CN112773585B

CN112773585B - Implant holder

Info

Publication number: CN112773585B
Application number: CN202011612705.0A
Authority: CN
Inventors: 李安伟; 王永胜
Original assignee: Hangzhou Wei Qiang Medical Technology Co ltd
Current assignee: Hangzhou Wei Qiang Medical Technology Co ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2023-11-14
Anticipated expiration: 2040-12-30
Also published as: CN112773585A

Abstract

The invention provides an implantation stent. The implantation support is cylindrical, and comprises a plurality of support rings which are axially arranged, and each support ring is of an annular structure; the composite wave support ring comprises at least one composite mechanism which can be combined along the circumference Xiang Kai and comprises two composite units connected along the circumferential direction, wherein the centroid of each of the two composite units takes a plane vertical to the axial direction as an interface and is separated on two sides of the interface; each composite unit comprises at least four supporting rods which are connected in sequence, the connecting points of any two adjacent supporting rods towards the proximal end form wave crests, the connecting points of any two supporting rods towards the distal end form wave troughs, the composite unit with the centroid at the distal end of the interface comprises at least two wave troughs, and the composite unit with the centroid at the proximal end of the interface comprises at least two wave crests.

Description

Implant holder

Technical Field

The invention relates to the technical field of medical equipment, in particular to an implantation bracket.

Background

At present, the minimally invasive interventional therapy has small trauma to patients, high safety and high effectiveness, so that the minimally invasive interventional therapy is affirmed by doctors and patients, and becomes an important treatment method for vascular diseases. The interventional treatment method is to implant a vascular stent into a lesion section of a patient by using a delivery system, wherein the implanted vascular stent can support a blood vessel of a narrow occlusion section by expanding or isolate a blood flow channel from an aortic aneurysm so as to keep lumen blood flow smooth.

It is found that the poor adherence of the stent has a certain incidence rate after the stent is implanted in a body, and the adherence of the stent has close relation with the supporting force. The metal material of the bracket provides supporting force for the whole bracket, if the whole bracket has smaller supporting force, the bracket is not beneficial to being attached to the wall of the blood vessel, the wall of the blood vessel can not be supported in local part easily, the endothelialization speed is too slow, and the risk of internal air leakage is easily caused. The excessive supporting force of the bracket is not beneficial to loading the bracket into the conveying device, so that the conveying device is oversized, and the supporting force of the bracket is excessive, so that the stimulation to the vascular wall is increased. Therefore, on the premise of ensuring that the bracket has certain supporting capacity, the effective improvement of the wall attaching performance of the bracket is a technical problem to be solved.

Disclosure of Invention

The invention aims to provide an implantation bracket with good supporting force and adherence.

In order to solve the technical problems, the invention adopts the following technical scheme: an implantation support which is cylindrical and comprises a plurality of support rings which are axially arranged, wherein each support ring is in an annular structure; at least one supporting ring is a composite wave supporting ring, the composite wave supporting ring comprises at least one composite mechanism, the composite mechanism can be combined along the circumference Xiang Kai and comprises two composite units connected along the circumferential direction, the centroids of the two composite units take a plane vertical to the axial direction as an interface, and the two composite units are separated on two sides of the interface; each composite unit comprises at least four supporting rods which are sequentially connected, the connection points of any two adjacent supporting rods towards the proximal end form wave crests, the connection points of any two supporting rods towards the distal end form wave troughs, the composite unit with the centroid at the distal end of the interface comprises at least two wave troughs, and the composite unit with the centroid at the proximal end of the interface comprises at least two wave crests.

In some embodiments, the composite units having centers at the distal end of the interface have large troughs, the peaks have small peaks, and the composite units having centers at the proximal end of the interface have small troughs, the peaks have large peaks;

in the composite mechanism, the number of the large wave crests is the same as or different from that of the large wave troughs, and the number of the small wave troughs is the same as or different from that of the small wave crests.

In some embodiments, the small valleys extend distally beyond the interface; and/or the small peaks extend proximally beyond the interface.

In some embodiments, two of the composite units are centrally symmetrically disposed.

In some embodiments, an included angle between any two adjacent support rods in each composite unit is an acute angle.

In some embodiments, the support bar of one of the composite units is connected to the support bar of the other composite unit, and the two support bars extend in the same direction.

In some embodiments, at least one support bar in the compound mechanism includes a plurality of arcuate segments that are arcuate.

In some embodiments, the support bar includes a plurality of arcuate segments connected along a length thereof;

The circle centers of two adjacent arc sections face to the two sides of the supporting rod respectively.

In some embodiments, the composite wave support ring includes a plurality of the composite mechanisms disposed circumferentially.

In some embodiments, in the axial direction, in any two adjacent support rings, the trough of the support ring at the proximal end and the crest of the support ring at the distal end are arranged in a staggered manner in the circumferential direction.

In some embodiments, the composite wave support ring comprises a plurality of support rods connected in an angle manner and is connected with the composite mechanism in a circumferential direction to form a ring shape;

the connection points of any two adjacent support rods positioned at the proximal end form wave crests, and the connection points of any two adjacent support rods facing the distal end form wave troughs; the composite wave support ring comprises at least one reinforcing unit, wherein the reinforcing unit is arranged between two adjacent wave crests or two wave troughs and can be combined along the periphery Xiang Kai.

In some embodiments, the reinforcement unit is located between two adjacent peaks of the composite unit.

