CN115844478A - Magnetic anastomat for treating rectal stenosis under single transanal passage - Google Patents
Magnetic anastomat for treating rectal stenosis under single transanal passage Download PDFInfo
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Abstract
本发明公开了一种用于经肛门单通路下治疗直肠狭窄的磁吻合器,包括第一磁吻合环、辅助操作装置以及第二磁吻合环;第一磁吻合环包括形状与尺寸完全相同的第一半圆形磁环和第二半圆形磁环,第一半圆形磁环的第一关节端与第二半圆形磁环的第二关节端被配置为沿周向的可旋转连接;辅助操作装置包括第一牵引线和第二牵引线,两牵引线的两头端被配置为分别能够与两控制端连接,两尾端被配置为通过牵拉使得两半圆形磁环的控制端相接,即控制第一磁吻合环从S形向O形变化;第二磁吻合环被配置为在直肠远端与在直肠近端的变化为O形的第一磁吻合环在端面相吸,以压榨直肠狭窄段。本发明解决了目前外科手术器械治疗吻合口狭窄时难以置入、创伤过大的问题。
The invention discloses a magnetic stapling device for treating rectal stenosis through an anal single channel, which comprises a first magnetic anastomotic ring, an auxiliary operation device and a second magnetic anastomotic ring; the first magnetic anastomotic ring includes The first semicircular magnetic ring and the second semicircular magnetic ring, the first joint end of the first semicircular magnetic ring and the second joint end of the second semicircular magnetic ring are configured to be rotatable along the circumferential direction Connection; the auxiliary operation device includes a first pull wire and a second pull wire, the two ends of the two pull wires are configured to be respectively connected to the two control ends, and the two tail ends are configured to make the two semicircular magnetic rings The control ends are connected, that is, the first magnetic anastomosis ring is controlled to change from S-shape to O-shape; Face-to-face suction to squeeze the narrow rectum. The invention solves the problems of difficult insertion and excessive trauma when surgical instruments are used to treat anastomotic stenosis.
Description
技术领域technical field
本发明属于临床用医疗器械技术领域,涉及外科用的吻合器,特别涉及一种用于经肛门单通路下治疗直肠狭窄的磁吻合器。The invention belongs to the technical field of clinical medical instruments, relates to a surgical stapler, in particular to a magnetic stapler for treating rectal stenosis through an anal single channel.
背景技术Background technique
随着低位及超低位直肠癌切除技术的不断成熟,低位直肠癌患者的生存期得以延长,保肛率不断提高,然而伴随着保肛率的提高,吻合口狭窄(anastomosis stenosis,AS)的发生率也随之升高。With the continuous maturity of low and ultra-low rectal cancer resection techniques, the survival period of patients with low rectal cancer has been prolonged, and the anus preservation rate has continued to increase. However, with the increase in the anus preservation rate, the occurrence of anastomosis stenosis (AS) rate also increased.
目前临床上针对直肠癌术后AS的治疗在排除肿瘤复发因素后可采用机械扩张治疗、内镜下球囊扩张、内镜下肠道支架置入术、内镜下吻合口放射状切开等。对于重度吻合口狭窄,机械扩张和内镜治疗效果有限,部分患者需要行近端结肠或回肠造口术。上述治疗方法各有优缺点,对于轻度AS患者大多可获得较好的治疗效果,而重度AS患者往往面临着外科手术的巨大创伤和有限的临床获益,因此针对重度AS患者探索微创、有效的治疗方法在临床中具有重要意义。At present, the clinical treatment of AS after rectal cancer surgery can use mechanical expansion therapy, endoscopic balloon dilatation, endoscopic intestinal stenting, and endoscopic anastomotic radial incision after the exclusion of tumor recurrence factors. For severe anastomotic strictures, mechanical dilation and endoscopic treatment have limited effects, and some patients require proximal colostomy or ileostomy. The above-mentioned treatment methods have their own advantages and disadvantages. Most patients with mild AS can obtain good therapeutic effect, while patients with severe AS often face huge surgical trauma and limited clinical benefits. Therefore, it is necessary to explore minimally invasive, Effective treatment methods are of great significance in clinical practice.
发明内容Contents of the invention
为了克服上述现有技术的缺点,本发明的目的在于提供一种用于经肛门单通路下治疗直肠狭窄的磁吻合器,以期解决目前外科手术器械治疗吻合口狭窄时难以置入、创伤过大的问题。In order to overcome the above-mentioned shortcomings of the prior art, the object of the present invention is to provide a magnetic stapler for the treatment of rectal stenosis through the anal single channel, in order to solve the problem of difficult insertion and excessive trauma when surgical instruments are used to treat anastomotic stenosis The problem.
