CN116407359A - Auxiliary apparatus for heart contraction - Google Patents

Abstract

The invention discloses a heart contraction auxiliary instrument. The device comprises a spring device and an elastic membrane arranged on the spring device, wherein the spring device comprises an annular upper elastic wire, an annular lower elastic wire and a plurality of rebound spring wires which are arranged between the upper elastic wire and the lower elastic wire and are uniformly distributed along the circumferential directions of the upper elastic wire and the lower elastic wire, the rebound spring wires are respectively connected to the upper elastic wire through top rings arranged at the end parts of the rebound spring wires, and are respectively connected to the lower elastic wire through bottom rings arranged at the other end parts of the rebound spring wires; a plurality of elastic films are symmetrically arranged on the plurality of rebound spring wires. In the device, the spring device and the elastic membrane are arranged on the outer wall of a heart in a systolic phase in a pre-expansion state, the spring device and the elastic membrane are pressed to expand outwards to store elastic energy in a diastole state, and the spring device and the elastic membrane are stressed to be smaller and rebound towards an original pre-expansion state in a systole state, so that the device has the effects of assisting the systole and increasing cardiac output.

Description

Translated fromChinese

一种心脏收缩辅助器械A systolic assist device

技术领域technical field

本发明涉及医疗器械技术领域，具体涉及一种适用于心衰治疗、增强心脏收缩功能、无源的心脏收缩辅助器械。The invention relates to the technical field of medical devices, in particular to a passive cardiac systole auxiliary device suitable for treating heart failure and enhancing cardiac systolic function.

背景技术Background technique

心力衰竭主要表现为心室收缩功能衰竭、射血分数降低、患者血液循环难以维持、下游器官供血不足，严重危害患者生命健康。心室辅助装置是以机械方式辅助心衰患者自体心脏做功的装置。目前安装心室辅助装置已经成为心衰治疗的有效方法，心室辅助装置的临床应用成功救治了许多心衰患者的生命。Heart failure is mainly manifested as ventricular systolic failure, decreased ejection fraction, difficulty in maintaining blood circulation, and insufficient blood supply to downstream organs, which seriously endanger the life and health of patients. A ventricular assist device is a device that mechanically assists the work of the native heart in patients with heart failure. At present, the installation of ventricular assist devices has become an effective method for the treatment of heart failure, and the clinical application of ventricular assist devices has successfully saved the lives of many heart failure patients.

目前临床应用的心室辅助装置，绝大多数是旋转叶片式、与血液直接接触型心室辅助装置，辅助原理为通过高速旋转叶轮将左或右心室内的血液抽出输送到主动脉以提高心输出量和提升血压，起到对患者心脏卸负荷的作用。该型心室辅助装置由于装置中的部件长期与血液接触、机械力对红细胞破坏性较强，容易出现泵内血栓、溶血、器官栓塞和胃肠道出血等不良事件，而且患者术后需要长期服药。同时该类型心室辅助装置外部电源供电提供能量来驱动旋转叶轮，也需要数据线进行数据监测和传输，因此穿过患者胸腔的导线也容易引起感染的发生。所以目前的有源、血液接触类心脏辅助装置的以上问题，严重限制了其临床应用。At present, most of the ventricular assist devices in clinical use are rotating vane type and direct contact with blood. The auxiliary principle is to pump the blood from the left or right ventricle to the aorta through the high-speed rotating impeller to increase the cardiac output. And increase blood pressure, play a role in unloading the patient's heart. This type of ventricular assist device is prone to adverse events such as thrombosis, hemolysis, organ embolism and gastrointestinal bleeding in the pump due to the long-term contact between the components in the device and the blood, and the mechanical force is relatively destructive to red blood cells, and patients need to take medicine for a long time after surgery . At the same time, the external power supply of this type of ventricular assist device provides energy to drive the rotating impeller, and also requires data lines for data monitoring and transmission, so the wires passing through the patient's chest are also prone to infection. Therefore, the above problems of the current active, blood-contact cardiac assist devices severely limit their clinical application.

