CN104740776B - Self energizing Ventricular resynchronization cardioverter defibrillators - Google Patents
Self energizing Ventricular resynchronization cardioverter defibrillators Download PDFInfo
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Abstract
本发明提供一种自供能心室再同步复律除颤器,具有心律监测部、脉冲发生器、刺激电极以及发电部。发电部包括发电主体、输出单元、电能存储单元、固定单元以及封装层。其中,发电主体为多层薄膜结构,包括位于发电主体中心的压电材料层,以及位于压电材料层两侧的电极层,发电主体通过贴附于心脏表面以采集心脏能量用于产生电能。输出单元与电极层相连接,用于将电流输出给电能存储单元。电能存储单元为脉冲发生器和刺激电极供电。固定单元位于发电主体的边缘,用于将发电主体固定于心外膜。封装层覆盖于发电主体、输出单元、电能存储单元以及固定单元的表面。本发明的自供能心室再同步复律除颤器植入后可终身使用而无需更换电池。
The invention provides a self-powered ventricular resynchronization defibrillator, which has a heart rhythm monitoring part, a pulse generator, a stimulating electrode and a power generation part. The power generation part includes a power generation main body, an output unit, an electric energy storage unit, a fixing unit and an encapsulation layer. Among them, the power generating body is a multi-layer film structure, including a piezoelectric material layer located in the center of the power generating body, and electrode layers located on both sides of the piezoelectric material layer. The power generating body is attached to the surface of the heart to collect heart energy for generating electrical energy. The output unit is connected with the electrode layer and is used for outputting current to the electric energy storage unit. The electrical energy storage unit powers the pulse generator and stimulating electrodes. The fixing unit is located on the edge of the generating body and is used for fixing the generating body on the epicardium. The encapsulation layer covers the surfaces of the generating body, the output unit, the electric energy storage unit and the fixing unit. After implantation, the self-powered ventricular resynchronization defibrillator of the present invention can be used for a lifetime without changing batteries.
Description
技术领域technical field
本发明涉及一种心室再同步复律除颤器,属于医疗器械领域。The invention relates to a ventricular resynchronization cardioverter defibrillator, which belongs to the field of medical equipment.
背景技术Background technique
随着人类对各种疾病的认识不断深入,越来越多的疾病已经可以采用植入式电子装置进行诊断或治疗。With the deepening of human understanding of various diseases, more and more diseases can be diagnosed or treated with implanted electronic devices.
对于存在心室收缩不同步的重度心衰患者,可以通过植入心室再同步复律除颤器进行治疗,以改善患者的心功能,减轻患者的心衰症状。然而现有的植入体内的心室再同步复律除颤器使用电池作为电源,其使用寿命为3-6年。一旦电池能量耗竭,就需要通过手术的方式更换电池。这既会给患者造成生理和心理上的痛苦,还会增加患者及其家庭的经济负担。For patients with severe heart failure with ventricular systolic asynchrony, implantation of a ventricular resynchronization defibrillator can be used for treatment to improve the patient's heart function and relieve the patient's symptoms of heart failure. However, the existing ventricular resynchronization defibrillator implanted in the body uses a battery as a power source, and its service life is 3-6 years. Once the battery is depleted, it needs to be replaced surgically. This will not only cause physical and psychological pain to patients, but also increase the financial burden on patients and their families.
