Implantable suture and suture embedding needle

Abstract

The invention discloses an implantable thread and a thread embedding needle. The implantable thread comprises a thread body hanging thread, a connecting thread and an indwelling part. The line body hanging line and the connecting line are both of a thin-line-shaped structure, the remaining part is of any one or a combination of multiple of an ellipsoid structure, a spindle body structure and a barb structure, and the diameter of the remaining part is far larger than the diameter of the line body hanging line and the diameter of the connecting line. The connecting lines and the remaining parts are distributed at intervals, the hanging line is located at the rear end of the line body, and the whole line body is in a bead string shape. The catgut embedding needle can be used for traditional Chinese medicine acupoint catgut embedding, displacement of the catgut embedding needle can be prevented, the step of repeatedly filling wires is reduced, meanwhile, the infection risk caused by frequent operation is reduced, and safe and efficient catgut embedding is achieved; the absorbable line is adopted as the wire rod, so that multi-point tissue anchoring can be formed after the line body is implanted, the wire rod is prevented from retreating along with the needle body during needle retreating operation, and the wire rod is fixed; the line body and the indwelling part adopt a differential degradation strategy, so that the comfort of the patient is improved; and in combination with a slow release technology, the effective retention time of the body in the body is prolonged, the catgut embedding frequency is reduced, and the clinical application effect of the acupuncture catgut embedding technology and the patient experience are remarkably improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to an implantable suture and a suture embedding needle. Background Art

[0002] Acupuncture catgut embedding, also known as acupoint catgut embedding, is a treatment method that combines traditional acupuncture theory with modern medical technology. By implanting absorbable wires (such as catgut, collagen or PDO wires) into specific acupoints, and utilizing the continuous stimulation of the acupoints during the degradation of the wires, the circulation of Qi and blood is regulated, tissue repair is promoted, and the purpose of treating diseases and regulating functions is achieved. Compared with traditional acupuncture, acupoint catgut embedding has the advantages of long-lasting stimulation, simple operation, and low trauma, and the effect can last for weeks to months. This method is widely used in traditional Chinese medicine acupuncture treatment, cosmetic shaping (such as face lifting and face slimming), weight loss, and conditioning of chronic diseases (such as arthritis and gastrointestinal dysfunction). It combines traditional therapeutic effects with the convenience and durability of modern technology.

[0003] According to the national standard GB / T 21709.10-2008, acupuncture thread embedding methods include cannula needle embedding, thread embedding needle embedding, and medical suture needle embedding. With technological advancements, two improved techniques are currently used clinically: the injection thread method and the folded and rotated thread embedding method. The injection thread method requires placing the thread at the front end of the acupuncture thread embedding needle tube, then injecting the thread into the target tissue using the needle core. The folded and rotated thread embedding method, on the other hand, places the thread at the front end of the needle tube, ensuring that the thread length inside and outside the needle tube is essentially the same, eliminating the need for a core. During operation, the thread is folded in half at the needle tip. Once the thread outside the needle hole has entered the skin and a needle sensation is confirmed, the needle is rotated and withdrawn to complete the embedding process.

[0004] Although these technologies have shown certain therapeutic effects in clinical applications, the current catgut embedding needles have the following problems in actual use:

[0005] 1. Reloading the thread body makes the operation cumbersome and inefficient, resulting in an increased risk of infection. The thread needs to be reloaded after each thread embedding operation. This repetitive manual needle pushing or threading operation not only increases the complexity of the operation, but also significantly reduces the treatment efficiency. In addition, during the repeated loading process, the thread is exposed to the air for a long time, greatly increasing the risk of infection. Although the thread embedding needles currently used are claimed to be disposable products, in reality, they are only used for one needle per person, rather than one needle per acupoint. This practice of repeated use of multiple acupoints further reduces the safety of the operation.

[0006] 2. Threads fall out during the implantation process, causing failed implantation or repeated implantation. For some softer threads, the "pushing the needle core and withdrawing the needle tube" action during routine implantation with disposable needles often causes the thread to get stuck, which can easily lead to failed implantation or multiple implantations, increasing the patient's pain.

