CN105662654A - Coronary artery protecting device - Google Patents

Abstract

The invention discloses a coronary artery protecting device which comprises an isolating part and a fixing part. The isolating part is used for isolating a potential obstacle from a coronary artery opening, and the fixing part is used for fixing the position of the isolating part. The device is provided with a grid structure, the grid structure is implanted into the joint portion of the ascending aorta and coronary artery through the peripheral arterial path, the grid structure is implanted before transcatheter aortic valve replacement, smoothness of blood flow in the coronary artery during the transcatheter aortic valve replacement operation and after the operation can be guaranteed, coronary occlusion complications is avoided, and therefore transcatheter aortic valve replacement can be achieved for an aortic valve disease patient whose ascending aorta root anatomical structure does not meet the current standard.

Description

A coronary protection device

technical field

The invention relates to a coronary artery protection device, in particular to a coronary artery protection device for transcatheter arterial valve replacement.

Background technique

Transcatheter aortic valve replacement (TAVR, transcatheteraorticvalvereplacement) is a popular new technology for cardiovascular intervention. This technology is to send the interventional catheter through the peripheral artery, and deliver the compressed artificial heart valve to the aortic valve area through the interventional catheter. It is a minimally invasive way to insert an artificial heart valve to complete the implantation of the artificial valve and restore the function of the valve. The technique is less invasive than open-heart surgery, thus greatly reducing the risk of cardiac surgery and shortening postoperative recovery time for patients. It has become the first-line treatment for patients with aortic stenosis internationally. The prospect of TAVR is currently generally optimistic. It is estimated that by 2025, the number of TAVR operations performed globally will reach about 300,000 cases per year.

However, the technique is currently still a high-risk procedure that can lead to fatal complications. Coronary artery blockage is one of the complications with a high mortality rate, which can cause acute myocardial infarction, cardiogenic shock and death. The main mechanism is that the native aortic valve overturns to block the coronary artery opening. In addition, the valve stent is placed too high, so that the skirt of the interventional valve blocks the coronary artery opening, which can also cause coronary artery obstruction and myocardial infarction. Therefore, the anatomical structure of the aortic root should be evaluated before TAVR, including the width of the sinus of Valsalva (should be more than 3 mm larger than the valve size), the height of the sinus of Valsalva (should be >15 mm), and the height of the coronary arteries (should be >12 mm). However, if the case screening is carried out according to this standard, 1/4 of the cases will be excluded and cannot receive TAVR surgery. In addition, even if TAVR is performed in full accordance with this standard, coronary artery blockage may still occur in a small number of cases. Therefore, the development of a device for coronary artery protection in TAVR allows many patients with unqualified aortic root conditions to undergo TAVR, which has huge social benefits and market demand.

Contents of the invention

In view of the above-mentioned defects in the prior art, the technical problem to be solved by the present invention is how to provide coronary artery protection for TAVR and avoid the risk of coronary artery blockage caused by TAVR.

In order to achieve the above object, the present invention provides a coronary artery protection device, which is also implanted at the junction of the ascending aorta and the coronary artery through the peripheral artery, and is implanted before transcatheter aortic valve replacement, which can guarantee TAVR Unobstructed coronary blood flow during and after the operation, avoiding the occurrence of coronary occlusion complications, and enabling transcatheter aortic valve replacement in patients with aortic valve disease whose anatomical structure of the ascending aortic root does not meet the current standards.

The coronary artery protection device provided by the present invention includes an isolation component for isolating potential barriers from the coronary artery opening and a fixing component for fixing the position of the isolation component, and the isolation component and the fixing component are connected to each other; the isolation The working position of the component is the junction of the root of the ascending aorta and the coronary arteries. Wherein, the potential obstacle may be an upturned native aortic valve, a skirt of an intervening valve, or any other object that may cause coronary artery blockage.

The coronary artery protection device can be transformed between a radially expanded first configuration and a radially contracted second configuration; wherein, the first configuration is that the device is implanted at the junction of the root of the ascending aorta and the coronary artery in the human body. The working configuration after the predetermined position, the second configuration is the delivery configuration when the device is delivered through the catheter.

Further, the second form is in the shape of a thin strip, so that it can be loaded in a long strip-shaped delivery sheath with a certain inner diameter, and sent from the outside of the body along the human artery to the root of the ascending aorta.

