CN102551829B - Magnetic compression anastomotic ball - Google Patents
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Abstract
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Translated fromChinese技术领域 technical field
本发明涉及胃肠吻合和肠肠吻合领域，具体涉及一种应用于胃肠端端吻合、端侧吻合或侧侧吻合以及肠端端吻合、端侧吻合或侧侧吻合的磁力压迫吻合球。The invention relates to the field of gastrointestinal anastomosis and intestinal anastomosis, in particular to a magnetic compression anastomosis ball applied to end-to-end, end-to-side or side-to-side anastomosis of the gastrointestinal tract and end-to-end, end-to-side or side-to-side anastomosis of the intestine.
背景技术 Background technique
胃肠吻合已有100多年的历史，大量不同的材料应用于胃肠吻合，包括丝线、羊肠线，不锈钢缝线，新型的单纤维线和可吸收线。在过去的30年里，吻合器装置受到外科医生们的追捧。然而手法吻合与器械吻合如何选择仍然是很多学派争论的问题。Gastrointestinal anastomosis has a history of more than 100 years, and a large number of different materials have been used in gastrointestinal anastomosis, including silk thread, catgut, stainless steel suture, new monofilament thread and absorbable thread. Stapler devices have become popular among surgeons over the past 30 years. However, how to choose between manual anastomosis and instrumental anastomosis is still a matter of debate among many schools of thought.
随着吻合技术的发展，手术并发症逐渐减少，但吻合口瘘仍然是最令人担心的术后并发症之一。吻合口瘘的发生率(1%—24%)有很大差异， 而低位直肠吻合口瘘（12%—19%）的发生率高于结肠吻合口瘘（11%）。吻合口瘘与较高的局部复发率和较低的长期生存率有相关性。此外，长期的胃肠功能也会受到吻合方式、方法和吻合口瘘等并发症的不利影响。近百余年来，人们对肠吻合技术进行了不懈探索，目的是建立比手工缝合更安全可靠、更方便、对肠功能影响小的吻合技术，新方法、新器械屡有报道，各种吻合技术已被证明可以与标准的手工吻合和吻合器技术相媲美。然而，大多数的替代吻合技术并不成熟。 With the development of anastomotic techniques, surgical complications have gradually decreased, but anastomotic leakage is still one of the most worrying postoperative complications. The incidence of anastomotic leaks (1%–24%) varied widely, with lower rectal leaks (12%–19%) being more common than colonic leaks (11%). Anastomotic leaks are associated with higher rates of local recurrence and lower rates of long-term survival. In addition, long-term gastrointestinal function will also be adversely affected by complications such as anastomosis method, method, and anastomotic leakage. For more than a hundred years, people have made unremitting explorations on the technology of intestinal anastomosis. Technique has been proven to be comparable to standard manual stapling and stapler techniques. However, most of the alternative anastomosis techniques are not mature. `` ``
1.钉式吻合术 1. Staple anastomosis
钉式手术吻合装置是由Hultl,Humer(布达佩斯)在1908年发明的，然而它的应用只是在最近30年中伴随着新的可靠的一次性医疗器械的发明才逐渐发展起来的。但是,钉式吻合比手法缝合导致的吻合口狭窄的几率明显增加，两者比率为8%：2%，而在死亡率、吻合口穿孔，伤口感染方面两者无明显差别。Lim等证实使用钉式吻合行人体胃肠道吻合时存在异物反应。这种反应主要是由于吻合器的材质引起的。除了会导致吻合口狭窄发生率较高之外，排除吻合水平的因素，目前的文献并没有证实钉式吻合比单纯的手法缝合具有更多的优势。钉式吻合在腹腔内吻合中的应用一直存在着争议。Matos数据库（循证医学数据）系统回顾分析了包括1233例病人(622例钉式吻合和611例手法缝合)的9个研究后得出结论：总体吻合口漏13%：13.4%，有临床表现的6.3%：7.1%，影像学表现的7.8%：7.2%，从而表明两种吻合方法并没有显著的差异。因而采用哪种方法往往取决于医生的经验,临床实际情况及所掌握的信息。而另一个系统性的回顾研究也表明,这两种方法(钉式vs手缝法)都是有效的,此时的选择一般根据医生的喜好。与此同时，其他前瞻性随机试验却显示不同的结论。他们认为无论在吻合时间，还是预防并发症方面，两种方法之间没有明显差异。 此外，尽管可以减少手术时间，并且可以使吻合口瘘大大减少，但由于更容易导致吻合口狭窄以及其他瑕疵，因此钉式吻合在结直肠吻合术中并不常规推荐。The staple surgical anastomotic device was invented by Hultl, Humer (Budapest) in 1908, yet its application has only gradually developed in the last 30 years with the invention of new reliable disposable medical devices. However, the probability of anastomotic stenosis caused by staple anastomosis is significantly higher than manual suture, the ratio of the two is 8%: 2%, but there is no significant difference between the two in terms of mortality, anastomotic perforation, and wound infection. Lim et al. confirmed that there is a foreign body reaction when using staple anastomosis for human gastrointestinal anastomosis. This reaction is mainly due to the material of the stapler. In addition to the higher incidence of anastomotic stenosis, the current literature does not prove that staple anastomosis has more advantages than simple manual suture, excluding the factors of anastomosis level. The application of staple anastomosis in intraperitoneal anastomosis has always been controversial. The Matos database (evidence-based medical data) systematically reviewed and analyzed 9 studies including 1233 patients (622 nail anastomosis and 611 manual suture) and concluded that the overall anastomotic leakage was 13%: 13.4%, with clinical manifestations 6.3%: 7.1%, and 7.8%: 7.2% of imaging performance, which shows that there is no significant difference between the two anastomosis methods. Therefore, which method to use often depends on the experience of doctors, the actual clinical situation and the information they have. While another systematic review also showed that both methods (staple vs hand stitch) are effective, the choice at this time is generally based on physician preference. Meanwhile, other prospective randomized trials have shown different conclusions. They believed that there was no significant difference between the two methods in terms of anastomosis time or prevention of complications. In addition, stapled anastomosis is not routinely recommended for colorectal anastomosis due to the increased risk of anastomotic stenosis and other defects, although operative time can be reduced and anastomotic leakage can be greatly reduced.
