WO2019075790A1

WO2019075790A1 - Blood vessel stent

Info

Publication number: WO2019075790A1
Application number: PCT/CN2017/109266
Authority: WO
Inventors: 胡清; 刘继勇; 潘幸珍; 王志高; 秦泗海; 谭茂彩
Original assignee: 科塞尔医疗科技苏州有限公司
Priority date: 2017-10-18
Filing date: 2017-11-03
Publication date: 2019-04-25
Also published as: CN107550611A; CN107550611B

Abstract

The invention relates to a blood vessel stent comprising a support body comprising a plurality of repetition units (1, 2), and a connecting piece comprising a plurality of repetition monomers (3, 4), wehrein the repetition units (1, 2) of the support body are axially arranged along the stent, and at least one repetition monomer (3, 4) is connected between two adjacent repetition units (1, 2) of the support body. The blood vessel stent has the advantages that the blood vessel stent is particularly applicable to coronary arteries, and good coronary artery support effects can be realized by the blood vessel stent; the support body of the blood vessel stent comprises the multiple repetition units (1, 2). The various repetition units (1, 2) can effectively deform in a coordination manner, accordingly, the axial shortening rate can be reduced, and accurate positioning effects can be realized during release.

Description

Blood vessel stent

Technical field

The invention belongs to the field of medical instruments, and in particular relates to a blood vessel stent.

Background technique

Coronary atherosclerosis is one of the major cardiovascular diseases that threaten human life in contemporary society. At present, clinical stent implantation is the main method for the treatment of coronary artery stenosis. After more than 20 years of clinical treatment, the method of interventional therapy is accepted by the vascular surgery community. At the same time, due to the small trauma, the patient can accept it. Now many hospitals in China have This work was carried out.

Currently, tubular stents are the most common type of stent used for coronary stenting. In terms of processing technology, tubular supports are generally fabricated by laser engraving or etching of metal pipes. In terms of design structure, the tubular support is generally composed of a support body and a connecting body. Depending on how the support and the connector are combined, they can be divided into two types, one is called an open-loop structure, such as the BX-Velocity bracket designed by Cordis; the other is called a closed-loop structure, such as Guidant. Designed Multi-Link bracket.

At present, the support and flexibility of the tubular stent are good, but there are still some problems:

1) The support bodies of most of the brackets are symmetrically arranged along the axial direction of the brackets, and the two ends of the connecting body are respectively connected with the outer side of the arc of the supporting body. When the supporting body is deformed along the circumferential direction when the bracket is expanded, the axial dimension of the bracket is shortened. The axial shortening rate is higher.

2) The support body and the connecting body are composed of straight segments and circular arc segments. When bending deformation occurs, the deformability is poor. Especially when implanting curved lesions, the ability of the stent to adapt to blood vessels is poor, which may cause damage to the endometrium. Or an adverse phenomenon such as an inflammatory reaction.

3) When the intravascular stent is subjected to periodic blood flow pulsation load, its fatigue strength is not only related to the load size, but also related to the material and structure size of the stent itself. Animal experiments prove that fatigue fracture occurs due to insufficient fatigue strength of the stent.

The long-term use of vascular stents as a heterologous body in the human body is closely related to the health of the patient after treatment. Therefore, not only the design and material requirements of the bracket are almost ideal, but also the mechanical properties such as support performance, compliant performance, fatigue life and fluid mechanics of the bracket are put forward, so it is necessary to develop a new type of vascular stent. Applied research.

Summary of the invention

The technical problem to be solved by the present invention is to overcome the deficiencies of the prior art and provide a blood vessel stent having different structures. The blood vessel stent has difficulty in forming intravascular restenosis, has good tissue compatibility, and has appropriate supporting force for blood vessels. It affects blood flow, has simple structure, convenient operation and accurate positioning, and can meet the needs of clinical treatment of vascular stenosis.

In order to solve the above technical problems, the present invention adopts the following technical solutions:

The present application relates to a blood vessel stent comprising a support body and a connecting body,

The support body includes a plurality of repeating units.

The connecting body comprises a plurality of repeating monomers,

The plurality of repeating units of the support body are arranged along the axial direction of the bracket,

The adjacent repeating units of the support are connected by at least one repeating monomer.

