CN2436105Y - MIniature wound closure apparatus - Google Patents

Abstract

Translated fromChinese

一种封闭微型血管创伤用的微型伤口封闭器,由止血元件,输送元件和自锁元件组成,止血元件的前端为由记忆合金丝编绕成紧密接触的三维曲面,后端呈丝状,与前端固接为一体;输送元件由管筒和管柄构成,自锁元件由锁管和锁头构成;锁管中部有外螺纹与管柄内螺纹相应;锁头由圆柱面和有开口狭缝的锥面头部构成;本实用新型利用形状记忆合金丝绕成的三维曲面做为暂时阻断血液流动的屏障,该屏障用生物相容性材料做成的输送系统可方便、安全、准确地送到伤口血管内。

A micro-wound sealer for sealing micro-vascular wounds, which is composed of a hemostatic element, a delivery element and a self-locking element. The front end of the hemostatic element is a three-dimensional curved surface that is braided by memory alloy wire, and the rear end is in the shape of a wire. The front end is fixed as a whole; the conveying element is composed of a tube and a handle, and the self-locking element is composed of a lock pipe and a lock head; the middle part of the lock pipe has an external thread corresponding to the internal thread of the pipe handle; the lock head is composed of a cylindrical surface and an opening slit The utility model uses a three-dimensional curved surface wound by a shape memory alloy wire as a barrier to temporarily block blood flow. into the blood vessels of the wound.

Description

Translated fromChinese

微型伤口封闭器micro wound closure

本实用新型涉及医疗器械，具体地说是一种微型伤口封闭装置。用来封闭介入诊疗手术及其它原因造成的微型伤口。The utility model relates to a medical appliance, in particular to a miniature wound sealing device. It is used to seal micro-wounds caused by interventional diagnosis and treatment operations and other reasons.

介入诊疗是指通过人体的各种通道，将一些特殊的微型器械送入人体的各个部位进行疾病诊断及治疗。介入诊疗是一种新型的医疗技术，属微型创伤手术，病人痛苦少，花费便宜，治疗范围广，疗效显著。这种手术往往需在人体的血管处开一个长2mm-15mm的口子，待诊疗结束后，如何简单、安全地封闭这种无法用传统缝合方法进行缝合的伤口，是一个挑战。特别当介入手术的人次逐年激增，而病人住院时间逐年降低的情况下，寻找简单安全的封闭微型伤口的方法和器械就显得越来越重要。Interventional diagnosis and treatment refers to sending some special micro-devices into various parts of the human body through various channels of the human body for disease diagnosis and treatment. Interventional diagnosis and treatment is a new type of medical technology, which is a micro-trauma operation, with less pain for patients, low cost, wide range of treatment and remarkable curative effect. This kind of operation often requires an opening of 2mm-15mm in length in the blood vessels of the human body. After the diagnosis and treatment, how to simply and safely close the wound that cannot be sutured by traditional suturing methods is a challenge. Especially when the number of interventional operations is increasing year by year, and the hospital stay of patients is decreasing year by year, it is more and more important to find simple and safe methods and instruments for sealing micro-wounds.

美国专利5948425发明了一种封闭微创伤口的器械和方法。该器械将一固体的colleage塞子送至伤口处。该固体的colleage塞子为生物吸收性材料，待一定时间后，这种塞子被人体伤口吸收。但这种固体的塞子，无法保证与伤口周围的良好配合，往往引起感染。美国专利6007563也发明了一种装置进行微创伤口的封闭。它用一个生物吸收性固体薄片从血管内壁先暂时阻止血液沿伤口外泻，然后向伤口处注射液体的凝血药物，待凝血药物固化后，伤口封闭完毕。放在血管内的生物吸收性薄片待几个月后，才能全部溶解。在专利6007563中，暂时阻止血液外流的固体片在伤口封闭后不取出来。美国专利5868788发明了一种器械也是用于封闭微型伤口。该器械特点是用球囊来暂时阻止血液的外流。在球囊泄气状态通过伤口送进血管，然后气囊充气。将充气的球囊紧贴伤口就可阻止血液沿伤口外流。然后向伤口处流射液态凝血药物，当液态凝血药物固化至半凝状态时，将球囊泄气取出。当凝血药物完全固化后，伤口封闭完毕。该发明器械，不需要将用来暂时阻止血液外流的零件长期放置在血管内，而较专利6007563优越。但由于球囊制作的成本和工艺的复杂，器械成本较高。更严重的是，球囊泄气后形状无法控制，当泄气后的球囊通过盛有半凝固态药物伤口处外撤时，会破坏药物的形态和平衡。US Patent No. 5,948,425 has invented a kind of apparatus and method for closing microtrauma wound. The device delivers a solid colleage plug to the wound. The solid colleage plug is a bioabsorbable material, and after a certain period of time, the plug is absorbed by the wound of the human body. However, such a solid plug cannot ensure a good fit around the wound and often causes infection. U.S. Patent 6007563 also invented a kind of device to carry out the closure of microtrauma wound. It uses a bioabsorbable solid sheet from the inner wall of the blood vessel to temporarily prevent the blood from leaking along the wound, and then injects liquid coagulation medicine into the wound. After the coagulation medicine solidifies, the wound is closed. It takes several months for the bioabsorbable sheet placed in the blood vessel to completely dissolve. In patent 6007563, the solid sheet that temporarily blocks the outflow of blood is not removed after the wound is closed. U.S. Patent No. 5,868,788 has invented a kind of apparatus and is also used for sealing micro-wound. The device features a balloon that temporarily blocks the outflow of blood. The deflated balloon is delivered through the wound into the blood vessel, and the balloon is then inflated. Pressing the inflated balloon against the wound stops blood from leaking along the wound. Then spray the liquid blood coagulation drug to the wound, and when the liquid blood coagulation drug solidifies to a semi-coagulated state, the balloon is deflated and taken out. When the coagulation drug is completely solidified, the wound is closed. The device of this invention does not need to place the parts used to temporarily prevent the outflow of blood in the blood vessel for a long time, and is superior to the patent 6007563. However, due to the cost of making the balloon and the complexity of the process, the cost of the device is relatively high. What's more serious is that the shape of the deflated balloon cannot be controlled. When the deflated balloon is withdrawn through the wound filled with semi-coagulated medicine, the shape and balance of the medicine will be destroyed.

