A coronary sinus artificial valve for treating myocardial ischemia

Abstract

The present invention discloses an artificial coronary sinus valve for treating myocardial ischemia, comprising: an external support, a spiral elastic sheet valve. The external support comprises a first fixing member and a second fixing member arranged along its center line and a plurality of struts distributed around the center line of the external support, wherein the strut comprises a plurality of sections connected in sequence from the first end to the second end, and any two adjacent sections are connected in a smooth transition; the spiral elastic sheet valve is a one-way flow guide attached to the inside of the external support, which has pressure compliance, and when the liquid flows from the first fixing member of the external support to the second fixing member and the liquid pressure is lower than the preset pressure value or when the liquid flows from the second fixing member of the external support to the first fixing member, the one-way flow guide is closed. The structural design of the artificial valve can effectively improve the perfusion and cardiac function of the myocardial tissue and solve the problem that the artificial valve is difficult to match the human anatomical structure.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly to a coronary sinus artificial valve for treating myocardial ischemia. Background Art

[0002] Coronary heart disease is a disease that seriously endangers human health.

[0003] Despite the continuous improvement of coronary artery revascularization technology and drugs, the field of coronary artery disease treatment still faces many problems that need to be solved urgently, and our understanding of coronary artery disease is far from enough. The main problems include: (1) Although coronary artery disease patients have received lifestyle changes, optimal drugs and revascularization treatment, some patients still have frequent angina pectoris. And as time goes by, the number of patients with recurrent angina pectoris has also increased significantly, becoming refractory angina pectoris. (2) With the widespread establishment of chest pain centers, more and more patients with acute myocardial infarction have received early interventional treatment, but the incidence of heart failure after myocardial infarction has not decreased significantly. The incidence of heart failure was 24.4% one year after myocardial infarction and 71.1% five years later. The mortality rate after early PCI of acute myocardial infarction is still 1-6% one year. After early revascularization treatment, MRI shows that some ischemic areas still exist after myocardial infarction. (3) Due to the inappropriate coronary artery anatomical structure, such as multi-vessel lesions and diffuse lesions, effective revascularization cannot be performed to obtain good epicardial coronary blood flow regardless of PCI or CABG. 7% or 1.8 million patients are expected to not undergo revascularization or have surgery failure [2] Even if coronary revascularization is successful, it can only directly improve epicardial coronary blood flow, but it cannot achieve a direct therapeutic effect on the improvement of myocardial microcirculation perfusion. Currently, there is no specific treatment measure for myocardial microcirculation. [3] These problems have become difficult problems in the treatment of coronary heart disease, and new treatment approaches are urgently needed.

[0004] In recent years, some new treatment methods targeting the coronary venous system to improve myocardial ischemia have gradually emerged, subverting the traditional concept of only treating the coronary artery system. They have shown good treatment prospects in the field of coronary heart disease treatment and have attracted widespread attention from the academic community. In the future, they may bring a new revolution in the field of coronary heart disease device treatment. The coronary venous system can improve cardiac blood supply, strengthen tissue perfusion, adjust tissue blood flow distribution, reduce myocardial load, and improve myocardial interstitial edema by changing the hemodynamics of the coronary venous system, thereby achieving the purpose of treating coronary heart disease, improving myocardial ischemia and heart failure.

[0005] The coronary veins are the return system for myocardial blood supply. The branches of the great cardiac vein, middle cardiac vein, small cardiac vein, posterior left ventricular vein, left atrial oblique vein, etc. are all collected in the coronary sinus and return to the right atrium. Due to the upright evolution of humans, the return of venous blood in the upper body has become easier under the action of gravity, so the venous valves have basically degenerated, including the coronary venous system. In particular, the huge myocardial tissue pressure generated by heart contraction has promoted venous return, making the degeneration of the valves of the coronary venous system inevitable. However, in the case of severe myocardial insufficiency or heart failure, a series of changes will occur in cardiac hemodynamics. At this time, the lack of function of the venous system valves will become an unfavorable factor restricting the efficiency of myocardial blood supply.

[0006] In clinical practice, coronary angiography can reveal that a large number of patients with coronary heart disease have coronary sinus congestion and poor blood return, which is similar to the situation of varicose veins in the lower limbs caused by impaired venous valve function, poor blood return or local reflux, which will cause poor blood supply to the lower limb muscle tissue. The lack of valves in the cardiac venous system will cause more complicated situations when the myocardium is not supplied with enough blood.

[0007] Studies have shown that after PCI, while cardiac function improves, coronary sinus blood flow indicators also increase significantly. [4] Therefore, it can be speculated that coronary artery perfusion pressure, myocardial contractility, and coronary venous return resistance should have a trinity effect on the state of coronary circulation.

