CN220344545U - Pulmonary valve stent and pulmonary valve - Google Patents

Abstract

The embodiment of the disclosure discloses a pulmonary valve stent and a pulmonary valve. The pulmonary valve stent comprises an upper crown section, a waist section and a lower crown section, wherein the upper crown section and the lower crown section are arranged in an open mode; the open inner diameter of the upper crown section is larger than the inner diameter of the waist section; the open inner diameter of the lower crown section is larger than that of the upper crown section; the upper crown section comprises a plurality of spliced first diamond structures; the waist section comprises a plurality of spliced second diamond structures; the waist section is provided with valve blades; the lower crown section is connected with the waist section through a transition section. The application provides a special support suitable for special symptoms through the asymmetric arrangement of the upper crown section and the lower crown section, which can be effectively applied to patients with excessively wide pulmonary artery trunk or right ventricular outflow tracts, and the support can be well adapted to the positions of the patients to prevent paravalvular leakage.

Description

Pulmonary valve stent and pulmonary valve

Technical Field

The disclosure relates to the field of medical instruments, in particular to a pulmonary valve stent and a pulmonary valve.

Background

Interventional pulmonary valve implantation is a recently emerging surgical technique for treating pulmonary valve regurgitation or stenosis after congenital heart disease correction. However, pulmonary artery structures after congenital heart disease correction are complex and diverse, and Philipp Bonhoeffer et al classify the pulmonary artery structures of multiple patients into 5 categories according to the geometry of the right ventricular outflow tract and pulmonary artery stems. Such a large and complex patient architecture is a significant challenge for the compatibility of the interventional instrument.

In China, when TOF patients are treated in early stage, ROVT reconstruction is carried out by adopting a right ventricular outflow tract-pulmonary artery transvalve patch technology, pulmonary valve reflux is left after operation, main pulmonary artery and right ventricular outflow tract are expanded or tumor parts are generated, and a certain proportion of patients have excessively wide pulmonary artery trunk or right ventricular outflow tract tumor, which can be visually called as large funnel shape or large inverted funnel shape. For large inverted funnels, the direction from the pulmonary artery inflow to the right ventricle is progressively larger, with excessively large right ventricular outflow tract tumors and right ventricles.

Currently, patients who perform transvalve patch surgery in early stages are treated, and most of pulmonary valve stents adopted are reducing bodies with large diameters at two ends and small diameters in the middle. When aiming at the patient with excessively wide pulmonary artery trunk or/and right ventricular outflow tract tumor, the valve stent corolla cannot be perfectly anchored due to poor matching with tissues, so that the valve stent is leaked; another situation is that the pulmonary artery is of a short size, and the proximal end of the stent overhangs the ventricle, resulting in hemodynamic problems.

Disclosure of Invention

In view of the above, embodiments of the present disclosure provide a pulmonary valve stent, a pulmonary valve; aiming at patients with expanded proximal and distal pulmonary artery, the pulmonary artery valve stent is a special stent which can be well adapted to the patients to prevent paravalvular leakage.

The first aspect of the application provides a pulmonary valve stent, which comprises an upper crown section, a waist section and a lower crown section, wherein the upper crown section and the lower crown section are all arranged in an open manner;

the open inner diameter of the upper crown section is larger than the inner diameter of the waist section;

the open inner diameter of the lower crown section is larger than that of the upper crown section;

the upper crown section comprises a plurality of spliced first diamond structures; the waist section comprises a plurality of spliced second diamond structures;

the waist section is provided with valve blades;

the lower crown section is connected with the waist section through a transition section.

Optionally, when the upper crown section is an inflow section, the outflow end of the leaflet is disposed toward the lower crown section;

when the lower crown section is an inflow section, the outflow end of the leaflet is disposed toward the upper crown section.

Optionally, the lower crown section is of a spiral horn-shaped structure;

the transition section comprises a positioning ring and a plurality of limiting rings, and the positioning ring and the limiting rings are respectively connected with the tops of the second diamond structures;

the sum of the numbers of the positioning rings and the limiting rings is not greater than the number of the second diamond structures.

Optionally, the spiral horn-shaped structure comprises a first adjusting section, a deformation supporting section and a second adjusting section, one end of the first adjusting section is fixedly connected with the positioning ring, and the other end sequentially penetrates through the limiting rings to be connected with one end of the deformation supporting section;

A limiting piece is arranged at the first end of the second adjusting section, and a through hole is formed in the limiting piece;

the other end of the deformation supporting section penetrates through the through hole and is connected with the second end of the second adjusting section;

the first adjusting section and the limiting rings are arranged in a clearance mode;

the deformation support section is arranged with the through hole in a clearance mode.

Optionally, the end of the spiral horn-shaped structure far away from the waist section is provided with a plurality of connecting parts;

the connecting parts are uniformly distributed.

Optionally, the first adjusting section, the deformation supporting section and the second adjusting section are all provided with a plurality of bending parts.

Optionally, the bending part is V-shaped.

Optionally, the lower crown section is of a dense net horn-shaped structure;

the dense net horn-shaped structure comprises a plurality of grids, and deformation directions of the grids are consistent;

the transition section is of an arc-shaped structure or a straight rod structure.

Optionally, the busbar of the dense net horn-shaped structure is a convex arc.

Optionally, the end part of the dense net horn-shaped structure far away from the waist section is provided with a plurality of connecting parts;

the connecting parts are uniformly distributed.

Optionally, the lower crown section is of an arc-shaped strip horn-shaped structure;

The arc strip horn-shaped structure comprises a plurality of arc pieces, and the arc pieces form a containing cavity.

Optionally, one ends of the plurality of arc-shaped pieces are respectively connected with bottom vertexes of the plurality of second diamond-shaped structures;

the outer diameter of a fitting circle at the joint of the arc-shaped pieces and the second diamond-shaped structures is smaller than that of a fitting circle at the free ends of the arc-shaped pieces;

the transition section is of an arc-shaped structure.