发明内容Contents of the invention
为解决上述问题,本发明提供一种自供能心室再同步复律除颤器,其特征在于,具有心律监测部、脉冲发生器、刺激电极以及发电部。发电部包括发电主体、输出单元、电能存储单元、固定单元以及封装层。其中,发电主体为多层薄膜结构,包括位于发电主体中心的压电材料层,以及位于压电材料层两侧的电极层,发电主体通过贴附于心脏表面以采集心脏能量用于产生电能。输出单元与电极层相连接,用于将发电主体产生的电流输出给电能存储单元。电能存储单元用于存储电能并为脉冲发生器和刺激电极供电。固定单元位于发电主体的边缘,用于将发电主体固定于心外膜。封装层覆盖于发电主体、输出单元、电能存储单元以及固定单元的表面。In order to solve the above problems, the present invention provides a self-powered ventricular resynchronization defibrillator, which is characterized in that it has a heart rhythm monitoring unit, a pulse generator, stimulating electrodes and a power generation unit. The power generation unit includes a power generation body, an output unit, an electric energy storage unit, a fixing unit and an encapsulation layer. Among them, the power generating body is a multi-layer film structure, including a piezoelectric material layer located in the center of the power generating body, and electrode layers located on both sides of the piezoelectric material layer. The power generating body is attached to the surface of the heart to collect heart energy for generating electrical energy. The output unit is connected with the electrode layer, and is used for outputting the current generated by the power generating body to the electric energy storage unit. The electrical energy storage unit is used to store electrical energy and power the pulse generator and stimulating electrodes. The fixing unit is located on the edge of the generating body and is used for fixing the generating body on the epicardium. The encapsulation layer covers the surfaces of the generating body, the output unit, the electric energy storage unit and the fixing unit.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,发电主体的形状为四边形,固定单元位于四边形的两条窄边的中间。In addition, the self-powered ventricular resynchronization defibrillator of the present invention may also have such a feature: wherein, the shape of the generating body is a quadrangle, and the fixing unit is located in the middle of the two narrow sides of the quadrangle.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,发电主体的形状为三角形,固定单元位于三角形的三个顶点。In addition, the self-powered ventricular resynchronization defibrillator of the present invention may also have such a feature: wherein, the shape of the generating body is a triangle, and the fixing unit is located at the three vertices of the triangle.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,发电主体的形状为长圆形。In addition, in the self-powered ventricular resynchronization defibrillator of the present invention, it may also have such a feature: wherein, the shape of the generating body is oval.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,压电材料层含有纳米级压电材料,纳米级压电材料为压电晶体、压电陶瓷和有机压电聚合物中的任意一种。In addition, in the self-powered ventricular resynchronization defibrillator of the present invention, it can also have such a feature: wherein, the piezoelectric material layer contains nanoscale piezoelectric materials, and the nanoscale piezoelectric materials are piezoelectric crystals, piezoelectric Any of ceramics and organic piezoelectric polymers.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,压电晶体为至少一层氧化锌纳米线阵列。In addition, the self-powered ventricular resynchronization defibrillator of the present invention may also have such a feature: wherein, the piezoelectric crystal is at least one layer of zinc oxide nanowire array.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,压电晶体、压电陶瓷、有机压电聚合物可以为纳米级压电材料的单层或多层结构。In addition, in the self-powered ventricular resynchronization defibrillator of the present invention, it can also have such a feature: wherein, piezoelectric crystals, piezoelectric ceramics, and organic piezoelectric polymers can be monolayers of nanoscale piezoelectric materials or multi-layer structure.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,输出单元具有输出电极和整流滤波电路。In addition, in the self-powered ventricular resynchronization defibrillator of the present invention, it may also have such a feature: wherein, the output unit has an output electrode and a rectification filter circuit.
另外,在本发明的自供能心室再同步复律除颤器中,还可以具有这样的特征:其中,封装层以生物相容性好的柔性高分子绝缘材料作为封装材料。In addition, the self-powered ventricular resynchronization defibrillator of the present invention may also have such a feature: wherein, the encapsulation layer uses a flexible polymer insulation material with good biocompatibility as the encapsulation material.
发明的作用与效果Function and Effect of Invention
根据本发明的自供能心室再同步复律除颤器,由于发电主体直接贴附于心脏表面,因此能够有效的将心脏的收缩与舒张使纳米级压电材料发生形变,从而转化为电能。因此只要心脏跳动,本发明即可利用患者自身的生物能而提供电能,免去了使用电池作为电源的必要,解决了电池能量耗竭后需要手术更换电池的问题。According to the self-powered ventricular resynchronization defibrillator of the present invention, since the power generating body is directly attached to the surface of the heart, it can effectively transform the nano-scale piezoelectric material into electrical energy due to the contraction and relaxation of the heart. Therefore, as long as the heart is beating, the present invention can utilize the patient's own bioenergy to provide electrical energy, avoiding the necessity of using a battery as a power source, and solving the problem of needing surgery to replace the battery after the energy of the battery is exhausted.
另外,由于本发明的发电主体采用点固定的方式将发电系统固定于心外膜,一方面能够有效的采集心脏运动产生的能量,另一方面也不会对心脏的收缩和舒张运动产生明显的影响。In addition, since the power generation main body of the present invention fixes the power generation system on the epicardium in a point-fixed way, on the one hand, it can effectively collect the energy generated by the heart movement, and on the other hand, it will not produce obvious effects on the systolic and diastolic movements of the heart. influences.
