CN105682615A - Medical device for implantation into luminal structures incorporating corrugated structural elements - Google Patents

Abstract

Expandable scaffolds or stents include circumferential elements having a corrugated pattern, which can include a plurality of linear or nonlinear segments. The corrugated pattern distributes stress more uniformly along the circumferential elements, improves radial strength of the scaffolds, reduces acute recoil after deployment, and reduces creep. The scaffolds can be made from a bioabsorbable material.

Description

For implantation into the medical treatment device including wave structure element in luminal structure

The cross reference of related application

This application claims the U. S. application number 14/060 submitted on October 22nd, 2013,012, the U.S. Provisional Application number 61/895 that on October 25th, 2013 submits to, the U.S. Provisional Application number 61/968 that on March 20th, 957 and 2014 submits to, the priority of 025, the content of each of these earlier applications is integrally incorporated herein with it by reference.

Invention field

The present invention relates to support (stent). Specifically, the present invention relates to the design of the geometry of support, its radial strength showing height and flexibility, and can be formed by biologically absorbable polymer.

Background of invention

Support is be placed in ill vascular sections to support the vascular mould bases (scaffolds) of blood vessel wall. In the process of angioplasty, support is used for repair and reconstruction blood vessel. In ill tremulous pulse sections, place support prevent elastical retraction and arterial occlusion. Support also prevents tremulous pulse to be partially stripped along intermediate layer. In a physiologically, support can be placed in the tube chamber of any space (such as tremulous pulse, vein, bile duct, urinary tract, digestive tract, tracheobronchial tree, cerebral aqueduct or urogenital system). Support also can be placed in the tube chamber of non-human animal (such as primates, horse, cattle, pig and sheep).

In general, there are two kinds of vascular mould bases or support: self-expanding and balloon-expandable. The state of expansion, expansion is expanded and presented to self-expanding support, once be released, automatically. By the support being in compressive state is inserted into affected areas such as narrow zone, self-expanding support is positioned in vascular. The compression of support or curling can adopt coiled up device complete (referring toHttp:// www.machinesolutions.org/stent_crimping.htm,In April, 2009). Support can also use the pipe that external diameter is less than the internal diameter of ill vascular regions to be compressed. Once remove compression stress or raising temperature, then stent-expansion is to fill the tube chamber of vascular. When support is released from the restriction of pipe, stent-expansion, to recover its original shape, abuts against tube wall in this process and is securely fixed in vascular.

Balloon expandable stent utilizes inflatable inferior vena cava balloon dilation. Can by the support being in unexpanded or rolled state being installed on the sacculus sections of conduit and implanting balloon expandable stent. After conduit is placed curling support, insert the catheter in blood vessel wall by puncturing and be moved through vascular until it is arranged in the vessel segments needing to repair. Then pass through and make foley's tube inflation abut against the inwall of vascular and make stent-expansion. Specifically, by making inflated make support plastic deformation to increase the diameter of support and to make stent-expansion.

There is common restriction in many supports. Such as, the problem that the support that main body is made up of polymeric material often has too much retraction and low radial strength. Need to solve the support Design of the improvement of these problems.

Summary of the invention

In one aspect, the present invention is provided to implant the expansible mould bases in body cavity, for instance support. Mould bases has compression or rolled state and expansion state, and including multiple ring week element, each ring week, element had a multiple wavy bending of peak and valley form alternately, multiple ring week element form the generally cylindrical shape with longitudinally (or cylinder) axle. Multiple ring week element include first ring week element, second ring week element and the 3rd ring week element. First and second ring week element be longitudinally adjacent, second and the 3rd ring week element be longitudinally adjacent. First and second ring week element connected by multiple first connecting elements; Second and the 3rd ring week element connected by multiple second connecting elements. At least one, element included at least one wavy bending including wavy pattern in ring week. Wavy pattern can include the linear sections of at least six (such as 6-64 linear sections, 6-36 linear sections etc.) being serially connected; When mould bases is in expansion state, each in the linear sections of described at least six not with the linear sections conllinear of adjacent connection. When mould bases is in expansion state, the linear sections of connection can be similar to sine wave period. The length of each in the linear sections connected can be identical or different from each other. Wavy pattern can also include shaped form sections. Wavy pattern can by whole ring week element and/or mould bases in all ring weeks element adopted.

In one embodiment, mould bases can include the polymeric material of biological absorbable, for instance PLLA (PLLA). In another embodiment, mould bases includes bioerodable metal.

Multiple first (or second) connecting element can comprise at least two connecting element, for instance three first (or second) connecting elements. First connecting element can be linear or curved, for instance S or Z-shaped. Labelling point can be included in the first or second connecting element.

In one embodiment, mould bases includes labelling point. Labelling point can be included in connecting element or be attached to connecting element. Labelling point can have cup-like configuration, and this cup-like configuration has oral area and bottom, and can include hole in bottom of cups.

In an embodiment of mould bases, first ring week element peak and valley with second ring week element peak and valley be substantially homophase. Each first connecting element by first ring week element paddy with second ring week element peak be connected, this peak and second ring week element paddy (paddy of this second ring week element with first ring week element paddy longitudinally-aligned) adjacent. In a further embodiment, second ring week element peak and valley with the 3rd ring week element peak and valley be substantially homophase, and each second connecting element be connected in side second ring week element peak (peak of this second ring week element by the first connecting element be connected to first ring week element), and opposite side be connected to the 3rd ring week element paddy, the 3rd ring week element paddy with the 3rd ring week element peak (the 3rd ring week element peak and second ring week element peak longitudinally-aligned) adjacent. In other embodiments, each second connecting element be connected in side second ring week element paddy (paddy of this second ring week element with second ring week element by the first connecting element with first ring week element connection peak adjacent), and opposite side be connected to the 3rd ring week element peak (the 3rd ring week element peak and the 3rd ring week element with second ring week element the longitudinally-aligned paddy of paddy adjacent), and each first connecting element is not longitudinally-aligned with any one second connecting element.

In an embodiment of mould bases, first ring week element peak and valley with second ring week element peak and valley be substantially homophase, and each first connecting element by first ring week element peak and second ring week element peak connect, wherein this second ring week element peak and first ring week element peak longitudinally-aligned. In a further embodiment, second ring week element peak and valley with the 3rd ring week element peak and valley be substantially homophase. Each second connecting element be connected in side second ring week element paddy (paddy of this second ring week element is adjacent with the peak being connected to the first connecting element), and opposite side be connected to the 3rd ring week element paddy (the 3rd ring week element paddy with second ring week element paddy longitudinally-aligned). In another embodiment, second ring week element peak and valley with the 3rd ring week element peak and valley be substantially homophase, and each second connecting element be connected in side second ring week element peak (peak of this second ring week element and second ring week element adjacent with the peak that the first connecting element connects), and opposite side be connected to the 3rd ring week element peak (the 3rd ring week element peak and second ring week element peak longitudinally-aligned).

In an embodiment of mould bases, first ring week element peak and valley with second ring week element peak and valley be substantially homophase, and each first connecting element by first ring week element peak and second ring week element paddy connect, this paddy with second ring week element peak (peak of this second ring week element and first ring week element peak longitudinally-aligned) adjacent. in a further embodiment, second ring week element peak and valley with the 3rd ring week element peak and valley be substantially homophase, and each second connecting element be connected in side second ring week element peak (peak of this second ring week element and second ring week element adjacent with the paddy of the first ring week element connection by the first connecting element), and opposite side be connected to the 3rd ring week element paddy (the 3rd ring week element paddy with the 3rd ring week element with second ring week element longitudinally-aligned peak, peak adjacent), and each first connecting element is not longitudinally-aligned with any one second connecting element.

In an embodiment of mould bases, when mould bases is expanded, this mould bases includes at least one continuous print helical pattern, this at least one continuous print helical pattern includes at least one first connecting element and at least one second connecting element, this at least one second connecting element of at least one first connecting element and this all connect at identical peaks or valleys place second ring week element. in the alternative embodiment of mould bases, when mould bases is expanded, this mould bases includes at least one continuous print helical pattern, this at least one continuous print helical pattern includes at least one first connecting element and at least one second connecting element, wherein this at least one first connecting element connect at the first link position place second ring week element, this at least one second connecting element connect at the second link position place being different from the first link position second ring week element, this continuous print helical pattern be additionally included between the first link position and the second link position second ring week element a part.

In one embodiment, at least one element in ring week include connecting element and ring week the recess of position that intersects of element.

Accompanying drawing is sketched

Fig. 1 shows the profile of mould bases.

Fig. 2 A show have different length ring week element the profile of mould bases.

Fig. 2 B shows the various amplitude of ring week element.

The sinusoid pattern of Fig. 2 C display repeatability.

Fig. 2 D shows the sinusoid pattern of non-repeatability.

Fig. 3 shows the detailed view of adjacent ring week element.

Fig. 4 A shows the details of the connecting element of mould bases one end.

Fig. 4 B-4F illustrates the various embodiments of various connecting elements.

Fig. 4 G shows the perspective view of labelling point.

Fig. 4 H, 4J and 4K show the cross section of the various embodiments of labelling point.

Fig. 5 A-Fig. 5 C shows the 3-D view of the mould bases obtained from different perspectives.

Fig. 6 shows the profile of the another embodiment of mould bases.

Fig. 7 shows the profile of the mould bases with another kind of spiral pattern.

Fig. 8 illustrates the profile of the mould bases containing difform multiple connecting elements.

Fig. 9 show have another kind of spiral pattern and different length ring week element the profile of mould bases.

Figure 10 A and Figure 10 B shows the three-dimensional perspective side view of the mould bases under rolled state.

Figure 11 A and Figure 11 B illustrates the profile of the mould bases of the present invention with another kind of spiral pattern.

Figure 12 illustrates the functional of connecting element.

Figure 13 illustrates mould bases and connecting element (the first and second connecting elements) geometry when expansion.

Figure 14 A and Figure 14 B illustrates the geometry of connecting element.

Figure 14 C shows how connecting element attaches to the various embodiments of adjacent ring week element.

Figure 15 A-E illustrates that connecting element can along the position of wavy bending attachment.

Figure 16 shows the radial deflection of connecting element and the attachment point of adjacent wavy bending.

Figure 17 A1,17A2 and Figure 17 B show the example of the phase place (phasing) of adjacent ring week element.

Figure 18 shows the profile of the another embodiment of mould bases, wherein has three the first connecting elements between two ring week elements.

Figure 19 A schematically depict the mould bases according to one embodiment of the invention, its in medium ring week element contain the wavy pattern being made up of multiple linear sections.

Figure 19 B is the close up view of the support described in Figure 19 A.

Figure 19 C schematically depict the wavy pattern shown in Figure 19 A and 19B.

Figure 19 D schematically depict the wavy pattern being made up of multiple shaped form sections.

Figure 20 A shows the profile according to one embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 20 B-20E shows the detailed view of the molded base part in Figure 20 A.

Figure 20 F shows the cross section of the labelling point in Figure 20 A.

Figure 20 G shows the side view of the mould bases in Figure 20 A.

Figure 21 A-21C depicts the three-dimensional side view of the molded base part of the expansion according to one embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 22 A depicts the sectional view of the mould bases according to one embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 22 B depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 23 depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 24 depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 25 A depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 25 B depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 26 A depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 26 B depicts the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A and 19B.

Figure 27 A-27B illustrates the 3-D view of the mould bases according to embodiment of the present invention, and it includes the wavy pattern shown in Figure 19 A and 19B and recess.

Detailed Description Of The Invention

The present invention relates to distensible vascular mould bases, including support. The master-plan of mould bases based on comprise connected by one or more connecting elements ring week element pair module design (term " connection " of gerund and occlusion is used interchangeably herein). Adopt agent approach, mould bases can by length and design different ring week element and connecting element assembling. When expanded, connecting element forms spiral pattern, and it can be helical structure.

