CN103189002A - Method and apparatus for forming a stoma trephine and anastomoses - Google Patents

Abstract

The invention relates to a stapler device, comprising: a stapler having a proximal end, a distal end, and a longitudinal axis, the stapler further comprising a trigger, an anvil docking pin aligned parallel to the longitudinal axis of the stapler, and a stapling device, the anvil docking pin and stapling device disposed at the distal end of the stapler; a detachable anvil comprising an anvil head and an anvil shaft, the anvil shaft being adapted to receive an anvil docking pin and trigger operation to cause actuation of a stapling apparatus, wherein the anvil shaft has a length of at least 4 cm. The invention also relates to a method of forming an anastomosis on two surfaces using the stapler apparatus of the invention, and a method of forming an ostomy trephine on a patient using the stapler apparatus of the invention. The invention further relates to the use of a stapler apparatus and an anvil for a stapler apparatus in these methods, as well as a kit of parts comprising a stapler apparatus of the invention and additional components.

Description

Translated fromChinese

用于形成造口环钻和吻合的方法及装置Method and apparatus for forming a stoma trephine and anastomoses

技术领域technical field

本发明涉及一种在传统开放手术和腹腔镜手术中在空腔脏器里产生造口环钻和吻合的方法及装置。The invention relates to a method and a device for producing stoma trepanation and anastomosis in hollow viscera in traditional open surgery and laparoscopic surgery.

背景技术Background technique

大量的疾病需要节段切除以去除某一器官的一部分。例如，炎症性肠病（如克罗恩病、溃疡性结肠炎）、结肠直肠癌和肠梗塞等可能需要切除部分的下消化（胃肠）道。切除后，胃肠道的两端必须彼此再接以维持器官功能运作。该再接的过程称为外科吻合。A large number of diseases require segmental resection to remove part of an organ. For example, inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), colorectal cancer, and intestinal infarction may require removal of part of the lower digestive (gastrointestinal) tract. After resection, the two ends of the GI tract must be reattached to each other in order for the organ to function. This rejoining process is called surgical anastomosis.

造口是两个空腔脏器间或一个空腔脏器和体外的人工开口。人工造口的产生，如结肠造口术、回肠造口术、尿道造口术、食管造口术和胃造口术，在疾病治疗中可以是很有用的医疗干预，尤其针对正常脏器通道必须绕道以允许废物排出体外或者向体内输送营养的情况。A stoma is an artificial opening between two hollow organs or between a hollow organ and the outside body. The creation of artificial stomas, such as colostomy, ileostomy, urethrostomy, esophagostomy, and gastrostomy, can be a useful medical intervention in the treatment of disease, especially for normal visceral access A condition in which a detour must be made to allow waste to exit the body or deliver nutrients to the body.

从历史上看，吻合和造口是通过传统的缝合实现。传统技术的造口环钻构建涉及对穿过腹壁的缺损的拉伸，以容纳外科医生第二指间关节的示指和第二指的宽度（基思利 M.R.B. 和威廉姆斯 N.S.，“肛门直肠和结肠手术”，第三版，桑德斯有限公司，2008）。这种相对不受控制的腹壁，尤其是腹直肌拉伸，很可能导致腹壁环钻所在位置变得薄弱，随着时间的推移，缺损的扩张将导致疝的形成。Historically, anastomoses and stomas have been achieved with traditional sutures. Traditional technique trephine construction of the stoma involves stretching the defect across the abdominal wall to accommodate the width of the surgeon's second interphalangeal joint of the index and second fingers (Keighley M.R.B. and Williams N.S., "Anorectal and Colon Surgery”, Third Edition, Saunders Ltd, 2008). This relatively uncontrolled stretching of the abdominal wall, especially the rectus abdominus, likely leads to weakening of the abdominal wall at the location of the trepanation, and over time, dilation of the defect will lead to herniation.

外科缝合偶尔应用在造口构建中。外科缝合更频繁地用于吻合术。Surgical sutures are occasionally used in stoma construction. Surgical sutures are more frequently used for anastomoses.

一般来说，外科环形吻合器用于空腔管状器官的吻合，例如，肠、食道和其他管状结构。环形吻合器能够提供两排或两排以上的周向安装的缝钉，使得管状器官的相对两边可以缝合得安全。同时，安装在吻合器壳中的内部环形刀片将创建一个内部内腔，使得管状器官的病变部分切除后，内腔的正常运作得以再造。Generally, surgical circular staplers are used for the anastomosis of hollow tubular organs, such as the intestine, esophagus, and other tubular structures. Circular staplers are capable of providing two or more rows of circumferentially mounted staples so that opposite sides of a tubular organ can be securely stapled together. At the same time, the internal annular blade installed in the stapler shell will create an internal lumen, so that the normal function of the lumen can be recreated after the diseased part of the tubular organ is resected.

当前使用的环形吻合器通常包含有钉砧和吻合器。该钉砧通过设于吻合器上的钉砧对接销对接到吻合器上。然而，当前缝合装置的构造限制了这些元件的对接，即在体内腔中吻合器钉砧到吻合器的对接。如果这种对接可以外部化，某些新手术或当前手术的元素将在有效性和安全性上受益。Currently used circular staplers usually include an anvil and a stapler. The nail anvil is butted on the stapler through the nail anvil docking pin arranged on the stapler. However, the configuration of current stapling devices limits the docking of these elements, ie, the docking of the stapler anvil to the stapler within the body lumen. Certain new procedures or elements of current procedures would benefit in efficacy and safety if this docking could be externalized.

WO 2004/089225、US 4576167、US 7422138、US 7318830和US 7547312中描述了环形吻合器的示例，其中相应的内容将作为参考合入本发明。Examples of circular staplers are described in WO 2004/089225, US 4576167, US 7422138, US 7318830 and US 7547312, the corresponding contents of which are incorporated herein by reference.

当代的结直肠手术试图在疾病治疗效果和人体结构与功能的保留间寻找平衡。遗憾的是，在低位直肠癌的治疗中，当肛肠（APER）完全切除和永久性结肠造口的形成对于优化肿瘤治疗通常是必要的，上述矛盾仍然是十分明显的。在这类病患中，相比肿瘤治疗和导致永久性结肠造口术及所有影响生命的后果的肛肠和正常肛肠功能的牺牲而言，保肛是次要的，这已经记录在医学和公共领域。折中方案的解决可能已经成为现代肛肠学科的“圣杯”。Contemporary colorectal surgery attempts to find a balance between disease treatment effect and preservation of human body structure and function. Unfortunately, in the treatment of low rectal cancer, when complete anorectal (APER) resection and permanent colostomy formation are often necessary for optimal tumor therapy, the above paradox remains evident. In such patients, rectal preservation is secondary to tumor therapy and the sacrifice of the anorectum and normal anorectal function leading to permanent colostomy with all life-affecting consequences, as has been documented in medical and public field. The resolution of compromises may have become the "holy grail" of modern anorectal science.

已经有多种技术来帮助保证超低位吻合，如经腹经骶、经腹经肛、经腹经括约肌或内括约肌。然而，这些技术在技术上都很难实施，并且可能显著损害括约肌机理，随之对节制造成严重损害。因此，这些技术没有广泛使用。Various techniques have been developed to help ensure an ultra-low anastomosis, such as transabdominal transsacral, transabdominal transanal, transabdominal transsphincter, or internal sphincter. However, these techniques are technically difficult to implement and may significantly impair the sphincter mechanism with consequent severe impairment of abstinence. Therefore, these techniques are not widely used.

在低位和超低位回肠或结直肠吻合术后，除了失去括约肌功能，结肠造口旁疝也是一种在造口形成后非常常见的并发症，在过去10年时间里报道的发病率高达48%。危险因素包括肥胖、恶性肿瘤、营养不良、类固醇治疗和提高腹内压的情况（基思利和威廉姆斯，2008）。环状造口似乎特别容易出现这种并发症，大概是因为它的构建需要相比端口造口更大的腹部环钻。这样的疝带来相当大的发病率，如，局部疼痛和肠梗阻，其中肠梗阻可能需要紧急外科手术将肠切除，具有较高的致死率。In addition to loss of sphincter function after low and ultra-low ileum or colorectal anastomosis, colostomy hernia is also a very common complication after stoma formation, with a reported incidence of up to 48% over the past 10 years . Risk factors include obesity, malignancy, malnutrition, steroid therapy, and conditions that raise intra-abdominal pressure (Keighley and Williams, 2008). A circumstomy seems to be particularly prone to this complication, presumably because its construction requires a larger abdominal trephine than a port stoma. Such hernias carry considerable morbidity, eg, localized pain, and intestinal obstruction, which may require emergency surgical removal of the bowel, with a high mortality rate.

在对直肠排泄失调患者的手术过程中矫正直肠造影异常，发明家已经使用一种前会阴方法来显示直肠和阴道（或前列腺）间的平面（威廉姆斯 N.S.等，Br J Surg，2005，92：598-604）。很明显从这样的手术中相对容易接近低位直肠，并在同时保留外部和内部肛门括约肌完整的情况下获得肛管。事实上，发明家已经证实了这种方法在开放手术中的实用性和安全性，称其为APPER（Anterior Perineal Plane for Anterior Resection，前会阴平面前切除术）技术（威廉姆斯 N.S.等，Ann Surg，2008,247:750-758），作为低位直肠癌和大绒毛状腺瘤情况下执行传统直肠切除手术的辅助步骤。To correct proctographic abnormalities during surgery on patients with rectal voiding disorders, inventors have used an anterior perineal approach to visualize the plane between the rectum and vagina (or prostate) (Williams N.S. et al., Br J Surg, 2005, 92 : 598-604). It is evident from such an operation that it is relatively easy to access the lower rectum and obtain the anal canal while leaving both the external and internal anal sphincters intact. In fact, the inventors have demonstrated the utility and safety of this approach in open surgery, calling it the APPER (Anterior Perineal Plane for Anterior Resection) technique (Williams N.S. et al., Ann Surg, 2008, 247:750-758), as an adjunct to traditional proctectomy in cases of low rectal cancer and large villous adenoma.

在低位直肠中，特别是最后10厘米尤其是最后5厘米的直肠，病变病理的切除和随后的l cavity吻合，采用传统缝合技术存在问题，因为肛侧切除的位置相对于肛门位置极低或者在APPEAR手术中创建的会阴腔没有足够的空间使得相对的砧轴和套针（钉砧对接销）充分对接。In the lower rectum, especially the last 10 cm and especially the last 5 cm, the excision of the lesion pathology and the subsequent l cavity anastomosis are problematic with traditional suturing techniques because the position of the lateral resection is extremely low relative to the anus or in the The perineal cavity created in the APPEAR procedure does not have enough space for adequate docking of the opposing anvil shaft and trocar (anvil butt pin).

本领域仍需要一种外科设备和技术使得产生结肠直肠低位和超低位回肠吻合的同时保持括约肌完整性并因此能够节制。本领域也仍然需要一种外科设备和技术使得造口的构建避免诸如结肠造口旁疝等问题。There remains a need in the art for a surgical device and technique that allows the production of colorectal low and ultra-low ileal anastomoses while maintaining sphincter integrity and thus enabling restraint. There also remains a need in the art for a surgical device and technique that allows the construction of a stoma avoiding problems such as parastomal hernias.

发明内容Contents of the invention

发明人确认和开发了一种特定手术，其增加肛管或体外对接能力可以提供明显的手术优势，此外，还开发了一种相当于传统设备的迭代和附属的外科实践方法以促进手术的改进。其他手术也可能受益于具有肛管或体外对接能力的外科吻合器。The inventors have identified and developed a specific procedure in which the addition of anal canal or extracorporeal docking capabilities can provide distinct surgical advantages and, in addition, have developed an iterative and adjunct approach to surgical practice equivalent to conventional equipment to facilitate surgical improvement . Other procedures may also benefit from surgical staplers with anal canal or extracorporeal docking capabilities.

因此，发明人开发出了一种改进的手术和新的促进设备专门来弥补解剖和手术上的困难，即一种肛管或体外外科吻合器装置。Therefore, the inventors have developed an improved procedure and a new facilitating device specifically to compensate for the anatomical and surgical difficulties, namely an anal canal or extracorporeal surgical stapler device.

这种新的吻合器装置适合于创建吻合和造口环钻的同时减少诸如失去括约肌控制、结肠造口旁疝等副作用。This new stapler device is suitable for creating anastomosis and stoma trepanation while reducing side effects such as loss of sphincter control, colostomal hernia, etc.

因此，本发明的第一方面提供了一种吻合器装置，包括：Therefore, a first aspect of the present invention provides a stapler device, comprising:

（a）具有近端、远端和纵轴的吻合器，该吻合器更进一步包括：(a) A stapler having a proximal end, a distal end, and a longitudinal axis, the stapler further comprising:

（i ）扳机；(i) the trigger;

（ii）与吻合器纵轴平行对齐的钉砧对接销；(ii) Anvil docking pins aligned parallel to the longitudinal axis of the stapler;

（iii）缝合装置，该钉砧对接销和缝合装置设置在吻合器的远端；(iii) a suturing device, the anvil butt pin and the suturing device are arranged at the distal end of the stapler;

（b）包含有砧头和砧轴的可拆分的钉砧，(b) a detachable anvil comprising an anvil head and anvil shaft,

其中，该砧轴适用于接收钉砧对接销和致使缝合装置启动的扳机操作，其特征在于，砧轴的长度至少为4厘米。Wherein, the anvil shaft is suitable for receiving the anvil butt pin and causing the trigger operation of the suturing device to start, and it is characterized in that the length of the anvil shaft is at least 4 cm.

由于砧轴的特定长度，钉砧更容易操作，允许肛管或体外钉砧与吻合器的衔接。Due to the specific length of the anvil shaft, the anvil is easier to handle, allowing the engagement of the anal canal or extracorporeal anvil with the stapler.

本发明还涉及一种外科吻合器的钉砧，其包含砧头和砧轴，特征在于砧轴的长度至少为4厘米。The present invention also relates to an anvil of a surgical stapler, which comprises an anvil head and an anvil shaft, characterized in that the length of the anvil shaft is at least 4 cm.

本发明还涉及对本发明的吻合器装置或外科吻合器的钉砧在吻合形成中的使用。The invention also relates to the use of the stapler device of the invention or the anvil of a surgical stapler in forming an anastomosis.

本发明更进一步涉及本发明的吻合器装置或外科吻合器的钉砧在造口环钻形成中的使用。The present invention still further relates to the use of the stapler device of the present invention or the anvil of a surgical stapler in the formation of a stoma trephine.

本发明还涉及用本发明的吻合器装置在两个表面间形成吻合的方法，其包括将需要缝合的第一表面连到吻合器装置的钉砧上，将钉砧对接销与砧轴接合，安放吻合器使得缝合装置与需要缝合的第二表面接合，激发缝合装置将第一表面和第二表面由钉砧连接在一起。The present invention also relates to a method for forming an anastomosis between two surfaces using the stapler device of the present invention, which comprises connecting the first surface to be stitched to the anvil of the stapler device, engaging the anvil butt pin with the anvil shaft, The stapler is placed so that the suturing device is engaged with the second surface to be sutured, and the suturing device is activated to join the first surface and the second surface together by the anvil.