由于本发明采用纳米级压电材料作为发电主体,不仅可以有效地将体内的生物能转化为电能,而且体积微小,更适合体内植入。Since the present invention uses nanoscale piezoelectric materials as the main body of power generation, it can not only effectively convert bioenergy in the body into electric energy, but also has a small volume and is more suitable for implantation in the body.
此外,由于本发明采用生物相容性好的柔性高分子绝缘材料封装,因此既能将发电主体与体内环境隔离,还可将心脏形变产生的压力有效的传导至压电材料。In addition, since the present invention is packaged with a flexible polymer insulating material with good biocompatibility, it can not only isolate the power generation body from the internal environment, but also effectively transmit the pressure generated by the heart deformation to the piezoelectric material.
并且,由于本发明的发电主体位于心脏外部,不与血液直接接触,因而不存在血栓形成以及中风(心肌梗塞或脑梗塞)的风险。Moreover, since the power generating body of the present invention is located outside the heart and does not come into direct contact with blood, there is no risk of thrombus formation and stroke (myocardial infarction or cerebral infarction).
附图说明Description of drawings
图1是本发明实施例一的自供能心室再同步复律除颤器的发电主体为四边形的示意图;Fig. 1 is a schematic diagram of a quadrilateral power generating body of a self-powered ventricular resynchronization defibrillator according to Embodiment 1 of the present invention;
图2是本发明实施例一的自供能心室再同步复律除颤器的发电主体的局部截面图;Fig. 2 is a partial cross-sectional view of the power generating body of the self-powered ventricular resynchronization defibrillator according to Embodiment 1 of the present invention;
图3是本发明实施例二的自供能心室再同步复律除颤器的发电主体为三角形的示意图;3 is a schematic diagram of a triangular power generating body of a self-powered ventricular resynchronization defibrillator according to Embodiment 2 of the present invention;
图4是本发明变形例的发电主体为长圆形的示意图;以及Fig. 4 is a schematic diagram of a modified example of the present invention in which the power generating body is an oval; and
图5是本发明实施例的电路图。Fig. 5 is a circuit diagram of an embodiment of the present invention.
具体实施方式detailed description
以下结合附图来说明本发明自供能心室再同步复律除颤器的具体实施方式,The specific embodiment of the self-powered ventricular resynchronization cardioverter defibrillator of the present invention will be described below in conjunction with the accompanying drawings,
<实施例一><Example 1>
图1是实施例1中自供能心室再同步复律除颤器的发电主体为四边形的示意图,如图1所示,自供能心室再同步复律除颤器20具有发电部200、心律监测部(图中未显示)、脉冲发生器17和刺激电极18。其中,发电部200包括发电主体21,输出单元、电能存储单元16、固定单元22以及封装层。发电主体21为矩形,在矩形的两条窄边上各具有一个固定单元22,用于将发电主体11以长轴方向沿着心脏收缩的方向固定于心外膜上。植入发电主体时,通过外科手术的方式显露出心脏,将发电主体沿着心脏收缩的方向设置并将固定部缝合在心外膜上,使得发电主体与心外膜相贴合,此时发电主体会随着心脏的跳动产生形变。Fig. 1 is a schematic diagram in which the power generating body of the self-powered ventricular resynchronization defibrillator in Embodiment 1 is a quadrilateral. (not shown in the figure), a pulse generator 17 and a stimulating electrode 18. Wherein, the power generating unit 200 includes a power generating body 21 , an output unit, an electric energy storage unit 16 , a fixing unit 22 and an encapsulation layer. The generating body 21 is rectangular, and has a fixing unit 22 on each of the two narrow sides of the rectangle, which is used to fix the generating body 11 on the epicardium in the long axis direction along the systolic direction. When the power generating body is implanted, the heart is exposed through surgery, the power generating body is set along the direction of heart contraction and the fixing part is sutured on the epicardium, so that the power generating body and the epicardium fit together. At this time, the power generating body It deforms with the beating of the heart.
固定单元22由封装层构成,并且固定单元22的内部没有电极或压电材料等发电结构,因此在使用缝线固定时不会破坏发电主体21的发电结构。发电主体21除了以固定单元22固定之外其余部分并不固定,以利于在心脏收缩的过程中使得发电主体21能够更好的发生形变。由于发电主体采用了矩形,并且安装方向与心脏收缩的方向一致,因此可以很好的采集心脏收缩产生的机械能。The fixing unit 22 is composed of an encapsulation layer, and there is no power generation structure such as electrodes or piezoelectric materials inside the fixing unit 22 , so the power generation structure of the power generation body 21 will not be damaged when it is fixed with sutures. Except for being fixed by the fixing unit 22 , the rest of the power generating body 21 is not fixed, so that the power generating body 21 can be better deformed during the systole. Since the generator body adopts a rectangular shape, and the installation direction is consistent with the direction of heart contraction, the mechanical energy generated by heart contraction can be well collected.