本实用新型的目的是克服上述不足，提供一种微型伤口封闭装置，用于封闭微型血管创伤，它利用形状记忆合金丝绕成的三维曲面做为暂时阻断血液流动的屏障，该屏障用生物相容性材料做成的输送系统可方便、安全、准确地送到伤口血管内。The purpose of this utility model is to overcome the above-mentioned deficiencies and provide a micro-wound sealing device for sealing micro-vascular wounds. It uses a three-dimensional curved surface wound by a shape-memory alloy wire as a barrier to temporarily block blood flow. The barrier uses biological The delivery system made of compatible materials can be delivered to wound blood vessels conveniently, safely and accurately.

本实用新型的目的是这样实现的：The purpose of this utility model is achieved in that:

一种封闭微型血管创伤用的微型伤口封闭器，由止血元件，输送元件和自锁元件组成，A micro-wound sealer for sealing micro-vascular wounds, consisting of a hemostatic element, a delivery element and a self-locking element,

止血元件由前端和后端两部分构成，前端为由记忆合金丝编绕成三维曲面，丝与丝之间紧密相连，曲面的中心丝露出曲面；后端呈丝状，其材质为与生物相容性的材料，后端垂直于前端的三维曲面，与前端固接为一体；The hemostatic element is composed of two parts, the front end and the rear end. The front end is a three-dimensional curved surface made of memory alloy wires, and the wires are closely connected. Capacitive material, the rear end is perpendicular to the three-dimensional surface of the front end, and is fixedly connected with the front end;

输送元件由管筒和管柄两部分构成，管筒呈空心柱状，其材质为与生物相容性的材料，管柄呈空心套管状，其材质为可承受一定压力的生物相容性高分子材料，管柄有前端口与管筒连接，该前端口以过度锥面连接管柄体；管柄后端口内有螺纹；The delivery element is composed of a tube and a handle. The tube is hollow cylindrical and its material is biocompatible. The tube handle is a hollow sleeve and its material is a biocompatible polymer that can withstand a certain pressure. Material, the handle has a front port connected to the tube barrel, the front port is connected to the handle body with an excessively tapered surface; the rear port of the handle has threads;

自锁元件由锁管和锁头构成；锁管为一空心管，其材质为与生物相容性的高分子材料，其中部有外螺纹与管柄内螺纹相应；锁头由连体的空心圆柱面和锥面头部构成，该锥面头部有中心孔和开口狭缝，该头部的锥面与管柄的过度锥面相应；The self-locking element is composed of a lock tube and a lock head; the lock tube is a hollow tube made of biocompatible polymer material, and there are external threads in the middle corresponding to the internal threads of the handle; the lock head is composed of a conjoined hollow tube. Composed of a cylindrical surface and a conical head, the conical head has a central hole and an opening slit, and the conical surface of the head corresponds to the excessive conical surface of the shank;

上述各组件的构造为：自锁元件的锁头装于输送元件的管柄的内腔，锁头圆柱面装于锁管的内孔，锁管的螺纹连接于管柄，止血元件的后端穿过锁管、锁头、管柄和管筒的中心，该前端进入人体血管。The structure of each of the above components is as follows: the lock head of the self-locking element is installed in the inner cavity of the pipe handle of the delivery element, the cylindrical surface of the lock head is installed in the inner hole of the lock pipe, the thread of the lock pipe is connected to the pipe handle, and the rear end of the hemostatic element Through the center of the locking tube, the locking head, the handle and the tube barrel, the front end enters the blood vessels of the human body.

