JP7414870B2 - New intra-aortic balloon blocking device - Google Patents

Description

The present invention relates to a novel intra-aortic balloon occlusion device. More specifically, the present invention relates to a novel intra-aortic balloon blocking device that can automatically inflate and deflate a balloon using a specific waveform of an electrocardiogram or arterial pulse wave as a trigger.

The technique of intra-aortic balloon occlusion is used to treat organ bleeding due to external or internal factors, and involves inserting a balloon-equipped catheter through an artery in an extremity, such as the femoral artery or brachial artery. By expanding a balloon (hereinafter referred to as inflation or inflation) within the abdominal aorta, blood flow downstream thereof is blocked (as appropriate, see FIG. 1; the same applies hereinafter). This suppresses bleeding from organs downstream from the blockage site (e.g., spleen, kidneys, liver, pelvic organs, etc.), and at the same time suppresses bleeding from organs that are essential for life support, such as the brain, heart, and lungs, even if only for a short time. It is possible to maintain or increase blood flow to organs. For bleeding in intra-abdominal organs such as the liver, bile, pancreas, spleen, kidneys, and intestinal tract, block it in Zone I (between the left subclavian artery branch of the thoracic descending aorta and the celiac artery branch), and then remove the pelvis. For bleeding in internal organs or lower extremities, block off at Zone III (between renal artery branches and right and left common iliac artery branches). Blocking Zone II (between the celiac artery branch and the renal artery branch) is not recommended because it has no additional effect compared to other Zones and increases the risk of organ ischemia. It won't happen. Intra-aortic balloon occlusion cannot stop bleeding on its own; temporary bleeding control is performed, in other words, radical hemostatic operations such as transcatheter arterial embolization (TAE) or hemostasis surgery are performed while the occlusion buys time. It is something.

REBOA (Resuscitative Endovascular Balloon Occlusion of Aorta) and IABO (Intra-Aortic Balloon Occlusion Catheter) A) reported that two people were injured during the Korean Civil War in 1954. The use of Lieutenant Colonel Hughes in a case was the first to be reported, and since 2016 when Prytime Medical (Boerne, TX)'s REBOA-ER was approved by the FDA, the number of cases of use has increased explosively.

However, this technique has the disadvantage of causing a number of medical complications, as described below. (b) Organ ischemic injury: Since blood flow downstream of the blocked site is blocked, organs are damaged reversibly or irreversibly due to ischemia. (b) Thrombosis: When blood stagnates for a long time or turbulence occurs, it clots and forms a thrombus. While the balloon is being inflated, a blood clot may form near the balloon, and when the balloon is deflated (hereinafter referred to as deflation) or the catheter is removed, the formed blood clot may fly to downstream organs and occlude blood vessels. (Lower limb artery embolism, splenic/renal/hepatic infarction, spinal cord infarction, superior mesenteric artery embolism, etc.). (c) Heart failure/cerebral hemorrhage: Because the blood in the body is collected in the upper body, blood pressure in organs upstream of the block may become too high. Blood pressure in the blood vessels of the brain can become high and cause them to rupture, causing cerebral hemorrhage. Furthermore, during balloon inflation, the heart experiences resistance when pushing out blood (hereinafter referred to as afterload), causing heart failure. (iv) Ischemia-reperfusion injury: When an organ is left in a state of ischemia for a certain period of time and then blood flow is resumed, the tissues and intracellular substances (various cytokines, potassium, etc.) damaged during the ischemic period are It is a phenomenon that is released into the blood and has an adverse effect on organs, tissues, and cells throughout the body or locally.

Attempts are currently being made to prevent complications by devising ways to use it. For example, there are methods called "intermittent REBOA" and "partial REBOA" (Non-Patent Documents 1 to 4).
"Intermittent REBOA" (hereinafter referred to as i-REBOA) is a method in which the balloon is intermittently fully deflated (full deflation) and blood flows downstream. This is a method of restarting blood flow downstream by providing a deflation period.
"Partial REBOA" (hereinafter referred to as p-REBOA) is a method in which the balloon is not completely inflated, but is used in an incompletely inflated state (partial inflation).The balloon is partially inflated until it is slightly narrower than the diameter of the aorta. This is a method to ensure downstream blood flow.

However, the above-mentioned techniques have not overcome the disadvantage that many complications such as organ ischemia damage occur.
For example, a problem with i-REBOA is that the cutoff time and blood flow restart time are not optimized. There is no medical basis for setting the inflation time to 30-90 minutes or the deflation time to 5-15 minutes. During the relatively long blood flow resumption time of 5-15 minutes, events may occur in which bleeding cannot be controlled or blood is not sufficiently delivered to the heart and brain due to blood being taken to downstream organs. , shock may worsen. For this reason, REBOA may not be able to achieve its original purpose, such as causing cardiopulmonary arrest or hypoxic encephalopathy. Furthermore, it is not clear how long the downstream organs can withstand blood flow interruption, which is insufficient to prevent organ ischemic damage. Moreover, thrombosis and ischemia-reperfusion injury can occur with a complete blockage time of 30-90 minutes, and afterload is applied over a relatively long period of time. In other words, it is an insufficient method to prevent complications such as organ ischemia damage while suppressing bleeding.
A problem with p-REBOA is that setting conditions for suppressing blood flow to suppress hemostasis while still maintaining blood flow to an extent that prevents ischemia in downstream organs is extremely difficult and may differ from case to case. In other words, the amount of bleeding differs for each case, and the degree to which the physiological feedback mechanism of the living body is expressed in response to the amount of bleeding also differs. Furthermore, cardiac output and blood vessel diameter change over time due to the influence of various drugs administered during treatment. Therefore, it is impossible to determine how large a balloon should be inflated in each individual case. Furthermore, it is necessary to manually adjust for changes over time. As mentioned above, this intra-aortic balloon blockage is performed during TAE or hemostasis surgery, so manually inflating/deflating and adjusting the balloon during such hemostasis operations places a heavy burden on the operating doctor. Sometimes it's impossible. That is, this method is also insufficient for preventing complications such as organ ischemia damage while suppressing bleeding.