Optionally, the arc-shaped piece comprises a deformation section, a support section and an edge section which are sequentially connected, and the support section is arranged between the deformation section and the edge section;

the deformation section is connected with the transition section;

the circle centers of the support section and the edge section are positioned on the same side, and the circle center of the deformation section is positioned on the other side;

the distance from the edge section to the first axis is not less than the distance from the support section to the first axis.

Optionally, the arc length of the support section and the arc length of the edge section are both greater than the arc length of the deformation section;

the radius of the support section is larger than that of the edge section;

the radius of the edge section is larger than the radius of the deformation section.

Optionally, the deformation section is a concave arc;

The support section and the edge section are both convex arcs.

Optionally, the deformation section and the support section are covered with a sealing film;

the edge section has a telescopic degree of freedom and a rotational degree of freedom about the junction of the edge section and the support section.

Optionally, the lower crown section comprises a deformation section and a support section, and the deformation section and the support section form a horn-shaped structure;

the deformation section is connected with the waist section, and the deformation section is perpendicular to the waist section;

the support section is arranged at the end part of the deformation section far away from the waist section, and the support section and the deformation section are arranged at an obtuse angle;

the transition section is of a concave arc structure.

Optionally, the lower crown section includes a positioning portion, a supporting portion, and a plurality of protecting portions, where the positioning portion, the supporting portion, and the plurality of protecting portions form a horn-shaped structure;

the radial dimension of the supporting part is larger than that of the positioning part;

the protection parts are arranged between the positioning part and the supporting part;

the positioning part is connected with the waist sections;

the supporting part is provided with a plurality of bending parts.

Optionally, the transition section is a connecting rod structure.

Optionally, the positioning part is a positioning circular ring;

the supporting part is a supporting circular ring;

the diameter of the supporting ring is larger than that of the positioning ring, and the positioning ring and the supporting ring are concentrically arranged.

A second aspect of the present application discloses a pulmonary valve comprising a pulmonary valve stent and a sealing membrane coated on the outside of the pulmonary valve stent.

The pulmonary valve stent provided by the embodiment of the disclosure can be effectively applied to patients with excessively wide pulmonary artery trunk or/and right ventricular outflow tract tumor through the asymmetric arrangement of the upper crown section and the lower crown section, namely, the patients gradually expanding in the direction from the pulmonary artery inflow tract to the right ventricle, and the special stent applicable to special symptoms is provided, and can be well adapted to the positions of the patients to prevent paravalvular leakage; the waist section serving as the middle section is arranged at the narrow part, so that the circulation requirement is met, and meanwhile, excessive supporting force is not needed to be born; the spiral horn-shaped structure can meet the size requirement of the affected part, flexibly match the size of the pulmonary artery, and effectively reduce the generation of hemodynamic disorder.

The foregoing description is only an overview of the disclosed technology, and may be implemented in accordance with the disclosure of the present disclosure, so that the above-mentioned and other objects, features and advantages of the present disclosure can be more clearly understood, and the following detailed description of the preferred embodiments is given with reference to the accompanying drawings.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present disclosure, and other drawings may be obtained according to these drawings without inventive effort to a person of ordinary skill in the art.

Fig. 1 is a schematic perspective view of a first embodiment provided herein.

Fig. 2 is a partial enlarged view of a in fig. 1.

Fig. 3 is a schematic view of the spiral horn structure of fig. 1.

Fig. 4 is a top view of fig. 1.

Fig. 5 is a schematic illustration of the anchor of fig. 1 at a patient.

Fig. 6 is a schematic perspective view of a second embodiment provided herein.

Fig. 7 is a schematic view of the spiral horn configuration of fig. 6.

Fig. 8 is a top view of fig. 6.

Fig. 9 is a schematic view of fig. 6 in a compressed state during delivery.

Fig. 10 is a schematic view of fig. 6 during release.

Fig. 11 is a schematic view of a third embodiment provided herein.

Fig. 12 is a top view of fig. 11.

Fig. 13 is a schematic view of a fourth embodiment provided herein.

Fig. 14 is a partial enlarged view of B in fig. 13.

Fig. 15 is a top view of fig. 13.

Fig. 16 is a schematic view of a fifth embodiment provided herein.

Fig. 17 is a top view of fig. 16.

Fig. 18 is a schematic view of a sixth embodiment provided herein.

Fig. 19 is a top view of fig. 18.

Reference numerals illustrate: 10. distal pulmonary artery trunk; 20. a native annulus; 30. a right chamber outflow tract; 100. an upper crown section; 200. a waist section; 300. a lower crown section; 310. a deformation section; 311. a first adjustment section; 312. a deformation support section; 313. a second adjustment section; 314. a limiting piece; 315. a bending part; 320. a support section; 321. a positioning part; 322. a support part; 323. a protective part; 330. an edge section; 400. a transition section; 410. a positioning ring; 420. a limiting ring; 500. an outer sheath; 600. and connecting the circular rings.

Detailed Description

The present disclosure is described in further detail below with reference to the drawings and the embodiments. It is to be understood that the specific embodiments described herein are merely illustrative of the relevant content and not limiting of the present disclosure. It should be further noted that, for convenience of description, only a portion relevant to the present disclosure is shown in the drawings.

In addition, embodiments of the present disclosure and features of the embodiments may be combined with each other without conflict. The technical aspects of the present disclosure will be described in detail below with reference to the accompanying drawings in conjunction with embodiments.

Unless otherwise indicated, the exemplary implementations/embodiments shown are to be understood as providing exemplary features of various details of some ways in which the technical concepts of the present disclosure may be practiced. Thus, unless otherwise indicated, features of the various implementations/embodiments may be additionally combined, separated, interchanged, and/or rearranged without departing from the technical concepts of the present disclosure.

