CN113769261A

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Info

Publication number: CN113769261A
Application number: CN202111183437.XA
Authority: CN
Inventors: 侯明晓; 杨耀; 卞晓明; 杨延宗; 肖鹏举; 郑成福
Original assignee: Dalian Corvivo Medical Co ltd
Current assignee: Dalian Corvivo Medical Co ltd
Priority date: 2021-10-11
Filing date: 2021-10-11
Publication date: 2021-12-10

Abstract

Translated fromChinese

本发明提供一种带瓣膜覆膜支架的主动脉内球囊反搏增效装置及使用方法，包括覆膜支架、瓣膜、球囊反搏系统和送放装置。覆膜支架与瓣膜一体，通过送放装置将带有瓣膜的覆膜支架与球囊和导管同时或分别输送到指定位置，释放支架后，球囊反搏系统开始运作。球囊充放气时与心电同步，球囊于心室舒张期充气，自体主动脉瓣关闭，瓣膜打开，充气球囊将覆膜支架内容积的血液驱入球囊近端和远端，由于球囊外部覆膜支架支撑，限制内置球囊膨胀产生的压力导致的弹性主动脉扩张；球囊于心室收缩期放气，自体主动脉瓣开放，由于覆膜支架支撑和单向瓣膜，避免球囊放气时其周围压力下降导致的弹性主动脉内径回缩和血液反流，覆膜支架内压力骤降，左室收缩期卸载。

The invention provides an intra-aortic balloon counterpulsation synergistic device with a valve-covered stent and a method for using the same, including a covered stent, a valve, a balloon counterpulsation system and a delivery device. The stent-graft is integrated with the valve, and the stent-graft with the valve, the balloon and the catheter are delivered to the designated position at the same time or separately through the delivery device. After the stent is released, the balloon counterpulsation system starts to operate. When the balloon is inflated and deflated, it is synchronized with the ECG, the balloon is inflated during ventricular diastole, the native aortic valve is closed, the valve is opened, and the inflated balloon drives the blood in the stent-graft volume into the proximal and distal ends of the balloon. The stent-graft outside the balloon is supported to limit the elastic aortic expansion caused by the pressure generated by the inflation of the built-in balloon; the balloon is deflated during ventricular systole, and the native aortic valve is opened. Due to the support of the stent-graft and the one-way valve, the balloon When the balloon is deflated, the surrounding pressure drops, resulting in retraction of the inner diameter of the elastic aorta and blood regurgitation.

Description

Intra-aortic balloon counterpulsation synergy device with valve covered stent and use method

Technical Field

The invention relates to the technical field of medical equipment, in particular to an intra-aortic balloon counterpulsation synergy device with a valve covered stent and a using method thereof.

Background

The saccule counterpulsation technique (IABP) in aorta is a mechanical auxiliary circulation device widely used in clinic at present, a catheter with saccule is implanted into descending aorta from arterial system, the saccule is expanded and contracted according to cardiac cycle, blood is driven to generate phase change in aorta, thereby increasing aortic diastolic pressure and perfusion of coronary artery, reducing systolic pressure and improving left ventricular ejection, and achieving the purpose of improving cardiac function.

The aortic balloon counterpulsation device comprises a balloon catheter and a counterpulsation machine serving as a balloon catheter driving part. The balloon catheter consists of a balloon and an air supply catheter, the selection standard is that the balloon blocks 90 to 95 percent of the aorta cavity after being inflated, and the volume of the balloon is more than 50 percent of the stroke volume of the heart. The counterpulsation machine comprises a monitoring part, a control part, a vacuum pump and a gas compressor. The air supply conduit is used for communicating the saccule with the vacuum pump and the air compressor. The control part identifies the electrocardio or pressure signals according to the monitoring data fed back by the monitoring part, and automatically regulates and controls inflation and deflation to achieve the optimal counterpulsation effect.

