Aorta balloon blocking device

Abstract

The utility model discloses an aorta balloon blocking device, which belongs to the technical field of medical instruments and comprises a multi-cavity catheter, an expandable balloon arranged at the end of the multi-cavity catheter and a guide wire matched with the multi-cavity catheter. The main cavity channel is used for a guide wire to enter and exit, an opening of the pressure measuring channel is formed in the lower portion of the expandable balloon, the liquid injection channel is used for filling and shrinking the expandable balloon, and an ultrasonic guide line and a radiation guide line which are as long as the multi-cavity catheter are arranged beside the main cavity pipeline and the pressure measuring pipeline in the multi-cavity catheter. According to the aorta balloon blocking device, the sending position of the balloon can be conveniently positioned, the expansion volume and pressure of the balloon can be monitored, and meanwhile damage to blood vessels can be avoided due to the arrangement of the front end of the multi-cavity catheter of the aorta balloon blocking device.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and particularly relates to an aortic balloon occlusion device. Background Art

[0002] Cardiac arrest (CA) is a widely concerned public health problem, which has a great impact on society and families. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a percutaneous aortic balloon placement technique, which temporarily blocks the blood flow to the lower body by placing a deployable balloon in the aorta to increase the blood flow to the heart and brain, thereby improving the success rate of cardiopulmonary cerebral resuscitation after cardiac arrest and achieving the purpose of temporary hemostasis for severely traumatic bleeding patients. This technique is applied in military medicine for the management of acute bleeding and traumatic shock.

[0003] Most current resuscitative endovascular balloon occlusion of the aorta procedures adopt the "blind push" method, and judge the position where the balloon catheter needs to be placed in the aorta according to the length of the catheter inserted into the patient's body. However, "blind push" requires doctors' excellent professional knowledge and operating skills. Due to the individual differences of patients, there will be some deviations in judging the entry position by length. At the same time, when the balloon expands, the conventional technique is to judge the expanded volume of the balloon according to the volume of gas or liquid injected. Due to the individual differences of patients, the expandable widths of blood vessels of different patients are different, and the blood vessels of some patients are more brittle. With the same expansion volume, the blood vessels of patients may be at risk. In addition, for the balloon catheter structures of commonly used PTCA or PTA, under the condition of no imaging, the fixed end of the balloon is relatively hard, especially the front end of the balloon will damage the blood vessels. Moreover, in the prior art, the position and filling size of the balloon are displayed by injecting contrast agent into the balloon, and it is impossible to locate before injecting contrast agent and radiation (interventional conditions).

[0004] Therefore, there is an urgent need for a device for resuscitative endovascular balloon occlusion of the aorta that is simple and convenient to operate, can be easily positioned, can be used in the rescue room, can be blind or can be easily positioned by ultrasound or radiation at the same time. Summary of the Utility Model

[0005] The technical problem to be solved by the utility model is to provide an aortic balloon occlusion device that can easily locate the position where the balloon is sent, real-time monitor the wall pressure of the balloon during inflation, and can easily locate the device in the body.

[0006] To solve the above technical problems, the technical solution adopted by the utility model is:

[0007] An aortic balloon occlusion device, comprising a multi-lumen catheter, an inflatable balloon disposed at the end of the multi-lumen catheter, and a guide wire adapted to the multi-lumen catheter. Inside the multi-lumen catheter, there are three parallel and independent circular lumen pipes, including a main lumen channel for the guide wire to enter and exit, a pressure measurement channel with an opening disposed below the inflatable balloon, and an injection channel for inflating and deflating the inflatable balloon. Inside the multi-lumen catheter, there are two ultrasonic guiding wires and two radiological guiding wires that are as long as the multi-lumen catheter and are disposed beside the main lumen pipe and the pressure measurement pipe.

