Peripheral leakage prevention support device and heart valve

Abstract

The invention discloses a peripheral leakage prevention stent device convenient to load and a heart valve, the peripheral leakage prevention stent device comprises a stent and is further provided with a flexible skirt edge, and the skirt edge has a spreading state in which the skirt edge axially extends and surrounds the periphery of the stent before being released; and in the stacking state, the annular peripheral leakage plugging part is driven by deformation when the stent is released and is folded and stacked in the axial direction of the released stent to form the annular peripheral leakage plugging part. By means of the peripheral leakage prevention technology, the interventional stent is more matched with the inner wall of a blood vessel, the stent is not prone to displacement and is more stable, the range of applicable people is widened, additional risks of operations are reduced, and complications such as peripheral leakage and thrombus are prevented and treated. Better hemodynamic performance is provided, the host endothelial cell climbing and covering function is enhanced, the occurrence probability of endocarditis is reduced, and the normal blood supply function of heart and blood vessels is recovered.

Description

[0001] This application is a divisional application of application number 201811024651.9; application date 2018.09.04; invention title "An easy-to-load anti-leakage stent device and processing method, skirt pleating method, heart valve". Technical Field

[0002] This invention relates to the field of medical device technology, and in particular to artificial stent devices for the heart and blood vessels. Background Technology

[0003] Since the 1970s, artificial heart valve replacement surgery has saved the lives of millions of patients as an effective treatment for end-stage heart valve disease. Artificial heart valve replacement technology represents a revolutionary breakthrough in heart valve treatment and holds great promise.

[0004] Paravalvular leak (PPL) is a serious complication specific to valve replacement surgery and is one of the common reasons for reoperation. Its occurrence is mainly related to pathological changes in the valve annulus tissue (degenerative changes, rheumatic or senile calcification, acute infective endocarditis invading the valve annulus or causing perivalvular abscess), size mismatch between the prosthetic valve and the valve annulus, and endocarditis of the prosthetic valve.

[0005] Not only in the heart, but also when artificial stents are implanted in other blood vessels or body cavities, the problem of paravalvular leakage can occur. For ease of explanation, this section will mainly take paravalvular leakage as an example.

[0006] After the occurrence of paravalvular leak, the following harms are often accompanied: (1) Paravalvular leak leads to severe hemolysis, anemia and progressive worsening of hemoglobinuria; (2) A large leak in the paravalvular leak causes abnormal changes in hemodynamics, resulting in decreased cardiac function or even heart failure, and the symptoms and signs do not improve significantly after conservative medical treatment; (3) Although the leak in the paravalvular leak is small, it is accompanied by infective endocarditis; (4) Paravalvular leak is accompanied by bioprosthetic valve failure.

[0007] There has been some research on valve prevention of paravalvular leakage both domestically and internationally. However, during transcatheter replacement, it has been impossible to reduce paravalvular leakage to below 5%. Therefore, further research is needed on how to further reduce paravalvular leakage.

[0008] Currently, the main method for treating valvular heart disease via transcatheter valve implantation involves first compressing an artificial heart valve into a delivery device. This device then delivers the valve to the site of the heart lesion via a blood vessel, where it is released to replace the diseased valve. Currently developed heart valves include balloon-expandable valves and self-expanding artificial heart valves. Self-expanding artificial heart valves generally consist of a mesh stent made of shape-memory metal and a unidirectionally opening valve sutured within the stent. During implantation, the stent expands itself to match the diseased valve annulus as closely as possible. While this can reduce paravalvular leakage to some extent, the irregular shape of the blood vessel wall after autocalcification still leads to varying degrees of paravalvular leakage and peripheral regurgitation. Balloon-expandable valves use a medical-grade stainless steel stent. During implantation, a balloon expands the stainless steel stent to match the diseased valve annulus as closely as possible.

[0009] Current bulb-expanding or self-expanding valves rely solely on the radial support of a metal stent to expand the vessel wall. For patients with regular vessel walls, valve selection can achieve a basic anastomosis between the vessel wall and the stent, reducing paravalvular leakage to a certain extent. However, for patients with irregular vessel walls due to calcification, varying degrees of paravalvular leakage will occur. Numerous clinical studies have shown that traditional valves cannot reduce paravalvular leakage to below 5%, and the risk of paravalvular leakage still exists. Currently, once a patient develops paravalvular leakage, the only solutions are repair or valve replacement, which involve significant surgical and life-threatening risks.

[0010] While there are some solutions in the existing technology, they all have certain shortcomings. For example, forming a ring pocket structure around the stent and filling the ring pocket with blood from the peripheral leak to further prevent the worsening of the paravalvular leak, but thrombi are easily formed in the ring pocket, and there is also a risk of thrombus dislodgement.

[0011] Some existing technologies also use water-absorbing and expanding materials to form an annular protrusion on the outer periphery of the stent to seal periocular leakage, but the water-absorbing and expanding materials also have the risk of falling off, posing a safety hazard.

[0012] Some existing technologies also place a flexible membrane at the blood inflow end of the stent. Before release, the flexible membrane is located on one side of the stent axis. After release, it is rolled up or folded near the blood inflow end to form a radial annular protrusion to seal paravalvular leak.

[0013] However, the flexible membrane is located on one side of the stent axis before release, which inevitably makes the product too long and puts higher demands on the delivery system. More importantly, in order to achieve the rolling or folding of the flexible membrane, an additional traction mechanism must be set up and controlled by the operator, which increases the complexity and difficulty of control. Some also use metal parts, which utilize the predetermined shape characteristics of the metal parts to drive the rolling or folding of the flexible membrane after release in the body. However, metal parts undoubtedly make the stent itself more complex and bring additional risks. In addition, due to the influence of the space around the stent, it is also difficult to lift the flexible membrane to the ideal position, so the effect is not ideal. Summary of the Invention

[0014] This invention provides an easy-to-install anti-leakage support device. The flexible skirt on the outer periphery of the support stacks itself upon release to form a leakage-sealing section. More importantly, the stacking of the flexible skirt is driven by the shape change of the support itself during release, i.e., it is linked to the deformation of the support itself, requiring no additional control and avoiding the use of metal components. The support device of this invention can flexibly seal the outer periphery of the support, and is safe and convenient to manufacture and use.

[0015] An easy-to-load anti-leakage support device includes a support and a flexible skirt, the skirt having:

[0016] In its extended state, it is axially extended and surrounds the outer periphery of the pre-release support;

[0017] In a stacked state, the supports are retracted and stacked along the axial direction after release, forming an annular leak sealing part;

[0018] The skirt hem has multiple cutting areas arranged circumferentially on at least one side of the axial direction, and the cutting areas are hollow structures.

[0019] Regarding the stent itself, this invention can employ many existing structures. The key improvement of this invention lies in the skirt on the outer periphery of the stent. The different states of the skirt are adapted to the stent before and after release. After the stent is loaded in the delivery system, it is in a radially compressed state, i.e., the state before release. Correspondingly, the skirt is in an extended state. In order to facilitate the stent's passage within the body, radial compression is maximized, and the skirt is extended axially. The difference between this invention and the prior art is that before the stent is released, the skirt surrounds the outer periphery of the stent, at least most of the area of ​​the outer periphery, rather than being located on one side of the stent's axial direction. Because the skirt is thin and has good flexibility, it can fit well against the outer periphery of the stent.

[0020] The stent is inserted into the body via the delivery system. By retracting the sheath of the delivery system, the stent is released. The stent gradually expands radially, marking the beginning of its release, until complete release. During this process, the stent's shape remains relatively stable and does not change further. The radial expansion is accompanied by circumferential changes, meaning its circumference increases.

[0021] After release, the stent is stably placed at the corresponding lesion location. Correspondingly, the skirt is in a stacked state. The radial expansion of the stent will cause the skirt to converge and stack in the axial direction, further thickening the outer periphery of the stent and forming an annular circumferential leakage sealing part.

[0022] The skirt is driven by the deformation of the stent during release. This can be due to the stent directly expanding the skirt outward, causing axial stacking, or it can be caused indirectly by a drive mechanism linked to the stent deformation acting on the skirt, thus prompting the skirt to enter a stacked state. Of course, it can also be a combination of both, or the combined effect of multiple factors such as the impact of blood flow in the body or the shape of the stent and skirt.

[0023] In the unfolded state, the axial extension of the skirt is to reduce the radial thickness. In addition, during loading, the skirt will also extend axially due to the action of the outer sheath. Of course, the axial extension of the present invention should not be strictly limited to being "must" be axially extended and straightened, but should be understood as the skirt "can" extend axially due to the structural characteristics of the skirt and its position or connection with the support.

[0024] When the skirt is axially gathered and stacked, there are no strict restrictions on the specific stacking structure, but at least the axial gathering will cause radial thickening to seal the leakage.

[0025] Several optional or preferred methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each method can be combined individually with respect to the overall solution above, or multiple methods can be combined with each other.

[0026] Optionally, the skirt enters a stacked state under the radial deformation support when the bracket is released.

[0027] As one way the skirt enters the stacked state, the deformation during stent release directly acts on and supports the skirt. The stent release is not instantaneous, but rather the first release end expands radially to form a funnel shape. As the stent gradually leaves the delivery system, this deformation is sequentially transmitted to the later release end. During this process, the gradually formed funnel shape allows the skirt to expand and axially close and stack under the guidance of the funnel shape. In addition, when the first release end faces the direction of blood flow, the impact of blood flow can also assist the skirt in axially closing.

[0028] Preferably, the skirt is made of an elastic material and is clamped to the outer periphery of the bracket when the bracket is released.

[0029] The use of elastic materials and the tightening state after release facilitate the axial retraction of the skirt and ensures that it remains stably stacked after release, preventing it from expanding axially and losing its sealing effect.

[0030] In this invention, the support itself can be made using existing technology, such as an overall cylindrical structure, processed by weaving or cutting, with a grid structure, the grid being a regularly arranged rhomboid grid or combined with other shapes in some parts.

[0031] In terms of specific application scenarios, stents can be used in the aorta, aortic valve, pulmonary artery, pulmonary valve, mitral valve, tricuspid valve, occluders, and ordinary blood vessels. The shape of the stent and whether it is covered with a lining can also be adaptively adjusted according to existing technology and actual needs.

[0032] Preferably, one section of the bracket in the axial direction is a drive-expanding structure that drives the skirt to retract and stack.

[0033] During release, the stent can be in a trumpet-shaped state. To further ensure that the skirt can be axially compressed and stacked, the stent itself can also adopt a trumpet-shaped drive expansion structure at the corresponding position of the skirt. Another effect is that the guiding effect of the expansion can help the skirt remain in a stacked state after the stent is fully released, so as not to loosen along the axis and ensure the effectiveness of the leakage sealing part.

[0034] Preferably, in the unfolded state, the skirt does not extend beyond the corresponding side of the support at either end along the axial direction of the support.

[0035] After the support is released, the first released end will flip outward. If the unfolded skirt covers this end, the first released end of the support may press against the inside of the skirt, causing the skirt to be unable to close axially, or even puncture the skirt. Therefore, the preferred method is to release at least a part of the support first, and then transfer the effect to the skirt. This will naturally guide the skirt to stack.

[0036] Preferably, one side edge of the support has a sharp corner structure, and before the support is released, the corresponding side of the skirt is not longer than the apex of the sharp corner on that side in the axial direction.

[0037] Existing supports are generally mesh structures, with mesh nodes or spikes at the release end, which may "catch" the skirt during release. Before the support is released, the corresponding side of the skirt may be unfolded as a single layer, rolled inward / outward, folded, or stacked. Regardless of the form, it is preferable that the axial edge portion is not longer than the apex of the sharp corner on that side. Preferably, at least a portion of the skirt is fixed to the support.

