交叉引用Cross-references
本公开引用于2023年06月27日递交的名称为“球囊鞘管及心衰治疗器械”的第202310770326.1号中国专利申请，其通过引用被全部并入本公开。The present disclosure refers to Chinese Patent Application No. 202310770326.1 filed on June 27, 2023, entitled “Balloon Sheath and Heart Failure Treatment Device,” which is incorporated herein by reference in its entirety.
本公开涉及医疗设备技术领域，特别涉及一种球囊鞘管及心衰治疗器械。The present disclosure relates to the technical field of medical equipment, and in particular to a balloon sheath and a heart failure treatment device.
心衰是指由于心脏的功能发生障碍、不能将血液完全排出心脏而导致血液的灌注不足，由此发生的一系列症状。心衰一般分为急性心衰和慢性心衰。Heart failure refers to a series of symptoms caused by insufficient blood perfusion due to dysfunction of the heart and inability to completely drain blood from the heart. Heart failure is generally divided into acute heart failure and chronic heart failure.
急性心衰以急性左心衰竭最为常见，是指因急性的心肌损害或心脏负荷加重，造成急性心排血量骤降、肺循环压力升高、周围循环阻力增加，继而引起肺循环充血而出现急性肺淤血、肺水肿水并可有伴组织、器官灌注不足和心源性休克的临床综合征。Acute heart failure is the most common type of acute left heart failure, which refers to a clinical syndrome characterized by acute myocardial damage or increased cardiac load, resulting in a sudden drop in cardiac output, increased pulmonary circulation pressure, and increased peripheral circulation resistance, which in turn causes pulmonary circulation congestion and acute pulmonary congestion, pulmonary edema, and may be accompanied by insufficient tissue and organ perfusion and cardiogenic shock.
慢性心衰分为右心衰竭和左心衰竭。右心衰竭时，右心室射血能力下降，右心残留较多血液，导致右心压力增加，血液流入右心费力。由于流入右心的是体循环血液，因此会有体循环淤血表现，又由于下肢处于身体的较低部位，因此下肢淤血最为严重。当水分从下肢血管里进入周围组织，便造成下肢水肿。左心衰竭时，因为流入左心的是肺循环血液，因此会导致左心房压和肺静脉压升高，继而引起肺淤血和肺水肿。Chronic heart failure is divided into right heart failure and left heart failure. In right heart failure, the ejection capacity of the right ventricle decreases, and more blood remains in the right heart, which leads to increased right heart pressure and difficulty in blood flowing into the right heart. Since the blood flowing into the right heart is systemic blood, there will be systemic congestion, and since the lower limbs are located in the lower part of the body, the congestion in the lower limbs is the most serious. When water enters the surrounding tissues from the blood vessels in the lower limbs, it causes lower limb edema. In left heart failure, since the blood flowing into the left heart is pulmonary blood, it will cause increased left atrial pressure and pulmonary venous pressure, which will then cause pulmonary congestion and pulmonary edema.
相关技术中，根据急性心衰的不同病情，初始治疗为吸氧，利尿剂、强心剂经静脉给与；病情仍不缓解，应用血管活性药物来扩张收缩血管；病情严重，血压持续降低甚至心源性休克，需要监测血流动力学并采用应急的非药物治疗方法。In the related technology, according to the different conditions of acute heart failure, the initial treatment is oxygen inhalation, and diuretics and cardiotonic drugs are given intravenously; if the condition is still not relieved, vasoactive drugs are used to dilate and constrict blood vessels; if the condition is serious, blood pressure continues to drop or even cardiogenic shock occurs, it is necessary to monitor hemodynamics and adopt emergency non-drug treatment methods.
相关技术中的治疗方式存在一定的局限性，例如，有些患者对静脉注射利尿剂治疗反应良好，但其他患者则不然。这是因为，当体内液体过多时，大部分多余的液体实际上并不是存在于血管腔中，而是存在于细胞周围的间隙中，这种组织称为间质。为了充分减轻充血，首先需要将细胞间质中多余的液体移入血管中。对于健康人体，这种功能是通过淋巴系统引流实现的，由淋巴系统将液体积极地引流到心脏上方的大静脉中。然而，对于急性心衰患者来说，大静脉内的压力可能非常高，这会减缓甚至阻止淋巴液流入大静脉，从而阻碍缓解充血的过程。研究发现，不彻底的利尿(即体液储留)是再住院和死亡的有力预测因子，多达一半的急性心衰患者出院时没有被完全“利尿”，导致约25％的患者在一个月内再次入院，约一半的患者在六个月内再次入院。There are certain limitations to the treatment methods in the related art. For example, some patients respond well to intravenous diuretic treatment, but others do not. This is because when there is too much fluid in the body, most of the excess fluid is not actually in the blood vessel cavity, but in the spaces around the cells, a tissue called the interstitium. In order to fully relieve congestion, the excess fluid in the interstitial tissue must first be moved into the blood vessels. In healthy people, this function is achieved through drainage by the lymphatic system, which actively drains the fluid into the large veins above the heart. However, for patients with acute heart failure, the pressure in the large veins can be very high, which can slow or even prevent the flow of lymph fluid into the large veins, thereby hindering the process of relieving congestion. Studies have found that incomplete diuresis (i.e., fluid retention) is a major risk factor for rehospitalization and death. Up to half of patients with acute heart failure are not fully “diureticized” when they are discharged from the hospital, resulting in about 25% of patients being readmitted to the hospital within one month and about half of patients being readmitted within six months.
如何提高心衰治疗的效果，是目前亟待解决的技术问题。How to improve the effect of heart failure treatment is a technical problem that needs to be solved urgently.
发明内容Summary of the invention
本公开实施例提供了一种球囊鞘管及心衰治疗器械，可用于治疗急性充血性心力衰竭，并能够获得良好的预后效果。The disclosed embodiments provide a balloon sheath and a heart failure treatment device, which can be used to treat acute congestive heart failure and can achieve a good prognosis.
根据本公开的一方面，提供了一种球囊鞘管，包括：主鞘管，具有彼此不相通的主管腔、副管腔、第一充压管腔和第二充压管腔，主管腔用于引导诊疗器械穿出，副管腔用于引导球囊导管穿出；第一球囊，与主鞘管的外壁密封连接并且与第一充压管腔和第二充压管腔的远端连通；主连接座，与主鞘管的近端连接并且包括与主管腔连通的第一端口、与副管腔连通的第二端口、与主管腔连通的第一侧口、以及与第一充压管腔和第二充压管腔连通的第二侧口，第一端口用于供诊疗器械穿入；副鞘管，与第二端口连通；副连接座，与副鞘管的近端连接并且包括与副鞘管连通的第三端口和第三侧口，第三端口用于供球囊导管穿入；以及与第一侧口连通的第一侧支管、与第二侧口连通的用于输入充压介质的第二侧支管，以及与第三侧口连通的第三侧支管。According to one aspect of the present disclosure, a balloon sheath is provided, comprising: a main sheath having a main lumen, a secondary lumen, a first pressurized lumen and a second pressurized lumen which are not connected to each other, the main lumen being used to guide the passage of diagnostic and treatment instruments, and the secondary lumen being used to guide the passage of a balloon catheter; a first balloon being sealed and connected to the outer wall of the main sheath and connected to the distal ends of the first pressurized lumen and the second pressurized lumen; a main connecting seat being connected to the proximal end of the main sheath and comprising a first port connected to the main lumen, a second port connected to the secondary lumen, a first side port connected to the main lumen, and a second side port connected to the first pressurized lumen and the second pressurized lumen, the first port being used for the insertion of diagnostic and treatment instruments; a secondary sheath being connected to the second port; a secondary connecting seat being connected to the proximal end of the secondary sheath and comprising a third port and a third side port connected to the secondary sheath, the third port being used for the insertion of a balloon catheter; and a first side branch being connected to the first side port, a second side branch being connected to the second side port for inputting a pressurized medium, and a third side branch being connected to the third side port.