[0008] The theoretical mechanism of improving myocardial blood supply by implanting a coronary sinus artificial valve is as follows: in the case of coronary artery stenosis, the perfusion pressure at the arterial end decreases significantly, and the coronary arteriovenous pressure difference decreases, affecting the perfusion of arterial blood to the microcirculation. After the coronary sinus artificial valve is implanted, the valve is closed during ventricular diastole, which can block the venous blood return from the right atrium and coronary sinus on the one hand. This phase reduces the pressure of the coronary venous system, thereby increasing the perfusion rate and amount of arterial blood to the tissue microcirculation; on the other hand, the valve will open during the systole of the heart, but due to the elasticity of the specially designed valve itself, it will bring about opening resistance, so the opening of the valve requires the venous system to reach a greater pressure, which comes from the contraction of the myocardium. The increased coronary sinus and venous pressures during this phase can be accumulated and converted into wedge pressure on the ischemic area. This makes the coronary microcirculation more sufficient in terms of blood flow and obtains a greater pressure difference between the capillaries and tissue fluid, thereby effectively perfusing the myocardial microcirculation. Due to the existence of a large number of microcirculatory networks, this process of increased pressure is more significant to the myocardium in the ischemic area, and it can further redistribute blood to the ischemic myocardial area at the microcirculatory level.

[0009] When the valve is open, due to the greater pressure difference formed across the two ends of the valve and the siphon effect formed by atrial diastole, during the valve opening period, the metabolized venous blood will return to the right atrium through the coronary sinus at a faster rate, so that the clearance process of metabolites in the microcirculation is more efficient. As a result, the perfusion efficiency and return efficiency of the myocardium are significantly increased, the blood flow distribution is further improved, and the blood supply of the whole heart is improved, especially it is more conducive to better blood supply to the ischemic myocardium, which can form a significant therapeutic effect on myocardial ischemia due to coronary heart disease.

[0010] The structure of the valve frame of the artificial valve in the prior art is generally designed by the intersection line method, arc straight line arc method and other methods. The valve frame prepared by the intersection line method is that a spatial entity intersects with another spatial entity in space, and the intersection line formed is used as the valve frame curve. Although this method of preparing the valve frame simplifies the design of the forming mold, the valve frame prepared by this method has a strong sense of space, and the spatial valve frame is difficult to fit well with the flat leaflet, which causes many troubles for the later leaflet design. In addition, the artificial valve in the prior art is difficult to match the human anatomical structure. Summary of the invention

[0011] In view of this, an object of the present invention is to provide a coronary sinus artificial valve for treating myocardial ischemia. The structural design of the coronary sinus artificial valve for treating myocardial ischemia can effectively improve myocardial ischemia and heart failure, and solve the problem that the artificial valve is difficult to match the human anatomical structure.

[0012] In order to achieve the above object, the present invention provides the following technical solutions:

[0013] A coronary sinus artificial valve for treating myocardial ischemia, comprising:

[0014] An outer bracket, the outer bracket comprising a first fixing member and a second fixing member arranged along the center line thereof and a plurality of support rods distributed around the center line of the outer bracket, the first fixing member and the second fixing member being used to fix the first ends and the second ends of the plurality of support rods together respectively, the support rod comprising a plurality of sections connected in sequence from the first end to the second end thereof, and any two adjacent sections being connected by a smooth transition;

[0015] A one-way flow guide is arranged inside the outer bracket, and the edge of the one-way flow guide is connected to the support rod. When the liquid flows from the first fixing part of the outer bracket to the second fixing part and the liquid pressure is not lower than the preset pressure value, the one-way flow guide is turned on; when the liquid flows from the first fixing part of the outer bracket to the second fixing part and the liquid pressure is lower than the preset pressure value or when the liquid flows from the second fixing part of the outer bracket to the first fixing part, the one-way flow guide is closed.

[0016] Preferably, in the above coronary sinus artificial valve for treating myocardial ischemia, the distance between the first end and the second end of the strut and the centerline of the external stent is smaller than the distance between any position between the two ends of the strut and the centerline of the external stent.

[0017] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the strut includes a first section, a second section and a third section connected in sequence from the first end to the second end thereof, the first section gradually moves away from the center line of the outer stent from the end connected to the first fixing member to the other end, and the third section gradually approaches the center line of the outer stent from the end connected to the second section to the other end.

[0018] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the plurality of struts are rotationally symmetrically arranged.