In some embodiments, each of the reinforcement units includes a plurality of angularly connected reinforcement bars; in any two adjacent reinforcing rods, the end parts of the reinforcing rods facing one end are mutually connected, and the respective end parts facing the other end can be mutually far away or close to each other so that the reinforcing units can be combined along the circumference Xiang Kai.

In some embodiments, the implant stent further comprises a covering film, and the plurality of support rings are arranged on the surface of the covering film at intervals.

In some embodiments, the support ring disposed at the proximal end of the covering film is the composite support ring.

In some embodiments, the peak of the composite unit having a centroid located proximal to the interface is a large peak;

the implantation support further comprises a bare support ring, wherein the trough of the bare support ring is connected to the proximal end of the tectorial membrane and is arranged in a staggered manner with the large crest of the composite wave support ring in the circumferential direction.

In some embodiments, any two adjacent support rings are connected by a connecting rod.

In some embodiments, the support ring is laser cut.

According to the technical scheme, the invention has at least the following advantages and positive effects:

the implant bracket adopts at least one composite wave supporting ring, the composite wave supporting ring comprises at least one composite mechanism, the composite mechanism comprises two composite units connected along the circumferential direction, the centroids of the two composite units take a plane vertical to the axial direction as an interface, and the two composite units are separated on two sides of the interface; each composite unit comprises at least four supporting rods which are connected in sequence, the connecting points of any two adjacent supporting rods towards the proximal end form wave crests, the connecting points of any two supporting rods towards the distal end form wave troughs, the composite unit with the centroid at the distal end of the interface comprises at least two wave troughs, and the composite unit with the centroid at the proximal end of the interface comprises at least two wave crests. The supporting rods in one of the composite units are intensively distributed at the far end and form a plurality of wave crests, the supporting rods in the other composite unit are intensively distributed at the near end and form a plurality of wave troughs, so that the distance between adjacent wave crests and wave troughs in the composite unit is smaller in the axial direction, the period between the adjacent wave crests and wave troughs is shortened in the circumferential direction, the number of the supporting rods in the composite supporting ring is increased, and the adhesion between the near end and the far end of the composite unit is improved.

In particular, the implantation stent comprises a tectorial membrane, and a composite wave support ring is adopted at the proximal end of the tectorial membrane, so that the attachment of the tectorial membrane at the proximal end to the vascular wall is facilitated, and the inner leakage prevention effect is further improved.

Drawings

Fig. 1 is a schematic view of the structure of a first embodiment of an implantable stent of the present invention.

Fig. 2 is a schematic structural view of a main body section of the implant carrier of fig. 1.

Fig. 3 is a schematic structural view of the compound mechanism in the first embodiment.

Fig. 4 is a schematic view of the structure of a second embodiment of the implant carrier of the present invention.

Fig. 5 is a schematic view of the structure of a third embodiment of an implantable stent of the present invention.

Fig. 6 is a partial schematic view of the proximal support ring of fig. 5.

Fig. 7 is a schematic structural view of a composite wave support ring in a fourth embodiment of an implantable stent of the present invention.

Fig. 8 is a schematic structural view of a composite wave support ring in a seventh embodiment of an implantable stent of the present invention.

The reference numerals are explained as follows:

1a, a bare support ring; 111a, wave trough; 2a, a main body section; 21a, a composite wave support ring; 216a, a compounding mechanism; 211a, a first compounding unit; 2111a, small peaks; 2112a, major trough; 212a, a second compounding unit; 2121a, large peaks; 2122a, small valleys; 213a, a support bar 213a;3a, a transition section; 4a, a long bifurcation section; 5a, a short bifurcation section; 8a, coating;

21b, a composite wave support ring; 6b, connecting rods;

21c, a composite wave support ring; 213c, support bar; 2131c, arcuate segments;

216d, a compounding mechanism; 2111d, small peaks; 2112d, major trough; 2121d, large peaks; 2122d, small valleys; 213d, support bar; 218d, a reinforcement unit; 2181d, reinforcing peaks; 2182d, reinforcing bars;

21e, a composite wave support ring; 216e, a compounding mechanism; 217e, main waveform element; 2171e, support bar; 2172e, main peak; 2173e, main trough; 218e, reinforcement units; 2181e, reinforcing peaks; 2182e, reinforcing bars.

Detailed Description

Exemplary embodiments that embody features and advantages of the present invention will be described in detail in the following description. It will be understood that the invention is capable of various modifications in various embodiments, all without departing from the scope of the invention, and that the description and illustrations herein are intended to be by way of illustration only and not to be construed as limiting the invention.

The invention provides an implantation stent which can be used for micro-wound interventional therapy, such as a covered stent and a venous stent. The implantation support not only has good supporting capability, but also has good adherence.

For ease of description, the definition "proximal" herein refers to the end that is closer to the heart in the direction of blood flow, and "distal" refers to the end that is farther from the heart. Wherein the intra-arterial blood flow direction is from the proximal end to the distal end.

First embodiment of implantable stent

Referring to the structure shown in fig. 1 to 2, the implant stent of the present embodiment includes a bare support ring 1a and a covered stent.

The bare support ring 1a is ring-shaped, and is a ring-shaped bare stent formed of a rigid wire having elasticity, and can be contracted or expanded in the radial direction. The specific structure of the bare support ring 1a in this embodiment may be a structure of a support ring in the related art, or may be a structure of a composite wave support ring or other support rings in this embodiment.

