技术领域Technical Field
本发明涉及医疗器械技术领域，更具体的说，它涉及一种近端吻合口加固组件、加固套件及圆型吻合器。The present invention relates to the technical field of medical devices, and more specifically, to a proximal anastomotic reinforcement component, a reinforcement kit and a circular stapler.
背景技术Background Art
吻合器包括直线型吻合器和圆型吻合器，它们可以在切割的同时通过吻合钉对组织钉合，广泛用于肠、胃、肺、胰腺等脏器组织的重建及组织切割、缝合或吻合。圆型吻合器的切割吻合部包括两部分，一部分为具有类似于伞形或蘑菇形形状的钉砧组件，另一部分为吻合器的钉仓组件。钉仓组件包括钉仓，还设置有环形刀，用于切割组织。圆型吻合器能够在组织上形成环形吻合钉线，并利用环形刀切割组织形成圆型吻合口。利用这种器械可以方便地进行管腔器官的吻合，通常用于食道、肠或胃肠手术。相比于常规手术的先用手术刀或手术剪切开，圆型吻合器在很大程度上减少了此类手术过程的风险，并缩短了手术时间，因而在外科手术上有非常广泛的应用。但仅仅通过吻合钉的硬性钉合并不能完全避免吻合口组织的出血、渗漏。这是因为吻合钉为刚性结构，与软组织的柔性不能完全匹配，导致钉孔出现出血及闭合切割端面渗漏。为解决上述问题，可以通过将吻合口加固修补片与吻合器联用，使得吻合器切割和封闭创面的同时，将加固修补片固定于创面，封堵吻合钉钉孔，提高创面强度，从而避免创面的渗漏和出血。Staplers include linear staplers and circular staplers, which can staple tissues with staples while cutting, and are widely used in the reconstruction of organs such as intestines, stomachs, lungs, and pancreas, as well as tissue cutting, suturing, or anastomosis. The cutting and anastomosis portion of the circular stapler includes two parts, one of which is a staple anvil assembly having an umbrella-like or mushroom-like shape, and the other is a stapler cartridge assembly of the stapler. The stapler cartridge assembly includes a stapler cartridge and is also provided with an annular knife for cutting tissue. The circular stapler can form an annular staple line on the tissue, and use the annular knife to cut the tissue to form a circular anastomosis. This instrument can be used to conveniently anastomose tubular organs, and is usually used in esophageal, intestinal, or gastrointestinal surgery. Compared with conventional surgery that first uses a scalpel or surgical scissors to open, the circular stapler greatly reduces the risk of such surgical procedures and shortens the operation time, and is therefore widely used in surgical operations. However, the hard stapling of staples alone cannot completely avoid bleeding and leakage of anastomotic tissue. This is because the anastomotic staples are rigid structures that cannot fully match the flexibility of soft tissues, resulting in bleeding from the staple holes and leakage from the closed cut end surface. To solve the above problems, the anastomotic stoma reinforcement patch can be used in conjunction with the stapler, so that while the stapler is cutting and closing the wound surface, the reinforcement patch is fixed to the wound surface to block the stapler holes, improve the wound surface strength, and thus avoid leakage and bleeding from the wound surface.
现有技术CN117379127A，公开了两个加固修补片分别套接于圆型吻合器钉砧组件与圆型吻合器的钉仓组件的技术方案，该方案中加固修补片在圆型吻合器的内外两侧均具有一段沿圆型吻合器轴线方向的延伸部分，这些延伸部分会与圆型吻合器摩擦接触，以增加加固修补片与圆型吻合器之间的连接稳固性。加固修补片位于圆型吻合器外侧的延伸部分在圆型吻合器进入组织官腔或端面荷包时与组织内侧粘膜容易产生粘连、摩擦，会造成加固修补片产生褶皱或移动脱离圆形吻合器，给组织吻合带来安全隐患，严重时甚至会导致吻合失败。The prior art CN117379127A discloses a technical solution in which two reinforcement patches are respectively sleeved on the anvil assembly of a circular stapler and the stapler cartridge assembly of a circular stapler. In this solution, the reinforcement patches have an extension along the axial direction of the circular stapler on both the inner and outer sides of the circular stapler. These extensions will have frictional contact with the circular stapler to increase the connection stability between the reinforcement patches and the circular stapler. The extension of the reinforcement patches located on the outer side of the circular stapler is prone to adhesion and friction with the inner mucosa of the tissue when the circular stapler enters the tissue cavity or the end face purse, which will cause the reinforcement patches to wrinkle or move away from the circular stapler, bringing safety hazards to tissue anastomosis, and even lead to anastomosis failure in severe cases.
针对这一问题，现有技术CN115211918A，公开了两个加固修补片分别通过固定件可拆卸连接于圆型吻合器钉砧组件与圆型吻合器的钉仓组件的技术方案，该方案中加固修补片仅在圆型吻合器的内侧均具有一段沿圆型吻合器轴线方向的延伸部分，这段延伸部分通过固定件与圆型吻合器可拆卸连接，其解决了加固修补片与组织内侧粘膜粘连、摩擦的问题。但该方案中加固修补片和圆型吻合器钉砧组件与圆型吻合器的钉仓组件的端面之间无连接关系，吻合过程中加固修补片受吻合钉影响容易翘边，从而无法准确的贴合吻合口，影响加固效果，严重时甚至会导致加固失败。In response to this problem, the prior art CN115211918A discloses a technical solution in which two reinforcement patches are detachably connected to the circular stapler anvil assembly and the circular stapler stapler magazine assembly through fixings. In this solution, the reinforcement patches only have an extension along the axial direction of the circular stapler on the inner side of the circular stapler. This extension is detachably connected to the circular stapler through fixings, which solves the problem of adhesion and friction between the reinforcement patches and the inner mucosa of the tissue. However, in this solution, there is no connection between the reinforcement patches and the end faces of the circular stapler anvil assembly and the circular stapler magazine assembly. During the anastomosis process, the reinforcement patches are easily warped by the anastomosis staples, so that they cannot accurately fit the anastomotic opening, affecting the reinforcement effect. In severe cases, it may even lead to reinforcement failure.
发明内容Summary of the invention
针对现有技术中存在的加固修补片与组织内侧粘膜粘连、摩擦的问题，以及加固修补片和圆型吻合器钉砧组件与圆型吻合器的钉仓组件的端面之间无连接关系，吻合过程中加固修补片受吻合钉影响容易翘边，无法准确的贴合吻合口的问题，本发明的目的在于提供一种近端吻合口加固组件、加固套件及圆型吻合器，以解决前述问题。In view of the problems in the prior art of adhesion and friction between the reinforcement patch and the inner mucosa of the tissue, and the lack of connection between the reinforcement patch and the end faces of the circular stapler anvil assembly and the circular stapler stapler magazine assembly, the reinforcement patch is easily warped due to the influence of the anastomotic staples during the anastomosis process and cannot be accurately fitted to the anastomotic stoma, the purpose of the present invention is to provide a proximal anastomotic stoma reinforcement assembly, a reinforcement kit and a circular stapler to solve the aforementioned problems.
本发明提供了一种近端吻合口加固组件，其包括近端加固片和近端固定组件，所述近端加固片包括端面部和柱面连接部，所述端面部为圆环片，所述柱面连接部的顶端固定在端面部底面，所述柱面连接部的内侧面与端面部内侧环形边对齐。所述端面部的底面具有多个凸起。所述凸起用于嵌入圆型吻合器钉仓中单钉的仓孔内。所述近端固定组件用于可拆卸连接柱面连接部与圆型吻合器的钉筒。The present invention provides a proximal anastomotic reinforcement component, which includes a proximal reinforcement sheet and a proximal fixing component, wherein the proximal reinforcement sheet includes an end face portion and a cylindrical connecting portion, wherein the end face portion is a circular ring sheet, wherein the top end of the cylindrical connecting portion is fixed to the bottom surface of the end face portion, and the inner side surface of the cylindrical connecting portion is aligned with the inner annular edge of the end face portion. The bottom surface of the end face portion has a plurality of protrusions. The protrusions are used to be embedded in the magazine hole of a single nail in the nail magazine of a circular stapler. The proximal fixing component is used to detachably connect the cylindrical connecting portion with the nail barrel of the circular stapler.
