

技术领域technical field
本发明涉及血管腔内治疗技术领域,尤其涉及一种用于闭合血管伤口的系统及方法。The present invention relates to the technical field of intravascular treatment, in particular to a system and method for closing a vascular wound.
背景技术Background technique
在经血管腔进行诊断和介入性血管手术时,通常需要在指定的血管壁上开设创口。这一类血管介入操作通常是在众所周知的Seldinger技术基础上进行的。在进行穿刺操作时,套管针依次穿过患者的皮肤、组织以及血管壁,从而构建出进入血管腔的通路。然后通过套管针引入导丝并通过脉管系统导航到所需的治疗部位。在导丝就位的情况下,首先移除套管针,然后可以在导丝上推进引导器护套,直到引导器护套的远端进入血管腔。随着引导器护套适当地定位在管腔内后,导管通过引导器护套引入血管系统,然后使用已存在的血管介入治疗技术对目标治疗位置进行手术。Transluminal diagnostic and interventional vascular procedures often require incisions in the designated vessel wall. This type of vascular intervention is usually performed on the basis of the well-known Seldinger technique. During the puncture operation, the trocar passes through the patient's skin, tissue and blood vessel wall in sequence, thereby constructing a passageway into the blood vessel lumen. A guidewire is then introduced through the trocar and navigated through the vasculature to the desired treatment site. With the guidewire in place, the trocar is first removed and the introducer sheath can then be advanced over the guidewire until the distal end of the introducer sheath enters the vessel lumen. With the introducer sheath properly positioned within the lumen, the catheter is introduced into the vascular system through the introducer sheath, and the target treatment site is then operated on using existing vascular interventional techniques.
在不再需要已建立的血管通路时,首先移除导管和引导器护套,然后通过经皮缝合施加装置进行创口缝合,该装置的远端能够穿过血管穿刺孔并且定位在血管腔内。缝合装置的中间部分能够向远端推进一根或多根针,穿过与进入穿刺部位相邻的血管壁组织。然后使用一根或多根针将缝合线进入创口相对两侧的血管壁,并将缝合装置从组织道中抽出,将缝合线的末端打结。在缝合线末端通过手动打结并且将线结沿组织道向下推进,直到将它定位在血管壁的外膜表面上。另一种创口缝合方式是用夹具或锁定片将缝合线固定在一起,该夹具或锁定片以手动推进的方式穿过组织后定位在穿刺部位旁边。然而,手动打结或单独的夹持构件进行创口缝合是困难的、耗时的,并且如果操作不正确,会产生额外的不良影响,还可能导致创口无法实现有效闭合。When the established vascular access is no longer needed, the catheter and introducer sheath are first removed and the wound sutured by a percutaneous suture application device, the distal end of which can be passed through the vessel puncture hole and positioned within the vessel lumen. The intermediate portion of the suturing device is capable of advancing one or more needles distally through the tissue of the vessel wall adjacent to the entry puncture site. The suture is then inserted into the vessel wall on opposite sides of the wound using one or more needles, the suture device is withdrawn from the tissue tract, and the ends of the suture are knotted. The suture ends are tied manually and the knot is advanced down the tissue tract until it is positioned on the adventitial surface of the vessel wall. Another way to close the wound is to hold the sutures together with clips or locking tabs that are manually advanced through the tissue and positioned next to the puncture site. However, manual knotting or a separate gripping member for wound closure is difficult, time-consuming, and, if performed incorrectly, has additional adverse effects and may result in ineffective wound closure.
公开号为CN109199485A的专利文献公开了一种用于使缝合线穿引通过组织的外科器械,所述外科器械包括第一钳口和第二钳口以及针,所述第一钳口和第二钳口设置在细长轴的远侧端部上,所述针能够沿穿过第一钳口的外侧壁的纵向通道选择性地进行移动。第一钳口具有被配置成安置可移除和可置换的缝合线盒的腔体。缝合线盒可连接到缝合线盒支架上,该缝合线盒支架在使用外科器械之前被移除,使得针朝远侧推进,从而使连接在缝合线盒支架上的缝合线穿过患者体内的组织。当针朝近侧回缩时,将后续的缝合线部分装载到针上。在缝合线穿过患者体内的组织时,钳口保持在身体中。该专利无法在完成组织的穿刺操作后快速的形成线结,不利于在完成介入手术后快速闭合创口。Patent document publication number CN109199485A discloses a surgical instrument for threading a suture through tissue, the surgical instrument comprising first and second jaws and a needle, the first and second jaws A jaw is provided on the distal end of the elongated shaft, and the needle is selectively movable along a longitudinal passage through the outer sidewall of the first jaw. The first jaw has a cavity configured to accommodate a removable and replaceable suture cartridge. The suture cassette is attachable to a suture cassette holder that is removed prior to use of the surgical instrument, such that the needle is advanced distally, thereby passing the suture attached to the suture cassette holder through the suture cassette holder in the patient. organize. As the needle is retracted proximally, subsequent suture portions are loaded onto the needle. The jaws remain in the body as the suture is passed through tissue in the patient. This patent cannot quickly form a knot after completing the tissue puncture operation, which is not conducive to quickly closing the wound after completing the interventional operation.
