An implant device for valvuloplasty

Abstract

The application relates to the field of medical devices, in particular to an implant device for valvuloplasty, which comprises a ring shrinkage component, a control element for controlling the shrinkage of the ring shrinkage component, a fixing element for anchoring the ring shrinkage component to heart tissue, the ring shrinkage component comprises a first ring shrinkage component and a second ring shrinkage component, the ring shrinkage component is anchored adjacently to a set ring shrinkage area of an autologous valve ring or atrium tissue through the fixing element, further comprising an elastic component, the elastic component is connected with the ring shrinkage component, the elastic component is provided with a channel, the control element is connected with the elastic component through the channel, and the control element is operated to drive the elastic component to shrink, the elastic component further drives the ring shrinkage component to uniformly shrink; the application not only simplifies the structure of the implant device, but also can realize uniform shrinkage, reduce the damage to the heart tissue, and has good clinical significance.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to an implantable device for valve repair. 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] Patent CN2022101932385 discloses an implantable device for valve repair, including 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. The valvular device includes at least two constricting ring members, which are adjacently anchored to the autologous valve annulus or atrial tissue by the fixation element. Manipulating the control element causes the constricting ring members to contract, with adjacent ends of the constricting ring members moving towards the center of the autologous valve. However, the applicant found in experiments that after the constricting ring members contract, the contraction torque is not evenly distributed on the constriction framework, resulting in different contraction strokes in different segments of the constriction framework. The constricting ring members do not form a uniformly curved ring after contraction, causing the morphology of the original valve annulus to change. This leads to a deformed shape of the autologous valve annulus after contraction, damaging cardiac tissue and easily causing various complications in the postoperative period.

[0005] 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

[0006] 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.

[0007] In terms of applications in atrioventricular valve surgery, this application aims to provide an implantable device for valve repair for patients with heart valve disease who require interventional treatment. This addresses the problem that in existing heart valve repair systems, the torque of the shrinking ring component during contraction is not evenly distributed on the shrinking skeleton, resulting in different contraction strokes in different segments of the shrinking skeleton. Consequently, the shrinking ring component does not form a uniformly curved ring after contraction, which alters the shape of the original valve annulus. This leads to deformities of the autologous valve annulus after contraction, causing damage to cardiac tissue and easily leading to various postoperative complications.

[0008] According to one aspect of this application, an implantable device for valve repair is provided, comprising a constricting ring member, a control element for controlling the contraction of the constricting ring member, and a fixation element for anchoring the constricting ring member to cardiac tissue. The constricting ring member includes a first constricting ring member and a second constricting ring member, which are adjacently anchored to a constricting ring region defined by an autologous valve annulus or atrial tissue via the fixation element. The device also includes an elastic member connected to the constricting ring member, the elastic member having a channel through which the control element passes and engages with the elastic member. Manipulating the control element causes it to contract the elastic member, and the elastic member further causes the constricting ring member to contract uniformly.

[0009] Furthermore, manipulating the control element causes the shrinking ring member to contract, and the adjacent ends of the shrinking ring member move closer to the center of the autologous valve, thereby driving the middle part of the set shrinking ring region to move closer to the center of the autologous valve and reducing the distance between adjacent leaflets.

[0010] Furthermore, the elastic member includes a first elastic element and a second elastic element, and the first elastic element and the second elastic element are respectively disposed on both sides of the circumferential direction of the shrinking ring member.

[0011] Furthermore, the first elastic element is disposed on one side inside the shrink ring member, and the first elastic element is fixedly connected to the shrink ring member.

[0012] Furthermore, the second elastic element is disposed on one side outside the shrink ring member, and the second elastic element is fixedly connected to the shrink ring member.

[0013] Furthermore, one end of the control element is fixed to the upper end of one side of the shrink ring member, and the other end of the control element first passes through the channel of the first elastic element, then through the channel of the second elastic element, and is connected to the lower end of the other side of the shrink ring member; the first elastic element is disposed on one side inside the shrink ring member, and the second elastic element is disposed on one side outside the shrink ring member, so that when the control element is pulled, the contraction stroke of the shrink ring member on the side closer to the first elastic element is less than the contraction stroke of the shrink ring member on the side farther away from the first elastic element.