本发明进一步设置为：所述近端加固片具有至少一个第一切口，第一切口沿柱面连接部轴线方向对端面部和柱面连接部进行切分，单一第一切口处的两切面可相互贴合。所述第一切口具有多个时，所有第一切口将近端加固片切分为环绕柱面连接部轴线分布的多个部分。近端加固片的每个部分均与近端固定组件连接。The present invention is further configured as follows: the proximal reinforcing sheet has at least one first incision, the first incision divides the end face portion and the cylindrical connecting portion along the axis direction of the cylindrical connecting portion, and the two cut surfaces at a single first incision can fit each other. When there are multiple first incisions, all the first incisions divide the proximal reinforcing sheet into multiple parts distributed around the axis of the cylindrical connecting portion. Each part of the proximal reinforcing sheet is connected to the proximal fixing assembly.
本发明进一步设置为：近端固定组件为具有单一开口的环形结构，或者近端固定组件由多个绕柱面连接部轴线分布的构件构成。The present invention is further configured such that: the proximal fixing assembly is an annular structure with a single opening, or the proximal fixing assembly is composed of a plurality of components distributed around the axis of the cylindrical connecting portion.
本发明进一步设置为：所述近端固定组件包括涨紧环，所述涨紧环包括多个弧形件，每个弧形件上均设置有第一插接部和第一插接槽，所有弧形件绕环绕柱面连接部轴线分布，相邻两弧形件之间通过第一插接部与第一插接槽的插接配合连接在一起。所述柱面连接部与所述涨紧环固定连接，所述涨紧环涨紧在圆形吻合器的钉筒内侧，所述涨紧环位于圆形吻合器的环形刀内侧。The present invention is further configured as follows: the proximal fixing assembly includes a tension ring, the tension ring includes a plurality of arc-shaped members, each arc-shaped member is provided with a first plug-in portion and a first plug-in groove, all arc-shaped members are distributed around the axis of the cylindrical connecting portion, and two adjacent arc-shaped members are connected together through the plug-in cooperation of the first plug-in portion and the first plug-in groove. The cylindrical connecting portion is fixedly connected to the tension ring, the tension ring is tightened on the inner side of the nail barrel of the circular stapler, and the tension ring is located on the inner side of the annular knife of the circular stapler.
本发明进一步设置为：所述近端固定组件还可替换为如下结构，其包括支架和卡扣，所述支架设置多个，每个支架均和柱面连接部与圆型吻合器固定连接。所述柱面连接部开设有多个绕柱面连接部轴线分布的第一扣接槽，每个第一扣接槽内卡接一个穿过支架顶端的卡扣。所述圆型吻合器开设有多个绕圆型吻合器轴线分布的第二扣接槽，每个第二扣接槽内卡接一个穿过支架底端的卡扣。The present invention is further configured as follows: the proximal fixing assembly can also be replaced with the following structure, which includes a bracket and a buckle, and the bracket is provided in plurality, and each bracket is fixedly connected to the cylindrical connecting part and the circular stapler. The cylindrical connecting part is provided with a plurality of first buckle grooves distributed around the axis of the cylindrical connecting part, and a buckle passing through the top end of the bracket is clamped in each first buckle groove. The circular stapler is provided with a plurality of second buckle grooves distributed around the axis of the circular stapler, and a buckle passing through the bottom end of the bracket is clamped in each second buckle groove.
本发明进一步设置为：所述第一切口具有多个。The present invention is further configured such that: there are a plurality of first incisions.
本发明进一步设置为：所述端面部顶部设置有凹槽，每个凸起内部具有一个凹槽。The present invention is further configured as follows: a groove is provided on the top of the end surface portion, and a groove is provided inside each protrusion.
本发明进一步设置为：凸起的最低点至端面部底面的竖直距离大于或等于0.1mm。The present invention is further configured such that: the vertical distance from the lowest point of the protrusion to the bottom surface of the end face portion is greater than or equal to 0.1 mm.
本发明进一步设置为：所述近端加固片为可降解生物加固片。The present invention is further configured such that: the proximal reinforcement sheet is a degradable biological reinforcement sheet.
本发明进一步设置为：端面部的厚度小于或等于0.3mm。The present invention is further configured such that the thickness of the end surface portion is less than or equal to 0.3 mm.
本发明还提供了一种加固套件，其包括上述近端吻合口加固组件和远端吻合口加固组件。所述远端加固组件包括远端加固片和远端固定组件，所述远端固定组件包括内固定件和外固定件，内固定件和外固定件可拆卸连接，所述远端加固片被夹紧在内固定件和外固定件之间。远端加固片、内固定件和外固定件三者均具有用于容纳圆型吻合器的中心轴的通孔，且三者的通孔轴线共线，三个通孔的径向上内固定件和外固定件均不超出远端加固片的外边缘，外固定件的通孔直径和远端加固片的通孔直径均大于或等于内固定件的通孔直径。所述内固定件用于可拆卸连接圆型吻合器的中心轴。The present invention also provides a reinforcement kit, which includes the above-mentioned proximal anastomotic reinforcement assembly and distal anastomotic reinforcement assembly. The distal reinforcement assembly includes a distal reinforcement sheet and a distal fixing assembly, and the distal fixing assembly includes an internal fixing member and an external fixing member, the internal fixing member and the external fixing member are detachably connected, and the distal reinforcement sheet is clamped between the internal fixing member and the external fixing member. The distal reinforcement sheet, the internal fixing member and the external fixing member all have a through hole for accommodating the central axis of the circular stapler, and the through hole axes of the three are collinear. In the radial direction of the three through holes, the internal fixing member and the external fixing member do not exceed the outer edge of the distal reinforcement sheet, and the through hole diameter of the external fixing member and the through hole diameter of the distal reinforcement sheet are both greater than or equal to the through hole diameter of the internal fixing member. The internal fixing member is used for detachably connecting the central axis of the circular stapler.
本发明进一步设置为：所述内固定件为弹性固定件，其通过摩擦力抵紧固定在圆型吻合器的中心轴上。The present invention is further configured as follows: the internal fixing member is an elastic fixing member, which is tightly fixed on the central axis of the circular stapler through friction force.
本发明进一步设置为：所述内固定件的内侧设置多个弹性紧固条，所有弹性紧固条平行于内固定件的轴线，并环绕内固定件的轴线分布。The present invention is further configured as follows: a plurality of elastic fastening strips are arranged on the inner side of the inner fixing member, and all the elastic fastening strips are parallel to the axis of the inner fixing member and are distributed around the axis of the inner fixing member.
本发明进一步设置为：所述远端加固片具有至少一个第二切口，第二切口沿远端加固片轴线方向切分远端加固片，单一第二切口处的两切面可相互贴合。所述第二切口具有多个时，所有第二切口将远端加固片切分为环绕远端加固片轴线分布的多个部分。The present invention is further configured such that: the distal reinforcing sheet has at least one second incision, the second incision divides the distal reinforcing sheet along the axis direction of the distal reinforcing sheet, and the two cut surfaces at a single second incision can fit each other. When there are multiple second incisions, all the second incisions divide the distal reinforcing sheet into multiple parts distributed around the axis of the distal reinforcing sheet.
本发明进一步设置为：所述内固定件具有至少一个第三切口，第三切口沿内固定件轴线方向切分内固定件。所述第三切口具有多个时，所有第三切口将内固定件切分为环绕内固定件轴线分布的多个部分。内固定件相邻的两个部分可拆卸连接。The present invention is further configured as follows: the internal fixing member has at least one third incision, and the third incision divides the internal fixing member along the axis direction of the internal fixing member. When there are multiple third incisions, all the third incisions divide the internal fixing member into multiple parts distributed around the axis of the internal fixing member. Two adjacent parts of the internal fixing member are detachably connected.
所述外固定件具有至少一个第四切口，第四切口沿外固定件轴线方向切分外固定件。所述第四切口具有多个时，所有第四切口将外固定件切分为环绕外固定件轴线分布的多个部分。The external fixing member has at least one fourth cutout, which divides the external fixing member along the axis of the external fixing member. When there are multiple fourth cutouts, all the fourth cutouts divide the external fixing member into multiple parts distributed around the axis of the external fixing member.