[0007] 3. Pain caused by displacement of the thread body after thread embedding. Postoperative movement or pressing may also cause thread displacement and cause pain. According to the "Meta-Analysis of Complications Related to Thread Lifting" published in the "Chinese Journal of Plastic Surgery" in 2023, 4 articles (covering 180 patients) reported the incidence of pain after thread embedding. There was no obvious heterogeneity among the studies, and the results showed that the incidence of postoperative pain was 17% (95% CI: 11% to 23%);

[0008] 4. The thread remains in the body for a short time. Multiple thread insertions within a treatment course increase the number of insertions and the financial burden on the patient. Currently, the effective time of the thread after a single thread insertion is approximately 2 weeks. To achieve the desired therapeutic effect, multiple thread insertions are required, usually 3-5 times per course of treatment. This increases the number of surgeries and the financial burden on the patient.

[0009] In view of the shortcomings of the existing technology, a quick, comfortable and long-lasting anti-displacement disposable thread embedding needle is needed. Summary of the Invention

[0010] In view of this, an object of the present invention is to provide an implantable suture and a suture embedding needle, wherein the implantable suture utilizes a retention portion made of an absorbable slow-release material to prevent the suture body from being displaced.

[0011] In order to achieve the above object, the present invention provides the following technical solutions:

[0012] The implantable wire body provided by the present invention includes a suspension wire, a connecting wire and a retention part. The suspension wire and the connecting wire constitute the main body of the wire body. The main body is a thin wire structure. The retention part is arranged at the front end of the body, and the diameter of the retention part is larger than the diameter of the suspension wire and the connecting wire.

[0013] Furthermore, the retention portion is any one or a combination of an ellipsoidal shape, a spindle shape, and a barbed structure, the connecting line and the retention portion are distributed at intervals, the suspension line is located at the rear end of the main body, and the entire line body is in a beaded shape.

[0014] Furthermore, the suspension line, connecting line and retention part are made of absorbable and degradable materials.

[0015] Furthermore, the absorbable and degradable material is selected from at least one of PGA synthetic thread, PGLA synthetic thread, PDO absorbable thread, collagen thread or animal casing protein thread.

[0016] Furthermore, the surface or interior of the retention portion is compounded with a sustained-release material, and the sustained-release material includes at least one of PLA, PGA, PLGA, PCL, PDO, collagen, silk fibroin, hyaluronic acid, chitosan, dextran, fibrin or gelatin.

[0017] Furthermore, the retention portion is loaded with active ingredients through co-spinning, surface coating or internal encapsulation technology.

[0018] Furthermore, an arrowhead structure is provided at the front end of the wire body, and the tip of the arrowhead structure forms a puncture slope.

[0019] The present invention provides a suture embedding needle constructed according to the above-mentioned implantable suture body, comprising a hollow needle tube and a needle handle, wherein the needle handle is arranged at the rear end of the hollow needle tube, and the front end of the hollow needle tube is provided with an oblique blade, and the implantable suture body is pre-placed on the needle tube.

[0020] Furthermore, the implantable suture is arranged inside the needle tube or hung on the needle tube. The external hanging is to fix the suspension line inside the needle tube, and the part where the connecting line and the retention part are alternately distributed is hung on the surface of the needle tube; when the needle tube penetrates the tissue, the implantable suture enters with the needle tube, and when the needle tube withdraws from the tissue, the implantable suture is retained in the tissue under the action of the retention part.

[0021] Furthermore, the thread embedding needle also includes a thread locker pre-placed on the needle tube; the folded section of the implantable thread body is fixed to the side wall of the needle tube through the thread locker; multiple thread embedding needles are combined and placed in a needle box, and the needle box can be stored in a sterilized package.

[0022] The beneficial effects of the present invention are:

