CN110123392B - Accurate location aortic valve passes through device - Google Patents
Accurate location aortic valve passes through device Download PDFInfo
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- CN110123392B CN110123392B CN201910233850.9A CN201910233850A CN110123392B CN 110123392 B CN110123392 B CN 110123392B CN 201910233850 A CN201910233850 A CN 201910233850A CN 110123392 B CN110123392 B CN 110123392B
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Abstract
本发明提供一种精准定位主动脉瓣通过装置,包括主导管、支撑架以及控制导丝;主导管依次包括首端、管身以及尾端;首端的侧壁周部连接有支撑架;控制导丝安装在所述主导管内部,控制导丝固定在首端内部,穿过管身,从尾端伸出;尾端设有支撑开关以及方向控制装置,支撑开关与支撑架连接并且用以控制支撑架的开合,方向控制装置与控制导丝相连接并且用以控制首端的方向。本发明针对主动脉瓣通过装置对准问题,在导管首端连接支撑架,可以避免主导管滑脱问题;支撑架还起到固定首端移动范围,防止其损伤血管内膜的作用,在较少次数内保证手术成功,减轻病人的痛苦,减少手术的时间,同时减少病人和术者在X线下的暴露时间,降低手术风险。
The invention provides a device for accurately positioning aortic valve passing through, comprising a main catheter, a support frame and a control guide wire; the main catheter sequentially includes a head end, a pipe body and a tail end; a support frame is connected to the peripheral part of the side wall of the head end; The wire is installed inside the main pipe, the control guide wire is fixed inside the head end, passes through the pipe body, and protrudes from the tail end; the tail end is provided with a support switch and a direction control device, the support switch is connected with the support frame and used to control The opening and closing of the support frame, the direction control device is connected with the control guide wire and used to control the direction of the head end. Aiming at the alignment problem of the aortic valve passing device, the present invention connects the support frame at the head end of the catheter to avoid the problem of slippage of the main catheter; the support frame also plays the role of fixing the movement range of the head end and preventing it from damaging the intima of the blood vessel. It can ensure the success of the operation within the number of times, reduce the pain of the patient, reduce the operation time, and at the same time reduce the exposure time of the patient and the operator under the X-ray, and reduce the operation risk.
Description
技术领域technical field
本发明涉及医疗器械领域,尤其涉及一种精准定位主动脉瓣通过装置。The invention relates to the field of medical devices, in particular to a device for accurately positioning aortic valve passing through.
背景技术Background technique
心脏瓣膜病是一种常见的心脏疾病,主要表现为二尖瓣、主动脉瓣、三尖瓣及肺动脉瓣由于各种原因出现结构性或功能性改变,导致心脏血液动力学异常,最终导致心力衰竭。心脏瓣膜病的发病率也随着人口的老龄化而明显增加。外科手术治疗仍是重度瓣膜病变患者的首选治疗手段,但对于高龄、合并多器官疾病、有开胸手术史以及心功能较差的患者,外科手术死亡率较高,部分患者甚至失去了手术机会。近年来,经导管瓣膜置换术或修复术逐渐成熟并广泛应用,在欧美国家已经成为老年高危患者心脏瓣膜常规手术方式。2002年,世界第一例经导管主动脉瓣置换术(TAVR)的成功,开创了瓣膜病介入治疗的新时代。到目前为止共有65个国家开展TAVR技术,累计病人超过30万例。Valvular heart disease is a common heart disease, mainly manifested as structural or functional changes in the mitral valve, aortic valve, tricuspid valve and pulmonary valve due to various reasons, resulting in abnormal cardiac hemodynamics and ultimately cardiac exhaustion. The incidence of valvular heart disease also increases markedly with an aging population. Surgical treatment is still the first choice for patients with severe valvular disease, but for patients with advanced age, multi-organ disease, history of thoracotomy, and poor cardiac function, surgical mortality is high, and some patients even lose the opportunity for surgery. . In recent years, transcatheter valve replacement or repair has gradually matured and been widely used, and has become a routine method of heart valve surgery for elderly high-risk patients in Europe and the United States. In 2002, the world's first successful transcatheter aortic valve replacement (TAVR) opened a new era of interventional therapy for valvular disease. So far, 65 countries have carried out TAVR technology, and the cumulative number of patients has exceeded 300,000.