Vascular mould bases can be formed by biologically absorbable polymer, bioerodable or biological absorbable metal or its combination. The limiting examples of biologically absorbable polymer includes PLLA (PLLA), poly-D-lactide (PDLA), poly-(D, L)-lactide (PDLLA), poly-(deamination tyrosine-based-tyrosine ethyl ester) carbonic ester (poly (desaminotyrosil-tyrosineethylester) carbonate), poly-(caprolactone) (PCL) and poly-(acid anhydride ester) salicylic acid. The limiting examples of bioerodable/biological absorbable metal includes containing or does not contain the ferrum of rare earth element, ferrous alloy, magnesium and magnesium base alloy, such as Mg-Sr alloy, Mg-Sr-Zn alloy, Mg-Zn-Zr alloy, Mg-Nd-Zn-Zr alloy, Mg-Zn-Al alloy, Mg-Zn-Ca alloy and metal glass (such as zirconium-based metallic glass).

Mould bases also can be formed by the various combination of metal Yu polymer. U.S. Patent number 7,846,361; 7,897,224 and 8,137,603. U.S. Patent Publication No. 2010/0093946. Alexy, etal., BioMedResearchInternational, 2013, ArticleID137985.

In general, mould bases is cylindrical or tubular articles, has cylinder (longitudinal direction) axle of cylinder length trend. The flexibility of height and significant radial strength are shown in the module geometry design of the present invention. In general, mould bases has the main body being mainly cylindrical shape, and this main body has multiple distensible ring week element. Ring week, the length of element can change. At least two ring week element can connect formation ring week element pair. Can there be one or more connecting element in the ring week forming this ring week element pair between element. Connecting element can have multiple different geometry, including the combination of linear, shaped form or two kinds of shapes. Every pair ring week element by least one connecting element with adjacent ring week element to connection. The ring week of one centering between element or ring week element between the quantity of connecting element can change.

Term used herein " ring week element (circumferentialelements) " refers to the structural detail of the circumference of the mould bases (it can be cylinder form) of the restriction present invention. In one embodiment, ring week element is subject to the restriction of two and the hypothesis plane of the cylinder axis perpendicular of mould bases. Ring week, element can comprise multiple wavy bending (or being made up of multiple wavy bendings). Wavy bending is the repetitive in ring week element, and can include peak and valley. Each ring week, the number of wavy bending of element can change from 2 to N, for instance 2,3,4,5,6,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,30,40,50,60 etc.

When vascular mould bases is expanded, connect a centering ring week element connecting element and/or connect adjacent pairs ring week element connecting element at least some of form continuous print spiral pattern.

In one embodiment, continuous print spiral pattern is oriented as substantially parallel with the cylinder axis of mould bases. Continuous print spiral pattern can also take other orientations. Continuous print spiral pattern can form helical structure, and can have one or more helical structure in particular embodiments, for instance, double-spiral structure or triple-helix structure, or 4,5,6 or the helical structure of higher number. When there is more than one helical structure, adjacent helical structure can be substantially parallel to one another. Adjacent helical structure can be not parallel each other. In one embodiment, there are two or more helical structures equidistant with the cylinder axis of mould bases.

Ring week, the shape of element can be consistent. Or, ring week element can be made up of various different shapes. Such as, ring week element wavy can be bent to form by a series of, this wavy bending can be repeatability or the non-repeatability pattern of sinusoid pattern, saw tooth pattern, square wave pattern or any other type, for instance, the combination of sine curve and sawtooth. The amplitude of wavy bending can change (amplitude is the zero-based peak deviation of function) in a ring week element or between two ring week elements. The amplitude of wavy bending and frequency can also change. Such as, ring week element can be made up of sinusoid pattern, this sinusoid pattern has a repeat patterns of various amplitude, 2:1:2:1,2:1 etc., wherein, it is shown that the amplitude scale of schedule of proportion oscillography sigmoid. Can also be other ratios, 3:1,4:1,5:1 etc. Ring week, element can be made up of one or more sections, and each sections has the wavy bending pattern of their own. Sections number in each ring week element can change between 1 to N, for instance, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,30,40,50,60 etc. The shape of sections can be linear or shaped form. Therefore, ring week element can be assembled in modular fashion by the various sections that can be similar or different. In mould bases, all ring weeks the length of element can be identical. Or, ring week the length of element can change, for instance, change in several of different ways. Such as, one pair interior ring week element length can be identical, and closer to mould bases one end ring week element length can than in the middle part of mould bases ring week element length longer or shorter.

The number of the connecting element (the first connecting element or the second connecting element) connecting adjacent ring week element can in from 1 to the scope of N, for instance, the number of 1,2,3,4,5,6,7,8,9,10 or higher, 10-20. The shape of connecting element can be other combinations any of linear, shaped form, S shape, reverse-s shape, Z-shaped, anti-Z-shaped or shape, including, for instance, linear and curved portion. Similarly, the number of the connecting element connecting adjacent ring week element pair can in from 1 to the scope of N (such as, 1,2,3,4,5,6,7,8,9 or 10), and the shape of this type of connecting element can be linear, shaped form, S shape, reverse-s shape, Z-shaped, anti-Z-shaped, or its combination in any. Connecting element can present different angles relative to the cylinder axis of mould bases, including 0-20 °, 20-40 °, 40-60 ° or 60-80 °; And, the angle of these connecting elements relative to the cylinder axis of mould bases can be on the occasion of or negative value. If connecting element is shaped form, its bending that can exist with connecting element selected portion place is concave surface and convex surface; The degree of bending can also change in a connecting element. Owing to flexible decline generally occurring when the number of connecting element increases, thus it is possible to vary the number of connecting element is to change the flexibility of mould bases.

When connecting element is S shape, it can have substantially S-shaped structure. In one embodiment, S shape connecting element has hyperbolic configuration, and it makes between ring week element more lax, enables mould bases to expand bigger. This S shape sections is more long, then there is more many lusitropic and dilatancy in structure. S shape connecting element can be able to be maybe angled for what smooth. In another embodiment, S shape connecting element includes at least three is linear part substantially: the first linear part substantially parallel with the cylinder axis of mould bases (such as, forming the angle of about 0 degree to about 20 degree relative to the cylinder axis of mould bases); Second linear part and axle perpendicular (such as, forming the angle of about 70 degree to about 90 degree relative to the cylinder axis of mould bases); And trigram part substantially parallel with axle (such as, forming the angle of about 0 degree to about 20 degree relative to the cylinder axis of mould bases). In still another embodiment, S shape connecting element includes at least three and is substantially in the form of linear part: the first linear part substantially parallel with the cylinder axis of mould bases (such as, forming the angle of about 0 degree to about 20 degree relative to the cylinder axis of mould bases); Second linear part and the first linear part perpendicular (such as, the second linear part is relative to the angle of the first linear part formation about 70 degree to about 90 degree); And trigram part is substantially parallel (such as with the first linear part, trigram part forms the angle of about 0 degree to about 20 degree with the first linear part) or with the second linear part perpendicular (such as, trigram part angle into about 70 degree to about 90 degree fractal relative to the second linear portion).

When connecting element is Z-shaped, it has substantially Z-shape structure.

When there is more than one connecting element between adjacent ring week element, connecting element along the circumference of mould bases in radial position symmetrically or non-symmetrically. If connecting element is symmetrically placed, then the radial distance (such as A-B and B-C) between every pair of connecting element is equal.

The radial position of connecting element listed herein is only presented for purposes of illustration, and connecting element can be placed on the arbitrfary point along mould bases circumference under without too much experiment by those of ordinary skill in the art relative to cylinder axis. Such as, the position of connecting element can by determining divided by n with 360 °, and wherein n is the connecting element number between adjacent ring week element. As n=3, connecting element can be symmetrically placed with the interval of about 120 ° around the circumference of support. When having the connecting element of two equal intervals between adjacent ring week element, they are located relative to each other for the position of about 180 °. It is to say, two connecting elements are oppositely oriented relative to each other.

Be only the purpose of reference, connect every centering ring week element connecting element be referred to as the first connecting element, and connect adjacent ring week element centering ring week element connecting element be referred to as the second connecting element. First and second connecting elements can be of similar shape or have different shapes. It addition, connect the element centering of ring week ring week element the shape of the first connecting element can have and identical maybe can have different shapes and length. Similarly, shape and the length of the connecting element connecting adjacent ring week element pair can be identical or can be different. As discussed further below, the first and second connecting elements may be configured to allow vascular mould bases expansion and not causing formed to ring week element bend substantially beyond by the ring week plane that formed of element after expanding. Therefore, adjacent ring week element between connecting element (such as, the second connecting element) can extend in response to the expansion of mould bases. In one embodiment, these connecting elements have S shape or are shaped form.

When mould bases is expanded, connect a centering ring week element connecting element and/or connect adjacent pairs ring week element connecting element at least some of form continuous print spiral (spiral) or spiral type (helical) pattern. In one embodiment, spiral or spirality pattern comprise at least some of first and second connecting elements. In another embodiment, spiral pattern comprises at least some of first connecting element. In the 3rd embodiment, spiral pattern comprises at least some of second connecting element. In the 4th embodiment, spiral pattern comprises at least some of first and second connecting elements, and at least some of ring week element. In the 5th embodiment, spiral pattern comprises at least some of first connecting element, and at least some of ring week element. In a sixth embodiment, spiral pattern comprises at least some of second connecting element, and at least some of ring week element.

The length of connecting element refers to the absolute distance advanced to the connecting element other end from one end of connecting element along connecting element.

The length of the second connecting element can more than, equal to or less than the length of the first connecting element.

The wavy bending of element of ring week can form the peak and valley of the near-end relative to vascular mould bases or far-end. First connecting element can connect the ring week element of a centering to paddy or paddy to paddy from peak to peak, peak. Similarly, the second connecting element can connect ring week element phase adjacency pair to paddy or paddy to paddy from peak to peak, peak. Peak to peak, peak can be in ring week of same cylinder axis or skew 180 ° between element to paddy or paddy to the connection of paddy; Other skew include but not limited to from same cylinder axis 5 °, 60 °, 90 ° and 120 °. Connecting element can connect the arbitrfary point on adjacent ring week element, includes but not limited to the arbitrfary point on peak, paddy, the rising part of wavy bending or sloping portion.

One centering one ring week element wavy bending can with another of this centering in ring week element wavy be bent into homophase or out-phase. If two ring week element be out-phase, then the number of degrees of phase contrast in the scope more than 0 ° to 180 °, can include but not limited to 5 °, 60 °, 90 ° and 120 °.

Similarly, the wavy bending of a centering can be bent into homophase or for out-phase with adjacent pairs wavy. If two ring week element be out-phase, then the number of degrees of phase contrast in the scope more than 0 ° to 180 °, can include but not limited to 5 °, 60 °, 90 ° and 120 °.

The wavy bending of element of adjacent ring week can be homophase or out-phase. If two ring week element be out-phase, then the number of degrees of phase contrast in the scope more than 0 ° to 180 °, can include but not limited to 5 °, 60 °, 90 °, 120 ° and 180 °.

When mould bases is applied radial expansion force (such as passing through dilating sacculus), the element radial dilatation also circumference elongation of ring week. On the contrary, when mould bases is applied external compressive force, the element radial contraction also circumference shortening of ring week. When mould bases is imposed radial expansion force, the amplitude of wavy bending declines. On the contrary, when mould bases is imposed external compressive force, the amplitude of wavy bending increases.

In another embodiment, mould bases comprises multiple polygon. Polygon has n bar limit, and wherein n is any positive integer. Such as, polygon can have the limit (design of the present invention is also contemplated by the polygon of higher order) within the scope of 3 to 30, article such as 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29 and 30, the polygon on limit, until the polygon on n bar limit. Polygonal limit can equal or different length. Limit relative in polygon can be substantially parallel to each other when mould bases is curled. Limit relative in polygon can also take other configurations each other.

Polygon multiple wavy can be bent to form by what connected by multiple connecting elements. Such as, polygon can be by two the wavy hexagons being bent to form connected by two connecting elements; Hexagon can comprise the first wave sigmoid by first segment and the connection of the second sections and the second wavy bending. Each hexagon comprises the silk of the first and second wavy bendings and can have similar and different width, length and thickness. Polygon can also be formed when without connecting element by multiple wavy bendings. Such as, polygon can be by two wavy tetragons being bent to form. In higher order polygon, for instance, n=8-30, wavy bending can be connected by multiple connecting elements.

