人造腹腔镜手术空间装置Artificial laparoscopic surgery space device
本发明属于医疗手术用品，具体涉及腹腔隔离的人造腹腔镜手术空间装置，可避免手术过程中，游离肌瘤细胞污染腹腔造成肿瘤移殖。The invention belongs to a medical surgical product, and particularly relates to an artificial laparoscopic surgical space device for abdominal cavity isolation, which can avoid tumor migration caused by free fibroid cells contaminating the abdominal cavity during the operation.
腹腔镜手术是微创技术中的一个重要组成部分，近年腹腔镜手术发展迅速，腹腔镜手术已逐渐普及,1995年FDA批准使用腹腔镜电机粉碎器，因妇科子宫肌瘤剔除或子宫切除的微创手术改善了手术和疾病相关的结局，全世界范围内数以千万的女性患者受益。Laparoscopic surgery is an important part of minimally invasive surgery. Laparoscopic surgery has developed rapidly in recent years, and laparoscopic surgery has become popular. In 1995, FDA approved the use of laparoscopic motor pulverizers, due to gynecological uterine fibroids removal or hysterectomy. Invasive surgery improves surgical and disease-related outcomes, benefiting tens of millions of female patients worldwide.
FDA的证据：约1/400至1/1000推测为子宫良性平滑肌瘤而实施子宫切除手术的妇女病理诊断为子宫平滑肌肉瘤，子宫平滑肌肉瘤预后一般较差，可能因电机粉碎器预后更差，电机粉碎术还可能发生其他风险，如：良性组织的播散和脏器的损伤，需要培训、经验和技巧。FDA evidence: Approximately 1 in 400 to 1/1000 of women with benign leiomyomas of the uterus are diagnosed as uterine leiomyosarcoma, and the prognosis of uterine leiomyosarcoma is generally poor, possibly due to poor prognosis of motor pulverizers. Motor pulverization may also present other risks, such as dissemination of benign tissue and damage to organs, requiring training, experience and skill.
造成术后恶性肿瘤移殖的原因为：现在手术粉碎剥离肌瘤过程中，采用直接在取物袋中粉碎的方式，无法避免粉碎过程中游离的肌瘤细胞污染腹腔造成转移。迫切希望研制一种专用新型医疗器械，简单、有效、操作方便的在肌瘤粉碎过程中将手术操作空间与患者腹腔完全隔离，避免污染腹腔造成转移。The cause of postoperative malignant tumor colonization is: in the process of smashing and dissecting fibroids, the method of smashing directly in the bag can not avoid the transfer of free fibroid cells to the abdominal cavity during the pulverization process. It is urgent to develop a special-purpose new medical device, which is simple, effective and easy to operate. The operation space is completely isolated from the abdominal cavity of the patient during the process of fibroid comminution, so as to avoid the contamination caused by contamination of the abdominal cavity.
发明内容Summary of the invention
本发明的目的是：克服现有术式的不足，创新设计一种专用手术器械-人造腹腔镜手术空间装置，在患者腹腔内，创造隔离的手术操作空间，防止切除肿瘤后粉碎过程中游离肌瘤细胞污染腹腔。The object of the present invention is to overcome the deficiencies of the prior art, and to design a special surgical instrument-artificial laparoscopic surgical space device to create an isolated surgical operation space in the abdominal cavity of the patient to prevent the free muscle during the pulverization process after the tumor is removed. Tumor cells contaminate the abdominal cavity.
本发明人造腹腔镜手术空间装置解决的技术问题所采用的技术方案是：The technical solution adopted by the technical device for solving the artificial laparoscopic surgical space device of the present invention is:
该人造腹腔镜手术空间装置由输送器、袋体组成(详见附图1结构示意图)。The artificial laparoscopic surgical space device is composed of a conveyor and a bag body (see the structural schematic diagram of FIG. 1 for details).
The artificial laparoscopic space device transporter is composed of an outer sleeve, a handle, an operating rod, an elastic body, a soft belt and a soft belt pull ring, and the bag body comprises a bag cylinder and an operation port.