[0008] A further improvement of the technical solution of the present utility model lies in that: the three circular lumen pipes of the multi-lumen catheter are respectively connected to a three-way Luer connector at the end of the multi-lumen catheter away from the inflatable balloon, and the main lumen channel and the pressure measurement channel are respectively connected to a pressure detection device through a three-way connector.

[0009] A further improvement of the technical solution of the present utility model lies in that: the diameter of the main lumen pipe is larger than that of the pressure measurement channel and the injection channel, and its opening is disposed at the top end of the multi-lumen catheter. The pressure measurement channel and the injection channel are in a closed state at the top end of the multi-lumen catheter.

[0010] A further improvement of the technical solution of the present utility model lies in that: the injection channel is provided with an injection port inside the inflatable balloon, and the pressure measurement channel is provided with a pressure measurement port below the inflatable balloon.

[0011] A further improvement of the technical solution of the present utility model lies in that: both ends of the inflatable balloon are fixed to the outer wall of the multi-lumen catheter by two balloon fixators, and the injection channel is connected to a syringe through a three-way connector.

[0012] A further improvement of the technical solution of the present utility model lies in that: the balloon fixator at the distal end of the inflatable balloon is fixed to the outer wall of the multi-lumen catheter inside the inflatable balloon, and the balloon fixator at the proximal end of the inflatable balloon is disposed on the outer wall of the multi-lumen catheter outside the inflatable balloon.

[0013] A further improvement of the technical solution of the present utility model lies in that: after the inflatable balloon is inflated and expanded, one end is oval and the other end is a spherical shape with a central depression, and the top end of the multi-lumen catheter is located at the center of the depression of the spherical end after the inflatable balloon is inflated and expanded. This setting can hide the end of the multi-lumen catheter of the aortic balloon occlusion device inside the inflated balloon after the balloon is inflated. This kind of operation design can not only avoid the damage to the blood vessel caused by the balloon fixing device due to its certain hardness, but also avoid the damage to the blood vessel caused by the end of the multi-lumen catheter. In the conventional design, the balloon is not disposed at the top end, but is at a certain distance from the end, and a double-J tube is designed at the end of the catheter to avoid damage to the blood vessel. This design will increase the cost.

[0014] A further improvement of the technical solution of the present utility model lies in: it further includes a tearable sheath, the length of the tearable sheath is greater than the length of the inflatable balloon, and the inner diameter of the tearable sheath is greater than the outer diameter of the multi-lumen catheter. After the catheter is inserted into the body of the operator, the tearable sheath can be removed to reduce the inner diameter, reduce the damage to blood vessels, prevent ischemic necrosis of the distal limb, and improve the survival rate at the same time.

[0015] A further improvement of the technical solution of the present utility model lies in: the diameter of the multi-lumen catheter does not exceed 2 mm, and the diameter of the tearable sheath does not exceed 2.4 mm.

[0016] A further improvement of the technical solution of the present utility model lies in: the aortic balloon occlusion device includes two specifications. One specification of the multi-lumen catheter is 35 - 40 cm, and the other specification of the multi-lumen catheter is 60 - 65 cm. Length scales are provided on the outer walls of the two specifications of multi-lumen catheters.

[0017] Due to the adoption of the above technical solution, the technical progress achieved by the present utility model is:

[0018] The aortic balloon occlusion device of the present application is provided with three channels on the multi-lumen catheter. Among them, the main channel is used to detect the pressure above the inflatable balloon, and the pressure measurement channel is used to detect the pressure below the inflatable balloon. According to the pressure changes monitored by the two channels, the degree of inflation of the inflatable balloon can be conveniently monitored, avoiding possible damage to the patient caused by a fixed inflation volume.

[0019] The fixing method of the inflatable balloon of the aortic balloon occlusion device of the present application is changed. The balloon fixator at the front end is arranged inside the inflatable balloon. After the inflatable balloon is filled, the outer end of the inflatable balloon is a spherical shape with a central depression, and the end of the multi-lumen catheter is located in the depression, avoiding damage to the blood vessel wall or other human tissues caused by the end of the multi-lumen catheter and the balloon fixator.

