Abstract:
Provided is a stent having a novel structure with which it is possible to suppress irregular deformation at the time of expansion and ensure strength in the skeletal structure. A stent 10 having a linear body 14 that extends helically in a circumferential direction while reciprocating in an axial direction by continuously alternating straight portions 16 and curved portions 18, wherein the plurality of straight portions 16 in the linear body 14 have a substantially constant thickness throughout the entire stent, and the plurality of curved portions 18 in the linear body 14 have different thicknesses.
Get Free WhatsApp Updates!
Notices, Deadlines & Correspondence
Technical field
[0001]The present invention, by being placed to extend within the body lumen such as a blood vessel, it relates to stents for medical use such as to maintain the internal diameter of the body lumen in an expanded state.
BACKGROUND
[0002]Conventionally, for example, in percutaneous transluminal coronary angioplasty (PTCA), constricted portion of the coronary artery, after being expanded with a balloon, in order to prevent restenosis, such as by recoil, the stent is used. The stent is composed of a linear body extending in the circumferential direction helically while reciprocating for example in the axial direction. That is, such a linear body, for example as described in JP-T 2011-502636 (Patent Document 1), a straight portion and a curved portion reciprocates in the axial direction by being provided alternately and continuously constitute the skeletal structure of the waveform.
[0003]
Then, the inserted stent into a body lumen such as a coronary artery in a contracted state in the radial direction, are spread radially by the balloon, or by self-expanding using shape memory effect of the stent itself, the body lumen It is placed in close contact with the inner wall surface. Thus, being prevented restenosis caused etc. recoil, so that the inner diameter of the body lumen is maintained in the expanded state.
[0004]
Incidentally, in the stent according to Patent Document 1, in order to eliminate the inclination of the stent both edges, the amplitude of the waveform linear body constituting the stent end portions are gradually changing, the length of the linear portion of the waveform striatum There has gradually decreases toward the tip. Incidentally, when the amplitude of the waveform linear body is partially reduced, in order deformation rigidity of the stent expansion direction is increased, there is a possibility that the expanded shape of the stent is distorted. Therefore, in the stent according to this Patent Document 1, in accordance with the amplitude of the waveform linear body goes to the tip of the small linear body, aspects gradually reducing the cross-sectional area of the linear body is disclosed.
[0005]
However, the present inventors have examined, reducing the cross-sectional area of the linear body, the basic strength of the skeleton structure of the stent tends to decrease significantly, bending deformation and exerted, for example, after the indwelling of the axial force such as by, it was found that there is a possibility that the stent will collapse.
CITATION
Patent Document
[0006]
Patent Document 1: JP-T 2011-502636 Patent Publication
Summary of the Invention
Problems that the Invention is to Solve
[0007]
The present invention was made against the background of the circumstances described above, the problem to be solved is, it is possible to suppress an irregular deformation during expansion, it is possible to secure the strength in the skeletal structure, a novel structure It is to provide a stent.
Means for Solving the Problems
[0008]
A first aspect of the present invention is a stent having a linear body and the straight portion and a curved portion extending back and forth while circumferentially spirally in the axial direction by an alternating series, the plurality of the said linear member while straight portions are substantially constant thickness across the stent, and is characterized in that is provided as having different thicknesses in the plurality of curved portions in the linear body .
[0009]
According to the structure and stent according to the present embodiment, partially in deformation stiffness in the expanded direction of the stent circumferential direction of the appropriate position by varying the thickness of the curved portion of the linear member constituting the stent it can be adjusted. Thus, for example, by suppressing the distorted deformation during expansion of the stent, it will also be more uniformly expanded.
[0010]
In particular, by varying the thickness for the appropriate curved portion of the plurality of curved portions provided on the linear body, it becomes possible to adjust the deformation amount at the time of stent expansion partly finely. On the other hand, since the thickness of a plurality of straight portions provided in the linear body being substantially constant throughout the stent, it is possible to ensure the basic strength of the skeleton structure exerted by the linear portion, e.g. concentration of stress and strain due to thin straight lines portions than other straight portion may also be avoided.
[0011]
A second aspect of the present invention, in the stent according to the first aspect, wherein the plurality of curved portions, with respect to the curved portion of the most numerous basic thickness, and thicker been curved portion is thinner the curved portion was one in which at least one is provided.