The use of cross-hatching and/or shading in the drawings is typically used to clarify the boundaries between adjacent components. As such, the presence or absence of cross-hatching or shading does not convey or represent any preference or requirement for a particular material, material property, dimension, proportion, commonality between illustrated components, and/or any other characteristic, attribute, property, etc. of a component, unless indicated. In addition, in the drawings, the size and relative sizes of elements may be exaggerated for clarity and/or descriptive purposes. While the exemplary embodiments may be variously implemented, the specific process sequences may be performed in a different order than that described. For example, two consecutively described processes may be performed substantially simultaneously or in reverse order from that described. Moreover, like reference numerals designate like parts.

When an element is referred to as being "on" or "over", "connected to" or "coupled to" another element, it can be directly on, connected or coupled to the other element or intervening elements may be present. However, when an element is referred to as being "directly on," "directly connected to," or "directly coupled to" another element, there are no intervening elements present. For this reason, the term "connected" may refer to physical connections, electrical connections, and the like, with or without intermediate components.

For descriptive purposes, the present disclosure may use spatially relative terms such as "under … …," under … …, "" under … …, "" lower, "" above … …, "" upper, "" above … …, "" higher "and" side (e.g., as in "sidewall"), etc., to describe one component's relationship to another (other) component as illustrated in the figures. In addition to the orientations depicted in the drawings, the spatially relative terms are intended to encompass different orientations of the device in use, operation, and/or manufacture. For example, if the device in the figures is turned over, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "below" … … can encompass both an orientation of "above" and "below". Furthermore, the device may be otherwise positioned (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. Furthermore, when the terms "comprises" and/or "comprising," and variations thereof, are used in the present specification, the presence of stated features, integers, steps, operations, elements, components, and/or groups thereof is described, but the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof is not precluded. It is also noted that, as used herein, the terms "substantially," "about," and other similar terms are used as approximation terms and not as degree terms, and as such, are used to explain the inherent deviations of measured, calculated, and/or provided values that would be recognized by one of ordinary skill in the art.

Example 1

Referring to fig. 1-4, the present application provides a pulmonary valve stent, including an upper crown segment 100, a waist segment 200, and a lower crown segment 300, where the upper crown segment 100 and the lower crown segment 300 are all disposed open. Wherein the open inner diameter of the upper crown section 100 is greater than the inner diameter of the waist section 200, and the open inner diameter of the lower crown section 300 is greater than the open inner diameter of the upper crown section 100; the lower crown section 300 is connected with the lumbar section 200 by a transition section 400.

The waist section 200 is provided with valve leaflets, and when the upper crown section 100 is an inflow section, the outflow ends of the valve leaflets are arranged towards the lower crown section 300; when the lower crown section 300 is the inflow section, the outflow end of the leaflet is disposed toward the upper crown section 100.

The upper crown section 100 comprises a plurality of spliced first diamond-shaped structures, and the waist section 200 comprises a plurality of spliced second diamond-shaped structures, wherein the area of the second diamond-shaped structures is smaller than that of the first diamond-shaped structures, and the number of the second diamond-shaped structures is consistent with that of the first diamond-shaped structures.

The lower crown section is connected with the waist section 200 through a transition section 400; preferably, the transition section 400 includes a positioning ring 410 and a plurality of limiting rings 420, wherein the positioning ring 410 and the plurality of limiting rings 420 are respectively connected with bottom vertices of the plurality of second diamond structures, i.e. the positioning ring 410 and the plurality of limiting rings 420 are suspended, so as to facilitate the penetrating arrangement of the lower crown section 300.

The sum of the numbers of the positioning rings 410 and the plurality of limiting rings 420 is not greater than the number of the second diamond structures, that is, the number of the limiting rings 420 is set so long as the connection bearing of the waist section 200 to the lower crown section 300 can be satisfied, and the number of the limiting rings 420 is not particularly limited.

The lower crown section 300 is of a spiral horn-shaped structure, the spiral horn-shaped structure comprises a first adjusting section 311, a deformation supporting section 312 and a second adjusting section 313, one end of the first adjusting section 311 is fixedly connected with a positioning ring 410, the other end sequentially penetrates through a plurality of limiting rings 420 to be connected with one end of the deformation supporting section 312, and the first adjusting section 311 is in clearance arrangement with the limiting rings 420.

The second adjusting section 313 is a spiral section which is sequentially increased in the radial direction, and through the arrangement of the second adjusting section 313, the whole spiral horn-shaped structure forms an open shape with larger inner diameter so as to be suitable for a disease area with enlarged right-room outflow tract.

The first end of the second adjusting section 313 is provided with a limiting piece 314, and the limiting piece 314 is provided with a through hole.

The other end of the deformation supporting section 312 penetrates through the through hole to be connected with the second end of the second adjusting section 313, and the deformation supporting section 312 is arranged in a clearance mode with the through hole; the other end of the deformation supporting section 312 is the end far from the first adjusting section 311.

Further, the limiting member 314 is a circular ring.

The lower crown section 300 body may be formed by a braiding process or may be formed by heat treating nickel titanium wire into a ring or spiral shape and then attached to the lumbar section 200.

Preferably, the first diamond-shaped structures in the upper crown section 100 and the second diamond-shaped structures in the waist section 200 are all provided with nine, nine first diamond-shaped structures are uniformly distributed, and nine second diamond-shaped structures are uniformly distributed.

The longitudinal axis of the first diamond structure is disposed in correspondence with the longitudinal axis of the second diamond structure, and it should be noted that, in this embodiment, the correspondence is: the two vertex connecting lines of the second diamond structure and the two vertex connecting lines of the first diamond structure are positioned in the same plane to form a corresponding group of deformation structures.

