JPS6344385B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an active heart capsule device used to assist blood circulation when the blood circulation function of the heart is weakened.

When the blood circulation function of the heart decreases, the blood flow to the whole body decreases, making it difficult to supply oxygen and nutrients.
Oxygen supply to the heart also decreases, and the heart's function deteriorates further.

In such cases, advanced medical treatments such as drug administration, blood and fluid transfusions, and assisted breathing using a ventilator are performed.

However, if these treatments do not improve cardiac function, if left untreated, cardiac function will decline → cardiac output will decrease → aortic pressure will decrease → coronary blood flow will decrease → oxygen supply to the myocardium will decrease. Falling into a vicious cycle of decrease → myocardial avascular necrosis → decrease in cardiac function,
Eventually, death ensues.

The only methods left to break this vicious cycle are auxiliary circulation and auxiliary hearts, and an even more advanced one is the artificial heart.

Auxiliary circulation, an auxiliary heart, is a device that mechanically assists or substitutes the pumping function of the heart temporarily or semi-permanently until the heart recovers its function in the event of such cardiogenic shock, and maintains blood circulation. An artificial heart attempts to completely and permanently replace the functions of the heart.

Up to now, dozens of types of auxiliary circulation and auxiliary hearts have been experimentally investigated for this purpose, and many have reached the point of clinical application. Among them, the aortic Burn procedure (ABP), the venous artery bypass procedure (-Abypass), and the left heart bypass procedure (L-bypass) are recognized as particularly useful.

However, installing these auxiliary circulation devices on the human body will cause an invasion of the circulatory system, so it is necessary to avoid installing them prophylactically.On the other hand, it takes time to install them, so it is necessary to If you don't wear it, you won't be able to deal with sudden changes, which creates a paradox.

In such cases, it can be attached and detached in a nearly non-invasive manner,
If there were a simple auxiliary circulation device that could be installed prophylactically without causing any damage to the circulatory or respiratory systems, it would be easy to ensure safety against death due to acute heart failure in patients. It is thought that it will become.

For such sudden cardiac arrest, the cardiac pine surge method is said to be effective. Usually this method is
Although it is performed manually, fatigue of the practitioner becomes a major problem, and it is considered impossible for one person to perform pine surgery for more than 5 minutes, considering the effect on hemodynamics, so several operators take turns. A method has been adopted to do so.

However, since this method has varying auxiliary effects, a method using a simple machine has also been developed.

As an example, the pneumopine surge method has been developed by Pencini et al. in Italy.

In this method, air piping is placed directly into the heart sac, and when air is introduced into the heart sac, the air pressure compresses the heart, pumping blood from the left and right ventricles, and when the air is removed, the pressure on the heart is released. , blood flows into the ventricles. By repeating this cycle, blood is pumped out.

In addition, a method developed by John Johns et al. in the United States involves inserting a rubber balloon into the cardiac sac and blowing air into it to inflate the balloon.
It compresses the heart and makes it pump blood.

In addition to these, by incising the heart sac to expose the heart, and placing a so-called heart cup, a hard plastic cup with an air chamber made of an elastic material on the inside, to allow compressed air to enter and exit the inner air chamber. Another method involves periodically compressing the heart to pump blood.

However, each of the above conventional methods has the following drawbacks.

That is, in the pneumopine surge method, pressure is applied to all parts within the cardiac sac. As a result, both the left and right atria receive the same pressure as the ventricles, and the pressure in the atria and the veins upstream of them increases abnormally, leading to bleeding from the lungs.
It is a highly invasive method.

The method developed by Johns et al. aims to apply pressure to the left ventricle as selectively as possible by inserting a balloon between the left ventricular wall and the cardiac sac and inflating the balloon. However, since the balloons initially expand, they break when high pressure is applied, making it impossible to apply sufficient pressure. In response, they covered the balloon with a non-stretchable cover, which prevented the balloon from expanding more than necessary when pressurized, allowing them to apply high pressure to rapidly compress the ventricles.

However, even with this method, since the balloon expands into a spherical shape, there is a large expansion in an unnecessary direction, that is, a direction parallel to the ventricular wall, and in order to achieve effective pressurization, a large amount of compressed air must be injected. the number of expansions,
In other words, it is not possible to increase the number of heartbeats. Therefore, the cardiac output obtained with this method is quite low. In addition, because only one balloon is attached near the left ventricular wall, it is not possible to selectively pressurize the right ventricle, which simultaneously compresses the right atrium and pushes blood back into the venous system, causing blood to flow back into the right ventricle. The inflow of blood will be obstructed. If the amount of blood flowing into the right ventricle decreases, the stroke volume of the right ventricle decreases, and as a matter of course, the stroke volume of the left ventricle also decreases. For these two reasons, with this method, it is not possible to obtain the stroke volume required by the body, and the effective circulating blood volume decreases over time, making it impossible to maintain hemodynamics for several hours. be.