本发明进一步设置为：所述远端加固片具有多个第二切口，所述内固定件具有多个第三切口，所述外固定件具有多个第四切口。The present invention is further configured as follows: the distal reinforcing piece has a plurality of second incisions, the internal fixing member has a plurality of third incisions, and the external fixing member has a plurality of fourth incisions.
本发明进一步设置为：内固定件的每个部分上均设置有第二插接部和第二插接槽，内固定件中相邻两部分通过第二插接部与第二插接槽的插接配合连接在一起。The present invention is further configured as follows: each part of the inner fixing member is provided with a second plug-in portion and a second plug-in slot, and two adjacent parts of the inner fixing member are connected together by plugging and matching the second plug-in portion and the second plug-in slot.
本发明进一步设置为：所述远端加固组件还包括扣合件，扣合件设置多个，所有扣合件环绕内固定件的轴线分布，所述扣合件穿过外固定件和远端加固片，并插入内固定片，与内固定片卡接。The present invention is further configured as follows: the distal reinforcement component also includes a fastening piece, a plurality of fastening pieces are provided, all of which are distributed around the axis of the internal fixing piece, the fastening piece passes through the external fixing piece and the distal reinforcement sheet, and is inserted into the internal fixing sheet to be clamped with the internal fixing sheet.
本发明进一步设置为：所述远端加固片为可降解生物加固片。The present invention is further configured such that: the distal reinforcement sheet is a degradable biological reinforcement sheet.
本发明进一步设置为：所述远端加固片的厚度小于或等于0.3mm。The present invention is further configured such that: the thickness of the distal reinforcement sheet is less than or equal to 0.3 mm.
本发明还提供了一种圆型吻合器，其包括上述加固套件、钉筒、抵钉座和中心轴。钉筒内固定有钉仓和环形刀，抵钉座内固定有钉砧和刀砧，中心轴与抵钉座固定连接，中心轴与钉筒固定连接或可拆卸连接。The present invention also provides a circular stapler, which includes the above-mentioned reinforcement kit, a nail barrel, a nail anvil and a central shaft. The nail barrel is fixed with a nail magazine and an annular knife, the nail anvil is fixed with a nail anvil and a knife anvil, the central shaft is fixedly connected to the nail anvil, and the central shaft is fixedly connected or detachably connected to the nail barrel.
所述端面部与钉仓的端面相贴，钉仓中每个单钉的仓孔内嵌入至多一个凸起。所述柱面连接部位于环形刀内侧，并通过近端固定组件与钉筒可拆卸连接。The end surface is attached to the end surface of the nail magazine, and at most one protrusion is embedded in the magazine hole of each single nail in the nail magazine. The cylindrical connecting part is located inside the annular knife and is detachably connected to the nail barrel through a proximal fixing assembly.
所述内固定件与中心轴可拆卸连接，所述远端加固片与钉砧的端面相贴。环形刀与刀砧相抵时，所述远端固定组件位于环形刀内侧。The inner fixing member is detachably connected to the central axis, and the distal reinforcing sheet is in contact with the end surface of the nail anvil. When the annular knife is against the anvil, the distal fixing assembly is located inside the annular knife.
本发明进一步设置为：刀砧径向上，内固定件的外边缘与刀砧内边缘的距离大于或等于2mm，外固定件的外边缘与刀砧内边缘的距离大于或等于2mm。The present invention is further configured such that: in the radial direction of the anvil, the distance between the outer edge of the inner fixing member and the inner edge of the anvil is greater than or equal to 2 mm, and the distance between the outer edge of the outer fixing member and the inner edge of the anvil is greater than or equal to 2 mm.
本发明进一步设置为：柱面连接部外壁与环形刀内壁的距离大于或等于2mm。The present invention is further configured such that the distance between the outer wall of the cylindrical connecting portion and the inner wall of the annular knife is greater than or equal to 2 mm.
综上所述，本发明相比于现有技术具有以下有益效果：本发明中近端加固片仅在圆型吻合器的内侧均具有一段沿圆型吻合器轴线方向的延伸部分，这段延伸部分通过近端固定组件与圆型吻合器可拆卸连接，其解决了近端加固片与组织摩擦、粘连的问题，减少了近端加固片在圆型吻合器上移动及形成褶皱的可能性。此外本发明中近端加固片上的凸起增加了近端加固片与圆型吻合器钉仓之间的连接强度，降低了吻合过程中近端加固片翘边的可能性，使得近端加固片能够准确贴合吻合口，保证了加固效果。在此基础上，本发明还提供了一种加固组件，其中的近端吻合口加固组件和远端吻合口加固组件均设置为分体结构，在不改变现有圆型吻合器结构的基础上，安装在现有圆型吻合器上，能够十分简便且低成本的实现现有圆型吻合器的结构改进。In summary, the present invention has the following beneficial effects compared with the prior art: the proximal reinforcing sheet in the present invention only has an extension along the axial direction of the circular stapler on the inner side of the circular stapler, and this extension is detachably connected to the circular stapler through a proximal fixing assembly, which solves the problem of friction and adhesion between the proximal reinforcing sheet and the tissue, and reduces the possibility of the proximal reinforcing sheet moving on the circular stapler and forming wrinkles. In addition, the protrusion on the proximal reinforcing sheet in the present invention increases the connection strength between the proximal reinforcing sheet and the stapler magazine of the circular stapler, reduces the possibility of the proximal reinforcing sheet warping during the anastomosis process, and enables the proximal reinforcing sheet to accurately fit the anastomotic opening, thereby ensuring the reinforcement effect. On this basis, the present invention also provides a reinforcement assembly, wherein the proximal anastomotic opening reinforcement assembly and the distal anastomotic opening reinforcement assembly are both arranged as split structures, which are installed on the existing circular stapler without changing the existing circular stapler structure, and can realize the structural improvement of the existing circular stapler very simply and at low cost.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为实施例1中近端吻合口加固组件的结构示意图；FIG1 is a schematic structural diagram of a proximal anastomotic reinforcement assembly in Example 1;
图2为体现实施例1中凹槽的示意图；FIG2 is a schematic diagram of a groove in Embodiment 1;
图3为实施例1中近端吻合口加固组件安装在圆型吻合器中钉筒上的示意图；FIG3 is a schematic diagram of the proximal anastomotic stoma reinforcement assembly in Example 1 installed on the stapler barrel of the circular stapler;
图4为实施例1中近端吻合口加固组件安装在圆型吻合器中钉筒上的剖面示意图；FIG4 is a cross-sectional schematic diagram of the proximal anastomotic stoma reinforcement assembly in Example 1 installed on the stapler barrel in the circular stapler;
图5为体现实施例1中凹槽与吻合钉相对位置关系的局部放大示意图；FIG5 is a partial enlarged schematic diagram showing the relative position relationship between the groove and the staple in Example 1;
图6为实施例2中近端吻合口加固组件的结构示意图；FIG6 is a schematic structural diagram of the proximal anastomotic reinforcement assembly in Example 2;
图7为实施例2中近端吻合口加固组件安装在圆型吻合器中钉筒上的示意图；FIG7 is a schematic diagram of the proximal anastomotic stoma reinforcement assembly installed on the stapler barrel of the circular stapler in Example 2;
图8为实施例2中近端吻合口加固组件安装在圆型吻合器中钉筒上的剖面示意图；FIG8 is a cross-sectional schematic diagram of the proximal anastomotic stoma reinforcement assembly installed on the stapler barrel in the circular stapler in Example 2;
图9为实施例3中的远端吻合口加固组件的底面结构示意图；FIG9 is a schematic diagram of the bottom structure of the distal anastomotic stoma reinforcement assembly in Example 3;
图10为实施例3中的远端吻合口加固组件的顶面结构示意图；FIG10 is a schematic diagram of the top surface structure of the distal anastomotic reinforcement assembly in Example 3;
图11为实施例4中的远端吻合口加固组件的底面结构示意图；FIG11 is a schematic diagram of the bottom structure of the distal anastomotic stoma reinforcement assembly in Example 4;
图12为实施例4中的远端吻合口加固组件的顶面结构示意图；FIG12 is a schematic diagram of the top surface structure of the distal anastomotic reinforcement assembly in Example 4;
图13为实施例5中圆型吻合器的整体结构示意图；FIG13 is a schematic diagram of the overall structure of the circular stapler in Example 5;
图14为实施例5中圆型吻合器拆掉击发手柄后的爆炸结构示意图；FIG14 is a schematic diagram of the explosion structure of the circular stapler in Example 5 after the firing handle is removed;
图15为体现实施例5中内固定件、外固定件与刀砧相对位置的局部结构示意图；15 is a partial structural schematic diagram showing the relative positions of the inner fixing member, the outer fixing member and the knife anvil in Example 5;
图16为体现实施例5中柱面连接部与环形刀相对位置的局部放大示意图；FIG16 is a partial enlarged schematic diagram showing the relative positions of the cylindrical connecting portion and the annular knife in Example 5;
图17为实施例6中圆型吻合器的结构示意图；FIG17 is a schematic diagram of the structure of the circular stapler in Example 6;
图18为实施例6中钉筒和中心轴拆分后的示意图。FIG. 18 is a schematic diagram of the nail barrel and the central axis after being separated in Example 6. FIG.