[0023] The present invention provides an implantable thread and a thread embedding needle, comprising a thread body suspension thread, a connecting thread, and a retention portion. The thread body suspension thread and the connecting thread are both thin thread-like structures, and the retention portion is any one or a combination of multiple structures selected from the group consisting of an ellipsoidal, spindle-shaped, and barbed structures, and the retention portion has a diameter much larger than that of the thread body suspension thread and the connecting thread. The connecting thread and the retention portion are spaced apart, the suspension thread is located at the rear end of the thread body, and the thread body as a whole is in the shape of a string of beads. The thread embedding needle can be used for thread embedding in traditional Chinese medicine acupuncture points, can prevent the thread embedding needle from shifting, and solves the problems of low operating efficiency, high infection risk, poor fixation, insufficient comfort, and short residence time in the prior art. The present invention provides a thread embedding needle that is quick, safe, comfortable and long-lasting to operate. By designing an integrated needle-thread structure, the steps of repeatedly loading the thread are reduced, while the risk of infection caused by frequent operation is reduced, thereby achieving safe and efficient thread embedding. Absorbable barbed ellipsoid (spindle) thread is used as the thread, so that the thread body can form multi-point tissue anchoring after implantation, avoiding the thread body from being withdrawn along with the needle body during the needle withdrawal operation, thereby achieving wire fixation. At the same time, the thread body and the ellipsoid (spindle) body adopt differentiated degradation strategies, and anti-inflammatory analgesic drugs are added. The preferential degradation of the thread body can effectively relieve traction pain and improve the comfort of the patient. Combined with the sustained-release technology, the effective residence time of the thread body in the body is further extended, the number of thread embedding times is reduced, and the clinical application effect and patient experience of the acupuncture thread embedding technology are significantly improved.

[0024] The thread embedding needle provided by the present invention adopts an integrated needle and thread design. Through the external thread embedding method, part of the thread is pre-folded in the inner cavity of the needle tube and fixed to the outside of the hollow needle tube by a circular thread locker, so that the thread body can move stably and synchronously during the puncture process. A thread body with an arrow-shaped head can also be selected, so that the thread body has the ability to puncture independently and can directly penetrate the tissue without the help of a needle tube. A barb-ellipsoid (spindle) composite structure is adopted, and the barbs are arranged in a spiral to generate radial tension and enhance tissue fixation. At the same time, combined with a streamlined geometric shape (such as an ellipsoid and a spindle), the resistance of the thread body to movement in the tissue is significantly reduced. The thread body is arranged in a beaded shape and adopts a sustained release structure design. Differential degradation is achieved by combining a thin cylindrical segment with a spindle segment and an ellipsoid segment: the cylindrical segment has a thinner diameter, which is used to connect to the tissue and ensure smooth implantation. Its rapid degradation characteristics can reduce the initial foreign body sensation; due to the large volume of the retention part, that is, the spindle segment and the ellipsoid segment are large in volume and have a slow degradation rate, the degradation time is long, and the mechanical stimulation effect can be maintained for a long time, while ensuring the therapeutic effect and significantly improving the patient's comfort. The invention increases the operation efficiency by 65.42% to 219.8%, provides a new solution for TCM acupoint catgut embedding technology, and has important clinical application value.

[0025] Other advantages, objects, and features of the present invention will be described in part in the following description and, in part, will be apparent to those skilled in the art upon examination of the following description or may be learned from practice of the present invention. The objects and other advantages of the present invention may be realized and obtained through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to make the purpose, technical solutions and beneficial effects of the present invention more clear, the present invention provides the following drawings for illustration.

[0027] Figure 1 The ellipsoid line.

[0028] Figure 2 For spindle line.

[0029] Figure 3 Barbed wire.

[0030] Figure 4 It is the ellipsoid barbed line.

[0031] Figure 5 It is a spindle barbed line.

[0032] Figure 6 It is an ellipsoid barbed line with an arrow.

[0033] Figure 7 It is a spindle barbed line with arrowheads.

[0034] Figure 8 It is an external thread embedding method.

[0035] Figure 9 It is the needle and thread integrated arrow method.

[0036] Figure 10 It is an external thread embedding method.

[0037] Figure 11 It is the needle and thread integrated arrow method.

[0038] Figure 12 Schematic diagram of the absorption of disposable thread embedding needles in the body to prevent displacement.

[0039] Figure 13 A comparative experimental diagram of the anti-displacement disposable thread embedding needle and traditional thread embedding methods (injection thread method, folding and rotating thread embedding method).

[0040] Figure 14 This is a schematic diagram of a plurality of anti-displacement disposable thread embedding needles being placed in a needle box.

[0041] In the figure, 1-thread body, 2-hanging thread, 3-connecting thread, 4-retention part, 41-ellipsoid segment, 42-spindle segment, 43-barb; 5-arrow; 6-hollow needle tube, 7-needle handle, 8-thread locker, 9-needle box. DETAILED DESCRIPTION

[0042] The present invention will be further described below with reference to the accompanying drawings and specific embodiments so that those skilled in the art can better understand the present invention and implement it. However, the embodiments are not intended to limit the present invention.

