A locking structure for use with a shapely device

Abstract

The application relates to the field of medical devices, in particular to a locking structure applied to a forming device, which comprises a contraction framework, a covering layer and a control element, the covering layer is provided with a fixing component for fixing the contraction framework and heart tissue, one end of the control element is connected with the contraction framework, and the other end of the control element is provided with a locking part, characterized in that: the contraction framework is provided with a containing part in the longitudinal direction, the containing part is provided with a locking hole, the other end of the control element is pulled to make the contraction framework realize contraction; meanwhile, the locking part is bent into the containing part and cooperates with the locking hole to realize locking; the application scheme improves the technical difficulties that the control element causes damage to the heart tissue after the shrink ring operation, and good technical effects are obtained, and the application scheme has good clinical significance.

Description

Technical Field

[0001] This application relates to the field of medical devices, specifically to a locking structure used in a prosthetic device. 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 a valvular repair device, comprising a contractile skeleton and at least one covering layer; the covering layer is fixedly connected to the contractile skeleton; the contractile skeleton has a predetermined shape and a contracted shape; the contractile skeleton is provided with at least one first fixing component for limiting the effective length of the control element acting on the contractile skeleton, and the covering layer is provided with multiple second fixing components for fixing the contractile skeleton to the heart tissue. When the contractile skeleton is in the contracted shape, the contraction stroke on one side of the contractile skeleton is greater than the contraction stroke on the other side. In implementation, pulling the control element causes the contractile skeleton to contract uniformly, thus repairing the autologous valve. However, after the control element is pulled, part of it is directly exposed outside the contractile skeleton, and the self-locking control element has a certain rigidity, making it very easy to puncture the heart tissue, and even potentially embed the other end of the control element into the heart tissue, posing a high risk.

[0005] In summary, although the above-mentioned technical solutions have achieved some success in clinical practice, the operation of the control elements may cause damage to cardiac tissue during actual surgery. Therefore, there is an urgent need for a new locking structure for use in angioplasty devices to solve the above 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 the application of atrioventricular valve surgery, this application aims to address the problem that existing atrioventricular valve repair devices, during clinical surgery, can cause damage to cardiac tissue due to the control element's ring-shrinking operation, leading to increased patient complications and affecting postoperative recovery. It proposes a locking structure for use in atrioventricular valve repair devices. This solution improves upon the technical difficulty of causing cardiac tissue damage after the control element's ring-shrinking operation, achieving good technical results and possessing significant clinical value.

[0008] According to one aspect of this application, a locking structure for use in a surgical device is provided, including a retractable skeleton, a cover layer, and a control element. The cover layer is provided with a fixing component for fixing the retractable skeleton to cardiac tissue. One end of the control element is connected to the retractable skeleton, and the other end of the control element is provided with a locking part. The retractable skeleton is provided with a receiving part in the longitudinal direction, and the receiving part is provided with a locking hole. Pulling the other end of the control element causes the retractable skeleton to retract; at the same time, the locking part bends into the receiving part and cooperates with the locking hole to achieve locking.

[0009] Furthermore, the receiving part is provided with at least two locking holes, and the locking holes are spaced apart in the longitudinal direction.

[0010] Furthermore, the control element is an elongated member, comprising a connecting portion and a locking portion, and the locking portion is made of a rigid material with a certain degree of elasticity.

[0011] Furthermore, pulling the other end of the control element causes the locking part to be squeezed by the locking hole. Pulling the other end of the control element further causes the locking part to gradually return to its natural shape and pass through the locking hole.

[0012] Furthermore, the middle area of ​​the locking part is hollowed out, and the outer edge of the locking part is provided with thorns.

[0013] Furthermore, during the ring-shrinking operation, the thorn passes through all the locking holes. The purpose of this design is to make the entire shaping device more forgiving. The thorn passing through multiple locking holes means that its locking stability is higher. Even if the thorn disengages from one of the locking holes, the remaining locking holes can still cooperate with the thorn and maintain its locked state.

[0014] Furthermore, the shrinking skeleton is provided with a connecting hole, which is located on one side of the shrinking skeleton in the circumferential direction, and the receiving part is located on one side of the shrinking skeleton in the longitudinal direction. During pre-assembly, the connecting part passes through the connecting hole. During the shrinking process, the other end of the control element will be bent and enter the receiving part. The receiving part is located on one side of the shrinking skeleton in the longitudinal direction, which will not increase the overall length of the shaping device, and at the same time, it can prevent the other end of the control element from being exposed outside the shrinking skeleton, contacting the heart tissue and causing damage to the heart tissue.