[0019] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the one-way flow guide includes an elastic sheet, and when the liquid flows from the first fixing member of the external stent to the second fixing member and the liquid pressure is not lower than a preset pressure value, the liquid can flow through the gap at the edge of the elastic sheet, and when the liquid flows from the first fixing member of the external stent to the second fixing member and the liquid pressure is lower than the preset pressure value or when the liquid flows from the second fixing member of the external stent to the first fixing member, the gap at the edge of the elastic sheet is closed.

[0020] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the one-way guide is a spiral elastic sheet. When the liquid flows from the first fixing member of the external stent to the second fixing member and the liquid pressure is not lower than a preset pressure value, the liquid pressure causes the spiral elastic sheet to form a conical spiral elastic sheet and the diameter of the conical spiral elastic sheet gradually decreases in the direction from the first fixing member of the external stent to the second fixing member.

[0021] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the width of the conical spiral elastic sheet gradually increases from the outer circle to the inner circle.

[0022] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, a plurality of the struts are provided with limit rings, and the outer ring of the spiral elastic sheet passes through the limit rings on the plurality of the struts in sequence.

[0023] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, a limiting post is provided on one of the struts, and a ring is provided at the outer ring end of the spiral elastic sheet, the ring is sleeved on the limiting post and the top of the limiting post has an anti-slip protrusion, and the inner diameter of the ring is larger than the outer diameter of the limiting post.

[0024] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the head end of the first fixing member and / or the second fixing member has a connection structure that can be connected to a joystick for implanting the artificial valve;

[0025] The connection structure and the operating lever can be relatively separated by operating the operating lever.

[0026] Preferably, in the above-mentioned coronary sinus artificial valve for treating myocardial ischemia, the connecting structure is an internal thread structure for cooperating with the external thread of the operating rod.

[0027] Preferably, the above coronary sinus artificial valve for treating myocardial ischemia further comprises barbs arranged on the outer side of the strut for hooking the blood vessel wall;

[0028] The outer side of the support rod is the side of the support rod facing away from the center line of the outer bracket;

[0029] When the artificial valve is not released, the barbs are attached to the outer side of the strut;

[0030] After the artificial valve is released, the barb is disposed at an angle greater than zero degrees with the outer side surface of the strut.

[0031] Preferably, the coronary sinus artificial valve for treating myocardial ischemia further comprises a sleeve sleeved on the middle part of the support rod, and the barb is arranged on the side of the sleeve facing away from the center line of the outer stent;

[0032] When the artificial valve is not released, the barbs are in contact with the sleeve;

[0033] After the artificial valve is released, the barb and the sleeve are arranged at an angle greater than zero degrees.

[0034] In the coronary sinus artificial valve for treating myocardial ischemia provided by the present invention, each strut includes a plurality of sections connected in sequence from the first end to the second end thereof, and any two adjacent sections are connected by a smooth transition. By designing the angle of the smooth transition between any two adjacent sections according to actual conditions, the artificial valve can be made more consistent with the human anatomical structure. In other words, any two adjacent sections are connected by a smooth transition section, and the curvature of the smooth transition section can be designed according to the conditions of the human anatomical structure, so that the artificial valve can be more consistent with the human anatomical structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0036] Figure 1 A schematic diagram of the structure of a coronary sinus artificial valve for treating myocardial ischemia provided by an embodiment of the present invention;

[0037] Figure 2 A schematic structural diagram of another angle of a coronary sinus artificial valve for treating myocardial ischemia provided by an embodiment of the present invention;

[0038] Figure 3 A schematic structural diagram of another angle of a coronary sinus artificial valve for treating myocardial ischemia provided by an embodiment of the present invention;

[0039] Figure 4 for Figure 3 A partial enlarged view of the middle A area;

[0040] Figure 5 A top view of a coronary sinus artificial valve for treating myocardial ischemia provided by an embodiment of the present invention;

[0041] Figure 6 Another schematic diagram of the structure of a coronary sinus artificial valve for treating myocardial ischemia provided in an embodiment of the present invention.

[0042] exist Figure 1-6 middle:

[0043] 1-first fixing piece, 2-second fixing piece, 2a-connecting thread, 3-support rod, 3a-first section, 3b-second section, 3c-third section, 3d-limiting ring, 3e-limiting column, 4-spiral elastic sheet, 4a-ring, 5-sleeve, 5a-barb. DETAILED DESCRIPTION

[0044] The purpose of the present invention is to provide a coronary sinus artificial valve for treating myocardial ischemia. The structural design of the coronary sinus artificial valve for treating myocardial ischemia can effectively solve the problem that the artificial valve is difficult to match the human anatomical structure.