[0043] Example 1

[0044] like Figure 1-Figure 7 The following are schematic diagrams of different shapes of thread bodies of the anti-displacement disposable thread embedding needle. Figure 1 is the ellipsoid line, Figure 2 For the spindle line, Figure 3 For barbed wire, Figure 4 is the ellipsoid barbed line, Figure 5 For spindle barbed wire, Figure 6 It is an ellipsoid barbed line with an arrow. Figure 7 The embodiment provides an implantable wire body with an arrow-shaped spindle barb wire, including a hanging wire, a connecting wire, and a retention part;

[0045] The suspension line and the connecting line constitute the main body of the wire body, and the main body is a thin wire structure. The retention part is arranged at the front end of the main body, and the diameter of the retention part is larger than the diameters of the suspension line and the connecting line; the suspension line is located at the rear end of the wire body, and the suspension line, the connecting line, and the retention part are made of absorbable sustained-release material; the retention part is arranged at the front end of the main body, and the diameter of the retention part is larger than the diameter of the wire body connecting line; the wire body suspension line, the connecting line and the retention part form a gradient degradation structure; and the retention part and the connecting line adopt a differentiated degradation rate design, and the degradation rate of the retention part is 20%-50% slower than that of the connecting line.

[0046] The gradient degradation structure in this embodiment means that when the wire body suspension line and the connecting line are degraded before the retention part; when the wire body suspension line and the connecting line are completely degraded, since there is more slow-release material in the retention part, the slow-release material in the retention part still exists, so the retention part needs to continue to degrade until all the slow-release materials in the retention part are degraded.

[0047] In this embodiment, the retention portions are arranged at intervals along the line connecting the wire bodies;

[0048] The retention portion in this embodiment is any one or a combination of multiple of an ellipsoid segment, a spindle segment, and a barbed structure; the connecting line and the retention portion are spaced apart, and the entire line body is in a beaded shape.

[0049] In this embodiment, the ellipsoid segments or spindle segments are spaced apart on the line connecting the linear bodies, and the diameter of the ellipsoid segments or spindle segments is larger than the diameter of the adjacent cylindrical segments, forming a gradient degradation structure;

[0050] In this embodiment, the length of the ellipsoid segment or spindle segment is 1.2-2 times the length of the cylindrical segment, and the diameter ratio of the ellipsoid segment / spindle segment to the cylindrical segment is 1.5:1-3:1.

[0051] The barb structure in this embodiment is arranged spirally along the surface of the wire body, and the inclined plane of the barb forms an angle of 30°-45° with the axis of the wire body; the barb height is 20%-30% of the wire body diameter, the spacing between adjacent barbs is 1.5-2 times the wire body diameter, and the barbs are inclined toward the wire body implantation direction.

[0052] The sustained-release material in this embodiment comprises at least one of PLA, PGA, PLGA, PCL, PDO, etc., and the material degradation rate of the ellipsoid segment / spindle segment is 20%-50% slower than that of the cylindrical segment.

[0053] The retention portion is loaded with active ingredients through co-spinning, surface coating or internal encapsulation technology. The active ingredients include vitamin B12, nuciferine, gypenosides or L-carnitine, and the weight proportion of the active ingredients is 0.5%-5%.

[0054] The barbed ellipsoid (spindle) of the retention part realizes the expansion of therapeutic functions after thread embedding through drug loading technologies such as co-spinning, surface coating or internal packaging, such as active ingredients such as complex vitamin B12, nuciferine, gypenosides or L-carnitine.

[0055] The front end of the wire in this embodiment may also be provided with an autonomous puncture arrow structure, the length of the arrow being 3-5 times the diameter of the wire, and the tip thereof forming a puncture slope of 42±1°.

[0056] The arrow structure and the wire connecting line in this embodiment adopt an integrated design. The elastic modulus of the arrow part is 300-500MPa, the elastic modulus of the wire connecting line is 50-150MPa, the tip of the arrow forms a puncture slope of 42±1°, and the length of the arrow is 3-5 times the diameter of the wire body.

[0057] The wire has a diameter of 0.3-2 mm and a total length of 25-200 mm. The wire surface is coated with a lubricating coating of hyaluronic acid or chitosan. The diameters of the connecting and hanging wires are 0.3-1.3 mm, and the diameter of the retention portion is 0.45-2 mm. The ratio of the retention portion to the connecting wire diameter is 1.5:1-3:1.

