Membrane protection acupuncture needle instrument

Abstract

A film protection acupuncture needle instrument is composed of film protection acupuncture needles (1), a needle box body (2), a support (3), a needle clamp (4) and a sealing bag (5), and is characterized in that a needle tip covering film (6) is arranged at the end, close to a needle tip (16), of the needle box body (2); a membrane protection acupuncture needle is a tool used for conducting puncture stimulation on specific parts of a human body according to the theory of traditional Chinese medicine and comprises but not limited to a common acupuncture needle, a three-edged needle and a needle knife. The invention discloses a film protection acupuncture needle which is an acupuncture needle for blocking pollution by adopting a protective film technology. The membrane protection acupuncture needle has the advantages that air floating objects can be prevented from polluting the exposed needle tip (16), the anti-pollution performance of the membrane protection acupuncture needle is remarkably improved, and sterile treatment safety of a patient adopting the membrane protection acupuncture needle is guaranteed.

Description

[0001] This application is a divisional application of the original invention entitled "Packaging Technology for Membrane Protected Acupuncture Needles". The original application was filed on June 21, 2022, and the application number is 202210703839.6. Technical Field

[0002] This invention relates to a membrane-protected acupuncture needle. Background Technology

[0003] Acupuncture, a medical practice with a history of over 3,000 years, is a treasure of traditional Chinese medicine and has been widely disseminated in more than 140 countries and regions around the world. Acupuncture is effective for 307 diseases and has shown significant effects in more than 100 of them.

[0004] Infection is a major challenge in the acupuncture industry, a technical problem that has remained largely unsolved since ancient times. Acupuncture treatments involve skin damage, and any deficiency in aseptic technique can allow pathogens to enter the body through the wound, causing infections of varying degrees. The ancient text *Zhenjiu Jiayi Jing* records cases of death due to acupuncture infection. Research indicates that HIV and hepatitis viruses can be transmitted through acupuncture.

[0005] Humanity has made numerous efforts to combat acupuncture infections. Needle sterilization methods have evolved from cauterization, dry heat, moist heat, chemical disinfectants, and isotope irradiation to industrial-scale sealed sterilization for single use, largely resolving the issue of needle aseptic safety. However, at the level of aseptic technique, the conflict between traditional methods and aseptic techniques remains fundamentally unresolved. The inventors, together with researchers from the Qingdao Municipal Center for Disease Control and Prevention, randomly sampled 3,575 acupuncture needles used by doctors and found that 22% of the needles were contaminated. Non-pathogenic bacteria, pathogenic bacteria, and hepatitis B antigen contamination accounted for 20.3%, 1.3%, and 0.3%, respectively. A random sample of 90 acupuncturists' hands was also examined, and 100% of them carried bacteria or viruses. Non-pathogenic bacteria, pathogenic bacteria, and hepatitis B antigen accounted for 88.9%, 7.8%, and 3.3%, respectively. Research on the disinfection effect of ethanol disinfectant showed that 75% ethanol had very limited disinfection effect, with a bacterial inactivation rate of only 47.5% and a hepatitis B virus inactivation rate of 42.5%. The conclusion is that cross-contamination is a serious problem in the acupuncture industry, with the key reason being contamination of the needles by doctors' hands.

[0006] In the past two decades, the emergence of membrane-protected acupuncture needles has brought a prospect of fundamentally solving the problem of doctors' hands contaminating the needles. The following is an analysis and comparison of various solutions to date.

[0007] Solutions to the problem of hand contamination of needles in the acupuncture industry

[0008] The disposable sterile acupuncture needle described in patent application number 200410104090.5 is characterized by: a pouch-shaped protective film 3 or a tubular protective film 4 made of medical rubber or other soft material suitable for use as disposable sterile medical product packaging material, covering an ordinary acupuncture needle. The diameter of the pouch-shaped or tubular protective film is wider than the diameter of the needle body, and it is soft and foldable. The pouch-shaped protective film 3 is closed near the needle tip, and the other end is fixed to the needle body 1 or needle handle 2 near the needle handle end 2. The tubular protective film is open near the needle tip, and the other end is fixed to the needle body 1 or needle handle 2 near the needle handle end 2. The needle and its pouch-shaped or tubular protective film 3 or tubular protective film 4 are sterilized and can be directly used for acupuncture treatment. The thickness of the protective films 3 and 4 is less than 0.2 mm. It is wrapped in an outer packaging made of material that meets the requirements for disposable sterile medical product packaging materials.