因此,本申请提供一种能够限定血管伤口四周的血管壁形态并快速完成缝合线打结操作的用于闭合血管伤口的系统。Therefore, the present application provides a system for closing a vascular wound that can define the morphology of the vascular wall around the vascular wound and quickly complete the suture knotting operation.
此外,一方面由于对本领域技术人员的理解存在差异;另一方面由于发明人做出本发明时研究了大量文献和专利,但篇幅所限并未详细罗列所有的细节与内容,然而这绝非本发明不具备这些现有技术的特征,相反本发明已经具备现有技术的所有特征,而且申请人保留在背景技术中增加相关现有技术之权利。In addition, on the one hand, there are differences in the understanding of those skilled in the art; on the other hand, because the inventor has studied a large number of documents and patents when making the present invention, but the space limit does not list all the details and contents in detail, but this is by no means The present invention does not possess the features of the prior art, on the contrary, the present invention already possesses all the features of the prior art, and the applicant reserves the right to add relevant prior art to the background art.
发明内容SUMMARY OF THE INVENTION
针对现有技术之不足,本发明的技术方案提供的是一种用于闭合血管伤口的系统,其至少包括能够用于封闭血管伤口的闭合主体,其特征在于,所述闭合主体至少包括能够引导系统沿导丝进入血管伤口内的导丝鞘管、能够对血管伤口进行封堵和限位的调节组件和对血管伤口进行缝合的缝合单元,其中,在所述调节组件按照其对血管伤口边缘区域的血管壁进行夹持的方式限定血管伤口的位置和大小的情况下,所述缝合单元的缝合针线能够沿预设的弧形穿刺路径以环绕血管伤口区域的方式完成缝合针线穿过血管壁的穿刺操作,从而构建出能够闭合血管伤口的线结圈,所述线结圈能够通过调节线结的位置的方式进行缩小,使得血管伤口在线结圈的约束下发生闭合。其优势在于,通过构建能够对血管壁进行固定限位结构,方便医护人员在完成介入手术后对血管伤口进行缝合,避免在缝合过程中血管壁出现褶皱和翻折等不利于快速的进行准确缝合的现象,降低了医护人员对血管伤口进行处理时的难度和工作强度,提高了医护人员缝合血管伤口的效率。此外,缝合单元能够建立预设的弧形穿刺路径,避免医护人员需要进行主观判断穿刺深度和角度的现有技术的缺陷,保证了缝合穿刺是在血管壁中层进行的,提高了血管伤口的缝合质量。缝合单元还通过设置预设线结,帮助医护人员完成穿刺操作后能够快速的进行缝合线的打结处理,解决了现有缝合手术中线结难以成形的缺陷。In view of the deficiencies of the prior art, the technical solution of the present invention provides a system for closing a blood vessel wound, which at least includes a closing body that can be used to close a blood vessel wound, characterized in that the closing body at least includes a system capable of guiding A guide wire sheath into which the system enters a vascular wound along a guide wire, an adjustment assembly capable of sealing and limiting the vascular wound, and a suturing unit for suturing the vascular wound, wherein the adjustment assembly is in accordance with its adjustment to the edge of the vascular wound. Under the condition that the position and size of the vascular wound are limited by the manner in which the vascular wall of the area is clamped, the suture thread of the suture unit can complete the suture thread passing through the vascular wall along the preset arc puncture path in a manner of surrounding the vascular wound area. The puncture operation is performed to construct a knot loop capable of closing the vascular wound, and the knot loop can be reduced by adjusting the position of the wire knot, so that the vascular wound is closed under the constraint of the knot loop. The advantage is that by constructing a structure that can fix and limit the blood vessel wall, it is convenient for medical staff to suture the blood vessel wound after the interventional operation is completed, and the folds and folds of the blood vessel wall are avoided during the suture process, which is not conducive to fast and accurate suture. It reduces the difficulty and work intensity of medical staff when dealing with vascular wounds, and improves the efficiency of medical staff in suturing vascular wounds. In addition, the suture unit can establish a preset arc-shaped puncture path, which avoids the defects of the prior art in which medical staff need to subjectively judge the puncture depth and angle, ensures that the suture puncture is performed in the middle layer of the blood vessel wall, and improves the suture of blood vessel wounds. quality. The suture unit also helps the medical staff to quickly tie the suture after completing the puncture operation by setting the preset knot, which solves the defect that the knot is difficult to form in the existing suture operation.