[0038] The fixation here is relative to the previous floating, meaning that at least a part of the skirt and the support remain in a constant relative position and are not affected by external factors such as blood flow. This makes it easier to control the position of the surrounding leakage sealing part.

[0039] Preferably, one portion of the skirt in the axial direction is a fixing band, which is sewn and fixed to the bracket.

[0040] The skirt can be fixed to the valve and the stent using existing technologies, such as using sutures to fix it to the stent. To ensure the fixation effect, it is generally sutured all around.

[0041] Optionally, the fixing strap is continuously stitched or intermittently stitched in the circumferential direction.

[0042] Continuous stitching can be seen as the dense back-and-forth threading of the seam between the support and the hem, while when multiple stitching points are used at intervals, each stitching point is relatively sparse, for example, 3 to 10 stitching points are set along the entire axis.

[0043] Preferably, the stent contains a valve and / or an inner lining.

[0044] As a further preferred embodiment, the skirt is made of the same material as the valve or inner membrane.

[0045] Depending on the application and the characteristics of the lesion site, the stent can be fitted with valves and / or inner lining. The skirt needs to be gathered and stacked, so it is a flexible material that can deform at least in the axial direction. Many existing valve materials (such as porcine pericardium) can also meet this requirement. In addition, since the valve materials themselves are relatively mature, using the same material for the skirt can save the process of biological verification of the materials, which is more conducive to the promotion and implementation of the product.

[0046] Preferably, the skirt consists of two skirts arranged along the axial direction, and the two skirts, when stacked, respectively form a first circumferential leakage sealing part and a second circumferential leakage sealing part.

[0047] Forming two circumferential leakage sealing sections not only solves the problem of limited axial shrinkage of a single skirt, but also, in practical application, provides a better sealing effect for circumferential leakage.

[0048] The support device is also equipped with a traction cable that drives the skirt into a stacked state, and the traction cable is linked to the radial deformation when the support is released.

[0049] The traction cable, as the driving mechanism that propels the skirt into a stacked state, is linked to the deformation of the support when it is released.

[0050] In addition to utilizing the inherent characteristics of the stent and skirt to drive skirt stacking, a driving mechanism can be set up. Before and after stent release, the skirt is transformed from a relatively flat, spread-out state to a stacked state in the axial direction of the stent by the driving mechanism. The stacking inevitably causes the skirt to expand outward in the radial direction, that is, to further thicken relative to the corresponding part of the stent. It supports the area below the valve periphery or seals the periphery leakage, which can effectively reduce the gap size between the stent peripheral membrane and the inner wall of the blood vessel, reduce periphery leakage, prevent peripheral reflux of the valve and loosening of the valve stent, solve the current problems of difficulty in fixing interventional valves and periphery leakage, and significantly improve the success rate of interventional cardiac valve surgery and improve the health level of patients.

[0051] Since a traction cable is introduced as a driving mechanism in the preferred embodiment of the present invention, the requirements for the fit between the skirt and the outer periphery of the bracket are relatively relaxed, and the skirt stacking can ultimately be achieved by relying on the traction cable.

[0052] Optionally, the skirt may be gapped, attached to, or clamped to the outer periphery of the bracket when the bracket is in the released state.

[0053] The gap, covering, or clamping can be understood as the fit and tightness of the skirt with the support as a whole. The gap means that the skirt fits relatively loosely with the outer periphery of the support, with a certain amount of room for movement. The covering can be understood as the skirt fitting snugly with the outer periphery of the support, which relatively restricts free movement without being too tight. The clamping utilizes the elasticity of the skirt or the support itself. Generally, the skirt is clamped to the outer periphery of the support by the outward expansion force of the support.

[0054] The radial expansion of the stent upon release is an inevitable process. In this invention, the traction cable and the stent's deformation are linked. The radial deformation of the stent, through force reversal, drives the skirt to be axially lifted and retracted. A flexible traction cable transmits the lifting force between the stent and the skirt. When the stent is released, its diameter increases, and two points that were originally close together circumferentially will be relatively far apart after release. The traction cable also utilizes this principle to lift the skirt through force reversal.

[0055] Preferably, the traction cable includes a driving part and a force-applying part, wherein the driving part is linked to the bracket during the release process, and the force-applying part is connected to the skirt and is pulled by the driving part during the release process of the bracket, having an axial displacement relative to the bracket to lift the skirt stack.

[0056] The driving part and the force-applying part, both of which are part of the traction cable, can be a section of a certain length or a point. While the driving part deforms with the support, it will also pull the force-applying part, thereby driving the skirt. The traction direction can be along the support axis or obliquely, but it must have at least an axial component, so that the force-applying part moves axially.

[0057] The terms "driving part" and "force-applying part" are used only to facilitate the explanation of their working principle and should be understood as relative concepts. That is, it is assumed that the driving part only changes its circumferential span, thereby causing the force-applying part to change its axial position. Conversely, when multiple force-applying parts change their circumferential span, they can also cause the associated driving parts to change their axial positions. In this case, the roles of the driving part and the force-applying part are interchanged. In actual movement, the traction cables are linked together at every point, or the traction cables are linked to the support. Without special consideration of the restraining effect of the support, different parts of the traction cable may be both driving parts and force-applying parts from different angles, having a dual role. Therefore, although different parts of the traction cable are named, the extension or threading method of the traction cable is not an additional limitation. It only emphasizes the linkage between different parts and between the traction cable and the skirt.

[0058] During stent release, the radial expansion of the stent is accompanied by circumferential changes, i.e., the circumference increases. The traction cable on the stent / skirt is linked to the radial expansion of the stent. The axial contraction corresponding to the circumferential expansion of the traction cable will drive and trigger the skirt to axially converge and stack, further thickening the outer periphery of the stent and forming an annular circumferential leakage sealing part.

[0059] In the compressed state before the bracket is released and the expanded state after the bracket is released, the length of the traction cable remains unchanged. In the expanded state of the bracket, the traction cable expands radially outward with the expansion of the bracket. As the circumferential extension length of the traction cable increases, its axial extension length shortens. While the axial shortening of the traction cable causes the skirt to fold axially, it enters a stacked state.

[0060] The driving part and the force-applying part of the traction cable can be a segment of a certain length or a point, as part of the traction cable. The circumferential span of the driving part increases as the support expands and deforms, the circumferential length of the traction cable increases, and the axial contraction and movement of the force-applying part that pulls and acts on the skirt moves, thereby driving the skirt folds.

[0061] When the support structure is compressed, i.e., the skirt is unfolded, the traction cable should be kept as straight or slightly taut as possible between the two points of the bend (guided by the support structure or skirt), at least not loose or extending to the outer side of the skirt's axial direction. This ensures timely feedback and axial lifting of the skirt when the support structure deforms during release; otherwise, loose sections will delay or even compensate for the support structure's deformation, affecting the skirt's lifting effect. When the support structure is expanded, the length of the traction cable should not be so long as to constrict the support structure and hinder its expansion.

[0062] The traction cable maintains the skirt-like folds and stacks when the support is fully inflated.

[0063] During the pre-fabrication of the support device, the skirt pleats are kept in a stacked state by the traction cable when the support is fully expanded. During the fabrication of the support device: a) the cut skirt is wrapped around the outer perimeter of the released support; b) the traction cable is threaded along a predetermined path on the skirt; c) the traction cable is tightened to bring the skirt into a stacked state; d) the tap of the traction cable is fixed.

[0064] When the skirt hem is in a stacked state, the traction cable extends circumferentially, resulting in better traction cable stretching.

[0065] The traction cable, whether extended, stretched, or tightened circumferentially, does not hinder the expansion of the support.

[0066] In the compressed state before the bracket is released, the skirt extends axially, and the traction cable extends axially but is not longer than the bottom side of the skirt.

[0067] Preferably, the drive unit is connected to the bracket, and the connected portion is entirely or partially located in the axial direction of the overlap area between the skirt and the bracket, or is completely offset from the overlap area between the skirt and the bracket in the axial direction.

[0068] The connection between the drive unit and the bracket may be exposed outside the skirt or surrounded by the skirt; the exposure or being surrounded may also be partial.

[0069] Preferably, the drive unit has a circumferential span change before and after the support is released, and at least one point on the drive unit serves as a force-applying part or is connected to a force-applying part, which obtains axial displacement relative to the support while the circumferential span changes.

[0070] Preferably, at least one segment of the skirt in the axial direction is a suspended segment on the outer periphery of the support, and the suspended segment has a stacked state that is lifted by the traction cable.

[0071] For the skirt to deform axially and then collapse and stack, at least one section relative to the outer periphery of the support must be able to move axially. The suspended section described in this invention should be understood as being able to move axially, not necessarily circumferentially. Therefore, it can also be considered an axially suspended section. To guide its axial movement, a guide mechanism can be provided. Thus, circumferential movement is not necessarily related to axial movement. Of course, from a local perspective, at least a portion can move circumferentially. This should be considered from the perspective of the suspended section as a whole, which may or may not have circumferential positioning.

[0072] The traction cable also utilizes the axial mobility of the suspension section to lift the suspension section. As for the force reversal of the traction cable, it can be achieved with the help of the support or skirt structure.

[0073] Preferably, the traction cable is threaded circumferentially between the skirt and the support.

[0074] To assist the skirt in entering a stacked state, the present invention provides a preferred driving method, which uses a circumferentially extending traction cable that is threaded or fixed between the support and the skirt to lift the skirt.

[0075] The driving part of the traction cable can be multiple segments or points distributed at intervals. It can be fixed or moved through the support, and may also be pulled through the skirt at the corresponding position while passing through the support.

[0076] The force-applying part of the traction cable can be multiple segments or points distributed at intervals, and it can be fixed or moved to pass through the skirt.

[0077] Preferably, the traction cable extends circumferentially along the support while also undulating in the axial direction of the support, forming a wave-like structure.

[0078] The traction cable, while threaded circumferentially, also features an axial undulating structure. When the support is released, the traction cable as a whole is subjected to radial support and expansion force, causing its undulating structure to unfold to a certain extent, which in turn causes the skirt to axially retract. Similarly, compared to after the support is released, the traction cable has greater axial undulation before the support is released.

[0079] Preferably, the traction cable extends circumferentially around the support.

[0080] Preferably, the driving part is a wave crest and fixed on the bracket, and the force-applying part is a wave trough and moves through the skirt.

[0081] In this invention, crests and troughs are relative terms, referring to the limits or reversal positions of the axial swing of the traction cable during its extension. The crests can correspond to each other or be staggered in the axial direction, and the same applies to the troughs.

[0082] In this preferred embodiment, the crests are fixed on the support, and the troughs move through the skirt. When the support is released, the distance between two adjacent crests will increase. There is a traction cable passing between the two adjacent crests and the middle trough. The length of the traction cable will not change, so it will pull the trough closer to the two lines of the two crests, which can realize the axial movement of the skirt until the skirt is gathered together and enters a stacked state.

[0083] Preferably, the first part is a wave crest that is movable through the support, and the second part is a wave trough that is movable through the skirt.

[0084] In this preferred embodiment, the wave crests are guided through the support, either through the grid gaps or through holes in the support, while the wave troughs are guided through the skirt. When the support is released, the distance between two adjacent wave crests will increase, and more importantly, the diameter of the support will increase, while the length of the traction cable will not change. Therefore, the drop between the wave crests and troughs will decrease, meaning the wave undulations will become smoother. Since the axial position of the wave crests is limited by the support, the wave troughs are lifted, which can realize the axial movement of the skirt until the skirt as a whole is gathered and enters a stacked state.

[0085] Preferably, the first part is a crest and is fixed to the bracket, or can be moved through the bracket, and the second part is a trough and is fixed to the skirt.

