CN109331266B

CN109331266B - Intravenous cardiac assist device and interventional treatment equipment using the same

Info

Publication number: CN109331266B
Application number: CN201811211506.1A
Authority: CN
Inventors: 杨清; 徐绍鹏; 于向东; 李永乐; 王清; 董邵壮; 郭一凡; 梁春坡; 姚华
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-10-17
Filing date: 2018-10-17
Publication date: 2025-02-25
Anticipated expiration: 2038-10-17
Also published as: CN109331266A

Abstract

The present invention relates to the field of medical device technology, and in particular to a venous heart assist device and an interventional treatment device using the same. The venous heart assist device includes: a balloon catheter, a first balloon, a second balloon and a third balloon; when in use, first control the inflation of the second balloon to expand it in the right atrium; then control the inflation of the first balloon and the third balloon to expand them in the superior vena cava and the inferior vena cava respectively; thereafter, control the deflation of the second balloon to form a negative pressure in the right atrium; then control the deflation of the first balloon and the third balloon. The present invention uses three balloons, and at the same time combines the coordination of corresponding control timings, which can effectively improve the function of the right atrium, improve the perfusion effect, help improve microcirculation disorders, speed up the microblood flow rate, improve ischemia and hypoxia, and provide good assistance to microcirculation, which is conducive to promotion and application.

Description

Venous heart auxiliary device and interventional therapy equipment applying same

Technical Field

The invention relates to the technical field of medical equipment, in particular to a venous heart auxiliary device and interventional therapy equipment using the same.

Background

At present, balloon counterpulsation (IABP for short) in the aorta is an auxiliary circulation mode based on oxygen supply and oxygen consumption theory at the earliest. The early IABP is used clinically in 1968, and is mainly used for circulatory support of patients with perioperative hemodynamic instability, cardiogenic shock or heart failure, and a vascular implantation intra-aortic balloon is usually required to be surgically incised. The occurrence of percutaneous puncture technology in the 80 th century of 20 enables the IABP to have the advantages of small trauma, less complications, simple operation and the like.

An IABP is a device that operates in synchronization with the cardiac cycle of the heart using the principle of "counterpulsation" to increase coronary blood flow and reduce cardiac afterload. A catheter with an air sac is implanted into the proximal end of the descending aorta, and in the systole of the heart, the air in the air sac is rapidly discharged, so that the pressure of the aorta is instantaneously reduced, the ejection resistance of the heart is reduced, the afterload of the heart is reduced, the discharge amount of the heart is increased, and the oxygen consumption of the cardiac muscle is reduced. The aortic valve in diastole is closed, and the air bag is filled rapidly to expel blood to the far side and the near side of the aorta, so that the diastolic pressure of the aortic root is increased, the coronary blood flow and the myocardial oxygen supply are increased, and the whole body perfusion is increased. However, the balloon catheter device in the prior art is often used as a balloon, and is only applied to the field of coronary perfusion. There are few applications in the coronary vein field and balloon catheter devices of the prior art are not ideal for use.

The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Disclosure of Invention

The invention aims to provide a venous heart auxiliary device and interventional therapy equipment using the same, which effectively improve the function of a right atrium, improve the perfusion effect of coronary veins, help to improve microcirculation disturbance, accelerate the speed of micro blood flow, improve the conditions of ischemia and hypoxia and ensure that microcirculation is well improved.

In order to achieve the above purpose, the present invention adopts the following technical scheme:

In a first aspect, the invention provides a venous heart auxiliary device, which comprises a balloon catheter, a first balloon, a second balloon and a third balloon, wherein the distal end of the balloon catheter sequentially passes through the first balloon, the second balloon and the third balloon, and the first balloon, the second balloon and the third balloon are respectively controlled by independent air paths so that each balloon can be selectively inflated and deflated.

As a further technical scheme, the venous heart auxiliary device further comprises a balloon pump set, wherein the balloon pump set is arranged at the proximal end of the balloon catheter and is respectively connected with the first balloon, the second balloon and the third balloon through independent air paths.

As a further technical scheme, the venous heart auxiliary device further comprises a control system, wherein the control system is connected with the balloon pump set, the control system is used for sending at least one group of action instructions to the balloon pump set, each group of action instructions sequentially comprises a second balloon inflation instruction, a first balloon inflation instruction, a third balloon inflation instruction, a second balloon deflation instruction, a first balloon deflation instruction and a third balloon deflation instruction according to time sequence control, and the balloon pump set carries out corresponding inflation action and deflation action according to the action instructions.