在一些实施例中，主管腔和副管腔分别呈圆孔状，并且主管腔的孔径大于副管腔的孔径；第一充压管腔和第二充压管腔位于主管腔和副管腔的两侧。In some embodiments, the main lumen and the auxiliary lumen are respectively in the shape of circular holes, and the aperture of the main lumen is larger than that of the auxiliary lumen; the first pressure-charging lumen and the second pressure-charging lumen are located on both sides of the main lumen and the auxiliary lumen.
在一些实施例中，主鞘管设有将第一充压管腔和第二充压管腔与第一球囊连通的至少一个通孔，第一球囊为在收缩状态与主鞘管的外壁相贴合的顺应性管壁状球囊。In some embodiments, the main sheath is provided with at least one through hole connecting the first and second inflation lumens with the first balloon, and the first balloon is a compliant wall-shaped balloon that fits with the outer wall of the main sheath in a contracted state.
在一些实施例中，第一球囊的材料包括硅胶、乳胶、聚氨酯、以及聚亚胺酯中的至少一种。In some embodiments, the material of the first balloon includes at least one of silicone, latex, polyurethane, and polyurethane.
在一些实施例中，主鞘管包括毗邻其远端的第一尖端部分，主管腔的远端穿出孔曝露于第一尖端部分的端面，副管腔的远端穿出孔曝露于第一尖端部分的侧面。In some embodiments, the main sheath includes a first tip portion adjacent to its distal end, the distal through-hole of the main lumen is exposed at the end surface of the first tip portion, and the distal through-hole of the secondary lumen is exposed at the side surface of the first tip portion.
在一些实施例中，第一侧支管、第二侧支管和第三侧支管的近端分别设有鲁尔接头三通。In some embodiments, the proximal ends of the first side branch, the second side branch, and the third side branch are respectively provided with a Luer connector tee.
在一些实施例中，球囊鞘管还包括：设于主连接座内的主止血阀；以及设于副连接座内的副止血阀。In some embodiments, the balloon sheath further includes: a main hemostatic valve disposed in the main connecting seat; and a secondary hemostatic valve disposed in the secondary connecting seat.
根据本公开的一方面，提供了一种心衰治疗器械，包括前述方面的球囊鞘管。According to one aspect of the present disclosure, a heart failure treatment device is provided, comprising the balloon sheath of the aforementioned aspect.
在一些实施例中，心衰治疗器械还包括：与副鞘管和主鞘管嵌套装配的球囊导管，球囊导管包括：多腔体管，具有彼此不相通的导丝穿入管腔、充压介质输送管腔和造影剂输送管腔、以及曝露于多腔体管的外壁并且与造影剂输送管腔的远端连通的造影剂输送孔；单腔管，与导丝穿入管腔的远端连通；第二球囊，与多腔体管的外壁和单腔管的外壁密封连接并且与充压介质输送管腔的远端连通；以及连接座，与多腔体管的近端连接并且包括与导丝穿入管腔连通的第一接头、与充压介质输送管腔连通的第二接头、以及与造影剂输送管腔连通的第三接头，第一接头用于供导丝穿入，第二接头用于输入充压介质，第三接头用于输入造影剂。In some embodiments, the heart failure treatment device also includes: a balloon catheter nested and assembled with the secondary sheath and the main sheath, the balloon catheter including: a multi-lumen tube, having a guidewire insertion lumen, a pressurized medium delivery lumen and a contrast agent delivery lumen that are not connected to each other, and a contrast agent delivery hole exposed to the outer wall of the multi-lumen tube and connected to the distal end of the contrast agent delivery lumen; a single-lumen tube, connected to the distal end of the guidewire insertion lumen; a second balloon, sealingly connected to the outer wall of the multi-lumen tube and the outer wall of the single-lumen tube and connected to the distal end of the pressurized medium delivery lumen; and a connecting seat, connected to the proximal end of the multi-lumen tube and including a first connector connected to the guidewire insertion lumen, a second connector connected to the pressurized medium delivery lumen, and a third connector connected to the contrast agent delivery lumen, the first connector being used for guidewire insertion, the second connector being used for inputting pressurized medium, and the third connector being used for inputting contrast agent.
在一些实施例中，导丝穿入管腔呈圆孔状并且其中心轴线重合于多腔体管的中心轴线；充压介质输送管腔和造影剂输送管腔分别呈弧形孔状环绕导丝穿入管腔。In some embodiments, the guidewire insertion lumen is in the shape of a circular hole and its central axis coincides with the central axis of the multi-lumen tube; the pressurized medium delivery lumen and the contrast agent delivery lumen are respectively in the shape of arc holes surrounding the guidewire insertion lumen.
在一些实施例中，第二球囊为非顺应性球囊，第二球囊的材料包括聚酰胺、聚醚嵌段聚酰胺、以及聚乙烯中的至少一种。In some embodiments, the second balloon is a non-compliant balloon, and the material of the second balloon includes at least one of polyamide, polyether block polyamide, and polyethylene.
在一些实施例中，造影剂输送孔位于第二球囊的远离单腔管的一侧。In some embodiments, the contrast agent delivery hole is located on a side of the second balloon distal from the single lumen tube.
在一些实施例中，单腔管包括毗邻其远端的第二尖端部分。In some embodiments, the single lumen tube includes a second tip portion adjacent to its distal end.
在一些实施例中，球囊导管还包括设于单腔管的外壁的显影元件。In some embodiments, the balloon catheter further comprises a developing element disposed on the outer wall of the single lumen tube.
在一些实施例中，球囊导管还包括加强套管，套设于多腔体管与连接座的连接处并将多腔体管与连接座密封连接。In some embodiments, the balloon catheter further comprises a reinforcing sleeve, which is sleeved at the connection between the multi-lumen tube and the connecting seat and seals the multi-lumen tube and the connecting seat.
根据本公开的一个或多个实施例，一方面，可以利用球囊鞘管的第一球囊和穿过球囊鞘管的球囊导管的第二球囊间歇对静脉进行封堵，从而减少静脉血向心脏回流，降低心前负荷，使得心室壁应力降低；另一方面，还可以使球囊鞘管的第一球囊和穿过球囊鞘管的球囊导管的第二球囊按照心脏节律同步进行充压与泄压，从而产生双重血流动力学效应，提升舒张压和冠脉灌注，降低心后负荷改善左心室射血。在治疗过程中或者治疗前后，球囊鞘管的主管腔还可以通入诊疗器械进行相关检测和治疗。因此，本公开实施例的球囊鞘管可用于治疗急性充血性心力衰竭，并能够获得良好的预后效果。According to one or more embodiments of the present disclosure, on the one hand, the first balloon of the balloon sheath and the second balloon of the balloon catheter passing through the balloon sheath can be used to intermittently block the vein, thereby reducing the reflux of venous blood to the heart, reducing the preload of the heart, and reducing the stress on the ventricular wall; on the other hand, the first balloon of the balloon sheath and the second balloon of the balloon catheter passing through the balloon sheath can be synchronously inflated and depressurized according to the heart rhythm, thereby producing a dual hemodynamic effect, increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection. During the treatment process or before and after the treatment, the main lumen of the balloon sheath can also be passed through diagnostic and treatment instruments for relevant testing and treatment. Therefore, the balloon sheath of the embodiment of the present disclosure can be used to treat acute congestive heart failure and can obtain a good prognosis.
根据在下文中所描述的实施例，本公开的这些和其它方面将是清楚明白的，并且将参考在下文中所描述的实施例而被阐明。These and other aspects of the disclosure will be apparent from and elucidated with reference to the embodiments described hereinafter.
为了更清楚地说明本公开实施例的技术方案，下面将对本公开实施例中所需要使用的附图作简单地介绍，显而易见地，下面所描述的附图仅仅是本公开的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据附图获得其他的附图。在下面结合附图对于示例性实施例的描述中，本公开的更多细节、特征和优点被公开，在附图中：In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following briefly introduces the drawings required to be used in the embodiments of the present disclosure. Obviously, the drawings described below are only some embodiments of the present disclosure. For those skilled in the art, other drawings can be obtained according to the drawings without creative work. In the following description of exemplary embodiments in combination with the drawings, more details, features and advantages of the present disclosure are disclosed, in which:
图1是本公开一些实施例的心衰治疗器械的结构示意图；FIG1 is a schematic diagram of the structure of a heart failure treatment device according to some embodiments of the present disclosure;
图2是本公开一些实施例的球囊鞘管的结构示意图；以及FIG2 is a schematic diagram of the structure of a balloon sheath tube according to some embodiments of the present disclosure; and
图3是本公开一些实施例的球囊导管的结构示意图。FIG. 3 is a schematic diagram of the structure of a balloon catheter according to some embodiments of the present disclosure.
