CN211094516U - Novel anal fistula tightening device - Google Patents
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Abstract
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Translated fromChinese技术领域technical field
本实用新型涉及紧线装置，具体涉及一种新型肛瘘紧线装置。The utility model relates to a thread tightening device, in particular to a novel anal fistula thread tightening device.
背景技术Background technique
高位复杂性肛瘘是结直肠外科难治性疾病之一，在我国，肛瘘的发病率占肛肠病发病人数的1.7-3.6%，而国外发病率为8.6/10万人，其中高位复杂性肛瘘患者约占全部肛瘘的10%。目前手术是治疗高位复杂性肛瘘的主要手段，但术后复发率仍较高。因此，高位复杂性肛瘘的治疗是困扰肛肠科医师的棘手难题，根据临床实践，考虑高位复杂性肛瘘的治疗困难在于，保护肛门功能与降低复发率始终是一对相互制约的矛盾。虽然目前临床上各种保留括约肌术式，如AFP填塞术、纤维蛋白封堵术及视频辅助下保留括约肌微创治疗术式（VAAFT）等已在肛瘘的治疗中开始广泛应用，但治疗效果仍不够理想，目前高位复杂性肛瘘仍以传统切开挂线术为主要治疗手段，但仍存在着挂线线材太过落后，紧线步骤太过繁琐，紧线时、紧线后患者疼痛较重，因此良好的肛瘘挂线、紧线方案的建立，爱伤、无痛观念是目前肛瘘的研究热点之一。High complex anal fistula is one of the refractory diseases in colorectal surgery. In my country, the incidence of anal fistula accounts for 1.7-3.6% of the incidence of anorectal disease, while the incidence abroad is 8.6/100,000 people. Among them, patients with high complex anal fistula It accounts for about 10% of all anal fistulas. At present, surgery is the main method for the treatment of high and complex anal fistulas, but the recurrence rate after surgery is still high. Therefore, the treatment of high complex anal fistula is a thorny problem for anorectal physicians. According to clinical practice, the difficulty of considering the treatment of high complex anal fistula is that protecting anal function and reducing recurrence rate are always a pair of contradictory constraints. Although various sphincter-preserving procedures, such as AFP tamponade, fibrin occlusion, and video-assisted sphincter-preserving minimally invasive therapy (VAAFT), have been widely used in the treatment of anal fistulas, the therapeutic effect is still It is not ideal. At present, traditional incision and threading is still the main treatment method for high-level complex anal fistulas. However, there are still problems that the threading and threading are too backward, and the tightening steps are too cumbersome. Therefore, the establishment of a good solution for anal fistula hanging and tightening, and the concept of loving injury and painless is one of the current research hotspots of anal fistula.
近年来，挂线疗法虽然在一定程度上有所改良，但是仍不能满足临床操作需求，如环形切割造成的肛门锁眼样畸形，术后紧线给患者带来的巨大痛苦及引流不充分等。陈玉根等研究设计定线挂线法，通过在肌肉内下方置入韧质皮垫改变所需切割组织的受力方向，将四周向中心切割的作用力变为由上向下的定向切割。但就临床实际操作而言，在肌肉远端垫入皮垫，排便后易造成粪便残留于皮垫处，清洁较为繁琐，长期炎性刺激，可造成假性愈合；且紧线后皮垫易嵌入切割肌肉内，易造成括约肌痉挛，患者出现持续疼痛不适。橡皮筋是目前最常使用挂线最常用的材料，许多人选用不同来源的橡皮筋进行挂线治疗，如普通橡胶圈或是外科手套橡胶圈，但是由于使用材料差异巨大、无法进行标准化，因此报道的结果可比性较差。In recent years, although the thread hanging therapy has been improved to a certain extent, it still cannot meet the needs of clinical operations, such as the anal buttonhole deformity caused by circular cutting, the great pain and insufficient drainage caused by the tight thread after surgery, etc. . Chen Yugen et al. studied and designed the method of setting the line and hanging the line. By inserting a ligament pad under the muscle to change the force direction of the tissue to be cut, the force of cutting from the surrounding to the center is changed to a directional cutting from top to bottom. However, as far as clinical practice is concerned, inserting the leather pad at the distal end of the muscle will easily cause feces to remain on the leather pad after defecation, which is cumbersome to clean, and can cause pseudo-healing due to long-term inflammatory stimulation. Embedded in the cutting muscle, it is easy to cause sphincter spasm, and the patient will experience persistent pain and discomfort. Rubber bands are the most commonly used material for thread hanging at present. Many people choose rubber bands from different sources for thread hanging treatment, such as ordinary rubber rings or surgical gloves rubber rings. The reported results were poorly comparable.