为了实现上述目的,本发明采用的技术方案是:In order to achieve the above object, the technical scheme adopted in the present invention is:
一种用于经肛门单通路下治疗直肠狭窄的磁吻合器,包括第一磁吻合环、辅助操作装置以及第二磁吻合环;A magnetic stapler for treating rectal stenosis through an anal single access, comprising a first magnetic anastomotic ring, an auxiliary operating device and a second magnetic anastomotic ring;
所述第一磁吻合环包括形状与尺寸完全相同的第一半圆形磁环和第二半圆形磁环,所述第一半圆形磁环的一端为第一控制端,另一端为第一关节端;所述第二半圆形磁环的一端为第二控制端,另一端为第二关节端;所述第一关节端与所述第二关节端被配置为沿周向的可旋转连接;The first magnetic anastomosis ring includes a first semicircular magnetic ring and a second semicircular magnetic ring that are identical in shape and size, one end of the first semicircular magnetic ring is the first control end, and the other end is the first control end. The first joint end; one end of the second semicircular magnetic ring is the second control end, and the other end is the second joint end; the first joint end and the second joint end are arranged in a circumferential direction rotatable connection;
所述辅助操作装置包括第一牵引线和第二牵引线,所述第一牵引线的两端分别为第一头端和第一尾端,所述第二牵引线的两端分别为第二头端和第二尾端;The auxiliary operation device includes a first pulling line and a second pulling line, the two ends of the first pulling line are respectively the first head end and the first tail end, and the two ends of the second pulling line are respectively the second a head end and a second tail end;
所述第一头端被配置为能够与所述第一控制端连接,所述第二头端被配置为能够与所述第二控制端连接,所述第一尾端和所述第二尾端被配置为通过牵拉使得所述第一控制端与所述第二控制端相接,即控制所述第一磁吻合环从S形向O形的变化;The first head end is configured to be connectable to the first control end, the second head end is configured to be connectable to the second control end, the first tail end and the second tail end The ends are configured to connect the first control end to the second control end by pulling, that is, to control the change of the first magnetic anastomotic ring from S-shape to O-shape;
所述第二磁吻合环被配置为在直肠远端与在直肠近端的变化为O形的所述第一磁吻合环在端面相吸,以压榨直肠狭窄段。The second magnetic anastomotic ring is configured to attract at the end face of the first magnetic anastomotic ring that changes into an O-shape at the distal end of the rectum to squeeze the rectal narrow section.
在一个实施例中,所述第一关节端与所述第二关节端通过旋转短轴连接,所述旋转短轴的一端连接所述第一关节端或所述第二关节端,另一端嵌入所述第二关节端或第一关节端的周向短槽中;所述第一尾端牵拉所述第一控制端,或所述第二尾端牵拉所述第二控制端,使得所述第一半圆形磁环或所述第二半圆形磁环沿所述旋转短轴转动,转动过程中所述第一半圆形磁环所在平面与所述第二半圆形磁环所在平面的夹角的变化范围为0°~180°。In one embodiment, the first joint end is connected to the second joint end through a short rotation shaft, one end of the short rotation shaft is connected to the first joint end or the second joint end, and the other end is embedded in In the circumferential short groove of the second joint end or the first joint end; the first tail end pulls the first control end, or the second tail end pulls the second control end, so that the The first semicircular magnetic ring or the second semicircular magnetic ring rotates along the short axis of rotation. During the rotation, the plane where the first semicircular magnetic ring is located and the second semicircular magnetic ring The range of the included angle of the plane is 0°-180°.
在一个实施例中,所述第一控制端与所述第二控制端的N-S极性相反,所述第一关节端与所述第二关节端的N-S极性相反;所述第一关节端与所述第二关节端相吸,实现所述可旋转连接;所述第一尾端和所述第二尾端被配置为通过牵拉使得所述第一控制端与所述第二控制端相吸。In one embodiment, the N-S polarity of the first control terminal is opposite to that of the second control terminal, and the N-S polarity of the first joint terminal is opposite to that of the second joint terminal; The second joint end is attracted to realize the rotatable connection; the first tail end and the second tail end are configured to make the first control end and the second control end attract each other by pulling .
在一个实施例中,所述第一半圆形磁环和第二半圆形磁环由钕铁硼永磁材料、铁氧体材料、钐钴材料或钕钴镍加工而成,边缘倒角,轴向充磁;第一半圆形磁环和第二半圆形磁环采用氮化钛镀层、镍镀层、环氧树脂镀层或派瑞林镀层进行表面防护。In one embodiment, the first semicircular magnetic ring and the second semicircular magnetic ring are made of NdFeB permanent magnet material, ferrite material, samarium cobalt material or neodymium cobalt nickel, and the edges are chamfered , Axial magnetization; the first semicircular magnetic ring and the second semicircular magnetic ring adopt titanium nitride coating, nickel coating, epoxy resin coating or parylene coating for surface protection.
在一个实施例中,所述第一控制端设置有第一穿线孔,所述第二控制端有第二穿线孔,所述第一穿线孔和所述第二穿线孔均为沿外环侧面向内环侧面的开孔;所述第一头端穿入所述第一穿线孔实现连接;所述第二头端穿入所述第二穿线孔实现连接。In one embodiment, the first control end is provided with a first threading hole, the second control end is provided with a second threading hole, and both the first threading hole and the second threading hole are along the side of the outer ring The opening on the side of the inner ring; the first head end passes through the first threading hole to realize connection; the second head end passes through the second threading hole to realize connection.
在一个实施例中,所述第一穿线孔和所述第二穿线孔均为径向孔。In one embodiment, both the first threading hole and the second threading hole are radial holes.