因此，发明一种适用于治疗心衰患者的非血液接触式、无源的心脏辅助装置来解决血液接触类、有源心室辅助装置的血液破坏等相关问题具有重要意义。Therefore, it is of great significance to invent a non-blood-contacting, passive cardiac assist device suitable for treating heart failure patients to solve related problems such as blood contacting and active ventricular assist devices.

发明内容Contents of the invention

基于传统心室辅助装置所存在的与血液接触容易造成血液破坏、导线感染及系统复杂易降低装置可靠性、患者植入心室辅助装置后需要长期服药的等问题，本发明的目的在于提供一种适用于心衰治疗、增强心脏收缩功能、无源的心脏收缩辅助器械。Based on the problems of traditional ventricular assist devices that contact with blood easily causes blood damage, lead infection and system complexity can easily reduce the reliability of the device, and patients need to take medicine for a long time after implanting a ventricular assist device, the purpose of the present invention is to provide a suitable For heart failure treatment, enhancement of cardiac systolic function, passive cardiac systolic assisting device.

为实现上述目的，本发明采用以下技术方案：To achieve the above object, the present invention adopts the following technical solutions:

一种心脏收缩辅助器械，该器械用于安装在心脏外壁辅助心脏收缩，包括簧式装置和设置在该簧式装置上的弹性膜，所述簧式装置包括环状的上弹性丝、环状的下弹性丝、以及设置在上弹性丝和下弹性丝之间并沿着上弹性丝和下弹性丝的周向均匀分布的多根回弹簧丝，多根回弹簧丝分别通过设置在其端部的顶环连接到上弹性丝上，并分别通过设置在其另一端部的底环连接到下弹性丝；在多根回弹簧丝上对称地设有多个弹性膜。A cardiac systole assisting device, which is used to be installed on the outer wall of the heart to assist cardiac contraction, includes a spring device and an elastic membrane arranged on the spring device, and the spring device includes a ring-shaped upper elastic wire, a ring-shaped The lower elastic wire, and a plurality of return spring wires arranged between the upper elastic wire and the lower elastic wire and distributed evenly along the circumferential direction of the upper elastic wire and the lower elastic wire, the plurality of return spring wires respectively pass through the The top ring at the top is connected to the upper elastic wire, and is respectively connected to the lower elastic wire through the bottom ring at the other end; a plurality of elastic membranes are symmetrically arranged on a plurality of return spring wires.

在本发明的心脏收缩辅助器械安装于心脏外壁的状态下，且在心脏收缩至最小体积时，簧式装置及弹性膜处于预膨胀状态；在心脏舒张期，簧式装置及弹性膜受压向外膨胀并储存弹性能；在心脏收缩期，簧式装置及弹性膜释放弹性能回弹，在整个心脏舒张期和心脏收缩期均紧密贴合于心脏外壁。In the state that the cardiac systole assisting device of the present invention is installed on the outer wall of the heart, and when the heart contracts to the minimum volume, the spring device and the elastic membrane are in a pre-expanded state; during the diastole, the spring device and the elastic membrane are pressed toward External expansion and storage of elastic energy; during systole, the spring device and elastic membrane release elastic energy and rebound, and are closely attached to the outer wall of the heart throughout diastole and systole.

所谓的预膨胀状态指的是，簧式装置及弹性膜处于自然状态时的尺寸小于心脏收缩至最小体积时的尺寸，在心脏收缩至最小体积时，簧式装置及弹性膜处于受压向外膨胀的状态。The so-called pre-expansion state means that the size of the spring device and the elastic membrane in the natural state is smaller than the size when the heart contracts to the minimum volume. When the heart contracts to the minimum volume, the spring device and the elastic membrane are pressed outward Inflated state.

优选地，所述弹性膜以包裹相邻的两根回弹簧丝的方式设置在簧式装置上。Preferably, the elastic film is arranged on the spring device in a manner of wrapping two adjacent return spring wires.

优选地，所述多根回弹簧丝与所述顶环、底环一体成形，相邻的两根回弹簧丝共用一个顶环或一个底环。Preferably, the multiple return spring wires are integrally formed with the top ring and the bottom ring, and two adjacent return spring wires share a top ring or a bottom ring.