As a result, no conclusion has been reached as to whether the use of this technique in trauma patients improves their prognosis. There is also data showing that the use of REBOA reduces the survival rate of trauma patients. Therefore, at present, REBOA must be applied with caution. Currently, the conditions for which it is applicable are very limited.

In addition, since neither i-REBOA nor p-REBOA is used in synchronization with the heartbeat, there is no need for the existing REBOA to repeatedly inflate and deflate the balloon; , manual expansion/deflation operations lasting several minutes are limited to manual saline injection. The devices used for this purpose can only perform slow expansion/deflation movements over a period of several minutes.

On the other hand, there is a technique called intra-aortic balloon pumping (hereinafter referred to as IABP), which repeatedly inflates and deflates a balloon rapidly in synchronization with heartbeat. The IABP drive device, which uses helium gas with low tube resistance instead of saline, enables highly responsive balloon expansion/deflation operations synchronized with heartbeats.
IABP is a technology used in the field of cardiovascular medicine, and is a type of auxiliary circulation method that supports the heart's pumping function, which has decreased due to heart failure, myocardial infarction, etc. REBOA is a technique that blocks or reduces blood flow. This is, so to speak, a technology in the opposite direction. In this technique, a balloon-equipped catheter is inserted primarily through the femoral artery, and a cylindrical balloon tip with hemispherical ends is placed in the descending aorta. The balloon is inflated/deflated and pulsates in accordance with the movement of the heart. Specifically, the electrocardiogram waveform and arterial pressure waveform are sensed, and the balloon is injected during the ventricular diastole of the heart, and the balloon is inserted during the ventricular systole of the heart to increase the amount of blood flowing into the coronary arteries through a pumping action. This has the effect of deflating the heart and reducing the afterload on the heart.

DIRECT REBOA Seminar Official Text REBOA Handbook, supervised by DIRECT Study Group, March 2021, Health Publishing. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA): update and insights into current practices and future directions for research and implementation Thrailkill et al. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine,2021 Jan 6 The complications associated with Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), Marcelo A F Ribeiro Junior et al., World J Emerg Surg., 2018 May 11 Kenji Fujita et al., “The forefront of hemorrhagic shock treatment using REBOA,” Surgery and Metabolism 54 (4), p. 163-169, October 2020.

Conventional intra-aortic balloon occlusion methods have not been able to sufficiently overcome complications such as organ ischemia damage. Therefore, an object of the present invention is to develop an intra-aortic balloon occlusion method that can further prevent the occurrence of complications, and to provide a device suitable for the method.

As a result of intensive studies to solve the above problems, the present inventors focused on the pulse wave, which affects the amount of bleeding, and particularly on the main constituent factors thereof, systolic blood pressure, diastolic blood pressure, and pulse rate. By inflating and deflating the balloon in response to the electrocardiogram and arterial pulse wave upstream of the balloon and controlling the values of systolic blood pressure, diastolic blood pressure, and pulse rate of the pulse wave downstream of the balloon, the balloon can be used while suppressing bleeding. We came up with the idea of preventing complications such as organ ischemia by flowing the minimum necessary amount of blood downstream, and arrived at the present invention.
That is, the present invention is as follows.
1. An intra-aortic balloon blocking device comprising a catheter inserted into the aorta and a balloon that can be inflated and deflated at the tip of the catheter,
By automatically inflating and deflating the balloon within the aorta using the electrocardiogram and/or the arterial pulse wave upstream of the balloon as a trigger, the maximum blood pressure and/or minimum blood pressure and/or pulse of the arterial pulse wave downstream of the balloon can be automatically inflated and deflated. This is an adjustment to lower the number.
The response time from the trigger of the electrocardiogram and/or arterial pulse wave waveform upstream of the balloon to the start of deflation/inflation of the balloon is 1 second or less;
The maximum inflation rate of the balloon is 50 cc/sec or more, and the maximum deflation rate is 50 cc/sec or more.
Intra-aortic balloon occlusion device.
2. The automatic balloon inflation and deflation is triggered by a waveform that indicates the start of ventricular systole of the heart, inflates the balloon during ventricular systole, and uses a waveform that indicates the start of ventricular diastole of the heart as a trigger to inflate the balloon during ventricular diastole. The intra-aortic balloon occlusion device of the first stage is to deflate the .
3. The automatic balloon inflation and deflation
The balloon deflates, triggered by a waveform that indicates the start of ventricular systole in the heart, at a rate of fewer beats out of multiple beats, and the period of time that appears between the start of ventricular diastole and the start of ventricular systole in the heart. It expands using that waveform as a trigger,
During the remaining beats, the balloon does not respond to the waveform and maintains the inflated state.
4. The automatic balloon inflation and deflation
At a rate of fewer beats among multiple beats, the balloon is deflated using a waveform indicating the start of ventricular systole of the heart as a trigger, or the balloon is maintained in a deflated state, and the ventricular flow starts from the start of ventricular diastole of the heart. Inflate triggered by any waveform that appears during the onset of systole,
During the remaining beats, the balloon is inflated or maintained in an inflated state during ventricular systole using a waveform indicating the start of ventricular systole as a trigger, and the balloon is deflated using a waveform indicating the start of ventricular diastole as a trigger.
The intra-aortic balloon occluding device according to 1 above.
5. 5. The intra-aortic balloon blocking device according to any one of 1 to 4 above, which inflates and deflates the balloon by moving helium gas or carbon dioxide gas.
6. Inside the aorta of any one of the first stages 1 to 5, which has a mechanism that adjusts the inflation and deflation of the balloon based on feedback from the measured values of systolic blood pressure and/or diastolic blood pressure and/or pulse rate of the arterial pulse wave downstream of the balloon. Balloon cutoff device.
7. The intra-aortic balloon blocking device according to any one of items 1 to 6, comprising an additional balloon that is installed in the aorta downstream of the balloon and completely blocks blood flow when inflated.