The upper crown section 100 is fixedly connected with the waist section 200 through three connecting parts, namely, three second diamond structures are connected with three first diamond structures, two vacant second diamond structures are arranged between every two connected second diamond structures, two vacant first diamond structures are arranged between every two connected first diamond structures, namely, three connecting parts are uniformly distributed, the centering of the upper crown section 100 and the waist section 200 is ensured, and the upper crown section 100 and the waist section 200 are prevented from being misplaced to cause damage to a human body.

In addition, the upper crown section 100 and the waist section 200 may be fixedly connected at least through two connection points, that is, at least two second diamond structures are correspondingly connected with two first diamond structures at opposite positions.

In this embodiment, the connection is preferably a connection post.

The end part of the upper crown section 100 far away from the waist section 200 is vertical or is arranged in a buckling manner, so that the end part of the upper crown section 100 is prevented from being in sharp contact with a human body, and the additional damage to the human body is effectively avoided on the premise of guaranteeing the supporting and positioning strength.

The waist section 200 is preferably arranged in a column in this embodiment.

Preferably, the first adjustment section 311, the deformation support section 312 and the second adjustment section 313 are integrally formed.

Preferably, the first adjusting section 311 and the second adjusting section 313 are circular arcs, and the deformation trend of the circular arcs is consistent with that of the deformation supporting section 312.

Further, the first adjusting section 311 and the second adjusting section 313 are both circular arcs, and the plane where the first adjusting section 311 is located is parallel to the plane where the second adjusting section 313 is located, that is, in this embodiment, the first adjusting section 311 and the second adjusting section 313 are both horizontally arranged, the horizontally arranged first adjusting section 311 is convenient to be connected with the transition section 400, and the horizontally arranged second adjusting section 313 prevents a sharp area from being formed at the end part, so as to prevent damage to the human body.

The spiral horn structure is in a truncated cone shape, the base angle of an isosceles trapezoid on the side face of the shaft of the truncated cone is theta, theta epsilon (0 DEG, 80 DEG), in the embodiment, the fitting generatrix of the spiral horn structure is a generatrix of a fitting truncated cone formed by the spiral horn structure, namely the caliber of the spiral horn structure is sequentially increased downwards, a structure which is different from the upper crown section 100 and has a larger inner diameter is formed, and the special expansion affected part of the outflow channel of the right chamber can be met.

Preferably, θ is 10 ° to 50 °.

Preferably, the positioning ring 410 and the plurality of limiting rings 420 are all shaped and arranged in number.

Further, the end of the spiral horn-shaped structure away from the waist section 200 may be further provided with a plurality of connection portions (not shown in the figure), and the plurality of connection portions are uniformly distributed.

Preferably, the connection portion is a connection claw.

In particular, the upper crown section 100, the lumbar section 200 and the lower crown section 300 may be provided with sealing membranes.

Referring to fig. 5, this is a schematic diagram of the stent released into the human body when the upper crown segment 100 is the outflow segment, after the stent is released, the upper crown segment 100 abuts against the distal pulmonary artery trunk 10, the waist segment 200 is located at the annulus of the original human body (i.e. the native annulus 20), the leaflets built in the waist segment 200 work instead of the original leaflets of the human body, the spiral horn-shaped structure of the lower crown segment 300 can support the enlarged right ventricular outflow tract 30, the spiral structure enables the lower crown segment 300 to be tightly attached to the inner wall of the right ventricular outflow tract 30, the probability of occurrence of the perivalvular leakage phenomenon is ensured to be avoided or reduced, and the movement of the prosthetic valve can be effectively prevented.

Through the asymmetric arrangement of the upper crown section and the lower crown section, the device can be effectively applied to patients with excessively wide pulmonary artery trunk or/and right ventricular outflow tract tumor, namely, patients with gradually expanding direction from pulmonary artery inflow tract to right ventricle, and a special bracket applicable to special symptoms is provided, and the bracket can be better adapted to the positions of the patients to prevent paravalvular leakage; the waist section serving as the middle section is arranged at the narrow part, so that the circulation requirement is met, and meanwhile, excessive supporting force is not needed.

In this embodiment, the spiral horn structure is not only a deformation power body, but also a supporting body, and the diameter of the ring is reduced by spiral or stretching, so as to meet the requirement of placement in the conveying device, and meanwhile, the first adjusting section 311 can also use a wire-shaped material with smaller diameter, such as nickel titanium wire, so that the diameter of the ring is reduced conveniently; when the device is delivered to a preset position of a human body and released, the internal diameter is expanded by the spiral drive trend of the spiral shape so as to reach the preset shape.

The spiral horn-shaped structure formed integrally is convenient to process, is simpler and more efficient after being unfolded, and can realize integral deformation by deformation along one direction; the traditional splicing arrangement of a plurality of diamonds ensures that the deformation directions of the plurality of diamond structures are consistent due to strict requirements on the arrangement of the plurality of diamond structures, and a preset structural state is formed after the integral deformation of the plurality of diamond structures, namely, the processing requirements on the lower crown section are strict, errors in manufacturing any structure can lead to errors of the integral form, damage to blood vessels can be caused, poor positioning can occur, and further, deviation of the integral placement position of the bracket is caused.

In addition, the traditional lower crown section is formed by splicing a plurality of diamond structures, and as the lower crown section is required to meet the requirement of partial contact on the length and radial support, the size and the number of the diamond structures can be correspondingly set, when the traditional single-layer length is insufficient, the diamond structures form a slender shape in the longitudinal direction after being released and stretched, but the diamond structures cannot be stretched too much in the radial direction, and the outer diameter of an opening of the formed integral structure is smaller.

If the requirement of large size after radial expansion is required to be met, the length of the plurality of diamond structures in the longitudinal direction is shortened, the fitting length with the human body part is shorter, the integral support and fixation are affected, and the integral displacement of the bracket can be caused in long-term use.