本发明还涉及一种在患者身上形成造口环钻的方法，其包括在患者身上需要形成造口的位置形成一个切口，放置本发明的吻合器装置的钉砧使得砧头进入患者体内而砧轴伸出切口，将砧轴对接到钉砧对接销上，激发缝合装置在被缝合的组织中分配一系列缝钉。The present invention also relates to a method for forming a stoma trephine on a patient, which comprises forming an incision at the position where the stoma needs to be formed on the patient, placing the anvil of the stapler device of the present invention so that the anvil head enters the patient's body and the anvil The shaft extends out of the incision, docking the anvil shaft to the anvil docking pin, and activating the stapling device to dispense a series of staples in the tissue being stapled.

 本发明还涉及组成本发明的吻合器装置的成套部件和防护装置。The invention also relates to the kit of parts and guards that make up the stapler device of the invention.

附图说明Description of drawings

图1展示了一个吻合器装置，其包含带有传统钉砧对接销70的吻合器50和传统的钉砧60；FIG. 1 shows a stapler device comprising astapler 50 with a conventionalanvil butt pin 70 and aconventional anvil 60;

图2展示了包含有吻合器100和钉砧200的本发明的吻合器装置；Fig. 2 shows the stapler device of the present invention comprising astapler 100 and ananvil 200;

图3展示了传统钉砧60到吻合器50的传统钉砧对接销70上的对接；Fig. 3 has demonstrated the docking oftraditional nail anvil 60 on the traditional nailanvil docking pin 70 ofstapler 50;

图4展示了本发明的钉砧200对齐并准备好对接到本发明的吻合器100的钉砧对接销130上；Fig. 4 shows that thenail anvil 200 of the present invention is aligned and ready to be docked on the nailanvil docking pin 130 of thestapler 100 of the present invention;

图5展示了传统钉砧60与传统钉砧对接销70完全对接的吻合器装置；Fig. 5 shows the stapler device in which thetraditional nail anvil 60 is fully docked with the traditional nailanvil docking pin 70;

图6展示了本发明的吻合器装置，其钉砧200与钉砧对接销130完全对接；Fig. 6 shows the stapler device of the present invention, itsnail anvil 200 is completely docked with the nailanvil docking pin 130;

图7展示了本发明的吻合器装置，其钉砧200与钉砧对接销130完全对接，并且该钉砧对接销完全缩进了吻合器100中。被缝合的组织将在砧头220和缝合装置150间的接口处250被处理；FIG. 7 shows the stapler device of the present invention, theanvil 200 is completely docked with theanvil butt pin 130 , and the anvil butt pin is completely retracted into thestapler 100 . The sutured tissue will be processed at theinterface 250 between theanvil 220 and thesuturing device 150;

图8展示了如图4所示的本发明的钉砧200，但是该钉砧被旋转了90°；Figure 8 shows theanvil 200 of the present invention as shown in Figure 4, but rotated by 90°;

图9展示了穿过图7所示A-A线的吻合工具的截面；Figure 9 shows a cross-section of the anastomotic tool through line A-A shown in Figure 7;

图10展示本发明的钉砧200通过对接手术前适当位置的荷包缝合附到一段肠340。该钉砧由夹钳370控制；Figure 10 shows theanvil 200 of the present invention attached to a section ofbowel 340 by a purse string suture in place prior to butt surgery. The anvil is controlled byclamp 370;

图11展示了通过在远端直肠残端350实施的肠切开术用抓紧的镊子300来缚住、取回和拉拔砧轴240；FIG. 11 shows the gripping, retrieval and pulling of theanvil shaft 240 with grippingforceps 300 through an enterotomy performed at the distalrectal stump 350;

图12a和12b展示了砧轴240通过远端残端350完全取回并露出体外以备砧轴240和钉砧对接销130的肛管或体外对接；12a and 12b show that theanvil shaft 240 is fully retrieved through thedistal stump 350 and exposed outside the body for anal or extracorporeal docking of theanvil shaft 240 and theanvil docking pin 130;

图13a和13b展示了完全对接的钉砧200和吻合器100。通过砧轴上的可视窗口可以看到一个钉砧对接指示物132；Figures 13a and 13b illustrateanvil 200 andstapler 100 fully docked. Ananvil docking indicator 132 can be seen through the viewing window on the anvil shaft;

图14展示了圆柱状腹壁皮肤和皮下组织400下至腹直肌鞘410的切除，并在该位置形成造口环钻；Figure 14 shows the excision of the cylindrical abdominal wall skin and subcutaneous tissue 400 down to therectus sheath 410, and the formation of the stoma trephine at this location;

图15展示了由十字切口打开的腹直肌鞘410；Figure 15 shows therectus sheath 410 opened by the cross incision;

图16展示了用牵开器（兰根贝克式牵开器）撑开的切口；Figure 16 shows the opening of the incision with a retractor (Langenbeck retractor);

图17展示了使用镊子300通过腹壁上的切口将本发明的钉砧200取回；Figure 17 shows the use offorceps 300 to retrieve theanvil 200 of the present invention through an incision in the abdominal wall;

图18展示了与钉砧对接销130对齐的带有加固网138的本发明的吻合器100，钉砧200与钉砧对接销130对齐做好接合的准备。该钉砧由夹钳370固定；Figure 18 illustrates thestapler 100 of the present invention withreinforcement mesh 138 aligned withanvil butt pin 130, withanvil 200 aligned withanvil butt pin 130 ready for engagement. The anvil is fixed byclamp 370;

图19展示了完全接合的钉砧200和吻合器100，钉砧缩进吻合器中；Figure 19 shows the fully engagedanvil 200 andstapler 100 with the anvil retracted into the stapler;

图20展示了在激发吻合器后生成的一排界定造口环钻450的缝钉440，随后将加固网138的未固定边缘139；FIG. 20 shows a row ofstaples 440 bounding thestoma trephine 450 generated after the stapler is activated, followed byunsecured edges 139 of thereinforcement mesh 138;

图21展示了通过新生成的造口环钻450取回的一段肠342；Figure 21 shows a section ofbowel 342 retrieved through a newly createdstoma trephine 450;

图22展示了在腹腔镜手术中使用夹钳370将本发明的钉砧200引入到腹壁。在切口的边缘形成有荷包缝合445；Figure 22 illustrates the use ofclamps 370 to introduce theanvil 200 of the present invention into the abdominal wall during laparoscopic surgery. Apurse string suture 445 is formed at the edge of the incision;

图23展示了腹腔内的砧头220和与吻合器结合前围住砧轴240的荷包缝合445；Figure 23 shows theanvil head 220 in the abdominal cavity and thepurse string suture 445 surrounding theanvil shaft 240 before being combined with the stapler;

图24展示了本发明的钉砧245，其包含有一个与本发明的吻合器装置的钉砧对接销130对接的通道221；Fig. 24 shows thenail anvil 245 of the present invention, which includes achannel 221 docked with the nailanvil docking pin 130 of the stapler device of the present invention;

图25展示了连到抽吸装置225上的抽吸装置配件227和本发明的吻合器100；Figure 25 shows thesuction device accessory 227 connected to thesuction device 225 and thestapler 100 of the present invention;

图26展示了当连到一个抽吸装置上，由钉砧245操作的一段肠345。Figure 26 shows a section ofbowel 345 manipulated byanvil 245 when connected to a suction device.

具体实施方式Detailed ways

肠管（或体外）对接是发明家开发的一种附加技术，其有助于在超低位切除和根据患者体质在距肛门边缘大约2到10厘米的吻合情况下APPEAR的实施。直到APPEAR技术的发展，接近该肛肠的远端部位（同时保留完整的肛门括约肌机理和其躯体神经）在过去是不可能的。通过提供相对容易的方式进入低位直肠和肛管，并保留内部和外部括约肌，在大多数情况下可以避免创建永久性造口的需求。Bowel (or extracorporeal) docking is an additional technique developed by the inventors that facilitates the implementation of APPEAR in cases of ultra-low resection and anastomosis at approximately 2 to 10 cm from the anal verge depending on the patient's constitution. Access to this distal portion of the anorectum (while preserving the anal sphincter mechanism and its somatic nerves intact) was not possible in the past until the development of the APPEAR technique. By providing relatively easy access to the lower rectum and anal canal, and preserving the internal and external sphincters, the need to create a permanent stoma can be avoided in most cases.

因此，本发明涉及一种根据诸如APPEAR（新近开发的保留括约肌/超低位结肠或回肠肛门吻合）和其他需要砧轴和吻合器组件体外对接并对组件的稳固和安全安装具有清晰和精确的指示的潜在手术，例如造口形成技术，等手术需要，适用于体外或肠管砧轴与吻合器对接的吻合器装置。Thus, the present invention relates to a method such as APPEAR (recently developed sphincter-preserving/ultra-low colonic or ileo-anal anastomosis) and others that require in vitro docking of the anvil shaft and stapler assembly with clear and precise indication of a firm and secure fit of the assembly Potential operations, such as stoma formation techniques, and other surgical needs, are suitable for stapling devices that are in vitro or intestinal anvil shafts docked with staplers.

本发明的吻合器装置如图2所示，包括：The stapler device of the present invention is shown in Figure 2, comprising:

a）具有近端120、远端140和纵轴180的吻合器100，该吻合器100更进一步包括：a) astapler 100 having a proximal end 120, a distal end 140 and a longitudinal axis 180, thestapler 100 further comprising:

（i ）扳机112；(i) trigger 112;

（ii）与吻合器纵轴180平行对齐的钉砧对接销130；(ii) theanvil docking pin 130 aligned parallel to the longitudinal axis 180 of the stapler;

（iii）缝合装置150，该钉砧对接销130和缝合装置150设置在吻合器100的远端140；(iii) asuturing device 150, theanvil butt pin 130 and thesuturing device 150 are arranged at the distal end 140 of thestapler 100;

（b）包含有砧头220和砧轴240的可拆分的钉砧200，(b) adetachable anvil 200 comprising ananvil head 220 and ananvil shaft 240,

其中，该砧轴240适用于接收钉砧对接销130和致使缝合装置150启动的扳机112操作，其特征在于，砧轴130的长度至少为4厘米。Wherein, theanvil shaft 240 is suitable for receiving the nail-anvil butt pin 130 and causing the trigger 112 to operate thesuturing device 150, and it is characterized in that the length of theanvil shaft 130 is at least 4 cm.

吻合器的“远”和“近“端是以使用者操作吻合器装置时吻合器两端相对用户的远近距离为参考的。近端最接近使用者，通常包括触发缝合装置运作的控制区域。远端远离使用者，但是接近该吻合器装置所应用的患者，所以一般来说缝合装置和钉砧对接销位于该部分。The "far" and "near" ends of the stapler are based on the distance between the two ends of the stapler relative to the user when the user operates the stapler device. The proximal end is closest to the user and generally includes a control area that triggers operation of the suturing device. The distal end is away from the user, but close to the patient to whom the stapler device is applied, so generally the stapling device and the anvil butt pin are located at this portion.

通常，纵轴在近端和远端间延伸并基本上穿过吻合器的中心。Typically, the longitudinal axis extends between the proximal and distal ends and passes substantially through the center of the stapler.

引述的“圆形”包括实质上的圆形和其他对可提供合适缝钉分布的本领域技术人员可言显而易见的结构。例如，如图9所示，缝合装置的截面可以为圆形，以便提供基本圆形配置的缝钉，然而，也可以使用椭圆形排布。通常，砧头、砧轴、钉砧对接销和吻合工具的截面基本上都可以为圆形，然而，可以提供其他安排使得它们形成适合的缝钉排布。Reference to "circular" includes substantially circular and other configurations that would be apparent to those skilled in the art that would provide a suitable staple distribution. For example, as shown in FIG. 9, the suturing device may be circular in cross-section to provide a substantially circular configuration of staples, however, an oval arrangement may also be used. Generally, the anvil head, anvil shaft, anvil butt pin and stapling tool can be substantially circular in cross-section, however, other arrangements can be provided so that they form a suitable staple arrangement.

该吻合器通常具有一个拉长主体，更优地，一个大体上圆柱形主体。这是允许其插入合适组织和器官的最佳形状。The stapler typically has an elongated body, more preferably a generally cylindrical body. This is the best shape to allow its insertion into suitable tissues and organs.

吻合器的主体包括扳机112和缝合装置150。更优地，吻合器的主体大体上是直的并且是不弯曲的。根据解剖和吻合器装置针对的器官，这种形状是很有用的。在吻合器的主体是直的或大体上直的（相对于弯曲的）的实施例中，由于在操作中影响吻合和造口环钻质量的摆动和移动更少，这种形状提供了更大的吻合器操控性。例如，相比于弯曲的吻合器，上述形状的吻合器更容易与直肠壁保持平行。The main body of the stapler includes a trigger 112 and astapling device 150 . More preferably, the main body of the stapler is substantially straight and not curved. This shape is useful depending on the anatomy and the organ to which the stapler device is intended. In embodiments where the main body of the stapler is straight or substantially straight (as opposed to curved), this shape provides greater Stapler maneuverability. For example, it is easier to keep a stapler of the above shape parallel to the rectal wall than a curved stapler.

在一些实施例中，吻合器包括一个把手区110，当用户使用吻合器时可以握住该区域。该把手区通常位于吻合器近端120（因此缝合的执行可以距离用户一定的距离），尽管它可能位于吻合器的其他地方。In some embodiments, the stapler includes a handle region 110 that a user can hold while using the stapler. This handle area is typically located at the proximal end 120 of the stapler (so the suturing can be performed some distance from the user), although it may be located elsewhere on the stapler.

本发明的吻合器装置可以用于各种开放、内窥镜或腹腔镜手术应用中，例如吻合、造口或造口环钻的形成，它们可以在例如胃肠（GI）道或胃肠道和体表间，但是更常用于任何管状器官或腔体器官。因此，该吻合器装置适合于作为外科吻合器，或者，在一些更具体的实施例中，作为管腔内吻合器。此外，考虑本发明的一些实施例中吻合器是环形的，该装置可以说是环形吻合器装置。The stapler device of the present invention can be used in various open, endoscopic or laparoscopic surgical applications, such as anastomosis, stoma or stoma trephine formation, which can be in, for example, the gastrointestinal (GI) tract or GI tract and body surfaces, but is more commonly used with any tubular or luminal organ. Accordingly, the stapler device is suitable as a surgical stapler, or, in some more specific embodiments, as an endoluminal stapler. Furthermore, considering some embodiments of the invention in which the stapler is annular, the device may be said to be an annular stapler device.

该吻合器装置通常是一次性使用的，在使用后将被处理。在优选的实施例中，该吻合器装置是无菌的。The stapler device is typically single-use and will be disposed of after use. In preferred embodiments, the stapler device is sterile.

 在一些实施例中，砧轴的长度是4、5、6、7、8、9到10厘米。在一些实施例中，砧轴的长度至少是4、5、6、7、8、9到10厘米。在一些优选的实施例中，砧轴的长度范围为4到50厘米，更优的为4到25厘米、4到20厘米、4到15厘米、4到12厘米、5到50厘米、5到25厘米、5到20厘米、5到15厘米、5到12厘米、5到10厘米、6到50厘米、6到25厘米、6到29厘米、6到15厘米、6到12厘米或6到10厘米。In some embodiments, the length of the anvil shaft is 4, 5, 6, 7, 8, 9 to 10 centimeters. In some embodiments, the length of the anvil shaft is at least 4, 5, 6, 7, 8, 9 to 10 centimeters. In some preferred embodiments, the length of the anvil shaft ranges from 4 to 50 centimeters, more preferably 4 to 25 centimeters, 4 to 20 centimeters, 4 to 15 centimeters, 4 to 12 centimeters, 5 to 50 centimeters, 5 to 50 centimeters. 25 cm, 5 to 20 cm, 5 to 15 cm, 5 to 12 cm, 5 to 10 cm, 6 to 50 cm, 6 to 25 cm, 6 to 29 cm, 6 to 15 cm, 6 to 12 cm or 6 to 10 cm.

