CN100591385C - Extendable soft stent with excellent follow-up capability to blood vessel - Google Patents

Extendable soft stent with excellent follow-up capability to blood vessel Download PDF

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Publication number
CN100591385C
CN100591385C CN200480018566A CN200480018566A CN100591385C CN 100591385 C CN100591385 C CN 100591385C CN 200480018566 A CN200480018566 A CN 200480018566A CN 200480018566 A CN200480018566 A CN 200480018566A CN 100591385 C CN100591385 C CN 100591385C
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China
Prior art keywords
annular construction
portion section
construction member
support
member element
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CN200480018566A
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Chinese (zh)
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CN1816367A (en
Inventor
佐野嘉彦
田中裕治
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Nipro Corp
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Nipro Corp
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Abstract

A stent formed in a tubular member, comprising a plurality of annular members (1) longitudinally arranged to hold an organic lumen in a patent state and one or a plurality of connection elements (2) connecting longitudinally adjacent annular members (1) and (1) to each other. Each of the annular members (1) further comprises a plurality of first annular member elements (11) and second annular member elements (12) continued to each other in the circumferential direction, and is extendable in the radial direction. Since the stent is soft, excellent in the follow-up capability to the lumen, and accordingly allowed to pass through the three-dimensionally meandering lumen, a shortening is not substantially produced and, in addition, a lateral hole can be formed.

Description

The support that blood vessel is had the extendable soft of excellent follow-up capability
Technical field
The present invention relates in the implant into body to keep support such as the diameter of the body cavity of blood vessel.
Background technology
Up to now, support has been used to expand such as the diameter of the body cavity of blood vessel and has held it in the chamber diameter of expansion.Support can be by various method expansions, such as air bag expansion, the expansion certainly of using shape-memory material, machinery expansion or similar approach.The most widely used method is an air bag expansion.In air bag expansion, the position that support is wished in balloon catheter is introduced body is by the airbag aeration expansion diameter with expansion cavity, even and still be retained in the position of expansion behind the air bag that removes venting from this position.Support generally includes and is used to expand and keeps such as the chamber diameter retaining part of the diameter in the chamber of blood vessel and be used for contact portions at the longitudinal direction connection chamber diameter retaining part of support, and support is suitable for keeping the shape of its expansion after expansion.
The support that comprises the suggestion of chamber diameter retaining part and contact portions, comprise, for example, comprise the support of a plurality of cylindrical parts, this cylindrical parts radially can be expanded respectively at it, and is connected to each other to be aligned in (JP-H06-181993 A) on the common axis; Comprising can be at the support of the tubular element of radial expansion, and this tubular element is formed (JP S62-231657 A) by the member of a plurality of elongations that intersect each other; The support that comprises the wire annular construction member of at least two integral body, wherein each wire annular construction member bending is to form a plurality of non-overlapping portion's sections straight basically, that connect at the axial bending place; These at least two annular construction members have at least one pair of aligned axial bending; And these at least two annular construction members connect (JP H08-155035 A) by at least one inflexible basically contact at least one pair of aligned axial bending place; By the support that the pipe with patterned shape forms, it has first and second serpentine pattern, and first and second serpentine pattern have the axis (JP H10-503676 A) that extends in first and second directions; And have the support of Unclosing structure, and comprising a plurality of cylindrical portion sections of opening, each section limits by the pillar of interconnection, and this Duan Zaiqi end is by a plurality of diagonal interconnection elements interconnection (JPH11-505441 A).
The support of these prior aries improves to a certain extent, but they are still applying load near the edge of expanded stent on the chamber such as blood vessel, causes chamber obstruction or narrow.In addition, not talkative these supports have enough flexibilities, and therefore, have the three-dimensional route that wriggles as fruit caving, and it often is difficult that support is inserted the target location.In addition, support can cause blood vessel injured during inserting the target location.If there is ramose blood vessel the position in inflation, is difficult on the support that places and forms sidewise hole.In addition, support has such problem, and the length of support is because expansion shortens promptly so-called shortening.
Summary of the invention
Consider above-mentioned situation, the invention provides the flexible support with fabulous autgmentability, its follow-up capability to the chamber fabulous (thereby making it can pass through three-dimensional chamber of wriggling) can not shorten basically, and can provide sidewise hole for support.
According to the present invention the support of (that is, first invention) comprise a plurality of can radial expansion and in aligned annular construction member of its longitudinal direction and one or more being used for two adjacent annular construction members at its longitudinal direction Connection Element connected to one another,
Each is included in the first annular construction member element and the second annular construction member element that the circumferencial direction of support alternately interconnects described annular construction member,
Described support, when opening in the plane, have such structure, it is the parallel linear portion section that the described first annular construction member element comprises three longitudinal extensions, promptly, first, second and trilinear portion section, the second linear portion section and trilinear portion segment length equate, and the length of the first linear portion section is greater than second and the length of trilinear portion section, the described first linear portion section is connected with the second linear portion section arch portion section that (towards the near-end of support) stretches out by left, and the described second linear portion section is connected with the trilinear portion section arch portion section that (towards the far-end of support) stretches out by to the right
Each comprises the parallel linear portion section of three longitudinal extensions described the second annular construction member element; Namely; First, second, and third linear portion section; Described the second linear portion section and the 3rd linear portion segment length equate; And the length of described the first linear portion section is greater than described second and the length of the 3rd linear portion section; Described the first linear portion section be connected the linear portion section arch portion section that (towards the far-end of support) stretches out by to the right and connect; And described the second linear portion section connects with the 3rd linear portion section arch portion section that (towards the near-end of support) stretches out by left
About the first and second annular construction member elements, the second annular construction member element is connected by the arch portion section with the first annular construction member element that is positioned at second annular construction member element top, this arch portion section (towards the near-end of support) is left protruded and is positioned between the trilinear portion section of the first linear portion section of the second annular construction member element and the first annular construction member element, and the second annular construction member element is connected by the arch portion section with the first annular construction member element that is positioned at second annular construction member element below, this arch portion section (towards the far-end of support) is to the right protruded and is positioned between the first linear portion section of the trilinear portion section of the second annular construction member element and the first annular construction member element, and two adjacent annular construction members are connected by Connection Element in the arch portion section of the first annular construction member element and the correspondence of the second annular construction member element.