[0058] The retention portion in this embodiment can solve the problem of insufficient anchoring force when the wire enters the tissue, and prevent displacement or withdrawal with the needle tube. In particular, the retention portion adopts a spiral barb structure, and the anti-withdrawal effect is particularly obvious.

[0059] The gradient degradation structure of the ellipsoid / spindle in this embodiment can overcome the problem of short degradation time in the prior art and avoid the problem of insufficient stimulation persistence;

[0060] Therefore, the implantable thread in this embodiment can simultaneously solve the problems of tissue fixation, degradation regulation, and treatment sustainability.

[0061] Example 2

[0062] like Figure 8 and Figure 9 The figure shows an enlarged schematic diagram of the needle head of the anti-displacement disposable thread embedding needle. Figure 8 It is an external thread embedding method. Figure 9 This embodiment uses the needle-thread integrated arrowhead method. The thread embedding needle provided in this embodiment includes a hollow needle tube and a needle handle. The needle handle is arranged at the rear end of the hollow needle tube. The front end of the hollow needle tube is provided with an oblique blade, which is used to puncture the tissue and insert the needle tube. The implantable thread body is pre-placed on the needle tube. The implantable thread body is arranged inside the needle tube or hung on the needle tube. The external hanging method is to fix the hanging thread inside the needle tube, while the connecting thread and the retention part are alternately hung on the surface of the needle tube. When the needle tube penetrates the tissue, the implantable thread body enters with the needle tube. When the needle tube withdraws from the tissue, the implantable thread body is retained in the tissue under the action of the retention part.

[0063] like Figure 10 and Figure 11 The figure shows the structural composition of the anti-displacement disposable thread embedding needle. Figure 10 It is an external thread embedding method. Figure 11 It is a needle-thread integrated arrow method, and the thread embedding needle in this embodiment also includes a thread locker pre-placed on the needle tube;

[0064] The folded section of the implantable suture is fixed to the side wall of the needle tube by a thread locker, which can be set at the opening of the needle tube. The thread locker is a circular structure fixed to the side wall of the needle tube. It keeps the suture body moving synchronously during puncture. When the needle is withdrawn, the thread locker moves up 3-5mm to release the suture body. The inclined direction of the barbs on the surface of the suture body in this embodiment forms an angle of 30°-45° with the axis of the needle body; the direction of the barbs is outward along the needle tube. When the needle tube enters the tissue, the direction of the barbs will not hinder the direction of travel. When the needle tube is withdrawn, the barbs can penetrate the tissue to prevent the implantable suture body from slipping out of the tissue.

[0065] In this embodiment, a hollow needle tube made of medical-grade stainless steel is used, with an oblique blade at the front end and a needle handle connected to the rear end. A folded barbed ellipsoid (spindle) thread is pre-installed in the needle tube and fixed by a thread locker; an arrow-shaped thread head structure can also be directly configured on the cylindrical needle tube.

[0066] The barb units of the wire body described in this embodiment are arranged in a spiral along the circumference of the needle body, and each barb is inclined toward the needle insertion direction. The inclined plane forms an angle of 30°-45° with the axis of the needle body. The barb height is 20%-30% of the wire body diameter, and the spacing between adjacent barbs is 1.5-2 times the wire body diameter, which increases the tissue anchoring force by 3-5 times compared with the barbless wire.

[0067] In this embodiment, the filament is a barbed-ellipsoid (spindle) composite structure, with cylindrical segments connected to ellipsoidal segments (spindle segments) in an intermittent arrangement. Alternatively, the filament head may have an arrowhead-shaped structure, with a length 3-5 times the filament diameter. The filament possesses autonomous puncture capability, allowing it to penetrate tissue directly without the aid of a needle.

[0068] In this embodiment, the length of the wire body is 25mm-200mm, and the diameter of the wire body is in the range of 0.3-2mm.

[0069] In this embodiment, the suture body adopts sustained-release technology and adds certain sustained-release materials, such as PLA, PGA, PLGA, PCL, PDO, collagen, silk fibroin, hyaluronic acid, chitosan, dextran, fibrin, and gelatin. This slows down the degradation of the absorbable suture over a long period of time, allowing it to maintain a certain mechanical stimulation within the system and thereby promote fat metabolism, thereby extending the single treatment cycle and reducing the number of thread embeddings.