在一个实施例中,所述第一头端设置有尺寸大于所述第一穿线孔的膨大端头,所述第二头端设置有尺寸大于所述第二穿线孔的膨大端头,所述膨大端头卡在内环侧面,第一尾端和第二尾端分别从外环侧面引出。In one embodiment, the first head end is provided with an enlarged end head whose size is larger than the first threading hole, and the second head end is provided with an enlarged end head whose size is larger than the second threading hole, and the The enlarged end is stuck on the side of the inner ring, and the first tail end and the second tail end are led out from the side of the outer ring respectively.
在一个实施例中,所述第一牵引线和第二牵引线为丝线或尼龙线或其他高分子材料制作的线状物。In one embodiment, the first pulling wire and the second pulling wire are wires or nylon wires or threads made of other polymer materials.
在一个实施例中,所述辅助操作装置还包括控制管,所述控制管中设置有轴向的第一控制孔和第二控制孔,所述第一控制孔用于供所述第一牵引线穿过,所述第二控制孔用于供所述第二牵引线穿过。In one embodiment, the auxiliary operation device further includes a control tube, and the control tube is provided with a first control hole and a second control hole in the axial direction, and the first control hole is used for the first traction The wire passes through, and the second control hole is used for the second pulling wire to pass through.
在一个实施例中,所述第一半圆形磁环的外径10-40mm、内径范围5-35mm;所述控制管的长度范围5cm-50cm。In one embodiment, the outer diameter of the first semicircular magnetic ring is 10-40mm, and the inner diameter is 5-35mm; the length of the control tube is 5cm-50cm.
与现有技术相比,本发明通过使两个半圆形磁环一端旋转连接,另一端展开,呈“S”形,具有较小的横截面积,从而能够以蛇形运动形式穿过直肠狭窄段,进入直肠近端;之后再以牵引线控制使其合拢呈“O”形。最后在直肠远端置入另一磁吻合环,二者相吸压榨直肠狭窄段,实现吻合。Compared with the prior art, the present invention connects two semicircular magnetic rings by rotating at one end and unfolding the other end in an "S" shape with a smaller cross-sectional area, so that it can pass through the rectum in a serpentine motion The narrow section enters the proximal end of the rectum; then it is controlled by a traction wire to close it into an "O" shape. Finally, another magnetic anastomosis ring is placed at the distal end of the rectum, and the two attract each other to squeeze the stenotic segment of the rectum to achieve anastomosis.
本发明通过使第一磁吻合环从“S”形到“O”形的变化和蛇形运动,有效解决了常规磁环不能通过狭窄段的问题,因此在设计磁吻合环外径时,可忽略置入操作问题,而使磁吻合环外径最大程度上接近直肠内径,为尽可能“铲除”吻合口瘢痕创造条件,实现吻合口长期通畅。The invention effectively solves the problem that the conventional magnetic ring cannot pass through the narrow section by making the first magnetic anastomotic ring change from "S" shape to "O" shape and serpentine movement, so when designing the outer diameter of the magnetic anastomotic ring, it can be Ignore the problem of insertion operation, and make the outer diameter of the magnetic anastomosis ring as close as possible to the inner diameter of the rectum to create conditions for "eradicating" the anastomotic scar as much as possible and achieve long-term patency of the anastomosis.
附图说明Description of drawings
图1是本发明的第一半圆形磁环的结构示意图。Fig. 1 is a structural schematic diagram of the first semicircular magnetic ring of the present invention.
图2是本发明的第二半圆形磁环的结构示意图。Fig. 2 is a schematic structural diagram of the second semicircular magnetic ring of the present invention.
图3是本发明的第一牵引线的结构示意图。Fig. 3 is a schematic structural view of the first pulling wire of the present invention.
图4是本发明的第二牵引线的结构示意图。Fig. 4 is a schematic structural view of the second pulling wire of the present invention.
图5是本发明的控制管结构示意图。Fig. 5 is a schematic structural diagram of the control tube of the present invention.
图6是本发明第一磁吻合环在置入直肠前形成的“S”形状态示意图。Fig. 6 is a schematic view of the "S" shape of the first magnetic anastomosis ring of the present invention before being placed in the rectum.
图7是本发明第一磁吻合环在变形成“O”形前的状态示意图。Fig. 7 is a schematic diagram of the state of the first magnetic anastomotic ring of the present invention before being deformed into an "O" shape.
图8是本发明第一磁吻合环变形成“O”形的状态示意图。Fig. 8 is a schematic diagram of the deformation of the first magnetic anastomotic ring into an "O" shape according to the present invention.
图9是本发明第一磁吻合环呈“S”形置入直肠远端的示意图。Fig. 9 is a schematic diagram of the first magnetic anastomosis ring of the present invention being placed in the distal end of the rectum in an "S" shape.
图10是本发明第一磁吻合环呈“S”形蛇形通过直肠狭窄段的示意图。Fig. 10 is a schematic diagram of the first magnetic anastomotic ring of the present invention passing through the rectal stenosis in an "S" shape.