Here, term " corresponding arch portion section " means the paired arch portion section that connects the first linear portion section and the second linear portion section, the paired arch portion section that perhaps connects the second linear portion section and trilinear portion section perhaps connects the paired arch portion section of the trilinear portion section and the first linear portion section.In order to eliminate the change of stent length when the expandable stent basically, preferably with Framework construction for making the linear portion section of winning than second linear portion section and the segment length of trilinear portion, and make adjacent annular construction member be connected at the part place of the arch portion section of second linear portion section that connects the corresponding annular member and trilinear portion section.In addition, preferably, distance the top of the arch portion section from the radially bisecting line of annular construction member to second linear portion section that connects the first annular construction member element and trilinear portion section is set at value in 1: 2 to 7: 8 scope with ratio from the radially bisecting line of annular construction member to the distance the top of the arch portion section of the first linear portion section that is connected the second annular construction member element and the second linear portion section.Though consider the degree of stent expansion and the effect of Connection Element, when the ratio between distance during less than 1: 2, expanded stent has the tendency that increases its length, and when the ratio between this distance during above 7: 8, it has the tendency that reduces length.In addition, adjacent annular construction member out-phase each other.Particularly preferably, adjacent two annular construction members out-phase half wavelength and on identical vertical straight line, connect each other by Connection Element.
The shape of Connection Element can for linearity or curve.Yet from the viewpoint of the formation of flexible and sidewise hole, Connection Element is preferably has the waveform that has one or more crests.Preferably, whenever necessary, provide two to six Connection Elements at regular intervals.
Can aim at those arch portion sections on the distally of annular construction member far away in the arch portion section on the nearside of near-ring shape member.The linear portion section of the linear portion section of the first annular construction member element and the second annular construction member element can be arranged at regular intervals circumferentially.Interval between the first linear portion section and the second linear portion section can equate with the interval between the trilinear portion section and the first linear portion section, still less than the interval between the second linear portion section and the trilinear portion section.
Can use rustless steel, tungsten, titanium, Nitinol and similar material to be used as the material of support.
(or second invention) according to a second aspect of the invention, a kind of support is provided, but this support comprises the annular construction member of radial expansion, this annular construction member comprises the wavy element that each has M shape waveform and links together at the circumferencial direction of annular construction member, this support comprises that also one or more longitudinal directions at support connect the Connection Element of described annular construction member, described annular construction member is aimed at the longitudinal direction of support, the bottom of the dell of the peak element in the top of the small peak (mountain) by paddy (trough) element at least one the wavy element that connects an annular construction member and at least one wavy element of another annular construction member connects two adjacent annular construction members with described Connection Element.
In the present invention, term " peak " means the wavy part of protruding (perhaps recessed towards the near-end of support) towards the far-end of support, and term " paddy " means the wavy part towards the far-end of support recessed (perhaps the near-end towards support protrudes).Term " the wavy element with M shape waveform " means the peak element that comprises the ripple (M shape) that has in two peak-to-peak paddy and has the bonded wavy element of GUYUAN part of the ripple (anti-M shape) at the peak between two paddy.Wavy element is not limited to specific shape, as long as wavy element has a paddy (or peak) between two peaks (or paddy).In addition, the four line portion sections (crestal line of peak and paddy) of forming the wavy element of each M shape adopt sinusoidal wave basically form, but they are not to adopt sinusoidal wave basically form.They can adopt the form of linearity or parallel lines.Under the sort of situation, be included in the corresponding first annular construction member element of line portion section of the junction point between M shape element and the anti-M shape element or the first linear portion section of the second annular construction member element, and the length of this line portion section is longer than two the line portion sections (the second linear portion section or the trilinear portion section of the corresponding first annular construction member element or the second annular construction member element) that form peak or paddy.Yet two line portion sections that form peak or paddy are not to have identical length, and the line portion section in centre position (the corresponding second linear portion section) can be shorter than the line portion section of lower position (corresponding trilinear portion section).
Here, preferably, the peak side of peak in wavy element that is positioned at the mid portion of two paddy in the wavy element stretched out, because when expandable stent, causes support to prolong at the peak that the paddy side is stretched out.In addition, the extension elongation at peak be preferably wavy element wave height 1/2 to 7/8.In addition, adjacent two annular construction members out-phase each other.Under such situation, preferably, two adjacent annular construction members each other the wavy element of out-phase half wavelength and connect on identical vertical straight line by Connection Element.