According to the device of the present invention, it is possible to realize an intra-aortic balloon occlusion method that can further prevent the occurrence of complications. As a result, patient prognosis can be improved and intra-aortic balloon occlusion can be used not only in cases of severe bleeding, but also for moderate and prophylactic use.

A schematic diagram of the human aorta is shown. It is shown for each physiological pressure. The minimum perfusion pressure is the minimum amount of blood required to maintain tissue. The relationship between the amount of bleeding (corresponding to the amount of tissue perfusion) and each physiological pressure was shown. The relationship between physiological pressure and bleeding in conventional REBOA was shown. (A) is a diagram for i-REBOA, and (B) is a diagram for p-REBOA. The relationship between physiological pressure and bleeding when using the device of the present invention is shown. (A) is a diagram when blood pressure is controlled, and (B) is a diagram when pulse rate is controlled. An embodiment of the device of the invention is shown installed in an artery. An embodiment of the device of the invention with an additional balloon is shown installed in an artery.

The present invention will be explained in detail below.
1. Configuration of an intra-aortic balloon blocking device The intra-aortic balloon blocking device is composed of a balloon catheter having a balloon at the tip of the catheter, a driving part for inflating and deflating the balloon, and a control part for controlling the inflation and deflation.
Furthermore, it is necessary to be able to input electrocardiogram and/or arterial pulse wave signals upstream of the balloon. For example, it may be provided with a terminal for signal input, or the device of the present invention may have a sensor for directly measuring the arterial pulse wave upstream of the balloon. The sensor may be, for example, a conventional invasive blood pressure sensor placed in a peripheral artery of the upper body, such as the radial artery. The sensor can be inserted through the brachial or radial artery, or a balloon-equipped catheter body can be equipped with a sensor that measures the arterial pulse wave upstream of the balloon at the tip, and the sensor can be inserted along with the balloon-equipped catheter through the femoral artery. You can.
Further, it is more preferable that the device is capable of inputting signals of arterial pulse waves downstream of the balloon. In this case, a terminal for signal input may be provided, or the device of the present invention may have a sensor for directly measuring the arterial pulse wave downstream of the balloon. The sensor may be, for example, the sensor of the invasive blood pressure meter described above. The sensor may be installed as shown below to measure the arterial pulse wave. You can place a sensor in the sheath (tube) placed in the femoral artery and measure the blood flow in the gap between the sheath and catheter, or you can measure blood flow from the femoral artery on the opposite side to the side where the balloon-equipped catheter is inserted. A single sheath may be left in place and the sensor inserted through it. Furthermore, a sensor may be attached to the catheter portion of the balloon catheter downstream of the balloon, and the catheter may be inserted from the femoral artery together with the balloon-equipped catheter. In this way, if a downstream sensor is installed and the downstream arterial pulse wave can be observed on a monitor based on the signal from the sensor, it becomes possible to check whether the downstream pulse wave is appropriately controlled.
The balloon blocking device of the present invention blocks the aorta by expanding the balloon, and opens the blood flow by contracting the balloon. Blocking the aorta includes complete blockage, which completely blocks the aorta, and partial blockage, which blocks part of the aorta. Similarly, opening includes not only full opening, in which the balloon is completely deflated, but also partial opening, in which the balloon is not completely deflated.
The degree of occlusion and the degree of opening of the aorta are adjusted by adjusting the degree of inflation of the balloon. It is more preferable that the degree of inflation of the balloon can be adjusted to 10 to 90%, and particularly preferably 0 to 100% so that the balloon can be sufficiently blocked and opened. Furthermore, it is more preferable that the level of swelling can be adjusted freely, that is, continuously, but it may also be adjustable in stages such as 0%, 20%, 40%, 60%, 80%, and 100%.
The balloon is automatically inflated and deflated according to the electrocardiogram and/or arterial pulse wave input signals upstream of the balloon. Normally, an electrocardiogram is input, but if there is noise due to the use of an electric scalpel, if the patient is in cardiac arrest or using a heart-lung machine, or if an electrocardiogram cannot be obtained properly due to arrhythmia, etc., the upstream arterial pulse wave is input. The input signal is used to automatically inflate and deflate the balloon.