图中：1、近端吻合口加固组件；11、近端加固片；111、端面部；112、柱面连接部；113、凸起；114、第一切口；115、凹槽；12、近端固定组件；121、弧形件；1211、第一插接部；1212、第一插接槽；122、支架；123、卡扣；2、远端吻合口加固组件；21、远端加固片；211、第二切口；22、远端固定组件；221、内固定件；2211、弹性紧固条；2212、第三切口；2213、第二插接部；2214、第二插接槽；222、外固定件；2221、第四切口；223、扣合件；3、钉筒；31、钉仓；311、仓孔；32、环形刀；4、抵钉座；41、钉砧；42、刀砧；5、中心轴；6、吻合钉。In the figure: 1, proximal anastomotic reinforcement component; 11, proximal reinforcement sheet; 111, end face portion; 112, cylindrical connection portion; 113, protrusion; 114, first incision; 115, groove; 12, proximal fixing component; 121, arc-shaped member; 1211, first plug-in portion; 1212, first plug-in slot; 122, bracket; 123, buckle; 2, distal anastomotic reinforcement component; 21, distal reinforcement sheet; 211, second Incision; 22, distal fixing assembly; 221, internal fixing member; 2211, elastic fastening strip; 2212, third incision; 2213, second plug-in portion; 2214, second plug-in slot; 222, external fixing member; 2221, fourth incision; 223, snap-fit member; 3, nail barrel; 31, nail magazine; 311, magazine hole; 32, annular knife; 4, nail support; 41, nail anvil; 42, knife anvil; 5, central axis; 6, anastomosis staple.
具体实施方式DETAILED DESCRIPTION
下面将结合附图说明对本发明的技术方案进行清楚的描述，显然，所描述的实施例并不是本发明的全部实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于发明的保护范围。The technical solution of the present invention will be clearly described below in conjunction with the accompanying drawings. Obviously, the described embodiments are not all embodiments of the present invention, and all other embodiments obtained by ordinary technicians in the field without making creative work are within the scope of protection of the invention.
需要说明的是，术语“中心”、“上”、“下”、“水平”、“左”、“右”、“前”、“后”、“横向”、“纵向”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，并不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。It should be noted that the directions or positional relationships indicated by terms such as “center”, “up”, “down”, “horizontal”, “left”, “right”, “front”, “back”, “lateral” and “longitudinal” are based on the directions or positional relationships shown in the accompanying drawings and are only for the convenience of describing the present invention and simplifying the description. They do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present invention.
本发明中的远端和近端是以医生手术时器械所处的位置而言，距离医生较近的一端为近端，距离医生较远的一端为远端。The distal end and the proximal end in the present invention refer to the position of the instrument when the doctor is performing surgery. The end closer to the doctor is the proximal end, and the end farther from the doctor is the distal end.
实施例1Example 1
如图1-5所示，为本发明实施例1中的近端吻合口加固组件，其包括近端加固片11和近端固定组件12，所述近端加固片11包括端面部111和柱面连接部112，所述端面部111为圆环片，所述柱面连接部112的顶端固定在端面部111底面，所述柱面连接部112的内侧面与端面部111内侧环形边对齐。所述端面部111的底面具有多个凸起113。所述凸起113用于嵌入圆型吻合器钉仓31中单钉的仓孔311内。所述近端固定组件12用于可拆卸连接柱面连接部112与圆型吻合器的钉筒3。本实施例中所述凸起113的分布与其所在圆型吻合器的单钉仓孔311分布一致，使每个单钉仓孔311内均嵌入一个凸起113，所述凸起113绕柱面连接部112中心线呈环形分布。As shown in Fig. 1-5, it is the proximal anastomotic reinforcement assembly in Example 1 of the present invention, which includes a proximal reinforcement sheet 11 and a proximal fixing assembly 12. The proximal reinforcement sheet 11 includes an end face portion 111 and a cylindrical connecting portion 112. The end face portion 111 is a circular ring sheet. The top end of the cylindrical connecting portion 112 is fixed to the bottom surface of the end face portion 111, and the inner side surface of the cylindrical connecting portion 112 is aligned with the inner annular edge of the end face portion 111. The bottom surface of the end face portion 111 has a plurality of protrusions 113. The protrusions 113 are used to be embedded in the magazine hole 311 of a single nail in the nail magazine 31 of the circular stapler. The proximal fixing assembly 12 is used to detachably connect the cylindrical connecting portion 112 with the nail barrel 3 of the circular stapler. In this embodiment, the distribution of the protrusions 113 is consistent with the distribution of the single nail magazine holes 311 of the circular stapler in which they are located, so that a protrusion 113 is embedded in each single nail magazine hole 311, and the protrusions 113 are distributed in a ring shape around the center line of the cylindrical connecting portion 112.
本实施例中近端加固片11仅在圆型吻合器的内侧均具有一段沿圆型吻合器轴线方向的延伸部分，这段延伸部分通过近端固定组件12与圆型吻合器可拆卸连接，其解决了近端加固片11与组织摩擦、粘连的问题，减少了近端加固片11在圆型吻合器上移动及形成褶皱的可能性。此外本实施例中近端加固片11上的凸起113增加了近端加固片11与圆型吻合器钉仓31之间的连接强度，降低了吻合过程中近端加固片11翘边的可能性，使得近端加固片11能够准确贴合吻合口，保证了加固效果。In this embodiment, the proximal reinforcement sheet 11 only has an extension along the axial direction of the circular stapler on the inner side of the circular stapler. This extension is detachably connected to the circular stapler through the proximal fixing assembly 12, which solves the problem of friction and adhesion between the proximal reinforcement sheet 11 and the tissue, and reduces the possibility of the proximal reinforcement sheet 11 moving on the circular stapler and forming wrinkles. In addition, the protrusion 113 on the proximal reinforcement sheet 11 in this embodiment increases the connection strength between the proximal reinforcement sheet 11 and the circular stapler stapler magazine 31, reduces the possibility of the proximal reinforcement sheet 11 warping during the anastomosis process, and enables the proximal reinforcement sheet 11 to accurately fit the anastomotic opening, ensuring the reinforcement effect.
具体的，本实施例中凸起113的最低点至端面部111底面的竖直距离大于或等于0.1mm。Specifically, in this embodiment, the vertical distance from the lowest point of the protrusion 113 to the bottom surface of the end surface portion 111 is greater than or equal to 0.1 mm.