所述止血元件的前端的三维曲面可以为球面、圆柱面；也可以为平面，该平面的形状可以为圆形、三角形、矩形。The three-dimensional curved surface of the front end of the hemostatic element may be a spherical surface or a cylindrical surface; it may also be a plane, and the shape of the plane may be a circle, a triangle, or a rectangle.

所述止血元件的前端和后端的丝径可以相等，也可以是后端的丝径大于前端，其连接可以是焊接、粘接，也可以为一根丝的连体构造。The wire diameters of the front end and the rear end of the hemostatic element may be equal, or the wire diameter of the rear end may be larger than the front end, and the connection may be welding, bonding, or a conjoined structure of one wire.

所述记忆合金丝的材质可以是镍钛、铁基、铜基记忆合金。The material of the memory alloy wire can be nickel-titanium, iron-based, copper-based memory alloy.

所述与生物相容性好的材质可以是不锈钢，钛合金、记忆合金、无毒塑料。The material with good biocompatibility can be stainless steel, titanium alloy, memory alloy, or non-toxic plastic.

所述止血元件的前端可以由记忆合金丝和生物相容性高分子外壳构成的组合丝构成，该生物相容高分子材料涂覆于记忆合金的外表，丝的横截面可以呈圆形、半圆形、椭圆形、矩形、三角形、多边形、异形。The front end of the hemostatic element may be composed of memory alloy wire and a composite wire composed of a biocompatible polymer shell. The biocompatible polymer material is coated on the surface of the memory alloy, and the cross section of the wire may be circular, semi-circular, Circle, oval, rectangle, triangle, polygon, shaped.

所述管柄有供进行药物注射的侧口，The handle has a side port for drug injection,

所述输送元件的管筒的外径在0.4-15mm之间，与外径相应的内径在0.2-14.9mm之间。The outer diameter of the tube barrel of the conveying element is between 0.4-15 mm, and the inner diameter corresponding to the outer diameter is between 0.2-14.9 mm.

本实用新型有以下积极有益的效果：The utility model has the following positive and beneficial effects:

本实用新型提供了一种简单、安全的器械用来封闭微型伤口。该器械的原理在于利用形状记忆合金的特点。采用形状记忆合金丝相互紧密接触构成的三维曲面，来暂时阻止血液沿伤口的外流。待用状态时，记忆合金丝被约束在一个薄壁管中呈直线或三维曲线状。使用时，记忆合金丝被推出管外，在无约束的情况下，该记忆金丝转化为三维曲面。该曲面可暂时阻止血液沿伤口的外流。然后向伤口处流射液态的凝血药物，待凝血药物固化成半凝固态时，将记忆合金丝沿输送管撤出。由于输送管的尺寸可做的很小，且可控制，克服了美国专利5868778中气囊带来的缺点。同时该实用新型结构简单，易操作。The utility model provides a simple and safe device for sealing micro wounds. The principle of the device is to utilize the characteristics of shape memory alloys. A three-dimensional curved surface formed by shape memory alloy wires in close contact with each other is used to temporarily prevent blood from flowing out along the wound. In the standby state, the memory alloy wire is constrained in a thin-walled tube in a straight line or three-dimensional curve. When in use, the memory alloy wire is pushed out of the tube, and the memory gold wire is transformed into a three-dimensional curved surface without restraint. This curved surface temporarily blocks the outflow of blood along the wound. Then spray liquid blood coagulation medicine to the wound, and when the blood coagulation medicine is solidified into a semi-coagulated state, the memory alloy wire is withdrawn along the delivery tube. Because the size of the delivery tube can be made small and controllable, the disadvantages brought by the air bag in US Patent No. 5,868,778 are overcome. Simultaneously, the utility model is simple in structure and easy to operate.

以下结合附图作进一步说明：Further explanation is given below in conjunction with accompanying drawings:

图1是本实用新型一实施例的结构示意图；Fig. 1 is the structural representation of an embodiment of the utility model;

图2是本实用新型平面曲面型止血元件的结构示意图，为俯视图；Fig. 2 is a schematic structural view of the planar curved hemostatic element of the present invention, which is a top view;

图3是图2的A-A剖视图；Fig. 3 is the A-A sectional view of Fig. 2;

图4是本实用新型圆柱面型止血元件的结构示意图，为俯视图；Fig. 4 is a schematic structural view of the cylindrical hemostatic element of the present invention, which is a top view;

图5是图4的B-B剖视图；Fig. 5 is the B-B sectional view of Fig. 4;

图6是图4的C-C剖视图；Fig. 6 is the C-C sectional view of Fig. 4;

图7是本实用新型球面型止血元件的结构示意图，为俯视图；Fig. 7 is a schematic structural view of the spherical hemostatic element of the present invention, which is a top view;

图8是图7的D-D剖视图；Fig. 8 is a D-D sectional view of Fig. 7;

