An implant device for repairing a valve

Abstract

The application relates to the field of medical devices, in particular to an implant device for repairing a valve, comprising a reshaping device, a control element for controlling the contraction of the reshaping device, a fixing element for anchoring the reshaping device to heart tissue, the reshaping device comprising at least two ring shrinkers, the at least two ring shrinkers being adjacently anchored to the autologous valve ring or atrial tissue through the fixing element, the control element being manipulated to make the ring shrinkers contract, and the adjacent ends of the ring shrinkers moving towards the center of the autologous valve, the application utilizes multiple ring shrinkers to be anchored to the heart tissue, and then the multiple ring shrinkers realize contraction, so that the adjacent ends of the ring shrinkers move towards the center of the autologous valve, the expanded valve ring can be uniformly contracted, the effective coaptation area of adjacent valve leaflets can be increased, and the regurgitation of the valve can be effectively repaired.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to an implantable device for repairing valves. Background Technology

[0002] With the aging population, the incidence of valvular heart disease has increased significantly. Mitral regurgitation (MR), in particular, has an incidence rate more than five times that of aortic stenosis. It is estimated that there are over 10 million patients with severe MR in my country. MR is caused by changes in the mitral valve leaflets and their structure, leading to poor anastomosis between the anterior and posterior leaflets, causing blood to flow backward from the left ventricle to the left atrium, resulting in various symptoms. Based on its pathogenesis, MR can be divided into primary (organic) and secondary (functional), each accounting for approximately 50%. Mild MR patients may remain asymptomatic for a long time and have a better prognosis. Severe MR patients may experience palpitations, chest tightness, and shortness of breath. Acute severe MR patients have poor tolerance and are prone to death. Clinical studies have shown that drug treatment can only improve symptoms but cannot prolong survival or determine the timing of surgery. Surgical valve repair or replacement is recognized as the standard treatment for MR and has been proven to alleviate symptoms and prolong survival. However, surgical treatment has disadvantages such as significant trauma, slow postoperative recovery, substantial postoperative pain, and high risks. Furthermore, 50% of MR patients are not suitable for surgery due to high-risk factors such as poor cardiac function, advanced age, or a history of open-chest surgery, thus failing to receive effective treatment. In the past decade or so, transcatheter mitral valve intervention technology has developed rapidly, especially with the launch of MitraClip, which has brought hope to many patients. Recent studies have shown that MitraClip is more effective than drug therapy in treating functional regurgitation. Faced with this huge market, major companies and investors are flocking to the field of MR treatment.

[0003] Therefore, MR therapy is entering an era of interventional treatment after traditional open-chest surgery and minimally invasive small-incision procedures. Interventional heart valve treatment offers the advantage of being less invasive compared to traditional methods, bringing hope to high-risk patients unsuitable for surgery. While interventional heart valve treatment has many advantages over traditional methods, it faces several technical challenges, such as difficulty in localization. This difficulty in localization introduces risks into interventional treatment. To obtain clear images, multiple administrations of contrast agents are required during the procedure, exposing patients to the harmful effects of these agents. Multiple and high-dose X-rays result in excessive cumulative radiation exposure, posing a risk of radiation damage. If the implant is not ideally positioned, displaced, or even dislodged due to localization problems, the patient may face the risk of undergoing traditional open-chest surgery again, seriously endangering their life. Therefore, ensuring timely and accurate implant localization is of great clinical value for interventional surgery.

[0004] US Patent 20210275306A1 discloses an exemplary method for performing a valve repair procedure, including introducing a catheter into the left atrium of the heart, deploying a first component from the catheter, anchoring the first component to the posterior side of the mitral valve annulus in the left atrium, deploying a second component from the catheter, anchoring the second component to the anterior side of the mitral valve annulus in the left atrium, deploying a flexible tensile member from the catheter, connecting the tensile member to the first and second components, and applying tension to the tensile member to pull the first and second components toward each other and bring the posterior and anterior sides of the mitral valve annulus closer together. This procedure is extremely complex and requires a high level of skill from the surgeon and precision in clinical angiography. On one hand, it significantly increases the operation time, which is detrimental to the patient's postoperative recovery. On the other hand, the second component is anchored to the anterior valve annulus, and then the first and second components are pulled towards each other. However, the anterior valve annulus is close to the aorta and its muscle tissue is relatively thin. During anchoring, it is easy to puncture the anterior valve tissue, thereby affecting the aorta and causing complications. Furthermore, this procedure requires the first and second components to exert force on each other, which means that the force on the anterior valve annulus anchoring point will be very large. The thin muscle tissue of the anterior valve annulus is prone to tissue tearing, affecting the repair effect.