[0045] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0046] In the description of the present invention, it should be understood that the terms "upper", "lower", "front", "back", "left" and "right" indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the positions or elements referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limitations of the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0047] See also Figure 1-Figure 2 The coronary sinus artificial valve for treating myocardial ischemia provided by the present invention includes an external support and a one-way guide. Among them, the external support includes a first fixing member 1, a second fixing member 2 and a plurality of struts 3. The first fixing member 1 and the second fixing member 2 are arranged along the center line of the external support. The plurality of struts 3 are distributed around the center line of the external support, in other words, the plurality of struts 3 are distributed circumferentially. The first fixing member 1 and the second fixing member 2 are used to fix the first end and the second end of the plurality of struts 3 together, respectively. In other words, the first fixing member 1 is used to fix the first ends of the plurality of struts 3 together, and the second fixing member 2 is used to fix the second ends of the plurality of struts 3 together.

[0048] The first fixing member 1 and the second fixing member 2 may both be fastening rings, and the fastening rings fasten together the first ends or the second ends of the plurality of supporting rods 3 bundled together.

[0049] Each support rod 3 includes multiple sections connected in sequence from the first end to the second end thereof, and any two adjacent sections are connected by a smooth transition. Each support rod 3 includes multiple sections, and any two sections are not on the same straight line. Any section of the multiple sections of the support rod 3 can extend along a straight line or along a curve. Any two adjacent sections are connected by a smooth transition, that is, any two adjacent sections are connected by a smooth transition section.

[0050] The one-way flow guide is arranged inside the outer bracket, that is, the one-way flow guide is located between a plurality of support rods 3. The edge of the one-way flow guide is connected to the support rod 3 to realize that the one-way flow guide is located inside the outer bracket.

[0051] When the liquid flows from the first fixing part 1 of the external bracket to the second fixing part 2 and the liquid pressure is not lower than the preset pressure value, the one-way flow guide is turned on; when the liquid flows from the first fixing part 1 of the external bracket to the second fixing part 2 and the liquid pressure is lower than the preset pressure value or when the liquid flows from the second fixing part 2 of the external bracket to the first fixing part 1, the one-way flow guide is closed. In this way, when blood flows from the first fixing part 1 to the second fixing part 2 and the liquid pressure is not lower than the preset pressure value, the blood can flow through the one-way flow guide. When blood flows from the second fixing part 2 to the first fixing part 1 or when the liquid flows from the first fixing part 1 of the external bracket to the second fixing part 2 and the liquid pressure is lower than the preset pressure value, the blood can no longer flow through the one-way flow guide, thereby preventing the backflow of blood.

[0052] In the artificial coronary sinus valve for treating myocardial ischemia provided by the present invention, each strut 3 includes a plurality of sections connected in sequence from the first end to the second end thereof, and any two adjacent sections are connected by a smooth transition. By designing the angle of the smooth transition between any two adjacent sections according to actual conditions, the artificial coronary sinus valve for treating myocardial ischemia can be made more consistent with the human anatomical structure. In other words, any two adjacent sections are connected by a smooth transition section, and the curvature of the smooth transition section can be designed according to the conditions of the human anatomical structure, so that the artificial coronary sinus valve for treating myocardial ischemia can be made more consistent with the human anatomical structure.

[0053] According to the changes in the pressure of the heart group tissue during the cardiac cycle, the favorable improvement of hemodynamics after the implantation of the coronary sinus artificial valve for the treatment of myocardial ischemia can be logically deduced. Because the valve has a certain elasticity, it requires a certain pressure to open. After the coronary sinus artificial valve is implanted, the pressure condition of the coronary circulation will change as follows: during the isovolumetric contraction period of the heart, the pressure in the microcirculation of the myocardial tissue increases rapidly, squeezing the blood to flow to the venous return system. Due to the presence of the valve, the microcirculation needs to reach a higher pressure to transmit the valve. This pressure must exceed the sum of the right atrial pressure and the pressure required to overcome the elasticity of the valve to open. Only then will the valve open and blood flow back to the right atrium. Before this, a high-pressure perfusion process will be formed in the microcirculation. Compared with the direct return of blood to the venous system under myocardial compression, it can fully realize the exchange of oxygen and nutrition. During the rapid ejection period and the slow ejection period, the myocardial tissue pressure reaches the maximum, and the coronary sinus artificial valve will fully open like the aortic valve to discharge the blood in the myocardial tissue to the right atrium. During the isovolumetric relaxation and rapid filling phases of the heart, the pressure in the myocardial tissue drops rapidly, and the pressure in the cardiac venous system also drops rapidly. At this time, the sinus coronary valve closes rapidly under the pressure of right atrial contraction and its own elasticity. The pressure on the venous system and the transmission of hydrostatic pressure caused by right atrial contraction are blocked by the valve. This creates a higher pressure difference between the coronary artery and the microcirculation, which causes more arterial blood from the coronary artery system to be perfused into the microcirculation. This forms a more efficient myocardial perfusion system than one without a coronary sinus valve. It can play a more significant role in cases of heart failure or refractory angina pectoris.

