Micro-channel liquid release acupuncture needle and manufacturing method thereof

Abstract

The invention discloses a micro-channel liquid release acupuncture needle and a manufacturing method thereof, and belongs to the technical field of medical equipment. The acupuncture needle comprises a tubular needle body which is internally provided with an axial through micro-channel; the needle tip is fixedly connected with one end of the needle body, blocks the micro-channel and is used for puncturing the skin; the shell is fixedly connected with the other end of the needle body, and an opening is formed in the shell to realize internal and external communication; the elastic film is positioned in the shell, separates the micro-channel from the opening of the shell, and has a contraction state and an expansion state; the hydrophobic breathable film is used for blocking the opening of the shell; the needle hole is formed in the side wall of the needle body and communicated with the micro-channel, and the needle hole is covered with a biocompatible degradable material used for temporarily plugging the needle hole. The acupuncture needle can automatically release liquid medicine after being inserted into the human body, manual injection or external equipment is not needed, operation is easy and convenient, and the treatment efficiency and the comfort level of a patient are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, in particular to the technical field of acupuncture, and specifically to a microchannel liquid-releasing acupuncture needle and a manufacturing method thereof. Background Art

[0002] Acupuncture is an important treatment method in traditional Chinese medicine. It regulates the flow of qi and blood in the meridians by needling specific acupuncture points on the human body to achieve the treatment of diseases and functional recovery. Traditional acupuncture mainly relies on physical stimulation to stimulate the body's self-healing ability, but in modern clinical applications, simple acupuncture techniques are sometimes difficult to meet the needs of certain complex cases, especially in the fields of pain management, nerve repair, and inflammation control. It is often necessary to combine drug-assisted treatment to enhance the efficacy, that is, drug acupuncture. This method combines drugs with acupuncture stimulation by injecting drugs into the acupuncture points. However, existing technologies usually rely on manual injection or external equipment, and the operation steps are cumbersome and the accuracy is low.

[0003] Microchannel technology has been widely used in the fields of microfluidics and drug delivery in recent years, but introducing microchannel structures into acupuncture needles faces significant challenges. The microchannel inside the needle body needs to be controlled within the diameter range of 10-30 microns, while ensuring the penetration and inner wall smoothness to achieve stable liquid delivery. However, existing processing technology has shortcomings in the consistency of microchannels, inner wall treatment and processing accuracy: the production of microchannel needle bodies requires extremely high processing accuracy. The diameter of the needle body is usually between 0.2-0.3 mm, and the diameter of the microchannel is only 10-30 microns. The realization of a through-type microchannel in such a small structure requires advanced processing technology, which is difficult to meet with traditional mechanical drilling; the inner wall of the microchannel must be smooth and biocompatible to reduce liquid delivery resistance and prevent blockage, which requires uniform coating of high-performance materials (such as polytetrafluoroethylene or other polymers) on the inner wall, but in extremely small channels, it is difficult to achieve this. There are technical difficulties in achieving uniform coating in the microchannel; biocompatible materials (such as gelatin or polylactic acid) are needed to seal the needle tip to ensure that they can be controlled to dissolve after contact with body fluids to open the liquid release channel. However, the coating accuracy, sealing strength and dissolution time consistency of the sealing material are difficult to control; the inside of the needle body needs to be pre-filled with a trace amount of therapeutic liquid, and the air in the microchannel is removed by vacuum pretreatment technology to prevent bubbles from affecting the stability of liquid release. However, how to achieve accurate liquid quantitative filling and maintain the vacuum state in the channel during the trace liquid filling process is still a current technical difficulty. Summary of the invention

[0004] In order to solve at least one of the above problems, the purpose of the present invention is to provide a microchannel liquid-releasing acupuncture needle and a method for manufacturing the same. The present invention realizes the integrated manufacturing of microchannel processing, high-performance inner wall coating, needle tip sealing and pre-filling of liquid medicine of acupuncture needle through innovative processing methods and process optimization, thus providing technical guarantee for accurate, effective and safe acupuncture treatment.

[0005] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0006] A microchannel liquid-releasing acupuncture needle, comprising:

[0007] A tubular needle body, wherein the needle body is provided with a microchannel axially penetrating the body;

[0008] A needle tip fixedly connected to one end of the needle body and blocking the microchannel at the end, used for piercing the skin;

[0009] A shell body fixedly connected to the other end of the needle body, with an opening provided on the shell body for communicating the inside and outside of the shell body;

[0010] The elastic film located in the shell is used to separate the microchannel from the opening on the shell; the elastic film includes two states: a contracted state in which the elastic film is contracted to a state in which one end face is closely attached to the end face of the needle body, and an expanded state in which the elastic film is expanded to a state in which the other end face is closely attached to the inner wall of the shell;

[0011] A hydrophobic breathable membrane for sealing the shell opening;

[0012] The side wall of one end of the needle body connected to the needle tip is provided with a needle hole connected to the microchannel, and a biocompatible degradable material is arranged at the needle hole to temporarily block the needle hole.