[0086] Similarly, when the support is released, the trough is lifted by the traction cable. Since the trough is fixed to the skirt, the skirt can also be lifted.

[0087] The connection methods between different wave crests and supports may be the same or different. Similarly, the connection methods between different wave troughs and skirts may be the same or different. For example, among two adjacent wave crests, one may be fixed to the support, while the other may move through the support. That is, the wave period shape of the traction cable may be similar, but the connection methods may be different.

[0088] Preferably, there are at least two traction cables, with their crests and troughs interlaced or spaced apart in the axial direction.

[0089] There can be multiple traction cables, each of which wraps around the support once and is arranged axially, but they have an undulating structure, which may cause them to intertwine.

[0090] A suitable staggering method can control the way the skirts are stacked, thereby improving the sealing effect.

[0091] Preferably, within the same wave structure cycle, the axial undulation length is greater than the circumferential extension length. This allows for better lifting efficiency, and the support can achieve a larger axial lifting amount with a certain degree of radial deformation.

[0092] Preferably, the drive unit is only connected to the skirt (at least a portion of which is fixed to or passes through the skirt) and includes at least two through-end points that interact with the skirt, the two through-end points having a circumferential span change before and after the bracket is released.

[0093] One type of driving mechanism uses a traction cable connected between the support and the skirt. The traction cable is either fixed to the support or at least passes through the support to form a path bend. The present invention also provides another type of traction cable arrangement, in which the traction cable is only threaded on the skirt and located on the outer periphery of the support, but the traction cable is neither fixed to the support nor directly utilizes the structural gap of the support for the bend.

[0094] The traction cable is threaded circumferentially and has an undulating structure. The traction cable as a whole is subjected to radial support and expansion force when the support is released. Its undulating structure will unfold to a certain extent, which will then drive the skirt to axially retract.

[0095] A portion of the traction cable, or a single traction cable, can serve as the smallest unit structure for driving the axial retraction of the suspended section. One such case is based on the deformation mechanism of a triangle. In a triangle, two sides remain unchanged in length, while the length of the third side increases. As the length of the third side increases, the included angle between the two sides that remain unchanged in length increases, and the corresponding vertex moves closer to the third side.

[0096] When the support is released, the circumference of the skirt expands, which can be regarded as the lengthening of the third side. The traction cable has a turning point before release. The traction cable itself is considered as the two sides with constant length, and the turning point is regarded as the intersection of these two sides. As the support is released, the intersection point will be closer to the third side.

[0097] If a turning point is added, the triangle may evolve into a quadrilateral or a polygon. Each side may be straight or curved when taut. The turning point can be provided by a bracket or skirt, or additional guides can be set.

[0098] Preferably, the traction cable acting on the suspended section includes one or more lifting units, each lifting unit including at least two connecting ends that interact with the skirt, and at least a portion of the lifting unit between the two connecting ends is a force-applying part connected to the skirt. The traction cable acts on the suspended section, but is not directly connected to the support; therefore, the force-applying part is lifted by the circumferential relative displacement of the two connecting ends of the lifting unit.

[0099] When the support is released, the overall expansion will also pull the skirt. Before release, the skirt has a circumferential fold. After release, it unfolds. The two ends of the lifting unit that interact with the skirt are relatively far apart, and at the same time, the force-applying part will cause the skirt to shrink in the axial direction.

[0100] Taking the triangular deformation mechanism as an example, the skirt portion between the two connecting endpoints serves as the deformable third side, and the force-applying portion serves as the vertex capable of axial movement, or at least has an axial component. The vertex can move closer to the third side when the support is released.

[0101] One of the connecting points and the force-applying part can be regarded as the first side of a triangle;

[0102] The other end of the connection and the force-applying part can be considered as the second side of a triangle;

[0103] Without considering the elastic deformation of the traction cable itself, the sum of the first and second sides remains unchanged. If the force-applying part and the skirt are in a fixed relationship, the lengths of the first and second sides will not change. If the force-applying part and the skirt are in a movable threading relationship, the lengths of the first and second sides may change, but the sum remains unchanged.

[0104] Although the triangle may have many deformations or derivatives, their mechanisms are largely the same: they all utilize the change in distance between two points on the skirt that move circumferentially relative to each other when the support is released, converting this change into axial movement of a third point. This is also the main difference between the drive mechanism of this invention and existing technologies, namely, using the deformation linkage between the traction cable and the support itself to drive the stacking of suspended sections.

[0105] Optionally, the force-applying part is fixed to the hem or can be moved along the hem.

[0106] The function of the force-applying part is to pull the skirt to move axially. There can be one or more connection points to the skirt in the same lifting unit. They can be fixed or movable. The skirt is provided with corresponding through holes for the traction cable to pass through.

[0107] During the movement, the point of force application relative to the traction cable is not limited to a fixed location. The point of contact between the point of force application and the skirt edge may change during the movement; that is, different parts of the traction cable may come into contact with the skirt edge. Therefore, the point of force application relative to the traction cable is a dynamically changing part, referring to the part that is currently in contact with the skirt edge.

[0108] Preferably, the force-applying portion of the traction cable is continuously distributed or spaced apart; in the spaced-apart state, the discontinuous portion transmits the traction force through the skirt.

[0109] The force application points of the same lifting unit may be one or multiple. If the traction cables are not continuously extending between the multiple points but are distributed at intervals, then the transmission can rely on the structure of the skirt itself.

[0110] The fact that the traction cable does not extend continuously can be interpreted as the lifting unit having multiple traction cables, and that these cables are not directly connected to each other. Lifting the skirt requires the coordination of multiple cables and cannot be achieved by relying on a single cable.

[0111] Preferably, the skirt is provided with a through hole, through which the force-applying part moves; there are one or more through holes, and at least one through hole is not on the line connecting the two through ends.

[0112] When the support is released, the two connecting ends move away from each other. However, if all the guide holes are on the line connecting the two connecting ends, the relative movement of the two connecting ends will not cause the skirt to move, or the axial lifting effect will be very insignificant. The extension direction of the traction cable can be flexibly controlled by the guide holes, which makes it easier to link multiple lifting units together.

[0113] Compared to the fixed-point lifting method of the force application part, the movable threading method can achieve the correction of the skirt lifting in the circumferential direction, preventing the sealing effect of circumferential leakage from being weakened due to unexpected deformation such as spiral twisting.

[0114] Preferably, the force-applying part is located between the two connection points along the extension direction of the traction cable.

[0115] When the bracket is released, the two connecting ends move away from each other in the circumferential direction and pull the force-applying part together, causing it to move axially or at least have an axial displacement component, so as to achieve double-sided oblique lifting of the skirt.

[0116] Preferably, the two connecting ends are aligned with each other in the axial direction.

[0117] When the stent is released, the maximum circumferential relative displacement can be obtained under the premise of a certain degree of release; otherwise, there will be an oblique component, which will weaken the lifting effect or reduce the lifting efficiency.

[0118] Preferably, the traction cable of each lifting unit is wavy, with one or more cycles, and the waveform is triangular, trapezoidal, rectangular or arc-shaped.

[0119] Even in the simplest lifting unit structure, there will be undulating structures between the force application part and the two ends of the lifting unit. When repeated continuously according to a certain pattern, there will be periodicity. The simplest is one cycle, while in complex cases there will be multiple cycles. For example, when there are multiple through holes, the lifting unit structure will become more complicated. Common and simple waveforms are triangular, rectangular, or trapezoidal shapes, which are easy to thread and stitch, and there is less interference between the traction cables in different parts.

[0120] Because the stent expands radially while shortening axially during release, the lifting unit undergoes changes in both circumferential span and axial length before and after stent release. Overall, these two changes are interconnected.

[0121] Preferably, the drive unit circles the support at least once, and the two ends of the drive unit converge at the force-applying unit.

[0122] Preferably, the two ends of the drive unit extend along both sides of the V-shaped path and converge at the force-applying part. The drive unit is positioned around the periphery of the support, and when the support deforms, the drive unit expands and then lifts the apex of the V-shape to move axially.

[0123] Preferably, the drive unit passes through the bracket or is simply placed around the periphery of the bracket.

[0124] To restrict the extension path of the traction cable, the traction cable can be moved through the support or skirt where a limit is needed, especially to maintain the V-shape.

[0125] For example, when the skirt is large, if the line is not tightened in the pre-formed state and the circumferential enclosure of the traction cable does not conform to the support, then the traction cable will not be triggered to lift when the support expands.

[0126] Preferably, a traction cable is threaded on the skirt and only on the skirt. The traction cable extends circumferentially along the support and undulates in the support axis in a wave structure. When the support is released, the traction cable changes its waveform under the drive of deformation, thereby lifting the skirt into a stacked state.

[0127] Although the traction cable is not directly connected to the support, it is still located on the periphery of the support. When the support expands radially, it will increase the area enclosed around the traction cable, causing the waveform to change. The waveform itself can have many shapes, and each cycle can be the same or different.

[0128] Preferably, the waveform of the traction cable is periodically distributed, and the waveform in each period is one or any combination of triangle, rectangle, trapezoid.

[0129] Preferably, the skirt is provided with two sets of through holes arranged along the axial direction, and each set of through holes consists of multiple through holes arranged circumferentially. The traction cable alternately passes through the through holes of different sets to form the wave structure.

[0130] Preferably, the traction cable alternately floats on the inner and outer surfaces of the skirt during the threading process.

[0131] Preferably, the two sets of through holes have the same number and are staggered.

[0132] Preferably, the skirt hem has multiple cutting areas arranged circumferentially on at least one side of the axial direction.

[0133] Artificial heart valve replacement devices require radial compression and loading into a delivery system, such as a sheath, before use. They are then transported through blood vessels to the body for release. To improve compliance and throughput during delivery and reduce friction on the vessel walls, a smaller diameter is preferred after loading and before release, with the skirt surrounding the stent. During radial compression loading, the ends of the skirt tend to become scattered and swollen, making it difficult to straighten and adhere to the stent's periphery. This makes it difficult to enter the sheath, and as loading nears completion, the accumulated resistance at the ends can damage the skirt or even cause it to detach from the stent. To address the issue of radial expansion and reduce the size during loading, this invention involves partial trimming at the axial end near the skirt to reduce the stacking thickness, making loading and delivery easier.

[0134] Preferably, the cutting area has a hollow structure.

[0135] As one of the cutting methods, hollowing out can maintain the integrity of the skirt hem. Using processes such as punching or laser cutting can also facilitate the cutting of standard shapes, making it easier to control errors and mass production.

[0136] Preferably, in each cutting area, the hollow structure consists of multiple through holes arranged along the axial direction of the support.

[0137] The hollow structure uses sequentially arranged through holes, which can retain connection points at the intervals between the through holes. This is beneficial for the overall shaping of the leakage sealing part and maintains necessary tension between different areas.

[0138] There are many options for the shape of the through hole itself, such as round, elliptical, polygonal or crescent-shaped. The shapes of the through holes in the same row can be the same or different.

[0139] Preferably, different cutting areas have the same hollow structure.

[0140] The same hollow structure makes it easier to mass-produce, and the mechanical properties are more evenly distributed in the circumferential direction, resulting in a more symmetrical ring-shaped stack.

[0141] Even for a single hollowed-out section, if the area is small enough, it can form an approximately symmetrical structure, which is another preferred approach.

[0142] The arrangement of multiple cutting areas along the circumference mainly refers to the fact that the cutting areas are distributed in the circumference. Although different cutting areas may be spaced apart, they are not concentrated in a local area of ​​the circumference.

[0143] Multiple cutting areas may or may not have clear boundaries. For example, when many through holes are densely arranged, they may be randomly or scattered. Therefore, it is not emphasized that there are clear boundaries between each cutting area. Even if there is a clear unit repetition structure, the dividing line between units can be the skirt generatrix, or it can be at a certain angle to the generatrix, such as being spirally distributed to a certain extent.