优选地，所述上弹性丝以穿设在各顶环中的方式与多根回弹簧丝连接；所述下弹性簧丝以穿设在各底环中的方式与多根回弹簧丝连接。Preferably, the upper elastic wire is connected to a plurality of return spring wires in a manner of passing through each top ring; the lower elastic wire is connected to a plurality of return spring wires in a manner of passing through each bottom ring.

优选地，所述上弹性丝、下弹性丝及多根回弹簧丝的直径分别为0.5mm-2mm。Preferably, the diameters of the upper elastic wire, the lower elastic wire and the plurality of return spring wires are respectively 0.5mm-2mm.

优选地，所述多根回弹簧丝的数量为10-40根。Preferably, the number of the plurality of return spring wires is 10-40.

优选地，所述多根回弹簧丝的数量为弹性膜数量的2倍。Preferably, the number of the plurality of return spring wires is twice the number of the elastic film.

本发明的有益效果：Beneficial effects of the present invention:

本发明的心脏收缩辅助器械可被压缩至较小尺寸并通过胸壁的小切口植入胸腔内，可减少手术时的创口，降低对患者的损伤，利于缩短患者恢复期。The cardiac systole assisting device of the present invention can be compressed to a smaller size and implanted into the chest cavity through a small incision in the chest wall, which can reduce wounds during surgery, reduce damage to patients, and help shorten the recovery period of patients.

本发明采用一种具有储能特性的、可安装于心脏外壁的、受压膨胀后自回弹的簧式装置和弹性膜来辅助心室收缩。本发明的心脏收缩辅助器械在安装于心脏外壁的状态下，且在心脏收缩至最小体积时，簧式装置及弹性膜处于预膨胀状态；在心脏舒张期，簧式装置及弹性膜受压向外膨胀并储存弹性能；在心脏收缩期，簧式装置及弹性膜释放弹性能回弹，在整个心脏舒张期和心脏收缩期均紧密贴合于心脏外壁。既可以实现装置与心脏的良好贴合，又能够辅助心脏收缩、增加心输出量。The invention adopts a self-rebounding spring-type device and an elastic membrane which has the characteristic of energy storage, can be installed on the outer wall of the heart, and expands under pressure to assist the contraction of the ventricle. When the cardiac systole assisting device of the present invention is installed on the outer wall of the heart, and when the heart contracts to a minimum volume, the spring device and the elastic membrane are in a pre-expanded state; during the diastole, the spring device and the elastic membrane are pressed toward External expansion and storage of elastic energy; during systole, the spring device and elastic membrane release elastic energy and rebound, and are closely attached to the outer wall of the heart throughout diastole and systole. It can not only achieve a good fit between the device and the heart, but also assist the heart to contract and increase the cardiac output.

本发明的心脏收缩辅助器械利用自身的膨胀后回弹的性能辅助心脏收缩，包裹于弹性簧丝外的弹性膜可增强对心脏的做功面积并降低对心脏外表面的损伤；回弹簧丝和弹性膜释放自身的回弹力辅助心脏收缩，与血液无接触，不会产生破坏血液；整个装置无源，无须外部动力源，避免了感染的发生且可靠性高；上、下弹性丝可实现装置在心脏外壁的安装、固定且避免装置脱落。The cardiac systole assisting device of the present invention utilizes its self-expanded rebound performance to assist cardiac contraction, and the elastic membrane wrapped outside the elastic spring wire can enhance the work area of the heart and reduce damage to the outer surface of the heart; the spring wire and the elasticity The membrane releases its own resilience to assist the heart to contract, without contact with the blood, and will not cause damage to the blood; the whole device is passive and does not require an external power source, which avoids the occurrence of infection and has high reliability; the upper and lower elastic wires can realize the device in the The installation and fixation of the outer wall of the heart and prevent the device from falling off.

附图说明Description of drawings

图1为本发明的心脏收缩辅助器械中簧式装置的结构示意图。Fig. 1 is a schematic structural view of the spring device in the cardiac systole assisting device of the present invention.

图2为本发明的心脏收缩辅助器械中弹性膜的结构示意图。Fig. 2 is a schematic structural view of the elastic membrane in the cardiac systole assisting device of the present invention.