在一些本发明的实施例中，吻合器的整体工作长度已经从行业标准的420毫米降到250到400毫米之间，优选地，300到350毫米之间，更优地，310到340毫米，最优地，320到330毫米或325毫米。降低吻合器的整体工作长度提供了更好、更稳定的人体工学平台，在操作和激发吻合器装置中加固了吻合设备的用户控制。In some embodiments of the present invention, the overall working length of the stapler has been reduced from the industry standard of 420 mm to between 250 and 400 mm, preferably between 300 and 350 mm, more preferably between 310 and 340 mm, Optimally, 320 to 330 mm or 325 mm. Reducing the overall working length of the stapler provides a better, more stable ergonomic platform, enhancing user control of the stapling device during operation and activation of the stapler set.

本发明的吻合器装置的钉砧相比现有技术领域的钉砧更细长，这种砧轴的伸长相比现有技术有几点优势。The anvil of the stapler device of the present invention is more slender than the anvil in the prior art, and the elongation of the anvil shaft has several advantages over the prior art.

例如，有了更长的砧轴，使用者更容易操作钉砧，并且对接手术可以在肛管或体外执行。For example, with a longer anvil shaft, it is easier for the user to manipulate the anvil, and docking procedures can be performed in the anal canal or outside the body.

伸长的轴也使得外科医生可以在肛管或体外夹牢钉砧，或者使得外科医生在体内夹牢钉砧再把砧轴带到肛管部或体外。这使得外科医生更清晰地看到钉砧对接到钉砧对接销。伸长的轴也使得外科医生可以在体外看到钉砧和吻合器的完全接合。因此，伸长的轴相比现有技术具有可视化优势。对于现有技术的吻合器，砧轴被组织掩盖或包围，使得很难给砧轴定位或者握紧该轴将其移动到合适的位置。然而，延长当前发明的砧轴可以克服这一问题。The elongated shaft also allows the surgeon to clamp the anvil in the anal canal or outside the body, or allows the surgeon to clamp the anvil inside the body and bring the anvil shaft to the anal canal or outside the body. This allows the surgeon to more clearly see the anvil docked to the anvil docking pin. The elongated shaft also allows the surgeon to visualize full engagement of the anvil and stapler outside the body. Thus, the elongated shaft has a visualization advantage over the prior art. With prior art staplers, the anvil shaft is covered or surrounded by tissue, making it difficult to position the anvil shaft or grip the shaft to move it into position. However, extending the anvil shaft of the current invention can overcome this problem.

此外，由于外科医生更容易看到看见，因此外科医生更容易确保钉砧对接销上砧轴完整对接的完成。现有技术领域的吻合器依靠可听见的“咔哒”声来确认对接。与之相比，本发明的吻合器额外提供了对接发生的视觉判断。因此，本发明的吻合器为患者提供了额外的安全保障。Furthermore, since it is easier for the surgeon to see, it is easier for the surgeon to ensure that complete docking of the anvil shaft on the anvil docking pin is accomplished. Prior art staplers rely on an audible "click" sound to confirm docking. In contrast, the stapler of the present invention additionally provides a visual judgment that docking has occurred. Therefore, the stapler of the present invention provides additional security for the patient.

该伸长的砧轴为吻合器的对接提供了从体内到肛管或体外的通道。伸长的长度仅受限于吻合器内部驱动轴为改进钉砧对接销和接合的砧轴进出吻合器的运动（收缩和伸展）所做的修改。The elongated anvil shaft provides a passage from inside the body to the anal canal or outside the body for docking of the stapler. The length of extension is limited only by modifications made to the stapler's internal drive shaft to improve movement (retraction and extension) of the anvil butt pin and engaged anvil shaft into and out of the stapler.

在实现当前发明的延伸砧轴前，由于现有技术吻合器固有的局限性，实施肛管或体外钉砧到钉砧对接销的对接是不可能的。Prior to the implementation of the extended anvil shaft of the current invention, it was not possible to perform docking of the anal canal or extracorporeal anvil to the anvil docking pin due to limitations inherent in prior art staplers.

由于本发明的吻合器装置即使在超低位切除和在肛门边缘大约2到10厘米范围内吻合（如APPEAR技术）的情况下仍允许创建带有肛管或体外对接的吻合，因此，它允许在不必切除括约肌的前提下切除较大的一段肠。例如，在溃疡性结肠炎或直肠癌的情况下，可以切除较大段的肠，以避免存留直肠病变，同时保留排便自制。Since the stapler device of the present invention allows creation of an anastomosis with an anal canal or extracorporeal docking even with ultra-low resection and anastomosis within approximately 2 to 10 cm of the anal margin (as in the APPEAR technique), it allows in Resection of a larger section of bowel without having to remove the sphincter. For example, in cases of ulcerative colitis or rectal cancer, larger segments of bowel may be removed to avoid remaining rectal lesions while preserving bowel continence.

本发明的钉砧对接销同样可以改变长度以适应不同长度的砧轴。通常，钉砧对接销伸入吻合器，这样当从侧面观察吻合器时（如图2所示），只有一段钉砧对接销可见。该钉砧对接销的直径小于砧轴的直径，使得钉砧对接销能够插入砧轴。特别地，钉砧对接销的直径小于等于砧轴240的内腔241（如图4所示）。在优选的实施例中，该钉砧对接销与吻合器的纵轴是同轴的或大体上同轴的（例如，间隔一段等于或小于钉砧对接销宽度或直径的距离，或者间隔任意一段距离而使得缝钉在钉砧对接销的周围能有合适空间分布）。The nail-anvil docking pin of the present invention can also be changed in length to adapt to anvil shafts of different lengths. Typically, the anvil butt pin extends into the stapler so that when the stapler is viewed from the side (as shown in Figure 2), only a section of the anvil butt pin is visible. The diameter of the anvil butt pin is smaller than the diameter of the anvil shaft, so that the anvil butt pin can be inserted into the anvil shaft. In particular, the diameter of the anvil docking pin is smaller than or equal to theinner cavity 241 of the anvil shaft 240 (as shown in FIG. 4 ). In preferred embodiments, the anvil butt pins are coaxial or substantially coaxial (e.g., spaced a distance equal to or less than the width or diameter of the anvil butt pins, or at any distance) from the longitudinal axis of the stapler. distance so that the staples can have a suitable spatial distribution around the butt pin of the nail anvil).

本发明的钉砧对接销可以是钝头的，也可以是套管针头的。套管针头的钉砧对接销，如图4所示，具有能够穿透组织的优势。例如，当在低位直肠创建吻合时，可能使用缝线或缝钉封闭该直肠残端，该套管针头的钉砧对接销可以用来穿透直肠残端缝合线并与钉砧对接。这确保了吻合器的放置在合适的位置，使得分配的缝钉能同时穿过远端残端和以和荷包缝合等方式连到钉砧上的结肠。The butt pin of the nail anvil of the present invention can be blunt or cannulated. The anvil butt pin of the trocar head, as shown in Figure 4, has the advantage of being able to penetrate tissue. For example, when creating an anastomosis in the low rectum, the rectal stump may be closed with sutures or staples, and the anvil butt pin of the trocar head may be used to penetrate the rectal stump suture and abut the anvil. This ensures that the stapler is placed in place so that the dispensed staples can pass through both the distal stump and the colon attached to the anvil in a manner such as a purse string suture.

缝合装置分发的缝钉能够安排成一个大体上圆形的排布。该缝钉排布参考缝合线。缝钉的合适放置可以使得它们对准圆形缝合线的圆周。或者，它们可以对准圆形缝合线的半径，或者对准该圆形的半径和圆周间的某个角度。可能存在多行缝钉，例如2、3、4或5行缝钉。在一些实施例中，缝合设备存在有可选的两行、三行或更多同轴行的缝钉环形安装在吻合器壳体内。The staples dispensed by the stapling device can be arranged in a generally circular arrangement. This staple arrangement references the suture. Proper placement of the staples can align them with the circumference of the circular suture. Alternatively, they may be aligned with the radius of the circular suture, or with an angle between the radius of the circle and the circumference. There may be multiple rows of staples, such as 2, 3, 4 or 5 rows of staples. In some embodiments, the stapling device has optional two, three or more concentric rows of staples annularly mounted within the stapler housing.

扳机112的形状可以为杆状，如图2所示。在这样的实施例中，激发扳机将促使缝合装置以机械力或机械能运转的方式开动。或者，该扳机可以只是个按钮，能够促使缝合装置自动开动，例如，使用内部组件的电能。The shape of the trigger 112 may be a rod, as shown in FIG. 2 . In such embodiments, activating the trigger will cause the stapling device to actuate mechanically or mechanically. Alternatively, the trigger could simply be a button that would cause the stapling device to actuate automatically, for example, using electrical power from the internal components.

吻合器的把手区和扳手最好使用者在握紧吻合器的把手区时能同时触发扳手。例如，图2所示，扳手（在图2所示实施例中为控制杆）附于吻合器的中部，把手区可向吻合器的近端延伸。Preferably, the handle area of the stapler and the wrench can trigger the wrench simultaneously when the user grips the handle area of the stapler. For example, as shown in FIG. 2, a wrench (in the embodiment shown in FIG. 2, a lever) is attached to the middle of the stapler, and the handle area may extend toward the proximal end of the stapler.

在一些实施例中，吻合器的远端也包含一个收缩装置114，如图2所示。用户可以旋转该收缩装置使得钉砧对接销（和钉砧，如果钉砧和钉砧对接销接合了）沿着吻合器的纵轴反向收回到吻合器主体中。如果钉砧与钉砧对接销接合，这将导致砧头移近缝合装置。图7所示的钉砧200，已完全和吻合器100接合并完全缩进吻合器中。吻合器装置组件的安排可以使得被缝合的组织陷于砧头和缝合装置之间。被缝合的组织陷在或固定在钉砧200和缝合装置150的接口处250。在手术中用到该设备时，由于砧头和缝合装置间的接口处250有需要处理的一层或几层组织，因此砧头和缝合装置通常不直接接触彼此。In some embodiments, the distal end of the stapler also includes a retraction device 114, as shown in FIG. 2 . The user can rotate the retraction device so that the anvil butt pin (and the anvil, if the anvil and anvil butt pin are engaged) are retracted back into the stapler body along the longitudinal axis of the stapler. If the anvil is engaged with the anvil butt pin, this will cause the anvil head to move closer to the stapling device. Theanvil 200 shown in FIG. 7 has been fully engaged with thestapler 100 and fully retracted into the stapler. The stapler device components are arranged such that the tissue being stapled is trapped between the anvil and the stapling device. The stapled tissue is trapped or secured at theinterface 250 of theanvil 200 and thestapling device 150 . When the device is used in surgery, the anvil and the suturing device usually do not directly contact each other because there is one or more layers of tissue to be treated at theinterface 250 between the anvil and the suturing device.

通过向相反的方向旋转收缩装置，钉砧对接销（和钉砧，如果钉砧和钉砧对接销接合了）能够从吻合器内移除。另外，用户可以轻易地从钉砧对接销上取下钉砧。By rotating the retraction device in the opposite direction, the anvil butt pin (and the anvil, if the anvil and anvil butt pin are engaged) can be removed from the stapler. Additionally, the user can easily remove the anvil from the anvil docking pin.

在优选的实施例中，只有在旋转收缩装置将砧头移到靠近缝合装置并且被缝合的组织陷入砧头和缝合装置间后，才执行激发扳机的操作。In a preferred embodiment, activating the trigger is performed only after rotating the retracting device moves the anvil closer to the stapling device and the stapled tissue becomes trapped between the anvil and the stapling device.

收缩装置可以达到引导钉砧对接销以任意适合的方式沿着纵轴进入吻合器的目的，例如，吻合器主体中将收缩装置连到钉砧对接销的杆，无论是直接的还是通过间接的组件。该杆可能有螺纹，使得将钉砧对接销收缩进吻合器时不会对钉砧对接销造成旋转。可以存在其他收缩机制对本领域的技术人员是显而易见的。The retraction device may serve the purpose of guiding the anvil butt pin into the stapler along the longitudinal axis in any suitable manner, for example, a rod in the stapler body connecting the retraction device to the anvil butt pin, whether directly or through an indirect components. The rod may be threaded so that retracting the anvil pin into the stapler does not cause rotation of the anvil pin. It will be apparent to those skilled in the art that other contraction mechanisms may exist.

上述收缩装置可以包括从收缩装置向外延伸的凸缘和/或切入收缩装置的凹槽，使得用户转动收缩装置更容易。图2所示的收缩装置114包括使得用户转动收缩装置更容易的凹槽。The retractor may include a flange extending outwardly from the retractor and/or a groove cut into the retractor to facilitate rotation of the retractor by a user. The retraction device 114 shown in FIG. 2 includes grooves to make it easier for the user to turn the retraction device.

对于本发明的吻合器，激发扳机将促使缝合装置启动。在一些实施例中，在使用中放置该装置以致需要缝合的其中一个表面通过砧头与钉砧连接。需要缝合的另一个表面相对于缝合装置放置以使得缝合装置启动后通过缝钉连接这两个表面。选优的，要缝合的表面保持在砧头和缝合装置的接口处250。With the stapler of the present invention, firing the trigger will cause the stapling device to activate. In some embodiments, the device is positioned in use such that one of the surfaces to be sutured is joined to the anvil by the anvil head. The other surface to be sutured is positioned relative to the suturing device such that after activation of the suturing device the two surfaces are joined by staples. Preferably, the surface to be sutured remains at theinterface 250 of the anvil and suturing device.

在一些是实施例中，缺少收缩装置，激发扳机促使钉砧对接销（和钉砧，如果钉砧和钉砧对接销接合了）朝吻合器的近端移动，而后缝合装置启动。In some embodiments, in the absence of a retraction device, the firing trigger causes the anvil butt pin (and the anvil, if the anvil and anvil butt pin are engaged) to move toward the proximal end of the stapler before the stapling device is activated.

在本发明的一些实施例中，在端平面的砧头截面大体上是圆形的，其直径根据要缝合的组织的不同而不同。例如，砧头的直径范围可以为10到50毫米，更优地，20到35毫米。在一些实施例中，砧头的直径为21、25、28或32毫米。In some embodiments of the invention, the cross-section of the anvil in the end plane is substantially circular, with a diameter that varies depending on the tissue to be stapled. For example, the diameter of the anvil may range from 10 to 50 mm, more preferably 20 to 35 mm. In some embodiments, the diameter of the anvil is 21, 25, 28 or 32 millimeters.

在特定的实施例中，钉砧带有颜色标记，为使用者提供关于砧头直径的即时视觉信息。通常，砧头的直径与缝合装置的直径对应，使得钉砧对接销收进吻合器中时砧头和缝合装置能够对齐。该吻合器也可以带有相应的颜色标记，为使用者提供关于吻合器的直径信息。缝合装置的直径范围可以为10到50毫米，更优地，20到35毫米。在一些实施例中，吻合工具的直径为21、25、28或32毫米。In certain embodiments, the anvil is color coded to provide the user with immediate visual information on the diameter of the anvil. Typically, the diameter of the anvil corresponds to the diameter of the suturing device so that the anvil and the suturing device can be aligned when the anvil butt pin is retracted into the stapler. The stapler can also be marked with corresponding colors to provide users with information about the diameter of the stapler. The diameter of the suturing device may range from 10 to 50 mm, more preferably 20 to 35 mm. In some embodiments, the diameter of the stapling tool is 21, 25, 28 or 32 millimeters.