[0005] Patent CN113558826A discloses a forming ring assembly, which includes a polymer braided tube, anchors, shrinkage threads, and a bidirectional shrinkage device; a delivery assembly for conveying the forming ring assembly to a target position; and a continuous anchoring assembly for fixing the forming ring assembly to the target position. In this design, the shrinkage threads are fixed at both ends of the forming ring. When the shrinkage threads are pulled, the ends of the forming ring experience significant force, causing them to move closer to the valve center. However, the middle area of ​​the forming ring is not subjected to the tension of the shrinkage threads or experiences less force. This results in only the ends of the forming ring moving closer to the valve center, while the distance between the middle area and the valve center remains unchanged, leading to uneven ring shrinkage and a generally poor repair effect.

[0006] In conclusion, although the above technologies have achieved some clinical success, they all have shortcomings, and there is an urgent need for a new implantable device for valve repair to solve these problems. Summary of the Invention

[0007] In view of the above and other concepts, this application is made. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0008] Regarding the application of atrioventricular valve surgery, this application aims to provide an implantable device for repairing valves in patients with heart valve lesions who require interventional treatment, thereby solving problems such as uneven annular shrinkage and significant regurgitation of the valve after annular shrinkage repair in existing technologies.

[0009] According to one aspect of this application, an implantable device for repairing a valve is provided, comprising a valvuloplasty device, a control element for controlling the contraction of the valvuloplasty device, and a fixation element for anchoring the valvuloplasty device to cardiac tissue. The valvuloplasty device includes at least two constriction ring members, which are adjacently anchored to an autologous valve annulus or atrial tissue by the fixation element. The control element is manipulated to cause the constriction ring members to contract, and adjacent ends of the constriction ring members are brought closer to the center of the autologous valve.

[0010] Furthermore, the at least two constriction ring members are anchored adjacently to the constriction ring region set by the autologous valve annulus or atrial tissue via the fixing element. The control element is manipulated to cause the constriction ring members to contract, and the adjacent ends of the constriction ring members move toward the center of the autologous valve, thereby causing the middle part of the set constriction ring region to move toward the center of the autologous valve.

[0011] Furthermore, the defined constricted annulus region refers to the annulus region corresponding to the middle part of the autologous leaflet. This defined constricted annulus region is close to the center of the autologous valve, which can reduce the distance between adjacent autologous leaflets, thereby increasing the contact area between the leaflets and reducing valve regurgitation.

[0012] Furthermore, the shaping device includes a first retractor member and a second retractor member, and when the control element is manipulated such that the first retractor member and the second retractor member contract, both ends of the first retractor member and both ends of the second retractor member move toward the center of the autologous valve.

[0013] Furthermore, the adjacent ends of the first and second shrinking ring members are located in the designated shrinking ring region; when the control element is manipulated to cause the first and second shrinking ring members to contract, the designated shrinking ring region moves toward the center of the autologous valve.

[0014] Furthermore, when the angioplasty device is used to repair mitral regurgitation, the designated annular region is the P2 region of the posterior leaflet annulus; when the first annular member and the second annular member contract, the P2 region of the posterior leaflet annulus will move closer to the center of the autologous valve, thereby increasing the contact area between the anterior and posterior leaflets and reducing valvular regurgitation.

[0015] Furthermore, the first and second constricting ring components can substantially cover the posterior valve annulus region after implantation in the heart.

[0016] Furthermore, after the first and second constricting ring components are implanted in the heart, one end of each of the two constricting ring components is located at the junction of the leaflets.

[0017] Furthermore, when the control element is manipulated to cause the shrinking ring member to contract, the distance between adjacent autologous leaflets decreases, their mating area increases, and the free edge of the autologous leaflet moves toward the center of the autologous valve.

[0018] Furthermore, the shrinking ring member has a sheet-like structure, a linear structure, or a ring-like structure, and the length of the shrinking ring member is less than or equal to one-third of the circumference of the autologous valve ring.

[0019] Furthermore, the shrinking skeleton includes several shrinking units, the length of one side of the shrinking unit is greater than the length of the other side of the shrinking unit, and adjacent shrinking units are fixedly connected on one side.