TAVR手术中非常关键的一步是导丝通过狭窄的主动脉瓣进入左室,只有完成这一步才能进行后续的步骤,现有的方式是通过术前的影像学评估帮助选择合适的跨瓣角度,用左冠脉造影导管作为指引导管,用直头导丝,反复操作尝试通过狭窄的主动脉瓣,有时耗时可能较长,且与术者经验以及策略有关,必要时还需更换不同指引导管进行尝试,无疑增加了手术时间,同时也增加了手术风险。主要原因是尚无专门的主动脉瓣跨瓣指引导管,目前主要是借用现有的冠脉造影导管来替代。A very critical step in the TAVR operation is to pass the guide wire into the left ventricle through the narrowed aortic valve. Only after this step can be completed, the subsequent steps can be carried out. The existing method is to help select the appropriate transvalvular angle through preoperative imaging evaluation. Using the left coronary angiography catheter as the guiding catheter and using a straight guide wire to repeatedly try to pass through the stenotic aortic valve may sometimes take a long time, and it is related to the experience and strategy of the surgeon, and different guiding catheters need to be replaced if necessary. Trying to do it will undoubtedly increase the operation time, but also increase the risk of surgery. The main reason is that there is no special aortic valve transvalvular guiding catheter, and the existing coronary angiography catheter is mainly used to replace it.
发明内容SUMMARY OF THE INVENTION
本发明的目的是为了解决现有技术中存在的缺点,而提出的一种精准定位主动脉瓣通过装置。The purpose of the present invention is to provide a precise positioning aortic valve passing device in order to solve the shortcomings existing in the prior art.
为实现上述目的,本发明采用了如下技术方案:To achieve the above object, the present invention has adopted the following technical solutions:
一种精准定位主动脉瓣通过装置,包括主导管、支撑架以及控制导丝;An accurate positioning aortic valve passing device, comprising a main catheter, a support frame and a control guide wire;
所述主导管依次包括首端、管身以及尾端;所述首端的侧壁周部连接有所述支撑架,所述支撑架为可开合结构,当所述支撑架撑开时,所述支撑架卡在主动脉瓣血管壁上;所述控制导丝安装在所述主导管内部,所述控制导丝固定在所述首端内部,穿过所述管身,从所述尾端伸出;所述尾端设有支撑开关以及方向控制装置,所述支撑开关与所述支撑架连接并且用以控制所述支撑架的开合,所述方向控制装置与所述控制导丝相连接并且用以控制所述首端的方向。The main pipe sequentially includes a head end, a pipe body and a tail end; the support frame is connected to the periphery of the side wall of the head end, and the support frame is an openable and closable structure. The support frame is clamped on the aortic valve vessel wall; the control guide wire is installed inside the main guide tube, the control guide wire is fixed inside the head end, passes through the tube body, and extends from the tail end Extend; the tail end is provided with a support switch and a direction control device, the support switch is connected with the support frame and used to control the opening and closing of the support frame, and the direction control device is connected with the control guide wire connected and used to control the direction of the head end.
优选地,所述支撑架为开合的伞状结构,所述支撑架包括支撑骨,所述支撑骨连接在所述首端和所述管身的相接处;当所述支撑骨处于闭合状态,所述支撑架紧贴在所述首端的侧壁周部;当所述支撑骨处于撑开状态,所述支撑架抵靠在所述主动脉瓣血管内壁。Preferably, the support frame is an open and closed umbrella structure, the support frame includes a support bone, and the support bone is connected at the junction of the head end and the pipe body; when the support bone is closed In the state, the support frame is in close contact with the peripheral portion of the side wall of the head end; when the support bone is in the open state, the support frame abuts against the inner wall of the aortic valve vessel.