Preferably, the isolation part has a grid structure, which will not affect the flow of blood; further preferably, the isolation part is tubular, and blood can flow into the lumen of the isolation part from the surrounding; further, the working state of the tubular isolation part It is arranged axially along the ascending aorta.

Preferably, the working position of the fixing component is inside the coronary artery, and the fixing component fixes the position of the coronary artery protection device through static friction with the coronary artery wall, so as to prevent the entire device from shifting and falling off; further preferably, the The fixing part is tubular with a grid structure; in this case, the cross-sectional diameter of its first form should be suitable for the inner diameter of the coronary artery, preferably slightly larger than the inner diameter of the coronary artery, usually preferably 2-5mm; preferably, The length of the fixing component is 2-6 cm, and the length is the depth at which the fixing component enters the coronary artery.

Preferably, the tubular shape is circular or elliptical, and this structure has a strong supporting force and is not easily deformed; as for the isolation component, when the interventional valve is implanted in the ascending aorta, it will have a compressive effect on the isolation component, which is relatively The strong supporting force can keep the blood flow in the tube unobstructed; for the fixed parts, the strong supporting force can produce better friction effect so as to be more firmly fixed, and can also keep the blood flow in the tube unobstructed.

Preferably, the grid structure is a rhombus grid structure, which can further improve the supporting force; the grid lines constituting the grid structure of the isolation parts can be slightly thicker than the grid lines of the fixed parts, because the isolation parts need stronger support.

Preferably, the diameter of the isolation part is 4-8 mm, and the length of the isolation part is 5-15 cm.

In a preferred embodiment of the present invention, the isolation member and the fixing member are in an integrated tubular shape with a bending angle in the middle, that is, the coronary artery protection device itself forms a bending angle in the first form, the The bending angle preferably ranges from 60° to 150°, furthermore, the bending angle is rounded and does not have a sharp outer contour that is likely to cause mechanical damage.

The wall of the ascending aorta is connected with the left coronary artery and the right coronary artery. In a preferred embodiment of the present invention, the working position of the isolation member extends upwards from the opening of the coronary artery and abuts against the root of the ascending aorta ( left or right), and its height is higher than the height of the interventional valve to be implanted, so a blood circulation channel is set up between the ascending aorta on this side and the coronary artery opening to ensure coronary blood flow unimpeded.

Preferably, the opening of the distal end of the first form of the isolating part is relatively large, and it is easy to enter catheters and guide wires, which is conducive to future coronary intervention; the cross-sectional diameter of the proximal end of the first form of the isolating part can be equal to or greater than the maximum cross-sectional diameter of the fixed part. In a preferred embodiment of the present invention, the shape of the isolation member is preferably a trumpet shape gradually increasing toward the distal end along the axial direction of the tube.

The left coronary artery and the right coronary artery provide blood flow to the heart to ensure the blood supply and oxygen supply of the heart. The fixing part enters the left/right coronary artery from the opening of the left/right coronary artery on the wall of the ascending aorta. Because the structures of the left and right coronary arteries have small differences, the shape of the fixing part of the present invention can be designed according to the shape of the left/right coronary arteries, and the diameter of the radial section is slightly larger than the inner diameter of the coronary arteries; further isolation parts can also be It is designed according to the shape between the left/right coronary artery and the ascending aorta; furthermore, the coronary artery protection device of the present invention can be individually designed according to individual differences to meet the different needs of different groups of people.

The "distal end" in the present invention refers to the end far away from the heart after the device is implanted at the junction of the root of the ascending aorta and the coronary artery. The end near the heart behind the predetermined position where the arterial root joins the coronary arteries.

Preferably, the total length of the coronary artery protection device is 10-20cm.

Preferably, the coronary artery protection device is made by integrated 3D printing.

In a preferred embodiment of the present invention, the coronary artery protection device is made of a self-expanding material, which can be compressed into a strip-like second shape outside the body, and can automatically return to the first shape after being released in vivo. In another preferred embodiment of the present invention, the device can also be released by the principle of balloon expansion. The device is compressed into a strip-like second shape outside the body, loaded on the outside of the balloon, and expanded after reaching the body. Returning the device to the first configuration.

Preferably, the coronary artery protection device is made of a metal material; more preferably, it is a nickel-titanium alloy material with temperature memory.