2.加压吻合术2. Compression anastomosis
从19世纪以来，肠道切除后的吻合方法一直备受关注。人们的目标就是要找到一个好的吻合方法来减少吻合口漏的发生。加压吻合术的原理就是用两个对立环相互卡住肠断端，并使其缺血，坏死，脱落，最后使环随肠内容物排出。尽管它的方法是安全有效的,但在临床中并不被广泛应用。Since the 19th century, the method of anastomosis after intestinal resection has attracted much attention. People's goal is to find a good anastomotic method to reduce the occurrence of anastomotic leak. The principle of pressurized anastomosis is to use two opposite rings to clamp the broken end of the intestine mutually, and make it ischemic, necrotic, and fall off, and finally the ring is discharged with the intestinal content. Although its method is safe and effective, it is not widely used in clinical practice.
(1)加压吻合术在1826年由Denan首次报道，他主要利用Lembert提出的技术原理来达到无缝肠吻合。它是将两端肠腔吻合起来形成压缩环,并使吻合环缺血坏死，脱落，从而使得吻合口愈合。1892年Murphy推出的“肠吻合钮”， 它主要是利用一个双金属环在持续压力作用下使肠断端保持连接状态;并在手术3,4天后使金属环脱落。然而,它的临床疗效非常有限。(1) Compression anastomosis was first reported by Denan in 1826. He mainly used the technical principle proposed by Lembert to achieve seamless intestinal anastomosis. It is to anastomose the two ends of the intestinal lumen to form a compression ring, and cause the anastomotic ring to be necrotic and fall off, so that the anastomosis can heal. In 1892, Murphy launched the "intestinal anastomosis button", which mainly uses a double metal ring to keep the broken end of the intestine connected under continuous pressure; and the metal ring falls off after 3 or 4 days of operation. However, its clinical efficacy is very limited.
(2) AKA-2 1984年,Kanshin等发明了AKA-2装置(Seidel Medipool,德国慕尼黑)。随后在1985年,Hardy等推出了可降解吻合环（BAR），包括许多前瞻性随机对照试验(RCTs)在内的众多出版物都报道说,不论是急诊手术还是择期手术，BAR都是安全有效的。AKA-2和BAR两者都是采用加压吻合的理念和肠吻合钮的特征。然而,与BAR不同的是,AKA-2环并不能够被吸收,而且往往在吻合后4到6天就断裂。另外,它只应用在经肛门吻合的手术中。BAR吻合的局限性包括:①荷包缝合失败;②结肠腔直径估计不准;③黏膜裂开;④吻合失败(肠道很可能被肠外的挤压损伤);⑤过多过大的压力会破坏设备;⑥环降解延迟;⑦降解物排出前可能会引起术后里急后重、大便次数增多的症状;⑧装置大且不好操作;⑨环的内径偏小导致的排便障碍。(2) AKA-2 In 1984, Kanshin and others invented the AKA-2 device (Seidel Medipool, Munich, Germany). Subsequently, in 1985, Hardy et al. introduced the degradable anastomotic ring (BAR). Numerous publications, including many prospective randomized controlled trials (RCTs), have reported that BAR is safe and effective in both emergency and elective surgery. of. Both AKA-2 and BAR are based on the concept of compression anastomosis and the feature of intestinal anastomosis button. However, unlike BAR, the AKA-2 ring is not resorbable and tends to break within 4 to 6 days after anastomosis. In addition, it is only used in transanal anastomosis. The limitations of BAR anastomosis include: ①failure of purse string suture; ②inaccurate estimation of colon lumen diameter; ③mucosa dehiscence; ④anastomosis failure (gut is likely to be damaged by extraintestinal extrusion); Destruction of equipment; ⑥ delay in ring degradation; ⑦ postoperative tenesmus and increased stool frequency may be caused by degradation products before they are discharged; ⑧ large device and difficult to operate; ⑨ defecation obstruction caused by small inner diameter of ring.