具体的，所述近端加固片11具有至少一个第一切口114，第一切口114沿柱面连接部112轴线方向对端面部111和柱面连接部112进行切分，单一第一切口114处的两切面可相互贴合。所述第一切口114具有多个时，所有第一切口114将近端加固片11切分为环绕柱面连接部112轴线分布的多个部分。近端加固片11的每个部分均与近端固定组件12连接。第一切口114的设置，使得近端加固片11可以在加固组织的基础上，保证吻合口在组织的张力的作用下，可以有一定的扩张量，从而便于将圆型吻合器从吻合口中取出，减少了圆型吻合器从吻合口中取出过程中吻合口撕裂的风险，从而提高了手术的成功率。此外，圆型吻合器的中心轴5可自第一切口114处进出近端加固片11，以便于在不改变现有圆型吻合器结构的基础上，实现近端加固片11在现有圆型吻合器上的拆装。Specifically, the proximal reinforcement sheet 11 has at least one first incision 114, and the first incision 114 divides the end face portion 111 and the cylindrical connection portion 112 along the axial direction of the cylindrical connection portion 112, and the two cut surfaces at a single first incision 114 can fit each other. When there are multiple first incisions 114, all first incisions 114 divide the proximal reinforcement sheet 11 into multiple parts distributed around the axis of the cylindrical connection portion 112. Each part of the proximal reinforcement sheet 11 is connected to the proximal fixing assembly 12. The provision of the first incision 114 allows the proximal reinforcement sheet 11 to ensure that the anastomosis can have a certain amount of expansion under the action of tissue tension on the basis of reinforcing the tissue, thereby facilitating the removal of the circular stapler from the anastomosis, reducing the risk of anastomotic tearing during the removal of the circular stapler from the anastomosis, and thus improving the success rate of the operation. In addition, the central axis 5 of the circular stapler can enter and exit the proximal reinforcing plate 11 through the first incision 114, so as to facilitate the assembly and disassembly of the proximal reinforcing plate 11 on the existing circular stapler without changing the structure of the existing circular stapler.
具体的，近端固定组件12为具有单一开口的环形结构，或者近端固定组件12由多个绕柱面连接部112轴线分布的构件构成。圆型吻合器的中心轴5可自近端固定组件12的开口处或近端固定组件12中相邻两构件之间的孔隙中进出近端固定组件12，以便于在不改变现有圆型吻合器结构的基础上，实现近端固定组件12在现有圆型吻合器上的拆装。Specifically, the proximal fixing assembly 12 is an annular structure with a single opening, or the proximal fixing assembly 12 is composed of a plurality of components distributed around the axis of the cylindrical connecting portion 112. The central axis 5 of the circular stapler can enter and exit the proximal fixing assembly 12 from the opening of the proximal fixing assembly 12 or from the gap between two adjacent components in the proximal fixing assembly 12, so as to realize the disassembly and assembly of the proximal fixing assembly 12 on the existing circular stapler without changing the structure of the existing circular stapler.
具体的，所述第一切口114具有多个，所有第一切口114绕柱面连接部112轴线均匀分布最佳。本实施例中第一切口114设置为两个。Specifically, there are a plurality of first cutouts 114, and it is best if all the first cutouts 114 are evenly distributed around the axis of the cylindrical connecting portion 112. In this embodiment, there are two first cutouts 114.
具体的，所述端面部111顶部设置有凹槽115，每个凸起113内部具有一个凹槽115，以便于凸起113处在吻合钉6自圆型吻合器的钉仓31的仓孔311中推出时，发生形变并顺利自仓孔311中脱出，保证近端加固片11与吻合口处的贴合效果。同时凹槽115的设置使得所述凸起113可通过模具在端面部111上压制成型，有助于降低凸起113在端面部111上的加工难度。Specifically, a groove 115 is provided at the top of the end surface 111, and each protrusion 113 has a groove 115 inside, so that when the staple 6 is pushed out of the magazine hole 311 of the staple magazine 31 of the circular stapler, the protrusion 113 is deformed and smoothly escapes from the magazine hole 311, thereby ensuring the fitting effect between the proximal reinforcing sheet 11 and the anastomotic opening. At the same time, the provision of the groove 115 enables the protrusion 113 to be pressed and formed on the end surface 111 by a mold, which helps to reduce the difficulty of processing the protrusion 113 on the end surface 111.
具体的，本实施例中所述近端加固片11为可降解生物加固片，可降解生物加固片的材料包括来自动物源完全可降解吸收的生物材料和或完全可降解吸收的高分子生物材料和或动物源与高分子合成且完全可降解吸收的生物材料，可降解生物加固片在组织愈合的过程中可提供足够力学张力，避免吻合钉6损伤周边组织，当组织愈合后，可降解生物材料自行降解，不会人体产生有害作用。Specifically, the proximal reinforcement sheet 11 described in this embodiment is a degradable biological reinforcement sheet. The material of the degradable biological reinforcement sheet includes completely degradable and absorbable biomaterials from animal sources and/or completely degradable and absorbable polymer biomaterials and/or completely degradable and absorbable biomaterials synthesized from animal sources and polymers. The degradable biological reinforcement sheet can provide sufficient mechanical tension during the tissue healing process to prevent the anastomosis staples 6 from damaging the surrounding tissues. After the tissue is healed, the degradable biomaterials will degrade on their own and will not cause harmful effects to the human body.
具体的，端面部111的厚度小于或等于0.3mm，以保证圆型吻合器的环形刀32能顺利切割端面部111。Specifically, the thickness of the end surface portion 111 is less than or equal to 0.3 mm to ensure that the annular knife 32 of the circular stapler can smoothly cut the end surface portion 111 .
本实施例中，近端固定组件12由多个绕柱面连接部112轴线分布的构件构成，具体的，所述近端固定组件12包括涨紧环，所述涨紧环包括多个弧形件121，每个弧形件121上均设置有第一插接部1211和第一插接槽1212，所有弧形件121绕环绕柱面连接部112轴线分布，相邻两弧形件121之间通过第一插接部1211与第一插接槽1212的插接配合连接在一起。所述柱面连接部112与所述涨紧环固定连接，所述涨紧环涨紧在圆形吻合器的钉筒3内侧，所述涨紧环位于圆形吻合器的环形刀32内侧。多弧形件121插接的结构设计，能够在不改变现有圆型吻合器结构的基础上，实现近端固定组件12在现有圆型吻合器上的拆装。本实施例中所述弧形件121设置两个。In this embodiment, the proximal fixing assembly 12 is composed of a plurality of components distributed around the axis of the cylindrical connection portion 112. Specifically, the proximal fixing assembly 12 includes a tensioning ring, which includes a plurality of arc-shaped members 121. Each arc-shaped member 121 is provided with a first plug-in portion 1211 and a first plug-in groove 1212. All arc-shaped members 121 are distributed around the axis of the cylindrical connection portion 112. Two adjacent arc-shaped members 121 are connected together by plugging and matching the first plug-in portion 1211 with the first plug-in groove 1212. The cylindrical connection portion 112 is fixedly connected to the tensioning ring, which is tightened on the inner side of the nail barrel 3 of the circular stapler. The tensioning ring is located on the inner side of the annular knife 32 of the circular stapler. The structural design of the plug-in connection of multiple arc-shaped members 121 can realize the disassembly and assembly of the proximal fixing assembly 12 on the existing circular stapler without changing the structure of the existing circular stapler. In this embodiment, two arc-shaped members 121 are provided.
具体的，所述柱面连接部112经多个第一切口114切分形成的多个部分与所有弧形件121一一对应，每个弧形件121与其对应的柱面连接部112部分固定连接。本实施例中每个弧形件121与其对应的柱面连接部112部分通过胶层固定连接。Specifically, the cylindrical connection part 112 is divided into multiple parts by multiple first cuts 114, which correspond to all the arc-shaped parts 121. Each arc-shaped part 121 is fixedly connected to its corresponding cylindrical connection part 112. In this embodiment, each arc-shaped part 121 is fixedly connected to its corresponding cylindrical connection part 112 by an adhesive layer.
优选的，在本实施例的基础上，还可使所述涨紧环与圆形吻合器的钉筒3二者位置相对固定，环形刀32以及环形刀32相对固定的结构均不与涨紧环和柱面连接部112接触，以减少涨紧环和柱面连接部112对环形刀32的移动造成的干扰。需要说明的是，此优选方案并未在图中示出。Preferably, on the basis of this embodiment, the tension ring and the stapler barrel 3 of the circular stapler can be relatively fixed in position, and the annular knife 32 and the relatively fixed structure of the annular knife 32 are not in contact with the tension ring and the cylindrical connecting portion 112, so as to reduce the interference of the tension ring and the cylindrical connecting portion 112 on the movement of the annular knife 32. It should be noted that this preferred solution is not shown in the figure.