When the aortic valve is closed in diastole, the saccule is inflated to generate positive pressure to drive blood to flow to the far and near sides of the aorta, so that the coronary artery perfusion and the whole body blood perfusion are improved, and the diastolic pressure is improved; when the aortic valve is opened in the systole, the balloon is deflated to generate negative pressure, reduce the resistance of the cardiac ejection and increase the cardiac discharge, thereby improving the left ventricular ejection, and at the moment, the blood is sucked into the blood containing cavity, the pressure of the aorta is reduced, and the afterload of the heart is reduced.

When the balloon is inflated to generate positive pressure and drive blood to flow to two sides of an aorta, the wall of an aortic blood vessel expands outwards due to the pressure generated by the expansion of the balloon; deflating the balloon to generate negative pressure, forcing blood to flow back to the contracted balloon, and simultaneously enabling the wall of the aortic blood vessel to be contracted inwards; greatly reduces the pushing effect of the saccule on blood, and leads to poor treatment effect.

Disclosure of Invention

According to the aortic balloon counterpulsation device for clinical use, when the balloon is inflated to generate positive pressure and drive blood to flow to two sides of an aorta, the wall of the aorta vessel expands outwards due to the pressure generated by the expansion of the balloon; deflating the balloon to generate negative pressure, forcing blood to flow back to the contracted balloon, and simultaneously enabling the wall of the aortic blood vessel to be contracted inwards; greatly reduces the technical problem of poor treatment effect caused by the pushing effect of the saccule on blood, and provides the aorta inner saccule counterpulsation synergistic device with the valve covered stent. The invention mainly conveys the covered stent, the valve, the saccule and the catheter to a specified position of the aorta through the delivery device, expands the aorta blood vessel by using the covered stent, and realizes the inflation and deflation of the saccule by using the saccule counterpulsation system, so that the valve is opened or closed under the positive and negative pressure generated by the inflation and deflation of the saccule, thereby realizing the synergistic function of the saccule counterpulsation in the aorta and simultaneously avoiding the retraction of the inner diameter of the elastic aorta and the blood backflow.

The technical means adopted by the invention are as follows:

the utility model provides a take sacculus counterpulsation increase device in aorta of valve tectorial membrane support, includes: the device comprises a covered stent with expansion and compression functions, a valve, a balloon counterpulsation system and a delivery device, wherein the valve is fixed at the far end of the covered stent, the balloon counterpulsation system is connected with the balloon through a catheter and is used for realizing inflation and deflation of the balloon, the delivery device is used for conveying the covered stent in a contraction state, the valve, the balloon and the catheter to designated positions in an aorta through the outside simultaneously or respectively, the covered stent released into the aorta is used for expanding aorta blood vessels, the balloon is arranged in the covered stent with the valve, and the valve is opened or closed under positive and negative pressure generated by balloon inflation and deflation, so that the synergistic function of the balloon counterpulsation in the aorta is realized, and meanwhile, the internal diameter retraction and blood backflow of an elastic aorta are avoided;

the covered stent with the valve and the saccule are simultaneously or respectively conveyed to a designated position through a delivery device, and after the covered stent is released, the saccule counterpulsation system starts to operate; the balloon is inflated and deflated synchronously with the electrocardio, the balloon is inflated in the diastole of the ventricle, the autologous aortic valve is closed at the moment, the valve at the far end of the covered stent is opened, and the inflated balloon drives the blood in the inner volume of the covered stent into the near end and the far end of the balloon; due to the support of the balloon external tectorial membrane stent, the expansion of the elastic aorta caused by the pressure generated by the expansion of the built-in balloon is limited; the balloon is deflated in the ventricular systole, and the autologous aortic valve is open at the moment, so that the support of the covered stent outside the balloon and the one-way valve at the far end of the balloon avoid the retraction of the inner diameter of the elastic aorta and the blood reflux caused by the reduction of the surrounding pressure when the built-in balloon is deflated, the pressure in the covered stent suddenly drops, and the left ventricular systole is unloaded; the mechanisms together complete the synergistic function of the reverse pulsation of the saccule in the aorta;

the covered stent with the valve has the length of 200-300mm and the diameter of 22-36 mm.