Wavy bending can comprise a sections or at least two sections (such as 3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,30,40,50,60 and N number of sections). Sections can be linear or shaped form. When sections is shaped form, the degree of bending can change. Sections can be concave surface or convex surface. Sections can contain only the linear part combined, or contains only the curved portion combined. Or, sections can contain both the linear part and curved portion that combine. Sections can comprise at least one bending placed in institute's reconnaissance along its length. Such as, sections can take the shapes such as n, C, U, V of formatting. Sections can also have the shape of ring, and wherein this ring can be circular or semicircle. Sections can be substantially in the form of the incumbent profile what is suitable for. The length of the sections of wavy bending, width and thickness can be equal or unequal. Each polygonal two the wavy bendings crossing over each ring week assembly can be identical or can be different. Polygonal multiple different profiles and represent each sections on polygonal limit and contain in the present invention. Such as, the sections representing polygonal limit can be linear or shaped form. In a polygon, the length of the sections comprising a wavy bending can equal to or more than the length of the sections of relative wavy bending. Polygon can be (that is, it contains at least one interior angle more than 180 °) of (that is, its all interior angles are less than 180 °) of convex surface or non-convex surface. Polygon can form the structure that the continuous print of the main body crossing over mould bases interconnects. Ring week element (or ring week element to) can contain different or substantially the same polygons. Different rings week, the polygon of element can be different or substantially the same. The surface area of adjacent polygons can be equal or unequal. Polygonal surface area, i.e. the area that limit surrounds, can be calculated through mathematical method by the length on polygonal limit. Http:// mathworld.wolfram.com/PolygonArea.html, in April, 2009.

One embodiment of the mould bases of the present invention illustrates in FIG. Ring week, element was to being shown as 1-4. The ring week element of 1-4 is marked in bracket by mould bases: 1 (5,6), 2 (7,8), 3 (9,10) and 4 (11,12). The connecting element (the first connecting element) between two ring week elements in a pair 1 is shown as 13-18, and the connecting element (the second connecting element) between 1 and 2 is shown as 19-21 by adjacent ring week element. Mould bases can contain labelling point 22. The polygon formed by wavy bending and the connecting element of mould bases is illustrated by the frame of 23 and 24.

Another embodiment of mould bases shows in fig. 2, herein, mould bases ring week element length different. Ring week, the circumferential length of element was A > B > C; But, this length sequence only shows presented for purposes of illustration. The amplitude of the wavy bending formed by ring week element A, B, C of being in the curling or complete rolled state of part also has length or the height (Fig. 2 B) of A ' > B ' > C '. In the embodiment illustrated, the ring week element with different length is as follows along the distribution of mould bases body: A-B (25,26), C-C (27,28), C-C (29,30), C-B (31,32), B-B (33,34), B-B (35,36), and B-A (37,38). But, other combinations many and distribution are also possible. The sinusoid pattern of Fig. 2 C display repeatability, wherein the amplitude of wavy bending is constant along this element in ring week. Fig. 2 D shows the sinusoid pattern of non-repeatability. In the sinusoid pattern of non-repeatability, the amplitude of wavy bending and/or general frequency can along ring week element polling system ground or change randomly.

Ring week, the length of element referred to that the point of the artificial selection from ring week element starts to advance along ring week element and return to the absolute distance of the point of identical artificial selection.

Formed adjacent two pairs ring week element the detailed view of a part of wavy bending show in figure 3. Ring week, element was shown as 39,40. They are connected by connecting element (the second connecting element), and this connecting element has two linear parts 41,4101 and S shape part 42. The wavy bending of element 40 of ring week has amplitude 43 and 44. In the embodiment illustrated, 44 more than 43.

Fig. 4 A shows the detail of the connecting element (the first connecting element) of mould bases one end. Ring week, element 46,47 was by connecting element (the first connecting element) 48-55 connection. Fig. 4 B-4F illustrates multiple embodiments, and wherein labelling point 54 can be attached to connecting element 56-59 at the difference place (such as at the some place at the some place of, multi-segmental linear along (and interruption) or bending or curved connecting element or its side) along connecting element 53. Fig. 4 G shows the perspective view of labelling point 251. Fig. 4 H, 4J and 4K show the cross section of the multiple embodiments of labelling point 252. Mould bases can take various forms for the cross section of labelling point, include but not limited to: penetrating space (see-throughvoid) (Fig. 4 H), there is the cup-like structure (Fig. 4 J) in the hole 255 of oral area 253, bottom 254 and bottom and there is the cup-like structure (Fig. 4 K) of oral area 253a and bottom 254a.

Fig. 5 A-Fig. 5 C shows the orthogonal view (5A) of mould bases, side view (5B) and end-view (5C). Ring week, element was marked as 60-64 and 65-70. Ring week element between connecting element be shown as 71,72,74,75 (the first connecting elements), and the connecting element between two pairs is marked as 73. The formation of helical design is shown as 76-78, and containing ring week element between connecting element and formed this to ring week connecting element (respectively the first and second connecting elements) between element. The ring week element forming a pair shows with high bright line 63,64.

Fig. 6 shows the sectional pattern of another embodiment of mould bases. Ring week, component labelling was 79-92, and ring week, element was to being shown as 79,80; 81,82; 83,84; 85,86; 87,88; 89,90 and 91,92. Spiral pattern is shown as 93-103, and comprise ring week element between connecting element (the second connecting element) 93,95,97,99,101 and 103 and form the alternating pattern of ring week of a pair connecting element (the first connecting element) 94,96,98,100 and 102 between element. In the illustration of Fig. 6, it is shown that the Partial shrinkage view of mould bases. Ring week, element was marked as 107,107 ', and connecting element is marked as 105,106. Mould bases shown in figure contains the spiral pattern 108-110 of the more than one that can be substantially parallel to each other.

Fig. 7 shows the sectional pattern of the mould bases with another kind of spiral pattern. In this embodiment, spiral pattern by ring week element between connecting element (the first connecting element) 112,115,118,121, ring week element wavy sweep 113,117,120, and connect adjacent two pairs ring week element connecting element (the second connecting element) 111,114,116,119,122 alternating pattern formed. In this embodiment, spiral pattern has the following repetitive sequence started from mould bases one end: the first connecting element, the second connecting element, wavy sweep, the first connecting element, the second connecting element, wavy sweep, and it repeats in whole mould bases. Other repetitive sequences are possible, include but not limited to: (a) first connecting element, wavy sweep, the first connecting element, repeat n time in whole mould bases main body; B () first connecting element, wavy sweep, repeat n time in whole mould bases main body; C () second connecting element, wavy sweep, repeat n time in whole mould bases main body; Or (d) second connecting element, wavy sweep, the second connecting element, repeat n time in whole mould bases main body;

Fig. 8 shows that wherein connecting element tool is of a variety of shapes and the embodiment being distributed in the main variation in vivo of whole mould bases of connecting element pattern. Specifically, in the embodiment illustrated, ring week element between connecting element be linear, 124-126 and 130-132, or be shaped form, 127-129,134-136 and 137-139. Ring week element between the existing linear part of one of curve connecting element have again curved portion 127-129. As being evident that in illustrating, the pattern of connecting element can change in whole mould bases main body, shaped form 137-139,134-136, linear 130-132, shaped form 127-129 and linear 124-126. The present invention contains other possible arrangement and geometries. Those of ordinary skill in the art can select the order of connecting element and type with the flexibility meeting vascular system and proposing and space requirement.

Fig. 9 show have another kind of spiral pattern and different length ring week element the sectional pattern of mould bases. This embodiment illustrates the module design character of mould bases, wherein different length ring week element and various different connecting element combination to form the mould bases with spiral pattern two kinds different. Ring week, element had length A_n、B_nAnd C_n. Such as, in one embodiment, circumferential length is A > B > C. Specifically, in the order shown in Fig. 9, A1 and A0 (140,144) and B₀-B₅(141,143) combine, B₀-B₅(141,143) again with C₀-C₆(142) combination. There is spiral pattern 145-147 and 153-154 two kinds different in this embodiment. Spiral pattern in 147 comprise formed to ring week connecting element (the first connecting element) 148,150,152 between element and ring week element between connecting element (the second connecting element) 149,151. Another spiral pattern 154 comprise formed to ring week connecting element (the first connecting element) 155,158 between element, ring week element wavy sweep 157,160 and ring week element between connecting element (the second connecting element) 156,159.

Figure 10 A and Figure 10 B shows the three-dimensional perspective side view of the mould bases being in curling or compressive state. Ring week, element was to being shown as 172,173. Formed ring week element a part a wavy bending 161,167 with ring week element between connecting element 162,166 (the second connecting element) adjacent. This connecting element be positioned at top or press close to/nested but not necessarily contact adjacent pairs ring week element wavy bending 163,171. Connect a centering ring week element connecting element be shown as 169,170 (the first connecting elements). This arrangement also can clearly see in Figure 10 B, be formed with ring week element a part a wavy bending 175,186 with ring week element between connecting element 176,185 (the second connecting element) adjacent. This connecting element be positioned at top or press close to/nested adjacent pairs ring week element wavy bending 180,184. Connect a centering ring week element connecting element be shown as 182 (the first connecting elements). Ring week, element was to being labeled as 183.

Figure 11 A shows the sectional pattern of the mould bases with another kind of spiral pattern. Ring week, element was marked as 458-464, and its, element was to being shown as 458,459 in medium ring week; 460,461 and 462,463. In this embodiment, spiral pattern by ring week element between connecting element (the first connecting element) 451,455, ring week element wavy sweep 452,454,456, and connect adjacent two couple ring week element connecting element (the second connecting element) 453,457 alternating pattern formed. In this embodiment, spiral pattern has the following repetitive sequence that the one end from mould bases starts: the first connecting element, wavy sweep, the second connecting element, wavy sweep, repeats in its whole mould bases. In Figure 11 A, the first and second connecting elements are linear.

Figure 11 B shows the sectional pattern of the mould bases with another spiral pattern. Ring week, element was marked as 465-472, and its, element was to being shown as 465,466 in medium ring week; 467,468; 469,470 and 471,472. In this embodiment, spiral pattern by connect adjacent two pairs ring week element connecting element (the second connecting element) 473,477, ring week element wavy sweep 474,476,478, and ring week element between connecting element (the first connecting element) 475,479 alternating pattern formed. In this embodiment, spiral pattern has the following repetitive sequence started from mould bases one end: the second connecting element, wavy sweep, the first connecting element, wavy sweep, and it repeats in whole mould bases. In Figure 11 B, the first and second connecting elements are S shape.

A problem in prior art design is when mould bases is expanded, and forms the wavy flexural deformation of adjacent ring week element. The present invention is designed as Curve guide impeller.

Figure 12 illustrate adjacent ring week element between connecting element functional. 199 and 200 is ring week element pair. Illustrate the connecting element of three types: linear 201 and shaped form 202,203. When mould bases is expanded, connecting element 201 is restrictive and can not allow the expansion of ring week element; But, connecting element 203 or 203 restricted less also allows expansion, without make adjacent pairs ring week deformed element beyond plane 197,198.

Figure 13 illustrates mould bases and the connecting element geometry when expansion. Ring week, element was to being shown as 206,207. The connecting element (the first connecting element) formed between the wavy bending of ring week element pair is marked as 208-210. To between connecting element be marked as 213. The geometric figure of expansion illustrates by forming triangle with 211,212 and 213. 208 and 210 are marked as 215,216 relative to the angle of cylinder axis formation. 211,212 and 213 angles formed are marked as 214. After expansion, angle 214 ', 215 ' and 216 ' all increases.

Figure 14 A and Figure 14 B illustrate the multiple embodiments of the geometrical shapes of connecting element, described connecting element may be located at the ring week of a centering between element (the first connecting element) or adjacent ring week element between (the second connecting element). Connecting element can be S shape, 217,217 ', 401,404-409, linear, 218,410,218 ', 413 (bendings), concave/convex, 219,219 ', 411,412, shaped form, 402,403,414. Connecting element can connect the arbitrfary point on adjacent ring week element, including: the arbitrfary point on the rising part (415,416,419,420,421,422,423,424,429,430,433) of peak (426,428), paddy (425,427) or wavy bending or sloping portion (417,418,431,432,434).