If the heart cup is properly attached, it compresses only the left and right ventricles, so blood can be pumped out efficiently and circulation can be maintained for a long period of time. However, this device cannot compress effectively unless it is adapted to the shape of the heart of the living body, so devices of many sizes must be prepared. Furthermore, the major drawback is that)
Because the size of the heart cup is considerably larger than the volume of the heart, it is difficult to insert it into the chest cavity, such as compressing the lungs. ) In order to provide long-term support, the chest must be closed after the cup is placed, but if the patient's heart function recovers,
The chest must be reopened to remove the device.
Reopening the thorax is highly invasive to the living body, and this assisted circulation method lacks the simplicity originally intended, and is no different from the usual assisted circulation method.
Furthermore, if the device is left in the thoracic cavity, there is a possibility that the lungs will become necrotic at the contact with the device.

The present invention compensates for the drawbacks of the conventional assisted circulation method, can maintain hemodynamics for several hours or more, and is simpler and newer. equipment).

Embodiments of the present invention will be described below based on the drawings. Reference numeral 1 is a sheet-shaped balloon manufactured by high-frequency bonding of medical vinyl chloride and having a suture glue margin 22 around the periphery. It is molded into a shape. In other words,) it is folded into a sheet shape or bellows shape without compressed gas, and the thickness is as thin as possible (for example, several
mm or less),) The size is large enough to adequately cover the ventricular wall,) When folded, the thickness is almost the same as that of the gas piping tube described later, and) It is easy to attach it along the outline of the heart. Yes,) does not put pressure on the atrium,) does not obstruct the movement of the heart when it is moving, and most importantly,) does not expand in multiple directions when compressed gas is introduced, and has a sheet-like double-sided structure. Or, the shape has a characteristic of mainly swelling only in one side, that is, in the direction perpendicular to the ventricular wall, in other words, in the direction orthogonal to the ventricular wall, such as an oval shape as shown in FIGS. It is formed into a circular shape as shown in the figure, an oval circular shape, a rectangular shape, and a slightly modified shape of these shapes to match the shape of the ventricular wall.

When molding into any of the above shapes,
The inside of the balloon is connected in a series so that the balloon inflates in a series, or the inside of the balloon is divided into several parts so that each part of the balloon inflates out of phase or inflates synchronously. It can be shaped like this. Moreover, blow molding, adhesion using a solvent, dove molding, and other molding methods can be employed as a molding method for these, depending on the material.

The dimensions of the sheet-shaped balloon 1 are, for example, 10 kg in weight.
For dogs with the shape shown in Figures 1 and 2, the dimension A in the major axis direction is 8 cm, and the dimension B in the minor axis direction.
should be 4 cm, and the diametrical dimension C in Figure 3 should be 6 cm. These dimensions A, B, and C must be changed appropriately depending on the size of the heart of the living body, but the maximum value of dimension A is 20 cm, and usually about 10 to 15 cm.

The material of the sheet-shaped balloon 1 is not limited to the above-mentioned medical vinyl chloride, but may have the following characteristics:
i.e.) not having much rubber elasticity; however, even in the case of highly elastic materials, those that are anisotropic and swell only in a specific direction, such as composite materials, are suitable for use;) having flexibility; and) having resistance to repeated fatigue. High strength,) High tensile strength and can be formed into a thin film,) No degeneration or deterioration in vivo, No adhesion to living tissue,)
Any material may be used as long as it has characteristics such as easy sterilization, and in addition to the above-mentioned medical vinyl chloride, polyurethane,
Examples include silicone rubber.

Reference numeral 2 designates a tube for gas piping, and in the sheet-shaped balloon 1 shown in FIG.
In the sheet-shaped balloon 1 shown in FIG. 2, the tip end is inserted into the balloon 1 about half of the dimension B along the longitudinal center line, and in the sheet-shaped balloon 1 shown in FIG. The tips are inserted into the balloon 1 about half of the dimension C along the center line, and are welded to the balloon 1 airtightly.

For the gas piping tube 2, it is preferable to use a tube with an inner diameter of about 2 mm to 10 mm, a wall thickness of about 0.1 mm to several mm, and which will not bend or collapse during use, such as a soft vinyl chloride tube. . Further, the gas piping tube 2 may be inserted into the balloon 1 for any length from any direction other than the direction along the center line of the sheet-like balloon 1.

Reference numeral 3 denotes side holes bored at several places at the tip of the gas piping tube 2 inserted into the sheet balloon 1;
It has a hole diameter of a size that allows air supply and exhaust from the sheet-like balloon 1 to be carried out quickly and reliably, for example, a hole diameter of about 0.5 mm to 3 mm.