[0015] Furthermore, the outer periphery of the receiving part is covered with a covering layer, and the receiving part is generally cylindrical; the outer layer of the receiving part is covered with a fabric covering layer, which can effectively prevent the other end of the control element from contacting the heart tissue, thus better protecting the heart tissue.

[0016] Furthermore, the plurality of connecting holes form a connecting channel on one side of the shrinking skeleton in the circumferential direction, and the connecting part is disposed in the connecting channel. The connecting channel can constrain the control element and prevent the control element from deviating after the shrinking ring operation.

[0017] Furthermore, the predetermined shape of the shrinkage skeleton matches the shape of the autologous valve annulus; the longitudinal cross-section of the shrinkage skeleton is arc-shaped.

[0018] Furthermore, when the contractile skeleton contracts, the contraction stroke of the heart tissue closer to the contractile skeleton is greater than the contraction stroke of the heart tissue farther from the contractile skeleton.

[0019] Furthermore, the covering layer is generally sheet-like; the multiple anchoring holes are evenly distributed on the covering layer.

[0020] Furthermore, the predetermined shape of the shrinkage skeleton matches the shape of the autologous valve annulus; the longitudinal cross-section of the shrinkage skeleton is arc-shaped.

[0021] Furthermore, when the contractile skeleton is in a contracted state, the heart tissue located on one side of the contractile skeleton moves toward the center of the autologous valve.

[0022] Furthermore, as the shrinking skeleton transforms from a predetermined shape to a shrinking shape, the perimeter of the shrinking skeleton gradually decreases.

[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, after the retraction ring operation, part of the control element is exposed outside the control retraction skeleton and comes into direct contact with the heart tissue. During the continuous beating of the heart, the control element may damage the heart tissue, causing more complications and affecting the patient's postoperative recovery. In one embodiment of this application, the retraction skeleton is provided with a receiving part in the longitudinal direction, and a locking hole is provided in the receiving part. During the retraction ring operation, the control element is pulled to drive the retraction skeleton to retract, and at the same time, part of the control element enters into the receiving part, so as to avoid it being exposed outside the retraction skeleton and damaging the heart tissue. 2. Unlike the prior art, in one embodiment of this application, at least two locking holes are provided. The purpose of this design is to make the fault tolerance of the entire shaping device higher. The thorn passing through multiple locking holes means that its locking stability is higher. Even if the thorn is dislodged from one of the locking holes, the remaining locking holes can still cooperate with the thorn and maintain its locked state.

[0024] 3. Unlike the prior art, in one embodiment of this application, the control element can achieve ring shrinkage repair while locking its shrinkage state in real time during the pulling process, without the need for additional operation steps for locking, saving the surgeon's operation time and reducing the difficulty of operation.

[0025] 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

[0026] 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: Figures 1a-1cThis is a schematic diagram of the overall structure of the shrinkage skeleton of the present invention.

[0027] Figures 2a-2d This is a schematic diagram of the structure of the control element of the present invention and a schematic diagram of the shape change of the locking part passing through the locking hole.

[0028] Figures 3a-3c This is a schematic diagram illustrating the process by which the shrinkable skeleton of the present invention transforms from a predetermined shape to a shrinkable shape.

[0029] Figures 4a-4c This is a schematic diagram of the unfolded retractable skeleton and the arrangement of the locking holes of the present invention.

[0030] Figures 5a-5h This is a schematic diagram of the structure of the conveying system of the present invention and a schematic diagram of the anchoring process of the anchoring component.

[0031] Figure 6a and Figure 6b This is a schematic diagram of the process by which the delivery system of the present invention enters the left atrium.

[0032] Figures 7a-7g This is a schematic diagram of the operation process for repairing the mitral valve in this invention.

[0033] The parts referred to by the numbers in the attached diagram are as follows: 1-Contraction skeleton, 11-Receiving part, 111-Locking hole, 12-Connecting hole, 13-Connecting channel, 2-Covering layer, 3-Control element, 31-Locking part, 311-Spiked barb, 32-Connecting part, 4-Fixing component, 5-Delivery system, 51-Control handle, 52-Delivery conduit, 53-Anchoring assembly, 531-Needle tube, 532-Needle pusher, 533-Guide, 534-Fixing loop. Detailed Implementation

[0034] 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.

[0035] 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.

[0036] 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.

[0037] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0038] 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.

[0039] In the existing technology, after the control element is tightened, part of the control element is exposed outside the control contraction skeleton and comes into direct contact with the heart tissue. As the heart continues to beat, the control element can damage the heart tissue, which can lead to more complications and affect the patient's postoperative recovery.