目前挂线疗法存在的问题：The current problems of hanging thread therapy:
1、挂线材质的选择不够规范：目前临床应用的挂线的材料主要为丝线和橡皮筋，或是药液与丝线的结合，近年来未见明显发展，药线的应用虽然在一定程度上减轻了挂线给患者带来的痛苦，但是就肛瘘患者本身的痛苦来说这些是微不足道的，且药线使用的药物多为有毒药物，其使用规范限制了祛腐药的使用。就目前普遍使用的橡皮筋和橡胶手套而言，其强度、抗氧化较差，创面挂线部位处于潮湿环境，时间稍长则易导致橡皮筋氧化，在紧线过程中因老化断裂，此外，橡皮筋无止痛作用。放眼当代材料学专家对挂线材料的研究少之又少，多种复合材料的研制目前仍是空白。1. The choice of thread hanging material is not standardized enough: At present, the main thread hanging materials used in clinical applications are silk thread and rubber band, or the combination of liquid medicine and silk thread. In recent years, there has been no obvious development. The pain caused by hanging the thread is alleviated, but these are insignificant in terms of the pain of anal fistula patients themselves, and most of the drugs used in the drug thread are toxic drugs, and their use specifications limit the use of anticorruption drugs. As far as the currently commonly used rubber bands and rubber gloves are concerned, their strength and anti-oxidation are poor, and the wound thread hanging site is in a humid environment. If the time is a little longer, the rubber band will be easily oxidized, and it will break due to aging during the thread tightening process. In addition, Rubber bands have no pain relief. Looking at contemporary materials experts, there are very few researches on thread-hanging materials, and the development of various composite materials is still blank.
2、肛门精细功能得不到保护：尽管切割挂线疗法理论上可以避免肛门功能受损、大便失禁的风险，但是部分患者仍有不同程度的肛门功能损害。Christeasen等研究发现，挂线疗法虽然在治疗高位经括约肌肛瘘，提高治愈率和降低复发率方面较为令人满意，但对患者肛门括约肌功能的远期评估并不乐观，有62%的患者出现不同程度的肛门自制功能下降。因此国外使用引流挂线即虚挂线来减少对肛门的损伤，仅使用了传统切割挂线的引流原理，不切断肛门括约肌，最大限度的保护了肛门的功能，但从长期随访结果来看，其治疗效果并不理想，且复发率较高。有文献报道采用虚挂线治疗高位肛瘘的治愈率仅在20-40%之间，尽管同时使用生物蛋白胶等其他方法，治愈率也没有明显上升。2. The fine functions of the anus are not protected: Although the cutting and hanging thread therapy can theoretically avoid the risk of anal function damage and fecal incontinence, some patients still have varying degrees of anal function damage. The study by Christeasen et al found that although thread-hanging therapy is satisfactory in the treatment of high transsphincteric anal fistula, improving the cure rate and reducing the recurrence rate, the long-term evaluation of patients' anal sphincter function is not optimistic, and 62% of patients have different symptoms. The degree of anal homemade function decreased. Therefore, foreign countries use drainage and hanging lines, that is, virtual hanging lines, to reduce the damage to the anus. Only the drainage principle of traditional cutting and hanging lines is used, and the anal sphincter is not cut off, which protects the function of the anus to the greatest extent. However, from the long-term follow-up results, Its treatment effect is not ideal, and the recurrence rate is high. It has been reported in the literature that the cure rate of treating high anal fistula with virtual hanging thread is only between 20-40%, although other methods such as biological protein glue are used at the same time, the cure rate has not increased significantly.
3、术后疼痛较为显著：术后紧线过程太过繁琐，紧线时、紧线后，由于橡皮筋对组织的切割作用，其产生的疼痛较重，是常人无法想象的。尤其是换药和紧线时，患者往往畏惧换药，对现代医疗水平产生疑问。3. Post-operative pain is more significant: the post-operative thread tightening process is too cumbersome. During and after the thread is tightened, due to the cutting effect of the rubber band on the tissue, the pain is heavier than ordinary people can imagine. Especially when changing dressings and tightening lines, patients are often afraid of dressing changes and question the level of modern medical care.