根据一种优选的实施方式,所述调节组件至少包括球囊、推杆和调节主体,所述球囊设置于所述导丝鞘管的管体上,并且其按照能够对血管伤口进行封堵的方式随导丝鞘管伸入到血管腔中;所述推杆设置于所述导丝鞘管的轴向上端,所述导丝鞘管远离血管伤口的一端的部分管体可调节地穿入所述推杆的管腔上,使得所述推杆通过沿所述导丝鞘管的轴线方向进行往复平移的方式改变推杆和球囊之间的距离。According to a preferred embodiment, the adjustment assembly at least includes a balloon, a push rod and an adjustment body, the balloon is arranged on the tube body of the guide wire sheath, and is capable of sealing the vascular wound according to the The push rod is arranged at the axial upper end of the guide wire sheath, and the part of the tube body at the end of the guide wire sheath away from the vascular wound can adjustably pass through the vascular cavity. into the lumen of the push rod, so that the push rod changes the distance between the push rod and the balloon by reciprocating translation along the axis direction of the guide wire sheath.
根据一种优选的实施方式,在所述球囊发生体积膨胀而封堵血管伤口并贴附在血管腔内壁上的情况下,所述推杆与导丝鞘管之间发生相对平移,使得所述推杆的端部也能够贴附在血管伤口边缘的血管腔外壁上。According to a preferred embodiment, when the balloon is expanded in volume to seal the vascular wound and adhere to the inner wall of the vascular lumen, relative translation occurs between the push rod and the guide wire sheath, so that the The end of the push rod can also be attached to the outer wall of the blood vessel cavity at the edge of the blood vessel wound.
根据一种优选的实施方式,所述缝合单元安装在所述推杆的杆腔的轴向下段腔室中;所述缝合单元的缝合针线包括缝合针和缝合线;在所述球囊与推杆分别贴附在血管腔的同一区域的内外壁上而夹紧血管腔壁时,所述缝合单元能够驱动缝合针沿预设的弧形穿刺路径从血管伤口两侧的血管壁中层中穿过,使得血管伤口两侧的血管壁通过跟随所述缝合针进入血管壁中层的缝合线进行连接。According to a preferred embodiment, the suture unit is installed in the axial lower chamber of the rod cavity of the push rod; the suture needle thread of the suture unit includes a suture needle and a suture thread; between the balloon and the push rod When the rods are respectively attached to the inner and outer walls of the same region of the blood vessel lumen to clamp the blood vessel lumen wall, the suture unit can drive the suture needle to pass through the middle layer of the blood vessel wall on both sides of the blood vessel wound along a preset arc-shaped puncture path. , so that the blood vessel walls on both sides of the blood vessel wound are connected by sutures that follow the suture needle into the middle layer of the blood vessel wall.
根据一种优选的实施方式,在所述缝合单元的缝合针能够从血管伤口一侧的血管壁表面刺入的情况下,缝合针牵引缝合线沿预设的弧形穿刺路径进入到血管伤口另一侧的血管壁中层,并且所述缝合针牵引缝合线从该血管壁中层穿出。According to a preferred embodiment, under the condition that the suture needle of the suture unit can penetrate from the surface of the blood vessel wall on one side of the blood vessel wound, the suture needle pulls the suture along the preset arc-shaped puncture path into the other side of the blood vessel wound. The middle layer of the blood vessel wall on one side, and the suture needle pulls the suture through the middle layer of the blood vessel wall.
根据一种优选的实施方式,在所述缝合针从血管壁穿出后,所述缝合针能够按照其针头刺入设置在所述推杆的杆腔中的接针头柱的方式与接针头柱连接。According to a preferred embodiment, after the suture needle is pierced from the blood vessel wall, the suture needle can be connected to the needle post in the manner in which the needle pierces the needle post provided in the rod cavity of the push rod. connect.
根据一种优选的实施方式,所述接针头柱上设置有与所述缝合针相连接的缝合线相配合形成线结圈的预制线结;所述接针头柱上的预制线结是利用与所述缝合针相连接的缝合线的末端线体以多圈缠绕在所述接针头柱的柱状表面的方式构建的。According to a preferred embodiment, the needle post is provided with a prefabricated knot that is matched with the suture connected to the suture needle to form a loop; the prefabricated knot on the needle post is made of The end thread body of the suture thread connected by the suture needle is constructed in a manner of winding multiple turns on the cylindrical surface of the needle head post.