If a plurality of diamond structures are arranged, the longitudinal length requirement is required to be met, the radial diameter requirement is required to be met, a plurality of layers of diamond structures are required to be arranged in the longitudinal direction, and the diamond structures of each layer can be simultaneously met only by arranging more layers of diamond structures, however, the arrangement not only causes longer processing period, but also has higher requirements on processing precision, because the more diamond structures are arranged, the more accurate requirements on splicing, positioning and deformation trend are met, and the probability that more joints are easy to cause problems in the use process is increased.

The spiral turns of the spiral horn-shaped structure are arranged, so that the requirements of the longitudinal direction and the radial direction can be met, the structure is simple, the use is convenient, and the problems existing in the traditional diamond-shaped structure are effectively solved.

Example two

Referring to fig. 6 to 10, the arrangement of the upper crown section 100, the lumbar section 200 is the same as that of the first embodiment; unlike the first embodiment, the following is: the first adjusting section 311, the deformation supporting section 312 and the second adjusting section 313 are also provided with a plurality of bending parts 315, so that the first adjusting section 311, the deformation supporting section 312 and the second adjusting section 313 are convenient to fold, and can be contained in the outer sheath 500.

When the integral stent is compressed, the upper crown section 100 and the waist section 200 are straightened and folded in the outer sheath 500 along the axial direction, and the lower crown section 300 with a spiral horn-shaped structure is converted from circumferential expansion into axial stacking through a plurality of bending parts 315, so that the lower crown section 300 is folded in the outer sheath 500.

Further, in the second diamond-shaped structure of the waist section 200, the axial lengths of the diamond-shaped lattices are unequal, the axial lengths of the diamond-shaped lattices provided with the positioning ring 410 and the limiting ring 420 are longer, and the diamond-shaped lattice design with a shorter length can provide space for the lower crown section 300 to be converted from circumferential expansion to axial stacking, so that the process is smoother.

In particular, the upper crown section 100, the lumbar section 200 and the lower crown section 300 may be provided with sealing membranes.

In the present embodiment, the number of the bending portions 315 is not particularly limited as long as the number of the bending portions 315 is set so as to compress the spiral horn-like structure.

When the outer sheath 500 is moved toward the lower crown section 300 of the stent, the upper crown section 100 first exposes the outer sheath 500, expands radially by its own memory property, assumes a released state, and further assumes a released state as the outer sheath 500 continues to move, as well as the lumbar section 200.

As the outer sheath 500 continues to be withdrawn (i.e., moved away from the upper crown segment), the first adjustment segment 311 returns axially to its original state, while the remainder of the lower crown segment remains in a compressed state within the outer sheath. The entire stent can be completely separated from the outer sheath by continued movement of the outer sheath 500, i.e., a completely released state can be exhibited.

Example III

Referring to fig. 11 and 12, in the present embodiment, the arrangement of the upper crown section 100, the lumbar section 200 is the same as that of the first embodiment; unlike the first embodiment, the following is: the upper crown section 100 and the lower crown section 300 are connected differently and the transition section 400 and the lower crown section 200 are arranged.

The connection between the upper crown section 100 and the waist section 200 is specifically: each first diamond structure is fixedly connected with the second diamond structure. In addition, the upper crown section 100 and the waist section 200 may be fixedly connected at least through two connection points, that is, at least two second diamond structures are correspondingly connected with two first diamond structures at opposite positions.

The lower crown section 300 is of a dense mesh horn structure; the dense net horn structure comprises a plurality of grids, and deformation directions of the grids are consistent.

The two open circles on the upper and lower sides of the lower crown section 300 are truncated cones formed by the upper and lower bottom surfaces, the base angle of an isosceles trapezoid on the axial side surface of each truncated cone is θ, θ is e (0 degrees, 80 degrees), in the embodiment, the fitting bus of the dense-mesh horn-shaped structure is a bus of the fitting truncated cone formed by the dense-mesh horn-shaped structure, namely, the caliber of the dense-mesh horn-shaped structure is sequentially increased downwards, so that a structure which is different from the upper crown section 100 and has a larger inner diameter is formed, and the special right-chamber outflow channel expansion affected part can be met.

Preferably, θ is 10 ° to 50 °.

In particular, the upper crown section 100, the lumbar section 200 and the lower crown section 300 may be provided with sealing membranes.

The transition section 400 in this embodiment is an arc-shaped structure or a straight rod structure, that is, the lower crown section 300 is fixedly connected with the waist section 200 through the transition section 400.

The busbar of close net loudspeaker form structure is protruding arc, and close net loudspeaker form structure's free end vertical setting or interior knot set up, prevents that tip from forming sharp-pointed department and damaging the human body.

The end of the close-mesh horn structure remote from the waist section 200 is provided with a plurality of connection portions.

In this embodiment, the connection part is a connection ring, and the connection ring is preferably provided with three connection rings, and the three connection rings are uniformly distributed.

Example IV

Referring to fig. 13 to 15, in the present embodiment, the arrangement of the upper crown section 100, the lumbar section 200 is the same as that of the third embodiment; unlike the third embodiment, the following is: the lower crown section 300 is an arcuate strip horn-like structure.

Specifically, the arcuate strip horn structure includes a plurality of arcuate members forming a receiving chamber, and the open end caliber of the receiving chamber is greater than the open inner diameter of the crown section 100.

The two open circles on the upper and lower sides of the lower crown section 300 are truncated cones formed by the upper and lower bottom surfaces, the base angle of an isosceles trapezoid on the axial side surface of the truncated cone is theta, theta epsilon (0 DEG, 80 DEG), in the embodiment, the fitting generatrix of the arc-shaped strip horn-shaped structure is the generatrix of the fitting truncated cone formed by the arc-shaped strip horn-shaped structure, namely the caliber of the arc-shaped strip horn-shaped structure is sequentially increased downwards, a structure which is different from the upper crown section 100 and has a larger inner diameter is formed, and the special right-chamber outflow channel expansion affected part can be met.