优选地,所述支撑架为网状,并且所述支撑架环绕在所述首端周部;或者所述支撑架为放射状,所述支撑骨为长条状,并且所述支撑骨的数量不少于3条。Preferably, the support frame is in the shape of a mesh, and the support frame is surrounded by the circumference of the head end; or the support frame is in a radial shape, the support bones are elongated, and the number of the support bones is different. less than 3.
优选地,所述支撑架与主动脉血管内壁的贴合部位为平滑的柔软材料。Preferably, the adhering part of the support frame and the inner wall of the aortic vessel is a smooth and soft material.
优选地,所述支撑架嵌入在所述首端的侧壁内,所述支撑架处于闭合状态时,所述支撑架的外直径和所述管身的外直径相同。Preferably, the support frame is embedded in the side wall of the head end, and when the support frame is in a closed state, the outer diameter of the support frame is the same as the outer diameter of the pipe body.
优选地,所述支撑架为设置在所述首端两侧的两个气囊。Preferably, the support frame is two airbags arranged on both sides of the head end.
优选地,所述气囊为纺锤状。Preferably, the airbag is spindle-shaped.
优选地,所述控制导丝包括转向节点,所述转向节点位于所述首端和所述管身的交接处,所述转向节点为可360度旋转的柔性结构。Preferably, the control guide wire includes a turning node, the turning node is located at the junction of the head end and the tube body, and the turning node is a flexible structure that can rotate 360 degrees.
优选地,所述方向控制装置是螺母旋钮或者拉杆,通过旋转或是拉动所述控制导丝控制所述转向节点的旋转,用以实现首端的旋转。Preferably, the direction control device is a nut knob or a pull rod, and the rotation of the steering node is controlled by rotating or pulling the control guide wire, so as to realize the rotation of the head end.
与现有技术相比,本发明的有益效果为:Compared with the prior art, the beneficial effects of the present invention are:
本发明针对主动脉瓣通过装置对准问题,在导管首端连接支撑架,在导管伸至主动脉瓣前时,支撑架卡在主动脉瓣血管内壁上,可以将导管卡住,不会因为血液流动冲击使得导管滑脱;此外,用支撑架卡住导管,方便首端改变方向,可以在较少的次数内成功试探到主动脉瓣的瓣口使装置通过,减轻病人的痛苦,减少手术的时间,同时减少病人和术者在X光下暴露的时间,降低手术风险。Aiming at the alignment problem of the aortic valve passing device, the present invention connects the support frame at the head end of the catheter, and when the catheter extends to the front of the aortic valve, the support frame is stuck on the inner wall of the aortic valve blood vessel, so that the catheter can be stuck, and the catheter will not be stuck because of The impact of blood flow causes the catheter to slip; in addition, the catheter is clamped with a support frame to facilitate the change of direction of the head end, and the valve opening of the aortic valve can be successfully probed in a few times to allow the device to pass through, reducing the pain of the patient and reducing the operation time. time, while reducing the exposure time of the patient and the operator to X-rays, reducing the risk of surgery.
附图说明Description of drawings
图1为支撑架为网状结构的一种精准定位主动脉瓣通过装置的剖面图;Fig. 1 is a sectional view of a kind of accurate positioning aortic valve passing device in which the support frame is a mesh structure;
图2为支撑架为气囊的一种精准定位主动脉瓣通过装置的剖面图。FIG. 2 is a cross-sectional view of a precise positioning aortic valve passing device with a support frame as a balloon.
具体实施方式Detailed ways
为使对本发明的目的、构造、特征、及其功能有进一步的了解,兹配合实施例详细说明如下。In order to have a further understanding of the purpose, structure, features, and functions of the present invention, the following detailed descriptions are given in conjunction with the embodiments.