在本发明的一些实施例中，吻合器还包括一个安全制动装置116，如图2所示。该安全制动装置由用户扳动，并且能够反向设置使其处于工作状态。当该安全制动装置被设置了，它将防止扳机被用户激发。因此，该安全制动装置可以防止吻合器被不小心触发。当该安全制动装置空闲的时候，扳机可以被激发，因此缝合装置也能被启动。In some embodiments of the present invention, the stapler further includes a safety stop device 116, as shown in FIG. 2 . The safety brake is pulled by the user and can be reversed to work. When the safety brake is set, it will prevent the trigger from being actuated by the user. Therefore, the safety stop device can prevent the stapler from being accidentally triggered. When the safety brake is idle, the trigger can be activated and thus the suturing device can also be activated.

上述缝合装置包括一个吻合器壳体、一个环形或圆柱形刀片、一排围绕环形刀片外表面周向设置的缝钉槽和传动刀片。该环形刀片和传动刀片在大体上平行吻合器纵轴的方向上是可移动的。缝合装置的直径通常是指吻合器壳体的直径。The above-mentioned suturing device comprises a stapler housing, an annular or cylindrical blade, a row of staple grooves and driving blades arranged circumferentially around the outer surface of the annular blade. The annular blade and drive blade are movable in a direction generally parallel to the longitudinal axis of the stapler. The diameter of the suturing device generally refers to the diameter of the stapler housing.

当使用该吻合器装置时，缝钉槽装有缝钉。本发明的吻合器装置使用的缝钉通常包含一块可变形的连续的金属或塑料片。该连续的金属或塑料片被弯曲以形成钉冠以及大体上垂直于该钉冠的两个锋利或锐利的钉腿。该钉腿刺穿要缝合的组织。这些钉腿的长度决定了缝钉的高度，并根据需要缝合的组织的厚度的不同而不同。例如，钉腿的长度（决定了的缝钉的高度）包括2、3、4、4.2、5.6、7、8、9、10、15、20、25、30、35、40和50毫米，优选地，在2到30毫米之间、3到20毫米之间或4到15毫米之间。当缝钉安装到吻合器上，该钉腿指向吻合器的远端。When using the stapler device, the staple slots are filled with staples. The staples used with the stapler devices of the present invention typically comprise a deformable continuous sheet of metal or plastic. The continuous sheet of metal or plastic is bent to form a crown and two sharpened or sharpened legs generally perpendicular to the crown. The staple legs pierce the tissue to be stapled. The length of these staple legs determines the height of the staple and varies depending on the thickness of the tissue to be stapled. For example, the length of staple legs (determined staple height) includes 2, 3, 4, 4.2, 5.6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40 and 50 mm, preferably Ground, between 2 and 30 mm, between 3 and 20 mm or between 4 and 15 mm. When the staple is installed on the stapler, the legs of the staple point to the distal end of the stapler.

上述钉冠的长度也可以不同，例如，钉冠的长度可以为2、3、3.8、4、5、6、7、8、9、10、11、12、13、14或15毫米。优选地，钉冠的长度在3到15毫米或3到10毫米之间。钉冠的长度决定了钉腿间彼此的距离。The length of the nail crowns can also be different, for example, the length of the nail crowns can be 2, 3, 3.8, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 millimeters. Preferably, the length of the crown is between 3 and 15 mm or 3 and 10 mm. The length of the crown determines the distance between the legs of the nail.

上述缝钉可以由任何合适的材料制成，例如钛、钛合金（如镍钛诺，也称作镍钛合金，其为钛和镍的合金）、不锈钢或适合手术用途的其他金属或塑料。此外，也可以使用生物降解的缝钉，例如，主要由聚乳酸配方制成。The staples may be made of any suitable material, such as titanium, titanium alloys (such as nitinol, also known as nitinol, which is an alloy of titanium and nickel), stainless steel, or other metals or plastics suitable for surgical use. In addition, biodegradable staples may also be used, for example, made primarily of polylactic acid formulations.

上述缝钉在使用前通常最初为“U”形或类似的形状，例如矩形或正方形，其中缝钉形成矩形或正方形的三个边（例如，钉腿的排布大体垂直于钉冠）。Such staples are typically initially "U" shaped or similar in shape prior to use, such as a rectangle or square, wherein the staples form three sides of the rectangle or square (eg, the legs are arranged generally perpendicular to the crown).

当使用者激发吻合器100的扳机112，环形刀片和缝钉将从吻合器壳体伸出。在远端传动刀片的推动下缝钉伸出，缝钉沿着吻合器的纵轴排出并穿过位于砧头和缝合装置间接口处250的一层或多层组织或物质。缝钉的钉腿刺穿要缝合的物质或组织。一旦缝钉刺穿了物质，钉腿压向砧头使得缝钉向内或向外弯曲，并保持缝钉在固定位置。钉腿可以弯曲到平行或大体上平行于钉冠。当钉腿向内弯曲，将形成典型的“B”形，与许多曾使用的缝钉相同。缝钉通过挤压钉砧变形而成扁平状，组织或物质层被扁平的缝钉连接在一起。When the user activates the trigger 112 of thestapler 100, the annular blade and staples will protrude from the stapler housing. Pushed by the distal drive blade, the staples are protruded, and the staples are expelled along the longitudinal axis of the stapler and pass through one or more layers of tissue or material at theinterface 250 between the anvil head and the stapling device. The legs of the staple penetrate the substance or tissue to be stapled. Once the staples have pierced the material, the legs of the staples press against the anvil to bend the staples inwardly or outwardly and hold the staples in place. The staple legs can be bent to be parallel or substantially parallel to the staple crown. When the staple legs are bent inward, it will form the typical "B" shape, the same as many staples that have been used. The staples are deformed into a flat shape by squeezing the anvil, and layers of tissue or material are held together by the flattened staples.

在缝合装置的致动或发射过程中，上述环形刀片或环钻将沿着吻合器的纵轴前进，切除吻合器所涉及的组织或物质。因此，一个环形或圆盘状组织将被吻合器切除。该吻合器装置移除后将在缝合在一起的表面或组织间建立一个连续的内腔。例如，这可以使得一段肠附到另一端肠或直肠残端，同时保留一个排泄物可以通过的空腔。此外，该环形刀片可以在内部腔（如会阴腔或胃肠道内腔）和体表间创建一个造口。该环形刀片的直径小于传动刀片和缝钉槽排布的直径，因此，只有在缝合线内的一端组织会被切除。缝合线被原封不动地留下以保证两个表面连接在一起。 During actuation or firing of the stapling device, the annular blade or trephine will advance along the longitudinal axis of the stapler, resecting tissue or material involved by the stapler. Therefore, a ring or disk of tissue will be removed by the stapler. Removal of the stapler device creates a continuous lumen between the stapled surfaces or tissues. For example, this can allow a section of bowel to attach to another bowel or rectal stump while leaving a cavity through which waste can pass. In addition, the circular blade can create a stoma between an internal cavity (such as the perineal cavity or the lumen of the gastrointestinal tract) and the body surface. The diameter of the annular blade is smaller than the diameter of the drive blade and staple groove arrangement, so only the end tissue within the suture will be resected. The sutures are left intact to ensure that the two surfaces are joined together. the

适合用于本发明的吻合器装置的缝合用具在US 4576167和US 5758814中详细描述了，这部分内容将合入本发明以作参考。Suturing implements suitable for the stapler device of the present invention are described in detail in US 4576167 and US 5758814, which are incorporated herein by reference.

此外，当使用该设备时，可以在需要被缝合在一起的两个组织层间放置加固网或其他加固材料。可选的，或附加的，该加固网也可以提供在要缝合组织的上方或下方。由于应用的缝钉穿过组织层和加固网，该加固网或其他物质加强了吻合或造口环钻的成形。该网也改善了两组织层间的密封性，有助于防止任何器官内腔内的物质泄漏到体腔中。加固网页有助于防止结肠造口旁疝等不良后果。Additionally, when using the device, a reinforcing mesh or other reinforcing material can be placed between two layers of tissue that need to be stitched together. Optionally, or additionally, the reinforcing mesh may also be provided above or below the tissue to be stapled. The reinforcement mesh or other substance enhances the formation of the anastomosis or stoma trephine as the staples applied pass through the layers of tissue and the reinforcement mesh. The mesh also improves the seal between the two tissue layers, helping to prevent any organ lumen contents from leaking into the body cavity. Reinforced webs help prevent unwanted outcomes such as colostomy hernias.

该网可以由任何合适的材料制成，如合成或生物材料。当操作该设备时，该网将在缝合装置启动前放置在钉砧对接销或砧轴上。The mesh can be made of any suitable material, such as synthetic or biological material. When operating the device, the mesh will be placed on the anvil butt pin or shaft prior to activation of the stapling device.

该网通常比砧头和缝合装置的宽度更宽。这确保缝钉可以纳入该网。该网可以是任何合适的形状，例如，圆形、方形或卵形等。如果该网为圆形，那么该网的直径通常大于该钉砧和/或该缝合装置的直径。通常，该网有合适的大小和形状来覆盖整个吻合或造口环钻周边。The mesh is usually wider than the width of the anvil and suturing device. This ensures that the staples can be incorporated into the mesh. The mesh may be of any suitable shape, eg round, square or oval, etc. If the mesh is circular, the diameter of the mesh is generally greater than the diameter of the anvil and/or the suturing device. Usually, the mesh is the right size and shape to cover the entire anastomotic or stoma trephine perimeter.

适用于该网的合成材料包括聚乙烯、聚酯和聚四氟乙烯（PTFE，例如，压缩的、膨胀的或电纺）。聚丙烯具有稳定性、坚韧性、惰性和良好的操控性。聚丙烯网是由排列在具有不同尺寸孔径的网状物中的聚丙烯纤维所构成。PTFE网具有光滑性、柔软性、坚韧性和良好的组织生长性。Suitable synthetic materials for the mesh include polyethylene, polyester, and polytetrafluoroethylene (PTFE, eg, compressed, expanded, or electrospun). Polypropylene offers stability, toughness, inertness and good handling properties. Polypropylene mesh is composed of polypropylene fibers arranged in a mesh with pores of different sizes. PTFE mesh has smoothness, softness, tenacity and good tissue growth.

生物网包括从牛、猪和马等身上取下的心包膜，或真皮组织等其他器官组织。The biomesh includes pericardium, or other organ tissues such as dermal tissue, taken from cattle, pigs, and horses, among others.

在一个实施例中，上述砧轴可以包括一个或一个以上的圆周缺口242，如图4和图8所示。这使得在手术期间更容易抓住钉砧，并且在用户和钉砧间提供了更灵活和更连续的移动。因此这些缺口被钳夹工具所使用。该砧轴可以包括一个或几个缺口，例如2、3、4、5、6、7、8、9、10或更多的缺口，以提供上述优势。例如，该砧轴可以包括1到2个、1到3个、1到4个、1到5个、1到6个、1到7个、1到8个、1到9个或1到10个缺口。这些缺口可以沿着砧轴的周向完全延展，例如形成环形凹槽，或者它们可以限制在砧轴的一端圆周内（如图4和图8所示）。该缺口可以成对出现，以致它们不用围绕整个砧轴周向延展，但是它们需要对齐，使得它们刚好位于砧轴的相对两边。一个砧轴可以包括1、2、3、4、5、6、7、8、9或10对，或1到2对、1到3对、1到4对、1到5对相对的缺口。In one embodiment, the above-mentioned anvil shaft may include one or more than onecircumferential notch 242, as shown in FIGS. 4 and 8 . This makes it easier to grasp the anvil during surgery and provides a more flexible and continuous movement between the user and the anvil. These notches are therefore used by the vise tool. The anvil shaft may comprise one or several notches, for example 2, 3, 4, 5, 6, 7, 8, 9, 10 or more notches, to provide the above mentioned advantages. For example, the anvil shaft may comprise 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9 or 1 to 10 gap. These indentations may extend completely along the circumference of the anvil shaft, eg forming annular grooves, or they may be confined within the circumference of one end of the anvil shaft (as shown in Figures 4 and 8). The notches can be in pairs so that they do not extend circumferentially around the entire anvil shaft, but they need to be aligned so that they are located on just opposite sides of the anvil shaft. An anvil shaft may include 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pairs, or 1 to 2, 1 to 3, 1 to 4, 1 to 5 pairs of opposing notches.

在更进一步的实施例中，如图4所示，该砧轴240可以包括一个可视窗口246。该钉砧对接销130也可以包括一个对接指示物132。当钉砧200与钉砧对接销130完全对接，通过可视窗口246可以看到对接指示物132。图6和13a展示了钉砧和钉砧对接销完全接合的情况下，通过可视窗口246看到对接指示物132.In a further embodiment, as shown in FIG. 4 , theanvil shaft 240 may include aviewing window 246 . Theanvil docking pin 130 may also include adocking indicator 132 . When theanvil 200 is fully docked with theanvil docking pin 130 , thedocking indicator 132 can be seen through theviewing window 246 . Figures 6 and 13a show thedocking indicator 132 seen through theviewing window 246 when the anvil and anvil docking pin are fully engaged.

该可视窗口为使用者获悉钉砧与吻合器的接合提供了信息。该可视窗口和对接指示物被设置为只用当钉砧与吻合器完全接合后，使用者才能通过该可视窗口看到该对接指示物。这种可视窗口、对接指示物和伸长的砧轴的组合与现有技术相比更具优势，因为伸长的砧轴的出现使得肛管和体外对接更便利，并且当使用该吻合器装置时，外科医生或其他使用者可以看到该可视窗口和对接指示物。This viewing window provides information for the user to be aware of the engagement of the anvil with the stapler. The viewing window and the docking indicator are set so that the user can see the docking indicator through the viewing window only when the anvil is fully engaged with the stapler. This combination of visual window, docking indicator and elongated anvil shaft is more advantageous than the prior art, because the appearance of the elongated anvil shaft makes the anal canal and extracorporeal docking more convenient, and when using the stapler device , the surgeon or other user can see the viewing window and docking indicator.

该对接指示物可以是一个可见的与钉砧对接销其他部分区分的标记。例如，该对接指示物可以是钉砧对接销的上色了（如红色）的一段，使得钉砧与吻合器对接时能提供快速的视觉确认。该对接指示物可以延伸到钉砧对接销的整个圆周，这样即使钉砧和钉砧对接销相对旋转了，仍能通过该可视窗口看到对接指示物。该对接指示物位于钉砧对接销上，这样只用当钉砧完全对接到钉砧对接销中，对接指示物才与可视窗口对齐。The docking indicator may be a visible mark that distinguishes it from the rest of the anvil docking pin. For example, the docking indicator can be a colored (eg, red) segment of the anvil docking pin so that a quick visual confirmation can be provided when the anvil is docked with the stapler. The butt indicator can extend to the entire circumference of the anvil butt pin, so that even if the anvil and the anvil butt pin are relatively rotated, the butt indicator can still be seen through the visible window. The docking indicator is positioned on the anvil butt pin so that the docking indicator is aligned with the viewing window only when the anvil is fully docked into the anvil butt pin.

