阅读说明：本技术 心脏辅助支架球囊系统及其制作方法以及心脏辅助装置 (heart auxiliary support balloon system, manufacturing method thereof and heart auxiliary device ) 是由 匡锋 井然 黄磊 王时惠 于 2019-09-19 设计创作，主要内容包括：本发明公开了一种心脏辅助支架球囊,属于器官辅助装置领域。本发明包括由记忆金属制作的支架,以及弹性材料制作的囊膜；所述囊膜套设在支架一端形成气囊；所述支架内部设置有与气囊内部连通的通气道；所述支架内部设置多组出入通道,每组出入通道由并排在一起且一端连通的通道进入段和通道退出段组成；每组出入通道中通道进入段和通道退出段连通的一端端部深入到支架的不同位置。本发明经皮穿刺置入,并且易于拆装,最大程度模拟心脏生理工作状态,起到心脏辅助作用,有利于受损心肌恢复生理功能,改善患者生活质量,并可作为心脏移植前过渡期使用；本发明方法简单,为患者节约了费用,保障了患者的安全。(The invention discloses a heart auxiliary support balloon, and belongs to the field of organ auxiliary devices. The invention comprises a bracket made of memory metal and a capsule membrane made of elastic material; the sac membrane is sleeved at one end of the bracket to form an air sac; an air channel communicated with the inside of the air bag is arranged in the bracket; a plurality of groups of access passages are arranged in the bracket, and each group of access passages consists of a passage entry section and a passage exit section which are arranged side by side and one ends of which are communicated; one end part of each group of the access passages, which is communicated with the passage entry section and the passage exit section, extends into different positions of the bracket. The invention is inserted by percutaneous puncture, is easy to disassemble and assemble, can simulate the physiological working state of the heart to the maximum extent, plays a role in assisting the heart, is beneficial to the recovery of the physiological function of the damaged cardiac muscle, improves the life quality of a patient, and can be used as a transition period before heart transplantation; the method is simple, saves the cost for the patient and ensures the safety of the patient.)

1. A heart auxiliary stent balloon system is characterized by comprising a stent made of memory metal with the transformation temperature of 10-37 ℃ and a balloon membrane made of elastic material; the sac membrane is sleeved at one end of the bracket to form an air sac; an air channel communicated with the inside of the air bag is arranged in the bracket; a plurality of groups of access passages are arranged in the bracket, and each group of access passages consists of a passage entry section and a passage exit section which are arranged side by side and one ends of which are communicated; one end part of each group of the access passages, which is communicated with the passage entry section and the passage exit section, extends into different positions of the bracket.

2. the heart assist stent balloon system of claim 1, wherein the end of each group of the access channels where the channel entrance section and the channel exit section are communicated is distributed at equal intervals and is located inside the stent.

3. The heart assist stent balloon system of claim 1, wherein the access channel comprises four.

4. A heart assist device comprising a control device and a heart assist stent balloon system according to any one of claims 1-3; the control device controls the inflation amount of the air bag and controls the flow of the medium flowing in any one of the inlet and outlet channels.

5. A heart assist device comprising a source of a first medium, a source of a second medium, a control device, and a heart assist stent balloon system according to any one of claims 1-3; the control device comprises a first medium pump, a computer and a plurality of second medium pumps; one end of the first medium pump is connected with the air channel, and the other end of the first medium pump is connected with a first medium source; each second medium pump is connected with a second medium source; the other end of each second medium pump is connected with a channel entrance section of one group of entrance and exit channels, and a channel exit section of each group of entrance and exit channels is connected with a second medium source; the computer controls the mode of operation of the first and the plurality of second media pumps.

6. The method for manufacturing the balloon system of the heart auxiliary stent according to any one of claims 1 to 3, wherein the covering section of the stent covered by the balloon film is determined according to the size and the shape of the heart of the patient; manufacturing a bracket with a plurality of groups of inlet and outlet channels and air ducts inside, and then spirally forming the bracket and a covering section according to the size and the shape of the heart; controlling the stent below the metamorphosis temperature, and covering the covering section with the cyst membrane to form the air sac.