Figure 14 C shows, attach in the wavy bending of ring week element in one end of connecting element some time, the other end of connecting element can attach to the directly corresponding peaks or valleys of adjacent ring week element, or attaches to skew 1,2,3,4,5,6,7,8,9 ... the point (this skew can be in either direction) of N (N can be any positive integer) individual wavy bending. In Figure 14 C, the two ends of connecting element are: 480 (peaks), 481 (paddy); 482 (peaks), 483 (paddy of 1 wavy bending of skew); 484 (peaks), 485 (paddy of 1 wavy bending of skew); 486 (paddy), 487 (peaks).

Figure 15 A-E illustrates that connecting element can along the position of wavy bending attachment. Connecting element is shown as linear herein; But, this shape is merely shown as the purpose of illustration, and connecting element can be any other shape that shaped form or S shape or the present invention contain. Embodiment shown here is applicable to the first and second connecting elements. Also show the cylinder axis of mould bases. Connecting element 220 can attach to the paddy 221 of a wavy bending and the peak 222 (Figure 15 A) of another wavy bending. Or, connecting element 224 can attach to the paddy of two wavy bendings or the either side (Figure 15 B) at peak 223,225. Connecting element 227 can attach to the paddy 226,228 (Figure 15 C) of two wavy bendings. Connecting element 230 also can attach to peak 229 and the paddy 231 (Figure 15 D) of two wavy bendings. Connecting element 234 also can attach to the rising part 232,235 (Figure 15 E) of two wavy bendings. Figure shown here illustrates the connecting element attaching to relative wavy bending; But, connecting element can attach to the wavy bending (Figure 16) (236-238) relative to cylinder axis radial deflection.

Can carrying out labelling mould bases proximally and distally relative to heart, near-end is nearest from aortic valve. Term peak and valley is proximally and distally arbitrarily definition relative to mould bases.

Figure 17 A1,17A2 and Figure 17 B show the example of the phase place (phasing) in adjacent ring week element. In Figure 17 A1, element 239,240 homophase (comparing cylinder axis 243 and 244) each other in ring week. In Figure 17 A2, ring week element 239 and 250 be part out-phase. On the contrary, in Figure 17 B, ring week element 242,247 180 ° of out-phase (comparing 245 and 248) each other.

Figure 18 shows the sectional pattern of the another embodiment of mould bases. Ring week, element was marked as 301-308, and its, element was to being shown as 301,302 in medium ring week; 303,304; 305,306; And 307,308. Spiral pattern is shown as 309-317, and comprise ring week element between connecting element (the second connecting element) 309,311,313,315 and 317 and form the alternating pattern of ring week of a pair connecting element (the first connecting element) 310,312,314 and 316 between element. Mould bases shown in figure contains more than one spiral pattern 318-320.

Figure 19 A schematically depict the profile of the mould bases according to one embodiment of the invention. Mould bases include three longitudinally adjacent ring week element 2010,2020 and 2030, one pair of which ring week, element 2010 was connected by the first connecting element 2012 (it is straight) with 2020, and ring week element 2020 be connected by the second connecting element 2022 (it is S shape) with 2030. Element 2010 and 2030 was illustrated as and included zigzag wave sigmoid pattern ring week, and it is made up of multiple line elements. Ring week, element 2020 can include wavy pattern 2050 (shade/dark parts), and it illustrates further below in association with Figure 19 B. For illustrative purposes, on the sectional view of wavy pattern 2050 overlap crenellation pattern in fig. 19 a.

Figure 19 B is the close up view of part in Figure 19 A, it also illustrates the detailed construction of wavy pattern 2050. In the wavy pattern 2050 described in fig. 19b, each wavy bending (namely contain peak and the paddy that is adjacent ring week element the repetitive of wavy bending pattern) include multiple linear sections 2051,2052,2053,2054,2055 and 2056 being serially connected. When mould bases is in expansion state, each linear sections not with the linear sections conllinear of adjacent connection. Linear sections in a wavy bending is similar to the cycle of sine wave jointly.

Although each wavy bending of the wavy pattern shown in Figure 19 A and 19B includes 6 linear sections, it is also possible to use each greater number of sections of wavy bending, for instance 8,10,12,16,20,24,32,36,48,64 etc. Each linear sections can be roughly the same length (change < 10%), or its length can change according to the expectations or needs. The shaped form sections of a series of connection can also be used to form wavy pattern. Such as, each wavy bending of mould bases includes a series of wavelet sigmoid or wavelet, and as shown in fig. 19d, 6 the shaped form sections wherein constituting wavy bending are marked as 2051a, 2052a, 2053a, 2054a, 2055a and 2056a. (Figure 19 C depicts the wavy pattern identical with shown by Figure 19 B, is different in that and with the addition of wavy elastic line, its as shown in Figure 19 D ring week element centrage). The number of the shaped form sections forming wavy pattern can also more than 6, for instance 8,10,12,16,20,24,32,36,48,64 etc. The shaped form sections in a wavy bending in Figure 19 D is also similar to the cycle of sine wave jointly.

Compared with two local stress points in the wavy bending in conventional Mold Base Design, such wavy pattern allows mould bases (mould bases especially being induced the polymeric material of crystallization to make by being expanded by mould bases) to have extra local stress point. Therefore, wavy pattern allows the stress being derived from the radial dilatation of mould bases to be more uniformly distributed along ring week element, and allows the distribution evenly of the derivative crystallization of polymeric material. As a result of which it is, the described mould bases including wavy pattern can have higher radial strength, acute retraction after the deployment that reduces and the creep that reduces.

Connecting element shown in Figure 19 A and 19B is linear or S shape. In other embodiments, connecting element can also include the wavy pattern with multiple linear sections or the shaped form sections linked together.

Although Figure 19 A and 19B illustrates the wavy pattern in ring week element 2020 in two wavy bendings of continuous print, but in further embodiment, such wavy pattern can cross over whole ring week element 2020. In other embodiments, all of ring week element can be made up of the wavy pattern repeated, as shown in Figure 20-27.

Figure 20 A illustrates the embodiment of the mould bases of the present invention, and wherein each ring week element is made up of the wavy pattern repeated. Ring week, element was marked as 321-330, and its, element was to being shown as 321,322 in medium ring week; 323,324; 325,326; 327,328 and 329,330. The peak and valley of mould bases can be substantially homophase. Using three connecting elements between element in the ring week that each two is longitudinally adjacent, on each ring week element, the wavy bending of each two uses one. Longitudinally adjacent ring week element 321 with 322 332 be connected to by straight (or linear) first ring week element; And longitudinally adjacent ring week element 322 with 323 to by S shape second ring week element 333 be connected. First connecting element 332 connects the paddy 3222 at the peak 3211 of ring week element 321 and ring week element 322. Second connecting element 333 connect paddy 3222 and adjacent with paddy 3232 ring week element 323 peak 3234 (paddy 3232 is longitudinally-aligned with paddy 3222). Above-mentioned connecting pattern repeats in whole support and forms spiral type, and it includes connecting element 331-340. Two labelling points 1902 and 1904 be positioned at mould bases every one end (first pair ring week element and last in the connecting element between ring week element).

The detailed view of the molded base part in Figure 20 A is shown in Figure 20 B-20E. In Figure 20 D, it is shown that the close-up sectional view of Figure 20 A, to be further illustrated by the wavy pattern repeated. In the present embodiment, two longitudinally adjacent ring week elements are shown as 353,354. They are connected by connecting element (the first connecting element) 355 and 356. The linear sections constituting the wavy pattern repeated is shown as 341-352.

Figure 20 F illustrates the sectional view of labelling point 1904, and it takes the shape of cup, and it has depression to hold radiopaque label at center. Figure 20 G is the side view of mould bases shown in Figure 20 A. Ring week, element was marked as 361-368, and formation is to 374-377. In ring week of centering, the connecting element between element is shown as 369,371 and 373, and the connecting element between two pairs of ring week elements is marked as 370,372. Connecting element 369-373 forms spiral type.

Figure 21 A illustrates the three-dimensional side view of the expansion molded base part according to one embodiment of the invention, and it includes the wavy pattern described in Figure 19 A-19B. Show three longitudinally adjacent ring week element 2110,2120 and 2130. Ring week, element 2110 and 2120 connected by the first straight connecting element 2115. Ring week, element 2120 and 2130 connected by the second connecting element 2125 of S shape. The exemplary dimensions of the various elements of mould bases can be such that the width w1 of the first connecting element can be about 100-200 μm, for instance 140-160 μm; The thickness d 1 of the first connecting element can be about 100-200 μm, for instance 120-150 μm; The width w2 of the second connecting element 2125 of S shape can be about 100-200 μm, for instance 150-180 μm; The width w3 of the linear sections constituting wavy pattern can be about 100-250 μm, for instance shown 160-200 μm. Figure 21 B is the three-dimensional side view of the another part of the expansion mould bases described in Figure 21 A. Figure 21 C is another 3-D view of the expansion mould bases described in Figure 21 A, it illustrates the labelling point 2148 being positioned in the middle part of connecting element 2145, this connecting element 2145 connect be positioned at one of mould bases vertical adterminal two ring week element 2140 and 2150. Labelling point can take the cup-like configuration shown in Figure 19 F.

Figure 22 A illustrates the section view pattern of the mould bases according to one embodiment of the invention, and wherein each ring week element wavy pattern described in Figure 19 A-19B all completely forms. This mould bases includes ring week element 2210,2215,2220,2225,2230,2235,2240,2245,2250,2255,2260,2265 and 2270. Each ring week, element included 6 wavy bending (u1, u2, u3, u4, u5, u6; As shown in the figure), and these in ring week element peak and valley alternately be all substantially homophase. For on ring week element every a paddy, the longitudinally adjacent ring week element of each two in 2215,2220,2225,2230,2235,2240,2245,2250,2255,2260 and 2265 all passes sequentially through S shape connecting element 2217,2222,2227,2232,2237,2242,2247,2252 and 2257 paddy and connects to peak.

Each ring week, the amplitude of wavy bending of element can be identical or different. The length of S shape connecting element 2217,2222,2227,2232,2237,2242,2247,2252 and 2257 can also be different. In one embodiment, two longitudinally adjacent ring week element the amplitude of wavy bending and the S shape connecting element being disposed there between may be designed so that, it makes when support is curled, S shape connecting element can be positioned in the profile of wavy bending, it is not necessary to bends out the tubular surface formed by ring week element.

For each wavy bending, the ring week element at this mould bases near-end 2210 and 2215 can be connected to valley floor by straight connecting element 2212 paddy. Ring week, the near-end pair of element 2210 and 2215 collectively formed proximal end region with connecting element 2212. The ring week element 2260 and 2270 of mould bases far-end wavy can be connected each by straight connecting element 2262 with being bent into peak to peak. Ring week element 2260 and 2270 and connecting element 2262 collectively form distal area. Although proximal end region and distal area both illustratively comprise two ring week elements substantially in phase, but in the two region any one or the two can also include the ring week element of two phase offset (such as 180 degree of out-phase), as in those embodiments shown in Figure 25 A and Figure 26 A. Labelling point 2282 and 2284 lays respectively in the connecting element of the connecting element of the near-end pair of connection ring week element 2210 and 2215 and the far-end pair of connection ring week element 2260 and 2270.

In mould bases shown in Figure 22 A, adjacent ring week element and ring week componentry between connecting element form the spirality pattern crossing over mould bases. In order to illustrate, for longitudinally adjacent ring week element 2250 and 2255, connecting element 2252 connects paddy 2251 and the peak 2256 (paddy 2253 with paddy 2251 longitudinally-aligned) adjacent with paddy 2253. Similarly, for longitudinally adjacent ring week element 2255 and 2260, connecting element 2257 connects paddy 2258 and the peak 2261 (paddy 2264 with paddy 2258 longitudinally-aligned) adjacent with paddy 2264. Therefore, ring week element 2250 part between connecting element 2247, peak 2246 and paddy 2251, connecting element 2252, ring week element 2255 part between peak 2256 and paddy 2258, then connecting element 2258 form continuous print spiral.

Figure 22 B illustrates the section view pattern of the mould bases according to another embodiment of the invention, and wherein each ring week element wavy pattern described in Figure 19 A and 19B completely forms. This section view pattern is substantially identical with the pattern described in Figure 22 A, each ring week element that difference is in that in this pattern includes 8 wavy bending (u1, u2, u3, u4, u5, u6, u7, u8, as shown in the figure), rather than the wavy bending in 6 shown in Figure 22 A.