[0013] As a specific embodiment of the present invention, a PTFE film or a Parylene film is provided on the inner wall of the microchannel or the inner wall of the pinhole to provide anti-clogging performance and reduce the chemical reaction between the liquid and the metal.

[0014] As a specific embodiment of the present invention, the biocompatible degradable material is soluble polylactic acid (PLA) or gelatin, and a trace amount of control agent (such as calcium ion crosslinking agent) can be added to the material to ensure that the seal dissolution rate is controllable within 10-30 seconds and the liquid release is stable.

[0015] As a specific embodiment of the present invention, two side surfaces of the hydrophobic breathable membrane are respectively abutted against a hard sieve plate, and sieve holes are arranged on the sieve plate to facilitate gas to pass through the shell and the hydrophobic breathable membrane.

[0016] Furthermore, the sieve plates on both sides of the hydrophobic breathable membrane are respectively a first sieve plate disposed at the opening of the shell and a second sieve plate disposed inside the shell.

[0017] A method for preparing a microchannel liquid-releasing acupuncture needle comprises the following steps:

[0018] S1. For the integrated structure in which the needle tip and the needle body are fixedly connected, a microchannel and a pinhole are processed in the needle body by using femtosecond laser engraving technology, and then the inner wall of the microchannel is processed to optimize the inner wall smoothness;

[0019] S2, integrating the needle body and the shell by laser welding;

[0020] S3, placing the acupuncture needle in a sealed chamber storing liquid medicine, with the needle hole immersed in the liquid medicine and the hydrophobic breathable membrane located outside the liquid medicine, evacuating the sealed chamber so that the gas in the shell flows outward and the elastic film expands, thereby assisting the liquid medicine to enter the liquid storage chamber through the microchannel, then inverting the acupuncture needle with the needle tip facing upward, pressurizing the sealed chamber so that the gas flows into the shell and the elastic film contracts, thereby discharging the gas in the microchannel, then immersing the needle hole in the liquid medicine and the hydrophobic breathable membrane located outside the liquid medicine, evacuating the sealed chamber so that the elastic film expands, thereby assisting the liquid medicine to fill the microchannel;

[0021] S4. Point the tip of the acupuncture needle upwards and let it stand to allow the medicinal liquid to separate from the outer wall of the acupuncture needle. Then, use a micro-spraying device in a vacuum environment to evenly coat the biocompatible degradable material on the needle tip outlet.

[0022] Compared with the prior art, the technical solution of the present invention has the following technical effects: the acupuncture needle of the present invention can automatically release the liquid medicine after being inserted into the human body, without relying on manual injection or external equipment to complete, and the operation is simple. The acupuncture needle of the present invention uses the contraction and expansion action of the elastic film to absorb the liquid medicine during the preparation process, and requires specific filling equipment to inject the liquid into the micro-through hole, which is simple to operate. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a half-section view of the overall structure of the microchannel liquid-releasing acupuncture needle;

[0024] Figure 2 yes Figure 1 A partial enlarged view of the upper part of acupuncture needle;

[0025] Figure 3 yes Figure 2 Assembly drawings of some of the components shown;

[0026] Figure 4 yes Figure 1 A partial enlarged view of the lower part of acupuncture needle;

[0027] Figure 5 It is a schematic diagram of the state of the elastic membrane of the acupuncture needle when it is in expansion;

[0028] Needle body 100 ; needle tip 200 ; housing 300 ; elastic film 400 ; hydrophobic breathable membrane 500 ; microchannel 110 ; needle hole 120 ; first sieve plate 610 ; second sieve plate 620 ; first annular member 700 . DETAILED DESCRIPTION

[0029] Embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0030] Example

[0031] Please refer to Figure 1 to Figure 4 , which shows a schematic structural diagram of a specific embodiment of the microchannel liquid release acupuncture needle of the present invention.