2. Automatic balloon inflation/deflation according to electrocardiogram and arterial pulse wave Systolic blood pressure (systolic blood pressure), diastolic blood pressure (diastolic blood pressure), and pulse rate are the main factors that affect the amount of bleeding.
The present invention inflates and deflates the balloon according to the electrocardiogram and the arterial pulse wave upstream of the balloon, and controls the downstream side of the balloon to lower systolic blood pressure (systolic blood pressure), diastolic blood pressure (diastolic blood pressure), and pulse rate. This invention is based on a new technical concept that ensures the required minimum amount of tissue perfusion downstream of the balloon while suppressing the amount of bleeding. To put it simply, a typical example of low levels of these factors is venous blood, and low-pressure, non-pulsatile venous bleeding is easy to control, and spontaneous hemostasis can occur. The present invention is an invention of a device that aims to control bleeding by changing arterial blood into a low-pressure, non-pulsating blood flow similar to venous blood flow, while also allowing the minimum necessary amount of blood to flow downstream of the balloon. .
For example, depending on the electrocardiogram, a balloon can be partially inflated during the ventricular systole of the heart when blood pressure rises to suppress downstream systolic pressure, and the balloon can be partially deflated during the ventricular diastole of the heart to allow blood to flow downstream. , blood can flow downstream while suppressing bleeding. While maintaining bleeding control, which is the original purpose of intra-aortic balloon occlusion, blood can flow downstream of the balloon to prevent complications.
Rather than simply stopping blood flow intermittently or partially, it is possible to reduce, stop, or restore blood flow downstream of the balloon using a high-frequency balloon movement pattern that responds to electrocardiograms and/or arterial pulse waves. By returning the balloon, the systolic blood pressure (systolic blood pressure), diastolic blood pressure (diastolic blood pressure), and pulse rate downstream of the balloon are controlled to lower, thereby suppressing bleeding and allowing blood to flow downstream. The purpose of IABP is to increase coronary artery blood flow during ventricular diastole and reduce upstream blood flow during ventricular systole to eliminate afterload. The balloon is adjusted in such a way that the balloon is completely deflated during the ventricular systole, and the blood flow is restarted, and the inflation and deflation movements are different from those of the present invention.

3. Control of Blood Pressure Downstream of the Balloon Automatic balloon inflation/deflation in response to an electrocardiogram and/or an arterial pulse wave upstream of the balloon can be performed as follows.
By inflating the balloon during ventricular systole of the heart and deflating the balloon during ventricular diastole of the heart, the blood pressure downstream of the balloon is controlled to be lowered and equalized.
Specifically, the balloon is inflated using a waveform indicating the start of ventricular systole, for example, immediately after the end of the P wave in an electrocardiogram, or a waveform indicating the timing when end-diastolic pressure is lowest in an arterial pulse waveform, as a trigger. Then, contraction is started using a waveform indicating the start of ventricular diastole, for example, near the apex of a T wave in an electrocardiogram or a dicrotic notch waveform in an aortic pulse wave. Just to be sure, the waveform at the end of ventricular diastole also indicates the start of systole, so it can be said to be a waveform indicating the start of ventricular systole. Similarly, since the waveform at the end of ventricular systole also indicates the start of diastole, it can be said to be a waveform indicating the start of ventricular diastole.
In the present invention, the balloon is inflated and deflated (including partial inflation and partial deflation) to completely block, completely open, partially block, and partially open the aorta. Since the degree of inflation of the balloon can be adjusted, complete blocking, complete opening, partial blocking, and partial opening can be freely performed. Note that, depending on the thickness of the aorta, complete expansion does not necessarily mean complete blockage. Rather, partial expansion often results in complete blockage.
The degree of inflation and deflation of the balloon is determined by taking into account the state of bleeding, the blood pressure of the pulse wave downstream of the balloon, and the pulse rate. The degree of expansion and contraction do not need to be constant, and may be changed midway depending on the state of bleeding and pulse wave. If the degree of bleeding cannot be controlled, the degree of inflation of the balloon is set high or the degree of deflation is set low. Conversely, if the pulse wave is less than the required minimum tissue perfusion amount, the degree of inflation of the balloon is set low or the degree of deflation is set high.
As described above, the device has a control program that can automatically inflate and deflate in response to electrocardiogram and/or arterial pulse wave signals.