Figure 23 illustrates the section view pattern of the mould bases according to another embodiment of the invention, and it includes the wavy pattern described in Figure 19 A and 19B. Mould bases includes ring week element 2310,2320,2330,2340,2350,2360,2370,2380, and it is sequentially connected with by connecting element 2312,2322,2332,2342,2352,2362,2372. Layout between ring week element 2300 and 2370 is similar to the pattern between elements 2200 and 2255 of the ring week in Figure 22 (S shape connecting element peak connect to valley floor adjacent ring week element to) in connecting pattern. Ring week, the straight connecting element 2312 that can pass through diagonal angle connect (paddy is to peak) by the near-end of element 2310 and 2320. Ring week, the straight connecting element 2372 that can pass through diagonal angle connect (paddy is to peak) by the far-end of element 2370 and 2380. Labelling point 2385 and 2387 lays respectively in the connecting element of the connecting element of the near-end pair of connection ring week element 2310 and 2320 and the far-end pair of connection ring week element 2370 and 2380.

Figure 24 illustrates the sectional view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern described in Figure 19 A and 19B. Mould bases includes ring week element 2410,2420,2430,2440,2450,2460 and 2470, and it is sequentially connected with by connecting element 2412,2422,2432,2442,2452 and 2462. Each ring week, element included 6 wavy bendings, and these in ring week element peak and valley alternately be substantially all homophase relative to cylinder axis. For on ring week element every a peak (or paddy), the longitudinally adjacent ring week element of each two is that peak connects to valley floor by the linear connecting element at diagonal angle. Connecting element is all substantially parallel to each other, and collectively forms, with ring week componentry, the spirality pattern crossing over mould bases. In order to illustrate, for longitudinally adjacent ring week element 2420 and 2430, connecting element 2422 connecting peak 2421 and the paddy 2431 adjacent with peak 2433 (it is longitudinally-aligned with paddy 2421). Similarly, for longitudinally adjacent ring week element 2430 and 2440, connecting element 2432 connecting peak 2435 and the paddy 2445 adjacent with peak 2443 (it is longitudinally-aligned with peak 2435). Therefore, ring week element 2430 part between connecting element 2422, paddy 2431 and peak 2435, ring week element 2440 part between connecting element 2432,2445 and peak 2446, form continuous print spiral followed by connecting element 2242.

Figure 25 A illustrates the section view pattern of the mould bases according to another embodiment of the invention, and wherein each ring week element wavy pattern described in Figure 19 A and 19B completely forms. Mould bases includes ring week element 2510,2515,2520,2525,2530,2535,2540,2545,2550,2555,2560,2565,2570,2575,2580, and it is sequentially connected with by connecting element 2512,2517,2522,2527,2532,2537,2542,2547,2552,2557,2562,2567,2572 and 2577. Each ring week, element included 6 wavy bending (u1, u2, u3, u4, u5, u6, as shown in the figure), and these, peak and valley alternately of element was substantially homophase in ring week, except first ring week element 2510 and last ring week element 2580, it is 180 degree of out-phase (or relative) with remaining ring week element. Except at first two ring week element 2510 and 2515 and latter two ring week element 2575 and 2580 (it can be connected to valley floor by longitudinally-aligned linear connecting element 2512 and 2577 peak for each wavy bending), each remaining longitudinally adjacent ring week, element was to being connected to paddy (or peak to peak) for each two wavy bending paddy by longitudinally-aligned linear connecting element. Ring week, the near-end pair of element 2510 and 2515 collectively formed proximal end region with connecting element 2512. Ring week, the far-end pair of element 2575 and 2580 collectively formed distal area with connecting element 2577. Although proximal end region and distal area both are shown as including the ring week element of two substantially 180 degree of out-phase (or toward each other), but in the two region any one or the two can also include the ring week element of two substantially homophases, such as those embodiments as shown in Figure 22 A.

In the mould bases shown in Figure 25 A, connecting element collectively forms, with ring week componentry, the spirality pattern crossing over mould bases. In order to illustrate, for longitudinally adjacent ring week element 2525 and 2530, connecting element 2527 connects paddy 2524 and the paddy 2531 (peak 2529 with peak 2523 longitudinally-aligned) adjacent with peak 2529. Similarly, for longitudinally adjacent ring week element 2530 and 2535, connecting element 2532 connecting peak 2533 and the peak 2534 (paddy 2538 with paddy 2531 longitudinally-aligned) adjacent with paddy 2538. Therefore, connecting element 2527, ring week element 2530 part between paddy 2431 and peak 2435, connecting element 2432, ring week element 2440 part between paddy 2531 and peak 2533, followed by connecting element 2532, (it continues to include connecting element 2537,2542,2547,2552,2557,2562 and 2567 to form continuous print spiral type, and the part between peak and its adjacent paddy on each ring week element, ring week element intersects with connecting element there.

Figure 25 B illustrates the section view pattern of the mould bases according to another embodiment of the invention, and wherein each ring week element wavy pattern described in Figure 19 A-19B completely forms. This section view pattern is substantially identical with the pattern described in Figure 25 A, each ring week element that difference is in that in this pattern includes 8 wavy bending (u1, u2, u3, u4, u5, u6, u7, u8, as shown in the figure), rather than the wavy bending in 6 shown in Figure 22 A.

Figure 26 A illustrates the section view pattern of the mould bases according to another embodiment of the invention, and wherein each ring week element wavy pattern described in Figure 19 A-19B completely forms. Mould bases includes ring week element 2610,2615,2620,2625,2630,2635,2640,2645,2650,2655,2660,2665,2670,2675 and 2680, and it is sequentially connected with by connecting element 2612,2617,2622,2627,2632,2637,2642,2647,2652,2657,2662,2667,2672 and 2677. Each ring week, element included 6 wavy bending (u1, u2, u3, u4, u5, u6, as shown in the figure), and these, peak and valley alternately of element was substantially homophase in ring week, except first ring week element 2610 and last ring week element 2680, it is 180 degree of out-phase (or relative) with remaining ring week element. Except at first two ring week element 2610,2615 and except latter two ring week element 2675,2680 (it can connect to valley floor respectively through longitudinally-aligned linear connecting element 2612 and 2677 peak for each wavy bending), each remaining longitudinally adjacent ring week, element was to being bent into paddy by longitudinally-aligned linear connecting element connect to paddy (or peak to peak) for each two is wavy. Ring week, the near-end pair of element 2610 and 2615 collectively formed proximal end region with connecting element 2612. Ring week, the far-end pair of element 2675 and 2680 collectively formed distal area with connecting element 2677. Although proximal end region and distal area both are shown as including the ring week element of two substantially 180 degree of out-phase (or toward each other), but in the two region any one or the two can also include the ring week element of two substantially homophases, such as those embodiments as shown in Figure 22 A.

Compared with design depicted in figure 25 (wherein connecting element and ring week componentry formation continuous print spiral type), first connecting element (2617,2627,2637,2647,2657 and 2667) of the present embodiment is longitudinally-aligned each other, second connecting element (2612,2622,2632,2642,2652,2662 and 2672) is also alignd longitudinally of one another, and the first connecting element and that the second connecting element is interleaved with and offset a complete wavy bending. Labelling point 2685 and 2687 lays respectively in the connecting element of the connecting element of the near-end pair of connection ring week element 2610 and 2615 and the far-end pair of connection ring week element 2675 and 2680.

Figure 26 B illustrates the section view pattern of the mould bases according to another embodiment of the invention, and wherein each ring week element wavy pattern described in Figure 19 A-19B completely forms. This section view pattern is substantially identical with the pattern described in Figure 26 A, each ring week element that difference is in that in this pattern includes 8 wavy bending (u1, u2, u3, u4, u5, u6, u7, u8, as shown in the figure), rather than the wavy bending in 6 shown in Figure 22 A.

Figure 27 A is the 3-D view of the mould bases according to another embodiment of the invention, and it includes the wavy pattern shown in Figure 19 A-19B. Figure 27 B is the back view of the amplification of the mould bases described in Figure 27 A. Shown in Figure 27 A be two ring week element 2710 and 2720, its by ring week element 2710 peak 2712 and ring week element 2720 paddy 2722 (it has the phase offset of 180 degree with peak 2712) between linear connecting element 2715 be connected. Ring week, element 2710 was connected to previous ring week element (not shown) also by the connecting element 2705 of S shape. Two connecting elements 2705 and 2715 all 2710 are connected with ring week element at same peak 2712 place. Connecting element 2715 connects with peak 2712 to form angle 2730 and more big angle 2735 relative with acute angle 2730. Angle 2735 can be obtuse angle (more than 90 degree and less than 180 degree), or more than 180 degree. The intersection at connecting element 2715 and peak 2712 and arrange in angle 2735 recess (recess can be connecting element or ring week element slightly depression or the minimizing of thickness, and can take variously-shaped, such as V-arrangement, U-shaped etc.). Such recess is folding with fatigue strength or the deformation of reduction thus contributing to curling and expansion at folding or curling point by the linear sections making wavy pattern. Recess can also be arranged on the both sides of ring week element, and can be disposed along in other point (connecting element and ring week element intersect herein) of ring week element. Recess can also be distributed in any other way along ring week element. Recess can also use together with conventional ring week element (such as the mould bases shown in Fig. 1) not including wavy pattern.

Mould bases can further include at least one radiopaque label, and it can be accommodated in labelling as herein described point. Radiopaque label can present various different size and shape. Radiopaque label can be that electronics is intensive or the label of refrangible x-ray, such as metallic or salt. The limiting examples of suitable label metal includes ferrum, gold, collargol, zinc and magnesium, and it is pure form or organic compound. Other radiopaque materials are tantalum, tungsten, platinum/iridium or platinum. Heavy metal and heavy soil element can be used for various compound such as ferrous salt, organic iodine material, bismuth or barium salt etc. Utilizable further embodiment can comprise the iron particle such as ferritin of natural encapsulation, and it can pass through cross-linking agent and cross-link further. Ferritin gel can be made up of by cross-linking the glutaraldehyde of low concentration (0.1-2%). Radiopaque label can be constituted together with the binding agent of one or more biodegradable polymer, described polymer such as PLLA, PDLA, PLGA, PEG etc. In the embodiment comprising radiopaque label, the compound of iron content or iron particle are encapsulated in PLLA polymeric matrix to generate pasty mass, and it can be injected or be otherwise disposed in the hollow container that a frame peripheral contains. In another embodiment, label can be made up of the material of biodegradable or biological absorbable.

Mould bases can also have transition region between petiolarea and main body. Transition region wavy can be bent to form by multiple, and each wavy bending comprises two the adjacent connecting elements connected by loop, and the width of loop changes in whole transition region. Transition region can comprise multiple polygon, and wherein the surface area circumference of the adjacent polygons in transition region increases. U.S. Patent Publication No. 20110125251. Transition region can take the setting that other are suitable.

The size of mould bases can change in following scope: length is about 10mm to about 300mm, length is about 20mm to about 300mm, and length is about 40mm to about 300mm, and length is about 20mm to about 200mm, length is about 60mm to about 150mm, or length is about 80mm to about 120mm. The internal diameter (I.D.) of support can range from about 2mm to about 25mm, about 2mm to about 5mm (such as, for coronary artery), about 4mm to about 8mm (such as, nervous system space in vascular and nonvascular CNS), about 6mm to about 12mm (such as, for ilium stock), about 10mm to about 20mm (such as, for iliac artery) and about 10mm to about 25mm (such as, for large artery trunks).

Assembly of the invention can serve as self-expanding support or uses together with free kick ductus bursae stent delivery system, including U.S. Patent number 6,168,617,6,222,097,6,331,186 and 6, and 478, the foley's tube stent delivery system recorded in 814. In one embodiment, the balloon catheter system disclosed in assembly of the invention and U.S. Patent number 7,169,162 uses together.

The mould bases of the present invention can use together with arbitrarily applicable conduit, and the diameter range of described conduit can be about 0.8mm to about 5.5mm, about 1.0mm to about 4.5mm, about 1.2mm to about 2.2mm or about 1.8mm to about 3mm. In one embodiment, the diameter of conduit is about 6French (2mm). In another embodiment, the diameter of conduit is about 5French (1.7mm).