实施例2Example 2
如图6-8所示，为本发明实施例2中的近端吻合口加固组件。本实施例中，近端固定组件12也是由多个绕柱面连接部112轴线分布的构件构成，本实施例与实施例1的不同之处在于，近端固定组件12的结构不同，具体的，近端固定组件12包括支架122和卡扣123，所述支架122设置多个，每个支架122均和柱面连接部112与圆型吻合器固定连接。所述柱面连接部112开设有多个绕柱面连接部112轴线分布的第一扣接槽，每个第一扣接槽内卡接一个穿过支架122顶端的卡扣123。所述圆型吻合器开设有多个绕圆型吻合器轴线分布的第二扣接槽，每个第二扣接槽内卡接一个穿过支架122底端的卡扣123。所有支架122之间各自独立，能够在不改变现有圆型吻合器结构的基础上，实现近端固定组件12在现有圆型吻合器上的拆装。As shown in Figures 6-8, it is the proximal anastomotic reinforcement assembly in Example 2 of the present invention. In this embodiment, the proximal fixing assembly 12 is also composed of a plurality of components distributed around the axis of the cylindrical connecting portion 112. The difference between this embodiment and Example 1 is that the structure of the proximal fixing assembly 12 is different. Specifically, the proximal fixing assembly 12 includes a bracket 122 and a buckle 123. The bracket 122 is provided in plurality, and each bracket 122 is fixedly connected to the cylindrical connecting portion 112 and the circular stapler. The cylindrical connecting portion 112 is provided with a plurality of first buckle grooves distributed around the axis of the cylindrical connecting portion 112, and a buckle 123 passing through the top end of the bracket 122 is clamped in each first buckle groove. The circular stapler is provided with a plurality of second buckle grooves distributed around the axis of the circular stapler, and a buckle 123 passing through the bottom end of the bracket 122 is clamped in each second buckle groove. All the brackets 122 are independent of each other, and the proximal fixing assembly 12 can be assembled and disassembled from the existing circular stapler without changing the structure of the existing circular stapler.
本实施例中所有支架122绕柱面连接部112轴线均匀分布，每个支架122的顶端和底端各连接一个卡扣123。本实施例中支架122设置四个。In this embodiment, all the brackets 122 are evenly distributed around the axis of the cylindrical connecting portion 112, and the top and bottom of each bracket 122 are respectively connected to a buckle 123. In this embodiment, four brackets 122 are provided.
实施例3Example 3
本实施例提供了一种加固套件，其包括实施例1或实施例2中的近端吻合口加固组件，以及远端吻合口加固组件。如图9-10所示，所述远端加固组件包括远端加固片21和远端固定组件22，所述远端固定组件22包括内固定件221和外固定件222，内固定件221和外固定件222可拆卸连接，所述远端加固片21被夹紧在内固定件221和外固定件222之间，通过远端加固片21与内固定件221和外固定件222大面积的面接触，提高远端加固组件对远端加固片21的支撑强度，减少远端加固片21在体内移动时翘边的可能性。所述内固定件221用于可拆卸连接圆型吻合器的中心轴5。The present embodiment provides a reinforcement kit, which includes the proximal anastomotic reinforcement assembly in embodiment 1 or embodiment 2, and the distal anastomotic reinforcement assembly. As shown in Figures 9-10, the distal reinforcement assembly includes a distal reinforcement sheet 21 and a distal fixing assembly 22, and the distal fixing assembly 22 includes an internal fixing member 221 and an external fixing member 222, and the internal fixing member 221 and the external fixing member 222 are detachably connected. The distal reinforcement sheet 21 is clamped between the internal fixing member 221 and the external fixing member 222, and the distal reinforcement sheet 21 is in large-area surface contact with the internal fixing member 221 and the external fixing member 222, so as to improve the support strength of the distal reinforcement assembly to the distal reinforcement sheet 21, and reduce the possibility of warping of the distal reinforcement sheet 21 when moving in the body. The internal fixing member 221 is used for detachably connecting the central axis 5 of the circular stapler.
具体的，远端加固片21、内固定件221和外固定件222三者均具有用于容纳圆型吻合器的中心轴5的通孔，且三者的通孔轴线共线，使远端加固组件提供的支撑力呈环形均匀分布在远端加固片21上。本实施例中远端加固片21、内固定件221和外固定件222均为环形。Specifically, the distal reinforcing sheet 21, the internal fixing member 221 and the external fixing member 222 all have a through hole for accommodating the central axis 5 of the circular stapler, and the axes of the through holes of the three are collinear, so that the supporting force provided by the distal reinforcing assembly is evenly distributed in an annular shape on the distal reinforcing sheet 21. In this embodiment, the distal reinforcing sheet 21, the internal fixing member 221 and the external fixing member 222 are all annular.
具体的，三个通孔的径向上内固定件221和外固定件222均不超出远端加固片21的外边缘，以留出远端加固片21与圆型吻合器中吻合钉6和环形刀32的接触空间。本实施例中内固定件221和外固定件222的外径均小于远端加固片21的外径。Specifically, the inner fixing member 221 and the outer fixing member 222 do not exceed the outer edge of the distal reinforcing sheet 21 in the radial direction of the three through holes, so as to leave contact space between the distal reinforcing sheet 21 and the staples 6 and the annular knife 32 in the circular stapler. In this embodiment, the outer diameters of the inner fixing member 221 and the outer fixing member 222 are both smaller than the outer diameter of the distal reinforcing sheet 21.
具体的，外固定件222的通孔直径和远端加固片21的通孔直径均大于或等于内固定件221的通孔直径，以免外固定件222和远端加固片21对圆型吻合器中心轴5与内固定件221之间的连接造成干扰。本实施例中外固定件222和远端加固片21的内径大于或等于内固定件221的内径。Specifically, the diameter of the through hole of the external fixing member 222 and the diameter of the through hole of the distal reinforcing sheet 21 are both greater than or equal to the diameter of the through hole of the internal fixing member 221, so as to prevent the external fixing member 222 and the distal reinforcing sheet 21 from interfering with the connection between the central axis 5 of the circular stapler and the internal fixing member 221. In this embodiment, the inner diameters of the external fixing member 222 and the distal reinforcing sheet 21 are greater than or equal to the inner diameter of the internal fixing member 221.
具体的，所述内固定件221为弹性固定件，其通过摩擦力抵紧固定在圆型吻合器的中心轴5上。本实施例中内固定件221为医用硅胶固定件。Specifically, the internal fixing member 221 is an elastic fixing member, which is fixed on the central axis 5 of the circular stapler by friction. In this embodiment, the internal fixing member 221 is a medical silicone fixing member.
具体的，所述远端加固组件还包括扣合件223，扣合件223设置多个，所有扣合件223环绕内固定件221的轴线分布，所述扣合件223穿过外固定件222和远端加固片21，并插入内固定片，与内固定片卡接，将远端加固片21、内固定件221和外固定件222紧密连接在一起。Specifically, the distal reinforcement assembly also includes a fastening piece 223, and a plurality of fastening pieces 223 are provided, and all the fastening pieces 223 are distributed around the axis of the internal fixing piece 221. The fastening piece 223 passes through the external fixing piece 222 and the distal reinforcement plate 21, and is inserted into the internal fixing piece, and is engaged with the internal fixing piece, so as to tightly connect the distal reinforcement plate 21, the internal fixing piece 221 and the external fixing piece 222 together.
具体的，所述远端加固片21为可降解生物加固片，可降解生物加固片的材料包括来自动物源完全可降解吸收的生物材料和或完全可降解吸收的高分子生物材料和或动物源与高分子合成且完全可降解吸收的生物材料，可降解生物加固片在组织愈合的过程中可提供足够力学张力，避免吻合钉6损伤周边组织，当组织愈合后，可降解生物材料自行降解，不会人体产生有害作用。Specifically, the distal reinforcement sheet 21 is a degradable biological reinforcement sheet. The material of the degradable biological reinforcement sheet includes completely degradable and absorbable biological materials from animal sources and/or completely degradable and absorbable polymer biological materials and/or completely degradable and absorbable biological materials synthesized from animal sources and polymers. The degradable biological reinforcement sheet can provide sufficient mechanical tension during the tissue healing process to prevent the staplers 6 from damaging the surrounding tissues. After the tissue is healed, the degradable biomaterials will degrade on their own and will not cause harmful effects to the human body.