[0144] Preferably, among the through holes in the same cutting area, the area of ​​the hole is larger the closer it is to the corresponding side edge of the skirt.

[0145] The cutting area itself is located at the top or bottom of the skirt hem. For example, in the cutting area at the bottom, the closer to the bottom edge of the skirt hem, the larger the hole area. That is, the closer to the edge of the skirt hem, the less residual skirt hem area there is, making it easier to attach to the outer perimeter of the bracket and facilitating loading.

[0146] Preferably, the inner edge of the through hole is a smooth curve.

[0147] The skirt has limited strength. If there is a sharp bend or corner on the inner edge after the through hole is formed, stress concentration will occur locally during deformation, which may cause tearing. However, using a smooth curve on the inner edge can greatly reduce this risk and improve the safety of use.

[0148] Preferably, the skirt has a toothed structure arranged circumferentially on at least one side in the axial direction, and the cutting area is between adjacent teeth.

[0149] As another preferred cutting method, the present invention cuts the skirt on at least one side in the axial direction, leaving a toothed edge with the teeth distributed circumferentially. Using this toothed structure, the skirt also achieves a smaller outer diameter at the cut end during radial compression, facilitating loading.

[0150] Furthermore, when using toothed cutting, the edges are open, which can avoid tangling or interference with the support or traction cable, and facilitate the release of the skirt.

[0151] Optionally, in the toothed structure, the shapes of each tooth may be the same or different.

[0152] Optionally, the tooth shape of each tooth can be one or a combination of several of the following: triangle, rectangle, trapezoid, and semicircle.

[0153] In the toothed structure, the shape of each tooth is not strictly limited, and the tooth shape can be combined with the hollowing method to reduce the residual area at the end of the skirt. The shape of the tooth includes both external features and size. For example, all teeth can be triangular, but large teeth and small teeth can be arranged alternately, or rectangular teeth and triangular teeth can be arranged alternately.

[0154] Preferably, all teeth have the same shape and are evenly distributed circumferentially.

[0155] The fact that all teeth are the same also means that they are evenly distributed in the circumferential direction. Since the toothed structure may be used at both ends of the skirt in the axial direction, the toothed structure at both ends can be the same or different. As for the same end, the even distribution can make the mechanical properties relatively uniform and adapt well in the circumferential direction, without the need for special positioning.

[0156] As a further preferred embodiment, in the triangle, both sides of the tooth tip are hypotenuses relative to the support axis; or one side is parallel to the support axis and the other side is a hypotenuse.

[0157] Preferably, before the bracket is released, the first-release side of the skirt extends axially out of the bracket, and this extended portion is the toothed structure.

[0158] To achieve a well-formed leak sealing section, the skirt should have sufficient axial length. However, if it is too long, especially before the support is released, and the side of the skirt that is released first extends axially beyond the support, then the support will be released after the skirt. When the support is turned outward, it may scrape or even jam the inner wall of the skirt, causing the skirt to be unable to close axially. If the skirt on that side adopts a toothed structure, this situation will be avoided.

[0159] The extended portion is released before the support. When the support is released, it can be smoothly flipped outward from the cutting area. Even if some teeth are in the blocking position, they will adaptively avoid the support due to the high degree of freedom of the teeth. As a further preferred option, the root portion of the tooth structure is at least not longer than the bottom end of the support.

[0160] If the root of the tooth is slightly longer than the edge of the corresponding side of the bracket, the above-mentioned risks still exist. Taking the bottom of the bracket as the first release end as an example, the top edge of the skirt is fixed on the bracket. In the unfolded state, the bottom of the skirt extends axially and grows out of the bottom edge of the bracket. The part of the skirt that extends out of the bottom of the bracket is a tooth-shaped structure.

[0161] Preferably, the side of the skirt with the cutting area is suspended on the outer periphery of the support, and a tension line is provided between the suspended side of the skirt and the support to limit the axial limit displacement of that side of the skirt.

[0162] Preferably, the side of the skirt that is suspended has a toothed structure arranged circumferentially, and the cutting area is between adjacent teeth; the pull line is connected to the top of each tooth.

[0163] The movement of the teeth can be restrained and restricted by the pull line, especially when the teeth are long. For example, the bottom of the skirt has a toothed structure and is suspended on the outer periphery of the support. The top of each tooth is provided with a pull line between the tooth and the support to limit the axial displacement of the skirt on that side.

[0164] Similar to the toothed structure, the hollow structure can also use a pull line. In addition, even if the skirt does not have a cutting area, a pull line can be used to assist in controlling the axial displacement of the skirt under relevant requirements. Moreover, the connection between the pull line and the skirt can be located in the middle of the skirt's axial direction, which can affect the shape and formation process of the leakage sealing part to a certain extent.

[0165] Preferably, the side of the skirt with the cutting area is fixed to the outer periphery of the bracket.

[0166] The skirt edge may have a cut area that is fixed to the bracket, usually as the rear release end side. The loading process is exactly the opposite, with the fixed cut area entering the sheath first. The cut area can be in the form of a cutout or edge cut.

[0167] Preferably, one side of the skirt edge along the axial direction has a toothed structure arranged circumferentially, and the cutting area is between adjacent teeth;

[0168] In the toothed structure, the apex of each tooth is fixed to the support, or the apex and edge of each tooth are both fixed to the support.

[0169] After edge shearing, a tooth-shaped structure is formed. The fixing method can be to fix only the apex of the tooth, or, in other words, to fix multiple sew points that are spaced apart.

[0170] If the edges of the teeth are also tightly sewn onto the support, this is called continuous stitching, which is used as a fixing strap. Continuous stitching provides higher connection strength, but it also causes additional radial expansion compared to intermittent stitching.

[0171] Preferably, the support has a mesh structure, and the tooth shape of each tooth is the same as the mesh shape of the corresponding part of the support.

[0172] Having the same tooth shape as the mesh shape makes it easier to sew, especially for continuous and dense stitching; on the one hand, it avoids excess parts, and on the other hand, it allows the edges of the teeth to fit well with the mesh skeleton.

[0173] Preferably, the side of the skirt where blood flows back in is provided with a circumferential stop pocket to receive the backflowing blood. The stop pocket has a backflow inlet so that it expands to prevent further backflow.

[0174] The stop pocket is also made of flexible material, which can be the same material as the skirt hem, or even be part of the skirt hem itself. The stop pocket is fixed to the outer periphery of the support by stitching. It has a sandwich structure, so it can expand radially when filled with blood.

[0175] The reflux inlet faces the perivalvular side, i.e., the top of the stent, to receive the perivalvular leak blood flow. After the blood flow enters the stop pocket, the stop pocket itself expands to press against the perivalvular area to prevent further reflux.

[0176] Preferably, after the stent is released, the leakage sealing part is located on the blood flow side of the stop pocket facing the stent (along the blood flow direction, the leakage sealing part and the stop pocket are arranged sequentially on the stent), and the leakage sealing part and the stop pocket abut against each other.

[0177] The plenum and the skirt can work together to prevent leakage. The plenum is closer to the peripapillary area, while the leakage block is located upstream of the normal blood flow and supports the plenum, thus playing a synergistic role.

[0178] Preferably, the side of the anti-reflux blood flow-inducing device is a closed structure, with multiple stitching parts that are fixed to the support distributed at intervals on the side facing the reflux blood flow-inducing device, and the reflux blood flow-inducing inlet is located between adjacent stitching parts.

[0179] Preferably, the reflux blood inlets are multiple and evenly distributed circumferentially.

[0180] Multiple reflux inlets are provided along the circumference, formed by intermittent stitching; that is, areas without stitching closure serve as reflux inlets. Multiple reflux inlets ensure uniform expansion of the retaining sac and good bearing capacity.

[0181] Preferably, the structure of the stopper is as follows:

[0182] Independent settings; or

[0183] It is an integral structure with the skirt hem; or

[0184] One part of it is also used for the hem; or

[0185] Part of it is done by the lining inside the stent; or

[0186] One part is done by the skirt, and the other part is done by the film inside the frame.

[0187] There are at least the following ways to prevent the formation of a pocket:

[0188] 1. The analgesic bag is independently installed on the material components. It can be designed as a sandwich structure, for example, the inner and outer layers can be a single structure connected by a bend at the bottom; or it can be designed as a non-single structure, with the inner and outer layers sealed by bottom stitching. In the top of the analgesic bag, the top edge of the inner layer is continuously fixed to the outer periphery of the support, generally using dense stitching. The outer layer is stitched to the support at intervals, forming several reflux entry points.

[0189] 2. The anti-bleed pocket and the skirt hem are integrated into one structure. The top of the skirt hem forms an anti-bleed pocket through axial detour, and the backflow inlet is cut out at an appropriate location.

[0190] 3. One part of the stop pocket is also served by the skirt. The stop pocket has a layered structure, including an inner layer and an outer layer. The bottom of the inner and outer layers are closed, and the top has the reflux blood inlet. One of the inner and outer layers is also served by the skirt.

[0191] For example, the inner part of the pocket is integrated with the skirt hem, and the outer layer is sewn separately around the outer perimeter of the skirt hem.

[0192] Alternatively, the outer layer of the pocket can be integrated with the skirt hem. First, an inner layer is sewn on separately, and then the top of the skirt hem is attached to and fixed to the outer perimeter of the inner layer, which also serves as the outer layer of the pocket.

[0193] 4. The membrane on the inner wall of the stent also serves as the inner layer of the retainer, and an outer layer covers the outer periphery of the stent.

[0194] 5. The film covering the inner wall of the support also serves as the inner layer of the stop pocket, and the top of the skirt also serves as the outer layer of the stop pocket.

[0195] Preferably, the stent has a push pocket on the blood flow side for assisting the skirt into a stacked state, the push pocket having a blood flow inlet to expand and push the skirt.

[0196] The push pocket is made of a flexible material, which can be the same material as the skirt or even be part of the skirt itself. The push pocket is fixed to the outer periphery of the support by stitching. It has a sandwich structure, so it can expand radially when filled with blood.

[0197] The inlet for blood flow faces away from the valve and is positioned to meet the normal blood flow direction. It is used to receive blood flow. After the blood flows into the blocking pocket, the expansion of the pocket itself can assist in pushing the skirt edge to move axially and close.

[0198] Preferably, when the skirt is laid out, the bottom edge extends beyond the push pocket.

[0199] After the push pocket expands, it contacts the skirt hem and pushes the skirt hem. If the two do not contact each other, the pushing effect will be poor. More preferably, in the unfolded state, the skirt hem wraps around or partially wraps around the push pocket at the bottom edge extension. In this way, the radial expansion of the push pocket can be well transferred to the skirt hem.

[0200] Preferably, one side of the push pocket is a closed structure, and the other side has multiple stitched parts that are fixed to the bracket at intervals, with the blood inlet between adjacent stitched parts.

[0201] Preferably, the downstream blood inlets are multiple and evenly distributed circumferentially.

[0202] Multiple blood flow inlets are arranged along the circumference, formed by intermittent stitching; that is, areas without stitching closure serve as blood flow inlets. Multiple blood flow inlets ensure uniform expansion of the retainer and provide good support.

[0203] The structure of the push pocket is as follows:

[0204] Independent settings; or

[0205] The membrane within the stent is an integral structure; or

[0206] Part of this is achieved through the lining within the stent.

[0207] The push-out pocket can be formed in at least the following ways:

[0208] 1. The push pocket is independently set on the material component. Due to its sandwich structure, the inner and outer layers can be a single structure connected by a bend at the top. When the inner and outer layers are not a single structure, they are sealed by a top stitch. At the bottom of the push pocket, the top edge of the inner layer is continuously fixed to the outer periphery of the support, generally using dense stitching. The outer layer is stitched to the support at intervals, forming several blood flow inlets.