[0020] The aortic balloon occlusion device of the present application is provided with an ultrasonic guiding wire and a radiation guiding wire, which can be positioned by using bedside ultrasound and bedside DR under the conditions of the rescue room, and can also be conveniently used in the operating room. When conditions permit, real-time monitoring of the instruments entering the operator's body can be carried out at any time through imaging devices such as ultrasound and electronic portal imaging devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 is a schematic structural diagram of the multi-lumen pipeline of the present utility model;

[0022] Figure 2 is a cross-sectional view of the multi-lumen pipeline of the present utility model;

[0023] Figure 3 is Figure 1 the enlarged view of the inflatable balloon part in

[0024] Figure 4 is a schematic diagram of the tear sheath of the present utility model;

[0025] Among them, 1. multi-lumen catheter, 2. inflatable balloon, 3. Luer connector, 4. main lumen conduit, 5. ultrasonic guide wire, 6. pressure measurement conduit, 7. injection channel, 8. radiation guide wire, 9. liquid injection port, 10. balloon fixator, 11. tear sheath, 12. pressure measurement port. Specific embodiments

[0026] The present utility model will be further described in detail below in conjunction with embodiments:

[0027] As Figures 1-3 shown, an aortic balloon occlusion device includes a multi-lumen catheter 1, an inflatable balloon 2 provided at the end of the multi-lumen catheter, and a guide wire adapted to the multi-lumen catheter. The multi-lumen catheter 1 is internally provided with three parallel and independent circular lumen conduits, one large and two small, including a main lumen channel 4 for the entry and exit of the guide wire, a pressure measurement channel 6 provided below the inflatable balloon 2, and a liquid injection channel 7 for filling and deflating the inflatable balloon 2. Two ultrasonic guide wires 5 and radiation guide wires 8 that are the same length as the multi-lumen catheter are provided beside the main lumen conduit and the pressure measurement conduit inside the multi-lumen catheter.

[0028] Three circular lumen conduits of the multi-lumen catheter 1 are respectively connected to a three-way Luer connector 3 at the end of the multi-lumen catheter away from the inflatable balloon 2, and various connections can be made as needed, such as connecting a syringe, etc. The main lumen channel 4 and the pressure measurement channel 6 are respectively connected to a pressure detection device through a three-way joint. As Figure 2 shown, from the cross-sectional view of the multi-lumen catheter 1, it can be seen that the main lumen conduit 4 has the largest diameter. The guide wire penetrates into the main lumen conduit 4, and the aortic balloon occlusion device is sent to a suitable position in the human body. Then, the guide wire is withdrawn from the main lumen conduit 4, the joint for inputting the guide wire of the three-way joint is closed, and at the same time, the joint connecting the main lumen channel 4 and the pressure detection device is opened for pressure monitoring.

[0029] The diameter of the main lumen conduit 4 is larger than that of the pressure measurement channel 6 and the liquid injection channel 7, and its opening is provided at the top end of the multi-lumen catheter 1. The pressure measurement channel 6 and the liquid injection channel 7 are in a closed state at the top end of the multi-lumen catheter 1. That is, the three circular lumen conduits are independent of each other and have openings at different positions. The liquid injection channel 7 is provided with a liquid injection port 9 inside the inflatable balloon 2, and the pressure measurement channel 6 is provided with a pressure measurement port 12 below the inflatable balloon. By detecting the pressure at the opening at the end of the main lumen conduit 4 and the pressure measurement port of the pressure measurement channel 6, it is judged whether the inflation degree of the inflatable balloon is appropriate.

[0030] Both ends of the inflatable balloon 2 are fixed to the outer wall of the multi-lumen catheter 1 by two balloon fixators 10. The liquid injection channel 7 is connected to a syringe through a three-way joint. The inflatable balloon can be filled by injecting saline or contrast agent into it. After the operation, the saline or contrast agent is drawn out to deflate the balloon.