[0014] Furthermore, the control element is provided with a limiting structure, and the limiting structure can cooperate with the elastic member to achieve locking.

[0015] Furthermore, the elastic member is a helical spring, and the limiting structure can cooperate with the spring to achieve locking. The advantage of this design is that the limiting structure and the spring have more locking points, making the control of the shrinking ring member more precise when it shrinks.

[0016] Furthermore, the shrinking ring component is composed of several shrinking rods with different diameters arranged together, and the diameter of the shrinking rods gradually decreases from one end to the other.

[0017] Furthermore, the diameter of the retraction rod at the end closer to the designated constriction ring region is smaller than the diameter of the retraction rod at the end farther from the designated constriction ring region. The advantage of this design is that the retraction rod at the end closer to the designated constriction ring region requires less torque to contract, resulting in greater contraction on that side. This allows the central region of the leaflet to move significantly towards the valve center, effectively increasing the contact area between adjacent leaflets and thus effectively repairing valvular regurgitation.

[0018] Furthermore, the retractable rod is configured in a U-shape; the U-shape makes it easier to retract, and the curvature of the retractable ring component is more uniform after retraction.

[0019] Furthermore, the shrinking ring member has a fixed rod at one end of the shrinking rod located in the designated shrinking ring area. The fixed rod is connected to the shrinking rod so that the shrinking rod forms a closed loop structure. The advantage of this design is that the shrinking ring member is easier to fit into the tissue after shrinking, is less likely to lift up, and reduces the risk of tissue puncture.

[0020] Furthermore, the shrink ring member is provided with a fabric covering layer, and during anchoring, the fixing element passes through the fabric covering layer and is inserted into the heart tissue.

[0021] Furthermore, as the shrinking ring member changes from a predetermined shape to a shrinking shape, the circumference of the shrinking ring member gradually decreases.

[0022] Furthermore, the contractile skeleton is made of a rigid material with a certain degree of elasticity, and the contractile skeleton can contract and relax accordingly with the heartbeat in the contraction state.

[0023] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following: 1. In the prior art, the shrinkage of the autologous valve annulus by the angioplasty device is not uniform, which can lead to a deformed shape of the autologous valve annulus after shrinkage, easily altering the shape of the original valve annulus, damaging cardiac tissue, and easily causing various complications in the postoperative period. In one embodiment of this application, the annulus shrinkage member is provided with an elastic member, so that when the annulus shrinkage member shrinks, the elastic member can distribute the torque evenly on the annulus shrinkage member, so that the annulus shrinkage member forms a uniformly curved ring after shrinkage, matching the anatomical structure of the autologous valve annulus. Under the premise of achieving annulus shrinkage repair, the shape of the autologous valve is not changed, damage to the original tissue is avoided, postoperative complications are reduced, and postoperative recovery of patients is beneficial.

[0024] 2. Unlike the prior art, in one embodiment of this application, the elastic member is provided with a channel, and the control element passes through the channel and cooperates with the elastic member to lock the retracted ring state. The advantage of this design is that there is no need to set other connecting structures (such as connecting holes) on the retracted ring member to cooperate with the control element, which simplifies the overall structure of the retracted ring member, and makes the anchoring area more extensive and less likely to be interfered with by other structures when the fixing element is anchored.

[0025] 3. Unlike the prior art, in one embodiment of this application, the first elastic element is disposed on one side inside the constricting ring member, and the second elastic element is disposed on the other side outside the constricting ring member. This makes the contraction stroke of the constricting ring member on the side closer to the first elastic element less than the contraction stroke of the constricting ring member on the side farther from the first elastic element when the control element is pulled. This causes the circumferential side of the constricting ring member to lift or rise towards the atrium, so that the amplitude of the circumferential side of the heart valve swinging towards the valve center is greater than the amplitude of the swinging on the other circumferential side. This allows the valve leaflet to swing towards the valve center, reducing the distance between adjacent leaflets, increasing the contact area between adjacent leaflets, and reducing regurgitation.