请结合参照图1和图2,本发明提供了一种精准定位主动脉瓣通过装置,包括主导管1、支撑架2以及控制导丝3。Please refer to FIG. 1 and FIG. 2 , the present invention provides a device for accurately positioning the aortic valve passing through, including a
主导管1依次包括首端11、管身12以及尾端13;首端11的侧壁周部连接有支撑架2,支撑架2为可开合结构,当支撑架2撑开时,支撑架2卡在主动脉瓣血管壁上;控制导丝3安装在主导管1内部,控制导丝3固定在首端11内部,穿过管身12,从尾端13伸出;尾端13设有支撑开关131以及方向控制装置132,支撑开关131与支撑架2连接并且用以控制支撑架2的开合,方向控制装置132与控制导丝3相连接并且用以控制首端11的方向。The
在使用时,支撑架2呈闭合状态,导管深入病人的体内,X线导引下送到达主动脉瓣前,通过支撑开关131打开支撑架2,支撑架2抵靠在病人的主动脉血管内壁,可以防止心脏中的血液喷涌导致主导管1被冲击后退,起到固定的作用。此外,主导管1被支撑架2固定后不会后退,就不会损伤病人的主动脉内膜,给病人造成二次伤害。支撑架2固定住首端11后,即可通过尾端13的方向控制装置132来控制主导管1内的控制导丝3,从而控制首端11的方向改变,进行主动脉瓣上空隙的对准,保证在较少的试探次数中成功对准空隙并保证主导管1通过。对准后即可通过支撑开关131收回支撑架2,使得装置能够顺利通过。When in use, the
在一实施例中,支撑架2为开合的伞状结构,支撑架2包括支撑骨,支撑骨连接在首端11和管身12的相接处;当支撑骨处于闭合状态,支撑架2紧贴在首端11的侧壁周部;当支撑骨处于撑开状态,支撑架2抵靠在主动脉瓣血管内壁。支撑架2的结构和雨伞的结构相似,支撑骨与支撑开关131之间通过连杆或是导丝相连,最后汇总连接于支撑开关131,支撑开关131可以上下或是左右拨动,带动连杆或是导丝,实现对支撑骨开合的掌控。支撑骨打开后抵靠在血管内壁,将主导管1的首端11固定在支撑架2的中央,既起到固定的作用,防止主导管1向外滑脱,又可以防止主导管1在血流冲击下左右晃动,无法指引导丝通过狭窄瓣膜口。支撑架2收起后紧贴主导管1的首端11侧壁,有利于主导管1顺利通过主动脉瓣。支架骨的材质与主导管1可以是相同的,表面为较为柔软的医用硅胶,防止损伤血管内膜。In one embodiment, the
进一步地,支撑架2为网状,并且支撑架2环绕在首端11周部;网状支架可以在保证支撑效果的同时,进一步防止首端11改变方向来试图对准并通过主动脉瓣时,不小心幅度过大损伤血管内膜,给病人带来不适和伤害。网状的支撑架2不妨碍血流从心脏涌到动脉,还可以减小血流对主导管1的管身12部分的冲击。或者支撑架2为放射状,支撑骨为长条状,并且支撑骨的数量不少于3条。至少3条支撑骨,才可以将主导管1的首端11固定在中心,并且保证支撑架2的稳定性。Further, the
优选地,支撑架2与主动脉血管内壁的贴合部位为平滑的柔软材料,这样在撑开支撑架2时,支撑架2抵靠在血管内壁,不会让病人感受到较大的疼痛。同时,支撑架2收起时紧贴在首端11的侧壁上,表面会有一点不平滑,柔软材料可以避免主导管1向病人体内进入时产生剐蹭,减小摩擦。Preferably, the fitting part of the
优选地,支撑架2嵌入在首端11的侧壁内,支撑架2处于闭合状态时,支撑架2的外直径和管身12的外直径相同,即收起状态时支撑架2紧贴在首端11的侧壁,其粗细和管身12粗细相同,这样在使用时不会因为主导管1粗细不同而使得病人产生不适。Preferably, the
在另一实施例中,支撑架2为设置在首端11两侧的两个气囊;优选地,气囊为纺锤状。支撑架2为气囊时,支撑开关131极为充气口,支撑开关131和支撑用的气囊中间通过充气管径连接。气囊在闭合状态时的贴合性比伞状的支撑架2更好,在将主导管1插入病人身体内的过程中给病人的刺激更少。此外,气囊充气后卡在血管壁上,固定性更强,并且相对来说更加平滑和柔软的气囊壁比起伞状支撑骨来说刺激性更小。纺锤状额度气囊可以只用中央直径最大的一圈抵住血管壁固定,不仅两端直径变小,留出空隙使得心脏中的血液得以流到主动脉血管,还给主导管1的首端11留出足够的活动空间可以转向试探,进行对准。In another embodiment, the