本发明还提供一种用于闭合血管伤口的方法,其特征在于,其至少包括将导丝鞘管的至少部分管体沿预先置入血管伤口内的导丝伸入到血管伤口内;设置在导丝鞘管伸入到血管伤口内的部分管体上的球囊通过体积膨胀的方式对血管伤口进行封堵;调节所述导丝鞘管与调节组件之间的相对位置,使得所述球囊与推杆按照两者分别贴靠在血管内外壁的方式对血管伤口进行限位和对血管壁的厚度进行测量;置于所述调节组件中的缝合单元的缝合针线能够沿预设的弧形穿刺路径以环绕血管伤口区域的方式完成缝合针线穿过血管壁的穿刺操作,并且从血管壁中穿出的缝合针线能够按照与预制线结相配合的方式构建出能够闭合血管伤口的线结圈。其优势在于,通过构建能够对血管壁进行固定限位结构,方便医护人员在完成介入手术后对血管伤口进行缝合,避免在缝合过程中血管壁出现褶皱和翻折等不利于快速的进行准确缝合的现象,降低了医护人员对血管伤口进行处理时的难度和工作强度,提高了医护人员缝合血管伤口的效率。此外,缝合单元能够建立预设的弧形穿刺路径,避免医护人员需要进行主观判断穿刺深度和角度的现有技术的缺陷,保证了缝合穿刺是在血管壁中层进行的,提高了血管伤口的缝合质量。缝合单元还通过设置预设线结,帮助医护人员完成穿刺操作后能够快速的进行缝合线的打结处理,解决了现有缝合手术中线结难以成形的缺陷。The present invention also provides a method for closing a vascular wound, which is characterized in that it at least comprises extending at least part of the tube body of the guide wire sheath into the vascular wound along a guide wire pre-inserted into the vascular wound; The balloon on the part of the tube body where the guide wire sheath extends into the vascular wound seals the vascular wound by volume expansion; the relative position between the guide wire sheath and the adjustment component is adjusted so that the balloon The balloon and the push rod are respectively abutted against the inner and outer walls of the blood vessel to limit the blood vessel wound and measure the thickness of the blood vessel wall; the suture thread of the suture unit placed in the adjustment assembly can follow a preset arc The shaped puncture path completes the puncture operation of the suture needle thread through the blood vessel wall in a way of surrounding the blood vessel wound area, and the suture needle thread passing through the blood vessel wall can be matched with the prefabricated knot to form a knot that can close the blood vessel wound lock up. The advantage is that by constructing a structure that can fix and limit the blood vessel wall, it is convenient for medical staff to suture the blood vessel wound after the interventional operation is completed, and the folds and folds of the blood vessel wall are avoided during the suture process, which is not conducive to fast and accurate suture. It reduces the difficulty and work intensity of medical staff when dealing with vascular wounds, and improves the efficiency of medical staff in suturing vascular wounds. In addition, the suture unit can establish a preset arc-shaped puncture path, which avoids the defects of the prior art in which medical staff need to subjectively judge the puncture depth and angle, ensures that the suture puncture is performed in the middle layer of the blood vessel wall, and improves the suture of blood vessel wounds. quality. The suture unit also helps the medical staff to quickly tie the suture after completing the puncture operation by setting the preset knot, which solves the defect that the knot is difficult to form in the existing suture operation.
根据一种优选的实施方式,所述导丝鞘管的伸入深度是受所述球囊在导丝鞘管的管体轴向上的位置所限定的;在所述球囊穿过血管伤口并在血管腔中形成堵塞时,血管内的血液能够从所述导丝鞘管上的侧孔进入所述导丝鞘管。According to a preferred embodiment, the insertion depth of the guide wire sheath is limited by the position of the balloon in the axial direction of the tube body of the guide wire sheath; when the balloon passes through the vascular wound And when a blockage is formed in the blood vessel lumen, the blood in the blood vessel can enter the guide wire sheath from the side hole on the guide wire sheath.
根据一种优选的实施方式,所述导丝鞘管按照其未伸入到血管伤口内的部分管体能够可调节地从所述调节组件的轴向下端插入到所述调节组件内的方式与所述调节组件连接;所述调节组件的调节主体套设在所述推杆上,使得推杆能够选择性地在所述调节主体的轴向上发生往复平移,其中,所述导丝鞘管的管体是穿过所述推杆而与所述调节主体进行连接的。According to a preferred embodiment, the guide wire sheath is different from the manner in which the part of the guide wire sheath that does not extend into the vascular wound can be adjustably inserted into the adjustment assembly from the axial lower end of the adjustment assembly. The adjustment components are connected; the adjustment body of the adjustment component is sleeved on the push rod, so that the push rod can selectively reciprocate and translate in the axial direction of the adjustment body, wherein the guide wire sheath tube The pipe body is connected with the adjusting body through the push rod.
附图说明Description of drawings
图1是本发明提供的一种优选的用于闭合血管伤口的系统的缝合单元的结构示意图;1 is a schematic structural diagram of a suturing unit of a preferred system for closing vascular wounds provided by the present invention;
图2是本发明提供的一种优选的用于闭合血管伤口的系统的结构示意图。FIG. 2 is a schematic structural diagram of a preferred system for closing vascular wounds provided by the present invention.