As a further technical scheme, the venous heart auxiliary device further comprises a pressure sensing device, wherein the pressure sensing device is connected with the control system and is used for detecting the pressures of the first balloon, the second balloon and the third balloon respectively and feeding back the pressures to the control system.

As a further technical scheme, the venous heart auxiliary device further comprises an electrocardiogram sensing device, wherein the electrocardiogram sensing device is connected with the control system and is used for detecting a heart signal map and feeding back the heart signal map to the control system.

As a further technical solution, the maximum inflation volumes of the first balloon and the third balloon are smaller than the maximum inflation volume of the second balloon.

As a further technical scheme, the balloon catheter is provided with a plurality of lumen structures, the plurality of lumen structures at least comprise a central lumen which is arranged in a penetrating way and three air passage lumens which are arranged on the periphery of the central lumen, and the three air passage lumens are respectively communicated with the first balloon, the second balloon and the third balloon.

As a further technical scheme, developing parts are arranged on the first balloon, the second balloon and the third balloon.

By adopting the technical scheme of the first aspect, the invention has the following beneficial effects:

The invention provides a venous heart auxiliary device, which is characterized in that a first balloon, a second balloon and a third balloon are respectively and correspondingly sent to an upper vena cava, a right atrium and a lower vena cava through balloon catheters, when the venous heart auxiliary device is used, the second balloon is firstly controlled to be inflated to expand the right atrium, then the first balloon and the third balloon are controlled to be inflated to expand the upper vena cava and the lower vena cava respectively, then the second balloon is controlled to be deflated to form negative pressure in the right atrium, and then the first balloon and the third balloon are controlled to be deflated.

In a second aspect, the invention also provides an interventional therapy device comprising the venous heart auxiliary device. The venous heart auxiliary device mainly comprises a balloon catheter, a first balloon, a second balloon and a third balloon, wherein the distal end of the balloon catheter is sequentially sleeved on the first balloon, the second balloon and the third balloon, and the first balloon, the second balloon and the third balloon are controlled through independent air paths respectively, so that each balloon can be selectively inflated and deflated. Of course, other features have been described above and will not be described in detail here.

By adopting the technical scheme of the second aspect, the invention has the following beneficial effects:

The invention provides an interventional therapy device which has the same beneficial effects as the venous heart auxiliary device as it comprises the venous heart auxiliary device. Moreover, the interventional therapy device not only can be applied to the interventional therapy of coronary veins, but also can be applied to other fields, has strong universality and is beneficial to popularization and application.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will briefly explain the drawings needed in the embodiments or the prior art, and it is obvious that the drawings in the following description are some embodiments of the present invention and that other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic structural view of an intravenous heart assist device according to an embodiment of the present invention;

Fig. 2 is a schematic view illustrating a use state of the venous heart auxiliary device according to the embodiment of the invention;

fig. 3 is a schematic structural diagram of an intravenous heart assist device according to another embodiment of the present invention.

The icons are 1-superior vena cava, 2-first balloon, 3-right atrium, 4-second balloon, 5-inferior vena cava, 6-third balloon, 7-balloon catheter, 8-balloon pump set, 9-electrocardiogram sensing device, 10-control system and 11-pressure sensing device.

Detailed Description

The following description of the embodiments of the present invention will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the invention are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The following describes specific embodiments of the present invention in detail with reference to the drawings. It should be understood that the detailed description and specific examples, while indicating and illustrating the invention, are not intended to limit the invention.

Example 1

As shown in fig. 1 to 3, the present embodiment provides a venous heart auxiliary device, which includes a balloon catheter 7, a first balloon 2, a second balloon 4 and a third balloon 6, wherein the distal end of the balloon catheter 7 is sequentially sleeved on the first balloon 2, the second balloon 4 and the third balloon 6, and it can be understood that the first balloon 2, the second balloon 4 and the third balloon 6 are sequentially arranged at the distal end of the balloon catheter 7 at intervals, and of course, the interval distance between the balloons can be flexibly set according to actual needs, and the same is true, and the size of each balloon can also be formulated into corresponding specific specifications according to different situations, so that the venous heart auxiliary device is not limited. Wherein, preferably, the maximum inflation volume of the first balloon 2 and the third balloon 6 is smaller than the maximum inflation volume of the second balloon 4. Moreover, the first balloon 2, the second balloon 4 and the third balloon 6 are controlled by independent air passages, respectively, so that each balloon can be selectively inflated and deflated.