具体的，所述远端加固片21的厚度小于或等于0.3mm，以保证圆型吻合器的环形刀32能顺利切割远端加固片21。Specifically, the thickness of the distal reinforcing sheet 21 is less than or equal to 0.3 mm, so as to ensure that the annular knife 32 of the circular stapler can smoothly cut the distal reinforcing sheet 21 .
实施例4Example 4
如图11-12所示，本实施例提供了一种加固套件，本实施例与实施例3的不同之处在于，本实施例中所述内固定件221的内侧设置多个紧固条2211，所有紧固条2211平行于内固定件221的轴线，并环绕内固定件221的轴线分布，以增加内固定件221的弹性形变量，拓宽内固定件221所能连接的中心轴5尺寸范围。本实施例中所有弹性紧固条2211环绕内固定件221的轴线均匀分布。As shown in FIGS. 11-12 , this embodiment provides a reinforcement kit. The difference between this embodiment and embodiment 3 is that a plurality of fastening strips 2211 are arranged on the inner side of the inner fixing member 221 in this embodiment. All fastening strips 2211 are parallel to the axis of the inner fixing member 221 and are distributed around the axis of the inner fixing member 221 to increase the elastic deformation of the inner fixing member 221 and widen the size range of the central axis 5 to which the inner fixing member 221 can be connected. In this embodiment, all elastic fastening strips 2211 are evenly distributed around the axis of the inner fixing member 221.
具体的，所述远端加固片21具有至少一个第二切口211，第二切口211沿远端加固片21轴线方向切分远端加固片21，单一第二切口211处的两切面可相互贴合。所述第二切口211具有多个时，所有第二切口211将远端加固片21切分为环绕远端加固片21轴线分布的多个部分。第二切口211的设置，使得远端加固片21可以在加固组织的基础上，保证吻合口在组织的张力的作用下，可以有一定的扩张量，从而便于将圆型吻合器从吻合口中取出，减少了圆型吻合器从吻合口中取出过程中吻合口撕裂的风险，从而提高了手术的成功率。此外，圆型吻合器的中心轴5可自第二切口211进出远端加固片21，以便于在不改变现有圆型吻合器结构的基础上，实现远端加固片21在现有圆型吻合器上的拆装。Specifically, the distal reinforcing sheet 21 has at least one second incision 211, and the second incision 211 divides the distal reinforcing sheet 21 along the axial direction of the distal reinforcing sheet 21, and the two cut surfaces at a single second incision 211 can fit each other. When there are multiple second incisions 211, all second incisions 211 divide the distal reinforcing sheet 21 into multiple parts distributed around the axis of the distal reinforcing sheet 21. The setting of the second incision 211 allows the distal reinforcing sheet 21 to ensure that the anastomosis can have a certain amount of expansion under the action of the tension of the tissue on the basis of reinforcing the tissue, thereby facilitating the removal of the circular stapler from the anastomosis, reducing the risk of tearing the anastomosis during the removal of the circular stapler from the anastomosis, thereby improving the success rate of the operation. In addition, the central axis 5 of the circular stapler can enter and exit the distal reinforcing sheet 21 from the second incision 211, so as to realize the disassembly and assembly of the distal reinforcing sheet 21 on the existing circular stapler without changing the structure of the existing circular stapler.
具体的，所述内固定件221具有至少一个第三切口2212，第三切口2212沿内固定件221轴线方向切分内固定件221。所述第三切口2212具有多个时，所有第三切口2212将内固定件221切分为环绕内固定件221轴线分布的多个部分。Specifically, the inner fixing member 221 has at least one third cutout 2212, and the third cutout 2212 divides the inner fixing member 221 along the axis direction of the inner fixing member 221. When there are multiple third cutouts 2212, all the third cutouts 2212 divide the inner fixing member 221 into multiple parts distributed around the axis of the inner fixing member 221.
所述外固定件222具有至少一个第四切口2221，第四切口2221沿外固定件222轴线方向切分外固定件222。所述第四切口2221具有多个时，所有第四切口2221将外固定件222切分为环绕外固定件222轴线分布的多个部分，内固定件221相邻的两个部分可拆卸连接。The external fixing member 222 has at least one fourth cutout 2221, and the fourth cutout 2221 divides the external fixing member 222 along the axis direction of the external fixing member 222. When there are multiple fourth cutouts 2221, all the fourth cutouts 2221 divide the external fixing member 222 into multiple parts distributed around the axis of the external fixing member 222, and two adjacent parts of the internal fixing member 221 can be detachably connected.
圆型吻合器的中心轴5可自第三切口2212和第四切口2221进出内固定件221和外固定件222，以便于在不改变现有圆型吻合器结构的基础上，实现远端固定组件22在现有圆型吻合器上的拆装。The central axis 5 of the circular stapler can enter and exit the inner fixing member 221 and the outer fixing member 222 through the third incision 2212 and the fourth incision 2221, so as to realize the disassembly and assembly of the distal fixing assembly 22 on the existing circular stapler without changing the structure of the existing circular stapler.
需要说明的是，通过扣合件223，内固定件221中每两个相邻的部分与外固定件222中的同一部分连接，即可使内固定件221的各部分连接为环形，外固定件222的各部分也连接为环形。It should be noted that, by connecting every two adjacent parts of the inner fixing member 221 to the same part of the outer fixing member 222 through the buckle 223, the parts of the inner fixing member 221 and the parts of the outer fixing member 222 can be connected into a ring shape.
具体的，本实施例中单一第三切口2212处的两切面可相互贴合，单一第四切口2221处的两切面可相互贴合，以使得内固定件221和外固定件222均为完整的环形，进一步提高远端加固组件提供的支撑力在远端加固片21环向上的均匀程度。Specifically, in this embodiment, the two cross-sections at the single third incision 2212 can fit together, and the two cross-sections at the single fourth incision 2221 can fit together, so that the inner fixing member 221 and the outer fixing member 222 are both complete rings, further improving the uniformity of the supporting force provided by the distal reinforcement assembly in the circumferential direction of the distal reinforcement plate 21.
具体的，所述远端加固片21具有多个第二切口211，所述内固定件221具有多个第三切口2212，所述外固定件222具有多个第四切口2221。本实施例中第二切口211、第三切口2212和第四切口2221均为两个。Specifically, the distal reinforcing sheet 21 has a plurality of second incisions 211, the inner fixing member 221 has a plurality of third incisions 2212, and the outer fixing member 222 has a plurality of fourth incisions 2221. In this embodiment, the number of the second incisions 211, the third incisions 2212, and the fourth incisions 2221 are all two.
具体的，内固定件221的每个部分上均设置有第二插接部2213和第二插接槽2214，内固定件221中相邻两部分通过第二插接部2213与第二插接槽2214的插接配合连接在一起，以提高内固定件221各部分间的连接强度，保证内固定件221各部分能够稳固的夹持在圆型吻合器的中心轴5上。Specifically, each part of the internal fixing member 221 is provided with a second plug-in portion 2213 and a second plug-in groove 2214. Two adjacent parts of the internal fixing member 221 are connected together by plugging and fitting the second plug-in portion 2213 and the second plug-in groove 2214 to improve the connection strength between the parts of the internal fixing member 221 and ensure that the parts of the internal fixing member 221 can be firmly clamped on the central axis 5 of the circular anastomosis device.