[0009] The disposable film-coated acupuncture needles and their packaging technology described in patent application number 201410064777.4 are characterized by: consisting of disposable film-coated acupuncture needles (1), a packaging box (2), and a sealed bag (3); the packaging box (2) consists of a box body (4), a needle holder plate (5) with a needle insert device, and a bracket (6); the box body (4) is provided with grooves (7) or buckles (8) or insert shafts (17) and a bracket connecting device (9); the box body (4) and the needle holder plate (5) are connected by grooves (7) or buckles (8). The components are interlocked together, or interlocked together by means of an interlocking shaft (17) and an interlocking hole (18) on the needle holder (5); the bracket (6) is provided with a box connecting device (14); the bracket connecting device (9) and the box connecting device (14) are connected to the box (4) and the bracket (6) by means of shaft and hole combination, so that the bracket (6) and the box (4) together form the structure of the packaging box (2) by rotation; the packaging box (2) containing disposable film-coated acupuncture needles (1) is packaged under negative pressure using a sealed bag (3). The sealed bag (3) is made of metal foil, plastic or aluminum-plastic composite film. The needle holder (5) is provided with multiple needle embedding devices (10); the needle embedding devices (10) use clamps (11) or grooves (12) to simply fix the acupuncture needle handle (13). The bracket (6) exposes the acupuncture needle handle (13) by rotation and supports the box (4). The sealed bag (3) has a pre-cut "Y" or "V" shaped opening slit (15) at one end of the seal. The packaging box (2) has a pre-installed pull tab (16) at the end of the opening slit (15).

[0010] The clamping solution method for disposable sterile acupuncture needles described in patent application number 201410857394.2 is characterized by comprising an acupuncture needle (1), a clamp body (2), a clamping device (3), a connecting device (4) on the clamp body, a conveying device (5), a connecting device (6) on the conveying device, a packaging box (7), and a connecting device (8) on the packaging box. The clamp body (2) is made of plastic, rubber, or metal. The clamping device (3) is a component of the clamp body (2); the clamping device (3) uses a clamping or slotting method to fix the acupuncture needle (1). The clamping body (2), the conveying device (5), and the packaging box (7) are all equipped with connecting devices; the connecting device (4) on the clamping body and the connecting device (6) on the conveying device or the connecting device (8) on the packaging box are connected by means of holes, shafts, clips, buckles, pins, etc.; the acupuncture needles are embedded side by side on the clamping body (2) by means of the clips or grooves located on the clamping device (3). If necessary, the connecting devices can be separated from each other. The clamping device (3) adopts the following... Figure 4 The horizontally arranged inserts (9) and grooves (15) are located on a lever arm parallel to the direction of the needle body. The clamping device (3) adopts the end inserts (11) and grooves (15) as shown in the figure. The end inserts (11) are located at one end of the groove, and their protrusions can push the needle handle to the empty space of the groove on the opposite side. First, multiple acupuncture needles (1) are neatly arranged and fixed on the clamping body (2) with the help of the clamping device (3); the clamping body (2) is connected to the conveying device (5) with the help of the connecting device (4) on the clamping body and the connecting device (6) on the conveying device to complete the coating process of the acupuncture needles (1); the clamping body (2) carries the acupuncture needles (1) that have completed the coating process and separates them from the conveying device (5), and then assembles them in the packaging box (7) with the help of the connecting device (4) on the clamping body and the connecting device (8) on the packaging box.