4 is a 3-way 2-position type solenoid valve, and one connection port 5 has two or more sheet-like balloons 1,
The gas piping tubes 2, 2 of 1 are connected to one system, and the other connection port 6, 7 is connected to a compressed gas supply pipe 8.
and an exhaust pipe 9 are connected. 10 is a device that controls opening and closing of the solenoid valve 4.

Next, to explain how to use the active cardiac pericardial device (dynamic pericardium device) constructed as described above, the patient's chest is opened, and the left ventricle 13 is inserted between the cardiac sac 11 and the epicardium 12. The sheet-like balloons 1, 1 are inserted into positions facing the interventricular septum 15 on the outer wall of the right ventricle 14, and the solenoid valve 4 is opened and closed by the control device 10 to supply compressed gas or other compressed gas. and evacuation are repeated, and two or more sheet-like balloons 1, 1 are synchronously inflated and deflated, that is, pumped, between the cardiac sac 11 and the epicardium 12, and the ventricular wall is moved into the ventricle. By applying pressure periodically from a direction perpendicular to the septum 15, the movement of the heart muscle is directly mechanically assisted to pump blood.

In addition, two or more sheet-shaped balloons 1,
There is also a configuration in which electromagnetic valves are separately connected to one gas piping tube 2, 2 to divide the system into two or more systems, and each sheet balloon 1 is driven in a different phase. In addition, in the case of one system or two or more systems, air-operated valves, other valves, or various pumps that produce pulsating flow, such as reciprocating pumps and rotary pumps, may be used instead of solenoid valves. The sheet balloon 1 may be configured to be driven. Further, in either the above-mentioned one system or two or more systems, a rotating or non-rotating connector may be used for each gas piping tube 2. Moreover, in either the above-mentioned one system or two or more systems, compressed gas may be supplied to each sheet-like balloon 1 through a filter. Further, a contrast agent may be applied to a part of the sheet-like balloon 1 or a part of the gas piping tube 2.

In the above active cardiac device, ventricular fibrillation,
When cardiac function has stopped due to cardiac arrest or the like, the number of beats of each sheet balloon 1 is controlled by the control device 10.
It can be set arbitrarily. However, it is important to set the value to a value that increases the cardiac output as much as possible. It is preferable that one cycle of the pulse of each sheet-like balloon 1 is set to 200 to 1500 [ms], and the time for pumping the compressed gas to compress the heart is set to 100 to 800 [ms]. In addition, when the heart is beating, cardiac function is controlled by synchronizing the drive of each sheet-shaped balloon 1 using the R wave, P wave, T wave of the electrocardiogram, the rising of the blood pressure waveform, or the peak value as a trigger. can be partially substituted. The phase delay between the trigger signal and the timing of inflating each sheet balloon 1 is set to 0 to 500 [ms], and the driving positive pressure is set to 0.1 to 1.0.
[Kg/cm ² ], driving negative pressure is -50 to -500
It is best to set it to [mmHg]. Note that the pressure of these driving gases can also be driven under different conditions for each sheet-shaped balloon 1.

After the assistance is completed, each sheet-shaped balloon 1 may be left in the cardiac sac 11 as it is, and the gas piping tube 2 may be cut off midway and implanted subcutaneously to make it reusable. A tapered flange 1 is attached to the gas piping tube 2 of each sheet-shaped balloon 1 as shown in FIG.
6 and a threaded part 17, and with a nut 19 having a suture ring 18 screwed into the threaded part 17, each sheet-like balloon 1 is attached to the cardiac pericardium 11 and the epicardium 12.
When inserting the suture ring 18 between the two, the suture ring 18 is sewn onto the heart lining 11, and after the assistance is completed, the gas piping tube 2 is turned in the direction in which the threaded part 17 comes off from the nut 19, and each sheet By wrapping the balloon 1 around the tip of the gas piping tube 2 and then pulling the gas piping tube 2 outside the body, each sheet-shaped balloon 1 is attached to the nut 19, the thoracic cavity 20,
The chest wall 21 may be pulled out in this order and taken out of the body. In this case, the tapered flange 16 serves to smoothly remove the sheet balloon 1 wrapped around the tip of the gas piping tube 2. In addition, instead of the threaded part 17 and the nut 19, a locking part other than the same and a locking part that can be attached and detached by rotation to the locking part, for example, a structure that can be attached and detached by rotation, such as a concave and convex part, male and female, etc., can be used. Sometimes.