(3)镍钛记忆合金(SMA) 多年以后人们又发现了一种新的镍钛记忆合金(SMA)的加压吻合装置。此装置既可作为加压吻合夹(CAC ,Netanya、Israel), 也可作为一个加压吻合环(BAR、NiTi Medical Technologies)。一般在术后一个星期左右,整个装置及坏死的组织开始脱离，并从体内排出。 (3) Nickel-Titanium Memory Alloy (SMA) Many years later, people discovered a new Ni-Ti Memory Alloy (SMA) pressurized anastomosis device. The device can be used either as a compression anastomotic clip (CAC, Netanya, Israel) or as a compression anastomotic ring (BAR, NiTi Medical Technologies). Usually about a week after the operation, the entire device and necrotic tissue begin to detach and be excreted from the body. the
Nitinol CAC 器械（Niti Medical Technologies）已经被FDA批准用于胃肠手术。这种器械由双环构成，在开放和弹性状态（0℃），直径30mm，开放角30度。在体温下，双环回到闭合形态并用持续的力量支持肠管，无论厚度及是否插入组织。这导致陷入的肠壁缺血及压迫吻合的形成。环的内径为8mm，并装有直径5mm切割刀片保持吻合时肠管的通畅。The Nitinol CAC device (Niti Medical Technologies) has been approved by the FDA for gastrointestinal surgery. This instrument consists of a double ring, in the open and elastic state (0°C), with a diameter of 30 mm and an opening angle of 30°. At body temperature, the double loops return to their closed configuration and support the bowel with sustained force, regardless of thickness and tissue insertion. This leads to ischemia of the trapped bowel wall and the formation of an oppressive anastomosis. The inner diameter of the ring is 8mm, and a cutting blade with a diameter of 5mm is installed to keep the intestinal tube unobstructed during the anastomosis.
(4)腔内压迫吻合环（EndoCAR） EndoCAR(镍钛形状记忆合金系列)，应用两个分离的合成环，装配在一个非常像环形吻合器的设备上。抵钉座（内有一个环）固定在肠管近断端，包含另一个环的吻合器经肛插入做直肠吻合。击发时，两个环通过镍钛合金弹簧所施放的预定的持续可控的压力（7.7牛顿或1.65磅）锁紧，同时环形刀切除进入的组织。对于侧侧吻合器械，存在一个同时发生的坏死-修复过程。7-10天后，随着这一过程的结束，器械将分离并自然排出。而且，纵向的金属尖端进一步固定两个肠管断端，以阻止组织由于轴向运动而滑脱。这种当代设备的优势是管腔内没有吻合疤痕的唇状缘，并且不需要尾翼便可安全的取出击发器。(4) Intracavitary compression anastomotic ring (EndoCAR) EndoCAR (nickel-titanium shape memory alloy series), using two separate synthetic rings, assembled on a device that is very similar to a circular stapler. The anvil (with a ring inside) is fixed at the proximal end of the intestine, and a stapler containing another ring is inserted through the anus for rectal anastomosis. When fired, the two rings are locked by a predetermined, continuous and controllable pressure (7.7 Newtons or 1.65 lbs) exerted by a Nitinol spring while the ring knife excises the incoming tissue. With side-to-side anastomotic instruments, there is a simultaneous necrosis-repair process. After 7-10 days, as this process is complete, the device will detach and pass naturally. Furthermore, the longitudinal metal tips further secure the two bowel stumps to prevent tissue slippage due to axial movement. The advantages of this contemporary device are the lack of an anastomotic scar lip in the lumen and the safe removal of the trigger without the need for fins.
两项独立的研究观察了猪模型中的爆破压。Kopelman等在9个动物测量了于0时（吻合成型后立即测量）平均的爆发压为247.7mmHg (100 -300mmHg)。而且Stewart等报告，与传统的双钉合技术相比，压缩吻合后爆破压显著增高。9例中有4例压缩吻合在吻合线上失败，而9例钉合吻合全部在钉合线上失败。（Fishers’检验，P﹤0.01）。吻合后两周测量爆破压显示相等的压力。压缩吻合有能力克服经典的后期阶段的吻合缺陷，吻合环脱落后爆破压也相等。Two independent studies looked at burst pressure in a porcine model. Kopelman et al. measured the average burst pressure at time 0 (immediately after anastomosis) of 9 animals was 247.7mmHg (100-300mmHg). Moreover, Stewart et al. reported that compared with the traditional double-staple technique, the burst pressure after compression anastomosis was significantly higher. Compression anastomosis failed at the staple line in 4 of the 9 cases, while all 9 stapled anastomoses failed at the staple line. (Fisher's test, P﹤0.01). Burst pressure measurements two weeks after anastomosis showed equal pressures. Compression anastomosis has the ability to overcome the classic late-stage anastomosis defect, and the burst pressure is also equal after the anastomotic ring is detached.
Kopelman等观察了吻合指数（距离吻合口近端及远端5cm的平均肠管直径比例，前外侧及后侧观察）2个月时为0.81（0.60-0.92）。Kopelman et al. observed that the anastomosis index (the ratio of the average bowel diameter 5 cm proximal to the distal end of the anastomosis, viewed anterolaterally and posteriorly) was 0.81 (0.60-0.92) at 2 months.
