Aorta intervention catheter device for heart failure

By designing an aortic interventional catheter device for heart failure, using the combined structure of the catheter and the capsule, the problem of the existing technology being difficult to effectively support patients with severe left heart insufficiency is solved, and direct assisted and hemodynamic support for cardiac function is achieved, reducing cardiac load and complication risk.

CN119971293APending Publication Date: 2025-05-13JIANGSU BIODA LIFE SCI CO LTD

Patent Information

Application Number
CN202510093732.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-21
Publication Date
2025-05-13

AI Technical Summary

Technical Problem

The prior art is difficult to effectively provide hemodynamic support to patients with severe left heart insufficiency, especially in cases where drug treatment is not effective.

Method used

An aortic interventional catheter device is designed, including a catheter, a capsule, an elastic diaphragm, a membrane and a gas source device. The catheter enters the left ventricle through the conical head, sucks blood during the systolic period, and stores it in the blood chamber of the sac; during the diastolic period, the blood is pumped back to the aorta to regulate the pressure.

Benefits of technology

The device is able to directly intervene in the aorta, assist in blood circulation, provide active hemodynamic support, improve cardiac function and systemic blood circulation, reduce cardiac load, and reduce risk of trauma and complications.

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Abstract

An aorta intervention catheter device for heart failure comprises a catheter and a bag body arranged at one end of the catheter, an elastic diaphragm is arranged in the bag body, an inner cavity of the bag body is divided into a blood chamber and an air chamber by the elastic diaphragm, the blood chamber is communicated with the catheter, an exhaust assembly is arranged on the bag body, and the air chamber is connected with an air source connector arranged on the bag body; the other end of the catheter is a proximal end, first guide films which are staggered at intervals and inclined towards one side of the proximal end and second guide films which are inclined towards a distal end are arranged on the inner wall of the catheter, and first guide holes and second guide holes which correspond to the first guide films and the second guide films and are communicated with an inner cavity of the catheter are respectively formed in the outer wall of the catheter; the proximal side of the second guide film is provided with at least one set of third guide films which are fixed to the inner wall of the catheter, incline towards the distal end and are tightly attached to each other to be closed. The aorta is directly intervened to enter the heart, and coronary artery blood perfusion is increased in the diastolic period; the left ventricular post-load is reduced in the systolic period, and the heart failure can be more directly treated.
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Description

Technical Field

[0001] The invention relates to the field of medical supplies, in particular to an aortic interventional catheter device for heart failure. Background Art

[0002] Heart failure (HF) refers to abnormal blood pumping during systole and / or diastole, impaired ventricular filling and / or blood discharge, and inability to fully discharge venous blood from the heart, leading to blood congestion in the venous system and insufficient blood perfusion in the arterial system, which in turn causes cardiac circulation disorders. This disorder is mainly manifested as pulmonary congestion and vena cava congestion. Heart failure is not an independent disease, but the terminal stage of heart disease development. The vast majority of heart failures begin with left heart failure, which first manifests as pulmonary circulation congestion.

[0003] At present, the treatment of heart failure mainly includes drug therapy and device therapy. Drug therapy mainly includes diuretics, ACEI, ARB, beta-blockers, etc. These drugs can improve the symptoms of patients with heart failure to a certain extent, but for patients with advanced heart failure, the effect of drug therapy is often not good. In terms of device therapy, intra-aortic balloon counterpulsation (IABP) is a common treatment method. Chinese patent 201980007005.8 discloses an "IABP balloon catheter and IABP drive device". The principle is to place a balloon counterpulsation catheter in the patient's aorta through arterial puncture. When the aortic valve is closed at the beginning of diastole, the IABP drive device inflates the balloon to make it full and expand, generating positive pressure, thereby increasing diastolic pressure and increasing blood perfusion of the whole body and coronary arteries; when the aortic valve opens during the systolic period of the heart, the balloon contracts rapidly, causing the aortic pressure to drop instantly, reducing the left ventricular afterload and increasing the cardiac output. However, for patients with severe left ventricular insufficiency, their own cardiac contraction function may be extremely poor, and IABP may not be able to play an effective auxiliary role.