Mould bases can be inserted in tube chamber or the body cavity of any vascular, expands its cross section tube chamber. The present invention in any tremulous pulse, vein, pipeline or the expansion as ureter or urethra in of other pipes, and can be used for treating narrowing or narrow of any tremulous pulse of including tremulous pulse under coronary artery, groin, main iliac artery, subclavian artery, Mesenteric artery or renal artery. Present invention also contemplates that other kinds of vascular blocks, those as caused by dissecting aneurysm. Can use the mould bases of the present invention and the experimenter of method treatment is mammal, including people, horse, Canis familiaris L., cat, pig, rabbit, rodent, monkey etc.

The mould bases of the present invention can by can at least one biologically absorbable polymer of crystallization being formed of different polymer representing wide scope. Generally, biologically absorbable polymer comprises the such as PLLA (PLLA) of the aliphatic polyester based on lactide main chain as homopolymer or copolymer, poly-D-lactide (PDLA), poly-D, L-lactide, Study of Meso-Lactide (mesolactide), Acetic acid, hydroxy-, bimol. cyclic ester, lactone, and formed in the copolymer portion with comonomer such as trimethylene carbonate (TMC) or 6-caprolactone (ECL). U.S. Patent number 6,706,854 and 6,607,548; EP0401844; And Jeonetal.SynthesisandCharacterizationofPoly(L-lactide)–Poly(ε-caprolactone) .MultiblockCopolymersMacromolecules2003:36,5585-5592. Copolymer comprises part such as the L-lactide or D-lactide with sufficient length so that copolymer energy crystallization and not because exist Acetic acid, hydroxy-, bimol. cyclic ester, Polyethylene Glycol (PEG), 6-caprolactone, trimethylene carbonate or mono methoxy end-blocking PEG (PEG-MME) and produce sterically hindered. Such as, in certain embodiments, more than 10, L or the D-lactide of 100 or 250 can arrange in the polymer in order. Support also can by biologically absorbable polymer compositions (such as U.S. Patent number 7,846,361; 7,897,224 and 8,137,603; And those disclosed in the U.S. Patent Publication No. 2010/0093946 of applicants co-pending) composition.

Based on the monomer type existed, following polymer can be used to name.

In embodiments of the invention, compositions comprises the base polymer of poly-(L-lactide) or PDLA. Other base polymeric composition include the blend gathering (L-lactide) and PDLA. Other favourable base polymeric composition include the D containing 10 to 30%, poly-(the L-lactide-co-d of L-lactide comonomer molar ratio, L-lactide) or poly-(D-lactide-co-d, L-lactide), and poly-(the L-lactide-co-glycolide) or poly-(D-lactide-co-glycolide) of the glycolide-co monomer mole ratio containing 10 to 20%.

Another embodiment comprises such base polymer: it is characterized in that gathering (L-lactide) part and/or PDLA part, modify copolymer with the form of block copolymer or blocky random copolymers with it to be connected, including gathering, (L-lactide-co-trimethylene carbonate or poly-(D-lactide-co-trimethylene carbonate) and (L-lactide-co-6-caprolactone) or poly-(D-lactide-co-6-caprolactone), wherein lactide chain length is enough to affect the crystallization of cross section. The cross section crystallization of the compositions containing copolymer provides the Moduli data of increase in tension test, it is to avoid the method reducing the hot strength of blend polymer.

Polymer composition can allow occur lactide racemate (stereo complex) crystal structure between L and D part, to improve the mechanical performance of biologically absorbable polymer medical treatment device further. The formation of racemate (stereo complex) crystal structure can be produced by the formula of such as following combination:

PLLA and poly-D-lactide and PLLA-co-TMC;

Poly-D-lactide and PLLA-co-TMC;

PLLA and poly-D-lactide-co-TMC;

PLLA and poly-D-lactide and poly-D-lactide-co-TMC;

PLLA-co-PEG and poly-D-lactide-co-TMC; And

Poly-D-lactide-co-PEG and PLLA-co-TMC.

Poly-lactide racemate compositions can be " capable of cold forming or bending ", does not need other heating. The present invention mould bases of cold bend(ing) can need not beat and can have enough flexibilities to be curled on carrier arrangement or to adapt to erose organ space. The ambient temperature of cold bend(ing) can be defined as room temperature, less than 30 DEG C. The mould bases of cold bend(ing) can provide enough flexibility when implanted, it is allowed to die set device is expansion in organ space (as the vessel lumen beaten). Such as, with regard to support, it is desirable to provide after fabrication the polymer composition of major part amorphous polymer, when making mould bases be tightened up when sacculus is expanded to implant by stretching, this polymer composition is particularly two grades of nestings or can crystallization when being positioned at the tortuous connecting element of end. This type of can the polymer mould bases embodiment of cold bend(ing) be not fragility and be implanted to internal contoured surface spatially before need not be preheated to flexible state. Cold bend(ing) makes these blends at room temperature be curled and not break, and, these blends can be expanded in physiological conditions and not break.

Poly-lactide racemate compositions and the non-racemic compositions of this paper embodiment can be processed to have block section, and it allows cross section crystallization, or even is also such when adding impact modifier in blend composition. Such blend introduces by producing one or two Tg (glass dissolution transition point) and the probability of the specific polymer composition of design apparatus or blend.

As understood in the art, the polymer composition of the customizable present invention is to adapt to the various requirement of selected medical treatment device. These requirements include mechanical strength, elasticity, flexibility, resilience and the degradation rate under physiology and local anatomical condition. Other effects of specificity group compound relate to any rate of release of attached by the dissolubility of metabolite, hydrophilic and water absorption and substrate or encapsulating medicine.

The effectiveness of polymeric implant can be evaluated by measuring mass loss, molecular weight reduction, the reservation of mechanical performance and/or tissue reaction. To mould bases performance more crucially hydrolytic stability, thermal transition degree of crystallinity and orientation. The determiner of other negative effect mould bases performances include but not limited to, monomelic impurities, ring-type and non-annularity oligomer, fault of construction and aging.

The mould bases made by above-mentioned polymer composition can be significantly amorphous after extruding or molding. Mould bases can carry out controlled re-crystallization strengthen with increment and the mechanical strength of induced crystallinity. Further crystallization can be introduced by the strain when device launches and induce. Such increment recrystallization can in the upper application of mould bases " blank (blank) " before secondary or final manufacture (as passed through cut) or after such secondary manufacture. Crystallization (and therefore mechanical performance) can also maximize by strain inducing before manufacturing further, as drawn polymer pipe, doughnut, sheet or film or monofilament by " cold ". Have observed that degree of crystallinity in mould bases, contribute bigger hardness. Therefore, the polymer composition of mould bases and stereo complex have both amorphous and para-crystal part. The polymer moieties being initially hemihedral crystal can be processed by the stretching of setter or expansion action. And the amorphous polymer feature of q.s is desired for flexibility and the elasticity of polymeric device. Common monomer component includes lactide, Acetic acid, hydroxy-, bimol. cyclic ester, caprolactone, two alkanone (dioxanone) and trimethylene carbonate. Support can also be built as allowing relatively evenly to be exposed to the local organization irrigating and acting on polymer architecture or circulating biological active factors and enzyme in bioadsorption processes.

The decomposition in situ kinetic rate of the polymeric matrix of organ space implant (such as angiocarpy bracket) be enough gradually to avoid tissue overload, inflammatory reaction or other more adverse consequencess. In one embodiment, mould bases is made into there are at least 1,2,3,4,5,6,7,8,9,10,11,12,24 or 36 months.

Pharmaceutical composition can be incorporated in polymer, for instance, by being grafted to polymer active site, or coating. The embodiment of the polymer of the present invention provides and is attached in polymeric matrix or polymer coating or is incorporated to the Biotherapeutics factor or other drug.

In another embodiment, compositions may be constructed in the medicine structurally encapsulated or be attached in polymeric matrix. The purpose of these additives is for such as support, it is possible to be to provide to cardiovascular system treatment or with the treatment in the vascular site of medical treatment device polymer contact. Encapsulating or the attachment type of polymer Chinese medicine may decide that the speed from mould bases release. Such as, medicine or other additives can pass through various known methods (including but not limited to covalent bond, nonpolar bond and ester bond or similar bioreversible bonding pattern) and be incorporated in polymeric matrix.

In one embodiment, the implantable medical device of biological absorbable can be covered by the coating of the biodegradable containing one or more barrier layers and biological absorbable, and wherein polymeric matrix contains the drug substance that one or more are above-mentioned. In this embodiment, barrier layer can comprise applicable Biodegradable material, includes but not limited to the biodegradable polymer being suitable for, including: polyester such as PLA, PGA, PLGA, PPF, PCL, PCC, TMC and these any copolymer; Polycarboxylic acids, condensing model, including maleic anhydride polymer; Poe; Poly-aminoacid; Poly(ethylene oxide); Polyphosphazene (polyphosphacenes); Polylactic acid, polyglycolic acid and copolymer thereof and mixture, such as PLLA (PLLA), PLA, poly-(lactide-co-hydroxyacetic acid), 50/50 (DL-lactide-co-glycolide); Poly-two alkanone; Poly-fumaric acid Asia propyl ester; Bunching peptide; Polycaprolactone and copolymer thereof and mixture, such as poly-(D, L-lactide-co-caprolactone) and polycaprolactone-co-butyl acrylate; Polyhydroxybutyrate valerate and blend; Merlon is as come from Merlon and arylide, poly-iminocarbonic ester and the polydimethyltrimethyl carbonic ester of tyrosine; Cyanoacrylate; Calcium phosphate; Poly-glucose aminopolysaccharide (polyglycosaminoglycans); Macromole such as polysaccharide (includes hyaluronic acid; Cellulose and hydroxypropyl methyl cellulose; Gelatin; Starch; Glucosan; Alginate and derivant thereof), proteins and peptides; And the mixture of above-mentioned arbitrary substance and copolymer. Biodegradable polymer can also be the polymer of surface erodable, such as poly butyric ester and copolymer, polycaprolactone, condensing model (crystallization and amorphous), copolymer-maleic anhydride and calcium zinc orthophosphate activated by thallium. The number on the barrier layer that the polymer support on device can have depends on the treatment requirement that the treatment required by patient is indicated. Such as, treating more long, the treatment material needed in a period of time is more many, and barrier layer is more many to provide medicine in time.

In another embodiment, additive in polymer composition can be the form of Medium Culture multicomponent pharmaceutical compositions, if (lastrelease) pharmaceutical preparation containing sustained release is to postpone early stage neointimal hyperplasia/smooth muscle cell migration and propagation, with complementary Biostatic substrate, the release of this complementary Biostatic substrate is for maintaining the open long term agent of vascular or positive reconstructing blood vessel agent, such as endothelial nitric oxide synthase (eNOS), nitric oxide donors and derivant such as aspirin or derivatives thereof, produce nitric oxide production hydrogel, PPAR agonist such as PPAR-alpha ligands (PPAR-α gands), tissue-type plasminogen activator, statins is atorvastatin such as, erythropoietin, darbepoetin (darbepotin), serine protease (SERP-1) and pravastatin, steroidal and/or antibiotic.

Pharmaceutical composition can be incorporated in polymer or can by spraying, impregnating or smear and be coated on the surface of polymer or then can be blended in polymeric blends by microencapsulation after mixing and extruding. U.S. Patent number 6,020,385. Can they pass through special-shaped or homotype bi-functional cross-linking agent link (referring to, http://www.piercenet.com/products/browse.cfm if pharmaceutical composition is covalently bonded to blend polymer? fldID=020306).