以色列的一项早期临床研究用EndoCAR实行了一组左半结肠吻合。4个患者入组。未发现器械相关并发症及吻合口瘘。基于上述研究，2007.5月在Uppsala(瑞典)和Leuven(比利时)开始了一项研究，以得到连续组40例患者的临床数据。入组患者有需要手术切除的良恶性疾病，并做高位结直肠吻合（距肛缘10-15cm之间）。初步结果显示,第一批10名患者，9名实行了高位骶前切除术，1名实行了左半结肠切除术。无瘘发生。An early clinical study in Israel performed a set of left colonic anastomosis with EndoCAR. 4 patients were enrolled. No device-related complications and anastomotic leakage were found. Based on the above studies, a study was started in Uppsala (Sweden) and Leuven (Belgium) in May 2007 to obtain clinical data of a continuous group of 40 patients. The enrolled patients had benign and malignant diseases that required surgical resection, and high colorectal anastomosis (between 10-15cm from the anal verge) was performed. Preliminary results showed that in the first batch of 10 patients, 9 underwent high presacral resection and 1 underwent left hemicolectomy. No fistula occurred.
这些令人信服的结果显示这种器械能够成为结直肠临床的革命性发明；然而，对于其在低位/超低位直肠吻合中的效果仍有疑虑。在盆底上放置吻合环会导致持续的肛管敏感（急迫感）。These convincing results suggest that this device could be a revolutionary invention in colorectal practice; however, doubts remain about its effectiveness in low/ultra-low rectal anastomosis. Placing an anastomotic ring on the pelvic floor can cause constant anal canal sensitivity (urgency).
(5)磁控吻合技术 在二十世纪八十年代有人发明了用于肠道吻合的磁力环,但这一理念并没有得到更好的推广。最近，美国旧金山加利福尼亚大学外科学系的报道了一项肠磁力吻合的研究 ，此研究对16头猪的肠管进行侧侧吻合，一组（8只）用磁控方式的吻合技术进行肠管侧侧吻合，另一组（8只）用手法和吻合器侧侧吻合肠管，给予表面大约3000磁感应强度。预实验单因素分析结果显示，当磁感应强度在3000/6000～ 6000/6000 磁通量时，可导致肠管吻合处在48小时内坏死和穿孔。实验结果提示，磁控方式的吻合和手法吻合或吻合器在吻合肠管吻合并发症方面无统计学意义。不引起肠管狭窄 ，磁性的肠管吻合有创新性，有广泛的应用前景，既往无相关报道。(5) Magnetic control anastomosis technology In the 1980s, someone invented a magnetic ring for intestinal anastomosis, but this concept has not been better promoted. Recently, the Department of Surgery, University of California, San Francisco reported a study of intestinal magnetic anastomosis. In this study, the intestinal tubes of 16 pigs were anastomosed side-to-side. For anastomosis, the other group (8 rats) anastomosed the intestinal tube side by side with manipulation and staplers, giving the surface a magnetic induction of about 3000. The results of single factor analysis of the pre-experiment showed that when the magnetic induction intensity was 3000/6000～6000/6000 magnetic flux, it could lead to necrosis and perforation of the intestinal anastomosis within 48 hours. The experimental results suggest that there is no statistical significance in the complications of intestinal anastomosis between magnetic control anastomosis and manual anastomosis or stapler. Magnetic bowel anastomosis is innovative and has broad application prospects without causing bowel stenosis, but there has been no related report before.
发明内容 Invention content
本发明要解决的技术问题是提供一种磁力压迫吻合球，确保不会发生由于吻合不全导致的吻合口瘘。The technical problem to be solved by the present invention is to provide a magnetic compression anastomotic ball to ensure that no anastomotic leakage caused by incomplete anastomosis will occur.
为了解决上述技术问题，本发明的技术方案为：In order to solve the problems of the technologies described above, the technical solution of the present invention is:
一种磁力压迫吻合球，包括磁性相互吸合的回转壳体Ⅰ和回转壳体Ⅱ，A magnetic pressure anastomosis ball, including a rotary shell I and a rotary shell II that are magnetically attracted to each other,
回转壳体Ⅰ的素线为一条圆滑曲线，曲线的两端距离轴线一定距离，形成回转壳体Ⅰ的大口端和小口端，素线上靠近大口端的点到轴线距离大于或等于靠近小口端的点到轴线的距离，回转壳体Ⅰ内腔具有一轴向延伸的筒体Ⅰ，筒体Ⅰ内端与回转壳体Ⅰ的小口端结合，外端伸出大口端；The prime line of the rotary shell I is a smooth curve, and the two ends of the curve are at a certain distance from the axis to form the large mouth end and the small mouth end of the rotary shell I. The distance from the point on the prime line close to the large mouth end to the axis is greater than or equal to the point near the small mouth end The distance to the axis, the inner cavity of the rotary shell I has an axially extending cylinder I, the inner end of the cylinder I is combined with the small mouth end of the rotary shell I, and the outer end extends out of the large mouth end;
回转壳体Ⅱ的素线为一条圆滑曲线，曲线的两端距离轴线一定距离，形成回转壳体Ⅱ的大口端和小口端，素线上靠近大口端的点到轴线距离大于或等于靠近小口端的点到轴线的距离，回转壳体Ⅱ内腔具有一轴向延伸的筒体Ⅱ，筒体Ⅱ内端与回转壳体Ⅱ的小口端结合，外端伸出大口端；The prime line of the rotary shell II is a smooth curve, and the two ends of the curve are at a certain distance from the axis to form the large mouth end and the small mouth end of the rotary shell II. The distance from the point on the prime line close to the large mouth end to the axis is greater than or equal to the point near the small mouth end The distance to the axis, the inner cavity of the rotary housing II has an axially extending cylinder II, the inner end of the cylinder II is combined with the small mouth end of the rotary housing II, and the outer end protrudes from the large mouth end;
吻合时，筒体Ⅰ在筒体Ⅱ内轴向滑动，在磁性吸力的作用下，回转壳体Ⅰ的大口端和回转壳体Ⅱ的大口端对合将它们之间的吻合处断端夹紧。During the anastomosis, the cylinder body I slides axially in the cylinder body II, and under the action of magnetic attraction, the large mouth end of the rotary housing I and the large mouth end of the rotary housing II fit together to clamp the broken end of the anastomosis between them .