Technical Field

the invention relates to a balloon system of a heart auxiliary stent and a manufacturing method thereof, belonging to the field of organ auxiliary devices.

background

the left heart failure refers to heart failure caused by left ventricular decompensation insufficiency, is common clinically, and is mainly characterized by pulmonary circulation congestion. Pure right heart failure is mainly seen in pulmonary heart disease and some congenital heart diseases, and is mainly manifested by blood stasis in body circulation. At present, patients with decompensated heart failure are mostly due to acute and chronic heart failure after myocardial infarction, myocarditis, cardiomyopathy and cardiac surgery, the mortality rate of the patients is high, and the prognosis is very poor; many patients with acute heart failure go to death by failing to bridge the decompensation phase of heart failure due to a lack of effective circulatory support. Therefore, there is an urgent need for a fast and efficient hemodynamic aid for both the physician and the patient, which can provide time for further treatment. Patients with acute and chronic cardiac failure in decompensation stage often need emergency cardiac function assistance, and patients with severe cardiac failure have poor drug conservative treatment effect, so that the patients with severe cardiac failure have the possibility of multi-organ functional failure or even death due to low cardiac output and insufficient organ perfusion at any time.

However, most of the heart assist devices in the prior art mainly use left heart assist or unilateral heart assist, and a heart assist device capable of meeting multiple tasks is not available for heart failure patients with complicated disease conditions or patients with total heart failure. Most patients in the decompensation period of heart failure urgently need temporary heart mechanical auxiliary devices, time is created for recovering the heart function or the time for heart transplantation is excessive, and the time for supporting the heart mechanical auxiliary devices is different.

Most of the current heart auxiliary devices are used and need to be implanted by an open chest operation, which causes great trauma to patients and is expensive.

Disclosure of Invention

The invention aims to solve the technical problem of providing a balloon system of a heart auxiliary stent and a manufacturing method thereof, wherein the heart auxiliary stent can be inserted in a percutaneous intervention mode by selecting reasonable materials, the method is simple, the thoracotomy wound is avoided, the operation cost is saved, and the safety of a patient is ensured.

In order to solve the technical problems, the technical scheme adopted by the invention is as follows: a heart auxiliary stent balloon system is characterized by comprising a stent made of memory metal with the transformation temperature of 10-37 ℃ and a balloon membrane made of elastic material; the sac membrane is sleeved at one end of the bracket to form an air sac; an air channel communicated with the inside of the air bag is arranged in the bracket; a plurality of groups of access passages are arranged in the bracket, and each group of access passages consists of a passage entry section and a passage exit section which are arranged side by side and one ends of which are communicated; one end part of each group of the access passages, which is communicated with the passage entry section and the passage exit section, extends into different positions of the bracket.

The technical scheme is that the end parts of one ends, communicated with the channel entrance sections and the channel exit sections, of each group of exit and entrance channels are distributed at equal intervals and are positioned in the support.

The technical scheme is that the access channel comprises four access channels.

A further technical scheme is that the heart assist device is characterized by comprising a control device and the heart assist stent balloon system; the control device controls the inflation amount of the air bag and controls the flow of the medium flowing in any one of the inlet and outlet channels.

A further technical solution is that a heart assist device, comprising a first medium source, a second medium source, a control device, and the heart assist stent balloon system as described above; the control device comprises a first medium pump, a computer and a plurality of second medium pumps; one end of the first medium pump is connected with the air channel, and the other end of the first medium pump is connected with a first medium source; each second medium pump is connected with a second medium source; the other end of each second medium pump is connected with a channel entrance section of one group of entrance and exit channels, and a channel exit section of each group of entrance and exit channels is connected with a second medium source; the computer controls the mode of operation of the first and the plurality of second media pumps.

The manufacturing method of the balloon system of the heart auxiliary stent is characterized in that a covering section of the stent covered by the balloon is determined according to the size and the shape of the heart of a patient; manufacturing a bracket with a plurality of groups of inlet and outlet channels and air ducts inside, and then spirally forming a guide wire covering section according to the size and the shape of the heart; controlling the stent below the metamorphosis temperature, and covering the covering section with the cyst membrane to form the air sac.

Adopt the produced beneficial effect of above-mentioned technical scheme to lie in:

1. The invention provides a heart assist device, which does not need to be in direct contact with blood, greatly reduces the risk of thrombus in the heart and blood vessels, and is expected to reduce the risk of stroke and cognitive dysfunction of a patient caused by the heart assist device.

2. The invention provides an in-vitro heart auxiliary device which can send a control signal and set the autonomous frequency and the inflation quantity of an inflation and deflation balloon to increase or decrease when the heart rate of a patient is too low or the cardiac ejection fraction is too low, and can ensure that the patient can maintain enough cardiac output under different states of cardiac functions to the maximum extent through different working modes.