[0011] The disposable film-coated acupuncture needle packaging described in patent number US 10,562,698 B2 includes: a packaging tray with a needle holder having a positioning groove for securely supporting and positioning the acupuncture needles therein; a movable support pivotally connected to one end of the packaging tray; a plurality of acupuncture needles, each comprising an elongated needle body securely housed in a corresponding positioning groove and having a shank extending into the movable support, each acupuncture needle including a retractable film sheath wrapped around the elongated needle body; and a sealing bag that encloses the packaging tray and the movable support with the acupuncture needles; the movable support is rotatable between a horizontal position and a generally vertical position when the sealing bag is removed from the packaging tray, in which the shank of the acupuncture needle is properly protected, and in the generally vertical position, the movable support acts as a leg supporting the packaging tray to expose the shank of the acupuncture needle for easy removal from the packaging tray.

[0012] The acupuncture needles described in this patent refer to tools used for puncturing and cutting specific parts of the human body surface according to traditional Chinese medicine theory, including but not limited to ordinary acupuncture needles, three-edged needles, and needle knives; membrane-protected acupuncture needles refer to acupuncture needles that adopt membrane protection technology, which can effectively prevent the doctor's hands from contaminating the needle body.

[0013] The needle holder (5) described in the patent application number 201410064777.4 and the clamping body (2) described in the patent application number 201410857394.2 both serve to hold acupuncture needles and are collectively referred to as needle clamps (4) in this patent.

[0014] The packaging materials involved in this patent are typically plastics that meet the quality requirements for medical product packaging materials. Metal materials may also be used for the packaging boxes and their supports when necessary.

[0015] The "disposable sterile acupuncture needles" and "disposable membrane-coated acupuncture needles" described in the above patents both fall under the category of "membrane-protected acupuncture needles" in this patent. While membrane-protected acupuncture needle technology to date can effectively prevent acupuncturists from contaminating the needle with their hands, thereby reducing the risk of iatrogenic infection, it still has the following drawbacks.

[0016] First, if a bag-shaped protective film or a tubular protective film covering the needle tip is used, the protective film will prevent the doctor from directly seeing the needle tip entering the acupoint, affecting the accuracy of acupoint selection and treatment.

[0017] Secondly, if the tubular protective film only covers the needle body and exposes the needle tip, when the entire row of film-protected acupuncture needles is taken out of the sealed bag for use, the probability of airborne microorganisms contaminating the exposed part of the needle tip will continue to increase as the exposure time of the needle tip extends. When the needle tip enters the human body, it will increase the risk of iatrogenic infection. Summary of the Invention

[0018] A needle tip covering film (6) is provided near the needle tip in the needle box body (2) to cover the needle tip (16). One side of the needle tip covering film (6) is fixed to the needle tip in the needle box body (2) and the other side is free so that the needle tip (16) can be pulled out from under the needle tip covering film (6). This scheme can prevent airborne particles from contaminating the exposed needle tip (16).

[0019] Compared with the prior art, the present invention has the following beneficial technical effects: One method is to set a needle tip covering film (6) near the needle tip in the needle box body (2) to cover the needle tip (16). One side of the needle tip covering film (6) is fixed to the needle tip in the needle box body (2) and the other side is free so that the needle tip (16) can be pulled out from under the needle tip covering film (6). This method can prevent airborne particles from polluting the exposed needle tip (16).

[0020] Secondly, protrusions (10) parallel to the needle body (12) are provided on both sides of the needle tip (16) on the surface of the needle box body (2). The height of the protrusions (10) is not less than or close to the radius of the needle body. With the support and protection of the protrusions (10), the needle tip can be prevented from being pressed and squeezed by the sealing bag (5) under negative pressure, thus preventing the sharp needle tip from bending and deforming.