Connection Element can adopt the form of linear line or curve.Preferably, whenever necessary, between two adjacent annular construction members, provide two to six Connection Elements at regular intervals.
Should be appreciated that, the four line portion sections of wherein forming the wavy element of M shape are linear and the wavy element in second invention parallel to each other, wavy element among corresponding first the present invention, wherein the first linear portion section is than second and the segment length of trilinear portion, and two wherein adjacent annular construction members are connected at the arch portion section place that connects the second linear portion section and trilinear portion section.
According to the present invention, can expect following effect: (1) entire bracket is fabulous to the follow-up capability in chamber, can be crooked because entire bracket has flexibility, form by multiple wavy pattern because form the annular construction member of the tubular wall of support, and it forms sidewise hole easily; (2) adjacent two annular construction members are connected by Connection Element at the arch portion section place of second linear portion section with little wave-amplitude that connects the ripple pattern and trilinear portion section, when expandable stent, the length of support does not change basically, as long as the distance the top of arch portion section, be set at ratio and belonged to from the interior value of 1: 2 to 7: 8 scope from the radially bisecting line of annular construction member to the distance the top of the arch portion section of the first linear portion section that is connected the second annular construction member element and the second linear portion section from the radially bisecting line of annular construction member to second linear portion section that connects the first annular construction member element and trilinear portion section.(3) because two adjacent annular construction members connect by the top of connecting elements in the arch portion section, this arch portion section is the peak of wavy pattern, when stent expansion, the top of arch portion section can curvature not be out of shape, and when support is crooked, the curvature distortion reduces, thereby can be so that when support is introduced the target location, to the injury minimum in chamber.
Description of drawings
Fig. 1 is the plane graph of the amplification of support according to an embodiment of the invention;
Fig. 2 is the expansion of support shown in Figure 1;
Fig. 3 is the plane graph of amplification that shows the extended mode of support shown in Figure 1;
Fig. 4 is Fig. 2 view that part is amplified;
Fig. 5 shows the embodiment of Connection Element of the present invention, shows situation about being connected with the arch portion section;
Fig. 6 is the expansion of support according to another embodiment of the invention;
Fig. 7 is the expansion of support according to another embodiment of the invention;
Fig. 8 is the expansion of support according to another embodiment of the invention;
Fig. 9 is the expansion of support according to another embodiment of the invention;
Figure 10 is the expansion of support according to another embodiment of the invention;
Figure 11 is the expansion of support according to another embodiment of the invention;
Figure 12 is the expansion of support according to another embodiment of the invention;
Figure 13 is the expansion (second invention) of support according to an embodiment of the invention;
Figure 14 is Figure 13 view that part is amplified;
Figure 15 is the part zoomed-in view that shows the modification of support shown in Figure 13;
Figure 16 is the flexible comparison chart between the support of support of the present invention and prior art;
Figure 17 is the shortening comparison chart between the support of support of the present invention and prior art;
Figure 18 holds the ability comparison chart for guaranteeing between the support of support of the present invention and prior art;
Figure 19 is the expansion of the support of prior art;
Figure 20 is the expansion of the support of prior art;
Figure 21 is the expansion of the support of prior art.
The specific embodiment
In the above in the support of Xian Dinging, distance the top of the arch portion section from the radially bisecting line of annular construction member to second linear portion section that connects the first annular construction member element and trilinear portion section is set at 3: 4 with ratio from the radially bisecting line of annular construction member to the distance the top of the arch portion section of the first linear portion section that is connected the second annular construction member element and the second linear portion section.Simultaneously, two adjacent annular construction members are the half wavelength of the wavy element of out-phase each other, and is connected to each other on identical vertical straight line by Connection Element.The annular construction member that is positioned at the every end of support is designed to make the arch portion section of each annular construction member to aim at respectively along the near-end or the far-end of support.
Embodiment 1
Fig. 1 is the plane graph of the amplification of support according to an embodiment of the invention, and Fig. 2 is the expansion of support shown in Figure 1, and Fig. 3 is the plane graph of amplification that shows the extended mode of support shown in Figure 1, and Fig. 4 be Fig. 2 view of part amplification.
Shown in Fig. 1 to 3, the support of embodiment 1 is a tubular element, is included in 11 annular construction members 1 of the longitudinal direction arrangement of support, is used to keep body cavity to open, and the Connection Element 2 of three arrangements between vertically adjacent two annular components 1,1, so that they are connected to each other.Each annular construction member 1 comprises three first annular construction member elements 11 and three second annular construction member elements 12, and to limit annular construction member, it can be expanded in radial direction in the circumferencial direction alternate interconnection for it.
Shown in Fig. 2 and 4, the first annular construction member element 11 and the second annular construction member element 12 are successive in vertical direction under the situation that support is opened in the plane.The first annular construction member element 11 comprises three parallel linear portion sections 111,112,113 at first, second and second position longitudinal extension.The equal in length of the second linear portion section 112 and trilinear portion section 113, but the length of the first linear portion section 111 is greater than second and the length of trilinear portion section.The first linear portion section 111 and the second linear portion section 112 are connected by the arch portion section of protruding left 114, and the second linear portion section 112 and trilinear portion section 113 are connected by the arch portion section 115 of protrusion to the right.