附图标记说明：Description of reference numerals:
100-球囊鞘管；300-球囊导管；500-心衰治疗器械；10-主鞘管；101-主管腔；102-副管腔；103-第一充压管腔；104-第二充压管腔；11-第一球囊；12-主连接座；121-第一端口；122-第二端口；123-第一侧口；124-第二侧口；13-副鞘管；14-副连接座；141-第三端口；142-第三侧口；15-第一侧支管；16-第二侧支管；17-第三侧支管；18-鲁尔接头三通；106-第一尖端部分；191-主止血阀；192-副止血阀；30-多腔体管；301-导丝穿入管腔；302-充压介质输送管腔；303-造影剂输送管腔；304-造影剂输送孔；31-单腔管；32-第二球囊；33-连接座；331-第一接头；332-第二接头；333-第三接头；311-第二尖端部分；312-显影元件；34-加强套管；193-主扩张器；1931-单腔导管；1932-扩张器座；194-副扩张器。100-balloon sheath; 300-balloon catheter; 500-heart failure treatment device; 10-main sheath; 101-main lumen; 102-secondary lumen; 103-first pressure lumen; 104-second pressure lumen; 11-first balloon; 12-main connector; 121-first port; 122-second port; 123-first side port; 124-second side port; 13-secondary sheath; 14-secondary connector; 141-third port; 142-third side port; 15-first side branch; 16-second side branch; 17-third side branch; 18-Luer connector tee; 1 06-first tip portion; 191-main hemostatic valve; 192-second hemostatic valve; 30-multi-lumen tube; 301-guide wire insertion lumen; 302-pressurized medium delivery lumen; 303-contrast agent delivery lumen; 304-contrast agent delivery hole; 31-single-lumen tube; 32-second balloon; 33-connecting seat; 331-first joint; 332-second joint; 333-third joint; 311-second tip portion; 312-developing element; 34-reinforcement sleeve; 193-main dilator; 1931-single-lumen catheter; 1932-dilator seat; 194-second dilator.
在下文中，仅简单地描述了某些示例性实施例。正如本领域技术人员可认识到的那样，在不脱离本公开的精神或范围的情况下，可通过各种不同方式修改所描述的实施例。因此，附图和描述被认为本质上是示例性的而非限制性的。In the following, only some exemplary embodiments are briefly described. As those skilled in the art will appreciate, the described embodiments may be modified in various ways without departing from the spirit or scope of the present disclosure. Therefore, the drawings and descriptions are considered to be exemplary and non-restrictive in nature.
心力衰竭目前已经是全球因病死亡的主要原因，其发病率呈逐年上升的趋势。心力衰竭是由于心室泵血或充盈能力减退，心脏排血量无法满足机体的代谢需要，使得器官与组织血液灌注不足，同时出现肺循环或体循环淤血。心力衰竭是各种心脏疾病进展到严重阶段的综合症，通常也被称为充血性心力衰竭。Heart failure is currently the leading cause of death worldwide, and its incidence is increasing year by year. Heart failure is caused by the decline of ventricular pumping or filling capacity, and the inability of the heart to discharge blood to meet the metabolic needs of the body, resulting in insufficient blood perfusion of organs and tissues, and congestion in the pulmonary circulation or systemic circulation. Heart failure is a syndrome of various heart diseases progressing to a serious stage, and is also commonly known as congestive heart failure.
通过降低心脏前负荷来降低心室壁应力是治疗急性充血性心力衰竭的基础。Frank-Starling机制(心力衰竭中代偿机制)表明预加载是心排血量的主要决定因素，并进一步指出在容量超负荷情况下的收缩期心衰患者中，减少容量过载可能会提高心排血量，至少不会降低心排血量。目前一些研究结果表明，心脏充盈压力的升高直接影响心衰患者的短期和长期预后。Reducing ventricular wall stress by reducing cardiac preload is the basis for the treatment of acute congestive heart failure. The Frank-Starling mechanism (compensatory mechanism in heart failure) indicates that preload is the main determinant of cardiac output, and further points out that in patients with systolic heart failure under volume overload, reducing volume overload may increase cardiac output, or at least not reduce it. Some current research results show that increased cardiac filling pressure directly affects the short-term and long-term prognosis of patients with heart failure.
目前治疗心衰的方法中，往往通过利尿疗法及扩张血管来降低心前负荷。通过专门的器械来减少心脏充血的方法有加速水分离、血液透析和一些创新方法如降主动脉内的泵。但是，出于担心可能会降低心输出量和全身血压的原因，目前很少有专门设计用于降低心脏前负荷的器械。Current treatments for heart failure often involve reducing cardiac preload through diuresis and vasodilation. Specialized devices to reduce cardiac congestion include accelerated water separation, hemodialysis, and innovative methods such as a pump in the descending aorta. However, there are currently few devices specifically designed to reduce cardiac preload due to concerns that they may reduce cardiac output and systemic blood pressure.
本公开实施例提供了一种球囊鞘管及心衰治疗器械，可用于治疗急性充血性心力衰竭，并能够获得良好的预后效果。The disclosed embodiments provide a balloon sheath and a heart failure treatment device, which can be used to treat acute congestive heart failure and can achieve a good prognosis.
如图1和图2所示，本公开一些实施例提供的球囊鞘管100应用于心衰治疗器械500。该球囊鞘管100包括主鞘管10、第一球囊11、主连接座12、副鞘管13、副连接座14、以及三个侧支管。主鞘管10具有彼此不相通的主管腔101、副管腔102、第一充压管腔103和第二充压管腔104，其中，主管腔101用于引导诊疗器械(图中未示出)穿出，副管腔102用于引导球囊导管300穿出。第一球囊11与主鞘管10的外壁密封连接并且与第一充压管腔103和第二充压管腔104的远端连通。主连接座12与主鞘管10的近端连接并且包括与主管腔101连通的第一端口121、与副管腔102连通的第二端口122、与主管腔101连通的第一侧口123、以及与第一充压管腔103和第二充压管腔104连通的第二侧口124，其中，第一端口121用于供诊疗器械穿入。副鞘管13与第二端口122连通。副连接座14与副鞘管13的近端连接并且包括与副鞘管13连通的第三端口141和第三侧口142，其中，第三端口141用于供球囊导管300穿入。第一侧支管15与第一侧口123连通，第二侧支管16用于输入充压介质并且与第二侧口124连通，第三侧支管17与第三侧口142连通。As shown in Figures 1 and 2, the balloon sheath tube 100 provided in some embodiments of the present disclosure is applied to a heart failure treatment device 500. The balloon sheath tube 100 includes a main sheath tube 10, a first balloon 11, a main connecting seat 12, a secondary sheath tube 13, a secondary connecting seat 14, and three side branches. The main sheath tube 10 has a main lumen 101, a secondary lumen 102, a first pressurized lumen 103, and a second pressurized lumen 104 that are not connected to each other, wherein the main lumen 101 is used to guide the diagnostic and treatment equipment (not shown in the figure) to pass through, and the secondary lumen 102 is used to guide the balloon catheter 300 to pass through. The first balloon 11 is sealed and connected to the outer wall of the main sheath tube 10 and is connected to the distal ends of the first pressurized lumen 103 and the second pressurized lumen 104. The main connection seat 12 is connected to the proximal end of the main sheath tube 10 and includes a first port 121 communicating with the main lumen 101, a second port 122 communicating with the auxiliary lumen 102, a first side port 123 communicating with the main lumen 101, and a second side port 124 communicating with the first pressurized lumen 103 and the second pressurized lumen 104, wherein the first port 121 is used for inserting diagnostic and treatment instruments. The auxiliary sheath tube 13 is communicated with the second port 122. The auxiliary connection seat 14 is connected to the proximal end of the auxiliary sheath tube 13 and includes a third port 141 and a third side port 142 communicating with the auxiliary sheath tube 13, wherein the third port 141 is used for inserting the balloon catheter 300. The first side branch tube 15 is communicated with the first side port 123, the second side branch tube 16 is used for inputting pressurized medium and is communicated with the second side port 124, and the third side branch tube 17 is communicated with the third side port 142.