Preferably, θ is 10 ° to 50 °.

The transition section 400 comprises a plurality of arc structures, and the longitudinal central axes of the arc structures are overlapped with the first axis; one end of the arc-shaped structure is connected with the bottom vertex of the second diamond-shaped structure, and the other end of the arc-shaped structure is connected with the deformation section 310, namely the transition section 400 is matched with the arc-shaped piece.

Through the independent setting of a plurality of arc pieces, when the conveyer releases, each arc piece is not interfered with each other, guarantees that the position after the release highly accords with the prospective position to can not draw each other, can not produce torsional force in changeover portion 400 department, also can not produce stress concentration point, can satisfy the great size demand after the release, can guarantee to have better anchoring effect again, effectively improve whole life.

In particular, the upper crown section 100, the lumbar section 200 and the lower crown section 300 may be provided with sealing membranes.

Through the unequal asymmetric arrangement of the upper crown section 100 and the lower crown section 300, the device can be effectively applied to a patient with enlarged right ventricle, namely, a patient with gradually enlarged direction from pulmonary artery inflow channel to right ventricle, and a special bracket applicable to special symptoms is provided, and the bracket can be better adapted to the patient and can prevent paravalvular leakage; the waist section 200, which is the middle section, is placed in a narrow position, and does not need to bear excessive supporting force while meeting the circulation requirements.

In addition, the pulmonary valve stent disclosed by the application is simple in structure, convenient to process, low in cost and beneficial to popularization and use.

Specifically, the arc-shaped member includes a deformation section 310, a support section 320 and an edge section 330 connected in sequence, the support section 320 is disposed between the deformation section 310 and the edge section 330, the deformation section 310 is connected with the transition section 400, that is, the edge section 330 is disposed at one end of the support section 320 far away from the deformation section 310.

The center of the supporting section 320 and the center of the edge section 330 are located on the same side, and the center of the deformation section 310 is located on the other side, in this embodiment, the deformation section 310 is a concave arc, which can ensure the connection transition with the transition section 400, and can prevent the sharp outer wall from being generated at the connection part, so as to prevent the damage to the inner wall of the affected part.

The supporting section 320 and the edge section 330 are convex arcs, so that a larger fitting surface with the inner wall of an affected part is ensured.

Preferably, the longitudinal central axis of the arc-shaped member is a first axis, the longitudinal central axis of the upper crown section 100 is a second axis, the longitudinal central axis of the waist section 200 is a third axis, and the first axis is overlapped with the second axis and the third axis.

The distance from the edge section 330 to the first axis is not less than the distance from the support section 320 to the first axis, i.e. the inner diameter of the edge section 330 is arranged incrementally outwards.

The arc length of the supporting section 320 and the arc length of the edge section 330 are both greater than the arc length of the deformation section 310, and the arrangement of the shorter deformation section 310 does not generate stress aggregation at the position on the premise of ensuring the connection strength with the transition section 400, so that the service life is prolonged, and the deformation section 310 is larger in stress and easy to break when being connected with the transition section 400 due to the fact that the radius is too small, and the radius is too large, so that the larger radial supporting force is not formed.

The radius of the edge section 330 is larger than that of the deformation section 310, the radius of the supporting section 320 is larger than that of the edge section 330, and the arrangement is that the supporting section 320 and the edge section 330 form a gentle slope, so that a joint area with a certain length is formed, sharp points and stress concentration cannot occur at any position, and a good anchoring effect is achieved through the supporting section 320 and the edge section 330.

In the present embodiment, the radius of the deformation section 310 is R1, the radius of the support section 320 is R2, and the radius of the edge section 330 is R3;

R1∈[1mm,5mm]；

R2∈[20mm,30mm]；

R3∈[5mm，20mm)。

in this embodiment, the free end of the edge section 330 is preferably provided as an inner buckle, which can not only achieve the supporting effect, but also can not damage the human body, thereby forming a smooth contact support.

The end of the edge section 330 far away from the support section 320 is provided with a connecting part, in this embodiment, the connecting part is a connecting ring 600, the number of the connecting rings 600 is consistent with that of the arc-shaped pieces, the stress of the connecting rings 600 in the use process is ensured to be uniform, and the arc-shaped pieces are prevented from being deformed.

In this embodiment, the connection ring 600 is disposed vertically.

In this application, the support section 320 with a larger radius can increase the overall size of the lower crown section 300, and the edge section 330 with a moderate radius is connected with the connecting ring 600, so that the tail of the lower crown section 300 is nearly parallel to the central axis of the bracket, and a larger anchoring area is formed.

Further, the outer diameter of the fitting circle where the transition section 400 is located is smaller than the outer diameter of the fitting circle where the support section 320 is located, the outer diameter of the fitting circle where the free ends of the edge sections 330 are located is larger than the outer diameter of the fitting circle where the support section 320 is located, that is, the inner diameter of the opening of the arc-shaped pieces far away from the waist section 200 is largest, the inner diameter of the accommodating chamber is gradually increased downwards, and the requirement of larger size is met. The deformation section is formed by an arc MN, and the curvature radius R _MN The device is reasonable in arrangement, and when the deformation section and the waist section are connected due to the fact that the radius is too small, the stress is large, the fracture is easy, and the formation of large radial supporting force is not facilitated due to the fact that the radius is too large; the support section is composed of an arc NP and an arc PQ, and the arcs at the two ends are tangent.