图11是本发明第一磁吻合环呈“S”形进入直肠近端的示意图。Fig. 11 is a schematic diagram of the first magnetic anastomotic ring entering the proximal rectum in an "S" shape according to the present invention.
图12是本发明第一磁吻合环在直肠近端由“S”形变为“O”形的过程示意图。Fig. 12 is a schematic diagram of the process of the first magnetic anastomotic ring changing from "S" to "O" shape at the proximal end of the rectum according to the present invention.
图13是本发明第一磁吻合环在直肠近端变为“O”形的示意图。Fig. 13 is a schematic diagram of the first magnetic anastomotic ring changing to an "O" shape at the proximal end of the rectum according to the present invention.
图14是本发明第一磁吻合环在直肠近端变为“O”形并撤去辅助操作装置后的示意图。Fig. 14 is a schematic diagram of the first magnetic anastomotic ring of the present invention after the proximal end of the rectum becomes "O" and the auxiliary operation device is removed.
图15是本发明第二磁吻合环置入直肠远端的示意图。Fig. 15 is a schematic diagram of the second magnetic anastomosis ring of the present invention placed in the distal rectum.
图16是本发明直肠近端的第一磁吻合环和直肠远端的第二磁吻合环相吸的示意图。Fig. 16 is a schematic diagram of the attraction between the first magnetic anastomotic ring at the proximal end of the rectum and the second magnetic anastomotic ring at the distal end of the rectum according to the present invention.
图17是本发明完成压榨吻合后排出磁吻合环的示意图。Fig. 17 is a schematic diagram of discharging the magnetic anastomosis ring after the press anastomosis is completed in the present invention.
图18是本发明实验验证中磁吻合器状态变化过程示意图。Fig. 18 is a schematic diagram of the state change process of the magnetic stapler in the experimental verification of the present invention.
具体实施方式Detailed ways
为使本发明实施例的目的、技术方案和优点更加清楚,下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments It is a part of embodiments of the present invention, but not all embodiments. The components of the embodiments of the invention generally described and illustrated in the figures herein may be arranged and designed in a variety of different configurations.
因此,以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围,而是仅仅表示本发明的选定实施例。基于本发明中的实施例,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。Accordingly, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.
应注意到:相似的标号和字母在下面的附图中表示类似项,因此,一旦某一项在一个附图中被定义,则在随后的附图中不需要对其进行进一步定义和解释。It should be noted that like numerals and letters denote similar items in the following figures, therefore, once an item is defined in one figure, it does not require further definition and explanation in subsequent figures.
在本发明的描述中,需要说明的是,若出现术语“上”、“下”、“内”、“外”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,或者是该发明产品使用时惯常摆放的方位或位置关系,仅是为了便于描述本发明和简化描述,而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。In the description of the present invention, it should be noted that if the orientation or positional relationship indicated by the terms "upper", "lower", "inner" and "outer" appear, it is based on the orientation or positional relationship shown in the drawings, or It is the orientation or positional relationship that the invention product is usually placed in use, and it is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation , and therefore cannot be construed as a limitation of the present invention.
此外,若出现术语“第一”、“第二”等仅用于区分描述,而不能理解为指示或暗示相对重要性。In addition, terms such as "first" and "second" are used only for distinguishing descriptions, and should not be understood as indicating or implying relative importance.
需要说明的是,在不冲突的情况下,本发明的实施例中的特征可以相互结合。It should be noted that, in the case of no conflict, the features in the embodiments of the present invention may be combined with each other.
如前所述,因直肠狭窄段的尺寸限制,现有的磁吻合环结构设计时,其外径受到限制,而小尺寸的磁吻合环显然难以实现有效的压榨吻合。基于此,本发明提供了一种用于经肛门单通路下治疗直肠狭窄的磁吻合器。As mentioned above, due to the size limitation of the rectal stenosis, the outer diameter of the existing magnetic anastomosis ring is limited in its structural design, and it is obviously difficult for a small-sized magnetic anastomosis ring to achieve effective compression anastomosis. Based on this, the present invention provides a magnetic stapler for treating rectal stenosis through anal single access.