[0020] Furthermore, the shrinking unit is generally trapezoidal or "M" shaped.

[0021] Furthermore, the outer fabric covering layer is at least one layer.

[0022] Furthermore, as the shrinking ring member changes from a predetermined shape to a shrinking shape, the circumference of the shrinking ring member gradually decreases.

[0023] Furthermore, the predetermined shape of the contractile ring component matches the shape of the autologous valve annulus, and the contractile skeleton is made of a rigid material with a certain elasticity. In the contractile state, the contractile skeleton can contract and relax accordingly with the heartbeat.

[0024] Furthermore, the control element is a slender member, and one end of the control element is fixed to the shrinking frame. Pulling the other end of the control element can cause the shrinking frame to shrink evenly.

[0025] Furthermore, it also includes a delivery system comprising multiple anchoring components. After entering the heart, the multiple anchoring components abut against the constricting ring member and anchor the constricting ring member to the heart tissue via a fixation element, and the fixation element has a preset shape.

[0026] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following: 1. In the prior art, during annular repair, the angioplasty ring can only reduce the distance from its two ends to the valve center. The middle area of ​​the angioplasty ring is less affected by the tension of the angioplasty line, resulting in a small distance it moves towards the valve center, thus the anti-regurgitation effect is generally poor. In one embodiment of this application, multiple angioplasty ring components are anchored to the heart tissue, and then the multiple angioplasty ring components are contracted, so that the adjacent ends of the angioplasty ring components move towards the center of the autologous valve. This can bring the set angioplasty ring area closer to the center of the autologous valve, reducing the distance between adjacent leaflets, thereby increasing the effective contact area between adjacent leaflets and effectively repairing valve regurgitation.

[0027] 2. Unlike the prior art, in one embodiment of this application, the angioplasty device includes at least two annular members, and at least two ends of the annular members are anchored in a set annular region, so that after the annular members contract, the set annular region can be significantly moved closer to the valve center, reducing the distance between adjacent leaflets and thus significantly increasing the contact area of ​​adjacent leaflets, effectively preventing valve regurgitation. At the same time, the multiple annular members have a more obvious and effective contraction effect on the autologous valve annulus compared to a single angioplasty member in the prior art.

[0028] 3. Unlike the prior art, in one embodiment of this application, the contractile skeleton is made of an elastic rigid material, and the contractile ring component can still follow the heartbeat with a certain amount of contraction and relaxation after contraction, so as to avoid excessive stiffness causing tearing of the heart tissue after contraction. At the same time, it can also achieve uniform contraction, avoiding the concentration of contraction force at a certain anchor point and causing damage to the heart tissue.

[0029] The embodiments of this application can achieve other beneficial technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0030] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1a and 1b This is a schematic diagram of the overall structure of the forming device of the present invention.

[0031] Figures 2a-2e The diagram illustrates how the two ends of the existing forming ring move closer to the center of the valve, but the distance from the middle region to the center of the valve does not change significantly. This is in contrast to the process of the shrinking ring component of the present invention moving closer to the center of the valve itself.

[0032] Figures 3a-3c This is a schematic diagram illustrating the process by which the operating control element of the present invention causes the contraction stroke on one side of the shrinking ring member to be significantly greater than the contraction stroke on the other side of the shrinking ring member.

[0033] Figure 4 This is a schematic diagram of the conveying system of the present invention.

[0034] Figure 5a and 5b This is a schematic diagram illustrating the process by which the delivery system of the present invention enters the right atrium through the superior vena cava and then passes through the interatrial septum to reach the left atrium.

[0035] Figures 6a-6h This is a schematic diagram of the operation process of repairing the mitral valve using the device for repairing the mitral valve of the present invention.

[0036] The parts referred to by the numbers in the attached figures are as follows: 1-forming device, 11-shrinking ring member, 111-shrinking skeleton, 12-outer fabric covering layer, 2-control element, 3-fixing element, 4-conveying system, 41-control handle, 42-conveying conduit, 43-anchoring assembly, 44-shrinking ring control element, 5-first shrinking ring member, 6-second shrinking ring member. Detailed Implementation

[0037] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0038] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0039] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter and their equivalents, as well as any possible additional items.

[0040] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0041] In this application, the proximal end refers to the end closer to the surgeon, and the distal end refers to the end farther from the surgeon; the direction in which the contractile member is longer is the circumferential direction; the direction perpendicular to the circumferential direction or the tangential direction of the circumferential direction of the contractile member is the longitudinal direction.