With continued reference to fig. 1, the bare support ring 1a has a peak and a trough 111a, the peak is a turning point of the rigid wire at the proximal end, the trough 111a is a turning point of the rigid wire at the distal end, and the trough 111a is close to and connected with the stent graft.

The stent graft includes a stent body and a stent 8a coated on the inner periphery or outer periphery of the stent body. The coating 8a may be formed of any suitable coating material including, but not limited to: low porosity woven or knitted polyester, dacron material, expanded polytetrafluoroethylene, polyurethane, silicone, ultra high molecular weight polyethylene, or other suitable material.

The stent body is cylindrical and comprises a main body section 2a, a transition section 3a, a long bifurcation section 4a and a short bifurcation section 5a. The main body section 2a and the transition section 3a are sequentially arranged from the proximal end to the distal end along the axial direction of the stent main body, and the long bifurcation section 4a and the short bifurcation section 5a are arranged in parallel at the distal end of the transition section 3a along the axial direction.

The implant stent in this embodiment may be used for implantation between the lower abdominal aorta and the common iliac artery of the renal artery, with the bare support ring 1a and the main body section 2a and the transition section 3a both being located in the abdominal aorta, the long bifurcation section 4a being located between the abdominal aorta and the common iliac artery and extending to the common iliac artery, and the short bifurcation section 5a being located between the abdominal aorta and the common iliac artery.

In other embodiments, the distal end of the stent body omits the transition section 3a, the long bifurcated section 4a and the short bifurcated section 5a, i.e., the stent is generally cylindrical without a bifurcated structure.

Specifically, the bracket main body comprises a plurality of support rings which are arranged along the axial direction and form a cylinder shape as a whole to form the bracket main body.

Each supporting ring is annular and is provided with a whole circle along the circumferential direction. Each support ring is capable of being contracted or expanded in a radial direction.

In this embodiment, the plurality of support rings in the main body section are all composite wave support rings. In other embodiments, one, two or other numbers of composite wave support rings may be provided according to actual needs, and in particular, may be provided according to actual needs. And the position of the composite wave supporting ring in the axial direction can be set according to actual needs. For example, a composite support ring may be used in only one of the support rings at the proximal end.

As shown in fig. 3, the composite wave support ring 21a includes a plurality of composite mechanisms 216a. A plurality of compound mechanisms 216a are circumferentially connected to form a wave shape. And the composite mechanism 216a can be opened and closed along the circumferential direction, so that the composite wave support ring 21a can be contracted or expanded along the radial direction.

Each of the compound mechanisms 216a includes two compound units connected along the circumferential direction, and the centroids of the two compound units take a plane perpendicular to the axial direction as a boundary F, and are arranged on two sides of the boundary F. Wherein the interface F is perpendicular to the axial direction of the body section such that one of the centroids of the two composite units is located at its proximal end and the other centroid is located at its distal end. The interface F in this embodiment is located at the center of the axial distance of the centroids of the two composite units such that the axial distance between the two centroids and the interface F is equal.

Centroid refers to the intersection of all hyperplanes dividing the composite unit into two equal parts, i.e. the average of all points making up a composite unit. The centroid of each composite unit can be obtained by calculating the arithmetic average of the coordinate components of all points constituting the composite unit. For example, the composite unit may be divided into several basic patterns, the centroid position and area of each pattern are found in engineering manual by table look-up method, and the centroid position of the composite unit is obtained by centroid calculation formula.

Each composite unit comprises at least four supporting rods 213a which are sequentially connected, the connection points of any two adjacent supporting rods 213a facing the proximal end form wave crests, the connection points of any two supporting rods 213a facing the distal end form wave troughs, the composite unit with the centroid positioned at the distal end of the interface F comprises at least two wave troughs, and the composite unit with the centroid positioned at the proximal end of the interface F comprises at least two wave crests.

In the composite mechanism 216a, when adjacent support rods 213a are connected, the turning point at the proximal end is a peak, i.e. two support rods 213a are disposed at two circumferential sides of the peak. The turning point at the distal end is a trough, i.e., a support bar 213a is provided on both circumferential sides of the trough.

Specifically, the two compounding units in the compounding mechanism 216a are the first compounding unit 211a and the second compounding unit 212a, respectively. Wherein the centroid CG1 of the first complex element 211a is located on the distal side of the interface F (the lower side of the interface F in fig. 3), and the centroid CG2 of the second complex element 212a is located on the proximal side of the interface F (the upper side of the interface F in fig. 3).

In this embodiment, the first composite unit 211a and the second composite unit 212a each include four support rods 213a, i.e., the first composite unit 211a includes two wave troughs and the second composite unit 212a includes two wave crests. In other embodiments, the number of the support rods 213a in the first and second composite units 211a and 212a may be set according to actual needs. For example, the first composite unit includes four support bars 213a, i.e., the first composite unit 211a includes two valleys, and the second composite unit 212a includes six support bars 213a, i.e., the second composite unit 212a includes three peaks.

To distinguish between peaks and valleys in the first and second composite units 211a and 212a, defining a valley in the first composite unit 211a as a large valley 2112a and a peak as a small peak 2111a; the valleys in the second composite unit 212a are defined as small valleys 2122a and the peaks as large peaks 2121a. That is, the composite unit having a centroid located distally of the interface F has a large trough 2112a and a small peak 2111a. The composite unit with centroid at the proximal end of interface F has a trough with small trough 2122a and a peak with large peak 2121a.