On the other hand, the second annular construction member element 12 comprises the parallel linear portion section 121,122,123 of three longitudinal extensions, that is, and and first, second and trilinear portion section.The equal in length of the second linear portion section 122 and trilinear portion section 121, but the length of the first linear portion section 121 is greater than second and the length of trilinear portion section.The first linear portion section 121 and the second linear portion section 122 are connected by the arch portion section of protruding to the right 124, and the second linear portion section 122 and trilinear portion section 123 are connected by the arch portion section 125 of protrusion left.
About the first and second annular construction member elements 11,12, the second annular construction member element 12 and the first annular construction member element 11 that is positioned at the second annular construction member element, 12 tops connect by the arch portion section of protruding left and be positioned between the trilinear portion section 113 of the first linear portion section 121 of the second annular construction member element 12 and the first annular construction member element 11 3, and the second annular construction member element 12 and the first annular construction member element 11 that is positioned at the second annular construction member element, 12 belows connect by the arch portion section of protruding to the right and be positioned between the first linear portion section 111 of the trilinear portion section 123 of the second annular construction member element 12 and the first annular construction member element 4.
In addition, radially bisecting line X from annular construction member, X ' is to the arch portion section 115 that connects, distance between 125 the top, with from bisecting line X radially, X ' is to the arch portion section 124 that does not connect, the ratio of the distance between 114 the top (promptly, distance the top of the arch portion section 115 from the radially bisecting line X of annular construction member to second linear portion section 112 that connects the first annular construction member element 11 and trilinear portion section 113 is with the ratio from the radially bisecting line X of annular construction member to the distance the top of the arch portion section 124 of the first linear portion section 121 that is connected the second annular construction member element 12 and the second linear portion section 122; The perhaps distance the top of arch portion section 125 from the radially bisecting line X ' of annular construction member to second linear portion section 122 that connects the second annular construction member element 12 and trilinear portion section 123, ratio with from the radially bisecting line X ' of annular construction member to the distance the top of the arch portion section 114 of the first linear portion section 111 that is connected the second annular construction member element 11 and the second linear portion section 112 is called " from bisecting line X radially to the distance rates the top of corresponding arch portion section " hereinafter) be set at 4: 5.Adjacent two annular construction members 1,1 are the half wavelength of out-phase annular construction member element each other, and, on identical vertical straight line, have Connection Element 2 interconnection of shown in Fig. 5 B, constructing by three at the second linear portion section 112 that connects the first annular construction member element 11 in the left side of arch portion section 115 a part and the second linear portion section 122 that is connected the second annular construction member element 12 on the right side of arch portion section 125 and the part place of trilinear portion section 123 with trilinear portion section 113.
Above-mentioned support is enough flexible to be made up of multiple wavy pattern because form the annular construction member of cradle wall to respond bending, and therefore fabulous to the follow-up capability in chamber.In addition, provide sidewise hole for support easily.Because two adjacent annular construction members link together in the second linear portion section with little wave-amplitude of each connection wavy pattern and the arch portion section place of trilinear portion section, and because the distance the top of arch portion section from the radially bisecting line of annular construction member to second linear portion section that connects first annular construction member and trilinear portion section, be set at 4: 5 with the ratio from the radially bisecting line of annular construction member to the distance the top of the arch portion section of the first linear portion section that is connected second annular construction member and the second linear portion section, any change can take place owing to the expansion of support in the length of support hardly.In addition, two adjacent annular construction members are the part place connection at the top of wavy pattern the arch portion section, and therefore when stent expansion, the top of wavy pattern can curvature not be out of shape, and when support is crooked, curvature distortion reduces, thus can be so that at guide support during to the position that will apply, and issuable injury minimum to blood vessel.
Embodiment 2
Below with reference to Fig. 6 embodiments of the invention 2 are described.
The support of embodiment 2 is the modification to the support of embodiment 1, wherein, be set at 7: 8 from bisecting line radially to the distance rates the top of corresponding arch portion section, and arch portion section 125,114,3 and arch portion section 124,4,115 are aligned with each other at the near-end of annular construction member 5 at the nearside of support respectively, perhaps aligned with each other at the far-end of annular construction member 6 in the distally of support, and Connection Element 2 forms shape shown in Fig. 5 E.As shown in Figure 6, support comprises 6 annular construction member 1a-1f, but it is a radial expansion, and two adjacent annular construction members 1 by three shown in Fig. 5 E wavy Connection Element 2 be connected to each other.
The arch portion section of annular construction member that is positioned at every end of support is aimed at along the near-end of support or far-end respectively.Promptly, the first linear portion section 121 of the first linear portion section 111, the second linear portion section 112 and the trilinear portion section 113 and the second annular construction member element 12 by shortening the annular construction member element 11 on the proximal lateral of annular construction member, annular construction member 1a is designed to make the position of arch portion section 114 and 3 and the position alignment of arch portion section 125.On the other hand, the first linear portion section 111 by shortening the first annular construction member element 11 on the distal side of annular construction member 1f and the first linear portion section 121, the second linear portion section 122 and the trilinear portion section 123 of the second annular construction member element 12, annular construction member 1f is designed to make the position of arch portion section 124 and 4 and the position alignment of arch portion section 115.