[0032] The microchannel liquid release acupuncture needle of the present invention comprises a needle body 100, a needle tip 200, a shell 300, an elastic film 400 and a hydrophobic breathable membrane 500. The needle body 100 of the present invention is tubular, made of medical stainless steel or cobalt-based alloy, with a diameter usually between 0.2 and 0.3 mm, a length of 30 to 50 mm, and a surface polished to reduce puncture resistance. An axially penetrating microchannel 110 is provided in the needle body 100, and the size of the microchannel 110 is generally controlled within the diameter range of 10 to 30 microns. The needle tip 200 is fixedly connected to one end of the needle body 100 and blocks the microchannel 110 at this end, so as to facilitate piercing the skin; a needle hole 120 connected to the microchannel 110 is provided on the side wall of the end of the needle body 100 connected to the needle tip 200, as a discharge port for the liquid medicine; the other end of the needle body 100 is fixedly connected to the shell 300, and an opening is provided on the shell 300 for connecting the inside and outside of the shell 300. The elastic film 400 is located in the housing 300 and is used to separate the microchannel 110 from the opening on the housing 300. The elastic film 400 has two states: one is that after the fluid in the microchannel 110 flows out of the needle body 100, the elastic film 400 shrinks to a shrink state in which the lower end surface is close to the end surface of the needle body 100 (such as Figure 2 the other is that after the medicine is filled into the needle body 100, the elastic film 400 expands to an expanded state in which the upper end surface is close to the inner wall of the housing 300 (as shown in FIG. Figure 5As shown). Since the shell 300 is provided with an opening, the fluid can enter the shell 300 from the outside of the shell 300, but the volume inside the entire shell 300 is small (for example, 0.2 to 5 microliters), and the opening of the shell 300 is also small, so the flow resistance of the liquid after entering is large, and it is difficult to discharge later. Therefore, the shell opening is blocked by a hydrophobic breathable membrane 500, and the hydrophobic breathable membrane 500 has the property of allowing gas to pass through but not drugs (for example, ePTFE), thereby limiting that only gas can enter and exit the shell 300. The gas flow resistance is smaller, which facilitates the later control of the pressure difference between the inside and outside of the shell 300 to push the elastic film 400 to move. A biocompatible and degradable material is provided at the pinhole 120 to temporarily block the pinhole 120.

[0033] When in use, the elastic film 400 is in an expanded state, and the drug solution is stored in the cavity surrounded by the elastic film 400 and the end surface of the needle body 100 (such as Figure 5 As shown in the figure, the acupuncture needle is inserted into the target acupuncture point of the human body, and the human tissue contacts with the biocompatible degradable material and promotes its dissolution. Then, under the action of the elastic film 400, the liquid medicine in the liquid storage chamber enters the human tissue through the microchannel 110 and the needle hole 120, thereby achieving the purpose of acupuncture treatment. The present invention uses the elastic film 400 to achieve the autonomous release of the medicine, and the whole process only requires the operation of acupuncture, which is simple to operate. At the same time, after the medicine is released, the acupuncture needle can be recycled.

[0034] In some embodiments, the inner wall of the microchannel 110 and the inner wall of the pinhole 120 are both provided with a PTFE film or a Parylene film to provide anti-clogging performance and reduce the chemical reaction between the liquid and the metal.

[0035] In some embodiments, the biocompatible degradable material is soluble polylactic acid (PLA) or gelatin, and a trace amount of a control agent (such as a calcium ion crosslinking agent) can be added to the material to ensure that the seal dissolution rate is controllable within 10 to 30 seconds and the liquid release is stable.

[0036] In some embodiments, the two sides of the hydrophobic breathable membrane 500 are respectively abutted against the hard sieve plate, and the sieve plate is provided with a sieve hole with a diameter less than 5 microns, so that the gas can pass through the housing 300 and the hydrophobic breathable membrane 500. Specifically, a first sieve plate 610 can be provided at the opening, and a second sieve plate 620 can be provided in the housing 300, and the hydrophobic breathable membrane 500 is fixed between the two sieve plates. In this way, by supporting the hydrophobic breathable membrane 500 with two sieve plates, the movement amplitude during its use can be reduced, and its life can be increased, and the amount of liquid medicine filled in the elastic film 400 when it is in an expanded state can be ensured to be constant. When specifically prepared, in some embodiments, a first annular member 700 is provided between the second sieve plate 620 and the elastic film 400, and the upper end face and the lower end face of the first annular member 700 are respectively abutted against the second sieve plate 620 and the elastic film 400, so that it is easy to install. In addition, the first annular member 700 can also be fixedly connected or integrally formed with the second sieve plate 620, so that it is easy to reduce the number of parts installed and shorten the process. In addition, an inner concave boss can be set at one end of the needle body 100 so that one end of the needle body 100 can be inserted into the shell 300. The inner concave boss is arranged opposite to the first annular member 700, and the two respectively press the two side surfaces of the elastic film 400, thereby fixing the elastic film 400 therebetween.