在本公开实施例中，以球囊鞘管100为例，定义球囊鞘管100或者其部件在延伸方向上更加靠近操作者的一端为“近端”，类似地，定义球囊鞘管100或者其部件在延伸方向上更加远离操作者的一端为“远端”。对于球囊导管300或者其部件的“近端”和“远端”的定义可参考球囊鞘管100，这里不再重复赘述。定义“侧口”为设于该部件的侧表面的孔口，定义“端口”为设于该部件的端面的孔口。In the embodiment of the present disclosure, taking the balloon sheath tube 100 as an example, the end of the balloon sheath tube 100 or its components that is closer to the operator in the extension direction is defined as the "proximal end", and similarly, the end of the balloon sheath tube 100 or its components that is farther away from the operator in the extension direction is defined as the "distal end". The definitions of the "proximal end" and "distal end" of the balloon catheter 300 or its components can refer to the balloon sheath tube 100, and will not be repeated here. The "side port" is defined as an orifice provided on the side surface of the component, and the "port" is defined as an orifice provided on the end surface of the component.
本公开实施例的球囊鞘管100用于为球囊导管300以及其它诊疗器械提供通路并且可以通过其球囊对血管进行封堵。可以从主连接座12的第一端口121将诊疗器械穿入主管腔101，从副连接座14的第三端口141将球囊导管300穿入副管腔102，利用第一侧支管15向主管腔101充入冲洗液，利用第二侧支管16向第一充压管腔103和第二充压管腔104充入充压介质，利用第三侧支管17向副管腔102充入冲洗液或者抽取血液。在一些实施例中，第一侧支管15、第二侧支管16和第三侧支管17的近端分别设有鲁尔接头三通18，从而允许多个互相兼容的流体使用同一条管路进行管理。The balloon sheath tube 100 of the disclosed embodiment is used to provide a passage for the balloon catheter 300 and other diagnostic and treatment instruments and can block blood vessels through its balloon. The diagnostic and treatment instruments can be inserted into the main lumen 101 from the first port 121 of the main connection seat 12, and the balloon catheter 300 can be inserted into the secondary lumen 102 from the third port 141 of the secondary connection seat 14. The main lumen 101 is filled with flushing liquid through the first side branch 15, and the first and second pressurized lumens 103 and 104 are filled with pressurized medium through the second side branch 16. The secondary lumen 102 is filled with flushing liquid or blood is extracted through the third side branch 17. In some embodiments, the proximal ends of the first side branch 15, the second side branch 16, and the third side branch 17 are respectively provided with a Luer connector tee 18, thereby allowing multiple mutually compatible fluids to be managed using the same pipeline.
在人体置入球囊鞘管100之后，可以以球囊鞘管100以及相关引导件为导向置入球囊导管300和/或诊疗器械，从而可以利用球囊鞘管100的第一球囊11和球囊导管300的第二球囊32对血管进行封堵，利用诊疗器械实施相关诊疗操作。在本公开的一些实施例中，在人体内置入球囊鞘管100和球囊导管300的操作过程依次为：使用穿刺针进行穿刺→在穿刺针中置入短导丝→拔出穿刺针→以短导丝为导向置入球囊鞘管100(球囊鞘管100的第一端口121预先安置有主扩张器193(如图2所示，该主扩张器193的单腔导管1931伸出球囊鞘管100的远端)，短导丝穿过球囊鞘管100的主管腔101)→拔出短导丝和主扩张器193→经预先安置于副连接座14的第三端口141的副扩张器194将长导丝穿入球囊鞘管100的副管腔102→拔出副扩张器194→以长导丝为导向置入球囊导管300→拔出长导丝。其中，短导丝、长导丝、主扩张器193和副扩张器194作为置入球囊鞘管100和球囊导管300时的中间辅助器械。After the balloon sheath 100 is inserted into the human body, the balloon catheter 300 and/or diagnostic and treatment equipment can be inserted using the balloon sheath 100 and related guide members as a guide, so that the first balloon 11 of the balloon sheath 100 and the second balloon 32 of the balloon catheter 300 can be used to block the blood vessels, and related diagnostic and treatment operations can be performed using the diagnostic and treatment equipment. In some embodiments of the present disclosure, the operation process of inserting the balloon sheath tube 100 and the balloon catheter 300 into the human body is as follows: use a puncture needle to perform puncture → insert a short guide wire into the puncture needle → pull out the puncture needle → insert the balloon sheath tube 100 guided by the short guide wire (the first port 121 of the balloon sheath tube 100 is pre-installed with a main dilator 193 (as shown in Figure 2, the single-lumen catheter 1931 of the main dilator 193 extends out of the distal end of the balloon sheath tube 100), and the short guide wire passes through the main lumen 101 of the balloon sheath tube 100) → pull out the short guide wire and the main dilator 193 → insert the long guide wire into the secondary lumen 102 of the balloon sheath tube 100 through the secondary dilator 194 pre-installed on the third port 141 of the secondary connecting seat 14 → pull out the secondary dilator 194 → insert the balloon catheter 300 guided by the long guide wire → pull out the long guide wire. Among them, the short guide wire, the long guide wire, the main dilator 193 and the auxiliary dilator 194 serve as intermediate auxiliary instruments when inserting the balloon sheath 100 and the balloon catheter 300.
根据本公开实施例的设计，一方面，可以利用球囊鞘管100的第一球囊11和穿过球囊鞘管100的球囊导管300的第二球囊32间歇对静脉进行封堵，从而减少静脉血向心脏回流，降低心前负荷，使得心室壁应力降低；另一方面，还可以使球囊鞘管100的第一球囊11和穿过球囊鞘管100的球囊导管300的第二球囊32按照心脏节律同步进行充压与泄压，从而产生双重血流动力学效应，提升舒张压和冠脉灌注，降低心后负荷改善左心室射血。在治疗过程中或者治疗前后，球囊鞘管100的主管腔101还可以通入诊疗器械进行相关检测和治疗。因此，本公开实施例的球囊鞘管100可用于治疗急性充血性心力衰竭，并能够获得良好的预后效果。According to the design of the embodiment of the present disclosure, on the one hand, the first balloon 11 of the balloon sheath tube 100 and the second balloon 32 of the balloon catheter 300 passing through the balloon sheath tube 100 can be used to intermittently block the vein, thereby reducing the venous blood backflow to the heart, reducing the preload of the heart, and reducing the stress of the ventricular wall; on the other hand, the first balloon 11 of the balloon sheath tube 100 and the second balloon 32 of the balloon catheter 300 passing through the balloon sheath tube 100 can be synchronously inflated and depressurized according to the heart rhythm, thereby producing a dual hemodynamic effect, increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection. During the treatment process or before and after the treatment, the main cavity 101 of the balloon sheath tube 100 can also be passed through diagnostic and treatment instruments for related testing and treatment. Therefore, the balloon sheath tube 100 of the embodiment of the present disclosure can be used to treat acute congestive heart failure and can obtain a good prognosis.