[0209] 2. The push pocket and the inner film of the bracket are an integral structure. After the inner film of the bracket is turned outward, it forms the push pocket through axial detour. The inner and outer layers are sewn together as before.

[0210] 3. One part of the push pocket is also served by the membrane inside the stent. The push pocket has a sandwich structure, including an inner layer and an outer layer. The top of the inner and outer layers is closed, and the bottom has the aforementioned blood flow inlet. One of the inner and outer layers is also served by the membrane inside or outside the stent.

[0211] For example, the inner part of the push pocket is an integral structure with the skirt hem, and the outer structure is only sewn on the outer perimeter of the skirt hem.

[0212] Alternatively, the outer layer of the push-up pocket can be integrated with the skirt hem. First, an inner layer is sewn on independently. Then, the top of the skirt hem is attached to and fixed to the outer periphery of the inner layer, serving as the outer layer of the push-up pocket. An entry point for blood flow can be cut out at an appropriate location.

[0213] The present invention also provides a heart valve, including a stent and a valve disposed within the stent, wherein the stent employs the easy-to-load anti-leakage stent device described in the present invention.

[0214] In a stent device, a membrane is provided inside the stent to form a unidirectional blood flow channel.

[0215] The present invention also provides a method for processing the aforementioned easy-to-load anti-leakage support device, comprising:

[0216] a. Wrap the cut skirt hem around the outside of the extended support frame;

[0217] b. Thread the traction cable along the predetermined path on the skirt hem;

[0218] c. Tighten the traction cable to cause the skirt to enter a stacked state;

[0219] d. Fix the tap of the traction cable.

[0220] The length of the traction cable is related to the size of the skirt relative to the expanded stent, the circumference of the expanded stent, and the size and number of the leak-sealing sections formed. Before loading and compression, the skirt is already sewn onto the stent. During the sewing process, the stent is generally in an expanded state. Therefore, the state of the skirt after sewing (before loading) is basically the same as that after the stent expands inside the body—that is, the stacked state of the expanded skirt. It can be considered that the skirt has already completed its predetermined shape during sewing. During compression loading, to reduce the radial dimension, the predetermined skirt is axially flattened. After the stent expands inside the body, the skirt can return to its predetermined stacked state.

[0221] To facilitate the threading of the traction cable, preferably, in step a, the skirt is laid flat on the outer periphery of the extended support.

[0222] In step a, at least a portion of the skirt hem is secured to the support.

[0223] In step a, the skirt is placed around the outer perimeter of the support, either in front or behind, and the skirt is sewn into a circumferentially closed tube shape.

[0224] As a preferred method for securing the taps, in step d, the traction cable has two taps that are knotted together. Besides knotting each other, the taps can also be knotted on their own. The knotting at the taps is merely to prevent the traction cable from detaching from the skirt and has no necessary connection or strict limitation with driving the skirt into a stacked state. Therefore, even if the taps are tied to the support, it should be considered an equivalent method.

[0225] The present invention also provides a method for skirting a stent device at the stent implantation site, wherein the stent device employs the easy-to-load anti-leakage stent device described in the present invention, and the skirt has:

[0226] Before stent release, the stent is in a spread-out state inside the sheath, axially extended and surrounding the outer periphery of the stent before release.

[0227] In the stacked state during or after stent release, the stents are gathered and stacked along the axial direction of the released stents to form an annular leakage sealing part.

[0228] The support device is also provided with a traction cable that is threaded only through the skirt. The traction cable is linked to the radial deformation when the support is released to drive the skirt into a stacked state.

[0229] The specific structure of the support device, skirt, and traction cable involved in the skirt pleating method can be found in the description of the support device with skirt in this invention, and will not be repeated here.

[0230] This invention employs a leakage prevention technology to ensure a better fit between the interventional stent and the vascular wall, making the stent less prone to displacement and more stable. This expands the applicable population, reduces surgical risks, and prevents complications such as leakage and thrombosis. It also provides better hemodynamic performance, enhances host endothelial cell adhesion, reduces the probability of endocarditis, and restores normal blood supply to the heart and blood vessels. Attached Figure Description

[0231] Figure 1a This is a schematic diagram of the structure of an aortic stent in the prior art;

[0232] Figure 1b This is a schematic diagram of the support device structure in Example 1;

[0233] Figure 2a This is a schematic diagram of the structure of the support device in Example 2 before the lifting unit is released;

[0234] Figure 2b This is a schematic diagram of the structure of the support device in Example 2 after the lifting unit is released;

[0235] Figure 2c This is a schematic diagram of the drive diameter expansion structure of the bracket;

[0236] Figure 3 This is a schematic diagram of the lifting unit structure in the support device of Example 3;

[0237] Figure 4 This is a schematic diagram of the traction cable threading in the support device of Example 4;

[0238] Figure 5a This is a schematic diagram of the traction cable threading in the support device of Example 5;

[0239] Figure 5b This is a schematic diagram of the traction cable floating and sinking in the support device of Example 5;

[0240] Figure 5c This is a schematic diagram of the skirt in the unfolded state in the support device of Example 5;

[0241] Figure 5d This is a schematic diagram of the skirt in the stacked state of the support device in Example 5;

[0242] Figure 6 This is a schematic diagram of the traction cable threading in the support device of Example 6;

[0243] Figure 7 This is a schematic diagram of the traction cable threading in the support device of Example 7;

[0244] Figure 8 This is a schematic diagram of the traction cable threading in the support device of Example 8;

[0245] Figure 9 This is a schematic diagram of the traction cable threading in the support device of Example 9;

[0246] Figure 10 This is a schematic diagram of the traction cable threading in the support device of Example 10;

[0247] Figure 11 This is a schematic diagram of the traction cable threading in the support device of Example 11;

[0248] Figure 12 This is a schematic diagram of the traction cable threading in the support device of Example 12;

[0249] Figure 13 This is a schematic diagram of the traction cable threading in the support device of Example 13;

[0250] Figure 14 This is a schematic diagram of the traction cable threading in the support device of Example 14;

[0251] Figure 15 This is a schematic diagram of the support device structure in Example 15;

[0252] Figure 16 This is a schematic diagram of the support device structure in Example 16;

[0253] Figure 17 This is a schematic diagram of the shape of the skirt cutting area in the support device of Example 17;

[0254] Figure 18 This is a schematic diagram of the shape of the skirt cutting area in the support device of Example 18;

[0255] Figure 19 This is a schematic diagram of the shape of the skirt cutting area in the support device of Example 19;

[0256] Figure 20 This is a schematic diagram of the shape of the skirt cutting area in the support device of Example 20;

[0257] Figure 21 This is a schematic diagram of the shape of the skirt cutting area in the support device of Example 21;

[0258] Figure 22a This is a schematic diagram of the support device in Example 22;

[0259] Figure 22b This is a schematic diagram of the structure of the anti-pocket portion in the support device of Example 22;

[0260] Figure 23 This is a schematic diagram of the support device in Example 23;

[0261] Figure 24This is a schematic diagram of the structure of the anti-pocket portion in the support device of Example 24;

[0262] Figure 25 This is a schematic diagram of the structure of the anti-pocket portion in the support device of Example 25;

[0263] Figure 26 This is a schematic diagram of the structure of the anti-pocket portion in the support device of Example 26;

[0264] Figure 27a This is a schematic diagram of the support device in Example 27;

[0265] Figure 27b This is a schematic diagram of the structure of the anti-pocket portion in the support device of Example 27;

[0266] Figure 28 This is a schematic diagram of the support device in Example 28;

[0267] Figure 29 This is a schematic diagram of the structure of the anti-pocket portion in the support device of Example 29;

[0268] Figure 30 This is a schematic diagram of the structure of the blocking pocket portion in the support device of Example 30.

[0269] Figure 31a This is a schematic diagram illustrating the principle of the distance between the lifting amount and the force-applying part in Example 31;

[0270] Figure 31b This is a schematic diagram illustrating the principle of the distance between the lifting amount and the force-applying part after the lifting unit is deformed in Example 31.

[0271] Figure 31c This is a schematic diagram of the thickness of the folded leak sealing part in Example 31;

[0272] Figures 32a-32c This is a schematic diagram of the structure of Example 32;

[0273] Figure 33a This is a schematic diagram of a conveying system in Example 33;

[0274] Figure 33b This is a schematic diagram of the bracket with a skirt in the loaded state in Example 33;

[0275] Figure 33c This is a schematic diagram of the skirted bracket in Example 33 in a semi-released state;

[0276] Figure 33d This is a schematic diagram of the bracket with a skirt in the released state in Example 33;

[0277] Figure 33eThis is a schematic diagram of the delivery system entering the aortic valve in Example 33;

[0278] Figure 33f This is a schematic diagram of the stent of the delivery system in the aortic valve region in Example 33.

[0279] Figure 33g This is a schematic diagram of the stent of the delivery system in Example 33 being fully released at the aortic valve site. Detailed Implementation

[0280] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0281] To better describe and illustrate the embodiments of this application, reference may be made to one or more accompanying drawings, but the additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the inventive creations of this application, the embodiments or preferred methods described herein.

[0282] In the easy-to-load anti-peripheral leakage stent device of the present invention, the stent itself can adopt the existing technology. One end of the stent in the axial direction is the first release end after entering the body, and the other end is the second release end. Depending on the physiological structure characteristics of different lesion sites in the body and the different operation methods of interventional surgery, during the stent release process, each side in the axial direction may be the first release end, and the other side is the corresponding second release end. Figure 1a Taking the aortic stent as an example, it includes a stent 1, which is made of materials such as nickel-titanium alloy. The top of the stent (as shown in the figure) has a connecting lug 1b for connecting to the delivery system. Depending on the application and requirements of the stent, a valve 1a or an inner lining 1c can be placed inside the stent. The peripheral leakage referred to in this invention is not strictly limited to the aortic valve; it can also be used in other locations in the body with similar physiological structures.

[0283] In the following embodiments, unless otherwise specified, the figures are as follows:

[0284] A solid triangle indicates that the tow cable is fixedly connected to the support at that location; if the area is also within the area enclosed by the skirt, the tow cable may or may not penetrate the skirt at that location, depending on the need for buoyancy.

[0285] A hollow triangle mark indicates that the traction cable passes through the support at that point. If the area is also within the area surrounded by the skirt, the traction cable may or may not pass through the skirt at that point, depending on the need for buoyancy.

[0286] A solid rectangular mark indicates that the traction cable at this point is fixedly connected to the skirt and does not pass through the inside of the support frame, but only extends around the outside of the support frame;

[0287] A hollow rectangular mark indicates that the traction cable at that location passes through the skirt but does not enter the inside of the support; it merely extends around the outside of the support.

[0288] Example 1

[0289] See Figure 1b In this embodiment, the support 1 has a flexible skirt 2 around its periphery. Before the support 1 is released, the skirt 2 is in an unfolded state, extending axially and surrounding the outer periphery of the support 1. After the support 1 is released, the skirt 2 is in a stacked state, closing and stacking along the axial direction of the released support 1 to form an annular circumferential leakage sealing part. This embodiment also includes a traction cable 4 that drives the skirt 2 into the stacked state. The traction cable 4 is linked to the radial deformation of the support 1 during release. During release within the body, the bottom edge of the skirt 2 is released first, followed by the top edge of the skirt 2.

[0290] In this embodiment, the traction cable is threaded circumferentially along the skirt as a whole. While extending circumferentially along the support, it also undulates in the support axis to form a wave structure with corresponding peak and trough structures.