[0004] Therefore, developing a new aortic interventional device that can actively provide hemodynamic support for patients with severe left ventricular dysfunction has become an important research direction in the field of medical devices. Summary of the invention

[0005] The purpose of the present invention is to overcome the deficiencies of the prior art and provide an aortic interventional catheter device for heart failure to solve the technical problems involved in the above-mentioned background technology.

[0006] The objective of the present invention is achieved through the following technical solutions:

[0007] An aortic interventional catheter device for heart failure comprises a catheter and a balloon arranged at one end of the catheter, wherein an elastic diaphragm is arranged in the balloon, and the elastic diaphragm divides the inner cavity of the balloon into a blood chamber and an air chamber, wherein the blood chamber is connected to the catheter, and an exhaust assembly is arranged on the balloon, wherein the exhaust assembly comprises a flow stop clamp and a Luer connector, and the air chamber is connected to an air source connector arranged on the balloon; the other end of the catheter is the proximal end, and the inner wall of the catheter is provided with a first guide membrane that is staggered at intervals and tilted toward the proximal end side and a second guide membrane that is tilted toward the distal end, and the outer wall of the catheter is respectively provided with a first guide hole and a second guide hole that correspond to the first guide membrane and the second guide membrane and are both connected to the inner cavity of the catheter; the proximal side of the second guide membrane is provided with at least one group of third guide membranes that are fixed on the inner wall of the catheter and tilted toward the distal end and are tightly closed to each other.

[0008] In the above invention, further, the proximal end of the catheter is connected with a conical head.

[0009] In the above invention, further, the tube body of the catheter is a flexible tube with a length of 80-120 cm and a diameter of 6-8 mm.

[0010] In the above invention, further, the capsule is made of a transparent material, and the volume of the capsule is 50-150 mL.

[0011] In the above invention, further, the catheter, the balloon, the first guide membrane, the second guide membrane and the third guide membrane are all made of polyurethane.

[0012] In the above invention, further, the number of the first conductive films is 8-12.

[0013] In the above invention, further, the number of the second guide films is 4-8.

[0014] The beneficial effects of the present invention are:

[0015] The aortic interventional catheter device for heart failure provided by the present invention enters the heart by directly intervening the aorta during use. During the cardiac systole, blood is sucked into the capsule from the left ventricle through the conical head and the first guide hole to relieve cardiac pressure; during the cardiac diastole, blood is transported back from the blood chamber to the ascending aorta through the second guide hole to increase aortic diastolic pressure, thereby improving cardiac function and systemic blood circulation. The present invention actively draws blood from the left ventricle and transports it back to the aorta. Therefore, for patients with severe left ventricular insufficiency, active hemodynamic support can also be provided to improve the patient's cardiac output. Heart failure can be treated more directly, and there is less risk of trauma and complications. Secondly, the present invention is used in conjunction with an air source device and a capsule, and the air chamber contraction and filling rate per unit time is fast, the blood pumping volume is sufficient, and the cardiac output can be increased by 1.5L / min-2.5L / min, which can effectively reduce the cardiac load of patients with heart failure. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 It is a structural schematic diagram of the present invention;

[0017] Figure 2 A working condition diagram of the present invention;

[0018] Figure 3 This is another operating condition diagram of the present invention.

[0019] In the figure, 1-conical head, 2-catheter, 3-second guide membrane, 4-first guide membrane, 5-sac, 6-elastic diaphragm, 7-blood chamber, 8-air chamber, 9-air source connector, 10-first guide hole, 11-second guide hole, 12-third guide membrane, 13-Luer connector, 14-flow stop clamp. DETAILED DESCRIPTION

[0020] The following describes the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict.