主鞘管10的各管腔的截面形状和布置方式不限。如图2所示，在本公开的一些实施例中，主管腔101和副管腔102分别呈圆孔状，其中，主管腔101的孔径R1大于副管腔102的孔径R2，第一充压管腔103和第二充压管腔104位于主管腔101和副管腔102的两侧。由于主管腔101需要通入诊疗器械，为使其能够顺利通入，故将其孔径设计的相对较大。副管腔102的孔径可以基于球囊导管300的第二球囊32在收缩状态的外径进行相应设计，以使球囊导管300能够顺利通过。主鞘管10可以采用挤出工艺成型，主管腔101和副管腔102的两侧腔体空间作为第一充压管腔103和第二充压管腔104。The cross-sectional shape and arrangement of each lumen of the main sheath 10 are not limited. As shown in FIG. 2, in some embodiments of the present disclosure, the main lumen 101 and the secondary lumen 102 are respectively in the shape of circular holes, wherein the aperture R1 of the main lumen 101 is larger than the aperture R2 of the secondary lumen 102, and the first pressurized lumen 103 and the second pressurized lumen 104 are located on both sides of the main lumen 101 and the secondary lumen 102. Since the main lumen 101 needs to be passed through the diagnostic and treatment equipment, in order to enable it to be passed smoothly, its aperture is designed to be relatively large. The aperture of the secondary lumen 102 can be designed accordingly based on the outer diameter of the second balloon 32 of the balloon catheter 300 in the contracted state, so that the balloon catheter 300 can pass smoothly. The main sheath 10 can be formed by an extrusion process, and the cavity spaces on both sides of the main lumen 101 and the secondary lumen 102 serve as the first pressurized lumen 103 and the second pressurized lumen 104.
如图2所示，在一些实施例中，主鞘管10包括毗邻其远端的第一尖端部分106，其中，主管腔101的远端穿出孔曝露于第一尖端部分106的端面，副管腔102的远端穿出孔曝露于第一尖端部分106的侧面。也即，诊疗器械可以从主鞘管10的第一尖端部分106的端面穿出，球囊导管300可以从主鞘管10的第一尖端部分106的侧面穿出。主鞘管10设计第一尖端部分106可以减少其在血管中行进的阻力，使得进入更加顺利。As shown in FIG. 2 , in some embodiments, the main sheath tube 10 includes a first tip portion 106 adjacent to its distal end, wherein the distal end through hole of the main lumen 101 is exposed at the end surface of the first tip portion 106, and the distal end through hole of the secondary lumen 102 is exposed at the end surface of the first tip portion 106. The exit hole is exposed on the side of the first tip portion 106. That is, the diagnostic and treatment instrument can pass through the end surface of the first tip portion 106 of the main sheath tube 10, and the balloon catheter 300 can pass through the side of the first tip portion 106 of the main sheath tube 10. The design of the first tip portion 106 of the main sheath tube 10 can reduce the resistance of its travel in the blood vessel, making it easier to enter.
在本公开的一些实施例中，主鞘管10和副鞘管13的材料可以包括聚酰胺、聚醚嵌段聚酰胺、丙烯腈-丁二烯-苯乙烯三元共聚物、以及聚对甲苯二甲酸乙二醇酯中的至少一种。In some embodiments of the present disclosure, the material of the main sheath tube 10 and the auxiliary sheath tube 13 may include at least one of polyamide, polyether block polyamide, acrylonitrile-butadiene-styrene terpolymer, and polyethylene terephthalate.
在本公开的一些实施例中，主鞘管10设有将第一充压管腔103和第二充压管腔104与第一球囊11连通的至少一个通孔(图中未示出，例如可以直接在主鞘管10与第一球囊11相对的外壁进行开孔以形成该至少一个通孔)，第一球囊11为在收缩状态与主鞘管10的外壁相贴合的顺应性管壁状球囊。顺应性管壁状球囊在收缩状态呈管壁状，其近端内壁和远端内壁可以与主鞘管10的外壁密封粘接，从而实现球囊密封。In some embodiments of the present disclosure, the main sheath 10 is provided with at least one through hole (not shown in the figure, for example, a hole can be directly opened on the outer wall of the main sheath 10 opposite to the first balloon 11 to form the at least one through hole) that connects the first and second pressurized lumens 103 and 104 with the first balloon 11, and the first balloon 11 is a compliant tubular wall-shaped balloon that fits the outer wall of the main sheath 10 in a contracted state. The compliant tubular wall-shaped balloon is tubular wall-shaped in a contracted state, and its proximal inner wall and distal inner wall can be sealed and bonded to the outer wall of the main sheath 10, thereby achieving balloon sealing.
第一球囊11采用顺应性材料，例如可以包括硅胶、乳胶、聚氨酯、以及聚亚胺酯中的至少一种，这样，可以在较低压力下获得较大的膨胀直径，并且，随着压力的提升，其膨胀直径增长明显，从而在膨胀后可以有效锚定，在血管中提供可靠支撑。此外，第一球囊11采用管壁状设计，在收缩状态与主鞘管10的外壁相贴合，从而可以获得较小外径，以尽量减小在血管中的行进阻力，减少对人体的伤害。The first balloon 11 is made of compliant material, for example, it may include at least one of silicone, latex, polyurethane, and polyurethane, so that a larger expansion diameter can be obtained at a lower pressure, and as the pressure increases, its expansion diameter increases significantly, so that it can be effectively anchored after expansion and provide reliable support in the blood vessel. In addition, the first balloon 11 adopts a tube wall design, and fits with the outer wall of the main sheath tube 10 in the contracted state, so that a smaller outer diameter can be obtained to minimize the travel resistance in the blood vessel and reduce damage to the human body.
在本公开实施例中，主连接座12和副连接座14的材料可以包括丙烯腈-丁二烯-苯乙烯三元共聚物、聚酰胺、聚碳酸酯、以及聚甲醛中的至少一种。主连接座12、副连接座14可以为其它器械或治疗介质提供进出通道，其材质相对主鞘管10和副鞘管13较硬，这样便于装配和器械操作。此外，还可以在其内安装止血阀。In the disclosed embodiment, the material of the main connection seat 12 and the auxiliary connection seat 14 may include at least one of acrylonitrile-butadiene-styrene terpolymer, polyamide, polycarbonate, and polyoxymethylene. The main connection seat 12 and the auxiliary connection seat 14 can provide access channels for other instruments or treatment media, and their materials are harder than the main sheath tube 10 and the auxiliary sheath tube 13, which is convenient for assembly and instrument operation. In addition, a hemostatic valve can be installed therein.
如图2所示，在一些实施例中，球囊鞘管100还包括设于主连接座12内的主止血阀191(图中仅为示意)，以及设于副连接座14内的副止血阀192(图中仅为示意)。主止血阀191和副止血阀192利用自身弹力挤压密封，防止血液流出，实现止血效果。主止血阀191和副止血阀192的材料例如可以包括硅胶、乳胶、聚氨酯、以及聚亚胺酯中的至少一种。As shown in FIG. 2 , in some embodiments, the balloon sheath 100 further includes a main hemostatic valve 191 (only for illustration) disposed in the main connection seat 12, and an auxiliary hemostatic valve 192 (only for illustration) disposed in the auxiliary connection seat 14. The main hemostatic valve 191 and the auxiliary hemostatic valve 192 utilize their own elastic force to squeeze and seal to prevent blood from flowing out, thereby achieving a hemostatic effect. The material of the main hemostatic valve 191 and the auxiliary hemostatic valve 192 may include, for example, at least one of silicone, latex, polyurethane, and polyurethane.
在本公开实施例中，第一侧支管15、第二侧支管16和第三侧支管17为可弯曲并且能够承受一定压力的单腔管，可以为各种治疗介质或冲洗介质提供通路，也可以在治疗中采集体液，其材料例如可以包括聚乙烯、聚氯乙烯、以及聚醚嵌段聚酰胺中的至少一种。In the embodiment of the present disclosure, the first side branch 15, the second side branch 16 and the third side branch 17 are single-lumen tubes that are bendable and can withstand a certain pressure. They can provide passages for various treatment media or flushing media, and can also collect body fluids during treatment. Their materials may include, for example, at least one of polyethylene, polyvinyl chloride, and polyether block polyamide.