Furthermore, the covered stent consists of a stent with expansion and compression functions and a covering film, the covering film is fixedly connected inside the stent and expands and contracts along with the stent, and when the covered stent is used in an aorta, the balloon is placed in the covering film after expansion.

Further, the valve consists of a valve prosthesis and a valve combining part, the valve combining part is fixedly connected with the far end of the covered stent, the valve prosthesis is fixedly connected with the valve combining part, and the valve prosthesis is opened or closed under positive pressure or negative pressure generated by expansion or contraction of the balloon.

Furthermore, the balloon counterpulsation system also comprises an external balloon counterpulsation host, wherein the external balloon counterpulsation host is communicated with the balloon through a catheter, and the external balloon counterpulsation host inflates and deflates the balloon through the catheter control by synchronizing the cardiac cycle and the electrocardio, so that the balloon is periodically expanded to the size just fitting the covered stent and contracted to the size of the initial balloon.

When the delivery device is used, the guide wire is placed in the catheter and is used for guiding the valve stent delivery part to deliver the covered stent and the valve in a contracted state to the designated position and then release the covered stent and the valve, and the balloon catheter delivery part is used for guiding the balloon and the catheter to deliver the balloon and the catheter to the designated position and then release the balloon and the catheter; after the delivery is finished, the guide wire is drawn out from the catheter;

or the delivery device is of a split structure, the guide wire firstly guides the covered stent and the valve to be delivered to the designated position through the valve stent delivery part and then releases the covered stent and the valve, and then guides the saccule and the catheter to be delivered to the designated position through the saccule catheter delivery part and then releases the covered stent and the valve.

Further, the stent and the covering film are fixed by sewing or bonding through suture; the valve prosthesis and the valve joint are fixed by physical clamping or suture sewing or bonding.

Further, the shape of the stent is a wave-shaped ring or a net-shaped ring.

Further, the covered stent and the valve are of an integrated structure; the total length of the stent graft with the valve is greater than the length of the balloon.

Further, the stent and valve joint is made of one or a combination of metal or high polymer material; the covering film is made of one or the combination of high polymer materials; the valve prosthesis is made of one or the combination of bovine pericardium, porcine pericardium or high polymer materials;

the metal is stainless steel, nickel-titanium alloy, cobalt-chromium alloy, titanium alloy, magnesium alloy or aluminum alloy;

the high polymer material is polytetrafluoroethylene, nylon, silica gel, PET or FEP.

The invention also provides a use method of the intra-aortic balloon counterpulsation synergy device with the valve covered stent, which comprises the following steps:

when in use, the covered stent with the valve, the saccule and the catheter are guided by the guide wire to be simultaneously or respectively conveyed to a specified position of the aorta through the valve stent delivery part and the saccule catheter delivery part, after the covered stent with the valve is released, the guide wire is drawn out from the catheter, and the catheter is connected with an external saccule counterpulsation host;

the contracted valve is changed into a diastolic state after the covered stent is released in the aorta, and the balloon is inflated and deflated by the external balloon counterpulsation host through synchronous control of the cardiac cycle and the electrocardio, so that the balloon is periodically expanded to the size just fitting the covered stent and contracted to the size of the initial balloon; the balloon is inflated in the diastole of the ventricle, at the moment, the autologous aortic valve is in a closed state, the valve at the distal end of the covered stent is opened by positive pressure generated by the expansion of the balloon, the inflated balloon drives the blood in the inner volume of the covered stent to the directions of the coronary artery and the valve, and the expansion of the elastic aorta caused by the pressure generated by the expansion of the built-in balloon is limited due to the support of the covered stent outside the balloon; the balloon is deflated in the ventricular systole, at the moment, the autologous aortic valve is in an open state, the valve is closed by negative pressure generated by the contraction of the balloon, and due to the support of the covered stent outside the balloon and the one-way valve at the far end of the balloon, the internal diameter retraction and blood reflux of the elastic aorta caused by the reduction of the ambient pressure when the built-in balloon is deflated are avoided, the pressure in the covered stent is suddenly reduced, and the left ventricle is unloaded in the systolic period;