Preferably, the repeating unit is composed of a circular arc segment or a polygonal line segment, and each of the repeating units is asymmetrically arranged along the axial direction of the stent.

Preferably, the repeating monomer is composed of a circular arc segment or a polygonal segment, and each of the repeating monomers is asymmetrically arranged along the axial direction of the stent.

Preferably, the plurality of repeating units of the support body comprise a plurality of first repeating units and a plurality of second repeating units, wherein the first repeating unit and the second repeating unit are alternately arranged, and the supporting body is The first repeating unit includes a plurality of first arc segments, and the adjacent first arc segments are connected by a first excessive arc, and the bending directions of the plurality of first arc segments of the first repeating unit Similarly, the second repeating unit of the support body includes a plurality of second circular arc segments, and the adjacent second circular arc segments are connected by a second excessive arc, and the plurality of second repeating units are The second arc segment has the same bending direction.

Preferably, the plurality of the first circular arc segments and the plurality of second circular arc segments have the same radius of curvature.

Preferably, the first repeating unit is obtained by rotating the second repeating unit by 180°.

Preferably, the first excessive arc and the second excessive arc are offset by 0.1 to 0.5 mm in the circumferential direction of the blood vessel stent.

Preferably, the plurality of repeating monomers of the connecting body comprise a plurality of first repeating monomers and a plurality of second repeating monomers, wherein the plurality of first repeating monomers have the same bending direction, and the plurality of second repeating monomers The direction of the bend is the same.

Preferably, one end of the first repeating monomer is connected to the outer side of the first excessive arc, and the other end is connected to the inner side of the second excessive arc; the second repeating monomer Connected to one end The outer side of the second excessive arc is connected to the inner side of the first excessive arc.

Preferably, the first repeating monomer and the second repeating monomer of the linker are rotated by 180°.

Preferably, the first repeating monomer has the same bending direction as the second circular segment of the second repeating unit; the second repeating monomer and the first round of the first repeating unit The arcs have the same bending direction.

Preferably, the first repeating unit and the second repeating unit of the connecting body have a radius of curvature greater than the first repeating unit and the second repeating unit of the supporting body to constitute the first circular arc segment and the second circular arc The radius of the segment curvature.

Preferably, the length of the connecting body in the axial direction of the blood vessel stent is 1 to 1.5 times the length of the support body in the axial direction of the blood vessel stent.

Preferably, the number of the first repeating unit and the second repeating unit of the support body is the same, and the number of units is 4-20.

Preferably, the number of the first repeating monomer and the second repeating monomer of the linker is the same or different, and the number of monomers is 2-16.

Preferably, the number of repeating units is greater than the number of repeating monomers.

Preferably, the distance between the first repeating unit and the second repeating unit in the axial direction of the blood vessel stent is 0.5 to 3 mm.

Preferably, the repeating unit repeating unit has a width of 0.05 to 0.3 mm.

Preferably, the width of the repeating monomer is 40 to 80% of the width of the repeating unit.

Preferably, the support body and the connecting body of the blood vessel stent have the same wall thickness.

Due to the implementation of the above technical solutions, the present invention has the following advantages compared with the prior art:

The blood vessel stent of the invention is particularly suitable for coronary artery, and has good supporting effect on the coronary artery. The support body of the blood vessel stent of the invention comprises a plurality of repeating units, and each repeating unit can effectively coordinate deformation, thereby reducing the axial shortening rate. Provides accurate positioning when released.

DRAWINGS

Figure 1 is a schematic view showing the structure of the stent of the embodiment 1 in a plane;

2 is an enlarged view of a first repeating unit and a second repeating unit;

Figure 3 is an enlarged view of the first repeating unit;

Figure 4 is an enlarged view of the second repeating unit;

Figure 5 is an enlarged view of the first repeating monomer;

Figure 6 is an enlarged view of the second repeating monomer;

Figure 7 is a schematic view showing the structure of the stent of the embodiment 2 expanded into a plane;

Figure 8 is a schematic view showing the structure of the stent of the embodiment 3 expanded into a plane;

Figure 9 is a schematic view showing the structure of the stent of the embodiment 4 in a plane;