该砧轴240可以包括一个可视窗口（如图4和图8所示，在图8中，钉砧旋转了90°，因此看不到可视窗口）。可选的，该砧轴可以包括多个可视窗口，例如，2、3、4、5、6、7、8、9或10，或更多，使得砧轴与钉砧对接销完全接合时能够看到对接指示物。该砧轴可以因此包括1到2个、1到3个、1到4个、1到5个、1到6个、1到7个、1到8个、1到9个或1到10个可视窗口。可选的，该砧轴可以包括一段透明或半透明的材料，使得砧轴与钉砧对接销完全接合时能够看到对接指示物。引述的“可视窗口”因此包括砧轴上透明或半透明的部分如同砧头侧面实际的孔或开口。Theanvil shaft 240 may include a viewing window (as shown in Figures 4 and 8, in Figure 8 the anvil is rotated 90° so the viewing window cannot be seen). Optionally, the anvil shaft may include a plurality of viewing windows, for example, 2, 3, 4, 5, 6, 7, 8, 9 or 10, or more, so that when the anvil shaft is fully engaged with the anvil docking pin Can see docking tokens. The anvil shaft may thus comprise 1 to 2, 1 to 3, 1 to 4, 1 to 5, 1 to 6, 1 to 7, 1 to 8, 1 to 9 or 1 to 10 Visual window. Optionally, the anvil shaft may include a section of transparent or translucent material such that the docking indicator is visible when the anvil shaft is fully engaged with the anvil docking pin. References to "visible windows" thus include transparent or translucent portions of the anvil shaft as well as actual holes or openings in the sides of the anvil.

在一个实施例中，由于钉砧对接销要插入到砧轴中，因此钉砧对接销更进一步包括一个保持装置134，当钉砧与钉砧对接销完全对接时将钉砧可逆地固定在适当位置。该砧轴包括一个适于接收钉砧对接销的内腔241。图4展示了本发明的一个钉砧200对齐并准备与钉砧对接销130对接。图24为钉砧对接销130插入到砧轴240的内腔241的横截面图。In one embodiment, since the anvil butt pin is to be inserted into the anvil shaft, the anvil butt pin further includes aholding device 134, which reversibly fixes the anvil in place when the anvil is fully engaged with the anvil butt pin. Location. The anvil shaft includes alumen 241 adapted to receive an anvil docking pin. FIG. 4 illustrates ananvil 200 of the present invention aligned and ready to interface withanvil docking pin 130 . FIG. 24 is a cross-sectional view ofanvil docking pin 130 inserted intolumen 241 ofanvil shaft 240 .

该保持装置可以表现为与砧轴内腔窄部相连的钉砧对接销的窄部和宽部。该钉砧内腔的形状与钉砧对接销的形状互补，因此，当钉砧与钉砧对接销完全接合时，砧轴内腔窄部与钉砧对接销的窄部对齐，致使钉砧可拆卸地固定到位。The retaining means can be embodied as a narrow portion and a wide portion of the anvil butt pin connected to the narrow portion of the inner cavity of the anvil shaft. The shape of the anvil cavity is complementary to that of the anvil butt pin, so when the anvil is fully engaged with the anvil butt pin, the narrow portion of the anvil shaft lumen is aligned with the narrow portion of the anvil butt pin so that the anvil can be Removably fixed in place.

如图4所示，该保持装置可以包括位于砧轴上的外部保持装置248和位于钉砧对接销上的内部保持装置134。该外部保持装置可以为砧轴的一段，当从砧轴中心径向向外的力与外部保持装置对齐时，该外部保持装置越过砧轴的圆周反向延伸。该外部保持装置也与砧轴内腔的窄部对应。例如，当内部保持装置134包括钉砧对接销的窄部和宽部（如图4所示），并且该钉砧对接销与砧轴对接，该砧轴240内腔241的窄部致使砧轴240的保持装置248被向外推。当内部保持装置134推过位于在外部保持装置248上砧轴内腔241的窄部，该外部保持装置回到它的初始位置，与砧轴的侧面对准。在外部保持装置248位置上的砧轴240内腔241的窄部与在内部保持装置134位置上的钉砧对接销的直径窄部对应，从而使该钉砧可拆卸地固定到位。As shown in FIG. 4, the retention means may include outer retention means 248 on the anvil shaft and inner retention means 134 on the anvil butt pin. The outer retaining means may be a section of the anvil shaft that extends back across the circumference of the anvil shaft when a force radially outward from the center of the anvil shaft aligns the outer retaining means. This external retaining means also corresponds to the narrow part of the internal cavity of the anvil shaft. For example, when theinternal retaining device 134 includes a narrow portion and a wide portion of the anvil butt pin (as shown in FIG. 4 ), and the anvil butt pin abuts the anvil shaft, the narrow portion of theanvil shaft 240lumen 241 causes the anvil shaft to The retaining means 248 of 240 are pushed outwards. When the inner retaining means 134 is pushed through the narrow portion of theanvil shaft lumen 241 located on the outer retaining means 248, the outer retaining means returns to its original position, aligned with the sides of the anvil shaft. The narrow portion of thelumen 241 of theanvil shaft 240 at the location of theouter retainer 248 corresponds to the narrower diameter of the anvil docking pin at the location of theinner retainer 134, thereby releasably securing the anvil in place.

这样的保持装置有时候用到棘爪簧对接机制。对于本领域技术人员可以使用其他保持装置是显而易见的。Such retention devices sometimes employ a detent spring docking mechanism. It will be apparent to those skilled in the art that other retaining means can be used.

除了将钉砧可逆地固定在适当位置，该存在保持装置的的另一个好处是，当钉砧与吻合器接合会发出听得到的响声，为使用者确认钉砧与吻合器的完全接合提供听觉信息。In addition to reversibly securing the anvil in place, another benefit of the presence retaining device is that it makes an audible sound when the anvil is engaged with the stapler, providing the user with an audible confirmation of full engagement of the anvil with the stapler. information.

该保持装置还使得在操作吻合器装置时钉砧不会从吻合器脱落。因此，该保持装置是该吻合器的一个有利的安全特性。The retention means also prevents the anvil from falling out of the stapler when the stapler device is being manipulated. Therefore, the retaining device is an advantageous safety feature of the stapler.

优选地，上述砧头在端平面有圆形截面。该砧头包括两个相对表面222和224。砧轴从这两个表面中的一个的中心向外延伸，并且垂直或大体上垂直于延伸出对接销的表面的平面。因此该砧轴的一端与砧头相连或和砧头集成在一起。在一些实施例中，该砧头包括一个延伸出砧轴的平的表面。其相对的表面为弧形、锥形或圆锥形。通常砧头的形状塑造为，在通过肠切开手术（进入小肠的外科切口）或通过空腔脏器（如胃、肠、食管或其他空腔脏器）的自有通道操作钉砧时，为钉砧提供无创性的顶部， Preferably, the above-mentioned anvil has a circular cross-section in the end plane. The anvil includes two opposingsurfaces 222 and 224 . The anvil shaft extends outwardly from the center of one of the two surfaces and is perpendicular or substantially perpendicular to a plane extending out of the surface of the butt pin. One end of the anvil shaft is therefore connected to or integrated with the anvil. In some embodiments, the anvil includes a flat surface extending beyond the anvil shaft. Its opposing surfaces are arcuate, tapered or conical. Usually the anvil is shaped so that when the anvil is manipulated through an enterotomy (surgical incision into the small intestine) or through the natural passage of a hollow viscus such as the stomach, bowel, esophagus, or other hollow viscera, Provides an atraumatic top for the anvil,

可选地，相对表面222或224中的一个可以是凹面，而另一个是凸面，这两个相对表面相互互补，并且砧头的厚度由这两个相对表面的距离决定。在该实施例中，砧轴从凹面222的中心延伸。通常，至少部分凹面是平的，当砧轴与钉砧对接销接合时，其垂直于吻合器的纵轴。Alternatively, one of the opposingsurfaces 222 or 224 may be concave and the other convex, the two opposing surfaces being complementary to each other, and the thickness of the anvil being determined by the distance between the two opposing surfaces. In this embodiment, the anvil shaft extends from the center of theconcave surface 222 . Typically, at least a portion of the concavity is flat and perpendicular to the longitudinal axis of the stapler when the anvil shaft is engaged with the anvil butt pin.

延伸出砧轴的砧头表面222通常包含多个凹口或凹坑，当钉砧与钉砧对接销接合并且钉砧对接销缩回吻合器中时，其与缝合装置150的缝钉槽对齐。这些凹口致使缝合装置启动后缝钉向内或向外弯曲。因此，一旦缝钉钉腿穿过需要缝合的组织并且被钉砧向内或向外弯曲，该缝钉被固定在适当的位置，而两个组织被固定在一起（例如，在创建吻合时或者创建造口过程中缝合的造口环钻创建中的两个内腔脏器）。在砧头222表面的凹口可以通过机械压制或雕刻等方式成形。Theanvil head surface 222 extending beyond the anvil shaft generally includes a plurality of notches or dimples that align with the staple slots of thestapling device 150 when the anvil is engaged with the anvil butt pins and the anvil butt pins are retracted into the stapler . These notches cause the staples to bend inwardly or outwardly when the stapling device is activated. Thus, once the staple legs pass through the tissue to be stapled and are bent inward or outward by the anvil, the staple is held in place and the two tissues are held together (e.g., when creating an anastomosis or The stoma trephine is sutured during the creation of the stoma creating two lumen viscera). The notch on the surface of theanvil 222 can be formed by mechanical pressing or engraving.

在本发明的一个实施例中，砧轴除了包括适于接收钉砧对接销的内腔241，还包括中空通道221，如图24所示。该中空通道可以从砧轴240的内腔241延伸并穿过砧头220的整个厚度，终止于砧头220表面224上的孔223。该砧轴可以包含多个这样的通道，各个通道终止于砧头表面224上不同的孔。可选地，该钉砧245可以包含一个在砧轴中的中空通道，其在砧头分出多个或网络通道，每个通道都终止于砧头表面224的一个孔。图24展示了根据本发明的实施例的钉砧245，其中，该钉砧包括中空通道221，其分出多个通道，每个通道都终止于砧头220表面224上的孔223.In one embodiment of the present invention, the anvil shaft includes ahollow channel 221 in addition to aninner cavity 241 suitable for receiving an anvil butt pin, as shown in FIG. The hollow channel may extend from thelumen 241 of theanvil shaft 240 and through the entire thickness of theanvil 220 , terminating in abore 223 in thesurface 224 of theanvil 220 . The anvil shaft may contain a plurality of such channels, each channel terminating in a different hole in theanvil face 224 . Optionally, theanvil 245 may comprise a hollow channel in the anvil shaft that branches out into a plurality or network of channels in the anvil head, each channel terminating in a hole in theanvil head surface 224 . 24 shows ananvil 245 according to an embodiment of the present invention, wherein the anvil includes ahollow passage 221 branching off into a plurality of passages each terminating in ahole 223 on thesurface 224 of theanvil head 220.

当钉砧245附到抽吸装置225上时，这些通道使得空气能够通过砧头。当抽吸应用到钉砧上，通过上述通道使用抽吸装置致使组织可逆地吸连到砧头，该钉砧能够用来操纵生物组织或其他物质。该抽吸会导致真空，促进了组织到砧头的可逆吸附。当组织处在合适的位置或可使用，例如，钳子或其他外科设备或外科医生的手指，那么可以移除该抽吸。These channels allow air to pass through the anvil head when theanvil 245 is attached to thesuction device 225 . When suction is applied to the anvil, the anvil can be used to manipulate biological tissue or other substances using the suction device through the above-mentioned channels to cause reversible suction of tissue to the anvil head. This suction results in a vacuum that promotes reversible adsorption of tissue to the anvil. The suction can be removed when the tissue is in place or accessible, eg, forceps or other surgical equipment or the surgeon's fingers.

该抽吸装置可以有配件227，其能够以和钉砧对接销相同的方式与砧轴接合。该钉砧245可以包括密封垫229，其在抽吸装置和钉砧通道间提供气密封。该密封垫可以置于砧头内多个通道汇作一个通道的地方，当该抽吸装置与钉砧接合，其也可以往下置于砧轴抽吸装置配件的终端。The suction device may have a fitting 227 that can engage the anvil shaft in the same manner as the anvil butt pin. Theanvil 245 may include agasket 229 that provides an airtight seal between the suction device and the anvil channel. The gasket can be placed in the anvil head where the channels converge into one channel, and it can also be placed down the terminal end of the anvil shaft suction device fitting when the suction device is engaged with the anvil.

可选地，该钉砧对接销130也可以配备一个或一个以上空心通道136，如图24所示。该中口通道使得吸入的空气能够穿过该钉砧对接销穿过砧头220上的通道221和孔223。因此，当钉砧与钉砧对接销接合，吻合器可以连到抽吸装置，即使当钉砧与吻合器接合，也可以操作要处理的组织。正如图25所示。本发明的吻合器100连到抽吸装置225上，该抽吸装置通过钉砧对接销130中的中心通道136将空气吸入并使得空气流过该钉砧对接销130.Optionally, theanvil docking pin 130 can also be equipped with one or morehollow channels 136, as shown in FIG. 24 . The central opening passage enables the inhaled air to pass through the anvil docking pin through thepassage 221 and thehole 223 on theanvil head 220 . Thus, the stapler can be connected to the suction device while the anvil is engaged with the anvil butt pin, and the tissue to be treated can be manipulated even when the anvil is engaged with the stapler. As shown in Figure 25. Thestapler 100 of the present invention is connected to asuction device 225 which draws air through acentral channel 136 in theanvil butt pin 130 and causes air to flow through theanvil butt pin 130.

优选地，在一些砧头有一个或一个以上通道的实施例中，该抽吸装置是可控的，因此用到组织上的大量抽吸应用可以是多样的，并由此防止对组织的损伤（对组织防止损伤的操作）。对组织的操作包括在各种外科手术中对组织和人体内器官的移动和切除，例如，在缝合造口的创建中肠的防止损伤固定和放回，特别是肠道的正确取向，以便其外置形成造口。图26展示了对一端肠的操作。Preferably, in some embodiments where the anvil has one or more channels, the suction means is controllable so that the application of a large volume of suction to the tissue can be varied and thereby prevent damage to the tissue (A procedure to prevent damage to tissue). Manipulation of tissues includes the removal and removal of tissues and internal organs of the human body in various surgical procedures, for example, the atraumatic fixation and replacement of the intestine in the creation of suture stomas, especially the correct orientation of the intestine so that it The stoma is formed externally. Figure 26 shows the manipulation of one end of the bowel.

在采用了本发明的吻合器装置的一个实施例中，更进一步包括了吻合器主体上计量器，其为使用者提供钉砧对接销缩回到吻合中的距离信息。当使用者转动收缩装置，该计量器随着该钉砧对接销在吻合器内的收缩距离长短而上下移动。该计量器可以包含一定的上限和下限。低于该下限，则该钉砧对接销没有足够缩回以使得缝钉通过砧头中的凹口被弯曲固定在合适的位置。超过该上限，则该钉砧对接销缩回过多并可能对位于砧头和缝合装置接口正处理的两组织造成损害。In one embodiment of the stapler device of the present invention, it further includes a meter on the stapler main body, which provides the user with information on the distance of the butt pin of the anvil retracted into the anastomosis. When the user rotates the shrinking device, the gauge moves up and down along with the shrinkage distance of the anvil butt pin in the stapler. The gauge can contain certain upper and lower limits. Below this lower limit, the anvil butt pin is not retracted enough to allow the staples to be bent into place by the notches in the anvil head. Exceeding this upper limit, the anvil butt pin retracts too much and may cause damage to the two tissues being treated at the interface between the anvil head and the suturing device.