如图1~图17所示,本发明主要包括第一磁吻合环、辅助操作装置以及第二磁吻合环8。As shown in FIGS. 1 to 17 , the present invention mainly includes a first magnetic anastomotic ring, an auxiliary operation device and a second magnetic
其中,参考图1和图2,第一磁吻合环包括第一半圆形磁环1和第二半圆形磁环2,或者仅由第一半圆形磁环1和第二半圆形磁环2组成。第一半圆形磁环1和第二半圆形磁环2的形状尺寸完全相同。Wherein, with reference to Fig. 1 and Fig. 2, the first magnetic anastomosis ring comprises the first semicircular
参考图1,第一半圆形磁环1的一端为第一控制端12,另一端为第一关节端13。参考图2,第二半圆形磁环2的一端为第二控制端22,另一端为第二关节端23。第一半圆形磁环1和第二半圆形磁环2的两端,均适宜为平滑面,以便于在端部的连接和旋转。在本发明中,第一关节端13与第二关节端23被配置为沿周向的可旋转连接,即第一关节端13与第二关节端23的连接方式能够实现第一半圆形磁环1与第二半圆形磁环2之间的相对旋转运动,当二者所在平面的夹角为0°时,第一磁吻合环的整体呈S形,而当二者所在平面的夹角为180°时,即第一控制端12和第二控制端22相接或相触时,第一磁吻合环的整体呈O形。Referring to FIG. 1 , one end of the first semicircular
参考图3和图4,辅助操作装置包括第一牵引线14和第二牵引线24。第一牵引线14的两端分别为第一头端141和第一尾端142,如图3所示。第二牵引线24的两端分别为第二头端241和第二尾端242,如图4所示。Referring to FIGS. 3 and 4 , the auxiliary operation device includes a first pulling
参考图6,本发明的第一头端141被配置为能够与第一控制端12连接,第二头端241被配置为能够与第二控制端22连接。通过牵拉第一尾端142或第二尾端242能够带动第一半圆形磁环1与第二半圆形磁环2之间的相对旋转运动,使得二者所处平面的夹角方式变化,当该夹角为180°时,第一控制端12与第二控制端22能够相接或相触。由此即可控制第一磁吻合环从S形向O形的变化。变化的过程如图7所示,结果如图8所示。Referring to FIG. 6 , the
使用时,变化为S形的作用是方便将第一磁吻合环通过直肠狭窄段5送入直肠近端4,变化为O形后第一磁吻合环的整体即位于直肠近端4。第二磁吻合环8被配置为在直肠远端6与在直肠近端4的变化为O形的第一磁吻合环在端面相吸,以压榨直肠狭窄段5。When in use, the function of changing to an S shape is to facilitate sending the first magnetic anastomotic ring into the
在本发明的实施例中,根据以上结构,本发明提供了第一种具体的旋转实现结构,即,第一关节端13与第二关节端23通过旋转短轴连接,该旋转短轴可以是切向或者周向的,显然,为了便于旋转,其长度应该较短。旋转短轴的一端连接第一关节端13或第二关节端23,另一端嵌入第二关节端23或第一关节端13的切向或者周向短槽中。使用时,通过第一尾端142牵拉第一控制端12,或第二尾端242牵拉第二控制端22,即可使得第一半圆形磁环1或第二半圆形磁环2沿旋转短轴转动,可实现第一半圆形磁环1所在平面与第二半圆形磁环2所在平面的夹角在0°~180°的范围内变化,即完成S形向O形的变化。In the embodiment of the present invention, according to the above structure, the present invention provides the first specific rotation realization structure, that is, the first
本实施例中,采用了机械转动的方式,显然,其优点在于便于操控,并且两个半圆形磁环即第一半圆形磁环1和第二半圆形磁环2始终结合为一体,不会分离。同时对第一半圆形磁环1和第二半圆形磁环2之间的磁力大小要求不高,然而其缺点在于加工相对较为复杂,该实施例仅是本发明的一种旋转实现形式。In this embodiment, the method of mechanical rotation is adopted. Obviously, its advantage is that it is easy to handle, and the two semicircular magnetic rings, that is, the first semicircular
为此,在本发明的另一个实施例中,本发明提供了第二种具体的旋转实现结构,第一关节端13与第二关节端23不再采用机械的连接方式,而是直接以磁力相吸。具体地,第一控制端12与第二控制端22的N-S极性相反,可自动对位吸引,第一关节端13与第二关节端23的N-S极性相反,可自动对位吸引。第一关节端13与第二关节端23相吸,实现本发明所述的可旋转连接方式。使用时,通过第一尾端142牵拉第一控制端12,或第二尾端242牵拉第二控制端22,即可使得第一半圆形磁环1或第二半圆形磁环2的转动,并最终实现第一控制端12与第二控制端22的相吸。因此,该结构同样可实现第一半圆形磁环1所在平面与第二半圆形磁环2所在平面的夹角在0°~180°的范围内变化,即完成S形向O形的变化。For this reason, in another embodiment of the present invention, the present invention provides a second specific structure for realizing rotation. The
本实施例中,采用了纯粹的磁力作用方式,不再需要复杂的机加工,通过适当调整磁力,亦可保证两个半圆形磁环即第一半圆形磁环1和第二半圆形磁环2结合的强度,本发明以此结构为较优结构。In this embodiment, a pure magnetic force action mode is adopted, and no complicated machining is required. By properly adjusting the magnetic force, two semicircular magnetic rings, that is, the first semicircular