输出单元具有输出电极14和整流滤波电路15,输出电极14用于将发电主体21产生的电能输出给电能存储单元16,在电能存储单元16之前还具有整流滤波电路15,用于对输出电极14输出的电流进行整流滤波。电能存储单元16将电能供应给自供能心室再同步复律除颤器的脉冲发生器17。脉冲发生器17通过刺激电极18对心室进行电刺激,实现心室再同步化治疗。The output unit has an output electrode 14 and a rectification and filtering circuit 15. The output electrode 14 is used to output the electric energy generated by the power generation body 21 to the electric energy storage unit 16. Before the electric energy storage unit 16, there is also a rectification and filtering circuit 15 for the output electrode 14. The output current is rectified and filtered. The electrical energy storage unit 16 supplies electrical energy to the pulse generator 17 of the self-powered ventricular resynchronization defibrillator. The pulse generator 17 electrically stimulates the ventricles through the stimulating electrodes 18 to realize ventricular resynchronization therapy.
图2是本发明实施例的自供能心室再同步复律除颤器的发电主体部分的截面图,发电主体21为多层薄膜结构,如图2所示,发电主体21的中心层为压电材料层31,在本实施例中,压电材料层31由ZnO纳米线阵列组成,压电材料层31的两侧分别为电极层32和电极层33,电极层32和电极层33分别与输出电极14相连接(图中未显示)。封装层34位于电极层32和电极层33的外侧,封装层34具有良好的绝缘性和生物相容性。Fig. 2 is the cross-sectional view of the power generation main body part of the self-powered ventricular resynchronization cardioverter defibrillator of the embodiment of the present invention, the power generation main body 21 is a multi-layer film structure, as shown in Fig. 2, the central layer of the power generation main body 21 is piezoelectric Material layer 31, in the present embodiment, piezoelectric material layer 31 is made up of ZnO nanowire array, the two sides of piezoelectric material layer 31 are respectively electrode layer 32 and electrode layer 33, and electrode layer 32 and electrode layer 33 are respectively connected with output Electrodes 14 are connected (not shown). The encapsulation layer 34 is located outside the electrode layer 32 and the electrode layer 33, and the encapsulation layer 34 has good insulation and biocompatibility.
图5是本发明实施例的电路图,如图5所示,发电主体21与整流滤波电路15相连接,发电主体21产生的电能经过整流滤波电路15后对电能存储单元16进行充电,电能存储单元16用于为用电器即本实施例中的心律监测部和脉冲发生器进行供电。Fig. 5 is a circuit diagram of an embodiment of the present invention. As shown in Fig. 5, the power generation main body 21 is connected with the rectification and filtering circuit 15, and the electric energy generated by the power generation main body 21 charges the power storage unit 16 after the rectification and filtering circuit 15, and the power storage unit 16 is used to supply power to electrical appliances, namely the heart rhythm monitoring unit and the pulse generator in this embodiment.
<实施例二><Example 2>
图3是本发明实施例的发电部为三角形的自供能心室再同步复律除颤器示意图,如图3所示,本发明的自供能心室再同步复律除颤器11的发电主体12为三角形,三角形的每个顶点位置均具有一个固定单元13,输出电极14与电极层(见图2)相连接,整流滤波电路15与输出电极14相连接,电能存储单元16连接于整流滤波电路15之后用于存储发电部产生的电能。Fig. 3 is a schematic diagram of a self-powered ventricular resynchronization defibrillator whose power generation part is a triangle according to an embodiment of the present invention. As shown in Fig. 3 , the power generation main body 12 of the self-powered ventricular resynchronization defibrillator 11 of the present invention is Triangle, each vertex of the triangle has a fixed unit 13, the output electrode 14 is connected to the electrode layer (see Figure 2), the rectification and filtering circuit 15 is connected to the output electrode 14, and the electric energy storage unit 16 is connected to the rectification and filtering circuit 15 It is then used to store the electrical energy generated by the power generation unit.