4、紧线的操作标准难以规范：虽然挂线疗法在治疗高位肛瘘具有明显的优势，但遗憾的是，目前尚没有统一的、可操作性强的挂线方案，在实际手术操作中紧线时间和紧线松紧度多为各专家临床经验总结，虽然对于临床有指导意义，但尚缺乏循证医学的基础和精细的解剖和病理学支持，且无长期的临床疗效观察。4. It is difficult to standardize the operation standard of thread tightening: although thread thread therapy has obvious advantages in the treatment of high anal fistula, unfortunately, there is no unified and operable thread thread suspension program at present. Time and tightness are mostly summed up from the clinical experience of various experts. Although they have guiding significance for clinical practice, they still lack the basis of evidence-based medicine and detailed anatomical and pathological support, and there is no long-term clinical efficacy observation.
实用新型内容Utility model content
实用新型目的：本实用新型目的在于针对现有技术的不足，提供一种新型肛瘘紧线装置，能够在紧线过程中达到止痛作用。Purpose of the utility model: The purpose of this utility model is to aim at the deficiencies of the prior art, and to provide a novel anal fistula tightening device, which can achieve analgesic effect during the tightening process.
技术方案：本实用新型提供一种新型肛瘘紧线装置，所述紧线装置包括弹性生物线和锁紧件，所述锁紧件用于将生物线的两端收缩扎紧；所述生物线设置为空心，且所述生物线的表面分布有若干针孔样漏口，所述针孔样漏口与生物线的空心部分相通，且所述若干针孔样漏口不分布在生物线的同一面。Technical scheme: The utility model provides a novel anal fistula tightening device, the tightening device includes an elastic biological thread and a locking piece, and the locking piece is used for shrinking and tying both ends of the biological thread; the biological thread It is set to be hollow, and a number of pinhole-like leaks are distributed on the surface of the biological thread. same side.
优选地，所述生物线由食品级硅胶制成。Preferably, the biological thread is made of food-grade silica gel.
优选地，所述生物线为中间细、两端粗的竹节样式结构。Preferably, the biological thread is a bamboo-like structure with a thin middle and thick ends.
优选地，所述锁紧件为硅胶球，所述硅胶球的两侧部均设有自锁孔，所述自锁孔位于硅胶球上端的孔径大于自锁孔位于硅胶球下端的孔径，所述生物线两端部的直径大于自锁孔位于硅胶球上端的孔径。Preferably, the locking member is a silica gel ball, and both sides of the silica gel ball are provided with self-locking holes. The diameter of the two ends of the biological thread is larger than the diameter of the self-locking hole located at the upper end of the silica gel ball.
优选地，所述两个自锁孔为相对布置。Preferably, the two self-locking holes are arranged oppositely.
优选地，所述两个自锁孔的间距为3mm。Preferably, the distance between the two self-locking holes is 3 mm.
优选地，所述硅胶球为椭圆球形。Preferably, the silica gel ball is an elliptical spherical shape.
优选地，所述生物线的两端部均设有多个均匀分布的棘齿。Preferably, both ends of the biological wire are provided with a plurality of evenly distributed ratchet teeth.
与现有技术相比，本实用新型的有益效果为：Compared with the prior art, the beneficial effects of the present utility model are:
（1）本实用新型的肛瘘紧线装置采用空心的弹性生物线，且生物线的表面分布有若干针孔样漏口，紧线前，可在线的一端连接注射器，向空心部分中注射止痛凝胶（如利多卡因凝胶），紧线时，由于线的弹性拉伸，可将止痛凝胶通过线表面的针孔样漏口逐渐渗透（缓慢释放止痛药物）入紧线区域肌肉组织中，达到止痛作用。此外，还可用注射器抽取生理盐水，连接在线的一端，向空心部分中注入生理盐水，生理盐水可通过线表面针孔样漏口流出，达到冲洗肛瘘内口区域的作用。此外，设计所述若干针孔样漏口不分布在生物线的同一面，可确保线在紧线时，增大线的受力面积，不易因为拉伸作用而导致线的断裂。(1) The anal fistula tightening device of the present invention adopts a hollow elastic biological thread, and the surface of the biological thread is distributed with a number of pinhole-like leaks. Glue (such as lidocaine gel), when the thread is tightened, due to the elastic stretching of the thread, the analgesic gel can gradually penetrate (slow release of pain medication) into the muscle tissue of the tight thread area through the pinhole-like leak on the thread surface , to achieve analgesic effect. In addition, a syringe can also be used to extract physiological saline, connect one end of the line, inject physiological saline into the hollow part, and the physiological saline can flow out through the pinhole-like leak on the surface of the line to achieve the effect of flushing the internal opening of the anal fistula. In addition, the several pinhole-like leaks are designed not to be distributed on the same side of the biological thread, which can ensure that when the thread is tightened, the force-bearing area of the thread is increased, and the thread is not easily broken due to stretching.