The aligning of arch portion section can be realized by the following method, aim at the position of arch portion section 115 and the position of arch portion section 124 and 4 by prolongation in the second linear portion section 112 and the trilinear portion section 113 of the first annular construction member element 11 of the annular construction member 1f of the distal side of support, aim at the position of arch portion section 125 and the position of arch portion section 114 and 3 by prolongation in the second linear portion section 122 and the trilinear portion section 123 of the second annular construction member element 12 of the annular construction member 1a of the proximal lateral of support simultaneously.
The support of the foregoing description is fabulous to the follow-up capability in chamber, because entire bracket is enough flexible to respond bending.In addition, provide sidewise hole for support easily.In addition, because prevent the top curvature distortion of dome element when expandable stent, and contingent curvature distortion is minimum when support is crooked, can avoid issuable injury to blood vessel when support is inserted the position that will apply.In addition, because the distance the top of arch portion section from the radially bisecting line of annular construction member to second linear portion section that connects the first annular construction member element and trilinear portion section, be set at 7: 8 with the ratio from the radially bisecting line of annular construction member to the distance the top of the arch portion section of the first linear portion section that is connected the second annular construction member element and the second linear portion section, the length of support can change when stent expansion hardly.
Embodiment 3
Below with reference to Fig. 7 embodiments of the invention 3 are described.
The support of embodiment 3 is the modification to the support of embodiment 1, and wherein, Connection Element 2 forms shape shown in Fig. 5 D.As shown in Figure 7, support comprises 10 annular construction members 1, but its be radial expansion and arrange in the longitudinal axis of support, adjacent annular construction member 1,1 by three shown in Fig. 5 D wavy Connection Element 2 be connected to each other.Above-mentioned support is fabulous to the follow-up capability in chamber, because entire bracket is enough flexible to respond bending.In addition, provide sidewise hole for support easily.In addition, prevent that when expandable stent the top of dome element from producing the curvature distortion, and contingent curvature distortion is minimum when support is crooked, thereby can avoids when support is inserted the position that will apply issuable injury blood vessel.In addition, the length of support does not show variation when stent expansion.
Embodiment 4
Below with reference to Fig. 8 embodiments of the invention 4 are described.
The support of embodiment 4 is the modification to the support of embodiment 1, wherein, be set at 3: 5 from bisecting line X radially to the distance rates the top of corresponding arch portion section, and be set at the twice of the distance between the first linear portion section 111 (121) and the second linear portion section 112 (122) in the distance between the second linear portion section 112 (122) and the trilinear portion section 113 (123), and Connection Element 2 forms shape shown in Fig. 5 C.As shown in Figure 8, support comprises 14 annular construction members 1, but its be radial expansion and arrange at its longitudinal direction, and adjacent annular construction member 1,1 is connected to each other by three Connection Elements 2 with shape shown in Fig. 5 C.
Above-mentioned support is poor unlike the support of explanation among the embodiment 1 to the excellent follow-up capability in chamber, because entire bracket is enough flexible to respond bending.In addition, provide sidewise hole for support easily.In addition, prevent that when expandable stent the top of dome element from producing the curvature distortion, and contingent curvature distortion is minimum when support is crooked, thereby can avoids when support is introduced the position that will apply issuable injury blood vessel.In addition, the length of support display change not when stent expansion.In this embodiment, be set at 3: 5 from the radially bisecting line of annular construction member to the distance rates the top of corresponding arch portion section, but the length of support changes when stent expansion hardly, because be set at the twice of the distance between the first linear portion section and the second linear portion section in the distance between the second linear portion section and the trilinear portion section.
Embodiment 5
Below with reference to Fig. 9 embodiments of the invention 5 are described.
The support of embodiment 5 is the modification to the support of embodiment 1, wherein, be set at 3: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section, and Connection Element 2 forms shape shown in Fig. 5 C.As shown in Figure 9, support comprises 14 annular construction members 1, but its be radial expansion and arrange at its longitudinal direction, and adjacent annular construction member 1,1 is connected to each other by three Connection Elements 2 with shape shown in Fig. 5 C.
Above-mentioned support is poor unlike the support of explanation among the embodiment 1 to the excellent follow-up capability in chamber, because entire bracket is enough flexible to respond bending.In addition, provide sidewise hole for support easily.In addition, when expandable stent, prevent the top curvature distortion of dome element, and contingent curvature distortion is minimum when support is crooked, thereby can avoids when support is inserted the position that will apply issuable injury blood vessel.Yet support can shorten when expansion, because be set at 3: 5 from the radially bisecting line of annular construction member to the distance rates the top of each arch portion section.
Embodiment 6
Below with reference to Figure 10 embodiments of the invention 6 are described.
The support of embodiment 6 is the modification to the support of embodiment 1, and wherein, the amplitude of wavy element 11,12 is set at 6/7, and Connection Element 2 forms waveform shown in Fig. 5 B.As shown in figure 10, support comprises 12 annular construction members 1, but its be radial expansion and arrange at its longitudinal direction, and adjacent annular construction member 1,1 is connected to each other by three Connection Elements 2 with shape shown in Fig. 5 B.The support of explanation in embodiment 1, this support is fabulous to the follow-up capability in chamber, because entire bracket is enough flexible to respond bending.In addition, provide sidewise hole for support easily.In addition, when expandable stent, prevent the top curvature distortion of dome element, and contingent curvature distortion is minimum when support is crooked, thereby can avoids when support is introduced the position that will apply injury blood vessel.In addition, the length of support can change when stent expansion hardly.