[0040] Example 1: like Figures 1a-1c As shown, in this embodiment, a shrinkable frame 1, a covering layer 2, and a control element 3 are included. The covering layer 2 is provided with a fixing component 4 for fixing the shrinkable frame 1 to the heart tissue. One end of the control element 3 is connected to the shrinkable frame 1, and the other end of the control element 3 is provided with a locking part 31. The shrinkable frame 1 is provided with a receiving part 11 in the longitudinal direction. The receiving part 11 is provided with a locking hole 111. Pulling the other end of the control element 3 causes the shrinkable frame 1 to shrink. At the same time, the locking part 31 bends into the receiving part 11 and cooperates with the locking hole 111 to achieve locking.

[0041] According to one example, the cover layer 2 is made of an implantable fabric material.

[0042] According to one example, the receiving portion 11 is provided with at least two locking holes 111, and the locking holes 111 are spaced apart in the longitudinal direction, such as... Figures 4a-4c As shown.

[0043] According to one example, the control element 3 is an elongated member, such as... Figure 2a and 2b As shown, the control element 3 includes a connecting part 32 and a locking part 31. The middle area of ​​the locking part 31 is hollowed out, and the outer edge of the locking part 31 is provided with a thorn 311. The control element 3 is made of shape memory metal material, which on the one hand can have a certain rigidity to maintain its shape, and on the other hand can make the locking part 31 have a certain elasticity and rigidity, and can lock its shrinking ring state in real time, making the operation very convenient.

[0044] According to one example, pulling the other end of the control element 3 causes the locking part 31 to be pressed against the locking hole 111. Further pulling the other end of the control element 3 causes the locking part 31 to gradually return to its natural shape and pass through the locking hole 111. Figure 2c and 2d As shown.

[0045] According to one example, during the ring retraction operation, the thorn 311 passes through all the locking holes 111. The purpose of this design is to make the overall forming device more forgiving. The thorn 311 passing through multiple locking holes 111 means that its locking stability is higher. Even if the thorn 311 disengages from one of the locking holes 111, the remaining locking holes 111 can still cooperate with the thorn 311 and maintain its locked state.

[0046] According to one example, the shrinking frame 1 is provided with a connecting hole 12, which is located on one side of the shrinking frame 1 in the circumferential direction, and the receiving part 11 is located on one side of the shrinking frame 1 in the longitudinal direction. During pre-assembly, the connecting part 32 passes through the connecting hole 12. During the shrinking process, the other end of the control element 3 will be bent and enter the receiving part 11. The receiving part 11 is located on one side of the shrinking frame 1 in the longitudinal direction, which will not increase the overall length of the shaping device, and at the same time can prevent the other end of the control element 3 from being exposed outside the shrinking frame 1, contacting the heart tissue and causing damage to the heart tissue.

[0047] According to one example, the outer periphery of the receiving portion 11 is covered with a fabric covering layer 2, and the receiving portion 11 is generally cylindrical; the outer layer of the receiving portion 11 is covered with a fabric covering layer 2, which can effectively prevent the other end of the control element 3 from contacting the heart tissue, thus better protecting the heart tissue.

[0048] According to one example, a plurality of the connecting holes 12 form a connecting channel 13 on one side of the shrink frame 1 in the circumferential direction, and the connecting part 32 is disposed in the connecting channel 13. The connecting channel 13 can constrain the control element 3 and prevent the control element 3 from deviating after the shrink ring operation.

[0049] According to one example, the predetermined shape of the contractile skeleton 1 matches the shape of the autologous valve annulus; the longitudinal cross-section of the contractile skeleton 1 is arc-shaped, such as... Figure 1c As shown.

[0050] According to one example, when the contractile skeleton 1 contracts, the contraction stroke of the heart tissue closer to the contractile skeleton 1 is greater than the contraction stroke of the heart tissue farther away from the contractile skeleton 1.

[0051] According to one example, the cover layer 2 is generally sheet-like in structure.

[0052] According to one example, the predetermined shape of the contractile skeleton 1 matches the shape of the autologous valve annulus; the longitudinal section of the contractile skeleton 1 is arc-shaped.

[0053] According to one example, when the contractile skeleton 1 is in a contracted state, the heart tissue located on one side of the contractile skeleton 1 moves toward the center of the autologous valve.

[0054] According to one example, as the shrinking skeleton 1 transforms from a predetermined shape to a shrinking shape, the perimeter of the shrinking skeleton 1 gradually decreases, such as... Figures 3a-3c As shown.