在本公开一些实施例中，主扩张器193和副扩张器194作为置入球囊鞘管100和球囊导管300时的中间辅助器械。如图2所示，以主扩张器193为例，其主要结构包括单腔导管1931和扩张器座1932，作用是为导丝进入主鞘管10提供通道。单腔导管1931的头端设有渐变段，这样方便主扩张器193通过主止血阀191与主鞘管10组装。单腔导管1931的材料可以包括聚乙烯、聚氯乙烯、以及聚醚嵌段聚酰胺中的至少一种，还可以加入硫酸钡等金属氧化物，从而具有显影性。扩张器座1932可以包含鲁尔接头(图中未示出)，其材料可与单腔导管1931的材料一致。In some embodiments of the present disclosure, the main dilator 193 and the auxiliary dilator 194 serve as intermediate auxiliary devices when inserting the balloon sheath 100 and the balloon catheter 300. As shown in FIG2 , taking the main dilator 193 as an example, its main structure includes a single-lumen catheter 1931 and a dilator seat 1932, which is used to provide a channel for the guidewire to enter the main sheath 10. The head end of the single-lumen catheter 1931 is provided with a gradient section, which facilitates the assembly of the main dilator 193 with the main sheath 10 through the main hemostatic valve 191. The material of the single-lumen catheter 1931 may include at least one of polyethylene, polyvinyl chloride, and polyether block polyamide, and metal oxides such as barium sulfate may be added to have developing properties. The dilator seat 1932 may include a Luer connector (not shown in the figure), and its material may be consistent with the material of the single-lumen catheter 1931.
参照图1所示，本公开实施例还提供一种心衰治疗器械500，包括前述任一实施例的球囊鞘管100。1 , the embodiment of the present disclosure further provides a heart failure treatment device 500 , comprising the balloon sheath 100 of any of the aforementioned embodiments.
该心衰治疗器械500可以包括相关诊疗器械、球囊导管300以及外部设备(如泵)等。心衰治疗器械500不但可以用于静脉封堵的治疗方案，还可以用于主动脉内反搏的治疗方案，在治疗急性充血性心力衰竭中能够获得良好的预后效果。The heart failure treatment device 500 may include relevant diagnostic and treatment devices, a balloon catheter 300, and external devices (such as a pump), etc. The heart failure treatment device 500 may be used not only for the treatment of venous occlusion, but also for the treatment of intra-aortic counterpulsation, and may achieve good prognosis in the treatment of acute congestive heart failure.
在本公开的一些实施例中，心衰治疗器械500还包括与副鞘管13和主鞘管10嵌套装配的球囊导管300。球囊导管300的具体结构形式不限，可以根据实际需求进行具体设计。In some embodiments of the present disclosure, the heart failure treatment device 500 further includes a balloon catheter 300 nested with the secondary sheath tube 13 and the main sheath tube 10. The specific structure of the balloon catheter 300 is not limited and can be specifically designed according to actual needs.
如图3所示，在一些实施例中，该球囊导管300的主要结构包括多腔体管30、单腔管31、第二球囊32和连接座33。多腔体管30具有彼此不相通的导丝穿入管腔301、充压介质输送管腔302和造影剂输送管腔303，以及曝露于多腔体管30的外壁并且与造影剂输送管腔303的远端连通的造影剂输送孔304。单腔管31与导丝穿入管腔301的远端连通。第二球囊32与多腔体管30的外壁和单腔管31的外壁密封连接并且与充压介质输送管腔302的远端连通。连接座33与多腔体管30的近端连接并且包括与导丝穿入管腔301连通的第一接头331、与充压介质输送管腔302连通的第二接头332、以及与造影剂输送管腔303连通的第三接头333，其中，第一接头331用于供导丝穿入，第二接头332用于输入充压介质，第三接头333用于输入造影剂。As shown in FIG3 , in some embodiments, the main structure of the balloon catheter 300 includes a multi-lumen tube 30, a single-lumen tube 31, a second balloon 32, and a connecting seat 33. The multi-lumen tube 30 has a guide wire insertion lumen 301, a pressurized medium delivery lumen 302, and a contrast agent delivery lumen 303 that are not connected to each other, and a contrast agent delivery hole 304 exposed to the outer wall of the multi-lumen tube 30 and connected to the distal end of the contrast agent delivery lumen 303. The single-lumen tube 31 is connected to the distal end of the guide wire insertion lumen 301. The second balloon 32 is sealed and connected to the outer wall of the multi-lumen tube 30 and the outer wall of the single-lumen tube 31 and is connected to the distal end of the pressurized medium delivery lumen 302. The connecting seat 33 is connected to the proximal end of the multi-lumen tube 30 and includes a first connector 331 connected to the guide wire insertion lumen 301, a second connector 332 connected to the pressurized medium delivery lumen 302, and a third connector 333 connected to the contrast agent delivery lumen 303, wherein the first connector 331 is used for guide wire insertion, the second connector 332 is used for inputting pressurized medium, and the third connector 333 is used for inputting contrast agent.
在利用本公开前述实施例提供的球囊鞘管100将上述球囊导管300置入人体并进行定位后，可以利用外部的充压介质输入设备，将第一球囊11和第二球囊32交替间歇充盈，从而实现对下腔静脉和锁骨下静脉的交替间歇封堵，以此来减少静脉血向心脏回流，或者，将第一球囊11和第二球囊32按照心脏节律同步充压与泄压，以此来提升舒张压和冠脉灌注，降低心后负荷改善左心室射血。此外，还可以利用外部的造影液输入设备，使造影液通过造影剂输送管腔303注入到血管中。在一些实施例中，造影剂输送孔304可以设计在第二球囊32的远离单腔管31的一侧。After the balloon catheter 300 is placed into the human body and positioned using the balloon sheath 100 provided in the aforementioned embodiment of the present disclosure, the first balloon 11 and the second balloon 32 can be alternately and intermittently filled using an external pressurized medium input device, thereby achieving alternate and intermittent occlusion of the inferior vena cava and the subclavian vein, thereby reducing the venous blood from flowing back to the heart, or the first balloon 11 and the second balloon 32 can be synchronously pressurized and depressurized according to the cardiac rhythm, thereby increasing the diastolic pressure and coronary perfusion, reducing the cardiac afterload and improving the left ventricular ejection. In addition, the external contrast medium input device can also be used. The device allows contrast fluid to be injected into the blood vessel through the contrast agent delivery lumen 303. In some embodiments, the contrast agent delivery hole 304 can be designed on the side of the second balloon 32 away from the single lumen tube 31.
多腔体管30内部的具体结构形式不限。如图3所示，在一些实施例中，导丝穿入管腔301呈圆孔状并且其中心轴线重合于多腔体管30的中心轴线，充压介质输送管腔302和造影剂输送管腔303分别呈弧形孔状环绕导丝穿入管腔301。多腔体管30的材料可以包括聚酰胺、聚醚嵌段聚酰胺中的至少一种。The specific structural form inside the multi-lumen tube 30 is not limited. As shown in FIG3 , in some embodiments, the guide wire insertion lumen 301 is in the shape of a circular hole and its central axis coincides with the central axis of the multi-lumen tube 30, and the pressurized medium delivery lumen 302 and the contrast agent delivery lumen 303 are respectively in the shape of arc holes surrounding the guide wire insertion lumen 301. The material of the multi-lumen tube 30 may include at least one of polyamide and polyether block polyamide.
如图3所示，在一些实施例中，单腔管31包括毗邻其远端的第二尖端部分311，这样有利于减少球囊导管300在血管中行进的阻力，使得进入更加顺利。单腔管31可以采用较为柔软的材料，例如可以包含聚氨酯、聚亚胺酯、聚醚嵌段聚酰胺、硅胶中的至少一种。As shown in Fig. 3, in some embodiments, the single lumen tube 31 includes a second tip portion 311 adjacent to its distal end, which is conducive to reducing the resistance of the balloon catheter 300 in the blood vessel, making it easier to enter. The single lumen tube 31 can be made of a relatively soft material, such as at least one of polyurethane, polyurethane, polyether block polyamide, and silicone.
