A type of acupoint implantation thread

Abstract

An acupoint implantation thread includes an inner core and an outer carrier arranged coaxially. The inner core is a solid columnar structure with spiral grooves on its surface. The outer carrier includes a substrate layer and a coating of traditional Chinese medicine extracts wrapped around the inner core. Both the inner core and the substrate layer are integrally formed from medical-grade biodegradable materials. The advantages of this invention are: layered degradation achieves controlled stimulation intensity: the outer PLGA layer degrades rapidly (10-30 days), initially providing enhanced treatment through drug release and rapid degradation physical stimulation; the inner PCL layer degrades slowly (30-60 days), later providing gentle and continuous stimulation through the stepwise degradation of the spiral grooves, adapting to the treatment needs from the acute to the remission phase of the disease.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to an acupoint implantation thread. Background Technology

[0002] Stimulating acupoints with external materials such as acupuncture and thread embedding can regulate the body's physiological state to prevent and treat diseases. Thread embedding therapy involves implanting, injecting, or embedding sutures into corresponding acupoints, using the physical and biochemical stimulation of the sutures to achieve the purpose of disease prevention and treatment. Currently, the types of thread used in clinical applications for acupoint embedding include ordinary catgut and chromium catgut. Ordinary and chromium catgut are absorbable surgical sutures made primarily from the submucosa of sheep or bovine intestines. Ordinary catgut is lighter in color but has a greater tissue reaction. Chromium catgut has a smaller tissue reaction compared to ordinary catgut, but its color is darker due to the presence of chromium. Utility Model Content

[0003] The purpose of this invention is to provide an acupoint implantation line to address the aforementioned deficiencies.

[0004] An acupoint implantation thread includes an inner core and an outer carrier arranged coaxially. The inner core is a solid columnar structure with spiral grooves on its surface. The outer carrier includes a substrate layer and a coating of traditional Chinese medicine extract wrapped around the inner core. Both the inner core and the substrate layer are integrally formed from medical biodegradable materials.

[0005] Preferably, the inner core is made of polycaprolactone (PCL), with a diameter of 0.15-0.3 mm and a degradation period of 30-60 days.

[0006] Preferably, the depth of the spiral groove is 0.05-0.08 mm and the pitch is 0.5-1 mm.

[0007] Preferably, the substrate layer is made of polylactic acid-glycolic acid copolymer (PLGA) with a thickness of 0.075-0.1 mm and a degradation period of 10-30 days.

[0008] Preferably, the herbal extract coating is a tanshinone solution or an astragalus polysaccharide solution.

[0009] Preferably, the thickness of the herbal extract coating is 5-20 μm.

[0010] Preferably, the length of the acupoint implantation line is 10-20mm, and both ends are arc-shaped.

[0011] The advantages of this invention are: layered degradation to achieve stimulation intensity regulation: the outer PLGA layer degrades quickly (10-30 days), and in the early stage, enhanced treatment is achieved through physical stimulation of drug release and rapid degradation; the inner PCL layer degrades slowly (30-60 days), and in the later stage, gentle and continuous stimulation is provided through the step-by-step degradation of the spiral groove, which is suitable for the treatment needs from the acute phase to the remission phase of the disease.

[0012] Combined stimulation enhances efficacy: The outer layer of Chinese herbal extract coating releases Chinese herbal ingredients, which work synergistically with the inner layer of mechanical stimulation to solve the problem of limited effect of single mechanical stimulation.

[0013] Biocompatibility optimization: Both PCL and PLGA are FDA-certified biodegradable medical materials, and the outer coating of traditional Chinese medicine extracts can reduce the inflammatory response in the early stages of degradation (such as the anti-inflammatory effect of tanshinone) and reduce the risk of tissue rejection.

[0014] Strong structural stability: The melt co-extrusion process ensures a tight bond between the inner and outer layers, preventing delamination and detachment; the spiral groove design enhances mechanical stimulation and improves the anchoring effect with the tissue, reducing the risk of displacement. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the structure of this utility model; Figure 2 This is a schematic diagram of the inner core structure; Figure 3 This is a schematic diagram of the substrate layer. Detailed Implementation

[0016] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of the embodiments of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. The components of the embodiments of this utility model described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0017] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0018] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0019] In the description of the embodiments of this utility model, it should be noted that if terms such as "upper," "lower," "inner," or "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the utility model product is in use, they are only for the convenience of describing the utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the utility model. Furthermore, if terms such as "first" or "second" appear in the description of this utility model, they are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0020] In the description of the embodiments of this utility model, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0021] As shown in the attached figure, an acupoint implantation thread includes an inner core 1 and an outer carrier 2 arranged coaxially. The inner core 1 is a solid columnar structure, and the surface of the inner core 1 is provided with a spiral groove 11. The outer carrier 2 includes a substrate layer 21 wrapped around the inner core 1 and a traditional Chinese medicine extract coating 22. The inner core 1 and the substrate layer 21 are both integrally formed from medical biodegradable materials.

[0022] In another technical solution, the inner core 1 is made of polycaprolactone (PCL), with a diameter of 0.15-0.3 mm and a degradation cycle of 30-60 days. The slow degradation of the inner PCL (30-60 days) provides a gentle and continuous stimulation through the stepwise degradation of the spiral grooves, adapting to the treatment needs from the acute phase to the remission phase of the disease.