Can be incorporated in mould bases the pharmaceutical preparation that maybe can be applied on mould bases include but not limited to (i) pharmacological agents as, (a) antithrombotic agent such as heparin, heparin derivatives, urokinase and PPack (dextroamphetamine proline acid arginine chloromethyl ketone), (b) antiinflammatory such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine and aminosalicylic acid (mesalamine), (c) antitumor agent/antiproliferative/anti-miotic such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, Epothilones (epothilones), endothelium statin (endostatin), blood vessel statin (angiostatin), angiopeptin (angiopeptin), the monoclonal antibody of smooth muscle cell proliferation can be blocked, thymadine kinase inhibitors, rapamycin (rapamycin), 40-0-(2-ethoxy) rapamycin (everolimus), 40-0-benzyl-rapamycin, 40-0 (4 '-methylol) benzyl-rapamycin, 40-0-[4 '-(1,2-dihydroxy ethyl)] benzyl-rapamycin, 40-pi-allyl-rapamycin, 40-0-[3 '-(2,2-dimethyl-1,3-dioxolanyl-4 (S)-Ji-propyl-2 '-alkene-1 '-Ji)]-20 rapamycins, (2 ': E, 4 ' S)-40-0-(4 ', 5 '.: dihydroxy penta-2 '-alkene-1 '-Ji) rapamycin, 40-0 (2-hydroxyl) ethoxy carbonyl methyl-rapamycin, 40-0-(3-hydroxypropyl)-rapamycin, 40-0-(hydroxyl) hexyl-rapamycin, 40-0-[2-(2-hydroxyl) ethyoxyl] ethyl rapamycin, 40-0-[(3S)-2,2-dimethyldioxolan-3-base] methyl-rapamycin, 40-0-[(2S)-2,3-dihydroxy the third-1-base]-rapamycin, 40-0-(2-acetoxyl group) ethyl rapamycin, 40-0-(2-nicotinylsalicylic oxygen) ethyl rapamycin, 40-0-[2-(N-25 morpholino) Acetoxvethyl]-rapamycin, 40-0-(2-N-imidazole radicals acetoxyl group) ethyl rapamycin, 40-0-[2-(N-methyl-N '-piperazinyl) acetoxyl group] ethyl rapamycin, 39-0-demethyl-3.9,40-0,0 ethylidene-rapamycin, (26R)-26-dihydro-40-0-(2-hydroxyl) ethyl rapamycin, 28-O desmethyl-rapamycin (28-OMethyrapamycin), 40-0-(2-amino-ethyl)-rapamycin, 40-0-(2-acetamidoethyl)-rapamycin, 40-0 (2-nicotinoyl amino-ethyl)-rapamycin, 40-0-(2-(N-methyl-imidazoles-2 '-Ji formamido group) ethyl)-30 rapamycins (40-0-(2-(N-Methyl-imidazo-2'ylcarbcthoxamido) ethyl)-30rapamycin), 40-0-(2-ethoxycarbonylamino group ethyl)-rapamycin, 40-0-(2-tolylsulfonyl-amino-ethyl)-rapamycin, 40-0-[2-(4 ', 5 '-two carbonyl ethyoxyls-1 ', 2 ', 3 '-triazole-1 '-Ji)-ethyl] rapamycin, 42-table-(tetrazole radical)-rapamycin (tacrolimus), and 42-[3-hydroxyl-2-(methylol)-2 Methylpropionic acid ester] rapamycin (CCI-779 (temsirolimus)) (WO2008/086369), d () anesthetis is lignocaine, bupivacaine and ropivacaine such as, (e) anticoagulant such as D-Phe-Pro-Arg chloromethyl ketone, containing the compound of RGD peptide, heparin, hirudin, antithrombase compound, platelet receptor antagonists, antithrombase antibody, antiplatelet receptor antibody, aspirin, prostaglandin inhibitor, platelet suppressant drug and Ticks antiplatelet peptide (tickantiplateletpeptides),(f) vascular cell growth accelerator such as somatomedin, activating transcription factor and translation accelerator, (g) vascular cell growth inhibitor such as growth factor receptor inhibitors, growth factor receptor antagonist, transcription repressor, translation repression thing, replication inhibitors, blocking antibody, the directed antibody of the Developing restraint factor, the bifunctional molecule being made up of somatomedin and cytotoxin, the bifunctional molecule that is made up of antibody and cytotoxin, (h) protein kinase and tyrosine kinase inhibitor (such as, tyrphostin (tyrphostins), genistein (genistein), quinoxaline class (quinoxalines)), (i) prostacyclin (prostacyclin) analog, (j) cholesterol reducing agent, (k) angiogenin (angiopoietins), l () antimicrobial is triclosan, cephalosporins, aminoglycoside and nitrofurantoin such as, (m) cytotoxic agent, cytostatics and cell propagation effect thing (affectors), (n) vasodilation, and (o) disturbs the material of endogenous vasoactive mechanism, (ii) gene therapeutic agents includes antisense DNA and RNA and encodes following DNA:(a) antisense RNA, b () tRNA or rRNA is to replace the endogenous molecule of defect or shortage, c () angiogenesis factor includes somatomedin such as acid and basic fibroblast growth factor, VEGF, epidermal growth factor, transforming growth factor a and P, come from hematoblastic endothelial cell growth factor (ECGF), come from hematoblastic somatomedin, TNFa, hepatocyte growth factor and insulin like growth factor, d () cell cycle inhibitor includes CD inhibitor, (e) thymidine kinase (" TK ") and other can be used for interference cell propagation material.

The other drug that can be incorporated in mould bases includes but not limited to: acarbose (acarbosc), antigen, receptor blocking agent, NSAID (non-steroidal anti-inflammatory drug) (NSAID, cardiac glycoside, aspirin, viral inhibitors (virustatics), aclarubicin, acyclovir, cisplatin, D actinomycin D, α-and β-sympathomimetic (sympatomimetics), (omeprazole (dmeprazole), allopurinol, Alprostadil, prostaglandin, amantadine, Ambroxol, amlodipine, methotrexate, S-aminosallcylic acid, amitriptyline, amoxicillin, Anastrozole, atenolol, azathioprine, balsalazide, beclometasone (beclomcthasone), betahistine, bezafibrate, bicalutamide, diazepam and diazepam derivant, budesonide, bufexamac, buprenorphine (buprcnorphine), methadone, calcium salt, potassium salt, magnesium salt, Candesartan, carbamazepine, captopril, cephalosporin (cefalosporins), cetirizine, chenodeoxycholic acid, ursodesoxycholic acid, theophylline and theophylline derivant, trypsin, cimetidine, clarithromycin, clavulanic acid, clindamycin, clobutinol, clonidine (clonidinc), sulfamethoxazole (cotrimoxazole), codeine, caffeine, the derivant of vitamin D and vitamin D, colestyramine, cromoglicic acid, coumarin and coumarin derivative, cysteine, cytosine arabinoside, cyclophosphamide, ciclosporin, cyproterone, cytabarine, dapiprazole, desogestrel, desonide, dihydralazine, diltiazem, peptide, dimenhydrinate, dimethyl sulfoxide, simethicone, domperidone (domperidone) and domperidone (domperidan) derivant, dopamine, doxazosin, doxorubicin (doxorubizin), doxylamine, dapiprazole, Benzodiazepines, diclofenac, sugar tobramycin antibiotic, desipramine, econazole, ACE inhibitor, enalapril, ephedrine, epinephrine, erythropoietin and erythropoietin derivatives, morphine alkanes, calcium antagonist, according to profit for health, modafinil (modafmil), orlistat, peptide antibiotics, phenytoin, riluzole, Risedronate (risedronate), sldenafil, topiramate (topiramatc), macrolide antibiotics, estradiol and derivatives of estradiol, progestogen and progestin derivative, testosterone and testosterone derivative, androgen and androgen element derivant, ethenzamide, Etofenamate, etofibrate (ctofibrate), fenofibrate (fcnofibrate), etofylline (etofylHne), etoposide, famciclovir, famotidine, felodipine, fenoftbrate, fentanyl, fenticonazole, gyrase inhibitors, fluconazol, fludarabine, flunarizine (fluarizine), fluorouracil, fluoxetine, flurbiprofen, ibuprofen, flutamide, fluvastatin, follitropin, formoterol, fosfomycin (fosfomicin), furosemide, fusidic acid, gallopamil, ganciclovir, gemfibrozil, gentamycin, Semen Ginkgo, Herba Hyperici perforati (SaintJohn'swort), glibenclamide, urea derivative as oral antidiabetic, glucagon, glycosamine and glucosamine derivatives, glutathion, glycerol and glycerol derivatives, hypothalamic hormone, goserelin, gyrase inhibitors, guanethidine, halofantrine, haloperidol, heparin and heparin derivatives, hyaluronic acid, hydralazine, hydrochlorothiazide and hydrochlorothiazide derivant, salicylic acid salt, hydroxyzine, idarubicin, ifosfamide, imipramine, indomethacin, indoramine, insulin, interferons, iodine and iodine derivant, isoconazole, isoproterenol, glucitol and glucitol derivant, itraconazole, ketoconazole, ketoprofen, ketotifen, lacidipine, lansoprazole, levodopa, levomethadone, thyroid hormones, thioctic acid and lipoic acid derivatives, lisinopril, lisuride, lofepramine, lomustine, loperamide, loratadine, maprotiline, mebendazole, mebeverine, meclizine, mefenamic acid, mefloquine, meloxicam, mepindolol (mcpindolol), meprobamate, meropenem, mesalazine (mesalazinc), mesuximide, Analgin (metamizole), metformin, methotrexate, methylphenidate, methylprednisolone, methixene, metoclopramide, metoprolol, metronidazole, mianserin, miconazole, minocycline, minoxidil, misoprostol, mitomycin, mizolastine (mizolastinc), moexipril, morphine and morphine derivatives, Radix Oenotherae erythrosepalae (eveningprimrose), nalbuphine, naloxone, tilidate, naproxen, narcotine, natamycin, neostigmine, nicergoline, nikethamide, nifedipine, niflumic acid, nimodipine, nimorazole, nimustine, nisoldipine, epinephrine and epinephrine derivant, norfloxacin, novaminesulfone, narcotine, nystatin, ofloxacin, olanzapine, olsalazine, omeprazole, omoconazole, ondansetron, oxaceprol, oxazacillin, oxiconazole, oxymetazoline, pantoprazole, acetaminophen, paroxetine, penciclovir, oral penicillin class, pentazocine, pentifylline, pentoxifylline, perphenazine, Pethidine, plant extract, phenazone, pheniramine, barbituric acid derivatives, Phenylbutazone, phenytoin, pimozide, pindolol, piperazine, piracetam, pirenzepine, piribedil, piroxicam, pramipexole, pravastatin, prazosin, procaine, promazine, propiverine, Propranolol, isopropylantipyrine, prostaglandins, prothionamide, proxyphylline, Quetiapine, quinapril, quinaprilat, ramipril, ranitidine, reproterol, reserpine, ribavirin, rifampicin, risperidone, ritonavir, ropinirole, roxatidine, Roxithromycin, ruscogenin (ruscogenin), rutin and rutin derivatives, sabadilla, albuterol, salmaterol, scopolamine, selegiline, Sertaconazole, Sertindole, sertralion, silicates, sldenafil, simvastatin, sitosterol, sotalol, spaglumic Acid, Sparfloxacin, spectinomycin, spiramycin, spirapril, spironolactone, stavudine, streptomycin, sucralfate, sufentanil, sulbactam, sulfonamides, sulfasalazine, sulpiride, sultamicillin, sultiame (sultiam), sumatriptan, succinylcholine chloride, tacrine, tacrolimus, talinolol (taliolol), tamoxifen, taurolidine, tazarotene, temazepam, teniposide, tenoxicam, terazosin, terbinafine, terbutaline, terfenadine, terlipressin, tertatolol, Tetracyclines (tctracyclins), teryzoline, theobromine, theophylline, butizine, thiamazole, phenothiazines, phosphinothioylidynetrisaziridine, tiagabine, tiapride, propanoic derivatives, ticlopidine, timolol, tinidazole, tioconazole, thioguanine, tioxolone, tiropramide, tizanidine, tolazoline (tolazolinc), tolbutamide, tolcapone, tolnaftate, tolperisone, topotecan, torasemide, antiestrogen, tramadol, tramazoline, trandolapril, tranylcypromine, trapidil, trazodone, triamcinolone and triamcinolone derivant, triamterene, trifluperidol, trifluridine, trimethoprim, trimeprimine, tripelennamine, triprolidine, trofosfamide (trifosfamide), tromantadine, trometamol, tropalpin, troxerutin (troxerutine), tulobuterol (tulobutcrol), tyramine, Tyrothricin, urapidil, ursodesoxycholic acid, chenodeoxycholic acid, valaciclovir, valproic acid, vancomycin, dimension storehouse oronain (vecuroniumchloride), viagra (Viagra), venlafaxine, verapamil, vidarabine, vigabatrin, viloxazine (viloazine), vinblastine, vincamine, vincristine, vindesine, vinorelbine (vinorclbinc), vinpocetine, viquidil, warfarin, xantinol nicotinate, xipamide, zafirlukast, zalcitabine, zidovudine, Zolmitriptan, zolpidem, zopiclone (zoplicone), zotepine (zotipine) etc.Referring to, for instance, U.S. Patent number 6,897,205,6,838,528 and 6,497,729.