Further, the first and second complex units 211a and 212a are disposed center-symmetrically. Specifically, when the first composite unit 211a is rotated 180 ° around the connection point of the first composite unit 211a and the second composite unit 212a, the first unit 221d overlaps with the second composite unit 212 a. In the modified embodiment, the first composite unit 211a and the second composite unit 212a are arranged non-centrally and symmetrically, that is, the first composite unit 211a cannot overlap with the second composite unit 212a after rotating 180 °.

Two adjacent support rods 213a in the first composite unit 211a are connected at an angle. In the present application, "angularly connected" means that the connection forms an angle of more than 0 degrees and less than 180 degrees. In particular, in the present embodiment, the first composite unit 211a has a wave shape. And the included angles between the supporting rods 213a in the first composite unit 211a are acute angles. In other embodiments, the included angles of the supporting rods 213a in the first composite unit 211a may be obtuse angles, or both acute and obtuse angles exist in the included angles of the supporting rods 213a in the first composite unit 211 a.

In any two adjacent support rods 213a in the first composite unit 211a, the ends of the support rods 213a toward one end are connected to each other, and the ends toward the other end are separated from or close to each other so that the composite units can be combined along the circumference Xiang Kai. For example, the proximal ends of the two support rods 213a are connected to each other, and the distal ends can be moved toward or away from each other.

Further, each supporting bar 213a in the complex unit is linear.

When the support rod 213a in the first composite unit 211a is connected to the support rod 213a, the connection point toward the proximal end constitutes a small peak 2111a, and the connection point toward the distal end constitutes a large trough 2112a.

Two adjacent support rods 213a in the second composite unit 212a are connected at an angle. In particular, in the present embodiment, the second composite unit 212a has a wavy shape. And the included angles between the supporting rods 213a in the second composite unit 212a are acute angles. In other embodiments, the included angles of the supporting rods 213a in the second composite unit 212a may be obtuse angles, or both acute and obtuse angles may exist in the second composite unit 212 a.

In any two adjacent support rods 213a in the second composite unit 212a, the ends of the support rods 213a toward one end are connected to each other, and the ends toward the other end are separated from or close to each other so that the composite units can be combined along the circumference Xiang Kai. For example, the proximal ends of the two support rods 213a are connected to each other, and the distal ends can be moved toward or away from each other.

Further, each supporting bar 213a in the complex unit is linear.

When the support rod 213a in the second composite unit 212a is connected to the support rod 213a, the connection point toward the proximal end forms a large peak 2121a, and the connection point toward the distal end forms a small trough 2122a.

In a composite mechanism 216a, the supporting rods 213a of the first composite unit 211a are connected to the supporting rods 213a of the second composite unit 212a, and the two supporting rods 213a extend along the same direction.

Preferably, in one compound mechanism 216a, the axial distance between the small peaks 2111a and the large valleys 2112a is d1, the axial distance between the large peaks 2121a and the small valleys 2122a is d2, and the axial distance between the large peaks 2121a and the large valleys 2112a is d3. The value of (d1+d2)/d 3 is 1 to 1.4. Within this range, with smaller ratios, small peaks 2111a are closer to large valleys 2112a, or small valleys 2122a are closer to large peaks 2121a, or small peaks 2111a are closer to large valleys 2112a while small valleys 2122a are closer to large peaks 2121a, i.e., the distance between small peaks 2111a to large valleys 2112a is smaller or the distance between small valleys 2122a to large peaks 2121a is smaller, which can ensure radial support force and facilitate instrument loading; with a larger ratio, the small peaks 2111a are farther from the large valleys 2112a, or the small valleys 2122a are farther from the large peaks 2121a, or the small peaks 2111a are farther from the large valleys 2112a while the small valleys 2122a are farther from the large peaks 2121a, i.e., the distance between the small peaks 2111a to the large valleys 2112a is greater or the distance between the small valleys 2122a to the large peaks 2121a is greater, thereby providing better radial support.

To achieve the ratio of heights in the above range, small peaks 2111a may be brought proximally beyond interface F and small valleys 2122a distally beyond interface F. Alternatively, neither minor peak 2111a nor minor trough 2122a exceeds interface F.

The wire diameters of the supporting rods 213a in the first and second composite units 211a and 212a are equal, and the periods of the first and second composite units 211a and 212a are equal. In other embodiments, the wire diameter of the support rod 213a may be different. In the present application, the stent is cut and made, and the "wire diameter" herein refers to the width of the supporting rod.

Specifically, in the present embodiment, the composite wave support ring 21a is formed by sequentially connecting a plurality of composite mechanisms 216a in the circumferential direction to form a ring shape. And the period and wire diameter between the compound mechanisms 216a are consistent. In other embodiments, the periodicity and wire diameter of the different compounding mechanisms 216a may also be non-uniform.

In other embodiments, the number of the compound mechanisms 216a in the compound wave supporting ring 21a may be one, two or other numbers, and may be specifically set according to practical needs.

When the number of the complex mechanisms 216a in the complex wave support ring 21a is plural, the plural complex mechanisms 216a may be arranged at intervals and uniformly in the circumferential direction. The two spaced-apart compound mechanisms 216a can be configured with a Z-shaped wave of equal height, an alternately configured wave of equal size, or other wave shapes according to the actual needs.