Embodiment 7
Below with reference to Figure 11 embodiments of the invention 7 are described.
The support of embodiment 7 is the form of the modification of embodiment 1, and wherein, Connection Element 2 is the S shape shown in Fig. 5 A.As shown in figure 11, support comprises 13 annular construction members 1, but its be radial expansion and arrange at its longitudinal direction, and adjacent annular construction member 1,1 is connected to each other by three S shape Connection Elements 2 shown in Fig. 5 A.The support of explanation in embodiment 1, entire bracket are enough flexible to respond bending, make that the support of present embodiment is fabulous to the follow-up capability in chamber.In addition, provide sidewise hole for support easily.In addition, when expandable stent, prevent the top curvature distortion of dome element, and contingent curvature distortion is minimum when support is crooked, thereby can avoids when support is introduced the position that will apply injury blood vessel.In addition, the length of support can change when stent expansion hardly.
Embodiment 8
Below with reference to Figure 12 embodiments of the invention 8 are described.
The support of embodiment 8 is the form of the modification of embodiment 1, wherein, be set at 3: 4 from bisecting line radially to the distance rates the top of corresponding arch portion section, and Connection Element 2 forms shape shown in Fig. 5 F.As shown in figure 12, support comprises 6 annular construction members 1, but its be radial expansion and arrange at its longitudinal direction, and adjacent annular construction member 1,1 is connected to each other by three Connection Elements 2 with shape shown in Fig. 5 F.As support illustrated among the embodiment 1, the support of present embodiment is fabulous to the follow-up capability in chamber, because entire bracket is enough flexible to respond bending.In addition, provide sidewise hole for support easily.In addition, when expandable stent, prevent the top curvature distortion of dome element, and contingent curvature distortion is minimum when support is crooked, thereby can avoids when support is introduced the position that will apply injury blood vessel.In addition, the length of support can change when stent expansion hardly.
Embodiment 9
Figure 13 is the expansion of the support of another embodiment of showing the present invention (second invention), and Figure 14 is the part zoomed-in view of support shown in Figure 13.
Shown in Figure 13 and 14, support of the present invention comprises 13 annular construction members 7, but its be radial expansion and arrange at its longitudinal direction.Adjacent two annular construction members 7,7 link together at its longitudinal direction by three Connection Elements 8.Annular construction member 7 is made up of the wavy element 7 of the M shape waveform that circumference connects, and arranges at its longitudinal direction.The independent ripple of forming wavy element 7 partly adopts sinusoidal wave basically form.The bottom 712 of the paddy of peak element 71a in the top 711 at the peak by the GUYUAN part 71b in the wavy element 71 that connects an annular construction member 7 and the wavy element 71 of another annular construction member 7 links together adjacent two annular construction members 7,7 by Connection Element 8.
Annular construction member 7 is the parts of the chamber wall of composition support, but and be the part of radial expansion, to be used for after support being placed in the blood vessel, keeping the chamber diameter of blood vessel.Annular construction member 7 comprises six wavy elements 71 that have M shape waveform and connect circumferentially respectively.Annular construction member 7 is arranged at the longitudinal direction of support.As shown in figure 10, wavy element 71 comprises peak element 71a and GUYUAN part 71b, its each have M shape waveform, be included in the paddy (peak) between two peaks (two paddy).For peak element 71a is provided at two peak-to-peak paddy with bottom 712, be that GUYUAN part 71b is provided at the peak with top 711 between two paddy simultaneously.
In order under identical wavelength, to improve the extended capability of support, preferably increase the wave-shape amplitude of wavy element 71.If have the peak (paddy) at top 711 (bottom 712) and stretch out in the GUYUAN part 71b of wavy element 71 (peak element 71a) side in that GUYUAN part 71b (peak element 71a) is intermediary, support prolongs when stent expansion.Therefore, preferably, the peak (paddy) with top 711 (bottom 712) stretches out in the peak of wavy element 71 element 71a (GUYUAN part 71b) side.Have the length of stretching out at the peak (paddy) at top 711 (bottom 712) and be the peak element 71a of wavy element 71 height (degree of depth of GUYUAN part 71b) 4/5.Adjacent two annular construction members 7,7 are the half wavelength of the wavy element of out-phase each other, and connects on identical vertical straight line by Connection Element 2.
Adjacent two annular construction members 7,7 are connecting between hithermost top 711 and the bottom 712 each other.As shown in figure 14, will be connected to the bottom 712 of the paddy of the peak element 71a among the wavy element 71 of the annular construction member 7 of distal side at the top 711 at the peak of the GUYUAN part 71b among the wavy element 71 of the annular construction member 7 of proximal lateral by Connection Element 8.
Connection Element 8 is fabricated to the curved shape (waveform) shown in Fig. 5 F, and three Connection Elements 8 are provided at respectively between adjacent two annular construction members 7,7.In addition, the top of the ripple pattern of wavy element 71 forms and has smooth contour.