Wherein: 1, the first repeating unit; 11, 13, the first arc segment; 12, the first excessive arc; 2, the second repeating unit; 21, 23, the second arc segment; 22, the second excessive circle Arc; 3, the first repeating monomer; 4, the second repeating monomer,

L1 first excessive arc 12 and second excessive arc 22 longitudinal phase error length; L2 first repeating unit 1 and second repeating unit 2 are spaced apart in the axial direction of the bracket; L3 length of the first repeating unit 1; L4 second The length of the repeating unit 2; L5 the length of the first repeating monomer 3; the length of the L6 second repeating monomer 4;

R1 radius of curvature of the arc segment 11 of the first repeating unit; R2 radius of curvature of the first repeating segment first arc segment 13; R3 radius of curvature of the second repeating unit arc segment 21; R4 second repeating unit arc segment a radius of curvature of 23; R5 a radius of curvature of the first repeating monomer 3; R6 a radius of curvature of the second repeating unit 4;

C1 bracket centerline.

Detailed ways

The present invention will be further described in detail below with reference to specific embodiments, but the invention is not limited to the following examples.

The blood vessel stent of the invention is mainly suitable for use in human blood vessels, and is particularly suitable for use in coronary arteries (see Fig. 1). During the implantation of the vascular stent into the coronary artery, the vascular stent is mounted on the balloon of the stent delivery system. At this time, the vascular stent is in a compressed state, and when the conveyor transports the vascular stent to the lesion position, the balloon is filled by the pressure pump. The balloon, the blood vessel stent is expanded outward to an expanded state to support the coronary artery, the blood vessel stent has a first cross section in a compressed state, a second cross section in an expanded state, and a diameter of the first cross section Less than the diameter of the second cross section. In the present invention, the first cross section and the second cross section are perpendicular to the axis of the blood vessel stent. In this embodiment, the outer diameter of the second cross section is 2 to 8 mm, preferably 2 to 5 mm.

The material of the blood vessel stent is one or more of stainless steel, memory alloy, titanium alloy, tantalum alloy, cobalt chromium alloy, biodegradable metal, biodegradable polymer, magnesium alloy, and pure iron. Stainless steel can be made of SUS-316L stainless steel or the like. The memory alloy may be a Ni-Ti alloy, a Cu-Al-Mn alloy or the like. Cobalt chromium The alloy may be CoCr-L605 cobalt chromium alloy or the like. Biodegradable metal is a metal that can be decomposed in the human body, such as pure magnesium, magnesium alloy, pure iron and iron alloy. The biodegradable polymer may be a biodegradable polymer such as polylactic acid, polyglycolic acid, poly(lactic acid-ε-caprolactone), poly(glycolic acid-ε-caprolactone). In addition, a biodegradable polymer material can be applied to the degradable metal in the body as a material for the vascular stent.

The blood vessel stent of the present invention can be molded in one time by laser engraving. Laser engraving production process: Firstly, the cutting path is created by CAM based on the bracket design drawing; secondly, the metal or polymer material is laser-cut; finally, the surface finish is improved by pickling and electrochemical processes to make the edges of the edges round.

As shown in FIG. 1 , a blood vessel stent according to Embodiment 1 of the present application, the blood vessel stent includes a support body and a connecting body, the support body includes a plurality of repeating units, and the connecting body includes a plurality of repeats. Monomer, a plurality of repeating units of the support are arranged along the axial direction of the support, and adjacent repeating units of the support are connected by at least one repeating monomer. The plurality of repeating units of the support body include a plurality of first repeating units 1 and a plurality of second repeating units 2, and the first repeating unit 1 and the second repeating unit 2 are alternately arranged at intervals, and the first repeating unit 1 obtained by rotating the second repeating unit 2 by 180°. The plurality of repeating monomers of the connecting body include a plurality of first repeating monomers 3 and second repeating monomers 4, and the first repeating monomer 3 and the second repeating monomer 4 of the connecting body are rotated by 180° owned. The first repeating unit 1 has a first excessive arc 12, and the second repeating unit 2 has a second excessive arc 22, the first excessive arc 12 and the second excessive arc 22 is 0.1 to 0.5 mm in the circumferential direction. The first repeating unit 1 and the second repeating unit 2 of the support body are arranged asymmetrically along the axial direction of the stent, and are spaced apart from each other by 0.1 to 0.5 mm in the axial direction. The adjacent repeating units of the support are connected by at least one first repeating monomer 3 or second repeating monomer 4. The number of the first repeating unit 1 and the second repeating unit 2 of the support is the same, and the number of units is 4-20. The number of the first repeating monomer 3 and the second repeating monomer 4 of the linker is the same or different, and the number of monomers is 2-16. The number of the first repeating unit 1 and the second repeating unit 2 of the support is larger than the number of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body. In this embodiment, the repeating unit of the support body and the repeating unit of the connecting body are composed of arc segments connected. The first repeating unit 1 of the support body comprises a plurality of first