[0026] 4. Unlike the prior art, in one embodiment of this application, the diameter of the contraction rod at the end closer to the set constriction ring area is smaller than the diameter of the contraction rod at the end farther from the set constriction ring area. The advantage of this design is that the contraction rod at the end closer to the set constriction ring area requires less torque to contract, resulting in greater contraction on the side closer to the set constriction ring area. This allows the central area of ​​the leaflet to move significantly towards the valve center, effectively increasing the contact area between adjacent leaflets and thus effectively repairing valvular regurgitation.

[0027] 5. Unlike the prior art, in one embodiment of this application, the shrinking ring member has a fixed rod at one end of the shrinking rod in the set shrinking ring area. The fixed rod is connected to the shrinking rod so that the shrinking rod has a closed loop structure. The advantage of this design is that the shrinking ring member is easier to fit the tissue after shrinking, is less likely to lift up, and reduces the risk of tissue puncture.

[0028] 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

[0029] 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 This is a schematic diagram of the structure of the shrink ring component of the present invention. Figure 1b A schematic diagram of the shrink ring structure for removing the fabric overlay.

[0030] Figures 1c-1d This is a schematic diagram of the shrinking ring component contracting under the action of the control element according to the present invention.

[0031] Figure 1e A schematic diagram of the shrinkage pattern of the shrink ring component structure to remove the fabric covering layer.

[0032] Figures 2a-2cThis is a schematic diagram of the shrinking ring component of the present invention shrinking on the mitral valve annulus.

[0033] Figure 3a and 3b This diagram illustrates the posterior dilation of the mitral valve and the deformed shape of the valve annulus caused by the constriction ring structure in the prior art.

[0034] Figures 4a-4b This is a schematic diagram showing the arrangement of the limiting mechanism of the present invention on the control element and the elastic member.

[0035] The parts referred to by the numbers in the attached drawings are as follows: 1-shrinking ring component, 11-first shrinking ring component, 12-second shrinking ring component, 13-shrinking rod, 14-fixing rod, 2-control element, 21-limiting structure, 3-fixing element, 4-elastic component, 41-first elastic element, 42-second elastic element, 5-channel, 6-fabric covering layer. Detailed Implementation

[0036] 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.

[0037] 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.

[0038] 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.

[0039] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0040] 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 length of the shrink ring member is longer is the circumferential direction; the direction perpendicular to the circumferential direction or the tangential direction of the circumferential direction of the shrink ring member is the longitudinal direction.

[0041] 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.

[0042] Example 1: In existing repair products, especially those used for annular valve repair, the uneven torque distribution during annular valve contraction results in the annular valve not having a uniformly curved ring shape after contraction. This alters the shape of the original valve, further damaging cardiac tissue and affecting the function of other blood vessels and tissues in the heart, leading to various postoperative complications in patients.

[0043] like Figure 1a , 1b As shown in Figure 2a, according to one example, an implantable device for valve repair includes a retractor ring 1, a control element 2 for controlling the contraction of the retractor ring 1, and a fixation element 3 for anchoring the retractor ring 1 to cardiac tissue. The retractor ring 1 includes a first retractor ring 11 and a second retractor ring 12. The retractor ring 1 is adjacently anchored to a retractor ring region defined by autologous valve annulus or atrial tissue via the fixation element 3. The device also includes an elastic member 4 connected to the retractor ring 1. The elastic member 4 has a channel 5, and the control element 2 passes through the channel 5 and engages with the elastic member 4. Manipulating the control element 2 causes the elastic member 4 to contract. Component 4 further drives the shrinking ring component 1 to achieve uniform contraction; compared with the existing technical solutions, the present invention provides an elastic component 4 with a channel 5. The control element 2 passes through the channel 5 and cooperates with the elastic component 4 to achieve locking. This not only eliminates the connection hole between the shrinking ring component 1 and the control element 2, simplifying the structure of the instrument and reducing interference during anchoring and needle insertion, but also increases the number of lockable "points" for the control element 2 during operation, making its control scale more precise. The elastic component 4 can also evenly distribute the contraction torque on the shrinking ring component 1, so that it forms a uniformly curved ring shape after contraction, which better matches the physiological and anatomical structure of the autologous valve, avoids damage to the original tissue, and has good clinical significance, such as... Figure 1e As shown.