[0070] In this embodiment, the barbed ellipsoids (spindles) of the thread body are loaded with drugs through co-spinning, surface coating or internal packaging, such as active ingredients such as complex vitamin B12, nuciferine, gypenosides or L-carnitine, to achieve the expansion of therapeutic functions after thread embedment, including but not limited to promoting fat metabolism, anti-inflammatory analgesia or tissue repair.

[0071] Example 3

[0072] like Figure 12 As shown, Figure 12 This embodiment provides a schematic diagram of a disposable suture embedding needle for preventing displacement and absorption within the body. The needle body is made of medical-grade stainless steel, and the hollow needle tube is equipped with a beveled blade at the front end. The blade angle is 42±1°, and the puncture force is 0.7-0.85N. The needle tube wall thickness is 0.11-0.4mm, with a tolerance of ±0.01mm. This allows for rapid penetration into tissue. The needle handle is designed for easy gripping.

[0073] Barbed ellipsoid (spindle) wire is an absorbable material with a certain strength and biological stability. The proximal end of the wire, about 5-100mm, is pre-placed in the lumen of the needle tube, and the distal end, about 10-150mm, is fixed to the outside of the hollow needle tube by a wire locker. The surface is provided with a spiral barb structure to enhance the tissue anchoring effect and ensure that the wire remains in the body when the needle is withdrawn. Using sustained-release technology and adding a certain amount of sustained-release material, the ellipsoid (spindle) wire achieves a gradient degradation characteristic by controlling the diameter difference between the wire and the ellipsoid (spindle). While maintaining the mechanical strength required for treatment, it reduces the patient's foreign body sensation, perfectly balancing the clinical needs of treatment effect and comfort.

[0074] The thread locker is a circular ring fixed to the opening on the side of the needle tube. Its diameter is slightly larger than the needle tube, and the suture passes through the thread locker. After the needle tube penetrates the tissue, the thread locker separates from the suture and is pushed above the needle body. As the suture needle is withdrawn, the suture body is retained in the tissue, ensuring that the suture body remains fixed during puncture and achieves controllable separation when the needle is withdrawn.

[0075] The working principle of the disposable thread embedding needle provided in this embodiment is as follows:

[0076] Through the coordinated work of the needle body, barbed ellipsoid (spindle) wire, thread locker and protection system, a safe and efficient thread embedding operation can be achieved. First, in the puncture preparation stage, the operator holds the needle handle and removes the protective needle cover. During puncture, the oblique blade at the front end of the needle body penetrates the tissue at an angle of 15-30°, and the thread locker fixes the barbed wire to ensure that the wire body enters the tissue synchronously with the needle body. After reaching the target depth, it begins to retract, and the thread locker is pushed above the needle body and separated from the wire body. The spiral barbs on the surface of the barbed wire form an anchor with the surrounding tissue to ensure that the wire body is stably retained in the tissue when the needle is withdrawn. Or choose a wire with an arrow-shaped head so that the wire body has the ability to puncture independently and can directly penetrate the tissue without the help of a needle tube. The wire body and the ellipsoid (spindle) degrade differently. On the one hand, the preferential degradation of the wire body can effectively relieve the pain caused by pulling; on the other hand, the ellipsoid (spindle) maintains a longer degradation cycle to ensure a continuous mechanical stimulation effect. Through the above design, the present invention realizes efficient and safe catgut embedding operation, and significantly improves the efficiency and effect of catgut embedding treatment.

[0077] like Figure 13 As shown, Figure 13The comparative experimental diagram of the disposable thread embedding needle for preventing displacement and the traditional thread embedding method (injection thread method, folded and rotated thread embedding method) is shown. The thread embedding needle provided in this embodiment complies with the medical device specifications, is used to prevent the implantable thread from shifting in the tissue, and integrates the absorbable barbed thread and the needle body into an integrated structure. This design adopts the method of placing the thread body in advance and cooperates with the thread locker to ensure the stable and synchronous movement of the thread body during the puncture process, completely avoiding the tedious steps of repeated loading of the wire in traditional operations. In terms of infection control, disposable sterile packaging reduces the postoperative infection rate. The spiral barb structure forms a multi-point mechanical anchor in the tissue, which improves the success rate of thread retention. The wire adopts sustained-release technology, which reduces patient discomfort by optimizing the shape of the wire body while ensuring a continuous stimulation effect.