after the balloon and the catheter are treated, the balloon and the catheter are withdrawn from the valve direction, the covered stent with the valve is left at the original position, when balloon counterpulsation treatment is still needed subsequently, the balloon, the catheter and the delivery device are replaced, the balloon and the catheter are conveyed to the designated position, and the covered stent with the valve can be repeatedly utilized to achieve the purpose of balloon counterpulsation synergy in the aorta.

Compared with the prior art, the invention has the following advantages:

1. the invention provides an aorta inner balloon counterpulsation synergy device with a valve tectorial membrane stent and a use method thereof.A balloon is inflated and deflated by utilizing an outer balloon counterpulsation host through synchronous control of a cardiac cycle and electrocardio, so that the balloon is periodically expanded to the size just fitting a tectorial membrane and contracted to the size of an initial balloon; the balloon is inflated in the diastole of the ventricle, at the moment, the autologous aortic valve is in a closed state, the valve at the distal end of the covered stent is opened by positive pressure generated by the expansion of the balloon, the inflated balloon drives the blood in the inner volume of the covered stent to the directions of the coronary artery and the valve, and the expansion of the elastic aorta caused by the pressure generated by the expansion of the built-in balloon is limited due to the support of the covered stent outside the balloon; the balloon is deflated in the ventricular systole, at the moment, the autologous aortic valve is in an open state, the valve is closed by negative pressure generated by the contraction of the balloon, and due to the support of the covered stent outside the balloon and the one-way valve at the far end of the balloon, the internal diameter retraction and blood reflux of the elastic aorta caused by the decrease of the surrounding pressure of the balloon during the deflation of the built-in balloon are avoided, the pressure in the covered stent is suddenly reduced, and the left ventricle is unloaded in the systolic period, so that the synergistic function of the counterpulsation of the balloon in the aorta is realized, and the purpose of improving the cardiac function is more effectively achieved.

2. According to the aortic inner balloon counterpulsation synergy device with the valve covered stent and the use method, the valve avoids backflow of blood.

3. According to the aortic inner balloon counterpulsation synergy device with the valve covered stent and the using method thereof, the covered stent limits the retraction of the inner diameter of the elastic aorta.

4. The aortic inner balloon counterpulsation synergy device with the valve covered stent and the use method thereof provided by the invention have the advantage that the efficiency of the device is effectively improved by adding the valve stent which is simply released on the basis of the existing balloon refuting device.

In conclusion, the technical scheme of the invention can solve the problem that when the balloon is inflated to generate positive pressure and drive blood to flow to two sides of the aorta, the wall of the aorta vessel expands outwards due to the pressure generated by the expansion of the balloon in the conventional aortic balloon counterpulsation device for clinic; deflating the balloon to generate negative pressure, forcing blood to flow back to the contracted balloon, and simultaneously enabling the wall of the aortic blood vessel to be contracted inwards; greatly reducing the pushing effect of the saccule on blood and causing the problem of poor treatment effect.

For the above reasons, the present invention can be widely applied to the field of improving cardiac function by using a synergistic device.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic structural diagram of an intra-aortic balloon counterpulsation synergy device with a valve covered stent in embodiment 1 of the invention.

Fig. 2 is a schematic structural diagram of the aortic inner balloon counterpulsation synergy device with the valve covered stent in embodiment 1 before release of the stent.

Fig. 3 is a schematic structural diagram of a balloon-inflated state of the aortic inner balloon counterpulsation synergy device with the valve covered stent after the stent is released in embodiment 1 of the present invention.

Fig. 4 is a schematic structural diagram of a balloon-deflated state after a stent of an intra-aortic balloon counterpulsation synergy device with a valve covered stent is released in embodiment 1 of the invention.