上述磁力压迫吻合球，所述筒体Ⅰ外端具有径向凸块，凸块的两侧具有轴向间隙；所述筒体Ⅱ的内周面具有轴向延伸的导向槽，在轴向方向上，导向槽中部具有防脱凸起；The above-mentioned anastomosis ball is pressed by the magnetic force, the outer end of the cylinder body I has a radial protrusion, and the two sides of the protrusion have axial gaps; the inner peripheral surface of the cylinder body II has an axially extending guide groove, in the axial direction On the middle part of the guide groove, there is an anti-off protrusion;
吻合时，导向槽接纳凸块引导筒体Ⅰ在筒体Ⅱ内轴向滑动，凸块越过防脱凸起继续轴向运动。When matching, the guide groove receives the protrusion to guide the cylinder body I to slide axially in the cylinder body II, and the protrusion continues to move axially over the anti-loosening protrusion.
上述磁力压迫吻合球，所述筒体Ⅱ外端具有径向凸缘。The above-mentioned magnetic force presses the anastomosis ball, and the outer end of the cylinder body II has a radial flange.
上述磁力压迫吻合球，所述回转壳体Ⅰ小口端部设有连通回转壳体Ⅰ和筒体Ⅰ之间空腔和胃肠腔的透孔；所述回转壳体Ⅱ小口端部设有连通回转壳体Ⅱ和筒体Ⅱ之间空腔和胃肠腔的透孔。The above-mentioned anastomosis ball is pressed by magnetic force, the end of the small mouth of the rotary shell I is provided with a through hole connecting the cavity between the rotary shell I and the cylinder I and the gastrointestinal cavity; the end of the small mouth of the rotary shell II is provided with a connecting hole The cavity between the rotating shell II and the cylinder II and the through hole of the gastrointestinal cavity.
上述磁力压迫吻合球，回转壳体Ⅰ和回转壳体Ⅱ的磁性吸合力通过下述结构实现：所述回转壳体Ⅰ和回转壳体Ⅱ大口端置有一对相互吸合的磁环。The above-mentioned magnetic force presses the anastomotic ball, and the magnetic attraction force of the rotary housing I and the rotary housing II is realized by the following structure: a pair of magnetic rings that attract each other are arranged at the big mouth ends of the rotary housing I and the rotary housing II.
上述磁力压迫吻合球，所述磁环具有2000-3000高斯的磁力。The above-mentioned magnetic force presses the anastomosis ball, and the magnetic ring has a magnetic force of 2000-3000 Gauss.
上述磁力压迫吻合球，所述回转壳体Ⅰ为去顶的半球壳或去顶的半椭球壳；所述回转壳体Ⅱ为去顶的半球壳或去顶的半椭球壳。The magnetic force compresses the anastomosis ball, the revolving shell I is a topped hemispherical shell or a topped semi-ellipsoidal shell; the revolving shell II is a topped hemispherical shell or a topped semi-ellipsoidal shell.
上述磁力压迫吻合球，所述筒体Ⅰ和筒体Ⅱ均为圆筒体，筒体Ⅰ的外径基本等于筒体Ⅱ的内径。The anastomosis ball is pressed by the above-mentioned magnetic force, the cylinder body I and the cylinder body II are both cylindrical, and the outer diameter of the cylinder body I is basically equal to the inner diameter of the cylinder body II.
上述磁力压迫吻合球，所述凸块为3个，相应地，导向槽为3个。The above-mentioned magnetic force presses the anastomosis ball, and there are three protrusions, and correspondingly, three guide grooves.
上述磁力压迫吻合球，所述吻合球由医用聚乙烯塑料制成，磁环厚度为2mm。The above-mentioned anastomosis ball is pressed by magnetic force, and the anastomosis ball is made of medical polyethylene plastic, and the thickness of the magnetic ring is 2mm.