As described above, the balloon is folded into a sheet shape or bellows shape and assembled into a sheet shape, and is inserted between the cardiac vesicle and the epicardium. 2) The balloon can be inflated only in the direction that compresses the ventricle, 2) The volume occupied within the cardiac sac when not being driven can be reduced, and does not impede the movement of the heart, 2) The balloon can be inflated from within the thoracic cavity. When each balloon is indwelled in the thoracic cavity, the balloons are shaped into a sheet (which is easy to remove) and suture glue is provided around the sheet. It has the advantage of being able to be sewn on and providing more reliable assistance.

The present invention also does not utilize rubber elasticity and allows the sheet-shaped balloon to be inflated to either both sides or one side of the sheet-like balloon.) The durability is improved.) The balloon does not inflate in unnecessary directions, and the ventricles are inflated. A balloon is required that inflates only in the direction perpendicular to the outer wall of the ventricle, effectively pushing against the outer wall of the ventricle, and applying effective compression to the ventricle.This also makes it possible to respond to high frequencies (beat rates). Since the balloon does not inflate to a greater extent, there is less risk of compressing the atrium.) Since the driving gas pressure can be increased, the sheet-shaped balloon can be inflated more quickly.

Since the present invention uses two or more sheet-shaped balloons, it can be attached to fit the individual shape of the heart, and the compression area can be adjusted.) It can reliably compress both the left and right ventricles. (The rate of compression of the atrium is drastically reduced, which prevents a decrease in venous return flow and prevents a decrease in cardiac output.) Because the shape of each balloon becomes smaller , easy to remove from the thoracic cavity,) the drive phase of the left and right sheet balloons can be changed to adjust the pressure generated in the left and right ventricles, and) the pressure generated in the left and right ventricles can be adjusted while the heart is beating. If there is a difference in the degree of malfunction of the left and right sheet balloons, this can be handled by changing the driving conditions of the left and right sheet balloons. Since the inside of the ventricle is divided into several parts that inflate, it is possible to gradually shift the phase of inflating these parts to give directionality to the compression of the ventricle, resulting in more effective pumping. It has the following advantages.

[Brief explanation of the drawing]

Figure 1 shows an example of a sheet balloon and a gas piping tube connected to it, Figure 2 shows another example of a sheet balloon and a gas piping tube connected to it, and Figure 3 shows a sheet balloon and a gas piping tube connected to it. FIG. 4 is a diagram showing yet another example of a balloon and a tube for gas piping connected thereto, FIG. It is a figure which shows an example of the removal of the sheet-like balloon from the thoracic cavity in a molded pericardial sac device. 1...Sheet balloon, 2...Tube for gas piping,
4... Solenoid valve, 8... Air supply pipe, 9... Exhaust pipe, 10... Control device.

Claims (1)

[Claims] 1. In a state where compressed gas is not introduced, the sheet-like
Or, it is shaped like a sheet folded into a bellows shape, and when filled with compressed gas, it expands to both sides or one side of the sheet, and is shaped to be inserted between the cardiac vesicle and the epicardium. An active type core for auxiliary circulation consisting of two or more sheet-shaped balloons, gas piping tubes connected to these sheet-shaped balloons, and a compressed gas supply/exhaust device connected to these gas piping tubes. equipment. 2. The active pericardial device for auxiliary circulation according to claim 1, wherein the gas piping tube is connected to supply and exhaust compressed gas to two or more sheet-shaped balloons in one system. 3. The active pericardial device for auxiliary circulation according to claim 1, wherein the gas piping tube is connected to supply and exhaust compressed gas to two or more sheet-like balloons in separate systems. 4. The active auxiliary circulation system according to any one of claims 1 to 3, wherein the compressed gas supply/exhaust device includes a solenoid valve, an air-operated valve, or another valve connected to a gas piping tube. A type of heartworm device. 5. The active pericardial device for auxiliary circulation according to any one of claims 1 to 3, wherein the compressed gas supply/exhaust device comprises a reciprocating pump or a rotary pump. 6. The active core for auxiliary circulation according to any one of claims 1 to 5, wherein the sheet-like balloon is formed so that the inside of the balloon is connected in series and inflated in a series. equipment. 7. Any one of claims 1 to 5, wherein the sheet-shaped balloon is formed so that the inside of the balloon is divided into several parts, and each part of the balloon inflates out of phase or in synchronization. Active cardiac sac device for auxiliary circulation as described in . 8. Claims 1 to 8, wherein the gas piping tube includes an engaging portion, a locking portion that is attached to and detached from the engaging portion by rotation, and a suturing ring provided on the locking portion. 8. Active cardiac capsular device for auxiliary circulation according to any of clause 7. 9. The active pericardial device for auxiliary circulation according to any one of claims 1 to 7, wherein the sheet-shaped balloon is provided with a suture glue margin on all or part of the periphery of the balloon. .