The adjacent composite wave support rings 21a are arranged in a staggered manner in the circumferential direction along the axial direction. This offset arrangement ensures that the large valleys 2112a of the proximal composite wave support ring 21a are offset circumferentially from the large peaks 2121a of the distal composite wave support ring 21 a. Further, the large wave trough 2112a of the composite wave support ring 21a at the proximal end is circumferentially offset from the small wave crest 2111a of the composite wave support ring 21a at the distal end. Further, the small wave trough 2122a of the composite wave support ring 21a at the proximal end and the large wave crest 2121a of the composite wave support ring 21a at the distal end are circumferentially staggered from each other, and the small wave trough 2122a of the composite wave support ring 21a at the proximal end and the small wave crest 2111a of the composite wave support ring 21a at the distal end are circumferentially staggered from each other, so that the gap size between the adjacent composite wave support rings 21a is ensured to be sufficiently uniform. By adopting the dislocation arrangement, the overall flexibility of the implanted stent is improved, and the implanted stent is suitable for complex vascular anatomy structures.

The composite wave support ring 21a in this embodiment has small wave troughs 2122a added between large wave crests 2121a, small wave crests 2111a added between large wave troughs 2112a, improves the metal coverage of the composite mechanism 216a, shortens the period between adjacent wave crests and wave troughs, and increases the adherence of the proximal end and distal end of the composite mechanism 216 a.

The small wave troughs 2122a and the small wave crests 2111a are alternately arranged in the embodiment, which is beneficial to uniformly improving the adhesion between the proximal end and the distal end. And compared with the equal-height Z-shaped waves with the same number of wave crests and wave troughs, the radial supporting force of the composite wave supporting ring 21a in the embodiment is smaller, thereby being beneficial to sheathing and reducing the stimulation to the vessel wall.

In other embodiments, the number of composite wave support rings 21a in the support ring of the main body section may be one, two or other numbers, and is specifically set according to practical needs. The position of the composite wave support ring in the axial direction of the main body section can also be set according to actual needs.

With continued reference to fig. 1, the composite wave supporting ring and the bare supporting ring 1a are arranged in a staggered manner in the circumferential direction, which is specifically shown as that the trough 111a of the bare supporting ring 1a and the large crest 2121a of the composite wave supporting ring are arranged in a staggered manner in the circumferential direction, in this embodiment, the trough 111a of the bare supporting ring 1a is arranged between the two large crests 2121a of the composite wave supporting ring, and in a modified embodiment, the trough 111a of the bare supporting ring 1a can be arranged between two second composite units of the composite wave supporting ring correspondingly.

The support rings in the transition section 3a, the long bifurcated section 4a and the short bifurcated section 5a may be support rings in the related art or the related structures of the composite wave support rings or other support rings in the present application, which will not be described in detail herein.

The support ring is formed by laser cutting, and compared with the method of braiding and forming in the related art, the support ring has larger wire diameter and thickness, improves the fatigue strength of the support ring, and further improves the fatigue strength of the whole support body.

The bare support ring 1a and all support rings of the stent body can be fixed on the inner surface or the outer surface of the covering film 8a by sewing or hot pressing, and the covering film 8a is supported by the plurality of support rings so that the stent body can be unfolded and maintained in a tubular structure when in use, thereby constructing a channel for blood to pass through. In one embodiment, a portion of the support ring is disposed on the inner surface of the coating 8a and a portion of the support ring is disposed on the outer surface of the coating 8 a.

Because the support ring of the main body section of the implantation stent adopts the composite wave support ring, the small wave troughs 2122a are added between the large wave crests 2121a, the small wave crests 2111a are added between the large wave troughs 2112a, the metal coverage rate of the composite mechanism 216a is improved, the period between the adjacent wave crests and wave troughs is shortened, and the adhesion between the proximal end and the distal end of the composite mechanism 216a is increased. The small wave troughs 2122a and the small wave crests 2111a are alternately arranged in the embodiment, which is beneficial to uniformly improving the adhesion between the proximal end and the distal end. And the composite wave support ring at the proximal end is beneficial to the attachment of the tectorial membrane at the proximal end of the main body section to the vascular wall, so that the effect of preventing internal leakage is improved.

Second embodiment of implantable stent

Referring to fig. 4, the difference between the present embodiment and the first embodiment of the implant stent is that:

the implantation stent of the present embodiment is a venous stent, and specifically includes a stent main body and a connecting rod 6b. The structure of the stent body may refer to the structure of the first embodiment of the implanted stent, and will not be described in detail herein.

Each connecting rod 6b is used for connecting two adjacent composite wave support rings 21b in the bracket body to form a cylindrical bracket body. The arrangement of the connecting rods 6b is not limited. For example, the specific shape of the connecting rod 6b, the number of connecting rods 6b between two adjacent support rings in the axial direction, and the connection position of the connecting rod 6b and the composite wave support ring 21b are not limited.

In this embodiment, the distal end of the connecting rod 6b is connected to the large wave trough of the composite wave support ring 21b located at the distal end, and the proximal end of the connecting rod 6b is connected to the large wave crest of the composite wave support ring 21b located at the proximal end.

The stent provided in this embodiment may include a coating film provided on the surface of the stent body, or may not be provided.

Other features of the implant stent of the present embodiment are described with reference to the first embodiment and will not be described in detail.

Third embodiment of implantable stent

Referring to fig. 5 to 6, the implant carrier in this embodiment is different from the first embodiment in that: at least one supporting rod 213c in the composite mechanism in this embodiment includes a plurality of arc-shaped segments 2131c, and the supporting rod 213c including the arc-shaped segments 2131c is more beneficial to the lamination of the composite wave supporting ring and the coating film, is beneficial to forming the integral cylindrical structure shape of the implanted stent, is convenient to be attached to the vessel wall, and reduces internal leakage.

