Aortic interventional catheter apparatus for heart failure

Abstract

An aortic interventional catheter apparatus for heart failure, comprising a catheter and a balloon body provided at one end of the catheter. An elastic diaphragm is provided in the balloon body. The elastic diaphragm divides an inner cavity of the balloon body into a blood chamber and a gas chamber. The blood chamber is in communication with the catheter. The balloon body is provided with an exhaust assembly. The gas chamber is connected to a gas source connector provided on the balloon body. The other end of the catheter is the proximal end. An inner wall of the catheter is provided with a first guide film and a second guide film which are staggered at intervals, the first guide film being inclined towards one side of the proximal end, and the second guide film being inclined towards the distal end. An outer wall of the catheter is respectively provided with a first guide hole and a second guide hole which correspond to the first guide film and the second guide film and are both in communication with the inner cavity of the catheter. A proximal side of the second guide film is provided with at least one set of third guide films fixed to the inner wall of the catheter, inclined towards the distal end, and closely attached to each other. In the present invention, the aortic interventional catheter apparatus is directly introduced into the aorta to enter the heart to increase the coronary artery blood flow perfusion during diastole, and reduce the load of the left ventricle during systole, so that heart failure can be treated more directly.

Description

Aortic interventional catheter device for heart failure Technical Field

[0001] This invention relates to the field of medical devices, and in particular to an aortic interventional catheter device for heart failure. Background Technology

[0002] Heart failure (HF) refers to an abnormality in the amount of blood pumped by the heart during systole and / or diastole, resulting in impaired ventricular filling and / or ejection functions. This leads to insufficient venous return to the heart, causing blood pooling in the venous system and insufficient arterial perfusion, thus resulting in circulatory disorders. These disorders primarily manifest as pulmonary congestion and vena cava congestion. Heart failure is not a standalone disease but rather the end stage of heart disease progression. The vast majority of heart failure cases begin with left ventricular failure, initially presenting as pulmonary congestion.

[0003] Currently, the main treatments for heart failure include drug therapy and device therapy. Drug therapy mainly includes diuretics, ACEIs, ARBs, and beta-blockers. These drugs can improve the symptoms of heart failure patients to some extent, but their effectiveness is often poor for patients with advanced heart failure. Regarding device therapy, intraaortic balloon pump (IABP) is a common treatment method. Chinese patent 201980007005.8 discloses an "IABP balloon catheter and IABP driving device." Its principle involves placing an balloon counterpulsation catheter in the patient's aorta via arterial puncture. During the early diastolic phase, when the aortic valve closes, the IABP driving device inflates the balloon, generating positive pressure and increasing diastolic pressure, thereby increasing blood perfusion throughout the body and coronary arteries. During the systolic phase, when the aortic valve opens, the balloon rapidly contracts, causing a sudden drop in aortic pressure, reducing left ventricular afterload, and increasing cardiac output. However, for patients with severe left ventricular dysfunction, their own cardiac contractile function may be extremely poor, and IABP may not be able to play an effective auxiliary role.

[0004] Therefore, developing a novel 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 this invention is to overcome the shortcomings of the prior art and provide an aortic interventional catheter device for heart failure, so as to solve the technical problems involved in the above background art.

[0006] The objective of this invention is achieved through the following technical solution:

[0007] An aortic interventional catheter device for heart failure includes a catheter and a balloon disposed at one end of the catheter. An elastic diaphragm is disposed within the balloon, dividing the balloon cavity into a blood chamber and an air chamber. The blood chamber communicates with the catheter. An air venting assembly is disposed on the balloon, including a flow stop clamp and a Luer connector. The air chamber is connected to an air source connector placed on the balloon. The other end of the catheter is the proximal end. The inner wall of the catheter is provided with staggered first guide membranes inclined towards the proximal end and second guide membranes inclined towards the distal end. The outer wall of the catheter is provided with first guide holes and second guide holes corresponding to the first and second guide membranes and communicating with the inner lumen of the catheter. At least one set of third guide membranes, fixed to the inner wall of the catheter and inclined towards the distal end, are disposed on the proximal side of the second guide membranes and are tightly closed to each other.