图9是图7的E-E剖视图；Fig. 9 is the E-E sectional view of Fig. 7;

图10是本实用新型自锁元件的组装图；Fig. 10 is an assembly diagram of the utility model self-locking element;

图11是图10中的锁头零件示意图；Fig. 11 is a schematic diagram of the lock head parts in Fig. 10;

图12是图11的右侧视图；Fig. 12 is the right side view of Fig. 11;

图13是图12的F-F剖视图；Fig. 13 is the F-F sectional view of Fig. 12;

图14为本实用新型的微型伤口封闭器的使用步骤图，示步骤a；Fig. 14 is a diagram of the usage steps of the miniature wound sealer of the present invention, showing step a;

图15同图14，示步骤b；Figure 15 is the same as Figure 14, showing step b;

图16同图14，示步骤c；Figure 16 is the same as Figure 14, showing step c;

图17同图14，示步骤d；Figure 17 is the same as Figure 14, showing step d;

图18同图14，示步骤e；Figure 18 is the same as Figure 14, showing step e;

附图编号：Drawing No.:

1．止血元件        11．前端          110．记忆合金丝1.Hemostatic component 11.front end 110． memory alloy wire

12．后端12. rear end

2．输送元件        21．管筒          22．管柄2. Conveyor components 21. Tube 22. handle

221．管柄前端口    222．管柄后端口   223．内螺纹221． Handle front port 222． Handle rear port 223． internal thread

224．过度锥面224． excessive taper

3．自锁元件        31．锁管          32．锁头3. Self-locking element 31. Lock tube 32． Lock

321．空心圆柱      322．锥面头部     323．外螺纹321． Hollow cylinder 322． Cone head 323. external thread

324．狭缝          325．中心孔       326．锥面324． Slit 325． Center hole 326． tapered surface

4．鞘管4. Sheath

5．凝血药物5. coagulation drugs

6．血管6. Blood vessel

请参照图1，本实用新型是一种封闭微型血管创伤用的微型伤口封闭器，由止血元件，输送元件和自锁元件组成，Please refer to Fig. 1, the utility model is a kind of miniature wound sealer that closes microvascular trauma, is made up of hemostatic element, conveying element and self-locking element,

止血元件1由前端11和后端12两部分构成，前端11为由记忆合金丝编绕成三维曲面，丝与丝之间紧密相连，曲面的中心丝露出曲面；后端12呈丝状，其材质为与生物相容性的材料，后端12垂直于前端11的三维曲面，与前端11固接为一体；The hemostatic element 1 is composed of two parts, thefront end 11 and therear end 12. Thefront end 11 is a three-dimensional curved surface made of memory alloy wires, the wires are closely connected, and the central wire of the curved surface is exposed; The material is a biocompatible material, therear end 12 is perpendicular to the three-dimensional curved surface of thefront end 11, and is fixedly connected with thefront end 11;

输送元件2由管筒21和管柄22两部分构成，管筒21呈空心柱状，其材质为与生物相容性的材料，管柄22呈空心套管状，其材质为可承受一定压力的生物相容性高分子材料，管柄有前端口221与管筒21连接，该前端口221以过度锥面224连接管柄体；管柄后端口222内有螺纹223；The delivery element 2 is composed of two parts: a tube tube 21 and a tube handle 22. The tube tube 21 is in the shape of a hollow column and its material is biocompatible material. The tube handle 22 is in the shape of a hollow sleeve and its material is a biological material that can withstand a certain pressure. Compatible polymer material, the handle has a front port 221 connected to the tube barrel 21, the front port 221 is connected to the handle body with an excessively tapered surface 224; there is a thread 223 in the rear port 222 of the handle;

自锁元件3由锁管31和锁头32构成；锁管31为一空心管，其材质为与生物相容性的高分子材料，其中部有外螺纹323与管柄内螺纹223相应；锁头32由连体的空心圆柱面321和锥面头部322构成，该锥面头部有中心孔325和开口狭缝324，该头部的锥面326与管柄的过度锥面224相应；The self-locking element 3 is made of a lock tube 31 and a lock head 32; the lock tube 31 is a hollow tube made of a biocompatible polymer material, and the middle part has an external thread 323 corresponding to the internal thread 223 of the pipe handle; The head 32 is composed of a conjoined hollow cylindrical surface 321 and a conical head 322. The conical head has a central hole 325 and an opening slit 324. The conical surface 326 of the head corresponds to the excessive conical surface 224 of the handle;

上述各组件的构造为：自锁元件3的锁头32装于输元件2的管柄22的内腔，锁头圆柱面装于锁管31的内孔，锁管31的螺纹323连接于管柄22，止血元件1的后端12穿过锁管31、锁头32、管柄22和管筒21的中心，该前端11进入人体血管6。The structure of the above-mentioned components is as follows: the lock head 32 of the self-locking element 3 is installed in the inner cavity of the pipe handle 22 of the input element 2, the cylindrical surface of the lock head is installed in the inner hole of the lock tube 31, and the thread 323 of the lock tube 31 is connected to the tube. The handle 22, therear end 12 of the hemostatic element 1 passes through the lock tube 31, the lock head 32, the handle 22 and the center of the tube barrel 21, and thefront end 11 enters the human blood vessel 6.