在优选的实施例中，该计量器位于该吻合器的末端，因此，当使用者握住该吻合器时，使用者的手不会挡住该计量器。In a preferred embodiment, the gauge is located at the end of the stapler so that the user's hand does not block the gauge when the user holds the stapler.

本发明的吻合器和吻合器主体可以由本领域技术人员所知的任何合适材料制成。例如，制成吻合器的材料可以包括塑料（如聚酰胺、聚苯乙烯、聚氯乙烯、聚丙烯、聚氨酯、聚碳酸酯或聚醚醚酮）、金属（如不锈钢或钛）或陶瓷。钉砧也可以由这些材料制成。The stapler and stapler body of the present invention can be made of any suitable material known to those skilled in the art. For example, the materials from which the staplers are made can include plastics (such as polyamide, polystyrene, polyvinyl chloride, polypropylene, polyurethane, polycarbonate, or polyether ether ketone), metals (such as stainless steel or titanium), or ceramics. Anvils can also be made from these materials.

本发明的第二方面提供了用于吻合器装置的钉砧200，其包括砧头220和砧轴240，其特征在于砧轴的长度至少为4厘米。A second aspect of the present invention provides ananvil 200 for a stapler device comprising ananvil head 220 and ananvil shaft 240, characterized in that the anvil shaft has a length of at least 4 cm.

该砧轴适用于接收钉砧对接销并使其与外科吻合器接合。该外科吻合器适合于形成吻合，并且通常为腔内环形吻合器。The anvil shaft is adapted to receive and engage an anvil butt pin with a surgical stapler. The surgical stapler is adapted to form an anastomosis and is typically an endoluminal circular stapler.

本发明的第三方面提供了本发明的吻合器装置或钉砧在吻合或造口环钻形成中的应用。A third aspect of the present invention provides the use of the stapler device or anvil of the present invention in stapling or stoma trephine formation.

该吻合或造口环钻可以形成在能够缝合的患者的任何理想表面或生物组织中。合适的生物组织包括器官壁、内胚层、外胚层、中胚层、消化道、小肠、大肠、十二指肠、空肠、回肠、盲肠、结肠、直肠、结缔组织、肌肉组织、上皮组织、胃、食管、气管、腹膜、腹直肌鞘、远端直肠残端、内皮、肠内皮、皮肤和腹壁。吻合或造口环钻可以形成在两个或更多上述生物组织间。对于吻合，两组织通常具有能够结合在一起形成吻合的内腔。例如，吻合可能形成在患者的两块肠之间，或肠道和远端直肠残端之间。这样的吻合通常称为端到端吻合。造口环钻可以形成在患者腹部或任何想要形成造口环钻的地方。The anastomotic or stoma trephine can be formed in any desired surface or biological tissue of the patient capable of suturing. Suitable biological tissues include organ walls, endoderm, ectoderm, mesoderm, digestive tract, small intestine, large intestine, duodenum, jejunum, ileum, cecum, colon, rectum, connective tissue, muscle tissue, epithelial tissue, stomach, Esophagus, trachea, peritoneum, rectus sheath, distal rectal stump, endothelium, intestinal endothelium, skin, and abdominal wall. Anastomotic or stoma trephines may be formed between two or more of the aforementioned biological tissues. For an anastomosis, two tissues typically have lumens that can be brought together to form an anastomosis. For example, an anastomosis may form between two pieces of the patient's bowel, or between the bowel and the distal rectal stump. Such an anastomosis is often referred to as an end-to-end anastomosis. The stoma trephine can be formed on the patient's abdomen or wherever it is desired to have a stoma trephine.

本发明的第四方面提供了使用本发明的吻合器装置在两表面或组织间形成或创建吻合的方法，其包括将需要缝合的第一表面或组织连到吻合器装置的钉砧200上，将钉砧对接销130与砧轴240接合，安放吻合器100使得缝合装置150与需要缝合的第二表面或组织接合，激发扳机通过缝钉将第一和第二表面或组织连接在一起。该方法可以称作是在第一和第二表面或组织的内腔间形成吻合，也可以是端到端的吻合。该内腔可以是肠道内腔，这取决于吻合的位置。A fourth aspect of the present invention provides a method for forming or creating an anastomosis between two surfaces or tissues using the stapler device of the present invention, which includes connecting the first surface or tissue to be stitched to theanvil 200 of the stapler device, Theanvil butt pin 130 is engaged with theanvil shaft 240, thestapler 100 is placed so that thesuturing device 150 engages with the second surface or tissue to be sutured, and the trigger is activated to connect the first and second surfaces or tissue together through staples. The method may be referred to as forming an anastomosis between the first and second surfaces or lumens of tissue, and may also be an end-to-end anastomosis. This lumen may be the intestinal lumen, depending on the location of the anastomosis.

在本发明的一个实施例中，形成吻合的方法更进一步包括通过第二表面的缝合线收回砧轴的步骤。该方法也可以包括操作一个收缩装置来收回钉砧对接销到吻合器中。该钉砧可以通过荷包缝合或其他本领域技术人员已知的任何合适方式附到第一表面（例如直肠或肠的一段）。In one embodiment of the present invention, the method of forming an anastomosis further comprises the step of retracting the anvil shaft through the suture of the second surface. The method may also include operating a retraction device to retract the anvil docking pin into the stapler. The anvil may be attached to the first surface (eg, a segment of rectum or intestine) by purse string sutures or any other suitable means known to those skilled in the art.

在用到荷包缝合的实施例中，第一组织以荷包缝合的方式紧密围绕砧轴，因此砧头被包进该第一组织的内腔。该砧轴穿过荷包缝合并露出以备对接进钉砧对接销。制成该缝合线的材料包括聚二氧六环酮（PDS）、聚乙醇酸、聚乳酸、尼龙和聚丙烯。In embodiments where a purse-string suture is used, the first tissue is pursed tightly around the anvil shaft such that the anvil is wrapped into the lumen of the first tissue. The anvil shaft is threaded through the purse string suture and exposed for docking into the anvil butt pin. Materials from which the suture is made include polydioxanone (PDS), polyglycolic acid, polylactic acid, nylon, and polypropylene.

该砧轴可以由镊子操纵。该镊子可以用来收回砧轴并使其越过第二表面的缝合线，因此第一表面被牵引并越过第二表面的缝合线。在启动缝合装置后，该缝合线指的是缝钉期望的位置。The anvil shaft can be manipulated by forceps. The forceps can be used to retract the anvil shaft over the suture of the second surface, whereby the first surface is pulled over the suture of the second surface. After activation of the suturing device, the suture line indicates the desired location of the staples.

在一些实施例中，第二组织可以用吻合器的钉砧对接销刺穿。这样的钉砧对接销包含一个套管针头，其适用于刺穿第二表面。该第二表面大约在圆形缝合线（或其他合适形状的缝合线，具体根据用到的缝钉的排布）中心的位置被刺穿。该第二表面包含一个孔或围绕缝合线指定位置的切口，该方法可以进一步包括使用缝合线或缝钉闭合该孔，然后用本发明的带套管针头的外科吻合器刺穿该缝合线。例如，当在一段肠或远端直肠残端间创建一个吻合，在使用带套管针头的吻合器或其他仪器刺穿该远端直肠残端前，可以使用缝合线或缝钉闭合或切除该远端直肠残端。可选地，在缝合线中心的远端残端（或其他组织）可以创建一个切口，以便通过该切口能够抓住并收回钉砧。这样可以确保两表面（肠的一段和远端直肠残端）在砧头和缝合装置间接口处的定位，以便启动缝合装置时缝钉可以穿过这两个表面。In some embodiments, the second tissue can be pierced with an anvil butt pin of the stapler. Such anvil butt pins include a trocar head adapted to pierce the second surface. The second surface is pierced approximately in the center of a circular suture (or other suitably shaped suture, depending on the arrangement of staples used). The second surface includes a hole or incision at a designated location around the suture, and the method may further comprise closing the hole with a suture or staples, and then piercing the suture with a surgical stapler with a trocar of the present invention. For example, when creating an anastomosis between a section of bowel or a distal rectal stump, the distal rectal stump may be closed or excised with sutures or staples before the distal rectal stump is pierced with a trocarted stapler or other instrument. Distal rectal stump. Optionally, an incision can be created in the distal stump (or other tissue) in the center of the suture so that the anvil can be grasped and retracted through the incision. This ensures the positioning of the two surfaces (bowel section and distal rectal stump) at the interface between the anvil and the suturing device so that the staples can pass through both surfaces when the suturing device is activated.

一旦带套管针头的钉砧对接销刺破第二表面，或者一旦砧轴通过第二表面的缝合线回缩，钉砧就可以对接到吻合器上。使用收缩装置是可选的操作（根据需要），然后激发扳机。因此缝合装置被开启，两个表面由缝钉固定在一起。缝合装置的环形刀片也确保了第一和第二组织的内腔间有连续的内腔。Once the anvil docking pin with trocar head pierces the second surface, or once the anvil shaft is retracted through the suture on the second surface, the anvil can be docked to the stapler. It is optional to use the retraction device (as needed) before firing the trigger. The suturing device is thus opened and the two surfaces are held together by the staples. The annular blade of the stapling device also ensures a continuous lumen between the first and second tissue lumens.

加固网可以提供在砧轴或钉砧对接销上，这样该网也被缝合到吻合上。该网可以置于被缝合的两表面或组织间。可选的，该网可以置于被缝合表面之上或之下。在一些实施例中，使用了一个或一个以上的网，例如，使用了2、3、4、5或者更多的。A reinforcement mesh can be provided on the anvil shaft or anvil butt pin so that this mesh is also sewn to the anastomosis. The mesh can be placed between the two surfaces or tissues being sutured. Optionally, the mesh can be placed over or under the surface being stitched. In some embodiments, one or more meshes are used, eg, 2, 3, 4, 5 or more are used.

如果使用了网，那么吻合器装置的环形刀片将对该网进行切割，使得处理的两个表面间有连续的内腔。为完全确保网在合适的位置，需要缝合网的外缘。If a mesh is used, the annular blade of the stapler device will cut the mesh so that there is a continuous lumen between the two surfaces being treated. To fully secure the mesh in place, the outer edges of the mesh will need to be sewn.

设定吻合器的位置的步骤可包括将第一和第二表面与砧头和缝合装置间的接口处250接合。该第一和第二表面陷于并被处理于砧头和缝合装置150表面222之间，因此当通过激发扳机112启动缝合装置150，吻合器的钉腿刺穿该表面并用缝钉将它们连在一起。环形刀片沿着纵轴的推进将在这两个表面或组织间创建一个连续的内腔。Positioning the stapler may include engaging the first and second surfaces with aninterface 250 between the anvil and the stapling device. The first and second surfaces are trapped and processed between the anvil and thesurface 222 of thesuturing device 150, so that when thesuturing device 150 is activated by firing the trigger 112, the legs of the stapler pierce the surfaces and attach them with the staples. Together. Advancement of the annular blade along the longitudinal axis will create a continuous lumen between these two surfaces or tissues.

图10到图13描绘了使用本发明的吻合器在靠近肛门边缘的肠中创建吻合。Figures 10 to 13 depict the creation of an anastomosis in the bowel near the anal verge using the stapler of the present invention.

图10展示了即将进行对接手术前本发明的延伸砧轴的放置。该钉砧经由近端肠中的荷包缝合附属物放置，通过使用特别改装的砧钳370将其拉到会阴腔，该砧钳与附属物的角度被设定以便沿着平行吻合器纵轴的方向抓住砧轴。通过沿着砧轴设置的其中一个缺口或缺口对242抓住该砧轴。可选地，可以使用标准的夹钳。该砧轴位于保留的远端直肠残端350之上，该部位预先由线性缝合装置或缝合线切除。Figure 10 illustrates the placement of the extended anvil shaft of the present invention immediately prior to a docking procedure. The anvil is placed via the purse-string appendage in the proximal bowel and is pulled into the perineal cavity by using specially adaptedanvil forceps 370 , which are angled to the appendage so that the anvil forceps are aligned along the longitudinal axis of the stapler. direction to grab the anvil shaft. The anvil shaft is gripped by one of the notches or pair ofnotches 242 provided along the anvil shaft. Alternatively, standard clamps can be used. The anvil shaft is positioned over the preserved distalrectal stump 350, which was previously resected with a linear suturing device or suture.

因此，本发明进一步延伸到夹钳370，其包括两个在一端通过可弯曲连接件（例如铰链或枢轴）相互连接的长形构件，该长形构件的另一端是弯曲的。该长形构件弯曲的部分与该长形构件不弯曲的部分可以成45°到135°角（例如，90°）。该长形构件通常是彼此对称的。该长形构件的弯曲端包括一个或一个以上弧形凹槽，其中，在长形构件相对位置上的凹槽是相互对齐的。这种对齐使得使用者闭合该夹钳时在夹钳上留有缺口，相对长形构件中对齐的凹槽决定着这些缺口。该凹槽适于用容纳本发明的吻合器装置的砧轴，当该夹钳闭合时可以可逆地固定钉砧。更优的是，该夹钳通过位于本发明的砧轴上的缺口242夹住砧轴。优选地，长形构件弯曲部分的弯曲度可以使得夹紧的钉砧沿平行吻合器纵轴的方向运动。Thus, the invention further extends to aclamp 370 comprising two elongate members interconnected at one end by a bendable connection such as a hinge or pivot, the other end of which is curved. The portion of the elongate member that is curved may be at an angle of 45° to 135° (eg, 90°) from the portion of the elongate member that is not curved. The elongate members are generally symmetrical to each other. The curved end of the elongate member includes one or more arcuate grooves, wherein the grooves at opposite positions of the elongate member are aligned with each other. This alignment leaves gaps in the jaws when the user closes the jaws, the gaps being determined by aligned grooves in the opposing elongate members. The recess is adapted to accommodate the anvil shaft of the stapler device of the present invention, reversibly securing the anvil when the jaws are closed. More preferably, the clamp clamps the anvil shaft through thenotch 242 on the anvil shaft of the present invention. Preferably, the curvature of the curved portion of the elongate member is such that the clamped anvil moves in a direction parallel to the longitudinal axis of the stapler.

当外科手术中操作钉砧时，合适的夹钳为外科医生提供更大的灵活性。该夹钳可以用在上述的接合和定位等步骤中。Fitting jaws provide the surgeon with greater flexibility when manipulating the anvil intraoperatively. The clamp can be used in the steps of engagement and positioning described above.

图11展示了通过穿过远端直肠残端缝合线的镊子300固定、收回砧轴，并将砧轴拉过远端残端上创建的肠切口。Figure 11 illustrates the fixation, retraction, and pulling of the anvil shaft through the bowel incision created on the distal rectal stump byforceps 300 threaded through the distal rectal stump suture.