Fig. 5 is a schematic structural diagram of the opening and closing of an intra-aortic balloon counterpulsation synergy device valve prosthesis with a valve covered stent in example 1 of the invention, wherein (a) is in an open state, and (b) is in a closed state.

Fig. 6 is a schematic structural view of a valve prosthesis and a valve joint of an intra-aortic balloon counterpulsation synergy device with a valve covered stent in embodiment 1 of the present invention after fixation.

In the figure: 1. covering a membrane stent; 11. a support; 12. coating a film; 2. a valve; 21. a valve prosthesis; 22. a valve bond; 3. a balloon counterpulsation system; 31. a balloon; 32. a conduit; 33. an external balloon counterpulsation host; 4. a feeding device; 41. a guide wire; 42. a valve stent delivery section; 43. a balloon catheter delivery section.

Detailed Description

It should be noted that the embodiments and features of the embodiments may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

The relative arrangement of the components and steps, the numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. Any specific values in all examples shown and discussed herein are to be construed as exemplary only and not as limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

In the description of the present invention, it is to be understood that the orientation or positional relationship indicated by the directional terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal" and "top, bottom", etc., are generally based on the orientation or positional relationship shown in the drawings, and are used for convenience of description and simplicity of description only, and in the absence of any contrary indication, these directional terms are not intended to indicate and imply that the device or element so referred to must have a particular orientation or be constructed and operated in a particular orientation, and therefore should not be considered as limiting the scope of the present invention: the terms "inner and outer" refer to the inner and outer relative to the profile of the respective component itself.

Spatially relative terms, such as "above … …," "above … …," "above … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

It should be noted that the terms "first", "second", and the like are used to define the components, and are only used for convenience of distinguishing the corresponding components, and the terms have no special meanings unless otherwise stated, and therefore, the scope of the present invention should not be construed as being limited.

As shown in the figures, the invention provides an intra-aortic balloon counterpulsation synergy device with a valve covered stent, comprising: the stent graft 1 with expansion and compression functions, a valve 2, aballoon 31, aballoon counterpulsation system 3 and a delivery device 4, wherein the valve 2 is fixed at the distal end of the stent graft 1, theballoon counterpulsation system 3 is connected with theballoon 31 through acatheter 32 and is used for realizing inflation and deflation of theballoon 31, the delivery device 4 is used for conveying the stent graft 1 in a contracted state, the valve 2, theballoon 31 and thecatheter 32 to designated positions in an aorta through the outside simultaneously or respectively, releasing the stent graft 1 in the aorta for expanding aorta blood vessels, theballoon 31 is arranged in the stent graft 1 with the valve 2, and the valve 2 is opened or closed under positive and negative pressure generated by inflation and deflation of theballoon 31, so that the synergistic function of balloon counterpulsation in the aorta is realized, and meanwhile, the internal diameter retraction and blood backflow of elastic aorta are avoided;

the covered stent 1 with the valve 2 and the saccule 31 are simultaneously or respectively conveyed to a designated position through the delivery device 4, and after the covered stent 1 is released, the saccule counterpulsation system 3 starts to operate; the balloon 31 is inflated and deflated synchronously with the electrocardiogram, the balloon 31 is inflated in the ventricular diastole, at the moment, the autologous aortic valve is closed, the valve 2 at the far end of the covered stent 1 is opened, and the inflated balloon 31 drives the blood in the covered stent 1 into the near end and the far end of the balloon 31; due to the support of the stent graft 1 outside the balloon 31, the expansion of the elastic aorta caused by the pressure generated by the inflation of the built-in balloon 31 is limited; the balloon 31 is deflated in the ventricular systole, the autologous aortic valve is open at the moment, and due to the support of the stent graft 1 outside the balloon 31 and the one-way valve 2 at the far end of the balloon, the internal diameter retraction and blood reflux of the elastic aorta caused by the reduction of the surrounding pressure when the balloon 31 is deflated, the pressure in the stent graft 1 is suddenly reduced, and the left ventricle is unloaded in the systolic period; the mechanisms together complete the synergistic function of the reverse pulsation of the saccule in the aorta;

the length of the stent graft 1 with the valve 2 is 200-300mm (the length refers to the total length of the stent graft 1 after the length of the valve 2 is calculated), and the diameter is 22-36 mm.