In Figure 14, for convenience, the right side of figure is set at the far-end of support.In addition, the part of the ripple that term " peak " expression is protruded to the right, and the part of the ripple that term " paddy " expression is protruded left.In addition, term " the wavy element with M shape waveform " is to comprise having at the peak elements of two peak-to-peak paddy (M shape) and having the bonded wavy element of the GUYUAN part at the peak (anti-M shape) between two paddy.It is noted that wavy element is not limited to any wavy element with specific waveforms, as long as it has a paddy (peak) between two peaks (two paddy).Can use any wavy element with different wave, such as, for example, two of wavy element peaks (two paddy) have identical wave height shown in Figure 15 a, and perhaps two of wavy element peaks (two paddy) have different wave height shown in Figure 15 b.Adopt sinusoidal wave basically form though form four line portion sections (crestal line of peak or paddy) of M shape element, these sections are not to adopt so sinusoidal wave basically form.They can adopt the form of straight line or parallel lines.
In the above-described embodiments, comprise that the length of linear portion section (first annular construction member element among the corresponding embodiment 1 or the first linear portion section of the second annular construction member element) of the point that connects M shape element and anti-M shape element is longer than the length of two linear portion sections forming paddy or peak.Yet, two linear portion sections (the first annular construction member element among the corresponding embodiment 1 or the second linear portion section and trilinear portion section of the second annular construction member element) of forming paddy or peak are not to have identical length, and the linear portion section in centre position (the corresponding second linear portion section) can be shorter than the linear portion section of lower position (corresponding trilinear portion section).The support of the foregoing description is fabulous to the follow-up capability in chamber, because entire bracket is enough flexible to respond bending, because the annular construction member of the chamber wall of the support of composition the foregoing description comprises the wavy element of a plurality of M of having shape waveforms.In addition, provide sidewise hole for support easily.
Support tends to that length shortens a little after expansion, because annular construction member by Connection Element at the top at the intermediary peak of the GUYUAN part of the wavy element that is positioned at an annular construction member be positioned between the bottom of intermediary paddy of peak element of wavy element of another annular construction member and connect, and the length of stretching out of the peak (paddy) in the wavy element be the peak of wavy element height (degree of depth of paddy) 4/5.In addition, two adjacent annular construction members link together in the centre of M shape element, make when expandable stent, and support does not cause the curvature distortion at the top at peak.In addition, because the warpage that whole M shape element produces is little, can be so that in guide support injury minimum to blood vessel during to the position that will be applied in.
[flexibility, shortening and the test of pipe diameter hold facility]
Figure 16-18 shows has the comparative result of unfolded support as shown in table 1 about flexible (flexibility), shortening and pipe diameter hold facility.
According to result shown in Figure 16, on flexibility, support of the present invention equates with the support of prior art basically.According to result shown in Figure 17, on shortening, support of the present invention is better than the support of prior art.In addition, be appreciated that by suitably selecting and prevent because the shortening that stent expansion causes to the distance rates the top of corresponding arch portion section from bisecting line X radially.According to result shown in Figure 180, on pipe radius hold facility, support of the present invention equates with the support of prior art basically.
By support is at one end fixing, and advance comes bending rack from the part of the support of stiff end 5mm, and measures the load of corresponding displacement amplitude, measures flexibility.
Air bag by using 3.0 mm dias comes pressure extended support with 8atm (for reference frame, the pressure of recommending) 30 seconds, and use the length of the expanded stent after profile projector (being made by MitutoyoCorporation) is determined to expand, carry out to shorten and measure.
In order to determine pipe diameter hold facility, 30 second expanded stent on carrying out compression verification by the air bag that uses 3 mm dias with the exert pressure support (for reference frame, the pressure of recommending) of 8atm with autoplotter (making) by ShimadzuCorporation.Result's data divided by the quantity of annular construction member to determine the result of pipe diameter hold facility.
Table 1
Remarks
Embodiment 1 (is 4: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section to Fig. 2, the shape of Connection Element: Fig. 5 B)
Embodiment 2 Fig. 6 (is 7: 8 from bisecting line radially to the distance rates the top of corresponding arch portion section, the shape of Connection Element: Fig. 5 E is aligned with each other at the top of the arch portion section of two ends of support)
Embodiment 3 (is 4: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section to Fig. 7, the shape of Connection Element: Fig. 5 D)
Embodiment 4 (is 3: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section to Fig. 8, the shape of Connection Element: Fig. 5 C is the twice of the distance between the first linear portion section and the second linear portion section in the distance between the second linear portion section and the trilinear portion section)
Embodiment 5 (is 3: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section to Fig. 9, the shape of Connection Element: Fig. 5 C)
Embodiment 6 Figure 10 (is 4: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section, the shape of Connection Element: Fig. 5 B, the amplitude of wavy element be embodiment 1 wavy element amplitude 6/7)
Embodiment 7 (is 4: 5 from bisecting line radially to the distance rates the top of corresponding arch portion section to Figure 11, the shape of Connection Element: Fig. 5 A)
Embodiment 8 (is 3: 4 from bisecting line radially to the distance rates the top of corresponding arch portion section to Figure 12, the shape of Connection Element: Fig. 5 F)
Embodiment 9 Figure 13 (length of stretching out at the intermediary peak of paddy be wavy element the peak height 4/5, form the shape of the corresponding ripple of wavy element: sinusoidal wave form, the shape of Connection Element: Fig. 5 A)
Compare support 1 Figure 19 (having wavy pattern and blood vessel retaining part) with contact element of waveform
Compare support 2 Figure 20 (the blood vessel retaining part with wavy pattern is connected to each other in the top and the bottom of ripple)
Compare support 3 Figure 21 (the blood vessel retaining part with wavy pattern is connected to each other in the top and the bottom of ripple)

Claims (13)

1. extendible flexible support that is used for blood vessel, but it is included in the annular construction member of the aligned a plurality of radial expansion of axial direction of support, with the Connection Element that is used on its axial direction, being connected adjacent annular construction member,