[0054] It should be noted that the support rod 3 may be a metal wire, and the plurality of support rods 3 are all elastic support rods 3 , and the plurality of elastic support rods 3 can be moved closer to or farther from each other to achieve contraction or expansion of the external support.

[0055] In a specific embodiment, the distance between the first end and the second end of the strut 3 and the center line of the external stent is less than the distance between any position between the two ends of the strut 3 and the center line of the external stent. That is, the distance between the first end and the second end of the strut 3 and the center line of the external stent is the smallest, and the distance between the remaining parts of the strut 3 and the center line of the external stent is greater than the distance between the first end and the second end of the strut 3 and the center line of the external stent. In other words, the strut 3 gradually moves away from the center line of the external stent from its first end to the second end and then gradually approaches the center line of the external stent. In this way, multiple struts 3 work together to support blood flow.

[0056] Preferably, the strut 3 includes a first section 3a, a second section 3b and a third section 3c connected in sequence from the first end to the second end thereof, the first section 3a gradually moves away from the center line of the external support from the end connected to the first fixing member 1 to the other end, and the third section 3c gradually approaches the center line of the external support from the end connected to the second section 3b to the other end. In other words, each strut 3 includes a first section 3a, a second section 3b and a third section 3c connected in sequence. The first section 3a gradually moves away from the center line of the external support from the end away from the second section 3b to the end connected to the second section 3b. The third section 3c gradually approaches the center line of the external support from the end connected to the second section 3b to the end away from the second section 3b. The second section 3b may extend parallel to the center line of the external support. In this embodiment, the first section 3a and the second section 3b have a smooth transition, and the second section 3b and the third section 3c have a smooth transition. By adjusting the length and angle of the first section 3a and the third section 3c, the artificial valve of the coronary sinus can be made more consistent with the human anatomical structure.

[0057] In order to ensure that the external support is subjected to balanced force, the plurality of support rods 3 can be arranged rotationally symmetrically. The plurality of support rods 3 are evenly distributed along the circumferential direction.

[0058] Of course, the support rods 3 may also be distributed non-uniformly, which is not limited here.

[0059] In another specific embodiment, the one-way flow guide includes an elastic sheet. When the liquid flows from the first fixing member 1 of the outer bracket to the second fixing member 2 and the liquid pressure is not lower than a preset pressure value, the liquid pressure can cause the elastic sheet to tilt, so that the edge of the elastic sheet has a gap, and the liquid can flow through the gap at the edge of the elastic sheet. When the liquid flows from the first fixing member 1 of the outer bracket to the second fixing member 2 and the liquid pressure is lower than the preset pressure value, the liquid pressure is not enough to cause the elastic sheet to tilt, and the gap at the edge of the elastic sheet is closed by its own elastic action. When the liquid flows from the second fixing member 2 of the outer bracket to the first fixing member 1, the liquid pressure and the elastic action of the elastic sheet itself both drive the gap at the edge of the elastic sheet to close.

[0060] In the above embodiment, the number of elastic sheets can be one. There is a gap between the free end of the elastic sheet and part of the support rods 3, and the fixed end of the elastic sheet can be fixedly connected to the remaining support rods 3. Or the one-way flow guide also includes an intermediate piece fixedly connected to the support rods 3, and the fixed end of the elastic sheet is fixedly connected to the intermediate piece. When the liquid flows from the first fixing member 1 of the outer bracket to the second fixing member 2 and the liquid pressure is not lower than the preset pressure value, the elastic sheet tilts toward the direction close to the second fixing member 2 so that the liquid flows through the gap at the edge of the elastic sheet. When the liquid flows from the first fixing member 1 of the outer bracket to the second fixing member 2 and the liquid pressure is lower than the preset pressure value, the pressure of the liquid is not enough to move the elastic sheet toward the direction close to the second fixing member 2, and the gap at the edge of the elastic sheet is blocked. When the liquid flows from the second fixing member 2 of the outer bracket to the first fixing member 1, the liquid pressure and the elastic action of the elastic sheet itself both drive the gap at the edge of the elastic sheet to close.