所述止血元件1的前端11的三维曲面可以为球面、圆柱面；也可以为平面，该平面的形状可以为圆形、三角形、矩形。The three-dimensional curved surface of thefront end 11 of the hemostatic element 1 can be a spherical surface or a cylindrical surface; it can also be a plane, and the shape of the plane can be a circle, a triangle, or a rectangle.

所述止血元件1的前端11和后端12的丝径可以相等，也可以是后端12的丝径大于前端11，其连接可以是焊接、粘接，也可以为一根丝的连体构造。The wire diameters of thefront end 11 and therear end 12 of the hemostatic element 1 can be equal, or the wire diameter of therear end 12 can be larger than thefront end 11, and the connection can be welding, bonding, or a conjoined structure of one wire .

所述记忆合金丝的材质可以是镍钛、铁基、铜基记忆合金。The material of the memory alloy wire can be nickel-titanium, iron-based, copper-based memory alloy.

所述与生物相容性好的材质可以是不锈钢，钛合金、记忆合金、无毒塑料。The material with good biocompatibility can be stainless steel, titanium alloy, memory alloy, or non-toxic plastic.

所述止血元件1的前端11可以由记忆合金丝和生物相容性高分子外壳构成的组合丝构成，该生物相容高分子材料涂覆于记忆合金的外表，丝的横截面可以呈圆形、半圆形、椭圆形、矩形、三角形、多边形、异形。Thefront end 11 of the hemostatic element 1 may be composed of a composite wire composed of a memory alloy wire and a biocompatible polymer shell, the biocompatible polymer material is coated on the surface of the memory alloy, and the cross section of the wire may be circular , Semicircle, Oval, Rectangle, Triangle, Polygon, Alien.

所述管柄22有供进行药物注射的侧口，The handle 22 has a side port for drug injection,

所述输送元件2的管筒21的外径在0.4-15mm之间，与外径相应的内径在0.2-14.9mm之间。The outer diameter of the tube 21 of the conveying element 2 is between 0.4-15 mm, and the inner diameter corresponding to the outer diameter is between 0.2-14.9 mm.

实施例详述：Example details:

图1给出了本实用新型的一种例子。该器械由止血元件1，输送元件2和自锁元件3组成。当该器械待用时，自锁元件3锁住止血元件1，使止血元件1不能在输送元件2内移动。下面着重就止血元件1，输送元件2和自锁元件3进行阐述。Fig. 1 has provided a kind of example of the present utility model. The device consists of a hemostatic element 1 , a delivery element 2 and a self-locking element 3 . When the device is ready for use, the self-locking element 3 locks the hemostatic element 1 so that the hemostatic element 1 cannot move inside the delivery element 2 . The following will focus on the hemostatic element 1 , the delivery element 2 and the self-locking element 3 to be explained.