[0021] It should be noted that the illustrations provided in the following embodiments are only schematic illustrations of the basic concept of the present invention, and thus the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components in actual implementation. In actual implementation, the type, quantity and proportion of each component may be changed arbitrarily, and the component layout may also be more complicated.

[0022] Example:

[0023] An aortic interventional catheter device for heart failure, see attached Figure 1 As shown, it includes a catheter 2 and a sac 5 arranged at one end of the catheter 2, wherein an elastic diaphragm 6 is arranged inside the sac 5, wherein the elastic diaphragm 6 divides the inner cavity of the sac 5 into a blood chamber 7 and an air chamber 8, wherein the blood chamber 7 is connected to the catheter 2, and an exhaust assembly is arranged on the sac 5, wherein the exhaust assembly includes a flow stop clamp 14 and a Luer connector 13, and the air chamber 8 is connected to an air source connector 9 placed on the sac 5; the other end of the catheter 2 is a proximal end, and the proximal end of the catheter 2 is connected to a conical head 1, so that the catheter 2 is easier to pass through the blood vessel, the resistance during the insertion process is reduced, and the catheter 2 can be more smoothly sent into the left ventricle. The inner wall of the catheter 2 is provided with a first guide film 4 that is staggered and tilted toward the proximal end side and a second guide film 3 that is tilted toward the distal end. The number of the first guide films 4 is preferably set to 8-12. The number of the second guide films 3 is preferably set to 4-8. The outer wall of the catheter 2 is provided with a first guide hole 10 and a second guide hole 11 corresponding to the first guide film 4 and the second guide film 3 and both communicating with the inner cavity of the catheter 2; the proximal side of the second guide film 3 is provided with at least one group of third guide films 12 fixed on the inner wall of the catheter 2 and inclined toward the distal end, and can be tightly closed with each other. The catheter 2, the elastic diaphragm 6, the first guide film 4, the second guide film 3 and the third guide film 12 are all made of soft and flexible polyurethane material, which is easy to deform when subjected to force, and has good durability and biocompatibility, is not easy to produce thrombosis, and is not easy to produce side effects.

[0024] In the implementation process of the present invention, the device is sent into the left ventricle along the aorta. The conical head 1 can reduce the resistance during the insertion process, so that the catheter 2 can smoothly pass through the aorta into the left ventricle, reducing the risk of damage to the blood vessels and the heart caused by the catheter 2 inserted into the aorta and the left ventricle. The length of the catheter 2 is 120cm and the diameter is 6-8mm. After the catheter 2 is inserted into the aorta, the excess gas is discharged through the Luer connector 13, and then the stop clamp 14 is clamped. The gas source device is connected to the balloon 5 through the gas source connector 9. When the heart failure patient is in an abnormal state of cardiac systole, refer to the attached Figure 2As shown, at this time, the catheter has entered the left ventricle through the aorta, and the pressure of the air chamber 8 is reduced by the external air source device. The elastic diaphragm 6 is deformed toward the side of the air chamber 8, and the blood flows into the catheter 2 under the action of negative pressure and impacts the third guide film 12, the second guide film 3 and the first guide film 4 in sequence. The third guide film 12, the second guide film 3 and the first guide film 4 are all deformed toward the distal end. At this time, the third guide film 12 is separated from each other and attached to the inner wall of the catheter 2. Further, the second guide film 3 is attached to the inner wall of the catheter 2 under the action of pressure, and the second guide hole 11 is closed. Blood can enter the catheter 2 through the proximal end of the catheter 2 and the first guide hole 10, and enter the blood chamber 7 of the capsule 5 along the catheter 2 for storage. Then reduce the left ventricular afterload of patients with heart failure and relieve heart pressure. The capsule 5 is preferably made of transparent material with a volume of 150mL.