[0061] In a specific embodiment, the one-way flow guide is a spiral elastic sheet 4. When the liquid flows from the first fixing member 1 of the outer bracket to the second fixing member 2 and the liquid pressure is not lower than the preset pressure value, the liquid pressure causes the spiral elastic sheet 4 to form a conical spiral elastic sheet 4, and the diameter of the spiral elastic sheet 4 gradually decreases from the first fixing member 1 to the second fixing member 2 of the outer bracket. In other words, the axis of the spiral elastic sheet 4 coincides with the center line of the outer bracket, the end of the conical spiral elastic sheet 4 with a larger diameter is close to the first fixing member 1, and the end of the conical spiral elastic sheet 4 with a smaller diameter is close to the second fixing member 2, and the liquid can flow through the gap between two adjacent turns of the spiral elastic sheet 4.

[0062] When the liquid flows from the first fixing member 1 of the external bracket to the second fixing member 2 and the liquid pressure is lower than the preset pressure value or when the liquid flows from the second fixing member 2 of the external bracket to the first fixing member 1, the spiral elastic sheet 4 is flat and multiple turns of the spiral elastic sheet 4 are located in the same plane, which can prevent the liquid from flowing back.

[0063] In the above embodiment, it should be noted that the edges of two adjacent circles of the spiral elastic sheet 4 can be overlapped together to prevent the liquid pressure from causing the center of the spiral elastic sheet 4 to be closer to the first fixing member 1 than the outer circle.

[0064] Furthermore, the width of the spiral elastic sheet 4 increases gradually from the outer circle to the inner circle. With this arrangement, the force acting on the spiral elastic sheet 4 is greater when the liquid flows back, and the spiral elastic sheet 4 is compressed more quickly when the liquid flows back.

[0065] Specifically, a plurality of support rods 3 are provided with limiting rings 3d, and the outer rings of the spiral elastic sheet 4 sequentially pass through the limiting rings 3d on the plurality of support rods 3. In this way, the spiral elastic sheet 4 can be circumferentially displaced relative to the outer bracket, making it easier for the spiral elastic sheet 4 to bear force.

[0066] In another embodiment, a limiting column 3e is provided on one of the support rods 3, and a collar 4a is provided at the outer end of the spiral elastic sheet 4. The collar 4a is sleeved on the limiting column 3e and the top of the limiting column 3e has an anti-slip protrusion, which can prevent the collar 4a from detaching from the limiting column 3e. The inner diameter of the collar 4a is larger than the outer diameter of the limiting column 3e, that is, the collar 4a can be displaced along the axial direction of the limiting column 3e, and the collar 4a can be displaced along the radial direction of the limiting column 3e, so that the collar 4a and the outer end of the spiral elastic sheet 4 can be displaced relative to the limiting column 3e, which is convenient for the spiral elastic sheet 4 to be subjected to force buffering.

[0067] Of course, the outer ring of the spiral elastic sheet 4 can also be welded to the support rod 3, which is not limited here. Specifically, the edge of the one-way flow guide is welded or clamped to at least one support rod 3.

[0068] Of course, the elastic sheet may also be in other shapes, which are not limited here.

[0069] In order to facilitate the implantation of the artificial coronary sinus valve, the head end of the first fixing member 1 and / or the second fixing member 2 has a connection structure that can be connected to the joystick used to implant the artificial coronary sinus valve; the connection structure and the joystick can be relatively separated by operating the joystick. Among them, the head end of the first fixing member 1 is the end facing away from the second fixing member 2, and the head end of the second fixing member 2 is the end facing away from the first fixing member 1. Through the above arrangement, during the implantation operation, the joystick used to implant the artificial coronary sinus valve is connected to the connection structure of the first fixing member 1 and / or the second fixing member 2. After the artificial coronary sinus valve is implanted in place, the release of the artificial coronary sinus valve is completed, and the connection structure and the joystick are relatively separated by operating the joystick, and then the joystick is taken out.

[0070] It is also possible that the connection structure is not provided, and the artificial coronary sinus valve is clamped or pushed using a joystick for implanting the artificial coronary sinus valve, so that the artificial coronary sinus valve is implanted in place.

[0071] In this embodiment, it is preferred that a connection structure is provided at the head end of the second fixing member 2. A connection structure may also be provided only at the head end of the first fixing member 1. Connection structures may also be provided at both the head end of the first fixing member 1 and the head end of the second fixing member 2, and the configuration only needs to be based on the specific implantation operation, which will not be described one by one here and are all within the scope of protection.