止血元件1由前端11和后端12两部分组成，如图3所示。前端11可由镍钛、铁基、铜基等各种形状记忆合金丝制成。这种具有超弹性特性的合金丝通过模具编绕成具有各种形状的三维曲面。整个曲面由记忆合金丝按一定规则编绕，丝与丝之间紧密相连。曲面的中心丝露出曲面。在图3中，三维曲面为简单的平面，丝采用螺旋型方式进行编绕。在平面的中心，记忆合金丝110露出平面。三维曲面也可绕成其它任何三维曲面。组成前端部分11的记忆合金丝，其横截面可采用各种形状，如圆形、三角形、矩形、半圆形。图2、图3、图4、图5、图6、图7、图8、图9给出了其它两种常用的曲面(圆柱面和球面)。后端部分12可由任何生物相容性好的材料组成，如不锈钢、钛合金、记忆合金、塑料等。后端部分丝的直径最好较前端部分丝的直径稍大，以增加推力。前端部分和后端部分可由任何方法进行连接，如焊接、粘接。前端部分11和后端部分12也可由一根丝制做。为了减少止血元件前端部分11的金属丝在刚进入血管时，戳伤血管壁。前端部分可由记忆合金丝芯和生物相容性高分子外壳构成的复合丝构成。这种生物相容高子材料可采用各种方法涂覆于记忆合金丝芯的外表。输送元件2的目的在于输送和约束止血元件1。它由管筒21和管柄22两部分构成。管筒21可由一切生物相容性材料制成。最好采用不锈钢薄壁管、钛合金管、金属丝强化的高分子复合管构成。外径在0.4-15mm，内径在0.2-14.9mm之间。输送元件的管筒21也可做成其它形状的空心柱状结构。柱的外形和内腔可做成各种形状，如三角形、半圆形等。管柄22彩和二通型的连接柄，由可承受一定压力的生物相容性高分子材料做成，如PolyCarboriate,ABS,PVC，等。管柄前端口221与管筒21连接，后端口222与自锁元件23连接。后端口222内有一内螺纹，与自锁元件细纹连接。管柄22也可有侧口，以进行药物的注射，如图1所示。自锁元件3由零件31和零件32构成。图10给出了自锁元件3的组装示意图。零件31为圆柱状。圆柱内径稍大于零件32中圆柱面321的外径。圆柱一端有一喇叭口，与零件32中322容性高分子材料制成。图11、图12、图13给出了零件32的示意图。它由生物相容性材料制成。图10给出零件31和32的组装图。使用时，当右旋零件31时，自锁元件3中的表面323与输送元件中表面223相接触，随着零件31向前，由狭缝324构成的中心孔325与输送元件中表面223相接触，随着零件31向前，由狭缝324构成的中心孔325就会越来越小，直到锁紧止血元件的金属丝。当左旋零件31时，零件31后退，中心孔325变粗，松动金属丝。The hemostatic element 1 is composed of two parts, afront end 11 and arear end 12, as shown in FIG. 3 . Thefront end 11 can be made of nickel-titanium, iron-based, copper-based and other shape memory alloy wires. This superelastic alloy wire is woven into three-dimensional curved surfaces with various shapes through a mold. The entire curved surface is braided by memory alloy wires according to certain rules, and the wires are closely connected with each other. The center filament of the surface emerges from the surface. In Fig. 3, the three-dimensional curved surface is a simple plane, and the wire is braided in a spiral manner. In the center of the plane, thememory alloy wire 110 is exposed out of the plane. A three-dimensional surface can also be wound into any other three-dimensional surface. The memory alloy wire forming thefront part 11 can have various cross-sections, such as circular, triangular, rectangular, semicircular. Figure 2, Figure 3, Figure 4, Figure 5, Figure 6, Figure 7, Figure 8, and Figure 9 show two other commonly used curved surfaces (cylindrical and spherical). Therear portion 12 can be made of any biocompatible material, such as stainless steel, titanium alloy, memory alloy, plastic, and the like. The diameter of the wire at the rear end is preferably slightly larger than the diameter of the wire at the front end to increase the thrust. The front part and the rear part can be connected by any method, such as welding, gluing. Thefront end portion 11 and therear end portion 12 can also be made from one wire. In order to prevent the metal wire at thefront end portion 11 of the hemostatic element from stabbing the blood vessel wall when it just enters the blood vessel. The front end part can be composed of a composite wire composed of a memory alloy wire core and a biocompatible polymer shell. The biocompatible high-grade material can be coated on the outer surface of the memory alloy wire core by various methods. The purpose of the delivery element 2 is to deliver and constrain the hemostatic element 1 . It consists of tube tube 21 and pipe handle 22 two parts. Tube 21 can be made of any biocompatible material. It is best to use stainless steel thin-walled tubes, titanium alloy tubes, and polymer composite tubes reinforced with metal wires. The outer diameter is 0.4-15mm, and the inner diameter is between 0.2-14.9mm. The tube tube 21 of the conveying element can also be made into a hollow columnar structure of other shapes. The shape and inner cavity of the column can be made into various shapes, such as triangle, semicircle and so on. The 22-color and two-way connection handles of the handle are made of biocompatible polymer materials that can withstand a certain pressure, such as PolyCarboriate, ABS, PVC, etc. The front port 221 of the handle is connected to the tube 21 , and the rear port 222 is connected to the self-locking element 23 . There is an internal thread in the rear port 222, which is connected with the fine thread of the self-locking element. The handle 22 may also have a side port for injecting medicine, as shown in FIG. 1 . The self-locking element 3 consists of a part 31 and a part 32 . FIG. 10 shows a schematic diagram of the assembly of the self-locking element 3 . Part 31 is cylindrical. The inner diameter of the cylinder is slightly larger than the outer diameter of the cylindrical surface 321 of the part 32 . One end of the cylinder has a bell mouth, which is made of 322 capacitive polymer material in part 32. FIG. 11 , FIG. 12 , and FIG. 13 show schematic diagrams of the part 32 . It is made of biocompatible materials. Figure 10 gives an assembled view of parts 31 and 32. During use, when the part 31 is rotated to the right, the surface 323 in the self-locking element 3 is in contact with the middle surface 223 of the conveying element, and along with the part 31 moving forward, the central hole 325 formed by the slit 324 is in contact with the middle surface 223 of the conveying element. Contact, as the part 31 moves forward, the central hole 325 formed by the slit 324 becomes smaller and smaller until the wire of the hemostatic element is locked. When the part 31 is rotated leftward, the part 31 retreats, the central hole 325 becomes thicker, and the wire is loosened.