Thus, the present embodiment can deliver the first balloon 2, the second balloon 4, and the third balloon 6 to the superior vena cava 1, the right atrium 3, and the inferior vena cava 5, respectively, through the balloon catheter 7.

When in use, the second balloon 4 is firstly controlled to be inflated to enable the second balloon to be inflated in the right atrium 3, then the first balloon 2 and the third balloon 6 are controlled to be inflated to enable the first balloon 2 and the third balloon 6 to be inflated respectively in the superior vena cava 1 and the inferior vena cava 5 to form a sealing effect, then the second balloon 4 is controlled to be deflated to enable the second balloon 4 to form negative pressure in the right atrium 3, and then the first balloon 2 and the third balloon 6 are controlled to be deflated.

According to the IABP principle, the second balloon 4 is inflated firstly, then the first balloon 2 and the third balloon 6 are inflated at the early stage of diastole, and the second balloon 4 is deflated firstly, then the first balloon 2 and the third balloon 6 are deflated before systole, so that the auxiliary circulation effect is achieved through the deflation synchronous with the cardiac cycle. In addition, the embodiment adopts three saccules, and simultaneously combines the cooperation of corresponding control time sequences, so that the function of the right atrium can be effectively improved, the perfusion effect is improved, the microcirculation disturbance is improved, the micro-blood flow speed is increased, the conditions of ischemia and hypoxia are improved, the microcirculation is well helped, and the popularization and the application are facilitated.

In this embodiment, in order to ensure that each gas path can be independently controlled. Preferably, the venous heart auxiliary device further comprises a balloon pump set 8, wherein the balloon pump set 8 is arranged at the proximal end of the balloon catheter 7, and the balloon pump set 8 is respectively connected with the first balloon 2, the second balloon 4 and the third balloon 6 through independent air paths. Further, the balloon pump set 8 is also connected with an air source device, and the air source device is preferably nitrogen, so that the balloon pump set is nontoxic, harmless and high in safety. Of course, those skilled in the art can further develop the invention on the basis of such a requirement as adding an air compressor or a gas filter.

In this embodiment, in order to facilitate control of the balloon counterpulsation timing, as a further technical scheme, the venous heart auxiliary device further comprises a control system 10, wherein the control system 10 is connected with the balloon pump set 8, the control system 10 is used for sending at least one group of action instructions to the balloon pump set 8, and each group of action instructions sequentially comprises a second balloon 4 inflation instruction, a first balloon 2 and a third balloon 6 inflation instruction, a second balloon 4 deflation instruction, and a first balloon 2 and a third balloon 6 deflation instruction according to time sequence control, and the balloon pump set 8 performs corresponding inflation and deflation actions according to the sent action instructions. That is, first, the second balloon 4 is controlled to be inflated so as to be inflated in the right atrium 3, then the first balloon 2 and the third balloon 6 are controlled to be inflated so as to be inflated in the superior vena cava 1 and the inferior vena cava 5, respectively, then the second balloon 4 is controlled to be deflated so as to form a negative pressure in the right atrium 3, and then the first balloon 2 and the third balloon 6 are controlled to be deflated.

The venous heart assist device of the present embodiment may be controlled in time by an electrocardiogram QRS waveform. For example, the venous heart auxiliary device further comprises an electrocardiogram sensing device 9, the electrocardiogram sensing device 9 is connected with the control system 10, and the electrocardiogram sensing device 9 is used for detecting a heart signal map and feeding back the heart signal map to the control system 10. Preferably, the electrocardiogram sensor means 9 is an electrocardiogram sensor.

Furthermore, as a further technical scheme, the venous heart auxiliary device further comprises a pressure sensing device 11, wherein the pressure sensing device 11 is connected with the control system 10, and the pressure sensing device 11 is used for respectively detecting the pressures of the first balloon 2, the second balloon 4 and the third balloon 6 and feeding back the pressures to the control system 10. The pressure sensing device 11 can monitor and feed back the pressures of the first balloon 2, the second balloon 4 and the third balloon 6 in real time, so that the pressure sensing device can monitor the pressures of the first balloon 2, the second balloon 4 and the third balloon 6, and can find out in time when the air leakage condition occurs to the balloons.