[0025] See attached Figure 3 As shown, when the heart failure patient is in the diastolic phase, the pressure of the air chamber 8 is increased by an external air source device, and the elastic diaphragm 6 is deformed toward the side of the blood chamber 7, thereby applying pressure to the blood chamber 7. The blood in the blood chamber 7 enters the catheter 2 under the action of pressure and impacts the first guide membrane 4, the second guide membrane 3 and the third guide membrane 12. The first guide membrane 4, the second guide membrane 3 and the third guide membrane 12 are all deformed toward the proximal end. At this time, the first guide membrane 4 is attached to the inner wall of the catheter 2 and closes the first guide hole 10. The third guide membrane 12 is still in a closed state, preventing blood from flowing into the left ventricle. Finally, the blood in the blood chamber 7 is released into the artery through the second guide hole 11, thereby increasing the blood perfusion of the coronary artery and systemic organs, and then restoring the patient's heart pressure.

[0026] In summary, the aortic interventional catheter device for heart failure provided by the present invention can assist blood circulation by directly intervening the aorta to enter the heart during use. When the patient is in abnormal diastole and / or systole, blood is sucked out from the left ventricle, and then the sucked blood is discharged into the aorta to regulate the pressure. It can treat heart failure more directly, and can also provide active hemodynamic support for patients with severe left ventricular insufficiency, and has less trauma and complication risks. Secondly, the present invention is used with an air source device, and the air chamber contraction and filling rate of the sac 5 per unit time is fast, the blood pumping volume is sufficient, and the blood pumping rate per unit time is fast, which can effectively reduce the cardiac load of patients with heart failure. Secondly, the present invention has a relatively simple structure and low manufacturing cost, and is suitable for large-scale promotion and use in clinical practice.

[0027] The above-mentioned embodiments only express the specific implementation of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention.

Claims

1. An aortic interventional catheter device for heart failure, characterized in that: The invention comprises a catheter and a sac arranged at one end of the catheter, wherein an elastic diaphragm is arranged in the sac, and the elastic diaphragm divides the inner cavity of the sac into a blood chamber and an air chamber, wherein the blood chamber is connected with the catheter, and an exhaust assembly is arranged on the sac, wherein the exhaust assembly comprises a flow stop clamp and a Luer joint, and the air chamber is connected with an air source joint arranged on the sac; the other end of the catheter is the proximal end, and the inner wall of the catheter is provided with a first guide membrane which is staggered at intervals and tilted toward the proximal end side and a second guide membrane which is tilted toward the distal end, and the outer wall of the catheter is respectively provided with a first guide hole and a second guide hole which correspond to the first guide membrane and the second guide membrane and are both connected with the inner cavity of the catheter; the proximal side of the second guide membrane is provided with at least one group of third guide membranes which are fixed on the inner wall of the catheter and tilted toward the distal end and are tightly closed to each other.

2. The aortic interventional catheter device for heart failure according to claim 1, characterized in that: The proximal end of the catheter is connected with a conical head.

3. The aortic interventional catheter device for heart failure according to claim 1, characterized in that: The tube body of the catheter is a flexible tube with a length of 80-120 cm and a diameter of 6-8 mm.

4. The aortic interventional catheter device for heart failure according to claim 1, characterized in that: The capsule is made of a transparent material, and the volume of the capsule is 50-150 mL.

5. The aortic interventional catheter device for heart failure according to claim 1, characterized in that: The catheter, the balloon, the first guide membrane, the second guide membrane and the third guide membrane are all made of polyurethane.

6. The aortic interventional catheter device for heart failure according to claim 1, characterized in that: The number of the first conductive films is 8-12.

7. The aortic interventional catheter device for heart failure according to claim 1, characterized in that: The number of the second guide films is 4-8.

Citation Information

Patent Citations

  • IABP balloon catheter and IABP drive device

    CN111542351A

  • Balloon micro catheter

    CN112807553A

  • In-vitro aorta counterpulsation device with pressure sensing and automatic regulating functions

    CN114191702A

  • Pulse type interventional artificial heart

    CN117679628A

  • Dribbling bag coronary vein hole suction catheter

    CN205698849U

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