[0012]
According to the structure and stent according to the present embodiment, based on the basic extended variant of the skeletal structure is realized by curved parts of the base thickness, or suppress localized large expansion deformation of a thick curved portion, and or increase locally small expansion deformation amount by thin curved portion can be adjusted. Incidentally, the curved portion of the base thickness may be the thickness and substantially the same linear portion, but by setting thicker than the linear portion, due to the strain or stress during expansion deformation in the curved portion is concentrated at one point almost it is possible to reduce the deterioration of the durability and strength.
[0013]
A third aspect of the present invention, in the stent according to the first or second aspect, the in the linear body and the thickness of the straight portion and the curved portion is substantially constant, different width dimensions in which it is different from the thickness at the curved portion by being.
[0014]
According to the structure and stent according to the present embodiment, since the thickness of the linear body is substantially constant, it is easy to manufacture.
[0015]
A fourth aspect of the present invention, in the stent according to any of embodiments of the first to third, while the stent central portion said linear portion is substantially constant length, the straight line in the stent side portions portion is provided with a long portion which is longer, in which the curved portion leading to the long most are thick.
[0016]
According to the structure and stent according to the present embodiment, by suppressing the amount of deformation of the easily around long section variations becomes large when expanded by a thick curved portion, avoid change amount in the vicinity of long portion of the stent becomes excessive it can.
[0017]
A fifth aspect of the present invention, in the stent according to the fourth embodiment, the long portion is provided at the tip Ryakuichi circumferential position in the stent circumferential direction from the linear body, leading to the long majority in which said curved portion is thick.
[0018]
For example, when approximating the inclination direction of the end surface of the stent in a vertical plane of the central axis, from the tip of the linear body by providing the long portion Ryakuichi circumferential portion in the stent circumferential direction, of the portion near the distal end of the linear body It can be reduced such that the straight portion is significantly shorter. Here, the structure and stent according to the present embodiment, by thickening the curved portion leading to such long section, it is possible to suppress the deformation amount of the long portion during stent expansion.
[0019]
A sixth aspect of the present invention is a stent according to any of embodiments of the first to fifth, while the stent central portion said linear portion is substantially constant length, the straight line in the stent side portions portion is provided with shortened short and small section, in which the curved portion leading to the short subsection is narrower.
[0020]
According to the structure and stent according to the present embodiment, the deformation amount of easily near short and small section deformation during expansion is reduced, can be adjusted to increase the narrower been curved portion.
[0021]
A seventh aspect of the present invention is a stent according to any of embodiments of the first to sixth, in the position closest to the tip of a length direction of said linear member, toward the stent length outwardly convex It said curved portion to be the one in which is thin.
[0022]
For example, when the inclination direction of the end surface of the stent when you Chikazukeyo the vertical plane of the central axis, the portion near the distal end of the linear body, the linear portion is hardly deformed tends shortened. Here, the structure and stent according to the present embodiment, the tip of the linear body by narrowing the nearest curved portion of the outer convex at the tip in the longitudinal direction, the linear portion is shortened prone linear body the portion near the can be easily deformed during expansion.
[0023]
An eighth aspect of the present invention, the in stent according to the first to seventh one aspect of progressively increases as the inclination angle of the spiral of the linear member to the stent central axis is at an end portion, the stent center are those to approach perpendicularly to the axis.
[0024]
According to the structure and stent according to the present embodiment, for example when it is placed in the bent portion or passes through the bent portion of the blood vessels, a phenomenon such as axial end portion of the stent is largely deformed lifted to the outer peripheral side it is possible to suppress. The inclination angle of the helix, for example, other continuously changing the length by reducing gradually the linear portion in the stent both side portions, partially stepwise changing by increasing the linear portion, for example the circumferential direction it is also possible.
[0025]
A ninth aspect of the present invention is a stent according to any of embodiments of the first to eighth, in the linear body, connecting part is provided for connecting the winding portions adjacent in the stent length directions it is what is.