[0044] According to one example, when the implantable device is used to repair the mitral valve, the designated annular region is the P2 region of the mitral valve, such as... Figure 2b and2c As shown; the P2 region corresponds to the middle region of the posterior leaflet. When the operating control element 2 causes the first shrinking ring member 11 and the second shrinking ring member 12 to contract, the adjacent ends of the first shrinking ring member 11 and the second shrinking ring member 12 will move significantly toward the center of the valve. That is, the P2 region will drive the posterior leaflet to move closer to the center of the valve. This reduces the distance between the posterior leaflet and the anterior leaflet, and greatly increases the contact area of ​​the two leaflets, which can effectively prevent valve regurgitation.

[0045] According to one example, the control element 2 is manipulated to cause the shrinking ring member 1 to contract, and the adjacent ends of the shrinking ring member 1 move toward the center of the autologous valve, thereby causing the middle part of the set shrinking ring region to move toward the center of the autologous valve and reducing the distance between adjacent leaflets.

[0046] According to one example, the elastic member 4 includes a first elastic element 41 and a second elastic element 42, and the first elastic element 41 and the second elastic element 42 are respectively disposed on both sides of the circumferential direction of the contraction ring member 1, such as... Figure 1b As shown.

[0047] According to one example, the first elastic element 41 is disposed on one side inside the shrinking ring member 1, and the first elastic element 41 is fixedly connected to the shrinking ring member 1; the second elastic element 42 is disposed on one side outside the shrinking ring member 1, and the second elastic element 42 is fixedly connected to the shrinking ring member 1; one end of the control element 2 is fixed to the upper end of one side of the shrinking ring member 1, and the other end of the control element 2 passes through the channel 5 of the first elastic element 41, then through the channel 5 of the second elastic element 42, and is connected to the lower end of the other side of the shrinking ring member 1; the first elastic element 41 is disposed on one side inside the shrinking ring member 1, and the second elastic element 42 is disposed on one side outside the shrinking ring member 1, such that when the control element 2 is pulled, the contraction stroke of the shrinking ring member 1 on the side closer to the first elastic element 41 is less than the contraction stroke of the shrinking ring member 1 on the side farther from the first elastic element 41, such as... Figure 1b and 1c As shown.

[0048] According to another example, the elastic member 4 includes only one elastic element, and the elastic member 4 is disposed on one side outside the shrink ring member 1, and when the implantation device is implanted, the elastic member 4 is located on the side close to the autologous valve annulus or autologous valve leaflet.

[0049] According to one example, the control element 2 is provided with a limiting structure 21, and the limiting structure 21 can cooperate with the elastic member 4 to achieve locking, such as... Figure 4a As shown.

[0050] According to a preferred embodiment, the elastic member 4 is a helical spring, and the limiting structure 21 can cooperate with the spring to achieve locking. The advantage of this design is that the limiting structure 21 has more locking points with the spring, making the control of the shrinking ring member 1 more precise during contraction. Figure 4b As shown.

[0051] According to one example, the constriction ring member 1 is composed of a plurality of constriction rods 13 arranged together. The diameter of the constriction rod 13 near the end of the set constriction ring region is smaller than the diameter of the constriction rod 13 away from the set constriction ring region. The advantage of this design is that the constriction rod 13 near the end of the set constriction ring region requires less torque to contract, resulting in greater contraction on the side near the set constriction ring region. This allows the central region of the leaflet to move significantly towards the valve center, effectively increasing the contact area between adjacent leaflets and thus effectively repairing valvular regurgitation.