（2）作为优选方案，所述生物线由食品级硅胶制成，食品级硅胶无毒，有弹性，可伸缩，强度较高，具有抗老化作用，能够延长本实用新型的使用寿命。(2) As a preferred solution, the biological thread is made of food-grade silica gel, which is non-toxic, elastic, stretchable, high in strength, and has anti-aging effects, which can prolong the service life of the utility model.
（3）作为进一步优选方案，所述生物线为中间细、两端粗的竹节样式结构，使切割的力量发生在括约肌的近端，减弱了局部括约肌的受压强度，减少了括约肌的缺损，进一步减轻患者紧线后带来的疼痛；此外，还能够达到缓慢切割的目的，且受力方向主要集中于所需切割组织的近端，避免了四周向中心的切割方式，达到切割和修复的方向一致，使切割和粘连有序进行。(3) As a further preferred solution, the biological thread is a bamboo-like structure with a thin middle and thick ends, so that the cutting force occurs at the proximal end of the sphincter, which weakens the compression strength of the local sphincter and reduces the defect of the sphincter. , to further reduce the pain caused by the patient after tightening the line; in addition, it can also achieve the purpose of slow cutting, and the direction of force is mainly concentrated on the proximal end of the tissue to be cut, avoiding the cutting method from all around to the center, achieving cutting and repairing The direction is consistent, so that the cutting and adhesion are carried out in an orderly manner.
（4）作为更进一步优选方案，所述锁紧件为硅胶球，所述硅胶球的两侧部均设有自锁孔，在紧线时，分别将生物线的两端拉伸后置于硅胶球两侧部的自锁孔，通过自锁孔将生物线的两端收缩扎紧，以达到紧线的目的。紧线时，可以通过弯钳钳夹或用手拿捏硅胶球向前推进来调节此硅胶线的张力，松紧度以患者可以忍受且又能达到缓慢切割为宜，紧线后若患者出现疼痛剧烈，不能忍受，亦可自行调节硅胶线张力，逐步紧线，直至脱落。因此该紧线装置可以有效地根据患者对疼痛的耐受程度，控制紧线切割的力度，间接缓解了患者紧线后带来的疼痛；此外，还摒弃了传统紧线中需用弯钳钳夹，丝线捆扎的繁琐，患者可自行紧线，无需特地到医院进行紧线，方便简单，减少了医疗资源和人力的浪费。(4) As a further preferred solution, the locking member is a silicone ball, and both sides of the silicone ball are provided with self-locking holes. When the thread is tightened, the two ends of the biological thread are stretched and placed on the The self-locking holes on both sides of the silicone ball are used to shrink and fasten both ends of the biological thread through the self-locking holes to achieve the purpose of tightening the thread. When the thread is tightened, the tension of the silicone thread can be adjusted by using curved pliers or holding the silicone ball by hand to push it forward. The tightness should be tolerated by the patient and can be cut slowly. , can not stand it, you can also adjust the tension of the silicone thread by yourself, and gradually tighten the thread until it falls off. Therefore, the wire tightening device can effectively control the cutting force of the tightening wire according to the patient's tolerance to pain, and indirectly relieve the pain caused by the patient after tightening the wire; Clamps and tying of silk threads are cumbersome, and patients can tighten the threads by themselves, without having to go to the hospital to tighten the threads, which is convenient and simple, and reduces the waste of medical resources and manpower.
（5）作为更进一步优选方案，所述生物线的两端部设有均匀分布的棘齿，一方面可使紧线松紧度做到量化，另一方面在生物线置入硅胶球两侧的自锁孔后，可通过棘齿进一步锁住生物线。(5) As a further preferred solution, the two ends of the biological thread are provided with evenly distributed ratchets, on the one hand, the tightness of the tight thread can be quantified; After self-locking the hole, the biological thread can be further locked by the ratchet.
附图说明Description of drawings
图1为本实用新型实施例的结构图。FIG. 1 is a structural diagram of an embodiment of the present invention.
附图中，1-生物线，2-锁紧件，3-自锁孔，4-棘齿。In the drawings, 1-biological wire, 2-locking piece, 3-self-locking hole, 4-ratchet.
具体实施方式Detailed ways
下面通过具体实施例和附图对本实用新型技术方案进行详细说明，但是本实用新型的保护范围不局限于所述实施例。The technical solutions of the present invention will be described in detail below through specific embodiments and accompanying drawings, but the protection scope of the present invention is not limited to the embodiments.