下面叙述本实用新型的使用方法：当器械通过鞘管4进入血管后，松动自锁元件3，止血元件1可沿管筒21自由移动。这时，向前推动止血元件使其前端部分移出管筒21外。止血元件的前端部分11由于其记忆效应，转变成丝与丝之间相互接触的三维曲面。这时，锁住自锁元件3使金属丝不能相对于管筒21移动。向后拉整个器械，三维曲面与血管口紧密相接，三维曲面暂时阻止血沿血管伤口流出。拔掉鞘管4，沿管筒21周围向伤口的周围注射液体或半液体的凝血药物，待药物停留一段时间，转化为半凝固状态不能随意流动时，将器械稍稍向前移动一段距离。然后，松动自锁元件3，使止血元件1可沿管筒21相对移动。握紧管筒21，将止血元件前端部位11沿管筒21完全移进管筒内。然后锁紧自锁元件3，撤出整个器械。而注射进伤口处的药物待完全固化后，伤口封闭完毕。图14-图18是整个使用过程的详细示意图。The usage method of the present utility model is described below: after the instrument enters the blood vessel through the sheath tube 4, the self-locking element 3 is loosened, and the hemostatic element 1 can move freely along the tube barrel 21. At this time, the hemostatic element is pushed forward so that the front end thereof moves out of the barrel 21 . Due to its memory effect, thefront end portion 11 of the hemostatic element transforms into a three-dimensional curved surface in which wires contact each other. At this time, the self-locking element 3 is locked so that the wire cannot move relative to the barrel 21 . Pull back the whole device, the three-dimensional curved surface is closely connected with the vascular opening, and the three-dimensional curved surface temporarily prevents blood from flowing out along the vascular wound. Pull out the sheath tube 4, inject liquid or semi-liquid coagulation medicine around the wound along the circumference of the tube tube 21, and move the instrument a little forward when the medicine stays for a period of time and is converted into a semi-coagulated state and cannot flow freely. Then, the self-locking element 3 is loosened so that the hemostatic element 1 can move relatively along the barrel 21 . Hold the tube tube 21 firmly, and move thefront end part 11 of the hemostatic element along the tube tube 21 into the tube tube completely. Then lock the self-locking element 3 and withdraw the whole instrument. After the medicine injected into the wound is completely solidified, the wound is closed. 14-18 are detailed schematic diagrams of the entire use process.

图14示步骤a，微型伤口封闭器沿鞘管送至血管内；Figure 14 shows step a, the miniature wound sealer is sent into the blood vessel along the sheath;

图15示步骤b，止血元件被推出管柄21，形成三维曲面；Figure 15 shows step b, the hemostatic element is pushed out of the handle 21 to form a three-dimensional curved surface;

图16示步骤c，止血元件的三维曲面与伤口接触，而注射部分凝血药物；Figure 16 shows step c, the three-dimensional curved surface of the hemostatic element is in contact with the wound, and part of the blood coagulation drug is injected;

图17示步骤d，继图c，凝血药物已填满整个伤口；Figure 17 shows step d, following Figure c, the coagulation drug has filled the entire wound;

图18示步骤e，撤出整个系统。Figure 18 shows step e, withdrawing the whole system.

Claims (8)