Support usually can also be coated with the antibiosis of at least one type. Such as, support can be coated with the antibody or polymeric matrix that can catch circulating endothelial cells. U.S. Patent number 7,037,772 (referring further to, U.S. Patent Publication No. 20070213801,200701196422,20070191932,20070156232,20070141107,20070055367,20070042017,20060135476,20060121012).

The mould bases of the present invention can also be formed by metal such as Ni-Ti (Ni-Ti). The method of metal composites and this device of production is disclosed in U.S. Patent number 6,013,854. Superelastic metal for this device is preferably superelastic alloy. Superelastic alloy is commonly referred to as " marmem ", and after the degree being deformed into common metal generation permanent deformation, recovers its original-shape. The present invention can superelastic alloy include:WithSpring alloy (Alloy is purchased from CarpenterTechnologyCorporation (ReadingPa.);Alloy is purchased from MetalImphy (Imphy, France)), it is purchased from CarpenterTechnologycorporation and LatrobeSteelCompany (Latrobe, Pa.) 316 rustless steels and MP35N alloy, and it is purchased from the super-elasticity Nitinol Ni-Ti alloy of ShapeMemoryApplications (SantaClara, Calif.). U.S. Patent number 5,891,191.

The mould bases of the present invention can manufacture in several ways. This device can be formed pattern as herein described by pipe formed by removing the different piece of tube wall. Therefore the device obtained will be formed by monolithic continuous print material, eliminates the needs for being linked together by different segment. The material of tube wall can adopt various technology to remove, including laser (such as YAG laser), electric discharge, chemical etching, Metal Cutting, these technology combination, or other technology known. U.S. Patent number 5,879,381 and 6,117,165, it is incorporated in their entirety herein. Form support in this way and allow to produce substantially stressless structure. Specifically, length is adaptable to the length of the diseased part of the tube chamber of support to be placed. So can avoid using support separately to cover whole affected areas.

In another embodiment, the method manufacturing tubular bracket includes: prepare the poly-lactide mixture of raceme; Manufacture the biodegradable polymer pipe of the poly-lactide mixture of raceme; This pipe of cut is until forming this mould bases. In this embodiment, the manufacture of mould bases can adopt substantially solvent-free molding technology or extrusion technique to carry out.

Can also with reference to U.S. Patent number 7,329,277,7,169,175,7,846,197,7,846,361,7,833,260,6,0254,688,6,254,631,6,132,461,6,821,292,6,245,103 and 7,279,005, these patents are wholly incorporated into this document with it. It addition, U.S. Patent Application No. 11/781,230,12/507,663,12/508,442,12/986,862,11/781,233,12/434,596,11/875,887,12/464,042,12/576,965,12/578,432,11/875,892,11/781,229,11/781,353,11/781,232,11/781,234,12/603,279,12/779,767 and 11/454,968, and U.S. Patent Publication No. 2001/0029397 is also wholly incorporated into this document with it.

The restriction of the content that the scope of the present invention is not shown and described specifically above. It will be appreciated by those skilled in the art that the example for described material, profile, structure and size has applicable replacement scheme. Quote in describing the invention and discuss many lists of references, including patent and various publication. Quoting and discussing of this type of list of references is intended for illustrating description of the invention and it is not an admission that any list of references is the prior art of invention as herein described. The all lists of references quoted in this specification and discuss are incorporated in their entirety herein. Those of ordinary skill in the art will recognize that the change of the techniques described herein scheme, amendment and other embodiments, without departing from the spirit and scope of the present invention. Although having shown that and describe certain embodiments of the present invention, but it will be clear to the person skilled in the art that can be changed and revise without departing from the spirit and scope of the present invention. The content illustrated in description above and accompanying drawing is intended for illustrating with and is not be as restriction.

Claims (36)

1., for implanting the mould bases in body cavity, described mould bases has compressive state and expansion state, and described mould bases includes:

Multiple ring week element, wherein each ring week element has a multiple wavy bending of peak and valley form alternately, the plurality of ring week element form the generally cylindrical shape with longitudinal axis,

Wherein said multiple ring week element include first ring week element, second ring week element and the 3rd ring week element, described first and second ring week element be longitudinally adjacent, described second and the 3rd ring week element be longitudinally adjacent, described first and second ring week element connected by multiple first connecting elements, described second and the 3rd ring week element connected by multiple second connecting elements, and

At least one of which ring week, element included at least one wavy bending including wavy pattern, and described wavy pattern includes the linear sections of at least six being serially connected; When described mould bases is in expansion state, each in the linear sections of described at least six not with the linear sections conllinear of adjacent connection.

2. mould bases as claimed in claim 1, wherein said wavy pattern includes 6 to 36 linear sections.

3. mould bases as claimed in claim 1, wherein when described mould bases is in expansion state, the linear sections that described at least six connects is similar to sine wave period.

4. mould bases as claimed in claim 1, wherein, the same length of each in the linear sections that described at least six connects.

5. mould bases as claimed in claim 1, at least one in wherein said ring week element includes multiple wavy bending, and each in the plurality of wavy bending includes wavy pattern.

6. mould bases as claimed in claim 1, each in wherein said multiple ring week element includes multiple wavy bending, each ring week element multiple wavy bending in each include wavy pattern.

7. mould bases as claimed in claim 1, each in wherein said multiple ring week element includes 6 to 12 wavy bendings.

8. mould bases as claimed in claim 1, wherein along one ring week element some place at least one recess is set, intersect with described ring week element in described some place the first or second connecting element.

9. mould bases as claimed in claim 1, wherein said mould bases includes the polymeric material of biological absorbable.

10. mould bases as claimed in claim 1, wherein said mould bases includes bioerodable metal.

11. mould bases as claimed in claim 1, plurality of first connecting element includes at least two connecting element.

12. mould bases as claimed in claim 11, plurality of first connecting element includes three connecting elements.

13. mould bases as claimed in claim 1, each in wherein said first connecting element is linear.

14. mould bases as claimed in claim 1, each in wherein said first connecting element is curved.

15. mould bases as claimed in claim 14, each in wherein said first connecting element includes the sections of S shape.

16. mould bases as claimed in claim 1, at least one in wherein said first connecting element includes labelling point.

17. mould bases as claimed in claim 1, wherein said first ring week element peak and valley with described second ring week element peak and valley be substantially homophase, and each in wherein said first connecting element by described first ring week element paddy with described second ring week element peak be connected, adjacent with described peak described second ring week element paddy with first ring week element paddy longitudinally-aligned.

18. mould bases as claimed in claim 17, wherein said second ring week element peak and valley with described 3rd ring week element peak and valley be substantially homophase, and each in wherein said second connecting element be connected in side described second ring week element peak, described second ring week element peak by the first connecting element be connected to first ring week element; And opposite side be connected to described 3rd ring week element paddy, with described 3rd ring week element paddy adjacent described 3rd ring week element peak with described second ring week element peak longitudinally-aligned.

19. mould bases as claimed in claim 18, each in wherein said first connecting element includes the sections of S shape, and each in wherein said second connecting element is linear.

20. mould bases as claimed in claim 18, each in wherein said first connecting element extends generally along identical ring circumferential direction with each in described second connecting element.

21. mould bases as claimed in claim 17, wherein said second ring week element peak and valley with described 3rd ring week element peak and valley be substantially homophase, and each in wherein said second connecting element be connected in side described second ring week element paddy, described second ring week element paddy adjacent with the peak of the first ring week element connection by the first connecting element with described second ring week element; And opposite side be connected to described 3rd ring week element peak, with described 3rd ring week element peak adjacent described 3rd ring week element paddy with described second ring week element paddy longitudinally-aligned, and each in wherein said first connecting element is not longitudinally-aligned with any one in described second connecting element.

22. mould bases as claimed in claim 21, each in wherein said first connecting element includes S shape or Z-shaped sections, and each in wherein said second connecting element includes S shape or Z-shaped sections.

23. mould bases as claimed in claim 1, wherein said first ring week element peak and valley with described second ring week element peak and valley be substantially homophase, and each in wherein said first connecting element by described first ring week element peak and described second ring week element peak connect, wherein said second ring week element peak with described first ring week element peak longitudinally-aligned.

24. mould bases as claimed in claim 23, wherein said second ring week element peak and valley with described 3rd ring week element peak and valley be substantially homophase, and each in wherein said second connecting element be connected in side described second ring week element paddy, described second ring week element paddy with by described first connecting element connect peak adjacent; And opposite side be connected to described 3rd ring week element paddy, described 3rd ring week element paddy with described second ring week element paddy longitudinally-aligned.

25. mould bases as claimed in claim 24, each in wherein said first connecting element is linear, and each in described second connecting element is linear.

26. mould bases as claimed in claim 23, wherein said second ring week element peak and valley with described 3rd ring week element peak and valley be substantially homophase, and each in wherein said second connecting element be connected in side described second ring week element peak, described second ring week element peak with described second ring week element with described first connecting element connect peak adjacent; And opposite side be connected to described 3rd ring week element peak, described 3rd ring week element peak with described second ring week element peak longitudinally-aligned.

27. mould bases as claimed in claim 26, each in wherein said first connecting element is linear, and each in described second connecting element is linear.

28. mould bases as claimed in claim 1, wherein said first ring week element peak and valley with described second ring week element peak and valley be substantially homophase, and each in wherein said first connecting element by described first ring week element peak and described second ring week element paddy connect, adjacent with described paddy described second ring week element peak with described first ring week element peak longitudinally-aligned.

29. mould bases as claimed in claim 28, wherein said second ring week element peak and valley with described 3rd ring week element peak and valley be substantially homophase, and each in wherein said second connecting element be connected in side described second ring week element peak, described second ring week element peak and second ring week element by the first connecting element with described first ring week element connection paddy adjacent; And opposite side be connected to described 3rd ring week element paddy, with described 3rd ring week element paddy adjacent described 3rd ring week element peak with described second ring week element peak longitudinally-aligned, and each in wherein said first connecting element is not longitudinally-aligned with any one in described second connecting element.

30. mould bases as claimed in claim 29, each in wherein said first connecting element extends generally along identical ring circumferential direction with each in described second connecting element.

31. mould bases as claimed in claim 1, wherein said multiple first connecting elements described first ring week element every a peaks or valleys place connect described first ring week element and described second ring week element.

32. mould bases as claimed in claim 1, wherein when described mould bases is expanded, described mould bases includes at least one continuous print helical pattern, at least one continuous print helical pattern described include at least one first connecting element and at least one second connecting element, at least one first connecting element described and at least one second connecting element described all identical peaks or valleys place with described second ring week element be connected.

33. mould bases as claimed in claim 1, wherein said mould bases is expansion, described mould bases includes at least one continuous print helical pattern, at least one continuous print helical pattern described includes at least one first connecting element and at least one second connecting element, at least one first connecting element wherein said first link position place connect described second ring week element, at least one second connecting element described be different from the second link position place of described first link position with described second ring week element be connected, described continuous print helical pattern be additionally included between described first link position and described second link position described second ring week element a part.

34. for implanting the mould bases in body cavity, described mould bases has compressive state and expansion state, and described mould bases includes:

Multiple ring week element, wherein each ring week element has a multiple wavy bending of peak and valley form alternately, the plurality of ring week element form the generally cylindrical shape with longitudinal axis, the longitudinally adjacent ring week element of each two is connected by multiple connecting elements; With

At least one labelling point, it has cup-like structure, and described cup-like structure has oral area and bottom.

35. mould bases as claimed in claim 34, at least one labelling point wherein said is additionally included in the hole at described bottom place.

36. for implanting the mould bases in body cavity, described mould bases has compressive state and expansion state, and described mould bases includes:

Multiple ring week element, wherein each ring week element has a multiple wavy bending of peak and valley form alternately, the plurality of ring week element form the generally cylindrical shape with longitudinal axis, the longitudinally adjacent ring week element of each two is connected by multiple connecting elements;

At least one in wherein said ring week element includes recess in connecting element and the position intersected of described ring week element.