circular arc segments

11, 13, and the adjacent first

circular arc segments

11, 13 are connected by a first excessive arc 12, the first The second repeating unit 2 includes a plurality of second

circular arc segments

21, 23, and adjacent second

circular arc segments

21, 23 are connected by a second excessive arc 22, and the plurality of first

circular arc segments

11 , 13 and multiple second arcs The curvature radii of the

segments

21, 23 are the same. The bending directions of the plurality of first

circular arc segments

11, 13 of the first repeating unit 1 are the same, and the bending directions of the plurality of second

circular arc segments

21, 23 of the second repeating unit 2 are the same. One end of the first repeating monomer 3 is connected to the outer side of the first excessive arc 12, and the other end is connected to the inner side of the second excessive arc 22; the second repeating unit 4 One end is connected to the outer side of the second excessive arc 22, and the other end is connected to the inner side of the first excessive arc 12. The first repeating unit 1 has the same bending direction as the second

circular arc segments

21, 23 of the second repeating unit 4; the second repeating unit 2 and the first repeating monomer 3 The

first arc segments

11, 13 have the same bending direction. The radius of curvature of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body is larger than the radius of curvature of the first repeating unit 1 and the second repeating unit 2 of the support. The distance between the first repeating unit 1 and the second repeating unit 2 of the support body in the axial direction of the blood vessel stent is 0.5 to 3 mm. The distance in the longitudinal direction of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body is the axial length of the first repeating unit 1 and the second repeating unit 2 of the support 1 to 1.5 times. The width of the first repeating unit 1 and the second repeating unit 2 of the support is 0.05 to 0.3 mm. The length of the first repeating monomer 3 and the second repeating monomer 4 of the connecting body in the axial direction of the blood vessel stent is 40 to the width of the first repeating unit 1 and the second repeating unit 2 of the support. 80%. The support body and the connecting body of the blood vessel stent have the same wall thickness.

The specific effects of this embodiment are as follows:

1) The axial shortening rate is low: the support body of the blood vessel stent of the present invention comprises a plurality of repeating units, and the first repeating unit and the second repeating unit are alternately arranged, and at least one of the adjacent repeating units of the supporting body is at least one The connecting bodies composed of arcs or broken lines are connected, and each repeating unit can effectively coordinate the deformation, thereby reducing the axial shortening rate and playing the positioning accurately.

2) Strong adaptability to blood vessels: the repeating unit of the support of the vascular stent of the present invention and the repeating monomer of the connecting body are connected by a circular arc or a broken line, and have strong deformability, good compliant performance, and good adaptability to blood vessels. Ability, accurate release and easy operation.

3) high fatigue strength: adjacent repeating units of the support of the blood vessel stent of the present invention are connected by at least one first repeating monomer or second repeating monomer, and the circular arc segments have the same radius of curvature and the same bending direction. Each repeating unit can effectively disperse the load, thereby improving the fatigue strength.

The above-mentioned contents of the embodiment 2 and the embodiment 1 are the same, and the difference is only in the following: the repeating unit of the support body and the repeating unit of the connecting body are all connected by a circular arc segment, as shown in FIG. 1 . 6 is shown. In the embodiment 2, the repeating unit of the support body and the repeating monomer of the connecting body are composed of polygonal line segments. Connected, as shown in Figure 7.