图12a和12b展示了钉砧通过远端残端肠切口完全取回并露出体外以备砧轴和吻合器的肛管或体外对接。用重新放置的钉砧钳370夹紧该钉砧，以稳固并促进对接。图12a和12b清楚地展示了钉砧对接销上的对接指示物和砧轴上的可视窗口，通过该窗口观察对接指示物可以确认对接是否完成。Figures 12a and 12b show the anvil fully withdrawn through the distal stump enterotomy and exposed outside the body for anal or extracorporeal docking of the anvil shaft and stapler. The anvil is clamped with repositionedanvil forceps 370 to stabilize and facilitate docking. Figures 12a and 12b clearly show the docking indicator on the anvil docking pin and the visible window on the anvil shaft, through which the docking indicator can be observed to confirm whether the docking is complete.

图13a和13b展示了完全对接的钉砧和钉砧对接销，通过可视窗口可以清楚看到钉砧对接指示物。通过激发扳机将两组织连接在一起，而后关闭该吻合设备，这样缝钉主体壳体穿过肠管进入到肛肠残端，同时注意对括约肌机制和肛肠残端350整段长度的穿越。当钉砧和吻合器放置在合适的位置，将启动缝合装置以创建吻合。Figures 13a and 13b show the fully docked anvil and the anvil docking pin, and the anvil docking indicator can be clearly seen through the viewing window. The two tissues are joined together by activating the trigger, and then the stapling device is closed so that the staple body housing passes through the bowel into the anorectal stump, taking care to traverse the entire length of the sphincter mechanism andanorectal stump 350 . When the anvil and stapler are in place, the stapling device is activated to create the staple.

本发明的设备的独特特性和设计使得该钉砧对接销-砧轴组件可以不受限制地应用在存在解剖差异的许多方面，例如，肥胖患者，和其他额外手术，例如，需要在体外接合缝钉钉砧组件和吻合器的减肥手术。The unique characteristics and design of the device of the present invention allow for unrestricted application of the anvil butt pin-anvil shaft assembly in many areas where anatomical differences exist, e.g., obese patients, and other additional procedures, e.g., requiring joint sutures outside the body Anvil components and staplers for bariatric surgery.

本发明的第五方面提供了一种用本发明的吻合器装置在患者身上形成或创建造口环钻的方法，其包括：A fifth aspect of the present invention provides a method of forming or creating a stoma trephine in a patient using the stapler device of the present invention, comprising:

 在形成造口的位置；at the site of stoma formation;

放置本发明的吻合器装置的钉砧200使得砧头220进入患者体内而砧轴240伸出切口；将砧轴240对接到钉砧对接销130上；Place theanvil 200 of the stapler device of the present invention so that theanvil head 220 enters the patient's body and theanvil shaft 240 extends out of the incision; theanvil shaft 240 is docked on theanvil docking pin 130;

激发扳机112在被缝合的组织中分配一系列缝钉。Firing trigger 112 dispenses a series of staples in the tissue being stapled.

在一些实施例中，形成造口的方法可进一步包括通过切口使用夹钳等收回砧轴的步骤。该夹钳用来操作砧轴使其穿过形成造口环钻的组织中的缝合线。该砧头可以连到某个器官、表面或组织上，例如肠或皮肤的一段，这样砧头就包含在器官的内腔中，而砧轴从该组织中探出。然后，该砧轴准备与钉砧对接销接合。因此，本发明的方法可以包括采用荷包缝合等通过砧头将钉砧附到器官上的步骤。In some embodiments, the method of forming a stoma may further include the step of retracting the anvil shaft through the incision using clamps or the like. The clamp is used to manipulate the anvil shaft through the suture in the tissue forming the stoma trephine. The anvil may be attached to an organ, surface or tissue, such as a section of intestine or skin, such that the anvil is contained within the lumen of the organ and the anvil shaft protrudes from the tissue. The anvil shaft is then ready for engagement with the anvil butt pins. Thus, the methods of the present invention may include the step of attaching the anvil to the organ through the anvil head using purse string sutures or the like.

本发明的另一个实施例中，该方法可能包括在钉砧对接销或砧轴上应用一个或一个以上的加固网。In another embodiment of the invention, the method may include applying one or more reinforcing meshes to the anvil butt pin or shaft.

至于形成吻合的方法，该网可以以任何顺序放置，因此该网可以位于缝合的组织之上或之下，当多个组织层需要缝合在一起时，该网可以放置在这些组织层中。如果使用了网，吻合器装置的环形刀片将切割该网，以确保形成造口环钻的器官内部和该器官外部间有连续的内腔。需要缝合该网的外缘，以便将其固定在合适的位置。As to the method of forming the anastomosis, the mesh can be placed in any order, so the mesh can be positioned above or below the tissue being sutured, and the mesh can be placed in layers of tissue when they need to be stitched together. If a mesh is used, the annular blade of the stapler device will cut the mesh to ensure a continuous lumen between the inside of the organ forming the trepan and the outside of the organ. The outer edges of this mesh will need to be stitched to hold it in place.

在本发明的另一个实施例中，形成造口环钻的方法进一步包括操作吻合器的收缩装置的步骤，通过该步骤可以收回钉砧对接销，并将钉砧与吻合器接合。In another embodiment of the present invention, the method of forming a stoma trephine further comprises the step of operating the retracting device of the stapler, by which the anvil docking pin can be retracted and the anvil can be engaged with the stapler.

在手术中操作或定位钉砧可能涉及镊子或夹钳370的使用，或两者的同时使用。Manipulating or positioning the anvil intraoperatively may involve the use of forceps or clamps 370, or both.

通过激发扳机启动缝合装置将致使缝钉的分配并通过该缝钉将置于砧头和缝合装置接口处处理的组织固定在一起。沿着纵轴推进的环形刀片将在内部腔体（例如腹腔）和体外间形成环钻。分配的变形了的缝钉通过将组织层固定在一起，使得环钻周边也得到了固定。Activation of the stapling device by firing the trigger will cause the staples to be dispensed and held together by the staples to the treated tissue placed at the interface of the anvil head and the stapling device. The annular blade advanced along the longitudinal axis will form a trephine between the internal cavity (eg abdominal cavity) and the external body. The dispensed deformed staples stabilize the trephine perimeter by holding the layers of tissue together.

图14到23描述了用本发明的吻合器创建造口换钻。Figures 14 to 23 describe the creation of a stoma drill with the stapler of the present invention.

在开放手术中形成造口（或造口换钻）通常先从腹壁皮肤和皮下组织400到腹直肌鞘410切除一个圆柱状，如图14所示。然后该鞘开一个十字切口，腹直肌沿着其纤维线分开（图15）。而后通过开腹引入合适大小的钉砧200。吻合器和钉砧的直径取决于造口环钻最终贯穿的肠的直径。To form a stoma (or to change the drill for stoma) in open surgery, a cylindrical shape is usually cut from the abdominal wall skin and subcutaneous tissue 400 to therectus sheath 410, as shown in FIG. 14 . The sheath is then made a cruciate incision and the rectus abdominis is divided along its fibrous line (Fig. 15). Anappropriate size anvil 200 is then introduced through laparotomy. The diameter of the stapler and anvil depends on the diameter of the bowel that the trephine will eventually penetrate.

然后，通过腹壁环钻插入镊子300，使其穿过后腹直肌鞘和腹膜（图17）。该镊子用于夹取砧轴并设计成不会对砧轴造成损坏。在一些实施例中，该镊子是钝的，但足够锋利一穿透它要越过的组织层。因此，当其穿过腹壁时可以看到其尖端是最优的。Then, insertforceps 300 through the abdominal wall trephine, passing through the posterior rectus sheath and peritoneum (Figure 17). The tweezers are used to grip the anvil shaft and are designed not to cause damage to the anvil shaft. In some embodiments, the tweezers are blunt, but sharp enough to penetrate the layers of tissue it is intended to traverse. Therefore, it is optimal to see its tip as it passes through the abdominal wall.

一旦夹取了该砧轴，钉砧接着将从出现在腹壁上的环钻中取出。Once the anvil shaft has been grasped, the anvil will then be removed from the trephination emerging from the abdominal wall.

体外使用的夹钳370用以夹紧砧轴，并将其固定，帮助砧轴与缝合装置上的钉砧对接销的接合（图18）。可选的加固网138设计成圆形，其直径大于等于钉砧的直径，可选地，在其制备时，其中心可以创建一个小的缺口。该网上的该缺口后面可以用来将该网插到钉砧对接销130上，如图18所示。Clamps 370 used outside the body are used to clamp the anvil shaft and hold it in place to facilitate engagement of the anvil shaft with the anvil docking pin on the suturing device (Fig. 18). Theoptional reinforcement mesh 138 is designed in a circular shape with a diameter greater than or equal to the diameter of the anvil, and optionally, a small gap can be created in its center during its preparation. The notch behind the mesh can be used to insert the mesh ontoanvil docking pin 130 as shown in FIG. 18 .

砧轴被夹钳370夹取并与吻合器的钉砧对接销130接合。一旦锁定成功，操作收缩工具封闭该加固网，以及位于砧头和缝合装置间的后腹直肌鞘和腹膜（图19）。接着，激发扳机启动缝合装置，再移除吻合器100，并带走盘状的加固网、后腹直肌鞘和腹膜，留下由缝合线440确定的精确的强化的缝合的环钻450。接着，该网138的边缘139可选地通过间断0 PDS（聚二氧六环酮）缝合线或缝钉缝合到前腹直肌鞘，使其贴紧前鞘并穿过分开的肌肉纤维完全环绕环钻（图20）。The anvil shaft is gripped by theclamps 370 and engaged with theanvil docking pin 130 of the stapler. Once locked in, the retraction tool is operated to close the reinforcement mesh, as well as the posterior rectus sheath and peritoneum between the anvil and the suturing device (Fig. 19). Next, the trigger is fired to activate the suturing device, and thestapler 100 is removed, taking away the disc-shaped reinforcement mesh, the posterior rectus sheath, and the peritoneum, leaving the precisely reinforced suturedtrephine 450 defined by thesuture line 440 . Next, theedge 139 of themesh 138 is optionally sewn to the anterior rectus sheath by interrupted 0 PDS (polydioxanone) sutures or staples so that it fits snugly against the anterior sheath and passes completely through the separated muscle fibers. Surround the trepanation (Fig. 20).

接着，结肠或回肠通过该环钻，并以惯有的方式形成造口（图21；现有技术已对造口的形成进行了描述，例如，基思利 M.R.B和威廉姆斯 N.S.，“肛门直肠和结肠手术”，第三版，桑德斯有限公司，2008年，第五章，175-278页）。The colon or ileum is then passed through the trephine, and a stoma is formed in the customary manner (Fig. 21; stoma formation has been described in the prior art, eg, Keighley, M.R.B and Williams, N.S., "Anal Rectal and Colon Surgery", Third Edition, Saunders Ltd., 2008, Chapter 5, pp. 175-278).

在腹腔镜手术中，造口环钻如前所述以开放术形成在后腹直肌鞘下，但仍然保持气腹。如果为了标本切片创建一个单独的腹壁切口，该砧轴可以插入腹腔并以与开放术相同的方式从腹中取出。如果不是这种情况，腹直肌肌肉纤维可以收回（如图16所示），通过后腹直肌鞘和腹膜中的腹壁环钻生成一个小切口。这自然导致腹腔的放气，失去气腹。In laparoscopic surgery, the stoma trephine is formed openly under the posterior rectus sheath as previously described, but remains pneumoperitoneum. If a separate abdominal wall incision is made for specimen sectioning, this anvil can be inserted into the abdominal cavity and removed in the same manner as the open procedure. If this is not the case, the rectus muscle fibers can be retracted (as shown in Figure 16), and a small incision is made through the posterior rectus sheath and the abdominal wall trephine in the peritoneum. This naturally leads to deflation of the abdominal cavity, loss of pneumoperitoneum.

 the

接着，聚丙烯缝线或PDS荷包缝合445将插入腹膜和后腹直肌鞘中的切口的边缘（图22）。使用带有腹中取出轴的夹钳370令钉砧200的砧头穿过该切口，荷包刺445被牢牢系在轴240上（图23）。Next, polypropylene sutures or PDS purse string sutures 445 will be inserted into the peritoneum and the edges of the incision in the posterior rectus sheath (Figure 22). The anvil head ofanvil 200 is passed through theincision using clamps 370 with an intra-abdominal extraction shaft andpurse strings 445 are securely tied to shaft 240 (FIG. 23).

接着，可选地，圆形或其他形状的网如上所述插在砧轴上。接着，砧轴和钉砧对接销完成所述的接合，并操作收缩工具收回钉砧对接销（必需的）。Next, optionally, a circular or other shaped mesh is inserted on the anvil shaft as described above. Then, the anvil shaft and the anvil butt pin complete the engagement, and operate the shrink tool to retract the anvil butt pin (necessary).

在启动缝合装置前，通常再造气腹，并且检查环钻和封闭枪的位置以确保没有外部的某段肠陷入钉砧和工具的缝合主体之间。一旦激发扳机启动缝合装置，该吻合器将缩回，并以惯有的方式构建造口（基思利和威廉姆斯）。Before activating the suturing device, the pneumoperitoneum is usually recreated, and the position of the trephine and closure gun is checked to ensure that no external piece of bowel is trapped between the anvil and the suturing body of the tool. Once the trigger is activated to activate the suturing device, the stapler is retracted and the stoma is constructed in the customary manner (Keighley and Williams).

将加固网合入该技术已经被发明家所开发，其被称为SMART(缝合网造口加固术)。将网合入的既往研究对开放手术具有指导意义，而该网通过腹进路放置在腹膜下。虽然这种技术相对简单，但是它显著增加了操作时间，并难以执行腹腔镜，需要拉伸改组织。使用本发明的吻合器装置可以简单快速地实施SMART技术，并且其将网放置在腹壁正确的层中，以防止粘连。该技术是可再生的，可以在开放手术和腹腔镜手术中轻松执行。该吻合器允许造口环钻的创建，同时用网加固了该造口环钻。它可以用来生成各种类型的造口，包括回肠造口术和结肠造口术中生成造口。该SMART技术还可以避免组织不必要的拉伸，因此降低了疝的发病率。Incorporating a reinforcement mesh into this technique has been developed by the inventors and it is called SMART (Sewing Mesh Stoma Reinforcement). Previous studies incorporating a mesh, which was placed subperitoneally through an abdominal approach, are instructive for open surgery. Although this technique is relatively simple, it significantly increases operating time and is difficult to perform laparoscopically, requiring stretching of the reconstructed tissue. The SMART technique can be performed simply and quickly using the stapler device of the present invention and it places the mesh in the correct layer of the abdominal wall to prevent adhesions. The technique is reproducible and can be easily performed in open and laparoscopic procedures. The stapler allows the creation of a stoma trephine while it is reinforced with a mesh. It can be used to create stomas of all types, including ileostomy and colostomy. This SMART technology also avoids unnecessary stretching of tissues, thus reducing the incidence of hernias.

使用带有一个或多个中空通道的钉砧245，如前所述以及如图24和25所示的抽吸改进，有助于确保构成造口的肠可以轻易从环钻取出，并被正确导向。由于在这样的手术中对进入腹腔的受限，因此在腹腔镜造口形成中，该策略是特别困难的。The use of ananvil 245 with one or more hollow passages, as previously described and with the improved suction shown in Figures 24 and 25, helps to ensure that the bowel forming the stoma can be easily removed from the trephine and correctly inserted. guide. This strategy is particularly difficult in laparoscopic stoma formation due to the limited access to the abdominal cavity in such procedures.