两个吻合胃或肠管的断端游离缘通过荷包缝合分别结扎固定于筒体Ⅰ和筒体Ⅱ的外周面上，在磁性吸力的作用下，回转壳体Ⅰ的大口端和回转壳体Ⅱ的大口端对合将它们之间的吻合处断端平滑无皱襞地夹紧，使两侧的浆膜面相互接合，建立胃肠愈合的必要条件。整个吻合球的表面光滑，不易损伤胃肠粘膜，脱落后在肠内运动时不易损伤肠道，便于排除体外。另外，筒体Ⅰ内腔构成了整个吻合球引流通道，便于肠内容物通过。本发明吻合口愈合后肠粘膜平整，避免由于吻合不全导致的吻合口瘘，无锋线和金属钉带来的各种不良反应，术后胃肠功能好，吻合组织的愈合过程顺利进行。The free edges of the broken ends of the two anastomotic stomach or intestinal tubes are respectively ligated and fixed on the outer peripheral surfaces of cylinder body I and cylinder body II through purse-string suture. The large-mouth end apposition clamps the broken ends of the anastomosis smoothly and without folds, so that the serosa surfaces on both sides are joined to each other, and the necessary conditions for gastrointestinal healing are established. The surface of the whole anastomosis ball is smooth, and it is not easy to damage the gastrointestinal mucosa, and it is not easy to damage the intestinal tract when moving in the intestine after falling off, so that it is easy to be excreted from the body. In addition, the lumen of cylinder body I constitutes the entire drainage channel of the anastomotic ball, which facilitates the passage of intestinal contents. The intestinal mucosa is smooth after the anastomosis is healed, avoiding anastomotic leakage caused by incomplete anastomosis, without various adverse reactions caused by front lines and metal nails, the gastrointestinal function is good after the operation, and the healing process of the anastomotic tissue proceeds smoothly.
附图说明 Description of drawings
下面结合附图对本发明的具体实施方式作进一步详细的说明：Below in conjunction with accompanying drawing, specific embodiment of the present invention is described in further detail:
图1为组件Ⅰ的结构示意图。Figure 1 is a schematic diagram of the structure of module I.
图2为图1中组件Ⅰ的另一视角的结构示意图。FIG. 2 is a structural schematic diagram of another viewing angle of component I in FIG. 1 .
图3为组件Ⅱ的结构示意图。Fig. 3 is a schematic structural diagram of module II.
图4为图3中组件Ⅱ的另一视角的结构示意图。FIG. 4 is a structural schematic view of another viewing angle of component II in FIG. 3 .
图5为图3中组件Ⅱ的另一视角的结构示意图。FIG. 5 is a structural schematic diagram of another viewing angle of component II in FIG. 3 .
图6为图3中组件Ⅱ的另一视角的结构示意图。FIG. 6 is a structural schematic diagram of another viewing angle of component II in FIG. 3 .
图7为组件Ⅱ的剖视结构示意图。FIG. 7 is a schematic cross-sectional structure diagram of the module II.
图中：1对合面Ⅰ,2筒体Ⅰ,3凸块,4透孔,5磁环容置槽,6对合面Ⅱ,7筒体Ⅱ,8凸缘,9导向槽,10防脱凸起,11回转壳体Ⅰ,12回转壳体Ⅱ。In the figure: 1 mating surface Ⅰ, 2 cylinder body Ⅰ, 3 protrusion, 4 through hole, 5 magnetic ring accommodation groove, 6 mating surface Ⅱ, 7 cylinder body Ⅱ, 8 flange, 9 guide groove, 10 anti-corrosion Take off the protrusion, 11 to rotate the housing I, and 12 to rotate the housing II.
具体实施方式Detailed ways
磁力压迫吻合球整体上包括组件Ⅰ和组件Ⅱ，图1～2示出了组件Ⅰ的整体结构，图3～7示出了组件Ⅱ的整体结构，下面对吻合球详细的介绍。The magnetic compression anastomotic ball generally includes component I and component II. Figures 1-2 show the overall structure of component I, and Figures 3-7 show the overall structure of component II. The anastomotic ball will be introduced in detail below.
从图中可以看出，组件Ⅰ包括回转壳体Ⅰ11和筒体Ⅰ2。为了使得吻合球不易损伤胃肠粘膜，脱落后在肠内运动时不易损伤肠道，便于排除体外，就要求回转壳体Ⅰ具有圆滑表面。回转壳体Ⅰ的素线为一条圆滑曲线，曲线的两端距离轴线一定距离，这样，回转壳体Ⅰ就具有两个开口端，分别为大口端和小口端。素线上靠近大口端的点到轴线距离大于或等于靠近小口端的点到轴线的距离。筒体Ⅰ位于回转壳体Ⅰ内腔且沿轴向方向延伸，筒体Ⅰ内端与回转壳体Ⅰ的小口端结合，外端伸出大口端，这样，筒体Ⅰ将回转壳体Ⅰ内腔分割为两部分，一部分为处于筒体Ⅰ和回转壳体Ⅰ之间的腔体，另一部分为筒体Ⅰ内腔。筒体Ⅰ和回转壳体Ⅰ之间的腔体可以容纳断端游离缘，筒体Ⅰ内腔保证了吻合口的通畅。另外，回转壳体Ⅰ上还设置有磁铁，在图中具体为磁环，置于回转壳体Ⅰ对合面Ⅰ1的磁环容置槽5内。It can be seen from the figure that the assembly I includes a rotary housing I11 and a cylinder I2. In order to make the anastomotic ball less likely to damage the gastrointestinal mucosa, less likely to damage the intestinal tract when moving in the intestine after falling off, and to facilitate excretion from the body, the rotary housing I is required to have a smooth surface. The prime line of the revolving shell I is a smooth curve, and the two ends of the curve are at a certain distance from the axis. In this way, the revolving shell I has two open ends, which are respectively a large opening end and a small opening end. The distance from the point on the prime line near the large mouth end to the axis is greater than or equal to the distance from the point near the small mouth end to the axis. The cylinder I is located in the inner cavity of the rotary housing I and extends in the axial direction. The inner end of the cylinder I is combined with the small mouth end of the rotary housing I, and the outer end protrudes from the large mouth end. In this way, the cylinder I will The cavity is divided into two parts, one part is the cavity between the cylinder body I and the rotary housing I, and the other part is the inner cavity of the cylinder body I. The cavity between the cylinder body I and the rotary housing I can accommodate the free edge of the broken end, and the inner cavity of the cylinder body I ensures the smoothness of the anastomosis. In addition, a magnet, specifically a magnetic ring in the figure, is also provided on the rotary housing I, which is placed in the magnetic ring accommodating groove 5 of the mating surface I1 of the rotary housing I.