[0291] When the support is released, under the traction of the support deformation, the peaks move relatively far apart in the circumferential direction, causing the troughs to rise. Since the traction cable moves through the skirt, they can pull or act on each other in each cycle to achieve overall linkage.

[0292] The top edge of the skirt 2 is fixed to the bracket. The skirt 2 has multiple cutting areas 5 arranged circumferentially on the bottom side in the axial direction, which can reduce the radial stacking thickness in the unfolded state, making it easier to load and transport.

[0293] Overall, the bottom edge of the skirt has a circumferentially arranged toothed structure, with the cutting area between adjacent teeth. The teeth are triangular and evenly arranged circumferentially.

[0294] Before the support is released, the first-release side of the skirt extends axially out of the support, and this extended part has a toothed structure.

[0295] Example 2

[0296] like Figure 2a Before release, the drive unit includes a first action part X1 and a second action part X2 that are respectively connected to the bracket, and the force application part Y1 is connected to the skirt.

[0297] like Figure 2bSince the total length of the traction cable in the lifting unit remains unchanged, that is, the total length of the sides L1 and L2 of the triangle remains unchanged, when the support is released, the perimeter of the first action part X1 to the second action part X2 increases, the first action part X1 and the second action part X2 move away from each other along the arrow direction on their respective sides, the shape of the triangle changes, and the force application part Y1, as the vertex, moves towards the line connecting the first action part X1 and the second action part X2 along the upward arrow direction, that is, it moves relative to the support in the axial direction, thereby realizing the lifting of the skirt.

[0298] In order to obtain a larger triangular deformation, the first action part X1 and the second action part X2 span one or more cells in the circumferential direction. For example, in this embodiment, they span approximately two cells. After the support is released, the central angle corresponding to the span distance of the first action part X1 and the second action part X2 in the circumferential direction is 60 degrees. Each lifting unit fills the entire circumference of the support. For ease of illustration, only two lifting units are shown in the figure, and the others are omitted.

[0299] All lifting units are connected in a wave-like pattern, with multiple cycles and a triangular waveform. In each lifting unit, along the extension direction of the traction cable, the force-applying part Y1 is located between the first acting part X1 and the second acting part X2, with the first acting part X1 and the second acting part X2 axially aligned (circumferentially the same position). Alternatively, the lifting units can be arranged at intervals, meaning that adjacent lifting units do not share a traction cable section. For ease of distinction, the traction cable is represented by a dashed line. In reality, the traction cable is threaded through the support or skirt in a floating manner; one section is on the outer surface of the skirt, and after passing through the threading hole, it passes to the inner surface of the skirt, and so on.

[0300] All lifting units are connected in a wave-like pattern, with multiple cycles and a triangular waveform. In each lifting unit, along the extension direction of the traction cable, the force-applying part Y1 is located between the first acting part X1 and the second acting part X2, with the first acting part X1 and the second acting part X2 axially aligned (circumferentially the same position). Alternatively, the lifting units can be arranged at intervals, meaning that adjacent lifting units do not share a traction cable section. For ease of distinction, the traction cable is represented by a dashed line. In reality, the traction cable is threaded through the support or skirt in a floating manner; one section is on the outer surface of the skirt, and after passing through the threading hole, it passes to the inner surface of the skirt, and so on.

[0301] See Figure 2c In another embodiment, the bottom of the bracket 1 has a driving diameter expansion structure 1d, which has a larger diameter closer to the bottom of the bracket. The driving diameter expansion structure 1d extends from the middle of the bracket to the end (bottom) of the bracket. In this embodiment, the generatrix of the driving diameter expansion structure 1d is approximately a straight line. The larger opening side (bottom) of the driving diameter expansion structure 1d is released first, followed by the smaller opening side. This allows it to further cooperate with the bracket flared structure during the release process on the skirt, guiding the skirt to stack axially.

[0302] The skirt 2 can be made of an elastic material, such as porcine pericardium, bovine pericardium, or other biocompatible elastic materials. In the released state, it is clamped around the outer periphery of the stent. The skirt itself is generally cylindrical, with a diameter smaller than the outer diameter of the stent at the corresponding position in the released state. This creates a clamping force between the stent and the skirt. During stent release, the release proceeds gradually outward along the axial direction, forming a flared intermediate state on the first released side, which guides the elastic skirt to stack axially.

[0303] The processing of a skirt with a traction cable includes:

[0304] Wrap the cut skirt hem around the extended support frame;

[0305] Thread the traction cable along the predetermined path on the hem of the skirt;

[0306] Tightening the traction cable causes the skirt to enter a stacked state;

[0307] Taps for securing the traction cable.

[0308] The length of the traction cable is related to the size of the skirt relative to the expanded stent, the circumference of the expanded stent, and the size and number of the leak-sealing sections formed. Before loading and compression, the skirt is already sewn onto the stent. During the sewing process, the stent is generally in an expanded state. Therefore, the state of the skirt after sewing (before loading) is basically the same as that after the stent expands inside the body—that is, the stacked state of the expanded skirt. It can be considered that the skirt has already completed its predetermined shape during sewing. During compression loading, to reduce the radial dimension, the predetermined skirt is axially flattened. After the stent expands inside the body, the skirt can return to its predetermined stacked state.

[0309] To facilitate the threading of the traction cable, in step a, the skirt is laid flat on the outer periphery of the extended support; at least a portion of the skirt can also be selectively fixed to the support according to the connection relationship between the traction cable and the support.

[0310] The skirt is placed around the front or back of the support frame, and the skirt is sewn into a circumferentially closed tube shape.

[0311] As a method of fixing the taps, in step d, the traction cable has two taps that are knotted together. In addition to knotting each other, the taps can also be knotted on their own. The knotting of the taps is only to prevent the traction cable from falling off the skirt and has no necessary connection or strict limitation with driving the skirt into a stacked state. Therefore, even if the taps are tied to the bracket, it should be considered as an equivalent method.

[0312] Example 3

[0313] See Figure 3In this embodiment, the force-applying parts Y1 and Y2 of the traction cable 4 are respectively moved through the skirt 2, and the entire lifting unit is trapezoidal.

[0314] When the support is released, the circumference increases, the first action part X1 and the second action part X2 move away from each other, the shape of the lifting unit changes, and the force application part Y1 and the force application part Y2 move closer to the line connecting the first action part X1 and the second action part X2, that is, they move relative to the support in the axial direction to achieve the lifting of the skirt.

[0315] Example 4

[0316] See Figure 4 In this embodiment, in the segment of the traction cable 4 periodic structure, the peaks X6, Y5, X7, Y6, and X8 are arranged sequentially in the circumferential direction and undulate in the axial direction. Each peak is located outside the skirt 2, that is, the corresponding support is not surrounded by the skirt. At this time, a fixing strap can also be set at the top edge of the skirt to further limit the axial relative position between the top edge of the skirt and the support.

[0317] Example 5

[0318] See Figure 5a In this embodiment, two traction cables 4 are arranged along the axial direction, which lift the corresponding parts of the skirt 2 at different stages of the support release. The peak of the lower traction cable is higher than the trough of the upper traction cable, and the same traction cable lifts in a circumferential manner.

[0319] See Figure 5b To further illustrate the buoyancy and penetration of the traction cable and the skirt, the dashed line in the diagram represents the section submerged below the skirt, while the solid line represents the section floating above the skirt. The buoyancy between the traction cable and the support is adjusted according to whether the traction cable is on or inside the skirt. For example, at wave crest X9, after the traction cable penetrates and sinks into the skirt along the direction of arrow A, it can directly penetrate the support and enter the support. However, it needs to return to the area between the support and the skirt as soon as possible and extend between the support and the skirt to wave trough Y7 to ensure the suspension of that part of the skirt.

[0320] See Figure 5c and Figure 5d In order to cooperate with the two traction cables, the skirt 2, although it is an integral structure, can be divided into two parts. On the periphery of the support 1, the skirt section 2h and the skirt section 2i are axially deflected to achieve suspension. The skirt section 2i is only fixed to the support 1 and then extends downward (towards the end of the support) to form the skirt section 2j. The skirt section 2j is a separate suspension section, and its free end is a floating edge.

[0321] The connection between skirt segments 2h and 2i has drooped down to below the top edge of skirt segment 2j. Therefore, the peaks and troughs of the two traction cables can be staggered. In the stacked state, skirt segments 2h and 2i are stacked by the lifting of the upper traction cable, but this does not affect skirt segment 2j. Skirt segment 2j is stacked independently by the lifting of the lower traction cable.

[0322] Example 6

[0323] See Figure 6 In this embodiment, the waveform of the traction cable 4 is changed, with the peaks being pointed and the troughs being flat, and the part of the traction cable 2 that moves through the support is located in the area surrounded by the skirt 2.

[0324] Example 7

[0325] See Figure 7 In this embodiment, the waveform of the traction cable 4 is changed, and the waveforms of the two traction cables are different. The upper traction cable has a flat top and a flat bottom; the lower traction cable has a flat top and a pointed bottom; and the part of the traction cable that moves through the support is in the area surrounded by the skirt 2.

[0326] Example 8

[0327] See Figure 8 The hollow rectangle in the diagram indicates that the traction cable passes through the skirt but not through the support.

[0328] In this embodiment, the traction cable is threaded circumferentially along the skirt as a whole. While extending circumferentially along the support, it also undulates in the support axis to form a wave structure with corresponding peak and trough structures.

[0329] In a segment of the 4-cycle structure of the traction cable, peaks X6, Y5, X7, Y6, and X8 are arranged sequentially in the circumferential direction and undulate in the axial direction. In the unfolded state, the axial positions of all peaks and troughs are the same, although they can also be staggered appropriately.

[0330] To facilitate the threading of the traction cable, a set of threading holes is set on the skirt corresponding to each wave crest, and another set of threading holes is set on each wave trough. The traction cable alternately passes through the different sets of threading holes to form a wave structure. During the threading process, the traction cable alternately floats on the inner and outer surfaces of the skirt.

[0331] Two adjacent peaks can be regarded as the driving part of the traction cable, that is, the two connecting ends that interact with the skirt. The two connecting ends have a change in circumferential span before and after the support is released. For example, the peaks X6 and X8 mentioned above are connecting ends.

[0332] When the stent is released, under the traction of the stent's deformation, the stent drives the traction cable in the skirt. The crests in the traction cable move relatively away in the circumferential direction, causing the troughs to rise. Since the traction cable moves through the skirt, they can pull or act on each other in each cycle to achieve overall linkage. The so-called crests and troughs are only relative; one is a crest and the other is a trough. When the stent is released, under the traction of the stent's deformation, the troughs also move relatively away in the circumferential direction, causing the crests to rise. Therefore, the movement of the two is relative, and the purpose is to pull them closer together in the axial direction.

[0333] During production, the top edge of the skirt is first fixed to the prepared bracket. Traction cables are then arranged circumferentially on the skirt. The traction cables are tightened to create pleats on the skirt, and the ends of the traction cables are tied together.

[0334] The length of the traction cable is related to the size of the skirt relative to the expanded stent, the circumference of the expanded stent, and the size and number of the leak-sealing sections formed. Before loading and compression, the skirt is already sewn onto the stent. During the sewing operation, the stent is generally in a released state. Therefore, the state of the skirt after sewing (before loading) is basically the same as after the stent is released in the body—that is, the stacked state of the skirt after release. It can be considered that the skirt has already completed its predetermined shape during sewing. During compression loading, in order to reduce the radial dimension, the predetermined skirt is axially flattened. After the stent is released in the body, the skirt can return to its predetermined stacked state.

[0335] Since tools can be used to operate the support in a compressed or semi-compressed state during sewing, the state of the skirt hem during sewing is not strictly limited in this invention.