4. Control of Pulse Rate Downstream of the Balloon Automatic balloon inflation/deflation in response to an electrocardiogram and/or an arterial pulse wave upstream of the balloon can also be performed as follows.
During the ventricular systole of the heart, which pumps blood throughout the body, the balloon is deflated during at least one of the fewer number of beats. For example, the balloon may be deflated at 2 out of 3 beats, 1 out of 4 beats, and 1 out of 11 beats. Pulsation will resume when the balloon is deflated. If it is 2 out of 3 times (1 time shut off, 2 open times), it will be 2/3, if 1 out of 4 times (3 times shut off, 1 time open), it will be 1/4, and once in 11 times. (blocking 10 times, opening once), the pulsation rate downstream of the balloon can be controlled to 1/11. The opening rate is set in consideration of the bleeding state, the blood pressure of the pulse wave downstream of the balloon, and the pulse rate. This ratio does not need to be constant, and may be changed midway depending on the bleeding condition and the like. If the degree of bleeding cannot be controlled, the rate of opening is decreased, and conversely, if the pulse wave does not meet the required minimum tissue perfusion rate, the rate of opening is increased.
In this way, the pulsation rate is controlled to lower, thereby suppressing bleeding and allowing blood to flow downstream of the balloon. It is particularly preferable that the number ratio of balloon deflation can be freely set, but it may also be set within a range of about 1:2 (2/3 of the beat) to 10:1 (1/11 of the beat).
Note that when the heart rate is high, a faster response time and faster inflation/deflation speed are required.
If the remaining three times are partially blocked when the pulse wave is opened every fourth time, the pulse wave will remain weak, but the concept is the same.
Specifically, the balloon deflates using a waveform that indicates the start of ventricular systole of the heart, such as immediately after the end of the P group in an electrocardiogram or a waveform that indicates the timing when the end-diastolic pressure is at its lowest in an aortic wave, and starts ventricular diastole. Any waveform that appears from the start of ventricular systole to the start of ventricular systole, such as near the apex of the T wave in an electrocardiogram, or the dicrotic notch waveform in an aortic pulse wave, or the waveform immediately after the end of the P wave in an electrocardiogram, or expansion in the aortic wave. The balloon is inflated using the waveform indicating the lowest end-stage pressure as a trigger. During the remaining beats, the balloon remains inflated without responding to the waveform. Just to be sure, the waveform at the end of ventricular diastole also indicates the start of systole, so it can be said to be a waveform indicating the start of ventricular systole. Since the waveform at the end of the cardiac systole is also followed by the start of the diastole, it can be said to be a waveform indicating the start of the ventricular diastole.
The balloon is inflated and deflated (including partial inflation and partial deflation) to completely block, completely open, partially block, and partially open the aorta. With the device of the present invention, complete shutoff, complete opening, partial shutoff, and partial opening can be freely performed. Note that, depending on the thickness of the aorta, complete expansion does not necessarily mean complete blockage. Rather, partial expansion often results in complete blockage.
As described above, the device has a control program that can automatically inflate and deflate in response to electrocardiogram and/or arterial pulse wave signals.

5. Control of blood pressure and pulse rate downstream of the balloon Automatic balloon inflation and deflation can also be performed by combining the two methods described above. In this method, the balloon is deflated during a smaller number of beats, and during the remaining beats, rather than blocking the aorta, blood pressure downstream of the balloon is controlled to allow blood to flow downstream of the balloon. For example, the following method is used.
1st beat (heart rate adjustment): Deflate the balloon using a waveform indicating the start of ventricular systole of the heart as a trigger, and inflate using a specific waveform that appears between the start of ventricular diastole and the start of ventricular systole as a trigger.
2nd beat (blood pressure adjustment): The next waveform indicating the start of ventricular systole maintains the inflated state (including the case where it contracts to some extent and narrows the blocked part) or expands, and the waveform indicating the start of ventricular diastole triggers contraction. do. Although it is difficult to define "a certain degree", it is a contraction that is approximately half the cross-sectional area of the aorta.
Third beat (blood pressure adjustment): Inflates using the waveform indicating the start of ventricular systole as a trigger, and contracts using the waveform indicating the start of ventricular diastole as a trigger. Repeat this.
Nth beat (heart rate adjustment): Maintain a contracted state with a waveform indicating the start of ventricular systole (including expanding to a certain extent and narrowing the open part) or contract between the start of ventricular diastole and the start of ventricular systole Expands using a specific waveform that appears as a trigger. Although it is difficult to define "a certain amount", it is an expansion that is approximately half the cross-sectional area of the aorta.
N+2nd beat (blood pressure adjustment): Same as the 2nd beat.
N+3rd beat (blood pressure adjustment): Same as the 3rd beat.
The degree of inflation, degree of deflation, and rate of release are set in consideration of the bleeding state, blood pressure of pulse waves downstream of the balloon, and pulse rate. These may be changed during the process.
The device has a control program that can automatically inflate and deflate in response to electrocardiogram and/or arterial pulse wave signals as described above.

[Principle of preventing organ ischemia while preventing bleeding]
We will explain in detail the mechanism that can prevent complications of organ ischemia by maintaining the required minimum perfusion pressure while preventing bleeding downstream of the balloon.
(1) What is bleeding control? Each physiological pressure can be expressed in Figure 2. The main factors constituting the pulse wave are arterial pressure, systolic blood pressure (systolic blood pressure), diastolic blood pressure (diastolic blood pressure), and pulse rate. Normal tissue perfusion occurs in areas where pulse waves are higher than tissue pressure. In other words, the tissue perfusion amount is the amount obtained by subtracting the tissue pressure from the pulse wave and integrating it over time, and is expressed by the area of the dark gray portion in FIG. 3. As a medical premise, the required minimum tissue perfusion rate is not as necessary as the normal range of arterial pressure, but is excessive. Furthermore, it does not have to be a wave consisting of peaks of systolic blood pressure and troughs of diastolic blood pressure, and may be a steady flow. In other words, the required minimum tissue perfusion amount is excessive for normal arterial pressure and pulse rate, and it is sufficient that the area of the dark gray portion shown in FIG. 3 is secured to some extent.
On the other hand, bleeding refers to blood in the arteries and veins and blood perfusing tissues flowing out of the blood vessels, so the amount of bleeding is also proportional to the area of the dark gray part. Therefore, suppressing the amount of bleeding can be thought of by reducing the area of the dark gray part in FIG. 3.
For example, the method of blocking an artery to stop bleeding is to lower the pulse wave during the blockage period, and in Figure 3, the area of the dark gray area is zero, so it is necessary to block the artery. Tissue perfusion downstream of the site also becomes zero. Furthermore, in the method of compressing the tissue, in FIG. 3, the area of the dark gray portion becomes zero by increasing the tissue pressure higher than the pulse wave. The amount of tissue perfusion in the compressed area also becomes zero.
(2) Conventional REBOA
Conventional i-REBOA can stop bleeding during 30-90 minutes of inflation, but there is no tissue perfusion. During this period, organ ischemia damage occurs and blood clots also occur. Although tissue perfusion can be resumed during contraction for 5-15 minutes, bleeding cannot be controlled during this period (Figure 4(A)). With p-REBOA, perfusion to downstream tissues can be ensured, but if the balloon is too inflated, the amount of bleeding cannot be suppressed, and if it is too inflated, the amount of tissue perfusion becomes insufficient (FIG. 4(B)). As described in [0006], in actual clinical practice, it is impossible to adjust the balloon to an appropriate state because the arterial pulse wave changes over time.
(3) Intra-aortic balloon blockade of the present invention Figure 5 (A) shows the physiological pressure response when the balloon is partially blocked during ventricular systole and partially to completely opened during ventricular diastole in the present invention. The idea is to ensure the required minimum tissue perfusion pressure while reducing blood loss. Further, FIG. 5(B) shows a diagram of physiological pressure when the ratio of complete blockage to partial release with respect to the pulse rate is 2:1. It shows a mechanism to suppress bleeding by controlling pulse rate.