在一实施例中,控制导丝3包括转向节点31,转向节点31位于首端11和管身12的交接处,转向节点31为可360度旋转的柔性结构,控制导丝3主要分为两段,一段位于主导管1的首端11内部,另有一段位于主导管1的管身12以及尾端13内部,中间通过转向节点31连接,转向节点31的转动可以带动整个首端11转动,明确整个控制导丝3的施力点,使得控制更加精准简单。优选地,方向控制装置132是螺母旋钮或者拉杆,通过旋转或是拉动控制导丝3控制转向节点31的旋转,用以实现首端11的旋转。方向控制装置132与控制导丝3之间为简单的机械连杆结构,通过方向控制装置132不同的移动操作来控制转向节点31前方位于首端11内部的控制导丝3的偏移角度,由于转向节点31较为柔软,于是整个控制导丝3在转向节点31处发生弯折,实现主导管1首端11的角度偏移,可以在手术时调整不同的角度进行尝试。In one embodiment, the
由上所述,本发明针对主动脉瓣通过装置对准问题,在主导管首端连接支撑架,在主导管伸至主动脉瓣前时,支撑架卡在主动脉瓣血管内壁上,可以将主导管卡住,不会因为血液流动冲击使得主导管滑脱;此外,用支撑架卡住主导管,主导管的首端是可以改变方向的结构,可以在较少的次数内成功试探到主动脉瓣的瓣口使装置通过,减轻病人的痛苦,减少手术的时间,同时减少病人和术者在X光下暴露的时间。由于病人的病情一般较为严重,耐受性较差,手术时间缩短,可以减少麻醉时间,降低手术风险。From the above, the present invention aims at the alignment problem of the aortic valve passing device, and the support frame is connected to the head end of the main catheter. The main catheter is stuck, and the main catheter will not slip due to the impact of blood flow; in addition, the main catheter is clamped with a support frame, the head end of the main catheter is a structure that can change the direction, and the aorta can be successfully probed in a small number of times The valve orifice of the valve allows the device to pass through, reducing pain for the patient, reducing the time of the operation, and reducing the exposure time of the patient and the operator to X-rays. Because the patient's condition is generally more serious, the tolerance is poor, and the operation time is shortened, which can reduce the anesthesia time and reduce the operation risk.
本发明已由上述相关实施例加以描述,然而上述实施例仅为实施本发明的范例。必需指出的是,已揭露的实施例并未限制本发明的范围。相反地,在不脱离本发明的精神和范围内所作的更动与润饰,均属本发明的专利保护范围。The present invention has been described by the above-mentioned related embodiments, however, the above-mentioned embodiments are only examples for implementing the present invention. It must be pointed out that the disclosed embodiments do not limit the scope of the present invention. On the contrary, changes and modifications made without departing from the spirit and scope of the present invention belong to the scope of patent protection of the present invention.
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