The support bar 213c including the arc segment 2131c is defined as an arc bar. Wherein, the quantity of arc pole is at least one in the compound mechanism, and specific quantity can set up according to actual conditions.

Preferably, the number of the arc-shaped rods in the compound mechanism is 3-6. And the position of the arc-shaped rod in the compound mechanism is not required.

Referring to fig. 6, the arc rod of the present embodiment includes two arc segments 2131c.

Specifically, the central angle of the arc segment 2131c is greater than 5 degrees and less than 50 degrees. And the centers of the two arc segments 2131c are respectively arranged at two sides of the arc rod, that is, the concave-convex directions of the arc segments 2131c are different, and the arc segments 2131c positioned at the upper part of the support rods 213c are protruded to the right side, and the arc segments 2131c positioned at the lower part of the support rods 213c are protruded to the left side, as shown in fig. 6.

In other embodiments, the number of arcuate segments 2131c in an arcuate bar may be three, four, or other numbers to ensure that the arcuate bar includes multiple segments of arcuate segments 2131c. At this time, the center angles of any adjacent two arc segments 2131c are aligned on both sides of the arc rod.

In the composite mechanism, the structures of two adjacent arc-shaped rods can be consistent or different.

The arc-shaped rods can be used in the support rods 213c of other support rings, and the structure, arrangement, number and the like of the arc-shaped rods can be set according to practical situations.

Fourth embodiment of implantable stent

Referring to fig. 7, the difference between the implant stent of the present embodiment and the first embodiment is that: the composite support ring of the proximal end of the body segment in this embodiment also includes a plurality of stiffening elements 218d therein. In other embodiments, the number of reinforcing units 218d in a composite support ring may be one, or a plurality of composite support rings each having reinforcing units 218d may be set according to the actual situation.

In this embodiment, the reinforcing units 218d are disposed in a one-to-one correspondence with the compounding mechanism 216d, i.e. a reinforcing unit 218d is disposed on a compounding mechanism 216 d. In other embodiments, stiffening element 218d may not be in a one-to-one relationship with compound mechanism 216d, i.e., at least one compound mechanism 216d may not have stiffening element 218d disposed thereon. Where other waveforms of the related art are provided between the compound mechanisms 216d, it is permissible to provide some of the compound structures without stiffening elements 218d, and other waveforms with stiffening elements 218d. In one embodiment, a compound mechanism 216d has a plurality of reinforcement units 218d disposed therein.

The reinforcement unit 218d is disposed between two adjacent support rods 213 d. In particular, in the present embodiment, the reinforcing unit 218d is disposed between two adjacent peaks of the composite unit. Or between two adjacent wave troughs. For example, stiffening element 218d in this embodiment is disposed between two large peaks 2121d of the second composite element. Or in some embodiments stiffening element 218d is disposed between two large valleys 2112d of the first composite element. Alternatively, stiffening element 218d is disposed between large valleys 2112d and small peaks 2111d in the first composite element, or between large peaks 2121d and small valleys 2122d in the second composite element.

Each reinforcement unit 218d can be joined along perimeter Xiang Kai. Specifically, stiffening element 218d expands as compound mechanism 216d expands; as compound mechanism 216d contracts, stiffening element 218d closes.

Stiffening element 218d includes a plurality of angularly disposed connected stiffening rods 2182d. In any adjacent two of the reinforcing rods 2182d, the ends of the reinforcing rods 2182d toward one end are connected to each other, and the ends toward the other end are separated from or brought close to each other so that the reinforcing units 218d can be joined along the circumference Xiang Kai. For example, the proximal ends of the two reinforcing rods 2182d are connected to each other, and the distal ends can be moved toward or away from each other.

In this embodiment, the number of the reinforcing rods 2182d in each reinforcing unit 218d is two. The connection point of the two reinforcing rods 2182d towards the proximal end forms a reinforcing peak 2181d, and two sides of the reinforcing peak 2181d are respectively provided with a reinforcing rod 2182d. In other embodiments, the number of the reinforcing rods 2182d may be three, four or other numbers, which may be specifically determined according to practical needs.

The reinforcing rod 2182d is connected to the middle portion of the support rod 213d of the complex mechanism 216d in the longitudinal direction. In the present application, the middle portion of the support bar 213d does not refer to the center position of the support bar 213d in the longitudinal direction, but refers to a region of a certain length range including the center position of the support bar 213d in the longitudinal direction, excluding both end portions of the support bar 213d in the longitudinal direction.

In some preferred embodiments, the stiffening rod 2182d is connected to the support rod 213d in a range of 0.4 to 0.8 support rod 213d lengths from proximal to distal.

When the reinforcing rod 2182d is connected to the supporting rod 213d, an angle is formed therebetween. In this embodiment, the angle between the reinforcing rod 2182d and the supporting rod 213d is acute. I.e. the angle between the support rod 213d and the stiffening rod 2182d connected thereto at the proximal end is acute.

Further, the reinforced peak 2181d is flush with the large peak 2121 d. In other embodiments, the large peaks 2121d may also extend beyond the stiffening peaks 2181d in the proximal direction, i.e., the axial distance between the stiffening peaks 2181d and the small valleys 2122d is less than the axial distance between the large peaks 2121d and the small valleys 2122 d. The reinforcing peak 2181d may also be slightly beyond the large peak 2121d in the proximal direction, i.e., the axial distance between the reinforcing peak 2181d and the small valley 2122d is slightly greater than the axial distance between the large peak 2121d and the small valley 2122 d.