[0072] like Figure 6As shown, in this embodiment, the connection structure is an internal thread structure for cooperating with the external thread of the joystick. By setting the internal thread structure, it is equivalent to setting a nut at the head end of the first fixing member 1 and / or the second fixing member 2. The connection structure and the joystick are rotated so that the external thread of the joystick is threadedly connected with the internal thread structure (connection structure), so that the joystick can be used to pull or push the coronary sinus artificial valve during the implantation of the coronary sinus artificial valve. After the coronary sinus artificial valve is implanted in place, the joystick is rotated so that the external thread of the joystick is relatively rotated and separated from the internal thread structure, so that the connection structure and the joystick are relatively separated.

[0073] The connection structure may also be configured as a buckle or other structure, and the joystick may be separated from the buckle by operations such as rotation or pressing, which will not be described in detail here.

[0074] In order to prevent the external stent from slipping off, the coronary sinus artificial valve provided in this embodiment also includes a barb 51 arranged on the outer side of the support rod 3, and the barb 51 is used to hook the blood vessel wall. When the coronary sinus artificial valve is not released, the barb 51 is attached to the outer side of the support rod 3; after the coronary sinus artificial valve is released, the barb 51 and the outer side of the support rod 3 are arranged at an angle greater than zero. Therefore, when the coronary sinus artificial valve is not released, the external stent of the coronary sinus artificial valve shrinks and is sleeved in the catheter. In this state, the barb 51 is attached to the outer side of the support rod 3 to avoid hindering the movement of the coronary sinus artificial valve in the catheter. When the catheter transports the coronary sinus artificial valve to the implantation position, the coronary sinus artificial valve is removed from the catheter to complete the operation of releasing the coronary sinus artificial valve. In addition, the barb 51 and the outer side of the support rod 3 are arranged at an angle greater than zero, so that the barb 51 slightly penetrates the blood vessel wall, and the operation of the barb 51 hooking the blood vessel wall is achieved, thereby preventing the external stent from slipping off. Through the above arrangement, the barbs 51 are elastic barbs, which can complete the operation of contraction and ejection relative to the branches 3.

[0075] In this embodiment, the outer side surface of each support rod 3 is provided with barbs 51. The outer side surface of the support rod 3 is the side of the support rod 3 facing away from the center line of the outer bracket.

[0076] In this embodiment, the direction of the tip of the barb 51 may be related to the setting position of the connection structure, or the direction of the tip of the barb 51 may be independent of the setting position of the connection structure. In this embodiment, the head end of the second fixing member 2 is provided with an internal thread structure (connection structure), and the tip of the barb 51 is directed toward the second fixing member 2.

[0077] In order to facilitate processing and setting, the coronary sinus artificial valve provided in this embodiment also includes a sleeve 5 sleeved on the middle part of the support rod 3, and the barb 51 is located on the side of the sleeve 5 facing away from the center line of the outer stent. When the coronary sinus artificial valve is not released, the barb 51 fits with the sleeve 5; after the coronary sinus artificial valve is released, the barb 51 and the sleeve 5 are set at an angle greater than zero.

[0078] Since each support rod 3 includes a first section 3a, a second section 3b and a third section 3c connected in sequence, and the second section 3b is the middle part of the support rod 3, it is preferred that the sleeve 5 is sleeved on the second section 3b. The sleeve 5 can be processed separately and then sleeved on the second section 3b, or the sleeve 5 can be directly processed on the second section 3b.

[0079] In this embodiment, the outer wall of the sleeve 5 is cut along a direction inclined to the axis of the sleeve 5, and the cut portion of the sleeve 5 body forms a barb 51, so that one end of the barb 51 is a sharp tip, and the other end is still connected to the body of the sleeve 5. Through the above arrangement, when the coronary sinus artificial valve is not released, the barb 51 fits with the sleeve 5, so that the outer wall of the sleeve 5 is flat, and further avoids hindering the movement of the coronary sinus artificial valve in the catheter.

[0080] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0081] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

[0082] In the description of this specification, the description with reference to the terms "one embodiment", "example", "specific example", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