3. The invention provides an in-vitro heart auxiliary device which is easy to disassemble and assemble, adopts modular construction and is convenient to replace when the working states of part of modules are abnormal.

4. the invention provides an in-vitro heart auxiliary device which simulates the physiological working state of the heart to the maximum extent, is beneficial to restoring the physiological function of damaged cardiac muscle, improves the life quality of patients and creates time for heart transplantation.

5. The invention also provides a heart auxiliary bracket which is accessed percutaneously, has simple method, avoids open chest surgery, reduces the wound to the patient to the maximum extent, saves the cost for the patient and ensures the safety of the patient.

Drawings

The present invention will be described in further detail with reference to the accompanying drawings and specific embodiments.

FIG. 1 is a schematic structural view of the present invention;

FIG. 2 is a schematic structural view of a heart assist stent of the present invention;

3 FIG. 3 3 3 is 3 a 3 schematic 3 view 3 of 3 the 3 cross 3- 3 sectional 3 structure 3 A 3- 3 A 3 of 3 FIG. 3 2 3; 3

FIG. 4 is a schematic view of the cross-sectional structure B-B in FIG. 2;

FIG. 5 is a schematic view of the cross-sectional structure C-C of FIG. 2;

FIG. 6 is a schematic view of the cross-sectional structure of FIG. 2 taken along line D-D;

FIG. 7 is a schematic view of the cross-sectional structure E-E of FIG. 2;

FIG. 8 is a schematic view of the cross-sectional structure F-F of FIG. 2;

Fig. 9 is a control principle framework diagram of the present invention.

1. A heart; 2-1, a bracket; 2-2, air bags; 2-3, a first channel entrance section; 2-4, a first channel exit section; 2-5, a second channel entrance section; 2-6, a second channel exit section; 2-7, a third channel entrance section; 2-8, a third channel exit segment; 2-9, a fourth channel entrance section; 2-10, a fourth channel exit section; 2-11, an air duct; 2-12, airway; 2-13, a third connecting channel; 2-14, a fourth connecting channel; 2-15, a first connecting channel; 2-16, a second connecting channel; 3. and a control device.

Detailed Description

The technical solutions in the embodiments of the present invention are 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. 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.

In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention, but the present invention may be practiced in other ways than those specifically described and will be readily apparent to those of ordinary skill in the art without departing from the spirit of the present invention, and therefore the present invention is not limited to the specific embodiments disclosed below.

in this embodiment, as shown in fig. 1, a heart auxiliary stent balloon is introduced, which comprises a stent 2-1 made of memory metal with a transformation temperature of 10-37 ℃ and a capsule membrane made of elastic material; the sac membrane is sleeved at one end of the bracket 2-1 to form an air sac 2-2; an air channel 2-11 communicated with the inside of the air bag 2-2 is arranged inside the bracket 2-1; a plurality of groups of access passages are arranged in the bracket 2-1, and each group of access passages consists of a passage entry section and a passage exit section which are arranged side by side and one end of each group of access passages is communicated; one end part of each group of the access passages, which is communicated with the passage entry section and the passage exit section, extends into different positions of the bracket 2-1.

The memory metal can be molded at will at low temperature, and can be restored to the original shape at high temperature; the heart auxiliary stent balloon system is easily implanted into a human body and recovers the shape in the human body; the temperature of a human body is about 37 ℃, so that the metamorphosis temperature needs to be controlled below 37 ℃ so as to better recover the original shape; in the prior art, since the low temperature can be easily controlled by ice water for cost saving, the transformation temperature is not lower than 0 ℃, preferably 0 ℃ or higher, more preferably 10 ℃ or higher, and still more preferably room temperature or higher.

In the embodiment, the end parts of the ends of each group of the access passages, which are communicated with the passage entrance section and the passage exit section, are distributed at equal intervals and are positioned in the bracket 2-1. How to control the support 2-1 to restore to the original state in sections easily avoids the situation that the space where the heart is positioned cannot be accommodated due to large-area original state restoration and also avoids the danger that the heart auxiliary support cannot be sleeved on the heart.