In some preferred embodiments, the axial distance between the reinforcing peaks 2181d and the small valleys 2122d is 0.8 to 1.2.

The wire diameters of the plurality of reinforcement units 218d in the composite wave support ring are all the same. In this embodiment, the reinforcing support ring is formed by laser cutting a tube, and the wire diameter is the width of the reinforcing rod 2182 d. In other embodiments, the wire diameter may be different between reinforcement units 218 d.

The periods of the plurality of reinforcement units 218d in the composite wave support ring are all the same. The period in the present application refers to the circumferential length of the reinforcing unit 218d, and is specifically related to the number and length of the reinforcing rods 2182d and the included angle between the reinforcing rods 2182 d. In other embodiments, the period between stiffening elements 218d in the composite support ring may be different.

Radial support force and compliance of the implanted stent are adjusted by adjusting the wire diameter and period of reinforcement unit 218 d.

Compared with the supporting ring adopting sine waves and other waves in the related art, the supporting ring adopting sine waves is additionally provided with the reinforcing units 218d, and further the reinforcing wave crests 2181d are introduced, so that the supporting ring adopting the composite wave needs to provide larger force, and the radial supporting force of the supporting ring adopting the composite wave is improved. In addition, the reinforcing unit 218d adds the reinforcing rod 2182d for adherence to the composite wave support ring, thereby improving the adherence of the reinforcing support ring and further improving the adherence of the main body section 2 d.

The addition of stiffening element 218d shortens the repetition period between peaks and valleys in compound mechanism 216d and improves the adherence of the corresponding end positions in the compound wave support ring.

In this embodiment, since the reinforcing rod 2182d is connected to the center of the supporting rod 213d in the length direction, and the proximal end of the reinforcing rod 2182d is flush with the proximal end of the supporting rod 213d, the axial dimension of the reinforcing rod 2182d is smaller than that of the supporting rod 213d, so that the supporting force provided by the reinforcing unit 218d is smaller, so that the supporting force of the reinforcing supporting ring is moderate, and therefore, the reinforcing peak 2181d ensures that the supporting force of the implanted stent is not increased too much on the basis of improving the adhesion of the reinforcing supporting ring, which is beneficial to protecting the inner wall of a blood vessel by using a smaller-sized conveyer sheath.

As can be seen from the foregoing embodiments, the adhesion of the composite mechanism 216d can be improved, and in this embodiment, the reinforcing means 218d and the composite mechanism 216d are stacked, and the advantages of both are combined, thereby improving the adhesion.

Fifth embodiment of implantable stent

This embodiment differs from the first embodiment of the implant carrier in that: the reinforcing unit in this embodiment includes four reinforcing bars connected to form two reinforcing peaks and one reinforcing valley, i.e., M-like shape.

Wherein, the two reinforced wave peaks are level. In other embodiments, the two reinforcing peaks may not be flush. In this embodiment, each reinforcing unit is located between two adjacent main peaks.

Other features of the implant stent of the present embodiment are described with reference to the fourth embodiment, and will not be described in detail.

Sixth embodiment of the implantable stent

The difference between this embodiment and the fourth embodiment of the implant carrier is that: the reinforcing unit in this embodiment includes three reinforcing rods, wherein two reinforcing rods are respectively connected with two supporting rods, and the other reinforcing rod is connected with the two reinforcing rods. Wherein the included angle between one reinforcing rod and the supporting rod connected with the reinforcing rod towards the proximal end is an acute angle, and the included angle between the other reinforcing rod and the supporting rod connected with the reinforcing rod towards the proximal end is an obtuse angle.

The three reinforcing bars are connected to form a reinforcing peak and a reinforcing trough, i.e., N-like shape.

Seventh embodiment of the implantable stent

Referring to fig. 8, the difference between the present embodiment and the fourth embodiment of the implantation stent is that: in this embodiment, the composite wave support ring 21e is further provided with a main wave unit 217e, and the reinforcing unit 218e is disposed on the main wave unit 217 e.

The main waveform unit 217e is connected to the complex mechanism 216e in the circumferential direction to form a ring shape. The composite wave supporting ring 21e may include only one composite mechanism 216e, may include a plurality of composite mechanisms 216e that are continuously connected, and may include a plurality of composite mechanisms 216e that are arranged at intervals.

The main waveform element 217e includes a plurality of angularly connected support bars 2171e, where "angularly connected" means interconnected and forming an included angle greater than 0 degrees and less than 180 degrees. And main waveform unit 217e is connected to compound mechanism 216e in the circumferential direction to form a ring shape. The support rods are sequentially connected to form a wavy form with undulation.

The proximal connection point of any two support struts 2171e in the primary waveform element 217e forms a primary peak 2172e and the distal connection point of any two support struts 2171e forms a primary valley 2173e.

In particular, in the present embodiment, the length of each support bar 2171e in the main waveform unit 217e is the same, and forms a sine waveform.

Stiffening element 218e is disposed between two adjacent dominant peaks 2172 e. In other embodiments, the reinforcement unit may be disposed between two adjacent main valleys 2173e, or may be alternately disposed between two main peaks 2172e and between two main valleys 2173e.

The reinforcing rod 2182e of the reinforcing unit 218e and the reinforcing peak 2181e are described with reference to the fourth embodiment.