该方法可以在患者（无论是人类还是非人类患者）体内进行。该方法还可以是对组织样本进行的离体方法。The method can be performed in a patient, whether human or non-human. The method can also be an ex vivo method performed on a tissue sample.

本发明的方法可以采用任何本发明的吻合器装置。例如，该方法可以采用包含一个或一个以上中空通道的钉砧245，该中空通道从砧轴延伸穿过砧头的整个厚度。因此，该方法可以进一步包括进行抽吸通过钉砧操被缝合的表面或组织的步骤。对被缝合的组织或表面的操作使其被放置在合适的位置，便于吻合或造口的形成。The methods of the invention may employ any of the stapler devices of the invention. For example, the method may employ ananvil 245 comprising one or more hollow passages extending from the anvil shaft through the entire thickness of the anvil head. Accordingly, the method may further comprise the step of performing suction on the surface or tissue being stapled through the anvil operation. Manipulation of the tissue or surface being stapled to bring it into position to facilitate the formation of an anastomosis or stoma.

本发明的第六部分提供了包含本发明的吻合器装置的成套部件，以及防护装置。该防护装置由塑料、金属或其他合适的材料制成，其安置在缝合装置和在传送过程中带有接合的钉砧的钉砧对接销之间。其通过防止缝合装置不被砧头挤压从而保护吻合器装置不受损害。该防护装置还可以防止缝合装置被不小心启动，例如，在一些实施例中，只有当钉砧对接销收缩进吻合器一段足够长的距离才能启动缝合装置。The sixth aspect of the present invention provides a kit of parts comprising the stapler device of the present invention, and a protective device. The guard is made of plastic, metal or other suitable material and is positioned between the stapling device and the anvil butt pin with the anvil engaged during transport. It protects the stapler device from damage by preventing the stapling device from being crushed by the anvil. The guard also prevents the stapling device from being inadvertently activated, eg, in some embodiments, only when the anvil butt pin is retracted a sufficient distance into the stapler to activate the stapling device.

该防护装置可以是圆柱形的，优选地，该防护装置包含一个中心孔，可以连接到钉砧对接销上，使得钉砧对接销可以穿过该防护装置的中心孔。该防护装置还可以包含一个从防护装置外沿到防护装置中心孔的通道，使得即使当钉砧接合了，该防护装置仍可以放置到钉砧对接销上或从钉砧对接销上移除。The guard may be cylindrical, preferably, the guard includes a central hole, and may be attached to an anvil butt pin such that the anvil butt pin can pass through the central hole of the guard. The guard may also include a passage from the outer edge of the guard to the central bore of the guard so that the guard may be placed on or removed from the anvil docking pin even when the anvil is engaged.

本发明的第七方面提供了包含本发明的吻合器装置的成套部件，以及加固网138。由于应用的缝钉同时穿过组织层以及该网，因此该网或其他加固物质可以强化形成的吻合或造口环钻。该网也可以加固两个组织层的密封性，防止任何物质从器官内腔漏到体腔中。该网可以由任何合适的材料制成，如合成材料或生物材料。A seventh aspect of the invention provides a kit comprising a stapler device of the invention, and areinforcement mesh 138 . As the staples applied pass through both tissue layers and the mesh, the mesh or other reinforcing substance can strengthen the formed anastomosis or stoma trephination. The mesh also reinforces the seal between the two tissue layers, preventing any material from leaking from the lumen of the organ into the body cavity. The mesh can be made of any suitable material, such as synthetic or biological material.

适用于该网的合成材料包括聚丙烯、聚酯和聚四氟乙烯（PTFE，例如压缩、膨胀或电纺）。聚丙烯具有稳定性、坚韧性、惰性和良好的操控性。聚丙烯网是由排列在具有不同尺寸孔径的网状物中的聚丙烯纤维所构成。PTFE网具有光滑性、柔软性、坚韧性和良好的组织生长性。Suitable synthetic materials for this mesh include polypropylene, polyester, and polytetrafluoroethylene (PTFE, e.g. compressed, expanded, or electrospun). Polypropylene offers stability, toughness, inertness and good handling properties. Polypropylene mesh is composed of polypropylene fibers arranged in a mesh with pores of different sizes. PTFE mesh has smoothness, softness, tenacity and good tissue growth.

生物网包括从牛、猪和马等身上取下的心包膜，或真皮组织等其他器官组织。The biomesh includes pericardium, or other organ tissues such as dermal tissue, taken from cattle, pigs, and horses, among others.

可选地，本发明的套件可能包含本发明的吻合器装置、网和防护装置。Optionally, a kit of the present invention may comprise the stapler device, mesh and guard device of the present invention.

本发明的套件可以进一步包括使用说明。该套件也可以进一步包括用来操纵砧轴的镊子。例如，当创建造口环钻时，可以用该镊子通过腹壁上的切口收缩砧轴。另外，该镊子可以帮助砧轴和钉砧对接销的对接。本发明的套件可以包括夹钳370，或其他特性组合，例如，吻合器装置、防护装置、网138和夹钳370。Kits of the invention may further include instructions for use. The kit may also further include forceps for manipulating the anvil shaft. For example, when creating a stoma trephine, the forceps can be used to retract the anvil shaft through the incision in the abdominal wall. In addition, the tweezers can help the docking of the anvil shaft and the anvil docking pin. Kits of the present invention may includeclamp 370 , or other combinations of features such as a stapler device, guard,mesh 138 andclamp 370 .

在一些实施例中，该套件是无菌的。该套件也可以是一次性的。In some embodiments, the kit is sterile. The kit can also be disposable.

本发明的第二以及后续方面的特性都是参照本发明的第一方面作出必要的修改。The features of the second and subsequent aspects of the invention are referenced mutatis mutandis to the first aspect of the invention.

实施例Example

参考以下实施例将对本发明进行进一步描述，这些实施例只是为了说明本发明，而不是限制本发明的范围。The present invention will be further described with reference to the following examples, which are intended to illustrate the present invention and not limit the scope of the present invention.

前会阴平面的超低位直肠前切除术（APPEAR技术）Ultra-low anterior proctectomy at the anterior perineal level (APPEAR technique)

录入14位患者，其中，7个为肿瘤，5个为溃疡性结肠炎，2个为创伤性直肠损伤。在术前和术后中位数2年，对患者进行评估。Fourteen patients were enrolled, of which 7 had tumors, 5 had ulcerative colitis, and 2 had traumatic rectal injuries. Patients were evaluated preoperatively and at a median of 2 years postoperatively.

14个患者中的9个接受了回肠造口术逆转并经历至少一年的随访，其中一个患者等待闭合。由于造口会阴瘘，四个患者尚未考虑回肠造口术逆转。14个患者中的3个有瞬态性功能障碍的记录，但没有泌尿系统疾病的发生。Nine of 14 patients underwent ileostomy reversal and had at least one year of follow-up, with one patient awaiting closure. Four patients had not yet been considered for ileostomy reversal due to stoma-perineal fistula. Transient sexual dysfunction was documented in 3 of 14 patients, but no urinary disorders occurred.

 当为肿瘤或创伤患者执行APPEAR手术，术后患者中位失禁（Wexner）评分为5（范围0-8，n=6），平均排便频率为3（范围1-8/天）。所有癌症都完全切除无局部复发。为溃疡性结肠炎患者执行恢复性直肠结肠切除术，中位失禁评分为2（范围0-6，n=3），平均每日排便频率为3（范围1-5）。在回肠造口闭合术后术前SF-36得分（衡量生活质量的36项简易调查问卷）没有明显改变，在会阴解剖后，肛肠生理试验没有变化。When APPEAR was performed on tumor or trauma patients, the median postoperative incontinence (Wexner) score was 5 (range 0-8, n=6) and the mean bowel frequency was 3 (range 1-8/day). All cancers were completely resected without local recurrence. Restorative proctocolectomy was performed for patients with ulcerative colitis with a median incontinence score of 2 (range 0-6, n=3) and a mean daily bowel frequency of 3 (range 1-5). Preoperative SF-36 scores (36-item short-form questionnaire measuring quality of life) were not significantly changed after ileostomy closure, and anorectal physiology tests were not changed after perineal dissection.

因此，该APPEAR手术为实现超低位保留括约肌造口提供了一种可选技术，这对于传统手术是不可能的。这是一种有前景的新手术，即使是目前的状况也有可能减少永久性造口的需要。在APPEAR等手术中使用本发明的吻合器装置，允许钉砧和吻合器肠管或体外接合，使得外科医生可以更清楚地看到钉砧对接到钉砧对接销中。伸长的轴也使得外科医生可以在体外看到钉砧和吻合器的完全接合。Therefore, this APPEAR procedure provides an alternative technique for achieving an ultra-low sphincter-sparing ostomy, which is not possible with conventional surgery. This is a promising new procedure that has the potential to reduce the need for permanent stomas even in the current condition. Using the stapler device of the present invention in APPEAR and other operations allows the anvil and stapler intestinal or extracorporeal engagement, so that the surgeon can more clearly see the anvil docked into the anvil docking pin. The elongated shaft also allows the surgeon to visualize full engagement of the anvil and stapler outside the body.

缝合网造口加固技术（AMART）Suture Mesh Stoma Reinforcement Technique (AMART)

结肠造口旁疝（PH）有很高的发病率。三个随机对照试验表明，加固网可以显著降低其发病率。然而，该技术是很耗时，难以在腹腔镜手术中执行，并且依赖环钻的手工拉伸。SMART可以解决这些问题。Colostomy hernia (PH) has a high incidence. Three randomized controlled trials showed that reinforcing the net can significantly reduce its incidence. However, this technique is time-consuming, difficult to perform laparoscopically, and relies on manual stretching of the trephine. SMART can solve these problems.

SMART使用本发明的吻合器装置在后腹直肌鞘和腹膜创建精确的环钻，同时将网在腹膜下周向固定到环钻。拉伸最小化。随机对照试验的9例（M:F 2:7，平均年龄55岁，范围24-77岁）PH高危患者，禁忌进行SMART（7个开放手术，2个腹腔镜手术）。SMART uses the stapler device of the present invention to create a precise trephine in the posterior rectus sheath and peritoneum while simultaneously securing the mesh to the trephine subperitoneally circumferentially. Stretch is minimized. Nine patients (M:F 2:7, mean age 55 years, range 24-77 years) in a randomized controlled trial of high-risk patients with PH who were contraindicated for SMART (7 open surgeries, 2 laparoscopic surgeries).

手术后（30天）没有与造口相关的病发。在48小时内所以造口功能正常。一个患者出院后出现与造口形成无关的肠梗阻，另一个患者在成功的心肺复苏术后突发临时性造口疼痛肿胀。在随访的13周（2-14），没有发现结肠造口旁疝。There were no stoma-related morbidities after surgery (30 days). Within 48 hours, the stoma functioned normally. One patient was discharged with ileus unrelated to stoma formation, and another patient had sudden onset of temporary painful stoma swelling after successful CPR. At 13 weeks (2-14) of follow-up, no parastomal hernia was found.

SMART是一种新的简单的在开放手术和腹腔镜手术中精确地创建加固造口环钻的方法，其减少了结肠造口旁疝的发病率。SMART is a new simple approach to precisely create a reinforcement trephine in open and laparoscopic procedures that reduces the incidence of paracolostomal hernias.

Claims (23)

1. anastomat device comprises:

(a) have the anastomat of near-end, far-end and the longitudinal axis, this anastomat further comprises:

(i) trigger;

(ii) dock pin with the nail anvil of anastomat longitudinal axis in parallel alignment;

(iii) stitching devices, described nail anvil butt joint pin and stitching devices are arranged on the far-end of anastomat; With

(b) detachable nail anvil, it includes anvil head and anvil axle,

Wherein, described anvil axle is suitable for receiving described nail anvil butt joint pin, and the operation of described trigger causes stitching devices to be activated, and it is characterized in that the length of anvil axle is at least 4 centimetres.

2. anastomat device according to claim 1 is characterized in that described anvil axle comprises one or more breach.

3. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described anvil axle comprises visual windows, described nail anvil butt joint pin comprises the butt joint indicant, when nail anvil docks with nail anvil when selling out full butt joint, can see this butt joint indicant by this visual windows.

4. according to the described anastomat device of above-mentioned arbitrary claim, the length that it is characterized in that the anvil axle is 6 centimetres to 20 centimetres.

5. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described nail anvil butt joint pin can be inserted in the described anvil axle, this nail anvil butt joint pin further comprises holding device, and when nail anvil docked the pin butt joint with nail anvil, described holding device was with the nail anvil fix in position.

6. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that stitching devices comprises anastomat housing, annular blade, driving blade and a row or multi-row seam nail groove that circumferentially arranges around the annular blade outer surface.

7. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described anvil head is arc, taper or taper shape.

8. according to the described anastomat device of above-mentioned arbitrary claim, it is characterized in that described nail anvil comprises one or more hollow channels, described hollow channel extends through the whole thickness of anvil head from the anvil axle.

9. be used for the nail anvil of anastomat device, comprise anvil head and anvil axle, it is characterized in that the length of anvil axle is at least 4 centimetres.

10. the described anastomat device of any one claim of front or nail anvil are coincideing or are making purposes in the formation that choma bores.

11. use the described anastomat device of above-mentioned arbitrary claim to form the method for coincideing between two surfaces, it comprises:

The first surface of needs stitching is connected to the nail anvil of anastomat device;

Nail anvil butt joint pin and anvil be coupling close;

Anastomat is positioned, so that stitching devices engages with the second surface that needs to sew up;

Activate described trigger, in order to the seam nail first surface and second surface are linked together.

12. method according to claim 11 comprises that further the operation constriction device is retracted to step in the anastomat with nail anvil butt joint pin and the nail anvil that engages.

13. according to claim 11 or 12 described methods, it is characterized in that by purse string suture first surface being connected to nail anvil.

14. according to each described method in the claim 11 to 13, it is characterized in that: further comprise net is applied on nail anvil butt joint pin or the anvil axle.

Make the method that choma bores 15. use the described anastomat device of above-mentioned arbitrary claim in patient's body, to form, comprising:

In the tissue of needs formation making-port, form otch;

Nail anvil to the anastomat device positions, thereby makes the anvil head be positioned at patient's body and the anvil shaft extension goes out otch;

The anvil axle is docked on the nail anvil butt joint pin of anastomat; And

Excite described trigger, in the tissue that is sewn, to distribute a series of seam nails.

16. method according to claim 15 is characterized in that, further comprises the step of regaining the anvil axle by otch.

17. according to claim 15 or 16 described methods, it is characterized in that, further comprise net is applied to nail anvil butt joint pin or anvil axle.

18. according to each described method in the claim 15 to 17, it is characterized in that, further comprise the operation constriction device, nail anvil butt joint pin and the nail anvil that engages are retracted to the step in the anastomat.

19. according to each described method in the claim 11 to 18, it is characterized in that, described nail anvil comprises one or more hollow channels, and described hollow channel extends through the whole thickness of anvil head from the anvil axle, and described method further comprises the step of aspirating by this anvil head.

20. kit comprises according to each described anastomat device in the claim 1 to 9, also comprises safety device.

21. kit comprises according to each described anastomat device in the claim 1 to 9, also comprises net.

22. according to claim 20 or 21 described kits, it is characterized in that, further comprise clamp.

23. kit according to claim 22, it is characterized in that, described clamp comprises the long element of a pair of symmetry, this a pair of long element at one end is connected to each other by hinge or flexible connector, the other end of described long element be crooked and comprise one or how with relative long element groove opposite.

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