[0026]
According to the structure and stent according to the present embodiment, the linear body, since the connecting portion for connecting the winding portions adjacent in the length direction of the stent from one another are provided, when the delivery or during placement of the stent, the line distance of winding portions adjacent in the length direction of shaped body can be avoided or too small or too large. Incidentally, such a connection part, by breaking strength is set appropriately, in the expanded state of the stent, may be partially or entirely is broken.
[0027]
A tenth aspect of the present invention, the first to ninth A stent according to any aspect of the, at each end of the stent longitudinal stent ends in the length direction of the linear body when the reference position of 0 ° in the circumferential direction, relative to corrugated cycle reciprocates constituted axis direction by alternating continuous with the straight portion and the curved portion of the linear body, the stent circumferential direction in the range from +1.5 period of -3.5 cycles, curved portion having different said thickness is one that is provided with a plurality.
[0028]
According to the structure and stent according to the present embodiment, in order to be able to avoid locally distorted deformation during stent expansion, curved thickness in consideration of the position of the end portion of the linear body is different part it is possible to set efficiently. In the present embodiment, the direction in which linear body extends spirally towards the stent center from the end to the positive side of the stent circumferential direction, the direction of extending virtually the linear member from the end portion spirally stent to the circumferential direction of the negative side. Further, in the stent according to the present embodiment, in the region outside the range of -3.5 period from +1.5 period stent circumferential direction, it is desirable that both the thick curved portion and thin curved portion is not provided thereby simplifying the stent structure and variations can be achieved.
The invention's effect
[0029]
According to the structure and stent according to the present invention, while securing the basic strength of the skeleton structure according to the linear portion of the linear body, by different curved portions of the thickness provided to the linear body, the deformation during stent expansion the is as it can be adjusted partially, it also becomes possible to improve the distorted deformation e.g. during stent expansion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0030]
[1] developed view showing leading the stent in a portion on the circumference of a first embodiment of the present invention.
[Figure 2] explanatory diagram for explaining a specific example of the wide portion in the stent shown in FIG. 1 (thick curved portion).
[Figure 3] explanatory diagram for explaining a specific example of a narrow-width portion (narrow curved portion) of the stent shown in Figure 1.
[Figure 4] explanatory diagram for explaining the expanded state of the indicated stent in Figure 1.
[5] explanatory diagram for explaining a specific example of the connecting portion in the stent shown in Figure 1.
[6] an explanatory view for explaining the expanded state of the stent shown in FIG. 1, (a) with shows the stent of the present invention the structure of the embodiment, (b) the stent of the comparative example It is shown.
[7] developed view showing leading the stent in a portion on the circumference of a second embodiment of the present invention.
[8] The third development view showing leading the stent in a portion on the circumference of the embodiments of the present invention.
[9] explanatory diagram for explaining another specific example of the wide portion in the stent according to the present invention (broad curved portion).
[10] explanatory diagram for explaining another specific example of the narrow width portion (narrow curved portion) of the stent according to the present invention.
DESCRIPTION OF THE INVENTION
[0031]
Hereinafter, to clarify the present invention more specifically, embodiments of the present invention, will be described with reference to the drawings in detail.
[0032]
First, in FIG. 1, the stent 10 as a first embodiment of the present invention is shown as an exploded view cut open with a single cutting line that extends part of the circumference to the center axis. The stent 10 includes a peripheral wall portion 12 of generally cylindrical shape as a whole, after the delivery to the site of the stenosis in a body lumen such as a blood vessel in a reduced diameter state, in an expanded enlarged state in the radial direction by being placed, thereby maintaining the expanded state spread the stenosis. In FIG 1, the stent 10 is shown in an initial state where diameter is also not also been expanded. In the following description, the longitudinal axis direction or stent 10, refers to the left-right direction in FIG. 1 as the direction of extension of the central axis 11 of the stent 10.
[0033]
More specifically, the peripheral wall portion 12 of the stent 10 has a basic skeleton formed of a single wire-like member 14 extending while reciprocating in the axial direction in the circumferential direction helically. Linear body 14 comprises a straight portion 16 extending substantially straight, the folded portion 18 of the curved portion connecting the straight portions 16 and 16 which are adjacent in the circumferential direction to each other. Then, by the folded portion 18 is provided on both longitudinal ends of the linear portion 16, and these straight portions 16 and the folded portion 18 is continuously alternately, circumferentially spirally while reciprocating in a wave in the axial direction extending, the basic skeleton of the stent 10 is constructed. Incidentally, for the explanation ease, the folded back portion that protrudes toward the one axial side (on the left in FIG. 1) with the folded portion 18a, the other axial side (in Figure 1 on the right the folded back portion which is convex toward) with the folded portion 18b, identifies them.