附图标记列表List of reference signs
1:闭合主体;2:导丝鞘管;3:调节组件;4:缝合单元;21:鞘管主体;22:拇指板;23:侧孔;24:导引外管;31:球囊;32:推杆;33:调节主体;34:导管;35:球囊注水阀门;321:弧形端部;322:外杆;323:内杆;324:连接板;331:滑槽;332:卡槽;333:刻度尺;41:缝合针;42:缝合线;43:传动组件;44:驱动杆;45:接针头柱;431:第一传动齿;432:第二传动齿;433:旋转件;434:弧形针体;451:第一柱体;452:第二柱体。1: closed body; 2: guide wire sheath; 3: adjustment assembly; 4: suture unit; 21: sheath body; 22: thumb plate; 23: side hole; 24: outer guide tube; 31: balloon; 32: push rod; 33: adjustment body; 34: catheter; 35: balloon water filling valve; 321: arc end; 322: outer rod; 323: inner rod; 324: connecting plate; 331: chute; 332: 333: scale; 41: suture needle; 42: suture; 43: drive assembly; 44: drive rod; 45: needle post; 431: first drive tooth; 432: second drive tooth; 433: Rotary part; 434: arc-shaped needle body; 451: first cylinder; 452: second cylinder.
具体实施方式Detailed ways
下面结合附图进行详细说明。The following detailed description is given in conjunction with the accompanying drawings.
实施例1Example 1
本申请还提供一种用于闭合血管伤口的系统,其可以包括闭合主体1、导丝鞘管2、调节组件3和缝合单元4。The present application also provides a system for closing a vascular wound, which may include a
根据一种具体的实施方式,闭合主体包括导丝鞘管2、调节组件3和缝合单元4。导丝鞘管2按照部分管体插入调节组件3的本体腔室内的方式与调节组件3连接。缝合单元4设置在调节组件3的本体腔室靠近导丝鞘管2的一端。在进行穿刺操作和缝合操作时,首先,带有针芯的穿刺针在医护人员的控制下依次穿过皮肤、组织和血管壁后插入到血管腔中。导丝沿穿刺针的针管进入血管腔内部。在导丝部分置入血管腔内后,拔出穿刺针,并且将闭合主体1的导丝鞘管2沿导丝置入血管腔内。调节组件3能够对血管伤口进行封堵,同时调节组件3能够通过夹持血管伤口周围的血管壁的方式限定血管壁的形态,使得血管伤口周围的血管壁能够保持一个稳定且平整的形态,从而方便缝合单元4的缝合针线能够沿预设的弧形穿刺路径以环绕血管伤口区域的方式完成缝合针线穿过血管壁的穿刺操作,从而构建出能够闭合血管伤口的呈“U型荷包形态”的线结圈。缝合单元4构建的线结圈能够在完成介入手术后,医护人员通过推结器推动线结圈的线结逐渐靠近血管外壁的方式缩小构成线结圈的缝合线42的长度,使得血管伤口两侧的血管壁在缝合线42的拉动下发生相互靠近的运动,从而实现伤口的闭合。According to a specific embodiment, the closure body includes a guide wire sheath 2 , an
如图2所示,导丝鞘管2可以包括鞘管主体21和拇指板22。其中,鞘管主体21插入调节组件3的管体的轴向上端连接有控制鞘管主体21沿其轴线方向进行移动的拇指板22。具体地,拇指板22按照贯穿调节主体33的方式与安装在调节主体33内部的鞘管主体21的端部进行连接,从而通过推动拇指板22沿调节主体33的轴线方向进行往复平移的方式实现导丝鞘管2与调节组件3之间的相对平移。医护人员在进行操作时能够通过控制拇指板22发生定向平移,使得导丝鞘管2带动球囊31进行上提操作,使得置入血管腔中的球囊31能够在发生体积膨胀的情况下贴附在血管伤口上,从而实现球囊31对血管伤口的封堵。优选地,鞘管主体21的管体上安装有能够对血管伤口进行封堵的球囊31。鞘管主体21靠近球囊31的管体侧面还开设有能够排出血液的侧孔23。在未发生膨胀的球囊31跟随鞘管主体21伸入到血管腔中时,球囊31会对血管造成一定程度的堵塞,导致血液会顺着鞘管主体21上的侧孔23流入到调节主体33。因此,鞘管主体21与拇指板22连接的端部还设有能够方便观察和排出血液的导引外管24。优选地,导引外管24的末端可以连接一个方便观察是否出现血液外流的透明储血囊。优选地,导引外管24能够跟随拇指板22在调节主体33上发生平移,使得导引外管24能够跟随鞘管主体21的运动而发生相同的平移,避免导引外管24与鞘管主体21发生分离,造成鞘管主体21内引出的血液污染装置其他部件。在将导丝鞘管2置入血管腔的过程中,医护人员通过观察与导引外管24的末端连通的透明储血囊中是否突然出现呈喷射状的血液的方式判断球囊31是否已进入到血管腔中。在球囊31进入血管腔而侧孔23没有完全进入血管腔时,鞘管主体22虽然也能够引出血流,但是进入导引外管24的血液在管道内的压力并不高,无法出现血液喷射的情况。当侧孔23完全进入到血管腔时,随着血管波动,侧孔23中血液的进入速度和压力激增,导致导引外管24中的血液能够喷涌而出,使得在透明储血囊中观察到血液喷射的情况。因此,医护人员在进行鞘管主体22的插入操作时,可以根据透明储血囊中出现血液喷射的现象来判断鞘管主体22的插入操作是否成功。As shown in FIG. 2 , the guide wire sheath 2 may include a