所述手柄固定在外套管的末端，弹性体穿过袋体的开口端、两端对称固定在操作杆前端，软带穿过袋口颈部，并从外套管和操作杆的间隙穿过连接至软带拉环。人造腹腔镜手术空间装置袋体可采用柔性材质制作、可用单一或复合高分子材料；袋体结构由袋口，承物囊和若干操作口组成，所述的袋口、承物囊及操作口连接成一体。The handle is fixed at the end of the outer sleeve, the elastic body passes through the open end of the bag body, and the two ends are symmetrically fixed to the front end of the operating rod, the soft belt passes through the neck of the bag mouth, and the connection is made from the gap between the outer sleeve and the operating rod. To the soft belt pull ring. The artificial laparoscopic space device bag can be made of flexible material and can be made of single or composite polymer material; the bag body structure is composed of a bag mouth, a bag and a plurality of operation ports, the bag mouth, the bag and the operation port Connected into one.
袋口连接在弹性体环形部；承物囊具有长颈部，囊体形状可采用球形、半球形、圆筒形、锥筒形或椭球形等各种形状，囊下部设有多个操作口。当袋口闭合后袋体为一不漏气密闭结构，袋体体积不小于0.3升，不大于5升。袋口可通过软带拉紧固定在悬浮组织上进行密闭，为增强密闭可靠性可通过外套管进入的管夹附件进行加固密闭，或在软带下端增设一个环形囊,其通气管路从外套管和操作杆的间隙穿过连接到体外,对通气管路充气、环形囊膨胀密封。The bag mouth is connected to the annular portion of the elastic body; the carrier bag has a long neck, and the shape of the capsule body can be various shapes such as a spherical shape, a hemispherical shape, a cylindrical shape, a cone shape or an ellipsoid shape, and a plurality of operation ports are arranged at the lower portion of the capsule. . When the bag mouth is closed, the bag body is a gas-tight structure, and the bag body volume is not less than 0.3 liter and not more than 5 liters. The bag mouth can be tightly fixed on the suspended tissue by the soft belt to be sealed, and the tube clamp accessory that enters the outer sleeve can be reinforced and sealed for enhancing the sealing reliability, or an annular capsule is added at the lower end of the soft belt, and the vent line is from the outer sleeve. The gap between the tube and the operating rod is connected to the outside of the body, the vent line is inflated, and the annular bladder is expanded and sealed.
操作口数量为2～5个，可利用不同颜色区分，操作口可为直接连接在承物囊下方的弹性环或胶片，形状呈圆环形、椭圆形或多边形，口径为5至30毫米，操作口之间间距为4至30厘米；操作口也可设过渡段与承物囊连接，其端部设弹性环或胶片，过渡段截面可采用圆形、椭圆形、多边形等各种形状。操作口可通过焊接或粘接方式与承物囊连接，手术中刺破或剪开操作口中心进行器械操作。The number of operation ports is 2 to 5, which can be distinguished by different colors. The operation port can be an elastic ring or film directly connected under the bag, and the shape is circular, elliptical or polygonal, and the diameter is 5 to 30 mm. The distance between the operation ports is 4 to 30 cm; the operation port can also be connected with the transfer bag, and the end portion is provided with an elastic ring or a film, and the cross section of the transition portion can adopt various shapes such as a circle, an ellipse and a polygon. The operation port can be connected to the sac by welding or bonding, and the operation of the instrument can be performed by puncturing or cutting the center of the operation port during the operation.
操作口可增设止逆通道，止逆通道由一薄膜筒状通道构成，一端连接在操作口顶端，另一端置于过渡段中或承物囊内，处于游离状态，当手术器械从止逆通道中穿过，通道处于开启状态，当手术器械从止逆通道中抽离，薄膜通道受袋体内气压作用，开口闭门防止袋体内气体、液体等其他物质从操作口顶端泄露。手术中可在操作口顶端安装辅助固定座，形状可采用卡座盘形、卡环、固定夹等形式。The operation port may be provided with a non-return channel formed by a film tubular channel, one end connected to the top end of the operation port, and the other end being placed in the transition section or in the carrier bag, in a free state, when the surgical instrument is from the non-return channel In the middle, the channel is in the open state. When the surgical instrument is pulled away from the anti-reverse channel, the membrane channel is subjected to the air pressure in the bag, and the opening is closed to prevent the gas, liquid and other substances in the bag from leaking from the top of the operation port. An auxiliary fixing seat can be installed at the top of the operating port during the operation, and the shape can be in the form of a card seat disc, a snap ring, a fixing clip or the like.