[0042] In existing technologies, autologous valves often cannot function properly during atrioventricular valve replacement. This traditional treatment method results in the entire valve being in a state of ostial regurgitation during the replacement process, leading to a very short operation time, high risk, and the potential for various complications.

[0043] Example 1: In existing technology, when the annuloplasty ring contracts, the distance between the anchor points is shortened by pulling the contraction line, thereby reducing the circumference of the valve annulus and preventing valve backflow. However, in existing products, when the contraction line is pulled, the two ends of the annuloplasty ring noticeably move closer to the center of the valve, such as... Figure 2a and 2b As shown, the distance from the middle region of the angioplasty ring to the center of the valve does not change significantly, causing the angioplasty ring to appear as an approximately elliptical shape after contraction. The middle region (P2) of the angioplasty ring corresponds to the central region of the posterior leaflet. If this region does not move towards the center of the valve or moves very little towards the center of the valve, the contact area between adjacent leaflets will be insufficient, resulting in a generally poor effect on repairing regurgitation.

[0044] like Figure 1a and 1b As shown, in this embodiment, the device includes a shaping device 1, a control element 2 for controlling the contraction of the shaping device 1, and a fixing element 3 for anchoring the shaping device 1 to the heart tissue. The shaping device 1 includes at least two retractable ring members 11, which are adjacently anchored to the autologous valve annulus or atrial tissue by the fixing element 3. The control element 2 is manipulated to cause the retractable ring members 11 to contract, and the adjacent ends of the retractable ring members 11 are brought closer to the center of the autologous valve.

[0045] According to one example, at least two constricting ring members 11 are adjacently anchored by the fixing element 3 to a constricting ring region defined in the autologous valve annulus or atrial tissue (the defined constricting ring region refers to the position of the autologous valve annulus corresponding to the middle region of the leaflet, because preventing valvular regurgitation essentially involves reducing the distance between adjacent autologous valve leaflets to increase the contact area between them. Therefore, the defined constricting ring region is the position of the autologous valve annulus corresponding to the middle region of the leaflet. When the constricting ring member contracts, the defined constricting ring region moves towards the valve center, making the middle region of the autologous valve leaflet significantly closer to the valve center to increase the contact area with its adjacent leaflets, achieving a good regurgitation blocking effect). The control element is manipulated to cause the constricting ring member to contract, and the adjacent ends of the constricting ring member move towards the autologous valve center, and the middle of the defined constricting ring region moves towards the autologous valve center.

[0046] According to one example, the retracting ring member 11 includes a first retracting ring member 5 and a second retracting ring member 6, and when the control element 2 is manipulated to cause the first retracting ring member 5 and the second retracting ring member 6 to contract, both ends of the first retracting ring member 5 and both ends of the second retracting ring member 6 move closer to the center of the autologous valve, such as... Figures 2c-2e As shown.

[0047] According to one example, when the angioplasty device 1 is used to repair mitral regurgitation, the set annulus contraction area is the P2 region of the posterior leaflet annulus; when the first annulus contraction member 5 and the second annulus contraction member 6, the P2 region of the posterior leaflet annulus will move closer to the center of the autologous valve, thereby increasing the contact area between the anterior and posterior leaflets and reducing valvular regurgitation.

[0048] According to one example, the first constricting ring member 5 and the second constricting ring member 6 can substantially cover the posterior valve annulus region after implantation in the heart.

[0049] According to one example, when the control element 2 is manipulated to cause the shrinking ring member 11 to shrink, the circumference of the autologous valve annulus decreases, the mating area of ​​adjacent autologous leaflets increases, and the free edge of the autologous leaflet moves toward the center of the autologous valve.

[0050] According to one example, the shrinking ring member 11 has a sheet-like structure, and the length of the shrinking ring member 11 is less than or equal to one-third of the circumference of the autologous valve ring.

[0051] According to one example, the first shrinking annulus member 5 and the second shrinking annulus member 6 successively repair the mitral valve annulus, such as... Figure 6g and 6h As shown.

[0052] According to one example, as the shrinking ring member 11 changes from a predetermined shape to a shrinking shape, the circumference of the shrinking ring member 11 gradually decreases.