优选地,调节组件3至少包括球囊31、推杆32和调节主体33。调节主体33套接在推杆32的轴向上端,并且,导丝鞘管2是按照穿过推杆32的方式进入到调节主体33内的。优选地,推杆32能够相对于调节主体33发生相对平移,从而改变推杆32与球囊31之间的距离,进而在球囊31发生体积膨胀而贴附在血管腔的内壁上时,推杆32通过向靠近球囊31的方向运动的方式使得推杆32远离调节主体33的端部能够抵靠在血管腔的外壁上。优选地,球囊31和推杆32均是与血管伤口同一外周区域的血管壁进行接触的。球囊31对血管壁的挤压力能够透过血管壁作用于推杆32。推杆32对血管壁的挤压力能够透过血管壁作用于球囊31。球囊31与推杆32的相对作用力能够将血管伤口周围的血管壁夹紧,从而限定血管伤口的位置,并且使得血管伤口周围的血管壁保持一个平整的状态,即限定了血管伤口的大小,避免血管壁的蠕动或介入手术的失误操作而造成血管壁的损伤以及引起血管伤口的二次扩大。优选地,在球囊31和推杆32的共同作用下限定了血管伤口周围的血管壁的形态,使得缝合单元4能够更好且更准确地完成穿刺操作,避免血管伤口边缘区域的血管壁自身的不可控运动而影响医护人员进行穿刺操作。血管壁本身是处于一个非完全静止/固定的状态,在医护人员进行穿刺时,可能在外力作用下发生严重变形,这是会严重影响穿刺效率和穿刺成功率的。Preferably, the
优选地,调节组件3还包括能够与球囊31连通的导管34。导管34附着在鞘管主体21的外部,并且导管34能够跟随鞘管主体21延伸至调节主体33内。优选地,导管34远离球囊31的一端穿过调节主体33与外界连通,并且导管34处于外界环境的端部还设置有能够根据需求选择性地向导管34内注入生理盐水的球囊注水阀门35。优选地,球囊31接收导管34内的生理盐水而发生膨胀。优选地,导管34的总容量、球囊31的最小容量和膨胀量是设定量,方便医护人员通过注射器等向导管34内注入生理盐水时,生理盐水的注入量和球囊31的膨胀程度呈正相关,方便医护人员把控球囊31的膨胀量。Preferably, the
优选地,推杆32包括圆锥形的弧形端部321和外杆322。弧形端部321能够贴附在血管外壁上。外杆322采用中空外杆。弧形端部321上开设有与外杆322的中空杆腔连通的开口,使得鞘管主体21能够从弧形端部321的开口插入到外杆322中。优选地,弧形端部321的开口内还安装有能够进行伤口缝合操作的缝合单元4。在弧形端部贴附在血管外壁上时,缝合单元4能够在医护人员的控制下进行穿刺操作。优选地,推杆32还包括按照与外杆322共轴线的方式设置在外杆322内的内杆323。内杆323采用空心管体,使得其内部能够用于容纳鞘管主体21。优选地,内杆323的轴向下端连接弧形端部321的上板体。优选地,内杆323上还连接有能够用于限制缝合单元4的驱动杆44的位置和固定安装接针头柱45的连接板324。优选地,连接板324的板面垂直于内杆323的轴线。连接板324能够限定驱动杆44的运动方向,使得驱动杆44仅能够在平行于内杆323的轴线的方向上进行平移。优选地,驱动杆44按照贯穿连接板324的板面的方式进行设置。连接板324靠近弧形端部321的表面上还安装接针头柱45。优选地,接针头柱45的轴线垂直于连接板324的板面。Preferably, the
优选地,调节主体33在壳体上沿其轴向开设有贯穿式的滑槽331和与滑槽331一体式开设的卡槽332。拇指板22能够置于滑槽331内,使得滑槽331能够限定拇指板22的运动方向。当拇指板22沿滑槽331的开槽方向移动至合适位置后,通过将拇指板22移动至卡槽332的方式实现拇指板22和调节主体33之间的相对固定。调节主体33的表面还设置有能够对拇指板22与刻度原点之间的距离进行测量的刻度尺333。优选地,拇指板22与刻度原点之间的距离即是球囊31与弧形端部321之间的间隙宽度。该间隙宽度是被两者夹持的血管壁的厚度,通过测量血管伤口区域的血管壁厚度,方便医护人员判断血管壁上是否夹杂结缔组织或脂肪组织。Preferably, the adjusting
如图1所示,缝合单元4至少包括缝合针41、缝合线42、传动组件43、驱动杆44和接针头柱45。优选地,缝合针41能够在外力的驱动下牵引缝合线42在血管壁上进行穿刺操作,从而将缝合线42串连在血管伤口两侧的血管壁中层中,使得医护人员在缩短位于血管壁中的部分缝合线42的总长度时,缝合线42能够带动血管伤口两侧的血管壁相互靠近,最后,血管伤口两侧的血管壁能够受缝合线42的拉扯逐渐靠近而贴合在一起,使得血管伤口能够在缝合线42的拉扯力的作用下实现闭合。优选地,弧形端部321的轴向上方设置能够带动缝合针41穿过弧形端部321的板体的传动组件43。传动组件43能够驱动缝合针41沿其规划出的弧形轨迹进行运动,使得缝合针41沿设定的弧形轨迹在血管壁中进行穿刺操作。优选地,传动组件43与驱动杆44按照啮齿配合的方式相连接,使得传动组件43能够在驱动杆44的驱动下发生定向转动。在缝合单元4的缝合针41能够从血管伤口一侧的血管壁表面刺入的情况下,缝合针41牵引缝合线42沿预设的弧形穿刺路径进入到血管伤口另一侧的血管壁中层,并且缝合针41牵引缝合线42从该血管壁中层穿出。As shown in FIG. 1 , the