[0336] Example 9

[0337] See Figure 9 Compared to embodiment 8, in this embodiment, two traction cables 4 are arranged axially, which lift the corresponding parts of the skirt 2 at different stages of the support release. The peak of the lower traction cable is higher than the trough of the upper traction cable, and the same traction cable lifts in a circumferential manner.

[0338] To further illustrate the buoyancy of the traction cables and the skirt, the dashed lines in the diagram represent cables sinking below the skirt, while the solid lines represent cables floating above the skirt. Since the traction cables do not pass through or are fixed to the support frame, the remaining portion, except for the fixing straps, can be considered a suspended section. Therefore, the two traction cables can influence each other through the force transmission from the skirt.

[0339] Example 10

[0340] See Figure 10 Compared to Example 8, the waveform of the traction cable 4 in this example has changed, with the peaks being pointed and the troughs being flat.

[0341] Example 11

[0342] See Figure 11 Compared to Example 8, the waveform of the traction cable 4 in this example has changed, with the peaks of the traction cable having flat tops and the troughs having flat bottoms.

[0343] Example 12

[0344] See Figure 12 Compared to Example 8, the waveform of the traction cable 4 in this example has changed, with the peaks of the traction cable having flat tops and the troughs having pointed bottoms.

[0345] Example 13

[0346] See Figure 13 Compared to Example 10, in this example, the crest portion of the traction cable 4 is fixed to the skirt 2.

[0347] Example 14

[0348] See Figure 14 Compared to embodiment 8, in this embodiment, the trough portion of the traction cable 4 is fixed to the skirt 2.

[0349] Example 15

[0350] See Figure 15 In this embodiment, compared to embodiment 1, the top edge of the skirt 2 is fixed to the bracket and has a cutting area 5. The top of the skirt 2 corresponds to the shape of the grid skeleton of the bracket and is continuously sewn and fixed to the bracket along the grid skeleton.

[0351] Example 16

[0352] See Figure 16 In this embodiment, compared to embodiment 15, the apex of the triangular tooth shape at the top edge of the skirt 2 is fixed to the bracket by spaced fixing points 3h.

[0353] Example 17

[0354] See Figure 17 Compared to Example 1, in this embodiment, the cutting area 5 consists of multiple through holes arranged along the axial direction of the support. There are reserved connection parts at the intervals between the through holes, which is beneficial to the overall shaping of the leakage sealing part and maintains the necessary tension between different areas.

[0355] The through holes are circular or elliptical in shape. Among the through holes in the same cutting area, the area of ​​the hole is larger the closer it is to the corresponding side edge of the skirt.

[0356] Example 18

[0357] See Figure 18In this embodiment, compared to embodiment 17, the cutting area 5 is a single through hole. The inner edge of the through hole is relatively smooth, and the hole width increases as it approaches the corresponding side edge of the skirt.

[0358] Example 19

[0359] See Figure 19 In this embodiment, compared to embodiment 17, there are no obvious boundaries between the cutting areas 5, and multiple through holes are densely arranged.

[0360] Example 20

[0361] See Figure 20 In this embodiment, compared to embodiment 1, the tooth shape of adjacent cutting intervals is trapezoidal.

[0362] Example 21

[0363] See Figure 21 In this embodiment, compared to embodiment 20, the tooth shape of adjacent cutting intervals is rectangular.

[0364] Example 22

[0365] See Figure 22a In this embodiment, the bracket 1 is provided with a flexible skirt 2. Before the bracket 1 is released, the skirt 2 is in an unfolded state, extending axially and surrounding the outer periphery of the bracket 1 before release. After the bracket 1 is released, the skirt 2 is in a stacked state, closing and stacking along the axial direction of the bracket 1 after release to form an annular leakage sealing part.

[0366] The top of the skirt also features a stop pocket 6 to catch peripheral reflux blood. The stop pocket 6 is made of a flexible material, such as the same material as the skirt. In this embodiment, the stop pocket 6 is independently structured with a layered structure, which can catch peripheral reflux blood and expand radially to press against the periocular area to prevent further reflux. Of course, the stop pocket 6 can also be integrated with the skirt, for example, by sewing the bottom of the stop pocket 6 to the support to form a top fixing band for the skirt.

[0367] The pleats can also be made by the lining within the support structure, for example; or part of them can be made by the skirt and another part by the lining within the support structure.

[0368] The stop pocket 6 has a reflux blood inlet 6a to expand itself and prevent further reflux. After the stent is released, the leakage sealing part is located on the side of the stop pocket facing the bottom of the stent 1, and it can play a synergistic role by abutting against the stop pocket 6.

[0369] The side of the pocket 6 facing away from the top of the support 1 is a closed structure. There are multiple stitching parts 6b that are fixed to the support 1 at intervals on the side facing the top of the support 1. The reflux inlet 6a is between adjacent stitching parts 6b. There are multiple reflux inlets 6a, which are evenly distributed along the circumference.

[0370] In this embodiment, the formation of the leakage sealing portion can be achieved using any of the methods described in the above embodiments. The proportion is achieved by setting a traction cable 4 that drives the skirt 2 into a stacked state; this traction cable 4 is linked to the radial deformation of the support 1 during release. During release within the body, the bottom edge of the skirt 2 releases first, followed by the top edge of the skirt 2.

[0371] In this embodiment, the traction cable is threaded circumferentially along the skirt as a whole. While extending circumferentially along the support, it also undulates in the support axis in a wave structure, with corresponding crest and trough structures. The crest is located at the top edge of the skirt 2 and is fixed to the support together with the skirt 2, while the trough moves through the skirt 2.

[0372] When the stent is released, under the traction of the stent deformation, the peaks move relatively far apart in the circumferential direction, causing the troughs to rise.

[0373] See Figure 22b A cross-sectional schematic diagram of the stop pocket 6 is shown. In this embodiment, the dashed line represents the bracket 1. The stop pocket 6 is independently set on the material component relative to the skirt 2 and is a sandwich structure, including an inner layer 6e and an outer layer 6d. The two can be an integral structure connected by a bend at the bottom. In this embodiment, the inner layer 6e and the outer layer 6d are not an integral structure and are sealed by a stitching at the bottom 6c.

[0374] Example 23

[0375] See Figure 23 The difference between this embodiment and embodiment 22 is that the skirt 22 has multiple circumferentially arranged cutting areas 5 on its axial bottom side, which can reduce the radial stacking thickness in the unfolded state, making it easier to load and transport. Overall, the bottom edge of the skirt 2 has a circumferentially arranged toothed structure, with cutting areas between adjacent teeth. The teeth are triangular and evenly arranged circumferentially. Before the support is released, the first-release side of the skirt extends axially beyond the support, and this extended part is a toothed structure.

[0376] Example 24

[0377] See Figure 24 Compared to embodiment 22, in this embodiment the dashed line represents the bracket 1, the outer layer 6d of the stop pocket is an independent part, and the inner layer 6e extends upward from the top of the skirt 2 and also serves as a part.

[0378] Example 25

[0379] See Figure 25 Compared to embodiment 22, in this embodiment the dashed line represents the support 1. The inner wall of the support 1 is provided with an inner covering film 1c. The outer layer 6d of the stop pocket is an independent part, and the inner layer 6e is also served by the inner covering film 1c.

[0380] Example 26

[0381] See Figure 26 Compared to embodiment 22, in this embodiment the dashed line represents the bracket 1. The inner wall of the bracket 1 is provided with an inner covering film 1c, which serves as the outer layer 6d of the pocket, extending upward from the top of the skirt 2, and the inner layer 6e is also served by the inner covering film 1c.

[0382] Example 27

[0383] See Figure 27a In this embodiment, the support 1 has a flexible skirt 2 around its periphery. Before the support 1 is released, the skirt 2 is in an unfolded state, extending axially and surrounding the outer periphery of the support 1. After the support 1 is released, the skirt 2 is in a stacked state, closing and stacking along the axial direction of the released support 1 to form an annular circumferential leakage sealing part. This embodiment also includes a traction cable 4 that drives the skirt 2 into the stacked state. The traction cable 4 is linked to the radial deformation of the support 1 during release. The top edge of the skirt 2 has a triangular toothed structure, and each apex is fixed to the support by spaced fixing points 3i. The lower part of the skirt 2 is a suspended section. When released inside the body, the bottom edge of the skirt 2 is released first, followed by the top edge of the skirt 2.

[0384] In this embodiment, the traction cable is threaded circumferentially along the skirt, extending circumferentially along the support while also undulating axially in a wave-like structure with corresponding crests and troughs. The crests are located at the top edge of the skirt 2, and the traction cable moves through the skirt 2 from the crests to the troughs, without penetrating the interior of the support. When the support is released, under the traction of the support deformation, the crests move relatively far apart circumferentially, causing the troughs to rise.

[0385] On the normal blood flow side of stent 1, i.e., the bottom end, there is a ring of push pockets 7 to assist the skirt 2 in entering a stacked state. The push pockets 7 have blood flow inlets to expand and push the skirt. The push pockets are made of a flexible material, which can be the same material as the skirt and has a sandwich structure, so that they can expand radially when filled with blood.

[0386] One side of the push pocket 7 is a closed structure, while the other side has multiple seam portions 7b that are fixed to the bracket 1 at intervals. Between adjacent seam portions 7b is a blood flow inlet 7a, which is multiple and evenly distributed circumferentially. When the skirt is unfolded, its bottom edge extends beyond the push pocket, so that the bottom edge extension of the skirt covers or partially covers the push pocket.

[0387] See Figure 27b The diagram illustrates a cross-sectional view of the push pocket 7. In this embodiment, the dashed line represents the support 1. The push pocket 7 is independently set on the material component relative to the skirt 2 and is a sandwich structure, including an inner layer 7d and an outer layer 7c. The two can be an integral structure connected by a bend at the top. In this embodiment, the inner layer 7d and the outer layer 7c are not an integral structure and are closed by a top stitch.

[0388] Example 28

[0389] See Figure 28 The difference between this embodiment and embodiment 27 is that the top edge of the skirt 2 does not have a toothed structure.

[0390] Example 29

[0391] See Figure 29 Compared to embodiment 27, in this embodiment the dashed line represents the bracket 1. The inner wall of the bracket 1 is provided with an inner covering film 1c. After the inner covering film 1c is turned outward, it forms a push pocket 7 through a roundabout way.

[0392] Example 30

[0393] See Figure 30 Compared to embodiment 27, in this embodiment the dashed line represents the bracket 1. The inner wall of the bracket 1 is provided with an inner covering film 1c, which also serves as the inner layer 7d of the push bag, while the outer layer 7c is set independently. The top edge of the outer layer 7c is sewn closed to the corresponding part of the inner covering film 1c.

[0394] Example 31

[0395] like Figure 31a and Figure 31b As shown, taking a lifting unit of the smallest unit as an example, assuming the length of the lifting cable is l, the distance between the first action part X1 and the second action part X2 before lifting is a, and the distance between the force application part Y1 and the line connecting the first action part X1 and the second action part X2 before lifting is h;

[0396] The distance between the first action part X1 and the force-applying part Y1 before lifting is b;

[0397] The distance between the second action part X2 and the force application part Y1 before lifting is b;

[0398] The total length of the traction cable of the lifting unit in the diagram before lifting is 2b = l.

[0399] After the lifting action, the distance between the first action part X1 and the second action part X2 is A, and the distance between the force application part Y1 and the line connecting the first action part X1 and the second action part X2 after the lifting action is H.

[0400] The distance between the first action part X1 and the force-applying part Y1 after lifting is B;

[0401] The distance between the second action part X2 and the force-applying part Y1 after the lifting is B;

[0402] In the diagram after lifting, the total length of the lifting unit's traction cable is 2B = l.