[0078] like Figure 14 As shown, the needle embedding needle uses a medical stainless steel needle tube and is manufactured in strict accordance with the GB 15811-2016 standard. The radius is 0.3-2.5mm, the tube wall thickness is controlled at 0.11-0.4mm, and the tolerance is maintained at a high precision level of ±0.01mm. The needle tip forms a 42±1° bevel blade, which meets the requirements of the ISO 7864:2016 standard, and the puncture force is stable in the optimized range of 0.7-0.85N. The needle body radius is selected according to the treatment site and patient tolerance. The needle handle is injection molded and meets the ISO 10993 biocompatibility requirements. The needle handle is designed to be easy to hold and has anti-slip textures on the surface. The needle and thread are pre-packaged to avoid assembly during surgery. To facilitate skin penetration, a pattern that increases friction is designed on the needle handle; multiple needle embedding needles are placed in a sterilized needle box, which is sealed with medical-grade transparent packaging material.

[0079] The thread is made of absorbable material with a length of 25mm-200mm to meet the depth requirements of different acupuncture points, and the thread diameter ranges from 0.3-2mm. In terms of material selection, it includes PGA synthetic thread, PGLA synthetic thread, PDO absorbable thread, synthetic thread or protein thread (various animal casing threads). The thread adopts sustained-release technology, which can evenly disperse the active substance in the thread, or add a sustained-release agent to the thread to form a film. At the same time, active ingredients such as vitamin B12, nuciferine, gypenosides or L-carnitine are compounded in the thread, and drug sustained release is achieved through co-spinning, surface coating or drug loading technology, thereby expanding the therapeutic function after thread embedding, including but not limited to promoting fat metabolism, anti-inflammatory analgesia or tissue repair.

[0080] The retention portion in this embodiment uses a barb-ellipsoid (spindle) composite wire body, with the barbs arranged in a spiral along the circumference of the needle body. The barbs of the wire body are 30°-45°, the barb height is 20%-30% of the wire body diameter, and the spacing between adjacent barbs is 1.5-2 times the wire body diameter. This increases the tissue anchoring force by 3-5 times compared to the barbless wire, enhancing tissue fixation. At the same time, combined with a streamlined geometric shape (such as an ellipsoid and a spindle), it significantly reduces the resistance to movement of the wire body in the tissue. In terms of structural arrangement, the cylindrical segment and the ellipsoid segment (spindle segment) are spaced apart and combined with sustained-release technology, adding certain sustained-release materials such as PLA, PGA, PLGA, PCL, PDO, collagen, silk fibroin, hyaluronic acid, chitosan, dextran, fibrin and gelatin, that is, slowing down the degradation of the absorbable suture for a certain period of time, so that it maintains a certain mechanical stimulation within the system. The cylindrical segment is used to connect the ellipsoid segment (spindle segment) to ensure that the wire is smoothly embedded in the tissue and degrades rapidly in the initial stage of implantation; while the ellipsoid segment (spindle segment) degrades slowly to maintain long-term mechanical stimulation. This thread embedding method has significant advantages. When pressing the surface of the body where the thread is embedded, the cylindrical segment can bend, effectively reducing the tingling sensation. In addition, the cylindrical segment degrades first, allowing the embedded thread in the body to transform from a traditional linear structure to multiple ellipsoidal or spindle structures, significantly reducing postoperative pain and foreign body sensation. At the same time, these ellipsoids or spindles remain arranged vertically, further extending the mechanical stimulation time, thereby significantly improving the thread embedding effect.

[0081] The needle and thread assembly process utilizes an externally mounted suture embedding technique. The core of this technique involves taking a specific length of absorbable suture, pre-positioning its proximal end within the needle lumen, and securing the distal end to the outside of the hollow needle via a circular thread locker, forming a folded structure. During puncture, the suture enters the tissue synchronously with the needle. Upon reaching the target depth, the thread locker automatically detaches, and the externally mounted barbed suture ensures the suture remains intact.