在本发明的实施例中,第一半圆形磁环1和第二半圆形磁环2均可由钕铁硼永磁材料、铁氧体材料、钐钴材料或钕钴镍等永磁材料加工而成,轴向充磁,并进行边缘倒角。同时,第一半圆形磁环1和第二半圆形磁环2可采用氮化钛镀层、镍镀层、环氧树脂镀层或派瑞林镀层等方式进行表面防护。In an embodiment of the present invention, both the first semicircular
在本实施例中,采用永磁材料加工第一半圆形磁环1和第二半圆形磁环2,可保证二者始终具备磁性,轴向充磁使得最终能与第二磁吻合环8在轴向的端面相吸。边缘倒角的方式,能保持结构表面光滑,便于使用时向体内置入。表面防护一方面可保护磁材料面,另一方面也防止对人体造成潜在损伤。显然,在实际应用中,本领域的技术人还可以采用更多类型的永磁材料或者其它的表面防护方案。In this embodiment, the permanent magnetic material is used to process the first semicircular
在本发明的实施例中,第一半圆形磁环1和第二半圆形磁环2的形状也可以是类似半圆的结构,即二者并非标准的半圆。同时,第一半圆形磁环1和第二半圆形磁环2的形状和尺寸的一致性也并非要求苛刻,只要满足二者分别在两端相吸或相触时,为一个大致的环形即可。例如,第一半圆形磁环1的外环半径可以稍大,或者,第二半圆形磁环2的内环半径可以稍大等等。但是,二者的轴向距离应该是一致的。因为只有这样,才能保证二者分别在两端相吸或相触时,形成的是一个完整的平滑端面,从而能够与第二磁吻合环8在轴向的端面完全贴合相吸,进行压榨。In an embodiment of the present invention, the shapes of the first semicircular
同样,容易理解,在本发明的实施例中,第一半圆形磁环1和第二半圆形磁环2的截面形状可以是矩形、梯形、类似跑道形状等多种形状,总体而言,其端面应为平面,而内外环侧面可以为斜面、直面或弧形面,根据加工难易程度等因素选择,这些选择均是本领域技术人员能够根据实际情况做出的常规选择。Equally, it is easy to understand that in the embodiment of the present invention, the cross-sectional shapes of the first semicircular
在本发明的实施例中,给出了第一头端141与第一控制端12的连接结构,以及第二头端241与第二控制端22的连接结构。参考图6,在第一控制端12设置有第一穿线孔11,第二控制端22有第二穿线孔21。第一穿线孔11和第二穿线孔21均为沿外环侧面向内环侧面的开孔,优选地,二者均为径向孔,即指向第一半圆形磁环1或第二半圆形磁环2圆心的通孔。第一头端141穿入第一穿线孔11并固定连接;第二头端241穿入第二穿线21并固定连接。In the embodiment of the present invention, the connection structure between the
本实施例中,通过穿孔的方式实现了牵引线与半圆形磁环的连接,穿线之后可在控制端绑扎,其连接紧固可靠。将第一尾端142和第二尾端242引出,即可通过牵拉第一尾端142或第二尾端242,进而牵拉第一控制端12或第二控制端22,带动第一半圆形磁环1或第二半圆形磁环2的整体旋转,使第一磁吻合环由S形向O形转变。In this embodiment, the connection between the traction wire and the semicircular magnetic ring is realized by means of perforation. After the wire is threaded, it can be bound at the control end, and the connection is fast and reliable. Pull out the
在本发明的实施例中,更进一步地,第一头端141设置有膨大端头,第二头端241设置有亦可设置膨大端头,第一头端141的膨大端头尺寸大于第一穿线孔11,第二头端241的膨大端头尺寸大于第二穿线孔21。即,第一穿线孔11允许第一牵引线14的第一尾端142穿过,但不允许第一牵引线14的第一头端141通过。第二穿线孔21可允许第二牵引线24的第二尾端242穿过,但不允许第二牵引线24的第二头端241通过。对于第一牵引线14,其膨大端头卡在第一半圆形磁环1的内环侧面,第一尾端142从第一半圆形磁环1的外环侧面引出。对于第二牵引线24其膨大端头卡在第二半圆形磁环2的内环侧面,第二尾端242从第二半圆形磁环2的外环侧面引出。In the embodiment of the present invention, further, the
本实施例中,给出了第一头端141与第一控制端12更优选的连接结构,以及第二头端241与第二控制端22更优选的连接结构。该结构实现了更加便捷的连接,且牵引线的撤出更加方便,同时避免了牵引线经过轴向端面,是本发明的优选结构。In this embodiment, a more preferable connection structure between the
在本发明的各个实施例中,第一牵引线14和第二牵引线24为丝线或尼龙线等,其长度适中,且应该具有较佳的强度、柔韧度和光滑度。同时,其直径显然不能过大,在便于操作和满足强度的前提下可任意选择。In various embodiments of the present invention, the first pulling
在本发明的实施例中,辅助操作装置还包括控制管3,参考图5,控制管3中设置有轴向的第一控制孔31和第二控制孔32,也即,控制管3为带有第一控制孔31和第二控制空32的中空管状物,其可由不锈钢、铜、高分子材料等加工而成。第一控制孔31用于供第一牵引线14的的第一尾端142顺利穿过,第二控制孔32用于供第二牵引线24的第二尾端242顺利穿过。即,第一牵引线14的第一尾端142可穿过第一穿线孔11和第一控制孔31。第二牵引线24的第二尾端242可穿过第二穿线孔21和第二控制孔32。In the embodiment of the present invention, the auxiliary operation device also includes a
本实施例中,设置的控制管3,利用其一端顶住第一半圆形磁环1,以保证牵拉控制线带动一个半圆形磁环时,另一个半圆形磁环保持不动,进而完成S形向O形的变化。In this embodiment, one end of the
具体地,当设置控制管3时,本发明的原理如下:Specifically, when the