Claims

1. A coronary sinus artificial valve for treating myocardial ischemia, characterized in that: include: An external bracket, the external bracket comprising a first fixing member (1) and a second fixing member (2) arranged along the center line thereof, and a plurality of support rods (3) distributed around the center line of the external bracket, the first fixing member (1) and the second fixing member (2) being used to respectively fix the first ends and the second ends of the plurality of support rods (3) together, the support rod (3) comprising a plurality of sections connected in sequence from the first end to the second end thereof, and any two adjacent sections being connected by a smooth transition; a one-way flow guide disposed inside the outer bracket, the edge of the one-way flow guide being connected to the support rod (3); when liquid flows from the first fixing member (1) of the outer bracket to the second fixing member (2) and the liquid pressure is not lower than a preset pressure value, the one-way flow guide is turned on; when liquid flows from the first fixing member (1) of the outer bracket to the second fixing member (2) and the liquid pressure is lower than the preset pressure value or when liquid flows from the second fixing member (2) of the outer bracket to the first fixing member (1), the one-way flow guide is closed; The support rod (3) comprises a first section (3a), a second section (3b) and a third section (3c) which are sequentially connected from the first end to the second end thereof, the first section (3a) gradually moves away from the center line of the outer support from the end connected to the first fixing member (1) to the other end, and the third section (3c) gradually moves closer to the center line of the outer support from the end connected to the second section (3b) to the other end; the plurality of support rods (3) are rotationally symmetrically arranged; The one-way flow guide is a spiral elastic sheet (4). When liquid flows from the first fixing member (1) of the external bracket to the second fixing member (2) and the liquid pressure is not lower than a preset pressure value, the liquid pressure causes the spiral elastic sheet (4) to form a conical spiral elastic sheet (4), and the diameter of the conical spiral elastic sheet (4) gradually decreases in the direction from the first fixing member (1) of the external bracket to the second fixing member (2).

2. The coronary sinus artificial valve for treating myocardial ischemia according to claim 1, characterized in that: The distance between the first end and the second end of the support rod (3) and the center line of the external support is smaller than the distance between any position between the two ends of the support rod (3) and the center line of the external support.

3. The coronary sinus artificial valve for treating myocardial ischemia according to claim 1, characterized in that: The one-way flow guide comprises an elastic sheet, and when liquid flows from the first fixing member (1) of the outer bracket to the second fixing member (2) and the liquid pressure is not lower than a preset pressure value, the liquid can flow through the gap at the edge of the elastic sheet; when liquid flows from the first fixing member (1) of the outer bracket to the second fixing member (2) and the liquid pressure is lower than the preset pressure value or when liquid flows from the second fixing member (2) of the outer bracket to the first fixing member (1), the gap at the edge of the elastic sheet is closed.

4. The coronary sinus artificial valve for treating myocardial ischemia according to claim 1, characterized in that: The width of the spiral elastic sheet (4) gradually increases from the outer circle to the inner circle.

5. The coronary sinus artificial valve for treating myocardial ischemia or heart failure according to claim 1, characterized in that: A limiting ring (3d) is provided on each of the plurality of support rods (3), and the outer ring of the spiral elastic sheet (4) passes through the limiting rings (3d) on the plurality of support rods in sequence.

6. The coronary sinus artificial valve for treating myocardial ischemia according to claim 1, characterized in that: A limiting column (3e) is arranged on one of the support rods (3), and a collar (4a) is arranged at the outer end of the spiral elastic sheet (4). The collar (4a) is sleeved on the limiting column (3e), and the top of the limiting column (3e) has an anti-slip protrusion, and the inner diameter of the collar (4a) is greater than the outer diameter of the limiting column (3e).

7. The coronary sinus artificial valve for treating myocardial ischemia according to claim 1, characterized in that: The head end of the first fixing member (1) and / or the second fixing member (2) has a connection structure capable of being connected to a joystick for implanting a coronary sinus artificial valve; The connection structure and the operating lever can be relatively separated by operating the operating lever.

8. The coronary sinus artificial valve for treating myocardial ischemia according to claim 7, characterized in that: The connection structure is an internal thread structure used to cooperate with the external thread of the joystick.

9. The coronary sinus artificial valve for treating myocardial ischemia according to claim 1, characterized in that: It also includes barbs (51) disposed on the outer side of the support rod (3) and used for hooking the blood vessel wall; The outer side surface of the support rod (3) is the side of the support rod (3) facing away from the center line of the outer bracket; When the coronary sinus artificial valve is not released, the barbs (51) are attached to the outer side of the strut (3); After the coronary sinus artificial valve is released, the barb (51) and the outer side surface of the support rod (3) are arranged at an angle greater than zero degrees.

10. The coronary sinus artificial valve for treating myocardial ischemia according to claim 9, characterized in that: It also includes a sleeve (5) sleeved on the middle part of the support rod (3), and the barb (51) is arranged on the side of the sleeve (5) facing away from the center line of the outer support; When the coronary sinus artificial valve is not released, the barbs (51) are in contact with the sleeve (5); After the coronary sinus artificial valve is released, the barb (51) and the sleeve (5) are arranged at an angle greater than zero degrees.

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