优选地,传动组件43可以包括第一传动齿431、第二传动齿432和旋转件433。第一传动齿431与第二传动齿432相互啮合,使得第一传动齿431在驱动杆44的驱动下带动第二传动齿432发生转动。优选地,第一传动齿431和第二传动齿432均安装在内杆323的侧壁上。第一传动齿431和第二传动齿432的转动轴杆固定安装在内杆323的侧壁上。优选地,至少两组第一传动齿431和第二传动齿432分别设置在内杆323的两侧,使得驱动杆44的运动能够同时带动两个按照相互平行的方式设置在内杆323两侧的第一传动齿431进行相同的转动。优选地,呈L型的旋转件433的一端与第二传动齿432的转动轴杆的端部连接,使得旋转件433能够跟随第二传动齿432的旋转发生同向的转动。优选地,旋转件433远离第二传动齿432的一端连接有能够用于安装缝合针41的弧形针体434。弧形针体434按照其弧形端部引出的切线垂直于旋转件433的轴线的方式固定安装在旋转件433上。在具体进行操作时,轴向向下运动的驱动杆44能够带动第一传动齿431发生顺时针旋转,第一传动齿431带动第二传动齿432发生逆时针旋转,第二传动齿432带动固定连接的旋转件433和弧形针体434发生同向转动。弧形针体434发生与第二传动齿432相同的逆时针旋转,从而带动设置在其运动前端的缝合针41穿过弧形端部321的板体后插入到血管壁中,使得缝合针41在弧形针体434的带动下在血管壁中层中完成一个弧形轨迹的穿刺操作,最终缝合针41从血管壁的另一侧穿出。优选地,缝合针41的穿刺操作中的弧形轨迹是受弧形针体434的长度、弧度以及弧形针体434与旋转件433的连接位置所限定的,即缝合针41运动过程中的弧形轨迹的弧度、弧形半径等是跟随弧形针体434的长度、弧度以及弧形针体434与旋转件433的连接位置的变化而发生变化的。优选地,弧形针体434可以采用轴向表面开设有凹槽的弧形柱状体,使得在弧形针体434的端部固定安装缝合针41的情况下,弧形针体434上还有能够用于医护人员进行摆线操作的缝合线42的容纳空间。优选地,接针头柱45按照其轴向下端柱体恰好处于弧形针体434带动缝合针41进行穿刺运动的弧形轨迹的末端,使得缝合针41从血管壁中穿出后能够直接刺入到接针头柱45的端部中,从而接针头柱45通过发生轴向上的运动的方式带动缝合针41与弧形针体434之间的分离。Preferably, the
优选地,接针头柱45包括第一柱体451和第二柱体452。第一柱体451按照部分柱体插入第二柱体452内部的方式设置第二柱体452的轴向下端。第一柱体451能够相对于第二柱体452发生伸缩运动,从而改变接针头柱45的总长度。第一柱体451和第二柱体452之间的连接结构可参考现有技术中液压杆结构或螺纹升降柱结构。优选地,缝合线41的末端线体按照缠绕在第一主体451的柱体上的方式构建出预制线结。当缝合针41刺入到第一柱体451中时,第一柱体451按照收缩进入第二柱体452内部的方式带动缝合针41轴向向上运动,并且使得缝合针41从预制线结的线圈内部穿过,从而与缝合针41连接的缝合线42能够穿过缝合线42自身的末端线体在第一柱体451上构建的预制线结。缝合线42在穿过其自身的末端线体构建的预制线结后,上吊结完全成型,使得缝合线42与线结共同构成能够约束血管伤口的线结圈。缝合线42的两个端部共同构成了一个可调节线圈的周长的线结,缝合线42的线体穿过血管伤口两侧的血管壁并形成一个周长可调节的线圈。医护人员通过调节线结的位置,使得线结构建的线圈的周长(线体的总长度)逐渐缩小,从而牵动血管伤口两侧的血管壁逐渐靠近,并且最终贴合在一起。Preferably, the
优选地,在确认球囊31与弧形端部321夹紧血管壁的情况下,缝合单元4操控预置针线进行穿刺缝合工作,使得缝合针41能够按照构建U型荷包的方式穿过被推杆32和球囊31所夹持的血管壁中层,并且缝合针41完成U型荷包缝合路径的穿刺操作后能够从预制线结中穿出,从而形成一个活动式线结。优选地,操作人员通过收束线结的方式收紧穿刺在血管伤口周围的缝合线42,通过缩短血管壁内缝合线42的长度使得血管受迫收缩,从而完成U型荷包缝合操作。Preferably, in the case of confirming that the
优选地,介入操作完成后可以直接通过推结器控制与缝合针41连接的缝合线42在“上吊结”接口内进行牵扯运动,从而实现对血管壁内缝合线42的收束。优选地,缝合线42远离缝合针41的末端预留部分未穿过血管壁的线体,该部分线体在接针头柱45上以多圈缠绕的方式形成“上吊结”的预制线结。Preferably, after the intervention operation is completed, the
实施例2Example 2
本发明还提供一种用于闭合血管伤口的方法,其至少包括The present invention also provides a method for closing a vascular wound, comprising at least
将导丝鞘管2的至少部分管体沿预先置入血管伤口内的导丝伸入到血管伤口内;Extending at least part of the tube body of the guide wire sheath 2 into the blood vessel wound along the guide wire pre-inserted in the blood vessel wound;
设置在导丝鞘管2伸入到血管伤口内的部分管体上的球囊31通过体积膨胀的方式对血管伤口进行封堵;The
调节导丝鞘管2与调节组件3之间的相对位置,使得球囊31与推杆32按照两者分别贴靠在血管内外壁的方式对血管伤口进行限位和对血管壁的厚度进行测量;Adjust the relative position between the guide wire sheath 2 and the