[0021] Third, the needle box body (2) and the bracket (3) are injection molded into one piece, and the edge (9) of the needle box body and the edge (13) of the bracket are made shallower or removed. A groove or weak part (14) is set between the injection molded needle box body (2) and the bracket (3). It can be bent from the groove or weak part, or it will break after being bent to a certain extent. The advantage of this solution is that the needle box body (2) and the bracket (3) are injection molded into one piece, which is formed in one step, does not require assembly, saves materials, and reduces costs. However, the bracket (3) still retains the protective function and appropriate support function of the needle handle (8). The bracket (3) is deformed and displaced, which does not hinder the use of the membrane-protected acupuncture needle (1) from the needle handle (8). Attached Figure Description

[0022] The present invention will be further described below with reference to the accompanying drawings.

[0023] Figure 1 This is a schematic diagram of the membrane-protected acupuncture needle described in the patent application number 200410104090.5.

[0024] Figure 2-Figure 5 This is a schematic diagram illustrating the construction of an embodiment of the membrane-protected acupuncture needle packaging technology described in this patent.

[0025] Explanation of reference numerals in the attached drawings: 1. Membrane-protected acupuncture needle; 2. Needle box body; 3. Support; 4. Needle clamp; 5. Sealing bag; 6. Needle tip covering film; 7. Needle tip covering film fixing side; 8. Needle handle; 9. Needle box body perimeter; 10. Boss; 11. Protective film; 12. Needle body; 13. Support perimeter; 14. Groove or weak part; 15. Shaft hole connection; 16. Needle tip; 17. "Y" or "V" shaped opening incision. Detailed Implementation

[0026] exist Figure 2 In the illustrated embodiment, the shaft hole connection between the needle box body (2) and the bracket (3) is shown. On both sides of the needle tip (16) on the surface of the needle box body (2), there are protrusions (10) parallel to the needle body (12). The height of the protrusions (10) is not less than the radius of the needle body. A needle tip covering film (6) is provided at the end of the needle box body (2) near the needle tip (16) to cover the needle tip (16). One side of the needle tip covering film (6) is fixed to the needle box body (2) near the needle tip, and the other side is free so that the needle tip (16) can be pulled out from under the needle tip covering film (6).

[0027] exist Figure 3In the illustrated embodiment, the needle box body (2) and the bracket (3) are injection molded as one piece; the needle box body (2) has protrusions (10) parallel to the needle body (12) on both sides near the needle tip (16), and the height of the protrusions (10) is not less than or close to the needle body radius; a rectangular plastic needle tip covering film (6) is provided near the needle tip of the needle box body (2), with the fixed side (7) of the needle tip covering film located near the needle tip of the needle box body (2), and the other side being free.

[0028] exist Figure 4 In the illustrated embodiment, the needle box body (2) and the support (3) are injection molded as one piece. The needle box body perimeter (9) and the support perimeter (13) are removed. A groove or weak part (14) is provided between the injection molded needle box body (2) and the support (3). It can be bent from the groove or weak part, or it can break after being bent to a certain extent. The support (3) has the function of protecting and supporting the needle handle (8). The support (3) is deformed and displaced, which does not prevent the use of the membrane-protected acupuncture needle (1) from the needle handle (8).

[0029] exist Figure 5 In the illustrated embodiment, the needle box body (2) containing the membrane-protected acupuncture needle and the bracket (3) are sealed in a sealed bag (5) under negative pressure. The sealed bag (5) is provided with a "Y" or "V" shaped opening (17).

[0030] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A membrane-protected acupuncture needle, comprising a membrane-protected acupuncture needle (1), a needle box body (2), a support (3), a needle clamp (4), and a sealed bag (5), characterized in that: in A needle tip covering film (6) is provided at the end of the needle box body (2) near the needle tip (16) to cover the needle tip (16). One side of the needle tip covering film (6) is fixed to the end of the needle box body (2) near the needle tip (16), and the other side is free.

2. The membrane-protected acupuncture needles according to claim 1 refer to tools used to puncture or cut specific parts of the human body surface for stimulation based on traditional Chinese medicine theory, including but not limited to ordinary acupuncture needles, three-edged needles, and needle knives.

3. The membrane-protected acupuncture needles according to claim 1 refer to acupuncture needles that employ membrane protection technology.

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