In a preferred embodiment of the present invention, the coronary artery protection device is an integrated circular tube with a grid structure, which can be transformed between a radially expanded first form and a radially contracted second form, which The first form has a bending angle, one side of the bending angle is an isolation component, which is used to isolate the potential obstruction from the coronary artery opening, and the other side of the bending angle is a fixing component, which is used to fix the position of the isolation component, The first shape of the integrated circular tube is close to the anatomical structure of the junction of the root of the ascending aorta and the coronary artery in the human body.

The present invention is invented based on the anatomical characteristics of the heart and the technical principle of transcatheter aortic valve replacement: during transcatheter aortic valve replacement, after the implanted interventional valve is fully expanded, the native aortic valve may be squeezed upwards , block the coronary artery opening, and the skirt of the interventional valve may also block the coronary artery opening. After the protective device is implanted, a tunnel can be opened between the ascending aorta on the outside of the interventional valve and the coronary artery opening to ensure blood flow. It flows into the coronary artery from the ascending aorta; on the other hand, the shape of the protective device conforms to the anatomical characteristics of the aortic root, and can be fixed well without dislocation; the device is located above the native valve annulus and outside the interventional valve, so it will not affect the intervention The function and fixation of the valve will not lead to paravalvular leak and valvular regurgitation.

The present invention has the following beneficial technical effects:

①Simple operation: the implantation process in the body of the present invention is the same as that of the current coronary stent implantation, and the operation is relatively simple.

②Simple and mature production: the basic material of the present invention can be conventional coronary artery and vascular stent materials, and the production method can also adopt the current conventional stent production method, so the production is relatively simple and mature.

③ High safety: The device will not affect the blood supply of the coronary arteries during and after implantation, and will not affect the function of human valves or interventional valves.

④ Does not affect coronary interventional therapy: The opening of the isolation part is large and trumpet-shaped, which is easy to enter the guide wire and catheter. In case of coronary artery disease in the patient in the future, the interventional therapy will not be affected.

The idea, specific structure and technical effects of the present invention will be further described below in conjunction with the accompanying drawings, so as to fully understand the purpose, features and effects of the present invention.

Description of drawings

Fig. 1 is a schematic diagram of a first form three-dimensional structure of a preferred embodiment of the present invention;

Fig. 2 is a perspective top view of the preferred embodiment in Fig. 1;

Fig. 3 is a schematic diagram of the anatomical structure of the working position of the present invention.

detailed description

As shown in FIG. 1 , it is a schematic structural diagram of a first form of a preferred embodiment of the present invention. The coronary artery protection device is tubular with a grid structure and includes an isolation part 1 and a fixing part 2. The parts of the device can be connected by conventional connection methods, or can be made by integral molding.

In this embodiment, the isolating part 1 and the fixing part 2 are an integrated circular tube, and its first shape is similar to the letter L as shown in the figure. The round tube has a rhombus grid structure, and the isolating part 1 and the fixing part 2 to form a bent round angle α, the size of α is determined by the angle between the central axis of the isolation component 1 and the central axis of the fixed component 2, preferably 60° to 150°; the grid line ratio of the isolation component 1 The grid lines of the fixed part 2 are slightly thicker, which can provide greater support.

The structure of the present invention is not limited to the L-shaped tubular shape, any structure that can realize isolation and fixation functions is feasible, such as T-shaped tubular shape, I-shaped tubular shape, etc.; the grid shape of the present invention is not unique, and any structure that can satisfy blood flow Both flow-through and shrink-expand shapes are available.

As shown in Figure 2, the isolation member 1 of this embodiment is a trumpet-shaped round tube, which gradually increases toward the distal end along the axial direction of the tube, and its working position is shown in Figure 3, abutting against the inner wall of the root of the ascending aorta , arranged upwards from the opening of the coronary artery; the working position of the fixing part is inside the coronary artery. When the interventional valve 3 is implanted, it will exert radial pressure on the isolation part 1. The isolation part 1 in this embodiment has a strong supporting force, which can keep the blood flow in the tube unobstructed, so that the blood flow can be smooth. into the coronary arteries.

The outer contour line of the present invention is consistent with the shape of the root of the ascending aorta and the proximal section of the coronary artery. The present invention can be designed into two types of left coronary artery type and right coronary artery type according to needs, the length of the fixing part is 2-6cm, the inner diameter is slightly larger than the inner diameter of the left and right coronary arteries of the human body, and the supporting force can be close to the existing coronary arteries. Artery stents to avoid damage to coronary arteries, and individual parameters can be designed according to individual differences to meet the needs of different coronary artery diameters in different people.