The above-mentioned contents of the embodiment 3 and the embodiment 1 are the same, and the difference is only in the following: the repeating unit of the support body and the repeating unit of the connecting body are all connected by a circular arc segment, as shown in FIG. 1 . 6 is shown. In the embodiment 3, the first repeating unit 1 and the second repeating unit 2 of the support body are connected by a circular arc segment, and the first repeating monomer 3 and the second repeating monomer 4 of the connecting body are Connected by a line segment, as shown in Figure 8.

The above-mentioned contents of the embodiment 4 and the embodiment 1 are the same, and the difference is only in the following: the repeating unit of the support body and the repeating unit of the connecting body are all connected by a circular arc segment, as shown in FIG. 1 . 6 is shown. In the embodiment 4, the first repeating unit 1 and the second repeating unit 2 of the support are connected by a fold line segment, and the first repeating monomer 3 and the second repeating monomer 4 of the connecting body are The arc segments are connected in series, as shown in Figure 9.

The blood vessel stent of the invention is particularly suitable for the coronary artery, has good support effect on the coronary artery, and has less damage to the coronary wall, and can effectively avoid the formation of intravascular restenosis after the stent implantation, and further, the blood vessel stent of the present invention It can well locate in the coronary artery, improve the accuracy of release, and is easy to operate. The vascular stent of the invention has simple structure, convenient production and low cost, and has important practical significance and good clinical application prospect.

The present invention has been described in detail above, and is intended to be understood by those skilled in the art of the invention, and is not intended to limit the scope of the invention. Equivalent variations or modifications made in accordance with the spirit of the invention are intended to be included within the scope of the invention.

Claims

A blood vessel stent, characterized in that: the blood vessel stent comprises a support body and a connecting body,

The support body includes a plurality of repeating units.

The connecting body comprises a plurality of repeating monomers,

The plurality of repeating units of the support body are arranged along the axial direction of the bracket,

The adjacent repeating units of the support are connected by at least one repeating monomer.
The blood vessel stent according to claim 1, wherein said repeating unit is composed of a circular arc segment or a polygonal segment, each of said repeating units being asymmetrically arranged along the axial direction of said stent, said repeating monomer It consists of a circular arc segment or a polygonal segment connected, and each of the repeating monomers is arranged asymmetrically along the axial direction of the stent.
The blood vessel stent according to claim 1, wherein the plurality of repeating units of the support body comprise a plurality of first repeating units and a plurality of second repeating units,

The first repeating unit and the second repeating unit are alternately arranged,

The first repeating unit of the support body includes a plurality of first circular arc segments, and adjacent first circular arc segments are connected by a first excessive arc, and the first plurality of first repeating units are first The arc segments have the same bending direction.

The second repeating unit of the support body includes a plurality of second circular arc segments, and adjacent second circular arc segments are connected by a second excessive arc, and the second repeating unit has a plurality of second The arc segments have the same bending direction.
The blood vessel stent according to claim 3, wherein a plurality of said first circular arc segments and said plurality of second circular arc segments have the same radius of curvature.
The blood vessel stent according to claim 3, wherein the plurality of repeating monomers of the connecting body comprise a plurality of first repeating monomers and a plurality of second repeating monomers, a plurality of first repeating monomers The bending directions are the same, and the bending directions of the plurality of second repeating monomers are the same.
The blood vessel stent according to claim 5, wherein one end of said first repeating unit is connected to an outer side of said first excessive arc, and the other end is connected to said second excessive arc The inner side; one end of the second repeating unit is connected to the outer side of the second excessive arc, and the other end is connected to the inner side of the first excessive arc.
The blood vessel stent according to claim 6, wherein said first repeating monomer has the same bending direction as said second circular segment of said second repeating unit; said second repeating monomer The bending direction of the first circular arc segment of the first repeating unit is the same.
The blood vessel stent according to claim 7, wherein a radius of curvature of the first repeating monomer and the second repeating monomer of the connecting body is larger than a first repeating unit and a second repeating unit of the supporting body Forming a radius of curvature of the first arc segment and the second arc segment.
The blood vessel stent according to claim 1, wherein the width of the repeating monomer is 40 to 80% of the width of the repeating unit.
The blood vessel stent according to claim 1, wherein the support body of the blood vessel stent and the connecting body have the same wall thickness.