组件Ⅱ包括回转壳体Ⅱ12和筒体Ⅱ7。为了使得吻合球不易损伤胃肠粘膜，脱落后在肠内运动时不易损伤肠道，便于排除体外，就要求回转壳体Ⅱ具有圆滑表面。回转壳体Ⅱ的素线为一条圆滑曲线，曲线的两端距离轴线一定距离，这样，回转壳体Ⅱ就具有两个开口端，分别为大口端和小口端。素线上靠近大口端的点到轴线距离大于或等于靠近小口端的点到轴线的距离。筒体Ⅱ位于回转壳体Ⅱ内腔且沿轴向方向延伸，筒体Ⅱ内端与回转壳体Ⅱ的小口端结合，外端伸出大口端，这样，筒体Ⅱ将回转壳体Ⅱ内腔分割为两部分，一部分为处于筒体Ⅱ和回转壳体Ⅱ之间的腔体，另一部分为筒体Ⅱ内腔。筒体Ⅱ和回转壳体Ⅱ之间的腔体可以容纳断端游离缘，筒体Ⅱ内腔接纳筒体Ⅰ，引导筒体Ⅰ在筒体Ⅱ内滑动。另外，回转壳体Ⅱ上还设置有磁铁，在图中具体为磁环，置于回转壳体Ⅱ对合面Ⅱ6的磁环容置槽5内。Component II includes a rotary housing II12 and a cylinder II7. In order to make the anastomotic ball less likely to damage the gastrointestinal mucosa, less likely to damage the intestinal tract when moving in the intestinal tract after falling off, and facilitate excretion from the body, the rotating shell II is required to have a smooth surface. The prime line of the rotary housing II is a smooth curve, and the two ends of the curve are at a certain distance from the axis. In this way, the rotary housing II has two open ends, namely a large opening and a small opening. The distance from the point on the prime line near the large mouth end to the axis is greater than or equal to the distance from the point near the small mouth end to the axis. The cylinder body II is located in the inner cavity of the rotary housing II and extends in the axial direction. The inner end of the cylinder body II is combined with the small mouth end of the rotary housing II, and the outer end extends out of the large mouth end. In this way, the cylinder body II will The cavity is divided into two parts, one part is the cavity between the cylinder body II and the rotary casing II, and the other part is the inner cavity of the cylinder body II. The cavity between the cylinder body II and the rotary housing II can accommodate the free edge of the broken end, and the inner cavity of the cylinder body II receives the cylinder body I, and guides the cylinder body I to slide in the cylinder body II. In addition, a magnet, specifically a magnetic ring in the figure, is also provided on the rotary housing II, which is placed in the magnetic ring accommodating groove 5 of the mating surface II6 of the rotary housing II.
吻合时，将组件Ⅰ和组件Ⅱ分别置于两个吻合胃或肠管的断端，相应的断端游离缘通过荷包缝合分别结扎固定于筒体Ⅰ和筒体Ⅱ的外周面上，筒体Ⅰ在筒体Ⅱ内轴向滑动，在磁性吸力的作用下，回转壳体Ⅰ的对合面Ⅰ和回转壳体Ⅱ的对合面Ⅱ对合将它们之间的吻合处断端夹紧，使两侧的浆膜面相互接合，建立胃肠愈合的必要条件。利用两个结构互补的半球体结构,将胃(肠)断端分别固定，相互嵌合后在胃肠腔内形成完整的球体,使胃肠两个断端浆膜面对合,在磁力压迫作用下,自动完成吻合、切割和脱落过程，恢复胃肠的连续性，球体自肛门排出，使用方法简便，安全性好，可有效地减少吻合口漏、吻合口狭窄等并发症。本发明保证了吻合口平滑无皱襞，确保不会发生由于吻合不全导致的吻合口瘘，吻合组织的愈合过程顺利进行。During anastomosis, component I and component II are respectively placed on the stumps of the two anastomotic stomach or intestinal tubes, and the free edges of the corresponding stumps are respectively ligated and fixed on the outer peripheral surfaces of cylinder I and cylinder II by purse-string suture. Sliding axially in the cylinder body II, under the action of magnetic attraction, the abutment surface I of the rotary housing I and the abutment surface II of the rotary housing II abut to clamp the broken end of the anastomosis between them, so that The serosal surfaces on both sides engage with each other, establishing the necessary conditions for gastrointestinal healing. Using two hemispherical structures with complementary structures, the stomach (intestine) stumps are respectively fixed, and a complete sphere is formed in the gastrointestinal cavity after mutual fitting, so that the serosal surfaces of the two stumps of the stomach and intestines are aligned, and the magnetic compression Under the action, the process of anastomosis, cutting and shedding is automatically completed, the continuity of the gastrointestinal tract is restored, and the sphere is discharged from the anus. It is easy to use and safe, and can effectively reduce complications such as anastomotic leakage and anastomotic stenosis. The invention ensures that the anastomotic stoma is smooth and free of folds, ensures that the anastomotic stoma leakage caused by incomplete anastomosis does not occur, and the healing process of the anastomotic tissue proceeds smoothly.