6. Maintaining blood flow to important organs upstream of the balloon As mentioned above, the inflation and deflation of the balloon is controlled, but of course the primary purpose of intra-aortic balloon blockage is to maintain blood flow to important organs upstream of the balloon such as the brain, heart, and lungs. If it is determined that the blood pressure upstream of the balloon cannot be maintained, the aorta may be completely blocked by switching to manual mode. More preferably, the device of the invention has a switching mode to manual operation and can be operated manually if necessary.

7. Device response time and maximum speed of balloon inflation/deflation In order to avoid delays in the timing of balloon inflation/deflation, the response of the device and the balloon inflation/deflation speed must be sufficiently fast relative to the movement of the heart. In other words, it needs to be sufficiently fast with respect to the movement of the electrocardiogram and aortic wave.
The response time of the device is preferably 1 second or less, more preferably 200 ms or less, even more preferably 100 ms or less, and particularly preferably 10 ms or less. The shorter the response time, the better.
Since the heart moves in milliseconds, it is considered that a time of about 1 ms is sufficient. More precisely, response time refers to the time it takes for an output signal to respond to an input signal to a control system.
The maximum speed of inflation is preferably 1 second or less, more preferably 100 ms or less to inflate 50 cc of the balloon. The maximum speed of contraction is also preferably 1 second or less, more preferably 100 ms or less for 50 cc contraction. The faster the expansion speed, the better, but since the heart moves in milliseconds, it may be sufficient to make it around 50cc/10ms.
Adding the response time and inflation speed, it will take less than 1 second + 1 second = 2 seconds from pressing the switch until the inflation is completed by 50cc.
In order to achieve this inflation/deflation speed, it is more preferable to inflate/deflate the balloon by moving helium gas or carbon dioxide gas, which has less tube resistance. Helium gas is superior in terms of less resistance, but carbon dioxide is less dangerous if the balloon bursts, so carbon dioxide is better for use in pre-hospital relief at disaster sites, battlefields, etc. It is easy to obtain and safe, and carbon dioxide gas also has merits.
As a driving part for moving these gases, typically a pump, a compressor-type pump or a bellows-type pump used in IABP, for example, may be used.

8. Shape of the Balloon The shape of the balloon is not particularly limited, and may be, for example, spherical or cylindrical with hemispherical ends. If the shape is cylindrical, depending on how the heart expands from the distal side to the proximal side or from the proximal side to the distal side, it can affect the blood pressure upstream or downstream, respectively. Furthermore, when the aortic pressure is high, the force exerted by the blood pressure to push the balloon away while the balloon is inflated. The force may deform or damage the catheter. Cylindrical balloons are supported by the blood vessel wall, so they have the advantage of being less prone to deformation. However, since a cylindrical balloon has a long major axis, it is difficult to adjust the position of the balloon, so care must be taken. If the balloon extends to the common carotid artery or subclavian artery, blood flow to the brain will be blocked when the balloon is expanded.

9. Benefits other than preventing organ ischemia The above method allows blood to flow downstream of the balloon while suppressing bleeding, making it possible to further suppress complications of organ ischemia. Since intermittent balloon movements are performed in milliseconds, long-term stagnation of blood flow does not occur, making it difficult for thrombus formation to occur, and furthermore, it is thought that the time during which afterload is applied can be shortened.
In addition, in conventional REBOA, it was necessary to manually manipulate the balloon during hemostasis operations such as TAE or surgery, which was an obstacle for doctors, but with the device of the present invention, a programmed mechanical Management is easy because it is automatically managed by operation.
Furthermore, REBOA can only be used in Zone I and Zone III, and if the balloon is abnormally misaligned in Zone II, there is a risk of increased bleeding or ischemic damage, and the position must be corrected. was there. However, since the device of the present invention ensures downstream blood flow, even if the balloon slips into Zone II, it can be used as is as long as the blood vessels that cause bleeding are blocked. .
Additionally, since complications are less likely to occur, there are the following indirect benefits: It can be used for a longer time than conventional REBOA. Expansion of adaptation to various conditions and diseases. It will be possible to use it for pre-hospital relief on battlefields and disaster sites, that is, outside hospitals. In other words, REBOA was only indicated for severe hypovolemic shock such as severe traumatic hemorrhage, but in the present invention, it can be used for mild to moderate shock, and during induction of anesthesia. It can be used prophylactically to prevent sudden drops in blood pressure, and can also be used to treat shocks caused by abnormal blood distribution, such as septic shock and anaphylactic shock. Therefore, it can be used as an emergency treatment even before a definitive diagnosis has been made based on thorough examinations at a hospital.