[0008] Furthermore, in the above-described invention, the proximal end of the catheter is connected to a conical head.

[0009] Furthermore, in the above-mentioned invention, the tube body of the conduit is a flexible tube with a length of 80-120cm and a diameter of 6-8mm.

[0010] Furthermore, in the above-mentioned invention, the capsule is made of a transparent material and has a volume of 50-150 mL.

[0011] Furthermore, in the above-described invention, the catheter, the capsule, the first guide membrane, the second guide membrane, and the third guide membrane are all made of polyurethane.

[0012] Furthermore, in the above-described invention, the number of the first conductive films is 8-12.

[0013] Furthermore, in the above-described invention, the number of the second conductive films is 4-8. Beneficial effects

[0014] The beneficial effects of this invention are:

[0015] The aortic interventional catheter device for heart failure provided by this invention, during use, directly enters the heart through the aorta. During cardiac systole, blood is drawn from the left ventricle into the capsule through a conical tip and a first guide port, reducing cardiac pressure. During cardiac diastole, blood is transported from the blood chamber through a second guide port back to the ascending aorta, increasing aortic diastolic pressure and thus improving cardiac function and systemic blood circulation. This invention actively draws blood from the left ventricle and returns it to the aorta, therefore, it can also provide active hemodynamic support for patients with severe left ventricular dysfunction, improving cardiac output. It can treat heart failure more directly and has fewer risks of trauma and complications. Furthermore, when used in conjunction with a gas source device and capsule, this invention achieves rapid chamber contraction and filling rates per unit time, sufficient blood pumping volume, and can increase cardiac output by 1.5L / min-2.5L / min, effectively reducing the cardiac load in heart failure patients. Attached Figure Description

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

[0017] Figure 2 is a diagram showing one application condition of the present invention;

[0018] Figure 3 shows another usage scenario of the present invention.

[0019] In the figure, 1-conical head, 2-catheter, 3-second guide membrane, 4-first guide membrane, 5-capsule, 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 Implementation

[0020] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0021] It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. Therefore, the drawings only show the components related to the present invention and are not drawn according to the actual number, shape and size of the components in the actual implementation. In the actual implementation, the form, quantity and proportion of each component can be arbitrarily changed, and the layout of the components may also be more complex.

[0022] Example:

[0023] A catheter device for aortic intervention in heart failure, as shown in Figure 1, includes a catheter 2 and a balloon 5 disposed at one end of the catheter 2. An elastic diaphragm 6 is disposed within the balloon 5, dividing the inner cavity of the balloon 5 into a blood chamber 7 and an air chamber 8. The blood chamber 7 communicates with the catheter 2. An air venting assembly is disposed on the balloon 5, including a flow stop clamp 14 and a Luer connector 13. The air chamber 8 is connected to an air source connector 9 placed on the balloon 5. The other end of the catheter 2 is the proximal end, which is connected to a conical tip 1, making it easier for the catheter 2 to pass through blood vessels, reducing resistance during insertion, and enabling smoother delivery of the catheter 2 into the left ventricle. The inner wall of the catheter 2 is provided with staggered first guide membranes 4 inclined towards the proximal end and second guide membranes 3 inclined towards the distal end. The number of first guide membranes 4 is preferably 8-12. The number of second guide membranes 3 is preferably 4-8. The outer wall of catheter 2 is provided with a first guide hole 10 and a second guide hole 11, which correspond to the first guide membrane 4 and the second guide membrane 3 and are both connected to the inner lumen of catheter 2. At least one set of third guide membranes 12 are provided on the proximal side of the second guide membrane 3, fixed to the inner wall of catheter 2 and inclined towards the distal end, and which can be tightly closed with each other. Catheter 2, elastic diaphragm 6, first guide membrane 4, second guide membrane 3, and third guide membrane 12 are all made of soft, flexible polyurethane material, which is easily deformed under stress and has good durability and biocompatibility, making it less prone to thrombosis and side effects.