为了保证吻合组织不会发生移位、分离、脱落、吻合不全等情况，确保手术的安全，所述筒体Ⅰ外端具有径向凸块3，凸块的两侧具有轴向间隙。所述筒体Ⅱ的内周面具有轴向延伸的导向槽9，在轴向方向上，导向槽中部具有防脱凸起10。吻合时，导向槽接纳凸块引导筒体Ⅰ在筒体Ⅱ内轴向滑动，凸块越过防脱凸起继续轴向运动。从图1中可以看出，凸块数量为三个，相应地，导向槽亦为三个，当然也可以是其它数量。导向槽中部具有防脱凸起10能够很好的防止吻合球的脱开。凸块的两侧具有轴向间隙是为了便于凸块具有径向的弹性，能够顺利的越过防脱凸起。In order to ensure that the anastomotic tissue does not displace, separate, fall off, and incompletely anastomose, and ensure the safety of the operation, the outer end of the cylinder I has a radial protrusion 3, and there are axial gaps on both sides of the protrusion. The inner peripheral surface of the cylinder body II has a guide groove 9 extending axially, and in the axial direction, the middle part of the guide groove has an
为了阻挡断端荷包缝合结扎后的断端游离缘从筒体Ⅱ外端脱出，图3可以很清楚地看出，筒体Ⅱ外端设置了径向凸缘。In order to prevent the free edge of the broken end after purse-string suture ligation from protruding from the outer end of the cylinder II, it can be clearly seen from Fig. 3 that a radial flange is provided at the outer end of the cylinder II.
为了保证吻合球内腔与胃肠道内腔的气压一致，所述回转壳体Ⅰ小口端部设有连通回转壳体Ⅰ和筒体Ⅰ之间空腔和胃肠道内腔的透孔4。所述回转壳体Ⅱ小口端部设有连通回转壳体Ⅱ和筒体Ⅱ之间空腔和胃肠道内腔的透孔4。In order to ensure that the air pressure in the inner cavity of the anastomosis ball is consistent with that in the inner cavity of the gastrointestinal tract, the end of the small mouth of the rotary shell I is provided with a through hole 4 connecting the cavity between the rotary shell I and the cylinder body I and the inner cavity of the gastrointestinal tract. The end of the small mouth of the rotary housing II is provided with a through hole 4 connecting the cavity between the rotary housing II and the cylinder body II and the inner cavity of the gastrointestinal tract.
上述的磁环具有2000-3000高斯的磁力，既能保证吻合的完整紧密，又能在吻合完成后顺利脱落排出，并且对吻合球周围组织无磁力影响。The above-mentioned magnetic ring has a magnetic force of 2000-3000 gauss, which can not only ensure the integrity and tightness of the anastomosis, but also smoothly fall off and discharge after the anastomosis is completed, and has no magnetic influence on the tissues around the anastomosis ball.
常见的，回转壳体Ⅰ和回转壳体Ⅱ的形状为去顶的半球壳或去顶的半椭球壳。所述筒体Ⅰ和筒体Ⅱ均为等径圆筒体，筒体Ⅰ的外径基本等于筒体Ⅱ的内径。Commonly, the shape of the rotary shell I and the rotary shell II is a topped hemispherical shell or a topped semi-ellipsoidal shell. Both the cylinder I and the cylinder II are cylinders with equal diameters, and the outer diameter of the cylinder I is basically equal to the inner diameter of the cylinder II.
吻合球由医用聚乙烯塑料制成，表面光滑，重量仅为10g，无异物反应，组织相容性好。每个磁环厚度仅为2mm，因此吻合完成后吻合球易于从胃肠道排出，无嵌顿发生，并且未脱落时机体无坠胀等不适反应，不会引起肠管成角、狭窄、粘连、梗阻甚至穿孔等并发症。The anastomotic ball is made of medical polyethylene plastic with a smooth surface, weighs only 10g, has no foreign body reaction, and has good tissue compatibility. The thickness of each magnetic ring is only 2mm, so the anastomotic ball is easy to be discharged from the gastrointestinal tract after the anastomosis is completed, without incarceration, and when the body does not fall off, there will be no discomfort such as bulging, and it will not cause intestinal angle, stenosis, adhesion, Complications such as obstruction or even perforation.
本发明的吻合球用途广泛，可用于胃肠、肠肠的端端及端侧吻合，高位及超低位的胃肠道吻合，明显简化了手术操作。The anastomosis ball of the present invention has wide applications, and can be used for end-to-end and end-to-side anastomosis of gastrointestinal tract and intestinal tract, and high-position and ultra-low-position gastrointestinal tract anastomosis, which obviously simplifies the operation operation.
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| CN108635003A (en)* | 2018-05-15 | 2018-10-12 | 中国人民解放军陆军军医大学第三附属医院（野战外科研究所） | A kind of stricture of esophageal anastomosis combination cutter device |
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