进入体内前操作杆、弹性体、软带连接袋体皆置放外套管内；操作杆由外套管尾部向前伸出时，弹性体自动打开带动袋口张开；当操作杆由外套管尾部向后拉出时，弹性体闭合缩入外套管内带动袋口闭合。向后拉动软带可在弹性体打开的状态下收缩袋口。Before entering the body, the operating rod, the elastic body and the flexible belt connecting bag body are placed in the outer sleeve; when the operating rod is extended forward from the outer sleeve tail, the elastic body automatically opens to drive the opening of the pocket; when the operating rod is extended from the tail of the outer sleeve When pulled out, the elastic body is closed and retracted into the outer sleeve to open the pocket opening. Pulling the flexible tape back can shrink the pocket when the elastomer is open.
从对应的患者腹壁切口操作通道拉出体外固定；第四步取出输送器将袋口拉出患者体外并固定；第五步将戳卡从相应的袋口进入承物囊内，通过任一戳卡向承物囊充气，至此在患者腹腔内建造一个完全密闭的人造气腹手术空间。建造成功后，将内窥镜、粉碎器、手术钳等操作器械从相应操作口分别进入手术空间装置，在窥镜观察下对剥离的肌瘤组织进行粉碎，粉碎结束后将器械从操作口撤出，利用手术缝线扎捆密闭操作口，之后直接利用输送器将袋体连同粉碎的肌瘤组织从手术切口取出。The first step of use: the bag body is sent into the surgical incision by the stamping card, the elastic body automatically opens the bag body; the second step places the peeled fibroid tissue in the bag body; the third step separates the operation port respectively
Pull out the external fixation from the corresponding patient abdominal wall incision operation channel; the fourth step is to take out the conveyor to pull the bag opening out of the patient's body and fix it; the fifth step is to poke the card into the bag from the corresponding bag mouth, through any stamp The card inflates the bag, and thus a completely enclosed artificial pneumoperitoneum is constructed in the patient's abdominal cavity. After successful construction, the endoscope, pulverizer, surgical forceps and other operating instruments are respectively inserted into the surgical space device from the corresponding operation ports, and the peeled fibroid tissue is pulverized under the speculum observation. After the pulverization, the instrument is removed from the operation port. The sealed operation port is tied with a surgical suture, and then the bag body and the pulverized myoma tissue are directly taken out from the surgical incision by a conveyor.
本发明有以下有益效果：The invention has the following beneficial effects:
1.封闭性：形成腹腔镜下封闭操作空间进行手术相关操作。1. Closedness: Form a laparoscopic closed operating space for surgical related operations.
2.电子绝缘性：袋体本身为高分子类绝缘产品，可避免腹腔镜的电能驱动器械与盆腹腔重要脏器如肠管、输尿管、膀胱等接触，从而避免机、电引起的损伤。2. Electronic insulation: The bag itself is a polymer insulation product, which can avoid the laparoscopic electric energy driving device and the important organs such as the intestine, ureter, bladder and the like in the pelvic and abdominal cavity, so as to avoid damage caused by machine and electricity.
3.物理“隔离”性：所有操作均在人造腹腔镜手术空间装置袋体内进行，对周围脏器无直接接触，可避免机械损伤，也避免操作器械对周围脏器不必要的干扰，利于术后胃肠道等功能恢复。3. Physical "isolation": All operations are carried out in the artificial laparoscopic surgery space device bag, no direct contact with surrounding organs, can avoid mechanical damage, and avoid unnecessary interference of the operating instruments on surrounding organs, which is conducive to surgery The function of the posterior gastrointestinal tract is restored.
4.盆腹腔内环境洁净性：手术操作及标本取出均在密闭人造腹腔镜手术空间内进行，避免了标本播散腹腔，避免了手术出血散流入盆腹腔，从而从源头上避免了标本如子宫肌瘤组织、囊肿剔除之囊内容物如畸胎瘤油脂毛发等的盆腹腔播散，也可以减少冲吸盆腹腔手术出血的手术时间，并可减少术后由于手术操作和残留积血块等引起的粘连。4. Clean environment in the pelvic and abdominal cavity: the operation and specimen removal are carried out in the closed artificial laparoscopic operation space, avoiding the specimen spreading the abdominal cavity, avoiding the bleeding of the operation into the pelvic cavity, thus avoiding the specimen such as the uterus from the source. The pelvic and abdominal cavity of the fibroid tissue and cysts, such as teratoma oil and hair, can also reduce the operation time of the abdominal pelvic surgery bleeding, and can reduce the postoperative operation due to surgical operation and residual blood clots. Adhesion.