[0031] The balloon fixator 10 at the distal end of the inflatable balloon 2 is fixed to the outer wall of the multi-lumen catheter 1 inside the inflatable balloon, and the balloon fixator 10 at the proximal end of the inflatable balloon 2 is arranged on the outer wall of the multi-lumen catheter 1 outside the inflatable balloon 2. After the inflatable balloon 2 is filled and expanded, one end is oval and the other end is a spherical shape with a central depression, and the top of the multi-lumen catheter 1 is located at the center of the depression of the spherical end after the inflatable balloon 2 is filled and expanded, so as to avoid damage to the blood vessel wall by the top of the multi-lumen catheter 1 and the balloon fixator 10.

[0032] In a preferred embodiment, the aortic balloon occlusion device further includes a tearable tear sheath 11, as Figure 4 shown. The length of the tear sheath 11 is greater than the length of the inflatable balloon 2, the inner diameter of the tear sheath 11 is greater than the outer diameter of the multi-lumen catheter 1, the front end of the tear sheath is pointed, and the rear end has a tearable mark. It can be directly inserted into the blood vessel along the guide wire. The tear sheath 11 entirely wraps the inflatable balloon 2, which is convenient for the aortic balloon occlusion device to be inserted into the blood vessel. After the multi-lumen catheter is inserted into the blood vessel, the tear sheath 11 can be withdrawn and torn up. The main function of the tear sheath 11 is to wrap the inflatable balloon 2 to facilitate its entry into the body.

[0033] In a preferred embodiment, the diameter of the multi-lumen catheter 1 does not exceed 2 mm, and the diameter of the tear sheath 11 does not exceed 2.4 mm.

[0034] The aortic balloon occlusion device includes two specifications. One specification of the multi-lumen catheter 1 is 35 - 40 cm, and the other specification of the multi-lumen catheter 1 is 60 - 65 cm. Length scales are provided on the outer walls of the two specifications of the multi-lumen catheter 1. When various instruments and equipment are not available, the appropriate specification of the aortic balloon occlusion device can be selected according to the needs of the operator, and it can be judged whether the required position is reached according to the above scales.

[0035] Usage method of the aortic balloon occlusion device:

[0036] When performing resuscitative aortic balloon occlusion, the doctor punctures the femoral artery of the patient. The guide wire of the aortic inflation balloon occlusion device is inserted into the main cavity channel 4 of the multi-lumen catheter 1. Heparinized saline is filled into the pressure measurement channel 6 and the main cavity channel 4. At the same time, the tearing sheath 11 is sleeved on the front end of the multi-lumen catheter 1 (the tearing sheath can also be not used). The inflatable balloon enters the patient's blood vessel through the interventional sheath in the contracted state. When the balloon partially enters the human body, the tearing sheath 11 can be torn off and removed (if the tearing sheath is not used, there is no such operation). It is judged whether the target position is reached according to the pressure detected at the front port of the main cavity channel of the inflatable balloon 2. The position of the instrument can also be displayed in real time by the ultrasonic display ultrasonic guiding line, or the position of the instrument can be displayed in real time by the imaging device (DR) showing the radiation guiding line. The guide wire is removed. Then, saline or contrast agent is filled into the inflatable balloon 2 through the liquid injection channel 7 to inflate the inflatable balloon 2. At the same time, the pressure change detected by the pressure measurement port 12 under the inflatable balloon 2 is monitored. When the pressure gradually decreases to 0, the target blood vessel is occluded.

[0037] The removal process of the aortic balloon occlusion device: Slowly release the pressure of the inflatable balloon 2 so that the blood flow can pass slowly. Monitor the pressure of the pressure measurement port under the inflatable balloon 2 to avoid sudden contraction of the inflatable balloon 2, causing instantaneous pressure. Then slowly contract the inflatable balloon 2 and withdraw the multi-lumen catheter 1.