具体的，本实施例中远端加固片21、内固定件221、外固定件222均由两部分构成，远端加固片21的两部分和内固定件221的两部分一一对应，远端加固片21的两部分还和外固定件222的两部分一一对应，远端加固片21的每部分和其对应的内固定件221部分及其对应的外固定件222部分固定连接，以便于快速进行远端吻合口加固组件在圆型吻合器的中心轴上的拆装。本实施例中远端加固片21的每部分和其对应的内固定件221部分及其对应的外固定件222部分通过胶层固定连接。Specifically, in this embodiment, the distal reinforcing sheet 21, the internal fixing member 221, and the external fixing member 222 are all composed of two parts, and the two parts of the distal reinforcing sheet 21 correspond one-to-one to the two parts of the internal fixing member 221, and the two parts of the distal reinforcing sheet 21 also correspond one-to-one to the two parts of the external fixing member 222. Each part of the distal reinforcing sheet 21 is fixedly connected to its corresponding part of the internal fixing member 221 and its corresponding part of the external fixing member 222, so as to facilitate the rapid disassembly and assembly of the distal anastomotic stoma reinforcement assembly on the central axis of the circular stapler. In this embodiment, each part of the distal reinforcing sheet 21 is fixedly connected to its corresponding part of the internal fixing member 221 and its corresponding part of the external fixing member 222 through an adhesive layer.
实施例5Example 5
如图13-16所示，本实施例提供了一种圆型吻合器，其包括实施例3或实施例4记载的加固套件、钉筒3、抵钉座4和中心轴5；As shown in FIGS. 13-16 , this embodiment provides a circular stapler, which includes the reinforcement kit described in Embodiment 3 or Embodiment 4, a nail barrel 3, a nail support 4 and a central axis 5;
钉筒3内固定有钉仓31和环形刀32，抵钉座4内固定有钉砧41和刀砧42，中心轴5与抵钉座4固定连接，中心轴5与钉筒3固定连接。钉筒3远离抵钉座4的一端连接用于控制钉筒3和抵钉座4相对移动的击发手柄。A nail magazine 31 and an annular knife 32 are fixed in the nail barrel 3, a nail anvil 41 and a knife anvil 42 are fixed in the nail anvil 4, a central shaft 5 is fixedly connected to the nail anvil 4, and the central shaft 5 is fixedly connected to the nail barrel 3. One end of the nail barrel 3 away from the nail anvil 4 is connected to a firing handle for controlling the relative movement of the nail barrel 3 and the nail anvil 4.
所述端面部111与钉仓31的端面相贴，钉仓31中每个单钉的仓孔311内嵌入至多一个凸起113。所述柱面连接部112位于环形刀32内侧，并通过近端固定组件12与钉筒3可拆卸连接。The end surface portion 111 is attached to the end surface of the nail magazine 31, and at most one protrusion 113 is embedded in the magazine hole 311 of each single nail in the nail magazine 31. The cylindrical connecting portion 112 is located inside the annular knife 32 and is detachably connected to the nail barrel 3 through the proximal fixing assembly 12.
所述内固定件221与中心轴5可拆卸连接，所述远端加固片21与钉砧41的端面相贴。环形刀32与刀砧42相抵时，所述远端固定组件22位于环形刀32内侧。The inner fixing member 221 is detachably connected to the central shaft 5, and the distal reinforcing sheet 21 is in contact with the end surface of the nail anvil 41. When the annular knife 32 abuts against the knife anvil 42, the distal fixing assembly 22 is located inside the annular knife 32.
本实施例中钉仓31中每个单钉的仓孔311内均嵌入一个凸起113。In this embodiment, a protrusion 113 is embedded in the magazine hole 311 of each single nail in the nail magazine 31.
具体的，内固定件221的外边缘与刀砧42内壁的距离大于或等于2mm，外固定件222的外边缘与刀砧42内壁的距离大于或等于2mm，以免内固定件221和外固定件222对环形刀32的切割造成阻碍。本实施例中内固定件221的外径与刀砧42内径之差大于或等于2mm，外固定件222的外径与刀砧42内径之差大于或等于2mm。Specifically, the distance between the outer edge of the inner fixing member 221 and the inner wall of the anvil 42 is greater than or equal to 2 mm, and the distance between the outer edge of the outer fixing member 222 and the inner wall of the anvil 42 is greater than or equal to 2 mm, so as to prevent the inner fixing member 221 and the outer fixing member 222 from hindering the cutting of the annular knife 32. In this embodiment, the difference between the outer diameter of the inner fixing member 221 and the inner diameter of the anvil 42 is greater than or equal to 2 mm, and the difference between the outer diameter of the outer fixing member 222 and the inner diameter of the anvil 42 is greater than or equal to 2 mm.
具体的，柱面连接部112外壁与环形刀32内壁的距离大于或等于2mm，以便于安装实施例1中记载的涨紧环，或者在加固套件内的近端吻合口加固组件1为实施例2记载的近端吻合口加固组件1时，使柱面连接部112与环形刀32之间存在缝隙，以减少柱面连接部112对环形刀32移动的干扰。本实施例中柱面连接部112外径与环形刀32内径之差大于或等于2mm。Specifically, the distance between the outer wall of the cylindrical connection part 112 and the inner wall of the annular knife 32 is greater than or equal to 2 mm, so as to facilitate the installation of the tension ring described in Example 1, or when the proximal anastomotic reinforcement component 1 in the reinforcement kit is the proximal anastomotic reinforcement component 1 described in Example 2, a gap is provided between the cylindrical connection part 112 and the annular knife 32 to reduce the interference of the cylindrical connection part 112 on the movement of the annular knife 32. In this embodiment, the difference between the outer diameter of the cylindrical connection part 112 and the inner diameter of the annular knife 32 is greater than or equal to 2 mm.
本实施例可用于痔上粘膜环形切除术、痔上粘膜C型切除术，以及痔上粘膜的选择性切除。This embodiment can be used for circular hemorrhoidal mucosal resection, C-type hemorrhoidal mucosal resection, and selective resection of hemorrhoidal mucosa.
实施例6Example 6
如图17-18所示，本实施例提供了一种圆型吻合器，本实施例与实施例5的不同之处在于，中心轴5与钉筒3可拆卸连接。本实施例可用于食道吻合，如管状胃与食道、结肠代食道与食道的端侧吻合；胃与食道吻合，如近端胃切除后，胃食道的端侧吻合；空肠与食道吻合，如全胃切除后，空肠食道的端侧吻合；胃与空肠吻合，如远端胃切除后，胃空肠的端侧吻合；回肠结肠吻合，如升结肠切除后，结肠回肠的端侧吻合；如结肠吻合，升结肠、横结肠切除后，结肠对结肠的端侧吻合；直肠吻合，如乙状结肠、直肠切除后，直肠对结直肠的端端吻合；肛肠吻合，如直肠脱垂、直肠前突、Ⅲ度以上痔疮等切除吻合。As shown in Figures 17-18, this embodiment provides a circular stapler, and the difference between this embodiment and embodiment 5 is that the central axis 5 is detachably connected to the nail tube 3. This embodiment can be used for esophageal anastomosis, such as end-to-side anastomosis between a tubular stomach and an esophagus, or between a colon and an esophagus; stomach and esophagus anastomosis, such as end-to-side anastomosis between the stomach and esophagus after proximal gastrectomy; jejunal anastomosis between esophagus, such as end-to-side anastomosis between the jejunal esophagus after total gastrectomy; stomach and jejunal anastomosis, such as end-to-side anastomosis between the stomach and jejunum after distal gastrectomy; ileocolic anastomosis, such as end-to-side anastomosis between the colon and ileum after ascending colon resection; such as colon anastomosis, end-to-end anastomosis between colon and colon after ascending colon and transverse colon resection; rectal anastomosis, such as end-to-end anastomosis between rectum and colorectum after sigmoid colon and rectum resection; anorectal anastomosis, such as resection and anastomosis of rectal prolapse, rectocele, and hemorrhoids of grade III or above.
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410721193.3ACN118593041A (en) | 2024-06-05 | 2024-06-05 | Proximal anastomotic stoma reinforcement component, reinforcement kit and circular stapler |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410721193.3ACN118593041A (en) | 2024-06-05 | 2024-06-05 | Proximal anastomotic stoma reinforcement component, reinforcement kit and circular stapler |
| Publication Number | Publication Date |
|---|---|
| CN118593041Atrue CN118593041A (en) | 2024-09-06 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410721193.3APendingCN118593041A (en) | 2024-06-05 | 2024-06-05 | Proximal anastomotic stoma reinforcement component, reinforcement kit and circular stapler |
| Country | Link |
|---|---|
| CN (1) | CN118593041A (en) |
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