Wherein, each is included in the circumferencial direction first annular construction member element alternately connected to one another and the second annular construction member element of annular construction member described annular construction member,
Wherein, in the expansion of support, the described first annular construction member element comprises the parallel linear portion section of three longitudinal extensions: first, second and trilinear portion section, the described second linear portion section of the described first annular construction member element and trilinear portion segment length equate, and by the arch portion section connection of projection to the right, and the length of the first linear portion section of the described first annular construction member element is greater than the length of described second and trilinear portion section of the described first annular construction member element, and be connected to the described second linear portion section of the described first annular construction member element left by the arch portion section of protruding
Wherein, in the expansion of support, the described second annular construction member element comprises the parallel linear portion section of three longitudinal extensions: first, second and trilinear portion section, the described second linear portion section of the described second annular construction member element and trilinear portion segment length equate, and connect by the arch portion section of protruding left, and the length of the described first linear portion section of the described second annular construction member element is greater than the length of described second and trilinear portion section of the described second annular construction member element, and be connected to the described second linear portion section of the second annular construction member element to the right by the arch portion section of protruding
Wherein, the described first annular construction member element and the second annular construction member element are connected to the first annular construction member element that makes the second annular construction member element and be positioned at second annular construction member element top and connect by the arch portion section of protruding left and be positioned between the trilinear portion section of the first linear portion section of the second annular construction member element and the first annular construction member element, and the second annular construction member element and the first annular construction member element that is positioned at second annular construction member element below connect by the arch portion section of protruding to the right and be positioned between the first linear portion section of the trilinear portion section of the second annular construction member element and the first annular construction member element, adjacent annular construction member connects in corresponding arch portion section by one or more Connection Element respectively, and this corresponding arch portion section connects the first annular construction member element of annular construction member and the second linear portion section and the trilinear portion section of the second annular construction member element separately.
2. support according to claim 1, wherein, adjacent annular construction member is connected at the place, top of the arch portion section that connects the second linear portion section and trilinear portion section.
3. support according to claim 1, wherein, distance the top of arch portion section from the radially bisecting line of annular construction member to second linear portion section that connects the first annular construction member element and trilinear portion section, with ratio from the radially bisecting line of annular construction member to the distance the top of the arch portion section of the first linear portion section that is connected the second annular construction member element and the second linear portion section in 1: 2 to 7: 8 scope.
4. support according to claim 1, wherein, adjacent annular construction member is out-phase each other.
5. support according to claim 1, wherein, adjacent annular construction member is the out-phase half wavelength each other, and wherein adjacent annular construction member connects on identical vertical straight line by Connection Element.
6. support according to claim 1, wherein, Connection Element adopts collinear form.
7. support according to claim 1, wherein, Connection Element adopts the form of curve.
8. support according to claim 7, wherein, Connection Element adopts wave-like form, and has the peak.
9. support according to claim 7, wherein, Connection Element adopts wave-like form, and has a plurality of peaks.
10. support according to claim 1 wherein, provides two to six Connection Elements with the interval that equates between described adjacent annular construction member.
11. support according to claim 1, wherein, the arch portion section of annular construction member that is positioned at every end of support is aimed at along the near-end of support or far-end respectively.
12. support according to claim 1, wherein, linear straight portion's section of the first annular construction member element and the second annular construction member element is arranged at regular intervals circumferentially.
13. support according to claim 1, wherein, each described first linear portion section and the distance between the second linear portion section at described first annular construction member element and the described second annular construction member element equals distance between the first linear portion section of the trilinear portion section of described first annular construction member element or the described second annular construction member element and described second annular construction member element or the described first annular construction member element, and described first annular construction member element and the described second annular construction member element each the described second linear portion section and the distance between the trilinear portion section greater than described first annular construction member element and the described second annular construction member element each the described first linear portion section and the distance between the second linear portion section.
CN200480018566A 2003-04-30 2004-04-27 Extendable soft stent with excellent follow-up capability to blood vessel Expired - Fee Related CN100591385C (en)

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SG11201401398XA (en) * 2011-11-02 2014-06-27 Nipro Corp Stent
WO2017185529A1 (en) 2016-04-27 2017-11-02 苏州天鸿盛捷医疗器械有限公司 Vascular stent, preparation method therefor, and application thereof
US11471309B2 (en) 2016-04-27 2022-10-18 Suzhou Venmed Technology Co., Ltd. Intravascular stent, preparation method and use thereof
CN105726174B (en) * 2016-04-27 2018-06-29 苏州天鸿盛捷医疗器械有限公司 A kind of intravascular stent, preparation method and application
CN114948334A (en) * 2022-04-11 2022-08-30 上海玮琅医疗科技有限公司 Pulmonary artery tectorial membrane support
CN115381591B (en) * 2022-08-01 2023-07-25 上海玮琅医疗科技有限公司 Straight-cylinder type superior vena cava bracket

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