[0023] In another technical solution, the depth of the spiral groove 11 is 0.05-0.08 mm, and the pitch is 0.5-1 mm. This enhances mechanical stimulation, improves the anchoring effect with tissue, and reduces the risk of displacement.

[0024] In another technical solution, the substrate layer 21 is made of polylactic acid-glycolic acid copolymer (PLGA) with a thickness of 0.075-0.1 mm and a degradation cycle of 10-30 days. The outer PLGA layer degrades rapidly (10-30 days), and in the initial stage, enhanced treatment is achieved through physical stimulation of drug release and rapid degradation.

[0025] In another technical solution, the herbal extract coating 22 is a tanshinone solution or an astragalus polysaccharide solution.

[0026] In another technical solution, the thickness of the herbal extract coating 22 is 5-20 μm. This allows for rapid drug release, achieving initial enhanced stimulation.

[0027] In another technical solution, the length of the acupoint implantation line is 10-20mm, and both ends are arc-shaped to avoid tissue damage during implantation.

[0028] Inner core: PCL granules are fed into the main screw barrel of a twin-screw extruder and melted into a uniform melt by electric heating (temperature set at 120-140℃, PCL melting point is about 60℃, the melting temperature needs to be 50-80℃ higher than the melting point to ensure fluidity) and screw shearing force.

[0029] Outer carrier: PLGA (PLGA, lactic acid: glycolic acid = 7:3) granules are fed into the side screw barrel of the extruder and heated to 160-180℃ (PLGA melting point is about 170℃), and melted into a uniform melt.

[0030] Concentric extrusion and layered molding Two types of melts are transported to the co-extrusion die through pipelines: the die is equipped with concentric double-hole flow channels (the central flow channel is for the inner PCL melt to pass through, and the annular flow channel is for the outer PLGA melt to pass through), and the diameter of the flow channels is matched with the design dimensions of the inner core and the outer carrier, respectively.

[0031] Under the pressure (5-10MPa) inside the mold, the melt is extruded from the die at the same speed (linear velocity 0.5-2m / min). At this time, the inner PCL melt and the outer PLGA melt are chemically bonded at the interface due to molecular diffusion, rather than simply physically bonded.

[0032] Cooling, curing and traction shaping The extruded material is immediately placed in a water-cooling tank (water temperature 20-30℃) and rapidly cooled to room temperature, allowing the inner and outer layers to solidify simultaneously and preventing delamination due to differences in shrinkage rates.

[0033] The cured liner is pulled at a constant speed by a traction machine (speed matched with extrusion speed, error ≤0.5%) to ensure stable diameter (real-time monitoring by an online diameter measuring instrument, automatically adjusting the traction speed when the deviation exceeds ±0.02mm).

[0034] Follow-up processing After the filament is dried (60℃ hot air, 30 minutes) to remove surface moisture, a traditional Chinese medicine extract solution (such as tanshinone aqueous solution, concentration 5%-10%) is sprayed onto the filament surface in 3-5 times through an ultrasonic atomizing nozzle (drying for 1 minute after each spray) to form a coating with a total thickness of 5-20μm. Ensure that the coating evenly covers the surface of the substrate layer. Cut to the designed length (10-20mm) using a cutting machine, and round the ends (to avoid scratching the tissue during implantation). Finally, it is sterilized (γ-ray irradiation, dose 25kGy) and packaged.

[0035] The above-described embodiments are only intended to illustrate the technical solution and features of this utility model, and are intended to enable those skilled in the art to implement them. They should not be used to limit the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model are within the scope of protection of this utility model. Anything not described in detail is prior art.

Claims

1. An acupoint implant line, characterized in that, Comprising The coaxial inner core (1) and outer layer carrier (2), the inner core (1) is a solid columnar structure, the surface of the inner core (1) is provided with spiral groove (11); The outer layer carrier (2) comprises a substrate layer (21) and a traditional Chinese medicine extract coating (22) wrapped outside the inner core (1); The inner core (1) and the substrate layer (21) are integrally formed by a medical degradable material.

2. The acupoint implantation line according to claim 1, characterized in that, The inner core (1) is made of polycaprolactone material, the diameter of the inner core (1) is 0.15-0.3mm, and the degradation period is 30-60 days.

3. The acupoint implantation line according to claim 2, characterized in that, The depth of the spiral groove (11) is 0.05-0.08mm, and the pitch is 0.5-1mm.

4. The acupoint implantation line according to claim 3, characterized in that, The substrate layer (21) is made of polylactic acid-hydroxy acid copolymer material, the thickness is 0.075-0.1mm, and the degradation period is 10-30 days.

5. The acupoint implantation line according to claim 4, characterized in that, The traditional Chinese medicine extract coating (22) is danshengketone solution or huangqipolysaccharide solution.

6. The acupoint implantation line according to claim 5, characterized in that, The thickness of the traditional Chinese medicine extract coating (22) is 5-20μm.

7. The acupoint implantation line according to claim 1, characterized in that, The length of the acupoint implant line is 10-20mm, and the two ends are arc surface structure.

Images