Eighth embodiment of implantable stent

The implant carrier of this embodiment differs from the seventh embodiment in that: the primary waveform unit includes a primary peak and a primary trough, wherein the plurality of primary troughs are flush. The main peak includes large peaks and small peaks alternately arranged in the circumferential direction. The method is characterized in that the arrangement sequence along the circumferential direction is as follows: … … small peak-large peak-small peak-large peak … …. Wherein the main waveform unit may refer to the description of the distal support ring in the first embodiment.

Wherein the large peaks exceed the small peaks in the proximal direction. The concrete steps are as follows: the support bars of the main waveform unit comprise a short support bar and a long support bar, the two short support bars are connected to form a small wave crest, and the two long support bars are connected to form a large wave crest. The length of the long support rod is longer than that of the short support rod.

Further, the ratio of the axial distance between the small peak and the main valley to the axial distance between the large peak and the main valley is (50% -80%): 1. The main waveform unit adopts a large peak and a small peak within the proportion range, so that the supporting ring can well balance the radial supporting force and the mechanical loading difficulty, and the best effect is achieved for the performance of the implanted stent.

The main wave peak adopts a structure with alternately arranged large wave peaks and small wave peaks, compared with waveforms with large wave peaks, the radial supporting force is reduced, the stimulation of mechanical devices with oversized blood vessels is avoided, and the mechanical loading of the implantation stent is facilitated. The small wave crest provides more gaps for the support main body, reduces the metal coverage rate, and is beneficial to improving the flexibility of the main body section.

The plurality of reinforcement units are arranged at intervals. The near ends of all the main wave troughs of the main wave form units can be correspondingly provided with a reinforcing unit, and the number of main wave peaks arranged between adjacent reinforcing units is not limited.

Other features of the implant stent of this embodiment will be described in detail with reference to the seventh embodiment.

The specific technical solutions in the above embodiments may be mutually applicable.

While the invention has been described with reference to several exemplary embodiments, it is to be understood that the terminology used is intended to be in the nature of words of description and of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the meets and bounds of the claims, or equivalences of such meets and bounds are therefore intended to be embraced by the appended claims.

Claims

1. The implantation support is characterized by being cylindrical, comprising a plurality of support rings which are axially arranged, wherein each support ring is of an annular structure; at least one supporting ring is a composite wave supporting ring, the composite wave supporting ring comprises at least one composite mechanism, the composite mechanism can be combined along the circumference Xiang Kai and comprises two composite units connected along the circumferential direction, the centroids of the two composite units take a plane vertical to the axial direction as an interface, and the two composite units are separated on two sides of the interface; each composite unit comprises at least four supporting rods which are sequentially connected, the connection points of any two adjacent supporting rods towards the proximal end form wave crests, the connection points of any two supporting rods towards the distal end form wave troughs, the composite unit with the centroid at the distal end of the interface comprises at least two wave troughs, and the composite unit with the centroid at the proximal end of the interface comprises at least two wave crests;

The wave trough of the composite unit with the centroid at the far end of the interface is a large wave trough, the wave crest is a small wave crest, the wave trough of the composite unit with the centroid at the near end of the interface is a small wave trough, and the wave crest is a large wave crest;

the small valleys extend distally beyond the interface; and/or the small peaks extend proximally beyond the interface;

the large wave trough of the composite wave support ring at the near end and the large wave crest of the composite wave support ring at the far end are staggered in the circumferential direction, and the small wave trough and the small wave crest are alternately arranged.

2. The implant stent of claim 1 wherein the implant stent comprises,

3. The implantable stent of claim 1, wherein two of the composite units are centrally symmetrically disposed.

4. The implantable stent of claim 1, wherein an included angle between any adjacent two of the support struts in each of the composite units is an acute angle.

5. The implantable stent of claim 1, wherein the support rod of one of the composite units is connected to the support rod of another of the composite units, and both of the support rods extend in the same direction.

6. The implantable stent of claim 1, wherein at least one support rod of the composite mechanism comprises a plurality of arcuate segments having an arcuate shape.

7. The implantable stent of claim 6, wherein the support rod comprises a plurality of arcuate sections connected along a length thereof;

8. The implantable stent of claim 1, wherein the composite wave support ring comprises a plurality of the composite mechanisms disposed circumferentially.

9. The implantable stent of claim 1, wherein in any two adjacent support rings in the axial direction, the trough of the support ring at the proximal end and the crest of the support ring at the distal end are arranged in a staggered manner in the circumferential direction.

10. The implant stent of claim 1, wherein the composite wave support ring comprises a plurality of support rods angularly connected and circumferentially connected to the composite mechanism in a ring shape;

11. The implantable stent of claim 10, wherein the reinforcement elements are located between adjacent ones of the peaks of the composite element.

12. The implantable stent of claim 10, wherein each of the reinforcement units comprises a plurality of angularly connected reinforcement bars; in any two adjacent reinforcing rods, the end parts of the reinforcing rods facing one end are mutually connected, and the respective end parts facing the other end can be mutually far away or close to each other so that the reinforcing units can be combined along the circumference Xiang Kai.

13. The implantable stent of claim 1, further comprising a cover, wherein a plurality of the support rings are disposed at intervals on the surface of the cover.

14. The implantable stent of claim 13, wherein the support ring disposed at the proximal end of the covering membrane is the composite support ring.

15. The implantable stent of claim 14, wherein the peak of the composite unit having a centroid proximal to the interface is a large peak;

16. The implantable stent of claim 1, wherein any two adjacent support rings are connected by a connecting rod.

17. The implantable stent of claim 1, wherein the support ring is laser cut.