10. Feedback Control Based on Blood Pressure, etc. Downstream of the Balloon The device of the present invention may have a function of analyzing the blood pressure and pulse rate of the arterial pulse wave downstream of the balloon and providing feedback to the inflation/deflation of the balloon. For example, if the downstream pulse wave is less than the required minimum tissue perfusion amount under the settings for inflation and deflation of the balloon at a certain point, the system automatically suppresses the degree of balloon inflation or increases the frequency of deflation. Adjust. Conversely, if bleeding cannot be suppressed, in other words, if the upstream pulse wave does not rise sufficiently, the degree of expansion is increased. This is a function that automatically responds in the direction of increasing the degree of downstream blood flow blockage, such as by increasing the frequency of inflation.

11. Device of the Invention with Additional Balloon The device of the invention may include an additional balloon that is placed in the aorta downstream of the balloon. The additional balloon completely blocks blood flow when inflated.
Although the intra-aortic balloon blocking device of the present invention described above has a sufficient effect of suppressing complications, if the amount of bleeding is excessively large, blood pressure in the upstream region may be maintained sufficiently by directing the blood flow downstream. It is also possible that there is no such thing. Normally, such cases should be dealt with by blood transfusion to quickly stop the bleeding, but there are many situations where blood transfusion or hemostasis cannot be done in time. At this time, instead of suddenly completely blocking Zone I as in conventional REBOA, we use a combination of Zone I blocking using the balloon of the present invention and Zone III completely blocking using an additional balloon, while sacrificing blood flow downstream of the lower limbs. This is a device to prevent ischemic damage to intra-abdominal organs that receive blood flow between the balloon and the additional balloon.
Aortic blockage using an additional balloon is performed when the blood pressure of the arterial pulse wave upstream of the upstream balloon becomes insufficient to maintain important organs such as the brain, heart, and lungs by inflating and deflating the upstream balloon. , is more preferably performed automatically.
Since the additional balloon does not need to be repeatedly inflated and deflated rapidly, it may be inflated and deflated by adding and withdrawing physiological saline.

12. Manufacturing method of the device of the present invention The device can be manufactured in accordance with the device for IABP, but the control program takes in the electrocardiogram and/or aortic wave signals upstream of the balloon, as described above, and controls the systolic blood pressure downstream of the balloon. And/or it is equipped with something that automatically inflates and deflates the balloon in a direction that lowers the diastolic blood pressure and/or pulse rate.

13. Method of Use: The balloon catheter of the device of the present invention is inserted through an artery of an extremity, such as the femoral artery or brachial artery, and the balloon is placed in the descending thoracic aorta or abdominal aorta. Various sensors are installed as described in "1. Configuration of intra-aortic balloon blocking device", and signals of electrocardiogram and/or arterial pulse wave upstream from the balloon, and downstream arterial pulse wave as necessary, are input. state.
Select a control program, for example, one of the control programs corresponding to [0012] 2, 3, or 4, and also select a waveform to indicate the start of ventricular systole and a waveform to indicate the start of diastole. All you have to do is set the waveform that appears from the start of diastole to the start of systole, set the degree of expansion, degree of contraction, and/or percentage of opening, and the rest is done automatically. Performs expansion and contraction.

Example 1 An example of the apparatus of the present invention An example of the apparatus of the present invention was shown (FIG. 6). Balloon catheter (1), gas supply tube (2) that supplies gas to the balloon, pump (3) to inflate and deflate the balloon, electrocardiogram sensor (4), upstream arterial pulse wave attached to the tip of the balloon catheter A sensor (5) and its signal conduction path (6) for measuring the downstream arterial pulse wave, a sensor (7) and its signal conduction path (8) for measuring the downstream arterial pulse wave, and a display that displays the signals from these. There is a control section (10) that controls expansion and contraction according to a section (9), an electrocardiogram, and an upstream aortic pulse wave.
A balloon catheter (1) is inserted from one side (11) of a sheath placed in both inguinal arteries. A sensor (7) for measuring downstream aortic waves is inserted through the other sheath (12).
When using the device of the present invention, the device of the present invention is inserted and placed into the aorta. As the control program, for example, a program ([0012]2) in which the balloon is inflated during ventricular systole and deflated during ventricular diastole is selected. In this case, for example, the waveform at the start of ventricular systole is set immediately after the end of the P wave of the electrocardiogram, and the waveform at the start of ventricular diastole is set at the peak of the T wave. Next, the degree of expansion, degree of contraction, and opening rate of the artery are set. After that, inflation and deflation are performed automatically according to the electrocardiogram and/or upstream arterial pulse wave. Further, even after that, the degree of expansion, degree of contraction, and opening ratio of the artery may be changed as necessary while observing the degree of bleeding, blood pressure of downstream pulse wave, and pulse.