[0053] According to one example, the contractile skeleton 111 has an elastic modulus in both the predetermined and contracted states. The fact that it still has an elastic modulus in the contracted state allows the shaping device 1 to have a certain extension and contraction stroke during the heart's beating process, thus avoiding tearing of the heart tissue.

[0054] According to one example, the control element 2 is an elongated member, and one end of the control element 2 is fixed to one end of the contractile frame 111. Pulling the other end of the control element 2 can cause the contractile frame 111 to contract evenly, which can avoid concentrating the contraction force at a certain anchor point and causing damage to the heart tissue.

[0055] According to another example, the delivery system 4 includes a control handle 41, a delivery conduit 42, and an anchoring assembly 43, with the fixing member 3 disposed within the anchoring assembly 43. The shaping device 1 is pre-installed within the delivery conduit 42, and when the shaping device 1 reaches the autologous valve annulus, the shaping device 1 is anchored at the autologous valve annulus by the fixing member 3.

[0056] According to one example, the fastener 3 is an anchor pin, and the structure of the fastener 3 can be of various forms (such as a hyperbolic needle), and the fastener 3 has a preset shape.

[0057] According to one example, the delivery conduit 42 is also provided with a retraction ring control member 44. The proximal end of the retraction ring control member 44 is connected to the control handle 41, and its distal end is detachably connected to the control element 2. After the retraction ring member 11 is anchored, the retraction ring control member 44 can be operated to pull the control element 2 relative to the retraction ring member 11 to one end. After the retraction is completed, the retraction ring control member 44 is disassembled from the control element 2 and removed from the body.

[0058] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An implantable device for repairing a valve, comprising a valvular device, a control element for controlling the contraction of the valvular device, and a fixation element for anchoring the valvular device to cardiac tissue, characterized in that: The angioplasty device includes at least two retractable ring members, which are anchored adjacently to the autologous valve annulus or atrial tissue by the fixing element. The control element is manipulated to cause the retractable ring members to retract, and the adjacent ends of the retractable ring members move toward the center of the autologous valve. The retractable ring members include a retractable skeleton and a covering layer. The retractable skeleton includes a plurality of retractable units. The length of one side of the retractable unit is greater than the length of the other side of the retractable unit, and adjacent retractable units are fixedly connected on one side. The retractable units are generally trapezoidal or "M" shaped.

2. The implantable device for valve repair according to claim 1, characterized in that: The at least two constriction ring members are anchored adjacently to the constriction ring region set by the autologous valve annulus or atrial tissue via the fixing element. The control element is manipulated to cause the constriction ring members to contract, and the adjacent ends of the constriction ring members move toward the center of the autologous valve, thereby causing the middle part of the set constriction ring region to move toward the center of the autologous valve.

3. The implantable device for valve repair according to claim 2, characterized in that: The shaping device includes a first retractor ring member and a second retractor ring member, and when the control element is manipulated so that the first retractor ring member and the second retractor ring member contract, both ends of the first retractor ring member and both ends of the second retractor ring member move toward the center of the autologous valve.

4. The implantable device for valve repair according to claim 3, characterized in that: The ends of the first and second retractable ring members adjacent to each other are located in the designated retractable ring region; when the control element is manipulated to cause the first and second retractable ring members to contract, the designated retractable ring region moves toward the center of the autologous valve.

5. The implantable device for valve repair according to claim 1, characterized in that: When the control element is manipulated to cause the shrinking ring member to contract, the distance between adjacent autologous leaflets decreases, and the free edge of the autologous leaflet moves toward the center of the autologous valve.

6. The implantable device for valve repair according to claim 1, characterized in that: The length of the shrinking ring member is less than or equal to one-third of the circumference of the autologous valve ring.

7. The implantable device for valve repair according to claim 1, characterized in that: The shrinking ring member has a predetermined shape and a shrinking shape, and as the shrinking ring member changes from the predetermined shape to the shrinking shape, the circumference of the shrinking ring member gradually decreases.

8. The implantable device for valve repair according to claim 7, characterized in that: The predetermined shape of the contractile ring component matches the shape of the autologous valve annulus, and the contractile skeleton is made of a rigid material with a certain elasticity. In the contractile state, the contractile skeleton can contract and relax accordingly with the heartbeat.

9. The implantable device for valve repair according to claim 1, characterized in that: The control element is a slender component, and one end of the control element is fixed to the shrinking frame. Pulling the other end of the control element can cause the shrinking frame to shrink.

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