图3为簧式装置的上、下弹性丝的结构示意图。Fig. 3 is a structural schematic diagram of the upper and lower elastic wires of the spring device.

图4为单个弹性膜包裹相邻两根回弹簧丝的结构示意图。Fig. 4 is a structural schematic diagram of a single elastic membrane wrapping two adjacent return spring wires.

图5为心脏收缩期心脏收缩辅助器械安装于心脏外壁时的结构示意图。Fig. 5 is a schematic diagram of the structure of the systolic assisting device installed on the outer wall of the heart during systole.

图6为心脏舒张期心脏收缩辅助器械安装于心脏外壁时的结构示意图。Fig. 6 is a schematic diagram of the structure of the systolic assisting device installed on the outer wall of the heart during diastole.

具体实施方式Detailed ways

以下结合附图对本发明的具体实施方式作进一步详细说明。The specific implementation manners of the present invention will be described in further detail below in conjunction with the accompanying drawings.

本发明的心脏收缩辅助器械用于安装在心脏外壁辅助心脏收缩，如图1～3所示，该器械包括簧式装置1和设置在该簧式装置上的弹性膜2，簧式装置1包括环状的上弹性丝3、环状的下弹性丝4、以及设置在上弹性丝3和下弹性丝4之间并沿着上弹性丝3和下弹性丝4的周向均匀分布的多根回弹簧丝11，多根回弹簧丝11分别通过设置在其端部的顶环12连接到上弹性丝3上，并分别通过设置在其另一端部的底环13连接到下弹性丝4；在多根回弹簧丝11上对称地设有多个弹性膜2。The cardiac systole assisting device of the present invention is used to be installed on the outer wall of the heart to assist cardiac contraction. As shown in FIGS. An annular upperelastic wire 3, an annular lowerelastic wire 4, and a plurality of elastic wires arranged between the upperelastic wire 3 and the lowerelastic wire 4 and evenly distributed along the circumferential direction of the upperelastic wire 3 and the lowerelastic wire 4Back spring wires 11, a plurality ofback spring wires 11 are respectively connected to the upperelastic wire 3 through thetop ring 12 arranged at its end, and connected to the lowerelastic wire 4 through thebottom ring 13 arranged at its other end respectively; A plurality ofelastic membranes 2 are arranged symmetrically on a plurality ofreturn spring wires 11 .

如图1所示，多根回弹簧丝11与顶环12、底环13可以采用一体成形的方式形成，相邻的两根回弹簧丝共用一个顶环或一个底环。As shown in FIG. 1 , a plurality ofreturn spring wires 11 , thetop ring 12 and thebottom ring 13 can be integrally formed, and two adjacent return spring wires share a top ring or a bottom ring.

如图3所示，上弹性丝3和下弹性丝4均为环状结构。上弹性丝3以穿过图1中所示的多根回弹簧丝11的顶环12的方式与多根回弹簧丝11连接；下弹性簧丝4以穿过图1中所示的多根回弹簧丝11的底环13的方式与多根回弹簧丝11连接。如图4所示，弹性膜2以包裹相邻的两根回弹簧丝的方式设置在簧式装置1上。多根回弹簧丝11的线径为0.5mm-2mm之间，数量为10-40根，弹性膜2数量为回弹簧丝11数量的一半，多个弹性膜均匀、对称地设置在簧式装置1上。As shown in FIG. 3 , both the upperelastic thread 3 and the lowerelastic thread 4 are ring-shaped. The upperelastic wire 3 is connected with a plurality ofreturn spring wires 11 in a manner of passing through thetop ring 12 of a plurality ofreturn spring wires 11 shown in FIG. 1 ; Thebottom ring 13 of thereturn spring wire 11 is connected with a plurality ofreturn spring wires 11 . As shown in FIG. 4 , theelastic membrane 2 is arranged on thespring device 1 in a manner of wrapping two adjacent return spring wires. The wire diameter of multiplereturn spring wires 11 is between 0.5mm-2mm, the number is 10-40, the number ofelastic membranes 2 is half of the number ofreturn spring wires 11, and the plurality of elastic membranes are evenly and symmetrically arranged on thespring device 1 on.