置于调节组件3中的缝合单元4的缝合针线能够沿预设的弧形穿刺路径以环绕血管伤口区域的方式完成缝合针线穿过血管壁的穿刺操作,并且从血管壁中穿出的缝合针线能够按照与预制线结相配合的方式构建出能够闭合血管伤口的线结圈。The suture thread of the
优选地,导丝鞘管2的伸入深度是受球囊31在导丝鞘管2的管体轴向上的位置所限定的。在球囊31穿过血管伤口并在血管腔中形成堵塞时,血管内的血液能够从导丝鞘管2上的侧孔进入导丝鞘管2。优选地,导丝鞘管2按照其未伸入到血管伤口内的部分管体能够可调节地从调节组件3的轴向下端插入到调节组件3内的方式与调节组件3连接。调节组件3的调节主体33套设在推杆32上,使得推杆32能够选择性地在调节主体33的轴向上发生往复平移,其中,导丝鞘管2的管体是穿过推杆32而与调节主体33进行连接的。Preferably, the insertion depth of the guide wire sheath 2 is limited by the position of the
需要注意的是,上述具体实施例是示例性的,本领域技术人员可以在本发明公开内容的启发下想出各种解决方案,而这些解决方案也都属于本发明的公开范围并落入本发明的保护范围之内。本领域技术人员应该明白,本发明说明书及其附图均为说明性而并非构成对权利要求的限制。本发明的保护范围由权利要求及其等同物限定。在全文中,“优选地”所引导的特征仅为一种可选方式,不应理解为必须设置,故此申请人保留随时放弃或删除相关优选特征之权利。It should be noted that the above-mentioned specific embodiments are exemplary, and those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the scope of the present invention. within the scope of protection of the invention. It should be understood by those skilled in the art that the description of the present invention and the accompanying drawings are illustrative rather than limiting to the claims. The protection scope of the present invention is defined by the claims and their equivalents. In the whole text, the features introduced by "preferably" are only an optional way, and should not be construed as a mandatory setting, so the applicant reserves the right to abandon or delete the relevant preferred features at any time.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210275698.2ACN114521931B (en) | 2022-03-18 | 2022-03-18 | A system and method for closing a vascular wound |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210275698.2ACN114521931B (en) | 2022-03-18 | 2022-03-18 | A system and method for closing a vascular wound |
| Publication Number | Publication Date |
|---|---|
| CN114521931Atrue CN114521931A (en) | 2022-05-24 |
| CN114521931B CN114521931B (en) | 2023-07-25 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210275698.2AActiveCN114521931B (en) | 2022-03-18 | 2022-03-18 | A system and method for closing a vascular wound |
| Country | Link |
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| CN (1) | CN114521931B (en) |
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| WO2024131963A1 (en)* | 2022-12-23 | 2024-06-27 | 丰凯利医疗器械(上海)有限公司 | Vascular suturing device and vascular suturing method |
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| WO2024131963A1 (en)* | 2022-12-23 | 2024-06-27 | 丰凯利医疗器械(上海)有限公司 | Vascular suturing device and vascular suturing method |
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