The deformation section 310 and the support section 320 are covered with a sealing film, the edge section 330 has a telescopic degree of freedom and a rotational degree of freedom around the connection of the edge section 330 and the support section 320, so that the whole lower crown section 300 has a certain torsion allowance, even if the lower crown section has the functions of stretching and rotating at the point P, and the lower crown section can adapt to patients with RVOT with more sizes.

In addition, the embodiment can effectively solve the problem of torsion resistance in the prior art, has good application property and good compliance, ensures the anchoring strength of the integral bracket, can not generate larger displacement in long-time use, and improves the integral use effect and the service life.

Or, the deformation section 310, the support section 320 and the edge section 330 are all covered with sealing films, so that the whole has good adaptation degree.

If the stent is required to have the capability of solving the torsion resistance, the sealing film may not cover the entire lower crown section 300.

Through the independent setting of a plurality of arc pieces, when the conveyer releases, each arc piece is not interfered with each other, guarantees that the position after the release highly accords with the prospective position to can not draw each other, can not produce torsional force in changeover portion department, also can not produce stress concentration point, can satisfy the great dimensional demand after the release, can guarantee to have better anchoring effect again, effectively improve whole life.

Example five

Referring to fig. 16 and 17, in the present embodiment, the arrangement of the upper crown section 100, the lumbar section 200 is the same as that of the fourth embodiment; unlike the fourth embodiment, the following is: the arrangement of the transition section 400 and the lower crown section 300.

The transition section 400 is any one of a concave arc structure, a straight rod or an arc rod.

The lower crown section 300 comprises a deformation section and a supporting section, the deformation section is connected with the waist section 200, the deformation section is perpendicular to the waist section 200, namely, the structure of the lower crown section 300 is approximately planar, the pulmonary valve can be effectively prevented from being impacted by blood to move upwards, and meanwhile, the peripheral leakage of the valve can be prevented due to the abduction structure of the deformation section. In particular, the upper crown section 100, the lumbar section 200 and the lower crown section 300 may be provided with sealing membranes.

The support section is disposed at an end of the deformation section away from the waist section 200, and the support section is disposed at an obtuse angle to the deformation section.

In this embodiment, the support section is preferably a hanger structure.

The deformation section comprises a plurality of spliced rhombic lattice structures, and the number of the rhombic lattice structures is consistent with that of the second rhombic structures.

Preferably, three hanging lug structures are arranged and are uniformly distributed.

Example six

Referring to fig. 18 and 19, in the present embodiment, the arrangement of the upper crown section 100, the lumbar section 200 is the same as that of the fifth embodiment; unlike the fifth embodiment, the following is: the arrangement of the transition section 400 and the lower crown section 300.

The lower crown section comprises a positioning part 321, a supporting part 322 and a plurality of protecting parts 323, and the radial dimension of the supporting part 322 is larger than that of the positioning part 321; the plurality of protection parts 323 are arranged between the positioning part 321 and the supporting part 322; the positioning portion 321 is connected to the waist section 200.

In particular, the upper crown section 100, the lumbar section 200 and the lower crown section 300 may be provided with sealing membranes.

The supporting part 322 is provided with a plurality of bending parts (namely a fish mouth structure) which are convenient for folding and storing the supporting part 322; specifically, when the integral stent is compressed, the support portion 322 may be axially converted into a radial direction by the plurality of bending portions 315, thereby entering the outer sheath.

In the present embodiment, the number of the bending portions 315 is not particularly limited as long as the compression of the supporting portion 322 is satisfied.

In this embodiment, the protection portion 323 is preferably an arc segment structure, and a plurality of arc segment structures are disposed at equal intervals.

The positioning portion 321 is preferably a positioning ring, the supporting portion 322 is preferably a supporting ring with elasticity, the diameter of the supporting ring is larger than that of the positioning ring, and the positioning ring and the supporting ring are concentrically arranged.

Preferably, the positioning portion 321, the supporting portion 322, and the plurality of protecting portions 323 form a horn-like structure.

The positioning portion 321 and the supporting portion 322 are used as a truncated cone formed by upper and lower bottom surfaces, the base angle of an isosceles trapezoid on the axial side surface of the truncated cone is θ, θ is e (0 ° 80 ° ], in this embodiment, the fitting busbar of the horn-shaped structure is a busbar of the fitting truncated cone formed by the horn-shaped structure, that is, the caliber of the horn-shaped structure sequentially increases downwards, so that a structure different from the upper crown segment 100 and having a larger inner diameter is formed, and a special right ventricular outflow tract expansion affected part can be satisfied.

Preferably, θ is 10 ° to 50 °.

The positioning ring is connected with a plurality of second diamond structures.

The transition section 400 is a link structure.

The end of the lower crown section 300, which is far away from the waist section 200, is provided with a plurality of connecting portions, and the plurality of connecting portions are uniformly distributed.

Preferably, the upper crown section and the waist section can be integrally machined by laser cutting.

Preferably, the upper crown section, the lumbar section and the lower crown section are self-expanding.

A second aspect of the present application discloses a pulmonary valve comprising a pulmonary valve stent and a sealing membrane coated on the outside of the pulmonary valve stent.

In the description of the present specification, reference to the terms "one embodiment/manner," "some embodiments/manner," "example," "specific example," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment/manner or example is included in at least one embodiment/manner or example of the present application. In this specification, the schematic representations of the above terms are not necessarily for the same embodiment/manner or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments/modes or examples. Furthermore, the various embodiments/modes or examples described in this specification and the features of the various embodiments/modes or examples can be combined and combined by persons skilled in the art without contradiction.

Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present application, the meaning of "plurality" is at least two, such as two, three, etc., unless explicitly defined otherwise.

It will be appreciated by those skilled in the art that the above-described embodiments are merely for clarity of illustration of the disclosure, and are not intended to limit the scope of the disclosure. Other variations or modifications will be apparent to persons skilled in the art from the foregoing disclosure, and such variations or modifications are intended to be within the scope of the present disclosure.