在本发明的心脏收缩辅助器械中，簧式装置中回弹簧丝、顶环、底环的材料包括但不限于血液相容性好的镍钛合金等记忆金属，上弹性丝、下弹性丝及弹性膜的材料包括但不限于血液相容性、弹性好的硅胶等。该器械可以被压缩至较小尺寸并通过胸壁上的小切口植入胸腔内，具体植入过程为：将器械压缩后通过胸壁上的小切口植入胸腔内，器械恢复到自然状态，将器械撑开从心尖位置向上推动套装在心脏外表面。为了操作方便，植入时上弹性丝为断开状态，穿过部分顶环，待器械整体套装在心脏外表面之后，再将上弹性丝封闭成环形。此时，如图3、4所示，簧式装置1上均匀布置的回弹簧丝11和弹性膜2贴合于心脏5的外表面，通过分别穿过顶环12和底环13的上弹性丝3和下弹性丝4将整个器械套在心脏外表面防止脱落。在心室舒张时(如图6所示)，回弹簧丝11和弹性膜2受到心脏向外膨胀的挤压力而向外膨胀，上弹性丝3和下弹性丝4也随之被拉长，回弹簧丝11和弹性膜2储存弹性能，当心脏收缩时(如图5所示)，回弹簧丝11和弹性膜2向内回弹释放弹性能辅助心脏收缩，上弹性丝3和下弹性丝4也随之收缩，以防止器械从心脏外表面脱落。由于自然状态下的器械的尺寸小于心脏体积最小时的心脏尺寸，因此，器械在整个心脏舒张期和心脏收缩期均紧密贴合于心脏5的外壁。In the cardiac systole assisting device of the present invention, the materials of the return spring wire, the top ring, and the bottom ring in the spring device include but are not limited to memory metals such as nickel-titanium alloys with good blood compatibility, upper elastic wires, lower elastic wires and The material of the elastic membrane includes, but is not limited to, blood-compatible, elastic silicone, and the like. The device can be compressed to a smaller size and implanted into the chest cavity through a small incision on the chest wall. The specific implantation process is as follows: after the device is compressed, it is implanted into the chest cavity through a small incision on the chest wall. The distraction pushes the sleeve upwards from the apex over the outer surface of the heart. For the convenience of operation, the upper elastic wire is in a disconnected state during implantation, and passes through part of the top ring. After the device is fitted on the outer surface of the heart as a whole, the upper elastic wire is closed into a ring shape. At this time, as shown in Figures 3 and 4, thereturn spring wires 11 and theelastic film 2 evenly arranged on thespring device 1 are attached to the outer surface of theheart 5, and the upper elastic rings passing through thetop ring 12 and thebottom ring 13 respectivelySilk 3 and lowerelastic wire 4 cover the whole instrument on the outer surface of the heart to prevent falling off. When the ventricle is diastolic (as shown in Figure 6), thereturn spring wire 11 and theelastic membrane 2 are expanded outward by the extrusion force of the heart's outward expansion, and the upperelastic wire 3 and the lowerelastic wire 4 are also elongated thereupon. Thereturn spring wire 11 and theelastic membrane 2 store elastic energy. When the heart contracts (as shown in Figure 5), thereturn spring wire 11 and theelastic membrane 2 rebound inwardly to release the elastic energy to assist the heart to contract. The upperelastic wire 3 and the lower elastic Thewire 4 also shrinks thereupon to prevent the device from coming off from the outer surface of the heart. Since the size of the device in the natural state is smaller than the size of the heart when the volume of the heart is the smallest, the device is closely attached to the outer wall of theheart 5 during the whole diastolic period and the systolic period.

本发明的心脏收缩辅助器械采用受压膨胀后具有储能回弹性能的簧式装置和弹性膜制成，通过簧式装置的上弹性丝和下弹性丝安装于心脏外壁，患者自体心脏舒张时器械受心脏外壁扩张力的挤压向外膨胀存储弹性能，心脏收缩时储存了一定弹性能的回弹簧丝和弹性膜向内回弹趋向于预膨胀状态，辅助心脏收缩增强心功能。The cardiac systole assisting device of the present invention is made of a spring device and an elastic film with energy storage and rebound performance after being compressed and expanded. The upper elastic wire and the lower elastic wire of the spring device are installed on the outer wall of the heart. When the patient's own heart relaxes The device is extruded by the expansion force of the outer wall of the heart and expands outward to store elastic energy. When the heart contracts, the spring wire and elastic membrane that store a certain amount of elastic energy rebound inward and tend to be in a pre-expanded state, assisting the heart to contract and enhance heart function.