图2是本发明实施例的自供能心室再同步复律除颤器的截面图,如图2所示,发电主体的中心层为压电材料层31,压电材料层31由ZnO纳米线阵列组成,压电材料层31的两侧分别为电极层32和电极层33,电极层32和电极层33分别与输出电极14相连接。封装层34位于电极层电极层32和电极层33的外侧。实际上整个自供能心室再同步复律除颤器11的表面均覆盖有一层绝缘性好的封装层34,封装层34可使用高分子聚合材料,并且封装层34具有良好的生物相容性,使得自供能心室再同步复律除颤器11在植入体内时不会引起排异反应。Fig. 2 is the cross-sectional view of the self-powered ventricular resynchronization defibrillator of the embodiment of the present invention, as shown in Fig. 2, the center layer of generating main body is piezoelectric material layer 31, and piezoelectric material layer 31 is made of ZnO nanowire array Composition, the two sides of piezoelectric material layer 31 are electrode layer 32 and electrode layer 33 respectively, and electrode layer 32 and electrode layer 33 are connected with output electrode 14 respectively. The encapsulation layer 34 is located outside the electrode layer 32 and the electrode layer 33 . In fact, the entire surface of the self-powered ventricular resynchronization defibrillator 11 is covered with a good insulating encapsulation layer 34. The encapsulation layer 34 can be made of a polymer material, and the encapsulation layer 34 has good biocompatibility. Therefore, when the self-powered ventricular resynchronization defibrillator 11 is implanted in the body, it will not cause rejection.
如图3所示,发电主体12的形状为三角形,在将其安装于心外膜上时,利用位于三角形三个顶点上的固定单元13将发电主体12固定于心肌壁的心外膜上。而发电主体12的三角形的各个边并不固定,这样既不会限制心脏的收缩和舒张,还有助于压电材料层随着心脏的运动发生形变从而产生电能。As shown in FIG. 3 , the power generating body 12 is triangular in shape. When it is installed on the epicardium, the power generating body 12 is fixed on the epicardium of the myocardium by using the fixing units 13 located on the three vertices of the triangle. However, each side of the triangle of the power generating body 12 is not fixed, so that the contraction and relaxation of the heart will not be restricted, and the piezoelectric material layer will be deformed with the movement of the heart to generate electric energy.
发电主体12制作成三角形的优点在于能够更多的采集心脏跳动的能量,这是因为在心脏跳动的过程中不仅有横向的收缩和舒张,也有纵向的收缩和舒张,当采用三角形的形状时,三角形的一个顶点设置为向着心尖的方向,而另外两个顶点设置为与心脏横向收缩的方向相平行,这样不论是心脏横向收缩是纵向收缩,均能够带动发电主体12变形。因此三角形的形状比四边形的形状能够更多的利用心脏跳动产生的能量。The advantage of making the power generation body 12 triangular is that it can collect more energy from the beating heart. This is because there are not only horizontal contraction and relaxation during the beating of the heart, but also longitudinal contraction and relaxation. When the triangular shape is adopted, One apex of the triangle is set toward the direction of the apex of the heart, while the other two apexes are set parallel to the direction of the heart's transverse contraction, so whether the heart's transverse contraction or longitudinal contraction can drive the generator body 12 to deform. Therefore, the shape of the triangle can use more energy generated by the beating of the heart than the shape of the quadrilateral.
固定单元13由封装层在相应的位置延展而形成,固定单元13的内部不含有压电材料和电极材料,因此可以避免在缝合时损伤压电材料层和电极层。The fixing unit 13 is formed by extending the encapsulation layer at a corresponding position, and the inside of the fixing unit 13 does not contain piezoelectric material and electrode material, so the piezoelectric material layer and the electrode layer can be avoided from being damaged during sewing.
<变形例><Modification>
本变形例与实施例一相比,除了发电主体的形状为长圆形以外,其它的设置均相同。如图4所示,发电主体42的形状为长圆形,在长圆形的两个顶点处具有固定单元41,发电主体42的形状为长圆形的优点在于没有尖锐的边角,有助于减轻对心脏的损伤。Compared with the first embodiment, this modified example has the same configuration except that the shape of the generating body is oblong. As shown in Figure 4, the shape of the generating body 42 is oblong, and there are fixed units 41 at the two vertices of the oblong. to reduce damage to the heart.
当然,本发明的自供能心室再同步复律除颤器的发电主体的形状可以为多种形状,不仅限于上述两个实施例中的三角形、四边形和长圆形。Certainly, the shape of the power generating body of the self-powered ventricular resynchronization defibrillator of the present invention can be in various shapes, not limited to the triangle, quadrangle and oblong in the above two embodiments.
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