[0082] Alternatively, an arrow-shaped suture head structure can be selected, with a head length 3-5 times the diameter of the suture body. This provides sufficient rigidity to prevent bending or deviation during puncture, ensuring accurate penetration of the target tissue layer. It can also effectively disperse local stress during puncture and prevent tip breakage. This design gives the suture head itself a puncture function, allowing it to penetrate the skin tissue directly without relying on the guidance of a traditional needle. This simplifies the puncture instrument and achieves true "needle-free" suture embedment. This design allows the suture body implant depth to be precisely controlled within a range of ±0.5mm, significantly improving the accuracy of treatment.

[0083] Specifically, the thread embedding efficiencies of the injection thread method, the folded and rotated thread embedding method, the external thread embedding method of the present invention, and the needle and thread integrated arrow method were compared, and the measured results are shown in the following table.

[0084] Table 1 - Thread embedding efficiency of different thread embedding methods

[0085]

[0086] According to the data in Table 1, the experiment counted each successful insertion of the thread into the pork as one experiment, and this was repeated 15 times to calculate the average value. The results showed that for one successful thread embedment, the injection thread method took 12.76 seconds, the folding and rotating thread embedment method took 8.85 seconds, the external thread embedment method of the present invention took 5.35 seconds, and the needle and thread integrated arrow method took 3.99 seconds. The external thread embedment method was 138.50% more efficient than the traditional injection thread method and 65.42% more efficient than the folding and rotating thread embedment method; the needle and thread integrated arrow method was 219.80% more efficient than the traditional injection thread method and 121.80% more efficient than the folding and rotating thread embedment method.

[0087] The above embodiments are merely preferred embodiments for the purpose of fully illustrating the present invention, and the scope of protection of the present invention is not limited thereto. Equivalent substitutions or modifications made by those skilled in the art based on the present invention are within the scope of protection of the present invention. The scope of protection of the present invention shall be subject to the claims.

Claims

1. An implantable thread, characterized in that: It includes a suspension line, a connecting line and a retention part. The suspension line and the connecting line constitute the main body of the line. The main body is a thin wire structure. The retention part is arranged at the front end of the body, and the diameter of the retention part is larger than the diameter of the suspension line and the connecting line.

2. The implantable thread according to claim 1, wherein: The retention portion is any one of an ellipsoidal shape, a spindle shape, and a barbed structure or a combination of multiple thereof; the connecting line and the retention portion are spaced apart; the suspension line is located at the rear end of the main body; and the entire line body is in a beaded shape.

3. The implantable thread according to claim 1, wherein: The suspension line, the connecting line and the retention part are made of absorbable and degradable materials.

4. The implantable thread according to claim 1, wherein: The absorbable and degradable material is selected from at least one of PGA synthetic thread, PGLA synthetic thread, PDO absorbable thread, collagen thread or animal casing protein thread.

5. The implantable thread according to claim 1, wherein: The surface or interior of the retention part is compounded with a sustained-release material, and the sustained-release material includes at least one of PLA, PGA, PLGA, PCL, PDO, collagen, silk fibroin, hyaluronic acid, chitosan, dextran, fibrin or gelatin.

6. The implantable thread according to claim 1, wherein: The retention part is loaded with active ingredients by means of co-spinning, surface coating or internal encapsulation technology.

7. The implantable thread according to claim 1, wherein: An arrowhead structure is provided at the front end of the wire body, and the tip of the arrowhead structure forms a puncture slope.

8. The suture embedding needle according to any one of claims 1 to 7, comprising a hollow needle tube and a needle handle, wherein the needle handle is disposed at the rear end of the hollow needle tube, and wherein: The front end of the hollow needle tube is provided with an oblique blade, and the implantable thread is pre-placed on the needle tube.

9. The thread embedding needle according to claim 6, wherein: The implantable suture is arranged inside the needle tube or hung on the needle tube. The external hanging is to fix the suspension line inside the needle tube, and the part where the connecting line and the retention part are alternately distributed is hung on the surface of the needle tube; when the needle tube penetrates the tissue, the implantable suture enters with the needle tube, and when the needle tube withdraws from the tissue, the implantable suture is retained in the tissue under the action of the retention part.

10. The thread embedding needle according to claim 6, wherein: The thread embedding needle also includes a thread locker pre-placed on the needle tube; the folded section of the implantable thread body is fixed to the side wall of the needle tube through the thread locker; multiple thread embedding needles are combined and placed in a needle box, and the needle box can be stored in a sterilized package.

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