Translated fromChinese

1．一种封闭微型血管创伤用的微型伤口封闭器，由止血元件，输送元件和自锁元件组成，其特征在于：1. A micro-wound sealer for sealing micro-vascular wounds, which is composed of a hemostatic element, a delivery element and a self-locking element, and is characterized in that:止血元件(1)由前端(11)和后端(12)两部分构成，前端(11)为由记忆合金丝编绕成三维曲面，丝与丝之间紧密相连，曲面的中心丝露出曲面；后端(12)呈丝状，其材质为与生物相容性的材料，后端(12)垂直于前端(11)的三维曲面，与前端(11)固接为一体；The hemostatic element (1) is composed of a front end (11) and a rear end (12). The front end (11) is a three-dimensional curved surface made of memory alloy wires, the wires are closely connected, and the central wire of the curved surface is exposed from the curved surface; The rear end (12) is filamentous, and its material is biocompatible material, the rear end (12) is perpendicular to the three-dimensional curved surface of the front end (11), and is fixedly connected with the front end (11) as a whole;输送元件(2)由管筒(21)和管柄(22)两部分构成，管筒(21)呈空心柱状，其材质为与生物相容性的材料，管柄(22)呈空心套管状，其材质为可承受一定压力的生物相容性高分子材料，管柄有前端口(221)与管筒(21)连接，该前端口(221)以过度锥面(224)连接管柄体；管柄后端口(222)内有螺纹(223)；The delivery element (2) is composed of two parts: a tube (21) and a handle (22). The tube (21) is in the shape of a hollow column, and its material is a biocompatible material. The handle (22) is in the shape of a hollow sleeve. , which is made of biocompatible polymer material that can withstand a certain pressure. The handle has a front port (221) connected to the tube barrel (21), and the front port (221) is connected to the handle body with an excessively tapered surface (224). ; There are threads (223) in the rear port (222) of the handle;自锁元件(3)由锁管(31)和锁头(32)构成；锁管(31)为一空心管，其材质为与生物相容性的高分子材料，其中部有外螺纹(323)与管柄内螺纹(223)相应；锁头(32)由连体的空心圆柱面(321)和锥面头部(322)构成，该锥面头部有中心孔(325)和开口狭缝(324)，该头部的锥面(326)与管柄的过度锥面(224)相应；The self-locking element (3) is composed of a lock tube (31) and a lock head (32); the lock tube (31) is a hollow tube made of a biocompatible polymer material, and the middle part has an external thread (323 ) is corresponding to the inner thread of the pipe handle (223); the lock head (32) is composed of a conjoined hollow cylindrical surface (321) and a conical head (322), and the conical head has a central hole (325) and a narrow opening Seam (324), the taper surface (326) of this head is corresponding to the excessive taper surface (224) of handle;上述各组件的构造为：自锁元件(3)的锁头(32)装于输送元件(2)的管柄(22)的内腔，锁头圆柱面装于锁管(31)的内孔，锁管(31)的螺纹(323)连接于管柄(22)，止血元件(1)的后端(12)穿过锁管(31)、锁头(32)、管柄(22)和管筒(21)的中心，该前端(11)进入人体血管(6)。The structure of the above-mentioned components is as follows: the lock head (32) of the self-locking element (3) is installed in the inner cavity of the pipe handle (22) of the conveying element (2), and the cylindrical surface of the lock head is installed in the inner hole of the lock pipe (31) , the thread (323) of the lock tube (31) is connected to the handle (22), and the rear end (12) of the hemostatic element (1) passes through the lock tube (31), the lock head (32), the handle (22) and The center of the tube tube (21), the front end (11) enters the human blood vessel (6).2．如权利要求1所述的微型伤口封闭器，其特征在于：所述止血元件(1)的前端(11)的三维曲面可以为球面、圆柱面；也可以为平面，该平面的形状可以为圆形、三角形、矩形。2. The miniature wound closure device according to claim 1, characterized in that: the three-dimensional curved surface of the front end (11) of the hemostatic element (1) can be a spherical surface or a cylindrical surface; it can also be a plane, and the shape of the plane can be a circle shape, triangle, rectangle.3．如权利要求1所述的微型伤口封闭器，其特征在于：所述止血元件(1)的前端(11)和后端(12)的丝径可以相等，也可以是后端(12)的丝径大于前端(11)，其连接可以是焊接、粘接，也可以为一根丝的连体构造。3. The miniature wound closure device according to claim 1, characterized in that: the wire diameters of the front end (11) and the rear end (12) of the hemostatic element (1) can be equal, or the wire diameters of the rear end (12) can be equal. The diameter is larger than the front end (11), and its connection can be welding, bonding, or a conjoined structure of a wire.4．如权利要求1所述的微型伤口封闭器，其特征在于：所述记忆合金丝的材质可以是镍钛、铁基、铜基记忆合金。4. The miniature wound sealer according to claim 1, characterized in that: the material of the memory alloy wire can be nickel-titanium, iron-based, copper-based memory alloy.5．如权利要求1所述的微型伤口封闭器，其特征在于：所述与生物相容性好的材质可以是不锈钢，钛合金、记忆合金、无毒塑料。5. The miniature wound sealer according to claim 1, characterized in that: the material with good biocompatibility can be stainless steel, titanium alloy, memory alloy, or non-toxic plastic.6．如权利要求1所述的微型伤口封闭器，其特征在于：所述止血元件(1)的前端(11)可以由记忆合金丝和生物相容性高分子外壳构成的组合丝构成，该生物相容高分子材料涂覆于记忆合金的外表，丝的横截面可以呈圆形、半圆形、椭圆形、矩形、三角形、多边形、异形。6. The miniature wound sealer according to claim 1, characterized in that: the front end (11) of the hemostatic element (1) can be composed of memory alloy wire and a composite wire composed of a biocompatible polymer shell, and the biophase The polymer material is coated on the surface of the memory alloy, and the cross section of the wire can be circular, semicircular, oval, rectangular, triangular, polygonal, or irregular.7．如权利要求1所述的微型伤口封闭器，其特征在于：所述管柄(22)有供进行药物注射的侧口，7. The miniature wound sealer according to claim 1, characterized in that: the handle (22) has a side opening for drug injection,8．如权利要求1所述的微型伤口封闭器，其特征在于：所述输送元件(2)的管筒(21)的外径在0.4-15mm之间，与外径相应的内径在0.2-14.9mm之间。8. The miniature wound closure device according to claim 1, characterized in that: the outer diameter of the tube (21) of the delivery element (2) is between 0.4-15mm, and the inner diameter corresponding to the outer diameter is 0.2-14.9mm between.

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