In a preferred embodiment, the stent graft 1 is composed of astent 11 having an expanding and compressing function and a stent 12, thestent 11 has a stent 12 fixedly connected to the inside thereof, and theballoon 31 is placed in the expanded stent 12 when used in the aorta as thestent 11 expands and contracts.

In a preferred embodiment, the valve 2 is composed of avalve prosthesis 21 and avalve combining part 22, thevalve combining part 22 is fixedly connected with the distal end of the covered stent 1, thevalve prosthesis 21 is fixedly connected with thevalve combining part 22, and thevalve prosthesis 21 is opened or closed under positive pressure or negative pressure generated by the expansion or contraction of theballoon 31.

In a preferred embodiment, theballoon counterpulsation system 3 further comprises an external balloon counterpulsation host 33, the external balloon counterpulsation host 33 is communicated with theballoon 31 through acatheter 32, and the external balloon counterpulsation host 33 is used for controlling the inflation and deflation of theballoon 31 through thecatheter 32 by synchronizing the cardiac cycle with the electrocardiogram so as to periodically expand theballoon 31 to a size just fitting the stent graft 1 and contract to a size of theinitial balloon 31.

In a preferred embodiment, the delivery device 4 is used for simultaneously delivering the stent graft 1, the valve 2, theballoon 31 and thecatheter 32 to a designated position, and comprises a guide wire 41, a valve stent delivery part 42 and a balloon catheter delivery part 43; when in use, the guide wire 41 is arranged in thecatheter 32 and used for guiding the valve stent delivery part 42 to deliver the covered stent 1 and the valve 2 in the contraction state to the appointed positions and then release the covered stent, and the balloon catheter delivery part 43 is guided to deliver theballoon 31 and thecatheter 32 to the appointed positions and then release the covered stent and the valve; after delivery is complete, the guidewire 41 is withdrawn from thecatheter 32;

or the delivery device 4 is of a split structure, the guide wire 41 firstly guides the covered stent 1 and the valve 2 to be delivered to a designated position through the valve stent delivery part 42 and then released, and then guides thesaccule 31 and thecatheter 32 to be delivered to the designated position through the saccule catheter delivery part 43 and then released.

In a preferred embodiment, thestent 11 and the covering film 12 are fixed by sewing or adhesion with a suture; thevalve prosthesis 21 and thevalve bonding portion 22 are fixed by physical clamping, suture stitching or adhesion.

In a preferred embodiment, thestent 11 is shaped as a wave-shaped ring or a mesh ring.

In a preferred embodiment, the stent graft 1 and the valve 2 are of an integral structure; with the covering of the valve 2 as a preferred embodiment, thestent 11 and thevalve combining part 22 are made of one or a combination of metal or high polymer materials; the coating film 12 is made of one or a combination of high polymer materials; thevalve prosthesis 21 is made of one or a combination of bovine pericardium, porcine pericardium or high polymer materials;

when in use, the covered stent 1 with the valve 2, thesaccule 31 and thecatheter 32 are guided by the guide wire 41 and are simultaneously or respectively delivered to a designated position in the aorta through the valve stent delivery part 42 and the saccule catheter delivery part 43, the valve stent delivery part 42 and the saccule catheter delivery part 43 are released, after the covered stent 1 with the valve 2 is released, the guide wire 41 is drawn out from thecatheter 32, and thecatheter 32 is connected with the external saccule counterpulsation host computer 33;