如图6所示,第一半圆形磁环1的第一关节端13与第二半圆形磁环2的第二关节端23对位相吸,第一半圆形磁环1的第一控制端12和第二半圆形磁环2的第二控制端22分别位于相吸位置的两侧,且位于同一平面上。第一牵引线14的第一尾端142依次穿过第一控制端12上的第一控制孔11和控制管3的第一控制孔31,并从控制管3穿出,第一牵引线14的第一头端141固定于第一穿线孔11。第二牵引线24的第二尾端242依次穿过第二控制端22上的第二控制孔21和控制管3的第二控制孔32,并从控制管3穿出,第二牵引线24的第二头端241固定于第二穿线孔21。与第一半圆形磁环1相比,第二半圆形磁环2更靠近控制管3。牵拉第二牵拉线24的第二尾端242,使其呈收紧状态,第一牵拉线14保持松弛状态,此时两个半圆形磁环呈“S”形。As shown in Figure 6, the first
如图7所示,当收紧并牵拉第一牵引线14的第一尾端141时,第一半圆形磁环1围绕第二关节端23可发生旋转变形。当持续牵拉第一尾端141达到一定程度时,第一半圆形磁环1的第一控制端12与第二半圆形磁环2的第二控制端22对位相吸,此时第一半圆形磁环1和第二半圆形磁环2形成“O”形,如图8所示。As shown in FIG. 7 , when the
在本发明的实施例中,第二磁吻合环8的外径与所述变化为O形的所述第一磁吻合环的外径相等。该尺寸限制使得第二磁吻合环8与第一磁吻合环的贴合更加规则。In the embodiment of the present invention, the outer diameter of the second magnetic
在本发明的实施例中,第一半圆形磁环1的外径10-40mm、内径范围5-35mm;控制管3的长度范围5cm-50cm。该尺寸能方便地使得部件置入体内,不影响压榨并便于退出。In the embodiment of the present invention, the outer diameter of the first semicircular
本发明在术中使用时,按以下步骤操作:When the present invention is used in the operation, operate according to the following steps:
a:使第一磁吻合环呈初始的“S”形,即第一关节端13与第二关节端23相吸,第一控制端12与第二控制端22不相吸。将呈“S”形的第一磁吻合环置入直肠狭窄段5的远端直肠6,如图9所示。本步骤中,第一半圆形磁环1与第二半圆形磁环2位于同一平面,二者所处平面夹角为0°,也可不完全处于同一平面,二者所处平面具有微小的夹角。a: Make the first magnetic anastomotic ring assume an initial "S" shape, that is, the first
b:呈“S”形的第一磁吻合环以蛇形运动形式逐步穿越直肠狭窄段5,进入直肠近端4,如图10所示。b: The first magnetic anastomosis ring in an "S" shape gradually passes through the rectal
c:呈“S”形的第一磁吻合环完全穿越直肠狭窄段5,整体进入直肠近端4,如图11所示。c: The first magnetic anastomosis ring in an "S" shape completely passes through the rectal
d:控制管3的近端抵触在第二半圆形磁环2的第二控制端22的外环侧面,操作者用手或其他医疗夹持器械固定控制管3后,牵拉第一尾端142,第一半圆形磁环1围绕第二关节端23发生旋转变形,如图12所示。d: The proximal end of the
e:持续牵拉第一尾端142达到一定程度时,第一半圆形磁环1的第一控制端12与第二半圆形磁环2的第二控制端22对位相吸,此时第一半圆形磁环1和第二半圆形磁环2形成“O”形,二者所处平面夹角为180°,呈“O”形的第一磁吻合环整体位于直肠近端4,如图13所示。e: When the
f:退去控制管3、第一牵拉线14和第二牵拉线24后,仅呈“O”形的第一磁吻合环整体位于直肠近端4内,如图14所示。值得说明的是,控制管3的近端抵触在第二半圆形磁环2的外环侧面,远端位于体外,因此可直接拔出。第一牵拉线14和第二牵拉线24可用线剪紧贴磁环剪断,如位置比较深,可使用结肠镜,在结肠镜下利用内镜下剪刀剪断。也可不用处理第一牵拉线14和第二牵拉线14,二者的存在与否对吻合没有实质影响。f: After withdrawing the
g:在远端直肠6内置入第二磁吻合环8,如图15所示。g: A second magnetic
h:直肠近端4内的第一磁吻合环和直肠远端6内第二磁吻合环8在轴向的端面相吸并压榨直肠狭窄段5,如图16所示。h: The first magnetic anastomotic ring in the
i:压榨一段时间(一般为5-14天)后,直肠狭窄段5被打通,第一磁吻合环和第二磁吻合环8相吸的整体结构脱落入直肠远端6内,并可自行排出体外,直肠吻合口7建立,如图17所示。i: After pressing for a period of time (usually 5-14 days), the
为对本发明的应用进行验证,本发明进行了动物实验如下:For verifying the application of the present invention, the present invention has carried out animal experiments as follows:
实验动物选用6只新西兰兔,雌雄各半,体重3-3.5kg,实验动物由西安交通大学实验动物中心提供。整个实验过程严格遵守西安交通大学实验动物管理相关规定,实验中确保动物福利,减少动物痛苦。As the experimental animals, 6 New Zealand rabbits were selected, half male and half male, weighing 3-3.5 kg. The experimental animals were provided by the Experimental Animal Center of Xi'an Jiaotong University. The whole experimental process strictly complied with the relevant regulations of Xi'an Jiaotong University on the management of experimental animals, ensuring animal welfare and reducing animal suffering during the experiment.