[0055] According to one example, it also includes a delivery system 5 for conveying the shaping apparatus, such as... Figures 5a-5c As shown, the delivery system 5 includes a control handle 51, a delivery conduit 52, and an anchoring assembly 53. The anchoring assembly 53 includes a needle tube 531, a needle pusher 532, a guide 533, and a fixing loop 534. During pre-installation, the shaping device and the anchoring assembly 53 are disposed within the delivery conduit 52. The needle pusher 532, the guide 533, and the fixing loop 534 are all disposed within the needle tube 531. The anchoring assembly is connected to the shrinkage skeleton 1 via the fixing loop 534. The proximal end of the guide 533 is connected to the control handle 51, and the distal end of the guide 533 is detachably connected to the anchoring assembly. Figure 5d As shown; during anchoring, the guide 533 is tightened so that the needle tube 531 abuts against the contractile skeleton 1 along the guide 533, and the pusher 532 is pushed so that the anchoring member passes through the outer fabric covering layer 2 and pierces into the heart tissue, as shown. Figures 5e-5h As shown.

[0056] The following is an exemplary procedure for repairing a mitral valve using a locking structure applied to a mitral valve repair device, as described in Embodiment 1: 1. Operate the delivery system 5 to allow it to enter the right atrium via the superior vena cava, then cross the interatrial septum to reach the left atrium, as shown below. Figure 6a and 6b As shown; 2. By operating the control handle 51, each needle tube 531 is pushed distally from the delivery catheter 52. At this time, the shaping device also extends from the delivery catheter 52 along with the needle tubes 531. Figure 7a As shown; 3. Tighten the guide 533 so that the distal ends of each needle tube 531 abut against the contractile skeleton 1. Observe the effect and operate to control the contractile skeleton 1 to adhere to the autologous valve annulus. Figure 7b As shown; 4. Pushing the pusher 532 causes the anchor to extend from the needle tube 531 and return to its preset shape. The plastic surgery device is anchored to the autologous valve annulus via the anchor. Figure 7c As shown; 5. By operating the retraction ring control component, the control element 3 can be pulled to one end relative to the retraction frame 1. At this time, the retraction frame 1 retracts, and simultaneously, the other end of the control element 3 bends into the receiving part 11, passes through the locking hole 111, and engages with the locking hole 111 to achieve locking. Figure 3c and 7d As shown; 6. Operate the delivery system to complete the mitral valve repair, such as... Figures 7e-7g As shown.

[0057] The foregoing description of exemplary embodiments of this application has been provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations and / or constructions disclosed. Clearly, many modifications and variations can be made by those skilled in the art based on the teachings above without departing from this application. The scope and equivalents of this application are intended to be defined by the appended claims.

Claims

1. A locking structure applied to a reconstructive device, the reconstructive device comprising a contractile skeleton, a cover layer, and a control element, wherein the cover layer is provided with a fixing component for fixing the contractile skeleton to cardiac tissue, one end of the control element is connected to the contractile skeleton, and the other end of the control element is provided with a locking part, characterized in that: The retractable frame has a receiving part in the longitudinal direction, and the receiving part has a locking hole. Pulling the other end of the control element causes the retractable frame to retract; at the same time, the locking part bends into the receiving part and cooperates with the locking hole to lock.

2. The locking structure applied to a molding device according to claim 1, characterized in that: The receiving part is provided with at least two locking holes, and the locking holes are spaced apart in the longitudinal direction.

3. The locking structure applied to a molding device according to claim 1, characterized in that: The control element is an elongated component, which includes a connecting part and a locking part, and the locking part is made of a rigid material with a certain degree of elasticity.

4. A locking structure applied to a molding device according to claim 3, characterized in that: The shrinkable frame is provided with a connecting hole, which is located on one side of the shrinkable frame in the circumferential direction, and the receiving part is located on one side of the shrinkable frame in the longitudinal direction; during pre-assembly, the connecting part passes through the connecting hole.

5. A locking structure applied to a molding device according to claim 3, characterized in that: Pulling the other end of the control element causes the locking part to be squeezed by the locking hole. Pulling the other end of the control element further causes the locking part to gradually return to its natural shape and pass through the locking hole.

6. A locking structure applied to a molding device according to claim 3, characterized in that: The locking part has a hollowed-out middle area, and the outer edge of the locking part is provided with thorns.

7. A locking structure for use in a molding apparatus according to claim 4, characterized in that: The plurality of connecting holes form a connecting channel on one side of the shrink skeleton in the circumferential direction, and the connecting part is disposed in the connecting channel.

8. A locking structure applied to a molding device according to claim 1, characterized in that: The predetermined shape of the contractile skeleton matches the shape of the autologous valve annulus; the longitudinal cross-section of the contractile skeleton is arc-shaped.

9. A locking structure applied to a molding device according to claim 1, characterized in that: The outer periphery of the receiving part is covered with a covering layer, and the receiving part is generally cylindrical.

10. A locking structure applied to a molding device according to claim 1, characterized in that: When the contractile skeleton contracts, the contraction stroke of the heart tissue closer to the contractile skeleton is greater than that of the heart tissue farther away from the contractile skeleton.

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