[0037] In addition, the present invention also discloses a method for preparing a microchannel liquid-releasing acupuncture needle, comprising the following steps:

[0038] S1. For the integrated structure in which the needle tip and the needle body are fixedly connected, a microchannel and a pinhole are processed in the needle body by femtosecond laser engraving technology, and then the inner wall of the microchannel is processed by chemical etching or a PTFE film or a Parylene film is coated by chemical vapor deposition, so as to optimize the smoothness of the inner wall and ensure smoothness and anti-clogging performance; in this step, the parameters of femtosecond laser engraving can be determined as needed, such as a wavelength of 1030nm and a pulse frequency of 100kHz;

[0039] S2, integrating the needle body and the shell by laser welding, and integrating the elastic film and the hydrophobic breathable membrane;

[0040] S3, placing the acupuncture needle in a sealed chamber storing liquid medicine, with the needle hole immersed in the liquid medicine and the hydrophobic breathable membrane located outside the liquid medicine, evacuating the sealed chamber so that the gas in the shell flows outward and the elastic film expands, thereby assisting the liquid medicine to enter the liquid storage chamber through the microchannel, then, inverting the acupuncture needle with the needle tip facing upward, pressurizing the sealed chamber so that the gas flows into the shell and the elastic film contracts, thereby discharging the gas in the microchannel (when the continuous liquid discharge at the needle hole is greater than the volume of the micro-through hole, it can be considered that the gas has been completely discharged), then immersing the needle hole in the liquid medicine, with the hydrophobic breathable membrane located outside the liquid medicine, evacuating the sealed chamber so that the elastic film expands, thereby assisting the liquid medicine to fill the microchannel;

[0041] S4. Point the tip of the acupuncture needle upwards and let it stand to allow the medicinal solution to separate from the outer wall of the acupuncture needle. Then, use a micro-spraying device in a vacuum environment to evenly coat the needle tip with a biocompatible degradable material (such as polylactic acid PLA or gelatin).

[0042] Although the embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A microchannel liquid release acupuncture needle, characterized in that: include: A tubular needle body, wherein the needle body is provided with a microchannel axially penetrating the body; A needle tip fixedly connected to one end of the needle body and blocking the microchannel, used for piercing the skin; A shell body fixedly connected to the other end of the needle body, wherein the shell body is provided with an opening; An elastic film located in the shell is used to separate the microchannel from the opening; the elastic film includes two states: a contracted state in which the elastic film is contracted to a state in which one end face is closely attached to the end face of the needle body, and an expanded state in which the elastic film is expanded to a state in which the other end face is closely attached to the inner wall of the shell; A hydrophobic breathable membrane for blocking the opening; Wherein, a needle hole communicating with the microchannel is provided on the side wall of one end of the needle body connected to the needle tip, and a biocompatible degradable material is provided at the needle hole for temporarily blocking the needle hole.

2. A microchannel liquid release acupuncture needle according to claim 1, characterized in that: The inner wall of the microchannel or the inner wall of the pinhole is provided with a PTFE film or a Parylene film.

3. A microchannel liquid release acupuncture needle according to claim 2, characterized in that: The biocompatible degradable material is soluble polylactic acid) or gelatin.

4. A microchannel liquid release acupuncture needle according to claim 2, characterized in that: The two sides of the hydrophobic breathable membrane are respectively in contact with a hard sieve plate, and the sieve plate is provided with sieve holes.

5. A method for manufacturing a microchannel liquid-releasing acupuncture needle, used for preparing the microchannel liquid-releasing acupuncture needle according to any one of claims 1 to 4, characterized in that: The steps include: S1. For the integrated structure in which the needle tip and the needle body are fixedly connected, a microchannel and a pinhole are processed in the needle body by using femtosecond laser engraving technology, and then the inner wall of the microchannel is processed to optimize the inner wall smoothness; S2, integrating the needle body and the shell by laser welding; S3, placing the acupuncture needle in a sealed chamber storing liquid medicine, with the needle hole immersed in the liquid medicine and the hydrophobic breathable membrane located outside the liquid medicine, evacuating the sealed chamber so that the gas in the shell flows outward and the elastic film expands, thereby assisting the liquid medicine to enter the liquid storage chamber through the microchannel, then inverting the acupuncture needle with the needle tip facing upward, pressurizing the sealed chamber so that the gas flows into the shell and the elastic film contracts, thereby discharging the gas in the microchannel, then immersing the needle hole in the liquid medicine and the hydrophobic breathable membrane located outside the liquid medicine, evacuating the sealed chamber so that the elastic film expands, thereby assisting the liquid medicine to fill the microchannel; S4. Point the tip of the acupuncture needle upwards and let it stand to allow the medicinal liquid to separate from the outer wall of the acupuncture needle. Then, use a micro-spraying device in a vacuum environment to evenly coat the biocompatible degradable material on the needle tip outlet.

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