5.对于恶性卵巢肿瘤患者，如果能够应用人造腹腔镜手术空间装置进行手术操作，即使肿瘤破裂，由于避免了破裂内容物散落盆腹腔，理论上可以不改变Ia期患者的手术分期，从而避免了后续的化疗治疗。5. For patients with malignant ovarian tumors, if the artificial laparoscopic space device can be used for surgical operation, even if the tumor is ruptured, since the ruptured contents are scattered to the pelvic and abdominal cavity, the surgical staging of patients with stage Ia can be theoretically avoided, thereby avoiding Follow-up chemotherapy treatment.
综上，人造腹腔镜手术空间装置可避免手术中的机械和热损伤，避免标本组织播散于盆腹腔，减少手术操作时间，减少术后粘连，并利于术后器官功能恢复。In summary, the artificial laparoscopic space device can avoid mechanical and thermal damage during surgery, avoid the spread of specimen tissue in the pelvic and abdominal cavity, reduce the operation time, reduce postoperative adhesion, and facilitate the recovery of postoperative organ function.
图1：操作口过渡段连接人造腹腔镜手术空间装置结构示意图；Figure 1: Schematic diagram of the structure of the artificial laparoscopic surgery space device connected to the transition section of the operation port;
图2：操作口直接连接人造腹腔镜手术空间装置结构示意图A；Figure 2: Schematic diagram of the structure of the operation device directly connected to the artificial laparoscopic surgery space device A;
Figure 3: Schematic diagram B of the operation device directly connected to the artificial laparoscopic surgery space device.
实施例一 Embodiment 1
参照图1，本发明输送器1包括(外套管1-1、手柄1-2、操作杆1-3、弹性体1-4、软带1-5、软带拉环1-6)、袋体2包括(袋口2-1、承物囊2-2、操作口2-3(过渡段2-3-1、弹性环2-3-2)。所述手柄1-2固定在外套管1-1的末端，弹性体1-4穿过袋口2-1、两端对称固定在操作杆1-3前端，软带1-5穿过袋口2-1，并从外套管1-1和操作杆1-3的间隙穿过连接至软带拉环1-6。袋体2为聚氨酯材质，袋体形状为圆筒形，体积2升。操作口2-3数量为3个，通过筒状过渡段2-3-1连接到承物囊2-2，弹性环2-3-2为聚氨酯材质，形状为环状直接粘接在操作口2-3顶端。Referring to Figure 1, the conveyor 1 of the present invention comprises (outer casing 1-1, handle 1-2, operating rod 1-3, elastomer 1-4, soft belt 1-5, soft belt pull ring 1-6), bag The body 2 includes (the bag mouth 2-1, the carrier bag 2-2, the operation port 2-3 (transition segment 2-3-1, the elastic ring 2-3-2). The handle 1-2 is fixed to the outer sleeve At the end of 1-1, the elastic body 1-4 passes through the pocket 2-1, and the two ends are symmetrically fixed to the front end of the operating rod 1-3, and the soft belt 1-5 passes through the pocket 2-1, and from the outer sleeve 1- 1 and the gap between the operating rods 1-3 is connected to the flexible belt pull ring 1-6. The bag body 2 is made of polyurethane, the shape of the bag body is cylindrical, and the volume is 2 liters. The number of the operation ports 2-3 is three. The tubular transition piece 2-3-1 is connected to the carrier bag 2-2, and the elastic ring 2-3-2 is made of polyurethane material, and is annularly bonded directly to the top end of the operation port 2-3.
实施例二 Embodiment 2
Referring to Figure 2, the conveyor 1 of the present invention comprises (outer casing 1-1, handle 1-2, operating rod 1-3, elastomer 1-4, soft belt 1-5, soft belt pull ring 1-6), bag The body 2 includes (the bag mouth 2-1, the carrier bag 2-2, the operation port 2-3). The handle 1-2 is fixed at the end of the outer sleeve 1-1, the elastic body 1-4 passes through the pocket 2-1, and the two ends are symmetrically fixed to the front end of the operating rod 1-3, and the soft belt 1-5 passes through the pocket 2-1, and connected to the flexible band pull ring 1-6 from the gap between the outer sleeve 1-1 and the operating rod 1-3. The bag body 2 is made of polyurethane, and the bag body has a cylindrical shape and a volume of 2 liters. The number of the operation ports 2-3 is three, which is made of polyurethane material, and the shape is an annular shape and is directly bonded to the carrier bag 2-2, and is distinguished by different colors.