单腔管31的外壁可以设置显影元件312，显影元件312可以设计在第二球囊32内。在手术中，可以利用外部影像探测设备(如X光探测设备)对显影元件312进行探测，从而精确获知其位置，实现精确定位。显影元件312的材料可以选自金、铂、铱、钽、钨等材料中的一种或多种。The outer wall of the single-lumen tube 31 may be provided with a developing element 312, and the developing element 312 may be designed inside the second balloon 32. During surgery, an external image detection device (such as an X-ray detection device) may be used to detect the developing element 312, so as to accurately know its position and achieve precise positioning. The material of the developing element 312 may be selected from one or more materials such as gold, platinum, iridium, tantalum, and tungsten.
在一些实施例中，第二球囊32为非顺应性球囊，其材料可以包括聚酰胺、聚醚嵌段聚酰胺、以及聚乙烯中的至少一种。非顺应性球囊的直径在膨胀到达一定值后，无论外部压力如何变化，都将保持该值，这样可以精准封堵指定位置的血管同时不会因为过度膨胀而损伤血管。In some embodiments, the second balloon 32 is a non-compliant balloon, and its material may include at least one of polyamide, polyether block polyamide, and polyethylene. After the diameter of the non-compliant balloon expands to a certain value, it will maintain this value regardless of how the external pressure changes, so that the blood vessel at the designated position can be accurately blocked without damaging the blood vessel due to excessive expansion.
如图3所示，在一些实施例中，球囊导管300还包括：套设于多腔体管30与连接座33的连接处并将多腔体管30与连接座33密封连接的加强套管34。加强套管34用于使多腔体管30和连接座33的连接密封牢固，也可以防止在连接处过度弯曲。加强套管34的材料可以包括聚酰胺、丙烯腈-丁二烯-苯乙烯三元共聚物、聚烯烃、聚醚嵌段聚酰胺等中的至少一种，还可以包含硫酸钡等金属氧化物。As shown in FIG3 , in some embodiments, the balloon catheter 300 further includes: a reinforcing sleeve 34 which is sleeved at the connection between the multi-lumen tube 30 and the connection seat 33 and seals the multi-lumen tube 30 and the connection seat 33. The reinforcing sleeve 34 is used to make the connection between the multi-lumen tube 30 and the connection seat 33 firmly sealed, and can also prevent excessive bending at the connection. The material of the reinforcing sleeve 34 can include at least one of polyamide, acrylonitrile-butadiene-styrene terpolymer, polyolefin, polyether block polyamide, etc., and can also include metal oxides such as barium sulfate.
根据本公开一些实施例的心衰治疗器械500的治疗实施案例如下：The treatment implementation cases of the heart failure treatment device 500 according to some embodiments of the present disclosure are as follows:
首先，通过穿刺套件在股静脉建立通道，并置入导丝；然后，将球囊鞘管100沿导丝(导丝穿入球囊鞘管100的主管腔101)自股静脉进入人体，将第一球囊11在造影下定位至下腔静脉，其位置位于肾静脉下方，固定球囊鞘管100；然后，在球囊鞘管100的副管腔102中置入导丝，使导丝沿着下腔静脉向上经过心脏、上腔静脉、头臂静脉至锁骨下静脉；然后，将球囊导管300沿导丝通过副管腔102到达指定位置，在此过程中，通过球囊导管300自带的造影剂输送孔304向血管中输送造影剂，以监测第二球囊32准确到达封堵位置。First, a channel is established in the femoral vein through the puncture kit, and a guide wire is inserted; then, the balloon sheath tube 100 is introduced into the human body from the femoral vein along the guide wire (the guide wire penetrates into the main lumen 101 of the balloon sheath tube 100), and the first balloon 11 is positioned in the inferior vena cava under angiography, and its position is located below the renal vein, and the balloon sheath tube 100 is fixed; then, a guide wire is inserted into the secondary lumen 102 of the balloon sheath tube 100, and the guide wire is passed upward along the inferior vena cava through the heart, the superior vena cava, the brachiocephalic vein to the subclavian vein; then, the balloon catheter 300 is passed through the secondary lumen 102 along the guide wire to the designated position. In this process, Contrast agent is delivered into the blood vessel through the contrast agent delivery hole 304 of the balloon catheter 300 to monitor that the second balloon 32 has accurately reached the occlusion position.
之后，将球囊鞘管100和球囊导管300分别连接压力泵，开始包含以下四个步骤的循环治疗流程：Afterwards, the balloon sheath tube 100 and the balloon catheter 300 are connected to the pressure pumps respectively, and a cyclic treatment process including the following four steps is started:
步骤一、第一球囊11在4-5s完成充压，压力保持15s，此时第二球囊32保持不充压状态；Step 1: The first balloon 11 is pressurized in 4-5 seconds, and the pressure is maintained for 15 seconds, while the second balloon 32 remains unpressurized;
步骤二、第一球囊11在4-5s内完成泄压，使血液流通1分钟；Step 2: The first balloon 11 is depressurized within 4-5 seconds, allowing blood to circulate for 1 minute;
步骤三、第二球囊32在4-5s完成充压，压力保持15s，此时第一球囊11保持不充压状态；Step 3: The second balloon 32 is pressurized in 4-5 seconds, and the pressure is maintained for 15 seconds. At this time, the first balloon 11 remains unpressurized;
步骤四、第二球囊32在4-5s完成泄压，使血液流通1分钟，此时第一球囊11保持不加压状态。Step 4: The second balloon 32 is depressurized in 4-5 seconds, allowing blood to circulate for 1 minute. At this time, the first balloon 11 remains in a non-pressurized state.
循环往复以上治疗过程数次，直至治疗结束。通过以上的治疗过程，可以减缓静脉血向心脏的回流，减轻心前负荷。Repeat the above treatment process several times until the treatment is completed. Through the above treatment process, the return of venous blood to the heart can be slowed down and the precardiac load can be reduced.
在治疗过程中或者治疗前后，主管腔101可以通入诊疗器械进行相关检测和治疗，诊疗器械例如可以为漂浮导管、消融导管等。During the treatment process or before and after the treatment, the main cavity 101 can be connected to a diagnostic and treatment instrument for relevant detection and treatment. The diagnostic and treatment instrument may be, for example, a floating catheter, an ablation catheter, and the like.
可见，对于静脉封堵的治疗方案，可以通过两个球囊配合间断的充压与泄压对静脉进行封堵，从而减少静脉向心脏的回血，减轻心前负荷，主管腔101可以为其他诊疗器械提供通道。It can be seen that for the treatment of venous occlusion, the vein can be blocked by intermittent inflation and decompression of two balloons, thereby reducing the return of blood from the vein to the heart and alleviating the precardiac load. The main cavity 101 can provide a channel for other diagnostic and treatment instruments.
根据本公开另一些实施例的心衰治疗器械500的治疗实施案例如下：The treatment implementation cases of the heart failure treatment device 500 according to other embodiments of the present disclosure are as follows:
首先，通过穿刺套件在股动脉建立通道，并置入导丝；然后，将球囊鞘管100沿导丝(导丝穿入球囊鞘管100的主管腔101)自股动脉进入人体，将第一球囊11在造影下定位至主动脉弓下方，其位置位于胸主动脉，固定球囊鞘管100；然后，在球囊鞘管100的副管腔102中置入导丝，使导丝沿着股动脉进入左锁骨下动脉、颈总动脉、头臂干动脉之一(具体依临床评估)；然后，将球囊导管300沿导丝通过副管腔102到达指定位置，在此过程中，通过球囊导管300自带的造影剂输送孔304向血管中输送造影剂，以监测第二球囊32准确到达封堵位置。First, a channel is established in the femoral artery through the puncture kit and a guidewire is inserted; then, the balloon sheath 100 is introduced into the human body from the femoral artery along the guidewire (the guidewire penetrates into the main lumen 101 of the balloon sheath 100), and the first balloon 11 is positioned below the aortic arch under angiography, and its position is located in the thoracic aorta, and the balloon sheath 100 is fixed; then, a guidewire is inserted into the secondary lumen 102 of the balloon sheath 100, and the guidewire is passed along the femoral artery into one of the left subclavian artery, the common carotid artery, and the brachiocephalic artery (specific details depend on clinical evaluation); then, the balloon catheter 300 is passed through the secondary lumen 102 along the guidewire to the designated position. During this process, contrast agent is delivered into the blood vessel through the contrast agent delivery hole 304 provided in the balloon catheter 300 to monitor whether the second balloon 32 accurately reaches the occlusion position.