the contracted valve 2 is changed into a diastolic state after the covered stent 1 is released in the aorta, the balloon 31 is inflated and deflated by the external balloon 31 counterpulsation host through synchronous control of the cardiac cycle and the electrocardio, so that the balloon 31 is periodically expanded to just fit the size of the covering film 12 and contracted to the size of the initial balloon 31; the balloon 31 is inflated in the diastole of the ventricle, at the moment, the autologous aortic valve is in a closed state, the distal valve 2 of the covered stent 1 is opened by generating positive pressure through the expansion of the balloon 31, the inflated balloon 31 drives the blood in the covered stent 1 to the directions of the coronary artery and the valve 2, and the expansion of the elastic aorta caused by the pressure generated by the expansion of the built-in balloon 31 is limited due to the support of the covered stent 1 outside the balloon 31; the balloon 31 is deflated in the ventricular systole, at the moment, the autologous aortic valve is in an open state, the valve 2 is closed by negative pressure generated by the contraction of the balloon 31, and due to the support of the stent graft 1 outside the balloon 31 and the one-way valve 2 at the far end of the stent graft, the internal diameter retraction and blood reflux of the elastic aorta caused by the reduction of the surrounding pressure when the balloon 31 is deflated are avoided, the pressure in the stent graft 1 is suddenly reduced, and the left ventricle is unloaded in the systole; the mechanisms together complete the synergistic function of the conventional intra-aortic balloon counterpulsation;

after theballoon 31 and thecatheter 32 are treated, the covered stent 1 with the valve 2 is withdrawn from the valve 2, the covered stent 1 with the valve 2 is left at the original position, when theballoon 31 counterpulsation treatment is needed subsequently, theballoon 31, thecatheter 32 and the delivery device 4 are replaced, theballoon 31 and thecatheter 32 are conveyed to the designated position, and the covered stent 1 with the valve 2 can be repeatedly used to achieve the purpose of the balloon counterpulsation synergy in the aorta.

Example 1

As shown in fig. 1-6, an aortic inner balloon counterpulsation synergy device with a valve covered stent comprises: a covered stent 1, a valve 2, aballoon counterpulsation system 3 and a delivery device 4.

1, coating the stent 1: consists of astent 11 and a covering film 12.

And (3) a valve 2: consists of avalve prosthesis 21 and avalve combining part 22.

Balloon counterpulsation system 3: consists of aballoon 31, acatheter 32 and an external balloon counterpulsation host 33.

The feeding device 4: comprises a guide wire 41, a valve stent delivery part 42 and a balloon catheter delivery part 43.

The stent graft 1 and the valve 2 are of an integrated structure, and the total length of the stent graft 1 is larger than that of the balloon 31 (the stent graft corresponds to a plurality of sizes according to the sizes of the aortic vessel walls of different patients, and the size of the stent graft is matched with the size of the aortic vessel walls). Thestent 11 is fixed on the outer side of the tectorial membrane 12, thevalve prosthesis 21 is fixed on thevalve combining part 22, and thevalve combining part 22 is fixed with the far end of the tectorial membrane stent 1 through a suture at the same time. Thestent 11 and the covering film 12 are fixed by suture, and thevalve prosthesis 21 and the valve joint 22 are fixed by suture. Thestent 11 and the cover film 12 are in a contracted state before being delivered into the aorta, and are in an expanded state after being delivered into the aorta for release. The cover 12 expands and contracts following thestent 11.

The delivery device 4 guides the valve 2 in the contracted state, the stent graft 1, theballoon 31, and thecatheter 32 to a predetermined position in the aorta and then releases the same, at which time the valve 2 is in the diastolic state, and thecatheter 32 is simultaneously connected to the extracorporeal balloon counterpulsation host 33. In this embodiment, the balloon is already placed inside the stent graft in vitro. Specifically, the covered stent 1 with the valve 2, theballoon 31 and thecatheter 32 are guided by the guide wire 41 to pass through the valve stent delivery part 42 and the balloon catheter delivery part 43 and are simultaneously delivered to a designated position, after the covered stent 1 with the valve 2 is released, the guide wire 41 is drawn out from thecatheter 32, and then thecatheter 32 is connected with the external balloon counterpulsation host 33 for balloon counterpulsation; the external balloon counterpulsation host 33 controls the inflation and deflation of theballoon 31 through the heart cycle and the electrocardio synchronization control, so that theballoon 31 is periodically expanded to just fit the size of the covering film 12 and contracted to the size of theinitial balloon 31. In this embodiment, the valve stent delivery portion 42 and the balloon catheter delivery portion 43 may be wrapped around the outside of the catheter or nested inside the outside of the catheter. The valve stent delivery part 42 can compress the stent into the outer sheath, the outer sheath is bonded with the valve stent delivery part 42, the valve stent delivery part 42 is moved outside the body to extract the outer sheath, and the stent is released automatically; the stent can also be wound and bound by adopting an operation line, and a wire is used for releasing operation.