In this embodiment, the number of the access passages includes four, as shown in fig. 2 to 8, including a first passage entry section 2-3, a first passage exit section 2-4, a second passage entry section 2-5, a second passage exit section 2-6, a third passage entry section 2-7, a third passage exit section 2-8, a fourth passage entry section 2-9, a fourth passage exit section 2-10, an air passage 2-11, an air passage 2-12, a third communication passage 2-13, a fourth communication passage 2-14, a first connection passage 2-15, and a second communication passage 2-16; as shown in fig. 7, the first channel entrance section 2-3 is communicated with the end of the first channel exit section 2-4 by a first connecting channel 2-15; as shown in fig. 8, the second channel entrance section 2-5 is communicated with the end of the second channel exit section 2-6 by a second communication channel 2-16; as shown in fig. 5, the third channel entrance section 2-7 and the third channel exit section 2-8 are communicated by a third communication channel 2-13; as shown in fig. 6, the fourth channel entrance section 2-9 is communicated with the fourth channel exit section 2-10 by a fourth communication channel 2-14; as shown in FIGS. 5-8, the third communicating channel 2-13, the fourth communicating channel 2-14, the first connecting channel 2-15 and the second communicating channel 2-16 are uniformly distributed in the guide wire 2-1 to complete the sectional control.

The embodiment also discloses a heart assist device, which is shown in fig. 9 and comprises a control device and the heart assist stent balloon system of the embodiment; the control device controls the inflation amount of the air bag and controls the flow of the medium flowing in any one of the inlet and outlet channels.

The embodiment also discloses a heart assist device, which is shown in fig. 9, and is characterized by comprising a first medium source, a second medium source, a control device and the heart assist bracket of the embodiment; the control device comprises a first medium pump, a computer and a plurality of second medium pumps; one end of the first medium pump is connected with the air channel, and the other end of the first medium pump is connected with a first medium source; each second medium pump is connected with a second medium source; the other end of each second medium pump is connected with a channel entrance section of one group of entrance and exit channels, and a channel exit section of each group of entrance and exit channels is connected with a second medium source; the computer controls the mode of operation of the first and the plurality of second media pumps.

Here, air is used as the first medium source and an ice-water mixture is used as the second medium source.

The embodiment also discloses a manufacturing method of the heart auxiliary stent, which is characterized in that a covering section of the stent 2-1 covered by a capsule film is determined according to the size and the shape of the heart of a patient; manufacturing a stent 2-1 with a plurality of groups of inlet and outlet channels and air ducts 2-11 inside, and then spirally forming a covering section of the stent 2-1 according to the size and the shape of the heart; controlling the stent 2-1 below the metamorphosis temperature, and covering the covering section with the cyst membrane to form the air sac 2-2.

For example, medical imaging equipment such as B-ultrasonic and heart CT is adopted, and a 3D printing technology is combined, so that the size and the shape of the heart can be easily obtained, and a human heart model can be manufactured; determining a covering section according to the size and the shape of the heart and the spiral turns of the heart auxiliary support as shown in figure 1; screwing the heart auxiliary support saccule onto the heart model from the bottom of the heart model to perform molding; then, installing an air bag, sleeving a bag membrane on the covering section of the bracket, and processing the bag membrane into the air bag;

In use, the heart assist device is connected as shown in fig. 1; a computer is used as a controller to control each access channel to be introduced with ice water, so that the guide wire 2-1 can be plastic at will, and the end part of the bracket 2-1 is inserted into the pericardium under the guidance of the guide wire after the percutaneous puncture intervention at the apex of the pericardium; then controlling ice water of the second channel entrance section 2-5 and the second channel exit section 2-6 to flow in, so that the section of the guide wire 2-1 is restored at the temperature of the human body, and in the restoration process, rotating the guide wire 2-1 to enable the spiral guide wire 2-1 to be sleeved on the periphery of the heart; after the section is recovered, controlling the ice water of the first channel entering section 2-3 and the first channel exiting section 2-4 to flow in again; the bracket 2-1 at the section is recovered to the original shape at the body temperature of the human body, and the bracket 2-1 is continuously rotated to complete the spiral; then controlling ice water of the fourth channel entering section 2-9 and the fourth channel exiting section 2-10 to flow in; the bracket 2-1 at the section is recovered to the original shape at the body temperature of the human body, and the bracket 2-1 is continuously rotated to complete the spiral; finally, controlling the inflow of ice water of the third channel entering section 2-7 and the third channel exiting section 2-8; the bracket 2-1 at the section is recovered to the original shape at the body temperature of the human body, and the bracket 2-1 is continuously rotated to complete the spiral; thereby completing the implantation of the balloon system of the heart auxiliary stent; when the air bag is used, the computer controls the air pump to blow air into the air bag according to the condition of a patient, so as to press the heart to assist the heart.

After use, the procedure is reversed in the order of guidewire intervention to remove the guidewire.