Claims (21)

1. The pulmonary valve stent is characterized by comprising an upper crown section, a waist section and a lower crown section, wherein the upper crown section and the lower crown section are arranged in an open mode;

the open inner diameter of the upper crown section is larger than the inner diameter of the waist section;

the open inner diameter of the lower crown section is larger than that of the upper crown section;

the upper crown section comprises a plurality of spliced first diamond structures; the waist section comprises a plurality of spliced second diamond structures;

The waist section is provided with valve blades;

the lower crown section is connected with the waist section through a transition section.

2. The pulmonary valve stent of claim 1, wherein when the upper crown segment is an inflow segment, the outflow end of the leaflet is disposed toward the lower crown segment;

when the lower crown section is an inflow section, the outflow end of the leaflet is disposed toward the upper crown section.

3. The pulmonary valve stent of claim 2, wherein the lower crown segment is a helical horn-like structure;

the transition section comprises a positioning ring and a plurality of limiting rings, and the positioning ring and the limiting rings are respectively connected with the tops of the second diamond structures;

the sum of the numbers of the positioning rings and the limiting rings is not greater than the number of the second diamond structures.

4. The pulmonary valve stent of claim 3, wherein the spiral horn-shaped structure comprises a first adjusting section, a deformation supporting section and a second adjusting section, one end of the first adjusting section is fixedly connected with the positioning ring, and the other end sequentially penetrates through a plurality of limiting rings to be connected with one end of the deformation supporting section;

a limiting piece is arranged at the first end of the second adjusting section, and a through hole is formed in the limiting piece;

The other end of the deformation supporting section penetrates through the through hole and is connected with the second end of the second adjusting section;

the first adjusting section and the limiting rings are arranged in a clearance mode;

the deformation support section is arranged with the through hole in a clearance mode.

5. A pulmonary valve stent according to claim 3, wherein the end of the spiral flare remote from the waist section is provided with a plurality of connections;

the connecting parts are uniformly distributed.

6. The pulmonary valve stent of claim 4, wherein the first adjustment segment, the deformation support segment, and the second adjustment segment are each further provided with a plurality of bends.

7. The pulmonary valve stent of claim 6, wherein the kink is V-shaped.

8. The pulmonary valve stent of claim 2, wherein the lower crown segment is a dense mesh horn-like structure;

the dense net horn-shaped structure comprises a plurality of grids, and deformation directions of the grids are consistent;

the transition section is of an arc-shaped structure or a straight rod structure.

9. The pulmonary valve stent of claim 8, wherein the generatrix of the dense mesh horn is a convex arc.

10. The pulmonary valve stent of claim 9, wherein an end of the dense mesh horn structure distal from the waist section is provided with a plurality of connections;

the connecting parts are uniformly distributed.

11. The pulmonary valve stent of claim 2, wherein the lower crown segment is an arcuate strip horn-like structure;

the arc strip horn-shaped structure comprises a plurality of arc pieces, and the arc pieces form a containing cavity.

12. The pulmonary valve stent of claim 11, wherein one end of each of the plurality of arcuate members is connected to a bottom apex of each of the plurality of second diamond-shaped structures;

the outer diameter of a fitting circle at the joint of the arc-shaped pieces and the second diamond-shaped structures is smaller than that of a fitting circle at the free ends of the arc-shaped pieces;

the transition section is of an arc-shaped structure.

13. The pulmonary valve stent of claim 12, wherein the arcuate member includes a deformed segment, a support segment, and an edge segment connected in sequence, the support segment disposed between the deformed segment and the edge segment;

the deformation section is connected with the transition section;

The circle centers of the support section and the edge section are positioned on the same side, and the circle center of the deformation section is positioned on the other side;

the longitudinal central axis of the arc-shaped piece is a first axis;

the distance from the edge section to the first axis is not less than the distance from the support section to the first axis.

14. The pulmonary valve stent of claim 13, wherein an arc length of the support segment, an arc length of the edge segment, are each greater than an arc length of the deformation segment;

the radius of the support section is larger than that of the edge section;

the radius of the edge section is larger than the radius of the deformation section.

15. The pulmonary valve stent of claim 14, wherein the deformation segment is a concave arc;

the support section and the edge section are both convex arcs.

16. The pulmonary valve stent of claim 15, wherein the edge segment has a degree of freedom to flex and a degree of freedom to rotate about a junction of the edge segment and the support segment.

17. The pulmonary valve stent of claim 2, wherein the inferior crown segment includes a deformation segment and a support segment, the deformation segment and the support segment forming a horn-like structure;

The deformation section is connected with the waist section and is perpendicular to the waist section;

the support section is arranged at the end part of the deformation section far away from the waist section, and the support section and the deformation section are arranged at an obtuse angle;

the transition section is of a concave arc structure.

18. The pulmonary valve stent of claim 2, wherein the inferior crown segment includes a positioning portion, a support portion, and a plurality of guard portions, the positioning portion, the support portion, and the plurality of guard portions forming a horn-like structure;

the radial dimension of the supporting part is larger than that of the positioning part;

the protection parts are arranged between the positioning part and the supporting part;

the positioning part is connected with the waist sections;

the supporting part is provided with a plurality of bending parts.

19. The pulmonary valve stent of claim 18, wherein the transition section is a linkage structure.

20. The pulmonary valve stent of claim 19, wherein the positioning portion is a positioning ring;

the supporting part is a supporting circular ring;

the diameter of the supporting ring is larger than that of the positioning ring, and the positioning ring and the supporting ring are concentrically arranged.

21. A pulmonary valve comprising the pulmonary valve stent of any one of claims 1-20 and a sealing membrane wrapped around the outside of the pulmonary valve stent.