The length of the isolation part is 5-15 cm, the diameter of the proximal end can be equal to or greater than the diameter of the fixed part, and the diameter of the distal end gradually expands to form a trumpet-shaped opening. The radial support force of the isolation part is relatively large, which can resist the pressure of the interventional valve. Under the pressure of the interventional valve, it can still maintain a circular tubular or elliptical tubular shape, ensuring that there is a lumen space in the isolation part connected to the fixed part.

The first form of the device of this embodiment is generally close to L-shaped, but the spacer part 1 and the fixing part 2 are connected by a smooth rounded transition, without sharp corners, so as not to damage human tissue during implantation, and the rounded corners The angle is designed according to the included angle between the coronary artery and the ascending aorta, so that the device of this embodiment can be naturally attached to the inner wall of the ascending aorta after being implanted in the human body.

The device can be transformed between the expanded first form and the contracted second form. The first form is the working form after the device is implanted at the predetermined position at the junction of the root of the ascending aorta and the coronary artery of the human body. The second form is The delivery configuration of the device as it is delivered through the catheter. This embodiment adopts the principle of self-expansion or balloon expansion. In vitro, the device can be compressed into strips and placed in the delivery system. After reaching the predetermined position of the aortic root, it can be restored by self-expansion or balloon expansion. It has the shape of the original design and has high hardness, and is firmly fixed in the predetermined position of the root of the ascending aorta through the action of the fixing component.

The manufacturing method of the coronary artery protection device in this embodiment is preferably laser engraving technology, but this manufacturing method is not unique, and in other preferred embodiments, it can also be manufactured by integrally formed 3D printing technology.

The coronary artery protection device of the present invention can adopt the following steps during actual implantation:

(1) outside the body, use a compression device to force the device into a thin strip, and then place it into the sheath of the delivery system;

(2) Insert the guide wire into the coronary artery from the ascending aorta, and send the delivery sheath equipped with the device into the coronary artery along the guide wire;

(3) Withdraw the delivery sheath and open the device;

(4) Release the device completely and exit the delivery system.

The above implantation steps and after implantation will not affect the function of the patient's own aortic valve, nor will it affect the coronary blood flow. After implantation, the function of the interventional valve will not be affected, and at the same time, it can protect the coronary artery The role of arteries to prevent coronary artery openings from being blocked.

The preferred specific embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make many modifications and changes according to the concept of the present invention without creative efforts. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the present invention through logical analysis, reasoning or limited experiments on the basis of the prior art shall be within the scope of protection defined by the claims.

Claims (10)

1. A coronary artery protection device, characterized in that the device comprises an isolation member for isolating potential obstructions from the coronary artery opening and a fixing member for fixing the position of the isolation member, the isolation member and the The fixing parts are connected together; the working position of the isolation part is the junction of the root of the ascending aorta and the coronary artery; the coronary artery protection device can be in the first configuration of radial expansion and the second configuration of radial contraction switch between. 2. The coronary artery protection device according to claim 1, wherein the isolation member has a grid structure. 3. The coronary artery protection device according to claim 1, wherein the isolation member is tubular. 4. The coronary artery protection device according to claim 1, characterized in that the working position of the fixing member is inside the coronary artery, and is fixed to prevent falling off by the static friction force between the coronary artery wall. 5. The coronary artery protection device according to claim 4, characterized in that the fixing member is tubular with a grid structure. 6 . The coronary artery protection device according to claim 1 , wherein the shape of the isolation member is a trumpet shape gradually increasing toward the distal end along the axial direction of the tube. 6 . 7. The coronary artery protection device according to claim 1, characterized in that the isolation member and the fixing member are in an integrated tubular shape with a bending angle in the middle. 8. The coronary artery protection device according to any one of claims 1-7, characterized in that the device is made of a self-expanding material. 9. The coronary artery protection device according to any one of claims 1-7, characterized in that the device realizes scaling by the principle of balloon expansion. 10. A coronary artery protection device, characterized in that the device is an integrated circular tube with a grid structure, and the coronary artery protection device can be in a radially expanded first form and a radially contracted second form Its first form has a bending angle, one side of the bending angle is an isolation part, which is used to isolate the potential obstruction from the coronary artery opening, and the other side of the bending angle is a fixing part, which is used for The position of the isolation component is fixed, and the first shape of the integrated circular tube is close to the anatomical structure of the junction of the root of the ascending aorta and the coronary artery in the human body.