本发明的心脏收缩辅助器械利用自身的膨胀后回弹的性能辅助心脏收缩，包裹于弹性簧丝外的弹性膜可增强对心脏的做功面积并降低对心脏外表面的损伤；回弹簧丝和弹性膜释放自身的回弹力辅助心脏收缩，与血液无接触，不会产生破坏血液；整个装置无源，无须外部动力源，避免了感染的发生且可靠性高；上、下弹性丝可实现装置在心脏外壁的安装、固定且避免装置脱落。The cardiac systole assisting device of the present invention utilizes its self-expanded rebound performance to assist cardiac contraction, and the elastic membrane wrapped outside the elastic spring wire can enhance the work area of the heart and reduce damage to the outer surface of the heart; the spring wire and the elasticity The membrane releases its own resilience to assist the heart to contract, without contact with the blood, and will not cause damage to the blood; the whole device is passive and does not require an external power source, which avoids the occurrence of infection and has high reliability; the upper and lower elastic wires can realize the device in the The installation and fixation of the outer wall of the heart and prevent the device from falling off.

最后应当说明的是，以上所示均为本发明的较佳实施方式，并不用于限制本发明，凡在本发明的精神和原则之内所做的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。Finally, it should be noted that the above are all preferred implementation modes of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention shall be Included within the protection scope of the present invention.

Claims (8)

1. A heart contraction auxiliary device, characterized in that the device is used for being installed on the outer wall of a heart to assist heart contraction and comprises a spring device and an elastic membrane arranged on the spring device, wherein the spring device comprises an annular upper elastic wire, an annular lower elastic wire and a plurality of rebound spring wires which are arranged between the upper elastic wire and the lower elastic wire and are uniformly distributed along the circumferential directions of the upper elastic wire and the lower elastic wire, the rebound spring wires are respectively connected to the upper elastic wire through top rings arranged at the end parts of the rebound spring wires, and are respectively connected to the lower elastic wire through bottom rings arranged at the other end parts of the rebound spring wires; a plurality of elastic films are symmetrically arranged on the plurality of rebound spring wires.

2. The heart contraction auxiliary apparatus according to claim 1, wherein the spring means and the elastic membrane are in a pre-expanded state in a state in which the apparatus is mounted to an outer wall of the heart and when the heart contracts to a minimum volume; during diastole, the spring device and elastic membrane are compressed to expand outwards and store elastic energy; in systole, the spring device and the elastic membrane release elastic energy to rebound, and the spring device and the elastic membrane are closely attached to the outer wall of the heart in the whole diastole and systole.

3. A systole auxiliary device as claimed in claim 1 or claim 2 wherein the elastic membrane is provided on the spring means in such a way as to wrap around two adjacent rebound spring wires.

4. A systole auxiliary device as claimed in claim 1 or claim 2 wherein the plurality of rebound spring wires are integrally formed with the top and bottom rings, and two adjacent rebound spring wires share one top or one bottom ring.

5. The heart contraction auxiliary apparatus according to claim 1 or 2, wherein the upper elastic wire is connected to a plurality of rebound spring wires so as to be penetrated in each top ring; the lower elastic spring wire is connected with the plurality of rebound spring wires in a penetrating manner in each bottom ring.

6. A systole auxiliary device as claimed in claim 1 or claim 2 wherein the upper elastic wire, lower elastic wire and plurality of return spring wires are each 0.5mm to 2mm in diameter.

7. The heart contraction assist apparatus according to claim 1 or 2, wherein the number of the plurality of rebound spring wires is 10 to 40.

8. The heart contractility assisting device of claim 7, wherein the number of said plurality of rebound spring wires is 2 times the number of elastic membranes.

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