Example 2 Device of the invention with an additional balloon The device of the invention with an additional balloon (FIG. 7) comprises, in addition to the device of Example 1, an additional balloon (13) placed downstream of the balloon. However, since the downstream arterial pulse wave can be measured by the sensor (14) at the tip of the additional balloon, there is no sensor for independently measuring the downstream arterial pulse wave. The additional balloon is a balloon used in conventional REBOA, which is inflated and deflated by the movement of physiological saline.
The additional balloon catheter is inserted through a sheath placed in the inguinal artery on the opposite side from where the upstream balloon was inserted, and is inserted into the common iliac artery branch to completely eliminate blood flow to the lower extremities or parts of the pelvic organs. to be cut off. Organ ischemia between the balloon and the additional balloon can be suppressed while maintaining blood flow upstream of the balloon and the additional balloon.
The method of use is basically the same as in Example 1, but in addition, an additional balloon is inflated in cases of massive bleeding and when blood transfusion or rapid hemostasis cannot be done in time.

The device of the present invention is extremely useful for patients as complications can be reduced, and it is also useful for the medical device industry as intra-aortic balloon isolation devices become widely used and the demand for them increases. Useful.

1 Balloon catheter 2 Gas supply pipe 3 Pump 4 Electrocardiogram sensor 5 Sensor for measuring upstream arterial pulse waves 6 Signal conduction path for upstream arterial pulse waves 7 Sensor for measuring downstream arterial pulse waves 8 Downstream arterial pulse waves Signal conduction path 9 Display section 10 Control section 11 Sheath for inserting the balloon catheter 12 Contralateral aorta sheath 13 Additional balloon 14 Sensor at the tip of the additional balloon

Claims (6)

An intra-aortic balloon blocking device comprising a catheter inserted into the aorta and a balloon that can be inflated and deflated at the tip of the catheter,
The balloon is automatically inflated and deflated within the aorta using an electrocardiogram and/or an arterial pulse wave upstream of the balloon as a trigger.
The automatic balloon inflation and deflation uses a waveform indicating the start of ventricular systole of the heart as a trigger to inflate the balloon during ventricular systole, and uses a waveform indicating the start of ventricular diastole of the heart as a trigger to enter ventricular diastole. is to deflate the balloon,
This adjusts the arterial pulse wave downstream of the balloon in the direction of lowering the systolic blood pressure and/or diastolic blood pressure and/or pulse rate.
The response time from the trigger of the electrocardiogram and/or arterial pulse wave waveform upstream of the balloon to the start of deflation/inflation of the balloon is 1 second or less;
The maximum inflation rate of the balloon is 50 cc/sec or more, and the maximum deflation rate is 50 cc/sec or more.
Intra-aortic balloon occlusion device. An intra-aortic balloon blocking device comprising a catheter inserted into the aorta and a balloon that can be inflated and deflated at the tip of the catheter,
The balloon is automatically inflated and deflated within the aorta using an electrocardiogram and/or an arterial pulse wave upstream of the balloon as a trigger.
The automatic inflation and deflation of the balloon is
The balloon deflates, triggered by a waveform that indicates the start of ventricular systole in the heart, at a rate of fewer beats out of multiple beats, and the period of time that appears between the start of ventricular diastole and the start of ventricular systole in the heart. It expands using that waveform as a trigger,
During the remaining beats, the balloon remains inflated without responding to the waveform, thereby controlling the systolic and/or diastolic blood pressure and/or pulse rate of the arterial pulse wave downstream from the balloon. It is adjusted in the downward direction,
The response time from the trigger of the electrocardiogram and/or arterial pulse wave waveform upstream of the balloon to the start of deflation/inflation of the balloon is 1 second or less;
The maximum inflation rate of the balloon is 50 cc/sec or more, and the maximum deflation rate is 50 cc/sec or more.
Intra-aortic balloon occlusion device. An intra-aortic balloon blocking device comprising a catheter inserted into the aorta and a balloon that can be inflated and deflated at the tip of the catheter,
The balloon is automatically inflated and deflated within the aorta using an electrocardiogram and/or an arterial pulse wave upstream of the balloon as a trigger.
The automatic inflation and deflation of the balloon is
At a rate of fewer beats among multiple beats, the balloon is deflated using a waveform indicating the start of ventricular systole of the heart as a trigger, or the balloon is maintained in a deflated state, and the ventricular flow starts from the start of ventricular diastole of the heart. Inflate triggered by any waveform that appears during the onset of systole,
During the remaining beats, the balloon is inflated or maintained in an inflated state during ventricular systole using a waveform indicating the start of ventricular systole as a trigger, and the balloon is deflated using a waveform indicating the start of ventricular diastole as a trigger. can be,
This adjusts the arterial pulse wave downstream of the balloon in the direction of lowering the systolic blood pressure and/or diastolic blood pressure and/or pulse rate.
The response time from the trigger of the electrocardiogram and/or arterial pulse wave waveform upstream of the balloon to the start of deflation/inflation of the balloon is 1 second or less;
The maximum inflation rate of the balloon is 50 cc/sec or more, and the maximum deflation rate is 50 cc/sec or more.
Intra-aortic balloon occlusion device. The intra-aortic balloon blocking device according to any one of claims 1 to 3, wherein the balloon is inflated and deflated by moving helium gas or carbon dioxide gas. The aorta according to any one of claims 1 to 4, comprising a mechanism for adjusting inflation and deflation of the balloon based on feedback from measured values of systolic blood pressure and/or diastolic blood pressure and/or pulse rate of arterial pulse waves downstream of the balloon. Inner balloon cutoff device. The intra-aortic balloon blocking device according to any one of claims 1 to 5, comprising an additional balloon that is installed in the aorta downstream of the balloon and completely blocks blood flow when inflated.