之后，将球囊鞘管100和球囊导管300分别连接压力泵，开始以下治疗流程：Afterwards, the balloon sheath tube 100 and the balloon catheter 300 are connected to the pressure pumps respectively, and the following treatment process begins:
当心脏舒张时，将第一球囊11和第二球囊32充盈封堵，当心脏收缩时，将第一球囊11和第二球囊32泄压，由此产生双重血液动力学效应：在心脏舒张时对两个球囊充压使血流向前，从而提高舒张压和冠脉的灌注；在心脏收缩时对两个球囊泄压以降低收缩压(心脏后负荷)，从而改善左室射血。通过压力泵可以在每一心动周期内对第一球囊11和第二球囊32充压泄压一次(按照1：1模式)，也可以在每两个心动周期内对第一球囊11和第二球囊32充压泄压一次(按照1：2模式)，还可以在每三个心动周期内对第一球囊11和第二球囊32充压泄压一次(按照1：3模式)。When the heart is in diastole, the first balloon 11 and the second balloon 32 are filled and blocked, and when the heart is in systole, the first balloon 11 and the second balloon 32 are depressurized, thereby producing a dual hemodynamic effect: when the heart is in diastole, the two balloons are inflated to make the blood flow forward, thereby increasing the diastolic pressure and coronary perfusion; when the heart is in systole, the two balloons are depressurized to reduce The pressure pump can inflate and release the first balloon 11 and the second balloon 32 once in each cardiac cycle (according to a 1:1 mode), inflate and release the first balloon 11 and the second balloon 32 once in every two cardiac cycles (according to a 1:2 mode), and inflate and release the first balloon 11 and the second balloon 32 once in every three cardiac cycles (according to a 1:3 mode).
在治疗过程中或者治疗前后，主管腔101可以通入诊疗器械进行相关检测和治疗，诊疗器械例如可以为冠脉球囊、冠脉支架等。During the treatment process or before and after the treatment, the main lumen 101 can be passed with diagnostic and therapeutic instruments for relevant detection and treatment. For example, the diagnostic and therapeutic instruments may be a coronary balloon, a coronary stent, etc.
可见，对于主动脉内反搏的治疗方案，可以通过两个球囊配合同时按照心脏节律进行充压与泄压，从而产生双重血流动力学效应，提升舒张压和冠脉灌注，降低心后负荷改善左心室射血；另外，主管腔101可以为其它诊疗器械提供通道。It can be seen that for the treatment of intra-aortic counterpulsation, the two balloons can be inflated and deflated simultaneously according to the heart rhythm, thereby producing a dual hemodynamic effect, increasing diastolic pressure and coronary perfusion, reducing cardiac afterload and improving left ventricular ejection; in addition, the main lumen 101 can provide a channel for other diagnostic and treatment equipment.
应当理解的是，在本说明书中，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”等指示的方位或位置关系或尺寸为基于附图所示的方位或位置关系或尺寸，使用这些术语仅是为了便于描述，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，并且因此不能理解为对本公开的保护范围的限制。It should be understood that in this specification, the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships or dimensions that are based on the orientations or positional relationships or dimensions shown in the accompanying drawings, and these terms are used only for the convenience of description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the scope of protection of the present disclosure.
此外，术语“第一”、“第二”、“第三”等仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者更多个该特征。在本公开的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。In addition, the terms "first", "second", "third", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first", "second", "third" may explicitly or implicitly include one or more of the feature. In the description of the present disclosure, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.
在本公开中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接，还可以是通信；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本公开中的具体含义。In the present disclosure, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or a communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present disclosure can be understood according to specific circumstances.
在本公开中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。In the present disclosure, unless otherwise expressly specified and limited, a first feature being “above” or “below” a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being “above”, “above”, and “above” a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being “below”, “below”, and “below” a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.
本说明书提供了能够用于实现本公开的许多不同的实施方式或例子。应当理解的是，这些不同的实施方式或例子完全是示例性的，并且不用于以任何方式限制本公开的保护范围。本领域技术人员在本公开的说明书的公开内容的基础上，能够想到各种变化或替换，这些都应涵盖在本公开的保护范围之内。因此，本公开的保护范围应以所附权利要求所限定的保护范围为准。This specification provides many different embodiments or examples that can be used to implement the present disclosure. It should be understood that these different embodiments or examples are purely exemplary and are not intended to limit the scope of protection of the present disclosure in any way. Those skilled in the art can conceive of various changes or replacements based on the disclosure of the present specification, which should all be included in the scope of protection of the present disclosure. Therefore, the scope of protection of the present disclosure should be based on the scope of protection defined by the attached claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310770326.1 | 2023-06-27 | ||
| CN202310770326.1ACN116688326A (en) | 2023-06-27 | 2023-06-27 | Saccule sheath tube and heart failure therapeutic apparatus |
| Publication Number | Publication Date |
|---|---|
| WO2025002122A1true WO2025002122A1 (en) | 2025-01-02 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2024/101354PendingWO2025002122A1 (en) | 2023-06-27 | 2024-06-25 | Balloon sheath and heart failure treatment instrument |
| Country | Link |
|---|---|
| CN (1) | CN116688326A (en) |
| WO (1) | WO2025002122A1 (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116688326A (en)* | 2023-06-27 | 2023-09-05 | 无锡帕母医疗技术有限公司 | Saccule sheath tube and heart failure therapeutic apparatus |
| CN116688327A (en)* | 2023-06-27 | 2023-09-05 | 无锡帕母医疗技术有限公司 | Catheter device and heart failure therapeutic apparatus |
| CN116747413A (en)* | 2023-06-27 | 2023-09-15 | 无锡帕母医疗技术有限公司 | Catheter device and heart failure therapeutic apparatus |
| CN119925787A (en)* | 2023-10-27 | 2025-05-06 | 深圳市纬康医疗科技有限公司 | A balloon sheath |
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| US20080183136A1 (en)* | 2007-01-29 | 2008-07-31 | Onset Medical Corporation | Expandable intra-aortic balloon pump sheath |
| CN107405198A (en)* | 2015-03-20 | 2017-11-28 | 耶拿阀门科技股份有限公司 | Heart valve prosthesis induction system and the method that heart valve prosthesis is conveyed with inducting device sheath |
| CN107735033A (en)* | 2015-05-05 | 2018-02-23 | W.L.戈尔及同仁股份有限公司 | The delivery cannula and method of shaping |
| CN113365689A (en)* | 2019-01-31 | 2021-09-07 | 马宝海德医疗有限责任公司 | Carotid stent implantation system and method |
| CN116688326A (en)* | 2023-06-27 | 2023-09-05 | 无锡帕母医疗技术有限公司 | Saccule sheath tube and heart failure therapeutic apparatus |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020016564A1 (en)* | 2000-05-31 | 2002-02-07 | Courtney Brian K. | Embolization protection sytem for vascular procedures |
| US20060074398A1 (en)* | 2004-09-30 | 2006-04-06 | Whiting James S | Transmembrane access systems and methods |
| US20080183136A1 (en)* | 2007-01-29 | 2008-07-31 | Onset Medical Corporation | Expandable intra-aortic balloon pump sheath |
| CN107405198A (en)* | 2015-03-20 | 2017-11-28 | 耶拿阀门科技股份有限公司 | Heart valve prosthesis induction system and the method that heart valve prosthesis is conveyed with inducting device sheath |
| CN107735033A (en)* | 2015-05-05 | 2018-02-23 | W.L.戈尔及同仁股份有限公司 | The delivery cannula and method of shaping |
| CN113365689A (en)* | 2019-01-31 | 2021-09-07 | 马宝海德医疗有限责任公司 | Carotid stent implantation system and method |
| CN116688326A (en)* | 2023-06-27 | 2023-09-05 | 无锡帕母医疗技术有限公司 | Saccule sheath tube and heart failure therapeutic apparatus |
| Publication number | Publication date |
|---|---|
| CN116688326A (en) | 2023-09-05 |
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