实施例1Example 1
一种新型肛瘘紧线装置，参照图1，包括弹性生物线1和锁紧件2，生物线1由食品级硅胶制成，生物线1为中间细、两端粗的竹节样式结构，生物线1设置为空心，且生物线1的表面分布有多个针孔样漏口，所述针孔样漏口与生物线1的空心部分相通，且所述若干针孔样漏口不分布在生物线的同一面，生物线1的两端部均设有11个均匀分布的棘齿4，相邻棘齿4之间的距离为6mm；锁紧件2用于将生物线的两端收缩扎紧，锁紧件2为椭圆球形硅胶球，所述硅胶球的两侧部均设有自锁孔3。A new type of anal fistula tightening device, referring to Figure 1, includes an elastic
其中，生物线1中间的直径为1.5mm，两端部的直径为2.5mm；所述椭圆球形硅胶球长为10mm，中心直径为6mm，自锁孔3位于硅胶球上端的孔径为2mm，自锁孔3位于硅胶球下端的孔径为1mm，两个自锁孔3的间距为3mm。Wherein, the diameter of the middle of the
本实施例的肛瘘紧线装置采用空心的生物线1，且生物线1的表面分布有若干针孔样漏口，紧线前，可在线的一端连接注射器，向空心部分中注射止痛凝胶（如利多卡因凝胶），紧线时，由于线的弹性拉伸，可将止痛凝胶通过线表面的针孔样漏口逐渐渗透（缓慢释放止痛药物）入紧线区域肌肉组织中，达到止痛作用。此外，还可用注射器抽取生理盐水，连接在线的一端，向空心部分中注入生理盐水，生理盐水可通过线表面针孔样漏口流出，达到冲洗肛瘘内口区域的作用。此外，设计所述若干针孔样漏口不分布在生物线1的同一面，可确保线在紧线时，增大线的受力面积，不易因为拉伸作用而导致线的断裂。此外，生物线1由食品级硅胶制成，食品级硅胶无毒，有弹性，可伸缩，强度较高，具有抗老化作用，能够延长本实用新型的使用寿命。此外，生物线1为中间细、两端粗的竹节样式结构，使切割的力量发生在括约肌的近端，减弱了局部括约肌的受压强度，减少了括约肌的缺损，进一步减轻患者紧线后带来的疼痛；此外，还能够达到缓慢切割的目的，且受力方向主要集中于所需切割组织的近端，避免了四周向中心的切割方式，达到切割和修复的方向一致，使切割和粘连有序进行。此外，锁紧件2为硅胶球，所述硅胶球的两侧部均设有自锁孔3，在紧线时，分别将生物线1的两端拉伸后置于硅胶球两侧部的自锁孔3，通过自锁孔3将生物线1的两端收缩扎紧，以达到紧线的目的。紧线时，可以通过弯钳钳夹或用手拿捏所述硅胶球向前推进来调节此硅胶线的张力，松紧度以患者可以忍受且又能达到缓慢切割为宜，紧线后若患者出现疼痛剧烈，不能忍受，亦可自行调节硅胶线张力，逐步紧线，直至脱落。因此本实施例可以有效地根据患者对疼痛的耐受程度，控制紧线切割的力度，间接缓解了患者紧线后带来的疼痛；此外，还摒弃了传统紧线中需用弯钳钳夹，丝线捆扎的繁琐，患者可自行紧线，无需特地到医院进行紧线，方便简单，减少了医疗资源和人力的浪费。此外，生物线1的两端部设有均匀分布的棘齿4，且相邻棘齿4之间的距离为6mm，一方面可使紧线松紧度做到量化，另一方面在生物线1置入硅胶球两侧的自锁孔3后，可通过棘齿4进一步锁住生物线1。The anal fistula thread tightening device of this embodiment adopts a hollow
如上所述，尽管参照特定的优选实施例已经表示和表述了本实用新型，但其不得解释为对本实用新型自身的限制。在不脱离所附权利要求定义的本实用新型的精神和范围前提下，可对其在形式上和细节上作出各种变化。As mentioned above, although the present invention has been shown and described with reference to specific preferred embodiments, this should not be construed as limiting the invention itself. Various changes in form and details may be made therein without departing from the spirit and scope of the present invention as defined by the appended claims.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110368066A (en)* | 2019-08-16 | 2019-10-25 | 南京市中医院 | A kind of novel anal fistula wire tensioning device |
| WO2022147894A1 (en)* | 2021-01-08 | 2022-07-14 | 深圳市中医院 | Adjustable continuous traction line hanging device for high anal fistula |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110368066A (en)* | 2019-08-16 | 2019-10-25 | 南京市中医院 | A kind of novel anal fistula wire tensioning device |
| WO2022147894A1 (en)* | 2021-01-08 | 2022-07-14 | 深圳市中医院 | Adjustable continuous traction line hanging device for high anal fistula |
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