[0052] According to one example, the retractable rod 13 is arranged in a U-shape; the U-shape makes it easier to retract, and the curvature of the retractable ring member 1 is more uniform after retraction.

[0053] According to one example, the shrinking ring member 1 has a fixed rod 14 at one end of the shrinking rod 13 located in the set shrinking ring area. The fixed rod 14 is connected to the shrinking rod 13 so that the shrinking rod 13 has a closed loop structure. The advantage of this design is that the shrinking ring member 1 is easier to fit the tissue after shrinking, is not easy to lift up, and reduces the risk of tissue puncture.

[0054] According to one example, the constriction ring member 1 is provided with a fabric cover layer 6, and when anchored, the fixing element 3 passes through the fabric cover layer 6 and is inserted into the heart tissue.

[0055] According to one example, as the shrinking ring member 1 changes from a predetermined shape to a shrinking shape, the circumference of the shrinking ring member 1 gradually decreases.

[0056] According to one example, the contractile skeleton is made of a rigid material with a certain degree of elasticity, and the contractile skeleton can contract and relax accordingly with the heartbeat in the contraction mode.

[0057] The product of this invention is not only applicable to the repair of mitral valve disease, but also to tricuspid valve disease.

[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 valve repair, comprising a constricting ring member, a control element for controlling the contraction of the constricting ring member, and a fixation element for anchoring the constricting ring member to cardiac tissue, wherein the constricting ring member includes a first constricting ring member and a second constricting ring member, the constricting ring member being adjacently anchored to a constricting ring region defined in autologous valve annulus or atrial tissue by the fixation element, characterized in that: It also includes an elastic member connected to the shrinking ring member. The elastic member has a channel, and the control element passes through the channel and is connected to the elastic member. By manipulating the control element, the control element causes the elastic member to contract, and the elastic member further causes the shrinking ring member to achieve uniform contraction. The shrinking ring member is composed of several shrinking rods with different diameters. The shrinking rod at one end of the shrinking ring member located in the set shrinking ring area has a fixed rod. The fixed rod is connected to the shrinking rod so that the shrinking rod has a closed loop structure.

2. The implantable device for valve repair according to claim 1, characterized in that: Manipulating the control element causes the shrinking ring member to contract, and the adjacent ends of the shrinking ring member move closer to the center of the autologous valve, thereby driving the middle part of the set shrinking ring region to move closer to the center of the autologous valve.

3. The implantable device for valve repair according to claim 1, characterized in that: The elastic member includes a first elastic element and a second elastic element, and the first elastic element and the second elastic element are respectively disposed on both sides of the circumferential direction of the shrinking ring member.

4. The implantable device for valve repair according to claim 3, characterized in that: The first elastic element is disposed on one side inside the shrink ring member, and the first elastic element is fixedly connected to the shrink ring member.

5. The implantable device for valve repair according to claim 3, characterized in that: The second elastic element is disposed on one side outside the shrink ring member, and the second elastic element is fixedly connected to the shrink ring member.

6. The implantable device for valve repair according to claim 4 or 5, characterized in that: Manipulating the control element causes the shrinking ring member to contract, and the contraction stroke of the shrinking ring member on the side closer to the first elastic member is less than the contraction stroke of the shrinking ring member on the side farther from the first elastic member.

7. The implantable device for valve repair according to claim 1, characterized in that: The control element is provided with a limiting structure, and the limiting structure can cooperate with the elastic member to achieve locking.

8. The implantable device for valve repair according to claim 1, characterized in that: The diameter of the retractable rod gradually decreases from one end to the other.

9. The implantable device for valve repair according to claim 8, characterized in that: The diameter of the contraction rod at the end closer to the set contraction ring area should be smaller than the diameter of the contraction rod at the end farther away from the set contraction ring area.

10. The implantable device for valve repair according to claim 8, characterized in that: The retraction rod is U-shaped.

11. The implantable device for valve repair according to claim 1, characterized in that: The shrink ring member is provided with a fabric covering layer. When anchored, the fixing element passes through the fabric covering layer and is inserted into the heart tissue.

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