acupuncture points are stimulated to relieve the symptoms of migraine. During the treatment process, by observing the patient's response to electrical stimulation, combined with the characteristics of different acupuncture points, the needle type is flexibly selected to achieve precise action.

[0034] The above merely describes the preferred embodiments of the present application and is not intended to limit the present application. Any modification, equivalent replacement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A composite piezoelectric material acupuncture needle, characterized by, It includes acupuncture needle body (1) and needle handle (7), the acupuncture needle body (1) front end is needle head (2), the acupuncture needle body bottom is provided with recess (4) or thread (8);The acupuncture needle body (1) rear end is coated with needle body insulating layer (3);The needle handle (7) one end is inserted into the recess (4) or is wound on the thread (8) with the acupuncture needle body (1) connection through the inner core (5) of flexible composite piezoelectric material, and the outer surface of the inner core (5) extending out is coated with the outer core (6) of insulating material, and is wound in the tail of acupuncture needle body (1).

2. A method of manufacturing a composite piezoelectric material acupuncture needle as claimed in claim, characterized by, It comprises the following steps: (1) acupuncture needle body preparation: select the needle body of medical stainless steel, process the recess or thread structure on the bottom of the needle body for packaging the needle handle made of flexible composite piezoelectric material, then coat the needle body insulating layer on the rear end of the needle body to form the acupuncture needle body; (2) flexible composite piezoelectric material preparation: the lead-free sodium bismuth titanate-barium titanate piezoelectric ceramic powder is mixed with polyvinylidene fluoride material according to the mass ratio of 5-7:3-5, polyacrylamide is added as a dispersing agent, and N-methyl pyrrolidone solvent is added for dissolution, and the uniform slurry is prepared after ultrasonic and mechanical stirring for 5-8 h, then the slurry is solidified and formed by forming process, the silver electrode is plated on the surface of the solidified and formed flexible piezoelectric film, and the electrode lead is reserved for packaging, then polarization treatment is carried out to obtain the flexible composite piezoelectric material for standby; (3) needle handle production and integration: the flexible composite piezoelectric material obtained in step (2) is used as the inner core, the insulating material is coated on the outer surface as the outer core, the exposed inner core at the front end is inserted into the recess at the bottom of the acupuncture needle body or wound on the thread, and fixed to realize the connection with the acupuncture needle body; the rear end part is wound on the rear end of the acupuncture needle body to form the needle handle.

3. The method for preparing the composite piezoelectric acupuncture needle according to claim 2, characterized in that, The needle body diameter in the step (1) is 0.2-0.3mm, and the length is 30-100mm.

4. The method for preparing the composite piezoelectric acupuncture needle according to claim 2, characterized in that, The needle body insulating coating is coated on the 1 / 3-2 / 3 length of the acupuncture needle body bottom extending forward.

5. The method for preparing the composite piezoelectric acupuncture needle according to claim 2, characterized in that, The addition amount of polyacrylamide is 1.0-1.5wt%, and the addition amount of N-methyl pyrrolidone solvent is 1.0-1.5ml / g.

6. The method for preparing the composite piezoelectric acupuncture needle according to claim 2, characterized in that, The ultrasonic power is 200-400W, and the stirring speed is 500-800r / min.

7. The method for preparing the composite piezoelectric acupuncture needle according to claim 2, characterized in that, The forming process of step (3) adopts casting forming method or injection forming method; the casting forming method is that the slurry is uniformly coated on the base film, the scraper height is controlled to form a 0.4-0.5mm thick blank layer, heated at 80-90℃ for 1-2h, and then molded after cooling and solidification; the injection forming method is that the slurry is injected into the mold cavity, and solidified and formed at a pressure of 15-20MPa and a temperature of 150-160℃.

8. The method for preparing the composite piezoelectric acupuncture needle according to claim 2, characterized in that, The needle body insulating layer and the outer core of the needle handle use epoxy resin or silicone resin as the insulating material.

9. Use of a composite piezoelectric material needle according to claim 1, wherein, Its application in the field of acupuncture needles.

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