Of course, in order to better play a role in reminding, the venous heart auxiliary device further comprises an alarm device, wherein the alarm device is connected with the control system 10, can give an alarm through sound when the balloon leaks, and can flash together with a prompting lamp.

In this embodiment, as a further technical solution, the balloon catheter 7 has a plurality of lumen structures, where the plurality of lumen structures at least includes a central lumen that is disposed through and three air path lumens that are disposed at the periphery of the central lumen (it is understood that the three air path lumens and the central lumen are all integrated in the balloon catheter 7), and the three air path lumens are respectively communicated with the first balloon 2, the second balloon 4 and the third balloon 6. The balloon catheter 7 is more compact in overall structure and facilitates its delivery in the blood vessel.

In this embodiment, as a further technical solution, a plurality of openings are provided on the side wall of the distal end of the balloon catheter 7, and the plurality of openings are respectively communicated with the central lumen. These openings can serve as suction openings for thrombi, through which they can be passed into the body, but can of course also serve as delivery openings for therapeutic or diagnostic agents. Preferably, these openings are located between the first balloon 2 and the second balloon 4, but also between the second balloon 4 and the third balloon 6.

In this embodiment, the connection relationship between the balloon and the corresponding air channel lumen may be designed coaxially, that is, the air channel lumen is disposed through the balloon and has a gap with the inner wall of the balloon. Of course, the connection relation between the balloon and the corresponding air passage lumen can also be set by adopting a common wall, and the balloon and the corresponding air passage lumen are shared by a section of arm, so that the air shuttle area is larger, and the air shuttle resistance is smaller.

In this embodiment, the balloon catheter 7 is not limited to a specific material, and may be formed by compounding a plurality of materials. For example, the balloon catheter 7 includes a first structural layer (inner layer), a marker layer (intermediate layer), and a second structural layer (outer layer), which are sequentially laminated from inside to outside. By such a configuration, it is possible to set the catheter to have desired characteristics such as suppression of bending of the catheter body.

Preferably, as a constituent material of the first and second structural layers, any one of polyamide resin, polyester polyamide resin, polyether polyamide resin, polyurethane, ABS resin, polyester elastomer resin, polyurethane elastomer resin, and fluorine resin (PFA, PTFE, ETFE, etc.) can be used. In particular, by using ABS resin or nylon as a constituent material of the first structural layer and the second structural layer, appropriate strength can be imparted to the distal end portion of the main body. Furthermore, by using a fluorine-based resin, preferably PTFE, for the first structural layer, the operability of the guide wire inserted into the lumen is improved.

Preferably, the material constituting the marker layer is preferably an X-ray opaque material such as barium sulfate, bismuth trioxide, tungsten, or the like. In addition, in the present embodiment, the balloon catheter 7 further includes a reinforcing layer disposed between any adjacent two of the first structural layer, the marker layer, and the second structural layer. For example, the reinforcing layer may be a pre-buried metal mesh. The mesh shape constituting the metal mesh is not particularly limited, and may be, for example, circular, approximately rectangular, or approximately elliptical. In addition, the reinforcing layer may be a spiral linear structure, and the strength of the catheter can be easily adjusted according to the number of spiral turns.

In this embodiment, the first structural layer (inner layer), the marker layer (intermediate layer), and the second structural layer (outer layer) may be bonded to each other by a suitable adhesive, or may be connected by a hot-melt method, or may be integrally formed by injection molding or the like. In addition, the balloon catheter 7 can be adaptively modified by those skilled in the art based on the above structure, for example, a hydrophilic coating is added on the surface of the balloon catheter 7, so that the lubricity of the balloon catheter is increased, and the pushing can be facilitated.

Preferably, in the present embodiment, developing portions are provided on each of the first balloon 2, the second balloon 4, and the third balloon 6 so that the positions of the respective balloons can be ensured to be confirmed under X-ray. In this embodiment, the first balloon 2, the second balloon 4 and the third balloon 6 may be improved as well, for example, each balloon may be of a double-layer membrane structure, and the double-layer membranes are sleeved together, so that the inflation and deflation can be synchronously performed, and the occurrence of air leakage can be reduced. In addition, for each balloon, it may be made of a macromolecular material such as polyurethane, silicone rubber, silica gel or rubber, a plastic or a biological film such as polyethylene or Polytetrafluoroethylene (PTFE), or other elastic materials.