实验动物术前禁食1天,不禁饮。3%戊巴比妥钠溶液耳缘静脉注射(1mL/kg),麻醉成功后仰卧位固定实验兔。下腹部及肛门周围剃毛备皮,常规消毒铺无菌洞巾。取下腹部正中切口长约8cm,逐层进腹后寻找直肠,经肛门插入14F胃管至直肠,在直肠下段处用1-0丝线部分结扎直肠制备直肠狭窄模型,经肛门内14F胃管推注造影剂后拔除胃管,立即行腹部X线检查,明确狭窄部位和狭窄程度。模型制备成功后,逐层关腹。同期,X线监视下经肛门置入呈“S”形的第一磁吻合环,蛇形运动推送,“S”形的第一磁吻合环完全越过直肠狭窄段5后,收紧牵拉线,第一磁吻合环变成圆形,退出控制管3。第二磁吻合环8采用成环后直接经肛门置入,直肠狭窄段5两端的第一磁吻合环和第二磁吻合环8对位吸合后手术操作即完成。磁环置入过程中X线显示磁吻合器状态变化过程见图18所示,图中:a.结肠造影显示直肠狭窄段5;b.推送呈“S”形的第一磁吻合环穿过直肠狭窄段5;b.呈“S”形的第一磁吻合环完全越过直肠狭窄段5至直肠近端4;c,d.第一磁吻合环状态变化过程;e.第一磁吻合环由“S”形磁环变为“O”形;f.推送远端的第二磁吻合环8;g.直肠狭窄段5两端的第一磁吻合环和第二磁吻合环8自动对位相吸(图中箭头所指为直肠狭窄段5)。Experimental animals were fasted for 1 day before operation, and were not allowed to drink. 3% sodium pentobarbital solution was injected into the ear vein (1 mL/kg), and the experimental rabbit was fixed in the supine position after successful anesthesia. The lower abdomen and around the anus were shaved to prepare the skin, and sterile drape was spread for routine disinfection. Remove the midline abdominal incision with a length of about 8 cm, enter the abdomen layer by layer, and search for the rectum, insert a 14F gastric tube through the anus to the rectum, partially ligate the rectum with 1-0 silk thread at the lower rectum to prepare the rectal stricture model, and push the 14F gastric tube through the anus After the injection of contrast medium, the gastric tube was removed, and an abdominal X-ray examination was performed immediately to clarify the location and degree of stenosis. After the model was successfully prepared, the abdomen was closed layer by layer. At the same time, under X-ray monitoring, the first "S"-shaped magnetic anastomosis ring was placed through the anus, and pushed in a serpentine motion. After the "S"-shaped first magnetic anastomosis ring completely crossed the
本发明通过丝线部分结扎法成功建立了直肠狭窄模型,直肠狭窄段5直径约4mm左右。本发明第一磁吻合环采用“S”变形和蛇形运动后均成功置入直肠近端4,并通过牵拉线和控制管3的操作,成功实现第一磁吻合环从“S”形到“O”形的变形成环过程。去除直肠狭窄模型制备时间,直肠狭窄磁吻合操作过程时间9.5~12min,平均用时10.67±0.93min。磁体排出时间为3~5天,平均3.67±0.81天。磁吻合器排出后行结肠造影可见狭窄段消失,1周后获取直肠狭窄吻合口标本,肉眼观察可见吻合口形成良好,吻合口直肠粘膜光滑平整。In the present invention, the rectal stricture model is successfully established through partial ligation of the silk thread, and the diameter of the
综上,本发明通过使第一磁吻合环从“S”形到“O”形的变化和蛇形运动有效解决了常规磁环不能通过狭窄段的问题,因此在设计磁吻合环直径时,可忽略置入操作问题,而使磁吻合环直径最大程度上接近直肠内径,为尽可能“铲除”吻合口瘢痕创造条件,实现吻合口长期通畅。本发明为经肛单通路下应用磁吻合技术治疗直肠癌术后吻合口狭窄做出了有益探索。进一步优化磁环设计和操作路径,有望在临床中应用。In summary, the present invention effectively solves the problem that the conventional magnetic ring cannot pass through the narrow section by making the first magnetic anastomotic ring change from "S" shape to "O" shape and serpentine motion. Therefore, when designing the diameter of the magnetic anastomotic ring, The problem of insertion operation can be ignored, and the diameter of the magnetic anastomosis ring can be close to the inner diameter of the rectum to the greatest extent, so as to create conditions for "eradicating" the anastomotic scar as much as possible and achieve long-term patency of the anastomosis. The invention makes a beneficial exploration for applying the magnetic anastomosis technique to treat anastomotic stenosis after rectal cancer operation under a single transanal channel. Further optimization of the design and operation path of the magnetic ring is expected to be applied in clinical practice.
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