[0403] The circumferential displacement change of the traction cable after lifting is: Δa=Aa; the axial displacement change of the force-applying part Y1 before and after lifting is:

[0404]

[0405] Therefore, it can be seen that the axial lifting length of the lifting unit is closely related to the circumferential displacement changes of the first and second working parts. In most cases, the circumferential expansion of the traction cable from the laid-out state to the stacked state is less than one revolution of the support.

[0406] The thickness of the leak-sealing section after folding is related to the number of folds, see [reference needed]. Figure 31c Assuming there are 3 through holes between the first action part X1 and the force application part Y1, if the traction cable is tightened, a 5-layer fold thickness will be formed at the part through which the traction cable passes.

[0407] In another embodiment, when the stent device is a balloon-expandable stent, the stent is pre-compressed onto the balloon, and upon release, the balloon is inflated by injecting saline solution, thereby expanding the stent. Figure 31a and Figure 31b As shown, the skirt is sewn onto the support. When the entire support expands, the distance between the first action part X1 and the second action part X2 increases, causing the lifting force part Y1 to move axially.

[0408] Example 32

[0409] See Figures 32a-32c In this embodiment, the support 1 has a flexible skirt 2 around its periphery. Before the support 1 is released, the skirt 2 is in an unfolded state, extending axially and surrounding the outer periphery of the support 1. After the support 1 is released, the skirt 2 is in a stacked state, closing and stacking along the axial direction of the released support 1 to form an annular circumferential leakage sealing part. This embodiment also includes a traction cable 4 that drives the skirt 2 into the stacked state. The traction cable 4 is linked to the radial deformation of the support 1 during release. During release within the body, the bottom edge of the skirt 2 is released first, followed by the top edge of the skirt 2.

[0410] The figure only shows the position of the skirt 2, which is basically located at one end of the axial direction of the stent 1 and adjacent to the blood inflow end (the direction of the hollow arrow in the figure indicates the normal blood flow direction in the use state). The stent 1 has a grid structure, such as the diamond grid in the figure. The axial length of the skirt in the unfolded state occupies half of the grid.

[0411] The top edge of the skirt 2 is fixed to the bracket. The skirt 2 has multiple cutting areas 5 arranged circumferentially on the top side in the axial direction, which can reduce the radial stacking thickness in the unfolded state, making it easier to load and transport. That is, the top edge of the skirt 2 is a toothed structure arranged circumferentially, and the cutting area is between adjacent teeth. The teeth are trapezoidal or triangular and evenly arranged circumferentially.

[0412] When the top edge of skirt 2 is fixed to the bracket, a seam point can be set only in the middle of the top edge of the toothed structure, with the seam points spaced apart in the circumferential direction. Development points are set on the bracket at the seam point locations.

[0413] In this embodiment, the traction cable is threaded circumferentially along the skirt as a whole. While extending circumferentially along the support, it also undulates in the support axis to form a wave structure with corresponding peak and trough structures.

[0414] When the support is released, under the traction of the support deformation, the peaks move relatively far apart in the circumferential direction, causing the troughs to rise. Since the traction cable moves through the skirt, they can pull or act on each other in each cycle to achieve overall linkage.

[0415] The dotted circle in the diagram can be used as the threading hole 2g. The traction cable 4 is only threaded on the skirt edge and floats between the corresponding threading holes.

[0416] In another embodiment, the traction cable can also be moved inside and outside the bracket at the threading hole in the uppermost row of the figure, that is, it can also serve as a seam point to maintain the axial relative position of the skirt and the bracket.

[0417] With the skirt unfolded, the skirt length *a* is the perimeter of the corresponding support, and the skirt width *b* is half the length of a rhombus. The skirt length is divided into five equal parts, each segment being *c*, and each segment corresponds to the length of two completed teeth, resulting in a total of 10 complete teeth. The tooth length *d* (upper base of the trapezoid) and the inter-tooth length *d* are equal. The skirt width is divided into four equal parts, each segment being *e*, meaning the tooth height is *e*.

[0418] When multiple guide holes (2g) are set, each lifting unit can be folded 3 times in the stacked state (one fold is required between two adjacent guide holes in the axial direction), forming a 4-layer membrane stack. By setting multiple guide holes, the constraint effect between the traction cable and the skirt can be increased, so that a more regular stacking effect can be achieved when the skirt is pulled up.

[0419] Specifically, taking a certain type of valve as an example, the skirt length is a = 95mm ± 0.2mm, and the skirt width is b = 8.80mm ± 0.2mm.

[0420] After dividing the skirt hem length into five equal parts, the length of each segment is c = 95 / 5 = 19mm ± 0.2mm.

[0421] The tooth profile length d and the inter-tooth length d = 19 / 4 = 4.75 mm ± 0.2 mm.

[0422] Tooth profile height e = 8.81 / 4 = 2.2mm ± 0.2mm.

[0423] Example 33

[0424] See Figures 33a to 33gThis embodiment provides a conveying system, including a handle 100, a sheath core assembly 102 connected to the handle 100, and an outer sheath tube 101 slidably sleeved on the outer periphery of the sheath core assembly 102. The outer sheath tube 101 can be controlled to slide axially relative to the sheath core assembly 102 by the handle 100.

[0425] The distal end of the sheath core assembly 102 is provided with a guide head 103 and an adjacent mounting head 104. The outer periphery of the mounting head 104 is provided with a slot or protrusion for connecting an interventional device. The interventional device can be, for example, a bracket 105 with a skirt 107 in the above embodiments. The proximal end of the bracket 105 is provided with a connecting ear 106 that can cooperate with the mounting head 104. In the loaded state, the bracket 105 is in a radially compressed state, located between the guide head 103 and the mounting head 104 and constrained by the outer sheath tube 101. The skirt is also in a corresponding unfolded state, located on the outer periphery of the bracket 105.

[0426] When the delivery system delivers the stent 105 to a predetermined location in the body, such as near the aortic valve 200, the outer sheath 101 retracts relative to the sheath core assembly 102, and the distal end of the stent 105, i.e. the first release end, is gradually exposed and begins to expand radially. Through the action of the stent 105 itself or in combination with the traction cable, the skirt 107 begins to be axially lifted and stacked. When the stent 105 is fully released, the skirt 107 enters the stacked state, forming a peripheral leakage sealing part, further preventing backflow at the aortic valve 200 site.

[0427] The various embodiments of the present invention can be combined with each other without technical conflict. The relevant principles and synergistic effects can be found in the relevant description in the invention content section.

[0428] The above description discloses only specific embodiments of the present invention, but the present invention is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Obviously, all such modifications and variations should fall within the protection scope claimed by the present invention. Furthermore, although some specific terms are used in this specification, these terms are only for convenience of explanation and do not constitute any special limitation on the present invention.

Claims

1. A leak-proof support device, comprising a support, characterized in that, It also features a flexible hem with the following characteristics: In its extended state, it is axially extended and surrounds the outer periphery of the pre-release support; In a stacked state, an annular circumferential leakage sealing portion is formed on the outer periphery of the bracket; On the side of the skirt where blood flows back in, there is a ring of a stop pocket to receive the backflow of blood from the peripheral leakage. After the stent is released, the leakage sealing part is located on the side of the stop pocket facing the stent where blood flows in, and the leakage sealing part and the stop pocket abut against each other.

2. The anti-leakage support device as described in claim 1, characterized in that, The blocking pocket is fixed to the outer periphery of the support by sewing. The blocking pocket has a closed structure on the side away from the reflux blood inflow. On the side facing the reflux blood inflow, there are multiple sewing parts that are fixed to the support at intervals. The reflux blood inlet is between adjacent sewing parts.

3. The anti-leakage support device as described in claim 1, characterized in that, The stop pocket is configured as a sandwich structure, including an inner layer and an outer layer, wherein the inner and outer layers are an integral structure connected by a bend at the bottom; or it is configured as a non-integral structure of inner and outer layers, which is closed by a stitch at the bottom. At the top of the blocking pocket, the inner top edge is continuously fixed to the outer periphery of the support, and the outer layer is sewn onto the support at intervals to form several reflux blood inlets.

4. The anti-leakage support device as described in claim 1, characterized in that, The stop pocket and the skirt hem are an integral structure. The top of the skirt hem forms the stop pocket through an axial detour and cuts out the reflux inlet.

5. The anti-leakage support device as described in claim 1, characterized in that, One part of the stopper is also served by the skirt. The stopper has a layered structure, including an inner layer and an outer layer. The bottom of the inner and outer layers are closed, and the top has the reflux inlet. One of the inner and outer layers is also served by the skirt.

6. The anti-leakage support device as described in claim 1, characterized in that, The blocking pocket has a sandwich structure, including an inner layer and an outer layer. The bottom of the inner and outer layers is closed, and the top has the reflux blood inlet. The inner wall of the bracket is provided with an inner lining membrane, the inner layer of the stop pocket is also made up of the inner lining membrane, and the outer layer of the stop pocket is either a separate part or extends upward from the top of the skirt and also serves as the outer layer.

7. A leak-proof support device, comprising a support, characterized in that, It also features a flexible hem with the following characteristics: In its extended state, it is axially extended and surrounds the outer periphery of the pre-release support; The stacked structures form a ring-shaped leak-sealing section. The skirt hem has multiple cutting areas arranged circumferentially on at least one side of the axial direction, and the cutting areas are hollow structures.

8. The anti-leakage support device as described in claim 7, characterized in that, The cutting area consists of multiple through holes arranged along the axial direction of the support, with the connecting parts retained at the intervals between the through holes.

9. The anti-leakage support device as described in claim 7, characterized in that, The skirt is clamped to the outer periphery of the bracket when the bracket is released, and is retracted and stacked along the axial direction of the bracket after release when the bracket is stacked.

10. A leak-proof support device, comprising a support, characterized in that, It also features a flexible hem with the following characteristics: In its extended state, it is axially extended and surrounds the outer periphery of the pre-release support; In a stacked state, the supports are retracted and stacked along the axial direction after release, forming an annular leak sealing part; At least a portion of the skirt is fixed to the bracket, and the bracket device is also provided with a traction cable that drives the skirt into a stacked state. The traction cable is linked to the radial deformation when the bracket is released, and the skirt is clamped to the outer periphery of the bracket when the bracket is released.

11. The anti-leakage support device as described in claim 10, characterized in that, The traction cable extends circumferentially along the support and also undulates in a wave-like structure along the support axis. The traction cable includes a driving part and a force-applying part, wherein the driving part is linked to the bracket during the release process, and the force-applying part is connected to the skirt and is pulled by the driving part during the release process of the bracket, having an axial displacement relative to the bracket to lift the skirt stack.

12. The anti-leakage support device as described in claim 11, characterized in that, The driving part of the traction cable is a series of segments or points distributed at intervals, and is threaded through the bracket in a fixed or movable manner. The force-applying portion of the traction cable consists of multiple segments or points spaced apart, and is threaded through the skirt in a fixed or movable manner.

13. The anti-leakage support device as described in claim 11, characterized in that, The drive unit is connected only to the skirt and includes at least two through-end points that interact with the skirt. The two through-end points have a circumferential span change before and after the bracket is released.

14. The anti-leakage support device as described in claim 11, characterized in that, The stent has a push pocket on the blood flow side to assist the skirt in entering the stacked state. The push pocket has a blood flow inlet to expand and push the skirt.

15. The anti-leakage support device as described in claim 14, characterized in that, When the skirt is unfolded, the bottom edge extends beyond the push pocket and covers or partially covers the push pocket. One side of the push pocket is a closed structure, and the other side has multiple stitched parts that are fixed to the bracket at intervals. The blood inlet is located between adjacent stitched parts.

16. A heart valve, comprising a stent and a valve disposed within the stent, characterized in that, The bracket adopts the anti-leakage bracket device according to any one of claims 1 to 15.

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