In summary, the invention provides a venous heart auxiliary device, a first balloon 2, a second balloon 4 and a third balloon 6 are respectively and correspondingly arranged on an upper vena cava 1, a right atrium 3 and a lower vena cava 5 through balloon catheters 7, when the venous heart auxiliary device is used, firstly, the second balloon 4 is controlled to be inflated to enable the right atrium 3 to be inflated, then the first balloon 2 and the third balloon 6 are controlled to be inflated to enable the upper vena cava 1 and the lower vena cava 5 to be inflated respectively, afterwards, the second balloon 4 is controlled to be deflated to enable negative pressure to be formed in the right atrium 3, and then the first balloon 2 and the third balloon 6 are controlled to be deflated.

Example two

The second embodiment provides an interventional therapy device, which includes the venous heart auxiliary device described in the first embodiment. The technical content disclosed in the first embodiment is also applicable to the second embodiment, and the technical features disclosed in the first embodiment are not repeated, and only the differences between the two are described below. The interventional therapy device may include a variety of devices for use with the venous heart assist apparatus.

For example, the interventional therapy device comprises an X-ray device connected to a control system 10 for generating and controlling X-rays for radiological examination of human tissue. The equipment has X-ray generator, patient bed, support, filter board, signal analysis and display, cooling system, body cavity treating tube, treating program, etc.

For example, the interventional therapy device comprises a suction device and a fluid supply device, which are connectable to the proximal end of the balloon catheter 7, respectively.

In summary, the present embodiment provides an interventional therapy device, which has the same beneficial effects as the venous heart assist device because the interventional therapy device includes the venous heart assist device. Moreover, the interventional therapy device can be simultaneously applied to the fields of coronary veins, coronary arteries and the like, has strong universality and is beneficial to popularization and application.

It should be noted that the above embodiments are merely for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the above embodiments, it should be understood by those skilled in the art that the technical solution described in the above embodiments may be modified or some or all of the technical features may be equivalently replaced, and these modifications or substitutions do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the present invention.

Claims

1. A venous heart assist device, comprising: a balloon catheter, a first balloon, a second balloon and a third balloon; the distal end of the balloon catheter is sequentially inserted into the first balloon, the second balloon and the third balloon, and the first balloon, the second balloon and the third balloon are respectively controlled by independent air circuits so that each balloon can be selectively inflated and deflated;

Also included: a balloon pump group, which is disposed at the proximal end of the balloon catheter and is respectively connected to the first balloon, the second balloon and the third balloon through independent air paths;

It also includes: a control system, which is connected to the balloon pump group, and the control system is used to send at least one group of action instructions to the balloon pump group, each group of the action instructions includes: a second balloon inflation instruction, a first balloon and a third balloon inflation instruction, a second balloon deflation instruction, and a first balloon and a third balloon deflation instruction in sequence according to the timing control, and the balloon pump group performs corresponding inflation and deflation actions according to the action instructions; when in use, first control the second balloon to be inflated so that it expands in the right atrium; then control the first balloon and the third balloon to be inflated so that they expand in the superior vena cava and the inferior vena cava respectively; thereafter, control the second balloon to be deflated so that negative pressure is formed in the right atrium; then control the first balloon and the third balloon to be deflated.

2. The venous cardiac assist device according to claim 1 is characterized in that it also includes: a pressure sensing device, which is connected to the control system, and is used to respectively detect the pressures of the first balloon, the second balloon and the third balloon and feed back to the control system.

3. The venous cardiac assist device according to claim 1 is characterized in that it also includes: an electrocardiogram sensor device, which is connected to the control system, and is used to detect a cardiac signal spectrum and feed it back to the control system.

4. The venous cardiac assist device according to claim 1 is characterized in that the maximum expansion volume of the first balloon and the third balloon are both smaller than the maximum expansion volume of the second balloon.

5. The venous cardiac assist device according to claim 1 is characterized in that the balloon catheter has multiple lumen structures, and the multiple lumen structures include at least a central lumen arranged through and three air path lumens arranged outside the central lumen, and the three air path lumens are respectively connected to the first balloon, the second balloon and the third balloon.

6. The venous cardiac assist device according to claim 1, characterized in that a developing portion is provided on the first balloon, the second balloon and the third balloon.

7. An interventional treatment device, characterized in that it comprises a venous cardiac assist device as described in any one of claims 1-6.