[0034]
In this embodiment, folded portions 18a, 18b are are substantially semicircular curved shape, such folded portions 18a, 18b are both, there is a curved portion of the linear body 14. Further, in the state shown in FIG. 1, the linear portion 16, the axial direction or substantially in parallel, and extends slightly inclined relative to the axial direction. In this embodiment in particular, the reciprocating amplitude of the linear body 14, i.e. the length L of the linear portion 16 1 (see FIG. 1), is substantially constant in the axial center portion of at least the stent 10, the linear body 14 but it has a substantially uniform wavy in multiple peripheral region located at least axially central portion of the stent 10. Incidentally, winding portions linear body 14 by a circumferentially extending helically while reciprocating in the axial direction, the amplitude of the linear body 14, i.e. extending in a width corresponding to the length of the linear portion 16 in the circumferential direction helically strip 19 is formed as a band-shaped body 19, 19 which are arranged adjacent in the axial direction is axially spaced by a predetermined distance (pitch). In this embodiment, the reciprocating amplitude structure of the linear body 14 with a substantially constant pitch over the entire stent 10 is formed.
[0035]
Incidentally, such a linear body 14 is, in this embodiment, there is a long-shaped member extending with a substantially rectangular thin plate cross-section. That is, the thickness dimension of the linear body 14 (linear portions 16 and the folded portion 18) is substantially constant over the entire length of the stent 10. Further, the width W of the linear portion 16 in the linear body 14 0 (see FIG. 1) is substantially equal over the entire length of the stent 10. Accordingly, the linear body 14, in the straight line portion 16, the thickness (cross-sectional area) are substantially equal over substantially the entire length of the stent 10. Incidentally, the stent 10 to such connecting portion 30 and the fragile portion 32 which will be described later is provided appropriately, at both ends of the linear body 14 width W 0 as needed large-diameter disc-shaped portion 20 from but it is provided, allowing such change in width by them, the width dimension W of all the straight portions 16 0 is a substantially constant thickness.
[0036]
Also, the width of the folded portion 18 is at least positioned in the axial central portion of the stent 10, the folded portion 18 of the most numerous basic thickness, greater width dimension slightly larger than the width of the linear portion 16 W 1 there is a. In the present embodiment, substantially it is the same width dimension, the largest in a predetermined length region of the longitudinal center of the folded portion 18 and the straight portion 16 at the boundary portion between the straight portion 16 in the circumferential end of the folded portion 18 width W 1 is such that a. The width dimension W of the folded portion 18 of the base thickness 1 is the width W of the linear portion 16 0 relative to, 1.0 W 0 L 3 and) short and small portion 24 extending linearly is provided.
[0048]
Specifically, straight portion 16 of the linear body 14, [1] a substantially constant basic length (L in the axial central portion 1 and the portion having a), the in [2] axially opposite side portions basic length greater length dimension than the dimension (L 2 and portion having a) (long portion 22), [3] the basic lengths smaller length dimension than the dimension in the axial direction both side portions (L 3 It is configured to include a portion (short and small portion 24) having a).
[0049]
Then, lengthwise opposite ends provided is turning portion 18a of the long portion 22, among 18b, at least one, as shown in FIG. 2, the width W 2 is provided in the axial center portion of the stent 10 basic thickness of the folded portion 18a, 18b width than (shown by two-dot chain line in FIG. 2) is greater (W 1
Documents
Application Documents
#
Name
Date
1
201917036921-IntimationOfGrant06-03-2024.pdf
2024-03-06
1
201917036921.pdf
2019-09-13
2
201917036921-PatentCertificate06-03-2024.pdf
2024-03-06
2
201917036921-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [13-09-2019(online)].pdf
2019-09-13
3
201917036921-STATEMENT OF UNDERTAKING (FORM 3) [13-09-2019(online)].pdf