Theballoon 31 is inflated in the diastole of the ventricle, at the moment, the autologous aortic valve is in a closed state, the stent distal valve 2 is opened by positive pressure generated by the expansion of theballoon 31, theinflatable balloon 31 drives the blood in the internal volume of the covered stent 1 to the directions of the coronary artery and the valve 2, and the expansion of the elastic aorta caused by the pressure generated by the expansion of the built-inballoon 31 is limited due to the support of the covered stent 1 outside theballoon 31; theballoon 31 is deflated in the ventricular systole, at the moment, the autologous aortic valve is in an open state, the valve 2 is closed by negative pressure generated by the contraction of theballoon 31, and due to the support of the stent graft 1 outside theballoon 31 and the one-way valve 2 at the far end of the stent graft, the internal diameter retraction and blood reflux of the elastic aorta caused by the reduction of the surrounding pressure when theballoon 31 is deflated are avoided, the pressure in the stent graft is suddenly reduced, and the left ventricle is unloaded in the systole. Further, when theballoon 31 is inflated, the valve 2 is opened by positive pressure generated by the expansion of theballoon 31, so that blood driven by the expansion of theballoon 31 is guided to be perfused to the coronary artery and the valve 2, and the expansion of the blood vessel wall of the aorta caused by the flow of the blood driven by the expansion of theballoon 31 is reduced; when thesacculus 31 is deflated, the valve 2 is closed by negative pressure generated by the contraction of thesacculus 31, blood is prevented from flowing back to the cavity of the covered stent 1 through the valve 2, meanwhile, the covered stent 1 supports the blood vessel wall, and the contraction of the blood vessel wall of the aorta caused by the negative pressure generated by the contraction of thesacculus 31 is reduced.

After theballoon 31catheter 32 is treated, theballoon 31catheter 32 is withdrawn from the valve 2, the covered stent 1 with the valve 2 is left in place, and when balloon counterpulsation treatment is needed subsequently, theballoon 31, thecatheter 32 and the delivery device 4 are replaced, and are delivered to the designated position, so that the covered stent 1 with the valve 2 can be reused, and the purpose of synergy is achieved.

Thestent 11 is made of metal, which is nickel titanium alloy; the valve joint 22 is made of a combination of metal and polymer material, the metal is a combination of magnesium alloy and aluminum alloy, and the polymer material is a combination of nylon and FEP; the covering film 12 is made of a combination of two polymer materials, namely polytetrafluoroethylene and silica gel; thevalve prosthesis 21 is made of a combination of bovine pericardium, porcine pericardium and a polymer material, and the polymer material is PET.

Example 2

Different from the embodiment 1, in the embodiment, the delivery device 4 is a split structure, the covered stent 1 with the valve 2 is guided by the guide wire 41 and is delivered to a designated position for release by the valve stent delivery part 42, and then the balloon catheter delivery part 43 is guided to deliver theballoon 31 and thecatheter 32 to the designated position and is connected with the external balloon counterpulsation host 33 for balloon counterpulsation.

In this embodiment, thebracket 11 and the cover film 12 are fixed by adhesion; thevalve prosthesis 21 and thevalve bonding portion 22 are fixed by physical clamping or adhesion.

Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.