[0024] In the specific implementation of this invention, the device is inserted into the left ventricle along the aorta. The conical head 1 reduces resistance during insertion, allowing the catheter 2 to smoothly pass through the aorta and enter the left ventricle, reducing the risk of damage to blood vessels and the heart caused by catheter 2 insertion into the aorta and left ventricle. The catheter 2 has a length of 120 cm and a diameter of 6-8 mm. After the catheter 2 is inserted into the aorta, excess gas is expelled through the Luer connector 13, and then the flow stop clamp 14 is tightened. The gas source device is connected to the capsule 5 through the gas source connector 9. When the heart failure patient is in an abnormal systolic state, as shown in Figure 2, the catheter has already entered the left ventricle through the aorta. The pressure in the air chamber 8 is reduced by the external gas source device, and the elastic diaphragm 6 deforms towards the air chamber 8. Blood flows into the catheter 2 under negative pressure and sequentially impacts the third guide membrane 12, the second guide membrane 3, and the first guide membrane 4. The third guide membrane 12, the second guide membrane 3, and the first guide membrane 4 all deform towards the distal end. At this time, the third guide membrane 12 separates from each other and closes, adhering to the inner wall of the catheter 2. Furthermore, the second guide membrane 3 adheres to the inner wall of the catheter 2 under pressure, sealing the second guide hole 11. Blood can then enter the catheter 2 through the proximal end and the first guide hole 10, and flow into the blood chamber 7 of the capsule 5 for storage. This reduces the afterload of the left ventricle in patients with heart failure and alleviates cardiac pressure. The capsule 5 is preferably made of transparent material and has a volume of 150 mL.

[0025] Referring to Figure 3, when a heart failure patient is in diastole, the pressure in the air chamber 8 is increased by an external air source device. The elastic diaphragm 6 deforms towards the blood chamber 7, thus applying pressure to the blood chamber 7. Under this pressure, the blood in the blood chamber 7 enters the catheter 2 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 all deform towards the proximal end. At this time, the first guide membrane 4 adheres to the inner wall of the catheter 2 and seals the first guide hole 10. The third guide membrane 12 remains closed, 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 blood perfusion to the coronary arteries and systemic organs, and thus restoring the patient's cardiac pressure.

[0026] In summary, the aortic interventional catheter device for heart failure provided by this invention, during use, directly intervenes in the aorta to enter the heart, assisting blood circulation. When the patient experiences abnormal diastolic and / or systolic function, blood is drawn from the left ventricle and then discharged into the aorta to regulate pressure, providing a more direct treatment for heart failure. For patients with severe left ventricular dysfunction, it can also provide active hemodynamic support with fewer traumatic and complication risks. Secondly, when used with a gas source device, the air chamber of this invention contracts and fills rapidly within 5 units of time, resulting in sufficient blood volume and a fast pumping rate per unit time, effectively reducing the cardiac load on heart failure patients. Furthermore, this invention has a relatively simple structure and low manufacturing cost, making it suitable for large-scale clinical application.

[0027] The embodiments described above are merely illustrative of specific implementations of the present invention, and while the descriptions are detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. An aortic interventional catheter device for heart failure, characterized in that, The device includes a catheter and a balloon disposed at one end of the catheter. An elastic diaphragm is disposed within the balloon, dividing the inner cavity of the balloon into a blood chamber and an air chamber. The blood chamber communicates with the catheter. An air venting assembly is disposed on the balloon, which includes a flow stop clamp and a Luer connector. The air chamber is connected to an air source connector placed on the balloon. The other end of the catheter is the proximal end. The inner wall of the catheter is provided with a first guide membrane that is spaced apart and inclined towards the proximal end, and a second guide membrane that is inclined towards the distal end. The outer wall of the catheter is provided with a first guide hole and a second guide hole that correspond to the first guide membrane and the second guide membrane and communicate with the inner cavity of the catheter. At least one set of third guide membranes that are fixed to the inner wall of the catheter and inclined towards the distal end, and tightly closed to each other, are disposed on the proximal side of the second guide membrane.

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

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

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

5. The aortic interventional catheter device for heart failure according to claim 1, characterized in that, The catheter, capsule, first guide membrane, second guide membrane, and 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 membrane is 8-12.

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

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