[0038] The above-described embodiments only represent several implementation manners of the present utility model, and the description is relatively specific and detailed. However, it should not be construed as a limitation of the scope of the utility model patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present utility model, several deformations and improvements can still be made, and these all belong to the protection scope of the present utility model.

Claims

1. An aortic balloon occlusion device, comprising a multi-lumen catheter (1), an expandable balloon (2) arranged at the end of the multi-lumen catheter, and a guide wire adapted to the multi-lumen catheter, characterized in that: The multi-lumen catheter (1) is provided with three parallel and mutually independent circular lumen pipes, one large and two small, including a main lumen pipe (4) for the guide wire to enter and exit, a pressure measuring channel (6) whose opening is arranged below the inflatable balloon (2), and an injection channel (7) for filling and deflation of the inflatable balloon (2). Two ultrasonic guide wires (5) and a radiation guide wire (8) that are connected to the length of the multi-lumen catheter are provided beside the main lumen pipe and the pressure measuring pipe in the multi-lumen catheter.

2. The aortic balloon occlusion device according to claim 1, characterized in that: The three circular lumen tubes of the multi-lumen catheter (1) are respectively connected to a three-way Luer connector (3) at one end of the multi-lumen catheter away from the inflatable balloon (2), and the main lumen tube (4) and the pressure measuring channel (6) are respectively connected to a pressure detection device via a three-way connector.

3. The aortic balloon occlusion device according to claim 2, characterized in that: The main lumen pipeline (4) has a diameter larger than that of the pressure measuring channel (6) and the injection channel (7), and its opening is arranged at the top end of the multi-lumen catheter (1); the pressure measuring channel (6) and the injection channel (7) are in a closed state at the top end of the multi-lumen catheter (1).

4. The aortic balloon occlusion device according to claim 3, characterized in that: The liquid injection channel (7) is provided with a liquid injection port (9) in the expandable balloon (2), and the pressure measuring channel (6) is provided with a pressure measuring port (12) below the expandable balloon.

5. The aortic balloon occlusion device according to claim 1, characterized in that: The two ends of the expandable balloon (2) are fixed to the outer wall of the multi-lumen catheter (1) via two balloon fixers (10), and the injection channel (7) is connected to the syringe via a three-way connector.

6. The aortic balloon occlusion device according to claim 5, characterized in that: The balloon fixer (10) at the distal end of the inflatable balloon (2) is fixed to the outer wall of the multi-lumen catheter (1) inside the inflatable balloon, and the balloon fixer (10) at the proximal end of the inflatable balloon (2) is arranged on the outer wall of the multi-lumen catheter (1) outside the inflatable balloon (2).

7. The aortic balloon occlusion device according to claim 6, characterized in that: After the inflatable balloon (2) is inflated and expanded, one end is elliptical and the other end is spherical with a central depression, and the top end of the multi-lumen catheter (1) is located at the center of the depression at one end of the spherical shape after the inflatable balloon (2) is inflated and expanded.

8. The aortic balloon occlusion device according to claim 1, characterized in that: It also comprises a tearable tear sheath (11), the length of the tear sheath (11) is greater than the length of the expandable balloon (2), and the inner diameter of the tear sheath (11) is greater than the outer diameter of the multi-lumen catheter (1).

9. The aortic balloon occlusion device according to claim 8, characterized in that: The diameter of the multi-lumen catheter (1) does not exceed 2 mm, and the diameter of the torn sheath (11) does not exceed 2.4 mm.

10. The aortic balloon occlusion device according to claim 1, characterized in that: The aortic balloon occlusion device comprises two specifications, wherein the multi-lumen catheter (1) of one specification is 35-40 cm long, and the multi-lumen catheter (1) of the other specification is 60-65 cm long. The outer walls of the multi-lumen catheters (1) of the two specifications are both provided with length scales.

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